www.SilentMajority.co.UK/FootInMouth
F&M NF&MG to ROYAL SOCIETY 011218.rtf

THE NATIONAL FOOT & MOUTH GROUP
AND
VETS FOR VACCINATION

SUBMISSION
TO

THE ROYAL SOCIETY

INQUIRY INTO INFECTIOUS DISEASES OF LIVESTOCK

WITH REFERENCE TO FOOT & MOUTH DISEASE

DECEMBER 2001

THE NATIONAL FOOT & MOUTH GROUP
An affiliation of organisations affected by 2001 UK epidemic

Co-ordinating Office:

3 The Common, Siddington, Cirencester, Glos  GL7 6EY

Tel: 01285 644319 / 01285 656812

EXECUTIVE SUMMARY

Foot and Mouth Disease in a developed European economy is not just a disease of agriculture but affects all areas of the community.  It carries with it a huge human, social and economic cost.

The purpose of this submission is to set before the Inquiry the far-ranging  consequences of current control policies and, in responding to the issues raised by the Inquiry, consider how alternative controls could be effected.

We consider that the key factors for consideration are; disease free status, the role of export markets, vaccination and the eradication of Foot and Mouth Disease in the UK, EU and on a global scale.

We have sought to demonstrate the wide, and often disproportionate impacts of the disease and its control, that have affected the rural economy, rural communities and  their social fabric, during the current epidemic.  Of great significance is the need to maintain normality for other sectors of the rural economy and ensure a form of disease control that does not cause extensive harm and financial loss to these interests.

We have also considered how the control of Foot and Mouth Disease must be viewed in relation to international trade and in conjunction with control procedures used both in mainland Europe and the rest of the world, particularly, third countries.

The role of modelling in forecasting disease spread and its subsequent control is addressed and regard is also had to the need for empirical evidence to direct future control procedures.   We have considered the adopted policies and their impacts and detailed alternative methods of control.

The issue of vaccination is fundamental to our consideration and we have put forward how we view its use and application both in the UK and Europe, and on a global scale.  We examine the current policies and practices that have militated against the use of vaccination in the current epidemic and suggest how these should be addressed.

Finally, in the construction of this response, we have sought to ensure that future control policies never again cause the indiscriminate slaughter of healthy animals in such vast numbers to maintain an economic market.  We are grateful to the Royal Society for including the concepts of ethics in conducting this Inquiry.

Acknowledgements:

The National Foot & Mouth Group and Vets for Vaccination gratefully acknowledge the help and assistance of various scientists and vets in the production of this submission and for the contributions from the many who have been affected by the disease.
 
CONTENTS

1	INTRODUCTION

2	CONTEXT & BACKGROUND

3	DISEASE FREE STATUS

3.1	Introduction

3.2	FMD Disease Free Status & the Maintenance of Export Markets

3.3	Risks of Infection from Imported Meat & Meat Products, and Other Sources of Infection

3.4	Ethical Implications of Disease Free Status

3.5	Justification for Retention of Disease Free Status

3.6	Disease Free Status in the Future

3.7	Conclusions on the Concept of Disease Free Status	

4	SURVEILLANCE

4.1	How effective are existing methods of disease surveillance?

4.2	What are the barriers, implications and costs of moving to more active surveillance?

4.3	How can science help surveillance at points of entry (import controls)? 

5	DIAGNOSIS

5.1	Accuracy of Diagnosis & Implications – UK 2001 FMD Epidemic
	
5.2	Capacity for Laboratory Diagnostic Testing

5.3	Diagnostic Procedures

	5.4	Consequences of Techniques Used in UK 2001 FMD Epidemic

5.5	Conclusions & Recommendations

5.6	Summary

CONTENTS, contd

6	PREDICTION, PREVENTION AND EPIDEMIOLOGY

6.1	Prediction & Prevention

6.2	Reducing Risk of Importation of FMD

6.3	Preventing the Imported FMD Initiating Primary Cases 

7	SCENARIO PLANNING

8	MODELLING OF DISEASE SPREAD

9	CONTROL OF OUTBREAKS OF FMD

9.1	Are present methods compatible with modern ethical views?

9.2	Socio-economic climate and fundamentals of national strategy

9.3	Control procedures and culling policies

9.4	Alternatives to Culling Policy

9.5	How might effective farm quarantine be achieved in future?

9.6	On culling versus vaccination

9.7	On comparison made between different programmes involving culling and vaccination 

9.8	Conclusions on Control if an Outbreak Occurs

9.9 	Summary

10	VACCINATION

10.1	Attendance of FMD scientists Dr Barteling & Dr Sutmoller

10.2	Vaccination Issues raised by Royal Society

10.3	What roles does vaccination play?

10.4	Implications of animals entering the food chain

CONTENTS, contd

10.5	Present vaccines, research, role of marker vaccines, and the other issues raised by the Royal Society

10.6	Use of  Vaccination, and Experience in Other Countries

10.7	Other factors affecting vaccination

10.8	Implications of FMD, and national and international control

10.9	Conclusions on Vaccination

11	CONCLUSIONS & RECOMMENDATIONS

NATIONAL FOOT & MOUTH GROUP
&
VETS FOR VACCINATION

SUBMISSION TO

THE ROYAL SOCIETY INQUIRY

1	INTRODUCTION

This joint submission to the Royal Society Inquiry is submitted on behalf of the National Foot and Mouth Group (NFMG) and Vets for Vaccination.

It is based on the experiences and observations of the organisations and individuals involved in the two groups during the course of the UK 2001 FMD epidemic.

In the NFMG letter to the Royal Society of 18 September 2001 the Group explained its formation and the role it has undertaken during the FMD outbreak.  Appendix 1

Vets for Vaccination was formed from a group of vets involved at first hand with the consequences of the epidemic and the effects of the adopted control policies.  The remit of the group was to bring the epidemic under control whilst protecting the rural economy.  A key issue was the use of vaccination to reduce the risk of spread of the disease and deliver a swift return to normality for rural economies and communities.

2	CONTEXT & BACKGROUND

2.1	It became clear within days of the FMD outbreak being announced, 21 February 2001,  that there may be significant consequences from this re-emergence of Foot and Mouth Disease (FMD) in the UK.

2.2	It soon became apparent that:

1	there were now massive livestock movements across the UK on a daily basis and that this is now routine practice,

2	there was no ability to accurately determine precisely how far the disease had already spread throughout the UK before;

a)	the occurrence of the disease had been recognised,

b)  	movement restrictions were imposed.

2.3	The consequences of this was that it was not possible to determine the scale of the outbreak that the UK was now facing.   What did become apparent was that the means of control of slaughter, cull and animal disposal had widespread implications.  

2.4	As the disease progressed it became evident that this was not just a disease of agriculture but that it affected all areas of the community.  It also created a huge human, social and economic cost.

2.5	Not surprisingly there was major public concern, not only from rural communities but also from the urban population, that the manner of control, and the pyres, pits and closure of the countryside, were immensely damaging to the concept and perception of rural areas.  This damage and harm was manifested in several ways:

1	The closure of the countryside and its despoilment, evidenced in the  control measures, created a massive and disproportionate loss to the tourism industry and associated rural businesses,

2	There was an immediate fall off in demand for the UK as an international tourist destination,  

3	Many associated rural businesses faced heavy financial losses, as markets, animal transportation, feed and supply merchants ceased to operate, as movement restrictions were imposed

4	Rural communities also faced enormous social and psychological problems in coming to terms with the destruction of their animals and the isolation and welfare problems created by movement restrictions.

2.6	Both the NFMG and Vets for Vaccination have been involved with farmers, rural business and communities during this time.  We have witnessed at first hand the implications of this disease and the impact of the adopted control policies on the various sectors of the rural community.  It is our contention that FMD must be regarded in the widest possible context.   

2.7  	It is no longer tenable to consider the control of FMD in the terms of cost benefit to agriculture.  The disease must now also be considered in relation to its impact on the environment and on the economic and social fabric of society.

2.8	It is in this context and against this background that we respond to the various issues raised by the Royal Society in its Call for Detailed Evidence.

3	DISEASE FREE STATUS

3.1	We are grateful that the Royal Society has thought it appropriate to address this concept as part of its Inquiry.  It is clear that this fundamental issue lies at the heart of the current policies adopted to control the disease.

	We have sought in Section 2 to briefly outline how these controls impacted on rural businesses and communities.  We submit the following:

3.2	FMD DISEASE FREE STATUS & THE MAINTENANCE OF EXPORT MARKETS

3.2.1	The maintenance of Disease Free Status in order to retain export markets of meat, meat products and milk products directed the Government to adopt the slaughter and cull policies, which it enforced to control the FMD epidemic.

3.2.2	The Government maintained that recourse to a policy of vaccination to control FMD would jeopardise the Disease Free Status of the UK and in turn delay the return to export markets.

3.2.3	The value of the meat, livestock and associated products export markets pre the FMD outbreak has been accepted as circa £550 million per annum.

3.2.4	The costs of controlling the FMD epidemic has been estimated as between £2 to £5 billion.   In addition to the cost of compensation paid to farmers there have been the massive costs of slaughter, disposal, cleansing and disinfecting.  Losses to tourism are estimated by the English & Welsh Tourist Boards to be circa £5.1 billion.  The Institute of Directors estimated the total cost to the nation could be as high as £20 billion.

3.2.5	The findings of the National Audit Office will be able to demonstrate more accurate figures, but in any event the costs to the nation far outweigh the loss of export markets, not only for this year, but for many years to come.

3.2.6	Therefore, in order to preserve export markets for one sector of the economy, ie. the meat and livestock industry, massive and disproportionate loss has been inflicted on many other sectors and on the national exchequer.

3.2.7	Most notably tourism and other rural businesses have been affected by the impacts of the FMD epidemic.

3.2.8	The issue of Disease Free Status is therefore one which must be re-appraised in assessing the future of farming and food production, and the control of FMD.  A key factor is whether the costs inflicted on other industries and the nation in general is justified to support only one sector of the economy, ie - agriculture.

3.2.9	It is our contention that several matters need to be addressed:

a)	What is the precise definition of Disease Free Status and what does it refer to? – The presence of antibodies or viraemia?

b)	What are the financial benefits it delivers?  Other countries that are not FMD free still achieve significant exports.  Is it all sectors of exports that need to be disease free, or vaccination free, or does it primarily apply to pedigree breeding stock?

c)	As the EU expands and incorporates those countries that are not currently disease free, eg Turkey, Poland, Estonia, etc it will be increasingly difficult to achieve and maintain DFS across the EU.

d)	Those countries which use vaccination do not appear to be seriously disadvantaged in exporting,  eg Brazil and Argentina

e)	Which export markets would we actually lose if we vaccinated – have these been qualified and quantified?

f)	It should be noted that science is constantly improving and that better vaccines and better means of detection of vaccinates are evolving

g)	Given the present and increasing extent of international trade and the  increased mobility of people and animals across borders it becomes ever more difficult to control and regulate disease surveillance systems.

h)	There will be a need to respond to changing circumstances; farmers may not be automatically compensated for FMD losses in the future

i)	We may need to recognise that it is not possible to prevent the disease from entering the UK or Europe and that what is needed is to develop an efficient, humane system of fighting the disease once it has occurred.

3.2.10	Through the course of the epidemic we have sought accurate figures from MAFF/DEFRA of the volume of meat from vaccinating countries entering the UK and EU – no definite figures are available and it is not known how much vaccinated meat and meat products are entering the UK.

This is a key issue for consideration – and we detail below our views on this.

3.3	RISKS OF INFECTION FROM IMPORTED MEAT & MEAT PRODUCTS, AND OTHER SOURCES

3.3.1	During the course of the epidemic it became clear that if animals were to be vaccinated there was a ‘perception’ that there may be consumer resistance to the purchase and consumption of vaccinated meat and meat products.

3.3.2	In order to determine whether this ‘perception’ had any basis in reality the NFMG sought to determine what quantities of FMD vaccinated meat and meat products were already being readily purchased and consumed in the UK.   Such products would obviously be imported as there is no FMD vaccination in the UK and the EU.

3.3.3	This information was sought from the Meat and Livestock Commission who directed us to DEFRA.

What emerged was that there are no accurate figures available to determine what quantities of meat and meat products from FMD vaccinating and FMD endemic countries are entering either the EU, or more specifically, the UK.

3.3.4	We append the correspondence with DEFRA at Appendix 2.  We also append a note of conversation with DEFRA on this specific issue. Appendix 3

It appears that meat and meat products can be imported into the UK, via any EU Border Inspection Post, without any further checks or controls.  Furthermore, the controls at the country of despatch may not necessarily be the controls at the country of origin.  DEFRA were at pains to point out that their figures only relate to country of despatch not  Country of Origin.

3.3.5	In addition it is not known how well regulated and enforced are the boundaries between FMD free and FMD occurring regions in certain areas of the world which the UK imports from, particularly in third countries.

3.3.6	Finally, the methods of determining whether animals are FMD free at the point origin or despatch relies solely on clinical pre mortem inspection with no laboratory testing to conclusively determine the presence of FMD.
	See Appendix 3

3.3.7	Although much attention has been paid to the likelihood of the UK 2001 FMD epidemic originating from illegal imports,  it is our contention that the infection may well be the result of ‘legal’ imports but derived from meat originating from an area of endemic FMD, which has passed through un-regulated or un-managed borders, into an FMD free area for exporting.  

3.3.8	Given that it appears impossible for borders between FMD free and FMD endemic areas to be properly controlled and regulated, and given that many animals are transported and moved considerable distances prior to importation either into the EU or the UK, it would seem only a matter of time before further FMD outbreaks occur either in the UK or elsewhere in mainland Europe.  

3.3.9	In addition there may be many other means by which infection could again enter the UK.  It is by no means clear what the origin of the current infection was, or how it was transmitted.  We need to have regard to other novel vectors, as yet unconsidered.  

The emphasis on uncontrollable routes of infection, such as airborne transmission has diverted attention from the more traditional routes.  In the current outbreak in the UK it was the movement of personnel and vehicles which posed the greatest risk of disease spread.   There may be implications that contaminated containers or human carriers may be involved in further re-introduction into the UK.

3.3.10	The issue regarding swill being fed to pigs is by no means conclusive.   Currently 4% of the UK pig population is swill fed.  However it is not known what proportion this is of the total volume of swill or catering waste.

With the disposal of waste food currently costing £80 per tonne the banning of swill feeding is of some economic significance to the catering industry.  The quantity of waste food is likely to increase as new Food Safety Measures are introduced; however the use of land fill as the means of disposal is environmentally unsound. 

This volume of waste that is increasingly sent to landfill may also be a contributory cause; as waste vehicles may be carrying infection and will probably not be subject to any form of bio-security or bio-sanitary protocol.

There are real and logisitical problems in handling waste food and maintaining bio-security; and as disposal costs increase there will be incentives to look at alternative illegal methods.  The processing of waste food at designated sites would seem to be a better alternative. 
3.3.11	The difficulty in tracing the source of an outbreak, identifying the various vectors that are involved, and establishing how, when and where the disease emerges and disperses, coupled with the subsequent problems of traceability, all militate against the likelihood of further outbreaks in the future being prevented, and, more importantly, contained.

The contention that we wish the Inquiry to consider is that it poses
great  risks to maintain DFS given;

1	the vulnerability and susceptibility of the resident  animal population, 

2	the extreme likelihood of further imported infection and its swift transmission once in the UK,

3	the costs and impacts of control required to maintain DFS, as evidenced by the costs and impacts of the current epidemic.

3.4	ETHICAL IMPLICATIONS OF DISEASE FREE STATUS

3.4.1	In addition to the financial, environmental, social and logistical problems of maintaining DFS it is also necessary to assess whether it is ethical to require millions of healthy animals to be slaughtered in order to maintain the economics of an export market.

3.4.2	Furthermore, it is not only those animals that have been slaughtered as part of the contiguous, 3 km culls, etc,  which raise questions as to the ethics of this method of control, but also the imposition of movement restrictions which has resulted in massive welfare problems throughout all the course of the epidemic and still remain.

3.4.3	Finally, there are the moral and ethical issues related to the livestock disposal schemes and welfare culls, which have become necessary as a result of the control policies, and are still resulting in millions of healthy animals being slaughtered purely for disposal.

3.4.4	These issues do not appear to have been given cognisance in determining the methods of control used in this outbreak.   Without wishing to appear emotive, it seems as those taking these decisions had become devoid of any ethical and moral considerations in dealing with this disease, through the course of this epidemic. 

	It is unlikely that in any future outbreak such practices will be accepted by the veterinary profession.  For any control policy to be successful it is necessary to have a mandate from the community.

We submit that the method of control for ‘stamping out’ FMD, involving the slaughter and cull of so many healthy animals, and the welfare problems inherent in the imposition of movement restrictions,  in order to provide the quickest return to DFS, is no longer acceptable.

We consider that vaccination provides a more humane and ethically acceptable  means of controlling the disease, and greatly reduces the costs and impacts to other sectors.
3.5	JUSTIFICATION FOR RETENTION OF DISEASE FREE STATUS

3.5.1	It is for all these foregoing reasons and considerations that we consider the issue of Disease Free Status is a concept that the Inquiry must clearly justify if it is to advocate its retention.

3.5.2	The consequences of maintaining DFS have been manifest in the control policies for FMD that were adopted and their consequences

3.5.3	Within the remit of the Policy Commission on Food and Farming’s terms of reference it appeared incumbent for the Commission to take a view on this matter.  We consider that in the light of the Commission’s findings in ‘advancing environmental, economic, health and animal welfare goals’, the Commission should also make representations to the Royal Society Inquiry on this fundamental issue.

3.6	DISEASE FREE STATUS IN THE FUTURE

3.6.1	It is our contention that if Disease Free Status is to be maintained it must be clearly demonstrated, qualified and quantified what benefits this delivers and these must be assessed against the economic, social and environmental costs, as demonstrated during the UK 2001 FMD epidemic.

3.6.2	From the current perspective we question whether the concept of DFS is one which should be maintained but that contingency plans should be put in place to deal with outbreaks as they occur; with recourse to vaccination programmes, as appropriate.  

3.6.3	Clarification must be sought, and representations need to be made, to both the EU and the Office International Epizooties (OIE), to consider the UK 2001 epidemic and determine other authorised and validated methods of FMD control as opposed to the slaughter and cull regime.

Negotiations should also be undertaken with the EU and with the OIE to determine protocols for the use of vaccination in the control of such outbreaks and which do not necessarily lead to extended periods of loss of DFS as a result.
 
The provisions set out in the OIE International Animal Health Code 2001, Chapter 2.1.1 on FMD must be re-appraised and re-evaluated in the light of the UK 2001 epidemic, and with regard to achieving global eradication. 

3.7	CONCLUSIONS ON THE CONCEPT OF DISEASE FREE STATUS

3.7.1	Taking into account all the foregoing considerations and  implications of maintaining DFS, both in the UK and in mainland Europe, we submit that it is timely to consider an alternative regime for controlling FMD.   

	In pursuance of this it is necessary for the UK, the OIE and the EU to discuss and negotiate different methods for the control of FMD  which reduces the current penalties associated with the use of vaccination to achieve and re-establish DFS.

3.7.2	In summary:

In order to determine whether the concept of DFS should be maintained for the UK and Europe we submit the following:

1	A full risk assessment of the likelihood of further outbreaks must be undertaken

2	The cost benefits of DFS must be qualified, quantified and assessed and considered against the economic, social, and environmental impacts of the current ‘stamping out’ policies.  Regard must also be had to the ethics of this approach.  

3	If, having taken account of the criteria in 1 and 2 above, it is decided  that the concept of DFS should be maintained, then the role of vaccination to control future outbreaks must be re-negotiated and determined by the OIE and EU,  so that vaccination does not result in such punitive penalties and an extended loss of DFS for the vaccinating country. 

4	SURVEILLANCE

4.1	How effective are existing methods of disease surveillance?

4.1.1	There is no other more effective surveillance system than one based on consensus and trust between the farmer and the local general veterinary practitioner.  

In most cases, the State Veterinary Service is reliant upon the farmer calling in either his local vet or the DEFRA vet, if he finds a suspect animal.

Formal surveillance is restricted to Veterinary Inspection at abattoirs and markets.  Occasional Veterinary Surveillance at collecting centres and other ad hoc events have proved useful.

Routine patrols of farms are very demanding on veterinary resources and not effective.  There are logistical problems in handling and examining stock that may be dispersed over a very wide area.  

Mass screening of milk or blood samples is an exceptionally efficient method of surveillance for slow spreading diseases. Strategic use of PCR for virus detection at dairies or abattoirs could be useful.

4.2	What are the barriers, implications and costs of moving to more active surveillance?

4.2.1	Veterinary practitioners now rarely get onto farms, as vet visits have become uneconomical in certain sectors of the industry.   In the current outbreak there were insufficient veterinary resources to allow routine patrol inspections of flocks and herds in suspect infected areas.   There was also the possibility that farmers hiding animals could hamper formal on-farm inspections.
4.2.2	In addition, someone has to pay both for the veterinary practitioner and the cost of any laboratory tests. The LVI system of contracting work out to private vets could be used to address this. 

4.2.3	Furthermore, there are now uncertainties facing the farmer and the large animal practitioner.  Changes within the agricultural industry have subsequently made any significant veterinary input into certain sectors totally uneconomic.  

However,  there is no doubt that the general practitioner still has a very important role in communicating with the livestock sector of the industry.  In the past this role has proved to be very effective at delivering  cost effective services.  

In an environment where financial resources are limited it may be more cost effective for some of the statutory duties (including surveillance)  of DEFRA  to be managed and implemented by general practitioners.

As in other areas, the development of a public/private partnership to deliver a surveillance strategy, may be an efficient, cost effective and reliable solution.

The use of local practitioners, acting as appointed, certified agencies, would also enable the restoration of trust and confidence in a process and relationship with the Ministry, which has become seriously undermined during the current epidemic.  

4.3	How can science help surveillance at points of entry (import controls)? 

4.3.1	Please refer to earlier Section regarding Disease Free Status and Risk of Infection from Imported Meat and Meat Products, and Other Sources.  Section 3.3

 
5	DIAGNOSIS

5.1	ACCURACY OF DIAGNOSIS & IMPLICATIONS
	UK 20001 FMD EPIDEMIC

5.1.1	Throughout the course of the epidemic we have become ever more concerned at the accuracy of the diagnosis of FMD.

The major impact and implications of FMD, in animal welfare, economic, social and environmental terms, direct that it is important for the presence of the disease to be accurately determined, in order to minimise the damaging consequences of the current control policies.

5.1.2	At the outset it was not appreciated that the diagnosis in some species, particularly sheep in this epidemic, was likely to be due to responses to other agents or infections and not necessarily FMD.   As time progressed and it became public knowledge that laboratory testing was not bearing out clinical diagnosis conducted in the field, there was increasing anxiety amongst farmers and the rural community that the necessity for some of the culls, and in particular the contiguous culls, was not proven.

5.1.3	In addition there was mounting distrust at the manner in which confirmed cases were being determined, via discussions with, and directions from, Page Street, as opposed to experienced and informed veterinary opinion on the ground, and without recourse to scientific laboratory testing to confirm diagnosis.

5.1.4	By mid April so great was the concern of many members of the public that they were prepared to publicly challenge the need for the Contiguous cull in many areas.  Notably the Forest of Dean became one of the first areas of the country where public distrust of the control process resulted in protests to stop the contiguous cull.

5.1.5	Here local people had first been concerned that the free roaming sheep had not been rounded up and quarantined at the start of the outbreak.  They were then appalled at the manner in which the cull was then carried out.   In some areas the roads through the Forest were closed and the slaughter was executed by the culling teams moving through the Forest and shooting the sheep with rifles.

5.1.6 	Several weeks later contiguous culls were still being authorised although it had never been made clear which of the free roaming sheep were, if at all, infected.  Also these culls were proceeding long after the incubation period for the disease had elapsed, where the animals were showing no clinical symptoms of the disease  and when their owners could demonstrate they had maintained full bio-security.

5.1.7	It was the appeal of Oaklands Community Farm, at Newnham on Severn, in the Forest of Dean, which highlighted this situation.  We append the report prepared by them detailing the situation as it pertained to them and others in their circumstances.  Such circumstances were apparent not only in the Forest of Dean but also in other areas of the country.  Appendix 4	

5.1.8	Of the 34 contiguous culls that were authorised in the Forest of Dean none showed positive results for FMD when laboratory tested.  	

In the intended cull of animals as dangerous contacts from Welshpool Market, where 40 local farmers refused to let their animals be killed, not one later proved positive.

We understand from Burges Salmon, solicitors, that of the 9 cases that were taken to appeal – no positives were subsequently found.  Of the 140 cases where their advice was sought only 2 subsequently proved positive.

In the cases dealt with by Alayne Addy, of Stephens-Scown solicitors, of the 200 cases they were involved in, only 1 went on to prove positive.

Where all were involved in resisting the culls it was only on the basis that the farmer could demonstrate that he had undertaken rigorous bio-security and firmly believed that his stock was healthy and had not been exposed to the disease.

5.1.9	A nation-wide picture was beginning to emerge that:

1	the accuracy of diagnosis was a major cause for concern,

2	the need for the contiguous cull was not scientifically proven and no account was being taken of local circumstances, experience and expertise.

3	risk assessments to determine the likelihood of the presence of infection were not being used to assess whether the disease could have spread.

5.1.10	In addition it was becoming clear through papers and reports in scientific journals that not only was there a growing public concern regarding diagnosis, how the disease was spreading and the adopted methods of control, but that recognised scientists in the field also did not support the contentions that were being advanced to justify the control policies.

		Principle amongst these were:

1	Paper in the Vet Record of 12 May 2001 on Relative risks of the uncontrollable (airborne) spread of FMD by different species – Alex  Donaldson, et al.                                                   Appendix 5 

2	Paper in the Vet Record of 12 May 2001 on Relative resistance of pigs to infection by natural aerosols of FMD virus – A Donaldson &  S Alexanderson                                                        Appendix 6

3	Letters in Vet Record of 12 May from various Ministry Vets on FMD control strategies and the number of negative test results from confirmed cases and contiguous culls.                  Appendix 7

4	Letter to the Vet Record of 19 May 2001 from Dr Alex Donaldson and Dr Paul Kitching on FMD diagnosis 		        Appendix 8

5.1.11	So great was our concern as to what constituted a confirmed case and how it was being diagnosed that we wrote on the 1 May 2001 to the Secretary of State asking to be informed. 

“1	What is the legal definition of a “confirmed case”  of foot and mouth?

2	Does the definition refer to:

		a	Clinical signs 

		b	The presence of live virus in the animal 

		c	The presence of post viral antibodies in the animal

		or a combination of a&b, or a&c, or b&c or all 3 criteria?

3	Has the legal definition changed over time?

4	Of the 1525 ‘confirmed’ cases to date (source: MAFF web site – 19.00 on Tuesday, 1 May 2001) what number have been, and will be, subject to serological testing?  

How many of the 1525 ‘confirmed’ cases have subsequently shown no presence of either live virus or post viral antibodies, (ie, proved negative with no evidence of the disease), when serologically tested?” 	
See Appendix 9 for full text

5.1.12	We also wrote 14 days later, as our concerns were extended to consider what the equivalent situation was regarding the testing of contiguous culls, dangerous contacts, slaughters on suspicion.

		See Appendix 10 

	We are still awaiting replies to both letters.

5.1.13	In order to inform this submission we have recently requested the information again.  At the time of writing this report it has still not been provided.

5.1.14	The Royal Society poses the question: 

	“How good are existing techniques”

We understand that Pirbright tested all the samples it received for antibodies and vireamia using ELISA, PCR and tissue culture 

We understand from Dr Paul Kitching, former head of FMD at Pirbright Animal Health Institute:

1	that if we assume that samples were collected on IP's from animals with suspect clinical signs, the tests are very sensitive and specific, approximating 100%.

2	samples were tested by ELISA, PCR and tissue culture

3	if blood was submitted, this was tested for virus and antibody, virus appears before clinical signs, so if an animal had suspect FMD, it would be virus or antibody positive, sometimes both, never neither. again the tests approach 100%.

Also from Warmwell. com: Dr Paul Kitchings 's response to Prof Ray Anderson of Imperial College  "Blood samples received at Pirbright are tested for both virus and antibodies; if both are negative then it would not be possible for that animal to have or have had FMD assuming they sent samples from the animals they suspected of having the disease."

In letter to Vet Record of May 19th Paul Kitching and Alex Donaldson write "On epithelial samples we carry out an ELISA and virus isolation using sensitive tissue culture, while in blood samples we look for viraemia and antibody.  The viraemia starts before clinical signs and is replaced around three to four days later by high anitbody titres, so animals with FMD have either virus or antibody or both in their blood.    We are also comparing the sensitivity of virus isolation with direct PCR on the epithelium samples, and so far we have a very strong correlation in the results - close to 100 %...........While it is never the intention that laboratory diagnosis would replace clinical diagnosis, we believe that laboratory support for a diagnosis of FMD in sheep, in particular, is essential.  For samples collected in the UK and submitted as recommended, we would expect a very high success rate and certainly above 90 %.

	5.2	CAPACITY FOR LABORATORY DIAGNOSTIC TESTING

5.2.1	Clearly, the samples that were received by Pirbright for testing were subject to sufficient tests to establish whether animals were infected.

5.2.2	However, there was insufficient capacity at Pirbright to deal with the rapid increase in the number of samples that needed to be tested.   This problem became even more acute when the cull was extended to contiguous premises and 3 km.

5.2.3	There was no ability to scale up the number of tests that could be undertaken, nor was it feasible to speed up the process.  Although PCR testing was undertaken it appears this was only to re-inforce the indications from the virus isolation tests, as its seems that PCR still remains unvalidated by the EU as a test for FMD, and therefore only the time consuming virus isolation test could be used to identify viraemia.

5.2.4	No other facilities for testing were made available and offers from private firms and individuals to assist in speeding up the rate and processing of testing were dismissed.   For example Dr Colin Fink of Micropathology, who undertakes testing for the NHS,  offered to undertake PCR testing but was not allowed to obtain the necessary material to develop his test facilities to respond to FMD.

5.2.5	This lack of capability to increase a)facilities, b) speed of diagnosis and the inability to respond to the huge increase in the number of samples which required testing resulted in even more cases of mis-diagnosis occurring.

5.3	DIAGNOSTIC PROCEDURES

5.3.1	Many vets who ‘confirmed’ cases on clinical signs had never seen FMD.  Many TVI’s were drafted in at short notice from outside the UK, they too were not familiar with the clinical symptoms.   There was little time to train these vets and it was not possible for them to receive experience in the field before being immediately placed in the position of ‘diagnosing’ and ‘confirming’ case.

Many vets did not have the relevant experience but were small animal vets, not used to dealing with large animals, farm conditions, or with farmers.  As a result they were often not in control of the situation or able to deal with farmers and the farmers questions.   Some lacked language and social skills and came from very different cultural backgrounds.  All this led to a lack of trust and confidence with the Ministry and the way it was dealing with the situation.

5.3.2	In addition the process of diagnosis which was conducted via Page Street did not improve the accuracy of diagnosis, but in many cases led to cases being ‘confirmed’, against the view of the vet on the ground, and  which later tested negative in laboratory tests.

This was especially the case when additional probangs were taken on the ground. 

Vets were often dealing with tense and difficult situations, and needed social skills and an ability to communicate with farmers and explain what needed to be done.   Many were unable or untrained to deal with these circumstances.  As a result communications and relationships between the Ministry and farmers became distrustful and threatening.   	

	5.4	CONSEQUENCES OF TECHNIQUES USED IN UK 2001 EPIDEMIC

5.4.1	Although we requested the national data on the lab test results for confirmed cases several times from MAFF, and now DEFRA, to date it has not been provided.

5.4.2	However, we have had the data on test results for the Welsh Cases, this was provided by the Welsh Defra Office on 15 November 2001:

It is our understanding that, of the 118 Infected Premises in Wales, 41 farms showed negative results on laboratory testing.  Also, we understand that not all of the remaining 77 farms were lab tested.  Given that clinical diagnosis in sheep cannot be relied on the incidence of the disease may have been even less than these figures indicate.

5.4.3	Given the views of Dr Kitching it would be reasonable to suggest that these test results can be relied upon for demonstrating the disease if it was present, and if it was not.

5.4.4	This clearly demonstrates that there has been a significant margin of error in determining and accurately diagnosing FMD.  From 119 Infected Premises in Wales it appears that at least 41, and maybe more, did not have the disease

Furthermore, the Infected Premises in Wales resulted in a further 493 farms being slaughtered, and again no lab test results have been made available to determine whether any of these farms had the disease and if it was necessary for them to be slaughtered.

5.5	DIAGNOSIS - CONCLUSIONS & RECOMMENDATIONS

	We believe the case is duly made for a reliable, fast, accurate diagnostic protocol to replace the provisions that were used in the UK 2001 epidemic.

Our recommendations are:

1	Recognising the limitation of existing techniques there is a need to immediately validate PCR testing to provide a swift, reliable, accurate test to confirm FMD.  Development of a cow side/ sheep side or farm gate test would be optimal.  We understand that development of such tests is now advancing – Vet Record 17 Nov 2001 P621-623	                                                  Appendix 11
	
2	There needs to be contingency plans to enable a swift scaling up of facilities and to increase the number of tests that can be undertaken within a very short space of time

3	To enable this increase in facilities, private diagnostic laboratories must be involved and commissioned to undertake some of the testing controlled by appropriate guidelines and regulations  

4	Local vets with a knowledge of the area and circumstances should be responsible for diagnosis.

5	Their diagnosis should be supported by a second opinion, particularly in cases where there is uncertainty or a farmer requests this.  There is a need for mentors to be available to assist vets who are inexperienced in FMD.

6	Testing facilities to confirm diagnosis should be available within the locality  – if (3) is followed this should enable regional testing facilities to be set up.

7	Diagnostic decisions must not be government based, taken at a central office with little knowledge of local conditions or circumstances

8	Diagnosis must be free of any political constraint and purely based on scientific diagnosis supported by laboratory testing,

5.6	SUMMARY

How good are existing techniques; what research is needed to improve them? 

For foot and mouth, diagnosis needs to be fast – to prevent spread and accurate – to stop excessive culling of healthy animals.  Lesions in cattle mouths are pathognomonic making diagnosis in cattle easy requiring only confirmatory laboratory diagnosis. This is not the case in other animals particularly sheep. Therefore primary diagnosis is based upon laboratory tests.  During this outbreak (in sheep), there have been large numbers of false positive results based upon clinical examination. 

Laboratory diagnosis and confirmation should move away from serology and move to detection of virus using PCR.  This would allow decisions to be made about the infectivity of individuals or flocks.  The development of rapid simple cow-side/sheep-side tests for use on the farm is essential.  This would allow more accurate and quicker diagnosis on the farm.  

In the current outbreak use of such equipment would have prevented the unnecessary slaughter of many thousands of healthy animals.  Using this type of tool, epidemiologists and clinicians could have made meaningful and accurate forecasts of exposure to virus.  Again only those flocks/herds that showed high levels of virus would have needed to be culled. Low-level flocks would have been better vaccinated.

Veterinary clinicians in the field did not have access to the full range of diagnostic tests. Those cases that were not FMD, but which mimicked it clinically, should have full range of diagnostic tests to further clinical knowledge and improve diagnostic skills.

How should individual animal diagnosis be linked to decision making ?

Diagnosis should be made by the clinician on the ground if possible, not by a person at Headquarters who has not seen the case.  This may involve consultation with an experienced colleague (2nd opinion by “mentor”). 

If lab testing is required to make diagnosis e.g. PCR in sheep, then the clinician on the ground should be the person responsible for making a risk assessment of the possibility of virus spread whilst the results are awaited. This should be a balanced decision. 

Suspect animals could have remained alive until the confirmatory tests were completed. The results would have been known by the time preparations for slaughter had been completed. There would have been no additional time loss and consequent virus spread if the target animals turned out to be virus positive.

Are there developments in other sciences or technologies that might help ? (eg what are the prospects of tele-medicine/teledetection ?)

Though in theory transmission of digital photographs via mobile phone to experienced colleagues is feasible, our experience in using this technique for diagnosis in other species had demonstrated considerable limitations.  It is cumbersome and there are undefined attributes and quality of definition that are simply not transmitted in a picture.  Research is also required to find methods to disinfect such equipment or protect it whilst still making it useable.

Who should manage the national diagnostic service ?

A public/private partnership for lab diagnosis would be ideal as this would be more likely to deliver better and quicker results without any political bias. There is little doubt and plenty of evidence that the diagnoses and subsequent actions have been politically biased in this current outbreak.
Practical field based solutions to diagnostic problems would be more likely to be researched.

Who should undertake the actual diagnosis ?

A trained, experienced veterinary surgeon on the ground, attending the case as described above supported by fast accurate laboratory testing, preferably PCR and with the development of new testing techniques, ultimately at the farm gate or cow/sheep side.

6	PREDICTION, PREVENTION AND EPIDEMIOLOGY

6.1	PREDICTION & PREVENTION

6.1.1	We consider that the risks of importing FMD have become far greater in the last few years, and that this is a trend which is set to increase rather than decrease.

6.1.2	With the demise of the eastern block as a defined unit, which provided a trade barrier, and a reduction in the use of vaccination globally, for reasons detailed below, the possibility of infection moving across continents has become a greater reality.

6.1.3	The increasing mobility of animals and people, changes in patterns of trade and an increasing globalisation of the market place has also resulted in an increased risk of infection moving across land masses, crossing borders and being imported to Europe and the UK.

6.1.4	However, it is important to ensure this trade globalisation is continued as it is this process which underpins the means of maintaining world peace.

6.1.5	To inform this Section of our submission, and to provide greater knowledge and understanding of this situation, we have consulted various scientists who have knowledge and expertise in these matters.  We have incorporated their comments into this submission and are grateful for their help, experience and knowledge in enabling us to take a view on these issues.    	

6.2	REDUCING RISK OF IMPORTATION OF FMD

6.2.1	It must be appreciated that currently, only one country in mainland Asia is recognised by the OIE as free of FMD, and no countries in mainland Africa.  Also the GDP per capita of FMD free countries without vaccination is on average 20 times higher than those countries which are not recognised as FMD free.

6.2.2	It must also be appreciated that the existing process of acquiring recognised freedom from FMD (as set out by the OIE) either on a zonal or countrywide basis, is an enormous undertaking and practically impossible for the majority of African and Asian nations, where there is extensive trade across land borders and weak administrative structures unable to control animal movement, exacerbated by civil unrest.  This being the case, and under pressure of the IMF, most countries have reduced FMD control over the past 15 years creating high risk situations in which FMD control falls between the stools of under-funded Government services and the farmers.  National vaccination programmes, or farmer based vaccination have, in most countries been too late to be effective.  National eradication programmes are high risk given the potential for re-introduction; even Taiwan, which was disease free for 70 years, gave up trying to eradicate FMD in 1997 since the risk of re-importation from China was too high.

 6.2.3	Also it must be understood that the situation FMD free countries face is mainly created through the voting habits of such FMD free countries; having bought their freedom at a price, the barriers are set high, and increasingly higher, in defence of that freedom.  FMD free countries have effectively created the set of limited and difficult choices for control which determined the scale of impact of the 2001 European epidemic.  The 3 month qualification period without FMD vaccination, but 12 to 24 month period if any vaccination were used, with non-scientific levels of restriction on animal product utilisation of vaccinated products, effectively gave little impetus to the use of vaccination.  This is a situation created by the voting habits of FMD free countries to maintain these periods.  Countries not recognised as FMD free have had no choice but to go along with the penalties in the hope of eventually securing exports. 

6.2.4	It must be noted that LEGAL imports have not been shown to be the cause of any outbreaks of FMD in Britain since 1967-8, and that the FMD control in Argentina and Uruguay has been far more stable under a vaccination system than under their recent attempts at non-vaccination, which resulted in enormous outbreaks in 2001 after re-introduction across land-borders.

6.2.5	The instability in the world FMD control in the 1990’s is, in part, a result of break up of central planned economies, and burgeoning, illegal  cross-border trade patterns in Asia and Africa. 

6.2.6	The other cause of world instability in FMD control is the existence of the barriers against vaccination which cause countries to cease the use of vaccination and expose themselves to potentially enormous consequences, such as in South America and Europe in 2001.  

FMD in 2001, in Argentina and Uruguay, reflects the trade barriers (OIE recommendations) placed against use of vaccination; FMD had been eradicated through vaccination, but under IMF pressure vaccination ceased, and enormous outbreaks followed the inevitable re-introduction of the disease.  

South America reflects the enormous scale of the Taiwan epidemic of 1997, and the UK epidemic of 2001 reflects the inevitable accidents of introduction in unprepared countries where the historical approach is a slaughter policy.

It must be noted that the pan-Asia strain of type O was first detected in the Punjab in 1990, at a time of instability in the central Asian region.  There is reason to suppose the introduction of this type occurred from the pastorist livestock systems with the extensive sheep movement of central Asia.  Where FMD (very often type O in sheep) had been controlled in the Soviet era by state sponsored vaccination, as Sino-Soviet trade became permitted at the end of 1980’s, and during civil conflict in Afghanistan, and following the collapse of the Soviet Union, conditions for instability in FMD control existed, and allowed for spread of the disease east and west through Asia and the Middle East.

6.2.7	Prevention of FMD, therefore, should not be at the consequence of penalisation of countries with FMD, since the effect would be to increase the economic impact on countries “which catch it”. The vicious circle must be broken.  Increasing barriers increases the consequence of FMD introduction, reducing control options (principally vaccination).

6.2.8	Reducing the barriers to trade can be achieved without effectively increasing risk.  There is no question that our legal import system has been effective for 34 years.

6.2.9	Creating a world system that encourages FMD control by creating incentives to control FMD that encourage LEGAL trading prospects would have benefits for the UK/Europe:

	a	Improved reporting of FMD internationally as the incentive to conceal	FMD is reduced or eliminated

b	Improved control in Asia and Africa as a result of incentives for FMD control to gain legal trade between countries within these regions, and in effect reduced numbers of illegal traders

c	Higher farm incomes in countries with FMD would assist FMD control, via incentives for the regional or local control of FMD.  High standards of meat export hygiene, coupled with pre-mortem examination and local administrative certification of FMD freedom, can effectively ensure zero risk in exports from and meat processing to FMD. 

d	The knock-on effect of changes by the OIE would be a global reduction in high risk smuggling, but more importantly, incentives for FMD control which enable countries which “catch” FMD to rapidly regain partial trading before regaining full freedom.

e	Prevention of FMD entry to Europe, therefore, is greatly connected to reducing illegal systems of meat product trade by creating incentives for FMD control at the global scale – this starts with the need for unbiased, independent science to assess risk and the removal, or reduction, in trade/political influenced decision making by the OIE, in Paris and at the Standing veterinary Committee in Brussels.  

Trade protectionism has created the “monster” of FMD and science based risk management can reduce this monster to size.

6.2.10	Our proposals are:

1	The system used for scientific advice to the OIE should be reviewed in order to demonstrate it is independent of trade and political influences, and open for peer-review.

2	This system could adopt measures (such as the Cochrane review system) for scientific review to demonstrate systematic approach with independence from trade or political bias.

3	The voting position of the UK (and other European representatives) representative to be open for peer-review and by stake-holders before voting occurs, in response to proposed changes to the Animal Health Code.

4	A move to placing the international control of FMD in livestock products AWAY from NATIONAL control approaches (country-wide or zonal freedom) to PROCESS BASED CONTROLS.  The principle change would make the PROCESSES in the export of livestock products (traceabiity, freedom at local level, pre-mortem examination, deboning and maturation  of meat) the principal form of control for countries wishing to export, thereby creating incentives for international investment in currently endemic countries and  incentives for FMD control, particularly in Africa, Asia and South America. 

Opposition can be expected from FMD free countries, as this threatens trade protectionist positions. 

6.3	PREVENTING THE IMPORTED FMD INITIATING PRIMARY CASES

	Reducing the Incidence of Primary Cases

6.3.1	It is recognised that FMD will continue to be imported from time to time, principally in legal and illegal imports of livestock products and possibly by other routes.

6.3.2	Preventing such importations may be almost impossible but the cost of measures to reduce rate of introduction must be balanced against the cost of reducing the consequence of importations (primary cases, and subsequent spread)

6.3.3	Primary cases in UK in the last 50 years have almost entirely been the result of meat imports (before de-boning, removal of offal etc), and in meat and bone meal in animal feeds, with primary cases occurring in pig units.

6.3.4	Pig units must remain critical control points for FMD control in the UK.

6.3.5	Free-range units, suspected as the point of entry of CSF in 2000, as well as swill-fed units must be considered high risk, but also (to a lesser degree) the small numbers of backyard or pet animals.

6.3.6	The banning of swill-feeding is one measure that would have immediate impact in risk reduction, even though tighter controls (frequency of inspections) or heat treatment might be equally effective. A ban on swill feeding, almost effectively removes the risk associated with import of meat products from FMD infected countries, and therefore it is questionable if ANY controls should remain to limit trade with FMD endemic countries in livestock products.  However the existence of free-range pig production necessitates some controls, either at the supply end (de-boned meat) or surveillance end (rapid detection of primaries).

6.3.7	In addition the risks of disposal of food and catering waste to landfill sites needs to be considered.  If infective material is present in this waste it can be dispersed by scavenging animals.  Also, as waste transport vehicles are not subject to bio-security or bio-sanitary measures,  infection could be transported, distributed and lead to future contact with susceptible animals. 

6.3.8	Recommendations

1	Ban on swill feeding would reduce risk, and may prevent the onward transmission of disease from FMD infected countries (including, in future, possibly EU countries).  Systems must be in place for FMD infected areas to verify that that slaughterhouse based controls are to satisfactory standards, since a small risk of entry to free-range pig production or backyard animals would occur (or via meat and bone meal to ruminants, if the practise continues).

2	New surveillance systems may be justified at remaining high risk points for primary disease. These may include the routine collection of samples at pig lairages/abbatoirs for rapid detection of multiple pathogens.  In view of the high levels of FMD virus found  in faeces it may be possible to use the PCR test for early detection of FMD virus in effluent. 

 	(an example is the proposed auto-sampling devices and pathogen detection system proposed to the EU FP5 programme, October 2001). 

3	Investigation and assessment of the risk of infection from catering waste and its transmission via waste disposal systems and via carrion from landfill should be undertaken.  

4	Alternative strategies should also be investigated.  For example, specialist waste processing centres, which would not only offer the benefit of reducing onward transmission of disease, but also provide cost savings to the food industry and reduce environmental pressure on landfill sites. 

7	SCENARIO PLANNING

7.1	The key questions that must be asked are:

	1	Was there a Contingency plan in the event of an FMD outbreak in the		UK?

	2	Was it followed?

Although we have been assured by Elliot Morley that there is a Contingency Plan lodged in the House of Commons library we have not been able to access this.  We also understand that a Contingency Plan has been submitted to the EU, but again we have not been able to acquire this.
We do not know, therefore, what the provisions of these plans included.

7.2	What is known is that 3 days elapsed between the identification of a suspect case of FMD and the imposition of movement restrictions.

These 3 days were critical in allowing the disease to be distributed and spread throughout the UK before controls were effected.  It was estimated that there had been 1.25 million animal movements during this time.

7.3	Prof Mark Woolhouse of Edinburgh University, addressing the Environment, Food and Rural Affairs Select Committee on 7 November, said that in his opinion, if movement restrictions had been imposed 3 days earlier, between 1/3 to ½  of all livestock would not need to have been slaughtered. 

7.4	If these contingency plans do exist what do they advocate as disease control measures?     Did  they recommend waiting 3 days before imposing movement restrictions?

7.5	Similarly, do  these contingency plans make provision for:

1	increasing the capacity of the diagnostic services in the event of an outbreak,

2	maintaining stocks of vaccine for emergency use,

3	responding to the increased need of personnel and equipment

4	establishing an organisation and network to deliver the required response,

5	providing information and advice

6	delivering effective disease control, with sufficient resources to respond to the need for immediate slaughter, disposal, cleansing and disinfecting in order to achieve a 24 hour cull of infected premises.

7.6 	If contingency, or scenario plans, do exist there is little evidence to support their ability to deal with this outbreak.  Such plans appeared totally inadequate in responding to the task of controlling the disease and bringing the outbreak to an end.  Furthermore, if the control was based on these adopted plans they showed no regard for considerations of a wider nature, including the impact on other economies and rural communities.

7.7	We consider that it may not be effective for either the Ministry or the State Veterinary Service to be responsible for the drawing up these plans but that the whole process of disease control and the methods adopted to deliver this may need to be evaluated and amended both at international and national level.  

7.8	Clearly this outbreak has demonstrated the widespread effect of FMD across the economic spectrum, together with environmental and socio-economic impact.  Any future planning must have regard to the complex and inter-related nature of the impacts of disease control.  

7.9	There appears to have been no update to the Cost Benefit Analysis adopted by the EU in 1993.  According to Hansard:

	11 May 2001 : Column: 462W 

	Mr. Flynn: To ask the Minister of Agriculture, Fisheries and Food, pursuant to his answer of 22 March 2001, Official Report, column 358W, on foot and mouth, what cost benefit analysis has been undertaken on the foot and mouth cull. [156097] 

	Ms Quin [holding answer 29 March 2001]: An EU risk assessment analysing the costs and benefits of both a vaccination and slaughter policy was published in 1993. This concluded that a slaughter policy would cost less than a vaccination policy. It was therefore decided that EU policy should be to slaughter and dispose of affected animals, or those animals exposed to infection, and that this was the most effective way of controlling the disease. 

	The results of this cost-benefit analysis confirmed the results of a cost-benefit evaluation of alternative control policies for foot and mouth disease which was published in 1973 following the 1967 outbreak. 

	End

7.10	The various costs of this epidemic can be summarised as:

1	£2.7 billion in compensation, slaughter, disposal, disinfecting – dealing with the epidemic - cost to Exchequer – Chancellor in pre- Budget statement 27.11.01

2	Cost to tourism and rural business £5.1 billion – source English & Welsh Tourist Boards

3	Overall and indirect costs to nation £ 20 billion – source Institute of Directors

7.11	It is now fundamentally clear that Cost benefit analysis of FMD control must be reviewed and account taken of all the factors involved in addition to those based in agriculture and economics.  Any future contingency or scenario planning policy must ensure that all these issues have been considered and addressed to reduce and minimise the impact of any future outbreaks of FMD.

8	MODELLING OF DISEASE SPREAD

8.1	We refer the RS Inquiry to the submissions of Alan Beat on the issue of the relevance and efficacy of the adopted models used in controlling the UK 2001 FMD outbreak.

8.2	NFMG and Vets for Vaccination have read his two submitted papers and fully endorse their observations and findings.                   See  Appendix 12 

8.3	We would also suggest to the Inquiry that the only way for the adopted models to demonstrate their relevance and efficacy in predicting the spread of the disease would be for the laboratory test results conducted on Infected Premises and Affected Premises to be published.

8.4	This data should conclusively determine whether the hypotheses advanced by the modellers have been borne out in reality, in field conditions and with any degree of accuracy.

8.5 	Sadly the data on the lab test results for both Infected Premises and Affected Premises has not been made available to us.  However, we are aware that such data is very incomplete.   Indeed, so few Affected Premises have been laboratory tested it will probably not be possible for any meaningful assessment to be undertaken.

8.6	What is known is that in the Welsh cases not all the 118 Infected Premises were subject to laboratory testing – we understand that circa 20 were not tested at all.  Of the remaining 100 or so cases; 41 showed negative results with no incidence of the disease.  Given that these then generated many contiguous culls, the impact of this mis-diagnosis cannot be over-estimated.   Furthermore the impact of the epidemic created massive and disproportionate losses to other sectors of the rural economy and many adverse socio-economic impacts on the rural community.

8.7	If predictive models are to be employed they must be accurate, robust and reliable.  This cannot be over-emphasised.   The huge, destructive impact of the disease is catastrophic in itself – it is crucial that this impact is not then further compounded by flawed, erroneous models which direct an even greater, unjustified impact and loss.

8.8	To quote Paul Kitching, former Head of FMD at Pirbright – 21 April 2001, C4 News who stated that no model was better than a model which relied on incorrect data.

8.9	From our own experience, as detailed in Section 5, on Diagnosis, the evidence we have obtained shows that from the Contiguous Culls that were resisted there is no evidence to support the modellers contentions of the need for the 3km and Contiguous Culls.  Most specifically in the Forest of Dean, of the 34 directed Contiguous Culls, not one showed positive results for FMD when laboratory tested.  In this instance the model was 100% in error.

8.10	The Government has yet to make available the lab test data to demonstrate that the need for the 3km and contiguous was justified.  Unless and until such data is published the models used to direct this policy must remain the subject of the severest criticism and disrepute.

	The adopted model used  to determine disease control policies has resulted in a massive experiment in FMD control.  However the lack of lab test data, on both confirmed and affected premises, has meant that this experiment has been conducted without sufficient results being recorded to truly determine either the efficacy, or error, of the model.  In terms of scientific and experimental protocol this is unacceptable. 

8.11	Given the hypothetical nature of the epidemiological model in the UK 2001 FMD outbreak, it does not seem sensible to suggest ways in which the models can be made flexible enough to cover all eventualities and be robust and reliable.  The evidence demonstrates that there were so many differences across the UK in terms of stocking rates, farming practices, geographical parameters, etc,  that it would be impossible for any model to allow for an accurate representation of all the situations on the ground and thus direct a sensible, reliable, predictive model to respond to all eventualities.

8.12	It is our belief that rather than directing resources to further theoretical and hypothetical models finance; would be better directed towards the development of swift, reliable, accurate diagnostics, for use preferably at farm gate, sheep/cow side, or available in the locality or region. As detailed earlier in the Section on Diagnosis.

    
9	CONTROL OF OUTBREAKS OF FMD

9.1	Are present methods compatible with modern ethical views?

9.1.1	FMD poses no threat to human health.  Also not all species of farm animals will suffer major clinical symptoms from the disease resulting in distress or mortality.  In particular, sheep may only experience mild infection and recover without any loss of vigour.  

9.1.2	The reason that culling was the preferred policy, to control the last FMD outbreak, was based purely on economic reasons; in that a stamping out of the disease, based on slaughter, currently only requires 3 months from the last outbreak before Disease Free Status (DFS) could be restored.

9.1.3	The recourse to a control policy involving vaccination currently delays the return to DFS and export markets of 12 months from the last outbreak.

9.1.4	However a programme of vaccination to contain the disease, used in conjunction with the slaughter of infected animals, could have controlled the disease without creating the massive and disproportionate impacts on other sectors of the rural economy, the environment and the social fabric of rural communities, which have been evidenced in this epidemic.  (See Section 3 on Disease Free Status for figures on economic impact)

9.1.5	Having regard to all these considerations, and against this background, it is difficult to justify the current control policies of slaughter and cull.

9.1.6	In addition, the control methods resulted in the slaughter of circa 4 million animals.   DEFRA – 4 Dec figure -   3,968,756 –  Slaughtered under FMD Cull.   Furthermore, the majority of these were healthy and did not have the disease.  

Indeed, not only were many Infected Premises later shown to test negative to the disease, but the percentage of infected stock culled as a result of Contiguous Cull, Slaughter on Suspicion, Dangerous Contact is estimated to be only about 18.5%.  Conversely, a staggering 81.5% were healthy and not infected.  (Source -  Prof David King giving evidence to EFRA Select Committee 7 November 2001).

9.1.7	Then, to further add to the number of healthy animals that had to be slaughtered as a result of this policy, are those resulting from the imposition of movement restrictions and the loss of export markets.  The number slaughtered as a result of Welfare Culls now stands at 2,010,753   
Source – DEFRA – 3 Dec 2001), under the livestock disposal scheme.

	It should also be noted that there was severe cruelty and suffering inflicted on livestock as a result of movement restrictions.    Animals were stranded on outlying fields and holdings and often without fodder, bedding or shelter.  Ewes were forced to lamb in dreadful field and weather conditions, and then lambs had to remain in flooded fields with no grazing or shelter.  Dairy heifers were calving down in fields away from farms, again with no shelter and facilities, and in totally unsuitable conditions and circumstances.   

In addition, managing the welfare problems of one group of animals on a holding, because of the limited resources of man power, etc, then compromised the welfare of stock in other areas of the holding.

Movement restrictions also led to animal being stranded without sufficient grazing, and often farmers could not afford supplementary feed to prevent starvation.

	Not only did this cause immense distress and suffering to the animals, but also to those farmers and vets who were left powerless to deal with the consequences.

	In other circumstances these occurrences would have been viewed as legal offences and would have been the subject of prosecutions.  There is undoubtedly a conflict of interest within DEFRA in managing, both, the FMD control program, and at the same time, promoting animal welfare.

9.1.8	In addition to the animal welfare issues is the matter of humane slaughter.  The killing of large numbers of animals under field conditions with poor handling facilities creates its own special problems.  There is no doubt that under these conditions it is not always possible to ensure humane slaughter of animals.  There needs to be better training, improved equipment and a greater understanding of the problems likely to be encountered.  

One of the authors of this report has personal experience of being sent a slaughter team of one man and a boy to handle load and slaughter some 180 pigs where there was no mechanical system for loading the pigs and only one worker on the farm.

9.1.9	These events must never be allowed to happen again.

	We should not forget the dreadful images that we all witnessed in March and April  – and it is the duty of this Inquiry to ensure that future disease control never again results in such animal suffering and cruelty.  	

9.1.10	In total approximately 6 million healthy animals (5,979,509 – to date) have been consigned to pyres,  landfill sites and render.  The scenes witnessed as a result of this control policy understandably offended against common decency.

9.1.11	The use of animals for food, clothing and other purposes can only be acceptable if these animals are recognised as living entities as opposed to purely units of commercial production, or an economic commodity.  Regard and respect must be had to the manner in which such animals are kept and slaughtered.

9.1.12	In a responsible, humane, modern society the loss of so many healthy animals to sustain an export market must clearly call into question the ethics of how such economies are maintained.  The killing of healthy animals, where there is no justified reason to believe that they are infected, is not defendable.

9.1.13	If, as a society, we are to transgress the line where healthy, sentient animals are to be treated solely as disposable, economic units, without any regard to,  or, respect for life, then the very basis of man’s relationship with other animals becomes debased and untenable.  

The ethical and moral code which underpins our treatment of animals and is enshrined in legislation must be respected.   The control of disease based purely on massive and indiscriminate slaughter in order to maintain an economic market, which is of benefit to a very few people,  does not comply with such an ethical and moral code and, therefore, cannot be accepted and must be rejected.

9.2	Socio-economic climate and fundamentals of national strategy

	Control of future epidemics in UK and Europe

9.2.1	The emphasis must be on immediate and enforced farm quarantine, in at-risk areas with increasing stringency of application in 10 km surveillance zones and 3 km protection zones.

9.2.2	The policy would be backed by a slaughter policy for infected premises,  until a pre-determined, pre-defined and pre-agreed threshold is reached, and then with a vaccination policy (vaccination to live) on a ring, zonal, administrative area or barrier basis according to circumstances.

9.2.3	The threshold at which vaccination is applied should be decided in advance in the contingency plan, with pre-determined time scales and definitions.  Delivery into animals in the field should begin within 48 hours of this pre-determined threshold being reached.

9.2.4	Penalties against the use of vaccination should be removed by prior arrangements, agreed in Europe with stakeholder participation.  Consideration is required on the need for legislation to allow mandatory vaccination where the decision is reached, or in protection or surveillance zones recourse to culling of herds refusing vaccination (or perhaps slaughter with reduced compensation).
	
9.2.5	It is our contention that vaccination must be the primary method of disease control.  The pre-agreed and pre-determined threshold should be based on an extremely limited number of cases.  There must be no extension of this pre-determined threshold during the course of the outbreak, nor should the threshold be increased or changed, to allow for slippage in its implementation. 

9.3	Control procedures and culling policies

9.3.1	Firstly, the question must be raised ‘Why was a Contingency Plan not put into action as soon as the risk of FMD was announced.’  It has been known that the pan Asia O strain of FMD had been moving westward for a considerable period of time.  Therefore it was incumbent on the Ministry to have prepared and updated a Plan to deal with such an event and to have put this into force in the event of the increasing likelihood of an outbreak.

9.3.2	Secondly, assuming a Contingency Plan exists, a fundamental requirement would have been to impose movement restrictions immediately the disease was confirmed.  But  movement restrictions were not imposed for 3 crucial days following the confirmation of the suspect outbreak.  

	It is our understanding that the disease was first suspected in Essex at Cheale Meats, but that 3 crucial days elapsed before Movement Restrictions were imposed.   By the time movement restrictions were imposed 90 premises were already infected and the disease was manifest as a multi-centric outbreak, in Essex, Northumberland and Devon.

Mark Woolhouse of Edinburgh Universtity ,giving evidence to the Environment, Food and Rural Affairs Committee on the 2 November 2001, stated that if movement restrictions had been imposed 3 days earlier the number of animals that would have had to have been slaughtered would have been reduced between 30 to 50 percent.

9.3.3	Thirdly, there must be accurate diagnosis to determine which animals are infected.  Disease control cannot and must not be based on indiscriminate slaughter.

9.3.4	It has become clear during this epidemic that not only has diagnosis been very inaccurate, but that there has been no definition of a ‘confirmed case’. 

It appears that the definition can apply to:

a	unconfirmed clinical symptoms, or

b	antibody positive animals, or

c	 the presence of viraemia in blood or other material.  

Latterly, however, it appears that antibody positive animals are no longer being listed as ‘confirmed’ cases.  Since the last ‘confirmed’ case was listed on the 30 September 2001, bringing the total of ‘confirmed’ cases to 2030 we understand that further flocks with antibody positive animals have been identified and slaughtered but these are now not recognised as ‘confirmed’ cases. 

This indiscriminate and arbitrary basis for diagnosis and confirmation is neither a scientific or tenable basis to determine;

a	the presence of disease, and 

b	the manner of its control

Also, as it became clear that clinical diagnosis was extremely unreliable, especially in sheep, there was no alteration of diagnostic practice to take account of this and improve the accuracy of diagnosis by using other techniques to determine the presence of disease before slaughter.

9.3.5	As referred to earlier, in the Section on Diagnosis,  we became so concerned at what constituted a ‘confirmed’ case that we wrote to the Secretary of State on two occasions to ascertain what the Ministry’s position was on this matter. See Appendix 9 & 10.   We are still awaiting a reply.

9.3.6	We also sought assurances as to which premises had been tested and for what; antibody, viraemia, and by what means.

9.3.7	Our experiences in the Forest of Dean, had given rise to great misgivings regarding the need for slaughter of Contiguous Culls.   The results we have now been able to obtain also call into question whether the Infected Premises were actually infected.  See attached letter to Minister setting out concerns as per submission on Animal Health Bill Amendments.                 Appendix 13

9.3.8	Also, nationally, a picture was emerging that many animals that were being slaughtered were not infected.   

It was reported in the National Press – Daily Telegraph – 11 May 2001, that 30 percent of cases confirmed in the field (clinical diagnosis) did not prove positive when laboratory tested at Pirbright Animal Health Laboratory.  

450 of the 1,573, confirmed cases to date had not proved positive when subject to testing – See earlier section on diagnosis for testing procedures at Pirbright.

	The following is the relevant extract from Hansard of 11 May 2001-12-01

Ms Quin [holding answer 27 April 2001]: As at 19:00 on 1 May 2001, there were 1,525 confirmed cases of which 305 gave a negative result on laboratory testing. A total of 208,352 animals relating to these 305 cases were slaughtered. For 364 cases either no samples were taken or the results are awaited. 

9.3.9	In addition, Paul Kitching, then head of FMD at Pirbright Animal Institute made public on Channel 4 news on the 21 April 2001 – that there was no justification for the scale of the contiguous cull, as the likelihood of the disease travelling more than 200 m from an outbreak and being of sufficient quantity to infect other herds was unlikely.

	A subsequent report in The Independent dated 24 June from Robert Mendick and Geoffrey Lean, who had interviewed Paul Kitching, made the same case:

	Referring to the Kitching/Donaldson/et al paper published in the Vet Record of 12 May, the article states “The research showed that the virus spread on the wind very much less than had been supposed…….  The research paper concluded that the virus unlikely to be carried even 200 yards in sufficient quantities to infect other herds.” 

9.3.10	It was becoming clear that disease control reliant on:

	a	inaccurate diagnosis, leading to 

	b	indiscriminate and inappropriate slaughter, with

c	an adopted policy of contiguous cull based on a mathematical model without the relevant science to support this approach, and without

d	an accurate on the ground assessment, by locally based inspectors, of the risk of disease transmission and appraisal of factors which may be the more realistic vectors or mechanisms of disease spread,

was resulting in many millions of animals being slaughtered unnecessarily.

9.3.11	It was also becoming apparent that those animals deemed as being ‘confirmed’ cases could not be slaughtered within the requisite 24 hours due to overload of the system generated by the vast numbers of animals also due to be slaughtered in the execution of the contiguous culls, slaughter on suspicions and dangerous contacts.

9.3.12	The net result was that those animals, herds and flocks which genuinely needed to be slaughtered were not being properly identified.  Many more animals were being identified for slaughter than needed to be. This resulted in the logistical problem of slaughter and disposal within 24 hours becoming even more difficult.

9.3.13	All these ‘confirmed’ cases then generated several contiguous culls, under the policy directed by the models, and in turn increased the logistics of slaughter, disposal, cleansing and disinfecting of Infected premises within 24 hours.

9.3.14	Furthermore the very process of culling, transportation and disposal was creating massive amounts of viral material being dispersed and distributed.

	Vets, valuers, slaughter teams and vehicles used for culling and transportation were all potential and real sources of dispersal of infection along roads and from premise to premise, without sufficient bio-security and bio-sanitary provisions and execution.

9.3.15	In addition the very methods of disposal created in themselves huge problems of pollution and contamination.   Pyres generated smoke and dioxin emissions that were a potential risk to the surrounding community.  They may also have contributed to disease spread.  Landfill sites had to be lined and sealed to prevent leakage of contaminants.   Long term effects have yet to be determined.   If any further BSE material is found to be present in cattle which has been disposed in this way then burying of these carcasses may lead to further infections.   Again the ethics of this control cannot be ignored.

	These practices were seen by a world wide audience and perceived to be mediaeval and barbaric with consequential losses to tourism and trade. 

9.3.16	Also there was the resultant impact on other sectors of the rural economy, and on rural societies and communities.   These effects may persist well into the future and provide an enduring reminder that the adopted control policies have inflicted long term damage to rural areas. 	 

9.3.17	All this direction of resources and man power towards the enactment of the slaughter and cull polices left no capacity for other appropriate methods of disease control to be effected.

9.4	ALTERNATIVES TO CULLING POLICY

	The Fundamental Principle of Farm Quarantine in FMD control

9.4.1	It must be recognised that the debate of culling versus vaccination in the outbreak of 2001 has shifted the focus away from the fundamental principle of FMD control, which predated the slaughter policy of 1892 – that of effective farm quarantine (isolation).

9.4.2	Effective farm quarantine (EFQ) prior to the 1967-8 epidemic appears to have been established rapidly and effectively in most outbreaks, with the exception of 1942, since the ratio of secondary to primary cases was generally very low, reported as less than 5.

9.4.3	It must also be recognised that culling policies (or vaccination) are admissions of failure of the central control measure –that of effectively controlling effective contact between animals on one farm and those on another.

9.4.4	The more stringent culling programme, or the size of vaccination zones, the greater the admission of failure in taking preventive measures to achieve farm isolation before and after virus reaches farms. 

Rapid slaughter (e.g the 24hr recommendation) of infected premises is again an admission of that herds are not effectively isolated , even after infection has been recognised.

9.4.5	EFQ appears to have been low in the last two major epidemics (1967-8 and 2001) for different reasons. 

9.4.6	In 1967-8 EFQ was at first low through the existence of a virus strain excreted in high quantity by aerosols and climatic conditions favouring “uncontrollable” spread between farms resulting in rapid spread in an arc from the proposed primary source, and eventually a 30% depopulation of farms in Cheshire, locally higher. 

This epidemic has resulted in enormous, and probably excessive, emphasis being placed on “uncontrollable “spread in research between 1968-2000, resulting in the lack of appreciation of the practical administration of controls needed to reduce local farm-farm spread by other routes.

9.4.7	EFQ in 2001 appears to have been low (despite the involvement of an FMD strain which is excreted in low amounts by aerosols) after the national movement standstill.  For example, 823 cases were reported in Cumbria, as a result of 41 infected farms at the time of standstill (20.02.01), a figure which would be higher if infected cases among contiguous culled farms were included.

9.4.8	It must be recognised that the basis of FMD control must be:

1	the understanding of virus production by infected animals and infected groups and,

2	the understanding of the process of virus entry into uninfected farms.

9.4.9	The recognised basis for FMD control (at least recognised by FMD expertise in UK before 2001) is that virus produced by animals on a farm CAN be prevented (by effective farm quarantine) from “leaking out” to neighbouring herds, with the exception of part of the aerosol component (“uncontrollable spread”).

9.4.10	It has apparently been overlooked by FMD epidemiologists in this epidemic that virus excretion by infected animals (particularly cattle) is FAR HIGHER in body secretions/excretions (saliva, urine, milk, faeces) than is produced in AEROSOL form from the respiratory tract.  The pan-Asia type O virus is recognised as being produced in relatively low amounts by aerosol, and this probably gave false hope to the epidemologists advising on strategy in the first weeks. 

However the published studies of Donaldson et al (2001) confirming that the pan-Asia type O isolate was produced in relatively low amounts by aerosol, FAILED to report if the infection was produced in large quantities by other routes, or was more stable in the environment (Donaldson had earlier published that virus strains of high stability often were excreted in reduced doses).

9.4.11	The importance of EFQ was belatedly given some attention and resources in late July and August when DEFRA decided to re-inforce voluntary bio-security measures with policing with DEFRA officials and local authorities, and various Blue Box Schemes were introduced.

9.4.12	Future control must recognise the central principle of effective farm quarantine; without it the local spread (and resultant cull or vaccination) and longer distance “jumps” (and resultant cull or vaccination on a zonal or regional basis) will assume larger proportions.

9.4.13	Consideration of the role of vaccination needs to recognise:

1	the probability of achieving effective farm quarantine in any area of intended control and,

2	the balance between aerosol and non-aerosol virus excretion of the outbreak strain, 

since vaccination impacts the latter to a far higher degree than the former, 
enormously reducing virus contamination, but only moderately affecting 
aerosol output. 

9.5	How might effective farm quarantine be achieved in future?

9.51	It must be recognised as a central principle of epizootic disease control – a re-discovery of “sanitation” as an effective measure.

9.5.2	It must also be recognised that it will be less effective where conditions favour high aerosol transmissability (some strains are produced in 300 fold higher levels by pigs, and climatic features may also affect transmission).

9.5.3	EFQ can be seen as a set of measures applicable over a wider area than simply the 3 or 10 km protection and surveillance zones.  These are preventive measures, and also measures to reduce the transmission from unknowingly infected, incubating farms, and those after infection has been discovered,  accompanied by enforcement where necessary, which:

a	Increase the distance between animals on neighbouring farms, reducing the rates of contamination of pastures at farm margins/boundaries and the rate of transmission between animals on neighbouring units by reducing the dose received in aerosol form (by dilution effect).

b	Reduce the potential for contact with animals or contaminated pastures on neighbouring units –  as above, but bringing in more effective bio-security at boundaries and use of “resting of pasture at boundaries” for periods after neighbouring farm animals have been moved.

c	Reducing before potential transmission events between animals on fragmented areas of farms – reducing the number of such “out-stationed” groups under license, improved bio-security procedures between handling livestock, in relation to feed movements, etc

d	On a farm and area basis, improving bio-security arrangements for high risk vehicles and people; milk tankers, feed lorries, veterinarians etc.  This will also involve some fundamental changes in farm design to increase the biosecurity when livestock or dairy products are removed from a farm, and deliveries of foodstuffs are received.

9.5.4	Increasing the effective distance between animals on neighbouring farms;

a	Safe Animal Separation (SAS); arrangements for stock to be moved at least one field (or 100 metres, whichever is larger) away from boundary of the farm. This could perhaps be backed by computer aided support organised through ADAS or others, using local area field plans.  The aim being to maximise distances between neighbouring ruminant groups, and to guide decision making for small farms, or fragmented farms, where the boundaries are high in proportion to the area.

b	Local grazing arrangements; voluntary systems would need to be supported by some form of liason officer (e.g. local vet inspectors (LVI’s, or ADAS, or other agencies with liason skills), perhaps , to draw up a plan for separation of grazing groups, particularly for common land.  Safe grazing would be vital within protection zones and surveillance zones, but advisable in any high area or period.  Photo-reconnaissance would probably assist this once grazing schemes have been put in place. 

9.5.5	Reducing potential transmission events involving visitors to farms:

a	National level bio-security advice should be given that is accurate to the potential frequency of virus contamination/transmission events, enabling farmers to prioritise their own bio-security efforts.

b	Enforcement of bio-security must be in proportion to the risk of transmission events; highest risk are infected premises and the activities of those connected; next being those within 3 and 10 km rings.  Facilities for disinfecting of major risk sources, ie milk tankers and feed lorries, vets, feed lorries, farm transport,  and adequate enforcement of these events - particularly spot checks on farm vehicles) need to be in place according to risk.

c	Incentives for high bio-security are important; the contiguous cull policy, a novel feature of the 2001 epidemic penalised those with excellent bio-security who lived next to those who unfortunately contracted the disease or those too lax to apply adequate bio-security.

Potentially the policy also reduced reporting since the index farm for an area might take out between 2 and 10 adjacent holdings, with long term social consequences for the person or farm which “brought it in”. 

High bio-security must be quantifiable and measurable by those at risk, in order to maximise their chance of avoiding infection, or being taken out by a contiguous cull. 
	
d	It must be recognised that unless vaccination is used, viral excretions and secretions can be highly contaminated before clinical signs are seen.  Therefore some form of local area HACCP analysis is needed to prioritise risk activities.  Given the potential consequences (culling),  closure of pathways, etc,  are inevitable over wide areas.  The exception would be where vaccination is used;  7-14 days after vaccination has been completed in an area, the risk of virus excretion, even if exposed, would be minimal and pathway restrictions not justified. 

9.5.6	Recommendations:

1	Bio-security enforcement is central to disease control and adequate resources must exist to enable this to be in place for the duration of the presence of disease and until it has been eliminated.

2	Emergency planning should incorporate setting up an administrative  system for achieving safe animal separation (SAS) in infected and at-risk areas.

3	Computerised support systems could be developed to optimise animal group spacing in infected areas, to assist administrative officers, e.g. LVI’s,  working with farmers to achieve maximum separation with limited overstocking and boundary use disputes.  The system produced should assist a  local area grazing plan to be devised which would be updated during the course of control activities and in relation to the farming calendar.

4	Incentives to achieve durable levels of bio-security are essential, which should include exemption from any contiguous cull policy if adopted, where this is verifiably the case.

5	Vaccination reduces virus excretion, particularly in milk, faeces, urine and from saliva, and  reduces need or restrictions on non-farm activities e.g. pathway closures.

9.6	On culling versus vaccination

9.6.1	Need for improved decision support to identify high risk animal groups for culling

9.6.1	It is recognised that slaughter of groups of animals on Infected Premises (IPs) is necessary to reduce rapid within-group build-up of infection and the high risk this presents for onward transmission. 

9.6.2	It does not follow that infection at an IP will lead automatically lead to infection in contiguous premises, although these are at high risk.

9.6.3	We do not support culling on Contiguous Premises, however if it  is to be continued it should be guided by expert systems and the decision supported, with rational scientific justification based on and incorporating:

1	analysis of risk factors,  farm specific information and an assessment of levels of bio-security to determine priorities for culling and surveillance.  

2	Risk factor analysis from the 2001 epidemic, the 1967-8 epidemic should assist the process, which should also incorporate GIS databases including where available field stocking data (previously proposed under effective farm quarantine) to calculate if there is a level of risk or probability that infection has occurred. 

9.6.4	The decision support must ALSO include the “risk –out” – risk of onward transmission by an animal group.  Small numbers of stock on well-separated farms, from other susceptible species,  may be of little or no consequence for onward transmission unless bio-security, and enforcement of bio-security, is demonstrably low. 

9.6.5	A blanket approach to culling which does not take into consideration the risk-in and risk-out factors sends a mixed message –de facto it implies that bio-security arrangements make little or no difference, which does not accord with an understanding of modes of spread of FMDV, past experience, or the belated discovery in the 2001 epidemic that,  variation in  farm infectiousness  to other farms has as bigger role as the culling programme, in the occurrence of cases (Ferguson et al, 2001). 

9.7	On comparison made between different programmes involving culling and vaccination 

9.7.1	It must be recognised that the level of understanding by veterinarians, and by evidence of information produced in the High Court in the Judicial review case (Kindersley vs MAFF), by the most senior MAFF veterinarians, was shamefully low, at least in the critical first month of the epidemic.

9.7.2	FMD control involving addition of vaccination cannot easily be compared to those involving culling alone since:

a	Where “vaccination to live” is applied, the economic penalties imposed will be set by the SVC in Brussels and are difficult to second guess – these penalties are in part risk-based, but also affected by “horse-trading” arrangements.  That this also applies to non-vaccination can be seen by the continued refusal to permit exports from Scotland, 5 months after the last case (exceeding the OIE Animal Code recommendations).

b	There is enormous difficulty in predicting the economic impact on farmers of slaughter only and slaughter/vaccination programmes since the restrictions applied by the EU and other trading partners have borne little resemblance to the OIE Animal Health Code Recommendations; 

For example:  two provinces of the Netherlands were legally able to export pigs, while 4 provinces of the same country had cases of FMD (March 2001).  Also, the maintenance of restrictions on the north of Scotland which has not had a case of FMD from February to November 2001.  This inconsistent and illogical application of barriers which defy rational prediction.

c	Vaccination policies – of zonal nature – should assist rural tourism and businesses to rapidly return to near normal, since vaccination very significantly affects both risk-in and risk-out assessments, and thereby after 14 days of application in an area, restrictions on foot-paths should be essentially relaxed, and tourism would constitute almost no risk inward to vaccinating areas. 

d	Vaccination costs are very low in comparison to slaughter and disinfecting costs, and therefore in principle vaccination zones can “afford” to involve far more animals and farms than culling policies – however epidemiological analsyses tended to equate cull farms and vaccinated farms as essentially the same (ie vaccination then kill approach).

e	The value of a control measure has been defined in the current epidemic mainly on the potential for reduction of cases – deriving from modelling human infections where the onus is on reduction of the maximum number of mortalities/cases.  In animal production, the onus is on returning agricultural productions systems and income to normal as rapidly as possible; and this cannot be predicted simply from comparing numbers of cases or numbers slaughtered/vaccinated. 

We need better systems for defining when trade can recommence, integrated with models for control of epizootic disease to find the optimal balance of approaches. However this will be difficult, since politicians have the final say in overcoming hurdles – e.g. the demand of the NFU for any future losses associated with vaccination to be underwritten. 

9.7.3	In the first month of the epidemic, the viewpoint of MAFF sources (and transferred apparently unchanged or unquestioned by the British Veterinary Association) was mostly:

a	outdated with little understanding or reference made to the rapid efficacy of novel emergency vaccines involving oil adjuvants and higher payloads.

b	Confused and misleading in the issue of “carrier animals” –  assertions were made , without foundation, that vaccination would result in “carriers” – statements ignorant of reality of FMD control under movement restrictions.   

Ignorance of the difference between the need to cull animals with acute infections as opposed to those with no evidence of disease (also called “carriers “ in the early stage) and those animals with persistent infection after 28 days of infection.

persistently infected animals – and should not be considered  true “carriers” in the epidemiological sense, in that onward transmission is rarely ever shown to have occurred –Thomson, 1996).

c	Insular in its thinking – the findings of the European Unions own proposed “Strategy for the Use of Emergency vaccination in the control of FMD” was ignored by expertise used by MAFF, and the very existence of this strategy and a debate on its proposed handling of FMD epidemics did not occur until the issue was raised by K.J Sumption from Edinburgh University in mid March.  It is recognised that difficulties existed in implementation of the policy proposed in the EU Strategy, but the difficulties were certainly no greater than those resulting from the applied  slaughter policy.

d	The existence of validated tests to differentiate vaccinated and infected animals were consistently denied.  The objectors to The EU strategy on the use of Emergency Vaccination raise issues of the validity of tests to ensure carrier animals do not remain in the population, and on post-vaccination surveillance. 

These objectors appear rather alone in the international FMD community on this issue. The objections appear motivated more by principle than example, and their case is eroded by repeated examples of the value of the approach – e.g. post-vaccination surveillance as conducted by Korea in 2000 has enabled that country to regain disease freedom in a year, the minimum under the OIE recommendations.  The objectors simply appeared to have little will to devise effective post-vaccination surveillance.  At the same time as criticising the Non Structural Protein  tests for not being “internationally validated” (to differentiate live and vaccinated animals), MAFF/DEFRA/Pirbright were making arrangements to scale up an ELISA test for use in millions of animals which itself was not (at least at the time objection was made to the NSP tests) internationally recognised or validated to OIE standards. This inconsistency serves to suggest that objections to vaccination were motivated by other considerations – principally the preferred policy of the EU and MAFF, which relates to the penalties imposed on vaccinating countries under the OIE Animal Health Code. 

9.8	Conclusions on Control if an Outbreak Occurs

	In conclusion, we consider the following points are fundamental to the containment and control of future outbreaks:

1	It is vital that the farmer, the local veterinary practitioner and the local DEFRA office can liase and operate in a culture of constructive co-operation to maintain vigilance for signs of the disease.

2	The trust and respect between these 3 key roles must be rebuilt and a consensus achieved as to how future surveillance is to be conducted.

3	Although we acknowledge that there are statutory procedures that must be followed, once clinical symptoms have been identified and the presence of the disease is suspected,  there is also a need for the subsequent process to be clear and easily understood by all those involved.

4	Given the implications of the extensive animal movements now occurring daily in the UK and Europe, the length of time taken to confirm the suspect case is critical.   An explicit Contingency Plan must set out and determine precisely how, when and where the laboratory confirmation of the suspect case is to be undertaken.  Most importantly it must define the time scale for these actions.
 
5	An agreed course of action, also specified and detailed in an adopted Contingency Plan, must then be followed.  

6	Such actions which are crucially time dependent and must involve:

a	Rapid and accurate laboratory diagnostic tests, if possible in regional facilities (or if developed – cow side/ farm gate) using PCR. – to ascertain definite confirmation, or otherwise,  of the disease in the shortest possible time.

b	Immediate isolation of suspect premise(s), imposition of movement restrictions and effective farm quarantine, involving full bio-security, bio-sanitary arrangements to the premise.

c	Notification and temporary holding position to neighbouring farms and small holdings.
	
d	A placing on alert of the relevant authorities and agencies

7	If laboratory confirmation is negative then it may be sensible to consider compensation for any losses to the farmer incurred through the imposition of restrictions and bio-security arrangements.  The purpose being to inculcate a culture of responsibility and incentive for farmers to swiftly report suspect cases without loss of earnings, even if the case subsequently proves to be a false alarm.

8	In the event of positive confirmation then the procedures discussed in Section 9.2 should be implemented:

Again a pre-agreed, adopted contingency plan must detail operations and involve:	 
		
a	Immediate slaughter of index premise

		b	Immediate imposition of nation wide movement restrictions

		c	Immediate effective farm quarantine 

		d	Tracing of dangerous contacts

		e	Surveillance and laboratory testing of contiguous premises, 

9	Should it be found that the disease has not been contained, but that it has already been dispersed and seeded before movement restrictions have been imposed, as happened in the current outbreak, then a vaccination to live policy must be applied at a pre-determined and pre-agreed threshold of confirmed cases.

9.9	Summary

	A culture of constructive co-operation must be established and maintained between the farmer, the local veterinary practitioners and the Ministry to ensure vigilance for signs of the disease.

	Swift, accurate, reliable diagnostic testing must be available and accessible to determine confirmation of the disease in the shortest possible time scale. 

	Nation wide movement restrictions must be imposed as soon as the disease is confirmed.

	The emphasis must be on immediate and enforced farm quarantine, in at-risk areas with increasing stringency of application in 10 km surveillance zones and 3 km protection zones.
	The policy would be backed by a slaughter policy for infected premises,  until a pre-determined, pre-defined and pre-agreed threshold is reached, and then with a vaccination policy (vaccination to live) on a ring, zonal, administrative area or barrier basis according to circumstances.

	The threshold at which vaccination is applied should be decided in advance in the contingency plan, with pre-determined time scales and definitions.  Delivery into animals in the field should begin within 48 hours of this pre-determined threshold being reached.

Vaccination must be the primary method of disease control.  The pre-agreed and pre-determined thresholds should be based on a extremely limited number of cases.  There must be no extension of this pre-determined threshold during the course of the outbreak; allowing the threshold to be increased or changed, or to allow for slippage in its implementation. 

10	VACCINATION

10.1	Attendance of FMD scientists Dr Barteling & Dr Sutmoller

10.1.1	After the Call for Detailed Evidence was issued we liased with the Royal Society and two experienced vets, Dr Simon Barteling and Dr Paul Sutmoller, in order that their experience and views could be heard by the Inquiry.  Both scientists have had long term involvement in the control of FMD and the use of vaccination as an integral means of control and eradication.

10.1.2	We understand that Dr Barteling and Dr Sutmoller have now submitted a list of various points which they would like to discuss with the Inquiry.

10.1.3	From our perspective we would be grateful for the opportunity of Dr Barteling and Dr Sutmoller also being asked to comment and respond to the issues that we have raised in our letter to the Inquiry of 26 November.  See Appendix 14.  

We would also appreciate the opportunity of attending this oral session of the Inquiry.

10.1.4	We call upon the Inquiry to consider our letter and the points raised.   We submit that the views of the two scientists on these matters would inform and expand the debate on the use of vaccination in the control and eradication of FMD, not only from the UK perspective, but also regarding the provisions of the OIE and the EU, and on the global scale.

10.2	Vaccination Issues raised by Royal Society

10.2.1	We submit that a more experienced and informed response to these issues would be provided by Dr Barteling and Dr Sutmoller, than ourselves.

However we would like to submit the following observations which address the use of vaccination in the EU, the different applications that could be utilised and the difficulties that were encountered in proposing the use of vaccination to control the current outbreak.

10.2.2	The report of the Scientific Committee on Animal Health and Animal Welfare entitled The Strategy for Emergency Vaccination against FMD was adopted on the 10 March 1999.  We assume the Royal Society has a copy of this document.

	The Terms of Reference state:
	
	The Scientific Committee on Animal Health and Animal Welfare have been requested to:

*	establish the criteria leading to a decision to implement emergency vaccination against foot and mouth disease;
  
  	*	establish guidelines for a vaccination program

*	prepare guidelines for the movement of animals and animal products within and without of the vaccination zone(s).

10.2.3	The document then went on to consider the rationale for the possible use of emergency vaccination, the various vaccines and tests that could be utilised, the possibility of carriers, and responses to the three issues raised in the terms of reference.

	The conclusion considers “that emergency vaccination can be a useful tool in the control of FMD outbreaks with a risk or tendency towards uncontrolled spread.”

	Several recommendations were then incorporated.  See Appendix 15

	These included:

	“The National Contingency Plans should consider the possibility of emergency vaccination and provide an estimate of all logistical requirements such as the number of vaccination teams required in different areas, in order to complete the task as rapidly as possible.”  

And also,

	“It is considered necessary for the Commission to pursue efforts to reach progress in negotiations within the framework of the World Trade Organisation for recognition of a regionalisation policy regarding trade restrictions for areas where FMD emergency vaccination has been applied, based on the principle of an acceptable risk.”

10.2.4	It is not known whether any of these recommendations were taken up in preparing the UK Contingency Plan for FMD control.

	Clearly there was no application made to the EU for emergency vaccination at the start of the outbreak.   

10.2.5	On the  5 April 2001 the EU Parliament, having regard to current circumstances,  resolved, inter alia, to: 

	“Calls on the Commission to review immediately the basic non-vaccination policy of the EU, and urges the Commission to bring forward possible alternatives which can be accepted world wide,  permitting free trade in animal products:”

	11 further ‘Calls’ expanding and proposing means by which this objective could be met then followed.   See Appendix 16

10.2.6	Again, as yet, it does not appear that there has been any further development on this resolution.

	Finally on the 6 September 2001 the European Parliament considered various issues regarding the UK FMD outbreak and inter alia:

1 	why vaccination had not been used to control the outbreak

2	what the various cost benefits were, 

3	why the outbreak had lasted so long and

4	that public opinion might not approve of a further massive destruction of contaminated and suspect animals 

	See Appendix 17

	There is clearly a growing momentum at EU level that alternative methods of control and vaccination must be considered.

10.2.7	What has become clear is that the current adopted methods of ‘stamping out’ adopted by the EU in 1991, have exacted massive and disproportionate costs on the economy, the environment and the social infrastructure of rural communities.  See earlier section on Control policies.

10.2.8	There is a major, fundamental need to consider a more acceptable and less damaging approach to control and eradicate FMD.

10.3	What roles does vaccination play?

10.3.1	We are not considering or suggesting the widespread use of prophylactic vaccination, but application of vaccination to live programmes to assist in controlling outbreaks as they occur.

10.3.2	Different scenarios require different approaches, for example:

a	Outbreaks are not always concentric, in the current UK epidemic this comprised multi-centric outbreaks as a result of animal movements prior to the imposition of movement controls.

b	Farming and grazing practices differ in various parts of the UK and the EU.

What is required is a vaccination to live policy on a ring, zonal, 
administrative area basis, according to circumstances. 

	We refer the Inquiry to the earlier sections of the submission regarding Control if an Outbreak Occurs – Section 9.2, 9.6, 9.7 and 9.8 and Summary of Section 9.

	A further example of application  is when it was considered that FMD may have become widely dispersed through the Hefted Flocks on the Welsh Upland.  The NFMG in collaboration with Dr Ruth Watkins, produced a plan to respond to this scenario, which we presented and discussed with the Chief Veterinary Officer, Jim Scudamore, and Head of Policy, Vaccination Section, Alison Reeves.  Copies of this are available – as it extends to 50 pages we have not appended it – but would be happy to supply a copy if this would be helpful.

	This case study clearly sets out the relationship between, the control of the disease, the rural economy, tourism, the maintenance of the environment in relation to common grazing, and the socio-economic impact of major losses of livestock through extended culling programmes.

10.4	Implications of animals entering the food chain

10.4.1	Although both the OIE and the Emergency Strategy for Vaccination set out various provisions which must be followed to deal with vaccinated meat entering the food chain, we have discussed this with Dr Sutmoller and we understand that these provisions are now under further consideration.

10.4.2	From our experience, in considering vaccination for the Hefted Sheep in Wales, the issue of deboning had significant implications for the end use of the carcasses, making it difficult for an economic return on the subsequent sale of sheep meat.  However, it was our contention that in those circumstances there were other considerations which needed to be borne in mind in relation to the cost benefit analysis of that situation.  In that situation we suggested that some form of compensation to underwrite any subsequent loss in market value was preferable to widespread slaughter of the hefted flocks and all its implications.

10.4.3	As regards the treatment of cattle meat and milk products there have been significant imports of both into the EU and the UK from areas of the world which have in the past, or currently, vaccinate.  As indeed the provisions of the OIE make clear;  it is possible to be achieve disease free status and maintain regular prophylactic vaccination.

10.4.4	During the course of the epidemic it became clear that the NFU was still maintaining that vaccinated meat was unsafe to eat and that there would be consumer resistance to its sale and consumption.  Having undertaken various research into the importation of meat and products from vaccinating countries, and aware of both the Food Standards Agency, and the Consumer Council statements on these concerns, both the NFMG and Vets for Vaccination produced briefing notes on vaccination addressing these issues.  We also wrote directly to the NFU on these matters on the 23 August.   See Appendices 18, 19, 20, 21 and 22.

10.4.5	The lack of clarity and clear advice to the NFU, from both the Government and the Science Group, is one of the contributory factors which made the NFU unwilling to agree to the vaccination programmes for Cumbria and Devon, which had been agreed with the EU.   See later section 10.7.1

10.4.6	As the purpose of the treatment is to reduce the risk of onward transmission of the disease,  (See Appendix 19,  FSA Statement.) this risk must be qualified and quantified.  The disease does not affect humans, therefore it  needs to be ascertained how likely is the possibility that the disease  will be transmitted.  It appears one of the main risks is the likelihood of untreated meat being used for swill feeding.

10.4.7	With all risks these must be put in context and determined against a range of parameters; it is not just the risk of onward infection that needs to be determined, but against a cost benefit analysis of all other factors.

10.4.8	We submit that the need for these treatments should be reconsidered and re-evaluated.  We would hope that this would be an area of discussion with Dr Barteling and Dr Sutmoller who, we understand, are currently preparing a paper on this subject for the OIE.

10.5	Present vaccines, research, role of marker vaccines, and the other issues raised by the Royal Society

10.5.1	These issues are raised and considered in the Emergency Strategy for Vaccination – 10.3.1999.   The document deals with the efficacy of high potency vaccines and the tests for differentiating infection from vaccination – See Section 4.  Further sections deal with carrier status.  It is our contention that there is sufficient information on these matters in that document to inform on these subjects and would refer the Inquiry to consider this.

	We accept that the document makes clear that further work is needed, both on these and the other matters outlined in the Royal Society questions.  We suggest that queries arising from these should be directed to Dr Barteling (one of the authors of the report) and Dr Sutmoller in oral session.   This would then provide the opportunity for the two scientists to bring to the Inquiry’s attention what has been progressed since the publication of the document.

10.6	Use of  Vaccination, and Experience in Other Countries

10.6.1	We address below the use of vaccination for rare breeds and zoological collections and our views on what we could learn from other countries. 

We would also be grateful if the Inquiry could also consider some additional  points which have affected the use of vaccination to control the current epidemic.

10.6.2	While we accept that the remit of the Inquiry is to address the scientific issues regarding the control of FMD, there are other related factors which have influenced the acceptance of the scientific rationale of vaccination, as a means of control, for example, the economic implications for farmers.

10.6.3	It became clear within the first month of the outbreak that the control methods based on movement restrictions, closure of the countryside, slaughter and subsequent disposal were resulting in massive and multiple impacts.  These impacts created disruption and disturbance across the full spectrum of the rural economy and communities.

10.6.4	The following 8 months of the epidemic continued the impact and we are all aware of the financial and other costs incurred.  There is now overwhelming evidence that alternative means of control, including vaccination, should be considered and adopted.   

10.6.5	It is our contention that these control measures, including vaccination, should not only apply to rare breeds and zoological collections, but for application in the widest sense to all animals to minimise the collateral impact of FMD.  

10.6.6	In this regard we ask the Inquiry to consider the experiences of other countries which use vaccination.  It is worthy of note that the Northumberland Inquiry visited and had regard to FMD control practices in several countries, including Argentina, Brazil and Uruguay.  It would be extremely useful if the Inquiry could invite those involved in vaccination programmes in those countries to give evidence.  

10.6.7	During the course of the epidemic various media coverage has been given to the use of vaccination in other countries.  Perhaps most notable was the Countryfile programme of 9 September which considered practices in Argentina.

	We attach a transcript of the program to provide an understanding of how prophylactic vaccination has been re-introduced in this scenario to control FMD.   Appendix 23

10.6.8	Other well documented examples have already been presented to the Inquiry in the submission from Mrs Anne Lambourne, and we ask the Inquiry to take due note of these examples and the various methods and uses employed that they describe.

10.6.9	In relation to the use of vaccination in the UK the key issue is how swift would be the return to disease free status if vaccination was utilised.

10.6.10Here it is interesting to note that the OIE appear to be introducing some flexibility in applying the 12 months criteria before allowing countries to regain DFS post vaccination.  The following extract was in a paper produced by Dr Keith Sumption of Edinburgh University and published earlier in the course of the epidemic:

	Keith Sumption: The recommendations of the world animal body are that freedom from FMD is regained 12 months after the last case of FMD if vaccination is used, or by 3 months if a stamping-out policy is applied. However, in the case of the European Union, the standing veterinary committee (SVC) has recently set 2 very surprising and interesting precedents, indicating that they are prepared, on the basis of risk assessments, to  approve international trade within the community with more relaxed rules than recommended by the OIE, Paris. An examples, they have approved regionalisation of Northern Ireland, so that apart from the county council of Newry and Mourne (where a case of FMD occurred in February), the rest of N. Ireland is approved for export of livestock and livestock products.(Brid Rogers, NI Agriculture Minister, 27/3/2001) This is considerably ahead of the 3 month period which needs to elapse under OIE recommendations to regain FMD freedom. Further, regionalisation of the FMD in the Netherlands was also approved, so that while active cases occur in 4 provinces, the rest of the country is now allowed to trade in livestock products (Reuters, 28/3/2001). Before the current outbreak, such flexibility in granting regionalisation and permitting trade from nations with active FMD would have been unheard of.  It is therefore illogical to expect that regionalisation would not be permitted by the SVC in mainland United Kingdom, to allow non-vaccinating parts of the UK to trade internationally in livestock, and also illogical that areas which have used vaccination, and which are shown after surveillance to be free of remaining virus presence, should also not be permitted to trade. Therefore it can now be expected that the SVC would grant permission to resume trade to areas on the basis of scientific risk assessment, as required under OIE and WTO regulations pertaining to animal health barriers to trade, and therefore allow resumption of international trade at earlier periods than have been suggested.

10.6.11What is paramount is that there now needs to be discussions with the OIE and the EU to determine precisely by what means DFS is to be determined and what time scales are then to be applied. 

10.7	Other factors affecting vaccination

10.7.1	Although two decisions to allow for preventative vaccination during the UK epidemic were sought and obtained from the EU, Decisions 257 and 324, these were not implemented.

10.7.2	The NFU sought reassurance and unequivocal advice on the concerns it had on the implications of the use of vaccination.  Clearly faced with the possibility of 100% compensation for slaughter, as opposed to the possible loss of market value for stock, milk or meat products, which had been vaccinated, there was little incentive to opt for vaccination.  

10.7.3	The Strategy for Emergency Vaccination recognised this dis-incentive – See Section 3.2.4 – notes
“Farmers whose herds/flocks are vaccinated and who suffer losses as a result of the restrictions placed on them should be fully compensated.  If not, they are unlikely to co-operate with an emergency vaccination program.”

10.7.4	Sadly this was not responded to in a positive manner by the Government, although the cost of underwriting any differential in market value, would have been far smaller than the costs of compensation for slaughter and disposal and other collateral impacts.

10.7.5	Furthermore there was considerable misunderstanding regarding the issues of loss of DFS, whether vaccinated animals became carriers, whether vaccinated and non-vaccinated animals could be differentiated, whether vaccinated animals could be consumed, and again the response of the Government and its advisers was not consistent and unequivocal in its advice.

10.8	Implications of FMD, and national and international control

10.8.1	In considering the control of future outbreaks of FMD the controls in the UK and Europe cannot be considered in isolation.

10.8.2	In the earlier section on ‘Reducing the risk of importation of FMD’ the case is made as to the prevalence of the disease in third countries and that a contributory factor in this increasing prevalence is the disincentive towards vaccination because of the penalties in loss of world trade that ensues.

10.8.3	We therefore face an increasing risk of importation of FMD, as greater incidence of the disease occurs in third countries, which previously vaccinated to control the disease. 

10.8.4	The UK and EU face difficult choices.  It needs to be determined whether the key objective in controlling the disease is to achieve freedom from FMD on a global scale, or whether the existing system of Disease Free Status in developed countries is to pertain.

10.8.5	The implications of this is that those countries which vaccinate to control FMD are disadvantaged in terms of trade opportunities.  The distinction consigns those countries to a lack of parity in world markets and ensures the continuation of trade protectionism for countries which are disease free.

10.8.6	If the objective is the global eradication of FMD then vaccination as a tool for achieving this will have to be employed.   However it will not be possible to move to global eradication, using vaccination, while punitive penalties ensue which militates against countries, particularly third countries, using this method of control. 

10.9	Conclusions on Vaccination

10.9.1	This is the first major outbreak of FMD since the decision was taken in 1991 for Europe to become FMD free and vaccination on mainland Europe was discontinued.  During this time there has also been the relaxation of trade barriers within the EU.

10.9.2	Given:

1	the increasing prevalence of the disease world wide, 

2	the increasing difficulty of preventing further outbreaks in the UK
	and Europe

3	the subsequent impacts of the disease on agriculture, the rural economy and society

It needs to be determined whether Disease Free Status is a) desirable
and b) maintainable.

10.9.3	If we wish to retain this status then vaccination as a means of control and eradication, used in conjunction with the slaughter of infected stock, must be considered a priority.   Resources and research must be provided – as detailed in the Strategy for Emergency, to overcome the perceived objections.

	Key among these the following must be addressed:

	1	Is it necessary to identify vaccinated stock?

2	What are the risks of onward infection from vaccinated meat, meat products, milk, etc and are all these treatments necessary?

3	How can the tests to determine whether the disease is present be modified?  Is it necessary to be antibody free, or should the presence of virus be the determining factor?

4	How great is the risk of vaccinated animals masking non-vaccinated carrier animals?

5	How can the penalties incurred by the use of vaccination be minimised, to ensure;

a	a swifter return to disease free status trading, and 

b	remove the trade dis-incentives which prevent third countries from using vaccination?	  	

11	CONCLUSIONS & RECOMMENDATIONS

Current policy with regard to FMD is one of cost benefit to the agricultural community.  It is not one of food safety or animal welfare.

It has been clearly demonstrated during the course of the UK 2001 FMD epidemic that there is a close inter-relationship and inter-dependency between the various sectors of the UK rural economy, the rural environment and its rural communities.  This socio-economic fabric must be viewed as a totality and the factors that affect it must not be treated in isolation.

The economic cost of the UK outbreak has created an impact far beyond that of agriculture.  In fiscal terms it has cost the nation £2.7 billion and, overall, circa £20 billion.   The level of disruption and disturbance to businesses will, in some cases, cause these businesses to fail and employment to be lost.

The issue of ethics is a paramount consideration.   We submit that it is totally wrong to require the indiscriminate slaughter of healthy animals to maintain an economic market.  We repeat our call to the Inquiry that such practices must not be allowed to happen again.

It cannot be overstated that a humane policy of control that minimises the impact of FMD on all sectors of the economy and communities must be implemented.

In a modern, developed society, disease control should not be reliant on a policy of slaughter to contain and eradicate disease.   Vaccination has already proved effective and economic in many other applications.  In comparison the costs of compensation, slaughter, disposal, cleansing and disinfecting far outweigh those of vaccination to live.

Vaccination is also easily utilised and does not require extensive equipment and man power for implementation.  Most importantly, it fundamentally reduces the impact of the disease on the many other diverse sectors of the rural economy and society.

The obstacles that remain to its use are primarily based on the loss of disease free status and export markets.  The penalties, that the loss of disease free status inflicts, militate against an equitable and fair world trade market.  This in turn may lead to an overall reduction in the use of vaccination world wide and, therefore, to an increase in the global incidence of the disease.  This increase in the prevalence of disease poses great risks to countries which are currently disease free.

In considering control of the disease in the UK and Europe it is crucial that discussions are undertaken with the OIE.  All the issues surrounding the exemption from Disease Free Status for 12 months post vaccination must be re-appraised and re-assessed.   Critical in this is the involvement of third countries and the need to move towards eradication on a global scale.

In order to maintain world stability it is vital that trade is neither penalised nor protected through such disease control procedures.  There is now a fundamental need for the economic dis-incentives for vaccination to be re-considered, re-evaluated and, where possible, and set aside.  

The key objective must be the control and eradication of FMD, whilst minimising its consequential impact, having regard to our ethical responsibilities in dealing with an animal disease and ensuring fair and equitable world trade.

We submit that vaccination must now constitute the primary means of FMD control.

We respectfully ask the Royal Society to have regard to the foregoing considerations and to recommend to Government that future policies are founded on a deliverable, implementable  and achievable programme of vaccination to control and eradicate Foot & Mouth Disease.

NATIONAL FOOT & MOUTH GROUP

VETS FOR VACCINATION                                                 DECEMBER  2001

APPENDICES

Appendix 1	NFMG Letter to the Royal Society of 18 September 2001

Appendix 2     Correspondence with DEFRA re Imports 

Appendix 3	Note of Conversation with DEFRA on Imports
		Treatment and inspection for meat entering UK 

Appendix 4	Submission from Camphill Village Trust - Oaklands Park Farm

Appendix 5	Paper in the Vet Record of 12 May 2001, p602-604 on Relative risks of the uncontrollable (airborne) spread of FMD by different species – Alex Donaldson, et al.

Appendix 6	Paper in the Vet Record of 12 May 2001, p600-601 on Relative resistance of pigs to infection by natural aerosols of FMD virus - 
A Donaldson &  S Alexanderson.                                                       

Appendix 7	Letters in Vet Record of 12 May 2001, p606-607 from various Ministry Vets on FMD control strategies and the number of negative test results from confirmed cases and contiguous culls.

Appendix 8	Letter to the Vet Record of 19 May 2001, p640 from Dr Alex Donaldson and Dr Paul Kitching on FMD diagnosis.

Appendix 9	Letter from Forest of Dean FMD Group to Secretary of State of 1 May 2001

Appendix 10	Letter from Forest of Dean FMD Group to Secretary of State of 14 May 2001

Appendix 11	Paper in the Vet Record 17 Nov 2001, p621-623 on Diagnosis of	  FMD by real-time fluorogenic PCR assay.
	
Appendix 12	  Papers from Alan Beat on Modelling of FMD

Appendix 13	NFMG Letter to Environment, Food and Rural Affairs Committee and other MPs re Amendments to Animal Health Bill –  6 November 2001

Appendix 14	NFMG & Vets for Vaccination letter to Royal Society Inquiry re Vaccination Issues  -  26 November 2001

Appendix 15	Strategy for Emergency Vaccination against Foot & Mouth Disease – 10 March 1999, Recommendations.

Appendix 16	Resolution of European Parliament – 5 April 2001 – Calling on the Commission to review immediately the basic non-vaccination policy for FMD

Appendix 17    Resolution of European Parliament – 6 September 2001 -  Regarding FMD, its control in the UK 2001 outbreak and implications for Europe

Appendix 18	Food Standards Agency advice regarding safety of FMD vaccines and vaccinated milk, meat and meat products

APPENDICES, contd

Appendix 19	National Consumer Council views on the sale and consumption of FMD vaccinated milk, meat and meat products

Appendix 20 	NFMD Vaccination Briefing Note

Appendix 21	Vets for Vaccination Briefing Note

Appendix 22	NFMG Letter to the NFU regarding FMD vaccination and safety of vaccinated milk, meat, etc – 23 August 2001

Appendix 23	Transcript of Countryfile programme of 9 September regarding FMD control and vaccination in Argentina

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