Feed Hazard Identification and Preventive Controls Modernized Regulatory Framework Proposal Consultation Summary - Respondent Comments and CFIA Responses
June 23, 2014 - July 25, 2014
Table of Contents
What We Heard
- Respondent Profile
- Key Respondent Messages
- Scope [Section 4.2 of Proposal]
- Hazard Identification [Section 4.3 of the proposal]
- Preventive Controls [Section 4.4 of the proposal]
- Record Keeping [Section 4.5 of the proposal]
- Roles and Responsibilities [Section 4.6 of the proposal]
- Annex 2 Proposed Outcome Based Regulatory Requirements [Annex 2 of the proposal]
- 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 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.
Appropriate hazard identification and preventive control procedures for feeds are an internationally recognized method of preventing or mitigating the risks associated with foods and feeds.
Risks associated with feeds and ingredients can be prevented outright or mitigated, either through controls on the finished product or via a systems approach. A systems approach means that the products are produced, transported, and stored in a safe and consistent manner, thus ensuring that each batch of feed that is manufactured will meet the same standards. Product controls only verify that individual products meet standards. Inspecting and enforcing a process-based system provides the regulator and the consumer with greater confidence in the feeds that are produced under that system.
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 Hazard Identification / Preventive Controls - Regulatory Framework Proposal, and undertook a 30-day consultation on hazard identification and preventive controls with respect to feed regulation to elicit stakeholder feedback on:
- hazard identification and analysis;
- preventive control plans;
- record keeping; and
- roles and responsibilities
The CFIA invited comments from interested parties from June 23, 2014 to July 25, 2014.
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 proposal on the CFIA website; and
- outreach directly to industry stakeholders by Agency staff.
Nineteen (19) written responses were received in respect of this consultation and 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 hazard identification and preventive controls 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||4|
|Feed Industry - Individuals or Businesses||4|
|Livestock Producers - Associations||6|
|Livestock Producers - Individuals or Businesses||0|
|Other Industry - Associations||2|
|Other Industry - Individuals or Businesses||0|
|Government (Canadian federal/provincial)||3|
Key Respondent Messages
- There is support for a shift from the present-day product-based framework to an outcome-and risk-based framework, however:
- Guidance should be developed in collaboration with regulated industry and outreach/education/training should be be provided to assist understanding and compliance with new requirements
- Respondents from Quebec noted provincial regulatory requirements for licencing/controls on medicated feed manufacturing
- CFIA framework should not duplicate current provincial requirements
- Several respondents noted that the proposal did not address the potential licencing of facilities and an inspection/enforcement strategy, resulting in
- Uncertainty as to how CFIA will deploy inspection resources and determine compliance;
- Uncertainty as to what role sector-specific feed/food safety programs will play within scope of framework and potential burden on feed manufacturers (commercial and on-farm);
- Requests for more detail on how the framework would apply to livestock producers, especially for hazards beyond the scope of current food safety programs;
- Advocacy by both farm organizations and the feed industry that participation in recognized programs should be sufficient to exempt on-farm participants from requirements and/or preclude CFIA inspection and minimized CFIA inspection oversight at commercial feed mills
The CFIA is pleased with the level of general support for the proposed hazard identification and preventive controls approach.
The CFIA recognizes that sound guidance documents will assist in the successful implementation of the modernized regulations and facilitate on-going compliance with regulatory requirements. The most important benefit of effective guidance and compliance promotion is improved and consistent feed safety from the implementation of effective preventive control measures.
The CFIA will continue to work with industry to develop a new suite of regulatory guidance documents that will significantly improve the format, content and accessibility of its guidance material. This new suite of documents will update or replace existing publications to help industry to comply with the Feeds Act and Regulations including:
- Guidance to clearly explain the intent of regulatory requirements. and
- Model systems to provide examples that when properly applied have been demonstrated to achieve compliance with the regulatory requirements. These would initially include generic models.
Further elaboration on the licensing and inspection/enforcement strategy for facilities will be included in a future proposal and will be in line with the CFIA's integrated Agency Inspection Model (iAIM).
Scope [Section 4.2 of Proposal]
There was general support with the proposal that all parties involved in the manufacturing, sale, and distribution of feeds and feed ingredients would be required complete a hazard identification and assessment for their own systems and products. However, a number of respondents (5) requested additional clarification on how the proposal would apply to farms, and whether producers would have to complete hazard identification and put in place preventive controls. In addition, there was a split between support for having exemptions for feed manufactured and used on farm (2) and those who felt that farms should be subject to the same requirements as commercial feed mills (3).
The proposal indicated that hazard identification would include hazards to human health, animal health, plant health and environmental implications. Some respondents (3) indicated that they had concerns with such a broad scope for hazard identification and suggested that the CFIA should focus on food safety.
Other comments on the scope of the proposal included:
- Concern that it would be burdensome for manufacturers who are involved in many steps of the feed supply chain to identify and assess all the hazards and have a PCP in place;
- Requests for further clarification on "other substances" that is included as part of the legislative text exempting feeds manufactured on farm; and
- A suggestion that additional training or education may be required for food manufacturers who send co-or by-products for use in feed to ensure that they are aware of their role in the feed supply chain.
The scope of the Feeds Regulations currently encompasses protecting human health, animal health, plant health and the environment and this is not anticipated to change in the future regulations. CFIA appreciates the concerns raised regarding the extent of this regulatory scope. The intent is not to duplicate controls under other provincial or federal regulations but to include hazards that can be transmitted via feed.
CFIA appreciates the support for proposing a systems-based (hazard identification + preventive controls) approach. Additional guidance for producers will be included in future communications to clarify under which circumstances the regulations would apply to feed manufactured on farms.
Hazard Identification [Section 4.3 of the proposal]
The proposal indicated that those involved in throughout the feed supply chain would be required complete a hazard identification and assessment with respect to the feed-related activities in which they are involved. In addition, an illustrative list of known or reasonably foreseeable hazards was included.
- Three (3) respondents indicated that hazard analysis should be centralized so that it is being done by appropriate experts and is consistent between firms;
- Two (2) respondents indicated that everyone should be responsible for identifying the risks associated with their business sector;
- Four (4) respondents indicated that the list of hazards should be considered as a minimum or example list and further comments were supplied indicating that the list needs to be updated regularly so it represents current hazards; and
- One (1) respondent indicated that the list should not be included in regulation as that would make it difficult to update in a timely manner.
Additional comments were received on the list of hazards which included suggestions for changes or additions to the list, such as:
- Including medications which are used outside of their label directions or which are not approved;
- Providing greater clarification on salmonella and any specific strains which would be considered hazards;
- Including risks posed by ingredients that are used in mixed feeds and
- Allowing the presence of trace amounts of approved processing aids which remain in feed ingredients following their processing.
CFIA intends to provide further elaboration on the nature, source and strategies to prevent or mitigate risks posed by known or reasonably foreseeable feed-borne hazards by way of reference to international guidance and standards, model systems and development of additional guidance where necessary in this regard.
Nutrient Guarantees [Section 4.3.1 of proposal]
There was unanimous agreement that Table 4 in Schedule I of the current regulations should be removed as it is considered an outdated way of controlling risks in feed. As an alternative approach, there was support for setting maximum levels only for nutrients which may pose health and safety risks when used at high levels. It was also suggested by one respondent that maximum nutrient levels which represent potential for toxicity in livestock should be considered as part of the feed manufacturer's hazard identification and assessment.
The CFIA will proceed as proposed to remove Table 4 from the modernized regulatory framework. The CFIA will collaborate with stakeholders to develop maximum nutrient levels for feeds and how best to include these levels in the modernized framework (for example in regulation versus guidance).
Toxic Substances [Section 4.3.2 of proposal]
There was general agreement with the proposal to introduce regulations to control toxic substances in feeds. Four (4) respondents expressed agreement with the proposal. A further six (6) asked questions looking for clarification on the scope of this proposal and the implications of the changes.
Questions/concerns that were raised included:
- Concern over potential overlap of this proposal with the Schedules that are already established under the Canadian Environmental Protection Act;
- Concern that few chemical contaminants have a treatment should animals be exposed to them, meaning animals affected by them may never be released from quarantine;
- Questions about the criteria to be applied for suspicion of contamination with a toxic substance; and
- Suggestions for things that should be included as a toxic substance such as unapproved medications or medications used at unapproved levels.
The CFIA takes note of the questions and concerns identified in stakeholder feedback to this particular aspect of the proposal and will consult further on a more expanded toxic substances regulatory proposal when it becomes available.
Preventive Controls [Section 4.4 of the proposal]
While there was general support for the proposed requirement for preventive control plans, most of the comments on this section were questions requesting further clarification or details on what would be required in a PCP, who would need one and the impact on farms.
- Although the PCPs will be outcome-based, the steps to achieving the standard seem very prescriptive.
- The proposal does not allow parries to determine to what extent this may represent an increase in regulatory burden depending on how CFIA implements this change.
- Detail is required on the extent to which the new regulations are expected to cover on-farm feed production.
- Requirement to develop, implement and maintain a written PCP should not apply to products and suppliers covered under other legislation e.g. pharmaceuticals.
- The need for additional controls beyond HACCP based food safety controls remain unclear.
- All links in the [feed] chain must be involved.
- We hope CFIA recognizes participation in approved programs for identifying hazards and preventive measures.
In summary, the two main concerns expressed in this section were recognition of existing feed/food safety programs such as those employed by the feed industry and on farm food safety programs and the impact this will have on farms who manufacture their own feeds.
Elements of a PCP [Section 4.4.3 of proposal]
No comments were received specifically on the seven elements of a PCP that were proposed. Two (2) comments were received indicating that the term "biosecurity" would require further clarification.
The majority of the commenters received regarding this section (7 of 9) commented on the discussion about imports and the proposed requirements for importers. Three commenters indicated that imported products should be subject to the same requirements and oversight as domestic product would be to ensure domestic manufacturers do not have a greater compliance burden.
Other points raised included:
- Considering the recognition of foreign food safety systems;
- Placing the responsibility on the importer to do the risk assessment; and
- Ensuring adequate consultation with industry as any proposals are further refined.
PCP vs HACCP [Section 4.3.2 of proposal]
Only one comment was received on this section; the references to HACCP should read "HAACP or HAACP equivalent".
As with the proposal to require the identification and assessment of hazards, CFIA intends to provide further elaboration expectations for preventive controls plans by way of reference to international guidance and standards, model systems and development of additional guidance where necessary.
Domestic and foreign, sector-specific programs may be considered as model systems providing they address the regulatory requirements set out in the modernized framework.
With respect to feed imports, further elaboration of control measures for imports more generally will be included in the consolidated framework proposal.
Record Keeping [Section 4.5 of the proposal]
All of the comments received on record keeping (6) indicated an acceptance of the need to keep records. Specific comments were mostly directed to the period of time that records would be required to be retained as well as questions regarding which records would be required.
- Records should be kept for 10 years to remain consistent with Health of Animals Act/Regulations record keeping requirements;
- Record retention should align with on farm food safety program requirements;
- Three (3) comments specifically indicated that a record retention period should be set with a fourth commenter requesting guidance on the retention period to ensure consistency; and
- The records required and the length of the retention period should be risk-based.
The CFIA will investigate and work with other program areas (for example, CFIA food programs) to identify and specify the kinds of records that will be required for retention and the appropriate retention period(s) to optimize the reliability of information along the feed and food production continuum.
Roles and Responsibilities [Section 4.6 of the proposal]
One commenter indicated that inspection resources should be directed to those who aren't controlling risk with industry program. An additional commenter indicated that the CFIA needs to take a strong role in education and communication, especially to producer groups.
Private Certification Programs [Section 4.6.3 of the proposal]
Five (5) commenters provided feedback on this section and all of them encouraged the recognition of specific private certification systems that are currently in use. Commenters felt that existing programs are working to control the risks and this would allow CFIA to lessen the inspection burden on certified facilities that have made the necessary program adjustments to comply with the new hazard identification and preventive control requirements and reallocate scarce inspection resources to commercial establishments that are not yet certified.
As indicated in the response to feedback received with respect to the proposed requirements for having preventive control plans (PCPs), domestic and foreign, sector-specific programs may be considered as model systems providing they address the regulatory requirements set out in the modernized feed framework. The CFIA will continue to collaborate with domestic industry organizations towards the recognition of such programs in the context of the modernized regulatory requirements and consider approaches to enable the recognition of foreign programs should the program proponents wish to pursue recognition.
Annex 2 Proposed Outcome Based Regulatory Requirements [Annex 2 of the proposal]
A number (9) of respondents provided feedback on the proposed requirements set out in Annex 2 of the proposal. Some comments were related to the terminology used, such as replacing the term "biosecurity" with "security" and "utensils" with "tools". Other comments included:
- Requests for further clarification on what "outcome based" program means.
- That any recognized third party program should give the same benefit, as long as it addresses the requirements.
- For farms that require a PCP there should be the option to have one integrated PCP rather than duplicating the work in multiple documents.
- The importance of reduced inspection frequency for certified facilities.
- That performance criteria that imply disease transmission from employee illness via animal food to animals should be removed.
- Recognize that vessels currently in use for the transportation of animal feed do not meet the standards required for human food.
- Recognize the significant and understandable difference between the purpose and function of these two "markets" for animal feed, so that a pet food oriented standard does not de facto become an unnecessary and burdensome farm operation standard.
The CFIA will take this feedback into account as the Annex will serve as the basis for developing industry guidance and sector-specific model systems that will elaborate on the regulatory requirements and how compliance will be assessed.
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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