Volume 6: Human Health, 1989-96
8. Development of guidance on occupational risks from BSE and other TSEs
Discussion
The factors in play
Was the response adequate?
Lessons for the future

8.190 Occupational risk was an urgent matter for consideration when BSE emerged. It involved what Dr Cawthorne termed 'physical' and 'infective' risks. By May 1988, HSE had sent a circular to their Inspectors on how to advise farmers and handlers about aggressive behaviour in infected animals. MAFF issued advice in July 1988 to their staff within the CVL and the VICs about safety precautions when handling animals and tissues. They followed this up with more detailed instructions in November.

8.191 However, these were far from being the only groups of workers exposed to risk. This chapter has reviewed what was done to advise the wide range of other workers who also might have been in contact with the BSE agent.

8.192 Two features of this story struck us particularly. The first was how long it took to issue simple warnings and advice even to those workers identified as at high risk. The second - which bore on the first - was the unsystematic way in which they were identified and decisions taken about who should contact them.

8.193 Why was this so? We thought there were several factors in play. Each of these is considered below. We go on to comment on the outcome so far as handling BSE was concerned and the lessons to be learnt.

The factors in play

(1) The system for preparing occupational guidance

8.194 Overall statutory responsibility for advising about risk to workers and ensuring adequate action rested with the HSE and the HSC. Intricate consultation arrangements applied under the legislation, involving not only HSE staff but also employers' and employees' representatives. A favoured method of operation was through codes of practice and guidance, which allowed flexibility of application. The emphasis was on the responsibility of employers to follow this through. HSE Inspectors advised, monitored known risks and how they were being dealt with, and where necessary prosecuted.

8.195 The HSE drew heavily on the advice of their expert advisory committees and groups. They also consulted and worked closely with 'sponsor' departments knowledgeable about the industries concerned and who had their own lines of communication with those working there.

8.196 These arrangements helped ensure advice was solidly based and workable. However, they meant that dealing with a complex issue could take considerable time. Thus, as this narrative shows, it took two years to agree advice to renderers.

(2) Ambivalence about who was in the lead in issuing guidance

8.197 The lead role in issuing guidance to specific groups of workers who might be affected by contact with the BSE agent was not clear-cut. Occupational risk and product risk were closely intertwined. Departments as employers were under a duty themselves to ensure the safety of their workers. Many regular channels of communication for specific categories of urgent information were in place between Departments and 'their' industries. MAFF was keen to use its own frequent contacts with individual trade organisations and professional bodies about all aspects of BSE to issue occupational advice. As they pointed out, it was MAFF ministers who were under fire on BSE and were expected to provide prompt advice.

(3) Limited HSE knowledge on slaughterhouses

8.198 The industries associated with animal slaughter were not traditional HSE territory. HSE saw them as a sphere where local authorities were in the lead. However, as discussed earlier in this volume and that on animal health, the responsibilities of local authorities were directed towards ensuring that meat products, rather than the workers themselves, avoided contamination. Although many of the handling and hygiene arrangements were relevant to both product and worker safety, the latter involved additional aspects, such as the risks from cuts or from inhalation. When MAFF pressed for immediate issue of advice to abattoir workers and knackeries, HSE were cautious about endorsing this until they were better informed on the practical considerations. A difference of view then developed between them and MAFF about what the advice ought to be. Similar considerations, though to a lesser degree, applied to other fields of work, notably veterinarians and butchers.

(4) Risk assessment and the Southwood Report

8.199 HSE were pioneers in the use of risk assessment in public policy making. Volume 15: Government and Public Administration illustrates the role they have played in developing this over the years in the public sector. Dr Gompertz described their approach to the real or potential risk as depending on an assessment of that risk and having to be 'reasonably practicable'. ¹ In 1996 they described this to the Select Committee on Agriculture as 'identifying all the hazards associated with the risk issue then expressing the likelihood that harm will be experienced by a specified population and what the consequences will be'. ²

8.200 These were still early days in developing their techniques and BSE, when it emerged, was a particularly intractable hazard to assess. They were faced with an animal disease of which the main apparent analogue - scrapie - did not infect humans working closely with sheep. The status of the BSE agent was likely to take years to establish. Meanwhile HSE lacked an information basis to apply the sort of structured risk assessment they were promoting as a basis for proportionate responses.

8.201 Their main source of information was the Southwood Report. While this was in preparation Dr Pickles had discussed with Dr Gompertz and his colleagues the occupational safety implications. The general view at that time was that BSE was only a hypothetical risk. In the discussions that ensued the view prevailed that it did not justify separate occupational guidance and (since it was not thought likely to be transmissible to humans) certainly not stricter precautions than those for recognised dangerous zoonoses.

8.202 When the Southwood Report appeared it was read by HSE, as by others, as indicating 'only a hypothetical risk'. Dr Gompertz told us:

I read the Southwood Report as soon as it was sent to me. My understanding from the report was that the risk to humans from transmission was thought to be remote from any route of transmission including accidental inoculation. It was not known even if there was any human hazard. ³

8.203 Dr Mayatt told us what she considered the key message to take from the Report, as regards occupational hazard:

Apart from ethical considerations (feeding of animal protein to ruminants), the changes of the rendering processes and the impact that has had on this area, the salient issue as regards occupational hazard was that the risk analysis was very much up in the air (ie whether or not BSE represented a risk in the occupational setting). ⁴

8.204 The Report did not specifically recommend action by HSE. The Working Party had understood from the exchanges between Dr Pickles and Dr Gompertz that they were already looking at the issues. Instead it simply recommended that HSE had the potential problems of BSE brought to their attention so that they could consider whether further guidance should be given. The press release was even lower key. It said HSE would be considering whether further action was necessary to ensure existing guidance was being followed.

8.205 It is plain from the way they approached the next steps that HSE did not feel they were being asked to carry out this work in a specially urgent or comprehensive way. MAFF soon began to press for discussion and issue of advice, in particular for farmers, slaughterers and those working at disposal sites. However, HSE interpreted this as a presentational rather than a safety problem. A terse manuscript comment by Dr Mayatt on the discussion that was eventually held with MAFF and DH on 9 June 1989 sums this up:

BSE and MAFF: media driven problems largely; MAFF has to be seen to be taking action. ⁵

8.206 Dr Matthews, for his part, referred after the meeting to 'the hitherto casual attitude of HSE'. ⁶

(5) Parallel review exercises

8.207 The 9 June meeting was the first of three meetings of the HSE task force specially constituted to follow up the Southwood Report, the HSE BSE Working Group. However, HSE also conducted two parallel exercises that bore on the preparation of occupational safety guidance about BSE.

8.208 The first was the preparation of guidance by the CDTFZ about the indications and appropriate safety measures for a selection of known zoonoses. Dr Gompertz told us that when he was first approached by Dr Pickles:

The approach from Dr Pickles came at a time when HSE had started to review the infectious diseases that might be transmitted from animals to humans in occupational settings, the occupational zoonoses. A cross divisional task force had already been established to do this. ⁷

8.209 BSE was excluded from this exercise as 'not proven', and the booklet that eventually appeared in 1993 did not refer to BSE. ⁸ It none the less figured on the task force's agendas, and action was discussed by the members. There was both a somewhat uncomfortable relationship and overlapping membership between its work and the deliberations of the HSE BSE Working Group, and in May 1990 it was decided to amalgamate the two. The nicety that BSE was still not considered by HSE to be a zoonosis was dealt with by an expanded title: the CTDFZ and BSE. This Group went into abeyance between October 1992 and December 1995.

8.210 The second exercise was a Working Group of the ACDP set up in February 1991 to prepare detailed guidance on the handling of TSEs. It was wound up on 24 May 1993. This guidance was inspired by the fresh interest in TSE research brought about by the emergence of BSE. We noted the new broader terms of reference for the ACDP which made its remit wider.

8.211 The exercise undertaken by the ACDP Working Group endured many vicissitudes and the guidance was not issued until September 1994. It gave comprehensive advice on precautions for work with all known TSEs, human and animal, including BSE. We discuss below the reasons for this 3 ½-year gestation period.

Was the response adequate?

8.212 With the exception of the ACDP guidance, HSE had completed by June 1992 the exercise of advising the main groups at risk, recommended by Southwood three years earlier. In June 1996 - outside the period covered by the remit of this Inquiry - the ACDP at the request of SEAC reviewed the principles of all the guidance so far issued to various occupational groups. They concluded that 'subject to some adaptation to specific occupational settings, the prudent precautions incorporated in the current guidance remain valid'. ⁹

8.213 This assessment did not, however, address the timeliness within which that advice had been issued. Unlike the safety of eating beef, concerns about worker safety had not attracted much public interest. The tempo of the action taken was decided by Departments either on their own initiative or in response to concerns that had been raised with them.

8.214 The HSE performed a useful unifying role on the content of the guidance that went out about BSE, since in most cases it was either issued under their aegis, or endorsed by them. Their overview role on assessment of occupational risk and maintaining a balanced approach meant it was rational for them to take a cautious line on any measures that were more rigorous than those being adopted for confirmed zoonoses. Their favoured approach to BSE was to reinforce general guidance and stress sensible working practices and precautions. As proponents of the application of risk assessment principles and a proportionate approach to hazards, this was a reasonable basis on which to seek to proceed.

8.215 However, unlike the approach adopted by DH in respect of medicines (discussed in vol. 7: Medicines and Cosmetics) of ranking the categories of risk as a guide to action, the HSE approach to worker safety did not appear to use any systematic ranking associated with the tissues and processes involved. Dr Mayatt described the list of occupational groups being arrived at by 'a brainstorming exercise. I do not recall an attempt to prioritise these groups.' ¹⁰ Dr Pickles rightly drew attention to this when the guidance for abattoirs was under discussion. Such an approach would, we believe, have been helpful in focusing action where it was most urgently needed.

8.216 Although the plan was that only general guidance would be issued, in practice the action had to be much more specific. Generalised guidance would have no practical impact. It was rightly agreed that advice would need to be tailored industry by industry, given the wide differences in processes involved and target audiences. There were different possible approaches to this. One was to issue a clear warning to alert those concerned, and to look to management then to develop and apply local codes of practice. Another was to issue direct advice about what should be done. Both these approaches were used to differing degrees though not, it would appear, on the basis of any predetermined strategy.

8.217 Hand-in-hand with this went the need to consider the timing of the preparation and publication of each piece of guidance. There needed to be clear perceptions about the most important hazards and how they should be dealt with. It appeared to us that this did not happen. Indeed, some of the highest-risk activities were dealt with only late in the process.

8.218 We considered in the light of the five background factors we discussed above whether the way the issue of guidance on occupational risk from BSE was handled was reasonable. All of them influenced what transpired.

8.219 However, we thought the determining factor was the HSE perception that DH, MAFF and the Southwood Working Party all believed the risk to humans to be remote, even from inoculation and before any precautionary measures were taken. Their sluggish initial response about meeting with MAFF and DH to discuss the remit laid on them while regrettable, was therefore not unreasonable. Their caution about agreeing to the issue of advice where they were not in a position to judge if it would be sustainable in practice was also not unreasonable and we do not criticise them for their approach.

8.220 Nevertheless, we are concerned that the outcome of the pace and attitude adopted was considerable delay in the issue of guidance to high-risk occupational groups. Some of the groups who waited longest to receive guidance were also in close contact with the highest-risk material.

8.221 Slaughterhouses were an area clearly needing urgent consideration and MAFF were right to press for this. We recognise the legitimate HSE concerns that advice MAFF proposed should be well-founded, their wish to establish their own base of knowledge and to ensure both sides of the industry were content with what was proposed. This was their established approach to preparing advice, using their advisory national groups. Accordingly we do not criticise the part they played in delaying the issue of guidance, though we think the consequent delay of several months was undesirable.

8.222 It is perhaps surprising that MAFF did not identify renderers handling cattle offal rather sooner, given that guidance to workers disposing of carcasses on tips had been an early concern. Moreover, the preparation of the guidance notes by HSE was long-drawn-out. However, there was continuous and intense dialogue with the rendering industry from the early days of the outbreak. The possible risks infected material posed for their workers cannot have escaped their members. The knackers' trade, and the use made by maggot farms and hunt kennels of unfit meat, were only belatedly recognised by Government as needing to be brought within their controls on BSE. We do not criticise the consequent delays in issuing occupational guidance to them.

8.223 In the case of the ACDP Working Group on BSE, the categories of worker involved were at particular risk of contact with highly infective tissue. We noted that when Dr Pickles was initially involved with the launch of the Working Group she commendably not only provided draft outlines of the scope of the document that might be prepared, but suggested a handling plan and timetable to enable it to appear at the earliest possible date. That timetable soon fell by the wayside and the process sank into a drafting morass.

8.224 Witnesses suggested a variety of reasons for this. They included uncertainty about appropriate decontamination procedures and about blood products, constantly emerging new information coupled with poor knowledge about thinking within SEAC, pressure of other work on the Secretariat and sidetracking into protracted drafting time on a professional letter of warning on neuro- and ophthalmic surgery procedures. Further delays were then incurred up to September 1994 though the document had been agreed in 1993, while DH finalised advice on at-risk patient groups 'inadvertently treated with CJD infected medicines or tissue grafts'. A background factor influencing the handling of the exercise was continuing debate, including controversy at a European level both over whether human TSEs were a Category 2 risk or, as some advocated, came in Category 3 requiring more rigorous safeguards. There was also debate over whether BSE should be categorised at all, as Germany, Austria and France had suggested, it being open to question whether it was a human pathogen. ¹¹

8.225 While all these help to explain why delay occurred, collectively they produced what seems to us a quite unacceptable delay. We have not in this instance embarked on the detailed exercise of attempting to identify whether individuals were responsible for this unfortunate outcome. It would have been disproportionate to do so. However, we must express our dismay that the sense of timeliness became lost. The system of refining drafts between DH and the ACDP Working Group, which met only infrequently, proved hopeless. Search for perfection in an area so uncertain as this was likely to be impossible to achieve. The best was again allowed to become the enemy of the good.

8.226 It seemed to us that one of the weaknesses in the way matters were approached was the absence of an overall framework within which the pathways of occupational risk could be systematically scrutinised and revisited. Had there been an audit of what happened to all bovine tissues of the kind we identify in vol. 7: Medicines and Cosmetics we believe this would have provided such a framework. This would, as one of its outcomes, have indicated the main occupational areas where handling advice needed to be provided. It would also have promoted the desirable process of establishing priorities, timing and responsibility for tackling them. A systematic and timetabled approach might then have been built into the exercise of issuing occupational guidance as a whole.

8.227 We also consider that, even if definitive judgements could not be made about risk, a degree of risk assessment could usefully have been applied by ranking the known points of exposure. This was, as we have noted, the approach used on medicines. Advice could then have been given about identifying hazard analysis critical control points (HACCP) in respect of working practices. The HACCP technique was later applied effectively in abattoirs to food hygiene risks.

8.228 A framework of the sort we are envisaging would also have been a ready means of identifying, as fresh information emerged, where occupational risk needed review.

Lessons for the future

8.229 We drew six general lessons from the way that BSE was handled in relation to occupational health.

8.230 (1) The best should not be allowed to become the enemy of the good. We saw great effort put into immaculate presentation and resolving all disagreements in documents. Admirable though these high standards are, the downside is that they can cause unacceptable delays. One witness put it graphically:

In a way, the Working Group was on a treadmill in the sense that any delay arising from the time needed to address a subject, or any other reason, was time during which new information became available requiring re-addressing subjects already dealt with. ¹²

8.231 (2) Established procedures while necessary should not be allowed to delay urgently needed action. It is good practice when producing guidance to involve as many of the parties concerned as possible. However, where speed is of the essence that may be counter-productive. Instead, it may be better if possible to issue initial guidance in prompt and simple form, to be later adjusted and amplified as necessary. Where normal consultation processes are short-circuited on grounds of urgency, this should of course be later explained and justified to those normally consulted. It will be necessary to reach a judgement in each case as to whether the situation is urgent.

8.232 (3) Establishing before a crisis arises where lead responsibility for advice lies is highly desirable. While HSE has overall responsibility for occupational safety guidance and the consistency and principles of the approach to this, we see no reason why Departments should not under standing arrangements take the lead on some matters. This should be explicitly agreed rather than leaving uncertainty and a degree of manoeuvring over who is calling the shots, and whose information system is to relay the agreed advice. In the case of a disease such as BSE we would see positive merit in advice clearly coming from a single authoritative source.

8.233 (4) Mixed messages are weak messages. Underplaying the reasons why action is needed can damage the outcome that the action is meant to secure. The importance of risk communication within and between Departments, as well as with the public at large, was inadequately recognised throughout the handling of BSE generally. This applied to advice on occupational safety issues as to other matters.

8.234 (5) Even where risk cannot be accurately assessed, it should be standard practice to categorise the matters that present the highest likely risk, and these should be dealt with first. This applies to occupational risks as much as to any other sorts.

8.235 (6) A properly constructed overview of what is being addressed overall should be drawn up and monitored. Where a threat that applies to a wide range of industries or activities is involved, a framework identifying the pathways for infection is essential and can provide a useful basis for establishing responsibility for action and setting timetables for its completion.