Animals >
Livestock Feeds >
Trade Memoranda
T-3-160 (supplement 1) - Draft -
Notification and Authorization of the Release of a Novel Feed for Research
Purposes
August 23, 2004
The purpose of this memorandum is to clarify the regulatory requirements for
research with novel feeds.
The release of all novel feeds composed of or derived from an
organism or organisms are subject to the authority of the Feeds Act and Regulations. Individuals or
companies who intend to conduct research with novel feeds, whether imported or
manufactured in Canada, are required to apply for and obtain an Authorization
of the Release of a Novel Feed for Research Purposes prior to the start of the
research, if either of the following conditions pertain to the research
- The applicant intends to conduct a livestock feeding trial, contained or
otherwise, with a novel feed (plant, microbial or animal sources) that is not
approved and/or registered by the Feed Section of the CFIA;
and/or -
-
The applicant intends to conduct research with novel feed or
with a feed that is/has a novel organism or parts or products thereof
incorporated into it (e.g. testing the
ensiling properties of a novel microorganism or a plant with a novel trait),
where the novel feed is not approved or registered by the Feed Section, and the
research establishment is associated with a livestock production/research
facility. This requirement does not apply when the research is taking place in
a contained laboratory environment. It is recommended that research
establishments consult with the Feed Section in advance of initiating the
research to determine if an application is required.
Authorizations of the Release of a Novel Feed for Research
Purposes do not apply to feeds or substances that are not regulated under the
Feeds Act and Regulations, including;
-
Feeds that will be fed to non-livestock species
and are, thus, not covered by the Feeds Act and Regulations. Livestock
species include horses, cattle, sheep, goats, swine, foxes, fish, mink,
rabbits, and poultry (chicken, turkey, ducks and geese). Individuals and
companies who intend to import experimental material for research with
non-livestock species may be subject to regulatory oversight by other
governmental departments;
-
Ingredients/products that may be considered as drugs or
veterinary biologics as per their purpose as defined in the research
protocol, product description, published literature or product label.
Experimental research conducted with ingredients/products for purposes other
than feed, e.g. for health-related claims, do
not require an authorization from the Feed Section but may require permits or
authorizations from other government departments. Research with a
ingredient/product that has a drug-related claim may require an experimental
studies certificate from the Veterinary Drugs Directorate, Health Canada while an
ingredient/product with a veterinary biologic function may require a permit
from the Veterinary Biologics
Section of the Canadian Food Inspection Agency. Where applicants are
uncertain of the category of the ingredient/product, they are encouraged to
consult first with the Veterinary Drugs Directorate or with the Veterinary
Biologics Section. Appendix I of T-3-160 provides the definitions of a feed, a drug
and a veterinary biologic.
Veterinary Biologics Section
Canadian Food Inspection Agency
2 Constellation Crescent
Ottawa, Ontario
K1A 0Y9
Telephone: 613-225-2342
Fax: 613-228-6612
|
Veterinary Drugs Directorate
Health Canada
Holland Cross Complex
Tower A, Ground Floor
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Telephone: 613-954-5687
Fax: 613-957-3861
|
Upon receipt of an application for an Authorization of Research with a Novel
Feed for Research Purposes, the Feed Section will conduct a preliminary review
of the novel feed and its intended purpose. Where the ingredient/product
description, published literature or label claims indicate that the
ingredient/product may be a drug or a veterinary biologic, the Feed Section
will return the application.
Application Procedures:
The Feed Section will review an application for the Authorization of the
Release of a Novel Feed for Research Purposes in accordance with the service
standard of 90 business days, conditional upon receipt of all
required information. When the novel feed and all livestock and livestock
products produced from the novel feed are disposed of in a manner that would
not result in the dissemination or entry of the novel feed and any livestock
and livestock products produced from the novel feed into the environment
including the food or feed chain, a limited safety review will be conducted by
the Feed Section. When the research animals and products thereof are intended
to enter the food chain, the feed chain or the environment, a comprehensive
safety review of the novel feed will be conducted and will include the detailed
characterization of the novel feed (and where applicable, the novel trait), all
information and data in respect of the novel feed that are relevant to
identifying risks to the environment, including risks to human or animal
health. Please note that entry into the food chain may be subject to approval
by Health Canada. Disposal into the environment must be in accordance with
federal, provincial and local environmental regulations.
| Administrative Application
Requirements:
|
| 1. |
A covering letter; |
| 2. |
A completed Application Form for Feed Registration or
Renewal with an application fee of $302.10 ($285.00 + GST); |
| For imported feeds (if applicable):
In addition to the administrative requirements outlined above, the following
information must also be submitted if the novel feed is to be imported into
Canada for research purposes:
|
| 3. |
Quantity of product to be imported, as determined by
experimental calculations showing the amount of feed required for the research
trial; |
| 4. |
Name and address of the manufacture; |
| 5. |
Means by which the product will enter the country
(courier, train, plane, etc.), the date
(approximate – make a 2-week window for entry) and the point of entry.
Where more than one shipment of the feed will be required to complete the
experiment, the means of entry into Canada, the port of entry, the quantities
to be imported and the date of importation must be provided for each shipment.
If the quantities and the dates of entry of the additional shipments are not
known at the time of application, separate applications will be required for
the additional shipments; |
| 6. |
Compliance with import requirements (e.g. import permits) of the Animal Health and Production
Division or the Plant Health and Production Division (if applicable). |
| Note: |
For feeds imported into Canada and containing animal
products or by-products, the country of origin of the feed and the country of
origin of the animal products and by-products must be identified. |
| Data Requirements: |
| Pursuant to Section 4.2 of the Feed
Regulations, the following information is required for the Notification
and Authorization of the Release of a Novel Feed for Research Purposes:
|
| 7. |
The purpose and the objectives of the proposed
research; |
| 8. |
A list of ingredients or formulation (if
applicable); |
| 9. |
A description of the novel feed; |
| 10. |
A description of the stability of the novel feed or
the novel trait (if applicable) e.g., fate of
a novel enzyme in the gastrointestinal tract and/or in the environment, if
known; |
| 11. |
Name and address of the manufacturer; |
| 12. |
If the novel feed was grown and/or processed in
Canada, in a location separate from the research facility, please provide the
following: |
|
a. |
the field trial number if the novel feed is composed of or
derived from a novel plant grown in Canada; |
|
b. |
the location of each processing facility, including the name,
address and contact information; |
|
c. |
A description of the measures taken to prevent the release of
the novel feed in the processing facility and during transport; |
| 13. |
The name of the person or body responsible for the
research; |
| 14. |
The name, address and contact information of the
person supervising the research; |
| 15. |
A concise protocol of the research including: |
|
a. |
The start date, end date and duration of the research; |
|
b. |
The target species; |
|
c. |
The experimental design and the methods of statistical
analysis; |
|
d. |
The treatments, replicates, number of animals per treatment,
allocation of animals, etc.; |
|
e. |
A list of the variables to be measured, to include methods and
frequency of measurements; |
|
f. |
The proposed (calculated) composition of the diet; |
| 16. |
The location of the proposed research; |
| 17. |
A description of the measures taken to prevent the
release of the novel feed in the research facility; |
| 18. |
A description of the animal housing facilities and
the access restrictions; |
| 19. |
A description of the disposal protocol: |
|
a. |
The method(s) to be used for the safe disposal of the livestock
and all livestock products and by-products produced by livestock fed the novel
feed; |
|
b. |
The method(s) to be used for the safe disposal of the leftover
novel feed or the feed containing the novel ingredient once the study has been
completed; |
|
c. |
The address and contact information of the disposal
facility; |
| 20. |
A description of the contingency plan to be followed
to minimize any adverse effects of an accidental release of the novel feed or
the animals fed the novel feed and products/by-products thereof (if
applicable); |
| If the novel feed, and/or research animals and
products thereof are intended to enter the food or feed chain, or the
environment, data that demonstrate the safety of the feed to humans, animals
and the environment must be submitted. Where the safety data available at the
time of application is insufficient to assess the safety of the novel feed and
the purpose of the proposed research is to generate additional safety data, an
Authorization of Release of Novel a Feed for Research Purposes may be granted
conditional on the safe disposal of the leftover feed, the research animals and
products thereof, i.e. no entry into the
food chain, feed chain or the environment. This condition may be revised upon
submission of a new application for a safety assessment and review of the
safety data generated during the research trial and any other data submitted by
the applicant in support of the safety of the feed. However, there is no
guarantee that the review time for the new information, if found satisfactory,
will coincide with marketability of the animals.
For guidance on the safety data that may be required,
please refer to the appropriate guidelines for the assessment of novel
feeds:
Guidelines for the
Assessment of Novel Feed from Plants with Novel Traits (Dir95-03)
Draft Guidelines for the Safety Assessment of Novel Feeds: Microbial
products [contact Feed Section]
Please note that not all requirements listed in the guidelines are
applicable to a feed that will be used for research purposes. Evaluations of
submissions for release into the food chain, the feed chain or the environment
will be on a case-by-case basis and data requirements may vary depending on the
novel feed and the intended disposal methods of all research material at the
end of the trial. It is recommended that applicants consult with the Feed
Section prior to assembling a data package for an authorization for the release
of a novel feed for research purposes.
Research trials that have been authorized by the Feed Section are subject to
inspection by the CFIA to verify that all conditions
placed on the research trial have been respected.
For more information, please contact:
Feed Section
Animal Health & Production Division
Canadian Food Inspection Agency
59 Camelot Drive
Ottawa, Ontario, Canada
K1A 0Y9
Telephone: 613-225-2342
Facsimile: 613-228-6614
|
|
