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Bovine spongiform encephalopathy import policy for bovine animals and their products and by-products

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TAHD-DSAT-IE-2005-9-8

Amendments: This policy has been revised and replaces any previous versions.

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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.

World Trade Organization (WTO) 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 Canada-United States-Mexico Agreement (CUSMA). One important obligation is that Canada should not 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:

Additional import conditions are often necessary and can be found either in commodity-specific import directives/policies 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 Safe Food for Canadians Act and the Safe Food for Canadians Regulations, the Feeds Act and the Feeds Regulations and the Fertilizers Act and Fertilizers Regulations.

The import of edible meat and meat products is regulated under the Health of Animals Act and Health of Animals Regulations, and the Safe Food for Canadians 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 Food-specific requirements and guidance – Meat products and food animals, under the authority of the Safe Food for Canadians 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 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

Definitions of BSE import policy terms

BSE-specific overview

The BSE import policy for animals, animal products and 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 (WOAH; founded as Office International des Épizooties (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 which includes animals of the species Bos taurus or Bos indicus and any animal that is the result of a cross with a Bos taurus or Bos indicus animal; but does not include other ruminants with purebred status (for example, yak or bison registration). All cattle crosses, therefore, are subject to SRM guidelines and BSE policy.

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 WOAH 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 WOAH classifies countries for BSE risk into 3 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 WOAH:

  1. Negligible BSE risk countries with no BSE cases reported
    • Argentina
    • Australia
    • Bolivia
    • Chile
    • China (Peoples' republic of)Footnote 2
    • Colombia
    • Costa Rica
    • Croatia
    • Cyprus
    • Hungary
    • Iceland
    • India
    • Korea (Republic of, South)
    • Latvia
    • Lithuania
    • Malta
    • Mexico
    • Namibia
    • New Zealand
    • Nicaragua
    • Norway
    • Panama
    • Paraguay
    • Serbia (excluding Kosovo)
    • Singapore
    • Uruguay
  2. Negligible BSE risk countries with atypical BSE cases only
    • Brazil
    • Romania
    • United States of America
  3. Negligible BSE risk countries with Classical BSE cases
    • Austria
    • Belgium
    • Bulgaria
    • Czech Republic
    • Belgium
    • Denmark
    • Estonia
    • Finland
    • France
    • Germany
    • Ireland
    • Israel
    • Italy
    • Japan
    • Liechtenstein
    • Luxembourg
    • Netherlands
    • Peru
    • Poland
    • Portugal
    • Slovakia
    • Slovenia
    • Spain
    • Sweden
    • Switzerland
    • United Kingdom (Northern Ireland 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:

  1. Controlled BSE risk countries with no BSE cases reported
    • Chinese Taipei
    • Ecuador
  2. Controlled BSE risk countries with Atypical BSE cases only
    • None at this time
  3. Controlled BSE risk countries with Classical BSE cases:
    • Greece
    • United Kingdom (England, Scotland 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 3, by country

Note the term "effectively enforced" as used by the WOAH, for negligible risk and controlled risk countries, speaks of audit and control mechanisms.

CFIA interprets effective enforcement as a country's competent regulatory authority's oversight of a feed ban program.

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.

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 (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 are to address potential cross-contamination with the bovine tissues listed below,Footnote 4 defined as SRM. The WOAH 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 SRM 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. Animal Products and By-products containing bovine materials

For import conditions please refer to the Automated Import Reference System (AIRS).

For policy information please refer to the Terrestrial Animal Products and By-products: Import Policy Framework.

2. Semen and in vivo derived bovine embryos collected and handled in accordance with the recommendations of the International Embryo Transfer Society (IETS)

No BSE-related conditions.

3. Live animals

For import conditions, please refer to the Automated Import Reference System (AIRS).

For policy/directive information, please refer to the Import Policies for Live Animals page

Import conditions related to BSE are based on the WOAH guidelines as follow:

Countries of negligible BSE risk and countries of controlled BSE risk

Article 11.4.7 of the WOAH Terrestrial Animal Health Code

and

Article 11.4.8 of the WOAH Terrestrial Animal Health Code

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 Request to Import a New Commodity or Import from a New Country of Origin.

4. 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 WOAH Terrestrial Animal Health Code or Article 11.4.4 of the WOAH 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.

Note

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: