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T-3-160 - (supplement 2) - Draft - Research with Feeds other than Novel Feeds: Research Exemptions

August 23, 2004

The object of this memorandum is to clarify the regulatory requirements for research with imported livestock feeds.  As per the Feeds Regulations, all feeds manufactured outside of Canada must be approved or registered by the CFIA.  However, feeds used for research purposes may be exempt from this requirement. Researchers and companies who intend to conduct research with feeds, other than novel feeds, must apply for a Research Exemption when such feeds are to be imported into Canada by a government, academic or private research establishment. Examples of imported feeds that require a research exemption include:

• Unapproved minerals, chemicals, chemically-synthesized ingredients;

• Mixed feeds that are not registered, even if the individual ingredients are approved or registered.

Research exemptions do not apply to the following:

• Feeds that are considered as novel feeds, as per the Feeds Regulations. Novel feeds include ingredients derived from an organism or organisms, or parts of products thereof, that have not been approved/authorized or registered by the Feed Section. Examples of novel feeds include forage additives, enzymes derived from novel organisms, plants with novel traits, and/or products and by-products of biotechnology-derived animals. Refer to T-3-160 Supplement 1 for more information on research requirements for novel feeds.

• Feeds that will be fed to non-livestock species and are, thus, not covered by the Feeds Act and Regulations.  Livestock species include horses, cattle, sheep, goats, swine, foxes, fish, mink, rabbits, and poultry (chicken, turkey, ducks and geese).   Individuals and companies who intend to import experimental material for research with non-livestock species may be subject to regulatory oversight by other governmental departments;

• Ingredients/products that may be considered as drugs or veterinary biologics as per their purpose as defined in the research protocol, product description, published literature or product label. Experimental research conducted with ingredients/products for purposes other than feed, e.g. for health-related claims, do not require an authorization from the Feed Section but may require permits or authorizations from other government departments. Research with a ingredient/product that has a drug-related claim may require an experimental studies certificate from the Veterinary Drugs Directorate, Health Canada while an ingredient/product with a veterinary biologic function may require a permit from the Veterinary Biologics Section of the Canadian Food Inspection Agency.  Where applicants are uncertain of the category of the ingredient/product, they are encouraged to consult first with the Veterinary Drugs Directorate or with the Veterinary Biologics Section. Appendix I of T-3-160 provides the definitions of a feed, a drug and a veterinary biologic.

  Veterinary Biologics Section Canadian Food Inspection Agency 2 Constellation Crescent Ottawa, Ontario K1A 0Y9 Telephone: 613-225-2342 Fax: 613-228-6612

  Veterinary Drugs Directorate Health Canada Holland Cross Complex Tower A, Ground Floor 11 Holland Avenue Ottawa, Ontario K1A 0K9 Telephone: 613-954-5687 Fax: 613-957-3861

Upon receipt of an application for an Authorization of Research with a Novel Feed for Research Purposes, the Feed Section will conduct a preliminary review of the novel feed and its intended purpose. Where the ingredient/product description, published literature or label claims indicate that the ingredient/product may be a drug or a veterinary biologic, the Feed Section will return the application.

Applications for Research Exemptions will be evaluated on a case-by-case basis, depending on the ingredients being fed, the safety of these ingredients to livestock, humans and the environment, and the intended fate of the research animals and products thereof. It is recommended that the research establishment consult with the Feed Section in advance of submitting an application for a Research Exemption. An application for a safety assessment may be required, in addition to the application for a research exemption, depending on the fate of the research material, including livestock, products thereof and any leftover feed:

1. Safe disposal of all research material (No entry into the food or feed chain):

   When the intent of the research establishment is to dispose of all livestock fed the unapproved feed, products thereof, and any unused feed in a safe manner, i.e. no entry into the food chain or the feed chain (including rendering), a safety assessment will not be conducted by the Feed Section and the research establishment is responsible for the safe disposal of all livestock, products thereof and leftover feed. The Feed Section will review an application for a research exemption in accordance with the service standard of 10 business days, conditional upon receipt of all required information. If the application is approved, the Canadian applicant will receive a letter of exemption allowing the importation of the feed, and this letter must accompany the shipment into Canada.

2. Entry of the research material into the food or feed chain:

   When the research establishment intends for the research livestock, products thereof, and any unused feed to enter into the food chain, feed chain or the environment, a safety assessment of the feed must be conducted and data demonstrating the safety of the feed to animals, humans and the environment must be submitted. In such a case, the researcher must apply for (1) a Research Exemption and (2) a safety assessment. The Feed Section will review such applications in accordance with the service standard of 90 business days, conditional on receipt of all required information.