23 JANUARY 2002








Why we submitted our response to the Inquiry







Benefits, Difficulty of Maintaining, Is DFS justified?


What criteria are used to determine the benefits  economic, scientific, ethical, animal welfare, others?





Efficacy, potency, availability,


Carriers, distinguishing between vaccinates and natural response to infection


As a means to determining DFS




What is the basis for the distinction between 3 and 12 months for return to DFS if vaccination as opposed to stamping out is used to control the disease?


Assessment of risk.




Surveillance Diagnostics Methodology


Contingency Plans Control Methods International perspective





We know that the purpose of the IDL Inquiry is to consider the science of FMD and its control in the future, but it might be useful to understand why we felt it imperative to make a submission to the Royal Society.


Both NFMG and Vets for Vaccination witnessed at first hand the consequences and implications of the adopted control methods. It is perhaps difficult from where we are today, in the elegant surroundings of 6 Carlton Terrace, to convey what it is like to be faced with the distress and despair of farmers appealing for help as they face the culling of their animals  which they are convinced are healthy, or with no food or pasture left to feed their stock.


So often there seemed no logic or sense in the killing of such animals and the stress and suffering of so many farmers and rural communities in the slaughter of so many animals going on around them, caused the question to be put: "Is this really the best modern science can offer?"


The massive, and often disproportionate, impact on other sectors, on communities and the ensuing animal welfare problems caused us to seek a better solution. So we are here today to submit that modern science can and must be assessed and reviewed to deliver acceptable alternatives.




In our submission to the RS we questioned the role and benefits of DFS and asked that several matters relating to these be addressed  Para 3.2.9.


Have these been qualified and quantified?


We do not know what other opinions the RS has received but would ask that in producing its report the RS answers the points that we have raised  to justify retention of DFS - if this is to be maintained.


Concurrent with this is the difficulty in preventing further importation of infection through either legal or illegal means  Para 3.3.3.


For the various reasons advanced we submitted that it will be increasingly difficult to maintain DFS  Para 3.3.11


The ethical considerations of DFS, as witnessed in the 2001 UK epidemic, with the adoption of a stamping out policy were a major cause for concern, - Para 3.4.4.


Subsequent to the submission of our report the Brussels Conference of 12/13 Dec 2001 took place. Many of the principles which we advanced in our report were supported by papers to the Brussels Conference. These considerations have now been included in our report and appended to this resume. See Para 3.6. This also contains our Conclusions on the Concept of DFS  Para 3.7.







The issues of efficacy, potency and availability of vaccines are key to the acceptance of the incorporation of vaccination as part of a control programme.

We have considered the published documents of Merial, Intervet and United BioMedical and consulted with virologists and raised this issue with the Chief Veterinary Officer regarding vaccination of the hefted flocks (Aug 2001).


Modern vaccines are highly purified and inactivated. If administered in the appropriate form and in the right conditions they can provide effective immunity when used as part of a programme to control the disease with subsequent surveillance and testing. Ref Drs Sutmoller, Barteling, Watkins, Merial publication, etc


The main opposition that we have encountered to the use of vaccination is that the non structural protein test, used to distinguish between response to vaccine as opposed to response to infection, has not yet been validated.


Merial have had the test independently assessed although the test is a described test, not yet proscribed, as it has not yet been validated.


Intervet have also announced a similar test  but again it has not been validated.


From our understanding vaccination by itself cannot cause the carrier status.


We refer to attached paper from Dr Sutmoller and discussion with Dr Dowl of Merial.


In our discussions regarding the vaccination of the hefted flocks, the subsequent surveillance and testing, using the NSP test to differentiate between response to vaccination as opposed to challenge pre or post vaccination, was to have provided an effective method of establishing the extent of disease spread, response to vaccination and in determining disease free status.


Even if the NSP test could not be used to determine DFS and the 12 month rule thus applied post vaccination, it is still our contention that vaccination would have provided a less disruptive and more proportionate and rational response to disease control and created less devastating impacts, both financially and socially.





The basis for the distinction between 12 and 3 months for return to DFS, if vaccination to live as opposed to stamping out is used to control the disease, is a fundamental consideration.


Throughout the course of the UK 2001 epidemic it is this issue which has been the main reason why vaccination has not been utilised.


We feel that it is imperative that the need for this distinction is scientifically reviewed and re-appraised. We would also like to raise with the RS whether any scientific rationale or justification has been advanced, either by the OIE or others, for the retention of this time scale.


We subscribe to the view, also articulated by others, that the basis for the return of DFS should not be hindered or influenced by political or economic considerations but based on science-based risk assessment.

We refer the Committee to the paper on Risk Assessment presented to the Brussels Conference by Dr Sutmoller and Dr Barteling, copy attached.


It is our intention to take up the issue of this distinction and its consequences with the OIE and the EU in the coming weeks.





In considering the science of control policies it is important to recognise that no control policy is risk free. The control based on the science of slaughter has eventually brought the current epidemic under control (although we believe antibody positive culls are still continuing), but at enormous cost and with many social and ethical implications.


Circa 10 million animals have been slaughtered (MLC figures and DEFRA agreed). The vast majority of these animals were not infected. It appears that the science to support this approach is inexact and even where science could refine the process the logistics required in testing and the scale of the outbreak made this impossible.


We have now received some of the preliminary laboratory results we have been seeking and they provide little reassurance that the application of the adopted science was well targeted and cost effective.


It is against this background that we submit our considerations to the Royal Society





We would now like to briefly address some of the main points of our submission.


Copies of Conclusions of Sections attached for ease of reference.









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.



MEAT IMPORTS  possibly sources of infection

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.





3.3.11 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.





3.6.1 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.


3.6.4 Many of these principles and contentions have been supported at the Brussels Conference into FMD of 12/13 December 2001.


3.6.5 The Conference recognised the international inter-dependency needed to contain and control the disease. Dr Jacques Diouf of the UN Food and Agriculture Organisation (FAO) speaking at the conference said:

"Effective control of the global threat of FMD requires a concerted international strategy to combat and control it at source, including in particular more assistance to the developing countries where the virus is endemic."

Appendix 24


3.6.6 The retention of Disease Free Status was also questioned by the UK Government Minister for Environment, Food and Rural Affairs, Margaret Beckett, ahead of the conference:


"I think one of the questions which should at least be put on the table is whether the whole basis of the international policy is right.


"The basis of policy across the world, not just in the EU, is if you have an outbreak of foot-and-mouth disease it must be eradicated, it must be stamped out, because it has always been regarded as such a danger.


"Is the policy of eradication right, if it is why is it, because what you then do flows from whether you are content to live with the disease or whether you are trying to get rid of it?"


Source: BBC Wednesday, 12 December, 2001, 09:04 GMT

EU considers farm disease rethink


3.6.7 In the comprehensive paper from the Committee of Agricultural Organisations in the European Union and the General Committee for Agricultural Co-operation in the European Union, COPA/COGECA, the various issues regarding DFS and vaccination, trading, socio-economic and ethical issues are addressed:


"International standards must be clarified and possibly adjusted in particular with regard to the distinction between prophylactic vaccination and emergency (protective or suppressive) vaccination in relation with regionalisation, provisions for disposal of products from within the zone, timing to recover the FMD free status and the trade implications." Appendix 25


3.6.8 It is the paper from Dr Paul Sutmoller and Dr Simon Barteling which specifically addresses these issues:


"Rationale risk management for the prevention, control and eradication of FMD must be carried out on science-based risk assessments. Presently, the discussion on "to vaccinate or not to vaccinate", and its consequences for international trade, relates to the fact that vaccinated animals may  like convalescent or sub-clinical infected animals  become (virus) carriers. Also, the argument is used that vaccinated animals will have antibodies against FMD and that this might obscure the tracing of the disease.


"But, how large is that risk of creating vaccinated carriers and what would be the risk posed by such animals? Does that risk justify the zero-risk approach of "stamping-out" or the killing of all vaccinated livestock? Are these measures really zero-risk?" Appendix 26


The paper then goes on to address; Dissemination of FMD, Carriers, Carriers and Vaccination, Vaccines, Control and eradication by vaccination, Trade in animals and animal products and Prevention, control and eradication of FMD.


This document is appended and we would ask the Inquiry to consider all the points it raises. We fully support the contentions and views expressed.

3.6.9 The Brussels Conference has fully endorsed our position that the policy of mass slaughter, to stamp out the disease to maintain DFS, is no longer acceptable.


3.6.10 The obstacles to vaccination must be scientifically reviewed as a matter of urgency. It must be questioned and established precisely why vaccination requires 12 months from the last case and the end of the vaccination programme before DFS can be re-instated. The justification for this policy requires precise definition and scientific evidence must be produced to support this contention.


If there is no scientific basis for the 12 month rule then this rule must be immediately reviewed. If evidence is produced to support its retention, and therefore only a slaughter policy can regain DFS within 3 months, then the EU and OIE must consider the wider costs and implications of DFS. The EU and OIE must then take the decision whether on economic, ethical, social, environmental and animal welfare grounds DFS can still be justified.


Crucial to these deliberations must be recognition by the EU and the OIE that disease control must promote and engender fair and equitable world trade, and that in the interests of all, global eradication must be the ultimate objective.





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.







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,





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.





6.3.8 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.





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. LVIs, 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.




9.8 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 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.






10.9 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?





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, communities and animal welfare 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.