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RG-1 Regulatory Guidance:
Chapter 5 - Research with Livestock Feeds

Section 1: Introduction

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Livestock feeds and feed ingredients manufactured, sold or imported into Canada are subject to the Feeds Act and Regulations as administered by the Canadian Food Inspection Agency (CFIA). The submission of an application to the CFIA for feeds that are to be used in research trials in Canada may be required before the research trial begins for either a research exemption or research authorization, depending on the feed category.

The objective of this chapter is to clarify the regulatory requirements for the use of livestock feeds in research trials conducted in Canada and to provide guidance to applicants in order to:

For general information on the regulation of feed in Canada, the legal authorities, more complete definitions for feed and livestock, and feed types, please see the RG-1 Introduction – Regulation of Livestock Feed in Canada.

When an application is required, an approval/authorization from the AFD must be granted prior to beginning the research trial; and in the case of imported feed, prior to importation. The applicant must be a Canadian individual or company.

It is recommended that the research facility always consider the time necessary to obtain the appropriate approvals and authorizations well in advance of their intended trial start dates. This is especially important for research where a safety assessment is required.

Please note that the Agency has been experiencing an increasing volume of questions on research requirements for substances that are not considered "feed" as defined in the Feeds Act and Regulations. Substances fed to livestock species may fall under the jurisdiction of other legislation, as for example, therapeutic products, veterinary biologics, and pest control products. In particular, the guidance document on classification of veterinary drugs and livestock feeds, on the Health Canada website could be helpful for classifying products that fall within that grey-zone interface between drugs and feeds. A classification request as per the instructions in the guidance document may be submitted prior to the submission of an application for research.

If questions remain following the review of this guidance, researchers may contact the Animal Feed Division (AFD) by email to obtain an opinion at afd_daa@inspection.gc.ca

Step 1: Determine the category of the feed: Feed (other than a Novel Feed) or Novel Feed

The first step is to determine whether the feed to be used in the research trial is a Feed (other than a Novel Feed) or a Novel Feed. The following key terms and definitions are important for understanding this guidance, and are triggers for determining the appropriate pathway for completing an application for research.

For purposes of this document, Feeds that are not Novel Feeds will be denoted as simply "Feed". When a reference applies to both Feeds and Novel Feeds, the term "Research Feed" will be used.

Feed

A feed that belongs to this category includes:

  • an unapproved feed ingredient, that is, not listed in Schedule IV or V
  • a feed ingredient listed in Schedule IV or V, but not meeting the purpose or description, including intended species, maximum inclusion rates, and standards as set out in the ingredient definition
  • an unregistered feed that is either a mixed feed or a Schedule IV or V, Part 2 ingredient

Examples of Feeds could include an unregistered premix, a chelated mineral, a new source of zeolite, or a previously unapproved vitamin which is chemically-synthesized.

Research with this category of feed may require the submission of an application for a Research Exemption or a Research Exemption with a Safety Assessment.

Novel Feed

The category of Novel Feed comprises all feed composed of, or derived from, an organism or organisms that is not listed in Schedule IV or V, or has a novel trait. Unregistered sources of ingredients listed in Part 2 of the Schedules that meet this definition continue to be considered Novel Feeds.

Examples of Novel Feeds could include:

  • Microbial sources: unregistered microbial strains, forage additives, fermentation products (such as enzymes, vitamins, biomass, etc.) from non-approved microorganisms, viable microbials and microorganisms with novel traits (bacteria, yeast and moulds), and products thereof
  • Plant sources: plants that exhibit novel traits, plants not previously authorized for use in livestock feed such as a new Brassica species and products thereof
  • Animal sources: products (milk, eggs, meat), by-products (such as meat and bone meal) of biotechnology-derived animals, insect larvae

Research with the category of Novel Feed requires the submission of an application for an Authorization of a Novel Feed for Research Purposes.

Step 2: Determine if an application is required

Determine if any of the exemption criteria outlined below is applicable.

Exemption criteria:

  • the research will be for feeding animal species, such as laboratory animals, companion animals, and livestock species not defined in the Feeds Regulations
  • the Research Feeds currently have valid registration numbers, including mixed feeds and registered sources of Part II ingredients, and they comply with current registration and labelling requirements. They must respect the purpose of the registration including the intended livestock species, and any specified maximum inclusion rates and standards
  • the research is for feed ingredients that are already approved and listed in Part I of Schedule IV or V of the Feeds Regulations, and meet the definition as described, including the purpose of the ingredient, the intended livestock species, and any specified maximum inclusion rates and standards
  • the Feed is not a Novel Feed, is manufactured in Canada, and safe disposal options are strictly met. Step 3 below discusses Safe Disposal

If any of the above conditions apply, a submission for a research exemption or a research authorization is not required. It is important to note, however, that other regulatory obligations and/or oversight from other programs in the CFIA or other government departments may still apply to your research trial.

Imported products, deemed to be exempt as above, are subject to import requirements from the CFIA or other jurisdictions. General information is outlined in the Automated Import Reference System (AIRs)

Step 3: Determine the fate of all research materials

The next step is to determine the degree of containment or confinement of all materials used in or generated from the research trial. The data requirements for an application will depend on whether or not safe disposal conditions are met, as defined below.

Safe disposal means that the feed, livestock, and all animal products or by-products from the research trial do not enter into the food chain, the feed chain, or the environment. Note that rendering is not considered a safe disposal option, as rendered products may reenter the food chain through their use as feed.

Any disposal into the environment must be in accordance with federal, provincial and municipal environmental regulations.

For an imported Research Feed, any remaining feed and animal products from animals fed that feed may need to be incinerated prior to disposal in a landfill facility. If they are not incinerated, the remaining feed and animal products may be composted only in a suitable landfill or waste disposal facility once the conditions have been authorized.

Once Steps 1 to 3 have been completed, proceed to the application steps outlined below.

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