2024-12-03
The Canadian Food Inspection Agency (CFIA) is launching a pilot project to test regulatory guidance for a new category of livestock feeds: microbial mitigants. A microbial mitigant ingredient is an active ingredient that is intended to be used to prevent the growth of microbial contaminants in livestock feeds. It is not intended to bring contaminated feeds back into compliance, nor be used to treat, prevent, or cure a disease or condition within the animal. Microbial mitigant products are specialty feeds (that is, mixed feeds). These products contain 1 or more microbial mitigant ingredients and carrier and require registration. This project will involve piloting the implementation of draft guidance using a limited number of pre-market applications assessed on a priority basis for products that would fall under this new feed category.
Background
Livestock producers and the feed industry have expressed a strong interest in having a pathway to market products intended to prevent the growth of microbial contaminants in livestock feeds.
In response to this feedback, the CFIA has begun developing draft regulatory guidance to describe the data requirements that would need to be addressed in pre-market applications for feed approval or registration of ingredients and products falling under the microbial mitigants category. Microbial mitigant ingredients require approval before they can be manufactured, sold, or imported into Canada.
Product eligibility
The pilot will consider microbial mitigant ingredients and products that meet the following criteria:
- have a purpose of preventing the growth of microbial contaminants in livestock feeds
- exert their microbial mitigation activity (mode of action) in the feed
- products that act in the animal and aim to treat, prevent, or cure a disease or condition would not be acceptable
- have supporting safety and efficacy data for a pre-market application, per the draft guidance
- be able to submit an application for pre-market evaluation within 3 to 6 months of receiving confirmation of eligibility
Pilot process
Interested companies will be able to submit their products for eligibility verification by CFIA using a pre-screening form. Approximately 5 eligible ingredients and their accompanying specialty products will be accepted into the pilot at this time, with a maximum of 1 set of applications per company.
If the CFIA considers that a product meets the criteria, the company will be invited to submit a pre-market application for approval or registration of the feed ingredient and the specialty feed containing that ingredient. The pre-market applications will need to address the data requirements set out in the draft guidance for the microbial mitigants category, to demonstrate safety and efficacy. Applications that are selected for the pilot will be prioritized in the queue for pre-market evaluation, to allow for focused testing of the draft regulatory guidance.
Note, participation in this pilot does not guarantee approval. All feeds must be demonstrated to be safe and efficacious following the pre-market evaluation. Given that the guidance will be in draft form, it is possible that additional data may be requested to satisfy the pre-market endpoints.
Participants in the pilot will be expected to provide detailed feedback on the guidance as part of the process. Depending on feedback and findings of the pre-market evaluations of submitted applications, the draft guidance will be revised. The CFIA may also conduct additional pre-consultation meetings to supplement feedback and input for guidance revisions. Following the pilot project stage, the draft guidance will be posted for public consultation prior to final publication.
Next steps
If you have any questions or would like to participate in the pilot project, please contact the CFIA's Animal Feed Program by email at cfia.afp-paa.acia@inspection.gc.ca, with "Microbial mitigants pilot project" in the subject line by January 15, 2025. Detailed information, along with the eligibility form and the draft guidance, will be made available to stakeholders interested in participating in the pilot project.