Bovine Spongiform Encephalopathy Import Policy for Bovine Animals and Their Products and By-Products

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TAHD-DSAT-IE-2005-9-7

Amendments: updated lists of countries of negligible and controlled risks

Table of Contents

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.

Overview

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.

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 is that Canada cannot impose more rigid requirements on its trading partners than it applies domestically for diseases that are present in Canada. Another important obligation and right relates to the concept of equivalence of veterinary infrastructure from one competent veterinary authority to another; another factor relates to equivalence of mitigating measures, which is the capability of different sanitary measures to achieve the same outcome. Provided these proposed mitigating measures achieve the same level of protection as those required by Canada, following an objective scientific evaluation, the Government of Canada will accept those measures of the trading partner as equivalent.

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 Foot & Mouth Disease (FMD), Tubercullosis (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. 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 the Meat Inspection Regulations, the Feeds Act and the 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 N, Chapter 4, under the authority of the Meat Inspection Regulations.

The Canada Border Services Agency (CBSA) 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.

Definitions of BSE Import Policy Terms

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 strategyFootnote 1.

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 and Bison, which includes cattle (Bos taurus [Aurochs, both feral and reared domesticated cattle] and Bos taurus indicus [Brahma cattle, Indian humped cattle, zebu, zebu cattle]) and all bison (Bison bison)Footnote 2.

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.

List of Countries by BSE Designation

The OIE classifies countries for BSE risk into three categories: 1) negligible risk; 2) controlled risk; and 3) undetermined risk.

The following countries are recognized by CFIA as having a negligible BSE risk in accordance with Chapter 11.4 of the Terrestrial Animal Health Code of the OIE:

Negligible BSE risk countries with no BSE cases reported:

  • Argentina
  • Australia
  • Chile
  • China (Peoples' republic of)Footnote 3
  • Colombia
  • Costa Rica
  • Croatia
  • Cyprus
  • Hungary
  • Iceland
  • India
  • Latvia
  • Lithuania
  • Mexico
  • Namibia
  • New Zealand
  • Norway
  • Panama
  • Paraguay
  • Republic of Korea (South)
  • Republic of Malta
  • Singapore
  • Uruguay

Negligible BSE risk countries with Atypical BSE cases only:

  • Brazil
  • Romania
  • United States of America

Negligible BSE risk countries with Classical BSE cases:

  • Austria
  • Bulgaria
  • Czech Republic
  • Belgium
  • Denmark
  • Estonia
  • Finland
  • Germany
  • Israel
  • Italy
  • Japan
  • Liechtenstein
  • Luxembourg
  • Netherlands
  • Peru
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom (Northern Ireland and Scotland only)

The following countries are recognized by CFIA as having a controlled BSE risk in accordance with Chapter 11.4 of the Terrestrial Animal Health Code, equivalent to Canada's status (as recognized by the OIE):

Controlled BSE risk countries with no BSE cases reported:

  • Chinese Taipei
  • Nicaragua

Controlled BSE risk countries with Atypical BSE cases only:

None at this time

Controlled BSE risk countries with Classical BSE cases:

  • France
  • Greece
  • Ireland
  • United Kingdom (England and Wales only)

Canada's determination of the date the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants was effectively enforcedFootnote 4, by country:

Note the term "effectively enforced" as used by the OIE, for negligible risk, and controlled risk countries speaks of audit and control mechanisms. The various sections of the OIE Terrestrial Animal Health code state "… demonstrated through an appropriate level of control and audit, including that of cross contamination, that for at least eight years neither meat-and-bone meal nor greaves derived from ruminants has been fed to ruminants….Footnote 5"

CFIA interprets effective enforcement as a country's competent regulatory authority's oversight of a feed ban program. The OIE Ad Hoc Committee's reports to the General session specifically uses the language that "…the appropriate legislation, control and audit of the proper implementation of the feed ban had been in force for at least eight years…" for all 12 member countries which the OIE ad hoc group recommends for BSE categorization in Annex 9 of the Report of the Meeting of the OIE Ad Hoc Group on Bovine Spongiform Encephalopathy Risk Status Evaluation of Member Countries, Paris, 12–14 November 2013.Footnote 6

Enforcement is defined by CFIA as the use of administrative tools as well as inspection powers granted under legislation to determine and compel compliance with the applicable laws. CFIA considers enforcement officials to include inspectors, veterinary inspectors, investigation specialists and officials of government agencies or departments who are designated to enforce legislation.Footnote 7

NOTE: - Certification statements regarding date of effective enforcement of the ban on the feeding of ruminants with meat-and-bone meal and greaves derived from ruminants do not necessarily apply to all commodities. Importers are advised to reference commodity specific certification requirements within this policy, the hyperlinked Terrestrial Animal Import Policies, as well as the Automated Import Reference System (AIRS) for commodity-specific instructions or to contact the CFIA local office (by province) for further information

January 1st 1996: Argentina, Iceland, Singapore, and Uruguay
January 1st 1998: Australia, Chile, New Zealand, and Paraguay
January 1st 1999: Brazil, Switzerland, Taipei China (a.k.a. Chinese Taipei and Taiwan), United States of America
January 1st 2000: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lichtenstein, Lithuania, Luxembourg, Malta, Mexico,Netherlands, Norway, Portugal, Slovakia, Slovenia, and Sweden, Poland, Spain, and United Kingdom
January 1st 2001: Colombia and Japan
January 1st 2002: India, Korea (Republic of), Panama and Peru
January 1st 2005: Bulgaria, Costa Rica, Israel
January 1st 2006: China (People's Republic of) excludes Hong Kong & Macao and Romania

BSE-Specific Import Conditions For Commodities Of Bovine Origin

An important tool for importers is the commodity specific Terrestrial Animal Import Policies as well as the Automated Import Reference System 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 1) through 8) are to address potential cross-contamination with the bovine tissues listed belowFootnote 8 (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.

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.

1. Milk, Milk Products and Colostrum

No BSE-related conditions.

2. Semen and In Vivo Derived Bovine Embryos Collected and Handled in Accordance with the Recommendations of the International Embryo Transfer Society

No BSE-related conditions.

3. Hides and Skins for Any End Use

see policy on TAHD-DSAT-IE-2001-1-2 Importation of Integumentary Tissue for both the BSE and non-BSE requirements.

Countries of negligible BSE risk

No BSE-related conditions.

4. Gelatin and Collagen Prepared Exclusively from Hides and Skins

See the Highly Processed Products directive AHPD-IE-2001-8-3 for both the BSE and non-BSE requirements.

5. Tallow with a Maximum Level of Insoluble Impurities of 0.15 Percent in Weight and Derivatives Made From This Tallow

See the Rendered and Raw Inedible Products directive AHPD-DSAE-IE-2002-10-4 for both the BSE and non- BSE requirements.

6. Dicalcium Phosphate (with no trace of protein or fat)

See the Highly Processed Products directive AHPD-IE-2001-8-3 for both the BSE and non-BSE requirements.

7. Meat and Meat By-Products

7.1. Deboned skeletal muscle meat, excluding mechanically recovered meat

All Countries: Certification by the veterinary administration that:

the deboned skeletal muscle meat (excluding mechanically separated meat) 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 which passed ante-mortem and post-mortem inspections and which has been prepared in a manner to avoid contamination with tissues listed in Article 11.4.14 of the OIE Terrestrial Animal Health Code 2013

7.2. 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 11.4.3 of the OIE Terrestrial Animal Health Code 2013 and:

a) the bovine animals from which the meat and meat products were derived were subjected to and passed ante-mortem and post-mortem inspections, the meat and meat products were deemed fit for human consumption in the country of origin, and the facility in which the animals were slaughtered and processed was approved by the CFIA;

And

b) Where indigenous cases of BSE have occurred, the meat and meat products 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 risk

Certification by the veterinary administration that the country complies with conditions in Article 11.4.4 of the OIE Terrestrial Animal Health Code 2013 and:

a) the bovine animals from which the meat and meat products were derived were subjected to and passed ante-mortem and post-mortem inspections, the meat and meat products were deemed fit for human consumption in the country of origin, and the facility in which the animals were slaughtered and processed was approved by the CFIA;

And

b) the bovine animals from which the meat and meat products were derived were subjected to a BSE slaughter process, which is any process for slaughtering an animal other than a process in which the animal is subjected, before slaughtering, to: (i) a stunning process in which a device is used to inject compressed air or gas into the animal's cranial cavity; or (ii) 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;

And

c) the meat and meat products do not contain mechanically recovered meat from the skull and vertebral column of bovine animals aged 30 months or older;

And

d) the meat and meat products do not contain, were not prepared from or were not contaminated with: (i) distal ileum of all ages of bovine animals, and (ii) 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 bovine animals aged 30 months or older.

Countries of undetermined BSE risk

Certification by the veterinary administration that:

a) the bovine animals from which the meat and meat products were derived were subjected to and passed ante-mortem and post-mortem inspections, the meat and meat products were deemed fit for human consumption in the country of origin, and the facility in which the animals were slaughtered and processed was approved by the CFIA;

And

b) the bovine animals, from which the meat and meat products were derived, were subjected to a BSE slaughter process, which is any process for slaughtering an animal other than a process in which the animal is subjected, before slaughtering, to (i) a stunning process in which a device is used to inject compressed air or gas into the animal's cranial cavity; or (ii) 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;

And

c) Any visible nervous and lymphatic tissues exposed during deboning were removed;

And

d) the meat and meat products do not contain mechanically recovered meat from the skull and vertebral column of bovine animals aged 12 months or older;

And

e) the meat and meat products do not contain, were not prepared from or were not contaminated with (i) distal ileum of all ages of bovine animals, and (ii) 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 bovine animals aged 12 months or older.

8. Blood and Blood By-Products for Inedible Uses

See the Rendered Products and Raw Inedible Products import directive AHPD-DSAE-IE-2002-10 for both BSE and non-BSE requirements.

9. 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 11.4.3 of the OIE Terrestrial Animal Health Code 2014 and:

a) the bovine animals from which the blood and blood by-products were derived were subjected to and passed ante-mortem and post-mortem inspections, the blood was deemed fit for human consumption in the country of origin, and the facility in which the animals were slaughtered and processed was approved by the CFIA;

And

b) the bovine animals, from which the blood and blood by-products were derived, were subjected to a BSE slaughter process, which is any process for slaughtering an animal other than a process in which the animal is subjected, before slaughtering, to (i) a stunning process in which a device is used to inject compressed air or gas into the animal's cranial cavity; or 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;

And

c) the blood was collected from bovine animals by a closed blood collection method such as using a hollow knife or cannula.

Countries of controlled BSE risk and Countries of undetermined BSE risk

Certification by the veterinary administration that the country complies with conditions in Article 11.4.4 of the OIE Terrestrial Animal Health Code 2014 (for controlled risk) and Article 11.4.5 of the OIE Terrestrial Animal Health Code 2014 (for a country of undetermined risk):

a) the bovine animals from which the blood and blood by-products were derived were subjected to and passed ante-mortem and post-mortem inspections, the blood was deemed fit for human consumption in the country of origin, and the facility in which the animals were slaughtered and processed was approved by the CFIA;

And

b) the bovine animals, from which the blood and blood by-products were derived, were subjected to a BSE slaughter process, which is any process for slaughtering an animal other than a process in which the animal is subjected, before slaughtering, to (i) a stunning process in which a device is used to inject compressed air or gas into the animal's cranial cavity; or 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;

And

c) The blood was collected from bovine animals by a closed blood collection method such as using a hollow knife or cannula.

10. 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 11.4.3 of the OIE Terrestrial Animal Health Code or Article 11.4.4 of the OIE Terrestrial Animal Health Code, as applicable, and where there has been an indigenous case:

a) the animals are identified by a permanent identification system enabling them to be traced back to demonstrate that the animals were not classified as exposed cattle nor under any restriction for movement, slaughter or destruction control, as described in the OIE Terrestrial Animal Health Code Chapter 11.4 on BSE;

And

b) The bovine animals were born after the date, as determined by CFIA, 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 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 policy TAHD-DSAT-IE-2003-3 Development of New Import Protocols - Procedures for Clients

11. 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 11.4.3 of the OIE Terrestrial Animal Health Code 2014; 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 policy TAHD-DSAT-IE-2003-3-8 Development of New Import Protocols - Procedures for Clients

12. Gelatin and Collagen Prepared from Bones

See the Highly Processed Products directive AHPD-IE-2001-8 for both the BSE and non-BSE requirements.

13. Tallow with Greater than 0.15 Percent Insoluble Impurities in Weight and Tallow Derivatives Made from Such Tallow

See the Rendered Products and Inedible Products import directive AHPD-DSAE-IE-2002-10-4 for both BSE and non-BSE requirements.

14. Dicalcium Phosphate Containing Protein or Fat

See the Highly Processed Products directive AHPD-IE-2001-8 for both the BSE and non-BSE requirements.

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.

15. Products Produced by Subjecting Bones to Rigorous Processes of Extraction and Purification such as Ossein, Bone Ash, Bone Charcoal and Bone Oil

See the Highly Processed Products directive AHPD-IE-2001-8 for both the BSE and non-BSE requirements.

16. Products and By-Products Produced by Rigorous Processes of Extraction and Purification Such as Animal Glue, Oleosterin, Triglycerides, Glycerol, and Sorbitan Esters

See the Highly Processed Products directive AHPD-IE-2001-8 for both the BSE and non-BSE requirements.

17. 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

Refer to the Animal Health Import Requirements, Pet Food, AHPD-DSAE-IE-2001-9.

For specific details regarding importation of ingredients for the manufacture of the pet food, please refer to the Rendered Products and Raw Inedible Products import directive AHPD-DSAE-IE-2002-10 for both BSE and non-BSE requirements.

18. Dried Processed Rawhide, Cattle Ears, Bull Pizzles, Cow Hooves or Tendons as Pet Chews

Refer to the Animal Health Import Requirements, Pet Food, AHPD-DSAE-IE-2001-9.

19. 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 11.4.3 of the OIE Terrestrial Animal Health Code or Article 11.4.4 of the OIE Terrestrial Animal Health Code, 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 policy TAHD-DSAT-IE-2003-3 Development of New Import Protocols - Procedures for Clients

20. 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.

Note: Importers are advised to reference commodity specific Terrestrial Animal Import Policies, as well as the Automated Import Reference System 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.

Date modified: