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Recall Guidance Material

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.