Search

| Advanced
Search

You are here :

Consumers

Industry

ACVM

Animal
products

Dairy
products

Plant
products

E-cert

Imported
foods

FSANZ,
labelling & composition

Organics

Processed
food and retail sale

Whats
New

Food
Safety Programmes

Exemption
from Food Hygiene Regulations

Wine

Policy &
Law

Science

Verification
Agency

Recalls &
Alerts

About Us & Contact
Us

Foodsafe Website

All
Consultation

All Forms

All
Publications

Registers &
Lists

Glossary/Acronyms

Website
notifications

Subscribe

Website
feedback

Have your
say about how to improve this site

- Print Friendly
- Help

Recall Guidance Material

Recall Guidance Material

Contents

Important Disclaimer

Every effort has been made to
ensure the information in this document is accurate.

NZFSA does not accept any responsibility or liability whatsoever for
any error of fact, omission, interpretation or opinion that may be
present, however it may have occurred.

Recall Guidance Material

Contents

Introduction

The
Purpose of a Product Recall

Roles
and Responsibilities

The
Role of the Food Industry

Product
Tampering / Extortion

Recalls
and the Law

The
Law, Recalls and Privileged Statements

The
Role of the Regulatory Authorities

Interface
with NZFSA

Primary Regulatory Management of Recalls

Recalls
of Product being sold in New Zealand

Recalls
and Overseas Countries

Australia

Regulatory
Audit of Business Generated Recalls

Levels
of Product Recall

Developing
an Effective Business Product Recall Procedure

Product
Recall Policy

The
Product Recall Plan

The
Product Recall Team

Definition
of Roles and Responsibilities

Product
Recall Contacts List

The
Decision to Recall

Sources
of Information

Risk
Assessment

The
Scope of the Recall

Notification
of a Product Recall

Communicating
with Regulatory Authorities/NZFSA

Communicating
with the Distribution Chain

Communicating
with the Consumer

Paid
Advertisements (applicable during a Recall or a Withdrawal)

Press
Release (applicable during Recall only)

Testing
and Reviewing the Product Recall Plan

Managing
a Product Recall

Staffing
a Recall

Using
a Consultancy or an Agency

Paying
for a Recall

Documenting
the Product Recall Process

Regaining
control of Affected Stock

The
Effectiveness of the Product Recall

Closing
the Product Recall

Reviewing
the Lessons Learned

Reviewing
the Product Recall Process

Final
Reports and Recommendations

Appendix
1: Roles and Responsibilities Diagram

Appendix
2: Example of a Recall Decision Tree

Appendix
3: Recall Criteria Guide

Appendix
4: Sample Trade Notification

Appendix
5: Schedule of National Newspapers

Introduction

This guidance material, developed by the New Zealand Food Safety
Authority (NZFSA) is a reference document for the food and beverage
industry. It aims to clarify and standardise procedures for the
identification and removal of unsafe food from the food chain. Recall
systems are a fundamental component of a food business’s food safety
programme.

This document will outline:

1. The roles of the
regulatory authorities and the food industry.

2. The risk assessment
process.

3. The elements of a
product recall plan.

4. The actions to take
when an unsafe food must be removed from the market.

5. NZFSA’s standards for
product recall advertisements as well as giving guidelines for media
communication.

A quick reference guide is also available from the NZFSA website: Recall Quick Reference Guide.

Even within the best managed food business, an issue involving the
safety of a foodstuff may occur. This could be the result of a packaging
defect, a preservation failure, a production problem, a storage problem, a
problem with the ingredients of a foodstuff or any other reason. It is
important that food businesses assume that a food safety issue may arise
with their products and, therefore, plan ahead. These systems and plans
should be periodically tested to ensure that they are comprehensive and
serve to remove an unsafe product from consumers and/or the distribution
chain.

Food businesses within the food service sector, such as restaurants,
caterers and takeaways may not need a recall plan. While these businesses
manufacture food, the food will be eaten shortly after it has been made.
Therefore, if a problem were to occur with this food, the food will have
been consumed before it can be recalled. However, while a recall plan is
not required in these circumstances, these businesses may be part of
another business’s recall. For example, they may need to remove recalled
stock from shelves and return it to the manufacturer or to ensure that
food that is subject to a recall is separated and identified from other
food until it is disposed of in accordance with the instructions provided
as part of the recall (this usually means ensuring the disposal of food so
that it cannot be used for human consumption). Therefore all food
businesses should be familiar with recall requirements and consider which
aspects should be included in their food safety programme.

Food businesses will inevitably remove products from the market for
reasons other than food safety. This eventuality is not covered in this
document. However, the procedures outlined here may be applicable in such
an event. Food businesses may wish to expand their recall and traceability
systems to encompass product issues not involving food safety.

The Purpose of a Product Recall

Recall is the isolation and removal of food which has been released
from a manufacturer’s direct control, and is under the control of others
in the storage, distribution, retail, and consumer chain.

The purpose of a product recall, in the context of this document, is to
protect public health by facilitating the efficient, rapid identification
and removal of unsafe food from the distribution chain and, by informing
consumers (where necessary) of the presence on the market of a potentially
hazardous food. An effective product recall will ensure that the unsafe
foods are contained and either destroyed or rendered safe.

NB. The elimination of the circumstances that caused the need for a
recall (corrective action) is an essential activity but not addressed in
this document. The removal of the product from consumer exposure should be
seen as the initial corrective action. Once this is achieved the
prevention of a recurrence must be addressed.

Roles and Responsibilities

The Role of the Food Industry

In accordance with the Food Act and other food legislation such as the
Animal Products Act or Wine Act, the primary responsibility for the safety
and suitability of the food for human consumption is borne by the food
industry. For a wide variety of reasons a manufacturer/trader may be
responsible for a situation where product is not safe and is in the hands
of others. On becoming aware of the situation the responsible
manufacturer/trader must take all reasonable steps to remove the product
from the possession of others.

Consumer demand for information and public health protection are also
key drivers for an effective product recall system. ‘Product life cycle
management’ and category and brand protection are also very important
considerations for any company. As a result, every food business is
encouraged to have a written and visible recall policy. This policy should
be supported by a product recall procedure, the contents and testing of
which should be guided by elements of this guidance note.

If a food business becomes aware of, or is notified of a potential food
safety incident, all necessary action must be taken to protect public
health.

Product Tampering / Extortion

Food products can be the target of isolated, post-production or
post-sale contamination. This could be accompanied by extortion demands or
it could be intended to cause adverse publicity or economic harm to a
supplier or retailer. In these circumstances any decision to recall the
product should be made only after full consultation with the police, the
relevant health authorities, NZFSA and the manufacturer, supplier or
retailer of the products. Widespread recall may not be appropriate or
necessary.

Recalls and the Law

The power for the NZFSA/Minister to initiate a recall exists in
legislation.

• The Food Act 1981

• The Animal Products Act
1999

• The Wine Act 2003

In each Act, the legal process that must be followed is set down. The
purpose of a NZFSA initiated recall needs to be understood and adhered to.
In most circumstances the need to exercise the legal power will result
from the failure of a business to act responsibly. It is not to be used as
a means of penalising a business. A recall action is not an impediment to
the taking of any other legal action that may be available to regulators
under any statute.

It is important to note that the ability for the NZFSA/Minister to
initiate a recall is not limited to matters of food safety. The wording in
legislation refers to "for the purpose of protecting the public" giving
considerable scope for recall including matters relating to food safety,
fraud, and non-compliance with food standards. In most circumstances this
legal power will predominantly be used with respect to matters of food
safety.

The Law, Recalls and Privileged Statements

The Director-General has power to make privileged statements to protect
consumers and to inform the public under:

• The Food Act 1981

• The Animal Products Act
1999

• The Wine Act 2003

There may be a relationship between a recall and a privileged
statement. Both are public statements. The following factors influence a
decision to make a privileged statement.

• The need for urgency. In
a situation where it is imperative that the public is informed with the
absolute minimum of delay, a privileged statement will be issued. A recall
may follow.

• Where the owner(s) of
product(s) are for whatever reason failing to manage a recall the question
of the need for privileged statement(s) should be asked. It may be
necessary for the NZFSA to correct inaccuracies that have been
created.

• A decision to make
privileged statement(s) may be made in conjunction with a NZFSA/Minister
initiated recall to further inform the public.

• Where the owner(s) of
product(s) are managing a recall appropriately and a high level of public
concern exists it may be prudent for the NZFSA to confirm to the public
that all reasonable steps are being taken in the form of a privileged
statement.

• Where the owner(s) of
the product(s) cannot be identified or contacted, and the situation
requires the public is informed without delay, a privileged statement will
be issued.

The Role of the Regulatory Authorities

The NZFSA is responsible for the administration and enforcement of food
legislation. There are several business units within NZFSA that may have a
role in food recall, depending on the legislation a food business is
administered by (e.g. Food Act (1981), Animal Products Act (1999), Wine
Act (2003)). In addition the NZFSA holds service contract agreements with
Public Health Units or Offices to enforce general food legislation via the
Food Act Officers (FAO).

The preferred position of the NZFSA is to support the actions of the
responsible business. In this process the responsible business would
be:

• addressing the matter
with urgency,

• keeping the NZFSA
(usually through its contracted Food Act Officers in Public Health Units,
NZFSA verifier or through a contracted third party agency) fully informed
from the first indication of a product ‘problem’ through all stages of the
recall,

• complying with all
reasonable requests the NZFSA officers may make on the recall process,

• taking all reasonable
steps to inform all persons who may have product that is unsafe or
potentially unsafe, and,

• retrieving that product
or having it disposed of in a suitable manner.

In providing that support the NZFSA will carry out the following
actions.

• Ensure that appropriate
recall plans are in place in the approval/registration of risk management
systems.

• Ensure that recall
procedures are appropriately addressed in the approval/recognition of
codes of practice.

• Have freely available to
businesses, documentation that provides sound guidance in the execution of
a recall.

• Have procedures in place
that ensures that the NZFSA is in close liaison with the business during
the crisis period and ensure that the business is meeting its
responsibilities.

• Conduct an audit of the
recall (usually through its contracted Food Act Officers in Public Health
Units, NZFSA verifier or through a contracted third party agency) after
its completion to establish its credibility.

The regulatory authorities also have a role in the food business with
advice on risk assessment and food companies should always consult the
local District Health Board / Public Health Unit (Public Health Offices) if they are considering the need to
remove unsafe food from the market. The NZFSA is also a source of risk
assessment advice for food businesses involved in recovering unsafe food
from distribution or the retail market. NZFSA has a role in the
co-coordinating national recalls that may affect more than one food and/or
more than one business.

In addition, NZFSA is obliged to report food incidents to other
(overseas) regulatory authorities in cases where unsafe food has been
exported.

Interface with NZFSA

District Health Boards/Public Health Units (DHB/PHUs), NZFSA
Verification Agency or Third Party Agencies are the interface between
NZFSA and the company. The company is expected to deal directly with these
representatives of NZFSA during the stages of the recall as their point of
contact and to follow their own non-conformance procedures eg Food Safety
Programme, Risk Management Programme.

The DHB/PHU’s, NZFSA Verification Agency or Third Party Agencies are
expected to make recommendations to NZFSA on the response level needed, to
assist NZFSA in appreciating the process and issues involved and to
follow-up on required corrective actions.

Primary Regulatory Management of Recalls

Recalls of Product being sold in New
Zealand

The Compliance & Investigation Group will co-ordinate all industry
initiated recalls and statutory initiated food recalls for products sold
on the domestic market (in some cases this will include Australia). They
will work with other parts of NZFSA, Public Health Units, and the domestic
food industry to ensure the necessary systems and procedures are in place
to recall food from the market place to protect consumers.

Recall information is posted on the NZFSA website (Food
Recalls for Consumers) by NZFSA.

Recalls and Overseas Countries

New Zealand has obligations under certain trading arrangements and as a
responsible trading country to notify relevant recall actions to overseas
countries. The responsibility for regulatory oversight/action in countries
other than New Zealand rests with the Group that has regulatory oversight
of the particular products concerned. They will work with other parts of
NZFSA, as appropriate, to ensure that appropriate measures are taken.

Australia

All food product recalls within New Zealand are notified to Australia
irrespective of whether recalled product has been sold in that country.
The notification process is managed by the Compliance & Investigation
Group. Australia reciprocates with similar notifications through Food
Standards Australia New Zealand (FSANZ).

Regulatory Audit of Business Generated
Recalls

It is the responsibility of the regulatory group that had the
regulatory oversight of the business recall to ensure that an audit of the
recall is carried out and to ensure that any deficiencies found in the
audit are rectified.

NB. At this time the regulator should ensure investigation has occurred
into the circumstances that led to the recall and that appropriate
corrective action and timeframes have been identified. The regulator has a
responsibility to ensure these are carried out.

Levels of Product Recall

Where food safety is concerned there are two levels of product
recall.

1. Recall: This is a removal of unsafe food from the
distribution chain and extends to food sold to consumers and therefore
involves communication with consumers.

2. Withdrawal (also known as Trade Recall): This is
the removal of an unsafe foodstuff from the distribution chain but does
not extend to food sold to the consumer.

The above terminology should always be used in all communication with
other businesses and regulatory authorities to avoid confusion.

In general, a recall should be initiated when food has been identified
as unsafe, a potential risk to public health, and has been distributed to
the consumer. A recall would be expected to occur where there is a
reasonable possibility that use or consumption of the food would cause
adverse health consequences or even death. Examples of when these
circumstances might exist include when there is the presence of pathogenic
organisms (e.g. Clostridium botulinum, Salmonella species,
Listeria monocytogenes), foodborne pathogenic viruses (e.g.
Hepatitis A), toxic chemicals (including presence of bacterial toxins) and
harmful foreign bodies (e.g. glass fragments).

Recall action may also be taken if the product has serious defects that
pose a potential health risk. Examples of when these circumstances might
exist include; when there are goods that are incorrectly labelled, for
example do not declare the presence of an allergen (eg. peanuts, milk or
milk products, soy etc); or have incorrect/insufficient cooking
instructions.

A withdrawal should be initiated when food has been identified as
unsafe, a potential risk to public health but it can be demonstrated that
the unsafe foodstuff remains wholly in the distribution chain and has not
reached the consumer. However, there are some situations where food is
distributed to the consumer but circumstances indicate a Withdrawal will
be sufficient to protect public health. Such decisions should always be
made in consultation with NZFSA.

There are two alternatives for remedial action:

1. Permanent removal of
the unsafe products from the market or from use;

2. Temporary removal of
the unsafe products from the market, followed by rectification of the
problem and a return to the market.

Developing an Effective Business Product Recall
Procedure

The features of an effective business product recall procedure
include:

1. The recall policy for
the business

2. The development and
maintenance of a product recall plan

3. Testing of the product
recall plan

4. Implementing the
product recall plan

5. Managing the product
recall plan

6. Closing a product
recall

7. Reviewing a product
recall and amending the product recall plan

Refer to Recall Plan Template as an example.

Product Recall Policy

All food businesses should develop a product recall policy. A product
recall policy is a simple, clear and unambiguous business statement on the
commitment to remove product that presents a risk to human health from the
market. It demonstrates the company’s commitment to protect public health.
It should clearly state the objective of the product recall plan and the
senior management’s commitment to providing the necessary resources to
ensure the successful removal of unsafe foods from the market. The product
recall policy should be in place prior to the development of the product
recall plan.

The Product Recall Plan

This should reflect the business policy on product recall. It must be a
written coherent document that effectively guides the business during a
recall event.

A multi-disciplinary recall team, where possible, should develop the
product recall plan. Examples of elements that may be incorporated into a
plan are:

• Reference to the product
recall policy

• List of member(s) of the
recall team

• Definition of roles and
responsibilities for product recall

• Contact names and
details including home telephone or mobile numbers

• Definitions of the two
classifications of a product recall (see Levels of Product Recall)

• A product recall
decision tree

• Mechanisms of
notification of a product recall

• Reference to the
company’s traceability system

• Guidelines for media
contact

• Sample press
releases

• Sample product recall
advertisements

• A product recall plan
testing procedure

• A product recall review
procedure

The Product Recall Team

Depending on the size and complexity of the business the team will be
one or more people. It is essential that there is a Recall Co-ordinator
who has the authority of the business to carry out that role. Therefore,
the Recall Co-ordinator should be appointed by, and have the full support
of senior management. The plan needs to stipulate that it is the
responsibility of the co-ordinator to maintain and retain full documented
evidence of all actions taken during the recall. This person should be
knowledgeable about every aspect of the business operations. The
co-ordinator will need inputs, in a recall situation, in relation to:

• production

• quality

• purchasing

• marketing

• sales

• legal services

• distribution and supply
chain

• consumer affairs/public
relations

The business will have examined these responsibilities and determined
who will provide these inputs into the team. Possibly these inputs will be
provided from outside the organisation on an ‘as needed’ basis, e.g. legal
advice. The important thing is that they are identified.

The responsibilities of the recall team will be to:

• develop the business
recall plan

• manage the maintenance
and testing of the recall plan

• update the recall
plan

• direct the product
recall activities

• recommend changes to the
business operations to minimise the need to remove unsafe foods from the
market.

Definition of Roles and Responsibilities

Effective product recall requires all employees to be clear about their
roles during a product recall and the boundaries of their
responsibilities. These need to be detailed in the plan. In a complex
business with many employees there would be advantages in detailing this
in diagrammatic form. A sample diagram is shown in Appendix 1.

Product Recall Contacts List

This is an essential feature of a good product recall plan and it can
be considered vital that an up to date contact list is maintained. It is
also the element that most quickly becomes inaccurate. Often contact lists
are not updated and this frequently becomes an issue during a product
recall. Valuable time can be wasted creating or updating the list during
the recall event and there is the risk that essential people are omitted
from the process. Responsibilities for updating the list should be
specified in the product recall plan and the accuracy of the list should
be frequently checked by the product recall team. The contact list itself
may be included in the recall plan, however as it is likely to require
frequent modification it may be more effective to provide clear direction
as to the location of the up to date contact list.

It is suggested that the contact lists available in or referenced by
the product recall plan are split into five sections as follows:

1. The product recall team
and senior management (include key personnel if not part of the recall
team)

2. Suppliers of ALL
ingredients (include water)

3. Distribution company
and business customers

4. Sources of technical
advice and support including laboratory facilities

5. Regulatory authorities
- general contact numbers for NZFSA and relevant regulatory authorities
are available on NZFSA’s website at the following addresses:

Food Act: Public Health Offices

Animal Products Act: NZFSA Verification Agency

Experience has shown that a significant number of food safety incidents
occur out of normal business hours. Therefore it is suggested that the
contact lists are as comprehensive as possible and are easily accessed to
facilitate fast and efficient information recovery, eg

• Contact

• Wk Phone

• Hm Phone

• Mobile

• Fax

• Email

The Decision to Recall

As far as practicable the parameters in relation to chemical, physical
and biological indicators that would render a product unsafe must be
predetermined. In the application of HACCP the hazard analysis will
provide the basis for making this determination. In situations where the
analysis has not been made, provision to evaluate the severity and impact
of hazards should exist. In these situations a recall decision tree may
assist.

A decision tree should be designed to clarify the thought processes
leading to a final decision on the necessity of product recall and the
appropriate type of product recall (i.e. Recall or Withdrawal).
Appendix 2 shows an example of a typical decision tree. However,
food businesses should draw up a decision tree applicable to their own
business and management structure.

The timely and effective removal of unsafe food from the market is
dependent on careful, considered risk assessment. Risk assessment should
only be carried out by, or with the co-operation of, a person who
technically competent to evaluate the severity and impact of food safety
hazards in foodstuffs. The risk assessment should be carried out in
recognition of the precautionary principle (see the section on Risk
Assessment). In this process the involvement of the appropriate regulator
should be included.

Sources of Information

The product recall team should always get their facts first hand. This
prevents the miscommunication that often hampers efficient product recall.
The information that is gleaned concerning the food safety hazard, the
product details, the likely distribution and the extent of the problem is
vital to good decision making. There is a high probability that
information gathered in the early stages of an investigation will be
faulty or flawed. This needs to be accounted for in the initial risk
assessment, which should always take a precautionary approach placing the
protection of the consumers’ health high on the list of priorities. The
precautionary approach requires companies to act to protect public health
even when limited details are available.

Initial information on a potential food safety incident can come from a
variety of sources but in the first instance it is likely to rest with
only one or two individuals in an organisation. It is important that these
individuals are aware of the product recall plan and that they take the
correct steps to ensure that a product recall team is convened. Training
of staff will be necessary to ensure that initial information is handled
appropriately.

Sources of initial information may be:

• Internal

• Quality and production
records

• Sales
representatives

• Employees

• External

• Ingredient
suppliers

• Packaging suppliers

• Regulatory agencies

• Distributors/business
customers

• Consumer complaints

• Media reports

Information should be verified at source where possible by the product
recall team. In the case of a consumer claiming illness, full details
should be obtained by contacting the customer or regulatory authority
where appropriate.

The product recall team should aim to collect the following minimum
data set on a suspected food safety incident:

• Product name

• Product description

• Batch codes involved

• Quantity of product
implicated

• Distribution details

• Whether the product has
been sold to consumers

• The nature of the
product fault (hazard).

This information should be verified and fed into the risk assessment
process that in turn informs a risk management decision on the level of
product recall (i.e. Recall or Withdrawal) and the urgency/resources
required.

Risk Assessment

Product recall is a risk management decision that requires food
businesses to be able to identify a potentially unsafe food. In addition a
business must be able to decide if the unsafe food can cause a potential
risk to public health and if so, determine the level of adverse health
effect and the affected population profile and size. This requires a food
business to carry out an assessment of the potential risks resulting from
the problem with the food. This is called a risk assessment.

Risk assessments should only be carried out by competent technical
people. If in doubt, food businesses are advised to seek suitably
competent technical advice and/or the local DHB/PHU (Public Health Officers).

Food businesses should follow an accepted model for risk assessment.
The Codex Alimentarius has developed a model for risk assessment
consisting of the following steps:

• Hazard Identification:
the identification of known or potential health effects associated with a
particular agent.

• Assessment: the
qualitative or quantitative evaluation of the degree of intake likely to
occur.

• Hazard Characterisation:
the qualitative or quantitative evaluation of the nature of the adverse
effect associated with the hazard.

• Risk Characterisation:
the integration of hazard identification, hazard characterization and
exposure assessment into an estimate of the risk and its associated
uncertainties.

The process is best understood using an example:

The Production Problem: The pH of an acid preserved
foodstuff is too high. The product is distributed at ambient temperature,
has a shelf life of one year, does not require re-heating and has been on
sale for one month.

Hazard Identification: The bacterium Clostridium
botulinum could grow during product distribution. Cl. botulinum
causes botulism, a condition where a person, who eats food where Cl.
botulinum has grown and produced toxin, can die.

Exposure Assessment: The product conditions and shelf
life are suitable for Cl. botulinum to grow and produce toxin.
There is no re-heating to degrade the toxin. The consumer is likely to
have bought the product. The chances of exposure to Cl. botulinum
toxin are high.

Hazard Characterisation: Cl. botulinum toxin is one of
the most potent neurotoxins known. If the toxin is ingested the chances
are high the consumer will develop severe breathing difficulties and may
die.

Risk Characterisation: The chances of exposure are high
and the consequences of exposure potentially lethal. A severe adverse
public health effect is likely. It is not possible to quantify the risk or
the uncertainties associated with the risk.

Risk management decision: Recall of product from the
affected batches with immediate effect.

The decision on whether to Recall or Withdraw a product or not is
therefore based on the identification of a hazard that makes a foodstuff
unsafe and its likelihood of affecting public health. To ensure that
public health is protected at all times a food business must adopt the
precautionary principle in its risk assessment activities. In the context
of this document the precautionary principle can be explained as:

Food businesses, faced with the production of a potentially unsafe food
should aim to document their hazard identification and risk assessment
logic. For an example form to assist in this process refer to Recall Hazard/Risk Analysis Worksheet.

For guidance on recall criteria, such as foreign matter, refer to
Appendix 3.

The Scope of the
Recall

The plan must detail how the business will scope the range of
product(s) and the batches to be recalled. It is not sufficient for a
business to determine that only a single batch should be recalled simply
because the problem has only been demonstrated in that batch. Businesses
should also consider the possibility of the same problem or type of
contamination occurring in different package sizes of the same line, in
product with a different use by date, in a different product line all
together or same or similar product packaged under a generic label. The
plan must demonstrate the processes that will be followed to determine why
batches produced prior to, and after the known event, do not suffer the
same problem. Production control mechanisms that make particular batches
unique will provide justifiable decisions in relation to scope. Failure to
demonstrate that uniqueness should cause escalation the scope of
the recall, possibly to the whole of the product on the market. The
business policy and action on product traceability will also be a factor
to be built into the plan.

If the hazard/risk is found to be one or more raw materials supplied to
the business, then the supplier of the raw materials and their customers
need to be notified and the affected supply chain alerted.

Notification of a Product Recall

Following on from the decision to recall the plan must detail the
processes to follow in notifying the recall.

If the decision is taken to initiate a Withdrawal then three levels of
notification are advised:

• Within the Company

• Regulatory
authorities/NZFSA

• Distribution Chain

• Distributors

• Wholesalers

• Retailers

• Caterers

If the decision is taken to initiate a Recall then four levels of
notification are advised:

• Within the Company

• Regulatory
authorities/NZFSA

• Distribution Chain

• Distributors

• Wholesalers

• Retailers

• Caterers

• Consumers

Communicating with Regulatory
Authorities/NZFSA

It is strongly recommended that the plan provides for communication
with the appropriate regulator at the earliest opportunity, after an
incident is identified that may lead to a recall. Support and advice from
the regulatory authority/NZFSA will be advantageous to the food business
and will help when dealing with the media and the public (businesses under
the Food Act or Food Hygiene Regulations refer to Public Health Offices, businesses under the Animal
Products Act refer to NZFSA Verification Agency). The method of communication
needs to be specified along with the commitment to liaise with the
regulator throughout the recall process. Companies should ensure that they
supply the following information available as soon as possible:

• Name of the company and
contact details (including after hours contact details)

• Name of the product

• Batch identification
codes

• Product details
including packaging size and type

• Date marks

• Amount of product on the
market

• Distribution details (is
the product exported – note: in this situation food distributed in
Australia is classed as exported)

• Names of the
companies/outlets selling to the consumer

• Nature of the food
safety risk

• Results of any
investigations (including any applicable test results)

• The level of product
recall being considered (i.e. Recall or Withdrawal)

• The rationale that was
applied in determining the scope of the recall

• Plans for trade and
public communications

• Timings for product
recall and communication.

Food businesses should continue to update the regulatory authorities or
the NZFSA throughout the product recall and formally close the product
recall with the regulatory authority by notifying them in writing. Food
businesses can expect close liaison in a recall situation from the
regulatory authority/NZFSA who are required to undertake an audit of the
recall, approximately within 10 days of notification, to ensure
effectiveness of both the recall and identified corrective actions.

Commercially Sensitive Information

Companies should be clear when communicating with the regulatory
authorities about information that is commercially sensitive or private in
nature. NZFSA, as a Public Service Department, is subject to government
administrative laws, which means that its actions are open to public
scrutiny. The Official Information Act 1982 makes provision for public
access to certain documents in the Authority’s possession. Section 9 of
the Act “Other reasons for withholding official information”, allows for
non-disclosure of certain confidential and commercially sensitive
information.

Communicating with the Distribution Chain

Procedures for notifying the distribution chain should contain detailed
methods for stopping product distribution, retail sale or catering usage.
It is also important that plans are developed with business customers to
store recovered product safely and in isolation from safe foods when it is
outside of the control of the company responsible for the product recall.
Recovered stock must be appropriately labelled or withdrawn. Further,
methods need to be developed to regain control over unsafe product from
the business customer and store it safely and in isolation from safe
product pending stock reconciliation and destruction (some businesses may
choose not to regain control of affected stock but may require their
customers or the consumer to destroy the product after prior notification
to the business involved).

Initial notification to the trade could be via telephone but this
should be followed up by written communication by fax or email. The
written communication should contain all the information necessary to
allow the business customer to remove the correct product from sale or
distribution. The need for urgency must be conveyed and there must be
assurance that the message has been received, understood and acted on.

Food businesses should include sample notifications in the product
recall plan. Sample notifications should take account of the information
below.

• The notification should
be clearly entitled ‘Urgent: Product Recall’ or ‘Urgent: Product
Withdrawal’ as appropriate in bold large lettering to ensure that the
notification is acted upon quickly.

• Avoid making the
notification look like a business letter or it may not be dealt with
urgently. The details included should facilitate immediate and unambiguous
identification of the product.

• The ‘action required’
part of the notification should clearly state:

• ‘Remove from
sale/distribution’ or ‘do not use’ in the case of a caterer

• ‘Notify us immediately
if this product has been sold to the public’

• ‘Notify us immediately
if this product has been distributed to other distributors or
retail/catering establishments. Please also notify these businesses of the
product recall without delay;

This part of the notification can also be used to specify:

• Plans for recovery of
product and disposal

• Notification of
quantities of stock recovered

• The need to identify
and quarantine the product

• Other details to
facilitate the recall/withdrawal of product

• Request any assistance
in notifying the public in case of a Recall.

Appendix 4 shows an example of a Trade Notification.

Communicating with the Consumer

Procedures for notifying consumers should detail which media sources
are to be used and how contacts will be informed. This may take the form
of a media release or paid advertisement in newspapers, on radio or
television. The form of media used will depend on the circumstances
involved.

Where product that is unsafe can be demonstrated to be in the hands of
consumers the plan should articulate the basic rule that the consumer will
be informed.

Options for communicating a recall to consumers include:

• paid advertisements in
selected press outlets that are identified to have coverage of the
consumers who can reasonably expected to have possession of the
product.

• a general media
release.

• placing warning notices
at locations where the product has been sold.

Paid Advertisements (applicable during a Recall
or a Withdrawal)

Paid advertisements are necessary in the case of a Recall or in the
case of a Withdrawal when a company cannot identify all its business
customers in the distribution chain. Food businesses should include sample
Recall/Withdrawal advertisements in the recall plan along with
instructions for placing advertisements in appropriate media. The
information below should be recognised when drafting guidelines for the
product recall plan.

When a food business is engaged in a Recall, as defined in this
guidance material, paid advertisements must be placed in the appropriate
newspaper(s) or radio as soon as possible.

When a food business is engaged in a Withdrawal, as defined in this
guidance material, but find, for whatever reason, that it is not possible
to contact all relevant customers then the food business should consider
expanding the Withdrawal to a Recall.

Product recall advertisements must be clear, simple,
unambiguous and in a prominent position towards the front of the
newspaper. Avoid including unnecessary information about the company or
turning the product recall advertisement into a marketing opportunity.
Product recall advertisements must be approved by NZFSA before
publishing.

Templates are available to use on the NZFSA website, for general
recalls Recall Newspaper Advertisement Template and for recalls
involving allergens Recall Newspaper Advertisement Template – Allergen
Warning.

A single contact can arrange newspaper adverts in some or all of the
national newspapers, namely:

Newspaper Advertising Bureau at Newspaper
Advertising Bureau or refer to Appendix 5.

Similarly there is a single contact that can arrange radio adverts in
some or all radio stations nationally:

The Radio Bureau at The Radio Bureau

Recall information is also posted on the NZFSA website (Food
Recalls for Consumers) by NZFSA.

NZFSA will publish the recall advertisement on their website
indefinitely.

Press Release (applicable during Recall
only)

The plan must specify that where the risk to the consumer is of such a
nature that immediate notification is appropriate, a press release will be
made to all sections of the media. Press releases have the advantage of
reaching the print media and electronic media and do not suffer from
delays that could accompany a paid advertisement. If press releases are
used there is often no financial cost to the company. However, as
companies cannot rely on the uptake of a press release this method should
only be used in addition to the routine paid advertisement process that
will be conducted in a longer time frame.

The press release should cover all the features detailed in the paid
advertisement (see above). A copy of a sample press release should be
placed into the product recall plan.

It is important to include local radio news desks, especially if the
product recall is isolated to specific areas. Follow-up phone calls to
media are recommended. To encourage journalists or editors to pick up on a
press release the following approach to writing the release should be
taken:

• Write ‘Press release –
for immediate release’ at the top of the page in bold print.

• Compose a title e.g.
Company ‘A’ recalls product ‘X’ due to health concerns.

• Place the synopsis of
the recall, the product, the problem and what is being done into the first
paragraph and the use the proceeding paragraphs to flesh out the
details.

• Include quotes from the
company that the journalist can use in the article.

• Finish the release with
‘ENDS’ to signify conclusion.

• Keep press releases to a
single page if possible.

For an example refer to Example Press Release.

Warning Notice or Point of Sale Notice (applicable during Recall
only)

Placing warning notices where the product has been sold will assist in
communicating to the consumer that there is a recall relating to that
particular product. For an example refer to Point of Sale Notice.

Testing and Reviewing the Product Recall
Plan

The product recall plan should specify the periods for review and the
names of the people responsible for the review. In most cases this will be
the product recall team. The plan should be examined for errors,
particularly in the contact lists or in light of any changes in the
company’s product recall or trading status. It is recommended that the
product recall plan is reviewed at least twice a year in accordance with a
documented procedure which is held as part of the product recall plan
itself.

It is essential that a product recall plan is periodically tested using
a ‘trial run’ or mock recall exercise. This can be considered as a
validation of the product recall plan. This procedure should also be
documented in the product recall plan. Companies that develop product
recall plans but do not test them may face problems when a real food
safety incident occurs.

It is easier and more cost effective to alter a product recall plan
when the food safety incident is part of an exercise without the pressures
of the real situation. It is recommended that product recall plans should
be validated on an annual basis or more frequently if appropriate.
Ideally, in order to determine a company’s preparedness and speed of
action the test should be unannounced and not prepared. It may be worth
exploring the possibility of an agreement with customers and/or
supermarkets for them to become involved in the product recall test,
thereby increasing the value of the exercise. Once the test is completed,
a review must be carried out with the relevant product recall team members
to correct and improve the process where necessary.

Managing a Product Recall

The management of a product recall should be driven by the product
recall plan. The plan should carry all the details necessary for the
product recall co-coordinators to manage a product recall
successfully.

Staffing a Recall

It is worth considering whether you would need help to manage a recall.
This could mean employing extra staff to enable permanent staff to deal
with the recall. Specialist help may also be required to draft and deliver
your recall message. Most importantly it is necessary to prepare
thoroughly prior to facing a real emergency.

Using a Consultancy or an Agency

Many firms involved in previous recall campaigns have felt the need to
ask for specialist advice from an external agency. There are consultants
who specialise in every type of marketing communication – from advertising
and direct mail, to public relations and corporate communications. There
are also many agencies that can give all-round advice. If your firm
already employs an agency, you can ask what experience it has in dealing
with food recalls or other areas of crisis communications.

Firms may not need to retain a consultancy in case of future recalls,
but having some relevant companies’ details on file may be useful.
Agencies may be listed with various trade associations or listed under
‘advertising agencies’ or ‘media information &/or services’ in the
telephone directory.

Paying for a Recall

A recall will cost money. Just as it makes sense to agree with your
suppliers and business customers in advance about who should organise a
recall if it is needed, you should also decide who would pay for what.
Insurance may cover the cost of carrying out a recall and any loss of
profits related to it. It is worth finding out if you already have this
cover under any existing business catastrophe or disaster insurance
policy. If not, you may want to consider taking out a specialist policy.

Documenting the Product Recall Process

All information gathered by the product recall team should be
documented along with the date, time and provider of the information. The
member of the product recall team gathering the information should sign
off on the record. It is useful to set up an incident log that is used to
record events chronologically. All product recall team members are
responsible for completing the incident log but the Recall Co-coordinator
should review the log to verify that this is happening. The incident log
will be useful in three ways:

1. It will serve as a
reference if facts need to be checked

2. It will serve as a
means by which the recall can be reviewed

3. It may serve as a legal
document should it become necessary.

Decisions that are taken should reference the evidence on which they
are based and should be entered in the incident log. The person
responsible for the decision should sign off on the record of the
decision. This is especially important in the risk assessment process that
determines the level of product recall (i.e. Recall or Withdrawal) and the
severity of the incident. The sequence of events and actions taken will be
very important in the review and should not depend on peoples’
memories.

Regaining Control of Affected Stock

A food business that has initiated a product recall may regain control
of the potentially unsafe product but must account for all missing
stock.

In some circumstances a food business may request a customer or the
consumer to destroy the affected product. However, the food business
should ensure that they reconcile the destroyed product in an appropriate
manner where possible.

If affected product is recovered either by; direct returns from
consumers; returns to retail outlets; returns via the distribution chain,
or product already in stock then the following considerations are
important:

• The product should be
returned to one central site or, in the case of a widely distributed
product, to major recovery sites.

• The recovered product
must be stored in an area that is separated from any other food
products.

• Accurate records must be
kept of the amounts of recovered product and the codes or identifiers of
that product.

• If the recovered product
is unfit for human consumption, it may be destroyed or denatured under the
supervision of the company management and/or the relevant regulatory
authority where legally required. Recalled products should not be disposed
of by placing in unsecured bins, dumpsters, etc., in a manner that could
result in subsequent removal by individuals for their own use or for sale
to others.

• If the food safety risk
can be safely removed from the recovered product through re-labelling or
reprocessing this may be done once it is clear that public health will be
protected.

The Effectiveness of the Product Recall

To be effective, the product recall notification must reach as far as
the product has been distributed. The effectiveness of the product recall
is assessed on the basis of the amount of product returned as a proportion
of the amount of product that left the manufacturer or distributor, while
taking into account the retail turnover of the product.

During the product recall progress must be reviewed so that its success
can be monitored. If it is decided that there is now little risk to the
public, the product recall can be judged to have been a success and
brought to an end but if there have been few returns and little response
to a high-risk problem the product recall procedure must be reassessed.
The product recall may then have to be repeated using different methods to
reach the consumer.

Closing the Product Recall

The plan needs to define the process for formally notifying all parties
that the incident has ended. This includes the regulator who will arrange
for the recall to be audited. The Recall Co-ordinator will ensure that the
document record is made available to the auditor to facilitate this
process.

Reviewing the Lessons Learned

Every product recall should be viewed as opportunity to learn and
improve the systems used in the food business. The Recall Co-coordinator
should initiate a formal review procedure involving the product recall
team and any key personnel who were involved. These could be external
contacts such as a retailer or caterer. It is suggested that the review
procedure should be documented as part of the product recall plan but
should be sufficiently flexible to be useful. Some of the elements that
should be included in a review are:

• A review of the cause of
the issue, identifying the real issue (not the symptoms) and immediate and
long term actions that will rectify the problem(s).

• A review of company
policies, procedures and actions to update them in light of the issue.

• A review of training
plans to improve awareness of the problem and ensure it is not
repeated.

• A review of management
structures, if reporting or lack of clarity on responsibilities
contributed to any problems with the product recall.

• A review of
investigations and analysis carried out on product returns.

• A review of stock
reconciliation.

Reviewing the Product Recall Process

Food businesses involved in product recall should review the product
recall process and amend the product recall plan if necessary. Some of the
elements to be considered in the review should be:

• The effectiveness of the
process. Did it work?

• Did the product recall
plan drive the recall?

• What problems were
encountered?

• How effective was the
internal and external communication to customers and authorities?

• Media coverage. Did it
communicate the message accurately?

• Customer care line. Did
it work, was it overloaded, did it cope or crash?

• What was the true cost
of the product recall; product, time, recall message costs, lost
sales?

• Accountabilities for the
product recall team. How effective were they?

• How did the team work
together?

Communicate the lessons learnt to the appropriate personnel
internally.

Final Reports and Recommendations

It is expected that the audit undertaken by the regularity
authority/NZFSA is reported to the NZFSA.

The final report shall include the following:

• The circumstances
leading to the product recall.

• The extent of
distribution of the relevant batch(es) in NZ and overseas.

• The action taken by the
business including any publicity, with names of newspapers in which
advertisements appeared.

• A copy of the product
recall notification (e.g advertisement, fax, email) to customers.

• A summary of stock
reconciliation (i.e. amount of stock recovered or notified as having been
disposed of).

• The method of disposal
or otherwise of recalled stock, with proof of activity undertaken (e.g.
landfill receipts etc).

• Action proposed for the
future to prevent a recurrence of the problem.

• Any difficulties
experienced in conducting the product recall.

• Any information relating
to relative effectiveness of recall communications (i.e newspapers vs
other communications).

• Costings involved in the
recall process.

Appendix 1: Roles and Responsibilities
Diagram

Appendix 2: Example of a Recall Decision
Tree

Appendix 3: Recall Criteria Guide

Microbiological Contamination

Where microbiological results indicate the presence of pathogens (ie
food poses a safety risk), refer to Microbiological Reference Criteria for
Food, MoH 1995, for pathogen levels MoH Microbiological Reference Criteria for Food and also
Food Standards Australian New Zealand Code Standard 1.6.1 Microbiological Limits for Food. In particular for dairy
products refer to DPC1: Animal Products (Dairy).

Listeria monocytogenes

Whilst there are at least six known species of Listeria, Listeria
monocytogenes is considered an immediate food safety risk,
particularly in Ready To Eat products where there is no further control
step. Recall advertisements and/or media releases need to specify
Listeria monocytogenes rather than simply Listeria when reporting
risk to consumers.

As part of the risk assessment the following factors should also be
considered:

• whether the product will support
the growth of Listeria monocytogenes

• whether sensitive populations are
likely to consume the product.

Listeria Traceback Guidance

Traceback includes investigation into the source of the Listeria
contamination, identifying affected product, undertaking corrective action
to eliminate the contamination source and demonstrating that the
corrective action has been effective.

Traceback should include investigation of all possible sources of
contamination. Experience suggests that Listeria contamination is most
commonly traced to either failure of a CCP (e.g. cooking step), or
environmental contamination. Once established in the environment Listeria
can be difficult to remove, due to the ability of the organism to form
biofilms that are resistant to many cleaning and/or sanitising chemicals,
and provide protection to vegetative cells from chemicals that would
otherwise be effective against Listeria.

Until the source of contamination has been identified product may not
be released for sale.

A 5 day clearance regime is generally considered to be sufficient to
demonstrate efficacy of the corrective actions taken. The clearance regime
(including sampling of product and the environment) needs to be agreed
with the regulatory authority/NZFSA.

Foreign Matter

Foreign matter can be broadly classified as:

1. food safety hazards and

2. non food safety hazards, or issues
of quality/wholesomeness.

Therefore, irrespective of whether foreign matter (FM) presents a food
safety hazard or not it can be expected that whenever FM is discovered in
food, or an incident occurs in the manufacturing process that could
reasonably lead to FM inclusion in food, corrective action will occur. The
nature of expected corrective action is the question – should the food be
recalled, or is it sufficient to investigate the process and take steps to
mitigate, where possible, any risks of re-occurrence?

In general, a case by case decision will be required. The following
provides some guidance and ‘rules of thumb’ for different types of foreign
matter.

General

Hard or sharp foreign matter in food may cause traumatic injury
including laceration and perforation of tissues of the mouth, tongue,
throat, stomach and intestine as well as damage to the teeth and gums and
may therefore be considered a physical food safety hazard particularly if:

• The product contains hard or sharp
foreign matter that measures 7 mm to 25 mm, in length, and

• The product is ready-to-eat, or the
intended use does not include further processing steps that would
eliminate, invalidate, or neutralize the hazard prior to consumption.

In most cases, where actual or possible inclusion of foreign matter
meeting the above criteria occurs in food that has been sold, and is not
‘one-off’ (i.e. multiple consumers are at risk) recall is indicated.

It is recommended advice and input into decision-making is sought
from the regulatory authority/NZFSA when:

• The product contains a hard or
sharp foreign object that measures 7 mm to 25 mm in length, and it is
proposed to subject the product to additional preparation or processing
that may have an effect on the presence of the foreign objects in the
finished food. For example, additional sifting of a product that may or
may not remove foreign objects, depending on the measurements of the
objects and the mesh aperture of the sifter.

• The product contains a hard or
sharp foreign object less than 7 mm or between 25 mm and 77mm in length
and the primary intended consumers of the product are children under 6
years of age, the elderly, or persons with dentures.

Glass

Consider the type and size of glass fragments present.

Where glass fragments are likely to include shards or splinters general
NZFSA practice has been to require recall, irrespective of the likely size
of the glass pieces.

Some glass is designed to shatter into rounded pieces rather than to
produce sharp fragments. In this case the size of the pieces may determine
whether a food safety hazard exists (see ‘general’).

Allergens

NZFSA recognises that food containing certain allergenic components
must be labelled to show the presence of the allergen, as per the ANZ Food
Standards Code (Standard 1.2.3 Mandatory Warning & Advisory Statements &
Declarations). Allergic individuals may be exquisitely sensitive to
the allergen and suffer life threatening consequences if they consume food
containing the allergen.

Where a recall is initiated, an allergy warning in the second line of
the heading of the newspaper advertisement is required. Refer to a
template for recall advertisement involving allergens Recall Newspaper Advertisement Template – Allergen
Warning

Allergy NZ is to be advised of all recalls involving allergens as soon
as possible.

Appendix 4: Sample Trade Notification

Appendix 5: Schedule of National Newspapers

No.

Newspapers

1

Northern Advocate

2

NZ Herald

3

Waikato Times

4

Bay of Plenty Times

5

Rotorua Daily Post

6

Gisborne Herald

7

Taranaki Daily News

8

Hawkes Bay Today

9

Wanganui Chronicle

10

Manawatu Evening Standard

11

Wairarapa Times Age

12

The Dominion Post

13

Nelson Evening Mail

14

Marlborough Express

15

Westport News

16

Greymouth Evening Star

17

Timaru Herald

18

The Christchurch Press

19

Otago Daily Times

20

The Southland Times

21

Sunday Star Times

22

Sunday News

Note: In some circumstances smaller community newspapers may be
a more effective way of disseminating recall information, this decision
should always be made in consultation with NZFSA.

All
information on this website is subject to a disclaimer.

Contact for enquiries

New Zealand Food Safety Authority
68-86 Jervois Quay
PO Box
2835
Wellington
NEW ZEALAND

Phone: +64 4 894 2500
Fax: +64
4 894 2501

Contact
this person

Home | Copyright |
Privacy | Security | Site Map | Search | newzealand.govt.nz | Disclaimer
| Contact Us | Jobs at
NZFSA