Volume 15: Government and Public Administration
5. Risk analysis: an analytical approach to policy-making
Risk analysis in the Department of Health

5.36 The ILGRA Report noted that DH used risk assessment when setting safety standards for medicines and foods, environmental hazards and medical equipment, and in addressing possible public health consequences. The approach was to examine end points such as mortality, morbidity, and societal costs, and to determine key areas for action on the basis of the scope for effective intervention and the possibility of setting objectives and targets. This was an equity-based approach, giving weight to the rights of the individual and the need to protect the weakest in society. Uncertainty was addressed by introducing safety factors (explained below) plus, where appropriate, the precautionary principle. ¹

5.37 DH also had methodologies for assessing exposure to certain hazards and its consequences. For example, an ADI or a TDI (see paragraph 5.13 above) could be obtained for a particular food chemical by dividing its NOAEL (paragraph 5.13) by a standard safety factor of 100 - a factor of 10 to account for uncertainties in extrapolating from animals to man, and a further factor of 10 to account for differences in susceptibility among the human population. ² Where an NOAEL was considered to be inappropriate, exposure was reduced until it was as low as reasonably practicable (ALARP). ³

5.38 Other evidence makes more explicit DH's caution about using quantitative methods in making microbiological risk assessments (MRAs). This was because:

1. for ethical reasons, effective dose response trials on humans (ie, trying out different levels of contamination and monitoring the reactions) were not possible;
2. most epidemiological studies would not provide appropriate dose response data;
3. the hazard associated with a pathogen and the extent of any consequential risk could vary between groups of people and according to physical conditions; and
4. experimental results might not accurately reflect what happened under natural conditions because pathogens could vary significantly in response to different environments. ⁴