Food Safety: Frameork for the Development of Food Safety Program Tools July 2001
Australia Ne Zealand Food Authority 2001 ISBN 0 642 34548 1 First published July 2001 This ork is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process ithout prior ritten permission from Australia Ne Zealand Food Authority (ANZFA). Requests and inquiries concerning reproduction and rights should be addressed to the Information Officer, ANZFA, PO Box 7168, Canberra MC, ACT 2610. An electronic version of this ork is available on the Australia Ne Zealand Food Authority (ANZFA) ebsite at http://.anzfa.gov.au. This electronic version may be donloaded, displayed, printed and reproduced in unaltered form only for your personal, non-commercial use or use ithin your organisation. ANZFA Australia PO Box 7186 Canberra Mail Centre ACT 2610 Australia Tel: +61 2 6271 2222 Fax: +61 2 6271 2278 Email: info@anzfa.gov.au ANZFA Ne Zealand PO Box 10559 Wellington Ne Zealand Tel: +64 4 473 9942 Fax: +64 4 473 9855 Email: nz.reception@anzfa.gov.au
FRAMEWORK FOR THE DEVELOPMENT OF FOOD SAFETY PROGRAM TOOLS 1 Contents Acknoledgments 2 Abbreviations 3 Introduction 4 What are food safety program tools? 5 The role and purpose of tools 5 The development of tools 5 Content and other attributes of tools 6 Style and format 7 Content and structure of the food safety program tool 7 1 Introduction 7 2 Scope of the tool 7 3 Purpose and use of the tool 7 4 Definitions and glossary of terms 7 5 Advice on complying ith the Food Acts and Food Safety Standards 7 5.1 State and Territory Food Acts 7 5.2 Food Safety Standard 3.2.1 Food Safety Programs 8 The HACCP approach 10 5.3 Food Safety Standards 3.1.1, 3.2.2 and 3.2.3 10 6 General information 11 6.1 Further assistance 11 6.2 References 11 Instructions on ho the tool should be used in practice 11 Useful references and ebsites 12 Commonealth Government organisations 12 State and Territory Government health departments and other food safety agencies 12 Australian organisations 13 International organisations/sites 13 Appendix Checklist for tool developers 15
2 FRAMEWORK FOR THE DEVELOPMENT OF FOOD SAFETY PROGRAM TOOLS Acknoledgments The Australia Ne Zealand Food Authority (ANZFA) prepared this document ith assistance from the Food Safety Program Tools Working Group: Mr Kerry Bell Mr Tony Doner Ms Tenille Fort Ms Catherine Gay Ms Brigid Hardy Mr John Hart Mr Tony Johnson (Chair) Mr Steven Neton Queensland Health Department Australian Food and Grocery Council Department of Human Services, Victoria Commonealth Department of Health and Aged Care Agriculture, Fisheries and Forestry Australia Restaurant and Catering Industry Association of Australia Australia Ne Zealand Food Authority Metcash Pty Ltd ANZFA expresses its appreciation of the assistance from these people and acknoledges that the vies contained in the document do not necessarily represent their vies or the vies of their organisations. This document is intended as a guide only: legal requirements are contained in the Food Standards Code and relevant food legislation and other applicable las. The information in this document should not be relied upon as legal advice or used as a substitute for legal advice. You should exercise your on skill, care and judgment before relying on this information in any important matter.
FRAMEWORK FOR THE DEVELOPMENT OF FOOD SAFETY PROGRAM TOOLS 3 Abbreviations ANZFA FAO HACCP WHO Australia Ne Zealand Food Authority Food and Agriculture Organization of the United Nations Hazard Analysis and Critical Control Point World Health Organization
4 FRAMEWORK FOR THE DEVELOPMENT OF FOOD SAFETY PROGRAM TOOLS Introduction There are four Food Safety Standards in Chapter 3 of the Australia Ne Zealand Food Standards Code. All food businesses in Australia are required to comply ith three of these standards. They are: Standard 3.1.1 Interpretation and Application Standard 3.2.2 Food Safety Practices and General Requirements Standard 3.2.3 Food Premises and Equipment The fourth of these standards, Standard 3.2.1 Food Safety Programs, is a model standard. It ill only apply to food businesses if a State or Territory Government chooses to introduce a requirement for food safety programs for some or all types of food businesses. If a State or Territory does introduce a requirement for food safety programs, it must use this model standard. None of these four Food Safety Standards apply to Ne Zealand. Standard 3.2.1 is based upon the internationally accepted principle that food safety is best ensured through the identification and control of hazards in the production, manufacturing and handling of food, as described in the Hazard Analysis and Critical Control Point (HACCP) system, adopted by the joint WHO/FAO Codex Alimentarius Commission. This standard enables States and Territories to require food businesses to implement a preventative food safety management system a food safety program. In practice, a food business can demonstrate that this preventative approach has been implemented by demonstrating compliance ith Standard 3.2.2 through documentation, record keeping and revie. Hoever, Standard 3.2.1 provides no detail on ho to develop and implement a food safety program. For example, it contains no detail on the means of controlling identified hazards, or the amount and type of documentation and record keeping necessary to demonstrate compliance. Consequently, many businesses, particularly small businesses, may require significant guidance and advice to assist them. This guidance can be provided in the form of food safety program tools (templates, guides, guidelines, etc.) that can assist individual businesses to develop and implement their food safety program. For the sake of brevity these food safety program tools are generally referred to as tools in this document. While some food businesses are required to comply ith Standard 3.2.1 and implement a food safety program, many food businesses that are not required to implement a food safety program may choose to do so for their on business purposes. This frameork document is intended to guide the production of practical, easy-to-use tools that can be used by individual food businesses and, in particular, small businesses, hether they are required or choose to implement a food safety program. This document is intended to facilitate a nationally consistent approach to the production of these tools. It is intended for use by food industry associations, other collective organisations, governments or individuals to develop tools appropriate to the types of food businesses ithin a food industry sector or sectors. It is not intended for use by individual food businesses. This document is advisory only and not part of food la.
FRAMEWORK FOR THE DEVELOPMENT OF FOOD SAFETY PROGRAM TOOLS 5 What are Food Safety Program Tools? Food safety program tools ( tools ) are defined as materials such as templates, models, softare and printed materials hich may be used directly by food businesses through customisation to create their on orkable, site-specific food safety programs hich meet the requirements of food la, in particular the Food Safety Standards. For the purposes of this document, tools do not include services such as direct input by consultants expert in the field of food safety. The Role and Purpose of Tools The principal purpose of tools is to provide sector-specific information that ill help individual food businesses ithin a food industry sector to develop and implement their on food safety program. A tool should provide an individual food business ith: simple, practical ho-to-do-it guidance on producing safe food and complying ith the Food Safety Standards; the flexibility to manage the business s on processes to suit its individual situation; an instruction process for the oner/manager and staff, hich explains ho to implement a food safety program; generally accepted practices and procedures specific to the food industry sector; a means to minimise the costs of implementing a food safety program; and a source of information to address the needs of the business oner/manager. The Development of Tools While a range of organisations, including governments, and individuals can develop food safety program tools, industry associations or groups are in the best position to take responsibility for the development of tools appropriate to the needs of businesses ithin their sector. Where practicable, tools should be national in their application and be developed ith this perspective in mind. The development process should be consultative and involve a representative section of the relevant food industry sector, including small business. Agencies that ill be required to enforce the Food Safety Standards should be offered the opportunity for involvement in the development process. Tool developers should make themselves aare of the differences beteen State and Territory Food Acts and, in particular, the application of Standard 3.2.1 in the different jurisdictions. (Note: All State and Territory Food Acts are in the process of being revieed. Developers should ensure they are aare of changes to relevant legislation.)
6 FRAMEWORK FOR THE DEVELOPMENT OF FOOD SAFETY PROGRAM TOOLS Tools should allo for flexible food safety programs consistent ith the needs of businesses ithin the sector. For example, simple food safety programs should be sufficient for many small and lo-risk businesses, provided that they address all of the core elements of a food safety program (required in Standard 3.2.1). A tool should be easy to customise into the operations of individual food businesses. This is an important aspect for tool developers to consider in the development process. It is strongly recommended that tool developers conduct trials of their tool to determine its user friendliness, practicality and ease of customisation by businesses. Trials ill allo modifications and improvements, if needed, to the tool before it is made generally available. ANZFA is happy to assist tool developers ith the development of sector-specific tools. For example, ANZFA is illing to advise on the development and content of tools and also to provide comment during the development process. Tool developers anting to seek advice, or to obtain further information, are invited to contact: The Food Safety Program ANZFA PO Box 7186 CANBERRA MC ACT 2610 Phone: +61 2 6271 2224 Email: food.safety@anzfa.gov.au Content and Other Attributes of Tools This frameork document is not intended to provide detailed instructions on the content of tools. Hoever, the folloing sections are intended to assist tool developers by providing a frameork for the development of tools that are consistent in their content, structure, style and utility. Tools should be limited to providing businesses ith advice on the minimum effective measures to comply ith food la. Hoever, it is acknoledged that some tool developers may consider it desirable to include guidance to businesses on other matters, such as product quality attributes, industry best practice, good manufacturing practices (GMP) or other current practices ithin the sector above minimum requirements. In these cases, the tool should distinguish beteen guidance on complying ith food la and guidance related to product quality or other matters. The Appendix to this document contains a checklist on the content and other attributes of food safety program tools. It is provided so that tool developers can quickly check that the individual requirements of the Food Safety Standards and other desirable attributes have been included or considered during the development process of their food safety program tool.
FRAMEWORK FOR THE DEVELOPMENT OF FOOD SAFETY PROGRAM TOOLS 7 Style and format Tools should be drafted in plain-language style and be as concise, simple and user-friendly as possible. It is desirable for tools to be drafted using a modular structure. This ill allo businesses to use the modules or sections that apply to their business and discard modules that do not apply to their activities and processes. Tools may be presented in different formats, including electronic, as determined by the tool developer. Content and structure of the food safety program tool To improve consistency across industry sectors and jurisdictions, the food safety program tool should reflect the content and structure outlined in the folloing sections. 1 Introduction This section of the tool should include the contact details of the developer. It should also include a description of back-up resources available to help businesses use the tool. It should be made clear that the tool itself is not mandatory. It is an aid for businesses in developing and implementing a food safety program and complying ith legislative requirements. The tool should refer to other relevant documents, including the Food Safety Standards. 2 Scope of the tool In this section, clearly describe the operational scope of the tool for the specific food industry sector and/or list in appropriate detail the types of food businesses to hich the tool is targeted. 3 Purpose and use of the tool Set out the purpose of the tool and explain ho it should be correctly used. 4 Definitions and glossary of terms The tool should include a list of appropriate definitions, including relevant terms that are specific to, and broadly used ithin, the particular industry sector. These terms should be defined in plain language and may be clarified using examples. (Note: definitions included in the tool should not differ from those in the Food Safety Standards and Food Acts). 5 Advice on complying ith the Food Acts and Food Safety Standards 5.1 State and Territory Food Acts All Australian businesses that handle food intended for sale or sell food in Australia are required to comply ith State and Territory Food (or Health) Acts (Note: sell is defined in the Food (or Health) Acts). This legislation generally does not apply to primary food production activities. Consequently, businesses, such as farms, that engage in primary food production are not required to comply ith the Food Safety Standards unless they engage in any process involving the substantial transformation of
8 FRAMEWORK FOR THE DEVELOPMENT OF FOOD SAFETY PROGRAM TOOLS food or the sale or service of food directly to the public. Additionally, in most jurisdictions, the Food Safety Standards do not apply to businesses regulated by any other food production legislation, for example State and Territory Meat or Dairy Acts. There are also some exemptions for community and charity fundraising events in relation to the skills and knoledge requirement in Standard 3.2.2 and in relation to food safety programs. The Food Safety Standards do not apply to food businesses in Ne Zealand. Tool developers should provide advice in their tool on the application of the Food Safety Standards to businesses ithin the sector and jurisdictions concerned. In this section the tool should: inform businesses of their obligation to comply ith the State and Territory Food (or Health) Acts; advise businesses ithin the sector on the application of the Food Safety Standards; and advise businesses that other las and regulations may apply to them. For example, other aspects of the Food Standards Code, such as labelling requirements, may apply and businesses that export food must comply ith the Australian Quarantine and Inspection Service (AQIS) Export Food Orders. 5.2 Food Safety Standard 3.2.1 Food Safety Programs The tool should provide guidance on developing and implementing a food safety program that is consistent ith Standard 3.2.1. This approach ill assist businesses required to comply ith Standard 3.2.1, as ell as those businesses that may choose to implement a food safety program for other reasons. Standard 3.2.1 requires a food business to systematically examine its food handling operations in order to identify potential food safety hazards that may reasonably be expected to occur. Where one or more food safety hazards have been identified, the business must develop and implement a ritten food safety program hich it must retain at its premises. The food business must comply ith its food safety program and ensure that it is audited by an approved food safety auditor, at the applicable audit frequency. The food business must also conduct a revie of the food safety program, at least annually, to ensure its adequacy. Tool developers seeking further information on the food safety audit system are advised to refer to the ANZFA ebsite and State and Territory health agency ebsites. In this section the tool should: describe the steps necessary to develop and implement an effective food safety program that ill assist individual businesses to demonstrate due diligence. Illustrative examples from the industry sector may be given; provide advice on the types of businesses, if any, in the different jurisdictions that have a mandatory requirement for a food safety program, and the timeframe for implementation; here available, include information on applicable audit frequency and the contact person to arrange an audit; and
FRAMEWORK FOR THE DEVELOPMENT OF FOOD SAFETY PROGRAM TOOLS 9 make clear that the food safety hazards and critical steps associated ith the operations of individual food businesses cannot all be addressed in the tool. The final responsibility for the development of a food safety program that appropriately addresses all the food safety hazards associated ith a food business remains ith that business. Standard 3.2.1 defines a food safety program that contains six core elements, listed belo. Each of these must be addressed in the tool. Hoever, tool developers may be flexible in the manner that the food safety program and its core elements are addressed. Hazard identification: systematically identify the potential hazards that may be reasonably expected to occur in all food-handling operations of the food business. Many hazards are generic for businesses ithin a particular food industry sector. These hazards should be described in tools for that sector. In addition to generic hazards, each food business has unique features that may alter a hazard or introduce ne hazards. These are referred to as site-specific hazards. In this section the tool should: describe the generic microbiological, chemical and physical hazards that can occur during every stage of the food-handling operations typical for businesses in the sector; and describe a process that businesses can use to identify site-specific food safety hazards. These can often be removed once identified. (Examples from the sector should be provided.) Hazard control: identify here, in a food-handling operation, each identified hazard can be controlled and the means of control. The tool should advise on the means of control for identified generic food safety hazards and here the hazards can be controlled. It should include advice on limits (referred to as critical limits in HACCP) for the controls. Limits can be obtained from a number of sources including research, reference books, papers from technical journals, codes of practice and legislation. For example, there are temperature control limits in Standard 3.2.2. Tool developers should validate critical limits and include appropriate validation information in the tool. Hoever, validation is not necessary for limits that are part of food la. Monitoring: provide for the systematic monitoring of the controls. The tool should provide information on the regular measurement and observation for each of the controls. This may include designating responsibility for, and frequency of, monitoring. Corrective action: provide for appropriate corrective action hen a hazard (or hazards) is found not to be under control. The tool should advise on corrective action necessary to bring a particular control point back under control before it leads to a safety hazard. Advice should also be given on hat action is necessary to prevent the situation from recurring.
10 FRAMEWORK FOR THE DEVELOPMENT OF FOOD SAFETY PROGRAM TOOLS Revie: provide for the regular revie of the program by the food business to ensure its adequacy. Revie consists of the activities undertaken to prove the ongoing effectiveness of a food safety program. The tool should include information on the type of revie activities recommended, ho often they should be undertaken, events that may trigger a revie and ho to record and use the results. Record keeping: provide for appropriate records to be made and kept by the food business demonstrating action taken in relation to, or in compliance ith, the food safety program. The tool should provide information on the amount and type of record keeping required by a food business to sho that its food safety program is effective. This ill depend upon the needs and the complexity of the food businesses for hich the tool is intended and the resources available to them. The HACCP approach The food safety program core elements are consistent ith the seven principles of the HACCP system (FAO, 1997). This can be donloaded from the FAO ebsite at.fao.org/docrep/6419e/6419e00.htm). The tool may refer to and use the Codex HACCP system principles to satisfy the food safety program requirement. Hoever, tool developers may choose to address the food safety program requirement ithout reference to HACCP, if this approach is considered preferable for the needs of the food businesses ithin the sector concerned. In tools that use the Codex HACCP system principles, include: a master or generic HACCP plan that is appropriate for businesses ithin the sector; information and advice on the application of the seven HACCP system principles and, preferably, also on the initial five steps in the application of the HACCP system; and include information on support programs applicable for typical businesses ithin the food industry sector concerned. 5.3 Food Safety Standards 3.1.1, 3.2.2 and 3.2.3 These standards apply to all food businesses in Australia but not in Ne Zealand. The food safety program tool should provide guidance on compliance ith all of the requirements of Standards 3.1.1, 3.2.2 and 3.2.3 applicable to businesses ithin the food industry sector concerned, ithin the context of a food safety program. ANZFA has published Safe Food Australia: A Guide to the Food Safety Standards. This publication has been prepared to assist ith the interpretation of these three standards. It explains the intent behind each of the requirements of these standards. Tool developers may find it helpful to use appropriate parts of Safe Food Australia in their tool, or refer businesses to it. It is recommended that tool developers use this frameork document in conjunction ith the Food Safety Standards and Safe Food Australia.
FRAMEWORK FOR THE DEVELOPMENT OF FOOD SAFETY PROGRAM TOOLS 11 There are some requirements in Standards 3.2.2 and 3.2.3 that are qualified by the phrase unless the food business demonstrates. This term has been included to allo businesses to demonstrate that an alternative system they may have in place ill not adversely affect the safety of the food. This is usually achieved by the business implementing a food safety program. Tool developers should consider the issue of alternative practices for typical businesses ithin the sector and, here appropriate, include suitable advice. Any alternative practices suggested must be validated. Additional guidance on compliance ith Standard 3.2.3 can be found in a proposed Australian Standard Design, Construction and Fit out of Food Premises. The purpose of the standard is to assist architects, food business proprietors and others involved in designing and fitting out ne food premises and altering existing food premises. Tool developers may find it helpful to use this Australian Standard in developing their tool. Alternatively, the tool may refer businesses to this Australian Standard. 6 General information 6.1 Further assistance It is desirable for tool developers to include a list of appropriate organisations and agencies that may assist food businesses in complying ith the standards. 6.2 References If considered desirable, the tool may include a list of suitable references for additional advice to food businesses on particular areas of concern, for example training packages and codes of practice. Instructions on ho the tool should be used in practice Tool developers should provide instructions on ho the tool is best used in practice by individual food businesses. This advice should include the appropriate practical steps for businesses to customise the tool to create and implement their on specific food safety program. These steps are listed belo and are suitable for most food industry sectors. Tool developers should advise businesses to: study and understand the instructions, support materials and/or training to help customisation of the tool and to seek assistance as required; customise the tool document to create the business s on food safety program ; seek a check of the appropriateness of the customised food safety program before it is implemented, for example local government Environmental Health Officers. (Although this is a useful step, in practice, it may not be possible in many situations); train food handlers in the specific tasks and processes that they are responsible for (from the food safety program). Food handlers should also be trained in health and hygiene, if needed; implement the procedures, monitoring and revie as described in the food safety program; and
12 FRAMEWORK FOR THE DEVELOPMENT OF FOOD SAFETY PROGRAM TOOLS arrange to have the food safety program audited as required by State/Territory la (if there is no mandatory requirement for a food safety program the business may or may not choose to have its food safety program audited). Useful References and Websites Commonealth Government organisations Organisation Agriculture, Fisheries and Forestry Australia Australian Quarantine and Inspection Service Australia Ne Zealand Food Authority Department of Health and Aged Care Web address.affa.gov.au.aqis.gov.au.anzfa.gov.au.health.gov.au State and Territory Government health departments and other food safety agencies State Ne South Wales Web address.health.ns.gov.au.safefood.ns.gov.au Northern Territory Queensland.nt.gov.au/nths.health.qld.gov.au.safefood.qld.gov.au South Australia Tasmania Victoria Western Australia ACT.health.sa.gov.au.dchs.tas.gov.au.foodsafety.vic.gov.au.health.a.gov.au.health.act.gov.au
FRAMEWORK FOR THE DEVELOPMENT OF FOOD SAFETY PROGRAM TOOLS 13 Australian organisations Organisation Australian Institute of Environmental Health Australian National Training Authority Bread Research Institute Food Australia: The Journal of the Australian Institute of Food Science and Technology Food Science Australia Quality Society of Australasia Standards Australia Web address.aieh.org.au.anta.gov.au.bri.com.au.foodaust.com.au.foodscience.afisc.csiro.au.qsanet.com.standards.com.au International organisations/sites Organisation Campden and Chorleyood Food Research Association Food and Agriculture Organization of the United Nations: Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application, Annex to CAC/RCP 1 1969, Rev. 3 (1997) Highfield Publications, UK Hospitality Institute of Technology and Management International Association for Food Protection: Publishes the Journal of Dairy Food & Environmental Sanitation and Journal of Food Protection International Organization for Standardisation LACOTS Local Authority Co-ordinating Body on Food and Trading Standards, UK Leatherhead Food Research Association, UK Microbiology Journals Database NZ Ministry of Agriculture and Forestry NZ Ministry of Health Web address.campden.co.uk.fao.org/docrep/6419e/6419e00.htm.highfield.co.uk.hi-tm.com.foodprotection.org.iso.ch.lacots.org.uk.lfra.co.uk.sciencekomm.at/journals/micro.html.maf.govt.nz.moh.govt.nz
14 FRAMEWORK FOR THE DEVELOPMENT OF FOOD SAFETY PROGRAM TOOLS UK Chartered Institute of Environmental Health UK Department of Health UK Food Standards Agency University of Guelph, Canada US Center for Food Safety and Applied Nutrition US Department of Agriculture: Links to the Food Safety Inspection Service (FSIS) US Food Code US Food and Drug Administration US Government food safety information site US Institute of Food Technologists US National Food Safety database World Health Organization: Links to FAO.cieh.org.uk.doh.gov.uk.foodstandards.gov.uk.plant.uoguelph.ca/riskcomm.cfsan.fda.gov.usda.gov http://vm.cfsan.fda.gov/~dms/foodcode.html.fda.gov.foodsafety.gov.ift.org.foodsafety.org.ho.org Standards for equipment Organisation European Hygienic Equipment Design Group International Association of Food Industry Suppliers NSF International, US Web address.ehedg.orgs.iafis.org.nsf.org
FRAMEWORK FOR THE DEVELOPMENT OF FOOD SAFETY PROGRAM TOOLS 15 APPENDIX Checklist for tool developers Does the food safety program tool include or take account of the folloing? Attributes or characteristics User friendliness and ease of customisation as determined through trialling Backup resources to help individual businesses Support of the food industry sector National applicability Based on a modular structure General contents Contact details of the developer Clear description of the operational scope and specific food industry sector Statement of the tool s non-mandatory status Instructions on ho businesses should use the tool Glossary of terms and definitions Skills and knoledge options for businesses Notification or registration requirements in the appropriate jurisdictions Food safety program requirements Generic hazards associated ith the sector A process to identify and eliminate or control site specific hazards Controls for the hazards Ho, hen, here and ho to monitor the controls Validation of controls that vary from or not included in Standard 3.2.2 Corrective actions Appropriate record keeping Appropriate revie of the food safety program Information relating to audit of the food safety program Statement that the final responsibility for the production of safe food remains ith the individual business
16 FRAMEWORK FOR THE DEVELOPMENT OF FOOD SAFETY PROGRAM TOOLS Elements of the food safety program from Standards 3.2.2 and 3.2.3 Food-handling controls Food receipt Food storage Food processing Food display Food packaging Food transportation Food disposal Food recall Health and hygiene requirements Requirements of food handlers: general requirements health and hygiene of food handlers Requirements for food businesses: health of persons ho handle food duties of food businesses hygiene of food handlers duties of food businesses general duties of food businesses Cleaning, sanitising and maintenance Cleanliness and aste management Cleaning and sanitising of specific equipment Maintenance Miscellaneous Temperature-measuring devices and calibration Single-use items Animals and pests