Feed Regulatory Renewal Consolidated Modernized Framework Proposal – November 2015
Overview of the Proposed Regulatory Changes
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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-based 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.
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 management-based 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.
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-based and systems-based approaches) and expected outcomes;
- 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:
- 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.
Sector-by-Sector Anticipated Impacts
- 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.
- 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 inter-provincially.
- Where retailers/distributors package or repackage feeds received in bulk or for other identified risks, they will be required to:
- perform a hazard analysis;
- 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 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 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.
- 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.
|Sector||Modernized Regulatory Requirements||Permissions|
|Preventive Control Plan||Product Labelling||Product Traceability||Licence|
|Mixed Feed Manufacturer||Yes||Yes||Yes||Maybe|
|Sell off farm (medicated/non-medicated feeds)||Yes||Yes||Yes||Maybe|
|On farm use only; non medicated feeds||No||No||No||No|
|On farm use only; medicated feeds||Yes||No||No||No|
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
59 Camelot Drive
Comments can also be emailed to Serge Tolusso
Comments received by April 8, 2016 will be taken into consideration prior to publication of the proposed regulations in Canada Gazette Part I
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