This document provides an overview and summary of Canada's new Safe Food for Canadians Regulation (SFCR) which comes into effect on January 15, 2019. It outlines the key elements of the new regulation including licensing requirements, preventive control measures, traceability rules, and the steps companies need to take to transition. The regulation aims to modernize and consolidate Canada's food safety rules and better protect consumers from foodborne illness.

1. Safe Food for Canadians Regulation – Are You Ready?
Presented By: Cameron Prince, VP Regulatory Affairs – The Acheson Group
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5. Safety Chain Presentation
Safe Food for Canadians Regulations
January 23, 2019

6. 1. Safe Food for Canadians Act and proposed Regulations
2. Overview of key elements and impact on current food safety
environment
3. Licensing
4. Preventive control measures
5. Traceability
6. Steps to transition
7. Questions
6
Agenda

7. • passed in 2012
• Was not in effect until SFC Regulations came into place
• driven by several major food safety incidents
• Weatherill report recommendations to improve food safety
and legislative base
• On June 18, 2018 the Government of Canada published the
final version of the Safe Food for Canadians Regulations with
an effective date of January 15, 2019.
• This makes the SFC Act and Regulations the primary food law
in Canada.
7
Safe Food For Canadians Act

8. • FSMA (Food Safety Modernization Act) in USA
• Single food approach to regulatory programs
• Relevance and limitations of current Food Acts
• Stronger import controls needed for global food supply chain
• Food fraud, intentional adulteration, tampering, food terrorism
now reality
• Insufficient fines and penalties
• Modern regulatory framework
8
Drivers

9. • Meat Inspection Act
• Fish Inspection Act
• Canadian Agricultural Products Act
• Consumer Packaging and Labelling Act (Food Parts Only)
• Food and Drugs Act (administered by Health Canada)
• Canadian Food Inspection Agency Act
9
Federal Food Acts Today

10. • Meat Inspection Act
• Fish Inspection Act
• Canadian Agricultural Products Act
• Consumer Packaging and Labelling Act (Food Parts Only)
• Food and Drugs Act (administered by Health Canada)
• Canadian Food Inspection Agency Act
These will be revoked as of passing of the SFCR
10
Federal Food Acts Future

11. • Prohibitions against food tampering and deceptive practices
• Strengthened food traceability
• Improved import controls
• Modernization and simplification of existing food legislation
• Aligned inspection and enforcement powers
• Authority to certify all foods for export
• New review mechanism
• Stronger fines and penalties
SFC Act applies to import, export and inter- provincial trade – generally not
Intra-provincial trade
11
Highlights of the SFC Act

12. 12
• Sets standards for food in Canada
• Administers the Food and Drugs Act
Health
Canada
• Operational delivery
• Food inspections, recalls, testing, enforcement, export
certification, facility licencing, penalties, etc.
• Reports to Ministers of Health and Agriculture
• Administers(controls) other food Acts
• ADMINISTERS SFC Act and Regulations
CFIA
•Investigation of Food Borne Illness outbreaks
Public
Health
Who Does What: Federal Food
Inspection

13. 13
• Significant regulatory initiative
• Consolidates 14 sets of regulations into 1
• Existing regulatory framework incorporated
• Commodity specific requirements remain
• Complex, thorough regulation package
• New Elements-Preventive Controls, Licensing, Traceability
• Incorporation By Reference NEW!
Regulations – Highlights

14. Part 1: Interpretation
Part 2: Trade
Part 3: Licences
Part 4: Preventive Control Measures
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:Grades and Grade Names
Part 13: Seizure and Detention
Part 14: Organic Products
Part 15: Temporary Non-Application to Certain Food Commodities and Persons
Part 16: Transitional Provisions
Part 17: Consequential Amendments, Repeals and Coming into Force
Schedules 1-9 outline net quantities, container sizes, legends, and other required information for
specific foods.
14
Structure of the SFCR

15. • Safer food
• Quicker food recall from
marketplace if unsafe or
violative
• Better food programs
• Better controls for
imported foods
15
Benefits for Consumers

16. • Fairer competition
• Better traceability and recalls
• Use of innovative technologies
• Greater accessibility to export certification
• Better prevention of food-borne illness outbreaks
• More flexible policy changes by CFIA
• More flexibility in meeting requirements: outcome based vs
prescriptive
• Improve trade opportunities, particularly for exporters
16
Benefits for Industry

17. • ALL food businesses require a licence and will have to develop
Preventive Control Programs.
• Greater CFIA inspection for companies that were low priority
• Fruit and vegetable dealers exempt from CFIA fruit and veg
licence (if member of Dispute Resolution Corporation).
• Costs and greater CFIA enforcement
– Use of Administrative Monetary Penalties (AMPs) and
other penalties
– Administrative costs for industry i.e. licence fees
– New costs to build food safety programs for companies
lacking existing programs
– More and higher inspection fees
17
Other Potential Industry Impacts

18. 18
• All companies engaged in international
or interprovincial trade will require a
licence (some exemptions)
• Replace current CFIA commodity licence
and registrations
• Companies must:
1. Apply for a licence
2. Identify products
3. Demonstrate they have a Preventive
Controls Program
• Pre-licensing inspection may be
necessary, based on risk
• licences can be suspended or cancelled
Licensing

19. • Preventive controls a condition of licensing
• Start with Hazard Analysis for ingredients and
processes
• Beyond HACCP, identification of all controls to
produce food meeting all regulations.
• Strong Supplier Assurance programs
– Importers: conduct detailed risk
evaluations
– Companies: maintain detailed and
documented policies, procedures, and
records.
• Companies will be audited by CFIA
• CFIA values GFSI certification, may minimize CFIA
attention
• HOWEVER GFSI is a business choice, SFCR is the
LAW!
19
Preventive Controls

20. • Stronger traceability requirements now
in place
• Trace products one step forward and
one step back.
• Processors:
– packaging and ingredients
traceable back to original vendor
– all finished products traceable to
first level of distribution
• Importers:
– trace back to the foreign
vendor/processor,
– trace products to first level of
distribution
20
Traceability

21. • Food Safety Enhancement Program (FSEP) and Quality
Management Program(QMP) were CFIA HACCP
programs for Agricultural and Seafood commodities,
based on Codex standards
• FSEP and QMP Limitations
– Prescriptive
– Do not address the USA and international
transitions beyond HACCP and CCP’s
SFCR PCPs replace these programs
21
Canada
Food Safety/Quality Environment

22. Everyone who:
• imports food
• manufactures, processes, treats, preserves, grades, packages, or
labels food for export or to be trade inter-provincially.
• Requests an export certificate
• Slaughters food animals for export or to be trade inter-
provincially
• Stores and handles a meat product in its imported condition for
inspection by the CFIA
• Exemptions: Food for personal use, food additives regulated by
Health Canada’s Health Products and Food Branch.
22
Who Needs a Licence?

23. Measures that prevent or mitigate hazards associated with
preparing food products. They are based on Codex
Alimentarius General Principles of Food Hygiene.
-CFIA
23
Definition
Preventive Controls

24. A written document that demonstrates how hazards and
risks to your food products are identified and eliminated (or
reduced to an acceptable level).
-CFIA
24
Definition
Preventive Control Plan

25. • Industry wide
• Based on Codex Principles of Food Hygiene
• New for companies unfamiliar with CFIA and
Food Safety Programs
• Online CFIA tool “do you need a Preventive
Control Plan?”
• Processors who have FSMA,FSEP, QMP, GFSI
certification or HACCP programs meet most
SFCR requirements
• Require controls for non-food safety
requirements such as weights and labelling
• No special emphasis and extra record keeping
for Supplier Assurance, Allergen Program,
Sanitation. No Preventive Controls Qualified
Individual (PCQI) required.
25
Preventive Controls

26. CFIA stepwise approach:
1. Assemble the team
2. Ensure the basic Preventive Controls (GMPs or PRPs) are in place
3. Perform a Hazard Analysis for inputs, process steps, and traffic flows.
Identify control measures, CCPs, and verifications
4. Measures for Market Fairness (labelling, grading, net quantity,
foreign market requirements, humane treatment of
animals, and post mortem examinations in
slaughterhouses)
5. Assemble documents and records
Suggested templates are also available on CFIA SFCR website.
26
Preventive Controls for Domestic
Processors and Exporters

27. • Written Preventive Control
program
• CFIA on-line tool “Do I Need
a Preventive Control Plan”
• CFIA on-line Self
Assessment Checklist for
Importers.
• CFIA templates for
Importers to use.
27
Preventive Controls for Importers

28. CFIA stepwise approach:
1. Understand food being imported
2. Research the foreign supplier and their programs
Meat and fish -foreign suppliers are on required exporter lists
or in good status with CFIA.
3. Assemble all the necessary information using the Templates.
Include all regulatory requirements i.e. food safety and
market fairness. Write the PCP and implement with
verifications.
28
Preventive Controls for Importers

29. • CFIA on-line tools to determine if they need a licence or preventive
controls.
• If broker is an importer, Importer PCP applies.
• Brokers with no storage facilities or transport vehicles - SFCR
difficult to apply.
• If a broker takes ownership then ships interprovincially - may
require a licence and PCP.
• If broker never take ownership (arrange sale and transport)- a
licence and PCPs may not be required.
Brokers and Distributors status with respect to SFCR can be
complicated and may need individual company evaluations.
29
Preventive Controls for Brokers and
Distributors

30. • Hazard Analysis
• Description of the control measures in place and evidence showing
effectiveness
• Description of the CCPs and related
– Control measures
– Critical limits
– Monitoring procedures
– Corrective action procedures
• Procedures to verify the written PCP is implemented and is effective
• Descriptions of the measures in place to ensure you meet the labelling,
packaging, grading, standards of identity, net quantity, and humane treatment
of animals applicable to your products
• Supporting documents including information you used to determine the
hazards associated with your foods, the CCP rationale and historical data
30
What to include in a
Preventive Control Plan (PCP)

31. • All food businesses including retailers
– Processing companies - trace ingredients one step
back and products to first level of distribution
– Retailers - trace products back to supplier
• Restaurants exempt
• CFIA on-line tool – What would your traceability requirements
be?
• Transporters also exempt. Transport regulations coming in next
phase.
31
Traceability

32. • Prepare and keep records with dates
• Identify the food
• Trace food one step back
• Trace food one step forward
• Identify and trace back to ingredients or animals you
slaughtered (if applicable)
• Maintain accessible, readable records for 2 years. Provide to
CFIA upon request.
32
Traceability – the Records

33. • Have recall and complaint programs
• Investigate food safety and regulatory issues immediately
• Report food safety risks to CFIA
• Record, investigate and respond to complaints
• Document recall procedures including company contacts.
• Conduct Mock Recalls at least once/year
• All recall details documented and kept for 2 years
• Recall effectiveness checks done and recorded
33
Traceability-Recall and Complaints
Requirements

34. Table 1: Proposed staged implementation approach for Part 4 requirements
Meat, Fish, Eggs,
Processed Eggs,
Dairy, Processed
Fruit or Vegetable
Products, Honey,
Maple
Fresh Fruits
and
Vegetables
All other
Foods
>$30,000 and
> 5 employees
All Other
Foods
>$30,000 and
< 5 employees
All Other
Foods
<$30,000
Preventiv
e control
measures
January 15,
2019
+ 1 year + 2 years + 3 years + 3 years
Written
preventiv
e control
plan
January 15,
2019
+1 year + 2 years + 3 years Not
required*
34
* In addition to all other foods, honey, maple and fresh fruit or vegetable
products would not need a written preventive control plan if they have gross
annual sales of food that is <$30,000
Proposed Phased-in Approach
Preventive Control Measures

35. Comparison FSMA v SFCR
• In FSMA Bioterrorism Act registration required; SCFR requires licence with mandatory PCPs
• FSMA Human Food Rule mainly focuses on food safety whereas SFCR requires HACCP and food safety
controls. plus consumer protection (weights, labels, composition standards etc.) in PCPs.
• SFCR covers all foods. FSMA does not include meat, poultry, catfish (USDA commodities)
• FSMA requires a PCQI. SFCR does not.
• Extensive US government financial support. Very limited in Canada.
• FSMA has Foreign Supplier Verification Program. CFIA licensed processors are recognized under FSVP.
• CFIA will charge fees for licences and services. FDA – limited cost recovery.

36. SFCR/FSMA Compatibility
• CFIA and USFDA have agreement on equivalency
• CFIA maintains a list of companies eligible to export to US.
• Canadian exporters to US must be licensed.
• US Food exporters can ship to Canada with no special provisions (subject to risk
management decisions)
• USDA and CFIA meat inspection trade rules remain mostly unchanged.
• Canadian exporters must still have Bioterrorism number from FDA
• Canadian companies must have a PCQI to ship to US.
• US companies may hold a SFCR import licence.

37. Integrating Tips
• Try to maintain one plan as much as possible for FSMA, SFCR, and GFSI.
• Canadian companies with existing HACCP systems are in good shape to meet both
SFCR and FSMA but need to be vigilant in assessing gaps.
• Canadian companies need to be aware of emphasis on environmental monitoring
by FDA
• Canadian companies need to address FSMA emphasis on Allergens, Supply Chain
and Sanitation
• Be ready for FDA and CFIA cross border audits of systems

38. • Meat, fish. Dairy, eggs, honey, maple companies must have a
licence now.
• Exporters must have licence now no matter what commodity.
• Commodities that have 1 or 2 years need to build PCPS now.
• If minimal food safety program in place, more preparation
will be ne
• If CFIA licensed and GFSI certified, understand SFCR and
identify potential gaps to compliance
• Communicate gaps to company and senior management
38
Next Steps, Timelines and Preparations

39. • CFIA resource challenges
• Years to complete integrated inspection approach
• Focus on high risk operations first
• Objective to visit licensed companies in 3 years
• Less CFIA attention for some
• Electronic auditing
• Possible licence before visit
• Inspectors will be generalists vs experts
• More rigorous enforcement, AMP’s for violations
• CFIA transparency for inspection results
39
Transition Expectations

40. My CFIA
• secure on-line portal now partially implemented to allow companies to carry out
many transactions on-line
• enrolment is free and easy to do
• there is no fee for enrolment
• apply for licences
• apply for export certificates
• pay fees for inspection services
• http://www.inspection.gc.ca/about-the-cfia/my-
cfia/eng/1482204298243/1482204318353
40
Additional Transition Resources

41. Thank You
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