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Royal Society Infectious

Disease in Livestock Inquiry

Follow-Up Review

Summary

Towards the end of the 2001 Foot and Mouth epidemic, the Royal Society was commissioned by the Government (Department for Environment, Food and Rural Affairs (Defra) and the Office of Science and Technology) to undertake a review of the scientific aspects of the control of infectious diseases in livestock. This was one of three commissioned investigations, the others being the "Lessons Learned" inquiry undertaken by Sir Iain Anderson and the Policy Commission on the Future of Farming and Food, chaired by Sir Donald Curry. The Royal Society's inquiry was undertaken by a committee chaired by Sir Brian Follett FRS, and was explicitly charged with looking to future developments. It reported in July 2002 (RS 2002) - The IDL Report.

This follow-up review highlights some particular issues and concerns identified in a more detailed review of progress on the various recommendations in the IDL report, which is involved in the process of following up the IDL recommendations and in producing this review, which has been endorsed by the Society's Council. We also shared a late draft of the annexes with Defra officials, who had the opportunity to comment on the factual accuracy.

Since July 2002 there have been a number of important developments at European and domestic level

* Defra's response to the IDL report and the Lessons Learned Inquiry in November 2002 (Defra 2002), and the issuing of a route map for the implementation of commitments in the response (Defra 2003a); with the latter being updated in July 2003 (Defra 2003b);

* The UK Animal Health Act 2002;

* The adoption on 29 September 2003 of a revised EU Directive for the handling of an outbreak of Foot and Mouth Disease (FMD), which will be transposed into domestic UK legislation;

* The laying before Parliament on 31 March 2004 of a revised contingency plan for handling an outbreak of FMD, after consultation with stakeholders;

* The testing of the contingency plan by a real-time national exercise (Exercise Hornbeam) at the end of June 2004;

The EU Directive on FMD gives a comprehensive set of guidelines for member states for both the prevention and the control of FMD in the event of an outbreak. In response, the United Kingdom, through Defra, published an updated contingency plan and the Animal Health and Welfare Strategy for Great Britain (Defra2004f) along with its associated 2004 development of improved animal health and welfare in the UK, as well as arrangements

References to sections in this report are in ( ) and references in { } are to paragraphs in annex A.
We welcome the detailed work that Defra has undertaken on many aspects of our recommendations. We acknowledge that some aspects will require longer to implement than the two years since the publication of our report, and provide below, as bullet points, some areas that require further attention, largely building on work already in progress1.

· The surveillance arrangements. (1)

· The arrangements for active Parliamentary scrutiny of the contingency plans, possibly by the Environment, Food and Rural Affair Select Committee. (2)

· The arrangements for a wider interim review of arrangements for handling infectious diseases in livestock. (2)

· The capture and handling of data during an outbreak. (3)

· The completion of the various projects analysing the data from the 2001 outbreak and other research to inform the decision making process on whether pre-emptive action beyond the culling of infected premises and dangerous contacts is required to control the outbreak. (4)

· The structure of technical input into the handling of an outbreak of an infectious disease. (4)

· Further action to ensure that emergency vaccination is a viable option for pre-emptive action, including the validation of Non Structural Protein (NSP) tests and a better understanding of the implications of vaccination by all stakeholders. (4, 5)

· The development of portable RT-PCR diagnostic equipment that can be used in the field and sensitive enough to detect virus in pre-clinical cases. (5)

· The need to ensure that animal health research is given the support it requires and is co-ordinated with support provided by research councils. (7)

· Training, especially of farm workers and an increase in the overall number of large animal veterinarians. (6,8)

Defra has undertaken a considerable amount of work since the publication of the two inquiry reports, has consulted on many issues with stakeholders and published many of the key documents on its website in a welcome increase in transparency. Apart from some fundamental work that still remains to be done, summarised in the bullets above, the crucial challenge for Defra is to ensure that it has brought together the many strands of its work on infectious diseases in livestock into a coherent structure, in particular ensuring that the command structure and the information flow arrangements designed to combat an outbreak are fully fit for purpose. The report on Exercise Hornbeam and knowledge gained during the exercise should provide helpful feedback in this regard.

Detailed Points

1. Surveillance

Defra has defined a sophisticated surveillance information system " RADAR {4.1} - which will be developed in a number of phases leading to a fully populated, comprehensive range of data sources by 2013. It is critical that the choice of the data sources is made in consultation with the user community, to ensure that researchers are able to make best use of the system. Plans must be put in place to address the reduced surveillance capacity during the development phase and, more fundamentally, it needs to be made clear how the completed system will enhance the surveillance or early diagnosis of non-endemic diseases. Government has to ensure that at all times the means of delivering rapid diagnosis are available and that provisions to ensure that delays will not occur are in place.

Current and future animal tracking systems will need to provide correct and up-to-date information in the event of an outbreak. Concerns have been raised by, amongst others, the National Audit Office that there are errors and gaps in the data in the current system (NAO 2003). We hope that the careful management of the proposed new tracking system is maintained so that the new animal tracking system can be implemented on time and within budget. In addition, we note that procedures for the IDL report’s recommendation that registration of all keepers of livestock have not been implemented {4.5}.

The control of illegal imports is still of concern despite a recent action plan from Defra and funding from Government {4.4}. There remains some confusion over the roles of Defra, HM Customs and Excise, and the Food Standards Agency in reducing the risk to animal and plant health posed by illegal imports.

2. Contingency Planning

The IDL report stressed the importance of; developing, in advance, detailed arrangements to counter an outbreak of an exotic animal disease epidemic; ensuring that these arrangements were known to the various stakeholders and where possible accepted by them; and regularly reviewing whether the arrangements were still relevant in terms of the ongoing technological developments and the known threats.

a. Parliamentary scrutiny

The IDL report recommended that the contingency plan should be brought before Parliament for debate. This recommendation aimed to ensure broad acceptance within the farming and livestock industry, and the general public, of an agreed set of procedures in the event of a future outbreak, many of which were bound to be contentious to one party or another. So far there has been no active Parliamentary scrutiny {3.1}, and it remains unclear whether the consultation process has provided the Government with

1 References to sections in this report are in ( ) and references in { } are to paragraphs in annex A.

political empowerment supported by the farming community and the general public, rather than just a legal and administrative framework to operate in the case of any outbreak scenario. The Environment, Food and Rural Affairs Select Committee may wish to consider if it could take responsibility for the scrutiny of the contingency plan.

b. Reviewing

The Animal Heath Act 2002 requires the contingency plan to be reviewed at least once a year. However, it is critical for a more extensive review to be undertaken every few years in which the wider context is considered, and actions are taken to ensure that the contingency plan is evolving in step with scientific, farming and societal changes. We therefore welcome the recently published Animal Health and Welfare Strategy and the commitment to review the Implementation Plan, a key part of the strategy, on an annual basis along with a formal five-year review of the ten year vision {3.5}. This strategy goes some way to satisfying the IDL recommendation that the Prime Minister establish a formal three yearly review procedure for diseases in livestock. However, we note with some concern that there is a five year gap between reviews.

It is important that careful consideration is given to the time period between reviews so that the Animal Health and Welfare Strategy and the contingency planning can keep pace with scientific, farming and societal changes.

c. Fire-drills

Defra organised a testing of the contingency arrangements culminating in a final exercise (Hornbeam) in June 2004. The real-time Hornbeam exercise was a welcome development to ensure all involved in an outbreak scenario are up to date with current procedures {7.3}. Such testing should continue on a regular basis because any one exercise is only committed to a single major scenario. The outbreak in 2001 was propagated by transport and sheep and so involved scenarios that were very different from those of the 1967 outbreak which involved wind and cattle.

We note that the outcome of the exercise has been studied by Defra’s Science Advisory Council and its epidemic diseases sub-group, who have recently issued their recommendations (Defra 2004k). We look forward to publication by Defra of a full report on the outcomes from the exercise and encourage the Department to seek comments from stakeholders.

d. Involvement of stakeholders

Defra has worked well to engage stakeholder groups in drawing up the contingency plan. There have been open consultations and a clear timeline for discussion and implementation of the updated contingency plan {3.1}. The engagement of stakeholders should ensure the contingency plan is kept up to date and relevant to the user communities’ that have to buy-in to the objectives and practical aims.

3. Basic control

a. Movement controls

A considerable amount of planning has been undertaken by Defra to put in place controls on livestock movements in the event of an outbreak {6.1}. An essential aspect of these controls will be the provision of an early warning system that can identify movement risk and initiate increased vigilance at the first indication of an outbreak. Both the EU Directive and Defra’s Contingency Plan appear to provide a clear chain of command once an outbreak is confirmed. Further work is required to ensure that a system is put in place that can quickly reduce movements in the event of an outbreak. The issue of movement control has become more important in recent years with the closure of many local slaughter houses resulting in increasingly longer journeys for animals to travel to slaughter and the increased risks of disease spread.

b. Biosecurity

The original IDL report recognised the role of disinfection during an outbreak and identified the need to ensure that people, vehicles and premises are adequately disinfected to minimise as far as possible further transmission of the disease {7.11}. The contingency plan specifies the biosecurity measures that should be implemented. However, the IDL report also stressed that the term biosecurity should encompass wider issues such as controls on all movements within specified risk areas, prudent sourcing of stock, quarantine, vaccination and testing in order to move away from the thinking that disinfection is the only ‘barrier’ that should be considered. Further research developments involving biosecurity measures should have an impact on future control measures, and the measures specified in the contingency plan will need to be updated to reflect this.

c. Culling infected premises and dangerous contacts

The IDL report recommended the culling of infected premises and dangerous contacts (DC’s) and the use of emergency vaccination if further pre-emptive action was required. While the policy of culling of infected premises is clear, work still needs to continue to establish a soundly based method for the identification of DC’s. Identification of DC’s will be informed from an epidemiological investigation of the data from previous outbreaks. Recent scientific publications have begun to make use of the data collected during the 2001 outbreak and forthcoming analysis may further elucidate the effect of culling on the progress of the disease {7.12}.

d. Data collection

Some work remains to be carried out on the capture, transmission, storage, processing and use of background and disease dependent information {9.1} for management of the disease control process. The use of geographical information systems (GIS) will be important in clearly identifying infected premises during an outbreak.

4. Further, pre-emptive, control measures

a. Identification of need for additional pre-emptive action

The IDL report stressed the need to examine the 2001 data for further information on the transmission characteristics and associated control methods in order to inform the decision as to whether more extensive pre-emptive control measures are required in a particular outbreak. To undertake this analysis a number of research contracts/grants have been awarded by the Wellcome Trust and public sources to explore the epidemiological information in the 2001 data and to develop modelling techniques. Some of the first analyses of this work have recently been published (Honhold 2004a; Honhold 2004b). These have indicated that, for the strain of the virus involved with the 2001 epidemic, the rapid culling of IP’s and DC’s and the imposition of strict biosecurity measures were the key control mechanism. It will however be some time before a significant proportion of the analytical results are published. Furthermore modelling will be required to explore sensitivity to different virus characteristics. It is important for policy makers to keep in touch with this work.

b. Decision making during outbreak

While many of the individual components within the contingency plans are in place, concern remains about some of the decision-making processes within Defra during an outbreak of an exotic infectious disease; in particular about testing the robustness of the criteria that would be used in the decision tree to determine whether to employ extended pre-emptive action and if so whether this should involve emergency vaccination or slaughter {7.2}.

We also remain concerned both about the effectiveness of arrangements for securing independent expert advice from outside Defra during an outbreak and about the mechanisms whereby this advice is then fed into decision making {3.9; 3.10}. We await the full report of Exercise Hornbeam to assess the expert advice requested and the impact of the decision making process in a large-scale fire drill.

c. Diagnostics

The key to the use of emergency vaccination, discussed fully in the next section, is the validation of Non-Structural Protein (NSP) tests. It is essential for NSP tests in cattle to be validated. In particular, issues of sensitivity and of identification of false positives need to be resolved so that a recognised diagnostic test can be used Europe-wide.

The other priority is the development of sensitive rapid tests that can be used outside of reference laboratories, to aid rapid diagnosis during an outbreak. Ideally these tests should be applicable in the field. Commercially used equipment is already available which, with appropriate reagents, can rapidly detect very small amounts of FMD virus in preclinical cases. More generally, there is still scope in this area for veterinary practice to make more use of developments in the medicinal area {8.3}.

5. Emergency vaccination

Although the IDL report recognised that rapid culling of infected premises and of epidemiologically determined dangerous contacts was the appropriate approach for the control of exotic diseases, it stressed that it was becoming increasingly unacceptable across Europe to cull and destroy large number of animals, as occurred in the 2001 outbreak, either as part of wider pre-emptive disease control or for welfare purposes. It is therefore imperative to find approaches whereby emergency vaccination can be employed in situations where pre-emptive action is required. Use of such vaccination procedures must be coupled with arrangements to ensure that the animals subsequently enter the food chain {7.7}. If there are problems associated with a non-slaughter approach then these need to be resolved.

Defra has put a great deal of effort into putting in place contingency arrangements for securing and delivering emergency vaccination in the event of an outbreak of FMD. These include securing derogations within the EU Directive

{7.7} that will ease the exit strategies after the use of emergency vaccination. More work is required to promulgate to stakeholders and the general public the exit strategies. In addition clear explanations of meat treatments required in a FMD outbreak must be provided. The drafting of Defra’s recent publication ’The role of vaccination in a future outbreak of FMD’ (Defra2004d) was not sufficiently clear in this respect {7.7}. Failure to clarify both the exit strategies and meat treatment protocols will undermine Defra’s sterling work in securing these derogations when the Directive was being drafted.

The contingency arrangements outline the scale of the delivery of emergency vaccination. Further information is required to assess whether the arrangements for scaling up vaccination capacity would meet the EU Directive requirements for a worse case scenario {7.5}. A consultation by Defra on the use of lay vaccinators was completed at the end of March (Defra2004j) resulting in two orders recently being laid before Parliament to allow trained personnel to handle and administer vaccine during an outbreak (Defra2004l).

The delay in obtaining validation of the NSP tests required to secure regaining of disease free status under a vaccination to live strategy remains a concern {8.2}. However, the recent Defra publication ’The role of vaccination in a future outbreak of FMD’ (Defra2004d) states that “the absence of an internationally validated test would not prevent the use of vaccination in the event of a future outbreak”.

6. Resources

a. State Veterinary Service (SVS)

The recent review of the SVS and its future role will potentially have a large impact on the delivery of the Animal Health and Welfare Strategy in the UK. The final shape and function of the service must ensure that it is fit for its purpose and of an adequate size. In particular there should be adequate coverage to manage the additional temporary veterinary support recruited in the event of an outbreak {10.5, 10.6}.

b. Vets and other skilled workers

Expertise that resides within private sector veterinary services and the veterinary schools is an essential resource during an outbreak. However, a shortage of the number of large animal veterinarians and the need for a critical mass to undertake the roles required of them will become an increasing problem unless action is taken to reduce the decline in recruitment to the profession {10.7}.

The provision of emergency vaccination during an outbreak is contracted out to Genus Plc, but the processes involved in provision of qualified teams still requires further planning. The amendment of the Veterinary Surgeons Act (1966) to allow the use of lay vaccinators will help resource any large scale emergency vaccination programme, but the overall veterinary management of the process will require careful planning {7.6}. The resources required for culling of animals also need to be considered carefully to ensure culling can take place within the guideline times.

7. Research

Defra has reviewed all of their research programmes into exotic diseases (Defra 2003c), and issued a joint call for proposals in this field with the Scottish Executive and BBSRC. It is to be hoped that the Science Advisory Council (SAC) will review the research programmes to identify missing elements. In addition the findings from relevant research world wide should be reviewed to inform future advice on research needs and if necessary updates of contingency arrangements. The proposal for five research institutes to develop better vaccines and anti-viral compounds should be a priority for the animal health research programme {5.2}. With Defra’s other significant responsibilities for sustainable development and climate change, its research budget is likely to be under severe pressure. It is essential that relevant animal health research is given a sufficient degree of priority. At the time of going to press we note with concern reports of a reduction in size of the Institute of Animal Health. It is important to ensure that this does not result in a reduced overall research capability. The IDL report recommended an expansion of this capability.

8. Education and training

The IDL report recommended that many areas of further education provision for education and training should be improved, across the range from farm workers through to veterinary surgeons {10.5}. We have noted the positive comments by the Chief Veterinary Officer (CVO 2004) and the extra resource being made available to veterinary colleges. Increased levels of co-ordination and training, particularly of farm workers, are still required to ensure a higher standard of disease prevention.

Annex A Analysis of Actions on the Major and Detailed Recommendations in the Royal Society Report

on Infectious Diseases in Livestock (IDL) 20021

Main Recommendation 1: The overall objective of policy must be to minimise the risk of a disease entering the country and, if it does enter, to ensure the outbreak is localised and does not develop into an epidemic.

Progress:

  1. A range of measures have been implemented at both the EU and UK level in the wake of the Foot and Mouth outbreak in the UK. The fundamental documents are the revised EU Foot and Mouth Directive (2003/85/EC) (EU 2003) and the Animal Health Act 2002 (AHA 2002). Defra has published a completely updated Foot and Mouth Disease Contingency Plan (Version 4.0) (Defra 2004a), Slaughter and Emergency Vaccination Protocols, and several additional documents e.g. on communications (Defra 2004e), surveillance (Defra 2003e) and the role of vaccination (Defra2004d). Defra has also circulated other draft documents to stakeholders on issues such as the treatment of products of vaccinated animals (Defra 2004d). A full list of relevant Defra publications is at annex C; these documents cover prevention, diagnosis and containment of Foot and Mouth disease by bringing together prevention and control mechanisms. In general, policy developments have made advances on all fronts but, as discussed below some recommendations have yet to be fully implemented.
  2. In addition a draft Animal Health and Welfare Strategy (Defra 2003d) was published for consultation in December 2003 followed by the full strategy in June 2004 (Defra 2004f). This document outlines five strategic outcomes with the broad aim of improving the health and welfare of animals and protecting society, the economy and environment against the impact of animal diseases.

Main Recommendation 2: The UK, and the EU, should seek to retain ‘disease-free’ status with respect to FMD and the other most serious infectious diseases. Under present circumstances, this status should be ‘disease-free without (routine) vaccination’. But this proviso could change if, for example, the risk of an outbreak occurring increased sharply, better vaccines became available or the trading regulations associated with disease-free status were further changed, so it must be kept under active review.

Maintaining disease-free status

R1.3 The UK should continue to strive for “disease-free” status against highly infectious diseases such as those listed in the OIE’s List A. (p5)

R1.4 Providing the level of international threat does not increase; there are improved import controls; and there is a demonstrable improvement in the arrangements for handling disease outbreaks, the UK should not adopt a policy of routine vaccination, and should retain the internationally recognised status of “disease-free without vaccination”. (p6)

Progress:

2.1 Maintaining disease-free status without routine vaccination is the underlying principle of EU and UK policy. The lack of a satisfactory prophylactic vaccine makes maintenance of the disease-free state without vaccination the only option at present.

Main Recommendation 3: Better contingency planning is vital. The Government must be empowered to act decisively during an outbreak. This requires prior debate about the control measures to be adopted. The Government’s Contingency Plans should therefore be brought before Parliament for debate and approval. The Plans should be subject to a practical rehearsal each year and should be formally reviewed triennially to ensure that they take account of: the latest information about the scale of international disease threat; changes in farming practice; scientific and technological developments; regulatory developments at national, EU and global level; and the country’s state of preparedness.

Current contingency planning

R1.1 The UK Government should bring before Parliament for debate a framework for the Contingency Plans covering the principles involved in handling outbreaks of infectious exotic diseases and the resources required for their implementation. (p1)

R9.4 The detailed strategies for controlling outbreaks of livestock diseases should be included in the published contingency plan, which should consist of an umbrella plan for matters that are common to all diseases, with specific modules for each disease. These plans should be rehearsed in an annual “fire drill” that must be realistic and involve Defra and all other relevant bodies including MoD. (p125)

Progress:

3.1 The EU FMD Directive requires Member States to draw up contingency plans detailing national measures required in the event of an outbreak of foot-and-mouth disease (FMD). The Animal Health Act 2002 specifies that a detailed Foot and Mouth Contingency Plan

1 The main recommendations are in boxes and the subsidiary recommendations, with a cross reference to the relevent page in the IDL report, are in italics.

should be published, laid before Parliament, and reviewed no less frequently than annually. The draft contingency plan was put out for consultation to stakeholders prior to the updated version being laid before Parliament on 31 March 2004 as a general paper, accompanied by a press release, but with no Parliamentary debate. The Contingency Plan (Defra 2004a) includes the slaughter protocol and the vaccination protocol, which have also been published separately (Defra 2004b; Defra 2004c).

  1. As part of planning and training, over 50 regional training events have taken place with the first full ‘fire-drill’ at the end of June 2004, Exercise Hornbeam. This exercise played out the strategic, tactical and operational responses to suspicion and confirmation of FMD and its spread. It involved operational partners, including other Government departments and agencies, devolved administrations, local authorities, and police forces, playing out Days 7 and 8 of an outbreak scenario in order to test the Government's preparedness as set out in its published Contingency Plan.
  2. On a wider scale, an umbrella plan for matters common to all diseases has not yet been actioned, with individual contingency plans being prepared for list A diseases from which the UK is at risk (Classical Swine Fever, Bluetongue, Newcastle Disease and Avian Flu). Wherever possible, common policy should be produced for matters common to all diseases to reduce unnecessary administration and to be as helpful as possible to the end users of the documents. Although this approach was accepted in the Government’s response to the report, much of the current planning appears to be at individual disease level without, as yet, the extraction of common principles.
  3. As part of the on-going process of revising the contingency plans, Defra announced in January 2004 that it was funding a year-long cost benefit analysis contract to inform future FMD Control Strategies. The aim is to inform the decisions over different disease control policies by taking into account the wider economic costs of four scenarios including the use of vaccination.

Review of Future Policy

R1.2 The Prime Minister should establish a formal procedure to review at three-yearly intervals: · the level of threat from imported animal diseases of

livestock · changes in livestock farming practices that could affect vulnerability to disease · scientific and therapeutic advances that could affect policy options · the UK’s and Europe’s state of preparedness. (p1)

Progress:

  1. The Government is still considering a formal three-yearly review process that would examine the threats from all diseases in livestock. The arrangements for dealing with these threats have been outlined in Animal Health and Welfare Strategy (Defra 2004f), including the management of the strategy through a science group and a strategy steering board. The strategy will be reviewed mid way through its 10 year programme with an annual review of the Implementation Plan. The only formal process is the annual review of the contingency plan, which requires publication and presentation before Parliament as a requirement of the Animal Health Act 2002.
  2. Equally, no formal review process exists at the EU Level, although the ‘Standing Committee on the Food Chain and Animal Health Section: Animal Health and Animal Welfare’ assists the European Commission in its development of new measures. The committee is made up of representatives of Member States and chaired by a European Commission representative.

Technical input to the decision making process

  1. Although not reflected in the numbered recommendations, the IDL report expressed concern (paragraph 9.20) that early drafts of the contingency plan did not appear to be taking sufficient account of the need to involve at the strategic level the Defra Chief Scientific Advisor (CSA), and strongly recommended the creation of a high level technical advisory committee chaired by the Department’s CSA. The input of expert advice is also reflected in the EU FMD Directive (Article 78), which requires Member States to create a permanently operational balanced expert group to ensure preparedness against an outbreak.
  2. The establishment of a FMD Expert Group has been included in the latest version of Defra’s Contingency Plan to bring it in line with the EU Directive. The Group has a clearly defined membership for ‘peacetime’ and an enhanced membership in the event of an outbreak. We note, however, that the core and enhanced membership of the Expert Group are currently made up of staff from Defra, the Veterinary Laboratories Agency and the Institute of Animal Health, with no independent members. While this meets the letter of the EU Directive (Article 78 (1)), it is not clear that it contains all the expertise that would be required during an outbreak.
  3. The contingency plan recognises the role of the Science Advisory Council and its sub-groups during an outbreak, and provides for cross representation at official level to the expert group to challenge policy decisions.

3.10 One of the first actions of the SAC was to establish an epidemic diseases sub-group to review the science underpinning Defra’s FMD contingency plan, and this

sub-group included co-opted members with expertise in veterinary and social science. The roles of the expert group and the SAC FMD group were rehearsed during exercise Hornbeam, a report on which is expected shortly. This sub-group has also reviewed the outcome of Exercise Hornbeam, and its views should input into the next review of the contingency plan and more generally to the FMD Expert Group.

4.2 When notified of a new disease incident in an EU Member State, a country on the border of the EU or a third party trading partner, Defra undertakes a qualitative risk assessment and publishes it on its website. 21 such reports have been published over the past 12 months. The OIE also provides surveillance information as well as the collection, analysis and dissemination of veterinary scientific information.

4.3 The OIE reference laboratory is currently funded through Main Recommendation 4: As a result of globalisation, annual contributions and additional voluntary donations the risk of invasion by exotic (i.e. non-endemic) animal from member countries, which is a matter for diseases has increased. It is essential that the UK, and the international discussion and decision. Defra has stated EU, strengthen their early warning systems and ensure that that adequate funding would be provided to the UK warnings are acted upon. This requires an EU risk and reference laboratories to enable them to fulfil their surveillance unit; better funding for the OIE reference national commitments (also paragraph 8.1). laboratories to track disease spread and type the strains; heightened animal disease surveillance on farms; and greater interaction between farmers and veterinarians to Import control improve the effectiveness of national surveillance. Import controls over meat products require tightening. R5.2 Defra should promote the speedy implementation of the

Action Plan on illegal importing and of a much more coordinated approach at all levels by all bodies concerned with import control. (p54)

Surveillance of infectious diseases

R3.1 Defra should undertake a systematic analysis of the information available on the relative threats to the UK from the range of diseases covered here (and other significant diseases such as TSEs and TB), taking account of the impact of globalisation and climate change, in order to set priorities for the national strategy for animal disease and surveillance. (p35)

R5.1 Defra should propose an EU-wide risk assessment unit and centralised database on surveillance and disease data, and a review of the bodies that provide early warning of animal disease threats. (p54)

Progress: Progress:

4.4 A revised Action Plan, published in June 2003, updated the original plan released in March 2002. There are several other bodies, each with their own role in import control, that work with Defra on different aspects. Government made available £6 million in 2003-04 to tackle illegal imports, which will be primarily delivered through Defra, HM Customs and Excise, and the Food Standards Agency working in partnership with other interested parties. Controls at airports for flights originating outside the EU are still very low key compared with some countries. There is, for example, scope for use of surveillance equipment to monitor luggage coming in from high risk countries.

4.1 The UK Veterinary Surveillance Strategy (launched in October 2003) is a ten-year programme seeking to Registering, monitoring and managing livestock address highlighted surveillance issues. A key part is a strategic goal to derive better value from surveillance R5.4 Defra should ensure that all keepers of livestock information and activities. Currently, data comes from a (including that not kept for food production) are properly range of sources including veterinary laboratories, registered and submit to Defra each year the name of abattoirs, private vets and livestock producers. An their nominated private veterinary surgeon and a health information management system called RADAR (Rapid plan approved by the same veterinary surgeon. (P54) Analysis and Detection of Animal-related Risks) is currently being implemented. A prototype has recently Progress: been completed with the various phases/milestones due 4.5 The Government’s response indicated that further for completion from April 2006 with the fully populated consideration was being given to the setting up of a system implemented by March 2013. During the current register to ensure that all keepers of livestock have development phase data sources are being selected and submitted the name of their veterinary surgeon and a loaded, with several further phases until completion in health plan that would allow effective monitoring and 2013. The first phase of the data loading is expected by management of livestock. While this is clearly an autumn 2005. additional burden on the keepers of animals, this has to

be weighed against the costs if there is an outbreak of an infectious disease.

8| December 2004 | Royal Society Infectious Disease in Livestock Inquiry Follow-Up Review The Royal Society

Main Recommendation 5: Routine vaccination against some of the OIE List A diseases is possible. While there are no overwhelming scientific or economic reasons against this approach being adopted we believe that, at present, the considerable technical problems and the trade implications argue against changing current arrangements. Nevertheless it is clear that the long-term solution is to develop a vaccine against FMD (and other diseases such as classical swine fever) that confers lifelong sterile immunity against all strains of the virus. An international research effort is required to develop such a vaccine.

Vaccination and disease-free status

R8.1 The Government should take the lead in developing an international research programme aimed at an improved vaccine that would permit routine and global vaccination of livestock against FMD and other List A diseases. (p105)

Progress:

  1. Under current legislation, “disease-free status without routine vaccination” is the Government’s position though contingency plans for FMD, Classical Swine Fever, Newcastle disease and Avian Flu allow for emergency vaccination. At the international level, the European Commission for the Control of Foot-and-Mouth Disease (EUFMD) (established under the auspices of the Food and Agriculture Organisation of the United Nations (FAO)) promotes foot and mouth research and coordinates national programmes at the EU level. It has a research group of the standing technical committee that co-ordinates information gathering on developments of vaccination technology. The Institute of Animal Health represents the UK on this committee.
  2. There has been increased investment in basic research programmes by several funding organisations, including for example a £3 million increase in Defra’s Disease Prevention research programme since 2002. This has led to the initiation of new research studies, including the developments of improved diagnostic tests and vector-borne diseases. Research is focusing on the underlying biology, where many gaps in knowledge exist, however there remains a lack of a coordinated research programme to develop a routine vaccine for FMD and other List A diseases. In correspondence from Defra we understand a global partnership of five research institutes, including the IAH, are putting together a proposal for a research programme to develop better vaccines and anti-viral compounds. It should be a priority that funding for this project should be found.

Main Recommendation 6: The precautionary principle should be adopted more widely to ensure that any disease outbreak cannot develop into an epidemic. One of the most effective means of achieving this is to minimise animal movements at all times. The Government should consider a system whereby early warning of infection triggers significantly enhanced precautionary measures.

Animal movements

R5.3 Defra should investigate all the issues connected with reducing animal movements and come forward with practicable solutions that strike the right balance between the legitimate interests of livestock owners, market systems and long-term disease control. (p54)

Progress:

  1. The current Defra arrangements for tracking animal movements have been the subject of a recent NAO report (NAO 2003). Although positive in principle about the long term ‘Livestock Identification and Tracing Programme’, which aims to bring together data into a single Livestock Register, the report was critical of the current livestock identification systems. The current system involves the Cattle Tracing System and the Animal Movements and Licensing System (sheep and pig movements with cattle movements reported via a link to the Cattle Tracing System), with both systems still based around extensive postal notification. The NAO report highlighted the high levels of errors and gaps in the data and the subsequent cost in terms of staff time, additional postage and European Commission penalties.
  2. Currently a six-day standstill period operates for the movement of livestock with exceptions for some breeding animals and for animals in shows where the six-day standstill is not triggered. Both exemptions require that the animal has met the agreed isolation requirements in a Defra approved isolation facility. Defra believes that the restrictions strike a balance between the needs of business and disease prevention. There is provision for this standstill period to be increased up to 20 days should early-warning triggers suggest a disease threat. Options are covered extensively in both the EU Directive and the UK Contingency Plan. However a question remains as to whether an early warning system is in place that can quickly trigger reduced movements. The severity of the 2001 epidemic was exacerbated by the fact that it took place during the peak sale season.
Main Recommendation 7: Rapid culling of infected been used, and goes a long way to making ‘vaccination
premises and known dangerous contacts, combined with to live’ a more feasible option.
movement control and rapid diagnosis, will remain
essential to controlling FMD and most other highly 7.2 The option to deploy pre-emptive emergency vaccination
infectious diseases. In many cases this will not be sufficient as a ‘firebreak’ has been incorporated into the
to guarantee that the outbreak does not develop into an contingency plan. The latest version of the plan include
epidemic. Given recent advances in vaccine science and the draft Emergency Vaccination Protocol published in
improved trading regulations, emergency vaccination April 2004, coupled with a decision tree to determine if
should now be considered as part of the control strategy pre-emptive action is appropriate and if so whether
from the start of any outbreak of FMD. By this we mean emergency vaccination should be used. The Animal
vaccination-to-live, under which meat and meat products Health act specifies that if the Secretary of State rejects
from animals vaccinated and subsequently found to be emergency vaccination the reasons for this decision must
uninfected may enter the normal human food chain. The be published before using pre-emptive slaughter. The
Government should prepare the regulatory framework and contingency plan provides some background to the
practical arrangements (e.g. validation of tests, and the decision points in the decision tree, and these are set out
supply of vaccines) that would allow this. There must at the in more detail in a further publication ’The role of
outset be an exit strategy agreed among the main vaccination in a future outbreak of FMD” (Defra2004d).
stakeholders to allow the country to return to the preferred
‘disease-free without vaccination’ status. 7.3 The recent national exercise, Exercise Hornbeam, was
designed to test Defra’s contingency planning in the
event of an outbreak of FMD. We understand that
emergency vaccination was deployed and that the public
Emergency vaccination report of the exercise and details of how emergency
vaccination was used during an outbreak scenario will be
R8.2 Emergency vaccination should be seen as a major tool of published shortly.
first resort, along with culling of infected premises and
known dangerous contacts, for controlling FMD outbreaks. 7.4 Ben Bradshaw’s letter of November 2003 (Annex B)
This policy should be vaccinate-to live, which necessitates stated that the use of vaccination as a control policy had
acceptance that meat and meat products from vaccinated to be coupled with validated Non Structural Protein (NSP)
animals enter the food chain normally. (p105) tests, but paragraph 45 of the contingency plan
(Defra2004a) states that “the absence of an
R8.3 In determining the arrangements for deploying internationally validated test would not prevent the use
emergency vaccination, Defra should: of vaccination in the event of a future outbreak”. A
· take account of the urgent need to achieve validation herd based test would be used and where there was a
for field use of the tests that discriminate infected from positive result a higher discriminatory (probing) test
vaccinated animals; would be used. The development and validation of NSP
· develop emergency vaccination strategies that integrate tests is discussed further under Recommendation 8.
theoretical and empirical epidemiology and the logistics
of delivery of vaccine cover; 7.5 The contingency plan outlines the scale of the delivery of
· establish an exit strategy that takes account of the emergency vaccination in terms of manpower in the
need for on-going surveillance, safeguards for those event of an outbreak. The contract at the outset allows
involved and agreement that products from vaccinated 50 vaccination teams to be ready with provision to scale
animals can enter the normal human food chain; them up to 150 teams (450 staff) within the first 5 days.
(p105) The contractor is on 5-day standby to implement a
vaccination programme from the time of confirmation of
R8.4 Defra should explore with the EU and OIE what disease. Within the 5-day time period, the particular
improvements to vaccines and surveillance tests are strain of the FMD virus would have to be identified and
required to allow disease free status to be based entirely the vaccine formulated ready for dispatch to the
on surveillance results without the requirement for a vaccination centres. Formulation could take up to 3 days
minimum waiting period. (p105) for a water-based vaccine or 4 days for an oil-based
vaccine. With the closure of the International Vaccine
Progress: Bank, previously maintained at the IAH Pirbright,
7.1 The EU Directive (September 2003) outlines the FMD vaccines will now be provided through a commercial
control strategy, which includes the provision of contract with Merial and access to the EU Vaccine Bank.
emergency vaccination. Arrangements for the possible However, in order to increase the pool of personnel
use of emergency vaccination have to be put in place by available to undertake the vaccination, the Veterinary
each Member State. The Directive takes account of new Surgeons Act (1966) has been amended by secondary
OIE rules, which enable disease free status to be applied legislation to allow the handling and administering of
for after six rather than 12 months. This is only three vaccination by lay vaccinators (Defra2004l).
months longer than the situation if no vaccination had
  1. The EU Directive requires a Member State to prepare all arrangements deemed necessary for emergency vaccination in an area at least 10km centred on an outbreak immediately the FMD outbreak is confirmed. The IDL report discusses the delivery of vaccine required in an outbreak (RS 2002; paragraphs 9.57 " 9.61). The IDL Report set out the manpower requirements for vaccination teams, should a widespread outbreak occur. It is not clear how the Defra arrangements for vaccination could be deployed at sufficient levels over the critical timescale.
  2. The creation of a satisfactory exit strategy after emergency vaccination is crucial, and it is important that all stakeholders understand exactly what is involved. During the consultation phase of the development of the EU Directive, Defra worked with EU officials and colleagues in other Member States to obtain derogations to the provisions in the period between the completion of surveillance testing and obtaining disease free status for a particular area. This ensures that meat and milk from vaccinated animals can be sold on the domestic market without having to undertake costly deboning or heat treatment [Articles 25-27, EU Directive (EU 2003)]. The recent publication on the role of vaccination (Defra2004d) does not mention these derogations in the sections dealing with each of the various animal species (cattle paragraph 17, pigs paragraph 23 and sheep paragraph 28) although they are described later in the document. This has caused some confusion, for example the front page of the Veterinary Times (VT 2004) entitled “Vaccinate to live in debt?” Defra is consulting on notes on the treatment of products from vaccinated animals which were designed to inform the relevant stakeholders. Furthermore we understand that Defra are currently preparing a paper to explain the meat treatments required in a FMD outbreak.

Use of anti-viral agents

7.8 The IDL report suggested that the fast growing field of anti-viral agents in human diseases should be periodically reviewed for possible spin-offs for animal diseases (RS 2002; paragraphs 1.18 and 10.15). In particular there is potential for providing rapid short term protection until the vaccines take effect. Some research is being undertaken at Pirbright and in the United States in this area.

Rare breeds and zoos

R9.2 As a matter of urgency, Defra should draw up arrangements for a process for the prior registration for vaccination of zoos and rare breed collections. (p125)

Progress:

7.9 The contingency plan and emergency vaccination protocol accept the recommendation for separate consideration of rare breeds and zoological collections. A prior registration scheme is being developed to allow rapid protection for those groups of animals identified in advance.

Handling an outbreak

R9.1 The main objective in dealing with an outbreak must be to ensure that it does not develop into an epidemic. This requires the following basic measures:

i. on suspicion of an outbreak, immediate imposition ofstrict local movement restrictions and biosecurity measures including culling the animal with clinical signs;

ii. on confirmation by an OIE Reference laboratory of an outbreak:

· mobilisation of the full emergency arrangements including all the additional logistic resources and the interdepartme