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Draft - Guide to Determine if a Plant is a
Novel Feed Source

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Table of Contents

1. Scope

This document has been prepared by the Animal Feed Division of the Canadian Food Inspection Agency (CFIA) to assist the proponent (developer or importer) of a plant proposed for use as a livestock feed in determining whether or not their plant, or products derived from it, would be considered a novel feed source.

Note that proponents must consider whether their plant is a novel feed source even if only products or by-products from the plant will be used as a livestock feed. For example, a determination of novelty must be made for plants that will be used to produce ethanol for use as fuel, in cases where the resulting by-products (distillers' grains) will be fed to livestock.

The concept of novelty is also applied to the use of plants for human food, and the environmental release of plants with novel traits (PNTs). Because food use, feed use and environmental release are regulated under different legislation having different purposes, the regulatory triggers for novel foods, novel feeds and PNTs are different. This document does not address the determination of whether a plant is a novel food or a PNT.

A worksheet is provided in Appendix I to assist proponents in determining whether their plant is a novel feed source or not.

2. Regulation of Livestock Feed

The manufacture, sale and import of livestock feeds is regulated in Canada under the Feeds Act and Regulations. Approved livestock feed ingredients are listed and defined in Schedules IV and V of the Feeds Regulations, with appropriate guarantees, standards, and label requirements.

The Animal Feed Division of the CFIA evaluates and regulates all feed ingredients, including novel feeds, in the same way. Any feed ingredient that is not already listed in Schedule IV or V of the Feeds Regulations, or that has been modified in such a way that it is significantly different from a conventional ingredient listed in Schedule IV or V, must undergo a pre-market assessment and approval before it can be manufactured, sold or imported as a feed ingredient in Canada.

The purpose of pre-market assessment of feed ingredients is to ensure that every feed ingredient is safe (in terms of animal health, human health, and the environment) and efficacious (fit for the intended purpose, with any claims substantiated) prior to being marketed. The evaluation also makes sure that the feed is accurately defined in Schedule IV or V, and that it is labelled appropriately for safe, effective use and for consumer protection.

2.1 Novel Feed Triggers

Feeds from plant sources, or parts or products derived from them, are novel if they are not approved for use as livestock feed in Canada (i.e., are not listed in Schedule IV or V of the Feeds Regulations), and/or if they contain a novel trait.

A novel trait is a characteristic of a feed from a plant source that can be inherited and is not substantially equivalent in terms of its specific use and safety to a characteristic of a similar feed from a plant source listed in Schedule IV or V of the Feeds Regulations.

The two triggers to consider when determining if a plant source intended for livestock feed use is novel are:

  1. Is the crop, or parts derived from it, listed in Schedule IV or V of the Feeds Regulations?
  2. If the crop, or parts thereof, is listed in Schedule IV or V of the Feeds Regulations does the plant source contain a characteristic new to the species, or has an existing characteristic been modified so that it falls significantly outside of the typical range for the unmodified conventional crop (includes enhancement or reduction/removal of a characteristic)?

The determination whether a plant is a novel feed source or not is based on a comparison of the plant with the unmodified conventional crop already existing in the Canadian marketplace used as livestock feed. If a crop is approved for livestock feed use, ingredients derived from it will be listed in Schedule IV or V of the Feeds Regulations. In general, conventional breeding with germplasm (breeding material) in cultivation in Canada will not usually result in a novel feed.

Once a novel feed from a plant source is authorized, the altered characteristic will not automatically be considered as part of the typical range for that crop. The altered characteristic will be deemed to be part of the conventional crop on a case by case basis with particular consideration given to history of use in Canada.

The following flowchart illustrates the general factors that are considered in determining whether a plant is a novel feed source.

Click on Image for Larger View
Framework for determining if the plant, or products or by-products derived from it, is a novel feed source.
Figure 1: Framework for determining if the plant, or products or by-products
derived from it, is a novel feed source.

2.1.1 Scenario 1: Crop, or parts derived from it, is not listed in Schedule IV or V

The proponent of a plant should first determine if the crop with which they are working is listed as an approved feed ingredient in Schedule IV or V of the Feeds Regulations. If the crop, or parts derived from it, are not listed in Schedule IV or V of the Feeds Regulations, mandatory pre-market assessment prior to use as livestock feed is required.

2.1.2 Scenario 2: Crop, or parts derived from it, is listed in Schedule IV or V but the plant contains a characteristic that is altered or that is new to the crop

For those crops listed in Schedule IV and V of the Feeds Regulations, proponents must first characterize their plant, and then use a comparative approach to determine if a new characteristic has been introduced, or an existing characteristic has been modified such that it falls outside of the typical range for the unmodified conventional crop.

The plant will be a novel feed source if a new characteristic has been introduced into the plant that does not exist in the unmodified conventional crop used as livestock feed in Canada. Note that it is the presence of the new characteristic in the plant that triggers regulatory oversight, not the method used to introduce the characteristic. Novel feeds may be created by a variety of methods, including traditional breeding, mutagenesis, cell fusion, or recombinant DNA techniques.

The plant will likewise be a novel feed source if an existing characteristic has been modified such that it falls outside of the typical range for that characteristic within the unmodified conventional crop. For example, significant changes in nutritional parameters which fall significantly outside the typical range for the unmodified conventional crop, based on Canadian experience, would trigger regulation as a novel feed.

The phenotype (physical expression) and genotype (genetic constitution) of the trait, as well as the mechanism of action that is responsible for the resulting trait, must be considered when determining novelty.

3. Comparative Approach

The determination of novelty for crops that are listed in Schedule IV and V of the Feeds Regulations is based on a comparative approach. Proponents must compare their plant with the unmodified conventional crop already existing in the Canadian marketplace used as livestock feed. If a crop is approved for livestock feed use ingredients derived from it will be listed in Schedules IV or V. These listed single feed ingredients have been assessed and found to be safe and efficacious for use as livestock feed in Canada.

By meeting an existing ingredient definition (e.g., characteristics of the plant in question fall within the typical range for the crop), a feed from a plant source is determined to be as safe and efficacious as material currently used as livestock feed in Canada. If characteristics of the plant in question fall significantly outside of the range for the conventional crop, or if the intended use of the feed derived from the plant is different from that of the conventional crop, the plant sourced feed does not meet the single feed ingredient definition for that crop. As a result, there may be potential safety and efficacy concerns and pre-market assessment of the plant is required.

It is important to note that single ingredient feed definitions listed in Schedule IV of the Feeds Regulations do not define all of the different characteristics of a crop for example, compositional parameters of a crop are not defined. Proponents should consider and compare characteristics of their plant against the following:

When using the comparative approach, proponents should compare their whole plant, not just a product of that plant, to the whole plant in the Canadian crop context. Several different feed ingredients may be derived from a given plant (e.g., flour, oil, meal, hulls). Evaluating, assessing and approving the plant as a whole will ensure compatibility with all current and future ingredients derived from that crop. For example, rather than comparing only the hulls of oats against unmodified conventional oat hulls, the whole oat plant must be compared to oats as a crop used in Canada.

In addition, the proponent should not compare their plant against complete or mixed feeds; for example, soybean should be compared to soybean, not to soybean mixed with added methionine.

4. Determining Whether or Not a Plant is a Novel Feed Source

4.1 Responsibility for Determining Whether a Plant is a Novel Feed Source

It is the responsibility of the proponent wishing to manufacture, import, or sell a plant, or a product derived from it, to consider whether or not it is a novel feed source. Proponents are not required to inform the Animal Feed Division of the CFIA if they have determined that their plant does not constitute a novel feed source. As administrators of the Feeds Act and Regulations, however, the Animal Feed Division must be satisfied with this determination, and may ask the proponent to provide supporting evidence.

Proponents are encouraged to consult the Animal Feed Division in cases where they have questions or are unsure; this can take the form of a telephone call, a letter with supporting rationale, or a face-to-face meeting. Consultation is especially beneficial for proponents who do not have experience with the Canadian feed regulatory system.

If a proponent chooses to consult with the Animal Feed Division regarding a novelty determination, the Division will respond with a letter providing an opinion on the novelty of the feed. If insufficient information is provided, proponents will be advised to gather further information to support an informed decision. The opinion of the Division will be based on the information provided by the proponent and currently available knowledge.

4.2 Supporting Evidence for the Novelty Determination Process

Proponents can demonstrate that they have performed due diligence in the novelty determination process by:

  • characterizing their plant;
  • using the comparative approach described in this document to compare their plant to the corresponding unmodified conventional crop within the Canadian feed context;
  • keeping records of the information used to make the novelty determination; and
  • consulting with the Animal Feed Division when they are unsure or require guidance.

5. Mandatory Pre-market Assessment of Novel Feed Sources

If the proponent determines that their plant is a novel feed source, they must submit an application to the Animal Feed Division of the CFIA for the pre-market assessment of their plant. Authorization from the Animal Feed Division is required prior to manufacture, sale or import of the plant.

For information on preparing an application, please refer to the "Guidelines for the Assessment of Novel Feeds: Plant Sources", available on the CFIA website.

It is recommended that proponents contact the Animal Feed Division to arrange for a pre-submission consultation with feed regulators before preparing and making a submission. Information on the pre-market assessment process is available on the CFIA website.

Appendix I

PDF (38 kb)

Work Sheet - Determination if a Plant is a Novel Feed Source

As stated in the Feeds Regulations, all feeds must be safe and efficacious. One way a proponent of a plant can demonstrate due diligence in this regard is to characterize their plant in terms of:

  • compositional parameters;
  • levels of endogenous allergens, toxins and anti-nutrients; and
  • other factors that affect feed safety.

Knowledge of the general characteristics of the plant will aid proponents in determining novelty as they work through the following worksheet.

It will also be helpful for proponents to consider the breeding history prior to starting the worksheet: In general, conventional breeding with germplasm in cultivation in Canada will not typically result in a novel feed. Enhancing a trait in cultivated species by introgressing genes from wild biotypes or using germplasm from outside Canada may result in a novel feed.

Describe any new characteristic or any existing characteristic of the plant that has been modified:

Plant genus and species:
Common name of plant:

1. Is it likely that this plant, or parts or products from it, will be fed to livestock?  

If the answer to question 1 is no, then STOP - the plant is not a feed, and thus is not regulated under the Feeds Act and Regulations. If the answer is yes, then continue.

2. Is the plant listed as an approved feed ingredient in Schedule IV or V of the Feeds Regulations?  

If the answer to question 2 is no, then the plant is a novel feed source, and will require a pre-market assessment by the Animal Feed Division. If the answer is yes, novelty has not been triggered under this consideration; please continue.

3. Will the use of this plant, either as a single ingredient feed or as part of a complete feed:  
3a) be different from previous use of the unmodified conventional crop in Canada? (e.g., feed now intended as an energy source where it was previously a protein source)?  
3b) change the amount of the plant incorporated into a given livestock species diet (e.g., rapeseed vs. canola)?  
3c) result in changes to ration formulation1?  
3d) allow the use of different feed processing techniques?  

If the answer to any part of question 3 is yes, the plant likely does not meet an existing ingredient definition2; please contact the Animal Feed Division as the plant may require a pre-market assessment. If the answer is no, novelty has not been triggered under these considerations; please continue.

4. Has the plant been modified such that:  
4a) it exhibits a characteristic that was not previously found in the unmodified conventional crop in Canada3?  
4b) it no longer exhibits a characteristic that was previously found in the unmodified conventional crop in Canada?  
4c) an existing characteristic (including compositional parameters4) has been modified such that it now falls significantly outside the typical range for the unmodified conventional crop in Canada (beyond incremental improvements historically made to the crop)?  
4d) there is a difference in bioavailability of a given compound?  
5. Is a new compound produced by the plant?  
6. Have levels of endogenous allergens, toxins or antinutrients been altered5?  

If the answer to any of questions 4-6 is yes, or the answer is unclear, please contact the Animal Feed Division, as the plant may be a novel feed source and may require a pre-market assessment. If the answer is no, novelty has not been triggered under these considerations; please continue.

7. Are you planning on making nutritional or efficacy claims associated with your product?  

If the answer to question 7 is yes, please contact the Animal Feed Division. Registration of this claim is required, since all feed claims must be registered.

Conclusion:  

If your responses to any of the considerations above indicate that you have developed a plant that is, or may be, a novel feed, or if you require further guidance, please contact the Animal Feed Division as the plant may require pre-market assessment.

1 An example of a change to ration formulation would be the use of corn modified to contain high lysine, which results in a decreased need for supplemental lysine in feed rations.

2 Single ingredient feeds must be defined and labelled appropriately for consumer protection. The ingredient definition is an accurate description of the feed and its approved purpose.

3 New characteristics may include agronomic characteristics that affect safety and efficacy.

4 Compositional analysis to support novelty determinations should focus on those plant parameters that could reasonably be expected to be affected by the modification. For example:

  • for imidazolinone herbicide tolerance resulting from mutations in the ALS genes, characterize the branched chain amino acids (valine, leucine, isoleucine) which are catalyzed by the AHAS enzyme
  • for drought tolerance, characterize the drought stress metabolites associated with the drought tolerance
  • for intentional modification of the fatty acid profile, characterize the fatty acid profile to determine if parameters are still within the typical range, and in addition, characterize other compositional parameters (e.g., fat content) that may be affected due to changes in metabolic pathway

5 Proponents should focus on endogenous allergens, toxins or antinutrients in the plant that could reasonably be expected to be affected by the modification.

Appendix II: Example - Novel Feed Determination

The following example is provided to assist proponents in determining whether or not their plant, or products derived from it, is a novel feed source.

Work Sheet - Determination if a Plant is a Novel Feed Source

Describe any new characteristic or any existing characteristic of the plant that has been modified:
Enhanced levels of the saturated fat, stearic acid, in the oil. The modified fatty acid profile will impart desirable physical properties that are useful in various food applications without the need for hydrogenation. The oil is intended for human consumption and the soybean meal is unchanged. The trait was developed through a combination of mutagenesis and conventional breeding.

Plant genus and species: Glycine Max
Common name of plant: Soybean

1. Is it likely that this plant, or parts or products from it, will be fed to livestock? Yes, soybean meal is regularly used as animal feed.

If the answer to question 1 is no, then STOP - the plant is not a feed, and thus is not regulated under the Feeds Act and Regulations. If the answer is yes, then continue.

2. Is the plant listed as an approved feed ingredient in Schedule IV or V of the Feeds Regulations? Yes, soybean seed, mill, hulls, oil, lecithin, flour, protein, and meal are approved for livestock feed use.

If the answer to question 2 is no, then the plant is a novel feed source, and will require a pre-market assessment by the Animal Feed Division. If the answer is yes, novelty has not been triggered under this consideration; please continue.

3. Will the use of this plant, either as a single ingredient feed or as part of a complete feed:  
3a) be different from previous use of the unmodified conventional crop in Canada? (e.g., feed now intended as an energy source where it was previously a protein source)? No
3b) change the amount of the plant incorporated into a given livestock species diet (e.g., rapeseed vs. canola)? No
3c) result in changes to ration formulation1? No
3d) allow the use of different feed processing techniques? No

If the answer to any part of question 3 is yes, the plant likely does not meet an existing ingredient definition2; please contact the Animal Feed Division as the plant may require a pre-market assessment. If the answer is no, novelty has not been triggered under these considerations; please continue.

4. Has the plant been modified such that:  
4a) it exhibits a characteristic that was not previously found in the unmodified conventional crop in Canada3? No
4b) it no longer exhibits a characteristic that was previously found in the unmodified conventional crop in Canada? No
4c) an existing characteristic (including compositional parameters4) has been modified such that it now falls significantly outside the typical range for the unmodified conventional crop in Canada (beyond incremental improvements historically made to the crop)? Yes, the levels of stearic acid fall well outside the typical range for conventional unmodified soybeans. The range for stearic acid in soybeans provided in the OECD consensus document is 2-5%. Enhanced stearic acid soybeans contain 16-24% stearic acid. Other associated changes included lower levels of palmitic and linolenic acid.
4d) there is a difference in bioavailability of a given compound? No
5. Is a new compound produced by the plant? No
6. Have levels of endogenous allergens, toxins or antinutrients been altered5? No

If the answer to any of questions 4-6 is yes, or the answer is unclear, please contact the Animal Feed Division, as the plant may be a novel feed source and may require a pre-market assessment. If the answer is no, novelty has not been triggered under these considerations; please continue.

7. Are you planning on making nutritional or efficacy claims associated with your product? No (at least not for livestock feed).

If the answer to question 7 is yes, please contact the Animal Feed Division. Registration of this claim is required, since all feed claims must be registered.

Conclusion: The trait of interest in this product falls well outside the typical range for the conventional unmodified crop in Canada and alters the nutritional profile of the feed. CFIA was notified, a risk assessment was completed, and this product was authorized as an animal feed in 2008.
Date Modified: 2010-07-16

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