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Overview of engagement process
Gut modifiers have been introduced as a new livestock feed category to allow for those products that act in the gastrointestinal tract of livestock. A consultation on the proposed guidance for registration requirements for gut modifier products was held from July 26 to September 19, 2022 by the Canadian Food Inspection Agency (CFIA)'s Animal Feed and Veterinary Biologics Division (AFVBD). Feedback was received from:
- national feed associations, both in Canada and the United States (U.S.)
- a national animal health association
- livestock producer associations
- livestock feed manufacturers
- regulatory consultants
- an international feed ingredient association
What we heard
There was overall support for the new gut modifier category as livestock feed and the added flexibility to the pre-market submission process it will provide for access to more products. This will allow for increased competitiveness for Canadian livestock producers. In particular, there was strong support for this category as it includes the consideration of environmental benefits as livestock feed claims, such as methane reduction.
Many comments highlighted the need to correct the use of the term "specialty feed" to align with the definition in the proposed new Feed Regulations; the guidance text has now been modified accordingly.
There was a request to refer to the new Canadian Feed Ingredient Table (CFIT) as proposed in the draft Feed Regulations rather than the current listing, Schedules IV and V. Until the new Feed Regulations are published in Canada Gazette, Part II, the reference to Schedules IV and V is the only legal listing; this will be updated upon final publication of the new regulations.
There were comments on the number and types of studies required to support claims for gut modifier products. The guidance on registration requirements for gut modifier products has been updated to simplify and clarify the requirements where they pertain to these specific products. Some of the comments suggested did not relate specifically to the subject of this guidance and were addressed in different guidance documents:
- RG-1 Chapter 2.8 Guidance on bridging an application to data from publicly available literature and previously approved feed applications
- RG-1 Chapter 2.9 Data flexibility for production performance endpoints and associated claims
Some respondents had questions about the process for registration renewals and the new streamlined approach. This section has been updated to align with the new mechanisms for renewals.
Some respondents had questions related to the measurement and reporting of shelf-life that extends beyond the scope of this guidance. Shelf-life and stability data for gut modifier products is required to demonstrate the stability of active ingredients and/or effectiveness of the product throughout its proposed shelf-life. Stakeholders should expect future engagement and consultation on shelf-life reporting applicable across all livestock feeds.
Respondents voiced an interest in having pathogen control options as either livestock feeds or veterinary drugs. At this time, products directly targeting pathogen control in the animal are classified as veterinary drugs. Further discussion around the pathogen control classification is out of the scope of this guidance.
Finally, some respondents expressed concern about the length of time required for the pre-market submission process. The CFIA acknowledges this concern; however, it is outside the scope of this guidance. The CFIA is working internally and with stakeholders on alternate strategies through its backlog reduction initiatives. This includes working with international regulators to align with international approvals where possible.
How the feedback was considered
The guidance, has been updated to improve the clarity related to considerations for either single ingredients or mixed feeds as gut modifiers. In addition, changes to the sections on the number of studies required to support production performance or gut modifier claims have provided ways that flexibilities can be included.
Rather than repeating guidance found in other documents, direct linkages to the appropriate documents have been added, as reflected above. Where new policies are being developed, comments have been noted.
It is noted that there is some confusion between this guidance and the anticipated modernized Feed Regulations that are yet to be published in Canada gazette, Part II. Any necessary changes to this document, including referring to the new CFIT, will be made at that time.
Next steps
We have considered the feedback and included changes in the final version of the guidance for registration requirements for gut modifier products. The CFIA looks forward to supporting this innovative new category of feed products.