Terrestrial Animal Health Import Requirements for Rendered and Inedible Products

TAHD-DSAT-IE-2002-10-7
July 22, 2011

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Amendments: Denmark and Panama added to the list of countries with negligible BSE risk. Clarification on when a Questionnaire is needed.

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Notes: This directive relates to Terrestrial Animal Health import requirements and does not remove any obligation to the Canadian importer to comply with the import requirements of other Canadian Food Inspection Agency (CFIA) programs and/or other departments, such as the Animal Feed Division, the Fertilizer section of the Plant Production Division, the Meat Program Division, or the Aquatic Animal Health Division.

Products for human consumption 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 Drug Regulations. Specific import conditions by commodity can be found in the Automated Import Reference System (AIRS).

Definition

Rendering plant: According to section 2.(1) of the Health of Animals Act, a rendering plant is defined as a place where animal by-products are prepared or treated for use in, or converted into, fertilizers, animal food, fats or oils, except those fats and oils used for human consumption. This includes any place where such products are stored, packed, marked, or from which they are shipped.

Examples of products from a rendering plant: meat meal, bone meal, meat and bone meal, liver meal, hoof and horn meal, feather meal, fish meal and derivatives, dried blood products, dried bone marrow, poultry digest, tallow (carboxylic esters), and fish oil¹.

Designated country or zone: means a country or zone determined by the CFIA to be free of reportable and immediately notifiable diseases that either affect or are transmitted by the species of origin of the animal, animal product, or by-product to be imported into Canada. Please note that the recognition of disease freedom by the CFIA is not solely dependent on World Organisation for Animal Health (OIE) status or country self-determination. The CFIA utilizes risk assessment methodology in order to determine if a hazard is present in a country and to evaluate the risk of transmission of that hazard resulting from the importation of animals, animal products, or by-products. Reportable and immediately notifiable diseases may be found at the following web links:

• Reportable Diseases and Immediately notifiable diseases

Please note that Canada accepts OIE classification for country bovine spongiform encephalopathy (BSE) risk categorization; therefore, the CFIA no longer routinely carries out independent assessment regarding a country's BSE categorization. Please refer to the World Organisation for Animal Health (OIE) website or the list included within this import directive for BSE categorization of countries.

Fish meal/oils: for the purposes of this directive, include meals/oils derived from all aquatic non-mammalian animals, including all species of fish and aquatic invertebrates (molluscs, crustaceans, etc.) or their body parts.

Hydrolysis: a reaction in which tallow is heated with water and either an acid or a base to produce carboxylic acids (also called fatty acids) and glycerol (an alcohol)².

Mammalian origin: within the context of this directive, includes any farmed animal species (e.g. ruminants [cattle, bison, goat, sheep], cervids, swine, equine, and their exotic relatives) that is not a reptile, avian, or fish.

Prohibited material: anything that is, or that contains any protein that originated from a mammal, other than:

1. a porcine or equine;
2. milk or products of milk;
3. gelatin derived exclusively from hides or skins or products of gelatin derived exclusively from hides or skins;
4. blood or products of blood; or
5. rendered fats, derived from ruminants, that contain no more than 0.15% insoluble impurities or their products³.

Ruminant: within this directive, means an animal of the subfamily bovinae and caprinae and includes cattle, buffalo, bison, sheep, goats, and their exotics' relatives.

Saponification: Process by which triglycerides are reacted with sodium or potassium hydroxide to produce glycerol and a fatty acid salt, called soap⁴.

Tallow: odourless, tasteless, waxy white fat consisting of suet (the hard fat about the kidneys and loins of cattle, sheep, and horses)⁵ or fats from other animals.

Transesterification: reaction of a triglyceride (fat/oil) with an alcohol to form esters and glycerol⁶.

Hydrolysis or transesterification at high temperature and pressure within this directive is defined as processing at not less than 133°C and 3-bar pressure, for not less than 20 minutes or, alternatively, for Saponification with 12 Molar NaOH at high temperature and pressure as processing at 140°C and 2-bar pressure for not less than 8 minutes.

Overview of Import Requirements for Rendered Products

Importation of rendered animal protein products from any species⁷ from any country that the CFIA does not recognize to be of negligible risk of BSE is prohibited, unless specific import conditions are described within this directive. The published import conditions can also be found in the Automated Import Reference System (AIRS). This prohibition on import of rendered animal protein applies to all end uses, including aquaculture and pet product manufacturing (food, treats, and chews, etc.). Import conditions for finished pet products can be found within the CFIA Import Procedures for Animals under Animals Products and By-Products.

An exemption from this prohibition may be considered on a case-by-case basis for certain rendered animal products that are not of ruminant origin. This exemption will only be granted after the successful completion of a risk assessment. Factors for consideration in the risk assessment include, but are not limited to, the zoosanitary status of the country of origin, prior assessment of the veterinary infrastructure, the nature of the product, the process and treatment applied to the product, the end use, and the potential for cross-contamination with ruminant material.

OIE recommendations for reducing the risk of BSE transmission for countries that trade in meals or greaves are that the raw material used to produce the meal has been:

1. reduced to a maximum particle size of 50 mm before heating; and
2. subsequently heated under saturated steam conditions to a temperature of not less than 133°C for a minimum of 20 minutes at an absolute pressure of 3-bar.

Negligible risk for BSE countries, but that are not designated free of other important ruminant diseases, must have certification, stating the ruminant meals or greaves exported to Canada meet the above treatment specifications.

Liquid products for retail sale (not for further processing), such as poultry digest or palatability enhancers, must be accompanied by a certificate of analysis, which is an original report issued by an independent (3^rd party) laboratory, stating that the product is free from micro-organisms of concern, along with all other documentation required (listed in Section I). The certificate of analysis, must accompany and be linked to the shipment(s). The specific conditions are to be determined prior to importation by Terrestrial Animal Health Division (TAHD) Headquarters. This requirement does not apply to fats and oils, such as fish oil or tallow. (See specific provisions for these products in Section II.)

When rendered products are included in prepared final products, such as pet food and fertilizers, importation of these finished commodities must be conducted in accordance with requirements of the respective directives for the finished product. Please refer to the appropriate directive, Import Policies and Directives.

Documentation

Import Permit

All products of a rendering plant require an Import Permit for entry into Canada under subsection 166(1) of the Health of Animals Regulations. Other documentation requirements are detailed by commodity within this or other directives, such as the BSE Import Policy. Importers are urged to verify the import conditions for their specific commodity, using AIRS.

The permit application process allows the CFIA to accurately classify imported material. The application provides the CFIA with the required information, including the presence of prohibited mammalian (i.e. ruminant) protein and the end use of the product. The finalized import conditions, listed in detail on the Import Permit, inform importers of their obligations associated with the classification of their imported product. The aim of the detailed listing of import conditions is to improve compliance with keeping prohibited material out of ruminant feeds. Importers must read and are legally required to comply with all of the conditions listed on their Import Permit.

Each shipment must be accompanied by a copy of the permit at the time of importation.

Facility Questionnaire

The Facility Questionnaire (Annex A) must accompany the application for Import Permit.

Certification

An official zoosanitary export certificate, issued by the official veterinary services of the country of origin, and/or a certificate of analysis, which is an original report issued by an independent (3^rd party) laboratory, (dependent on commodity type) must accompany each shipment of rendered product (except for fish oil) and must comply with the requirements in the Import Permit.

Statement from renderer

The Statement from the Renderer must include the name and address of the rendering plant that produced the product, the date (range) of production, the presence or absence of prohibited material, and state that the moisture content is lower than 12%.

Shipping invoice

The shipping invoice must state the name of the consignor and consignee, the product and its end use, and the country of origin.

If the product is made of, or contains, prohibited material, the Shipping Invoice must state the name of the consignor and consignee and that the product contains prohibited material. It must also include on the product label and shipping invoice the cautionary statement: "Feeding this product to cattle, sheep, deer or other ruminants is illegal and is subject to fines or other punishment under the Health of Animals Act."

Record-keeping requirements for rendered products (meals, greaves, fats, and oils)

Records of the name and address of any place to which the imported product is sold or distributed must be maintained for ten (10) years following importation. These records must be made available for inspection by the CFIA upon request, as required by subsections 166(1) and (2) of the Health of Animals Regulations.

"Every person who imports or has the possession, care or control of any product of a rendering plant shall keep a record of a) the name and address of the rendering plant and the date of production of the product; b) the name and address of the exporter; c) the name and quantity of, and any other information that is sufficient to identify, the product; d) the name and address of any person to whom any product is distributed or sold and the information referred to in paragraph c) with respect to that product; and e) whether or not the product is, or contains any, prohibited material."

List of Countries by BSE Designation

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:

1. Argentina
2. Australia
3. Chile
4. Denmark
5. Finland
6. Iceland
7. New Zealand
8. Norway
9. Panama
10. Paraguay
11. Singapore
12. Sweden
13. Uruguay

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:

1. Austria
2. Belgium
3. Brazil
4. Canada
5. Chinese Taipei
6. Colombia
7. Cyprus
8. Czech Republic
9. Estonia
10. France
11. Germany
12. Greece
13. Hungary
14. Ireland
15. Italy
16. Japan
17. Latvia
18. Liechtenstein
19. Lithuania
20. Luxembourg
21. Mexico
22. Netherlands
23. Poland
24. Portugal
25. Republic of Malta
26. Slovak Republic
27. Slovenia
28. Spain
29. Switzerland
30. United Kingdom
31. United States of America

General Requirements

In this directive, the requirements for the importation of rendered products are divided into three sections:

• Section I: deals with specific requirements for the import of meals and greaves.
• Section II: focuses on the specific requirements for the import of fats and oils.
• Section III: addresses the specific requirements for the import of raw inedible products (prior to being rendered).

Section I - Meals or Greaves 

Meals or greaves, (e.g., feather meal, meat meal, liquid poultry digest, etc.).

Note: there are specific requirements for fish meals, dried bovine blood, and blood products.

1. Product of terrestrial animal origin, not detailed elsewhere

1.1 Negligible risk for BSE and designated countries

a. Import Permit

Each shipment must be accompanied by a copy of the permit which must be presented at the first point of entry.

b. Official Zoosanitary Export Certificate of Origin

Each shipment must have an official zoosanitary export certificate clearly describing the product and specifying the country of origin.

1.2 From a country whose rendering inspection system is recognized as equivalent to Canada's and that is designated as free of diseases of concern and is of controlled risk for BSE (i.e. the U.S.)

a. Import Permit

Each shipment must be accompanied by a copy of the permit which must be presented at the first point of entry.

b. Official Zoosanitary Export Certificate

Each shipment must be accompanied by an ORIGINAL export certificate, endorsed by a full-time salaried veterinarian of the central competent veterinary authority. For the U.S., that is either the United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS), Animal and Plant Health Inspection Service (APHIS), the United States Food and Drug Administration (FDA), or the National Oceanic and Atmospheric Administration (NOAA)] certifying that:

1. the (indicate name of products) covered by this export certificate and Import Permit no. A (indicate Import Permit number) were only produced at (indicate name and address of the producer as identified in the Import Permit) and were only exported to Canada from (indicate name and address of the producer/exporter as identified in the Import Permit);
2. the producing/exporting facility(ies) DOES NOT receive, store, or process any ruminants⁸ and things derived from ruminants, and the product has been prepared, processed, stored, and otherwise handled in a manner to avoid contamination with any ruminant tissues or derived from ruminants; and
3. the raw materials used to produce the meal have been reduced to a maximum particle size of 50 mm before heating. Subsequently, the raw material has been heated under saturated steam conditions to a temperature of not less than 133°C for a minimum of 20 minutes at an absolute pressure of 3-bar, OR the rendered products have a moisture content of less than 12%. (It is a dry product.)

Note: Ruminants, along with the things derived from ruminants, of Canadian origin or from a negligible risk for BSE country are exempted and are permitted within the establishment. For further instructions, please refer to the nearest CFIA local animal health office (by province).

1.3 Liquid Products

Liquid products include such products as poultry digest or fish protein hydrolysate. However, the term does not apply to fats or oils. (Section III includes the specific import conditions for fats and oils.)

Note: The 12% moisture content attestation does not apply to liquid products. These products must be accompanied by an Import Permit and the official zoosanitary export certificate, along with the following documentation:

a. Importer's declaration (signed, dated, and linked to the shipment being imported), stating that the product is:

1. for further processing:

   The product is going for further processing in Canada (e.g. to a pet food or feed manufacturer), and the liquid rendered products imported will not be sold at the retail level without further processing to negate micro-organisms of concern; or

2. for retail sale:

   The product is going for retail sale in Canada, and the liquid rendered products imported have been processed in a manner to negate micro-organisms of concern and are accompanied by a certificate of analysis (an original report issued by an independent [3^rd party] laboratory) and linked to the shipment that states freedom from the micro-organisms of concern. The specific conditions are to be determined prior to importation by TAHD Headquarters. (Details will be listed on the Import Permit accompanying the shipment.)

b. Statement from the renderer

A statement from the renderer for non-prohibited material must accompany each shipment and must indicate the name and address of the rendering plant that produced the product, the date of production (range), and that the moisture content is lower than 12% for dry products, and that the plant does not handle prohibited material.

The imported product does not contain any PROHIBITED MATERIAL, as defined by section 162 of the Health of Animals Regulations. This product may be used in the manufacture of feed for ruminants.

1.4 From non-designated countries but recognized to be of negligible BSE risk by the CFIA

Please note that a permit to import may be issued only after successful completion of a risk assessment. Factors to be considered in the risk assessment include, but are not limited to, the zoosanitary status of the country of origin, prior assessment of the veterinary infrastructure, the nature of the product, the process and treatment applied to the product, the end use, and the potential for cross-contamination with the product of a lesser zoosanitary status.

a. Import Permit

Each shipment must be accompanied by a copy of the permit which must be presented at the first point of entry.

b. Official Zoosanitary Export Certificate

The certificate must be signed by an official full-time veterinarian of the competent authority stating that:

1. For meals or greaves that include prohibited (ruminant) material, the raw materials used to produce the meal have been reduced to a maximum particle size of 50 mm before heating. Subsequently, the raw material has been heated under saturated steam conditions to a temperature of not less than 133°C for a minimum of 20 minutes at an absolute pressure of 3-bar;
2. For meals or greaves that include only non-prohibited (non-ruminant) material, the raw materials used to produce the meal have been reduced to a maximum particle size of 50 mm before heating. Subsequently, the raw material has been heated under saturated steam conditions to a temperature of not less than 133°C for a minimum of 20 minutes at an absolute pressure of 3-bar.

The certificate must also attest that every precaution was taken during the handling, processing, packaging, and storage to prevent direct or indirect contact of the product with any animal product or by-product of a lesser zoosanitary status.

c. Statement from the renderer

A statement from the renderer for non-prohibited material must accompany each shipment and must indicate the name and address of the rendering plant that produced the product, the date of production (range), and that the moisture content is lower than 12% for dry products, and that the plant does not handle prohibited material. (For liquid products, see section 1.1.)

The imported product does or does not contain any PROHIBITED MATERIAL, as defined by section 162 of the Health of Animals Regulations.

1.5 Non-designated countries that are not negligible risk of BSE

• Terrestrial animal-derived protein is prohibited.

2. Fish meal

The following countries are currently approved to import fish meal into Canada.

All negligible risk for BSE countries:

1. Australia
2. Argentina
3. Chile
4. Denmark
5. Finland
6. Iceland
7. New Zealand
8. Norway
9. Panama
10. Paraguay
11. Singapore
12. Sweden
13. Uruguay

Non-negligible risk for BSE countries:

1. Mauritania
2. Mexico
3. Peru
4. United States of America

a. Import Permit

Each shipment must be accompanied by a copy of the permit which must be presented at the first point of entry.

b. Official Zoosanitary Export Certificate

Fish meal has been approved for import from all negligible risk for BSE countries, as well as for a small number of countries that are not negligible risk for BSE following a successful risk assessment. Please consult AIRS to verify the detailed certification requirements established by country for the countries listed above.

3. Dried bovine blood and blood meal products

3.1 Negligible risk for BSE and designated countries

a. Import Permit

Each shipment must be accompanied by a copy of the permit which must be presented at the first point of entry.

b. Official Zoosanitary Export Certificate of Origin

Each shipment must have an official zoosanitary export certificate clearly describing the product and specifying the country of origin.

3.2 From countries, including the U.S., assessed by the CFIA as free of all important ruminant diseases and of controlled or undetermined risk for BSE

Note that contamination (from cattle aged 30 months or older) of the blood via neural tissue leaking from the penetrative captive bolt stun hole would result in the blood being contaminated with specified risk material (SRM), and the subsequent material would be treated as SRM under Canadian regulations. This is the case whether the SRM contamination of bovine blood was incidental or otherwise.

a. Import Permit

Each shipment must be accompanied by a copy of the permit which must be presented at the first point of entry.

b. Official Zoosanitary Export Certificate

The Official Zoosanitary Export Certificate should be signed by an official full-time veterinarian of the competent authority, stating that the blood has been collected 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. In addition, the Certificate should state that the bovine animals were subjected to both ante-mortem and post-mortem inspection, and after collection via the method indicated below, no contamination of the blood or blood product occurred with the following tissues:

• 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, and palatine tonsils from all bovine animals aged 30 months or older; the distal ileum from bovine animals of all ages;
• and collected from / using one of the following methods:
  1. bovine animals that were killed using a non-penetrative method, in accordance with humane slaughter practices⁹,¹⁰; or
  2. bovine animals that are under 30 months of age, as determined by an age determination plan (Hazard Analysis Critical Control Point [HACCP] - type plan), approved by the Veterinary competent authority, with appropriate controls, monitoring, verification, and corrective measures in place, ensuring no incidental inclusion of animals of 30 months or older; or
  3. using a closed collection system in a manner that avoids contamination with the neural tissue leaking from the stun hole of animals aged 30 months or older, whether incidental or otherwise; or
  4. that trimming, washing, scraping and/or vacuuming the head hide to remove any grossly visible brain material has been carried out, and subsequent leakage of brain material from the stun hole is prevented via the application of edible grease to the stun hole area immediately after stunning; AND
  5. every precaution was taken to prevent direct or indirect contact during the slaughter, processing, and packaging of the blood / blood product with any animal product or by-product of a lesser zoosanitary status.

Alternative methods of prevention of cross-contamination of bovinae blood/blood products with SRM will be assessed by the CFIA's review of scientific risk assessments, submitted by the applicant/exporting country before a permit may be issued.

3.3 From countries not designated by the CFIA as free of all important ruminant diseases and which are of controlled or undetermined risk for BSE

Note that contamination (from cattle aged 30 months or older) of the blood via neural tissue leaking from the penetrative captive bolt stun hole would result in the blood being contaminated with SRM, and the subsequent material would be treated as SRM under Canadian regulations. This is the case whether the SRM contamination of bovine blood was incidental or otherwise.

a. Import Permit

Each shipment must be accompanied by a copy of the permit which must be presented at the first point of entry.

b. Official Zoosanitary Export Certificate

The Official Zoosanitary Export Certificate should be signed by an official full-time veterinarian of the competent authority, stating that the blood has been collected 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. In addition, the Certificate should state that the bovine animals were subject to both ante-mortem and post-mortem inspection and that, after collection via the method indicated below, no contamination of the blood or blood product occurred with the following tissues:

• 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, and palatine tonsils from all bovine animals aged 30 months or older; the distal ileum from bovine animals of all ages;
• and collected from/using one of the following methods:
  1. bovine animals that were killed using a non-penetrative method, in accordance with humane slaughter practices¹¹; or
  2. bovine animals that are under 30 months of age, as determined by an age determination plan (Hazard Analysis Critical Control Point [HACCP]-type plan), approved by the Veterinary competent authority, with appropriate controls, monitoring, verification, and corrective measures in place, ensuring no incidental inclusion of animals of 30 months or older; or
  3. using a closed collection system in a manner that avoids contamination with the neural tissue leaking from the stun hole of animals aged 30 months or older, whether incidental or otherwise; or
  4. that trimming, washing, scraping and/or vacuuming the head hide to remove any grossly visible brain material has been carried out, and subsequent leakage of brain material from the stun hole is prevented via the application of edible grease to the stun hole area immediately after stunning; AND
  5. the manufacturing method for the blood and blood products included heating to a minimum core temperature of 70°C for at least 30 minutes; AND
  6. Every precaution was taken to prevent direct or indirect contact during the slaughter, processing, and packaging of the blood/blood product with any animal product or by-product of a lesser zoosanitary status.

Alternative methods of prevention of cross-contamination of bovinae blood / blood products with SRM will be assessed by the CFIA's review of scientific risk assessments, submitted by the applicant/exporting country before a permit may be issued.

Section II - Rendered fats and oils

Requirements for fish oils, tallow or suet showing a maximum level of insoluble impurities of 0.15% in weight, and their derivatives, mixed oils, yellow grease, and used cooking oils (restaurant waste).

1. Fish oil from all countries and for all end uses, other than for human consumption

If fish oil is being imported for human consumption, see Fish and Seafood Division, Import Inspection Program, for import requirements.

Note: Each shipment of less than one (1) litre of fish oil, as defined within this directive, for scientific use (research or diagnostic uses) must be accompanied by the importer's declaration (signed and dated letter), stating that the fish oil is for in vitro laboratory use & will not be fed, in any form, to any animal; as well, it must state that the fish oil will not be used or incorporated into a fertilizer.

Import Permit

Subsection 166(1)  of the Health of Animals Regulations specifies that records must be kept for a minimum of 10 years. (See above Records section in Overview of import requirements for rendered products in the introduction to this directive).

1.1 Avian and mammalian fats and oils

Note: Fat and oil products for human consumption, not being rendered products, do not all require an import permit from all countries of origin. These products fall under the authority of both the Meat Inspection Act and Regulations, as well as pertinent sections of the Health of Animals Act and Regulations, and Food and Drugs Act and Regulations. Import conditions may vary based on assessments of these products and the equivalency of the country of origin. Importers are urged to verify import conditions by specific country of origin via the Meat Hygiene Manual of Procedures, Chapter 10, Annex A, or AIRS.

A non-bovine origin fat or oil that is produced on a fully dedicated line will be classified according to the category of species of origin, and must be accompanied by an official veterinary certificate to that effect, along with the other requirements listed in the pertinent section below (points 2, 3, and 4).

The fat/oil that is produced on a non-dedicated line will be considered a mixed bovinae fat/oil, due to the risk of cross-contamination with bovine fats/oils, and will have to meet either the certificate of analysis (an original report issued by an independent [3^rd party] laboratory) requirements for tallow with less than or equal to 0.15% insoluble impurities (points 2.1, 2.2, 2.3) or the zoosanitary export certificate requirements for tallow with greater than 0.15% insoluble impurities (point 2.3b).

Line dedication, or its absence, and the subsequent specific import conditions will be indicated on the Import Permit conditions which must accompany and be linked to the shipment.

2. Tallow with less than or equal to 0.15% insoluble impurities of bovine origin

2.1 Tallow with less than or equal to 0.15% insoluble impurities of bovine origin and mixed fats/oils of any origin (avian or mammalian) for all end uses, and yellow grease and post-consumer cooking oil for animal feed or further processing from any country.

Note: For bovine origin fats and oils to be used for human consumption, extra certification requirements are listed in 2.2, 2.3, and 2.4.

a. Import Permit

Note: that products for human consumption do not all require an import permit from all countries of origin. Verify import conditions by specific country of origin via the Meat Hygiene Manual of Procedures, Chapter 10, Annex A, or AIRS.

Each shipment must be accompanied by a copy of the permit (if required), and the import permit, when required, must be presented at the first point of entry.

b. Certificate of Analysis

The certificate of analysis, which is an original report issued by an independent [3^rd party] laboratory, showing a maximum level of insoluble impurities of 0.15% in weight, as established using the American Oil Chemists' Society (AOCS) method Ca 3a-46, must be tied directly to the shipment being imported. The testing methodology may be obtained by contacting:

AOCS
P.O. Box 17190
Urbana, IL 61802-6996 USA
general@aocs.org

c. An Importer's declaration (signed and dated), stating whether the product is intended for human consumption or inedible/industrial uses must be tied to the shipment for export.

2.2 Tallow with less than or equal to 0.15% insoluble impurities of bovine origin for human consumption from negligible risk of BSE country

a. Official Meat Inspection Certificate (OMIC) also known as Official Zoosanitary Export Certificate; and

b. Certificate of Analysis

The certificate of analysis, which is an original report issued by an independent [3^rd party] laboratory, showing a maximum level of insoluble impurities of 0.15% in weight, as established using the American Oil Chemists' Society (AOCS) method Ca 3a-46, must be tied directly to the shipment being imported. The testing methodology may be obtained by contacting:

AOCS
P.O. Box 17190
Urbana, IL 61802-6996 USA
general@aocs.org

Importers are reminded to verify that specific import conditions have been established by Meat Programs Division via either the Meat Hygiene Manual of Procedures, Chapter 10, Annex A by country of origin, or within AIRS.

2.3 Tallow with less than or equal to 0.15% insoluble impurities of bovine origin for human consumption from controlled risk of BSE country

a. Official Meat Inspection Certificate (OMIC) also known as Official Zoosanitary Export Certificate

The official veterinary certification must state that:

1. the tallow was derived from animals that were stunned using a BSE slaughter process and not subjected, prior to slaughter, to a stunning process with a device that injected compressed air or gas into the cranial cavity;
2. the product was not prepared from or was not contaminated with:
   • distal ileum of bovine animals of all ages; and
   • 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.

b. Certificate of Analysis

The certificate of analysis, which is an original report issued by an independent [3^rd party] laboratory, showing a maximum level of insoluble impurities of 0.15% in weight, as established using the American Oil Chemists' Society (AOCS) method Ca 3a-46, must be tied directly to the shipment being imported. The testing methodology may be obtained by contacting:

AOCS
P.O. Box 17190
Urbana, IL 61802-6996 USA
general@aocs.org

Importers are reminded to verify that specific import conditions have been established by Meat Programs Division via either the Meat Hygiene Manual of Procedures, Chapter 10, Annex A by country of origin, or within AIRS.

2.4 Tallow with less than or equal to 0.15% insoluble impurities of bovine origin for human consumption from undetermined risk of BSE country

a. Official Meat Inspection Certificate (OMIC) also known as Official Zoosanitary Export Certificate

The official veterinary certification must state that:

1. the tallow was derived from animals that were stunned using a BSE slaughter process and not subjected to air injection stunning and pithing; and
2. the product was not prepared from or was not contaminated with:
   • distal ileum of bovine animals of all ages; and
   • 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 12 months or older.

b. Certificate of Analysis

The certificate of analysis, which is an original report issued by an independent [3^rd party] laboratory, showing a maximum level of insoluble impurities of 0.15% in weight, as established using the American Oil Chemists' Society (AOCS) method Ca 3a-46, must be tied directly to the shipment being imported. The testing methodology may be obtained by contacting:

AOCS
P.O. Box 17190
Urbana, IL 61802-6996 USA
general@aocs.org

Importers are reminded to verify that specific import conditions have been established by Meat Programs Division via either the Meat Hygiene Manual of Procedures, Chapter 10, Annex A by country of origin, or within AIRS.

3. Suet (tallow with greater than 0.15% insoluble impurities) and its derivatives

Tallow with greater than 0.15% insoluble impurities derived from the carcasses of animals of the sub-family bovinae for any end use

3.1 From negligible risk of BSE countries

a. Import Permit

Each shipment must be accompanied by a copy of the permit which must be presented at the first point of entry.

b. Official Zoosanitary Export Certificate of Origin

The official zoosanitary export certificate should clearly describe the product and specify the country of origin.

3.2 From controlled risk of BSE countries

a. Import Permit

Each shipment must be accompanied by a copy of the permit which must be presented at the first point of entry.

b. Official Zoosanitary Export Certificate

The official veterinary certification must state that:

1. the product was derived from bovine animals which were not subjected, prior to slaughter, to a stunning process with a device that injected compressed air or gas into the cranial cavity, or to a pithing process, and which were subject to and passed ante-mortem and post-mortem inspection; and
2. the product was not prepared from or was not contaminated with
   • the distal ileum of all ages of bovine animals; and
   • 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.

3.3 Tallow with greater than 0.15% insoluble impurities from undetermined risk of BSE countries is restricted

3.4 Derivatives of tallow with greater than 0.15% insoluble impurities from undetermined risk of BSE countries

a. Import Permit

Each shipment must be accompanied by a copy of the permit which must be presented at the first point of entry.

b. Official Zoosanitary Export Certificate

The official veterinary certification must state that the product(s) was:

1. derived from bovine animals from a negligible BSE risk country;
2. derived from bovine animals from a controlled risk country, which meet all of the conditions listed in 3.2b; or
3. produced by hydrolysis, saponification, or transesterification, using high temperature and pressure, as defined in this directive. (See detailed attestation requirements in General Overview.)

4. Other Fats and Oils

4.1 From designated countries

To be considered as designated, the country of origin must be assessed by the CFIA as free of the following diseases of the species concerned:

Non-bovinae ruminant origin - from countries designated by the CFIA as free from foot-and-mouth disease (FMD) and recognized to be of negligible risk for BSE.

Swine origin - from countries designated by the CFIA as free from swine vesicular disease, African swine fever, classical swine fever, and FMD.

Poultry origin - from countries designated by the CFIA as free from Newcastle disease and highly pathogenic avian influenza (fowl plague).

a. Import Permit

Each shipment must be accompanied by a copy of the permit which must be presented at the first point of entry.

b. Official Zoosanitary Export Certificate of Origin

The official zoosanitary export certificate should clearly describe the product and specify the country of origin.

4.2 From non-designated countries

A permit to import may be issued only after successful completion of a risk assessment, considering the animal health status of the country, the nature of the product to be imported, the process and treatment applied to the product, the potential cross-contamination after processing, as well as the end uses of the product.

Section III - Raw Inedible Animal Products and By-Products

Note: raw inedible fish (non-mammalian, aquatic animal derived) product conditions are under review by the Aquatic Animal Health Division of the CFIA.

These products are also covered by the Meat Inspection Act, and Health of Animals Act, and related regulations. The importer of raw inedible animal products/by-products must refer to the Meat Programs Division, Import Program, Manual of Procedures, Chapter 10, Annex A for country specific requirements. For any additional requirements beyond those listed in this directive regarding importation of an aquaculture commodities, please refer to the National Aquatic Animal Health Program (NAAHP) website. The importer should also verify import conditions in AIRS.

1. From the U.S.

The CFIA requires an Official Meat Inspection Certificate (OMIC) (inedible). Please refer to the Meat Hygiene Manual of Procedures, Chapter 10, Annex A, United States.

2. From other designated countries

The following products are permitted with an OMIC (inedible):

1. Ruminant origin - from countries designated by the CFIA as free from FMD and recognized to be of negligible risk for BSE
2. Swine origin - from countries designated by the CFIA as free from swine vesicular disease, African swine fever, classical swine fever (hog cholera), and FMD
3. Poultry origin - from countries designated by the CFIA as free from Newcastle disease and highly pathogenic avian influenza (fowl plague)

The Terrestrial Animal Health Program requires that the official zoosanitary export certificate state that the animals from which the products are derived were raised and slaughtered in that country, and that the country is free of the above-mentioned diseases (as applies to the species of origin). (Please refer to the Meat Hygiene Manual of Procedures, Chapter 10, Annex A, which lists import conditions by country or to AIRS.

3. From non-designated countries

1. Ruminant raw inedible animal parts from countries not recognized to be of negligible BSE risk or free of FMD by the CFIA are prohibited.
2. Non-ruminant raw inedible animal parts

Case-by-case evaluation by TAHD Headquarters is required.  If permission is granted, the importation will require an Import Permit and an OMIC (inedible).

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Annex A - Facility Questionnaire

Importation of Non-Ruminant Rendered Products From Countries of Controlled Risk for BSE

A product of a rendering plant can only be imported into Canada under a permit issued under section 160 of the Health of Animals Regulations (See definition of Rendered in Import Directive # TAHD-DSAT-IE-2002-10-2).

Requests for approval for importation of rendered products from countries of controlled risk for BSE¹²(which are also free of other important terrestrial animal diseases and whose rendering inspection system has been assessed as equivalent to Canada's by the CFIA) require that the Canadian importer fill out an Import Permit application form and complete the questionnaire found below.

Currently, for terrestrial animal (mammal and avian) meals, only the United States (U.S.) has met the above requirements.

For fish meals (all aquatic non-mammalian animals, including invertebrates), the following countries have been approved for imports to Canada: Mauritania, Mexico, Peru, and the U.S. Countries classified as negligible risk for BSE are automatically approved for import of fish meals to Canada.

The exporting establishments of fish meal from all the above countries must complete the questionnaire, and have it endorsed by the central competent veterinary authority, in order to ensure that no prohibited material is mixed with the fish meal.

No questionnaire is required for the import of fish oils, as defined within this directive.

Once completed, the questionnaire below must be endorsed and certified, or signed, as the case may be, by all of the following authorities:

1. The management of the facility listed in question 1 below;
2. The applicant for the Import Permit must be a Canadian resident to acknowledge having read and being aware of the contents of the questionnaire; and
3. A full-time, salaried veterinarian of the federal government agency who is responsible for animal health in the country of origin (i.e. for the U.S., either from the United States Department of Agriculture [USDA] or from the United States Food and Drug Administration [US FDA] or by a full-time, salaried veterinarian of the National Oceanic and Atmospheric Administration [NOAA]).

Completed and endorsed questionnaires are valid for one year past the date of endorsement by the central competent veterinary authority (CCA). An importer may renew the validity period of the questionnaire for each subsequent year, provided there have been no changes within the establishment. This no-change status to the information within the original questionnaire is to be confirmed by having a dated, signed, stamped CCA letterhead letter tied to the original questionnaire, indicating that there have been no changes at the exporting establishment, and that this has been confirmed by the CCA.

1. Complete the name and the address of the facility where your product is processed, produced, packaged, stored, or otherwise handled.  (Note: a questionnaire must be completed for each facility.)

2. In the following area list (please number) all animal origin materials received, stored, processed, or otherwise handled in this facility; list the type of ingredients, species of origin, and country of origin. (If more space is needed, include an attachment.)

Type (e.g. meals, offals, meat, tallows, egg, milk, blood, gelatin)	Species of Origin	Country of Origin

These are provided as examples only, and your facility may have other animal origin materials. Please list all animal origin materials in your facility(ies).

3. List all products that will be exported to Canada and the individual ingredient list by product. (Attach list or label if necessary.)

Comments:

4. For dry rendered meals only
Is the moisture content of the rendered meals manufactured, stored, processed, or otherwise handled in this facility less than 12%?

Yes No
If no, indicate moisture content

5. Liquid products (e.g., poultry digest or fish protein hydrolysate)
Is the product for further processing in Canada?

Yes No

a. If no, please indicate the processing time and temperature, or pH or other processing that the product has undergone.

6. Fats and oils of animal origin (including yellow grease or used fats or oils from commercial enterprises)

a. Is the oil/fat a single species origin product?

Yes If Yes, which species?

No Describe:

b. For bovine origin oil/fat (sole source or mixed product - see section II - Rendered Fats and Oils within the Import Directive above).

Does the product contain less than 0.15% insoluble impurities?

Yes Attach a certificate of analysis¹³ from an independent third party

No

7. What is the name of the competent federal regulatory agency (e.g., for U.S. origin product USDA/APHIS/FSIS or FDA or NOAA), which oversees (inspects and approves) the production of your product and which has the authority to provide government certification for materials being exported to Canada?

Signature of Canadian importer

Title of Canadian importer

Date (yyyy/mm/dd)

Signature of facility official

Title of facility official

Date (yyyy/mm/dd)

Signature of Veterinary Inspector

 

OFFICIAL SEAL

Title of Veterinary Inspector

Name of Veterinary Inspector

Date (yyyy/mm/dd)

For FISH (AQUATIC ANIMAL) MEALS only.

The section below should only be completed for fish meal facilities if they were inspected by a non-veterinary inspector (e.g. U.S. NOAA). The questionnaire must be endorsed or counter-endorsed by an official full-time, salaried federal government veterinarian.

Signature of Inspector

 

OFFICIAL SEAL

Title of Veterinary Inspector

Name of Veterinary Inspector

Date (yyyy/mm/dd)

Signature of Official Government Veterinarian

 

OFFICIAL SEAL

Title of Official Government Veterinarian

Date (yyyy/mm/dd)

 

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1. Reference: sections 46(1), 166, and 170 the Health of Animals Regulations.

2. Hydrolysis. Encylopaedia Britannica Online. (Accessed October 22, 2008).

3. Health of Animals Regulations section 162. (1).

4. Saponification, (2009) In About.com: Chemistry. (Accessed, October 22, 2009).

5. Tallow. (2009). In Encyclopaedia Britannica Online. (Accessed, October 23, 2009).

6. Transesterification within the article on biodiesel (2009) of the website of Energy Systems Research Unit (ESRU) located within the Department of Mechanical Engineering at the University of Strathclyde in Glasgow. (Accessed, October 23, 2009).

7. This definition includes blood meal from all species, feather meal, and fish meal, as defined above.

8. Ruminant means an animal of the subfamily bovinae and caprinae and includes cattle, buffalo, bison, sheep, goats, and their exotics' relatives.

9. Animal Welfare in Slaughter Plants. (Accessed May 07, 2010).

10. The Jarvis electric stun box for humane cattle stunning (Accessed May 07, 2010).

11. Animal Welfare in Slaughter Plants (Accessed May 07, 2010).

12. OIE assessment of country classification for BSE risk.

13. using the American Oil Chemists' Society (AOCS) method Ca 3a-46, AOCS