Alejandra Colina Ibarra University of Guelph Food Safety Policy, Crop 6250 June 2004

1. A CASE OF RECALL POLICY AND ITS APPLICATIONS OCCURRED IN A COMPANY THAT PRODUCES AND PACKAGES PASTEURIZED MILK Alejandra Colina Ibarra University of Guelph Food Safety Policy, Crop 6250 June 2004

2. What is a recall? • A firm’s voluntary removal from further sale or use, of a marketed food that violates legislation enforced by the Canadian Food Inspection Agency. (HC 1999) • Sometimes, for many different reasons, a product may be manufactured and sold which may make some people ill or injure them, or is in violation of the legislation. When an unsafe or violative food product has left the control of the manufacturer, it must be removed from the market. (CFIA, 2001)

3. RECALL POLICY CANADA • Definitions • “Mandatory recall” means a recall as per Section 19 of the Canadian Food Inspection Agency Act. • 19.(1) Where the Minister believes on reasonable grounds that a product regulated under an Act or provisions 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 served on any person selling, marketing or distributing the product, order that the product be recalled or sent to a place designated by the Minister.” • “Product Withdrawal” means a firm’s removal from further sale or use of a marketed product that does not violate legislation administered or enforced by the CFIA. It is not considered to be a recall.

4. Recall Classifications (CFIA,2001 ) • “Class I” is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. • “Class II” is a situation in which the use of, or exposure to, a violative product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote. • “Class III” is a situation in which the use of, or exposure to, a violative product is not likely to cause any adverse health consequences.

5. RECALL POLICY U.S. [e-CFR Title 21: Food and Drug, PART 7-Enforcement Policy, Subpart C] Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective

6. RECALL POLICY US [e-CFR Title 21: Food and Drug, PART 7-Enforcement Policy, Subpart C] • Recall may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of the Food and Drug Administration. • Recall is generally more appropriate and affords better protection for consumers than seizure, when many lots of product have been widely distributed.

7. RECALL STATISTICS IN THE U.S. (FDA,2002 ) Source of data: Recall Operations Staff, Division of Compliance Management and Operations, Office of Enforcement, HFC-210

8. RECALL STATISTICS IN THE U.S. (FDA,2002 ) Source of data: Recall Operations Staff, Division of Compliance Management and Operations, Office of Enforcement, HFC-210

9. RECALL STATISTICS IN CANADA (CFIA,2004) 158 recalls and allergy alerts reported 44 recalls and allergy alerts reported until May 30th 2004 Source of data: CFIA, Food Recall Archives.

10. Prepare the Press Release (if required) Prepare the Distribution List Assemble the Recall Management Team Identify all products to be recalled Detain and Segregate all products to be recalled which are in your firm's control Notify the CFIA Recall Procedures (recommended steps of conducting a recall) (CFIA,2001)

11. Control the recalled product(s) Decide what to do with the recalled product(s) Prepare and distribute the Notice of Recall Verify the effectiveness of the recall Continuation…... Fix the cause of the recall if the problem occurred at your facility

12. SOME OF THE COMMON PROBLEMS WITH RECALLS, POTENTIAL IMPACTS AND RECOMMENDED SOLUTIONS FOR THE CFIA. 1. PRESS RELEASE AND NOTICE OF RECALL

13. Continued …. 2. INFORMING THE CFIA OF A RECALL

14. Continued…. 3. NOTIFICATION OF CUSTOMERS

15. Recall Policy. Application in a Company that Produces and Packages Pasteurized Milk Milk Company received complaint from a customer reporting “fermentation” of the milk(no sample) Milk Company checked HCPP didn’t find problem in the process Second complaint from a customer (sample) Packaging Company detected the fault on the package (recall of the lot). Packaging Company analyzed the defect product (ISO 9002) and sample from Milk Company Milk Company found “possible cause” from a defect in the package (detention and recall of the lot ) Package Company proceeded to the destruction of the product and preventive actions

16. CASE ANALYSIS Number of defected packages: 56, 749 Number of defected packages recovered: 55,930 Number of diseased people reported: 1 Cause of the defected packages: A piece of paper was stocked in the machine that forms the edges of the packages and caused a “hard fold-end”. Corrective Action: Implementation of a UV lamp in the machine that forms the edges in order to detect this kind of problem and an increase of the number of tests during the production. Packaging Company came to the conclusion that the product didn’t violate any legislation, and that if the product were handled properly the packages wouldn’t have suffered any rupture. Therefore, both companies managed the case as a withdrawal.

17. The Question ? Do you think this recall procedure case would be handled differently in Canada or the U.S.? If so how? According to my findings the CFIA and the FDA would most likely managed the case in the same manner.

18. Conclusion and Recommendations • Management commitment • Appropriate training in all levels • Firm’s Ethics (core values) • Importance of customer satisfaction and customer health • Effective Communication IN THE END A WITHDRAWAL OR VOLUNTARY RECALL IS ABOUT ETHICS. A GOVERNMENT ACTION AGAINST A FIRM WOULD PROVE MUCH MORE COSTLY • Should a firm report to CFIA or FDA about their withdrawals?

19. May 28 - ALLERGY ALERT - Undeclared walnuts in THE CAKERY QUALITY DESSERTS 8" CHOCOLATE VOLCANO cake • UNDECLARED WALNUTS IN THE CAKERY QUALITY DESSERTS 8" CHOCOLATE VOLCANO CAKE • OTTAWA, April 28, 2004 - The Canadian Food Inspection Agency (CFIA) is warning people with allergies to walnuts not to consume The Cakery Quality Desserts 8" Chocolate Volcano cake. The affected product may contain walnuts which are not declared on the label. This alert is of concern to those individuals who have allergies to walnuts. • The affected product, The Cakery Quality Desserts 8" Chocolate Volcano cake, is sold frozen and is known to have been distributed in Ontario. • Consumption of this product may cause a serious or life-threatening reaction in persons with allergies to walnuts. There has been one reported reaction to this product. • The CFIA is continuing its investigation. • For more information, consumers and industry can call the CFIA at 1-800-442-2342. 8:00 a.m. to 4:00 p.m. local time - Monday to Friday. • For information on receiving recalls by electronic mail, or for other food safety facts, visit our web site at www.inspection.gc.ca. • CFIA, 2004 (last checked; May 31, 2004)

20. May 28 - HEALTH HAZARD ALERT - Le CABANON brand HARISSA contains Sudan I • HEALTH HAZARD ALERT • Le CABANON BRAND HARISSA CONTAINS SUDAN I • OTTAWA, May 28, 2004 - The Canadian Food Inspection Agency (CFIA) is warning consumers not to consume Le Cabanon brand Harrisa, a hot sauce in tube. This product contains a non-permitted colour, Sudan I, which is considered to be carcinogenic. • The following product is affected by this alert: • Brand and Product Code Number Manufacturer • Harissa, 150g/142 ml tube All codes from 27/02/04 to 20/06/06 Le Cabanon S.A., • 84850 Camaret, France • The CFIA is working with importers to remove the affected product from the marketplace. This product may have been distributed nationally. • Sudan I, a red dye, is not allowed as a food colour in Canada. It has been shown to cause cancer in laboratory animals and these findings could also be significant for human health. There have been no reported illnesses associated with the consumption of this product. • The CFIA is monitoring the effectiveness of the recall. • For more information, consumers and industry can call the CFIA, Monday to Friday, 8 a.m. to 4 p.m. local time, at 1-800-442-2342. • For information on receiving recalls by electronic mail, or for other food safety facts, visit our web site at www.inspection.gc.ca.