Feed Regulatory Renewal Consolidated Modernized Framework Proposal – November 2015
Detailed Discussion of the Proposed Regulatory Framework

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Scope

The mandate of the CFIA and the Feeds Act support the protection of public health, as well as animal health, plant health, and the environment. With this in mind, the Agency proposes the following scope for a risk-based feed regulatory framework that would apply to:

  • the manufacture and distribution of feed ingredients and mixed feeds ("feeds") alike, enabling oversight on an "end-to-end" approach throughout the feed supply chain.
  • feeds for food-producing animals, including species not currently defined as "livestock" in the Act and Regulations (e.g. deer, elk, bison, and other mammals and birds that produce food products [meat, milk and eggs]).
  • domestically produced and imported feed (approaches to the application of the framework on imported products is provided in this proposal).
  • feeds manufactured for export.
  • hazards with human health, animal health, plant health, and environmental implications.

The proposed regulatory scope aligns with the current scope of the Feeds Regulations, with the exception of feeds manufactured for export. New authorities in the Agricultural Growth Act expand the authority in the Feeds Act to include feeds manufactured for export. New or modernized approaches are being proposed to continue regulating safe feeds for livestock.

"Regulated parties" are those to whom the Feeds Act and Regulations are applicable. As indicated in the Feeds Act, no person shall manufacture, sell or import into Canada any feed unless the feed is registered as prescribed, conforms to the prescribed standards and is packaged and labelled as prescribed. However, the Feeds Act also indicates that it does not apply in respect of a feed that is manufactured by a livestock producer if it is not offered for sale and has not had incorporated into it any drug or other substance that may adversely affect human or animal health or the environment. This means that regulated parties are those that are involved in the manufacture, import, export and sale of feeds. However, if a feed is made on-farm by a producer as long as that feed is not sold (i.e. it's used on the farm that made it) and does not have drugs incorporated into it, the manufacture of that feed is exempt and the Feeds Act and Regulations (including the changes proposed in this document) would not apply. Should a producer make a feed and sell it, that would be considered a commercial activity and they would become a regulated party. Or if a producer makes a feed for their own use, but it includes a drug, they would also become a regulated party and need to comply with the regulations, including the changes proposed here.

Modernized Regulatory Requirements

Species

The current Feeds Act and Regulations apply to feeds for certain livestock species, where "livestock" is defined in the Act as follows:

  • "Livestock" means horses, cattle, sheep, goats, swine, foxes, fish, mink, rabbits and poultry and includes such other creatures as may be designated by regulation as livestock for the purposes of this Act.

In addition, the Regulations further define:

  • "Cattle" means animals of the species Bos Taurus or Bos indicus; and
  • "Poultry" means chickens, turkeys, ducks and geese.

A number of other food-producing animals are not currently included in that definition. It is proposed that the scope of the species to which the Feeds Regulations apply would be expanded to include feeds for animals that are raised for human consumption. This would include:

  • Game birds (e.g. quail and pheasant)
  • Cervids (e.g. deer, elk)
  • Bison (e.g. Bison or Bison bonasus)
  • Camelids (e.g. alpaca)
  • Ratites (e.g. ostrich, emu)
  • Fish (clarifying which species would be included)
  • Honeybees

Proposed Approach To:

Species: The scope of the species to which the Feeds Regulations apply would be expanded to include feeds for animals that are raised for human consumption. This would include:

  • Game birds (i.e. quail)
  • Cervids (i.e. deer, elk)
  • Camelids (i.e. alpaca)
  • Ratites (i.e. emu)
  • Fish (i.e. non-salmonids)
  • Honeybees

In addition, feed for species such as mink and fox which do not enter the food or feed chain would no longer be regulated.

Feed for species such as mink and fox which do not enter the food or feed chain would be removed from the list of species for whose feeds would be subject to the regulatory framework.

To facilitate this change, the Agricultural Growth Act amends the definition of "livestock" in the Feeds Act as follows:

  • "livestock" means any animals designated by regulation as livestock for the purposes of this Act;

This definition will not change until the modernized regulations come into effect.

Expanding the scope of species would allow for more consistent application of the Feeds Regulations.

The feed that animals consume can result in residues in meat, milk and eggs if the feed risks are not controlled. By expanding the scope of species to include other farmed animals, consumers can rest assured that the feeds these animals consume are subject to regulatory controls and CFIA oversight. As mink and fox are raised for their fur, and none of their products or by-products enter the food or feed chain, it is considered appropriate for CFIA to remove the oversight of their feeds for the scope of the regulations.

Have your say

The CFIA is seeking comments on its proposal to:

  • Expand the scope of species for which feeds would be subject to the regulatory framework (food-producing species of game birds, cervids, bison, camelids, ratites and honeybees);
  • Clarify the species of fish for which feeds would be subject to the regulations; and
  • Remove mink and fox from the scope of the livestock definition.

Standards and General Requirements

Current standards in s. 14-25 of the Feeds Regulations focus on composition and characterization of feeds (s. 14 approved ingredients, feed-additive medications; s. 20-22 composition), record-keeping (s. 15 for customer-formula and consultant-formula feeds, veterinary prescription feeds), eligibility of certain feeds for registration (s. 17-18), hazardous and other extraneous materials in feed (s. 19), specifications for guaranteed analyses required on labels (s. 24) and analytical tolerances applied to test results in relation to guarantees provided (s. 25).

The range of existing standards will be reviewed, revised, reduced or expanded as appropriate to address regulatory objectives (outcome-, risk-based and systems-based approaches) and expected modernization outcomes.

Safety Standards

To underscore the modernized regulatory framework's focus on health and safety, it is proposed that certain safety requirements are placed in regulation. This would include maximum levels for some nutrients, maximum levels for some specific contaminants, and required caution and warning statements.

Maximum Nutrient Levels

Given the proposed removal of Table 4 in Schedule I from the Regulations, it is also proposed that some nutrients which pose health and safety concerns (to animals or via residues in animal products used as human food) have maximum limits set in regulation. This may include standards for copper, zinc or iodine for some or all species whose feeds are subject to the regulations. Additional proposals and opportunities for stakeholder consultation will be provided regarding the maximum nutrient levels before they are incorporated into regulatory framework.

Maximums for Certain Contaminants

Section 19 of the current regulations sets out limits on what a feed may not contain. This includes limits on the amount of weed seeds, fluorine, mould, must or heat damage, proteins derived from certain animals, extraneous material and aflatoxins. It is proposed that these limits are updated and additional limits are added for new contaminants of concern such as heavy metals, dioxins or other mycotoxins.

Proposed Approach To:

Feed Safety Requirements: The range of existing standards will be reviewed, revised, reduced or expanded as appropriate to address current regulatory objectives (outcome-, risk-based and systems-based approaches) and expected outcomes. This includes:

  • Maximum levels for some nutrients
  • Maximum levels for contaminants

Hazard Identification

As indicated in the CFIA's Feed Hazard Identification / Preventive Controls – Regulatory Framework Proposal, it is proposed that all those involved throughout the feed supply chain complete a hazard identification and assessment with respect to the feed-related activities in which they are involved. The hazard identification and assessment must be carried out on incoming materials; materials sourced in-house, feed formulation, processes, and transportation by the feed or ingredient manufacturer.

Reminder:

The term "feed" refers to both mixed feeds and ingredients.

Animal feed and feed ingredients can act as a route of entry for hazards into human food and for hazards that pose a risk to animal health, plant health (e.g. pests and diseases of domestic or international quarantine significance), or the environment (e.g. invasive plant species not known to be present in a local ecosystem). To mitigate the associated risks, hazards in feeds must be identified and assessed prior to their manufacture, distribution, and feeding to animals. Multifaceted assessments are often necessary to consider both the safety to animals as the primary consumers of the feed and safety to humans as the consumers of resulting food of animal origin (e.g. meat, milk, fish, and eggs). In some cases, the risk to persons who work with and mix feed, as well as the risk to plant health or the environment also requires assessments.
To modernize the current regulatory framework regarding the identification of hazards, the Agency proposes to

  • Review and update the list of prescribed deleterious substances currently contained in section 4 of the Regulations.
  • Revise the list of specific hazards and standards identified for feeds, as appropriate.
  • Identify specific hazards and maximum limits in feeds in guidance (build on current RG-8).
  • Include known hazards and limits, where appropriate, in ingredient descriptions set out in Schedule IV.

Preventive Control Plans

It is proposed that the regulations under the Feeds Act establish minimum standards for the manufacturing and the safety of feeds for everyone the Feeds Act applies to who imports, manufactures or sells feed, regardless of the commodity or size of operation. This would be a fundamental improvement in Canada's feed safety regulatory framework. This would include requirements that address seven key elements to good manufacturing and agricultural practices:

  1. Products and processes;
  2. Sanitation, pest control, sanitizers and chemical agents;
  3. Hygiene and competencies;
  4. Equipment and conveyances to be used in an establishment;
  5. Physical structure and maintenance of the establishment;
  6. Receiving, transportation and storage; and
  7. Investigation and notification, complaints and recall procedures.

The proposed requirements are integral to any feed safety system. They are recognized pre-requisites for safe feed and require that industry anticipate and take the necessary measures to address the hazards that can be present in a feed, on the equipment or in the establishment and its facilities where that feed is manufactured. Each element would address specific hazards in the feed manufacturing continuum. Regulated parties would still have to comply with all the other requirements of the proposed regulations and any other applicable regulations (such as Health of Animals).

Following the identification of hazards a preventive control plan (PCP) would be required from any regulated party that manufactures or sells feed or imports or exports feeds. Farms that make their own feed and do not incorporate into it any medications or harmful materials and do not sell it would be exempt from the Feeds Act and Regulations and would not require a preventive control plan.

The requirement for a PCP would improve feed safety by requiring that these regulated parties implement a system-based approach to their operations that focusses on prevention and management systems. The steps related to the preparation of a PCP in the proposed regulations are expected to be consistent with HACCP which is the internationally recognized approach to food safety. They include the identification of:

  1. All hazards
  2. Critical control points and other control points, and related control measures that are validated by evidence
  3. Critical Limits and other limits
  4. Monitoring procedures
  5. Corrective action procedures
  6. Verification procedures
  7. Record keeping procedures

It is proposed that…

Control measures will need to be validated by evidence that demonstrates they effectively control identified hazards.

CFIA will provide "model systems", drawn initially from existing information that has been validated and proven effective, when properly applied.

CFIA will also provide guidance on "validations", consistent with Codex.

In preparing the PCP, which is based on HACCP principles, the regulated party would need to identify and document the potential hazards associated with their feed or processes, and demonstrate how those hazards will be controlled. Hazards may impact food safety, animal or plant health or the environment. The PCP should demonstrate how all hazards will be controlled, not just those that have a food safety implication. PCP preparation and maintenance strengthens the management of the operations by requiring the regulated party to be actively engaged in the development of feed safety systems, including proactively determining how they will monitor their operations, respond and correct deviations as they occur, and maintain ongoing compliance.

The regulated party would be required to maintain the PCP and associated records to assess its ongoing effectiveness and ensure its continuous improvement.

The PCP would need to address how specified requirements, including elements 1-7 listed in the previous section, would be met, as applicable. It would also be where regulated parties would identify the measures they have taken to comply with other relevant regulatory requirements, including those such as packaging and labelling provisions.

The PCP will be one of the key tools used by the inspector in verifying compliance with the Act and Regulations.

Many facilities already engage in these kinds of activities. The proposed requirements will strengthen the feed-safety system and focus on the system will support the preparation of safe feed products. These businesses will be well placed to comply with the proposed Hazard Identification and Preventive Control requirements.

Annex 3 contains the proposed requirements for a written PCP.

Labelling and Standards of Identity

The proposed regulations would not fundamentally change the approach to labelling and standards of identity. They would, however, provide some additional flexibility while adding elements for safety and traceability.

Labelling provisions currently exist in the Feeds Regulations. Labels play an important role in the safe and proper use of feeds. Proper labelling allows a purchaser and user of a feed to distinguish one product from another and provides information on what the feed is and how it is to be used. Risks associated with the representation and use of feed products can be mitigated by the use of labels. Products which are not labelled, or do not have the appropriate information on the label, may be unintentionally used in a manner that is not safe and causes an animal health, food safety or environmental hazard.

The intent with these proposed regulations is to improve flexibility in labelling while better aligning requirements internationally, improving traceability and mitigating safety risks.

The existing requirements of the Feeds Act and its regulations apply to all livestock feeds manufactured, imported or sold in Canada. These requirements would be maintained in the proposed regulations.

Labelling standards for feed will also remain while being modernized to improve flexibility for things such as additional guarantees.

The CFIA previously engaged stakeholders to discuss this proposal under the Feed Labelling Regulatory Framework Proposal. Feedback from that consultation has resulted in some changes which are further outlined in Annex 2.

Claims

As proposed in the Feed Ingredient Assessment and Authorization – Regulatory Framework Proposal a list of permissible claims will be developed. The permissible claims list would be a list of feed claims that can be made on feed labels without CFIA pre-market registration of the feed. The claims would be non-proprietary, any conditions of the claim would need to be met, and the claims must be truthful and verifiable.

The CFIA, Health Canada and regulated industry will work closely together to develop a "permissible claims" list as a component of a modernized approach to feed labelling.

In May 2015, CFIA outlined an approach to accommodating a permissible claims list and invited the feed industry to submit a list of claims to the CFIA to consider in order to develop a preliminary claims list for broader consultation. It was proposed to the feed industry that this list would be incorporated into the modernized regulatory framework by reference which would enable amending on a regular basis. The CFIA will prepare and distribute a separate proposal regarding an initial permissible claims list for stakeholder review and comment at a later date.

Should a feed company wish to make a proprietary claim on a label or should a claim not appear on the permissible claims list, they would still be able to have the claim assessed and approved via the CFIA's pre-market registration process.

Collective Terms

In reviewing the feedback received to the 2013 Feed Labelling Regulatory Framework Proposal, the CFIA noted that respondents raised concerns about a proposed requirement for the labelling of a full list of ingredients on all feed labels. Most respondents indicated that allowing the use of "collective terms" for certain groupings of ingredients (as suggested by the CFIA in the context of the labelling proposal) would help reduce some burden associated with the labelling of ingredients and provide some flexibility. Conversely, a couple of respondents representing individual livestock producers raised concerns that the use of collective terms would allow feed companies to not disclose specific ingredients.

Given that a detailed outline of what collective terms might be allowed and the scope of ingredients they would comprise was not elaborated in the 2013 labelling proposal, the Agency prepared the Proposal – Feed Ingredient Collective Terms on Labels for a separate consultation on this subject. The CFIA invited comments from interested parties via a preliminary consultation from early June to mid-July 2015. A second comment period was provided to interested parties between mid-December 2015 and mid-January 2016.

Following the completion of the consultation period, the CFIA prepared the "Consultation Summary – Respondent Comments and CFIA Responses" report that includes a revised set of collective feed ingredient terms that will be permitted on feed labels.

International Labels

Labels for use on feeds intended for distribution in multiple jurisdictions (e.g. U.S., EU, Canada), are often:

  • Labels that contain information in languages other than English or French
  • Labels that contain information that is not the same in all languages or not the same across jurisdictions

This presents a challenge for companies who must comply with Canadian requirements, while choosing an effective way of labelling their products. To provide additional flexibility for these "international labels", while still meeting the Canadian requirements:

  • Information on labels, where different from Canadian regulatory requirements, shall:
    • be truthful, accurate, verifiable, mathematically-consistent;
    • not be incorrect or misleading;
    • not contradict or conflict with Canadian requirements (e.g., maximum levels of fish flesh pigmenting agents in feeds in different jurisdictions) with respect to risks to public and animal health;
    • not be seen to represent an endorsement by the CFIA of compliance with other jurisdictions' regulatory requirements;
    • Canadian labelling information must appear on the label;
    • additional labelling flexibilities: apply the same flexibilities that will apply to domestic labels (additional guarantees, etc.).
  • Additional label information would be permitted but must not conflict with or contradict Canadian requirements, for example:
    • directions or guarantees that exceed Canadian maximums would not be allowed;
    • claims that do not align with Canadian requirements / policies for feed would not be allowed;
    • alternative units of measurement may be used provided the results are mathematically equivalent;
    • information does not need to be identical in all languages.
  • Products bearing such labels would still require registration

Pre-market registration will provide for consistent application of the regulations / policies as a single point for verification of compliance. Applications for labels with information in languages other than English or French would require a certificate of translation or attestation regarding the accuracy of the translation at the time of registration to demonstrate that label information does not conflict with Canadian standards.

This approach provides level playing field for products bearing domestic and international labels, is responsive to industry / market needs and is enforceable.

Traceability and Record Keeping

While many companies have implemented voluntary traceability systems, not all companies have the basic record-keeping practices necessary for timely feed safety investigations, recalls or withdrawals. The resulting information gaps within the feed supply chain can lead to a less efficient response to a feed safety incident.

The proposed regulations would apply the international standard for traceability established by Codex Alimentarius to all feed manufacturers, licence holders and persons importing, exporting or trading inter-provincially. The Codex standard calls for tracking of feed forward to the immediate customer and backwards to the immediate supplier ("One step forward, one step back" ). These requirements are aimed at enhancing consumer protection during a feed safety incident by providing for more accurate information to facilitate the rapid identification of the origin and movement of a feed through the feed supply chain.
Currently, in some recall situations, information is provided to the CFIA but crucial time is lost deciphering company encryptions or codes, or illegible records. The proposed regulations would address this challenge by requiring that traceability information be provided electronically, upon request, in plain text and in a format that can be imported and manipulated by standard commercial software, in French or English. The information would need to be accessible in Canada.

Proposed Approach To:

Traceability: For persons importing, exporting or trading domestically, tracing of feed forward to the immediate customer and backwards to the immediate supplier ("One step forward, one step back" ) is proposed. These requirements are aimed at enhancing protections during feed contamination incidents to expedite the rapid identification of the origin and movement of feed through the supply chain.

Additional traceability requirements are also introduced via labelling requirements such as providing contact information for the manufacturer of the feed and a lot number for all feeds.

The CFIA encourages regulated parties to be proactive in enhancing their traceability and record-keeping systems beyond the proposed minimum requirements.

Have your say

The CFIA is seeking comments on:

  • If the proposed approach to feed traceability will be sufficient to expedite the rapid identification of the origin and movement of feed through the supply chain?

Permissions

Introduction

As a key component of the CFIA's modernized, Integrated Agency Inspection Model (iAIM), a "permission" is defined as an official consent (e.g., permit, certificate, licence and registration) granting legal authorization to a regulated party to conduct specified activities.

The CFIA proposes to continue to use some of its longstanding authorities to grant permissions associated with feed ingredients and mixed feeds as well as to take advantage of some new authorities provided by the Agricultural Growth Act in respect of granting permissions to persons or establishments to conduct specified activities.

Reminder:

"Permission" means…

  • Licences or permits
  • Registrations of products, persons or establishments
  • Ingredient Approvals
  • Research Exemptions

or any other CFIA authorization required before an activity may be conducted.

Current Situation

The Feeds Act and Regulations have long contained authorities to require the registration of feeds (products) for domestic sale and for imported feeds. Since the early 1980's, the categories and numbers of feeds requiring mandatory registration have decreased to the point where it is estimated that some 95% of domestic feeds are exempt from this requirement. On the other hand, all mixed feeds manufactured and imported into Canada from other countries require mandatory registration prior to importation including those that would not require registration if manufactured domestically. Conversely, there have not been authorities in the Feeds Act and Regulations to require the licencing, registration or permitting of persons or facilities to conduct specified activities.

The CFIA has been issuing permits to operators of domestic inedible rendering plants in Canada since 1997 as part of its BSE prevention programming using authorities provided by the Health of Animals Act and Regulations. Among other end-uses, rendered animal by-products are commonly used in livestock feed rations as ingredients, for example, meat and bone meal, feather meal and tallow. All rendering plants must operate under a CFIA permit; conditions on permits and inspection frequencies are tied to the risks of the activities performed and products manufactured by the rendering plants.

Permissions – Ingredients

Authorization

Canadian feed manufacturers and livestock producers benefit from access to a large number of approved ingredients for use in feeds. Ingredients are assessed and approved for use in livestock feed before being added to the list of approved ingredients. As outlined previously in the Feed Ingredient Assessment and Authorization – Regulatory Framework Proposal, a number of flexibilities are proposed for ingredient approvals. It is proposed that there will continue to be a list of approved feed ingredients, and only ingredients on that list may be used to manufacture livestock feeds. As in the current framework, it is proposed that before an ingredient is imported, manufactured or sold in Canada, proponents will need to apply for authorization for any feed ingredient that:

  • is new (i.e. not on a positive list);
  • has been modified such that it differs significantly from a conventional ingredient; or
  • is represented for a purpose other than the one(s) for which it has already been authorized.

As part of the ingredient assessment and authorization framework it is proposed that:

Application Format – as in the current regulations it is proposed that an application must be made for ingredient authorization. While applicants will have to submit all of the required information in their application package, the format and presentation of that application package will not be dictated by a rigid format. This will minimize the applicant's regulatory burden by allowing them to use or reformat an existing application package (such as one submitted to another country) rather than having to submit a package prepared specifically for Canada.

Notification of New Applications – At the present time, the CFIA does not disclose whether applications for new or modified ingredients have been received or the status of the application in the evaluation queue. It is proposed that the CFIA adopt a "notice of submission" mechanism for all feed ingredient applications that will make this information publically available

International Data – The framework will continue to require that a proponent provide satisfactory scientific evidence for the assessment and authorization of ingredients. Rather than having only one authorization pathway as is the case in the current framework, it is proposed that the type and amount of information required in support of an ingredient assessment will be subject to one of three authorization pathways:

  1. For a feed ingredient that is new to the global market – If Canada is the first country in which approval is sought and where it will be marketed (i.e. it has not been approved as a feed ingredient anywhere else in the world), a full assessment process and data package will be required to support the application to have the ingredient authorized.
  2. For a feed ingredient that is new to the Canadian market – If an ingredient is already authorized as a feed ingredient in another country and the following criteria are met, a modified application package would be allowed:
    • If the ingredient has already been authorized in a country which the CFIA has recognized as having an authorization process that is equivalent to that used by Canada; a modified application package would be allowed. An applicant would need to submit evidence of the foreign authorization and a summary characterizing the ingredient and indicating it is the same ingredient, its intended purpose and directions via the application process.
    • Voluntary submission of data – Proponents that have authorized ingredients which are eligible to submit a modified application package may still choose to submit the full package on a voluntary basis

In cases where a modified application is submitted for assessment, it is anticipated applicants would benefit from a shorter service standard and a reduced user fee once adjustments to operational procedures have been implemented.

If, however, the ingredient has been authorized in a country which the CFIA does not recognize as having an equivalent authorization process, a full data package will be required.

Intended Purpose Assessment – CFIA proposes to continue to require that feed ingredients have an intended purpose or purposes identified that corresponds to the definition of a feed and allows for proper categorization of the product (for example, as a protein feed, energy feed, vitamin etc.). For feed ingredients whose intended purpose would not correspond to a purpose attributed to a feed (for example, ones which would not supply a nutrient that is required by livestock), evidence to support a recognized feed purpose would be required to make the application eligible for authorization as a feed. This approach is consistent with other international feed regulatory jurisdictions where ingredients are classified and regulated on the basis of purpose and scientific evidence in support of the intended purpose is provided.

In response to stakeholder feedback regarding its role in assessing and authorizing feed ingredients, the CFIA plans to redefine its role with respect to ingredient performance assessment. Submission and pre-market assessment of scientific evidence supporting ingredient performance would only apply where failure of a product to perform an identified purpose would have significant health or safety implications to animals or humans. The scope of this approach would include the submission of evidence to demonstrate nutritional essentiality. Other examples of products for which evidence of performance would have to be submitted for assessment would include information about the bioavailability of a nutrient or the ability of an ingredient to fulfill an intended effect (e.g. prevent feed oxidation, adjust feed pH ). Categories of ingredients or criteria for which purpose evidence would not be required would be established by policy.

Safety Assessment – Feed ingredients must be safe. Consultations to date with stakeholders have confirmed they feel that the government has a central role to play in the assessment and authorization of ingredients within the scope of safety in respect of animal health, human health (via food residues and worker/by-stander exposure), and the environment.

The Regulations will be designed to continue to provide objectives and general criteria which proponents will need to consider when preparing the safety component of an application for an ingredient assessment, while still providing flexibility for applications to be tailored based on history of use and complexity of the product. The general criteria would include aspects pertaining to the identity and characterization of an ingredient (e.g. what it is, what it will be used for, how it was developed, etc.), intended purpose of the ingredient, information requirements to be used to identify risks, and manufacturing process.

Consultation – To enhance the transparency of the ingredient authorization process and meet the CFIA's requirements for consultation, it is proposed that the CFIA consult with stakeholders on the results of its ingredient assessments and recommended outcome prior to final authorization. The CFIA proposes that a post-assessment notification and consultation approach be taken prior to final authorization for ingredients which have been assessed and found to be acceptable for inclusion in the list of authorized ingredients by the CFIA. The applicant would be notified and asked to supply a description of the product and relevant information that was presented to the CFIA for assessment. This information would then be posted on the CFIA website, and interested parties notified via listserv, for a short period (e.g., 2-4 weeks) of public review and comment. The CFIA will review input from the public on the proposed decision and will consider scientific or economic rationale submitted in favour of or opposed to the decision. The CFIA will either reconsider the ingredient in light of the new information or issue a final approval of the ingredient and begin the process to add it to the list of approved feed ingredients.

Proposed Approach To:

New Ingredients: Ingredients will be assessed and approved for use in livestock feed before being added to the list of approved ingredients.

  • Data from international approvals will be considered
  • Ingredients must demonstrate a feed purpose
  • Safety assessments will continue to be required
  • New ingredients will be subject to consultation prior to final approval

A positive list of approved feed ingredients is proposed to be incorporated by reference to aid in timely updates.

Registration

Beyond the assessment and authorization of new ingredients for feeding to livestock, there are a number of ingredients that, by virtue of their being listed in Parts II of Schedules IV and V, are subject to mandatory registration of the ingredient on a source-by-source basis. This higher level of control is necessary to confirm and re-affirm (upon the expiry and renewal of registration) the consistency of the ingredient over time, the specifics of manufacturing and analytical practices employed and other risk factors.

The table below provides information on how many feed ingredients are currently authorized by CFIA for feeding to livestock in Canada and the distribution of these ingredients between the Schedules and Parts of the Schedules to the Feeds Regulations.

Table – Authorized Feed Ingredients (February 2015)
Schedule # Number (% of total) – Authorized Ingredients
Part I
Number (% of total) – Authorized Ingredients
Part II
Total
Schedule IV 703
(84%)
135
(16%)
838
Schedule V 386
(99%)
2
(1%)
388
Total 1,089 137 1,226

In section 5.7 of the CFIA's Feed Ingredient Assessment and Authorization – Regulatory Framework Proposal, it was proposed that CFIA would modernize aspects of its approach to ingredient regulation by:

  • Reviewing existing ingredients for alignment with their descriptions, compositional criteria, current science, intended use and safety to animals, humans and the environment;
  • Making amendments to the purpose of ingredients currently in the Schedules and creating new categories or groupings of categories for ingredient types based on intended purpose, especially for the Class 8 Miscellaneous Products listed in Schedule IV; and
  • Considering merging Parts I and II of the schedules into a single list.

It is further proposed that the registration of individual sources of certain ingredients, regardless of whether they are of domestic or international origin, continues in the future. The basis for ingredient registration will focus on issues of higher risk to health and safety attributable to the source of the ingredients (for example, by-products or wastes from industrial activities that may result in the ingredient having elevated levels of contaminants beyond levels known or reasonably foreseeable in other feedstuffs).

Positive List of Authorized Ingredients

Canada has benefitted from employing a positive list of authorized feed ingredients in Schedules IV and V, and this use of a positive list approach continues to be supported by stakeholders in consultations to date. As shown above, the current list already contains over 1200 ingredients that are categorized according to intended purpose, are described, and identify appropriate guarantees as necessary. Only those ingredients, listed in these schedules, may be used in the manufacture and sale of feeds in Canada, or in feeds imported into Canada.

In section 6.4 of the CFIA's Feed Ingredient Assessment and Authorization – Regulatory Framework Proposal, it was noted that timely amendments to the ingredient Schedules that form part of the Regulations has been problematic. As an alternative approach, the CFIA had an interest in pursuing the ability to incorporate, by reference, documents into regulations that are externally or internally generated, and that may change over time. This would provide increased flexibility and timely updating.

In February 2015, section 5.1 of the Feeds Act, by way of the Agricultural Growth Act, came into effect where:

5.1 (1) A regulation made under subsection 5(1) may incorporate by reference any document, regardless of its source, either as it exists on a particular date or as it is amended from time to time.

Use of this new incorporation by reference authority will be explored as a mechanism to enable having a discrete, enforceable positive list of authorized feed ingredients in the modernized feed regulatory framework so that Schedules IV and V can be removed from the structured regulation and be referred to as a list that the CFIA maintains outside of regulation. This will allow for more timely updates to the list of ingredients so that industry and inspection staffs have transparent access to the most current list of ingredients. Part of this includes the need to provide adequate consultation, as proposed above under the heading "Consultation" above.

In September 2014, CFIA signalled to its stakeholders that a comprehensive review of currently-authorized feed ingredients was being initiated and industry experts were invited to express their interest in collaborating with CFIA on the review of groupings of ingredients (for example, oilseed products, vitamins etc.). As part of this review project, the scope includes determining whether certain ingredients which are currently required to be registered by source should continue to be registered and if there are others that are not subject to registration at present but should be going forward. Once the range of authorized ingredients has been reviewed and compiled, the CFIA will propose a revised list with the updated ingredient descriptions, including any changes to ingredients subject to registration, and seek stakeholder feedback on the proposal. Given the scope of this project, it is not expected to be completed by the time the new regulations come into effect. Any changes that have been completed will be included and the CFIA will continue to work collaboratively with industry to update and modernize the list in the future.

Additional analysis may be needed to verify that the authorized ingredients are also suitable for the additional species that are proposed to be brought under the definition of livestock.

A modernized and relevant list of authorized feed ingredients will continue to allow feed manufacturers to take advantage of a wide range of products when formulating livestock feeds.

Permissions – Mixed Feeds

Registration

Pre-market assessment and registration of mixed feeds is currently one of the regulatory mechanisms used to help ensure the safety and efficacy of livestock feeds sold in Canada. The regulations currently exempt the vast majority of standard feeds, such as complete feeds, supplements, customer formulas and veterinary prescription feeds. These are estimated to account for approximately 90 – 95% of the feeds manufactured in Canada. The remaining types of feeds, which require registration, typically represent feeds that are not as straight forward such as feeds that may have higher concentrations of nutrients, directions for use that are not standardized, feeds that are more variable due to source differences, or those feed types that are less typical (such as enzyme supplements). In addition, feeds that have a claim on the label or which have additional label information (such as extra nutrient guarantees) also require pre-market registration.

Historically, all feeds required pre-market registration. When the regulations were last updated in the early 1980's, a number of exemptions to registration were granted for types of feeds that were well understood at the time. As the regulatory modernization process is moving forward, it has been recognized that past knowledge and familiarity with some feed types has grown sufficiently that the CFIA is taking this opportunity to examine the importance pre-market registration plays for other feeds.

The requirement for pre-market registration is viewed as a costly and unnecessary step by some regulated parties. In addition, due to the volume of submissions received, it can take a few to many months for a new feed to be registered, thus delaying the entry of that product into the Canadian market. Currently, both registered and unregistered feeds are subject to CFIA inspection oversight during routine feed mill and retail inspections.

It is proposed that additional types of feeds be exempted from registration. Given changes in technology and knowledge of nutritional requirements for livestock, pre-market registration does not continue to play a useful role for all feed types. However, there are a few categories of feeds that, at a minimum, will continue to require registration as there are health and safety or consumer protection concerns associated with these feeds, including:

Milk replacers
These are fed to young animals as a sole source of nutrition. Failure to provide adequate nutrition or provide clear and appropriate feeding instructions can quickly result in issues of animal health.
Feeds delivered via water
A number of vitamins and other supplements are being fed to animals via their water. Since water intakes are highly variable and dependant on activity, external temperature and even feed composition (such as salt intake), there is concern that feed supplements that are delivered through the water can be consumed at unsafe levels which may result in issues of animal health or residues in the animal products.
Medicated Minerals
These minerals are not typically mixed into a complete feed and there are concerns regarding intake of the mineral and thus the medication may not be delivered at the correct level. Excessive consumption may result in animal health or food safety concerns (residues) and under medication results in medications not working effectively. Oversight of these by way of product registration helps to address exposure concerns.
Flavouring agents
These are mixtures of flavouring ingredients. All flavouring ingredients have maximum use rates for safety. Combinations of these individual flavouring ingredients can result in their use at levels that are higher than approved. In addition, the use of the flavouring agent needs to be set at levels that do not present a safety risk.

Table 4 (Schedule I)

Table 4 of Schedule I sets out nutritional standards which are used to exempt complete feeds and some supplements from registration. Currently, if a complete feed provides nutrients which fall within Table 4 or a supplement has directions for use which would result in a complete feed that provides nutrients which fall within Table 4 the feed can be exempted from registration. Both CFIA and stakeholders recognize that the values in Table 4 no longer have the same nutritional relevancy that they did when the table was introduced. In addition, stakeholders have indicated that they feel Table 4 prevents innovation for new feed products. Feeds will continue to be required to be suitable for their intended purpose and must meet an animal's nutritional requirements. As some of the maximum limits which are currently set in Table 4 have health and safety implications for animals and for residues in animal products, it is also proposed that maximum limits for certain nutrients be set. See the section on Safety Standards above for further details on maximum limits in feeds.

The CFIA will prepare and distribute separate proposals for stakeholder review and feedback regarding nutrient maximums by species or classes of species (for example, for broiler versus laying chickens) as appropriate as part of its on-going regulatory development and consultation activities.

Customer and Consultant Formula Feeds

Customer and consultant formula feeds are defined types of mixed feeds in the Regulations which are currently exempted from registration. Given the proposed flexibilities outlined above, it is also proposed that customer and consultant formula feed types will be removed from the regulations. Customer formula feeds were designed to allow a producer to request that a manufacturer make a specific formula for them without having to comply with the exemption from registration criteria. Given that Table 4 nutrient restrictions will be removed and most feeds will be exempt from registration, the customer formula exemption would no longer be necessary. Feeds that are proposed to continue to require registration are due to health and safety concerns, and any maximum limits set will also be due to health and safety concerns so all feeds, whether requested by a producer or made commercially by a manufacturer should meet those requirements. Consultant formula feeds were designed to exempt feeds that are formulated for a specific purchaser.

Given the flexibilities being introduced to further reduce registration requirements and that any restrictions would be based on health and safety concerns, it is proposed that the:

  • "customer formula feed" definition will be retained but modified to accommodate on-farm feed manufacturing for own use and enable the application or exemption of certain regulatory requirements (for example, concerning the manufacture of medicated feeds) not exempted from the scope of the Feeds Act; and
  • "consultant formula feed" definition and exemptions will no longer be required.

Have your say

The CFIA is seeking comments on its proposal to:

  • Retain a modified "customer formula feed" definition and requirements focussed on on-farm feed manufacturing not exempted from the scope of the Feeds Act; and
  • Remove the "consultant formula feed" definition and exemptions from the Regulations.

Veterinary Prescription and Medicated Feeds

It is proposed that there is no change to the approach for veterinary prescription and medicated feeds. The addition of a medication, either via a veterinary prescription or as per the CMIB, is currently allowed without the medication being a trigger for registration. It is proposed that this continues in the new regulations. The feed to which the medication is being added must be compliant with the regulations and meet any standards or labelling requirements.

Stakeholders are advised that as a response to the Federal Action Plan on Antimicrobial Resistance and Use in Canada, Health Canada's (HC) Veterinary Drugs Directorate (VDD) is preparing several initiatives including measures to increase the oversight of medically-important antibiotics used in livestock feeds. As CFIA partners with HC to regulate medicated livestock feed in Canada, amendments to the Feeds Regulations may be necessary to accommodate proposed HC policy and regulatory changes. It is anticipated that HC will lead a separate stakeholder consultation, with CFIA support, regarding proposed policy and regulatory change.

Permissions – Persons or Establishments

Domestic (Inter-provincial) Trade

Individual and establishment permissions represent a tool to identify a regulated party and authorize him, her or the establishment to conduct an activity. The CFIA proposes to grant permissions authorizing regulated parties to conduct specific activities to meet regulatory requirements.

Two types of permission are envisioned:

  • Permissions with a Preventive Control Plan (PCP) as a condition (where parties with frequent transactions will be required to have effective PCPs in place in order to be granted a permission); and
  • Permissions without a Preventive Control Plan (where parties participating infrequently in regulated activities subject to regulatory requirements (e.g., one-time imports or exports of a regulated article) may be eligible for permissions without PCPs.

The condition that certain permission holders develop, implement and maintain effective preventive control plans (PCPs) suitable to the size and complexity of their operations is a key requirement of the permissions regime. This is integral to regulated parties assuming greater responsibility for the safety and compliance of their products. Details on the proposed elements of a feed preventive control plan and the expected outcomes and performance criteria are outlined in the CFIA's Feed Hazard Identification/Preventive Controls – Regulatory Framework Proposal.

The CFIA would place a higher priority on oversight of regulated parties by way of permissions where the consequence of non-compliance would have a greater impact on human health, animal health, plant health or the environment. Regulated parties who strive to adopt the best practices and innovative, commercial or technological strategies would be recognized by the CFIA through adjustments to oversight, as appropriate.

Permissions would describe all relevant activities the applicant is approved to conduct. An application may be made for each physical location, a number of physical locations, or by activity (for example, import, export), at the discretion of the applicant.

The following sections of this consolidated proposal will discuss these two types of permissions in greater detail.

Legal Authorities

Recent amendments to the Feeds Act by way of Agricultural Growth Act provide expanded authorities to the CFIA to issue permissions with respect to operators and establishments involved in feed-related activities.

5.2 (1) The Minister may, on application, register a person, or issue a licence to a person, authorizing them to conduct a prescribed activity in respect of a prescribed feed that has been imported for sale—or that is to be exported or to be sent or conveyed from one province to another—or both register a person and issue them a licence.

5.3 (1) The Minister may, on application, register an establishment as one where a prescribed activity may be conducted in respect of a prescribed feed that has been imported for sale or that is to be exported or to be sent or conveyed from one province to another.

5.4 Subject to the regulations, the Minister may amend, suspend, can cel or renew a registration made under subsection 5.2(1) or 5.3(1) or a licence issued under subsection 5.2(1).

The Agricultural Growth Act has also been used to amend a broad exemption provision in the Feeds Act that applies to livestock producers who manufacture feeds at the farm level:

4. This Act does not apply in respect of a feed that is manufactured by a livestock producer if it is not sold and has not had incorporated into it any drug or other substance that presents a risk of harm to human or animal health or the environment.

Scope

With the new authorities from the Agricultural Growth Act, under the proposed regulations, domestic manufacturing and distribution of feed constituting trade in an inter-provincial context could be required to obtain a permission from the CFIA and comply with the requirements of the Feeds Act and its Regulations or other conditions set out in the permission.

As context for prescribing activities and prescribing feeds in regulations as required by sections 5.2(1) and 5.3(1) of the Feeds Act set out above, the following factors could be taken into consideration for establishments in Canada:

  • product type (e.g. ingredients, mixed feeds, medicated feeds);
  • intended use (e.g. for sale directly to customer, for resale);
  • intended species (e.g. ruminants, poultry, multiple species);
  • processing activities (e.g. pelleting, extruding, drying);
  • annual volume of production; and
  • use of higher risk materials (e.g. medications, prohibited material).

The requirement for a permission could further be restricted to instances where risks posed by hazards are considered as known or reasonably foreseeable from activities and/or in feeds and feed ingredients. Hazards would include something inherent in a feed that can pose a risk of harm.

Bearing these factors in mind, it is proposed that the following criteria will be applied in the prescribing of activities and of feeds where operators or establishments would be subject to requiring permissions with Preventive Control Plans as a condition:

  • Manufacture, package, label, sell any feeds which are subject to warnings (public health risks) and cautions (animal health risks) with respect to ingredients and mixed feeds
    • this could include feeds for non-ruminants containing prohibited animal proteins, medicated feeds, certain ingredients or feeds containing certain ingredients where cautions and warnings will be required to be labelled and carried forward onto labels of other feeds containing these products;
    • certain medicated feeds that are not required to be withdrawn prior to animals being shipped for processing and pose minimal risks to non-target species could be exempted
  • Manufacture, package, label, sell, any feeds which are subject to any maximum use restrictions (via ingredients or other feeds containing such ingredients)
    • Example – carotenoid pigments added to feeds to colour flesh in fish;
  • Establishments not dedicated to the manufacture of feeds or feed ingredients to require permission
    • Example – facility makes livestock feed and pet food in same facility;
    • Example – facility make biofuel as principal product; distillers' dried grains (DDGs) are co/ by-products from biofuel production for sale or distribution into the livestock feed supply chain.

Depending on the criteria that would be applied to the requirement for a permission, issuance of permissions in light of "emergency" circumstances may also be necessary to address temporary interruptions in the supply of feeds, for example

  • a feed manufacturer in one province steps in to supply customers of a feed manufacturer in a neighbouring province which has suspended operations due to a fire or to address other urgent operational issues.

In the case of permissions that would not have PCPs as a condition, it is proposed that they would be required in the following instances:

  • Human food manufacturers already complying with a preventive control plan under the SFCR would not need a separate plan when supplying a by-product of food manufacture to feed, provided the feed would still be suitable as a food and is not further processed.

The proposed permissions would be valid for a period of two years and subject to a fee to be identified in a user fee proposal being developed for consultation at this time. Regulated parties would be able to apply for multiple permissions (for each establishment, activity or commodity) or a single permission (for all their establishments, activities and commodities).

The permission application would serve to collect basic information about the prospective permission holder, where feed businesses are located and key activities (e.g. manufacturing feed to be exported or traded inter-provincially, importing and exporting with a certificate).

Exemptions

It is further proposed that regulated parties not required to obtain a permission could include the following:

  • primary producers, such as livestock producers or their operations, are not expected to be covered by the proposed domestic permissions regime provided they do not sell or convey feeds across provincial boundaries;
  • feed or feed ingredient manufacturers who are not involved in trade across provincial boundaries;
  • transporters of feed, unless there is a plant or animal health requirement to address potential risks of transmission of diseases or pests posed by the movement of feeds between provinces; and
  • facilities that store or retail feeds but are not involved in importing, exporting or preparing the commodity, provided it remains packaged and sealed from receipt to transportation, and meets the requirements of the relevant legislation.

Anticipated Outcomes

The issuance of permissions in this regard would improve the existing regulatory environment by:

  • providing an accurate, current and complete picture of who is involved in the preparation of feed in inter-provincial trade in Canada allowing for the collection of essential data to conduct oversight on the basis of risk;
  • enabling industry to take a more systematic approach to PCPs to cover activities in multiples locations or activities across multiple programs (such as feed and food);
  • providing an additional enforcement tool that can be acted upon to compel compliance/respond to non-compliance in situations where risks of harm to public, animal or plant health or the environment from feeds are identified;
  • enabling better CFIA oversight of higher risk prescribed activities and feeds
    • triggering of notification by permission holder and inspection by CFIA where holder seeks to move to activities/feeds of a higher level of risk than their existing permission authorizes them for;
  • having a single, consistent approach to requirements for permissions across CFIA programs; and
  • implementing a scheme based on a systems approach.

Have your say

The CFIA is seeking comments on:

  1. Are there other situations where it would be appropriate to require a permission that would not have PCPs as a condition?
  2. Are there other situations or businesses that would want to choose to obtain a permission even if they are not obligated to have one? Would allowing "voluntary licensing" be beneficial to industry?

    Given that:

    • the iAIM proposes to exempt transporters from the requirement to obtain a permission unless there is an animal or plant health requirement; and
    • section 170(1) of the Health of Animal Regulations obliges persons operating a conveyance to have procedures in place to prevent the contamination of animal food for ruminants with prohibited material (animal health risk). Further, there are other hazards that could pose a food safety and/or animal health risk if not properly managed during the transportation of bulk feeds. This is especially the case where conveyances are used to transport a range of feeds and non-feed items.
  3. Are there specific situations related to transportation of feeds where a requirement for permission for feed transporters might be necessary to control risks?

Importers

Canada is dependent on imports of feeds and feed ingredients to enable the manufacture of highly cost-effective and nutritionally-effective feeds that contribute significantly to competitive livestock production systems. Over $269 million of animal feed products were imported into Canada in 2013. The main countries of origin include feed imports from the United-States (78.68%), France (7.3%) and China (3.72%).

To protect the health of the animal and plant resource bases and the environment, imports must be free from pests and diseases. To support a fair and competitive marketplace, products entering Canada must also meet domestic feed regulatory requirements, including those for safety, nutrition, composition, product identification (e.g. labelling), packaging and quality. With the ever-increasing rate of global trade comes ever-increasing risk to our domestic animals and plants. As the number of countries exporting feeds to Canada increases, the robust oversight of feed imports is a key component of the modernized regulatory framework.

Current Situation

With respect to the importation of feed ingredients, the current regulatory framework takes a two-tiered approach to oversight:

  • For ingredients that the Agency has assessed, authorized and listed in Parts I of Schedules IV and V to the Feeds Regulations (representing many common grains, oilseeds, rendered animal proteins and fats, minerals, flavouring agents), oversight is provided by the Canada Border Services Agency (CBSA) and the CFIA at the border. Documentation for imports is checked for conformance (including any applicable to animal and plant health) with regulatory import requirements set out in the Automated Import Reference System (AIRS). The vast majority of authorized ingredients are contained in Parts I of both Schedules (84% and 99% respectively) subject to this level of oversight.;
  • For ingredients that the Agency has assessed, authorized and listed in Parts II of Schedules IV and V to the Feeds Regulations, CFIA registration of each individual source of the listed ingredients is required prior to the ingredient being allowed entry into Canada. Registration of ingredients in Part II serves to enable a closer scrutiny of safety or other risks that are ingredient-specific. Confirmation of registration and conformance with other requirements as set out in AIRS is also undertaken by CBSA and CFIA at the border prior to entry.
  • Please refer to the "Ingredient Authorization" section of this proposal above for a more detailed discussion about anticipated changes to feed ingredient assessment and authorization by the Agency going forward.

With respect to mixed feeds,

  • All mixed feeds originating from outside of Canada require mandatory CFIA registration prior to importation. Registration enables the CFIA to confirm compliance with domestic regulatory requirements prior to the products being allowed entry into Canada.
  • Imported mixed feeds are subject to the same registration fees that apply domestic feeds as set out in chapter 1 (Table 1) of the Agency's RG-1 Regulatory Guidance: Feed Registration Procedures and Labelling Standards.

The table below provides information on how many feed ingredients and mixed feeds are registered by CFIA for sale in or importation into Canada and the distribution of these registrations between Canadian and foreign registrants.

Table – Distribution of Domestic and International Feed Registrations (February 2015)
Feed Type Number (% of total) – Feed Product Registrations
Canadian
Number (% of total) – Feed Product Registrations
Foreign
Total
Feed Ingredients
(% of total)
264
(51%)
259
(49%)
523
Mixed Feeds
(% of total)
3,703
(71%)
1,484
(29%)
5,187
Total
(% of total)
3,967
(69%)
1,743
(31%)
5,710

The table below provides a summary of the top 10 countries outside of Canada with registrants for feeds registered by the CFIA.

Table – Distribution and Number of International Feed Registrations by Country (February 2015)
Country Feed Ingredient
Registrations (#)
Mixed Feed
Registrations (#)
Total Registrations
USA 226 1,379 1,605
France 4 40 44
United Kingdom 2 20 22
Belgium 1 14 15
Scotland 0 8 8
Denmark 2 6 8
Spain 0 7 7
Netherlands 5 1 6
Switzerland 1 4 5
Germany 2 3 5
All Other (9) Table Note 1 13 5 18
Total 259 1,484 1,743

Table Note

Table Note 1

includes Brazil, Finland, Malaysia, Japan, Norway, Italy, Ireland, Trinidad and Tobago, and India

Return to table note 1  referrer

Post-entry compliance of the actual imported feeds themselves is most often verified at destination (feed retail and commercial feed mills), but these may not be the most appropriate sites to have any non-compliance corrected.

With respect to domestic traceability of feed imports, many importers of rendering plant products (for example, meat and bone meal, feather meal, blood meal, poultry fat and other animal protein and fat products authorized for feeding to animals) and many animal foods have been subject to traceability requirements in Part XIV of the Health of Animals Regulations since the late 1990's. These requirements do not, however, extend to all imported feeds and feed ingredients. Even if some importers have implemented voluntary traceability systems for feeds not subject to the Health of Animals Regulations, not all importers have the basic record-keeping practices necessary for timely feed safety investigations, withdrawals or recalls.

Proposal – Introduction

Changes in global demand, production and distribution environments, technological advancements, coupled with industry consolidation, have resulted in significant increases in the complexity, speed and volume of trade.

In this operating environment, the CFIA should be able to identify regulated parties and understand the nature and risk of their regulated activities. Furthermore, the level of CFIA's oversight should correspond to the regulated party's ability to meet regulatory requirements.

Given the geographical size of Canada, the extensive range of air, land and sea points of entry, the distribution of domestic livestock populations and trading patterns for feed, an expansion of inspection capacity to more closely scrutinize imports of feeds at points of entry would represent a more resource intensive approach to oversight that would see CBSA and CFIA retaining the majority of responsibility for the verification of compliance of imports with domestic requirements. Such an approach runs contrary to CFIA objectives and strategies regarding responsibilities for assuring compliance and the provision of oversight. In addition, this approach would not represent a proactive, pre-entry means of addressing potential safety or other risks associated with products originating from outside Canada.

Proposal – Options for Consideration

In the case of feed imports, the CFIA is considering a range of oversight options that could offer a combination of alternative, effective and flexible approaches to enable market access while providing sufficient oversight to minimize domestic health and market risks. These options include:

1. Continuing with some manner of product permissions (ingredient and mixed feed registration) for import control (modified status quo)

Beyond the proposed mandatory registration requirements for certain feed ingredients and mixed feeds, regardless of their country of origin (as discussed above in the "Permissions – Ingredients" and "Permissions – Mixed Feeds" sections respectively of this proposal), the CFIA could review the current mandatory registration requirements imposed on all mixed feed imports using more current risk-based criteria to better identify the feeds that may pose the highest risks to public, animal and plant health and the environment and adjust the regulatory framework accordingly. Such criteria could include:

  • feed type (e.g. ingredients, mixed feeds, medicated feeds);
  • intended use (e.g. for import directly by end user, import for sale/distribution to end users );
  • intended species (e.g. ruminants, poultry, multiple species);
  • manufacturing processes (e.g. pelleting, extruding, drying);
  • volumes of product imported;
  • use of higher risk materials in the feed (e.g. medications, proteins prohibited from feeding to ruminants);
  • compliance history; and
  • typical country(ies) of origin of products.

While pre-market product assessments and permissions are often considered to be burdensome and time-consuming by industry stakeholders, there may be merit in providing for an import-specific product-by-product assessment and permissions option.

This option:

  • would have CFIA retaining responsibility for verifying that the imported feed complies with domestic regulatory requirements;
  • includes having the CFIA assess the adequacy of the hazard identification undertaken by the applicant for the feed to be registered and the prevent control plan implemented to address risks posed by any identified hazards;
  • may not provide for a level marketplace playing field where similar products from domestic sources not subject to mandatory registration have less impeded access to the Canadian marketplace;
  • could represent a potential accommodation for "voluntary" product registrations for situations where prospective feed importers or exporters would prefer this control measure and its associated compliance obligations to other control measures and their associated compliance obligations given the nature of the product, market share and other operational considerations.

To address existing traceability gaps for imports in the context of the domestic feed supply chain and as discussed in the Traceability and Record Keeping section of this proposal, this option would see importers being responsible for complying with traceability requirements based on the international standard for traceability established by the Codex Alimentarius to all feed importers.

Requiring compliance with traceability requirements would:

  • improve the importer's and CFIA's ability to manage issues when a risk is identified in an imported feed;
  • not represent a single measure sufficient to proactively address potential safety or other risks associated with products originating from outside Canada.

2. Requiring importers to obtain a permission with a preventive control plan (PCP) as a condition

As discussed in the Permissions – Domestic (Inter-provincial) Trade), section of this proposal, this option aligns with the guiding principles of CFIA's iAIM and approach being taken by other modernized CFIA regulatory frameworks (for example, the Safe Food for Canadians Regulations). It provides the tools to improve regulatory oversight at appropriate points in the feed supply chain.

As discussed in section 4.4 of the Feed Hazard Identification/Preventive Controls – Regulatory Framework Proposal published by the CFIA in June, 2014, importers could be called upon to demonstrate that foreign manufacturers have designed, developed, implemented, and verified preventive control plans that are comparable with those required by domestic manufacturers to assure the safety of feed and feed ingredients and compliance with other Canadian regulatory requirements.

Importers would have to have PCPs of their own that include elements which apply to their operation. Importers without facilities, for example, would not be expected to address physical structure and maintenance. However, all importers would, at a minimum, need to include the following elements in their PCPs:

  • Element 1: Process and Product Controls
  • Element 7: Traceability, recall, and complaints

Importers who are involved in further handling or repackaging of feeds would address all seven elements required in a PCP.

Several regulated parties currently import feed commodities into Canada to be subsequently brought into compliance before being offered for sale. This practice is particularly used to correct non-compliance related to product labelling and often on products for smaller market segments. In order to allow existing practices to continue, the scope of this option would also permit non-compliant feed to be imported or traded inter-provincially on the condition that the feed is clearly labelled with, "For further manufacture only", that it is imported to a single location and that it is brought into compliance within three months after the day on which it is imported or traded inter-provincially (unless a longer period is specified by the Minister). However, a prohibition is proposed against the mixture/dilution of imported contaminated feed with non-contaminated feed in order to bring the product into compliance. This is in keeping with international practice in the feed sector and current regulations.

This option would:

  • make importers most responsible for assuring that feeds comply with Canadian regulatory requirements for safety, composition, labelling and others;
  • provide an accurate, current and complete picture of who is involved in the preparation of feed in inter-provincial trade in Canada;
  • enable industry to take a more systematic approach to PCPs to cover activities in multiple locations or activities across multiple programs (such as feed and food)
  • increase the scope of regulated parties to which this more robust oversight approach would apply, particularly those who are importers of ingredients listed in Parts I of Schedules IV and V, where the bulk of compliance verification takes place at points of entry by CBSA and CFIA
    • Consequently, this option may be viewed as intrusive and may create a disincentive for certain current importers to continue importing feeds in future.
  • allow for the collection of essential data to conduct oversight on the basis of risk;
  • enable better CFIA oversight of higher risk prescribed activities and feeds
    • triggering of notification by permission holder and inspection by CFIA where holder seeks to move to activities/feeds of a higher level of risk than their existing permission authorizes allows;
  • provide an additional enforcement tool that can be acted upon to compel compliance/respond to non-compliance in situations where risks of harm to public, animal or plant health or the environment from feeds are identified;
  • represent a single, consistent approach to requirements for permissions across CFIA programs and a scheme based on a systems approach.

3. Authorizing operators or establishments in other countries (by way of permissions) to export feeds directly to Canadian customers

Under this option, feeds manufactured in other countries could be eligible to obtain a permission from the CFIA to export feeds to Canada. This option would be contingent, however, on the foreign country having been assessed and found to have comparable regulatory and oversight systems for feed as those in Canada.

This option would:

  • compel the foreign exporter, by way of conditions on the permission, to assume responsibility for the compliance of products intended for the Canadian market to meet domestic regulatory requirements;
  • preclude Canadian importers from having to have preventive control plans for products imported from suppliers in such countries;
  • oblige importers to comply with traceability requirements in the event risks are identified in products they import; and
  • enable the CFIA to modify, suspend or cancel the foreign establishment's permission in the event feeds are determined to not comply with Canadian safety or other domestic requirements.

At present, the Government of Canada has not assessed and identified any countries whose feed regulatory system is comparable to ours nor is it anticipated to be an option that will be available to importers in the immediate (1-3 years) future.

Permissions not requiring a preventive control plan (PCP) as a condition

The proposed regulations would include certain exemptions to the PCP condition on permissions for the importation of feeds, including:

  • feed carried on any conveyance intended for the animal that it accompanies; or
  • samples for scientific analysis, trade shows or other marketing purposes.

Transshipment of feed through Canada is also proposed for exemption from a PCP requirement, provided the shipment travels through Canada in bond.

Have your say

The CFIA is seeking comments on:

  • which option or combination of options discussed above should the CFIA consider enabling in a modernized feed regulatory framework? Please include a rationale with your comments; and
  • if there are any other options the CFIA should consider enabling? Please include a description of the option(s) with your comments.

Exporters

While the trade of feed in Canada is largely domestic in nature, over $381 million of Canadian animal feed products were exported abroad in 2013. The main destinations for Canadian feed exports are the United States (61.9%), Singapore (6.73%), Philippines (5.6%), Mexico (4.53%) and Japan (3.95%).

Current Situation

Currently, feeds intended for export from Canada and so labelled are exempted from the operation of the Feeds Act and the Regulations. Where trading partners seek certification by a "competent authority" as a condition of export market access, export certificates (e.g. for U.S.) and certificates of free sale are issued by CFIA on a voluntary basis.

In not regulating exports, CFIA has limited capability to prevent the export of unsafe feeds to other countries given current exemptions from the Act and Regulations

Proposal

To increase assurance that feeds in international trade originating from Canada are safe, it is proposed that all feeds manufactured in Canada intended for export meet Canadian standards for safety and other domestic compliance requirements. In keeping with the principles of iAIM and as discussed in terms of domestic trade and imports of feed, exporters would also be obliged to obtain a permission from the CFIA with a condition of having a preventive control plan to address risks posed by any identified hazards in their feeds and achieve any other domestic compliance requirements that would apply. Recent amendments to the Feeds Act by way of the Agricultural Growth Act now provide the CFIA with the authorities to:

  • require exporters to obtain a permission in this regard (Feeds Act, section 5.2); and
  • issue any certificate or other document setting out any information that is necessary to facilitate the export of any feed (Feeds Act, section 5.5).

Exemptions from some domestic requirements for feeds intended for export would be identified so feeds could meet a foreign country's non-health and safety compliance requirements where they differ from Canadian ones.

In the case of the export of feed ingredients not authorized by CFIA for feeding in the domestic market, exporters might still be able to obtain a CFIA export permission provided that the ingredient:

  • is prepared or manufactured in accordance with Canadian regulatory requirements (for example, in accordance with an appropriate preventive control plan);
  • meets any other applicable requirements specified by the importing country; and
  • can be certified by the CFIA for an export market if required by the importing country.

This modernized approach to feed export oversight would:

  • establish a more consistent, robust framework to support export market access opportunities;
  • demonstrate clear authority and provide mechanisms of oversight for feed exports to international markets;
  • align favourably with approaches being proposed for food exports under the CFIA's proposed Safe Food for Canadians Regulations and the Integrated Agency Inspection Model (iAIM); and
  • enable the CFIA to modify, suspend or cancel the foreign establishment's permission in the event feeds are determined to not comply with Canadian safety or other domestic requirements.

Have your say

The CFIA is seeking comments on its proposal to:

  • require exporters to obtain a permission from the CFIA to export feed to international markets;
  • require exporters to have preventive control plans as a condition for obtaining permissions to export animal feed from Canada; and issue export certificates for animal feed when required by trading partners.

Permission Requirements

With new authority from the Agricultural Growth Act, under the proposed regulations, everyone importing, manufacturing feed for export or for inter-provincial trade, or exporting a feed for which they are requesting an export certificate, would be required to have a permission and comply with the requirements of the Feeds Act and its Regulations. This would improve the existing system by:

  • Implementing a permission scheme that will be based on a systems approach;
  • Providing an accurate and complete picture of who is involved in the preparation of feed for inter-provincial trade or export (in some cases) and import of feed into Canada;
  • Allowing for the collection of essential data to conduct oversight on the basis of risk;
  • Having a single, consistent approach to requirements for licensing and registration across CFIA programs.

In addition, industry would be able to take a more systemic approach to permissions and PCPs to cover activities in multiples locations or activities across multiple programs (such as feed and food).

The proposed permission would be valid for a period of two years, for a fee of approximately $250Footnote 2, and regulated parties would be able to apply for multiple permissions (for each establishment, activity or commodity) or a single licence (for all their establishments, activities and commodities).

The permission application would collect basic information about the licence holder, where feed businesses are located and key activities (e.g. manufacturing feed to be exported or traded inter-provincially, importing and exporting with a certificate). Permission numbers would be generated, as well as a number for each establishment covered by the permission. It may also collect information to enable risk-based oversight such as:

For establishments in Canada:

  • product type (e.g. ingredients, mixed feeds, medicated feeds)
  • intended use (e.g. for sale directly to customer, for resale)
  • intended species (e.g. ruminants, poultry, multiple species)
  • processing (e.g. pelleting, extruding, drying)
  • annual volume of production
  • use of higher risk materials (e.g. medications, prohibited materials)
  • compliance history
  • the number of employees and annual gross sales to identify small and micro-businesses.

For importers:

  • product type (e.g. ingredients, mixed feeds, medicated feeds)
  • intended use (e.g. for sale directly to customer, for resale)
  • intended species (e.g. ruminants, poultry, multiple species)
  • processing (e.g. pelleting, extruding, drying)
  • annual volume of product imported
  • use of higher risk materials (e.g. medications, prohibited materials)
  • typical country of origin of products

Permission renewal every two years would ensure CFIA has up-to-date information on permission holders and their activities. This information is necessary for risk-based oversight.

Based on the information received in the permission application, an inspection prior to the issuance, renewal, or amendment of a permission may be required depending on product risk and compliance history. This is likely to be the case initially for feed that has historically been recognized as having higher safety risks, such as medicated feeds, or feeds containing prohibited materials.

When there is non-compliance, the proposed regulations would allow the Minister to suspend a permission. For example, a permission would be suspended immediately, upon notice, where there is a risk of injury to human health. This enforcement tool would complement other compliance and enforcement measures available to inspectors.

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