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Recall Guidance Material

Recall Guidance Material=20
Contents

Important Disclaimer

Every effort has been = made to=20 ensure the information in this document is accurate.

NZFSA does not accept any responsibility or liability = whatsoever for=20 any error of fact, omission, interpretation or opinion that may be = present, however it may have occurred.

Recall Guidance Material

Introduction

The=20 Purpose of a Product Recall

Roles=20 and Responsibilities

The=20 Role of the Food Industry

Product=20 Tampering / Extortion

Recalls=20 and the Law

The=20 Law, Recalls and Privileged Statements

The=20 Role of the Regulatory Authorities

Interface=20 with NZFSA

Primary Regulatory Management of Recalls

Recalls=20 of Product being sold in New Zealand

Recalls=20 and Overseas Countries

Australia

Regulatory=20 Audit of Business Generated Recalls

Levels=20 of Product Recall

Developing=20 an Effective Business Product Recall Procedure

Product=20 Recall Policy

The=20 Product Recall Plan

The=20 Product Recall Team

Definition=20 of Roles and Responsibilities

Product=20 Recall Contacts List

The=20 Decision to Recall

Sources=20 of Information

Risk=20 Assessment

The=20 Scope of the Recall

Notification=20 of a Product Recall

Communicating=20 with Regulatory Authorities/NZFSA

Communicating=20 with the Distribution Chain

Communicating=20 with the Consumer

Paid=20 Advertisements (applicable during a Recall or a = Withdrawal)

Press=20 Release (applicable during Recall only)

Testing=20 and Reviewing the Product Recall Plan

Managing=20 a Product Recall

Staffing=20 a Recall

Using=20 a Consultancy or an Agency

Paying=20 for a Recall

Documenting=20 the Product Recall Process

Regaining=20 control of Affected Stock

The=20 Effectiveness of the Product Recall

Closing=20 the Product Recall

Reviewing=20 the Lessons Learned

Reviewing=20 the Product Recall Process

Final=20 Reports and Recommendations

Appendix=20 1: Roles and Responsibilities Diagram

Appendix=20 2: Example of a Recall Decision Tree

Appendix=20 3: Recall Criteria Guide

Appendix=20 4: Sample Trade Notification

Appendix=20 5: Schedule of National Newspapers =

Introduction

This guidance material, developed by the New Zealand Food = Safety=20 Authority (NZFSA) is a reference document for the food and = beverage=20 industry. It aims to clarify and standardise procedures for the=20 identification and removal of unsafe food from the food chain. = Recall=20 systems are a fundamental component of a food business=92s food = safety=20 programme.

This document will outline:

1. The roles = of the=20 regulatory authorities and the food industry.

2. The risk = assessment=20 process.

3. The = elements of a=20 product recall plan.

4. The actions = to take=20 when an unsafe food must be removed from the market.

5. NZFSA=92s = standards for=20 product recall advertisements as well as giving guidelines for = media=20 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=20 safety of a foodstuff may occur. This could be the result of a = packaging=20 defect, a preservation failure, a production problem, a storage = problem, a=20 problem with the ingredients of a foodstuff or any other reason. = It is=20 important that food businesses assume that a food safety issue may = arise=20 with their products and, therefore, plan ahead. These systems and = plans=20 should be periodically tested to ensure that they are = comprehensive and=20 serve to remove an unsafe product from consumers and/or the = distribution=20 chain.

Food businesses within the food service sector, such as = restaurants,=20 caterers and takeaways may not need a recall plan. While these = businesses=20 manufacture food, the food will be eaten shortly after it has been = made.=20 Therefore, if a problem were to occur with this food, the food = will have=20 been consumed before it can be recalled. However, while a recall = plan is=20 not required in these circumstances, these businesses may be part = of=20 another business=92s recall. For example, they may need to remove = recalled=20 stock from shelves and return it to the manufacturer or to ensure = that=20 food that is subject to a recall is separated and identified from = other=20 food until it is disposed of in accordance with the instructions = provided=20 as part of the recall (this usually means ensuring the disposal of = food so=20 that it cannot be used for human consumption). Therefore all food=20 businesses should be familiar with recall requirements and = consider which=20 aspects should be included in their food safety programme.

Food businesses will inevitably remove products from the market = for=20 reasons other than food safety. This eventuality is not covered in = this=20 document. However, the procedures outlined here may be applicable = in such=20 an event. Food businesses may wish to expand their recall and = traceability=20 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=20 from a manufacturer=92s direct control, and is under the control = of others=20 in the storage, distribution, retail, and consumer chain.

The purpose of a product recall, in the context of this = document, is to=20 protect public health by facilitating the efficient, rapid = identification=20 and removal of unsafe food from the distribution chain and, by = informing=20 consumers (where necessary) of the presence on the market of a = potentially=20 hazardous food. An effective product recall will ensure that the = unsafe=20 foods are contained and either destroyed or rendered safe.

NB. The elimination of the circumstances that caused the = need for a=20 recall (corrective action) is an essential activity but not = addressed in=20 this document. The removal of the product from consumer exposure = should be=20 seen as the initial corrective action. Once this is achieved the=20 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=20 Animal Products Act or Wine Act, the primary responsibility for = the safety=20 and suitability of the food for human consumption is borne by the = food=20 industry. For a wide variety of reasons a manufacturer/trader may = be=20 responsible for a situation where product is not safe and is in = the hands=20 of others. On becoming aware of the situation the responsible=20 manufacturer/trader must take all reasonable steps to remove the = product=20 from the possession of others.

Consumer demand for information and public health protection = are also=20 key drivers for an effective product recall system. =91Product = life cycle=20 management=92 and category and brand protection are also very = important=20 considerations for any company. As a result, every food business = is=20 encouraged to have a written and visible recall policy. This = policy should=20 be supported by a product recall procedure, the contents and = testing of=20 which should be guided by elements of this guidance note.

If a food business becomes aware of, or is notified of a = potential food=20 safety incident, all necessary action must be taken to protect = public=20 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=20 it could be intended to cause adverse publicity or economic harm = to a=20 supplier or retailer. In these circumstances any decision to = recall the=20 product should be made only after full consultation with the = police, the=20 relevant health authorities, NZFSA and the manufacturer, supplier = or=20 retailer of the products. Widespread recall may not be appropriate = or=20 necessary.

Recalls and the Law

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

=95 The Food = Act 1981

=95 The Animal = Products Act=20 1999

=95 The Wine = Act 2003

In each Act, the legal process that must be followed is set = down. The=20 purpose of a NZFSA initiated recall needs to be understood and = adhered to.=20 In most circumstances the need to exercise the legal power will = result=20 from the failure of a business to act responsibly. It is not to be = used as=20 a means of penalising a business. A recall action is not an = impediment to=20 the taking of any other legal action that may be available to = regulators=20 under any statute.

It is important to note that the ability for the NZFSA/Minister = to=20 initiate a recall is not limited to matters of food safety. The = wording in=20 legislation refers to "for the purpose of protecting the public" = giving=20 considerable scope for recall including matters relating to food = safety,=20 fraud, and non-compliance with food standards. In most = circumstances this=20 legal power will predominantly be used with respect to matters of = food=20 safety.

The Law, Recalls and Privileged = Statements

The Director-General has power to make privileged statements to = protect=20 consumers and to inform the public under:

=95 The Food = Act 1981

=95 The Animal = Products Act=20 1999

=95 The Wine = Act 2003

There may be a relationship between a recall and a privileged=20 statement. Both are public statements. The following factors = influence a=20 decision to make a privileged statement.

=95 The need = for urgency. In=20 a situation where it is imperative that the public is informed = with the=20 absolute minimum of delay, a privileged statement will be issued. = A recall=20 may follow.

=95 Where the = owner(s) of=20 product(s) are for whatever reason failing to manage a recall the = question=20 of the need for privileged statement(s) should be asked. It may be = necessary for the NZFSA to correct inaccuracies that have been=20 created.

=95 A decision = to make=20 privileged statement(s) may be made in conjunction with a = NZFSA/Minister=20 initiated recall to further inform the public.

=95 Where the = owner(s) of=20 product(s) are managing a recall appropriately and a high level of = public=20 concern exists it may be prudent for the NZFSA to confirm to the = public=20 that all reasonable steps are being taken in the form of a = privileged=20 statement.

=95 Where the = owner(s) of=20 the product(s) cannot be identified or contacted, and the = situation=20 requires the public is informed without delay, a privileged = statement will=20 be issued.

The Role of the Regulatory = Authorities

The NZFSA is responsible for the administration and enforcement = of food=20 legislation. There are several business units within NZFSA that = may have a=20 role in food recall, depending on the legislation a food business = is=20 administered by (e.g. Food Act (1981), Animal Products Act (1999), = Wine=20 Act (2003)). In addition the NZFSA holds service contract = agreements with=20 Public Health Units or Offices to enforce general food legislation = via the=20 Food Act Officers (FAO).

The preferred position of the NZFSA is to support the actions = of the=20 responsible business. In this process the responsible business = would=20 be:

=95 addressing = the matter=20 with urgency,

=95 keeping = the NZFSA=20 (usually through its contracted Food Act Officers in Public Health = Units,=20 NZFSA verifier or through a contracted third party agency) fully = informed=20 from the first indication of a product =91problem=92 through all = stages of the=20 recall,

=95 complying = with all=20 reasonable requests the NZFSA officers may make on the recall = process,=20

=95 taking all = reasonable=20 steps to inform all persons who may have product that is unsafe or = potentially unsafe, and,

=95 retrieving = that product=20 or having it disposed of in a suitable manner.

In providing that support the NZFSA will carry out the = following=20 actions.

=95 Ensure = that appropriate=20 recall plans are in place in the approval/registration of risk = management=20 systems.

=95 Ensure = that recall=20 procedures are appropriately addressed in the approval/recognition = of=20 codes of practice.

=95 Have = freely available to=20 businesses, documentation that provides sound guidance in the = execution of=20 a recall.

=95 Have = procedures in place=20 that ensures that the NZFSA is in close liaison with the business = during=20 the crisis period and ensure that the business is meeting its=20 responsibilities.

=95 Conduct an = audit of the=20 recall (usually through its contracted Food Act Officers in Public = Health=20 Units, NZFSA verifier or through a contracted third party agency) = after=20 its completion to establish its credibility.

The regulatory authorities also have a role in the food = business with=20 advice on risk assessment and food companies should always consult = the=20 local District Health Board / Public Health Unit (Public Health Offices) if they are considering = the need to=20 remove unsafe food from the market. The NZFSA is also a source of = risk=20 assessment advice for food businesses involved in recovering = unsafe food=20 from distribution or the retail market. NZFSA has a role in the=20 co-coordinating national recalls that may affect more than one = food and/or=20 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=20 exported.

Interface with NZFSA

District Health Boards/Public Health Units (DHB/PHUs), NZFSA=20 Verification Agency or Third Party Agencies are the interface = between=20 NZFSA and the company. The company is expected to deal directly = with these=20 representatives of NZFSA during the stages of the recall as their = point of=20 contact and to follow their own non-conformance procedures eg Food = Safety=20 Programme, Risk Management Programme.

The DHB/PHU=92s, NZFSA Verification Agency or Third Party = Agencies are=20 expected to make recommendations to NZFSA on the response level = needed, to=20 assist NZFSA in appreciating the process and issues involved and = to=20 follow-up on required corrective actions.

Primary Regulatory Management of Recalls

Recalls of Product being sold in New=20 Zealand

The Compliance & Investigation Group will co-ordinate all = industry=20 initiated recalls and statutory initiated food recalls for = products sold=20 on the domestic market (in some cases this will include = Australia). They=20 will work with other parts of NZFSA, Public Health Units, and the = domestic=20 food industry to ensure the necessary systems and procedures are = in place=20 to recall food from the market place to protect consumers.

Recall information is posted on the NZFSA website (Food=20 Recalls for Consumers) by NZFSA.

Recalls and Overseas Countries

New Zealand has obligations under certain trading arrangements = and as a=20 responsible trading country to notify relevant recall actions to = overseas=20 countries. The responsibility for regulatory oversight/action in = countries=20 other than New Zealand rests with the Group that has regulatory = oversight=20 of the particular products concerned. They will work with other = parts of=20 NZFSA, as appropriate, to ensure that appropriate measures are = taken.

Australia

All food product recalls within New Zealand are notified to = Australia=20 irrespective of whether recalled product has been sold in that = country.=20 The notification process is managed by the Compliance & = Investigation=20 Group. Australia reciprocates with similar notifications through = Food=20 Standards Australia New Zealand (FSANZ).

Regulatory Audit of Business = Generated=20 Recalls

It is the responsibility of the regulatory group that had the=20 regulatory oversight of the business recall to ensure that an = audit of the=20 recall is carried out and to ensure that any deficiencies found in = the=20 audit are rectified.

NB. At this time the regulator should ensure investigation has = occurred=20 into the circumstances that led to the recall and that appropriate = corrective action and timeframes have been identified. The = regulator has a=20 responsibility to ensure these are carried out.

Levels of Product Recall

Where food safety is concerned there are two levels of product=20 recall.

1. Recall: This is a removal of unsafe food = from the=20 distribution chain and extends to food sold to consumers and = therefore=20 involves communication with consumers.

2. Withdrawal (also known as Trade Recall): = This is=20 the removal of an unsafe foodstuff from the distribution chain but = does=20 not extend to food sold to the consumer.

The above terminology should always be used in all = communication with=20 other businesses and regulatory authorities to avoid = confusion.

In general, a recall should be initiated when food has been = identified=20 as unsafe, a potential risk to public health, and has been = distributed to=20 the consumer. A recall would be expected to occur where there is a = reasonable possibility that use or consumption of the food would = cause=20 adverse health consequences or even death. Examples of when these=20 circumstances might exist include when there is the presence of = pathogenic=20 organisms (e.g. Clostridium botulinum, Salmonella species,=20 Listeria monocytogenes), foodborne pathogenic viruses (e.g. = Hepatitis A), toxic chemicals (including presence of bacterial = toxins) and=20 harmful foreign bodies (e.g. glass fragments).

Recall action may also be taken if the product has serious = defects that=20 pose a potential health risk. Examples of when these circumstances = might=20 exist include; when there are goods that are incorrectly labelled, = for=20 example do not declare the presence of an allergen (eg. peanuts, = milk or=20 milk products, soy etc); or have incorrect/insufficient cooking=20 instructions.

A withdrawal should be initiated when food has been identified = as=20 unsafe, a potential risk to public health but it can be = demonstrated that=20 the unsafe foodstuff remains wholly in the distribution chain and = has not=20 reached the consumer. However, there are some situations where = food is=20 distributed to the consumer but circumstances indicate a = Withdrawal will=20 be sufficient to protect public health. Such decisions should = always be=20 made in consultation with NZFSA.

There are two alternatives for remedial action:

1. Permanent = removal of=20 the unsafe products from the market or from use;

2. Temporary = removal of=20 the unsafe products from the market, followed by rectification of = the=20 problem and a return to the market.

Developing an Effective Business = Product Recall=20 Procedure

The features of an effective business product recall procedure=20 include:

1. The recall = policy for=20 the business

2. The = development and=20 maintenance of a product recall plan

3. Testing of = the product=20 recall plan

4. = Implementing the=20 product recall plan

5. Managing = the product=20 recall plan

6. Closing a = product=20 recall

7. Reviewing a = product=20 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=20 recall policy is a simple, clear and unambiguous business = statement on the=20 commitment to remove product that presents a risk to human health = from the=20 market. It demonstrates the company=92s commitment to protect = public health.=20 It should clearly state the objective of the product recall plan = and the=20 senior management=92s commitment to providing the necessary = resources to=20 ensure the successful removal of unsafe foods from the market. The = product=20 recall policy should be in place prior to the development of the = product=20 recall plan.

The Product Recall Plan

This should reflect the business policy on product recall. It = must be a=20 written coherent document that effectively guides the business = during a=20 recall event.

A multi-disciplinary recall team, where possible, should = develop the=20 product recall plan. Examples of elements that may be incorporated = into a=20 plan are:

=95 Reference = to the product=20 recall policy

=95 List of = member(s) of the=20 recall team

=95 Definition = of roles and=20 responsibilities for product recall

=95 Contact = names and=20 details including home telephone or mobile numbers

=95 = Definitions of the two=20 classifications of a product recall (see Levels of Product = Recall)

=95 A product = recall=20 decision tree

=95 Mechanisms = of=20 notification of a product recall

=95 Reference = to the=20 company=92s traceability system

=95 Guidelines = for media=20 contact

=95 Sample = press=20 releases

=95 Sample = product recall=20 advertisements

=95 A product = recall plan=20 testing procedure

=95 A product = recall review=20 procedure

The Product Recall Team

Depending on the size and complexity of the business the team = will be=20 one or more people. It is essential that there is a Recall = Co-ordinator=20 who has the authority of the business to carry out that role. = Therefore,=20 the Recall Co-ordinator should be appointed by, and have the full = support=20 of senior management. The plan needs to stipulate that it is the=20 responsibility of the co-ordinator to maintain and retain full = documented=20 evidence of all actions taken during the recall. This person = should be=20 knowledgeable about every aspect of the business operations. The=20 co-ordinator will need inputs, in a recall situation, in relation = to:

=95 = production

=95 = quality

=95 = purchasing

=95 = marketing

=95 sales

=95 legal = services

=95 = distribution and supply=20 chain

=95 consumer = affairs/public=20 relations

The business will have examined these responsibilities and = determined=20 who will provide these inputs into the team. Possibly these inputs = will be=20 provided from outside the organisation on an =91as needed=92 = basis, e.g. legal=20 advice. The important thing is that they are identified.

The responsibilities of the recall team will be to:

=95 develop = the business=20 recall plan

=95 manage the = maintenance=20 and testing of the recall plan

=95 update the = recall=20 plan

=95 direct the = product=20 recall activities

=95 recommend = changes to the=20 business operations to minimise the need to remove unsafe foods = from the=20 market.

Definition of Roles and = Responsibilities

Effective product recall requires all employees to be clear = about their=20 roles during a product recall and the boundaries of their=20 responsibilities. These need to be detailed in the plan. In a = complex=20 business with many employees there would be advantages in = detailing this=20 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=20 be considered vital that an up to date contact list is maintained. = It is=20 also the element that most quickly becomes inaccurate. Often = contact lists=20 are not updated and this frequently becomes an issue during a = product=20 recall. Valuable time can be wasted creating or updating the list = during=20 the recall event and there is the risk that essential people are = omitted=20 from the process. Responsibilities for updating the list should be = specified in the product recall plan and the accuracy of the list = should=20 be frequently checked by the product recall team. The contact list = itself=20 may be included in the recall plan, however as it is likely to = require=20 frequent modification it may be more effective to provide clear = direction=20 as to the location of the up to date contact list.

It is suggested that the contact lists available in or = referenced by=20 the product recall plan are split into five sections as = follows:

1. The product = recall team=20 and senior management (include key personnel if not part of the = recall=20 team)

2. Suppliers = of ALL=20 ingredients (include water)

3. = Distribution company=20 and business customers

4. Sources of = technical=20 advice and support including laboratory facilities

5. Regulatory = authorities=20 - general contact numbers for NZFSA and relevant regulatory = authorities=20 are available on NZFSA=92s 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=20 occur out of normal business hours. Therefore it is suggested that = the=20 contact lists are as comprehensive as possible and are easily = accessed to=20 facilitate fast and efficient information recovery, eg

=95 Contact

=95 Wk Phone

=95 Hm Phone

=95 Mobile

=95 Fax

=95 Email

The Decision to Recall

As far as practicable the parameters in relation to chemical, = physical=20 and biological indicators that would render a product unsafe must = be=20 predetermined. In the application of HACCP the hazard analysis = will=20 provide the basis for making this determination. In situations = where the=20 analysis has not been made, provision to evaluate the severity and = impact=20 of hazards should exist. In these situations a recall decision = tree may=20 assist.

A decision tree should be designed to clarify the thought = processes=20 leading to a final decision on the necessity of product recall and = the=20 appropriate type of product recall (i.e. Recall or Withdrawal).=20 Appendix 2 shows an example of a typical decision tree. = However,=20 food businesses should draw up a decision tree applicable to their = own=20 business and management structure.

The timely and effective removal of unsafe food from the market = is=20 dependent on careful, considered risk assessment. Risk assessment = should=20 only be carried out by, or with the co-operation of, a person who=20 technically competent to evaluate the severity and impact of food = safety=20 hazards in foodstuffs. The risk assessment should be carried out = in=20 recognition of the precautionary principle (see the section on = Risk=20 Assessment). In this process the involvement of the appropriate = regulator=20 should be included.

Sources of Information

The product recall team should always get their facts first = hand. This=20 prevents the miscommunication that often hampers efficient product = recall.=20 The information that is gleaned concerning the food safety hazard, = the=20 product details, the likely distribution and the extent of the = problem is=20 vital to good decision making. There is a high probability that=20 information gathered in the early stages of an investigation will = be=20 faulty or flawed. This needs to be accounted for in the initial = risk=20 assessment, which should always take a precautionary approach = placing the=20 protection of the consumers=92 health high on the list of = priorities. The=20 precautionary approach requires companies to act to protect public = health=20 even when limited details are available.

Initial information on a potential food safety incident can = come from a=20 variety of sources but in the first instance it is likely to rest = with=20 only one or two individuals in an organisation. It is important = that these=20 individuals are aware of the product recall plan and that they = take the=20 correct steps to ensure that a product recall team is convened. = Training=20 of staff will be necessary to ensure that initial information is = handled=20 appropriately.

Sources of initial information may be:

=95 = Internal

=95 Quality = and production=20 records

=95 Sales=20 representatives

=95 = Employees

=95 = External

=95 = Ingredient=20 suppliers

=95 Packaging = suppliers

=95 = Regulatory agencies

=95 = Distributors/business=20 customers

=95 Consumer = complaints

=95 Media = reports

Information should be verified at source where possible by the = product=20 recall team. In the case of a consumer claiming illness, full = details=20 should be obtained by contacting the customer or regulatory = authority=20 where appropriate.

The product recall team should aim to collect the following = minimum=20 data set on a suspected food safety incident:

=95 Product = name

=95 Product = description

=95 Batch = codes involved

=95 Quantity = of product=20 implicated

=95 = Distribution details

=95 Whether = the product has=20 been sold to consumers

=95 The nature = of the=20 product fault (hazard).

This information should be verified and fed into the risk = assessment=20 process that in turn informs a risk management decision on the = level of=20 product recall (i.e. Recall or Withdrawal) and the = urgency/resources=20 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=20 business must be able to decide if the unsafe food can cause a = potential=20 risk to public health and if so, determine the level of adverse = health=20 effect and the affected population profile and size. This requires = a food=20 business to carry out an assessment of the potential risks = resulting from=20 the problem with the food. This is called a risk assessment.

Risk assessments should only be carried out by competent = technical=20 people. If in doubt, food businesses are advised to seek suitably=20 competent technical advice and/or the local DHB/PHU (Public Health Officers).

Food businesses should follow an accepted model for risk = assessment.=20 The Codex Alimentarius has developed a model for risk assessment=20 consisting of the following steps:

=95 Hazard = Identification:=20 the identification of known or potential health effects associated = with a=20 particular agent.

=95 = Assessment: the=20 qualitative or quantitative evaluation of the degree of intake = likely to=20 occur.

=95 Hazard = Characterisation:=20 the qualitative or quantitative evaluation of the nature of the = adverse=20 effect associated with the hazard.

=95 Risk = Characterisation:=20 the integration of hazard identification, hazard characterization = and=20 exposure assessment into an estimate of the risk and its = associated=20 uncertainties.

The process is best understood using an example:

The Production Problem: The pH of an acid = preserved=20 foodstuff is too high. The product is distributed at ambient = temperature,=20 has a shelf life of one year, does not require re-heating and has = been on=20 sale for one month.

Hazard Identification: The bacterium = Clostridium=20 botulinum could grow during product distribution. Cl. = botulinum=20 causes botulism, a condition where a person, who eats food where = Cl.=20 botulinum has grown and produced toxin, can die.

Exposure Assessment: The product conditions and = shelf=20 life are suitable for Cl. botulinum to grow and produce = toxin.=20 There is no re-heating to degrade the toxin. The consumer is = likely to=20 have bought the product. The chances of exposure to Cl. = botulinum=20 toxin are high.

Hazard Characterisation: Cl. botulinum toxin is = one of=20 the most potent neurotoxins known. If the toxin is ingested the = chances=20 are high the consumer will develop severe breathing difficulties = and may=20 die.

Risk Characterisation: The chances of exposure = are high=20 and the consequences of exposure potentially lethal. A severe = adverse=20 public health effect is likely. It is not possible to quantify the = risk or=20 the uncertainties associated with the risk.

Risk management decision: Recall of product from = the=20 affected batches with immediate effect.

The decision on whether to Recall or Withdraw a product or not = is=20 therefore based on the identification of a hazard that makes a = foodstuff=20 unsafe and its likelihood of affecting public health. To ensure = that=20 public health is protected at all times a food business must adopt = the=20 precautionary principle in its risk assessment activities. In the = context=20 of this document the precautionary principle can be explained = as:

Food businesses, faced with the production of a potentially = unsafe food=20 should aim to document their hazard identification and risk = assessment=20 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=20 Appendix 3.

The Scope of = the=20 Recall

The plan must detail how the business will scope the range of=20 product(s) and the batches to be recalled. It is not sufficient = for a=20 business to determine that only a single batch should be recalled = simply=20 because the problem has only been demonstrated in that batch. = Businesses=20 should also consider the possibility of the same problem or type = of=20 contamination occurring in different package sizes of the same = line, in=20 product with a different use by date, in a different product line = all=20 together or same or similar product packaged under a generic = label. The=20 plan must demonstrate the processes that will be followed to = determine why=20 batches produced prior to, and after the known event, do not = suffer the=20 same problem. Production control mechanisms that make particular = batches=20 unique will provide justifiable decisions in relation to scope. = Failure to=20 demonstrate that uniqueness should cause escalation the = scope of=20 the recall, possibly to the whole of the product on the market. = The=20 business policy and action on product traceability will also be a = factor=20 to be built into the plan.

If the hazard/risk is found to be one or more raw materials = supplied to=20 the business, then the supplier of the raw materials and their = customers=20 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=20 processes to follow in notifying the recall.

If the decision is taken to initiate a Withdrawal then three = levels of=20 notification are advised:

=95 Within the = Company

=95 Regulatory = authorities/NZFSA

=95 = Distribution Chain

=95 = Distributors

=95 = Wholesalers

=95 = Retailers

=95 = Caterers

If the decision is taken to initiate a Recall then four levels = of=20 notification are advised:

=95 Within the = Company

=95 Regulatory = authorities/NZFSA

=95 = Distribution Chain

=95 = Distributors

=95 = Wholesalers

=95 = Retailers

=95 = Caterers

=95 = Consumers

Communicating with Regulatory=20 Authorities/NZFSA

It is strongly recommended that the plan provides for = communication=20 with the appropriate regulator at the earliest opportunity, after = an=20 incident is identified that may lead to a recall. Support and = advice from=20 the regulatory authority/NZFSA will be advantageous to the food = business=20 and will help when dealing with the media and the public = (businesses under=20 the Food Act or Food Hygiene Regulations refer to Public Health Offices, businesses under the = Animal=20 Products Act refer to NZFSA Verification Agency). The method of = communication=20 needs to be specified along with the commitment to liaise with the = regulator throughout the recall process. Companies should ensure = that they=20 supply the following information available as soon as = possible:

=95 Name of = the company and=20 contact details (including after hours contact details)

=95 Name of = the product

=95 Batch = identification=20 codes

=95 Product = details=20 including packaging size and type

=95 Date = marks

=95 Amount of = product on the=20 market

=95 = Distribution details (is=20 the product exported =96 note: in this situation food distributed = in=20 Australia is classed as exported)

=95 Names of = the=20 companies/outlets selling to the consumer

=95 Nature of = the food=20 safety risk

=95 Results of = any=20 investigations (including any applicable test results)

=95 The level = of product=20 recall being considered (i.e. Recall or Withdrawal)

=95 The = rationale that was=20 applied in determining the scope of the recall

=95 Plans for = trade and=20 public communications

=95 Timings = for product=20 recall and communication.

Food businesses should continue to update the regulatory = authorities or=20 the NZFSA throughout the product recall and formally close the = product=20 recall with the regulatory authority by notifying them in writing. = Food=20 businesses can expect close liaison in a recall situation from the = regulatory authority/NZFSA who are required to undertake an audit = of the=20 recall, approximately within 10 days of notification, to ensure=20 effectiveness of both the recall and identified corrective = actions.

Commercially Sensitive = Information

Companies should be clear when communicating with the = regulatory=20 authorities about information that is commercially sensitive or = private in=20 nature. NZFSA, as a Public Service Department, is subject to = government=20 administrative laws, which means that its actions are open to = public=20 scrutiny. The Official Information Act 1982 makes provision for = public=20 access to certain documents in the Authority=92s possession. = Section 9 of=20 the Act =93Other reasons for withholding official information=94, = allows for=20 non-disclosure of certain confidential and commercially sensitive=20 information.

Communicating with the Distribution = Chain

Procedures for notifying the distribution chain should contain = detailed=20 methods for stopping product distribution, retail sale or catering = usage.=20 It is also important that plans are developed with business = customers to=20 store recovered product safely and in isolation from safe foods = when it is=20 outside of the control of the company responsible for the product = recall.=20 Recovered stock must be appropriately labelled or withdrawn. = Further,=20 methods need to be developed to regain control over unsafe product = from=20 the business customer and store it safely and in isolation from = safe=20 product pending stock reconciliation and destruction (some = businesses may=20 choose not to regain control of affected stock but may require = their=20 customers or the consumer to destroy the product after prior = notification=20 to the business involved).

Initial notification to the trade could be via telephone but = this=20 should be followed up by written communication by fax or email. = The=20 written communication should contain all the information necessary = to=20 allow the business customer to remove the correct product from = sale or=20 distribution. The need for urgency must be conveyed and there must = be=20 assurance that the message has been received, understood and acted = on.=20

Food businesses should include sample notifications in the = product=20 recall plan. Sample notifications should take account of the = information=20 below.

=95 The = notification should=20 be clearly entitled =91Urgent: Product Recall=92 or =91Urgent: = Product=20 Withdrawal=92 as appropriate in bold large lettering to ensure = that the=20 notification is acted upon quickly.

=95 Avoid = making the=20 notification look like a business letter or it may not be dealt = with=20 urgently. The details included should facilitate immediate and = unambiguous=20 identification of the product.

=95 The = =91action required=92=20 part of the notification should clearly state:

=95 =91Remove = from=20 sale/distribution=92 or =91do not use=92 in the case of a = caterer

=95 =91Notify = us immediately=20 if this product has been sold to the public=92

=95 =91Notify = us immediately=20 if this product has been distributed to other distributors or=20 retail/catering establishments. Please also notify these = businesses of the=20 product recall without delay;

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

=95 Plans for = recovery of=20 product and disposal

=95 = Notification of=20 quantities of stock recovered

=95 The need = to identify=20 and quarantine the product

=95 Other = details to=20 facilitate the recall/withdrawal of product

=95 Request = any assistance=20 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=20 are to be used and how contacts will be informed. This may take = the form=20 of a media release or paid advertisement in newspapers, on radio = or=20 television. The form of media used will depend on the = circumstances=20 involved.

Where product that is unsafe can be demonstrated to be in the = hands of=20 consumers the plan should articulate the basic rule that the = consumer will=20 be informed.

Options for communicating a recall to consumers include:

=95 paid = advertisements in=20 selected press outlets that are identified to have coverage of the = consumers who can reasonably expected to have possession of the=20 product.

=95 a general = media=20 release.

=95 placing = warning notices=20 at locations where the product has been sold.

Paid Advertisements (applicable = during a Recall=20 or a Withdrawal)

Paid advertisements are necessary in the case of a Recall or in = the=20 case of a Withdrawal when a company cannot identify all its = business=20 customers in the distribution chain. Food businesses should = include sample=20 Recall/Withdrawal advertisements in the recall plan along with=20 instructions for placing advertisements in appropriate media. The=20 information below should be recognised when drafting guidelines = for the=20 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=20 newspaper(s) or radio as soon as possible.

When a food business is engaged in a Withdrawal, as defined in = this=20 guidance material, but find, for whatever reason, that it is not = possible=20 to contact all relevant customers then the food business should = consider=20 expanding the Withdrawal to a Recall.

Product recall advertisements must be clear, = simple,=20 unambiguous and in a prominent position towards the front of the=20 newspaper. Avoid including unnecessary information about the = company or=20 turning the product recall advertisement into a marketing = opportunity.=20 Product recall advertisements must be approved by NZFSA before=20 publishing.

Templates are available to use on the NZFSA website, for = general=20 recalls Recall Newspaper Advertisement Template and for = recalls=20 involving allergens Recall Newspaper Advertisement Template =96 Allergen = Warning.

A single contact can arrange newspaper adverts in some or all = of the=20 national newspapers, namely:

Newspaper Advertising Bureau at Newspaper=20 Advertising Bureau or refer to Appendix 5.

Similarly there is a single contact that can arrange radio = adverts in=20 some or all radio stations nationally:

The Radio Bureau at The Radio = Bureau

Recall information is also posted on the NZFSA website (Food=20 Recalls for Consumers) by NZFSA.

NZFSA will publish the recall advertisement on = their website=20 indefinitely.

Press Release (applicable during = Recall=20 only)

The plan must specify that where the risk to the consumer is of = such a=20 nature that immediate notification is appropriate, a press release = will be=20 made to all sections of the media. Press releases have the = advantage of=20 reaching the print media and electronic media and do not suffer = from=20 delays that could accompany a paid advertisement. If press = releases are=20 used there is often no financial cost to the company. However, as=20 companies cannot rely on the uptake of a press release this method = should=20 only be used in addition to the routine paid advertisement process = that=20 will be conducted in a longer time frame.

The press release should cover all the features detailed in the = paid=20 advertisement (see above). A copy of a sample press release should = be=20 placed into the product recall plan.

It is important to include local radio news desks, especially = if the=20 product recall is isolated to specific areas. Follow-up phone = calls to=20 media are recommended. To encourage journalists or editors to pick = up on a=20 press release the following approach to writing the release should = be=20 taken:

=95 Write = =91Press release =96=20 for immediate release=92 at the top of the page in bold print.

=95 Compose a = title e.g.=20 Company =91A=92 recalls product =91X=92 due to health = concerns.

=95 Place the = synopsis of=20 the recall, the product, the problem and what is being done into = the first=20 paragraph and the use the proceeding paragraphs to flesh out the=20 details.

=95 Include = quotes from the=20 company that the journalist can use in the article.

=95 Finish the = release with=20 =91ENDS=92 to signify conclusion.

=95 Keep press = releases to a=20 single page if possible.

For an example refer to Example Press Release.

Warning Notice or Point of Sale Notice (applicable during = Recall=20 only)

Placing warning notices where the product has been sold will = assist in=20 communicating to the consumer that there is a recall relating to = that=20 particular product. For an example refer to Point of Sale Notice.

Testing and Reviewing the Product = Recall=20 Plan

The product recall plan should specify the periods for review = and the=20 names of the people responsible for the review. In most cases this = will be=20 the product recall team. The plan should be examined for errors,=20 particularly in the contact lists or in light of any changes in = the=20 company=92s product recall or trading status. It is recommended = that the=20 product recall plan is reviewed at least twice a year in = accordance with a=20 documented procedure which is held as part of the product recall = plan=20 itself.

It is essential that a product recall plan is periodically = tested using=20 a =91trial run=92 or mock recall exercise. This can be considered = as a=20 validation of the product recall plan. This procedure should also = be=20 documented in the product recall plan. Companies that develop = product=20 recall plans but do not test them may face problems when a real = food=20 safety incident occurs.

It is easier and more cost effective to alter a product recall = plan=20 when the food safety incident is part of an exercise without the = pressures=20 of the real situation. It is recommended that product recall plans = should=20 be validated on an annual basis or more frequently if appropriate. = Ideally, in order to determine a company=92s preparedness and = speed of=20 action the test should be unannounced and not prepared. It may be = worth=20 exploring the possibility of an agreement with customers and/or=20 supermarkets for them to become involved in the product recall = test,=20 thereby increasing the value of the exercise. Once the test is = completed,=20 a review must be carried out with the relevant product recall team = members=20 to correct and improve the process where necessary.

Managing a Product Recall

The management of a product recall should be driven by the = product=20 recall plan. The plan should carry all the details necessary for = the=20 product recall co-coordinators to manage a product recall=20 successfully.

Staffing a Recall

It is worth considering whether you would need help to manage a = recall.=20 This could mean employing extra staff to enable permanent staff to = deal=20 with the recall. Specialist help may also be required to draft and = deliver=20 your recall message. Most importantly it is necessary to prepare=20 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=20 ask for specialist advice from an external agency. There are = consultants=20 who specialise in every type of marketing communication =96 from = advertising=20 and direct mail, to public relations and corporate communications. = There=20 are also many agencies that can give all-round advice. If your = firm=20 already employs an agency, you can ask what experience it has in = dealing=20 with food recalls or other areas of crisis communications.

Firms may not need to retain a consultancy in case of future = recalls,=20 but having some relevant companies=92 details on file may be = useful.=20 Agencies may be listed with various trade associations or listed = under=20 =91advertising agencies=92 or =91media information &/or = services=92 in the=20 telephone directory.

Paying for a Recall

A recall will cost money. Just as it makes sense to agree with = your=20 suppliers and business customers in advance about who should = organise a=20 recall if it is needed, you should also decide who would pay for = what.=20 Insurance may cover the cost of carrying out a recall and any loss = of=20 profits related to it. It is worth finding out if you already have = this=20 cover under any existing business catastrophe or disaster = insurance=20 policy. If not, you may want to consider taking out a specialist = policy.=20

Documenting the Product Recall = Process

All information gathered by the product recall team should be=20 documented along with the date, time and provider of the = information. The=20 member of the product recall team gathering the information should = sign=20 off on the record. It is useful to set up an incident log that is = used to=20 record events chronologically. All product recall team members are = responsible for completing the incident log but the Recall = Co-coordinator=20 should review the log to verify that this is happening. The = incident log=20 will be useful in three ways:

1. It will = serve as a=20 reference if facts need to be checked

2. It will = serve as a=20 means by which the recall can be reviewed

3. It may = serve as a legal=20 document should it become necessary.

Decisions that are taken should reference the evidence on which = they=20 are based and should be entered in the incident log. The person=20 responsible for the decision should sign off on the record of the=20 decision. This is especially important in the risk assessment = process that=20 determines the level of product recall (i.e. Recall or Withdrawal) = and the=20 severity of the incident. The sequence of events and actions taken = will be=20 very important in the review and should not depend on peoples=92=20 memories.

Regaining Control of Affected = Stock

A food business that has initiated a product recall may regain = control=20 of the potentially unsafe product but must account for all missing = stock.

In some circumstances a food business may request a customer or = the=20 consumer to destroy the affected product. However, the food = business=20 should ensure that they reconcile the destroyed product in an = appropriate=20 manner where possible.

If affected product is recovered either by; direct returns from = consumers; returns to retail outlets; returns via the distribution = chain,=20 or product already in stock then the following considerations are=20 important:

=95 The = product should be=20 returned to one central site or, in the case of a widely = distributed=20 product, to major recovery sites.

=95 The = recovered product=20 must be stored in an area that is separated from any other food=20 products.

=95 Accurate = records must be=20 kept of the amounts of recovered product and the codes or = identifiers of=20 that product.

=95 If the = recovered product=20 is unfit for human consumption, it may be destroyed or denatured = under the=20 supervision of the company management and/or the relevant = regulatory=20 authority where legally required. Recalled products should not be = disposed=20 of by placing in unsecured bins, dumpsters, etc., in a manner that = could=20 result in subsequent removal by individuals for their own use or = for sale=20 to others.

=95 If the = food safety risk=20 can be safely removed from the recovered product through = re-labelling or=20 reprocessing this may be done once it is clear that public health = will be=20 protected.

The Effectiveness of the Product = Recall

To be effective, the product recall notification must reach as = far as=20 the product has been distributed. The effectiveness of the product = recall=20 is assessed on the basis of the amount of product returned as a = proportion=20 of the amount of product that left the manufacturer or = distributor, while=20 taking into account the retail turnover of the product.

During the product recall progress must be reviewed so that its = success=20 can be monitored. If it is decided that there is now little risk = to the=20 public, the product recall can be judged to have been a success = and=20 brought to an end but if there have been few returns and little = response=20 to a high-risk problem the product recall procedure must be = reassessed.=20 The product recall may then have to be repeated using different = methods to=20 reach the consumer.

Closing the Product Recall

The plan needs to define the process for formally notifying all = parties=20 that the incident has ended. This includes the regulator who will = arrange=20 for the recall to be audited. The Recall Co-ordinator will ensure = that the=20 document record is made available to the auditor to facilitate = this=20 process.

Reviewing the Lessons Learned

Every product recall should be viewed as opportunity to learn = and=20 improve the systems used in the food business. The Recall = Co-coordinator=20 should initiate a formal review procedure involving the product = recall=20 team and any key personnel who were involved. These could be = external=20 contacts such as a retailer or caterer. It is suggested that the = review=20 procedure should be documented as part of the product recall plan = but=20 should be sufficiently flexible to be useful. Some of the elements = that=20 should be included in a review are:

=95 A review = of the cause of=20 the issue, identifying the real issue (not the symptoms) and = immediate and=20 long term actions that will rectify the problem(s).

=95 A review = of company=20 policies, procedures and actions to update them in light of the = issue.

=95 A review = of training=20 plans to improve awareness of the problem and ensure it is not=20 repeated.

=95 A review = of management=20 structures, if reporting or lack of clarity on responsibilities=20 contributed to any problems with the product recall.

=95 A review = of=20 investigations and analysis carried out on product returns.

=95 A review = of stock=20 reconciliation.

Reviewing the Product Recall = Process

Food businesses involved in product recall should review the = product=20 recall process and amend the product recall plan if necessary. = Some of the=20 elements to be considered in the review should be:

=95 The = effectiveness of the=20 process. Did it work?

=95 Did the = product recall=20 plan drive the recall?

=95 What = problems were=20 encountered?

=95 How = effective was the=20 internal and external communication to customers and = authorities?

=95 Media = coverage. Did it=20 communicate the message accurately?

=95 Customer = care line. Did=20 it work, was it overloaded, did it cope or crash?

=95 What was = the true cost=20 of the product recall; product, time, recall message costs, lost=20 sales?

=95 = Accountabilities for the=20 product recall team. How effective were they?

=95 How did = the team work=20 together?

Communicate the lessons learnt to the appropriate personnel=20 internally.

Final Reports and = Recommendations

It is expected that the audit undertaken by the regularity=20 authority/NZFSA is reported to the NZFSA.

The final report shall include the following:

=95 The = circumstances=20 leading to the product recall.

=95 The extent = of=20 distribution of the relevant batch(es) in NZ and overseas.

=95 The action = taken by the=20 business including any publicity, with names of newspapers in = which=20 advertisements appeared.

=95 A copy of = the product=20 recall notification (e.g advertisement, fax, email) to = customers.

=95 A summary = of stock=20 reconciliation (i.e. amount of stock recovered or notified as = having been=20 disposed of).

=95 The method = of disposal=20 or otherwise of recalled stock, with proof of activity undertaken = (e.g.=20 landfill receipts etc).

=95 Action = proposed for the=20 future to prevent a recurrence of the problem.

=95 Any = difficulties=20 experienced in conducting the product recall.

=95 Any = information relating=20 to relative effectiveness of recall communications (i.e newspapers = vs=20 other communications).

=95 Costings = involved in the=20 recall process.

Appendix 1: Roles and = Responsibilities=20 Diagram

Appendix 2: Example of a Recall = Decision=20 Tree

Appendix 3: Recall Criteria = Guide

Microbiological Contamination

Where microbiological results indicate the presence of = pathogens (ie=20 food poses a safety risk), refer to Microbiological Reference = Criteria for=20 Food, MoH 1995, for pathogen levels MoH Microbiological Reference Criteria for Food = and also=20 Food Standards Australian New Zealand Code Standard 1.6.1 Microbiological Limits for Food. In particular = for dairy=20 products refer to DPC1: Animal Products (Dairy).

Listeria monocytogenes

Whilst there are at least six known species of Listeria, = Listeria=20 monocytogenes is considered an immediate food safety risk,=20 particularly in Ready To Eat products where there is no further = control=20 step. Recall advertisements and/or media releases need to specify=20 Listeria monocytogenes rather than simply Listeria when = reporting=20 risk to consumers.

As part of the risk assessment the following factors should = also be=20 considered:

=95 whether the product = will support=20 the growth of Listeria monocytogenes

=95 whether sensitive = populations are=20 likely to consume the product.

Listeria Traceback Guidance

Traceback includes investigation into the source of the = Listeria=20 contamination, identifying affected product, undertaking = corrective action=20 to eliminate the contamination source and demonstrating that the=20 corrective action has been effective.

Traceback should include investigation of all possible sources = of=20 contamination. Experience suggests that Listeria contamination is = most=20 commonly traced to either failure of a CCP (e.g. cooking step), or = environmental contamination. Once established in the environment = Listeria=20 can be difficult to remove, due to the ability of the organism to = form=20 biofilms that are resistant to many cleaning and/or sanitising = chemicals,=20 and provide protection to vegetative cells from chemicals that = would=20 otherwise be effective against Listeria.

Until the source of contamination has been identified product = may not=20 be released for sale.

A 5 day clearance regime is generally considered to be = sufficient to=20 demonstrate efficacy of the corrective actions taken. The = clearance regime=20 (including sampling of product and the environment) needs to be = agreed=20 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=20 of quality/wholesomeness.

Therefore, irrespective of whether foreign matter (FM) presents = a food=20 safety hazard or not it can be expected that whenever FM is = discovered in=20 food, or an incident occurs in the manufacturing process that = could=20 reasonably lead to FM inclusion in food, corrective action will = occur. The=20 nature of expected corrective action is the question =96 should = the food be=20 recalled, or is it sufficient to investigate the process and take = steps to=20 mitigate, where possible, any risks of re-occurrence?

In general, a case by case decision will be required. The = following=20 provides some guidance and =91rules of thumb=92 for different = types of foreign=20 matter.

General

Hard or sharp foreign matter in food may cause traumatic injury = including laceration and perforation of tissues of the mouth, = tongue,=20 throat, stomach and intestine as well as damage to the teeth and = gums and=20 may therefore be considered a physical food safety hazard = particularly if:=20

=95 The product contains = hard or sharp=20 foreign matter that measures 7 mm to 25 mm, in length, and =

=95 The product is = ready-to-eat, or the=20 intended use does not include further processing steps that would=20 eliminate, invalidate, or neutralize the hazard prior to = consumption.

In most cases, where actual or possible inclusion of foreign = matter=20 meeting the above criteria occurs in food that has been sold, and = is not=20 =91one-off=92 (i.e. multiple consumers are at risk) recall is = indicated.

It is recommended advice and input into decision-making = is sought=20 from the regulatory authority/NZFSA when:

=95 The product contains a = hard or=20 sharp foreign object that measures 7 mm to 25 mm in length, and it = is=20 proposed to subject the product to additional preparation or = processing=20 that may have an effect on the presence of the foreign objects in = the=20 finished food. For example, additional sifting of a product that = may or=20 may not remove foreign objects, depending on the measurements of = the=20 objects and the mesh aperture of the sifter.

=95 The product contains a = hard or=20 sharp foreign object less than 7 mm or between 25 mm and 77mm in = length=20 and the primary intended consumers of the product are children = under 6=20 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=20 NZFSA practice has been to require recall, irrespective of the = likely size=20 of the glass pieces.

Some glass is designed to shatter into rounded pieces rather = than to=20 produce sharp fragments. In this case the size of the pieces may = determine=20 whether a food safety hazard exists (see =91general=92).

Allergens

NZFSA recognises that food containing certain allergenic = components=20 must be labelled to show the presence of the allergen, as per the = ANZ Food=20 Standards Code (Standard 1.2.3 Mandatory Warning & Advisory Statements &=20 Declarations). Allergic individuals may be exquisitely = sensitive to=20 the allergen and suffer life threatening consequences if they = consume food=20 containing the allergen.

Where a recall is initiated, an allergy warning in the second = line of=20 the heading of the newspaper advertisement is required. Refer to a = template for recall advertisement involving allergens Recall Newspaper Advertisement Template =96 Allergen = Warning

Allergy NZ is to be advised of all recalls involving allergens = as soon=20 as possible.

Appendix 4: Sample Trade = Notification

Appendix 5: Schedule of National = Newspapers=20

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=20 a more effective way of disseminating recall information, this = decision=20 should always be made in consultation with NZFSA.=20

All=20 information on this website is subject to a disclaimer= .=20

Recall Guidance Material

Recall Guidance Material

Contents

Introduction

The=20 Purpose of a Product Recall

Roles=20 and Responsibilities

The=20 Role of the Food Industry

Recalls=20 and the Law

The=20 Law, Recalls and Privileged Statements

The=20 Role of the Regulatory Authorities

Primary Regulatory Management of Recalls

Levels=20 of Product Recall

Developing=20 an Effective Business Product Recall Procedure

Product=20 Recall Policy

The=20 Product Recall Plan

The=20 Product Recall Team

Definition=20 of Roles and Responsibilities

Product=20 Recall Contacts List

The=20 Decision to Recall

The=20 Scope of the Recall

Notification=20 of a Product Recall

Testing=20 and Reviewing the Product Recall Plan

Managing=20 a Product Recall

Documenting=20 the Product Recall Process

Regaining=20 control of Affected Stock

The=20 Effectiveness of the Product Recall

Closing=20 the Product Recall

Reviewing=20 the Lessons Learned

Reviewing=20 the Product Recall Process

Final=20 Reports and Recommendations

Appendix=20 1: Roles and Responsibilities Diagram

Appendix=20 2: Example of a Recall Decision Tree

Appendix=20 3: Recall Criteria Guide

Appendix=20 4: Sample Trade Notification

Appendix=20 5: Schedule of National Newspapers =

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=20 Zealand

Recalls and Overseas Countries

Australia

Regulatory Audit of Business = Generated=20 Recalls

Levels of Product Recall

Developing an Effective Business = Product Recall=20 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=20 Recall

Notification of a Product Recall

Communicating with Regulatory=20 Authorities/NZFSA

Commercially Sensitive = Information

Communicating with the Distribution = Chain

Communicating with the Consumer

Paid Advertisements (applicable = during a Recall=20 or a Withdrawal)

Press Release (applicable during = Recall=20 only)

Warning Notice or Point of Sale Notice (applicable during = Recall=20 only)

Testing and Reviewing the Product = Recall=20 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