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| Agenda Item 5 | CAP 04/2 |
FAO/WHO Regional Conference on Food Safety for Asia and Pacific
Seremban, Malaysia, 24-27 May 2004
Food safety legislation;
the use of science and risk-based approaches to harmonization
(Paper prepared by Australia)
2. Challenges and opportunities for harmonizing national food safety regulation
3. 'Farm to table' and performance-based approaches to food safety regulation - the role of HACCP
4. International harmonization of food safety regulations
5. Regional strategies for the harmonization of food safety regulations
Numerous challenges and opportunities exist for harmonizing food safety legislation both at the national and international level. This paper discusses key risk-based principles and processes - such as risk analysis, and the use of 'farm to table' approaches and HACCP (Hazard Analysis and Critical Control Point) process control systems - that are increasingly being elaborated to support harmonized and transparent food safety regulations. Risk communication is particularly difficult for countries and the importance of ensuring all stakeholders are involved in the regulatory process is also discussed. The importance of giving priority to public health in implementing food safety legislation, while at the same time taking into consideration socio-economic implications through regulatory impact assessments, is also discussed. Finally, challenges and opportunities facing the international harmonization of food safety legislation are considered, in particular the influence of international trade and trade agreements, and the use of Codex Alimentarius Commission (Codex) norms. International linkages, such as regional alliances, information exchange networks and technical cooperation, are touched on as means to assist international harmonization of food safety regulations and to enhance global public health and trade. Recommended approaches for the implementation of consistent national and international risk-based food safety regulatory strategies are outlined.
Food law in many countries has traditionally consisted of legal definitions of unsafe food, and the prescription of enforcement tools for removing such food from markets and penalizing responsible parties post market. Food laws generally do not, however, provide food control agencies with a clear mandate and authority to prevent food safety problems. The result is that many countries have food regulatory systems that are reactive and focus on the enforcement of legislation rather than directing and encouraging the use of preventive and holistic approaches to reducing the risk of food borne illness.
While many countries have recognised that food regulatory systems need to be under-pinned by systematic and objective food regulatory principles, with clear food safety objectives in mind, a number of countries have struggled to recognise the value of these approaches. As a consequence, food safety regulations in these countries continue to incorporate a patchwork of provisions that do not conform to science-based food safety objectives. These regulatory systems often fail to be fully effective in protecting public health, and can compromise domestic food markets and trade capacity.
Proactive approaches to food safety control and regulatory systems have been driven over recent times as a consequence of a number of factors including:
In order to assist member states consolidate and better coordinate food regulatory systems, international agencies such as the United Nations Food and Agriculture Organization (FAO), the World Health Organization (WHO)1 and Codex, have acted in the face of these (at times competing) factors by elaborating objective risk-based decision-making criteria for establishing food safety regulations that are transparent and proactive in scope. The key to these initiatives is the development and use of risk analysis principles.
Objective justification of food safety regulations is being increasingly undertaken internationally by demonstrating that the need for public health and safety measures are in balance with socio-economic considerations2. In order to achieve this balance a number of countries and international organizations are increasingly using risk analysis systems to characterize risks (both in terms of food safety and economic impacts), devise acceptable risk management options, and communicate with all relevant stakeholders in these processes.
Risk analysis consists of three inter-related components; risk assessment, risk management and risk communication. Each component is discussed in Conference Theme B - The Application of Risk Analysis in Food Control - challenges and benefits that includes how risk analysis frameworks are being elaborated by international agencies, and specific case studies undertaken by Food Standards Australia New Zealand (FSANZ).
Risk analysis has been incorporated into a structured approach by many countries in the setting of food safety regulations and been elaborated by the Codex as the basis of many of its norms. Codex is a joint body of the FAO and WHO that is charged with developing international food norms (such as standards, guidelines and codes of practice) to enhance global public health and assist in the harmonization of standards to facilitate international trade. Codex has recognised the importance of adopting risk-based principles by introducing Working Principles for Risk Analysis into the Codex Procedural Manual3 by which all Codex committees operate.
Whilst the basic principles and benefits of risk analysis are widely recognised and increasingly applied internationally, variation remains in the manner in which different countries apply it and the degree to which it is formalized within domestic regulatory processes.
Key issues of contention include the manner in which scientific uncertainty (where scientific evidence is insufficient) is factored into risk analysis; equivalence criteria (where risk-analyses performed on similar products by differing agencies or different countries result in dissimilar risk management approaches); and the manner and extent to which `other legitimate' factors are taken into consideration in establishing food safety regulations. These issues are currently the subjects of ongoing international debate.
To assist governments of the region institute effective and transparent risk analysis frameworks that are in line with Codex and international trade agreements, FAO and WHO, in collaboration with the International Life Sciences Institute (ILSI) and the Industry Council for Development (ICD), are developing a range of tools including a risk analysis manual4 and providing regional workshops on risk analysis.
Risk assessment is the primary step of risk analysis and is based on (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterizations (see Theme B paper).
While not all countries have sufficient scientific resources, capabilities, or data to carry out risk assessments, it may not be necessary in all cases to have integrated systems for this purpose. Greater resources for risk assessments are being applied at the national, regional and international level and governments should take advantage of these assessments when developing domestic regulations. For example, risk assessments developed by joint FAO/WHO expert committees such as the Joint Expert Committee on Food Additives and Contaminants (JECFA), the Joint Expert Meeting of Pesticide Residues (JMPR) and the Joint Expert Meetings on Microbial Risk Assessments (JEMRA) are applicable internationally.
FAO have recently reviewed data on food borne illness across a number of developing countries and evaluated the use of such data in assisting risk assessments and in determining risk management options (including means to assess the economic impact of such decisions)5. Related issues are discussed in Conference Theme E - Food borne disease monitoring and surveillance systems.
Risk management is a distinct step from risk assessment and consists of weighing identified regulatory alternatives in consultation with all interested stakeholders. This includes considering the outcomes of risk assessments and other relevant factors such as cost effectiveness, including the impact on industry and enforcement agencies, and the types of potential regulatory intervention (e.g. code of practice versus a mandatory standard).
In general terms, risk management should be established through a transparent national food policy involving formal procedures of stakeholder consultation. Establishment of the acceptable risk level is an inherently political decision considering a broad variety of public health, socio-economic and environmental factors. However, in reaching these decisions, governments need to consider whether the desired level of protection is no more trade restrictive than necessary to comply with obligations under international agreements. Greater balance in risk management is being attained in many countries by the adoption of transparent regulatory impact assessments (RIA). The RIA is a method of systematically and consistently examining and consulting on the potential impacts arising from government decisions, and communicating the outcomes to decision-makers. Food RIAs attempt to develop and assess different regulatory options in order to balance competing public health and socio-economic interests.
A number of national legislative models exist in the development of transparent risk management and RIA frameworks for food safety. For example, FSANZ has incorporated risk management transparency and RIA requirements established by the Council of Australian Governments in its development of standards (see FSANZ Guide to Applications and Proposals6). The Organization for Economic Co-operation and Development (OECD) has also established a guide to regulatory impact analysis in the Recommendation of the Council of the OECD on Improving the Quality of Government Regulation7.
An example of the use of a food regulatory RIA is one conducted in 1999 for the introduction of mandatory food safety programmes in Australia by the then Australia New Zealand Food Authority (now Food Standards Australia New Zealand). RIAs are required in Australia (and many other countries) under federal obligations for all proposed regulations. Four safety standards were adopted in Australia: three mandatory standards that variously defined food safety, acceptable food safety practices, and food premises and equipment. A fourth voluntary standard recommends that food businesses develop certifiable food safety programmes where hazards are identified in food handling operations (note this voluntary standard is being implemented as a mandatory standard in some Australian states).
The cost benefit study predicted that ongoing cost for businesses for implementing these safety standards would be approximately A$1,000 per business; 35% lower than for pre-existing regulations that incorporated a patchwork of legislation. Indirect benefits included that the new standards allowed for greater industry flexibility in food safety control systems and innovation in food production. Costs to government of implementing administrative and auditing systems to enforce the new standards were determined to be almost 50% higher (approximately A$48m) with local governments bearing much of this cost. The study inferred that a 20% reduction in food borne illness would result from the adoption of the standards that was equated to a saving of A$500m in productivity and health costs.
On this basis, Australian governments determined that the food safety standards represent a tangible means of achieving highly significant savings that would benefit the entire Australian community and adopted the majority of the standards into the Food Standards Code. The effectiveness of the standards is to be assessed ten years. Note these food safety standards were not included in New Zealand due to different policy approaches to food safety regulations and perceived equivalence in the effectiveness of existing national food safety measures in New Zealand.
Effective communication of information and opinion on risks associated with real or perceived hazards in food is an essential and integral component of risk analysis, whether it is related to immediate food safety crises or as a component of food legislation development.
Risk communication makes stakeholders aware of the process at each stage of risk assessment. This helps to ensure that the logic, outcomes, significance, and limitations of the analysis are clearly understood by all the stakeholders. Information pertinent to the assessment may be available from many stakeholders. Industry stakeholders may, for example, have unpublished data crucial to the risk assessment that may influence risk management options and decisions. To the extent that it is practical and reasonable, interested parties should be involved in identifying management options, developing the criteria for selecting those options and providing input to the implementation and evaluation strategy.
Risk communication may originate from official sources at international, national or local levels. It may also be from other sources such as industry, trade, consumers and other interested parties.
When a final risk management decision has been reached, it is important that the basis for the decision be clearly communicated to all interested parties. Effective risk communication should have goals that build and maintain trust and confidence. It should facilitate a high degree of consensus and support by all interested parties for the risk management option(s) being proposed.
The report of a joint FAO/WHO Expert Consultation - The Application of Risk Communication to Food Standards and Safety Matters8 elaborates principles and guidelines for risk communication that should be used by all governments to underpin transparency and inclusiveness in food regulatory matters.
The scope of food safety regulation has expanded in recent years to the entire food supply chain - from primary production through to consumption. This `farm to table' approach aims to identify the multiple points along the food supply chain that can compromise food safety, and the coordinated interventions required to assure food safety. This approach to food safety arises from a desire to prevent risks rather than detecting them in the final product and places a particular emphasis on on-farm management and production practices.
A progressive evolution of food legislation has also occurred in many countries away from detailed specification or product standards toward horizontal outcome-based performance standards. Performance-based standards specify what food safety objective has to be achieved rather than defining how it is to be achieved, and are becoming prevalent in countries where common elements exist in the focus and nature of food safety and regulatory systems.
Performance standards depend on food producers maintaining process controls that demonstrate, through verifiable documentation, that a food safety objective is being met. Performance standards thus allow suppliers to take greater responsibility for producing safe food, providing flexibility for processing innovation. However, for high-risk foods, precise and specific product and processing regulations may still be applied.
Performance standards allow producers to be proactive in adopting voluntary food safety controls including codes of good hygienic practice and process-control systems such as HACCP (Hazard Analysis and Critical Control Point). HACCP-based food safety standards adhere to science-based food safety assessment and management principles within a defined risk analysis framework and can be applied at various levels across the food chain.
Performance- based standards and HACCP systems are being increasingly adopted in a number of countries for high-risk food products. For example, Australian food standards require HACCP systems to be applied to the production of minced fermented meat products. New Zealand dairy regulations require the application of HACCP in the manufacture of milk and dairy products. Mandatory food safety programmes employing HACCP principles are being introduced to other high-risk food businesses in Australia over the next few years. Similar generic provisions for the application of HACCP in food production are in place in the EU and are mandated in the United States for seafood, meat, poultry, and fruit juice.
As the introduction of HACCP-based systems may be difficult in small and medium-sized food businesses with limited capacity and knowledge, its implementation is best achieved by collaboration within the food industry, and by the involvement of training and regulatory agencies at the national and international level (see below).
Another outcome of the commercial and regulatory introduction of HACCP is that developing countries wishing to trade in developed markets have increasingly needed to adopt HACCP systems. For example, in Malaysia, the Ministry of Health operates a voluntary HACCP certification programme in response to the EU requirements for HACCP in fish processing plants. Over 40 food processing plants were certified under the programme at the end of 2001 and, as a consequence, a key priority of food hygiene regulations will be the implementation of Codex-based HACCP systems in other export-oriented sectors.
The growing use of HACCP as a science-based industry and regulatory food safety system has also influenced Codex to adopt and develop guidelines for HACCP9. Codex is in the process of incorporating HACCP into codes of hygienic practice under development in the Codex Committee for Food Hygiene. HACCP systems are thus becoming benchmarks for international food safety standards and trade and should be made the mainstay of all national food safety regulations.
Various international agencies have developed tools and programmes to assist the adoption and integration of HACCP process controls into food production. This includes FAO/WHO HACCP Principles; a Practical Teacher's Handbook10. FAO has also instituted training projects targeting food processing plants in various countries11 that need to upgrade their technical skills to improve the quality of their products and meet the requirements for export. The United Nations Industrial Development Organization (UNIDO) has also instituted a number of HACCP-based capacity building efforts in a variety of developing countries12.
International trade in bulk foods commodities and processed foods has undergone a significant expansion over recent decades, driven by the demands of rising populations and expanding income growth in most countries and increased export opportunities.
The expansion in global food trade has brought into sharp focus differences in the food safety control systems (both private and public) and regulatory approaches adopted by various countries. The diverse emphases and efforts various countries have on food safety are highlighted in international fora. Moreover, these differences can influence international disputes that can impede food trade. Differences in food safety legislation occur even between nations that have established scientific risk-based frameworks for national food safety standards.
The diversity in food safety regulations between countries has a number of origins including:
Countries can, and do, align food safety regulations either through bilateral or multilateral agreements in order to facilitate trade. Bilateral agreements are generally developed between major trading partners in order to facilitate trade. For example, Australia and New Zealand decided in 1996 to work towards unilaterally harmonizing many food standards in order to reduce regulatory trade barriers and industry costs. In 1998, the United States and Canada signed an agreement under which agricultural trade in many sectors would be facilitated - including the harmonization of certain food safety standards.
The most comprehensive multilateral agreement that aims to minimize the impact on trade of inconsistent and occasionally incompatible food, health and environmental regulatory measures is the Sanitary and Phytosanitary (SPS) Agreement of the WTO. Standards set by other international organizations, such as the World Organization for Animal Health (OIE) and the International Plant Protection Convention (IPPC) also attempt to harmonize regulations in the animal and plant sector, respectively. While not directed at food safety regulations, the Technical Barrier to Trade Agreement (TBT) of the WTO also requires that technical regulations on traditional quality factors, fraudulent practices, packaging, labelling etc. imposed by countries should not be more restrictive on imported products than they are on domestically produced products. The TBT Agreement also encourages the adoption of international standards.
The SPS Agreement confirms the right of WTO member countries to apply measures to protect human, animal and plant life and health. The Agreement covers all relevant laws, decrees, regulations; testing, inspection, certification and approval procedures; and packaging and labelling requirements directly related to food safety. Member states are asked to apply only measures that are based on scientific principles - principally risk assessment and only to the extent necessary according to their determined appropriate level of protection, and not in a manner that may constitute a disguised restriction on international trade.
Justification of food safety regulations under the SPS Agreement can be achieved in different ways. Principally:
The SPS Agreement presumes Codex norms (including those related to food additives, veterinary drugs and pesticide residues, contaminants, methods of analysis and sampling, and codes and guidelines of hygienic practices) are consistent with provisions of SPS. Thus, Codex standards serve as a benchmark for comparison of national sanitary measures. While it is not compulsory for member states to apply Codex standards, it is in their best interests under the SPS Agreement to harmonize national food standards with those elaborated by Codex.
The justification of food regulatory measures can also be established under the SPS Agreement through a risk analysis of the regulatory measure as described previously and in Conference Theme B.
Food safety norms developed by Codex provide a basis for food safety harmonization because they reflect sound, contemporary, internationally recognised science and, increasingly, the application of risk analysis.
They also reflect a broad international consensus on the methodology for developing food safety standards on the basis of scientific data and other technical information (e.g. how to take account of differences in dietary patterns between countries). Moreover, Codex standards are developed through a consensus-seeking process and in almost every case are adopted by consensus.
Although comprehensive data are not available, it is known that Codex norms have been widely adopted by many countries as the basis for their food standards. For example, in 2001 the Codex Coordinating Committee for Africa noted that a number of member states of the Economic Community of West African States (ECOWAS) free trade zone decided to adopt Codex standards in order to harmonize regional food standards.
As Codex norms are increasingly referenced or adopted, it is important that they are technically sound and fully address contemporary food safety risks using consistent risk based principles. Codex norms need also to be credible to industry and consumers and trading partners and applicable to both developed and developing countries.
It is often the case that importing and exporting countries operate different food inspection and certification systems. The reasons for such differences include different prevalence of particular food safety hazards, differing national choice in the management of food safety risks, and differences in the historical development of food control systems.
In such circumstances, and in order to facilitate trade while protecting public health, exporting and an importing country may work together to consider the effectiveness of sanitary measures of the exporting country to meet the appropriate level of sanitary protection of the importing country. Application of the principle of equivalence has mutual benefits for both exporting and importing countries. While protecting the health of consumers, it serves to facilitate trade and minimize the costs of regulation to governments, industry, producers, and consumers by allowing the exporting country to employ the most convenient means in its circumstances to achieve the appropriate level of protection of the importing country. Importing countries may be able to reduce the frequency and extent of verification measures following a judgment of equivalence of measures applied in the exporting country.
Codex has also developed practical guidance for governments desiring to enter into bilateral or multilateral equivalence agreements.14
The SPS Agreement encourages the provision of technical assistance to member states, especially developing countries, through either bilateral agreements or through international organizations (e.g. the FAO/WHO Trust Fund for Participation in Codex that provides funds to enhance developing nation attendance and engagement in Codex standard setting). These SPS Articles referring to capacity building have had only limited impact in fostering the regulatory capacity of developing countries due to limitations in funding or lack of recognition of these rights by developing countries. Substantial coordinated investment among developed country members and appropriate international organizations, international banks and non-government organization/industry partners will be needed if the real food safety regulatory challenges faced by developing countries are to be addressed.
The Standards and Trade Development Facility (STDF) is one example of a partnership that aims to strengthen donor coordination in standard setting related to food safety, the SPS Agreement, and plant and animal health in developing countries. The STDF is a joint initiative of the World Bank, FAO, OIE, WHO, and WTO which operates by (a) provision of small grants for pilot projects that build capacity in standards setting and development in developing countries, (b) assistance to government and private sector in meeting international standards, such as those referenced in the WTO Agreements, and (c) strengthened inter-agency coordination and donor collaboration in the delivery of technical assistance in standards. The STDF will also implement a database of capacity building projects in the areas of food safety, plant, and animal health conducted by all the agencies involved in the STDF, which will allow for increased coordination of capacity building efforts.
The success of the SPS Agreement in accomplishing both enhanced international trade and food safety will ultimately be determined by the degree to which all countries are able to institute comprehensive and effective food control systems. As Codex and domestic regulatory standards will influence each other, it is likely that food safety standards will become increasingly harmonized especially in terms of criteria used to develop standards and systems introduced to ensure their effectiveness.
Many countries, especially the least developed, have neither the capacity nor the resources to fully address the challenges or take opportunities arising from the introduction of risk-based food safety legislation. Strengthening and building food safety regulatory systems in these countries will improve food security and public health, and lead to improved international trade opportunities.
Capacity building should be tackled on a regional basis. Whenever needs common to countries in a particular region can be identified, governments of the region should collaborate to exchange information and share technical assistance resources to meet these needs.
These issues are more fully explored in Conference Theme C - Prioritization and co-ordination of capacity building activities.
FAO, WHO and Codex15 have identified capacity building to enhance national food safety regulatory systems, and regional alliances, as key food safety priorities. These were key themes at the FAO/WHO Global Forum of Food Safety Regulators16 in 2002. A second Global Forum will be held in Bangkok, Thailand, from 12 to 14 October 2004, with the theme Building Effective Food Safety Systems. Two main areas for discussion will be:
International organizations such as FAO and WHO are well positioned to take leadership in building alliances, establishing frameworks for exchange of information, and coordinating capacity building activities related to food safety. Such coordination avoids duplication and overlap of work, allows proper sequencing of technical assistance to specific countries, captures lessons learned from related countries, and enhances ownership. It also provides a system for transparent and regular review and evaluation of capacity building initiatives in order to ensure they are successful and sustainable.
One of the first steps in building alliances is the establishment of clear and integrated communication between regional government agencies to provide regular exchange of information related to food safety activities. These issues are more fully explored in Conference Theme D - Information exchange, education and communication.
To facilitate information exchange on food legislation, FAO, along with the SPS- standard setting organizations and WTO have developed an International Portal on Food Safety, Animal and Plant Health17 to provide a single access point to international standards, notifications, and related texts, and national legislations and regulations. This portal will also be launched during this Conference.
Examples of regional communication networks include the Association of South East Asian Nations (ASEAN) nations who have shown their commitment to better coordinate food safety efforts through the ASEAN Food Safety Network. A key plank of the South-East Asian region of the WHO (WHO/SEARO) food safety strategy also includes the need for governments of the region to ensure food safety legislation is regularly revised and evaluated, especially in the light of Codex standards.
Another aspect fundamental to national and international food regulatory harmonization efforts is the need to assess the capability and constraints of individual food control systems through a country needs assessment (see also Conference Theme C discussion).
The needs assessment process is assisted by development of a country profile that includes a review of existing legislation and regulations, food inspection activities, laboratory capacities, public health concerns, priorities for export access, etc. The purpose of the country profile is to provide an overall appreciation of the needs for capacity building and technical cooperation including technical assistance and human and institutional capacity building, both in the immediate and longer term.
The result of the needs assessment provides useful information to design a coherent and integrated approach for internal actions and external assistance to meet the specific needs of individual countries. The assistance provided should be coordinated by the international agencies and other parties involved, taking into consideration the agencies' respective mandates, resources and expertise.
Regional needs assessments are being addressed, for example, by the Western Pacific Regional Office of the WHO (WPRO) that has been active in implementing a strategy18 through the WHO Pacific Food Safety Initiative to enhance food safety- related information sharing amongst Pacific Island countries. This includes an online database of country-specific information about food importation and food legislation.
FSANZ has also been active in conjunction with WPRO and other international agencies in assisting countries in South-East Asia, including Vietnam, Indonesia and South Pacific countries to review food legislative structures to facilitate the introduction of transparent risk- based food safety regulations that are aligned with international trade requirements (see Theme B paper).
1 See Joint FAO/WHO Publication Assuring Food Safety and Quality: Guidelines for strengthening national food control systems. http://www.fao.org/DOCREP/006/Y8705E/Y8705E00.HTM
2 Food safety regulation: an overview of contemporary issues. S. Henson and J. Caswell. Food Policy 24: 589-603. 1999
3 www.codexalimentarius.net/procedural_manual.stm
4 http://www.fao.org/es/ESN/food/capacity_tools_ramanual_en.stm
5 The Economics of Food Safety in Developing Countries. S. Henson. FAO. ESA Working Paper 03-19. 2003
6 http://www.foodstandards.gov.au/_srcfiles/revised_Guide_Props_Appls_July02.pdf
7 http://193.51.65.78/puma/regref/pubs/rco95/foreword.htm
8 http://www.fao.org/DOCREP/005/X1271E/X1271E00.htm#TOC
9 Recommended International Code of Practice - General Principles of Food Hygiene. Codex 1999.
10 http://www.who.int/foodsafety/publications/fs_management/haccp_teachers/en/
11 http://www.fao.org/es/ESN/food/capacity_projects_africa_en.stm
12 http://www.enyox.com/dev/unido-tcb/index.php?cccpage=projects_list&set_z_sidenav=0
13 Guidelines on the judgment of equivalence of sanitary measures associated with food inspection and certification systems ALINORM 03/30A, Appendix II, adopted by the 26th Session of the Codex Alimentarius Commission, July 2003.
14 Guidelines for the development of equivalence agreements regarding food import and export inspection and certification systems (CAC/GL 34-1999)
15 http://www.fao.org/DOCREP/MEETING/006/y9805e.htm
16 http://www.foodsafetyforum.org/
17 IPFSAPH Concept paper, (INF/6, 26th Session of CAC, July, 2003) : http://www.fao.org/docrep/pdf/meeting/006/y9489e.pdf