Update Project Chapter 2: Risk Analysis Draft May 2008 1 PRINCIPLES AND METHODS FOR THE RISK ASSESSMENT OF CHEMICALS IN FOOD 2 3 CHAPTER 2: RISK ANALYSIS 4 5 Contents 6 7 CHAPTER 2: RISK ANALYSIS............................................................................................1 8 2.1 INTRODUCTION..................................................................................................................1 9 2.2 THE RISK ANALYSIS PARADIGM .........................................................................................1 10 2.2.1 Definitions of hazard and risk ...................................................................................2 11 2.2.2 Role of exposure assessment......................................................................................3 12 2.2.3 Interactions between risk assessment and risk management.....................................3 13 2.2.3.1 Problem formulation ...........................................................................................4 14 2.2.3.2 Priority setting for JECFA and JMPR ................................................................4 15 2.2.4 The role of risk assessment in risk analysis...............................................................4 16 2.2.4.1 Hazard identification...........................................................................................5 17 2.2.4.2 Hazard characterization ......................................................................................5 18 2.2.4.3 Exposure assessment...........................................................................................6 19 2.2.4.4 Risk characterization...........................................................................................6 20 2.3 REFERENCES......................................................................................................................7 21 22 23 2.1 Introduction 24 JECFA and JMPR have provided scientific advice to Member States since 1956 and 1961, 25 respectively, and to the general subject committees of the CAC since its formation in 1963. 26 However, the structural framework for these interactions was quite informal until the 27 development of the risk analysis paradigm. 28 The first risk analysis paradigm for public health was proposed by the United States 29 National Academy of Sciences (NAS) (NRC, 1983) and focused on assessing the risk of 30 cancer from chemicals in food. The decision process was divided into three major steps: 31 research, risk assessment and risk management. In the NAS paradigm, the principal steps 32 were considered to be sequential, with the decision process commencing with research and 33 concluding with the decision, but such an approach does not recognize the possible influence 34 of risk analysis on data needs or of the impact of political, social and economic objectives. 35 36 2.2 The risk analysis paradigm 37 Risk analysis has since been defined by the CAC as “a process consisting of three 38 components: risk assessment, risk management and risk communication” (CAC, 1997, 2006). 39 CAC (2006) goes on to define the three components of risk analysis as follows: 40 41 Risk assessment: A scientifically based process consisting of the following steps: (i) hazard 42 identification, (ii) hazard characterization, (iii) exposure assessment, and, (iv) risk characterization. 43 44 Risk management: The process, distinct from risk assessment, of weighing policy alternatives, in 45 consultation with all interested parties, considering risk assessment and other factors relevant for the 46 health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting 47 appropriate prevention and control options. 48 49 Risk communication: The interactive exchange of information and opinions throughout the risk 50 analysis process concerning risk, risk-related factors and risk perceptions, among risk assessors, risk 1 Update Project Chapter 2: Risk Analysis Draft May 2008 1 managers, consumers, industry, the academic community and other interested parties, including the 2 explanation of risk assessment findings and the basis of risk management decisions. 3 4 The risk analysis paradigm (see Figure 2.1) is a formal representation of the risk 5 analysis process in which it is made clear that there is both functional separation of the three 6 components and at the same time a requirement for communication and interaction between 7 those with responsibility for each of the three components. Within risk analysis, a functional 8 separation between risk assessors and risk managers is necessary to ensure scientific 9 objectivity of the risk assessment process. Further background information on risk analysis 10 can be found in Kaferstein & Hueston (2000). 11 12 13 14 Figure 2.1. Risk analysis (from FAO/WHO, 1997b) 15 16 The use of risk analysis methodology facilitates consistent and orderly decision- 17 making. Risk assessment is undertaken by the Joint Expert Committees, like JECFA and 18 JMPR, rather than the Codex Committees. Joint Expert Committees base their evaluations on 19 scientific principles and ensure necessary consistency in their risk assessment determinations. 20 The respective Codex Committees take responsibility as risk managers in making the final 21 decisions on establishing maximum limits for pesticide residues, veterinary drugs, 22 contaminants and additives in food. The CAC recognized the need to revisit risk analysis 23 approaches applied by Codex Committees and the Joint Expert Committees. At the request of 24 the CAC, three consecutive Joint FAO/WHO Expert Consultations were held between 1995 25 and 1998 on the application of risk analysis to food standard issues (FAO/WHO, 1995, 26 1997b, 1999). 27 28 2.2.1 Definitions of hazard and risk 29 The Joint Expert Consultations were by and large devoted to the three components of risk 30 analysis: risk assessment, risk management and risk communication, respectively. The first 31 Consultation, held in 1995 in Geneva, explored the risk analysis domain and focused on risk 32 assessment (FAO/WHO, 1995). The Consultation was also aware of the need for uniform 33 terminology on risk analysis in the work of Codex and considered risk analysis definitions 34 from different sources. The Consultation drafted definitions of risk analysis terms related to 35 food safety and recommended them to the CAC. The CAC subsequently amended these 36 definitions, adopted them on an interim basis and published the definitions in the Procedural 37 Manual (FAO/WHO, 2001, and subsequent updates). The definition of two terms—hazard 38 and risk—should be mentioned in particular. These are fundamental in the risk analysis 39 process, but different words for these two terms do not exist in many languages other than 40 English. Codex has adopted the following definitions for hazard and risk in relation to food to 41 cover not only chemical agents, but also biological and physical agents (CAC, 1997, 2006): 42 43 Hazard: a biological, chemical or physical agent in, or condition of, food with the potential to cause an 44 adverse health effect. 45 46 Risk: a function of the probability of an adverse health effect and the severity of that effect, 47 consequential to a hazard(s) in food. 48 49 The Codex definition of hazard differs from that of other bodies, for which a hazard is a 50 property associated with the chemical or agent rather than the chemical or agent itself. Thus, 51 a single chemical could represent multiple hazards (e.g. it could be a reproductive toxicant 2 Update Project Chapter 2: Risk Analysis Draft May 2008 1 and a carcinogen). As part of the project for the Harmonization of Approaches to the 2 Assessment of Risk from Exposure to Chemicals, the IPCS (2004) has defined hazard and 3 risk assessment slightly differently from Codex: 4 5 Hazard: Inherent property of an agent or situation having the potential to cause adverse effects 6 when an organism, system or (sub) population is exposed to that agent. 7 8 Risk: The probability of an adverse effect in an organism, system or (sub)population caused under 9 specified circumstances by exposure to an agent. 10 11 It is these IPCS definitions that most clearly describe the approaches of JECFA and JMPR. 12 13 2.2.2 Role of exposure assessment 14 It should be kept in mind that in general, risk analysis principles apply irrespective of the 15 nature of the hazard. The definition of hazard relates to chemical and microbiological 16 contaminants as well as to changes in the condition of food as a result of genetic 17 modification. Several components of the risk analysis process were subject of additional Joint 18 Expert Consultations. Two Consultations focused on exposure assessment (FAO/WHO, 19 1997a, 2000). 20 With regard to chemical hazards, the Consultations pointed to the further need for 21 harmonized approaches to the risk assessment of food additives, contaminants and residues of 22 pesticides and veterinary drugs, particularly in the assessment of exposure. Different 23 approaches are currently applied by JECFA and JMPR in establishing standards for the 24 various classes of chemicals. These approaches sometimes differ for historical reasons only, 25 while in other cases they are fully justifiable. In view of the increased importance of Codex 26 standards under the WTO Agreement on the Application of Sanitary and Phytosanitary 27 Measures (the SPS Agreement), harmonization of these approaches should be pursued to the 28 extent possible. The Consultations made interesting