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Feed Ingredient Assessment and Authorization – Modernized Regulatory Framework Proposal – Consultation Summary – Respondent Comments and CFIA Responses

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Table of Contents

November 20, 2013 - December 20, 2013

Introduction

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 maintaining animal and human health, as well as environmental and economic stability. The modernization of the Regulations is being designed to benefit the collective Canadian feed industry which includes commercial feed manufacturers, retailers, importers, exporters, ingredient manufacturers, and farmers. 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.

Within the scope of the current feed regulatory framework, all feed ingredients require pre-market assessment and authorization prior to manufacture, sale and importation for feeding to livestock. Ingredients are assessed for efficacy and safety in the interest of protecting human health (food safety and occupational health), animal health and the environment. Once authorized, feed ingredients are listed in Schedules IV or V of the Regulations. Safe, effective feeds and feed ingredients contribute to the production of safe food products as well as healthy and efficient livestock.

About the Consultation

Following preliminary pre-consultation activities with stakeholders and interested parties during 2012, the Agency embarked on further consultation in 2013 by way of more subject-specific workshops and proposals (or "modules") given the comprehensive, complex nature of the feed regulatory modernization project. To this end, the Agency prepared and posted the module, Feed Ingredient Assessment and Authorization - Regulatory Framework Proposal, and undertook a 30-day consultation on feed ingredient regulation to:

Figure 1 – Proposed Feed Ingredient Assessment and Authorization Process
Figure 1. Description follows.
Description of Figure 1

The figure illustrates, by way of labelled bubbles organized in a circle and joined to each other with arrows, a proposed series of six steps that the CFIA will follow in the assessment and authorization of feed ingredients:

  1. Application;
  2. Notification of Application;
  3. Assessments;
  4. Assessment Outcomes;
  5. Positive List; and
  6. Post-authorization Controls.

In the centre of this circle of six bubbles is a rectangle labelled as Authorization; it is linked to the bubbles by an arrow between steps 5 and 6 to indicate that an ingredient would be authorized in this proposed process following the Positive List step.

The CFIA invited comments from interested parties from November 20, 2013 to December 20, 2013.

The primary mechanisms to facilitate the consultation involved the:

Twenty-one (21) responses were received in respect of this consultation and two (2) additional responses received during pre-consultation in 2012 specifically regarding feed ingredient assessment and authorization have been considered in the preparation of this summary.

This report consolidates and summarizes the comments received during this consultation and the pre-consultation period that directly pertain to the feed ingredient proposal and the CFIA's response to those comments.

What We Heard

Respondent Profile

Table 1 provides a summary of the number of written comments received and from whom they were received.

Table 1: Respondent Profile
Category of RespondentDistribution
Feed Industry – Associations6
Feed Industry – Individuals or Businesses6
Livestock Producers – Associations4
Livestock Producers – Individuals or Businesses0
Other Industry – Associations4
Other Industry – Individuals or Businesses0
Government (Canadian federal/provincial)3
Total23

Key Respondent Messages

CFIA Response

In seeking to prepare a modernized positive list of authorized feed ingredients, the CFIA will initiate a review of the organization and classification of feed ingredients currently authorized for feeding to livestock and will consult with regulated industry on the ingredient re-organization and classification. In addition, the CFIA will invite industry representatives to review and modify existing authorized ingredient descriptions to better reflect how the ingredients are currently represented and used. The CFIA will also invite regulated industry to collaborate on the development of a positive list of permissible claims.

Classification of Feed Ingredients [Section 4 of Proposal]

A few (4) responses included comments that current feed versus veterinary drug classification criteria and associated guidance falls short of recognizing that "a continuum of products/substances exist that go beyond providing nutritional benefits to animals but do not fall within the definition of a drug i.e. to prevent, treat, mitigate or cure disease. The regulatory framework should recognize this continuum and risks and be clear on which substances are feeds or drugs".

Process-specific Comments

Notification of Applications [Step 2 in Figure 1, Section 5. 3 of proposal]

CFIA Response

The CFIA will investigate how notice of application processes are designed and administered by other jurisdictions and take the information gathered into account in developing such a process and guidance related to feed ingredient applications.

Assessments [Step 3 in Figure 1, Section 5. 4 of proposal]

Consultation on Proposed Outcomes [Step 4 in Figure 1, Section 5. 6 of proposal]

Several comments were received in response to this section of the proposal (10):

CFIA Response

The Agriculture Growth Act has provided authority to incorporate information by reference. To meet the requirements for documents incorporated by reference, the CFIA will be obliged to consult on additions/modifications to a positive list of authorized ingredients [see Step 5 in Figure 1, Section 5.7 in the proposal] even though the list is managed outside of the formal regulatory process. Even the "traditional" (current) approach to managing ingredient changes to the Regulations requires consultation i.e. to pre-pub updated Schedules for public review and comment prior to finalization (final publication). The CFIA will seek opportunities to streamline consultations in a way that is consistent with the Government's commitment to transparency.

Positive List of Authorized Ingredients [Step 5 in Figure 1, Section 5. 7 of proposal]

Other Areas of Potential Regulatory Change [Section 6 of the proposal]

CFIA Response

The CFIA has further investigated the feasibility of providing data exclusivity as part of a modernized feed regulatory framework. Under Canadian law, any data submitted is not considered to be intellectual property. As another consideration, the form in which the data is presented to the CFIA may be the subject of copyright. While the CFIA can treat the data as confidential business information but it is not published or otherwise disclosed directly, it is thought that copyright protection would offer limited practical value to exclusivity given the goal of the applicant.

The CFIA will continue to investigate the feasibility of amending or making new regulations under the Feeds Act to give exclusive use or marketing rights for a period of time with respect to an ingredient to the first applicant who successfully provides the requisite data. If such regulations are feasible, consideration will also be given to the impact such regulations would have on industry access and competitiveness.

Next Steps

The CFIA will prepare a consolidated proposal which will take into consideration the comments received on this proposal, as well as those on the Feed Labelling and Feed Hazard Identification and Preventive Controls proposals. Further clarification on the proposed requirements will be provided in the consolidated proposal. The consolidated proposal will be distributed and posted for further stakeholder consultation.

The CFIA would like to thank everyone who contributed their time to this consultation process and shared their views.

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