1. Canadian Supply Chain Food Safety Coalition
Update on Canada’s New Food Safety Regulations and the New Rules under the US Food Safety Modernization Act
Canadian National Millers Association
13 September 2016
Winnipeg Fairmont, Winnipeg, Manitoba
Albert F. Chambers
Executive Director
(change)

2. Presentation Outline Canadian Supply Chain Food Safety Coalition
Update – What’s happened in the last 12 months?
FSMA rules – SFCA regulations - Quick Outline
Questions

3. Canadian Supply Chain Food Safety Coalition (CSCFSC) - Background
Established – December 2000, incorporated August 2007
Our Vision: Canada’s agriculture, fisheries and food industry will have a world-class reputation for producing and selling safe food.
Our Mission: To facilitate, through dialogue within the food industry and with all levels of government, the development and implementation of a national, coordinated approach to food safety to ensure credibility in domestic and international marketplaces.

4. CSCFSC Membership
Open to national, provincial & regional or local associations whose members are actively involved in the food supply chain
Includes associations representing all segments -- input suppliers through to final marketers
Allied members - provide services to the supply chain

5. Update – What’s happened in the last 12 months?
FSMA implementation date this month not next year
Canada Gazette I publication delayed to Dec 2016
Canada/US enter into Food Safety Systems Recognition Arrangement (05/16)
FDA published 6 final rules & updated
FDA published draft guidance on preventive controls for human & for animal food (08/16)
FDA updated/extend implementation date deadlines (08/16)

6. FSMA & SFCA – A quick outline
1st set out FSMA requirements
2nd a brief outline of SFCA proposed regulations
Highlight the similarities & differences

7. FSMA – Why does it matter?
1st major piece of federal legislation addressing food safety since 1938.
1st legislation to address Intentional Adulteration and Food Defense.
Focuses on Prevention instead of Response
Updates requirements for Good Manufacturing Practices
Extends the FDA’s food safety regime outside the USA
Catches US regime up with international trends in food safety regulation
Does not cover meat, poultry, processed egg products

8. SFCA – Why does it matter?
Also 1st major reform of federal food safety legislation in decades!
Covers all food produced in Canada (imports, exports, interprovincial trade)
Combines 4 Acts & 13 sets of Regulations
Designed to catch Canada up with global food safety regulatory trends

9. FSMA – What does it include?
Eventually than 50 rules, guidelines & studies, including:
Preventive controls for human food (Sept 2015)
Current Good Manufacturing Practices (Sept 2015)
Preventive controls for produce (Nov 2015)
Preventive controls for animal food (Nov 2015)
Foreign Supplier Verification Program (Nov 2015)
Voluntary Qualified Importer Program
Accreditation of 3rd Party Auditors/Certification Bodies (Nov 2015)
Sanitary Transportation (April 2016)
Record Availability Requirements (April 2014)
Prior Notice of Imported Food (May 2013)
Intentional Adulteration (May 2016)

10. SFCA – What does it include?
One new regulation & Incorporation by Reference
Horizontal provisions applying to all food imported and prepared for trade inter-provincially (e.g licensing, preventive controls, traceability, record-keeping)
Commodity–specific food safety requirements
Commodity-specific trade & consumer provisions (e.g. standards of identity, grades, container sizes, inspection marks, labelling)
Complementary regulations regarding disclosure of information and administrative monetary penalties

11. FSMA – Facility Registration
Updated requirements under the Bio-terrorism Act (2002)
Biennial registration even years (between 1/10 and 31/12)
2016 changes require:
contact of the US agent for foreign food facilities
Type of activity conducted for each food product category
Assurance that the FDA will be permitted to inspect the facility
Starting in 2020
All submissions to be filed electronically
A unique facility identifier (UFI) for each domestic and foreign facility
SFCA proposes licensing domestic facilities (except farms) with more than $30K annual sales

12. FSMA – Preventive Controls for Food
Mandatory comprehensive, prevention-based controls across the food supply
Based on modified Codex HACCP approach called Hazard Analysis and Risk-Based Preventive Controls (HARPC) = currentGMPs + hazard analysis + preventive controls, + intentional adulteration & food defense + supply chain controls
FDA issued detailed draft guidance in August 2016
14 chapters (not all in this draft)
Includes guidance on HARPC approach, Food Safety Plan, etc

13. FSMA – current GMPs 1st revision since 1986 Includes: Personnel
Plant & grounds
Sanitary operations
Sanitary facilities & controls
Equipment & utensils
Processes & controls
Warehousing & distribution
Defect action levels

14. SFCA – Preventive Controls
Licensed food businesses must:
Undertake a “determination” of hazards
Control the hazards using validated controls
Eliminate any biological, chemical or physical hazards
Have Preventive controls covering
Maintenance & Operation of the Establishment
Sanitation & Pest control
Conveyances & Equipment
Conditions respecting establishment
Unloading, Loading & Storing
Competency
Hygiene
Communicable diseases & Lesions
Investigation & Notification
Complaints & Recall

15. FSMA – Written Food Safety Plan
Prepared by one or more “preventive controls qualified individuals”.
Includes:
hazard analysis
preventive controls
supply-chain program
recall plan
monitoring procedures the implementation of the preventive controls
corrective action procedures
verification procedures
records.

16. SFCA – Preventive Control Plan
Be prepared, kept & maintained
Include description
Hazards determined to present a risk of contamination of the food
Control measures
Validation evidence
For CCPs (limits, monitoring, corrective actions)
Verification procedures
Documentation to substantiate implementation
Supporting documentation
[Limited detail to date & does not appear to meet market (e.g. ISO or GFSI FSMS expectations]

17. FSMA – Supply-Chain Program
Requires use of approved suppliers
Written supply-chain program
Documented verification activities focused on supplier applied controls
On-site audits
Sampling & testing raw materials
Review of supplier’s food safety records (hazard analysis, preventive controls, records, etc)
Supplier’s food safety performance & history
Records
SCFA does not require supplier approval program

18. FSMA – Intentional Adulteration & Food Defense
Focus is on facilities that involve
bulk liquid receiving and loading;
liquid storage and handling;
secondary ingredient handling; and
mixing and similar activities.
Plan to include:
A vulnerability assessment & .
Identification of Actionable Process Steps
Focused mitigation strategies
Monitoring, Corrective actions & Verification activities
Training of personnel and supervisors
Recordkeeping
SFCA regs do not include intentional adulteration or food defense

19. FSMA – Sanitary Transport
Covers: US shippers (truck or rail) & foreign shippers (truck, rail, ship, air, container, etc.)
Includes requirements regarding:
Vehicles and transportation equipment - design & maintenance
Transportation operations - measures taken to ensure food safety & protect against unintentional or intentional contamination
Training - sanitary transportation
Records
SFCA regs do not include transportation between food businesses

20. FSMA -Foreign Verified Supplier Program
US importers/agent/consignee required to evaluate risks by considering:
Nature of hazards in the food
Foreign suppliers procedures & controls
US food safety regulations & the supplier’s compliance
Suppliers food safety performance history
FSVP does not apply to imports under seafood or juice HACCP
US importers to undertake supplier verification
Flexible approach – annual on-site audit or less frequent if can be justified

21. FDA/CFIA Food Safety Systems Recognition Arrangement
Concluded May 2016 – FDA’s 2nd arrangement (NZ)
Covers FDA/FSMA products
Based on joint review that concluded “comparable control measures and systems” re food safety
Outcome - Exporters to comply with domestic requirements
Requirements:
Foreign supplier must be under oversight of CFIA
Food must be in scope of arrangement (i.e. not meat/poultry, etc)
Importer needs to document above
Importer must determine & document that supplier is in good compliance standing with CFIA
FDA warns “not a green light” to access

22. FSMA – Coming into force
Registration – in effect 2012 – biennial – new requirements in 2016 & 2020
Preventive controls for human food –
Large firms – cGMPs & PCs – 19 September 2016
Small firms (less than 500 employees) – cGMPs & PCs - 09/2017
Very small firms (less $1Million sales) - cGMPs & PCs - 09/2018
Foreign Supplier Verification Program
18 months after publication of the final rule (May 2017) or
6 months after the foreign supplier is required to meet FSMA requirements (depends on size – small - 01/2018)

23. SFCA - When will it come into force?
The basic answer is: “We don’t know!”
Needs to move through Canada Gazette process:
Publication in Part 1 (minimum 75 day consultation for WTO)
Review of comments & changes
Publication in Part II (Final Regulation)
Part I timing – likely December 2016
Part II timing – some time in 2017
CFIA is contemplating 3 forms for a transition:
Based on type of food business (e.g. currently registered - year 1, fresh produce - year 2, all others – year 3)
Based on size of business over 3 years
Or, some mixture of 1 & 2

24. Conclusion (1)
Both the FSMA rules & SFCA regulations are long & complex documents
In intent & in many cases in approach, they are very similar:
Outcome based not prescriptive
Prevention oriented
Written plans based on hazard analysis
Preventive controls
Recall
Etc.

25. Conclusion (2) In some aspects they are quite different:
FSMA includes:
Intentional contamination/food defense
Supply-chain controls
Transportation
Reaches dramatically outside the US borders
SFCA consolidates in one Act & one set of regulations four (4) Acts & 13 regulations

26. Questions?

27. Contact Information
Website:
Albert Chambers
Executive Director
Canadian Supply Chain Food Safety Coalitoin