MODELS FOR GOVERNANCE OF RISKS

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CHAPTER 2: MODELS FOR GOVERNANCE OF RISKS

INTRODUCTION

‘Political system’ or governance is a concept that emphasises the interaction of a political ‗sphere‘ and its environment (Almond & Powell 1978, p.3). The environments include international, socio-economic and cultural ones and, for the purpose of this study, specifically the technical/scientific environments. The interactions with environments are expressed in various ways over many years of development of political systems. Governance of risks presents a specific case. Research on South Africa‘s governance of risk is described in the following chapters according to the plan summarised in Table 2-1.
This chapter includes:

•    A brief reference to the criteria for good governance applied in the research (section 2.2)
•    Characteristics of models as identified in the continuum of development, to guide the reader (section 2.3)
•    Thoughts on the most advanced model for risk governance that includes more information on the framing‘ step (section 2.4)
•    Some detail on the historical development of the paradigm, risk analysis (section 2.5)
•    Examples to illustrate the application of the models by different countries and the African region (section 2.6, 2.7)
•    Notes on international bodies (section 2.8).

GOOD GOVERNANCE CRITERIA

Criteria for good governance introduce a dimension to an assessment of governance models. These criteria are applied to the level of implementation of principles. The criteria identified were ethical conduct, independency, accountability, excellence, transparency, openness, participation, and effectiveness. Although these are interlinked and overlapping and may not be well comprehended by scientists that are not in the field of governance, these are, nevertheless, a broad indication of perceptions that people may have of good governance. The criteria are described in more detail in Chapter 3 as well as Chapter 8.

CHARACTERISTICS OF DIFFERENT GOVERNANCE MODELS FOR RISK ANALYSIS

The democratisation of the decision-making process of a political system concerning ‘risks’ is characterised by the evolution of a continuum of various models. Three characteristic models can be identified (Millstone 2007, p. 484). A brief explanation of the evolution of governance models should suffice to comprehend the importance of considering improvement of South African governance of GMOs and serves as reference to compare the progress in development of the South African governance of genetically modified organisms (GMOs) and also governance of toxicological assessment of new pesticides (crop protection products).
The earliest model, the technocratic model, assumes that policy decisions are based on ‗sound science‘ only. The model does not permit separation between science and decision making (risk assessment and risk management) and operates independently of social, cultural and economic conditions. Functional separation between the policy makers and risk assessors is not clearly defined in many countries, lending itself to political influences. This has changed to some extent since the mad cow disease debacle in Europe (Dreyer et al. 2006, p.10). In the ‘decisionist‘ model, functional separation between risk assessment and risk management is a prominent feature, though socio-economic considerations are of some interest.
The ‘co-evolutionary model‘, described by Renn (2008) as the ‘transparent‘ model (democratic model described by Millstone 2007), improves on the decisionist model by including ‘other legitimate factors‘ such as socio- economic considerations in a holistic concept of risk governance. This model, according to Millstone (2007), is motivated by institutional and legal arrangements of governance within environments that keep on changing. Millstone et al. (2008, p.11) commented that in many countries this model is still not invoked in legislation.
Structures for risk governance in general are currently emerging under the auspices of the newly established International Risk Governance Council (IRGC, online). The emphasis of these models on the importance of socio-economic matters, whether risk or benefit, is of particular importance as a recent requirement in risk governance. This is the focus of research globally.
The expression ‘risk governance‘ is now widely used and often relates to bridging ‘sound science‘ with democratic ‘participation‘ (De Marchi 2003, p.171). ‘Ideal‘ risk governance in a democratic system, illustrating the broad scope of democratic governance, is defined as:
The totality of actors, rules, conventions, processes and mechanisms concerned with how relevant [food] risk information is collected, analysed and communicated, and decisions on [food] safety management are made. [Food] risk governance includes, but extends beyond, the three components of risk analysis (risk assessment, risk management, risk communication). It also involves co-ordination between public bodies, commercial and civil society actors, and wider contextual factors such as institutional arrangements, legislative procedures and political culture (Dreyer et al. 2006, footnote 3, p.9).

THOUGHTS ON THE MOST ADVANCED MODEL

SAFE FOODS Project

The SAFE FOODS Project, funded by the European Commission, was designed to assist in improving food safety governance for Europe. One of the important achievements was a model for food safety/risk governance (Figure 1) (König et al, 2010). The model proposed by this project falls within the most advanced category of models, the ‘transparent‘ model.
The ‗risk governance‘ model proposed by SAFE FOODS for the European Commission details the requirements of the transparent model. It comprises five components, which include the three constituents of risk analysis that is, risk–benefit assessment, risk management (decision making, implementation and monitoring) and risk communication, as well as two additional steps (or phases). These are a ‘framing‘ step before the risk assessment, which relates to the ‘risk assessment policy‘ step by the Codex (CAC 2011); and an ‘evaluation‘ step before risk management. The purpose of these additional two steps is to promote efficient and transparent mechanisms of interaction between risk assessment and risk management (Koenig 2010, Ely et al, 2009).Communication and engagement with stakeholders and the public are integrated into every stage of the process (Ely et al, 2009).
In a special issue of the journal Food Control, various authors gave thought to the implementation of the proposals from the SAFE FOODS project. Of note, are the application to GMO assessment (Kuiper & Davis 2010), the role of an interface committee to improve transparency, open and participatory management (Knudsen 2010), methods and approaches to assess social impact (Cope et al. 2010), and economic assessment (Trail & König 2010).

Framing

A ‘framing‘ step in risk analysis in the most advanced governance model mentioned in section 2.3 is of importance in this study and described in more detail here. See also the definition for risk governance in section 2.3
Framing for assessments of possible risk (food safety and environmental risks) is considered the ‘meta-level‘ of risk governance as it refers to all process within the dynamic iterative nature of risk analysis (Ely et al 2009, Kuiper & Davis 2012). It is a continuous, exploratory process with goals of food and environmental safety. More specific to the new assignment for assessment, the problem is formulated and the assessment planned according to the objectives of risk analysis as well as formal evaluation step to weight risk, cost and benefits (Kuiper & Davis 2010).
The role players are risk managers, risk assessors and stakeholders (CAC 2011, Ely et al 2009). It serves as formal opportunity for role-players to communicate prior to risk assessment and is the guideline to follow in case of value judgements (Jackson & Jansen 2010). Codex views the framing step (risk assessment policy step) as primarily a managerial initiative, whereas the European Food Safety Authority (EFSA) has risk assessment policy development as a self-tasking activity. It is suggested by Ely et al. (2009) that policy development should be undertaken jointly by risk managers and risk assessors and as a matter of transparency in a democratic milieu, with inputs from a wide range of stakeholders.
Three stages in framing have been identified (Ely et al 2009):
1 Review: This is an on-going process of adapting and improving as a response within the global context of scientific and technical developments, socio-economic and political changes and new legislative requirements but also from own experience and insight. During the review process those activities that govern the selection and characterisation of the threat (harm), as well as criteria that are employed in screening, are included. Decision (policy decisions) are made regarding uniform risk assessment methodologies (approaches, principles), sufficiency of scientific and technical data and priorities for allocating resources to different aspects of screening, assessment and evaluation
2 Referral: This is the stage where the safety/risk problems are identified, and assessments formulated. The responsibility of risk assessors at this stage is to ‘screen‘ the product for the most appropriate approach for assessment.
3 Terms of reference: During this stage, uncertainties and data gaps are identified, as well as external experts and specific participatory procedures, if required. The questions are formulated to be addressed and guidance on management of the possible
In a study on risk assessment of chemicals of food and dietary importance, the Food Safety in Europe (FOSIE) Project, the framing step is described by emphasis on problem formulation. This is a process described by ‘planning dialogue‘ to clarify management goals, the purpose and scope of the assessment and the available resources to conduct the assessment. It is an iterative process that should undergo rigorous review by risk managers, scientific peers, and other stakeholders (Renwick et al. 2003, pp.1216 – 1217). The objectives include ‘harmonising principles applied to risk assessment, interpretation of data, consensus scientific transparency and justifiable issues in risk assessment issues and a description of the problem formulation with the outcome of a plan as the initial step in risk assessment. The process includes consideration of whether assessment is needed; who should be involved in the assessment and management; how it will provide information to the decision makers; whether data is available for an evaluation of risks; the level of available resources and a timeline for completion of the assessment. Specific information is described as a detailed inventory of prior knowledge and information on exposure such as the population and geographical area. Consideration should be given to relevance for the society and the range of health endpoints to identify quantifiable indicators or processes in risk characterisation. The assessment that follows should be such that scientifically sound and credible characterisation of the risk could be described, to make appropriate managerial decisions‘ (Renwick et al. 2003, pp. 1217-1218).

PAPERS PREPARED FROM THIS THESIS
CONFERENCE PRESENTATIONS
LIST OF ABREVIATIONS AND ACRONYMS
GLOSSARY
LIST OF FIGURES
LIST OF TABLES
ABSTRACT
CHAPTER 1: INTRODUCTION
General 1
1.2 Problem identification
1.2.1 Regulatory requirements: GMOs and new pesticide
1.2.2 Compliance costs and consequences of delays
1.2.3 Communication and capacity building
1.2.4 Trust in risk governance
1.2.5 Conclusion
1.3 AIM
1.4 OBJECTIVES
CHAPTER 2:  MODELS FOR GOVERNANCE OF RISKS.
2.1 Introduction
2.2 Good governance criteria
2.3 Characteristics of different governance models for risk analysis
2.4 Thoughts on the most advanced model 
2.4.1 SAFE FOODS Project
2.4.2 Framing
2.5 Historical development of the paradigm: risk analysis
2.5.1 General
2.5.2 Perspective on European risk governance of food
2.6 Examples of different structures
2.6.1 Reform in European countries
2.6.2 European Food Safety Authority.
2.6.3 United Kingdom
2.6.4 Argentina
2.6.5 Australia – New Zealand.
2.7  Centralised risk assessment initiatives in Africa
2.8 International organisations
2.8.1 World Trade Organization.
2.8.2 Organization for Economic Cooperation and Development.
2.9 CONCLUSION
CHAPTER 3:  A CRITICAL SCIENTIFIC REVIEW ON SOUTH AFRICAN GOVERNANCE OF GMOs
ABSTRACT
3.1 INTRODUCTION
3.2 METHODOLOGY
3.3 RESULTS AND DISCUSSION
3.3.1 Criteria
3.3.2 Functional separation between risk assessment and risk management
3.3.3 Scientific Excellence
3.3.4 Transparency
3.3.5 Participation
3.3.6 Limitations of the model
3.4 CONCLUSION AND RECOMMENDATIONS
CHAPTER 4: IMPROVING SOUTH AFRICA‘S GMO RISK GOVERNANCE BY CONSIDERING NEW ASSESSMENT APPROACHES: BIOFORTIFIED SORGHUM CASE STUDY
ABSTRACT
4.1 INTRODUCTION
4.2 SURVEYS ON OPINIONS OF STAKEHOLDERS AND SCIENTISTS
4.2.1 Aspects of the regulatory structure
4.2.2 Aspects affecting risk assessment
4.3 DELAYS
4.4 ASSESSMENT OF SOUTH AFRICAN GMO LEGAL INSTRUMENTS
4.4.1 The GMO Act
4.4.2 Application forms.
4.4.3 Food safety
4.4.4 Environmental safety
4.4.5 South African GMO guidelines
4.5 Case Study: Sorghum
4.6 Risk governance and risk assessment
4.7 Approach: comparative risk assessment
4.7.1 Substantial equivalence and comparative risk assessment
4.7.2 GM food safety
4.8 APPROACH: PROBLEM FORMULATON FOCUS ON ENVIRONMENTAL RISK ASSESSMENT
4.8.1 Theories about assessment of risks
4.8.2 Essence of the process in environmental risk assessment
4.8.3 Environmental risk evaluation, management and communication
4.9 CONCLUSIONS
4.10 PROPOSALS
CHAPTER 5: FOOD SAFETY: IMPORTANCE OF COMPOSITION: CASSAVA (MANIHOT ESCULENTA, CRANTZ)
ABSTRACT
5.1 INTRODUCTION
5.2 CONVENTIONAL FOOD SAFETY AND NUTRITIONAL LANDSCAPE
5.3 UNINTENDED COMPOSITIONAL DIFFERENCES
5.4 SAFETY/RISK ASSESSMENT OF GM FOOD
5.5 CONSIDERATIONS FOR COMPOSITIONAL ASSESSMENT OF FOODS FROM GMOs
5.6 ASSESSMENT OF METABOLIC PATHWAYS
5.7 CASSAVA STUDIES: CYANOGENIC GLYCOSIDES
5.8 NON-TARGETED TECHNIQUES: GENOMICS, TRANSCRIPT PROFILING, PROTEOMICS AND METABOLOMICS
5.9 DISCUSSION AND CONCLUSIONS
CHAPTER 6:  AN ANALYSIS OF THE PRECAUTIONARY PRINCIPLE: POSSIBLE UNINTENDED CHANGES IN ENDOGENOUS ALLERGENS IN GMOs
ABSTRACT
6.1 INTRODUCTION
6.2 DESCRIPTION OF TERMS
6.3 INTERNATIONAL AGREEMENTS AND LAWS OF PARLIAMENT
6.4 CORE OF THE DEBATE
6.5 ANALYSIS OF THE PRECAUTIONARY APPROACH (PRINCIPLE) AND ITS APPLICATION
6.6 ACCEPTABLE SOLUTIONS?
6.7 ADVANCED TECHNOLOGIES
6.8 ADDITIONAL STEP IN RISK ANALYSIS
6.9 ASSESSMENT OF ENDOGENOUS ALLERGENS
6.10 DISCUSSION
6.11 CONCLUSIONS AND RECOMMENDATIONS
CHAPTER 7: A MODEL FOR GMO RISK GOVERNANCE
7.1 INTRODUCTION
7.2 COMPARISON BETWEEN SOUTH AFRICAN RISK GOVERNANCE AND MODELS OF RISK GOVERNANCE
7.3 IDENTIFYING ELEMENTS FOR IMPROVEMENT OF SOUTH AFRICAN RISK GOVERNANCE
7.4 A GOVERNANCE MODEL FOR SOUTH AFRICA
7.5 IMPLEMENTATION
7.6 CONCLUSION
CHAPTER 8:  GOVERNANCE OF TOXICOLOGICAL ASSESSMENT OF PESTICIDES
ABSTRACT
8.1 INTRODUCTION
8.2 METHODOLOGY
8.3 RESULTS
8.4 DISCUSSION
8.5 CONCLUSION AND PROPOSALS
CHAPTER 9:  SUMMARY, CONCLUSIONS AND PROPOSALS
9.1 INTRODUCTION
9.2 ANALYSIS OF GOVERNANCE OF GMOs IN SOUTH AFRICA
9.3 APPROACHES TO RISK ASSESSMENTS.
9.4 A RISK GOVERNANCE MODEL FOR GENETICALLY MODIFIED ORGANISMS
9.5 TOXICOLOGICAL ASSESSMENTS OF NEW PESTICIDE MOLECULES
9.6 APPRAISAL OF THE MODELS
9.7 IMPLEMENTATION
9.8 RECOMMENDATIONS
REFERENCES

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