Feed Regulatory Renewal Consolidated Modernized Framework Proposal November 2015

Transcription

1 Feed Regulatory Renewal Consolidated Modernized Framework Proposal November 2015

2 Contents Purpose... 3 Objectives... 3 Overview of the Proposed Regulatory Changes... 5 Highlights... 7 Sector-by-Sector Anticipated Impacts... 8 Detailed Discussion of the Proposed Regulatory Framework Scope Modernized Regulatory Requirements Species Standards and General Requirements Safety Standards Labelling and Standards of Identity...20 Traceability and Record Keeping Permissions Introduction Current Situation Permissions - Ingredients Authorization Registration Positive List of Authorized Ingredients Permissions Mixed Feeds Registration Table 4 (Schedule I) Customer and Consultant Formula Feeds Veterinary Prescription and Medicated Feeds Permissions Persons or Establishments Domestic (Inter-provincial) Trade Importers Exporters Permission Requirements Feed Framework Proposal 1 RDIMS#

3 Risk-based Oversight Support for Small Businesses Expected Coming into Force of the Proposed Regulations Guidance Documents and Model Systems User Fees Modernization Conclusion Next Steps Annex 1: What We Heard from Consultations Annex 2: Proposed Labelling Requirements Annex 3: Written PCP Feed Framework Proposal 2 RDIMS#

4 Purpose Following extensive stakeholder pre-consultation in 2012, the CFIA developed and released a series of subject-specific proposals for public review and comment regarding the modernization of Canada s federal feed regulatory framework: Feed ingredient Assessment & Authorization (Completed - Consultation closed December 2013); Feed Labelling (Completed - Consultation closed December 2013); and Feed Hazard Identification and Preventive Controls (Completed - Consultation closed July 25, 2014) As a next step in its regulatory development process, the CFIA has prepared this Consolidated Proposal for further consultation with stakeholders such as suppliers of feed ingredients, commercial feed mills, feed distributors and feed retailers, livestock producers, industry associations, other government departments and international trading partners. The proposal seeks to: 1. Integrate the first three modules to demonstrate how they will work together to provide a robust, risk-based regulatory framework; 2. Add information on facility permissions (licensing/inspection/enforcement) to demonstrate how the principles of the modernized Integrated Agency Inspection Model (iaim) will apply in a feed context; and 3. Propose additional key regulatory requirements not addressed in the proposals/consultations to date. On the basis of feedback received from consultation on these proposals, the CFIA will prepare a comprehensive regulatory proposal for publication in the Canada Gazette Part I in the coming months. Objectives At a corporate level, the CFIA has embarked on a comprehensive change agenda to strengthen its foundation of legislation, regulatory programs, and inspection delivery with the following goals: Legal frameworks that are robust, flexible, and consistent with international approaches and appropriate for 21st century; Regulations that reduce unnecessary compliance burden and support innovation while maintaining public safety, as well as environmental and economic sustainability; and Inspection delivery that is based on common inspection activities and standard processes, and supported by a renewed training regime. With respect to the Agency s livestock feed regulatory program, the achievement of these goals is being realized: Feed Framework Proposal 3 RDIMS#

5 Amendments to modernize the Feeds Act were tabled in Parliament in December 2013 as part of the Agricultural Growth Act, a comprehensive bill that aimed to modernize several statutes administered by the CFIA. The Agricultural Growth Act and the statutory amendments it contained in it received Royal Assent and came into force in late February As part of a comprehensive, multi-year regulatory modernization process, the CFIA launched its Feed Regulatory Renewal project in January 2012 as one of several priority frameworks for modernization; and Following extensive development and consultation during , the CFIA has finalized a modernized, Integrated Agency Inspection Model (iaim) that is being implemented across all Agency food, animal and plant health regulatory programs. In initiating the Feed Regulatory Renewal project in 2012, the following project-specific objectives have formed the basis for proposals and consultation to date: Develop a modernized risk- and outcome- based regulatory framework for feeds which: safeguards feeds and the food production continuum; attains the most effective and efficient balance between fair and competitive trade in the market; and minimizes regulatory burden. In bearing these objectives in mind, this proposal also identifies how both the Feeds Act amendments provided by the Agricultural Growth Act and the iaim are influencing the design of a modernized regulatory framework for livestock feed. Feed Framework Proposal 4 RDIMS#

6 Overview of the Proposed Regulatory Changes Synopsis The modernized regulatory framework proposes to: Build a stronger, more transparent and flexible feed ingredient assessment and authorization process as the basis for a safe and competitive feed supply chain; Enable the consideration and adoption of ingredient authorization processes and decisions of other jurisdictions to reduce burden and promote market access; Update the positive list of authorized feed ingredients and capitalize on new legal authorities to improve timeliness and accuracy so ingredient definitions reflect current characteristics, science and technology; Reduce the number of feeds that will require mandatory pre-market registration; Adopt an outcome- and systems-based approach to feed safety and compliance which will require regulated parties to conduct hazard identification and put in place preventive controls to address risks posed by any identified hazards. An outcome-based approach allows for the application to a wide range of feeds and processes and to reflect differences in the size of businesses and processing complexity; Increase flexibility in labelling requirements; Implement a risk-based permissions (licencing/registration) regime for individuals or establishments and traceability requirements to better support risk management along the feed supply chain and timely response to incidents where risks to public, animal or plant health or the environment is required; Enhance the oversight of feed imports and exports to improve alignment with domestic requirements. Other aspects of the regulations, such as standards, will be updated to better reflect current science, production practices and technology. Feed Framework Proposal 5 RDIMS#

7 Canada s current feed regulations are focused on setting standards for feeds and controlling risks via product registration and other forms of pre-market assessment and approval. The Feed Regulatory Renewal project, taking into account new authorities provided by the Agricultural Growth Act and other Canadian Food Inspection Agency (CFIA) transformation initiatives, represents an opportunity for Canada to fundamentally change its regulatory framework for feed control and oversight and to continue to position Canada as a leader in feed safety and incident response. The proposed regulations will reflect internationally recognized standards and managementbased requirements, including good manufacturing practices and the Codex Code of Good Animal Feeding Practices. The feed chain as a whole will need to take on this preventive control approach to address hazards before they become a problem. The proposed regulations will also reflect the guiding principles of the CFIA s modernized, Integrated Agency Inspection Model (iaim), developed following extensive consultations in 2012 and 2013, and support its implementation. The proposed regulatory framework would further: enable regulated parties to rapidly mitigate emerging feed and food safety risks; confirm industry responsibility and accountability for preparing safe feed; enable the CFIA to apply a consistent science and risk-based approach to oversight; reduce unnecessary regulatory burden on stakeholders; reflect changes in science and technology; support innovation; and, address other regulatory requirements in a more current, consistent manner. The proposed regulations will be supplemented by a suite of new guidance documents that outline the intent of the requirements and will assist regulated parties in complying with the requirements, along with model systems that have been demonstrated to achieve compliance when properly applied. The CFIA will release examples of guidance documents and plain language model systems developed to assist small businesses to meet the requirements and intends to consult with industry to determine how best to draft guidance documents to help industry achieve regulatory compliance. Feed Framework Proposal 6 RDIMS#

8 Highlights The following sections provide an overview of the key elements of the proposed framework. With respect to the Modernized Regulatory Requirements: The scope of the species to which the Feeds Regulations would apply would be expanded to include feeds for animals that are raised for human consumption but are not currently regulated, including cervids (e.g., deer, elk), bison and honeybees; The range of existing product-oriented standards for feeds, including safety standards, will be reviewed, revised, reduced or expanded as appropriate to address current regulatory objectives (outcome-, risk- and systems-based approaches) and expected outcomes; o new authorities provided by the Agricultural Growth Act will also be taken advantage of to incorporate technical and other standards by reference wherever possible (e.g. positive list of authorized ingredients) to support more frequent and timely updating; Hazard identification and assessment would be required by all those involved throughout the feed supply chain with respect to the feed-related activities in which they are involved; Following the identification and assessment of hazards, a preventive control plan (PCP) would be required from any regulated party that manufactures or sells feed domestically or imports or exports feeds; Labelling requirements, would provide additional flexibility while adding elements for safety and traceability; and International standard for traceability established by Codex Alimentarius would be applied to all feed manufacturers, licence holders and persons importing, exporting or trading feeds domestically. With respect to Permissions (authorizations, registrations and licences): A robust, more risk-based and transparent ingredient assessment and authorization process would be implemented: o opportunities to accept application packages and/or foreign country authorizations for new ingredients will be examined where the foreign country's feed ingredient approval process meets Canadian requirements; A reduction in the kinds of mixed feeds that would require pre-market registration is proposed; for reasons of risk, only milk replacers, feeds administered via water, medicated mineral feeds and flavouring agents of any origin (domestically-produced or imported) would be subject to mandatory registration; and New authorities provided by the Agricultural Growth Act would be activated to require persons or establishments to obtain permissions (licences or registrations) to engage in inter-provincial, import and export trade activities. Feed Framework Proposal 7 RDIMS#

9 Sector-by-Sector Anticipated Impacts Domestic Trade Ingredient Manufacturers/Suppliers - New feed ingredients must be assessed and authorized by CFIA before they can be manufactured or sold for use in livestock feed. - Submissions for new ingredient authorization will require data to support the safety of the ingredient as well as information to support the feed purpose for the ingredient. - The CFIA will collaborate with Health Canada and industry to develop and maintain a list of permissible claims that can be used on certain ingredient labels without need for pre-market approval. - Authorized ingredients for sale or distribution in Canada must comply with standards and labelling requirements for the ingredient as set out in the Regulations (including new requirements for traceability) and CFIA s positive list of authorized feed ingredients (currently Schedules IV and V of the Regulations) - Clarity on requirements for the use of global (multijurisdictional) labels on feed ingredients to be included in modernized regulations. - Ingredient manufacturers will be required to perform a hazard analysis and create and implement a written preventive control plan to address risks to public, animal or plant health or the environment posed by the hazards. - Sector-specific programs that include compliance with feed regulatory requirements as a specification may be considered as Model Systems and be taken into consideration by the CFIA in the design and delivery of risk-based inspection oversight programs. - A permission may be required where ingredients are sold or distributed inter-provincially. - Some ingredients may require registration of each source, in cases where there are source specific requirements or concerns regarding safety (for example, fractionated palm fatty acid distillates, mineral complexes (cobalt, copper, manganese, zinc etc. amino acid chelates)). Commercial Feed Mills - The number of mixed feed products that will require mandatory pre-market CFIA registration will be reduced. - For feed products that will continue to require pre-market registration, the manufacturer must register the feed and provide any supporting information before the feed is sold. - Mixed feeds must meet all of the regulatory standards that apply to their products (for example, contaminant limits, only contain authorized feed ingredients, etc.). - Any medications in mixed feeds must be authorized for that use and used in accordance with the CMIB or a veterinary prescription. - Feeds must be labelled in accordance with the proposed modernized labelling standards. - Additional flexibility for allowing information on the label without requiring registration has been provided by allowing additional useful guarantees and permissible claims. Feed Framework Proposal 8 RDIMS#

10 - Mixed feed manufacturers will be required to perform a hazard analysis and create and implement a written preventive control plan to address risks posed to public, animal and plant health and the environment posed by the hazards. - Sector-specific domestic programs (for example, FeedAssure) that include compliance with feed regulatory requirements as a specification may be considered as Model Systems and be taken into consideration by CFIA in the design and delivery of risk-based inspection oversight programs. - A permission may be required where feed manufacturers sell or distribute mixed feeds interprovincially. Feed Retailers/Distributors - Where retailers/distributors package or repackage feeds received in bulk or for other identified risks, they will be required to: o perform a hazard analysis; o create and implement a written preventive control plan to address risks posed by the hazards to public, animal and plant health and the environment; and label feeds in accordance with labelling requirements. - Feeds and feed ingredients retailed or distributed must meet all of the regulatory standards that apply to their products, including new requirements for traceability. - A permission may be required where feeds are sold or distributed inter-provincially. On-Farm Feed Manufacturers (Livestock Producers) The Feeds Act generally exempts feeds made on-farm by livestock producers unless they are being sold off the farm or have a drug or other substance that presents a risk of harm to human or animal health or the environment incorporated into them. Feeds manufactured on farm and sold: Feeds which are manufactured on-farm and then sold, even if in small quantities, are subject to the same requirements as those for commercial feeds listed above. - Feed manufacturers will be required to perform a hazard analysis and create and implement a written preventive control plan to address the hazards. - A permission may be required where feeds are sold or distributed inter-provincially. - Feeds must be labelled in accordance with the proposed labelling standards. - If a manufacturer plans to make a feed type that will continue to require pre-market registration, they must register the feed and provide any supporting information before the feed is manufactured. - Any medications added to feeds must be authorized for that use and used in accordance with the CMIB or a veterinary prescription. Feed Framework Proposal 9 RDIMS#

11 - Feed manufacturers are responsible for ensuring their products meet all of the regulatory standards that apply to their products (for example, do not exceed contaminant limits, only contain authorized feed ingredients, etc.). - Inspection of on-farm feed manufacturers that are selling feed will be based on the iaim model and frequency will be dependent on a number of risk factors. Sector-specific domestic programs (for example, on-farm programs within the scope of CFIA s Food Safety Recognition Program) that include compliance with feed regulatory requirements as a specification may be considered as Model Systems and be taken into consideration by CFIA in the design and delivery of risk-based inspection oversight programs. Feeds manufactured on farm and used on farm (i.e. not sold): - If a feed is manufactured on farm and used on that same farm and the feed has not had incorporated into it any drug or other substance that may adversely affect human or animal health or the environment, the feed is exempt from the Feeds Act and Regulations and is not subject to CFIA oversight. - If the feed is manufactured on farm and does contain a medication or other substance that may adversely affect human or animal health or the environment, the feed is subject to the operation of the Feeds Act and Regulations. It must meet all of the requirements as laid out above for feeds sold off the farm with some exemptions (such as for labelling requirements). Farms that manufacture medicated feed are subject to CFIA inspection as an on-farm feed manufacturer. - Sector-specific domestic programs (for example, on-farm programs within the scope of CFIA s Food Safety Recognition Program) that include compliance with feed regulatory requirements as a specification may be considered as Model Systems and be taken into consideration by CFIA in the design and delivery of risk-based inspection oversight programs. Importers - Importers may be required to obtain a permission and have a preventive control plan. - Importers are required to take responsibility for the products that they import. - As part of the preventive control plan they will be required to demonstrate that they are ensuring feeds and feed ingredients which they import meet all of the Canadian standards including any composition, manufacturing or labelling requirements. - Feeds must meet all of the regulatory standards (maximum limits, only use approved ingredients, etc.). - Feeds must be labelled at time of importation in accordance with the proposed labelling standards. - If an importer plans to import a feed type that will continue to require pre-market registration, they must ensure the feed is registered prior to import. Feed Framework Proposal 10 RDIMS#

12 Exporters - Feeds for export will be required to meet the Canadian standards for safety. - Feeds for export will also need to meet all of the other Canadian standards unless a derogation is specifically granted by the CFIA in order to meet the importing country s requirements. Permissible derogations will be for things like labelling, or composition where safety is not compromised. - Exporters will require a preventive control plan and may require a permission. Summary Modernized Regulatory Requirements Permissions Sector Preventive Control Plan Product Labelling Product Traceability Licence Ingredient YES YES YES Maybe Manufacturer Mixed Feed YES YES YES Maybe Manufacturer Retailer/Distributor YES Maybe YES Maybe Importer YES YES YES Maybe Exporter YES Maybe YES Maybe Livestock Producers Sell off farm (medicated/nonmedicated feeds) On farm use only; non medicated feeds On farm use only; medicated feeds YES YES YES Maybe NO NO NO NO YES NO NO NO Feed Framework Proposal 11 RDIMS#

13 Your opinion counts The CFIA welcomes feedback from its stakeholders and the public on the proposed regulatory changes presented in this document. Written comments regarding any element of the proposed regulations should be forwarded to: Animal Feed Division Canadian Food Inspection Agency Ottawa, Ontario K1A 0Y9 Comments can also be ed to Comments received by XXXXX will be taken into consideration prior to publication of the proposed regulations in Canada Gazette Part I Feed Framework Proposal 12 RDIMS#

14 Detailed Discussion of the Proposed Regulatory Framework 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. Feed Framework Proposal 13 RDIMS#

15 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: 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 (e.g. 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. - Game birds (e.g. quail and pheasant) - Cervids (e.g. deer, elk) - Bison (e.g. Bison bison or Bison bonasus) - Camelids (e.g. alpaca) - Ratites (e.g. ostrich, emu) - Fish (clarifying which species would be included) - Honeybees 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. Feed Framework Proposal 14 RDIMS#

16 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. Feed Framework Proposal 15 RDIMS#

17 Standards and General Requirements Current standards in s of the Feeds Regulations focus on composition and characterization of feeds (s. 14 approved ingredients, feed-additive medications; s composition), recordkeeping ( s.15 for customer- and consultant-formula feeds, veterinary prescription feeds), eligibility of certain feeds for registration (s ), 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- 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. 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- and systems-based approaches) and expected outcomes. This includes: - Maximum levels for some nutrients - Maximum levels for contaminants 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. Feed Framework Proposal 16 RDIMS#

18 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 Reminder: manufacturer. 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 The term feed refers to both mixed feeds and ingredients. 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 pract ices: 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 Feed Framework Proposal 17 RDIMS#

19 7. Investigation and notification, complaints and recall procedures. The proposed requirements are integral to any feed safety system. They are recognized prerequisites 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 systembased 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. Feed Framework Proposal 18 RDIMS#

20 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. Feed Framework Proposal 19 RDIMS#

21 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 In May 2015, CFIA outlined an approach to accommodating approach to feed labelling. 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 Feed Framework Proposal 20 RDIMS#

22 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 from early June to mid-july 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: o be truthful, accurate, verifiable, mathematically-consistent; o not be incorrect or misleading; o 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; Feed Framework Proposal 21 RDIMS#

23 o not be seen to represent an endorsement by the CFIA of compliance with other jurisdictions regulatory requirements; o Canadian labelling information must appear on the label; o 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: o directions or guarantees that exceed Canadian maximums would not be allowed; o claims that do not align with Canadian requirements / policies for feed would not be allowed; o alternative units of measurement may be used provided the results are mathematically equivalent; o 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. Feed Framework Proposal 22 RDIMS#

24 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 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. manipulated by standard commercial software, in French or English. The information would need to be accessible in Canada. 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 recordkeeping 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? Feed Framework Proposal 23 RDIMS#

25 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. Feed Framework Proposal 24 RDIMS#

26 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: Feed Framework Proposal 25 RDIMS#