Animals > Livestock Feeds > Novel Feeds / Biotechnology  

Directive 95-03:
Guidelines for the Assessment of Novel Feeds:
Plant Sources

This document updates Regulatory Directive 95-03 "Guidelines for the Assessment of Livestock Feed From Plants with Novel Traits." The original Directive 95-03 was first published April 21, 1995.

Table of Contents

1.0 INTRODUCTION

1.1 Scope

This directive applies to novel feeds from plants, or parts or products thereof, that have not been previously used as livestock feed in Canada, and/or have a novel trait and that are not substantially equivalent to approved products already on the market in Canada.

Prior to the release of a novel feed (i.e., use as livestock feed) authorization from the Feed Section, Canadian Food Inspection Agency (CFIA) is required.

This document is a guide for the preparation of an application of the release of a novel feed. It includes criteria that will be considered in the assessment of safety and efficacy of a novel feed. This directive is not intended to explicitly define all of the data that might be required in the course of the assessment.

More information on novel feeds and Feed Section activities is available.

1.2 Definitions

Biotechnology: 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 (Canadian Environmental Protection Act).

Carrier DNA: DNA used to expedite the preparation or the transformation of genetic material into a plant but which is itself not part of the construct.

Coding region: A DNA sequence which can be translated to produce a protein.

Construct: An engineered DNA fragment (e.g., plasmid) which contains, but is not limited to, the DNA sequences to be integrated into a target plant’s genome.

Counterpart: A feed or feeds selected by the applicant, to which the novel feed will be compared. The chosen counterpart should be, if possible, the closest genetic equivalent and may be a previously assessed and authorized novel feed. Since there will be a range of characteristics among varieties within a species, comparison with several counterparts may show that the novel feed has characteristics within the normal range exhibited by that species. If the closest genetic equivalent is not similar to the novel feed (e.g., in the case of a plant intentionally modified for composition), consideration may also be given to comparison with those products the novel feed was designed to emulate.

Database citations: Publically available sources of nucleotide or protein sequence information. Five commonly used databases and their website addresses are:

• GenBank: An annotated collection of all publicly available DNA sequences maintained by the National Institute of Health (NIH).

• DNA Data Bank of Japan: The officially certified DNA bank of Japan, which collects DNA sequences from researchers.

• EMBL Nucleotide Sequence: A database of DNA and RNA sequences collected from the scientific literature, patent applications, and directly submitted from researchers and sequencing groups.

• The SWISS-PROT Protein Sequence Data Bank: A database of protein sequences produced collaboratively by Amos Bairoch (University of Geneva) and the EBI.

• The FARRP Allergen Database: A database containing a list of unique known and putative allergens that were identified by searching publicly available protein databases.

Environment: The components of the earth (including air, land and water, all layers of the atmosphere, all organic and inorganic matter and living organisms) and all interacting natural systems that include components referred to above (Feeds Regulations). This includes natural and managed ecosystems which include agricultural ecosystems.

Familiarity: The knowledge of the characteristics of a plant species and experience with that plant species in Canada.

Feed: Any substance or mixture of substances containing amino acids, anti-oxidants, carbohydrates, condiments, enzymes, fats, minerals, non-protein nitrogen products, proteins or vitamins, or pelletizing, colouring, foaming or flavouring agents and any other substance manufactured, sold or represented for use:
a) for consumption by livestock,
b) for providing the nutritional requirements of livestock, or
c) for the purpose of preventing or correcting nutritional disorders of livestock, or any such substance for use in any such substance or mixture of substances (Feeds Act).
Includes a feed derived through biotechnology.

Gene flow: The transfer of genetic material by interbreeding from one population of a species to another population (same or related species), thereby changing the composition of the gene pool of the receiving population.

Genetic Modification: Any intentional change to the heritable traits of an organism. This includes, but is not limited to: traditional breeding, recombinant nucleic acid techniques, somaclonal variation, electroporation, mutagenesis, and similar techniques.

Insert: That part of the construct which is integrated into the recipient plant’s genome.

Irritant: Any agent capable of eliciting an abnormally excited or sensitive condition in a body part of a human or other animal.

Livestock: Means horses, cattle, sheep, goats, swine, foxes, mink, fish, rabbits and poultry and includes such other creatures as may be designated by regulation as livestock for the purposes of the Feeds Act.

Noncoding region: DNA sequences which lie outside of an open reading frame and which are not translated to become part of a protein. These might include scaffold attachment regions, promoters, leader sequences, enhancers, introns, terminators, and any other sequences that are used for gene expression either in the plant or other hosts, such as origins of replication, transposon elements, T-DNA borders, lox sequences, etc.

Novel feed: Means a feed comprising an organism or organisms, or parts or products thereof, that:
a) is not set out in Schedule IV or V, or
b) has a novel trait (Feeds Regulations).

Novel trait: Means a characteristic of the feed that:
a) has been intentionally selected, created or introduced into the feed through a specific genetic change, and
b) based on valid scientific rationale, is not substantially equivalent in terms of its specific use and safety both for the environment and for human and animal health, to any characteristic of a similar feed that is set out in Schedule IV or V (Feeds Regulations).

OECD Consensus Documents: Reports published by the Organization for Economic Cooperation and Development (OECD) that contain technical information for use in the regulatory assessment of products of biotechnology. These documents are mutually recognized among member countries of the OECD.

Plant with Novel Traits (PNT): A plant containing a trait not present in plants of the same species already existing as stable, cultivated populations in Canada, or containing a trait present at a level significantly outside the range of that trait in stable, cultivated populations of that plant species in Canada.

Safety Assessment: Encompasses hazard identification, risk estimation, and risk evaluation and management.

Stability: The ability of the trait to be expressed in the modified plant line and plant lines derived therefrom in a consistent, reliable, and predictable manner.

Substantial Equivalence: Equivalence of the feed from a plant, within a particular plant species, in terms of its specific use and safety to the environment and human and animal health, to those in that same species, that are in use and generally considered as safe in Canada, based on valid scientific rationale.

Trait: The phenotypic characteristic(s) conferred to the recipient plant by specific genetic changes.

Transgenic Plant: A plant in which one or more genes, genetic constructs, or traits have been introduced using recombinant DNA techniques, which could be considered to include the insertion of genetic material from the same or different species.

Unintended effects: By the insertion/mutation of defined DNA sequences, additional traits may be acquired or existing traits could be lost or modified. Unintended effects may be deleterious, beneficial or neutral with respect to health of plant and safety to livestock and humans.

Vector: An autonomously replicating DNA molecule into which foreign DNA is inserted and then propagated in a host cell.

1.3 Legal Authorities

The legislative authorities under which the CFIA regulates novel feeds are:

For the regulation of novel feeds:

The Feeds Act, R.S. 1985 chapter F-9,
The Feeds Regulations, 1983 F-9 SOR/83-593

For the collection of fees:

Canadian Food Inspection Agency Fees Notice, Canada Gazette, Part 1 (05/13/2000)

1.4 Determination of Novelty

Feed Section authorization of the release of a novel feed for livestock is necessary when the feed, derived from a plant, 1) is considered unfamiliar when compared with products already on the market in Canada, and/or 2) has a novel trait that has been intentionally selected, created or introduced into the feed through a specific genetic change, and 3) based on valid scientific rationale is not substantially equivalent in terms of its specific use and safety both for the environment and for human and animal health, to any characteristic of a similar feed that is set out in Schedule IV or V of the Feeds Regulations.

For those novel feeds derived from a plant containing a novel trait, it is the presence of the novel trait in the 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. Novel feeds may be created by such methods as traditional breeding, mutagenesis, cell fusion, or recombinant DNA techniques. Traditional breeding may produce a plant that will require authorization from the Feed Section, depending on the selected trait’s level of expression in comparison with existing trait ranges based on Canadian experience. A substantive change in agronomic, nutritional or compositional characteristic(s) of a plant that are outside the accepted range for a given species would constitute a novel trait, thus triggering the requirement to apply for authorization of the release of the novel feed derived from the plant.

For example, a new wheat line with an increase in yield that is similar to increases seen historically in wheat lines cultivated in Canada would not be considered a novel feed. A new sclerotinia resistant canola line with resistance many fold higher than that currently grown in Canada would be a novel feed. The introduction of a trait from wild biotypes or from germplasm originating outside of Canada, is more likely to produce a novel feed than conventional breeding with approved Canadian germplasm.

The trigger for regulation is novelty, not risk.

It is the responsibility of the proponent to determine whether they have created a novel feed. This determination must be based on appropriate data and must include a comparison of the plant to an appropriate counterpart in terms of its specific use and safety for the environment and for human and animal health. Proponents should, based on their expertise and relevant scientific literature, determine the range of a selected trait based on Canadian experience to determine if they have created a novel feed. If the proponent determines that the plant is not novel, the information to support the determination must be retained and presented to the CFIA on request.

Before introducing a new plant into the Canadian market it is necessary to consider whether it would be classified as novel under the regulatory provisions of the Feeds Act, the Food and Drugs Act, and the Seeds Act and their respective regulations.

The factors that determine novelty are different for plants with novel traits (PNTs), novel feeds and novel foods, due to different regulatory triggers. To ensure compliance with all directives and guidelines, consultation with the Plant Biosafety Office (PBO) and the Feed Section, CFIA and with the Novel Foods Section, Health Canada is encouraged.

When a proponent contacts the CFIA's Feed Section or the Plant Biosafety Office, or Health Canada’s Novel Foods Section for guidance on a novelty determination of a plant and its feed and food products, a meeting will be organized among all three groups to review the case, analyze the factors that contribute to its status and provide guidance on the appropriate regulatory oversight.

Where a plant variety has been determined to be a PNT, the feed and food products derived therefrom will likely be considered novel. On the other hand, in some cases, a plant variety may not be found to be a PNT but the characteristics of the feed and food products derived therefrom would lead the Feed Section and the Novel Foods Section to conclude that they are novel. In other cases, a plant could be considered a PNT by the Plant Biosafety Office if it is new to the Canadian environment, while the feed and food products would not be novel if they have a previous history of safe use in the marketplace. In order to respond to a request for guidance regarding a novelty determination from a proponent, additional information may be required for regulatory authorities to reach a decision.

1.5 Novelty Guidance

The following are supplied to provide guidance on whether an application for the authorization of the release of a novel feed is required:

Feed not Listed in Schedule IV
Authorization is required for the release of feed from plants, or parts or products thereof, that are not listed in Schedule IV or V of the Feeds Regulations.

Feed Containing a Novel Trait
Authorization is required for the release of feed from plants, or products thereof, that has a novel trait that has been intentionally selected, created or introduced into the feed through a specific genetic change which based on valid scientific rationale is not substantially equivalent in terms of its specific use and safety both for the environment and for human and animal health, to any characteristic of a similar feed that is set out in Schedule IV or V of the Feeds Regulations.

Intra-specific Crosses
After a plant is authorized for release as livestock feed, all progeny of the modified plant and its sister lines which have been derived from the original transformation and their progenies, are also authorized for livestock feed use provided that the proponent has determined:

• no inter-specific crosses are performed;
• the intended uses are similar;
• based on characterization, these plants do not display any additional novel traits and are substantially equivalent, in terms of their specific use and safety for the environment and for human and animal health, to plants currently in use as livestock feed; and
• the novel genes are expressed at a level similar to that of the authorized line.

The CFIA may ask the proponent to provide evidence supporting these conclusions.

Inter-specific Crosses
After a plant is authorized for release as livestock feed, a livestock feed safety assessment of the plant created from the first interspecific cross will be required. Subsequent to an authorization by the Feed Section for that interspecific cross, the proponent may not be required to apply to the Feed Section for authorization of further lines, provided that the proponent has determined:

• the intended uses are similar;
• based on characterization, these plants do not display any additional novel traits and are substantially equivalent, in terms of their specific use and safety for the environment and for human and animal health, to plants currently in use as livestock feed; and
• the novel genes are expressed at a level similar to that of the authorized line.

The CFIA may ask the proponent to provide evidence supporting these conclusions.

Intentional Trait Stacking
Please advise the Feed Section, at least 60 days prior to the intended livestock feed use of plants having stacked traits, resulting from intentional intra-specific or inter-specific crosses between novel plants already authorized for livestock feed use. Following the proponent's notification, the Feed Section will issue a letter (within 60 days of notification) informing the proponent of any concerns the Feed Section may have regarding the livestock feed use of the plant with stacked traits. The Feed Section reserves the right to request and review data to support the safe use of the modified plant in livestock feed use. Stacking of traits with potential incompatible management requirements, possible negative synergistic effects, or where feed use of the plant is altered may result in the requirement for a safety assessment. Until all livestock feed concerns have been resolved, the modified plant must not be used as livestock feed.

Re-transformation/Re-mutation
A re-transformation/re-mutation, i.e.,
- transformation of a plant, with the identical construct(s) as a previously authorized plant of the same species
- mutation of the same gene in a plant as a previously authorized plant of the same species which conveys the same novel trait as a transformation/mutation in a previously authorized plant may not require an application to the Feed Section, provided that:

• the method is identical to that used previously;
• the intended uses are similar;
• based on characterization, the plant does not display any additional novel traits and is substantially equivalent, in terms its specific use and safety for the environment and for human and animal health, to plants currently in use as livestock feed in Canada;
• the novel genes are expressed at similar levels as that of the authorized line.

The CFIA may ask the proponent to provide evidence supporting these conclusions. The CFIA recommends consultation with the Feed Section, the Plant Biosafety Office and Health Canada for further guidance.

1.6 Safety Assessments

The Feed Section conducts livestock feed safety assessments based on familiarity and substantial equivalence. Familiarity with the feed is knowledge of the characteristics of a plant species and experience with use as feed of that plant species in Canada, i.e., listed in Schedule IV or V of the Feeds Regulations. Substantial equivalence is based on the comparison of properties between the modified plant and an appropriate counterpart. Taking into consideration both intended and unintended effects, similarities and differences between the modified plant and its counterpart are identified. Those aspects in the modified plant which are determined to be equivalent to the counterpart are accepted and the safety assessment then focuses on the differences. The concept of substantial equivalence is endorsed by international groups such as OECD and FAO/WHO.

In the feed safety assessment, molecular, compositional, nutritional and toxicological data of the novel feed are compared to those of an appropriate counterpart. The identification and subsequent determination of levels of key nutrients, anti-nutrients and endogenous toxins and allergens is an important aspect of the determination of substantial equivalence. The OECD Consensus documents on individual crops may be of assistance as a reference to aid in the determination of the key elements to be examined.

Assessments are conducted on a case-by-case basis. The assessment process uses a weight of evidence approach, all studies submitted are evaluated and considered in the decision-making process. Certain studies detailed in this document may not be required, based on valid scientific rationale, supported by appropriate data or literature references.

Characterization data should be generated with genetically stable, modified lines that are representative of the final feed product. Once a novel feed is authorized by the Feed Section, further variety development does not result in the need to submit an application to the Feed Section unless additional novel traits are introduced, or the feed is deemed by the proponent not to be substantially equivalent based on data from appropriate studies.

1.7 Applications

Applicants are encouraged to consult with the Feed Section in the early stages of the development of a novel feed for clarification on the specific information that is required by the Feed Section to conduct the safety assessment.

Proponents of novel feeds are strongly encouraged to apply for authorization of the release of the novel feed well in advance of the anticipated time of commercialization. Applications are processed on a first-come, first-served basis. Complete applications allow for timely evaluations and minimize requests for further information.

Studies must be designed and conducted in accordance with sound scientific concepts and principles and where appropriate, Good Laboratory Practices. Studies must be carried out by qualified research personnel using suitable methods. Complete descriptions of the methods used to generate submitted data must be provided, including the sensitivity and quality control and quality assurance procedures. Data must be analyzed using appropriate statistical techniques, when applicable. Primary data must be made available upon request. All parts of the application must be fully legible, with particular attention paid to analytical gels (e.g., SDS-PAGE gels and Western blots). Any scientific references used to support the data package must be provided with the application.

A reviewer’s checklist for analytical techniques, developed with Health Canada and the United States Department of Agriculture’s Animal and Plant Health Inspection Services, is available to provide guidance on the preparation of quality data.

1.8 Procedures for Submitting an Application

For every application for authorization, the applicant must submit the following:

• One application form (CFIA 0009), filled out and signed by an authorized representative and the Resident Canadian Agent form (CFIA 1194), if required;
• Fees as described in the Feed Section Trade Memorandum T-3-20 for a Category 3 Feed requiring a safety and efficacy assessment. The application fee is non-refundable;
• Data as outlined in this directive. Please note that this document is not intended to explicitly define all of the data that might be required in the course of the assessment. Additional information may be requested by the Feed Section on a case by case basis.

Applicants must submit a hard copy version of the application and are encouraged to submit an electronic (cd) copy of the application.

The applicant must establish a company file and a signing authority list with the Feed Section, as per Trade Memorandum T-3-20.
The forms CFIA 0009, CFIA 1194 and T-3-20 are available.

Applications should be addressed to:

Feed Section
Animal Health and Production Division
Canadian Food Inspection Agency
59 Camelot Drive,
Ottawa, Ontario K1A 0Y9

1.9 Submission to Other Regulatory Parties

Where a novel feed from a plant could reasonably be expected to be released into the Canadian environment and/or used as human food, the Plant Biosafety Office, CFIA, and/or Novel Foods Section, Health Canada will require an application(s) for authorization of the PNT and/or novel food. It is the responsibility of the applicant, and not of the Feed Section, to contact these offices.

Applicants seeking authorization of the release of a novel feed in Canada are encouraged to seek authorization for their product in the United States and Canada simultaneously, if the product is regulated in the United States. Obtaining such authorizations may minimize the movement of unauthorized material across the border .

1.10 Confidential Information

Information provided to the CFIA by applicants for the purposes of obtaining authorization of the release of novel feeds may be protected under the federal Access to Information Act, Section 20.

All requests for such information are subject to the federal Access to Information and Privacy (ATIP) Acts. For further information, please consult with CFIA’s ATIP service, at (613) 225-2342.

2.0 DEVELOPMENT OF THE MODIFIED PLANT

Sufficient data must be submitted to characterize the modified plant and permit comparison with the appropriate counterpart(s).

Most of the questions regarding characterization of the modified plant can be addressed by data generated in the developmental stage. Based on the method of development of the novel feed, e.g., traditional breeding, mutagenesis, rDNA, provide information as appropriate.

2.1 Host and Donor Organisms

All relevant information on the host and donor, or parental organisms must be included in the application. A review of the literature for information relevant to a feed safety assessment of the host plant and related varieties and the donor organisms used in the development of the modified plant should be provided. Required information for both host and donor includes, but is not restricted to:

2.2 The Modified Plant

Provide the following information:

2.3 Description of the Modification/ Breeding History

Sufficient information on the process used to introduce the novel trait should be provided to enable an assessment of both intended and potential unintended effects.

Provide the following information:

For products of recombinant DNA techniques, provide the following:

2.4 The Novel Trait(s)

Provide the following information in regards to newly expressed material, which is either introduced or modified native material:

2.5 Marker Genes

Any transformation markers used in the development of the plant must be identified and characterized as per the novel trait. Any secondary effects on the biochemistry, physiology and secondary metabolism of the host plant, must also be characterized. Information must be provided on the consequences to the final plant.

Because antibiotics are routinely mixed with livestock feed, a determination of the potential for their inactivation during storage as a result of the activity of any expressed antibiotic resistance marker gene should be conducted.

The use of marker genes that confer resistance to clinically important antibiotics should be avoided.

3.0 NUTRITIONAL DATA

Feed ingredients derived from the novel plant should be described, including information on processing and estimated feeding rates.

Nutrient and antinutrient composition of the major plant components and byproducts used in livestock feed should be considered. For example, composition of whole plant corn or corn silage in addition to grain should be determined. Consideration should also be given to by-product streams in which nutrients or antinutrients are concentrated.

A comparison of the composition of the novel feed ingredient, to that of the same feed ingredient derived from an appropriate counterpart must be undertaken. These comparisons should be based on analysis of representative samples derived from appropriate growing areas over one or more growing season(s). Comparison to literature ranges for nutritional composition of nearest genetic equivalents or counterparts may be an acceptable alternative. Data should demonstrate the uniformity or variability of the composition of the final product and include the analysis/characterization of the gene products (e.g., in the case of proteins, any post translational modifications are of interest).

Scientific investigations presented in support of nutritional evaluation must be: designed to facilitate statistical analysis; analyzed by appropriate statistical methods; and, for those feeds which are able to grow in Canada, conducted under conditions similar to those expected to occur in Canada. As a minimum, the experimental design should include two locations, two treatments (novel feed vs. control), and three replicates. Representative samples should not be pooled for analysis. Nutrient and antinutrient analysis should be done in duplicate, according to accepted AOAC or other recognized methods.

The raw data and printouts of statistical analysis must accompany the application. Statistical differences in composition should be assessed in terms of biological significance.

3.1 Nutrient Composition

Provide, at a minimum:

Based on the preceding evaluation and the intended use of the feed, the following information may also be required:

The OECD consensus documents which detail the key nutrients and antinutrients to be analysed in various crop species should be consulted for guidance on relevant components.

Unusual or unanticipated results in nutrient or antinutrient analysis must be subject to further investigation.

In the case of novel feeds which have been intentionally modified in terms of nutritional composition (e.g., altered amino acid or fatty acid profile) or functionality (e.g., digestibility, bioavailability), nutrient and antinutrient analysis and comparison with the appropriate controls should be conducted as described above. Data to support any claims associated with the modification must also be provided. These feeds should be subjected to assessment of potential consequences to safety and efficacy of the intentional nutritional modification.

4.0 DIETARY EXPOSURE

Complete details should be supplied on the predicted amount of the novel feed in the complete livestock diet. Estimates of dietary exposure to the novel feed may play a key role in determining the data required for a safety and efficacy assessment. In addition, data on the effects of animal age and species with respect to the intended use of the novel feed may be necessary. Feeds that are present in low levels in a complete diet may be of less concern than those intended to be significant components of the diet.

5.0 TOXICOLOGY DATA

5.1 Endogenous Toxins

5.2 Newly Expressed Material

Provide the following information in regards to newly expressed material, which is either introduced or modified native material:

Please refer to the Feed Trade Memorandum T-3-141 and Supplement 1 and Supplement 2 that contain further information on traditional toxicity study requirements for feeds.

If bacterially produced protein is used in place of plant produced protein, biochemical, structural and functional equivalency of the two proteins must be demonstrated.

6.0 ALLERGENICITY DATA

The potential for allergenic response in humans (in terms of bystander/occupational safety) should be considered on the basis of the history of the host/parental and donor organisms and/or the novel traits introduced.

6.1 Endogenous Allergens

6.2 Newly Expressed Proteins

At present there is no definitive test that can be relied upon to predict allergic response in humans to a newly expressed protein. A case by case, step wise approach (such as the FAO/WHO 2000 or 2001 decision tree) should be applied in the assessment of possible allergenicity of newly expressed proteins.

Provide the following information in regards to newly expressed proteins which are either introduced or modified native material:

7.0 LABORATORY ANIMAL/LIVESTOCK FEEDING TRIALS

Conducting whole plant feeding trials for safety assessments may be impractical due to variations in composition and difficulty in feeding sufficient quantities of the particular substance in question. Detecting potential adverse effects and relating these conclusively to an individual characteristic of the plant can be difficult. As such, every effort should be made to fully characterize the plant with respect to appropriate counterparts. If characterization of the plant is insufficient to conduct a thorough safety assessment, or if it raises safety concerns, properly designed animal feeding studies may be requested using in vitro produced protein, whole plant or appropriate plant parts. For those studies which use plant or plant parts, the material used in the studies should be representative of the material that will be used in Canada. Laboratory animal studies and/or livestock feeding trials may be required to address any toxicological concerns arising from an assessment of the data submitted under sections 2.1 to 6.0.

Animal studies may also be needed as evidence of nutritional adequacy, including nutrient bioavailability. The necessity for these studies would be determined based on an assessment of the data submitted under sections 2.1 to 6.0.

In the case of intentional modification of the nutritional composition or functionality, in vitro and/or in vivo studies to support the safety and efficacy of the feed are required.

Authorization of the release of a novel feed for research purposes must be obtained from the Feed Section prior to conducting livestock feeding trials with novel feeds in Canada. For guidance on applying for authorization of the release for research purposes please refer to Trade Memorandum T-3-160, Supplement 1.

8.0 EVALUATION OF ENVIRONMENTAL SAFETY

An evaluation of the environmental impact of the release of the novel feed into the environment, will be required if an assessment has not already been undertaken by the Plant Biosafety Office, CFIA.

This assessment will take into consideration the following:

9.0 METHOD OF DETECTION AND IDENTIFICATION REQUIREMENTS

A decision regarding authorization of the release of a novel feed will not be made until the following is submitted to CFIA:

1. An appropriate method for the detection and identification of the novel feed.

2. Written agreement to provide the CFIA with reference material suitable to support the method.

Consultation with the CFIA is recommended prior to submission to determine appropriate detection and identification methodologies and reference material.

Guidance on what constitutes a suitable method is provided.

10.0 REGULATORY DECISION

Based on the information received and after evaluating the potential impact on livestock, humans and the environment, the Feed Section will:

1. Authorize the release of the novel feed where there is minimal risk*.

2. Refuse to authorize the release of the novel feed where the use poses an unacceptable risk.

3. Follow-up with the applicant for additional information that the Feed Section requires to complete the assessment ("deficiency letter"), followed by one of the decisions above. The Feed Section will consider the application closed if no response to the deficiency letter is received after one year from the date of the deficiency letter.

* Conditions may be imposed on authorizations to manage risk

11.0 HARMONIZATION OF APPROVALS OF PNTs, NOVEL FEEDS AND NOVEL FOODS

The authorization of a PNT intended for environmental release, for use as novel food and as novel feed will be granted in a harmonized fashion to minimize the potential for unapproved products to enter the Canadian environment or food or feed supplies. Proponents and importers should be aware that approvals are required from all three regulatory bodies prior to environmental release or food or feed use.

A novel feed from a PNT that could reasonably be expected to be released into the environment or used as food will not be authorized for livestock feed use until:

• the Plant Biosafety Office, CFIA, is ready to authorize the PNT for environmental release under the authority of the Seeds Act and Regulations, and

• the Novel Foods Section, Health Canada, is ready to provide notification of no objection for human food use of the novel food under the authority of Division 28 of the Food and Drug Regulations.

Where plant derived products are intended for exclusive use as food, feed or molecular farming, consultations among regulatory authorities will be required to assess any potential risks, and management thereof, associated with release of the product into a commodity stream for which it is not intended.

Please note that once the assessments have been completed, the applicant is notified in writing by the CFIA and Health Canada (separate letters) on their respective decisions regarding the application.

12.0 POSTING OF DECISION

After a regulatory decision has been made, the Feed Section posts a decision document, which is a record of the assessment, on the CFIA website. The decision documents explain the regulatory decision reached by the Feed Section and the Plant Biosafety Office following their evaluations.

13.0 NEW INFORMATION REQUIREMENTS

If at any time the proponent becomes aware of any new information regarding risk to the environment, to livestock or human health that could result from the release of the novel feed or lines derived from it, the proponent must immediately provide such information to the CFIA.

On the basis of new information, regardless of source, the CFIA will re-evaluate the potential impact on and risk to the environment, including the potential impact on and risk to human or animal health with respect to the livestock feed use. The CFIA may impose additional conditions respecting the release or use as livestock feed, may change the conditions respecting these authorizations or cancel the authorizations and require the proponent to stop the release or use as livestock feed and take any appropriate action necessary to eliminate or minimize the risk.

This bulletin is published by the Animal Health and Production Division, Canadian Food Inspection Agency. For further information, please contact:

Feed Section
Animal Health and Production Division
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario
K1A 0Y9

Telephone: (613) 225-2342
Facsimile: (613) 228-6614

Directive 95-03 "Guidelines for the Assessment of Novel Feeds: Plant Sources", has been prepared to provide guidance regarding the submission of an application for the authorization of the release of a novel feed, as may be required under the Feeds Regulations. Please be aware that the information provided in these guidelines is not exhaustive and will be updated as appropriate to reflect current scientific knowledge. For further clarification, applicants are strongly recommended to consult with the Canadian Food Inspection Agency's Feed Section. For all purposes of interpreting and applying the law, applicants are invited to consult the official versions of the relevant Acts and Regulations.