CFIA Feed Regulatory Renewal Project Shawn MacEachern Animal Feed Division (CFIA) Fish Feed and Nutrition Workshop September 12th, 2017

Outline Background Drivers for Change Overview – Proposed Modernized Regulatory Framework Anticipated Outcomes AMR / Research

CFIA Transformation Agenda Background CFIA Transformation Agenda The CFIA has embarked on a comprehensive change agenda to strengthen its foundation of legislation, regulatory programs, and inspection delivery Goals: Legal framework that is 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 Inspection delivery model that is based on common inspection activities and standard processes, and supported by a renewed training regime (Integrated Agency Inspection Model (iAIM)

Major drivers and influences (internal) Feed Regulatory Renewal Major drivers and influences (internal) Recognition by the Animal Feed Division/CFIA internal partners of the benefits of a renewed feed regulatory framework GoC commitments to reduce regulatory burdens/trade barriers (ex. Red Tape Reduction and Regulatory Cooperation Council initiatives) Legislative modernization (Agricultural Growth Act)

Major drivers and influences (external) Feed Regulatory Renewal Major drivers and influences (external) Key stakeholders see a need for regulatory change (2010 Animal Nutrition Association of Canada White Paper, 2011 Future of Feeds Forum) International drivers Codex Code of Practice on Good Animal Feeding (2004) and Task Force on Animal Feeding (2012 -) U.S. FDA FSMA animal feed safety rules (2015) and implementation (on-going) CFIA Safe Food for Canadians Act and Regulations

Overview – Proposed Modernized Regulatory Framework

Scope of Framework Domestic Ingredient Manufacturing/Products Feed Manufacturing/Products Distribution/Retail On-farm Feed Manufacturing E x

Key Regulatory Requirements Species – Standards – Hazard ID – PCPs Labelling – Traceability

Scope of Species Keep Add Remove Horses Game birds (e.g. quail) Mink Cattle Cervids (e.g. deer, elk) Fox Sheep Camelids (e.g. alpaca) Goats Ratites (e.g. emu) Swine Fish (e.g. non-salmonids) Fish Honey bees Rabbits Poultry (chickens, turkeys, ducks and geese

Standards Maximum Nutrient Levels Maximum Contaminant Levels Remove Table 4 (Range of Nutrient Guarantees for Complete Feeds for Use in the Exemption of Feeds from Registration) and replace with maximum limits for nutrients Consulted on Poultry, Swine and Beef & Dairy Fish maximum nutrient standard Maximum Contaminant Levels Expand the list of contaminants with maximum limits set in regulation (fluorine, aflatoxins, heavy metals, dioxins, mycotoxins, etc.) Currently consulting – closes Sept 22/17 Incorporation by Reference

Preventive Control Plans (PCPs) 1 Identify all hazards 2 Identify (critical) control points 3 Set (critical) limits 4 Monitoring procedures 5 Corrective action procedures 6 Verification procedures 7 Record keeping

Increased Flexibility Labelling Increased Flexibility Permissible Claims Guarantees International Labels

Increased Consumer Protection Labelling (cont.) Increased Consumer Protection List of Ingredients Bilingual Labelling

Traceability One step back One step forward Records

Permissions

Permissions - Feeds Ingredient Assessment & Approval Product Registration Domestic Facility Licences Importer Licence Exporter Licence Infrequent Activity Permissions

Assessment & Authorization of Ingredients Permissions – Products - Domestic Assessment & Authorization of Ingredients 1 Application 2. Notification of Application 3. Assessments 4. Assessment Outcomes 5. Authorization / Positive List 6. Post-authorization Controls Consultation

Registration of Mixed Feeds (cont.) Permissions – Products - Domestic Registration of Mixed Feeds (cont.) Proposal: Further increase the number of feeds that will be exempt from registration All feeds will continue to be required to comply with regulatory requirements for labelling and not exceed maximum limits Feed claims must be made under a permissible claims scheme or they will require registration. Medicated mineral feeds, feeds added to water and flavouring agents will continue to require registration

Licencing – Domestic, Importers & Exporters Permissions – Persons / Facilities Licencing – Domestic, Importers & Exporters Feeds Regulations is to licence any person who sends or conveys feeds across provincial or international borders; and imports feeds for sale

Feed Regulatory Renewal Anticipated Outcomes A systems-based approach requiring hazard identification and preventive control plans Risk-based permissions regime Reduced number of feeds requiring registration

Anticipated Outcomes (cont.) Feed Regulatory Renewal Anticipated Outcomes (cont.) Increased traceability of feeds Enhanced oversight of feed imports and exports Use of incorporation by reference for timely changes to technical documents

Support for Stakeholders Developing industry and inspector guidance Developing model systems Proposed staggered coming into force to allow Small Business more time to meet some new requirements

Regulatory Renewal Project: Next Steps and Timelines Phase 3: Consultation on Proposed Framework Feed Regulatory Modernization Phase 4: Complete Package Preparation and Pre-publication (CG Part I) Phase 5: CG Part II Apr-16 Jun-16 Aug-16 Oct- 16 Dec- 16 Feb-17 Apr-17 Jun 17 Aug-17 Oct-17 Dec-17 Feb-18 23

Government of Canada Response to Antimicrobial Resistance Health Canada has made a number of regulatory changes respecting medications CFIA working with Health Canada to accommodate these changes Health Canada/Provincial Vet Assoc and CAHPRAC taking the lead on developing the scheme – More info to come!

Research Requirements Feeds that are to be used in research trials in Canada may require the submission of an application to the CFIA before the research trial begins for either a research exemption or an authorization for release.

The Exemption Criteria You are not required to submit a research application to AFD when: The feed(s) used in the research will be fed to species not regulated by AFD The substances being fed are not feeds and are therefore not regulated under the Feeds Act and Regulations

Research Requirements: Novel ingredients (Domestic or Imported) – Application for an Authorization for the Release of Novel Feeds for Research Purposes Domestic ingredients/feeds - No application required if all ingredients are approved and the research facility accepts full responsibility for safe disposal. Imported ingredients/feeds – Application for Research Exemption required.

Research Requirements: Guidance Document Regulatory Guidance document has been drafted When in doubt – It’s easy to find out! AFD_DAA@inspection.gc.ca

Consultation CFIA completing consultations on our proposed technical changes Next major consultation will be Gazette I If you’d like to be included on our distribution list please contact: Shawn MacEachern: shawn.maceachern@inspection.gc.ca or visit www.inspection.gc.ca

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