canada’s safe food for€¦ · fruit & veg., honey, maple (including meat importers) fresh...

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.


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

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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 ?

Keith Mussar


[email protected]

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mailto:[email protected]

Canada’s Safe Food for

Canadians Act and Regulations Session #2

Keith Mussar


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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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


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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http://inspection.gc.ca/DAM/DAM-aboutcfia-sujetacia/STAGING/text-texte/regs_safe_food_regulations_cnsldtn_foodregs_1427726282343_eng.pdf








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 ?

Keith Mussar


[email protected]

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mailto:[email protected]