Novel Feeds from Microbial Sources

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What are microbial feeds?

Microbial products are routinely used in livestock feed and are composed of or derived from microorganisms (bacteria, yeast, moulds). They are classified into one of two categories:

  • Viable microorganisms: include silage inoculants which aid in the preservation of forages by fermentation, and direct-fed microbials (DFM) for improving animal production parameters. Silage inoculants and direct fed microbials may be composed of one or more strains of microorganisms. The safety and viability of each individual strain in a mixed product must be evaluated and each strain must be registered before a product can be evaluated and registered;
  • Non-viable microbial products: include biomass, metabolites of microbial fermentations such as amino acids, vitamins, enzymes, and by-products/residuals of fermentations processes undertaken for the manufacture of foods and beverages, such as spent grains and yeast biomass remaining after the manufacture of beer or ethanol.

All microbial feeds, whether composed of live microorganisms, fermentation products or residuals, must be evaluated and approved / registered prior to being used in livestock feeds. Approved ingredients are listed in Schedules IV or V of the Feeds Regulations. Ingredients listed in Part 1 of the Schedules do not require registration, while those listed in Part 2, such as viable microbial strains, must be registered by the Feed Section. Microbial products or ingredients may have specific data requirements necessary for supporting safety or efficacy claims (e.g., enzymes, amino acids, microbial strains).

Is it a feed, a drug or a veterinary biologic?

An important delineation for microbial products is the classification of a product as a feed, a drug or a veterinary biologic. These definitions are especially important for viable microorganisms. Where product literature or label claims, company advertising claims (on the internet or otherwise) or scientific literature indicate that the active ingredient may be a drug or a veterinary biologic, applicants are advised to consult with the appropriate government department, i.e. the Veterinary Drugs Directorate at Health Canada or the Veterinary Biologics Section of the CFIA. The permitted claims or label statements for viable microbial products for feed use are described in section 3.22 (Viable Microbial and Yeasts) of the Feed Registration Procedures and Labelling Standards and serve as a guide in deciding which regulatory agency should receive the submission.

What are novel microbial feeds

Novel microbial feeds are feeds composed of or derived from microorganisms that :

  • are not approved as livestock feed in Canada (not listed in Schedules IV or V of the Feeds Regulations) e.g. Bacillus coagulans
  • and/or contain a novel trait e.g. glucanase produced by a strain of Aspergillus oryzae developed by mutagenesis or by recombinant DNA (rDNA) techniques.

A novel trait is an intentional genetic modification that results in a feed that is not substantially equivalent in terms of use and safety to an approved feed ingredient derived from microbial sources set out in Schedules IV or V of the Feeds Regulations. For those novel feeds containing the novel trait, it is the presence of a novel trait in the microorganism that triggers regulatory oversight under the Feeds Regulations, not the method used to introduce the trait. Hence the microorganism rather than the process is subject to regulatory oversight. Genetic modification techniques used in strain development include mutagenesis, recombinant DNA techniques, cell fusion, etc.

Examples of regulatory decisions to determine novelty of microbial feed products/ingredients

Ingredient/Product Is it novel? Why?
Viable Bacillus coagulans Yes This species has not been approved for use as a feed ingredient in Canada
Bacillus coagulans fermentation extract dehydrated - does not contain viable cells Yes This species has not been approved as a source of feed ingredients in Canada
Viable Enterococcus faecium No Enterococcus faecium is approved as per Schedule IV part 2 of the Feeds Regulations.
Viable Enterococcus faecium, genetically modified by mutation Yes The strain has been genetically modified
Lysine, derived from a genetically modified Corynebacterium glutamicum Yes The production strain has been genetically modified
Phytase enzyme derived from a fungus Neurospora crassa Yes This species has not been approved as a source of feed ingredients in Canada
Phytase enzyme, present in Aspergillus niger fermentation extract dehydrated derived from a fermentation with a wild type strain of A. niger No Aspergillus niger fermentation extract dehydrated is listed in Schedule IV part 1
Phytase enzyme, present in Aspergillus niger fermentation extract dehydrated derived from a fermentation with a mutant strain of A. niger Yes The producing organism, A. niger, has been genetically modified

About Schedule IV and Schedule V of the Feeds Regulations

Schedule IV and V of the Feeds Regulations list feed ingredients approved for use in livestock feed in Canada. Schedule IV comprises a range of ingredients such as forages and roughages, energy feeds, protein sources, vitamins, minerals, fermentation products and other miscellaneous products while Schedule V is restricted to flavouring ingredients. Each Schedule is divided into two parts:

Schedule IV part 1 and Schedule V part 1 list ingredients that do not require registration if they meet regulatory safety and labelling standards.

Schedule IV part 2 and Schedule V part 2 list ingredients that must be registered due to safety and/or efficacy concerns.

Safety assessment of novel microbial feeds

All novel feeds from microbial sources must be assessed by the Feed Section of the CFIA before they can be used as livestock feed in Canada. This assessment considers the safety of the feed to livestock, to humans via worker/by-stander exposure and consumption of animal products, and to the environment. Approval of a microbial product for use in food processing or other industrial purposes in Canada or in other countries, or approval for use in livestock feeds in other countries, does not constitute approval or authorization for use in livestock feeds in Canada. Applicants should contact the Feed Section in order to receive the draft Guidelines for the Safety Assessment of Novel Feeds: Microbial Sources.

Research with novel microbial feeds

Researchers in private, governmental or academic research establishments who intend to conduct research with novel feeds may require an authorization from the Feed Section.

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