FAO-WHO Global Forum of Food Safety Regulators

Agenda Item 4.2 b) GF/CRD New Zealand-1

FAO/WHO Global Forum of Food Safety Regulators
Marrakesh, Morocco, 28 - 30 January 2002

New Zealand's approach to food safety management

CONFERENCE ROOM DOCUMENT SUBMITTED BY NEW ZEALAND
COUNTRY REPORT

Summary
Introduction
The regulatory model and roles within it
Risk management framework
Legislative framework
Joint Australia New Zealand Food Standards Code
Small and less developed businesses
Measuring performance: evaluating the New Zealand system

Summary

This paper outlines the application in New Zealand of a risk-based approach to food safety. It focuses on four key areas within the overall system in place in New Zealand: the roles within the government's regulatory model, the risk management framework, legislation, and measuring the regulatory system's performance.

The New Zealand government has taken a partnership approach with food operators, assisting sectors to develop the tools they need to meet the mandatory outcome standards. These include templates and codes of practice to assist operators to implement HACCP-based systems and risk management programmes. The approach has proven successful in contributing to the overarching goal of the food safety regulatory system: ensuring that the food that reaches consumers is safe and fit for purpose. The challenges for the future are in continuing to expand application of this approach across the entire food sector and measuring performance of the system.

INTRODUCTION

This paper outlines New Zealand's approach to food safety management. It focuses on four key areas within the overall system in place in New Zealand: the roles within the government's regulatory model, the risk management framework, legislation, and measuring the regulatory system's performance. It is important to note that the system is integrated and presented as a total package. Each of the key areas is integral to the system.

THE REGULATORY MODEL AND ROLES WITHIN IT

The New Zealand government's regulatory model is based on the principle that food operators must demonstrate the safety of their produce. Food operators are responsible for identifying the food safety hazards in their operations and maintaining approved systems to address them. As long as regulatory food safety outcome standards are met, food operators have the freedom to innovate in their processes.

The model maps the relationships among the three key parties in the food sector: government (standard-setting, approvals, enforcement), independent agencies (evaluators, verifiers, auditors - also government if circumstances require), and food operators (businesses, industry sectors).

Government:

sets outcome standards that food operators' risk management programmes must meet,

approves food operators' risk management programmes;

sets competency and system standards that independent audit/verification agencies and their staff must meet;

approves independent audit/verification agencies and their staff;

sets performance criteria for food operators and independent audit/verification agencies so that good performance can be rewarded and/or recognised;

conducts compliance and overall system audit to gain feedback that the system is working and outcomes are being achieved; and

enforces the outcome based standards.

Independent audit/verification agencies:

ensure that their systems and staff meet government-set standards to maintain their approval to operate;

evaluate, audit, and verify food operators' approved programmes on a contractual basis to those food operators; and

report to the food operator and the regulator.

Food operators:

design and validate a risk management programme specific to their products and processes that meet government-set standards; and

contract independent audit/verification agencies to evaluate, audit, and verify their compliance with their approved programme.

Government is implementing the model across the food sector. This includes harmonising systems, to the greatest extent possible, across the two government ministries responsible for administering food legislation: the Ministry of Agriculture and Forestry (MAF) and the Ministry of Health (MoH). The model is also being implemented across food producers, through legislative and administrative changes.

RISK MANAGEMENT FRAMEWORK

New Zealand has been moving to a risk management approach to food regulation for a number of years. In June 2000, MAF and MoH jointly published a generic risk management framework for the food sector. Both Ministries are now working to implement this framework (the publication is available on the MAF and MoH websites).

The framework allows the regulatory oversight of food safety to be broad enough to encompass all components of the food chain, and to ensure that optimal hazard controls are applied where they will be most effective in reducing risks. The generic risk management framework follows the principles of the hazard analysis and critical control point (HACCP) system, which can be summarised in four key steps:

risk evaluation - establishment of a risk profile, possibly through a formal risk assessment;

assessment of risk management options - systematic assessment of the likely impact of different sanitary measures on preventing, eliminating or reducing risks to human health;

implementation of the risk management decision - design and implementation of sanitary measures, and establishment of performance and/or process parameters; and

monitoring and review - evaluation of the effectiveness of the sanitary measures that have been implemented, using monitoring and surveillance data.

Effective food safety risk management relies on appropriate risk communication and stakeholder representation at all these steps. Implementation of the framework of the administration of food safety in New Zealand allows decisions to be made that are proportionate to the health risks involved, allow innovation and flexibility in application of sanitary measures, and allow due regard to be taken of the costs as well as the benefits of the risk management options. To achieve such goals, it is recognised that interaction between government, industry, consumer groups, foreign governments, and other stakeholders needs to occur on many levels.

International developments increasingly influence New Zealand's national regulatory environment and impact directly on the domestic marketplace. These include risk-based approaches taken to policy and scientific decisions in the context of the World Trade Organisation's SPS Agreement (Agreement on the Application of Sanitary and Phytosanitary Measures) and the Codex Alimentarius Commission. Similarly, bilateral and multilateral agreements on the equivalence of sanitary measures for food in international trade are increasingly reliant on the consistent and transparent risk management at the national level. This provides strong impetus for a domestic risk management framework that is harmonised with the principles and practices adopted by international organisations.

LEGISLATIVE FRAMEWORK

In implementing a risk management approach, New Zealand is establishing a legislative framework that accommodates the approach but also facilitates flexibility. The legislative framework has three key elements:

statutes (primary law, passed by Parliament) contain the fundamental principles,

regulations (secondary law, passed by the executive arm of government) contain outcomes to be achieved, and

standards/specifications (tertiary law, issued by regulatory agencies) provide technical, `how to' detail (only where absolutely necessary).

New Zealand's risk management approach begins on the farm. The Agricultural Compounds and Veterinary Medicines Act 1997, which commenced in July 2001, codifies a risk based legislative approach for agricultural compounds and veterinary medicines.

In the animal product sector, the Animal Products Act 1999 provides for risks to be managed through the value chain, from farm through processors to consumers. The key mechanism used for this purpose is a risk management programme, which processors of animal products must have in place by the end of an agreed transition period. The programme must take into account the principles of hazard analysis and critical control point (HACCP) systems and be approved by MAF. Risk management programmes must be independently evaluated and verified. Specific market access requirements which require export certification are generally undertaken concurrently with risk management programme requirements.

By way of specific example, in the New Zealand dairy sector, a review of the dairy industry legislation is underway, with the aim of updating the legislation so that it better reflects the regulatory model. In advance of that legislative change, the model was implemented as a voluntary option for operators in July 2000. Approximately 65% of registered dairy premises elected to move to the model system. Two independent agencies have been approved and are operational for evaluating dairy product safety programmes and for verifying operators' compliance with them.

In the mixed food sector, MoH administers a system based on the model as a voluntary option under the Food Act. There is a transitional process in place where operators may choose to have a HACCP based food safety programme and gain exemption from complying with the prescriptive requirements of the Food Hygiene Regulations. The food safety programme is approved by MoH, and compliance with the programme is verified by independent auditors. A wide range of food businesses have adopted the system, with supermarket chains and other chain retailers leading the transition.

JOINT AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE

The New Zealand government views prescriptive compositional or processing requirements as generally unnecessary, preferring to allow flexibility for innovation in processes and consumer choice in composition. While food safety is regulated using a risk based approach, under the legislation described above, food composition and labelling are regulated under the joint Australia New Zealand Food Standards Code. New Zealand's participation in the development and implementation of the Food Standards Code is based on a bilateral Treaty signed between the New Zealand and Australian Federal Governments in late 1995. The Food Standards Code was substantially completed and agreed to by New Zealand national and Australian federal, state, and territory health ministers in November 2000, and came into force in both countries shortly after.

The part of the Code that applies in both countries (Chapters 1 and 2) currently operates in parallel with the relevant parts of the pre-existing Australian Food Standards Code and the New Zealand Food Regulations during a two-year transition period. At the end of the transition period, the Australian Food Standards Code and the relevant parts of the New Zealand Food Regulations will be repealed, and Chapters 1 and 2 of the Code will become the single regulatory mechanism for food composition and labelling standards in both countries.

SMALL AND LESS DEVELOPED BUSINESSES

New Zealand participates in the work of the Codex Committee on Food Hygiene (CCFH) on assisting small and less developed businesses to design and implement HACCP based programmes. New Zealand joins with other countries who recognise that there are a variety of factors that may cause a business to be in this category. Current estimates suggest that over 96% of New Zealand enterprises would be involved. The adaptation of this most effective risk management tool to their circumstances is very important to New Zealand.

The New Zealand government recognises that many small businesses have neither the expertise to develop risk management programmes for themselves, nor the resources to contract experts' services. Sectors are encouraged to pool their resources to develop codes of practice and templates that are detailed enough for individual operators to adopt, with only minor customisations. The government has taken a partnership approach with industry, assisting sectors to develop the tools they need. In New Zealand's experience, involving food operators in the development process contributes to the practicality and applicability of final templates or codes of practice and to the satisfaction and compliance by food operators with the final template or code of practice. The overall stepwise approach has been successful: operators can build upon their existing good manufacturing/hygienic practices (GMP / GHP), rather than starting over with a completely unrelated system.

MEASURING PERFORMANCE: EVALUATING THE NEW ZEALAND SYSTEM

New Zealand is still developing criteria by which to measure the performance of the risk based food safety regulatory system. Criteria being considered include reductions in the occurrence of food-borne illness in New Zealand and compliance with risk-based programmes. While these are useful indicators, neither of these criteria go to the core of assessing the effectiveness or otherwise of specific control measures. Addressing this issue is more complex.

One mechanism currently being pursued in New Zealand is to develop risk profiles for a range of food/hazard combinations. This will then form an integral part of the risk evaluation step in the risk management process. It will also contribute to decision making on future sanitary measures that might be imposed or changed. It is intended that this will establish a scientifically justifiable, consistent and transparent approach to the management of food safety risks.

New Zealand's expectation is that with the passage of time and our skill in the application of performance measurement approaches, performance measurement will become fully integrated into our regulatory system.

Summary

New Zealand is taking an active risk management approach to food safety regulation. The government's regulatory model clearly defines relationships among government, independent audit/verification agencies, and food operators. New Zealand's legislative framework is aimed at ensuring that food operators appropriately manage the food safety risks involved in their processes so that consumers can be assured that the food they consume is safe and fit for purpose.



Agenda Item 4.2 b)	GF/CRD New Zealand-1
FAO/WHO Global Forum of Food Safety Regulators Marrakesh, Morocco, 28 - 30 January 2002 New Zealand's approach to food safety management CONFERENCE ROOM DOCUMENT SUBMITTED BY NEW ZEALAND COUNTRY REPORT Summary Introduction The regulatory model and roles within it Risk management framework Legislative framework Joint Australia New Zealand Food Standards Code Small and less developed businesses Measuring performance: evaluating the New Zealand system Summary This paper outlines the application in New Zealand of a risk-based approach to food safety. It focuses on four key areas within the overall system in place in New Zealand: the roles within the government's regulatory model, the risk management framework, legislation, and measuring the regulatory system's performance. The New Zealand government has taken a partnership approach with food operators, assisting sectors to develop the tools they need to meet the mandatory outcome standards. These include templates and codes of practice to assist operators to implement HACCP-based systems and risk management programmes. The approach has proven successful in contributing to the overarching goal of the food safety regulatory system: ensuring that the food that reaches consumers is safe and fit for purpose. The challenges for the future are in continuing to expand application of this approach across the entire food sector and measuring performance of the system. INTRODUCTION This paper outlines New Zealand's approach to food safety management. It focuses on four key areas within the overall system in place in New Zealand: the roles within the government's regulatory model, the risk management framework, legislation, and measuring the regulatory system's performance. It is important to note that the system is integrated and presented as a total package. Each of the key areas is integral to the system. THE REGULATORY MODEL AND ROLES WITHIN IT The New Zealand government's regulatory model is based on the principle that food operators must demonstrate the safety of their produce. Food operators are responsible for identifying the food safety hazards in their operations and maintaining approved systems to address them. As long as regulatory food safety outcome standards are met, food operators have the freedom to innovate in their processes. The model maps the relationships among the three key parties in the food sector: government (standard-setting, approvals, enforcement), independent agencies (evaluators, verifiers, auditors - also government if circumstances require), and food operators (businesses, industry sectors). Government: sets outcome standards that food operators' risk management programmes must meet, approves food operators' risk management programmes; sets competency and system standards that independent audit/verification agencies and their staff must meet; approves independent audit/verification agencies and their staff; sets performance criteria for food operators and independent audit/verification agencies so that good performance can be rewarded and/or recognised; conducts compliance and overall system audit to gain feedback that the system is working and outcomes are being achieved; and enforces the outcome based standards. Independent audit/verification agencies: ensure that their systems and staff meet government-set standards to maintain their approval to operate; evaluate, audit, and verify food operators' approved programmes on a contractual basis to those food operators; and report to the food operator and the regulator. Food operators: design and validate a risk management programme specific to their products and processes that meet government-set standards; and contract independent audit/verification agencies to evaluate, audit, and verify their compliance with their approved programme. Government is implementing the model across the food sector. This includes harmonising systems, to the greatest extent possible, across the two government ministries responsible for administering food legislation: the Ministry of Agriculture and Forestry (MAF) and the Ministry of Health (MoH). The model is also being implemented across food producers, through legislative and administrative changes. RISK MANAGEMENT FRAMEWORK New Zealand has been moving to a risk management approach to food regulation for a number of years. In June 2000, MAF and MoH jointly published a generic risk management framework for the food sector. Both Ministries are now working to implement this framework (the publication is available on the MAF and MoH websites). The framework allows the regulatory oversight of food safety to be broad enough to encompass all components of the food chain, and to ensure that optimal hazard controls are applied where they will be most effective in reducing risks. The generic risk management framework follows the principles of the hazard analysis and critical control point (HACCP) system, which can be summarised in four key steps: risk evaluation - establishment of a risk profile, possibly through a formal risk assessment; assessment of risk management options - systematic assessment of the likely impact of different sanitary measures on preventing, eliminating or reducing risks to human health; implementation of the risk management decision - design and implementation of sanitary measures, and establishment of performance and/or process parameters; and monitoring and review - evaluation of the effectiveness of the sanitary measures that have been implemented, using monitoring and surveillance data. Effective food safety risk management relies on appropriate risk communication and stakeholder representation at all these steps. Implementation of the framework of the administration of food safety in New Zealand allows decisions to be made that are proportionate to the health risks involved, allow innovation and flexibility in application of sanitary measures, and allow due regard to be taken of the costs as well as the benefits of the risk management options. To achieve such goals, it is recognised that interaction between government, industry, consumer groups, foreign governments, and other stakeholders needs to occur on many levels. International developments increasingly influence New Zealand's national regulatory environment and impact directly on the domestic marketplace. These include risk-based approaches taken to policy and scientific decisions in the context of the World Trade Organisation's SPS Agreement (Agreement on the Application of Sanitary and Phytosanitary Measures) and the Codex Alimentarius Commission. Similarly, bilateral and multilateral agreements on the equivalence of sanitary measures for food in international trade are increasingly reliant on the consistent and transparent risk management at the national level. This provides strong impetus for a domestic risk management framework that is harmonised with the principles and practices adopted by international organisations. LEGISLATIVE FRAMEWORK In implementing a risk management approach, New Zealand is establishing a legislative framework that accommodates the approach but also facilitates flexibility. The legislative framework has three key elements: statutes (primary law, passed by Parliament) contain the fundamental principles, regulations (secondary law, passed by the executive arm of government) contain outcomes to be achieved, and standards/specifications (tertiary law, issued by regulatory agencies) provide technical, `how to' detail (only where absolutely necessary). New Zealand's risk management approach begins on the farm. The Agricultural Compounds and Veterinary Medicines Act 1997, which commenced in July 2001, codifies a risk based legislative approach for agricultural compounds and veterinary medicines. In the animal product sector, the Animal Products Act 1999 provides for risks to be managed through the value chain, from farm through processors to consumers. The key mechanism used for this purpose is a risk management programme, which processors of animal products must have in place by the end of an agreed transition period. The programme must take into account the principles of hazard analysis and critical control point (HACCP) systems and be approved by MAF. Risk management programmes must be independently evaluated and verified. Specific market access requirements which require export certification are generally undertaken concurrently with risk management programme requirements. By way of specific example, in the New Zealand dairy sector, a review of the dairy industry legislation is underway, with the aim of updating the legislation so that it better reflects the regulatory model. In advance of that legislative change, the model was implemented as a voluntary option for operators in July 2000. Approximately 65% of registered dairy premises elected to move to the model system. Two independent agencies have been approved and are operational for evaluating dairy product safety programmes and for verifying operators' compliance with them. In the mixed food sector, MoH administers a system based on the model as a voluntary option under the Food Act. There is a transitional process in place where operators may choose to have a HACCP based food safety programme and gain exemption from complying with the prescriptive requirements of the Food Hygiene Regulations. The food safety programme is approved by MoH, and compliance with the programme is verified by independent auditors. A wide range of food businesses have adopted the system, with supermarket chains and other chain retailers leading the transition. JOINT AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE The New Zealand government views prescriptive compositional or processing requirements as generally unnecessary, preferring to allow flexibility for innovation in processes and consumer choice in composition. While food safety is regulated using a risk based approach, under the legislation described above, food composition and labelling are regulated under the joint Australia New Zealand Food Standards Code. New Zealand's participation in the development and implementation of the Food Standards Code is based on a bilateral Treaty signed between the New Zealand and Australian Federal Governments in late 1995. The Food Standards Code was substantially completed and agreed to by New Zealand national and Australian federal, state, and territory health ministers in November 2000, and came into force in both countries shortly after. The part of the Code that applies in both countries (Chapters 1 and 2) currently operates in parallel with the relevant parts of the pre-existing Australian Food Standards Code and the New Zealand Food Regulations during a two-year transition period. At the end of the transition period, the Australian Food Standards Code and the relevant parts of the New Zealand Food Regulations will be repealed, and Chapters 1 and 2 of the Code will become the single regulatory mechanism for food composition and labelling standards in both countries. SMALL AND LESS DEVELOPED BUSINESSES New Zealand participates in the work of the Codex Committee on Food Hygiene (CCFH) on assisting small and less developed businesses to design and implement HACCP based programmes. New Zealand joins with other countries who recognise that there are a variety of factors that may cause a business to be in this category. Current estimates suggest that over 96% of New Zealand enterprises would be involved. The adaptation of this most effective risk management tool to their circumstances is very important to New Zealand. The New Zealand government recognises that many small businesses have neither the expertise to develop risk management programmes for themselves, nor the resources to contract experts' services. Sectors are encouraged to pool their resources to develop codes of practice and templates that are detailed enough for individual operators to adopt, with only minor customisations. The government has taken a partnership approach with industry, assisting sectors to develop the tools they need. In New Zealand's experience, involving food operators in the development process contributes to the practicality and applicability of final templates or codes of practice and to the satisfaction and compliance by food operators with the final template or code of practice. The overall stepwise approach has been successful: operators can build upon their existing good manufacturing/hygienic practices (GMP / GHP), rather than starting over with a completely unrelated system. MEASURING PERFORMANCE: EVALUATING THE NEW ZEALAND SYSTEM New Zealand is still developing criteria by which to measure the performance of the risk based food safety regulatory system. Criteria being considered include reductions in the occurrence of food-borne illness in New Zealand and compliance with risk-based programmes. While these are useful indicators, neither of these criteria go to the core of assessing the effectiveness or otherwise of specific control measures. Addressing this issue is more complex. One mechanism currently being pursued in New Zealand is to develop risk profiles for a range of food/hazard combinations. This will then form an integral part of the risk evaluation step in the risk management process. It will also contribute to decision making on future sanitary measures that might be imposed or changed. It is intended that this will establish a scientifically justifiable, consistent and transparent approach to the management of food safety risks. New Zealand's expectation is that with the passage of time and our skill in the application of performance measurement approaches, performance measurement will become fully integrated into our regulatory system. Summary New Zealand is taking an active risk management approach to food safety regulation. The government's regulatory model clearly defines relationships among government, independent audit/verification agencies, and food operators. New Zealand's legislative framework is aimed at ensuring that food operators appropriately manage the food safety risks involved in their processes so that consumers can be assured that the food they consume is safe and fit for purpose.