The CFIA Food Safety Investigation and Recall …2015...What is a Food Recall? Removal from sale or use, or correction, of a marketed product that poses a health risk or is non-compliant

© 2014 Her Majesty the Queen in Right of Canada

(Canadian Food Inspection Agency), all rights reserved. Use without permission is prohibited.

The CFIA Food Safety Investigation and Recall Process

Presented to: Canadian Society of Nutrition Management

Dates: May 8 & 9, 2015

Presented by: Fred Jamieson, Food Safety Recall Specialist, Food Safety and Investigation, Office of Food Safety and Recall, Control and Risk Management Directorate, Canadian Food Inspection Agency

RDIMS #6635925

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Outline

• Mandate of the Canadian Food Inspection Agency (CFIA) and the Office of Food Safety and Recall (OFSR)

• Definition of a recall

• The Food Safety Investigation and Recall Process

• Recall Statistics (Annex)

• CFIA area/provincial contacts

Canadian Food Inspection Agency –Food Related Mandate

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• CFIA’s mandate: “safeguarding food, animal and plants…”

• CFIA enforces or administers 13 Acts and Regulations related to plants, animal or food

• Involves food that is sold domestically, food that is imported into Canada and food that is exported from Canada

Office of Food Safety and Recall

• Office of Food Safety and Recall (OFSR)

• Food Safety Investigations and Recall

• Food Safety Technical Assessment and Analysis

• National coordination of referred food safety investigations and recalls

• Primary contact with the Public Health Agency of Canada (PHAC) in foodborne illness outbreak investigations

• Contact point with Health Canada for Health Risk Assessments

• Single point of contact with international food emergency offices

• Ensure consistency of decision making

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IndustryProvincial/municipal agencies

HealthCanada

PHAC CFIA

Develops health policies and standards; Conducts health risk assessments

Implements food safety control investigations; Initiates/responds to recalls

Outbreak surveillance/Investigations related to human health

Regulatory compliance and enforcement; food safety investigations; risk assessment; recall warnings; and effectiveness checks

Outbreak Investigations (human illnesses, institutions)

International partners

Information exchange

Canada’s food recall system involves all food safety partnersØ At the federal level, Health Canada and the Public Health Agency of

Canada (PHAC) are responsible for human health, surveillance and risk assessments

Ø The CFIA is responsible for verifying food safety regulatory compliance

Effective response to a potential or confirmed food safety issue requires cooperation and collaboration among all parties to ensure timely response

What is a Food Recall?

Removal from sale or use, or correction, of a marketed product that poses a health risk or is non-compliant with respect to legislation enforced by the CFIA

Food safety hazards that may result in a recall:

• Food allergies and sensitivities (e.g. peanuts, tree nuts,

milk, eggs)

• Microbiological (e.g. Listeria monocytogenes, E. coli

O157:H7)

• Physical / extraneous material (e.g. glass, wood)

• Chemical (e.g. melamine, lead, patulin)

• Nutritional (e.g. excessive or deficient levels of vitamins

and minerals, inaccurate sodium and sugar declarations)

• Others: Choking (e.g. konjac jelly cups); Tampering 6

The Food Recall Process

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Triggers

• Consumer and industry complaints

• Foodborne illness outbreaks

• Notification of a food safety issue from a company

• CFIA audit or inspection findings

• Laboratory results

• Referrals from other federal, provincial or municipal authorities

• Referrals from foreign governments

• Media

• Associations

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Goals of Food Safety Investigations

• Confirm the hazard and the nature / extent of the problem, i.e.

• Follow the Food: consumer/complainant, retail/institution, distribution/warehouse, manufacture, supplier, importer

• Identify the product(s) affected

• Identify the firms affected (retailer, manufacturer, importer, supplier)

• Identify the underlying cause, i.e.

• The food safety deviation that caused the incident to occur

• Collect information and verify the accuracy and completeness of findings to be provided to Health Canada for a Health Risk Assessment

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Food Safety Investigations

On-Site Activities:

• Understanding the process

• Observing practices and reviewing documented procedures

• Observing / inspecting equipment and conditions

• Verifying the accuracy and completeness of information

• Collecting and analyzing samples where appropriate

On average, the CFIA conducts 3,500 food safety investigations per year leading to approximately 300 recall incidents

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Food Safety Investigation - Traceback

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• Systematic process used to follow the food in the distribution system from the consumer to the manufacturer, importer or to the raw material’s origin if needed

• Traceback challenges:• Product information• Complexity of the distribution system• Retail practices• Manufacturing practices• Jurisdiction



Health Risk Assessment (HRA)

• If a potential health risk has been identified, a formal request for an HRA is submitted to Health Canada.

• The purpose is to determine what level of human health risk a specific food/hazard represents.

• The Food Directorate at Health Canada delivers HRAs according to established protocols and time standards (8 hours for a Health Risk 1)

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Health Risk Assessment (HRA)

• The level of health risk is determined by taking into

account the hazard identification, the exposure

assessment, the hazard characterization and the risk

characterization

• Health Risk 1: reasonable probability that the consumption/exposure to a

food will lead to adverse health consequences which are serious or life-

threatening, or that the probability of a foodborne outbreak situation is

considered high.


food will lead to temporary or non-life threatening health consequences, or

that the probability of serious adverse consequences is considered remote.


food is not likely to result in any adverse health consequence. The

situation identified may be an indication of a breakdown in Good

Manufacturing Practices; in Good Agricultural Practices; in Good Practices

in Veterinary Medicine some other relevant factor.

• The determination of health risk serves as an input 16



Recall Decisions

• Recall decisions are based on a combined weight of evidence approach that includes:

• HRA from Health Canada

• Epidemiological assessments provided by PHAC or provincial / territorial health authorities

• Traceback / trace forward information

• Actions already initiated by the company

• Most recalls are conducted voluntarily by the industry upon request from the CFIA.

• When the company does not agree to voluntarily conduct a recall, the CFIA may request that the Minister issue a mandatory recall order

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Legislation – Mandatory Recall Orders

Section 19, the Canadian Food Inspection Agency Act:

(1) Where the Minister believes on reasonable grounds that a product regulated under an Act or provision that the Agency enforces or administers by virtue of Section 11, poses a risk to public, animal or plant health, the Minister may, by notice or distributing the product, order that the product be recalled or sent to a place designated by the Minister.

• This power has been used 7 times since the creation of the Agency

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Classes of Recalls

Class II

Class III

Class I

Temporary adverse health consequences or probability of serious adverse health consequences is remote

Adverse health consequences not likely, regulatory contravention

Serious adverse health consequences, possibly even fatal

Public Warning may be issued

Usually no Public Warning

Public Warning is usually issued

Note: public warnings are not issued for Class I recalls where product is not sold to consumers.

Depth of recall: wholesale/warehouse, retail (includes hotel, restaurants, institution (HRI), manufacturer) and consumer level

Recall Implementation

• The recalling firm has the responsibility of:• Conducting the recall

• Ensuring that its actions have been effective in removing

the product from the marketplace

• Identifying and notifying the product consignees

(wholesalers, distributors, retail stores)

• Product consignees have the responsibility of removing the affected product from sale

• Recall effectiveness checks • Visiting / calling vendors

• Statistically based

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• Protecting confidential business and personal

information, and maintaining the integrity of the food

safety investigation are significant impediments to the

release of information prior to a recall being

implemented.

• Information shared when a recall is implemented:

• Public warnings

• Photos of recalled products

• E-mail notifications

• Recalls are posted on the CFIA and Healthy Canadians websites

• http://www.inspection.gc.ca

• http://www.healthycanadians.gc.ca

• Recalls and safety alerts mobile application and social media

Food Safety and Recall Communication

http://www.inspection.gc.ca

http://www.healthycanadians.gc.ca

CFIA’s Food Recall Report Web page

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Healthy Canadian Web site

Communications during High Profile and Emergency Events

Public communications activities during high profile

and emergency events may include:

• News release

• Media technical briefing

• Questions and answers

• Backgrounder

• Chronology of events

• Food safety investigation summary posted on CFIA website 25

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Food Safety and Recall Communication

Industry

• Templates• Translation Service /Release to News Media• Food Investigation Response Manual• Recall Plans/Guides (4)

Consumer

Information sheets:• Allergies • Causes of Foodborne illness• Food safety tips and facts• Specific products/risks



Disposition of Recalled Product

• The recalling firm provides an action plan for the disposition of recalled product• CFIA verifies the plan

• Some products may be salvageable, for example: relabelled or cooked; others may de discarded or shipped back to the originating country

• Salvaged product must be brought into compliance with legislation / regulations

• Decisions on the appropriate product disposition method are made by Area Operations

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Verification of Effectiveness

• CFIA officials conduct effectiveness checks to verify that the recalling firm has effectively recalled the product

• On occasion, the CFIA may request the assistance of officials from provincial and territorial governments in conducting recall effectiveness checks

• If the recall is determined to be ineffective, the CFIA will request the firm to redo the recall

• If a firm is unwilling to remove the product from sale and appropriately dispose of it, the CFIA may:• seize and detain the product

• recommend that a recall order be issued by the Minister of Health

• issue a public warning29

Corrective Action / Follow-Up

• After recalled product is removed from the marketplace, the CFIA continues to work with the processor, manufacturer or importer to ensure that any problems that led to the recall are resolved.

• monitors the company’s corrective action to prevent reoccurrence of the food safety hazard

• monitors the recovery, reconciliation and disposition of

recalled product and any affected product remaining in the

company’s control

• CFIA works with industry sectors or foreign countries to address broader issues that go beyond one company or sector

• may involve the review of Government of Canada standards

and policies to determine whether changes are necessary

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Food Recall Statistics

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Food Recall Incidents and Total Recalls

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Food Recall Incidents by Area of Concern from April 1, 2013 to March 31, 2014

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180

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77

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Allergen

Chemical

Extraneous Matter

Microbiological

Other

Food Recall Incidents by Class from April 1, 2013 to March 31, 2014

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83

96

139 Class I

Class II

Class III

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CFIA Contacts

Atlantic - (506) 381-7683

Quebec - (866) 806-4115

Ontario - (416) 665-5049

Manitoba - (204) 797-4501

Saskatchewan - (306) 529-0671

Alberta - (587) 230-2518

British Columbia - (604) 292-5780

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Documents

The CFIA Food Safety Investigation and Recall …2015...What is a Food Recall? Removal from sale or use, or correction, of a marketed product that poses a health risk or is non-compliant