Archived - Proposal – Veterinary Biologics in Feeds

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Archived

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June 2016

Purpose

The Canadian Food Inspection Agency (CFIA) has embarked on a comprehensive change agenda to strengthen its foundation of legislation, regulatory programs and inspection delivery. These directions set the context for the renewal of the federal Feeds Regulations (Regulations).

The goal of modernizing the Regulations is to develop a modernized risk- and outcome- based regulatory framework for feeds which:

• safeguards feeds and the food production continuum;
• attains the most effective and efficient balance between fair and competitive trade in the market; and
• minimizes regulatory burden.

The current modernization of the Regulations has provided the opportunity to review the regulatory oversight of the use of veterinary biologics in feeds and recommend possible updates or amendments to the current requirements, as deemed necessary.

Current Situation and Discussions

In Canada, veterinary biologics are regulated by the CFIA and include animal health products such as vaccines, antibody products, and in vitro diagnostic test kits that are used for the prevention, treatment, or diagnosis of infectious diseases in animals. Using authorities provided by the Health of Animals Act and Regulations, the Canadian Centre for Veterinary Biologics (CCVB) of the CFIA is responsible for the licensing of all veterinary biologics manufactured and/or distributed in Canada. To meet the requirements for licensure, a veterinary biologic must be shown to be pure, potent and effective when used as directed in the target species. The licensing submission must also contain data demonstrating that the product can be manufactured and used without adversely affecting animal health, human health, food safety or the environment.

While the primary route of administration for licensed veterinary biologics is through injection or addition to water, there is currently one (1) veterinary biologic licensed in Canada to be administered as a livestock feed additive. The current Feeds Regulations do not exempt feeds containing veterinary biologics from mandatory registration prior to manufacture, sale and/or import into Canada.

Consequently, in addition to the mandatory licensing requirements for the veterinary biologic mentioned above, each livestock feed containing a veterinary biologic that is destined for sale in the Canadian marketplace would also be subject to mandatory registration under the Feeds Regulations for the resulting feed/veterinary biologic product, administered by the Animal Feed Division (AFD) of CFIA. This additional regulatory requirement for manufacturers who wish to market or sell their licensed veterinary biologic incorporated in a livestock feed, that would otherwise be exempt from registration, may be unnecessary.

Discussions between the AFD and the CCVB of CFIA were held to identify and compare current and future regulatory oversight measures for veterinary biologics in feeds and to identify potential impacts on their respective regulatory measures, through the lens of a modernized Feeds Regulations. Discussions with CCVB indicated there would be minimal impact to their respective regulatory oversight if changes were proposed to the Feeds Regulations with respect to regulating veterinary biologic products for inclusion in livestock feeds.

Proposal and Anticipated Outcomes

Given that veterinary biologic products undergo an extensive safety and efficacy assessment by the CCVB, it is proposed that the Feeds Regulations would be amended to include an exemption from mandatory registration for livestock feeds containing a veterinary biologic, provided that the veterinary biologic is licensed for that purpose and used according to the manufacturer's label recommendations, and that the feed would otherwise be considered exempt from registration. This approach would be comparable to the exemption from registration criteria that are currently in place in the Feeds Regulations with respect to the addition of medicating ingredients (authorized by Health Canada) to livestock feeds.

As with any modification, consideration must be given to ensure it is made within an enforceable regulatory framework. Therefore, it is further proposed that the modernized Regulations would include the establishment of a compendium, incorporated by reference in the Regulations, to stipulate the conditions of use and labelling requirements for feeds containing veterinary biologics. To achieve uniformity of regulatory oversight, this new compendium would utilize the same formatting as the Compendium of Medicating Ingredients Brochures (CMIB) and, if applied in compliance with the Regulations, would exempt the resulting feed product from mandatory registration under the Feeds Regulations.

Appendix I is a mock-up of a suggested Compendium of Non-Feed Products Authorized for Use in Feeds.

This modernized regulatory approach to the oversight of veterinary biologics use in feeds would:

• allow flexibility for the addition of licensed veterinary biologics to livestock feeds without the need of additional pre-market assessment and authorization;
• allow for timely updates to the compendium as new feed additive veterinary biologics are licenced for this purpose;
• allow CFIA to minimize duplication while maintaining regulatory oversight for hazards that may negatively impact human or animal health or the environment; and,
• reduce the regulatory burden on industry wishing to get beneficial products into the marketplace.

As an example, the approach described above could also be applied to the inclusion of licensed colostrum products in livestock feed. The manufacturer of the colostrum product would need to provide the CCVB with sufficient data to support the immune benefits (minimum IgG levels) when used in feeds, such as registered milk replacers. This could reduce additional registration requirements with CFIA for the resulting feed/veterinary biologic product and would no longer limit the use of colostrum solely as a direct-fed product.

While this proposal specifically references feed-additive veterinary biologics, this approach could also be appropriate for other non-feed products that have been licensed/registered or authorized by another Government of Canada department or agency for inclusion/administration via feeds and would benefit from similar oversight where applicable.

We strongly encourage you to provide your input and feedback, which is critically important to the success of the regulatory modernization initiative. Written comments may be forwarded by July 15, 2016 to:

Sergio Tolusso
Canadian Food Inspection Agency
Animal Feed Division
59 Camelot Drive
Ottawa, ON K1A 0Y9
Email: Sergio.tolusso@inspection.gc.ca
Fax: 613-773-7565

Appendix I – Compendium of Non-Feed Products Authorized for Use in Livestock Feeds

Escherichia coli Polyclonal Antibodies, Chicken Egg Origin – Brochure #1

Date Revised: YYYY-MM

Approved Brands

1. Hyper-Egg K-88 (Nutratech)

Approved for use

In meal or pellet feed for swine.

Approved claims

For swine – Claim 1

Claim 1: As an aid in the prevention of diarrhea due to infection with enterotoxigenic Escherichia coli K-88.

Approved inclusion level:

Add egg powder containing polyclonal antibodies to E. coli K-88 at the rate of 2-4 kg per metric tonne of feed.

Directions:

Feed to piglets during the two week period following weaning.

Warning:

1. Not for human consumption. (Required on premix and supplement labels only.)

Notes:

1. Store in a cool and dry place.
2. Avoid humidity and direct sunlight.
3. Feed should not be pelleted at temperatures above 70°C.