Feed Ingredient Assessment and Authorization – Modernized Regulatory Framework Proposal – Consultation Summary – Respondent Comments and CFIA Responses
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Table of Contents
- What We Heard
- Next Steps
November 20, 2013 - December 20, 2013
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:
- map out a six-step authorization process (Figure 1); and
- propose changes to current processes and requirements to be applied in a modernized ingredient assessment and authorization framework.
The CFIA invited comments from interested parties from November 20, 2013 to December 20, 2013.
The primary mechanisms to facilitate the consultation involved the:
- direct distribution of the proposal to stakeholder groups, individuals and other interested parties who have been engaged in Agency feed regulatory modernization consultation activities to date;
- posting of the feed ingredient proposal on the CFIA website; and
- outreach directly to industry stakeholders by Agency staff.
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
Table 1 provides a summary of the number of written comments received and from whom they were received.
|Category of Respondent||Distribution|
|Feed Industry – Associations||6|
|Feed Industry – Individuals or Businesses||6|
|Livestock Producers – Associations||4|
|Livestock Producers – Individuals or Businesses||0|
|Other Industry – Associations||4|
|Other Industry – Individuals or Businesses||0|
|Government (Canadian federal/provincial)||3|
Key Respondent Messages
- There was general support for the range of CFIA proposals, particularly those related to the modification of requirements associated with the assessment of feed ingredients, including:
- the Agency's proposal to accept applications for ingredient authorization in Canada based on those prepared and submitted to other jurisdictions (for example, the US and European Union) for assessment and authorization;
- undertaking a process to evaluate the authorization systems employed in other jurisdictions with a view to recognizing equivalency of approaches to streamline the authorization process in Canada; and
- focus the assessment of ingredient performance to only situations where health and safety may be negatively impacted
- There was widespread support for continuing to manage authorized ingredients by way of a positive list; and
- Regulated industry was supportive and willing to work collaboratively with the CFIA to
- update the positive list of authorized ingredients; and
- develop and implement a list of allowable claims to replace the process of pre-market assessment and authorization of claims by the CFIA.
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".
Notification of Applications [Step 2 in Figure 1, Section 5. 3 of proposal]
- Several respondents (11) provided feedback on this proposed new process step
- Eight (8) respondents were generally supportive; one (1) was not, remaking that notification should be done on a voluntary basis only by applicant if they wish to.
- It was noted that from a feed industry perspective, the notification step would offer an opportunity to reduce effort on the part of applications (i.e. proponents may choose not to submit an authorization application if it can be seen that one for the same ingredient is already in the queue).
- Respondents encouraged the CFIA to look at how this process is administered by other jurisdictions (for example the Pest Management Regulatory Agency of Health Canada)
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]
- General comments (4) that the proposed ingredient assessment and authorization process needs to be more responsive and timely, the focus should be on assessment of safety.
- International data [Section 5. 4.1 of proposal]
- Many (15) respondents commented on this aspect of proposal;
- There is general support for CFIA's proposal to accept modified application packages for an ingredient that is already authorized as a feed in another country as well as authorizing ingredients in Canada that have been authorized by another jurisdiction provided the CFIA considers the other jurisdictions' authorization process to be equivalent to Canada's where the CFIA's criteria are met. One respondent even suggested that Canada consider evaluating the processes employed by Australia/New Zealand, the European Union, Japan, Mexico, and the United States for equivalence.
- It was also suggested that the CFIA be transparent about the process they plan to use to determine equivalency and that a published listing of countries that are considered equivalent in the authorization process would be useful to the Canadian feed industry.
- Some respondents felt the proposal failed to clarify how it would serve to harmonize the list of authorized ingredients in different jurisdictions.
- Two (2) respondents suggested the CFIA accept/recognize the authorized feed ingredient list published by the Association of American Feed Control Officials (AAFCO) in lieu of maintaining a Canada-specific list.
The CFIA will further investigate an approach to assess the equivalency of ingredient authorization processes used by other jurisdictions and will elaborate further on this commitment in future.
- Intended Purpose [Section 5. 4.2 of proposal]
- Several responses to this section of the proposal were submitted (12)
- The majority of feed industry and producer organizations who commented on this section of the proposal generally supported it, noting that the marketplace should determine whether a feed ingredient works or not and that the proposal would reduce burden, time and cost to regulated industry.
- Much additional clarification, however, is sought by many of the respondents. For example, it was requested that the CFIA more clearly define the terms "purpose" and "claim", identify which ingredients would/would no longer require evidence to demonstrate performance, if/where a number of ingredients would fit into existing purpose groups (e.g. enzymes, direct-fed microbials), how a proposed new purpose for an already authorized ingredient would be brought forward and how the proposal serves to harmonize ingredients authorized in Canada with those in other jurisdictions.
- Claims assessment [Section 5. 4.4 of proposal]
- Several responses to this section of the proposal were received (12)
- Feed industry organizations and two (2) producer organizations commented that they are generally supportive of the proposal regarding a positive list of pre-approved claims for ingredients Two (2) producer orgs commented that CFIA oversight as to the appropriateness of claims would be important to them.
- Only two (2) respondents commented specifically that they generally supported the refocus of oversight on claims to those with health and safety implications alone.
- Again, several respondents requested more clarity on the process that would be followed to have claims added to list.
In collaborating with regulated industry to develop a positive list of permissible claims, a mechanism to add claims to the list will also be identified as a part of this project.
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):
- A number of respondents were generally supportive of the proposal to consult on the outcome of applications prior to final decisions being taken (6) but three (3) others were not supportive
- For those who were not in favour, they expressed concerns with the potential for additional time being required to complete the authorization process and public/competitor comments might be frivolous, irrelevant or anti-competitive.
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]
- Nine (9) respondents commented
- Feed industry respondents were particularly supportive of the proposal to retain a positive list of authorized ingredients.
- Several organizations expressed an interest in working with CFIA to update current authorized ingredient descriptions of importance to their respective sectors (for example, the oilseed and animal protein meals and fats sectors, the enzymes sector).
- One (1) feed industry business has consistently advocated that ingredients already authorized by US and EU governments (and not on our positive list) should be added without the benefit of a proponent application ("grandfather-in") while revisions are being made to the list.
Other Areas of Potential Regulatory Change [Section 6 of the proposal]
- Mechanisms for Proprietary Approvals [Section 6.3]
Out of eight (8) comments received on this part of the proposal, four (4) respondents were generally in favour but an equal number were not supportive
- It was noted that under the current regulatory system, there is no specific mechanism which provides for exclusivity of data that is provided by an applicant and used during the ingredient authorization process. Stakeholders requested that a mechanism for data exclusivity be considered as part of a modernized framework, contending that a data exclusivity mechanism would recognize and protect feed ingredient innovations, encourage new ingredient development and allow sponsors to recoup their research and development costs.
- Some feed industry and the animal health products sector respondents expressed general support ("The aquaculture feed industry has no issues with the CFIA initiative to include a mechanism to provide data exclusivity.").
- Other individual feed industry respondents and a producer organization did not support the proposal, citing, for example, that "CFIA's business not to grant exclusive commercial rights to anyone".
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.
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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