Novel Feeds - Frequently Asked Questions

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What are novel feeds?

Novel feeds are feeds composed of or derived from microorganisms, plants or animal sources that:

• are not approved as livestock feed in Canada (not listed in Schedule IV or V of the Feeds Regulations)
• These include non-traditional sources, such as Bacillus coagulans or papaya; feeds used or approved in other countries; and products approved for other uses in Canada.
• and/or contain a novel trait

A novel trait is an intentional genetic change that results in a feed that is not substantially equivalent in terms of use and safety to a similar feed set out in Schedules IV or V of the Feeds Regulations. The genetic change may be created by methods such as traditional breeding, mutagenesis, cell fusion or recombinant DNA techniques.

Novel feeds include microbial products (e.g. forage inoculants, fermentation products) plants with novel traits, and plants with no history of use as feed, and products/by-products of biotechnology-derived animals.

How are novel feeds assessed for safety?

All novel feeds must be assessed by the Animal Feed Division 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.

The CFIA bases the safety assessment of a novel livestock feed product on data and supporting scientific evidence. The principles for the CFIA safety assessments were developed through international technical consultations, broad-based stakeholder consultations, and through expert consultations by each of the following: World Health Organization (WHO), the Food and Agriculture Organization (FAO) of the United Nations, and the Organization for Economic Co-operation and Development (OECD).

What are biotechnology-derived animals?

Several statutes within the Government of Canada define Biotechnology as "The application of science and engineering in the direct or indirect use of living organisms or parts or products of living organisms in their natural or modified forms". This broad definition encompasses organisms developed through traditional breeding methods and newer technologies such as genetic engineering.

As such "biotechnology - derived animal" is an extension of the definition of biotechnology and may include, but is not limited to, the following categories of animals:

1. Genetically engineered or modified animals in which genetic material has been added, deleted, silenced or altered to influence expression of genes and traits.
2. Clones of animals derived by nuclear transfer from embryonic and somatic cells.
3. Chimeric animals that have received transplanted cells from another animal.
4. Interspecies hybrids produced by any method.
5. Animals derived by in-vitro cultivation such as maturation or manipulation of embryos.

What are feed ingredients from animal sources?

Many products and by-products derived from animals are approved for use as ingredients in livestock feed in Canada. Approved livestock feed ingredients include animal proteins (milk, blood meal, meat and bone meal) animal fats and oils (tallow), and marine proteins (fish meal). These products, which are used for protein or energy sources in livestock feeds are listed in Schedule IV of the Feeds Regulations.

What are novel feeds from microbial sources?

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

• are not approved as livestock feed in Canada (not listed in Schedule 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 Schedule 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.

What are novel feeds from plant sources?

Novel feeds from plant sources include any plants and products/by-products derived therefrom that:

• are not approved as livestock feed in Canada (not listed in Schedule IV or V of the Feeds Regulations) e.g. papaya
• and/or contain a novel trait e.g. herbicide tolerant soybean
• 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 plants of the same species set out in Schedule IV or V of the Feeds Regulations.
  
  For those novel feeds containing a novel trait, it is the presence of a novel trait in a plant that triggers regulatory oversight, under the Feeds Regulations, not the method used to introduce the trait. Hence the plant rather than the process is subject to regulatory oversight. As such, novel feeds may be created by such methods as traditional breeding, mutagenesis, cell fusion, or recombinant DNA techniques. Substantive changes in agronomic, nutritional and compositional characteristic(s) of a plant that are outside the accepted range of variation for a given species, based on Canadian experience, would trigger regulation as a novel feed. In general, traditional breeding with approved germplasm in cultivation in Canada will not usually result in a novel feed.

How do we know that a gene in a novel feed doesn't pose a risk to animal or human health?

Although the CFIA verifies the safety of novel feeds before they ever reach the marketplace, people may still wonder what happens to this DNA or genetic material once an animal eats it.

It's virtually impossible for an intact plant protein in feed to survive processing (including grinding and cooking) as well as an animal's digestive system. Processing destroys the complex structure of proteins to some degree before the animal even eats the feed. Once an animal consumes the feed, the digestive process breaks proteins down even further so that they can be used by the animal.

Scientific research to date has concluded that the normal processes of digestion in both ruminants (animals with more than one stomach) and non-ruminants appear to be more than adequate to prevent any intact proteins from being absorbed across the intestinal wall. To date, no transgenic proteins have been found in the milk, meat and eggs from animals that have consumed novel feeds. A discussion of such research can be found in the document Considerations for the Safety Assessment of Animal Feedstuffs Derived from Genetically Modified Plants, published by the Organisation for Economic Co-operation and Development (OECD).

Fragments of plant DNA from conventionally-bred plants (that is, non-genetically engineered) have been detected in animal tissues and it is likely that fragments of transgenic DNA may be detected in tissues of animals fed GE plants. There is no evidence, however, that plant DNA-from genetically engineered or conventionally bred plants-integrates into the genetic material of the animal.

Is a new mineral considered a novel feed?

No, since it is not synthesized by an organism; however, it is considered a new, unapproved feed ingredient, and cannot be sold, marketed or represented for use in livestock feeds before it's safety to animals and humans is assessed.

Are unapproved chemicals considered novel feeds?

Yes, if they are derived from a novel organism, e.g., vitamin D3 synthesized by a genetically modified microorganism.

Are forage additives containing microbial ingredients considered novel feeds?

Yes, if these microbial ingredients consist of or are derived from unapproved or non-registered microorganisms.

I want to import a novel feed. What do I need to know?

Before you import a novel feed for any purpose, you must apply to the Animal Feed Division for authorization.

If I want to conduct research with novel feeds, what do I need to know?

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