Canada’s Safe Food for Canadians Act and Regulations Session #1 Keith Mussar Keith Mussar & Associates December 17, 2015 Keith Mussar & Associates 1
Canada’s Safe Food for
Canadians Act and Regulations Session #1
Keith Mussar
Keith Mussar & Associates
December 17, 2015
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AT A GLANCE
• Safe Food for Canadians Act
• Safe Food for Canadians Regulation • Food Safety Provision
• Enforcement through Licensing
• Path Forward & Timeline
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Food Regulatory Oversight in Canada
Food & Drugs Act
Food & Drug Regulations
Agricultural Products Act
Consumer Packaging & Labelling Act
Meat Inspection Act
Fish Inspection Act
Processed Products Regulations
Consumer Packaging & Labelling Regulations
Meat Inspection Regulations
Fish Inspection Regulations
Organic Products Regulations
+ 7 Other Regulations
Health Canada
Nutrition Labels Ingredient Lists
Food Additives & Colours
Canadian Food Inspection Agency
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• Tylenol recall (1982)
• Jack in the Box E.coli (1993)
• Green onions Hepatitis A (2003)
• Green onions E.coli (2006)
• Peanut butter Salmonella (2007)
• Lead paint in toys (2007)
• Melamine dairy (2007)
• Peanut Salmonella (2008)
• Listeria meat recall (August 2008)
• Beef recall – E.coli (October 2012)
Consumer food safety awareness
Global supply chains
Regulators limited authority to prevent import of unsafe food
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How Did We Get Here ?
Safe Food for Canadians Act
Safe Foods for
Canadians Act
(2012)
•Prohibitions on movement of
food
•Licensing – importers,
exporters & manufacturers
•Incorporation by reference
•Enhanced inspector authority
•Agricultural Products Act
•Consumer Packaging
& Labelling Act
•Meat Inspection Act
•Fish Inspection Act
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• Shifts point of enforcement to port of entry or provincial boundary
• Common legislative, regulatory & oversight framework for all food
• Disclosure of personal and confidential business information
• Criminal law
6. (1) (2) It is prohibited to manufacture, prepare, package, label, sell, import a product that is labeled or packaged in contravention of a provision of the regulations
10.(2) It is prohibited for a person to send or convey from one province to another-or to import or export a food unless the person is authorized to do so by a registration, license or both
10. (3) It is prohibited for a person to send or convey from one province to another — or to import or export — a prescribed food commodity unless the food commodity meets the requirements of the regulations.
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12. It is prohibited for a person to have in their possession for the purpose of sending or conveying from one province to another — or for the purpose of exporting — a prescribed food commodity, unless it meets the requirements of the regulations.
13. (1) It is prohibited for a person to conduct a prescribed activity in respect of a prescribed food commodity that has been imported — or that is to be exported or to be sent or conveyed from one province to another — unless the activity is conducted in accordance with the regulations.
13. (2) It is prohibited for a person to conduct a prescribed activity in respect of a prescribed food commodity that has been imported — or that is to be exported or to be sent or conveyed from one province to another — unless the person is authorized to conduct that activity by a registration, a licence or by both
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7. It is prohibited for a person to tamper with any food commodity, its label or its package with intent to
(a) render the food commodity injurious to human health; or (b) cause a reasonable apprehension in others that the food commodity is injurious to human health.
8. It is prohibited for a person to threaten to render a food commodity injurious to human health.
Safe Food for Canadians Act
Food Safety Prohibitions
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Safe Food for Canadians Act & Regulations
Safe Foods for
Canadians Act (2012)
Safe Food for Canadians
Regulation (2016)
•Licensing – importers, exporters &
manufacturers
•Prohibitions on trade
•Agricultural Products Act
•Consumer Packaging
& Labelling Act
•Meat Inspection Act
•Fish Inspection Act
•Licensing
•Enhanced trade, food safety &
compliance requirements
•Fresh fruit & vegetable
Consumer Packaging &
Labelling Regulations
Meat Inspection Regulations
Fish Inspection Regulations
Processed Products
Regulations
Dairy Products Regulations
Egg Regulations
Honey Regulations
Livestock and Poultry Carcass
Grading Regulations
Maple Products Regulations
Processed Egg Regulations
Organic Products Regulations
CFIA Reorganization -2014-15
• Policy, Operations & Inspectorate to Single Food Structure-2014
• Integration of food, animal health and plant health business units
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Food Safety & Licensing
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• Preventive Control Plan
• Documented & exercised food traceability & recall plan
• Document retention and formatting requirements • Available in Canada within 24 hours of request or sooner
• Electronic documents: single file, plain text, imported into & manipulated with standard commercial software
• Non encrypted = plain text
• Documents retained for two (2) years
• Lot numbers on all products
• Enhanced product data reporting
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Safe Food for Canadians Regulation-Food Safety Requirements
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SFCR-Preventive Control Plan
Documented
Preventive
Control Plan
Technical
Regulatory
Compliance
Food
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Food Safety System Requirement - Preventive Control Plan
Determination of Biological,
Chemical and Physical Hazards
Treatments and Processes
Maintenance and Operation of
Establishments
Sanitation, Pest Control and Non-
food Agents
Conveyances and Equipment
Conditions Respecting
Establishments
Unloading, Loading & Storing
Employee Competency
Employee Hygiene
Communicable Diseases and
Lesions
Investigation, Notification and
Recall
Description of biological,
chemical & physical hazards
Control measures for each
Evidence to validate control
measure effectiveness
Description of Critical Control
Points
Description of the Critical
Limits for CCPs
Corrective action procedures
for each CCP
Verification procedures that
assure compliance to SFCA &
Regulations
Substantiating documentation
Elements specific to meat &
commodities
Preventive Control Elements Control Plan Content
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Food additives
Alcoholic beverages
Taxonomic families Rubiaceae: coffee beans
Malvaceae: cocao beans
Poaceae: corn, wheat, rice barley
Cannabacea: hops
? Unpasteurized milk
Unprocessed-will be manufactured, processed or treated in Canada
Labelled “For further preparation only”
Not a consumer prepackaged food
Bring into compliance within 3 months of importation or interprovincial transfer
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Exemptions to the Preventive Control Requirement
Exemptions Exemption Criteria
14 Fresh fruit & vegetables packed in field & convey from one province to another to be manufactured, processed, treated, preserved, graded by license holder
Scientific analysis
Evaluation
Trade shows
Market analysis - consumer testing?
Not intended for human consumption (e.g. pet food)
• Labelled “not for human consumption”
Transshipment in bond
Personal use
Intended for passenger or crew use on conveyance
Import limit 100 kg or less
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Exemptions to the Preventive Control & Licensing Requirement
Imported Product Exemptions Exemption Criteria
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6. (1) (2) Prohibited ……..to import a product that is labeled or packaged in contravention provision of the regulations
10. (3) Prohibited ……. to import, convey, export — a food unless the food meets the requirements of the regulations.
12. Prohibited for a person to have in their possession …… for the purpose of conveying, exporting — a food, unless it meets the requirements of the regulations.
• 14 (1) (a) labelled “For further preparation only”
(b) brought into compliance within 3 months by license holder
(c) Ministerial permission for longer period
• 14 (3) prohibited to comply by blending contaminated with non-contaminated food
SFCA & Regulation non-compliant food may be exported if:
• 11(2) (a) requirement exists in foreign state
(b) document that requirement in foreign state is met
(c) food labelled “Export” or “Exportation”
SFCA Prohibition SFCR Approach to SFCA Prohibition
Enforcement Through Licensing Ke
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CFIA Licensing-Who Needs a License ?
• All domestic manufacturers convey product from one
province to another
• Manufacturers of food for internet sale
• Importers of food & food commodities
• Canadian food exporters [require export certificate]
Transporters, distributors & warehouses are outside of the
scope of the regulation
Exception: meat distributors & warehouses; facilities for CFIA
inspection
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Requirements to Hold a License
• Food manufacturers, importers, exporters, must have a
fixed place of business in Canada OR
• Fixed place of business in a country that CFIA has recognized
as having a food safety system that provides a similar level of
protection to that of Canada
• Importer must send or convey the food into Canada directly from
the foreign country in which the importer has a fixed place of
business
• Food Safety System - Documented Preventive Control Plan –
PCP
• Documented product traceability & recall plan – “one step
forward and one step back”
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Requirements to Hold a License
• Register establishments
• Import fresh fruit &/or vegetables: Dispute Resolution
Corporation (DRC) membership
• Importer attest to the safe production & regulatory compliance of
imported & manufactured food
• Pay the license fee - $250 renewable every two years
• Enhanced product data reporting upon licensing and at import
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Manufacturing Processing Treating Preparing Preserving Grading Storing Packaging Labelling Importing Exporting
In the case of meat product Handing & storing in
imported condition: CFIA inspection
Storing
Slaughtering
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Activity-Based Licensing
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CFIA Licensing Options
• Single license with each establishment registered (single
PCP option)
• Multiple license option
• License each establishment
• PCP for each licensed establishment
• Canadian importer may hold multiple licenses – even
specific license for each supplier
• U.S. non-resident importers allowed to hold a CFIA license
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Import License Data Reporting Requirements
• Product types imported (e.g. fish, meat, cheese, processed products)
• Intended use (e.g. ready to eat, preserved, for further processing)
• Processing (e.g. canning, pasteurization, freezing, drying, packaging)
• Annual volume of products imported
• Typical country of origin of products
• License holders name, address and license number
• Name & address of the supplier or from whom the food is being
imported
• Name & address of person who manufactured or processed the food
• Address where the food is to be delivered in Canada
• Description of the food & the packaging: common name, brand name,
lot number,
• Quantity imported
• Data must be provided prior to import; or at time authorized by the
Minister (CSA )
At License Application
Prior to Import
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• Company contact
• Company 24 hour emergency contact
• Attestation
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SFC
Act
November
2012
SFCR
Micro & Small
Consultation
Closes
June
2015
Safe Food for
Canadians
CG I
SFCR
CG II
Federal
Election
August
2015
Late
2016
Early
2016
Regulatory Modernization Timeline
October
2015
SFCR
Stakeholder
Comments
Full
Enforcement
2018
Projected Coming into Force Timeline
Meat, Seafood,
Dairy & Cheese
Canned & Frozen
Fruit & Veg.,
Honey, Maple
(including meat
importers)
Fresh Herbs
& Spices;
Fresh Fruit &
Vegetables
Processed Foods &
Commodities e.g.
Spices-regulated only
under F&D Act
License 2016 2016
2017
PCP 2016 2017
2018
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Questions ?
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Canada’s Safe Food for
Canadians Act and Regulations Session #2
Keith Mussar
Keith Mussar & Associates
December 17, 2015
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About the Regulation
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New Regulatory Architecture
Generic outcome-based regulations applicable to all food categories & supply chain
Commodity specific requirements
Guidance
Incorporation by Reference New Definitions
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• 165 Pages of regulation • 15 Parts, Divisions, Sections
• 16 Documents incorporated by reference > 200 pages
• Interpretive guidance • New definitions and CFIA
interpretation
• New compliance & enforcement standards • Outcome based regulations- evidence
based compliance
• Audited food safety practices with complimentary inspection
• Inspection frequency & oversight based on company risk profile
The Parts
• Part 1 Interpretation
• Part 2 Trade
• Part 3 Licenses
• Part 4 Preventive Control Plans
• Part 5 Traceability
• Part 6 Commodity Specific Requirements
• Part 7 Recognition of Foreign Systems
• Part 8 Ministerial Exemptions
• Part 9 Inspection Legends
• Part 10 Packaging
• Part 11 Labelling
• Part 12 Standards of Identity
• Part 13 Grades and Grade Names
• Part 14 Seizure and Detention
• Part 15 Organic Products
About the Regulation
Complex Regulation
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Biological, Chemical and Physical Standards for Food
Ante-mortem Examination and Presentation Procedures for Food Animals
Beef, Bison, and Veal Carcass Grade Requirements
Fundamentals of the Post-mortem Examination Program
Preventive Control Plan Requirements for Biological Hazards in Meat Products
Canadian Grade Compendium
Grade Standard Requirements for Fresh Fruits or Vegetables Imported from the United States
Guidelines for Canadian Drinking Water Quality - Summary Table
Maximum Quantity Limits for Personal Use Exemption
Minimum Drained Weights and Average Drained Weights for Processed Fruit or Vegetable Products in a Hermetically Sealed Package
Units of Measurement for the Net Quantity Declaration of Certain Foods
CAN/CGSB 32.310 standard of the Canadian General Standards Board - Organic Production Systems - General Principles and Management Standards
CAN/CGSB 32.311 standard of the Canadian General Standards Board - Organic Production Systems - Permitted Substances Lists
CAN/CGSB 32.312 standard of the Canadian General Standards Board - Organic Aquaculture Standards
ISO/IEC 17011 standard of the International Organization for Standardization - Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies
ISO/IEC 17065 standard of the International Organization for Standardization - Conformity assessment - Requirements for bodies certifying products, processes and services
http://www.inspection.gc.ca/about-the-cfia/acts-and-regulations/regulatory-initiatives/sfca/progress-on-the-consolidation-of-food-regulations/eng/1419984548471/1419984608208
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Provisions Incorporated by Reference
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Outcome-Based Regulations
• Floor drain must be located 2.5
feet from each wall
• Light intensity in product
grading locations must be 5 lux
• Floor drain must be located so
that all water drains freely from
the surface and no residual
water remains on the floor
• Adequate lighting must be
provide to allow for proper
grading of the product
• “Every operator must ensure
that the establishment, and any
equipment, facility and
conveyance in it, is maintained
in a clean and sanitary
condition to prevent the
contamination of the food”
(Element 2)
Prescriptive Approach Safe Food For Canadians
• Industry has flexibility to select best option to achieve the desire outcome
• Onus is on industry to provide evidence to CFIA that the outcome is met
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• Annual gross sales < $30,000 exempt from written PCP
• Unless: meat, fish, dairy products, eggs, processed eggs products, processed fruits & vegetables
• Adjust exemption trigger: increase sales exemption, number of employees?
• No license requirement for companies not requiring registration or certificates?
• No cost for license for companies gross sales <$30,000 ?
• Longer transition period for companies with gross sales <$100,000 ?
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Approach to Small Companies Under SFCR
• Audit business processes – (i) thoroughness of PCP (ii) does company execute PCP
• Documented evidence supporting food safety & compliance controls
• Audit frequency determined by company risk rating
• Third party food safety certification influences company risk rating-certification does not replace CFIA oversight
• CFIA regional inspector company contact point-access to Ottawa measured
• Audits-teams of CFIA inspectors
• Multiple day audits
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Inspection Under Safe Food for Canadians Regulation
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CFIA Issue Escalation
Inspector
Inspection Manager
Regional Chief Inspector
Area Chief Inspector
Area Director General
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Safe Food for Canadians Act
Food Safety Modernization Act
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Meat, poultry, egg products X Pet food X Transportation, distribution &
Storage • Licensing vs. registration • Foreign supplier verification • Third party certification
Information Resources
Safe Food for Canadians Act
http://laws-lois.justice.gc.ca/eng/acts/S-1.1/index.html
Draft Safe Food for Canadians Regulatory Text
http://inspection.gc.ca/DAM/DAM-aboutcfia-sujetacia/STAGING/text-
texte/regs_safe_food_regulations_cnsldtn_foodregs_1427726282343_eng.pdf
Draft CFIA Integrated Inspection Model
http://www.inspection.gc.ca/about-the-cfia/accountability/inspection-
modernization/integrated-agency-inspection-model/iaim-
consultation/eng/1390935174455/1390935603829
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Questions ?
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