ASEAN Australia Development Cooperation Program. Program Stream. Strengthening Risk Assessment Capability to Support Food Safety Measures Project

Transcription

1 ASEAN Australia Development Cooperation Program Program Stream Strengthening Risk Assessment Capability to Support Food Safety Measures Project Project Design Document AusAID & ASEAN Secretariat 28 th January 2005

2 AADCP Program Stream Strengthening Risk Assessment Capability to Support Food Safety Measures Project - PDD Table of Contents ABBREVIATIONS...II GLOSSARY OF TERMS...IV 1. BACKGROUND PROJECT ORIGIN REGIONAL DEVELOPMENT CHALLENGE TO BE ADDRESSED PRIOR AND ONGOING INITIATIVES ASEAN CONTEXT INTERNATIONAL CONTEXT SCOPE AND JUSTIFICATION FOR PROPOSED INTERVENTION GAPS IN ONGOING INITIATIVES OPTIONS FOR INTERVENTION JUSTIFICATION FOR THE PROPOSED INTERVENTION PROJECT DESCRIPTION GOAL AND OBJECTIVES COMPONENT OUTPUTS AND INDICATIVE ACTIVITIES INPUTS COSTS PHASING, DURATION AND LOCATION MANAGEMENT AND COORDINATION ARRANGEMENTS MANAGEMENT RESPONSIBILITIES COORDINATION AND REVIEW PROJECT MONITORING AND EVALUATION OVERVIEW KEY PERFORMANCE INDICATORS AND MEANS OF VERIFICATION RISK MANAGEMENT PROGRAM LEVEL ISSUES LINKS TO SUB-PROGRAM OBJECTIVES LINKS TO OTHER PROJECTS SUGGESTED APPROACH TO ACTIVITY CONTRACTING ANNEXES...26 A1 LOGICAL FRAMEWORK A2 RISK MANAGEMENT MATRIX A3 IMPLEMENTATION AND RESOURCE SCHEDULE A4 COST SCHEDULE A5 ASEAN PARTICIPATION TRUST FUND GUIDELINES i

3 Abbreviations AADCP AADCP-PS AEGFS AFTA-CER AFSN AHMM AIP AMAF AMC AMMST ASCFST ASEAN ASEC AWGFS CLMV Codex COMP COST EFSA EU FAO FSANZ GHP GMP HPA ILSI INT IPCS JECFA JEMRA JMPR PCC PCG SOM AMAF ASEAN Australia Development Cooperation Program ASEAN Australia Development Cooperation Program Program Stream ASEAN Expert group on Food Safety ASEAN Free Trade Area Closer Economic Relations ASEAN Food Safety Network ASEAN Health Ministers Meeting Australian Implementing Partner ASEAN Agriculture and Forestry Ministers Meeting Australian Managing Contractor ASEAN Ministers Meeting on Science and Technology ASEAN sub-committee on Food Science and Technology Association of Southeast Asian Nations ASEAN Secretariat ASEAN Working Group on Food Safety Cambodia, Lao PDR, Myanmar, Vietnam Codex Alimentarius Commission Enhancing ASEAN Competitiveness ASEAN Committee on Science and Technology European Food Safety Agency European Union Food and Agriculture Organization (of the United Nations) Food Standards Australia New Zealand Good Hygienic Practice Good Manufacturing Practice Hanoi Plan of Action International Life Sciences Institute Strengthening ASEAN Economic Integration ILO, UNEP and WHO International Program on Chemical Safety Joint FAO/WHO Expert Committee on Food Additives Joint FAO/WHO Expert Meeting on Microbiological Risk Assessment Joint FAO/WHO Expert Meeting on Pesticide Residues Program Coordinating Committee Project Coordinating Group Senior Officials Meeting of the ASEAN Ministers of Agriculture and Forestry ii

4 SOM HD SOM S&T SME SPS US US-FDA VAP WHO WTO Senior Officials Meeting on Health Development Senior Officials Meeting on Science and Technology Small to medium enterprise Sanitary and Phytosanitary United States of America United States Food and Drug Administration Vientiane Action Programme World Health Organization World Trade Organization iii

5 Glossary of Terms Risk Analysis Risk Assessment Risk Management Risk Communication Food Safety Measure ASEAN 6 National Focal Points Regional and National Project Focal Points A process consisting of three elements: risk assessment, risk management and risk communication. The scientific evaluation of known or potential adverse health effects resulting from human exposure to foodborne hazards. The process consists of the following steps: Hazard identification: Hazard characterization Exposure assessment Risk characterization The definition includes quantitative risk assessment, which emphasizes reliance on numerical expressions of risk, and also qualitative expressions of risk, as well as an indication of the attendant uncertainties. The process of weighing policy alternatives to accept, minimize or reduce assessed risks and to select and implement appropriate food safety measures. An interactive process of exchange of information and opinion on risk among risk assessors, risk managers, and other interested parties. Risk communication is an integral and ongoing part of the risk analysis exercise, and ideally all stakeholder groups should be involved from the start. Risk communication makes stakeholders aware of the process at each stage of the Risk Assessment. This helps to ensure that the logic, outcomes, significance, and limitations of the Risk Assessment are clearly understood by all the stakeholders. Measures implemented to manage food safety risks, including, but not limited, to standards and guidelines, food control systems (eg HACCP) and food inspection and monitoring programs The countries comprising Brunei Darussalam, Indonesia, Malaysia, Philippines, Singapore, Thailand Focal Points from the AEGFS, ASCFST and AFSN Focal Points that will be key participants for the Project. Project Focal Points will be selected from the National Focal Points (above). Exchange Rate Australian $1 = US$ 0.76 iv

6 Project Name: Program and project ref no: Link to program objectives Expected duration: Indicative Cost: Problem(s) to be addressed: Target group(s): Key performance indicators: Project summary table Strengthening Risk Assessment Capability to Support Food Safety Measures Project Enhancing ASEAN Competitiveness COMP 6 The Project will focus on strengthening risk assessment capability for food products. The Project goal and purpose corresponds to the first and third Sub-Program objectives, namely to promote the application of technological innovations in the animal and plant health and food safety services to meet international health and safety requirements, and to support the harmonisation of food and agriculture product standards and specifications. Two years A$1,192,444 (includes A$98,195 of ASEAN participation costs) the identification and training of experts with relevant scientific backgrounds in the methodology of risk assessment; the strengthening of existing networks amongst relevant experts and between experts and the national regulatory agencies within ASEAN member countries; the strengthening of existing networks amongst relevant experts and between the national regulatory agencies at a regional level; and improved knowledge of available data to support risk assessment and data deficiencies within the ASEAN region. The Project will target two groups, the first are scientific experts who either currently or potentially are involved in undertaking risk assessment for ASEAN Member Countries. The second are risk managers who are officials of the regulatory agencies or people responsible for developing food standards. Output 1.1: Two training courses developed and delivered over a five day period for up to 42 Member Country / ASEC participants. Output 1.2: Case studies completed and presented at Recall session Output 2.1: A directory of ASEAN risk assessors and risk managers collated from workshop and risk assessment training participants is posted and maintained on the AFSN website. Output 2.2: Second Workshop involving AEGFS, ASCFST and the AFSN representatives from each Member Country conducted with presentations on regional skill and data requirements. Expected inputs 165 person days Component 1 and 2 60 person days Component 3 Project administration inputs Travel and accommodation for 2 training courses and associated recall sessions Travel and accommodation for 2 workshops v

7 Goal To build confidence in ASEAN's ability to support domestic safe food production and consumption, and facilitate international trade competitiveness. Purpose To harness the scientific and technical capability within ASEAN to improve capacity to undertake risk assessment to: support development of ASEAN regional assessment positions and harmonised risk management measures, including alignment with Codex standards; strengthen ASEAN positions in Codex and WTO SPS negotiations; and strengthen food control measures Component Objective 1 To improve the ability of ASEAN experts to conduct scientific risk assessment and raise awareness/profile amongst ASEAN risk managers (SOM AMAF, SOMHD, COST) Component Objective 2 To strengthen risk communication (build networks) to support the use of risk assessment for development of science based food safety measures in ASEAN Component Objective 3 To effectively and efficiently manage and monitor Project implementation Output 1.1 Training in chemical and microbiological risk assessment procedures conducted. Output 2.1 Models for national and regional networking developed and a directory of national risk assessment coordination arrangements established. Output 3.1 Project activities effectively and efficiently planned, coordinated and managed by the AIP Output 1.2 Model risk assessments, relevant to ASEAN, undertaken by regional multidisciplinary teams. Output 2.2 Risk assessment skills and data deficiencies within ASEAN identified and strategies to address these through regional and international networks developed. Output 3.2 AMC and ASEAN informed of Project progress through effective monitoring, review and reporting of Project plans and achievements vi

8 1. Background 1.1 Project Origin The development of the ASEAN Australia Development Cooperation Program (AADCP) commenced in One of the three agreed components was the Program Stream, which was designed in October 2002 with an Australian Managing Contractor (AMC) appointed in May As part of the agreement between the Australian Agency for International Development (AusAID) and the ASEAN Secretariat (ASEC) to pursue the development of the AADCP - Program Stream (AADCP-PS), a planning mission was undertaken in late 2000 to evaluate and select ASEAN and Australian sourced project concept papers. This resulted in two documents - Strengthening ASEAN Economic Integration (INT) and Enhancing ASEAN Competitiveness (COMP) defining two broad sub-program areas. Seven projects were selected for inclusion in the COMP group, including COMP 6 - Strengthening ASEAN Capability in Risk Assessment in Support of Food Safety Measures. AusAID mobilised a design mission in October 2004 to progress preparation of two design documents for projects in the COMP sub-program including COMP Policy Environment The AADCP-PS aims to promote sustainable development within ASEAN by providing assistance with priority regional development challenges through regional cooperation. The Vientiane Action Programme (VAP), which supersedes, the Hanoi Plan of Action (HPA) in setting the policy direction for the ASEAN Secretariat, identifies priorities including: to enhance the competitiveness of the food and agriculture [and forestry] sectors by promoting inter- and extra- ASEAN trade; to foster science and technology as a key factor in sustaining growth and enhancing community well-being and promoting integration in ASEAN through the provision of technical services to meet the needs of economic integration; and to support socio-cultural development by enhancing food security. The 9th ASEAN Summit (Bali Concord II) initiated the preparation of sectoral road maps and program areas which set out measures to deliver ASEAN's policy objectives Operating Environment Three sectors within ASEAN have a direct interest in the development of risk assessment capability to support food safety measures; the agro based sector, under the ASEAN Agriculture and Forestry Ministers Meeting (AMAF); the human development (healthcare) sector under the ASEAN Health Ministers Meeting (AHMM) and the science and technology sector under the ASEAN Ministers Meeting on Science and Technology (AMMST) Each sector has prepared strategies to address the VAP in relation to food safety through its own policy committees and working groups: the ASEAN Food Safety Network (AFSN) reports to AMAF through the Senior Officials Meeting on Agriculture and Forestry (SOM-AMAF); the ASEAN Expert Group on Food Safety (AEGFS) reports to AHMM through the Senior Officials Meeting on Human Development (SOM-HD); and the ASEAN sub-committee on Food Science and Technology (ASCFST) is a sub-committee of the Committee on Science and Technology (COST), which reports to AMMST. 1

9 Figure 1.ASEAN and Australian initiatives and planning related to COMP 6 The current Project directly addresses a number of the strategies identified within ASEAN to address the relevant VAP priorities: harmonisation of national standards both within ASEAN and with Codex standards, where these exist; compliance with the requirements, rights and obligations of the WTO agreement on the Application of Sanitary and Phytosanitary Measures; coordination of ASEAN common positions in international fora, such as Codex; increasing the level of credibility and competency of national food regulatory authorities; development of technical skills needed by the ASEAN priority sectors; and strengthening food control systems. The development of the capacity for scientific experts within ASEAN to undertake science based risk assessments, at both the national and regional level, is identified as an essential competence for the achievement of the identified measures. Both Codex and the WTO SPS agreement recognise science based risk assessment as an essential component in the development of standards and other food safety control measures (Figure 2). Risk assessment also underpins the development of food safety management systems. Risk assessment, risk management and risk communication together form the three component parts of risk analysis (Figure 3). 2

10 Figure 2: Risk Assessment and the WTO SPS Agreement WTO AGREEMENT ON THE APPLICATION OF SANITARY AND PHYTOSANITARY MEASURES Article 5 Assessment of Risk and Determination of the Appropriate Level of Sanitary or Phytosanitary Protection 1. Members shall ensure that their sanitary or phytosanitary measures are based on an assessment, as appropriate to the circumstances, of the risks to human, animal or plant life or health, taking into account risk assessment techniques developed by the relevant international organizations. 2. In the assessment of risks, Members shall take into account available scientific evidence; relevant processes and production methods; relevant inspection, sampling and testing methods; prevalence of specific diseases or pests; existence of pest- or disease-free areas; relevant ecological and environmental conditions; and quarantine or other treatment. Figure 3: Risk Analysis Framework Risk Analysis Framework Risk Assessment? science based Risk Management? Policy based Risk Communication? interactive exchange of information and opinions concerning risks FAO/WHO 1995 Strengthening ASEAN risk assessment capability also contributes to the AADCP goal of strengthening regional cooperation to promote economic development through: measures to enhance AFTA-CER linkages, specifically as risk assessment is an essential component of standards and conformance activities on food; regional measures to strengthen social policy formulation, specifically food safety policy; and strengthen regional cooperation in science. 3

11 1.2 Regional development challenge to be addressed The COMP 6 concept paper, prepared by the AADCP planning mission in 2000, identifies that the regional move towards facilitated movement of products, including food, in the ASEAN region, has resulted in a need to strengthen national food control programmes. It is identified as essential for ASEAN to foster confidence in food available from the region through the development of such programs. However, the foundation of a strong food control programme requires science-based decisions made using risk assessment. Without a strong scientific basis, food control measures, including standards, may be subject to challenge both between ASEAN Member Countries and internationally. At meetings with the project design mission in October 2004, the chairs of the three ASEAN sectoral groups involved in food safety ANFS, AEGFS and ASCFST and the ASEAN Food Safety Network (AFSN) identified that: Scientists within the region, including those in the CLMV countries (Cambodia, Lao PDR, Myanmar and Vietnam), possessed the necessary skills to undertake and were aware of the principles of risk assessment. Much of this awareness had been gained from attendance at workshops and seminars held within the region since the preparation the COMP 6 concept paper in However, these experts lack the detailed knowledge and familiarity with the procedure to enable them to undertake effective risk assessments in practice. Within ASEAN Member Countries, networks between relevant experts, between risk assessment experts and the national food regulatory authorities, who develop and implement risk management, were often poorly developed. This was identified as a significant impediment to the establishment of harmonised food control measures based on risk assessment within ASEAN at the regional and national level. It was noted that there was a need for Member Countries to establish internal networks between ministries, laboratories, research institutes and academia in order to support the implementation of risk assessment at a national level but that different models would suit different countries. The lead agencies in relation to food safety report to different ministries in different countries and, therefore, through different sections within ASEAN. The need for strengthened communication between the three sectors at the regional level was identified as critical to the implementation of regional risk assessment in support of ASEAN cooperation in Codex and the WTO, and facilitation of regional/international food trade. The priority for risk assessment within ASEAN was in relation to risks associated with agricultural and veterinary chemicals, heavy metals, natural toxins (including mycotoxins and biotoxins) and pathogenic organisms in food. Building risk assessment skills and capability within the region is needed to enable ASEAN members to: utilise internationally prepared risk assessments, such as those produced by the Joint FAO/WHO Expert Committee on Food Additives and Contaminants (JECFA), the Joint FAO/WHO Expert Meeting on Pesticide Residues (JMPR) and the Joint FAO/WHO Expert Meeting on Microbial Risk Assessment (JEMRA), to determine their applicability to ASEAN specific conditions when considering the adoption of Codex standards by ASEAN; develop coordinated ASEAN risk assessments to support the development of ASEAN standards, such as maximum residue levels of agricultural and veterinary chemicals, where Codex standards have not been developed or are not appropriate for the region; participate more effectively in the development of Codex standards and within the WTO SPS committee through the ability to present regional, science based positions; and prioritise food control measures, such as inspection and surveillance, on the basis of food safety risk to maximise their effectiveness. 4

12 Risk assessment is a process which involves the establishment of multi-disciplinary teams able to assess and quantify hazards, and identify the routes and conditions of exposure in order to characterise risks. As a consequence, in addition to enhancing the skills of appropriately qualified scientists within the region, effective risk assessment also requires the systems and infrastructure to enable these experts to communicate, both with each other and to the regulatory agencies that establish and implement risk management solutions based on the risk assessment outcomes. There is a need to build and strengthen communication networks within the region to support the development of risk assessment competency and ensure that risk assessments can be effectively incorporated into ASEAN risk management decisions in the form of standards and other food safety control measures. 2. Prior and ongoing initiatives 2.1 ASEAN context A large number of projects on food safety have been undertaken or are ongoing within ASEAN, although the majority have a focus on developing risk management capacity through enhancing analytical capability and implementation of control systems, such as HACCP and quality assurance, and not on risk assessment capability. In this context, Australia has been a significant provider of assistance, for example, between 1995 and 1999, the ASEAN-Australia Economic Cooperation Program, the predecessor to the AADCP, implemented a substantial program on Quality Assurance for Fresh and Processed Tropical Fruits. Within the AADCP-Program Stream there are three other projects which directly address the food supply:? Quality Assurance Systems for ASEAN Fruit and Vegetables;? Quality Assurance and Safety of ASEAN Fish and Fish Products- HACCP Approach; and? Strengthening Animal Health Management and Biosecurity Project. The first project deals with food quality assurance rather than food safety. The second and third projects, Fish and Fishery Products and Animal Health, both address food safety, however in both cases the emphasis of the project is on the development and implementation of HACCP based systems aimed at managing established risks, whereas the current project focuses on the assessment of new or changed risks. AusAID is also supporting Food Standards Australia New Zealand (FSANZ) to provide a range of programs to food regulators within the region in risk analysis and harmonisation of food standards including topics on harmonisation of regulations for food additives, and GMO safety assessment, regulation and labelling. As indicated above, these programs differ from the proposed Project in focussing on providing officials from food regulatory agencies with an overarching understanding of risk analysis as a whole rather than on building a specific familiarity with risk assessment. Between 2001 and 2004, the International Life Sciences Institute (ILSI) sponsored annual workshops on food safety standards harmonisation and short training courses on safety and risk assessment of agricultural genetically modified organisms (GMOs) for ASEAN countries. These programs principally involve food regulatory officials from the ASEAN countries. The EC-ASEAN ECP program on standards and conformity assessment has a sub-program on food which focuses on activities related to: strengthening food testing laboratories' capacities; strengthening inspection capacities; strengthening capacities in food standardization & food legislation information; and promoting the application of HACCP, GMP and GHP in the selected food industry SMEs. 5

13 Whilst this project also addresses food safety measures, its focus is on analysis and compliance capability and as such, it does not overlap with the proposed Project. 2.2 International context A number of workshops and training programs addressing risk analysis and science based decision making have been held or are proposed to be held in the Asia Pacific region, including: The 3rd Asian Conference on Food Safety and Nutrition held in Beijing in October 2000 and sponsored by ILSI, included presentations on the use of risk assessment in the development of food control measures. A FAO RAP/NFPA sponsored regional 1 day workshop on food safety was held in Bangkok in June 2002 at which the importance of sound science and risk based decision making was discussed. A FAO/WHO workshop on applying food safety risk analysis in Asia was held in Kuala Lumpur in This workshop provided information on practical approaches to chemical risk assessment. The FAO/WHO Asia Pacific Regional Conference on Food Safety held in Seremban, Malaysia, during May 2004, discussed the importance of science and risk based approaches to effective harmonisation of food safety legislation. The Food Standards Australia New Zealand (FSANZ) International Training Program held a 5 day residential course on Chemical Risk Analysis in Canberra in November The objectives of this program included enabling participants to understand the risk analysis framework and identify the methodology used in risk assessment. FSANZ has also scheduled courses on safety assessment and management of genetically modified foods and on microbiology risk assessment in food regulation to be held in April-May The FSANZ International Training program is targeted at senior technical and scientific officers from food regulatory programs in the Asia-Pacific region. The training courses and workshops on risk assessment and risk analysis conducted to date have evidently been highly successful in raising awareness amongst ASEAN food regulators of the importance of risk analysis in developing standards and other food control measures. However, it is significant that, to date, neither the scientific experts nor the regulatory authorities have been successful in producing risk assessments that have been implemented in the form of regional food safety measures in support of the ASEAN goals and objectives. This is attributed within the three food related sectors within ASEAN to a lack of practical "hands-on" experience in risk assessment by the relevant scientific experts and by poor communication networks between regulators and experts. 3. Scope and justification for proposed intervention 3.1 Gaps in ongoing initiatives Food Safety falls within the mandate of three ASEAN sectoral groups, AFSN, AEGFS and ASCFST. Similarly, within each ASEAN member country, the responsibility for food safety is divided between a number of ministries. In some countries, such as Thailand and the Philippines, food regulation is the responsibility of agricultural sector ministries (eg agriculture, fisheries), in others, such as Malaysia, responsibility lies with the Health Ministry. Indonesia has a centralised food administration which reports directly to the President's Office. However, risk assessment is a procedure that requires the formation of multi-disciplinary teams comprising experts with a range of skills to identify and characterise hazards and determine exposure. The exact expert mix of each team will depend upon the nature of the risk assessment being undertaken. Generally the appropriate experts will be drawn from both agricultural and health sectors, from government as well as universities and other research institutes. In order for the food regulatory agencies within ASEAN Member Countries to develop and implement food 6

14 safety measures based on risk assessment, they must be aware of and have access to the necessary scientific expertise. For ASEAN risk assessments to be accepted, the competency of the scientific experts must also be recognised by the regulatory agencies. Risk communication in the form of peer support and correspondence amongst and between experts undertaking risk assessment also strengthens the veracity of the assessments. As a result, although each ASEAN sector is committed to the implementation of risk assessment to support the development of science based food safety measures in ASEAN, progress to achieving this has been hampered by poor communication networks both at national and regional levels. Substantial weaknesses remain in terms of: the identification and training of experts with relevant scientific backgrounds in the methodology of risk assessment; the existing networks amongst relevant experts and between experts and the national regulatory agencies within ASEAN member countries; the existing networks amongst relevant experts and between the national regulatory agencies at a regional level; and knowledge of available data to support risk assessment and data deficiencies within the ASEAN region. 3.2 Options for intervention The COMP 6 paper prepared in 2000 proposed to develop risk assessment capability to: equip ASEAN with skills needed for science-based decisions on food safety-related issues; and enhance ASEAN capacity in formulating positions in international deliberations on food safety matters. This was to be achieved through a project consisting of four workshops designed to provide handson experience of the application of risk assessment methodology for chemicals and toxicants, and microbiological risk assessment. The AEGFS, ASCFST and AFSN all recognise the importance of hands-on risk assessment training. However, the ASEAN priorities in term of risk assessment capability have been cla rified since the preparation of the COMP 6 concept paper. The three ASEAN groups consider the priorities to be for skills in: chemical risk assessment, in relation to agricultural and veterinary chemicals, heavy metals and natural toxins (eg aflatoxin); and microbiological risk assessment. It is therefore proposed to modify the hands-on training component of the project to meet these priorities. The three ASEAN groups responsible for food safety, also recognised that in order to achieve the second objective there is a critical need to enhance communication among the trained experts and between the experts and the regulatory officials who will use the risk assessments in formulating positions on food safety matters. The second objective of the COMP 6 paper was also considered to be somewhat restrictive in terms of the overarching ASEAN objectives for food safety. The importance to ASEAN being able to engage pro-actively within international forums such as Codex and WTO was confirmed. However, risk assessment is also necessary to support regional harmonisation and the implementation of food control measures which in turn support confidence in ASEAN as a supplier of safe food. At the present time, there is no mechanism by which ASEAN countries can share risk assessments in order to alleviate trade disputes or to support the preparation of ASEAN regional standards where no relevant international standard exists. After consideration of the options and the revised budget available it was concluded that the Proje ct should comprise two parts: training experts in risk assessment; and raising awareness of risk 7

15 assessment experts and strengthening the communication networks to support the implementation of risk assessment outcomes. 3.3 Justification for the proposed intervention Regionality There is substantial trade in food both within and external to the region. Eight of the ASEAN Member Countries are members of the WTO (Table 1) and all are members of Codex. Trade is increasing but is limited by a lack of harmonisation between countries. Both WTO and Codex require that food safety measures, including standards, be developed using scientific based risk assessment principles. Enhancing the ability of ASEAN member countries to undertake risk assessment to support the implementation of harmonised food safety measures will facilitate increased trade and also facilitate improved health outcomes within ASEAN Member Countries. Furthermore, an increased capacity to undertake risk assessment will enhance the capacity of ASEAN countries to present a united science based front at the WTO and FAO on issue which affect trade in the region. Table 1: ASEAN Member Country Membership of WTO WTO members Brunei Darussalam Cambodia Indonesia Malaysia Myanmar The Philippines Singapore Thailand WTO observer status Laos Vietnam Target groups and ASEAN participation The target group for this Project are experienced scientific experts within the ASEAN Member Countries who are responsible for providing risk assessment advice to national regulatory authorities and the risk management staff within these authorities. The risk assessment training program is specifically targeted at scientific experts from appropriate supporting disciplines. Risk assessment in relation to food borne chemicals and food microbiology is a significant specialisation and it is unlikely that there are many experts in the region with substantial experience in the area. Nonetheless it is anticipated that experts with a more general scientific background will be able to participate and become familiar with the skills necessary to participate in food risk assessment. Suitable experts may be found in government, scientific institutes, research facilities and universities. Appropriate scientific experts for training might include persons with a minimum of tertiary level qualifications and experience in: chemical hazard assessment - toxicology, pharmacology, biochemistry, human or veterinary pathology; food production and manufacturing - food science and technology, chemistry, agricultural science and food production; exposure assessment nutrition, dietetics, dietary surveillance and/or modelling; and 8

16 microbiology. The second element of the Project, the development of risk communication networks is focussed both at the scientific experts undertaking risk assessment and also at the regulators (risk managers) who translate the risk assessment into standards and other food safety measures. Sustainability of benefits In addition to the three ASEAN sectoral groups directly involved in food safety identified previously, AFSN, AEGFS and COST, ASEAN has created an ASEAN Expert Working Group on Codex under SOM-AMAF that will also have an interest in the successful outcomes of the Project. The Project objectives have been designed to contribute to elements of the Vientiane Action Programme (VAP). The VAP indicates a long-term commitment of Member Countries to enhance the competitiveness of the food and agriculture by promoting trade, fostering science and technology and supporting socio-cultural development through enhanced food security. All three sectors (agriculture, health, and science and technology) will be involved in the Project and a key component is to encourage the development of communication networks between them in risk assessment to support food safety, at both the national and regional level. The other key component of the Project is to familiarise appropriate scientific experts with the practice of risk assessment and build support networks amongst them, through participation in intensive training and mentored case studies, undertaken by regional multi disciplinary teams. The training materials used and risk assessment developed in this Project will provide models for the ongoing preparation and implementation of regional risk assessments within ASEAN. The last element of the Project will be a workshop for all three sectors, at which appropriate International Bodies will be invited, to review both the networks developed and the risk assessment experience gained and identify strengths and weaknesses for ongoing cooperation. Ultimately the sustainability of both the skills and networks developed during the Project depends upon the ability and commitment of the individual ASEAN Member Countries to ensure that appropriately qualified personnel within the countries are enabled maintain and developed into the future, once the Project is completed. Impact on poverty, gender and the environment The Project will not have any immediately direct and unilateral impact on poverty, gender or the environment. However, there are some Project specific issues of relevance. In the longer term, improved food safety measures in the region will lead to greater confidence in safe food production and better export market access for ASEAN food products. In turn, along with the commercial sector, this will result in lower production costs and increased market opportunities for small-scale farmers who are often poor. Improved access to affordable safe food will also strengthen food security within the region leading to improved health outcomes. In the long term, training in risk assessment and the establishment of communication networks to support its application to food safety measures is likely to be of greater assistance to the CLMV countries as they presently have a lower capability in these areas than other ASEAN Member Countries. In selecting participants for training, an appropriate gender balance is required, provided that nominees also have the appropriate qualifications in relevant scientific disciplines and the newly acquired skills will be applicable to their day-to-day work. This can be achieved through effective selection criteria for training participants being developed for Project activities. In addition, the AIP is to ensure that possible adverse impacts of project activities on women through changing patterns of production or trade are documented and strategies developed to limit project perpetuation of such impacts. The potential indirect impact on the environment of this Project is equivocal. On the one hand, efforts leading to safer food production have the potential to increase the overall output of the food in each country and thus put greater strains on environmental resources, which are already overburdened in some instances. On the other hand, more efficient production of safe food and 9

17 diversified markets with a restricted increase in absolute outputs may have beneficial environmental outcomes as wastage will be reduced and, consequently, less land and resources will be required to achieve the same levels of output. AADCP capacity to contribute There is presently a wide distribution of capabilities and networks to support the development of risk based food safety measures across ASEAN Member Countries. Some countries have the capacity to progress the objectives of the Project within their respective jurisdictions. However, because international best practices in risk assessment is highly refined and specialised in other areas of the world, even the more developed economies in the region need access to opportunities for continuous improvement. Recognising the existing capabilities within the region, the provision of assistance at the regional level provides the opportunity for AADCP to bring together Australian/New Zealand and ASEAN expertise to provide practical experience in best practice as exemplified in international risk assessment protocols. In this regard, Australian/New Zealand expertise is recognised internationally and Australian/New Zealand experts have a long history of active participation in Joint FAO/WHO expert committees and consultations on risk assessment in relation to food safety and in Codex and the WTO committees, both from government and the private sector. 4. Project Description 4.1 Goal and objectives The Project Goal is: To build confidence in ASEAN's ability to support domestic safe food production and consumption, and facilitate international trade competitiveness. The Project Purpose is: To harness the scientific and technical capability within ASEAN to improve capacity to undertake risk assessment to: support development of ASEAN regional assessment positions and harmonised risk management measures, including alignment with Codex standards; strengthen ASEAN positions in Codex and WTO SPS negotiations; and strengthen food control measures. Component Objective 1: To improve the ability of ASEAN experts to conduct scientific risk assessment and raise awareness/profile amongst ASEAN risk managers (SOM AMAF, SOMHD, COST). The presence within ASEAN of appropriate scientific experts who are familiar with practical risk assessment procedures and the recognition of these experts by regulatory authorities responsible for developing and implementing food safety measures, including standards, will encourage the development within ASEAN of a culture of science based regulatory decision making, consistent with the principles of the WTO SPS agreement and Codex. The emphasis of this component will be on providing appropriately qualified and experienced ASEAN scientific experts with hands-on practical training in risk assessment and then presenting the outcomes, in the form of a series of model risk assessments undertaken as case studies during the training, to ASEAN food regulators. It is proposed that appropriate scientific experts from the ASEAN member countries will be nominated by each country following a coordinated workshop involving the three ASEAN sectors involved in food safety (Output 2.1). It is envisage that there will be one training program each on chemical risk assessment and microbiological risk assessment Each program will comprise a 5 day intensive course in hands-on 10

18 risk assessment. Trainees will then be formed into a number of regional multidisciplinary teams (up to nine teams) and each team given a case study in risk assessment to undertake upon return to their home countries. Each case study will focus on an area of relevance to ASEAN as a whole. Where trainees have existing experience in the field, projects relevant to their interests and expertise may also be chosen, although this may not always be the case for trainees drawn from similar but nonfood disciplines (eg medical toxicology, veterinary pathology or dietetics). Mentoring will be provided by the AIP during this period to assist the teams including specific trips to the CLMV countries to provide added support to these participants. Five to seven months after their initial training course, the trainees will be recalled for a second, 2 day session at which their case studies will be presented and reviewed. Finally the case studies will be presented to a workshop of food regulators and risk managers as models for ASEAN risk assessment capability (see Component Objective 2). Component Objective 2: To strengthen risk communication (build networks) to support the use of risk assessment for development of science based food safety measures in ASEAN. Risk communication is an essential component in the application of risk assessment to science based regulatory decision making. One of the impediments to effective risk communication within ASEAN at present is that responsibility for food safety is dispersed amongst a number of sectors at both national and regional levels. This Component of the Project will focus on two activities: the development and documentation of risk communication networks within ASEAN member countries; and the identification of gaps that may exist within ASEAN, in terms of scientific and technical skills, and data availability, and develop strategies to address these deficiencies through international cooperation. Component Objective 3: To effectively and efficiently manage and monitor Project implementation. The successful attainment of Objectives 1 and 2 requires effective management and monitoring strategies to ensure that the Project is responsive to its changing operating environment. This component is aimed at ensuring that Project activities are effectively and efficiently planned, coordinated and managed and that the AMC and ASEC (and associated committees and working groups) are kept informed of Project progress through effective monitoring, review and reporting of Project plans and achievements. 4.2 Component outputs and indicative activities Component 1 Output 1.1: Training in chemical and microbiological risk assessment procedures conducted. It is envisage that there will be two 5 day intensive courses on hands-on risk assessment, one on chemical risk assessment and one on microbiological risk assessment, specifically addressing issues of concern to ASEAN. All participants should have scientific backgrounds appropriate to the practice of either chemical or microbiological risk assessment in relation to food safety. It is anticipated that nominated participants for the respective courses will be representative of the full range of relevant disciplines. It will be necessary for the AIP to brief the National Project Focal Points (discussed further in Section 5.1) on the selection of appropriate participants for the two courses at the inception workshop conducted as part of Output 2.1. At the meeting with the chairs of the three ASEAN sector committees, it was identified that there were appropriate scientist with relevant expertise within the CLMV countries to participate in the proposed training program. Participants will be familiarised with the component parts of risk assessment (i.e. hazard identification, hazard characterization, exposure assessment and risk characterization) prior to focussing on those components that are appropriate to their qualifications and experience. In this context, it is intended that the training be a desk exercise using data from relevant sources that are likely to be available to participants in their home countries. Participants should be familiarised with the potential range of such data sources. Risk assessments carried out by international expert bodies (JECFA, JMPR and JEMRA), FAO/WHO consultations, IPCS monographs and published 11

19 reports from national/regional regulatory bodies in developed countries (eg FSANZ, Health Canada, US FDA and EFSA) would form a relevant basis for the materials used in these courses. Indicative activities required for the output are: development of appropriate training materials; presentation of two intensive training courses developed and delivered over five day periods by experts with practical experience in relevant components of risk assessment and in provision of training for whom English is a second language, that includes; o evaluation of participant knowledge; o selection of training exercises to be undertaken during the training course and take home risk assessment projects relevant to the identified needs of ASEAN member countries; and o assessment of participant s competence, within the scope of the components of risk assessment and in relation to individual training focus. Output 1.2: Model risk assessments, relevant to ASEAN, undertaken by regional multidisciplinary teams. It is envisaged that a number of regional multi-disciplinary teams will be established at the conclusion of each risk assessment training course (Output 1.1). In order to encourage cooperative participation and learning, each team should, as far as possible, comprise a mix of ASEAN 6 and CLMV members and seek to have a balance of stronger and weaker members in terms of the components of risk assessment. Each team will choose a team leader who will coordinate the case study and be responsible for its final presentation to risk managers. The teams will be given a case study to take home in the form of risk assessment on a topic of relevance to ASEAN. After returning to their home countries, the members of each team will work together (using , phone and fax), with mentoring from the AIP, to prepare a risk assessment. Experts from similar disciplines should be encouraged to work cooperatively within teams to establish a learning culture based on peer support. Provision has been made to enable the AIP to undertake two visits to the CLMV countries to provide additional mentoring and, in particular, to facilitate accesses to communication facilities such as , telephone and fax. A recall training session lasting for 2 days should be held between 5 and 7 months after the original course. The multidisciplinary teams will present their risk assessment for discussion and review by the other teams and the expert trainers. The team leader of each case study team will be reaffirmed and requested to present their final risk assessment to risk managers (Output 2.2). Indicative activities for the output are: identification of appropriate case study topics that are achievable in the context of the Project and the participants' competencies; support and advice provided to participants during the case study through mentoring; case studies completed and presented at a recall session which is held 5 to 7 months after initial risk assessment training courses, attended by the trainers who participated in the initial course; and assessments of actual outcomes against planned approach for risk assessment case studies to: o determine lessons learned; and o identify future strategies based on participant experiences. Component 2 Output 2.1: Models for national and regional networking developed and a directory of national risk assessment coordination arrangements established. 12

20 In order to identify the Project focal point within individual member countries and with ASEAN as a region and also to raise awareness of risk assessment across all three ASEAN sectors involved in food safety, it is proposed that a workshop be held at which the members of all three ASEAN sectoral groups involved in food safety (AEGFS, ASCFST and AFSN) would attend (the inception workshop). The purpose of the meeting would be to enable the representatives from each ASEAN member country to: discuss a range of models for risk communication networks and develop strategies for implementation of preferred models, by each ASEAN member country, and an agreed ASEAN regional model; nominate National Project Focal Points and select a Regional Project Focal Point 1 from among the national nominees; and discuss the skill necessary for participants in hands-on risk assessment training. It is also envisaged that a directory of the three sector focal points for each country could be compiled at the workshop to form the basis of a regional risk communication network. Subsequently, the contacts for risk assessment i.e. the experts trained in the risk assessment courses, could also be added to the network. The ASEAN network on food safety website currently provides an example of effective food safety communication network within ASEAN that could be used to disseminate information about risk assessment and risk management contacts. Indicative activities to achieve the output include: a workshop involving AEGFS, ASCFST and AFSN representatives from each Member Country with decisions made on National and Regional Project Focal Points; examples of national risk assessment coordination arrangements communicated to member countries and national and regional networking strategies developed; a directory of ASEAN risk assessors and risk managers collated from workshop and risk assessment training participants is posted and maintained on the AFSN website; and communication and networking support by lead consultant through regular contact with focal points from the AEGFS, ASCFST and AFSN through a documented communication strategy. Output 2.2: Risk assessment skills and data deficiencies within ASEAN identified and strategies to address these through regional and international networks developed. Following the completion of expert training in risk assessment (Component 1) a second workshop for the members of all three ASEAN sectoral groups involved in food safety (AEGFS, ASCFST and AFSN) will be held. Nominated team leaders from the risk assessment training case study groups will also attend this workshop (from Output 1.2). Representatives from international bodies (e.g. FAO, WHO) and industry (ILSI) would also be invited to attend (at their own expense). The purpose of the meeting will be to: review progress on the development of risk communication networks nationally and regionally; examine the risk assessments prepared through the training exercises, including discussing their suitability for use as the basis of ASEAN risk management measures (e.g. standards) and activities in international forums (e.g. Codex); and identify expertise and data deficiencies in ASEAN risk assessment and develop strategies to address them through future cooperation with international bodes (eg FAO and WHO). Indicative activities to achieve this output are: 1 Each ASEAN agency has national focal points from which National Project Focal Points will be selected. The National Project Focal Points will then appoint a Regional Project Focal Point. 13