Volume 15: Government and Public Administration
5. Risk analysis: an analytical approach to policy-making
Risk analysis in MAFF - general approach

5.22 The description in the ILGRA Report of MAFF's approach to risk assessment noted that the Ministry used both quantitative and qualitative methods. Food safety standards, mostly determined internationally, generally involved tolerability limits based on scientific judgement. Microbiological organisms were mainly controlled by ALARP-based risk assessments. Regulation of animal diseases that might pose public health risks depended on whether the risk was well known. If it was, risk management was adopted (eg, quarantine). Where scientific knowledge was insufficient to quantify the risk - the Report cited BSE as an example - a precautionary regime was adopted and a 'decision framework' was developed, which analysed objectives as well as direct and indirect effects, and took full account of the multifaceted and complex nature of food safety. ¹

5.23 The Report recorded MAFF's view that:

1. safety-related Regulations had to balance protecting human health with the need to avoid imposing excessive costs on industry, ² and take account of public expectations, confidence and reputation, consumers' perceptions, uncertainty, and other qualitative factors as well as experts' judgement;
2. safety, although the prime objective, might have to be balanced with objectives such as ensuring fair competition;
3. safety benefits from regulation were often difficult to quantify; and
4. current regulatory regimes were complex and interacted with each other and with non-regulatory approaches such as industry codes of practice and information for the public. ³

5.24 As the Report also noted, MAFF used cost-benefit analysis (CBA), ⁴ but considered that while some risk assessments (eg, environmental risks) needed to include costs and benefits, this was not possible in other areas (eg, the release of genetically modified organisms).

5.25 Mr Brian Dickinson (MAFF, Food Safety) and Dr William Denner (MAFF, Food Science) told the Inquiry that, by 1988, MAFF had a 'well-ordered system for food chemical risk assessment': ⁵

For chemical risks in food (additives, contaminants and residues) there were well-established methods for assessing any toxicological risks and determining No Observed Adverse Effect Levels (NOAEL); after applying a suitable safety factor (often 100) the NOAEL was used to derive Acceptable or Tolerable Daily Intakes (used for additives and contaminants) and Maximum Residue Limits (for pesticides and veterinary medicines) . . . The broad thrust was thus to prevent any unnecessary risk in food. ⁶

5.26 However:

Microbiological contamination was approached in a very different way. The main problems were to identify the main organisms which might cause food poisoning, the foods which acted as vehicles for the organisms and the sources of contamination, the behaviour of the organisms in food and the factors which encouraged their growth or death . . . The emphasis was upon risk control rather than complete prevention (except for especially serious hazards such as botulinum toxin). Much more than for chemical risks, the emphasis was upon bringing businesses to assess and manage risks for themselves (and on reminding consumers what they should do). ⁷

5.27 Dr Denner indicated that the distinction arose from historical circumstances:

Prior to the onset of 'Listeria hysteria' and the salmonella in eggs incident, MAFF had largely left the whole area of microbiological food safety to DH. Although there were food scientists in the Food Science Group with extensive knowledge of the practical application of hygiene controls in various aspects of food manufacture, we did not have any mainstream microbiologists among the advisory staff in headquarters. There were however a limited number of microbiologists in our laboratories working on microbiological methods including a significant source of expertise on botulism in our Aberdeen laboratory.

As the political importance of microbiological food safety increased, a new Microbiology Branch was set up in my Division in 1989. It became necessary to second temporary staff from other parts of MAFF and the AFRC [Agriculture and Food Research Council] because the immediate need for staff in post outstripped the pace of recruitment of permanent staff from outside the Civil Service.

There was a marked contrast between the well-ordered system for food chemical risk assessment and that for microbiological risk assessment. There were no DH independent committees to which problems could be referred for advice. There was no co-ordinated system of surveillance as had been put in place on the chemical side by MAFF almost 20 years previously. Any microbiological surveillance carried out with Government funding was carried out by the Public Health Laboratory Service. ⁸

5.28 On the other hand, Mr Cruickshank (of MAFF) told the Inquiry that during the period 1986-89:

I do not think . . . we discussed risk assessment quite in those terms. More recently it has become a well-recognised term and the expression is well known and understood. I do not think at that point it was so well understood, and it was certainly rarely used. ⁹

He continued:

I think we tended to use another couple of legal concepts . . . in dealing with any risk, one would apply the concept of reasonableness . . . in some cases it was explicitly stated in legislation. In other cases the advice we got from our own lawyers was that anything we did had to be reasonable. That tended to mean it had to be based on scientific advice. If we were purporting to ban something, or restrict its use, we had to have pretty good scientific advice to suggest it should be banned or restricted, or whatever.

The other concept that came in [w]as a European law concept, the concept of proportionality which, as I understand it, basically means you do not use a sledgehammer to crack a nut. ¹⁰

5.29 In response to the question 'What happens if the scientific advisers say: "This is possible, but we have not got any evidence that it actually happens"?', Mr Cruickshank said:

Well, that is really what was happening with BSE of course. And it put us in a very difficult situation . . . nobody was saying to us: 'This disease is likely to be transmissible.' Therefore, we paused a long time before we classified BSE as a zoonosis. On the other hand, it did not stop us doing anything, of course. The fact that one does not have scientific advice does not mean one does nothing. One can try to avoid problems arising; but it does mean that one has great difficulty in banning the sale or use of a product. ¹¹

He agreed with the proposition 'the scientific advice must be that there is evidence that such and such occurs before the Government can act to stop it', commenting: 'Yes, that was the policy.' ¹²