Public summary of the meeting on
28th November 2000

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The Spongiform Encephalopathy Advisory Committee (SEAC) met in London on 28 November 2000.

BSE Inquiry Report

SEAC had a first consideration of the Phillips Inquiry, and concentrated on the report's findings on Advisory Committees. A detailed summary of the discussion and conclusions is given in the Annex to this Public Summary. Key conclusions reached were the need to clarify with Departments the role of SEAC in explaining issues to the public in addition to giving advice to Ministers; to draw the public's attention to the lack of knowledge in some areas; to be more pro-active in identifying problems that might be discussed, rather than mainly relying on Government Departments to draw up the agenda; to be more up to date and open in identifying conflicts of interest; and agreement that SEAC's advice should relate to scientific aspects and that the Committee should not stray or be asked to stray into wider policy areas outside of the remit of the committee. There was also recognition of the problem of overcrowded agendas, the consequences of which would be helped but not solved if papers were circulated earlier.

Members were asked to let the secretariat know by 15 December if there were other items from the Phillips Report which they would wish to discuss at future meetings.

Members were updated on the independent scientific assessment of the origin of BSE which was being jointly commissioned by the Minister of Agriculture and the Secretary of State for Health against the background of the significant amount of public interest. SEAC considered that it was important to keep an open mind on this matter which would be difficult to resolve unequivocally one way or another.

Sheep surveillance

SEAC received an update on progress towards launching next year the first phases of the Government's National Scrapie Plan and were asked to consider further risk reduction strategies to address the theoretical possibility that BSE might be present in the national flock. At its meeting in May 2000 Members had agreed that improved understanding of the genetics involved in disease susceptibility could be exploited to devise intervention strategies to reduce the prevalence of scrapie infection and that early consideration should be given to a targeted breeding programme. During the current discussion, however, concern was expressed by some Members that a breeding programme based on the selection of a limited number of genotypes might result in the reduction in the incidence of clinical disease but have little effect on the level of sub clinical infections. It was suggested that rather than breeding for resistance to scrapie infection, what was needed to protect public health was a highly sensitive test for TSEs that could be used to screen all carcases going into the food chain for signs of infection. On the other hand, it was argued that there was already a large body of published evidence to indicate that genotyping could be used as an aid in genetic selection to reduce the level of infection as measured by the ability to detect the presence of the abnormal prion as well as the level of clinical disease in the sheep flock and that this ought to be pursued now as an option. It was also suggested that as a guiding principle in animal disease control, it was normally better to rely on methods which reduced the level of a disease in animals that might enter the food chain rather than rely on end product testing for disease in animals as they enter the food chain. While research so far had not found evidence of sub clinical infection in resistant sheep, the methods used were not necessarily sensitive enough to find it. Rapid methods of sufficient sensitivity could take a long time to develop.

SEAC decided to set up a small sub group urgently to review the evidence in an attempt to agree its approach both on the fundamental principles inherent in the National Scrapie Plan, and on certain detailed aspects of it. If necessary, this would need to be followed quickly by a special full SEAC meeting.

Research is currently underway to check whether or not BSE is or has been present in sheep. SEAC was asked to advise on the criteria that might be used to define unequivocally whether a sample contained BSE or not, given the need to distinguish BSE from strains of scrapie that have similar characteristics. The Committee concluded that, from a scientific viewpoint, a single case of apparent BSE would not normally be regarded as a reliable indicator of whether BSE was in the sheep population at the time of sampling, although, on public health grounds, precautionary action might needed to be taken in such a situation. However it would be desirable for the case to be diagnosed as positive by all of the tests available.

Rendering condensate

In June 1999, SEAC advised that, "Rendering condensate should no longer be spread on any land, and not just those fields where cattle might graze". SEAC was asked whether its advice applied to both surface spreading and soil injection of untreated condensate, whether it applied to both untreated and treated rendering condensate, and whether or not the nature of the raw material from which the rendering condensate is derived affected the position. Background information given to SEAC included a risk assessment (95 KB) by the Water Research Centre which concluded that treatment of condensate produced from the highest risk raw material could reduce the risk to acceptable levels even under the worst case conditions assumed. In discussion, however, SEAC questioned whether there was evidence that treatment did in fact remove the assumed levels of infectivity. This needed to be checked before SEAC could support the spreading of treated rendering condensate to agricultural land. SEAC did not see any difference between the risk from surface spreading and soil injection - neither seemed acceptable for untreated condensate. The nature of the material being rendered did, however, significantly change the risk presented by the condensate. Finally, SEAC supported a proposed investigation of the wider pathways for disposing of waste from rendering plants and similar processes.

Surgical instruments

The Committee were informed of the Department of Health's strategy to combat the theoretical and presently unquantifiable risk of person to person transmission of vCJD via surgical instruments. A major initiative had been launched to improve standards of washing, decontamination and general hygiene, earlier identified by the Committee to be key steps in reducing risk. This would take some time to yield results. In the meantime, single use instrument sets for tonsillectomies were likely to be introduced in the first instance.

The Committee welcomed the overall risk reduction strategy and the advances being made on decontamination. The committee also endorsed the concept of using tonsillectomy as a pilot scheme to see how single-use instruments would work in practice. In addition, the Committee recommended that the introduction of single-use instruments for other higher risk procedures should not be abandoned; that instrument labelling and tracking should be improved; that the monitoring of decontamination procedures should be both frequent and robust; and that it would be desirable for the reforms outlined to encompass private and military hospitals as well as the NHS.

CJD Incidents Panel

The Committee was informed about a new CJD Incidents Panel that has been set up as a sub group of the Advisory Committee on Dangerous Pathogens/SEAC Joint TSE Working Group. This panel assists health authorities and clinicians managing incidents of potential transmission of CJD and vCJD between patients through clinical interventions. The panel advises on the management of the potential risks including withdrawing instruments and informing patients who may have been exposed to risk. The Committee took note, and were of the view that the mechanisms being put in place for handling such incidents would need to be able to demonstrate rapid and effective response to incidents as they emerge. This could be aided by the formation of generic approaches developed through experience of considering individual incidents

BSE epidemiology update including other countries

SEAC was informed that the GB BSE epidemic in cattle continued to decline broadly in line with forecasts, with confirmed cases around 45% lower so far this year than during the same period last year. The number of 1996 born cases remained at 3 in GB, of which just 1 had been born after the August 1996 feed ban, plus 1 in Northern Ireland. Meanwhile, the number of reported cases in France had risen sharply, and 2 cases had been reported both for Spain and for Germany.

The FSA updated SEAC on the statements it had recently made, and the actions it had undertaken in relation to imported beef. These included pressing the European Commission to introduce compulsory labelling of country of origin of all meat products, including processed products; asking enforcement authorities to step up spot checks on beef imported into the UK; and considering the need to tighten regulations governing imported beef and the enforcement of the over thirty month rule, especially in relation to meat products. FSA officials would be making a fact finding visit to Paris the next day.

In discussion, SEAC registered its concern about the rising incidence of BSE in other European countries. Particular concern was expressed about the risk resulting from the difficulty of enforcing the Over Thirty Month Rule on imports, and the lack of a consistent application of that rule to all meat and meat products. A risk assessment was suggested in relation to younger animals in countries with rising BSE levels. Finally the Committee noted that a SEAC sub group would be meeting the Chairman of the FSA on 5 December to look at risk and risk issues.

Update on BSE modelling

Professor Roy Anderson of Imperial College updated SEAC on recent modelling work, not yet published, by his group. Allowing for a 60% reduction in maternal transmission cases due to the Offspring Cull, this group's estimate of the number of animals entering the food chain in GB within 12 months of developing clinical disease, assuming 10% maternal transmission, had now fallen to 0.8 animals this year (i.e. "probably less than 1") and 0.5 animals in 2001 (with specified risk material removal rules safeguarding public health even in those cases).

vCJD update

The Committee conducted its regular review of epidemiological information on vCJD. The Committee was informed that the total number of cases of confirmed and probable cases of vCJD now stood at 87, of which 5 were still alive. Four cases are known to have occurred abroad (1 in Ireland and 3 in France, including 1 probable case in France). The implications of a case of vCJD in a 74 year old were discussed. These included the possibility that the low autopsy rate among the elderly who have suffered from dementia could mean some cases were not being identified. The Committee were informed of research underway to investigate this, and that further vCJD disease modelling was now in train to allow for a wider age range of cases.

Investigation into vCJD cases in Leicestershire

The Committee was updated on the investigation into 5 vCJD cases in a part of Leicestershire. Surveys of local residents had been carried out and a local case control study is underway. A final report is anticipated in March 2001.

The Committee was also informed of work underway by the National CJD Surveillance Unit, the Public Health Laboratory Service and local Consultants in Communicable Disease Control, in conjunction with the Department of Health, to agree a more systematic approach to investigations of potentially linked cases of vCJD.

Timing of publication of agendas

SEAC agreed that, from now onwards, their agenda will be published 1 or 2 days before the Press Conference following each meeting as an attachment to the operational note for journalists. This would give advance notice of what had been discussed.

R&D updates

The R&D updates by the Department of Health and by the Ministry of Agriculture were postponed due to lack of time.

Review of BSE controls

Members noted that the Food Standards Agency's review of BSE controls would be finalised just before the end of the year. The FSA also tabled a paper on private kills and invited Members to comment by correspondence as there was insufficient time to discuss this item at the meeting.

Next meeting

The next meeting of the Committee will be held on 28 February 2001. The Press Briefing for this meeting will be held on 21 March when the public summary of the Committee's discussions at that meeting will be published.

SEAC
December 2000

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ANNEX

BSE Inquiry Report:  Key points discussed by SEAC and draft conclusions on them

1. Inquiry's finding: an Advisory Committee should explain the reasoning on which their advice is based. (Volume 1, para .1275).

SEAC considered whether the current method and language of giving SEAC advice via Public Summaries or attachments to Public Summaries is satisfactory. In discussion it was suggested that all SEAC meetings might be held in public in the interest of greater openness and of increasing the public's understanding. On the other hand, it was argued that this could inhibit SEAC's think tank function, for example in relation to pre-publication scientific information, and that it could expose the Committee to pressure and lobbying. The Committee concluded by noting that it had already made some progress towards greater openness, e.g. in the Public Summaries, Press Conferences, and more recently by publishing its agendas. More, however, could be done including making the Public Summaries more detailed, and by giving more flavour of the discussions. It was also intended to hold a public meeting in September 2001, which would be a useful pilot for possible subsequent open meetings. Finally, SEAC wished to clarify with Departments its role in explaining TSE issues to the public, as opposed to limiting itself to giving Government Department scientific advice.

2. Inquiry finding: an Advisory Committee should not water down its formulated assessment of risk out of the anxiety not to cause public alarm (Volume 1 para .1275).

SEAC considered whether this happened at present. The Committee concluded it was important not to hide uncertainty. They decided to aim to be more pro-active in drawing attention to areas where there are gaps in scientific knowledge, and to be more clear in future about what they knew and what they did not know.

3. Inquiry finding: contingency planning is a vital part of Government. The existence of Advisory Committees is not an alternative to this. The Advisory Committees should, where their advice will be of value, be asked to assist in contingency planning.

SEAC considered whether it was sufficiently pro-active on contingency planning. The Committee concluded that it should have a role in identifying up and coming problems that should be brought to the attention of Government Departments rather than, as at present, relying solely mainly on Government Departments to identify the issue which it should discuss.

4. Inquiry finding: the terms of reference should specify with as much precision as possible the role of the Committee. (Volume 1, para .1291).

Specifying the role of SEAC in relation to advising the public was relevant also to the finding.

5. Inquiry finding: potential conflicts of interest should not preclude selection of those Members otherwise best qualified, but conflicts of interest should be declared and registered. (Volume 1, para .1291).

The Committee identified a problem in that, while Members' interests were publicly declared in the SEAC Annual Reports, the information was historical and could be up to a year out of date. The Committee therefore agreed that, in future, a list of up to date interests(27kb pdf) should be made publicly available on the website, and that attention to this should be drawn in the Annual Reports. The Committee also agreed that Members should make public information on grant applications that represented a potential conflict of interest in addition, of course, to research work already underway.

6. Inquiry finding: where advice is required only on those ingredients of a policy decision which fall within the particular expertise of the Committee, questions should be formulated with precision to achieve that result. (Volume 1, para .1291).

The Committee considered whether it was being asked specific enough questions and whether they are scientific (as opposed to policy) questions. The Committee concluded that there should be more emphasis in future on ensuring that the questions put to it were essentially scientific ones, and likewise its answers.

7. Inquiry finding: advice should be in terms that it can be understood by a lay person. (Volume 1, para .1291).

The Committee considered whether SEAC Members Chairman participate in public debate as individuals or as SEAC Members. It concluded that Members participated as SEAC Members only when making formal statements on behalf of SEAC, notably at the SEAC Press Conferences and during interviews associated with those conferences. At other times, Members spoke as individuals.

8. Inquiry finding: the advice of the Committee, together with any papers necessary for the full understanding of that advice, should be circulated to all within Government with responsibility for policy decisions in respect of which the advice is relevant. (Volume 1, para .1291).

Although this finding is directed at Government rather than at Advisory Committees, SEAC considered the parallel question of whether it received sufficient information to make informed decisions. It concluded that the standard of papers was normally very high and that the literature service it received was excellent. However, Members felt strongly that they needed more time to consider papers - at least one week - than was given them at present.

9. Inquiry finding: the advice of the Committee should normally be made public by the Committee. (Volume 1, para .1291).

SEAC considered the problem of handling interim scientific results that have not been peer reviewed. The Committee concluded that they would not normally expect to have access to such information. However, there might be exceptional cases where the authors felt that the matter was of sufficient interest that SEAC should be given advance notification of it. This would include cases where SEAC's expertise would be useful. However, normally such information should be kept confidential. Considerable importance was attached by SEAC to the peer review process.

10. Additional question not linked to specific Inquiry finding.

SEAC considered whether the heavy agendas for SEAC meetings are a problem and whether anything could be done about this. The Committee concluded that the agendas were normally too heavy. This could be alleviated partly by prioritising items for discussion, and partly by circulating papers sooner. The length of the daily meetings might need to be extended, but two day meetings should be avoided if possible.

11. Additional question not linked to specific Inquiry finding.

SEAC considered its role regarding TSE research. The Committee agreed that its role was not to co-ordinate research or to identify all gaps. That should be a role more for the Joint Funders Group. SEAC's role is to identify potential gaps in research, but it cannot be comprehensive in this.

SEAC
December 2000

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