Memorandum

Richard North

1 May 2002

Subject: FMD Contingency planning

 

 

 

 

There can be no serious question that effective contingency planning is vital to the successful control of foot and mouth disease epidemics. Given the vital nature of this activity, there seems to be a strong case for evaluating the roles of the Commission and member states in the preparation, approval and adequacy of the plans actually produced in the EU area - and the provisions made for their implementation.

 

Having regard to the Temporary Committees mandate, and in particular its requirement: to analyse the management of the foot-and-mouth epidemic and the implementation of Community law in this regard to date; and to make proposals to look into vaccination policy in particular and for political and legislative initiatives with regard to the prevention and fighting of diseases in the agricultural sector in general, these aspects of the epidemic management seem clearly within its remit.

 

Legal base

 

Member states are, by virtue of Article 5 of Directive 90/423/EEC, required to submit to the Commission contingency plans for dealing with foot and mouth disease. Furthermore, the criteria for the contingency plans are set out in Commission Decision 91/42/EEC, which must be applied. Additionally, the Commission was empowered to adopt recommendations setting out explanatory notes on the criteria, which had to be published. Two documents were produced:

 

VI/5211/95 - Contingency plans for epidemic diseases

VI/6319/98 - Guidelines for FMD contingency plans in non-vaccinating countries (now redesignated XXIV/2655/1999)

 

The Commission responses

 

The Commission has already been questioned on aspects of the contingency planning and has offered draft responses[1].

 

In particular, the Commission was asked whether the contingency plans took account of the possibility of the detection of an uncontained epidemic and made/ facilitated appropriate responses[2]. Its response was that no member state had based its contingency plan on more than 2000 outbreaks with about 50 new outbreaks per day for several weeks. The whole calculation made for the European Union in preparation of Council Directive 90/423/EC estimated in a worst case scenario 13 primary outbreaks, each with 150 secondary outbreaks, throughout the community over 10 years. Experts of the FAO-EUFMD Research Group had also estimated that the likelihood of virus introduction into the United Kingdom, Ireland but also Sweden and Finland would be extremely low.

 

On this basis, the Commission considered that it could not be reasonably expected from any member state to design a contingency plan causing more outbreaks within months than the ten years estimate for the whole community.

 

Additionally, the Commission has been asked whether it considered that the contingency plans "were adequate to deal with the outbreak, particularly in relation to the UK outbreak", to which the Commissions response was:

 

"There have been several missions carried out by the Commissions Food and Veterinary Office in the UK during the recent crisis to evaluate the implementation of Community and national legislation on FMD control. There have been no major flaws found"[3].

 

Analysis

 

In its guidelines for foot and mouth contingency plans[4], the Commission itself refers to three classes of outbreak: the isolated outbreak; the outbreak of middle severity; and a "very large" outbreak in dense areas. In another authoritative report[5], dated 1999, the authors consider the risk of foot and mouth disease for Member States "remains extraordinarily high" as a consequence of:

 

7        the presence of countries where foot and mouth disease is endemic on the periphery of the EU;

7        the possibility of illegal introduction into the EU, because of price differences, of infected animals, especially sheep/goats, or meat, meat products, milk and milk products contaminated with foot and mouth disease virus;

7        the movement of tourists and migrants from infected areas which may carry infective fomites.

 

Considering just these two sources, without even resorting to common-sense prudence, a very good case was being made for the preparation of contingency plans which took account of the possibility of a very large outbreak in a high density livestock area at any time.

 

Then, in an American academic newsletter published in 1998[6], the question was addressed: What if a highly contagious livestock disease-foot-and-mouth disease suddenly appeared in California? The newsletter referred to a publication entitled: "The Potential Impact of Foot-and-Mouth Disease in California". The author was Javier M. Ekboir, formerly a post-doctoral fellow in the Department of Agricultural and Resource Economics at UC Davis. (Then with CIMMYT in Mexico City.) Ekboirs project was in cooperation with the UC School of Veterinary Medicine, and was supported by the California Department of Food and Agriculture.

 

In his paper, he postulated that the chances of such a disaster were unknown, but may be increasing because of "more intensive international travel and trade" (A scenario which applied equally to the EU member states). In the past, outbreaks in FMD-free zones had been commonly met with "stamping-out" programs - which meant slaughtering all exposed as well as all infected animals, cleaning and disinfecting all livestock premises, and then waiting to be declared FMD-free again. That was the official policy in California.

 

But a crucial finding of Ekboirs model scenarios was that, in an area crowded with livestock such as Tulare County, a day or two delay in diagnosing the disease, establishing a quarantine zone, and starting the stamping-out program could make the difference between a contained outbreak and a statewide economic disaster. "The opportunity for decisive intervention lasts only one week," he emphasised. On this basis, it is clear that the possibility of a large, uncontained epidemic had been considered in 1998. By no stretch of the imagination could it be considered an unrealistic scenario against which it would be unreasonable to make any planning provision.

 

If the experts on which the Commission relied are worthy of their name, then they must have foreseen a similar possibility in any member state, especially in the context of the implementation of the Single Market, which encouraged intra-community trade. If they failed to do so, then there is a case for arguing that this represented a major failing on their part. In this event, there is some justification for examining the adequacy of expert advice on which the Commission relies, and its judgement in choosing its sources of expertise.

 

If they did foresee the possibility of a large, uncontained epidemic, then the Commissions claim that member states "could not be reasonably expected from any member state to design a contingency plan causing more outbreaks within months than the ten years estimate for the whole community" was either disingenuous or dangerously complacent. In any event, it could represent a major failure on the part of the Commission to communicate an entirely reasonable scenario against which it was not only reasonable but necessary to plan and thence to ensure that suitable provision was made for this scenario in member state contingency plans. Clearly, there is scope for further investigation of this issue.

 

Actual contingency planning

 

All fifteen member states submitted contingency plans to the Commission, which were approved on 23 July 1993 (Commission Decision 93/455/EEC). They should have been framed in accordance with ten criteria specified by the Commission for contingency plans (Commission decision 91/42/EEC), as follows:

 

1. the establishment of a crisis centre on a national level, which shall coordinate all control measures in the Member State concerned;

2. the provision of a list of local disease control centres with adequate facilities to coordinate the disease control measures at a local level,

3. the supply of detailed information about the staff involved in control measures, their skills and their responsibilities;

4. each local disease control centre must be able to contact rapidly persons/organizations which are directly or indirectly involved in an outbreak;

5. equipment and materials shall be available to carry out the disease control measures properly;

6. detailed instructions shall be provided on action to be taken on suspicion and confirmation of infection or contamination, including proposed means of disposal of carcases;

7. training programmes shall be established to maintain and develop skills in field and administrative procedures;

8. diagnostic laboratories must have facilities for post-mortem examination, the necessary capacity for serology, histology, etc., and must maintain the skills for rapid diagnosis. Arrangements must be made for rapid transportation of samples;

9. details shall be provided of the quantity of foot and mouth disease vaccine estimated to be required in the event of a reinstatement of emergency vaccination;

10. provisions shall be made to ensure the legal powers, necessary for the implementation of the contingency plans.

 

An immediate issue here is whether these criteria, in themselves, were adequate guidance for what is, in fact, a complex undertaking. For instance, entirely missing is any reference to preparing strategies for different eventualities. Yet, presumably, these were the criteria against which the member state plans were judged. If the criteria themselves were inadequate, the question must be asked as to why that was the case - for a well-known disease where there is more than adequate experience and expertise in control measures

 

That notwithstanding, the Food and Veterinary Office (FVO) then undertook a programme of evaluating the adequacy of these plans, beginning with Belgium in 1999, covering Finland, Sweden, Portugal, Austria and Germany in 2000. One inspection was carried out in Spain, finishing on 16 February 2001. An inspection was planned for the United Kingdom in 2001 but the epidemic intervened. It is now planned for 28 October - 1 November 2002. An immediate query must be why, when the Commission experts apparently considered Finland and Sweden to be "low risk", these countries were inspected at such an early stage in the programme.

 

It should then be noted that, by the time of this exercise had commenced, DGXXIV had issued more detailed guidelines on foot and mouth disease contingency plans which, inter alia, required that: "Scenarios must take account of the needs to take more extensive measures than the basic package of measures laid down as obligatory in EU legislation"[7]. It added: "It is very well possible that additional measures may be taken to prevent a local outbreak becoming a disaster". Clearly, the guidance offered was pointing member states in the direction of planning to avoid a major outbreak, an outbreak which must have been greater than in the 1/150 scenario claimed by the Commission as worst case scenario to be used as the basis for their plans.

 

As to the adequacy of the UK plan, what comes over very with very great clarity from the Commissions response is that question was not answered. Evaluating the implementation of Community and national legislation is not the same as evaluating the adequacy of the contingency plan.

 

Furthermore, the finding of "no major flaws" sits ill with the Response from Institute for Animal Health (IAH) to call for detailed evidence by the Royal Society Inquiry into Infectious Diseases of Livestock, which asked: How effective is the present national infrastructure and logistical support? The IAH response was: "The chaos at the start of the epidemic clearly showed that the national infrastructure and logistical support was inadequate for dealing with an epidemic of the scale encountered", a perception with accords with the experience of many commentators at the time. Crucially, the Commissions view also does not accord with the view of the UK government, viz Lord Whitty in the House of Lords who stated:

 

"the contingency plan provided the general overview by which we responded to the disease part of the problem with the original contingency plan was that we assumed that we were faced with a new outbreak, whereas in fact the outbreak had been spreading for some considerable time due to the trading patterns within the industry at the time Therefore, it was implemented in line with what we had told the European Commission. Since then, in some respects we have had experience of some of the shortcomings of that plan"[8]

 

He then added: "In the event we were dealing with the kind of outbreak that was not really covered by the contingency plan".

 

A possible explanation for this variance in viewpoints is that the Commission approved the contingency plan, which determined in part the "national infrastructure and logistical support" and is not, therefore, an impartial actor. If it agreed that the contingency plans were inadequate, then it opens itself to criticism as to why it approved them in the first place. Thus several questions remain to be satisfactorily answered:

 

1.      Was the contingency plan adequate and, if not, why not?

 

2.      Could or should the contingency which did arise in the UK have reasonably been predicted?

 

3.      If it could or should have been predicted, why wasnt it?

 

4.      If it was predicted, why was no provision made for it in the contingency plan - did the failures lie at European level, the member states or both?

 

5.      How can systems and decision-making be improved to ensure that predictable contingencies are adequately planned for?

 

Furthermore, since the Commission approved the plan in 1993 yet only commenced an evaluation programme six years later, it is appropriate to question the validity of the approval process and/or the reason for the delay in carrying out evaluations. Surely these should have been done before approval? Then, if the FVO, with its missions on the ground at crucial times during the epidemic, apparently failed to note the "chaos at the start of the epidemic", it would seem necessary to question the competence (or terms of reference) of the officials concerned. These are issues that the Temporary Committee could with some validity consider.

 

The vaccination question

 

Central to the whole consideration of the adequacy of contingency plans is the question of emergency vaccination. Here, it will be recalled that there was considerable public debate in the UK on whether this option should be employed, with clear evidence of vacillation on the part of the UK government. Yet, in the Commission guidelines, it is clearly stated that:

 

"Each Member State shall have available detailed plans for emergency vaccination. Member States should decide in advance the criteria that would apply before embarking on this strategy"[9].

 

Determination of the criteria was undoubted assisted by the Report of the Scientific Committee on Animal Health and Animal Welfare[10], which advised that the rationale for using emergency vaccination for foot and mouth disease was:

 

1. Fear that after the introduction of FMDV into a free region, it may spread out of control; In particular, outbreaks in areas containing high densities of susceptible animals and inadequate resources of manpower or rendering plants for the slaughter and disposal of animals or outbreaks involving a predicted risk of airborne virus spread beyond the protection zone;

 

The Report was of further assistance in providing what amounted to a check-list to aid decision-making, which is reproduced below:

 

Table 1 - List of criteria for consideration in decision-making related to protective emergency vaccination

 

Criteria

For vaccination

Against vaccination

Population density of susceptible animals

High

Low

Clinically affected species

Significant number of pigs involved

Predominantly ruminants

Movement of potentially infected animals or products out of the protection zone

Evidence

No evidence

Predicted airborne spread of virus from infected premises

High

Low or absent

Suitable vaccine

Available

Not available

Origin of outbreaks (traceability)

Unknown

Known

Incidence slope of outbreaks

Rising rapidly

Shallow or slow rise

Distribution of outbreaks

Widespread

Restricted

Public reaction to total stamping out policy

Strong

Weak

Acceptance of regionalisation after vaccination

Yes

No

 

 

By any objective assessment, in the early days of the epidemic, the situation would have "scored" at least seven out of the "for vaccination" ten criteria, in which case conformity with the advice given would have strongly indicated that an emergency programme should have commenced. Here, the Commissions guidelines are of further assistance[11] in that they state:

 

"Since in general there is a large lag phase before they exert an effect, the measures have to be taken as early as possible during an outbreak".

 

Further direction toward the implementation of an emergency vaccination strategy can be gleaned from the recitals of Commission Decision of 30 March 2001 (2001/257/EC) laying down the conditions for the control and eradication of foot and mouth disease in the United Kingdom in application of Article 13 of Directive 85/511/EEC, where it states:

(5) In addition to the measures within the framework of Directive 85/511/EEC, the United Kingdom apply the pre-emptive killing of susceptible animals in holdings situated in close proximity to infected or suspect holdings, taking into account the epidemiological situation, the high density of susceptible animals in certain parts of the territory and the poor expression of clinical signs in certain susceptible species.

 

(6) Killing of animals for disease reasons must be carried out in accordance with Council Directive 93/119/EEC of 22 December 1993 on the protection of animals at the time of slaughter or killing (8).

 

(7) Large scale killing of animals of infected or contaminated holdings may quickly exhaust the capacities for safe destruction of carcasses and thereby unavoidably delay the pre-emptive killing and this may lead to the amplification and spread of the virus.

 

On this basis, the permission was granted for the United Kingdom to carry out emergency vaccination in certain areas. But, when questioned as to why the option of ring (sic) vaccination had not been used, the Commission replied that:

 

"It was impossible to lay down an appropriate vaccination strategy, taking into account that vaccination does not prevent from stamping out of infected and in-contact premises in accordance with EC legislation"[12]

 

On a website dedicated to the foot and mouth crisis[13], however, the following comment is posted:

 

"We are frankly quite sickened to hear the string of excuses as to why the UK did not vaccinate - in particular the mischievous (because wilfully inaccurate) statements of some scientists in this country who loudly reiterate that "the disease had spread too far for vaccination to have been of any use in bringing the disease under control". Uruguay illustrates quite dramatically how vaccination was precisely the tool to use in that situation. This is just the point that must be made again and again - that the uncontained, multiple focus epidemic with unknown foci and uncontained spread is precisely the circumstance when vaccination should be used".

 

Here, it must be recalled that, prior to the 2001 epidemic in the UK, vaccines had been used successfully for the control of outbreaks in Bulgaria (1994), Thrace province of Turkey (1995, 1996), Macedonia (1996) and Yugoslavia (1996) and in South-Africa (2000).

 

Then, in Uruguay in 2001, an epidemic broke out which lasted from the end of April until the end of August. The incident rates were comparable with those of the UK in 2001 and were about 50 per day one month after the outbreak. At this point vaccination of all the cattle was started. There was no slaughter on infected farms because the farmers resisted the idea. Instead, animals were quarantined and there was a standstill of animal movement. Almost 11 million cattle were vaccinated - the 12 million sheep grazing beside them were not.

 

Vaccination was carried out by the farmers themselves. It continued until the beginning of June followed by a booster programme until the third week of July. The outbreak incidence rate quickly dropped to a few incidences per day. Movement restrictions were discontinued on the 6th of June. On the 26th of August Uruguay had its last outbreak. There were no documented cases of animals vaccinated with a qualified vaccine causing new outbreaks.

 

Arguably, the UK could have controlled the disease by vaccination using the present potent vaccines. Equally, it can be asserted that the cost in terms of money and the suffering of rural communities - including farmers suicides - was many times higher than in Uruguay.

 

This again poses many more questions than have as yet been asked. Thus, points which deserve further investigation by the Temporary Committee are:

 

1.      Whether the UK government had produced an adequate emergency vaccination strategy in accordance with Council Directive 90/423/EC, as amplified by Commission Decision 91/42/EEC, Commission working documents VI/5211/95 - Contingency plans for epidemic diseases - and VI/6319/98 - Guidelines for FMD contingency plans in non-vaccinating countries (as redesignated XXIV/2655/1999).

 

2.      If a strategy was not prepared, did the failure so to do lie at European or member state level, or both?

 

3.      If a strategy was prepared, why was it not implemented, apparently when the criteria set out in XXIV/2655/1999 and the Strategy for Emergency Vaccination against Foot and Mouth Disease (FMD) were apparently satisfied?

 

Additionally, of importance to the general requirement for transparency and accountability, it could be asked why the Commission seems to be attempting to justify ex post facto what appears to be an indefensible decision by the UK authorities not to vaccinate.

 

Conclusions

 

Following the UK epidemic there had been a flurry of activity by the Commission, member states, and other nations, to revise and update contingency plans in the light of UK experience. That activity, in itself, seems clearly to demonstrate that which has been admitted by the UK government - but not the Commission - that the contingency plan with which their veterinary authorities were working was inadequate.

 

Arguably, the fact that prompt remedial measures are now being taken is healthy - even if redolent of shutting the stable door after the horse has bolted - and there is some sentiment now that we should be looking to the future and not raking over the coals of the past. However, there seems to be a strong case to argue that, in the planning for the contingency of foot and mouth disease, there were a series of major failures in government, and in administrative systems, possibly at multiple levels of government.

 

Here, simply correcting the failures of the past does not address the address the reason for those failures. Furthermore, if they arose as a result of system defects, there will be nothing to stop other failures occurring in the future, albeit perhaps in different although allied areas. For that reason, it is important not only to observe that some failures occurred - and even these have not been fully defined - but also to determine why they occurred.

 

It may well be that some failures were unavoidable, given the uncertainties of the very nature of contingency planning, where events have to be predicted in a world where there are infinite possibilities. But equally possible, there were some avoidable failures and it is here that an honest, frank appraisal of the nature of those failure and the reasons for them can be of great value in the prevention of further failure. To that effect, it is relevant to cite a book by H. Petrovski, "To Engineer is Human: The role of failure in successful design". His offering was:

 

"I believe that the concept of failure - mechanical and structural failure in the context of this discussion - is central to understanding engineering, for engineering design has as its first and foremost objective the obviation of failure. Thus the colossal disasters that do occur are ultimately failures of design, but the lessons learned from those disasters can do more to advance engineering knowledge than all the successful machines and structures in the world. Indeed, failures appear to be inevitable in the wake of prolonged success, which encourages lower margins of safety. Failures in turn lead to greater safety margins and, hence new periods of success. To understand what engineering is and what engineers do is to understand how failures can happen and how they can contribute more than successes to advance technologies"[14].

 

The great danger is that the wrong lessons are learned, in the manner of generals who are always fighting the last war. In this context, while the view can be taken that vaccination was the appropriate response for the last epidemic, this does not mean that it will necessarily be appropriate for the next epidemic. Thus, the adequacy of responses to future potential disasters may well rest of the adequacy of the evaluation of the failures which this Temporary Committee alone seems in a position to determine.

 

ends



[1] SANCO/10018/2002 - Rev.2

[2] op cit - Section C. Q3 p.18

[3] Strategy for Emergency Vaccination against Foot and Mouth Disease (FMD), op cit. Q4, pp 19-19.

[4] Doc. XXIV/2655/1999

[5] Strategy for Emergency Vaccination against Foot and Mouth Disease (FMD). Report of the Scientific Committee on Animal Health and Animal Welfare. Adopted 10 March 1999

[6] The Newsletter of the UC Agricultural Issues Center, Vol 12. No. 2. 1998

[7] P.11 Section 6.12 (Scenarios)

[8] Official Report (Hansard), 6 February 2002, Col 632.

[9] op cit, P.9 Section 6.9 (Emergency vaccination)

[10] Strategy for Emergency Vaccination against Foot and Mouth Disease (FMD), p4 (Rationale)

[11] P11 Section 6.13 (Emergency vaccination)

[12] SANCO/10018/2002 - Rev.2 Section A.1 8(1).

[13] www.warmwell.com

[14] New York: St Martins Press, 1985.