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| Agenda Item 6 | CAP 04/3 |
FAO/WHO Regional Conference on Food Safety for Asia and Pacific
Seremban, Malaysia, 24-27 May 2004
The application of risk analysis in food control -
challenges and benefits
(Prepared by Food Standards Australia New Zealand, Canberra, Australia)
4a. Practical actions which have been taken by Australia
As its name states, Food Standards Australia New Zealand (FSANZ) sets food standards for both Australia and New Zealand. However, in this paper, the role of FSANZ is confined to the Australian context only. As part of the food regulatory system in Australia, FSANZ applies risk analysis to underpin its decision-making process. FSANZ has developed a scientifically rigorous and transparent process for setting food standards and is happy to be sharing its experience with colleagues in this Conference.
Risk analysis is used to develop an estimate of the risks to human health and safety, to identify and implement appropriate measures to control the risks, and to communicate the risks and measures applied to stakeholders. In order to operate effectively, the various activities associated with risk analysis must also be supported by an infrastructure, including legislation, testing laboratories, enforcement systems, coordination between jurisdictions and clear lines of responsibilities. Further information on FSANZ's activities may be obtained from FSANZ's website1.
In this paper the general framework of risk analysis and Australia's experience in its application in order to maintain and enhance the safety of the food supply are presented. The paper focuses on the challenges and benefits in applying risk analysis and uses specific case studies to illustrate key points.
There is now wide international agreement on the framework for Risk Analysis as it is applied in the regulatory context of food and human health and safety in order to facilitate a risk and evidence based approach to decision making2. The framework has three major components: risk assessment, risk management; and risk communication. In developing food standards within this framework, the primary consideration is the impact on human health and safety. However, when developing risk management options there are often a number of other considerations, such as economic impact and feasibility of implementation, that are taken into account in order to select the most appropriate option.
Risk Assessment: The objective of risk assessment is to determine the degree of risk associated with the food under consideration by answering three questions: What can go wrong (scenario)? How likely is that to happen (likelihood)? If it happens, what are the consequences (magnitude)? The process of risk assessment can be divided into four distinct steps - hazard identification, hazard characterization, exposure assessment and risk characterization. The integrated information from these steps provides an estimate of the health and safety risk based on the likelihood of the occurrence of an adverse event and the magnitude of the consequences.
Risk Management: The objective of this stage is to establish if and what food regulatory measures are required to mitigate the risk to a level that is acceptable to the community. Risk management options are developed and assessed for their effectiveness in dealing with the health and safety risks while considering the impact of each option on relevant stakeholders such as primary producers, food manufacturers, retailers, consumers, and government.
Risk Communication: Risk communication, including community consultation, is an essential element in the risk analysis process. It is useful to have risk communication activities at various stages of the process to allow appropriate involvement of stakeholders. Effective risk communication benefits all participants by ensuring a rigorous and transparent risk analysis process, adequately informed stakeholders and a high level of community confidence in the regulatory system.
Below is a graphical representation of the risk analysis framework.
Figure 1. The Risk Analysis Framework consisting of the three elements of risk assessment, risk management and risk communication.
The application of risk analysis to the development of food regulation is a key element in ensuring that a country fulfils its rights and obligations under the World Trade Organization (WTO) trade agreements. In the context of this paper, the WTO agreement of most relevance to food regulation is the Agreement on the Application of Sanitary and Phytosanitary Measures3 (the SPS Agreement). The SPS Agreement requires that regulatory measures adopted by a member country must be based on scientific principles and not maintained without sufficient scientific evidence. Member countries are required to base their measures on an assessment of the risks to human life and health. Risk assessments performed at the national level should take into account risk assessment methodologies developed by the relevant international organizations and be appropriate to the circumstances. In the case of food safety, the relevant international standards setting body is the Codex Alimentarius Commission (CAC). The CAC and its various committees and other bodies are generically referred to as 'Codex'.
Codex standards are the benchmarks against which national food measures and regulations are evaluated. Member countries can introduce measures which achieve a higher level of protection than that achieved by a Codex standard, but only if there is a scientific justification, or as a consequence of setting a higher appropriate level of protection (ALOP). In determining ALOP, countries must take into account the objective of minimizing negative trade effects.
There are a number of principles that underpin the SPS agreement that are of importance, including:
The risk analysis framework provides for the evaluation of existing knowledge around food borne hazards or potential hazards, and assists in determining the best ways of managing those hazards in order to mitigate the risk of disease or other adverse health effects. Risk analysis also takes into account the need to communicate with affected parties and interested stakeholders such as potential consumers, other risk assessors, public heath professionals, and other government agencies. In other words - undertaking risk analysis entails a process of:
Codex has defined the three components of risk analysis and in mid 2003 Codex finalized and adopted its Working Principles for Risk Analysis by incorporating it into the Codex Procedural Manual4 These principles provide an approach and guidance in developing Codex standards and related texts, based on risk analysis. Codex is currently working to develop a guidance document on risk analysis for use by member governments (Proposed Draft Working Principles for Risk Analysis for Food Safety), which was discussed at the May 2004 meeting of the Codex Committee on General Principles.
The working principles state that risk analysis used in Codex should be:
Further principles are elaborated to the effect that the risk analysis should be structured around its three components and there should be a functional separation of risk assessment and risk management in order to avoid any confusion regarding functions, to avoid conflicts of interest, and to ensure the scientific integrity of the risk assessment.
Finally, because of the many uncertainties that may exist in the process of risk assessment and risk management, any risk management options that are selected should take account of the level of certainty and the characteristics of the hazard.
Australia has fully integrated the principles and processes of risk analysis into its food regulatory system. Risk analysis is applied both in the development of food standards, as well as to address food emergencies that result from emerging hazards or breakdowns in control systems.
In Australia, FSANZ operates as the risk assessor on food safety issues. Within Ministerial guidance and subject to ultimate Ministerial responsibility, it also operates as the risk manager, particularly in food safety emergency situations, such as the examples outlined below. Finally, as the food regulator, FSANZ undertakes most, although not all, of the risk communication. Depending on the issue, colleagues in health and agriculture may also have a role in this area.
It is also recognised that the depth and breadth of the risk analysis will be proportionate to the urgency and complexity of the issues to be addressed. In normal circumstances it is usually possible to allocate sufficient time to perform all the risk analysis steps comprehensively. However, in an emergency situation it may be necessary to make a decision within a short period of time. In such circumstances, it is important that the risk analysis framework is preserved as much as possible to ensure that decisions are based on rational considerations. Provisional risk management measures that may be applied in an emergency situation must be revised within a reasonable time as new information becomes available.
In the Australian context, risk analysis is applied to the full range of hazards that may be associated with food and impact on human health. These include chemical hazards, infectious agents (such as microbial hazards and prions), nutrients (both in terms of deficiencies and excesses), and whole foods (such as genetically modified, irradiated and other novel foods).
The risk assessment methodology applied to each type of hazard may vary depending on the available methodology and information. For example, a fully quantitative methodology is generally used with chemical hazards while a qualitative or semi-quantitative approach is used to address microbiological hazards. Risk management measures may take the form of food standards, including prohibitions, restrictions, maximum limits on contamination and/or labelling requirements. Other risk management measures may include advice to specific at- risk populations, co-regulatory measures with industry such as guidelines and codes of practice and general advice to the community.
Over the past several years, Australia has taken significant steps to increase the effectiveness of its risk communication activities. For many years, Australia has made public its rationale underpinning decisions on food regulatory measures and the documentation is now available electronically. In addition, Australia develops information about regulatory measures that aim to be easy to understand and actively communicated in a broad range of community, industry and professional events.
There are a number of challenges and benefits in the application of risk analysis at the national level. Some of these are listed below:
Four case studies are discussed below, based on Australian experiences, to illustrate the application of risk analysis principles in the context of food safety issues.
In recent years there has been increasing scientific interest in a class of chemicals known as chloropropanols. The major chloropropanols are 3-chloro-1,2-propanediol (3-MCPD) and 1,3-dichloro-2-propanol (1,3-DCP), both of which can be found in a number of foods. Whilst it has been known for several years that chloropropanols can occur in soy and oyster sauces made from hydrolyzing vegetable proteins, a UK survey of soy and oyster sauces released in 2001 indicated the presence of high levels of 3-MCPD in some products.
Subsequently, FSANZ initiated its own food safety risk assessment and an analytical survey of soy and oyster sauces available at Australian retail outlets to ascertain the level of risk from chloropropanols in the Australian food supply.
Initially the dietary exposure assessment component of this national risk assessment utilized the frequency and levels of contamination in samples from the UK survey, together with Australian food consumption data. However, as Australian test data became available, these were used in the dietary exposure assessment. The hazard identification and characterization components of the Australian risk assessment relied heavily on the work of the 57th meeting of the JECFA5 held in 2001.
The national risk assessment concluded that the higher levels of chloropropanols in soy and oyster sauces posed an unacceptable food safety risk to consumers. Risk management decisions were taken in three areas:
Throughout the consideration of this issue, there was close communication between agencies and the relevant industry bodies. As soon as it was identified that certain products posed an unacceptable food safety risk, consumers were alerted by internet notices and newspaper advertisements and the affected individual products were recalled. Subsequently the full Australian risk assessment (Chloropropanols in food - an analysis of public health risks-technical series report number 15) has been published on the FSANZ website.6
The formation of chloropropanols in food is still not fully understood, and Australian government agencies continue to liaise with relevant industry sectors to determine the source of chloropropanols in food, as well as monitoring the international literature. Initially there was very little data on chloropropanols in the Australian food supply and the data could be collected only after a testing capability was established. In the interim, Australia was able to draw on the work of the international expert bodies and other regulators to facilitate risk management decisions.
Nitrofurans are synthetic broad-spectrum antimicrobial agents used in some countries in human and veterinary medicine. There are four main nitrofuran chemicals referred to in the scientific literature, namely, furazolidone, furaltadone, nitrofurantoine and nitrofurazone.
In 1993, JECFA withdrew the health standard (ie. acceptable daily intake) for these nitrofurans due to the incomplete nature of the toxicological database and concerns about carcinogenicity in animal studies. As a result, many countries, including Australia, subsequently restricted, or prohibited, the use of nitrofurans in food-producing animals and subsequently, detectable residues in food products were not permitted.
In October 2003, data became available indicating that very low levels of a furazolidone metabolite, 3-amino-oxazolidinone, had been found in certain imported prawns. Where residues had been detected, they were only at a few parts per billion (ug/kg). However, in the absence of a specific maximum residue level (MRL) in the Food Standards Code, these residues were not permitted.
As a result of these test findings, FSANZ undertook a risk assessment to establish the level of food safety risk to consumers from the levels of residue being detected in prawns. The risk assessment was undertaken to help inform enforcement agencies as to whether any risk managements actions should be taken to protect consumer health, such as testing of prawns and/or recalls of batches of prawns containing detectable residues. The dietary exposure assessment component of the risk assessment utilized the residue concentrations found in an industry survey, and the hazard identification and characterization was based on a re-evaluation of the data summarized in the JECFA monographs.
The risk assessment indicated that the risk arising from these trace residues in prawns was very low and that the prawns were safe to eat. It was not considered necessary to recall prawns that had entered into distribution within Australia. However, given that these residues were not compliant with the Food Standards Code, the enforcement authorities were advised to introduce import testing of prawns for nitrofurans. A relatively low frequency of testing has been implemented, commensurate with the level of food safety risk to the consumer.
The issue of nitrofuran residues in imported prawns has received considerable media attention within Australia and FSANZ and other government agencies have stressed that these prawns are safe to eat. However, the paucity of toxicological data and the absence of an acceptable daily intake posed a particular challenge to the risk assessment. These residues had been detected in other countries but Australia was unable to confirm their presence until a testing methodology was established. This also made the communication of the level of risk to the community more difficult, particularly in the light of sensational media reporting. FSANZ plans to publish its risk assessment on its website.
Listeria monocytogenes in certain food categories poses a potential public health and safety problem, especially for vulnerable sub-populations such as pregnant women, the immunocompromised and the elderly. While the incidence of systemic infection caused by L. monocytogenes in food is low, the consequences can be severe and include death. In 2002, FSANZ performed a microbiological risk assessment to estimate the public health risk posed to Australian and New Zealand consumers from the consumption of cooked crustacea contaminated with L. monocytogenes.
The risk assessment utilized data derived from a survey of L. monocytogenes in cooked prawns undertaken by FSANZ in 20027, and from public health information on the frequency of Listeriosis. This survey was undertaken because of a lack of national information on the level of Listeria contamination of this food in Australia. Probabilistic modelling undertaken as part of the risk assessment estimated that, if there was no growth of the organism during domestic storage, one case of listeriosis every 1,600 years may arise from the consumption of contaminated crustacea in Australia. Modelling of a worst-case scenario, which assumed that cooked prawns would be stored in a domestic refrigerator for a maximum of three days after purchase (allowing growth of L. monocytogenes), indicated that there could be one case of listeriosis caused by cooked crustacea every 2.5 years in Australia.
The risk assessment concluded that the risk of contracting Listeriosis from this commodity is very low. This was based on:
As a result of the risk assessment, the low risk to the general population posed by L. monocytogenes in cooked crustacea did not warrant a microbiological limit. However, it was recognized that the risk may be higher for certain subpopulations and that alternate risk management measure were needed.
Additional advice for susceptible populations (in the form of an advisory fact sheet) was considered the most appropriate risk management strategy. FSANZ has previously developed such advisory material and is currently revising its fact sheet for persons at risk.
A copy of the full microbiological risk assessment is available from FSANZ website9.
How to firstly ensure that foods derived from genetically modified (GM) crops and other GM organisms could be demonstrated to be as safe as their conventional counterparts, and secondly, to ensure that consumers have information about the food they purchase through appropriate labelling.
In Australia food produced using gene technology is subject to a scientific safety assessment before it may enter the food supply. The mandatory pre-market approval process applies to all GM foods whether grown domestically, or in other countries. There are similar procedures for the assessment of GM foods in other countries such as Canada, Japan, the United States, the United Kingdom and other parts of Europe. In addition, the FSANZ safety assessment process for GM foods is consistent with the approach developed by the Codex Alimentarius Commission.
FSANZ undertakes the safety assessment of GM food according to five key principles:
The risk analysis framework established for the regulation of GM foods in Australia and New Zealand is arguably one of the most scientifically robust, consultative and transparent in the world today. Valuable experience gained by FSANZ is being used to improve the regulatory system for GM plant-derived foods and assist the development of guidelines for the future regulation GM foods derived from microorganisms, animals and fish, and foods produced using novel production techniques or containing novel ingredients.
Each country will meet the challenges of food regulation in its own way and which suit its particular circumstances. Some examples of how Australia has contributed to an international and regional response are given below.
International contributions to risk analysis activities
With the expertise FSANZ has in food regulation and in the application of risk analysis to address food safety issues, it regularly contributes to regional and global dialogue on food safety issues and specifically risk analysis. FSANZ contributes to the international dialogue on food safety issues through Codex meetings, expert panels, and at international consultations in the World Health Organisation (WHO). For example, FSANZ contributes to the work of joint FAO/WHO Expert Committee on Food Additives (JECFA), Joint FAO/WHO Meetings on Pesticide Residues (JMPR) and the joint FAO/WHO Meetings on Microbiological Risk Assessment (JEMRA), and provides expert advice and data to FAO/WHO expert consultation meetings.
Capacity building in risk analysis
FSANZ is also involved in technical assistance programmes with neighbouring regional countries. Technical assistance is usually provided via collaborative projects with support from agencies such as AusAID, APEC, FAO, WHO, the Organization for Economic Co-operation and Development (OECD), and MFAT (the New Zealand Ministry of Foreign Affairs and Trade). These programmes seek to:
The form of international capacity building is varied and includes the following:
Examples of the types of programms undertaken in recent years include:
Activity |
Country |
Collaborating Agency |
Food recall programme |
Fiji |
WHO |
Training workshop on safety and risk assessment of agriculture-related GMOs |
ASEAN countries |
ASEAN/ILSI |
Food recall programme |
Vanuatu |
WHO |
User guide for food labelling and compositional standards |
Indonesia |
AusAID |
Risk assessment training (2 programmes: chemical and microbiological risk assessment) |
12 regional economies |
APEC/AusAID |
Food safety training programme development |
Viet Nam |
WHO |
Development of food legislation |
Viet Nam |
WHO |
Safety assessment of genetically modified food |
Regional economies |
APEC |
In the last six months, FSANZ has undertaken a major review of its contribution to capacity building in the region. It has restructured its offerings and now offers a comprehensive training programme. Details can be found on the FSANZ website.
Developing Strategic Alliances
In order to improve food safety generally, FSANZ has sought the creation of linkages and alliances with regional and international organizations. Such alliances have enhanced the capacity of FSANZ to access external funding in order to be able to deliver technical assistance projects. Alliances have been developed with:
(a) World Health Organization (WHO) Western Pacific Regional Office
There has been very significant activity with WHO's Western Pacific Regional Office. A major focus for FSANZ has been its training activity in Vietnam. In addition to its interest in this particular activity, WHO WPRO has indicated that it wishes to discuss collaboration in delivering the FSANZ- developed training programmes on risk assessment and standards development to other countries in the Asia Pacific region, in particular in the South Pacific.
(b) International Life Sciences Institute (ILSI)
FSANZ has had discussions with ILSI on joint work on food safety, genetically modified foods and in the area of food/drug interface products. FSANZ and ILSI (South East Asia) are developing a draft protocol/agreement concerning such collaboration.
(c) Bilateral Links
FSANZ also provides professional advice and guidance on risk analysis to individual countries on a bilateral basis. A recent initiative involved a strategic assessment of the food safety system for the Government of Brunei in 2003.
Case Study: Training in risk assessment in support of food safety measures
FSANZ, through funding support from APEC and AusAID, was able to deliver two training programmes designed to improve the capacity of developing member economies to undertake risk assessments.
The training consisted of two, two-week courses. The first course (Hanoi, July 2002) concentrated on the risk assessment of contaminants, natural toxicants and pesticide residues in food. The second course examined microbiological risk assessment and was held in Ho Chi Minh City in October 2003.
Participants were drawn from a number of countries in the region, including: Brunei Darussalam, China, Chinese Taipei, Hong Kong, Indonesia, Lao People's Democratic Republic, Malaysia, Papua New Guinea, Philippines, Republic of Korea, Singapore, Thailand, South Korea and Viet Nam. Participants were provided with comprehensive training materials and during the intensive hands-on programme were instructed in how to undertake a risk assessment, and in the roles and responsibilities of risk assessors.
A recently completed programme involved training in the safety assessment of genetically modified (GM) foods. FSANZ, with funding support from APEC, conducted a one-week training programme in the safety assessment of GM foods. The course focussed on international perspectives for safety assessments of GM foods, including examination of approaches and guidelines established by Codex and FAO/WHO, a review of international approval systems, and an overview of current methodology.
Firstly, countries should apply risk analysis principles in the management of food safety risks. This is both a requirement of the WTO (the SPS Agreement in particular), but is also a useful tool for the efficient identification of risks and the devising of appropriate risk management strategies.
The most effective food regulatory system, in the view of FSANZ, is one in which countries have clearly defined the responsibilities of food regularly agencies in managing food safety issues. As a country that has a more complex food regulatory system than most, the importance of this is well known. Food safety emergencies are not the ideal time to be deciding who has responsibility for a particular issue.
Food safety emergencies are the best test of the quality of a food regulatory system. They are usually characterized by incomplete data, public concern and a lack of time to make a full risk assessment. In such circumstances, countries should undertake a provisional risk assessment, which must be revised as additional scientific data becomes available. The technical, scientific and management skills that are required to operate an effective food safety system in the 21st century are not easily come by. Developed countries have an obligation to ensure that their expertise is shared, both by information sharing and the provision of technical assistance (particularly training) to developing countries.
As part of the information sharing, countries can exchange documented risk assessments relating to food safety hazards to facilitate consistency and a common understanding of food hazards. FSANZ has found that placing technical reports and risk assessments on its website to be an excellent mechanism for encouraging this type of exchange.
Finally, the best risk assessment techniques and superlative risk management strategies are useless if there is poor communication of these aspects to stakeholders, particularly consumers. The 1990s were characterized by a loss of faith in a number of countries in the ability of the food regulators to protect public health and safety in those countries, not least because of poor communication. The level of public trust is closely related to the openness and transparency of the regulator. As new food safety risks emerge, food regulators need to ensure that there is a clear and consistent message about those risks which is continuously communicated to industry and consumers, and that in turn, the regulator listens carefully to what those industry and consumer voices are saying. Food safety is a shared responsibility and everyone must feel that they have a role to play in delivering a safer future.
1 http://www.foodstandards.gov.au/
2 Report of the Joint Expert FAO/WHO Consultation on Application of Risk Analysis to Food Standards Issues. 13-17 March 1995; Report of a Joint FAO/WHO Consultation on Risk Management and Food Safety. 27-31 January 1997; FAO/WHO Expert Consultation on Application of the Risk Communication to Food Standards and Safety Matters. 2-6 February 1998.
3 http://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm
4 http://www.codexalimentarius.net/procedural_manual.stm
5 Joint FAO/WHO Expert Committee on Food Additives
6 http://www.foodstandards.gov.au/
7 FSANZ Survey of Listeria monocytogenes in Cooked Prawns, 2002.
8 The limit of detection for the enumeration method used
9 http://www.foodstandards.gov.au/_srcfiles/P239listeriaFAR.pdf