Volume 15: Government and Public Administration
5. Risk analysis: an analytical approach to policy-making
Basic definitions

5.6 Risk assessment, the term most often used in the BSE documents, is one part of a joint FAO/WHO definition of risk analysis, which comprises

1. risk assessment - (a) hazard identification; (b) hazard characterisation; (c) exposure assessment; and (d) risk characterisation;
2. risk management - (a) risk evaluation; (b) option assessment; (c) implementation of management decision; and (d) monitoring and evaluation; and
3. risk communication - an interactive exchange of views with those involved or affected covering the whole process. ¹

5.7 There is a key distinction between a hazard and risk:

. . . hazard is an intrinsic property of, for example, a food chemical, whereas risk is a measure of the probability that the food chemical will produce adverse effects through the circumstances of human contact with it. ²

The same hazard may pose different risks - for example, the same dose of a particular poison may cause more virulent reactions in some groups of people than in others, because the former are more susceptible to it (for example, because of their age or for genetic reasons). Also, the nature of a hazard and the extent of the risks that it poses may only become known over time, as more is learned about its properties and potential pathways of infection.

5.8 Risk assessment and management involved the use of a number of concepts for which acronyms were often used. The following examples were particularly relevant to the BSE story.

5.9 ALARP (As Low As Reasonably Practicable) was 'inherent in the general duties of the Health and Safety at Work Etc Act 1974'. ³ This Act placed legal responsibility for the safety of workers and the public on the employer who controlled an industrial plant.

The injunction laid down in safety law is that any risk must be reduced so far as reasonably practicable, or to a level which is 'as low as is reasonably practicable'. ⁴

The Courts had expressed the view that the term 'reasonably practicable' was narrower than 'physically possible' and involved a degree of proportionality (see below) - ie, the benefit in terms of risk reduction had to be proportionate to the cost imposed (in terms of money, time, etc) by the measures needed to achieve it. ⁵ Also:

The ALARP principle may be taken for all practical purposes as indistinguishable from ALARA (so far as is reasonably achievable). ⁶

5.10 Hazard Analysis Critical Control Point (HACCP) was a three-stage system of control applicable to 'all stages of food manufacturing from raw material acquisition to product sale and consumption' ⁷ which:

1. described and assessed the hazards associated with all stages of the process;
2. identified Critical Control Points at which it was necessary to control these hazards; and
3. established procedures through which Critical Control Points could be effectively monitored.

The HACCP approach:

. . . shifts the emphasis from final product testing to process and raw material control . . . [it] has the potential to identify areas of concern where failure has not yet been experienced, making it particularly useful for new operations. ⁸

It was endorsed in 1990 by the Committee on the Microbiological Safety of Food (the Richmond Committee), firstly in connection with food manufacturing 'if properly carried out' ⁹ and later in relation to slaughterhouses. ¹⁰

5.11 The precautionary principle was defined in a number of ways. For example:

. . . it is better to be safe than sorry. ¹¹

. . . where the analytical basis for assessment of risk is weak, the lack of full scientific certainty should not be used as a reason for postponing cost effective measures particularly where there are threats of serious or irreversible damage. ¹²

. . . acting to reduce risk in advance of a complete scientific understanding, by extension of evidence and in the exercise of reasonable foresight. ¹³

5.12 The idea of proportionality, 'a European law concept', ¹⁴ was associated with the Government's Deregulation Initiative, described in Chapter 7. Regulation was to be 'aimed at the right target and [was to be] no more than is needed to achieve the objective', while 'risk management techniques are used when there is doubt about the level of risk and the type of regulation needed to deal with a problem'. ¹⁵

5.13 NOAEL (No Observable Adverse Effects Level) was used when licensing medicines or assessing risks in food from additives or residues. Other concepts were used when assessing certain kinds of risks:

1. ADI and TDI (Acceptable or Tolerable Daily Intakes) - in connection with the risks of additives or contaminants in food;
2. AOEL (Acceptable Operator Exposure Level) - in connection with the risks from pesticides; and
3. MRL (Maximum Residue Limits) - in connection with the persistence of chemicals in the soil, in water, or in food.

5.14 Risk perceptions were shaped by psychological and cultural factors, and might vary among different groups in society. Scientists tended to compare and rank different risks according to probabilities. The 'lay' public view might be more subjective, taking account of the novelty of the risks, the extent to which exposure to these risks was within their control, and whether the hazards were man-made or 'natural'. These varying views had to be reconciled, and risk communication was an important part of that process:

The best way of ensuring that the public and the experts understand each other is to explain the scientific issues and to give people the opportunity to make their views known. ¹⁶

5.15 Cost-benefit analysis (CBA) was a system of financial appraisal that also took account of external and non-monetary costs and benefits to individuals, organisations and society as a whole. It involved adding up the costs (in the wider sense just mentioned) of construction, operation, maintenance, etc, throughout the lifetime of a project or programme, converting them to present-day values by applying a discount rate, and treating the likely benefits likewise. If benefits exceeded costs, the project was worthwhile. CBA was traditionally associated with the appraisal of large capital projects (roads, airports, power stations, etc), but it could also be used to assess options for regulation or for managing risk, thereby forming part of the process of risk management.

5.16 In practice, it was not straightforward to apply the CBA approach. It was difficult to maximise benefits and to evaluate non-monetary factors or uncertainties. Moreover, seeking to attach monetary or other comparative values to human life, health and preferences was controversial and subjective, although it was necessary to attempt this if the costs and benefits of precautionary regulations and procedures were to be assessed. In doing so, the aim was not to calculate 'compensation' for the loss of a life (which would be impossible), but to assess:

. . . the value to be attached to a small reduction in risk that would result in the saving of a life as it relates to an unknown individual. ¹⁷

5.17 Sensitivity analysis was the process of assessing the effects of different assumptions about the future and their likelihood. ¹⁸ It provided a means of testing the robustness of a chosen course of action and identifying ways of proceeding if things went wrong.