Transcript No Slide Title

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
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)
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.
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.
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 wellbeing from products that present a risk
of injury or gross deception or are
otherwise defective
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.
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
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
RECALL STATISTICS IN CANADA
(CFIA,2004)
CFIA Food Recalls and Allergy Alerts 2003
25
20
15
CFIA Food Recalls and Allergy Alerts 2004
10
18
5
16
14
0
12
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
10
8
158 recalls and allergy alerts reported
6
4
2
0
Jan
Feb
Mar
Apr
May
44 recalls and allergy alerts reported until May
30th 2004
Source of data: CFIA, Food Recall Archives.
Recall Procedures (recommended steps of
conducting a recall)
(CFIA,2001)
Assemble the Recall Management Team
Notify the CFIA
Identify all products to be recalled
Detain and Segregate all products to be recalled which are in your firm's control
Prepare the Press Release (if required)
Prepare the Distribution List
Continuation…...
Prepare and distribute the Notice of Recall
Verify the effectiveness of the recall
Control the recalled product(s)
Decide what to do with the recalled product(s)
Fix the cause of the recall if the problem occurred at your facility
SOME OF THE COMMON PROBLEMS WITH RECALLS,
POTENTIAL IMPACTS AND RECOMMENDED SOLUTIONS
FOR THE CFIA.
1. PRESS RELEASE AND NOTICE OF RECALL
PROBLEMS
POTENTIAL IMPACTS
RECOMMENDED
SOLUTIONS
 The hazard is
 Distributors, retailers and
 Put the word URGENT in
not clearly
consumers may not
the title of the notice
described
understand the seriousness of  Be brief and to the point, do
 The urgency of
the hazard
not include promotional
the recall is not  Consumers may use the
information
clearly stated
recalled product before they
 Tell consumers what to do
 Instructions to
are aware of the hazard
with the product e.g.,
consumers are  The CFIA or the recalling firm
destroy, return to the store
not clear
may have to issue a second
for a refund
press release
Continued ….
2. INFORMING THE CFIA OF A RECALL
PROBLEMS
 CFIA is not notified
of the recall
 CFIA is notified
days or weeks after
the problem is
identified by the
manufacturer
POTENTIAL IMPACTS
RECOMMENDED
SOLUTIONS
 Hazardous product may not be
 Notify the CFIA immediately if
removed from distribution and
you suspect a product that your
sale in a timely manner
firm has manufactured and sold
 Consumers who purchased the
may pose a risk to the health of
product may use it before they are
consumers
aware of the hazard
Continued….
3. NOTIFICATION OF CUSTOMERS
PROBLEMS



The firm decides to

remove the product
from the retail level
without informing

customers of the recall
Customers are not
notified until days after

the recall was classified
Customers are not
notified
POTENTIAL IMPACTS
Distributors, retailers and
consumers may not be aware of
the hazard
Hazardous product may not be
removed from sale or distribution in
a timely manner
Consumers may use the recalled
product before they are aware of
the hazard
RECOMMENDED
SOLUTIONS

Inform all customers of the recall
immediately and in writing
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)
Packaging Company
detected the fault on the
package (recall of the lot).
Package Company
proceeded to the
destruction of the product
and preventive actions
Milk Company checked
HCPP didn’t find problem in
the process
Packaging Company
analyzed the defect product
(ISO 9002) and sample
from Milk Company
Second complaint from a
customer (sample)
Milk Company found “possible
cause” from a defect in the
package (detention and recall
of the lot )
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.
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.
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?
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 1-800-4422342. 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)
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
Harissa, 150g/142 ml tube
Code Number
All codes from 27/02/04 to 20/06/06
Manufacturer
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.