Veterinary Biologics in Feed Proposal
Consultation Summary – Respondent Comments and CFIA Responses
June 13, 2016 – July 15, 2016
Table of contents
- About the Consultation
- What We Heard
- Next Steps
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 Feeds Regulations (Regulations).
The goal of modernizing the Regulations is to reduce compliance burden and support innovation while ensuring feeds are safe and contribute to the production and maintenance of healthy livestock, safe foods of animal origin and do not pose a significant risk to the environment. The modernization of the Regulations is being designed to benefit the collective Canadian feed industry which includes livestock producers, commercial feed manufacturers, retailers, importers, exporters, ingredient manufacturers, and food processors. As well as aligning with other international feed regulatory regimes, modernization also maintains the objective of enhancing animal health and food safety for the Canadian public.
The oversight of veterinary biologics administered via livestock feeds is just one part of the Regulations which is being addressed as part of the modernization project. The Canadian Centre for Veterinary Biologics (CCVB) of the CFIA is responsible for the assessment and licensing of all veterinary biologics manufactured or imported for distribution in Canada. In addition, each livestock feed containing a veterinary biologic that is destined for sale in the Canadian marketplace is currently subject to mandatory feed registration requirements under the Feeds Regulations, administered by the CFIA. In keeping with the goal of reducing compliance burden and supporting innovation while maintaining animal and public health protection, the CFIA's livestock feed and veterinary biologics programs collaborated to identify an alternative regulatory approach to subjecting a product to two distinct authorization processes.
The CFIA undertook a consultation from June 13, 2016 to July 15, 2016 on the veterinary biologics in livestock feeds proposal to outline the alternative approach to the current regulatory oversight requirements.
This report consolidates and summarizes the comments received during the consultation period that directly pertain to the veterinary biologics in livestock feeds proposal and the CFIA's response to those comments.
The CFIA would like to thank everyone who participated in the consultation and for contributing their time to the consultation process and sharing their views.
About the Consultation
The primary mode of consultation involved the preparation and posting of the Proposal – Veterinary Biologics in Feeds on the CFIA website and outreach directly to industry stakeholders, government partners and CFIA staff. Sixteen (16) sets of comments were received in response to the veterinary biologics proposal.
What We Heard
|Category of Respondent||Distribution|
|Feed Industry – Individual||6|
|Feed Industry – Association||3|
|Livestock Producer – Individual||0|
|Livestock Producer – Association||1|
|Other Feed Inputs||4|
|Government (Canadian Federal/Provincial)||2|
The feed industry association comments represent Canadian and American commercial feed manufacturers, as well as some of the larger feed ingredient groups. The Canadian feed manufacturers association represents 90 percent of commercial feed manufactured in Canada, while the US association represents about 75 percent of commercial feed manufactured in the US. The "Other Feed Inputs" listed in the table above that responded included industry consulting firms and a trade association representing the developers, manufacturers and distributors of animal pharmaceuticals, biologics, feed additives and animal pesticides in Canada.
Key Respondent Messages
There was considerable consensus among respondents regarding the alternative regulatory oversight discussed in this proposal. Respondents indicated they agreed with the concept of the suggested approach and felt it would:
- protect both the animal and plant resource bases as well as the environment;
- represent a step forward by CFIA; and,
- reduce regulatory burden by eliminating duplicate registration requirements.
While stakeholders provided suggestions for improvement regarding additional products that may also benefit from this form of regulatory oversight, the CFIA did not receive any feedback indicating an outright disagreement with the proposed concept.
The comments the CFIA received from livestock producers focused mostly on the importance of CFIA:
- maintaining oversight for veterinary biologic products; and,
- ensuring the quality and formula of these products are controlled.
Document Format and Incorporation by Reference
The proposal suggested that the Agency's current Compendium of Medicating Ingredients Brochures (CMIB) would be utilized as a template in formatting the proposed Compendium of Non-Feed Products Authorized for Use in Livestock Feeds (Compendium). Furthermore, the proposal indicated the Compendium would be incorporated by reference in the Regulations to allow for timely updates to the document, as required. Those respondents commenting on this aspect of the proposal were generally in agreement with the suggestion to mirror the formatting of the new document with that of the CMIB. In addition, respondents also agreed that this new compendium should be incorporated by reference in the regulations to allow flexibility in updating the document as needed.
The CFIA will utilize the current CMIB format to create the proposed Compendium of Non-Feed Products Authorized for Use in Livestock Feeds and will seek to incorporate this document by reference in the Regulations.
In keeping with the CFIA's Incorporation by Reference Policy, the CFIA will provide a plan regarding the frequency and process for the review and revision of the incorporated document as part of the formal Canada Gazette Part I publication.
Compendium – Scope of Products
The proposal suggested that 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. Clarification was requested from some respondents with respect to what "other" products could potentially be included in the Compendium to allow greater flexibility.
Respondents also provided a number of suggestions for inclusion within the scope of the Compendium, including:
- viable yeast supplements;
- direct fed microbial / forage additives; and,
- probiotics or prebiotics.
The CFIA agrees that other products may benefit from this method of oversight and has not identified any other specific product types at this time. The suggestions provided above, i.e. viable yeast supplements and forage additives, are presently regulated as feeds and as such would not be appropriate for this Compendium approach.
Health Canada continues to implement changes to their regulatory oversight with respect to drugs, (Regulations Amending the Food and Drug Regulations (Veterinary Drugs – Antimicrobial Resistance), including establishing a list of veterinary health products (VHPs) that may provide an additional pathway for products such as probiotics or direct fed microbials. Once Health Canada has finalized their oversight approach, CFIA will explore possible opportunities within policy guidance and development that may provide added flexibility regarding the addition of VHPs to livestock feeds.
In addition, CFIA will continue to work with our partners at Health Canada to assist in differentiating products as drugs or feeds (Guidance document on classification of veterinary drugs and livestock feeds).
Once finalized, the CFIA further commits to sharing the criteria and process for the inclusion of other product types into the proposed Compendium of Non-Feed Products Authorized for Use in Livestock Feeds.
The CFIA is preparing a formal regulatory proposal for publication in the Canada Gazette Part I (anticipated in 2017) which will incorporate the comments received on all the consultation proposals, public meetings, stakeholder workshops and submissions and other outreach activities that have been used over the course of the project. A draft of the Compendium will be available for public review and comment at the time of the Canada Gazette publication.
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