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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

 

 

 

For the attention of:

Susan Ivory

DEFRA

1a Page Street

London  SW1P 3PQ

 

                                                                                                         20 February 2004

 

Dear Ms Ivory

 

CONSULTATION ON DEFRA’S FMD CONTINGENCY PLAN – Version 3.1 DECISION TREE & SLAUGHTER PROTOCOL

 

Please find attached our response to Defra’s consultation on the above and the relevant supporting papers.

 

A great deal of progress has been made in providing for the use of emergency, protective vaccination.  In particular we welcome the derogation obtained from the EU which will allow vaccinated meat and meat products destined for the UK market to be treated in the same way as un-vaccinated product, post vaccination and testing.

 

However, we are disappointed to note that several of the points which we submitted in February 2003, in response to consultation on the earlier version of the Contingency Plan, have not been addressed.

 

Although we have taken part in Defra’s FMD Stakeholder meetings and submitted responses to all the consultations which that has involved there is still no Vaccination Protocol element within the Contingency Plan.  We append the list detailing these concerns which we prepared for consideration at a recent meeting with Simon Hewitt, Fred Landeg, Jean Kennedy and Sue Whitehead of AMED, relating to FMD matters.

 

Can we suggest that a Vaccination Protocol should also be included as an Annex to the Contingency Plan and that this should deal with the issues raised in the communication detailed above and appended.

 

In addition there is also a need for a more simple “Handbook on FMD Emergency Vaccination”  to explain the process and what is entailed for those who will not want/need the detail contained in the FMD Contingency Plan.

 

If you have any queries regarding the attached papers please do not hesitate to contact us.

 

Yours sincerely

 

 

Janet Bayley

NFMG Co-ordinator

 

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

 

 

 

DEFRA FOOT & MOUTH CONTINGENCY PLAN – Version 3.1,  DECISION TREE & SLAUGHTER PROTOCOL

 

NFMG RESPONSE TO CONSULTATION – 20 February 2004:

 

 

1            INTRODUCTION

 

The NFMG welcome the revision of the Government’s Contingency Plans for use in the event of a future outbreak of Foot and Mouth (FMD). 

 

We note and support the progress that has been made over the last 12 months relating to emergency, protective vaccination and thank the AMED team for the work it has undertaken and the advances that have been made.

 

However we have two over-riding concerns which we would like you to consider:

 

a          that the key issue of Emergency Vaccination, as a means of controlling FMD, is not yet sufficiently developed in the Contingency Plan, and

 

b          the inclusion in the Contingency Plan of the use of pre-emptive and ‘firebreak’ culling of animals not exposed to disease, as a means of FMD control.

 

We wish to first address these concerns and then respond to the particulars within the Contingency Plan, the Decision Tree and the Slaughter Protocol.

 

 

2            EMERGENCY VACCINATION

 

2.1            Requirement for Emergency Vaccination Protocol

 

The amended Animal Health Act places upon the Secretary of State a “Duty to consider vaccination”  in relation to any occurrence of FMD, and whether “treating animals with serum or vaccine is more appropriate than any other means of preventing the spread of disease.”      See Section 14B.

 

In addition, the revised EU Directive for the Control of FMD, adopted December 2003 and due for transposition into UK law by June 2004, also states in Annex XVII – Criteria and Requirements for Contingency Plans, that:

 

“Member states shall ensure that contingency plans meet at least the following requirements:

 

Para 10            Detailed plans shall be available for emergency vaccination”

 

See EU Directive, 9474/2/03 – Annex XVII Page 2

 

Furthermore Article 14 (3) of the adopted EU Directive also states:

“The competent authority shall, immediately upon confirmation of the first outbreak of foot and mouth disease prepare all arrangements necessary for emergency vaccination in an area at least the size of the surveillance zone established in accordance with Article 21.”   See Page 36 of the EU Directive.

 

While a detailed Contingency Plan, Decision Tree and Slaughter Protocol has been prepared and submitted for consideration and consultation, thus far, the Contingency Plan does not contain an equivalent Vaccination Protocol which has been put forward for consultation and to be used in the event of a future outbreak.

 

Given that both the UK Animal Health Act and the revised EU Directive now provide for the use of Emergency Vaccination as a means of FMD control we consider that a Vaccination Protocol should now be drawn up to form part of the UK FMD Contingency  Plan.

 

We submit that this is a major deficiency within the Contingency Plan and should be addressed with urgency.

 

 

2.2       Scope and Extent of Vaccination Protocol

 

As part of our submission to the Royal Society Inquiry we developed a Draft Programme for the Containment, Control and Eradication of FMD incorporating Emergency Vaccination.  We attached the Programme and its supporting papers to our response to Version 2.5/3 of the UK FMD Contingency Plan in February 2003.                                                     

 

The document was not intended to be prescriptive – but to illustrate how such a process could be applied and to stimulate debate and discussion.  However there are several factors which we submit should be included within the Government’s own Emergency Vaccination Protocol, namely:

 

 

1          Criteria and Thresholds for determining use of vaccination

 

2            Provision and availability of appropriate NSP free vaccines for the different sero-types of FMD and the relevant differential tests.

 

3            Procedures determining when, what, where and how vaccination will be applied and how this will be recorded

 

4          Bio-security and other measures to be employed in the vaccination zone;

 

i            during vaccination,

 

ii            post vaccination and prior to the commencement of sampling, and

 

iii            during sampling and awaiting results.

 

 

5          Post vaccination surveillance – measures and application

 

6          A sampling and sero-surveillance programme to determine which flocks and herds have been exposed to infection and to define what additional screening may be needed.

 

            Note:   Such a sampling programme should be agreed in advance with the OIE to define what data and information will need to be submitted in order to determine Disease free status in accordance with Article 2.1.1.7 of the Animal Health Code, Chapter 2 relating to FMD and as per Item 6.

 

7            Similarly there is need for agreement within the EU to determine that intra-community trade will be determined in accordance with the OIE declaration of Disease free status.

 

8          To disseminate the relevant information and instigate appropriate training prior to a future outbreak with veterinarians, farmers, and all others likely to be involved in delivery of a vaccination protocol.

 

9          To establish a clear timetable setting out the necessary time scales that each process would require and the implications for all those involved in the rural economy – including the time frame for the re-opening the countryside post vaccination.

 

As set out in the Draft EU Directive, principally but not exclusively in Section 8

dealing with Vaccination, some of these elements have been developed.  Articles

49 – 58 provide the initial framework as to how vaccination will be utilised to control

an outbreak.

 

However there would appear to still be substantial areas which need clear and full

detail and articulation if Emergency Vaccination is to be meaningfully applied.

                       

Furthermore, it may be very difficult to implement such a control if the relevant ‘Stakeholders’ have not had an opportunity to consider and understand how such a process would operate. 

 

 

3          PRE-EMPTIVE AND FIREBREAK CULLING

 

3.1       FMD CONTINGENCY PLAN – Version 3.1, Decision Tree and Slaughter Protocol

 

At Page 89 of the Contingency Plan (3.1)  in Annex B – Decision Tree for Disease Control Strategies Against FMD in Para 3 it states: ”…there are a range of additional options and strategies potentially available…   The range of options includes:-“ 

 

“pre-emptive or ‘firebreak’ culling of animals which are not on infected premises nor are dangerous contacts nor are necessarily exposed to disease, in order to prevent the wider spread of the disease out with the area”.

 

The Decision Tree sets out the factors which are to be taken into account in deciding which strategy to adopt to control the disease, while the Slaughter Protocol outlines the processes and actions that may be taken to slaughter animals in order to control and eradicate the disease.

 

 

 

3.2            Validity of Pre-emptive and ‘Firebreak’ Culling to Control FMD

 

We submit that until the full epidemiological data relating to the UK 2001 FMD epidemic has been independently and scientifically analysed and assessed the legitimacy for the use of pre-emptive and firebreak culling, as a means FMD control, has not been determined.

 

We contend that all the other measures, as detailed within the Contingency Plan and EU Directive, provide the necessary controls to bring an outbreak under control and eradicate the disease.

 

Furthermore, the information relating to incidence of disease in 2001 that has been made available, indicates that the use of pre-emptive culling as a control method resulted in massive numbers of healthy animals being slaughtered, with the attendant logistical problems of disposal and compensation payable – and many other socio-economic impacts.

 

We draw your attention to the recent paper by Dr P Kitching in the Vet Journal – Vol 167 Issue 2 addressing the role of modelling and the policy it directed in 2001.

 

Also we appended our assessment of the data we obtained regarding this to our response in February 2003 to UK FMD Contingency Plan version 2.5.

 

We again draw your attention to the very low number of positive cases of FMD that were confirmed when laboratory tested.  Also, the figures we obtained for the Great Orton burial site provide compelling evidence that such measures are neither a proportionate nor rational response to control the disease.   These were also included in Appendix 1 of our submission in February 2003.

 

We urge that pre-emptive culling should not form any part of the disease control process, or at the very least be deferred until the analysis referred to above has been undertaken and the results published.

 

In addition the revised EU Directive does not make provision for pre-emptive or firebreak culling of animals which are considered not to have been exposed to the disease.  See Article 8 ‘Preventive Eradication Programme’ – which only refers to animals ‘likely to be contaminated and, if considered necessary, of epidemiological linked production units or adjoining holdings.’

 

The Directive does not provide for the firebreak culling as detailed in the UK FMD Contingency Plan.  See Page 92,  Para 14, Page 93 Paras 20, 21, 22 and Page 106, Para 1 – 4.     

 

“Legislation in England and Wales allows for slaughter of:

 

·         Animals to prevent the spread of FMD, eg a ‘firebreak cull’.”

 

In addition we also question the interpretation of the EU Directive in Para 13 of Page 92 of the UK FMD Contingency Plan:

 

“The Directive requires slaughter of all susceptible animals on infected premises, and provides for culling of susceptible animals on epidemiologically linked holdings, as well as culling of susceptible animals on holdings where FMD is suspected.” 

 

Our emphasis.  From our reading of the Directive it does not allow for Slaughter on Suspicion unless it can be shown that animals are likely to be contaminated.  Also such animals must have samples taken and be subject to clinical examination.

 

 

4            RESPONSE TO PARTICULARS IN CONTINGENCY PLAN

 

Firstly we welcome the clarity and detail that has been provided in some sections of the Contingency Plan, that the document is now freely available in the public domain and is to be subject to widespread consultation and revision.

 

Our response refers to the relevant pages and paragraphs within the document:

 

 

Page 20  Para 2.21   Outline of Policies

 

·         Diseased and other susceptible animals on infected premises will be culled with a target of within 24 hours of report.  Dangerous contacts will be culled with a target of within 48 hours of report.

 

Response:            What is the definition of Dangerous Contacts? 

 

Given the 4 categories for slaughter referred to in the Decision Tree – see Page 92 Para 14 the term ‘dangerous contacts’ appears to extend to three of the categories listed, namely:

 

·         Animals affected or suspected of being affected with FMD

·         Animals in the same place or in contact with animals affected or suspected of being affected with FMD

·         Animals which are believed to have been exposed to FMD infection.

 

We submit that definitions of what is meant by “dangerous contacts” should be set out in a glossary or appendix so that there is clarity and understanding on this.   Also, given the confusion that arose in 2001, explicit definitions of what is meant by “slaughter on suspicion”,  “contiguous cull”, “firebreak cull”,  “pre-emptive” and “preventive slaughter”  should be detailed in advance.   

 

With reference to the Decision Tree on Page 92 it appears that the term “Dangerous Contacts” could be applied to all categories detailed in Paras 15 to 19.  – A very extensive and wide interpretation of Dangerous Contacts.

 

If this is so, this should be made explicit to avoid mis-understanding and mis-interpretation, both now and at the time of the next epidemic.

 

We also submit that “slaughter on suspicion” and “being exposed to the disease” – are not two separate categories but one. 

 

Ie “Animals slaughtered on suspicion of being exposed to the disease.”

 

 

Page 22            SECTION 3 – Resources

 

Involvement of Armed Forces – Human Resources – Defra Legal Services – Vaccination Teams

 

Response:  We are very concerned that the Vaccination element of disease control is to be contracted out whereas many other elements of disease control which require resources are to be met either from within Defra or from other Ministries.

 

There is no detailing of the procedures that will be adopted by sub-contractors or how vaccination will be applied.  Furthermore, with reference to the number of Vaccination Teams, (Page 35 and Annex D Page 109), we submit that 50 vaccination teams could well be insufficient to deal with an outbreak using vaccination.  It is vital that there will sufficient manpower to  deliver vaccination as quickly as possible to ensure immunity is conferred in the shortest time scale. 

 

We therefore welcome the proposed changes to the Vet Surgeons Act and Medicines Act to provide for lay vaccinators but submit that the ability to quickly and efficiently scale up operations and the number of operatives is key to the success of a vaccination programme.  As yet this does not appear to have been addressed.

 

In addition the role of farmers and private vets to assist in this process has not been set out, defined, explained or addressed.

 

We are very concerned that insufficient resources have been set aside to deliver a Vaccination programme – and submit that this responsibility should remain within the purview of Defra – and be given the same access to resources as pursuance of a Slaughter policy would involve.  It is our contention that in contracting out the Vaccination Programme and its delivery the Department has abrogated its responsibility to deliver a workable vaccination policy – and meet the requirements of the EU Directive as detailed below:

 

“The competent authority shall, immediately upon confirmation of the first outbreak of foot and mouth disease prepare all arrangements necessary for emergency vaccination in an area at least the size of the surveillance zone established in accordance with Article 21.”   See Article 14 (3) Page 36 of the EU Directive.

 

See also later comments on Annex D

 

Page 35   Para 3.80            Stores to supply vaccination teams

 

Response:            As expressed above we do not consider that 50 vaccination teams will be sufficient – and are very concerned that there is inadequate provision to ‘ramp up’ either the number of operatives or the necessary equipment.   Again we doubt whether the provisions of the Article 14 (3)  of the EU Directive have been met.

 

 

Page 36            SECTION 4 – Key Operations

 

Emergency Vaccination

 

Page 36            Para 4.2             Current operational arrangements

 

Please see our comments above in relation to resources and contracting out of vaccination operations.

 

Page 36            Para 4.4       Timing

 

4.4       …..It is probable that the time necessary for veterinary assessment of epidemiological data, the use of the Decision Tree and the development of advice on the strategic deployment of vaccination make it unlikely that vaccination would start as soon as five days after the first confirmed case.”

 

Response:            We are concerned that the start of vaccination may be delayed beyond the 5 days referred to above.  A key element in the effective use of vaccination is that immunity is conferred as soon as possible.

 

This should be compared with the time scale allocated for the removal/slaughter of “dangerous contacts” – ie within 48 hours of report of infection.

 

If dangerous contacts is to include contiguous premises and these are to be slaughtered within 48 hours – this gives an indication of how necessary it is to be able to commence vaccination to provide a firebreak vaccination zone as soon as possible.  

 

The Contingency Plan must be explicit as to when it is envisaged that vaccination could commence after the initial outbreak – if all other criteria specified in Annex  X of the Directive are met.  If more than 5 days – how many more?

 

Page 37             Operation Process

 

We will submit our response to this when dealing with Annex D later.

 

Animal Welfare

 

Page 37               Para 4.7

 

Response:            We regret that it is only ‘consideration’ that is to be given to setting up an animal welfare forum in the event of an FMD outbreak.   

 

Given the magnitude of welfare issues which arose in 2001 – and that these may be further exacerbated by the need to impose animal movement restrictions as soon as the disease is confirmed – we submit that such a body should be convened at the start of the outbreak.

 

Furthermore, the deliberations of such a group may be an important consideration in determining whether a vaccination policy should be pursued.

 

Page 37            Para 4.10

  

Response:              We welcome and support the proposal to establish and run a national fodder brokering service if the lack of feed becomes a problem.

 

 

Page 39             Para 4.20 – 4.35   Disposal, disposal hierarchy, etc               

 

We note that policy developments and environmental constraints have now determined that commercial incineration, followed by rendering are the preferred disposal methods.  However at para 4.26 it states that “Incineration capacity is limited and will only be able to deal with small isolated outbreaks or the first few days of a new outbreak or disease recrudescence.”

 

Thus, recourse to rendering would soon have to be taken up.  Here again disposal capacity is limited.

 

Response:    Given the additional constraints on the disposal of carcasses that would be imposed in the event of a future outbreak we consider that this limitation should be given greater weight in determining the control method, and inter alia, the number of animals thus requiring slaughter, ie whether to use culling or vaccination for disease control.  The full constraints on disposal must be properly factored in to the decision making process and the decision tree.  We submit that protective vaccination as opposed to suppressive vaccination would generate the least demand for disposal facilities

 

 

Page 42            Paras 4.36 – 4.41 Serology

 

Response 1:            Far greater detail is afforded in the Plan to provision for the various disposal methods after slaughter, ie, incineration, rendering, etc than for the details relating to serology, capacity and surveillance.

 

Given that pursuance of a vaccination policy will generate many animals which will require testing post vaccination, have sufficient facilities been provided to deal with this increased need and capacity for testing?

 

While welcoming the change in policy to bring vaccination forward we are concerned that this has not been matched by the need to provide additional testing facilities to deal with the testing of vaccinated animals. 

 

Para 4.36 states that the main use of serological surveillance “is likely to be as part of the surveillance of protection and surveillance zones following an outbreak..”

 

However, if emergency, protection vaccination is used this will require these animals to be tested – and in the Contingency Plan the only reference to this comes in Para 4.40  “In a vaccination zone surveillance will be carried out, after a minimum of 30 days have elapsed since vaccination was completed, to establish whether any vaccinated herd or flock had become infected with virus.”

 

Given that the sensitivity and specificity of the tests may necessitate more animals to be screened than during normal serological surveillance there could well be a need for additional testing facilities.  This does not appear to have been addressed.

 

Response 2:   We understand that several types of real time RT-PCR tests are under development by various commercial companies world-wide and at the IAH, Pirbright.

 

Given the importance of fast and accurate diagnosis in determining presence and extent of infection we submit it would be very helpful for DEFRA to publish a position statement (similar to the references in the Decision Tree relating to what vaccine is being obtained and from where) to make clear what the current  and emerging situation is.

 

If the situation is that such tests require validation in order for recognition by the OIE in its Manual of Standards for Diagnostic Tests and Vaccines, and for licensing for use in the UK and the EU, then it would be very helpful to know what time scales are likely to apply.

 

If Government funding is needed to bring this work forward may we suggest that this would be a worthwhile investment.   Rapid diagnosis is a key tool in control and eradication.

 

 

 

Page 45      SECTION  5 – Management Information and Communications

 

Page 46             Para 5.7   Website   &  Para 5.9   Helpline

 

Response:    Not all farmers have access to computers and the Defra website, and  our experience of the helpline in 2001 was that it was not properly briefed to deal with the queries that were put.  

 

In many instances the helpline was the only interface between the Ministry and affected farmers, livestock owners, affected businesses and rural communities.   Very often operators were left trying to explain policies which communities did not feel were justified, and which the operators themselves could not defend.  It should not be left to these people on the front line to defend policy – and there needs to be a chain of command along which calls can be referred for response at a higher level.

 

Page 48            Para 5.20     Expert Group

 

Response:            We are extremely concerned that no Expert Group has as yet been established.   Given that the Government is committed to bringing forward a workable and feasible vaccination policy it is vital that experts in vaccination are involved in such a Group and should be operational now in devising the practical applications needed in carrying out vaccination.

 

In drawing up a Vaccination Programme we also submit that those who have had field experience of controlling FMD with emergency, protective vaccination should be involved first hand to prepare the necessary plans and arrangements    

 

Furthermore, in the light of the evolution and enactment of the Contiguous and firebreak culls utilised in 2001 we ask that expertise is drawn not only from those founded in modelling – but also from those with experience and qualification in FMD diagnosis, disease control and research.

 

We have here particular regard to the views/involvement of A Donaldson & P Kitiching of IAH Pirbiright during 2001 – and on which they later submitted evidence to the EU FMD Inquiry.

 

Given the extensive number of committees and bodies considered necessary that are referred to in Section 6 – it seems remarkable that such an Expert Group has not yet been convened – as its deliberations should lie at the very heart of evolving policy.

 

 

Page 49     SECTION 6 – Strategic Level Plan

 

Response:            We welcome the detailing in this section of the various committees, boards and bodies who will be taking decisions and how these decisions will be fed into policy and operational outcomes.

 

It is helpful to see how the command structure will operate and we much appreciate the transparency that has been afforded to the process of policy formulation and accountability both for decisions and actions.

 

Page 80    Para   7.22   Vaccination Operations

 

Response:            We again express concern that the vaccination element of disease control is to be contracted out and that there may insufficient provision of vaccination teams and resources.

 

In addition if such a limited number of teams is proposed are the supplies and equipment also equally limited?  What ability will there be to source and obtain extra equipment and supplies of sufficient quantities to scale up operations.

 

Also the number of ‘team positions’ is shown as 2 – this again seems very limited compared with other provisions, ie Disease Reporting Team – 15,  Operations (non-veterinary)  12,  Veterinary Operations 6.

 

If vaccination is to be properly considered as a disease control option then it seems incumbent that neither the number of vaccination teams nor the availability of supplies and equipment should be a limiting factors.

 

Again we question whether the provisions of Article 14 (3) of the EU Directive have been met.

 

 

Page 89     Annex B     DECISION TREE FOR DISEASE CONTROL STRATEGIES

   AGAINST FMD

 

Paras 2 and 3

 

Response:            Para 2 sets out the provisions of the EU Directive – which “requires  the slaughter of all susceptible animals on infected premises, and provides for culling of susceptible animals on epidemiologically linked holdings (known as dangerous contacts).”  However no mention is made of the significant provisions in the Directive relating to vaccination.

 

However Para 3, which deals primarily with the UK legislation and its provisions then adds, “The new FMD Directive has also moved emergency vaccination to the forefront of disease control strategies.  The range of options includes:”  The paras then details 3 further options including:

 

·         pre-emptive or ‘firebreak’ culling of animals which are not on infected premises nor are dangerous contacts nor are necessarily exposed to the disease, in order to prevent the wider spread of the disease outwith an area.”

 

This gives the impression that pre-emptive or ‘firebreak’ culling forms part of the provisions of the EU Directive.  This is not the case as this provision only forms part of UK legislation as in Section 14B of the amended Animal Health Act.

 

We submit that the provisions of the EU Directive should be set out clearly and independently from the additional provisions which arise from the amended Animal Health Act.

 

 

Page 90   Para 5

 

Response:   This para includes 4 principles to be taken into consideration in determining which control strategy will be adopted.  However it does not include the principle which has been included in the revised EU Directive, namely:

 

“At the same time the Community is also a community of values, and its policies to combat animal diseases must not be based purely on commercial interests but must also take genuine account of ethical principles.”

 

See Para 1 of the revised EU Directive on Page 2.

 

We submit that such consideration should also form part of the UK Government’s deliberations in determining which control strategy should be adopted.

 

 

Page 90/91   Para 9

 

Response:  We submit that there have been no changes to this statement since the publication of Version 3 of the UK FMD Contingency Plan in March 2003.

 

We are therefore concerned that the situation remains as stated – and that no advance on this position has been made in the last 12 months, as it remains as expressed in March 2003, namely:

 

“9         The Inquiries investigated in detail the issues involved in employing emergency vaccination.  Between them they highlighted a range of significant questions that would need to be addressed, particularly as regards vaccination to live, but concluded that once these were resolved, the option of emergency vaccination to live should be the preferred approach.  The Government is committed to tackling these issues in consultation with all interested parties so that it is in a position to trigger an emergency vaccination campaign should the need arise.  As part of this process it is essential to have stakeholder support and the Government has engaged in dialogue with a wide range of stakeholders in order to achieve, so far as possible, a shared understanding in advance of an outbreak of the factors which influence the choice of control options.  The Decision Tree is intended to assist in this process.”

 

Response:  As stated above it is worrying that this statement in the Contingency Plan has not changed in the last 12 months, despite many stakeholder meetings and the resolution of several issues during negotiations relating to the EU Directive.

 

We submit that there should now be a position statement from the UK Government setting out which issues have been resolved and those which remain still to be addressed.   In addition those matters that have been agreed with stakeholders should be listed.

 

We append to this submission our recent correspondence with the Chief Veterinary Officer – and consider that the three issues which we raise should now be clarified.

 

Please see attached letter to CVO  -  15 January 2004

 

 

 

 

Page 91    Para 11            Protective Vaccination

 

Response:    This sets out many of the criteria which would be taken into account in deciding to use emergency vaccination.  However one of the key criteria which was added to the revised EU Directive has been omitted.  We submit that this should be included:

“If it is foreseeable that a control strategy without emergency vaccination would lead to significantly higher economic losses in the agricultural and non-agricultural sectors.”

 

See Annex X – Revised EU Directive – Additional criteria Page 2

 

 

Page 91     Para 12            Suppressive Vaccination  (Vaccinate to kill)     

 

Response:            We note that this para states “It (suppressive vaccination) could also be used where there is an urgent need to reduce the amount of virus circulating in an areas and reduce the risk of spread beyond that area.”

 

However this rationale is not applied to the section on Protective Vaccination (Vaccinate to live) Paras 10 and 11.   We submit that this outcome would apply equally whether used for a ‘vaccinate to live’ or a ‘vaccinate to kill’ regime – as vaccination would substantially reduce the amount of virus circulation in both circumstances.  We therefore consider the same paragraph should be added to the Protective Vaccination section.

 

Page 92    Para 13 & 14, 15 –19   Stamping out Policy

 

Response:   Please see our earlier comments relating to:

 

Interpretation of EU Directive, the validity of firebreak culls and the definitions of ‘dangerous contacts’, Decision tree, etc on Pages 4, 5 & 6 and 10,11 of this submission.

 

While welcoming the detail afforded in Paras 15-19 as to the processes that will be adopted we submit that the lack of definitions will allow interpretation of ‘dangerous contacts’ on a very extensive basis.

 

We feel clarity is needed to differentiate between animals on infected premises – where animals (some) are infected and the remainder affected – and thus all will need to be slaughtered,

 

As opposed to animals which are believed to have been exposed to disease – as per the definition in Article 14 (2) of the EU Directive.

 

While welcoming the statement in Para 18 “That action that we take will depend or a risk assessment.”   We find the next statement would then appear to relate more to pre-emptive or firebreak culling:

“Where it is believed that the likelihood is that exposed animals are at a high risk of becoming diseased they will be slaughtered.”

 

We ask that Para 15 – 19 should be revisited and clearer definitions be provided.   We also ask that the validity and need for firebreak culling in Para 20 – 22 should be re-considered in the light of independent assessment of the epidemiological data from 2001.

 

Para 18             Same section as above

 

Response:            We welcome the inclusion of the sentence “A decision to slaughter will be taken by the veterinary inspector based on information gathered during the inquiry and account will be taken of levels of bio-security.  The action that we take will depend on risk assessment.”

 

However we urge that for all farmers and livestock holders should be fully briefed and kept updated on farm bio-security and effective farm quarantine – perhaps on an annual basis – so that should a future outbreak of FMD occur they know immediately how to isolate themselves, their farm, their animals and put in place all necessary measures to protect against infection.

 

Para 20            To prevent the spread of disease

 

Response:            Pre-emptive culling etc.   

 

Our main concern is that a decision to impose a blanket cull will again result in many healthy animals being needlessly killed, create major logistical problems, rule out proper veterinary risk assessment, generate distress and despair amongst farmers and livestock owners and adversely impact on the wider rural economy and society.

 

We cannot stress enough how little evidence has been advanced to substantiate this approach post the 2001 epidemic.

 

We submit that once nation wide movement restrictions are imposed, effective farm quarantine established and the requisite bio-security enforced – via the ‘Blue Box’ approach if necessary, transmission of the disease will be halted.

 

If some form of firebreak is needed – then a recourse to fire-break vaccination, on a vaccinate to live approach, would reduce virus amplification and transmission to a far greater extent than ‘firebreak’ or pre-emptive culling.

 

We urge that pre-emptive culling should be removed from the Contingency Plan and Decision tree as a means of controlling disease and we note that it does not feature in the revised EU Directive.

 

Please see also our Response to Page 106  Annex C Disease Control ‘Slaughter’  Protocol,  Paras 2 & 3

 

 

Page 94   The Decision Tree Flow Chart

 

Response:            We submit that there should be a link from Box 5 asking ‘Are resources and disposal capacity available for additional cull strategies’ back to the vaccination line if there is ‘No’ disposal capacity available.  It should not result solely in endemic FMD as the Decision Tree shows or to the box ‘Stamping out and additional cull strategies’.

 

Page 95   Decision Tree

 

Response:  We very much welcome the detail which has been provided in the Decision Tree – Factors to be considered – which first appeared in Version 3.0 of the Contingency Plan last March – and has been updated in part in Version 3.1.

 

With reference to the validation of differential tests to be used for post vaccination surveillance. Page 96/97 Para 2.  We understand that proposals are currently under consideration with the OIE to design the appropriate sampling and surveillance regime to determine which herds and flocks have been exposed to disease and those which have solely responded to vaccination.

 

This regime may enable submission of appropriate data to the OIE to recover DFS before the validation of the specific differential tests is completed.  No doubt DEFRA is aware of this situation – and will be able to utilise this approach should a further outbreak of FMD occur.

 

However we note that there has been little advancement in some areas since March 2003, namely on Page 97 para 2 where it appears that as yet Pirbright have not been able to determine or recommend an NSP test for the Government to hold as a contingency reserve.  Is this still the current position?

 

Page 97 para 3 Also we re-iterate our concerns as to the number of vaccination teams envisaged (50) and whether sufficient supplies and resources are available, and how numbers can be ramped up.    What worst case scenario planning has been used to determine personnel and supply levels?

 

We also note that on Page 97 in para 3 it states:  “to meet the needs of any reasonable disease scenario.”  Without any definitions as to “reasonable” this is, at best, very subjective.

 

On Page 98 in Para 5 we note that the additional criteria in Annex X of the revised EU Directive has not yet been incorporated into the section on economic considerations and feel that it should form part of the process:


“If it is foreseeable that a control strategy without emergency vaccination would lead to significantly higher economic losses in the agricultural and non-agricultural sectors.”

 

Page 98  Decision Box 3: Is the exit strategy “vaccinate to live”?

 

With reference to the controls on products from vaccinated animals. 

 

We greatly welcome the advances that have been achieved in obtaining derogation

from the EU so that vaccinated meat and products do not need to be treated

differently from non vaccinated meat and products after NSP testing when destined

for the domestic market.

 

With reference to food labelling.

 

We very much hope that agreement has now been reached with the Food Standards Agency and the National Consumer Council that vaccinated products will not require labelling.   A joint statement agreed by FSA and NCC, with the agreement of the food retailers would be very helpful on this.

 

Page 99  Para 8

 

Response:            With reference to Socio-political factors to be considered we submit that the additional criteria in Annex 10 referred to above should also be included and in addition that regard should be had to Para 1 of the revised EU Directive:

 

“At the same time the Community is also a community of values, and its policies to combat animal diseases must not be based purely on commercial interests but must also take genuine account of ethical principles.”

 

Also on Page 99 Para 9 relating to Economic considerations we submit that the statement: 

·         value of exports versus wider benefit to wider rural economy

 

deserves some further expansion and detail relating to what ‘exports’ are to be included and how the ‘wider rural economy’ is to be assessed.

           

Page 102   Annex A   Some of the routes by which animals can be exposed to infection

:

a)         Direct contact with infected animals

 

Response:             As stated earlier, a clear and detailed farm quarantine and bio-security plan, which includes pre-determined safe animal separation distances, should be put in place as soon as FMD is confirmed.  This would reduce the likelihood of infected animals having direct contact with susceptible animals – and thus reduce onward transmission.  Such plans should be agreed in advance of an outbreak – and adherence to them taken into account in assessing these criteria of the Slaughter Protocol.

 

b)            Airborne Spread

 

Response 1:            In the 2001 epidemic the issue of airborne transmission gave rise to grave concern.  We are mindful of the papers subsequently published in the Vet Record regarding the relative risks of uncontrollable (airborne) spread and the relative resistance of pigs to infection by natural aerosols of FMD. *

 

We urge that in assessing this possible transmission route DEFRA will consult widely with FMD scientists to ascertain the true level of risk which airborne spread may pose so that it is correctly ascertained and not over-stated.

 

In general:              We submit that all the criteria detailed in this section on Animals exposed to infection would benefit from inclusion in a detailed Farm Quarantine and Bio-security protocol, explaining what precautions need to be taken.

 

Such a protocol should show what measures should be put in place to limit possible transmission of the disease in each section, a – j, as soon as the first case is confirmed.

 

Response 2:    While it is important to detail the means by which animals can be exposed to disease we are concerned that there is no rating, or order of magnitude  as to the likelihood that these routes would cause transmission of disease.

 

Also we submit it is important to detail what measures could and should be taken to mitigate and diminish the means of disease transmission,  eg effective farm quarantine, safe separation distances between animals, appropriate bio-security measures,  movement of milk tankers, etc. also please see later comments on bio-security.

 

These issues are ones which we feel should have the input of the Expert Group referred to in Section 5 on Page 48, which is still to be set up.

 

We draw your attention to the Papers published in the Vet Record in 2001 referring to airborne spread and other means of transmission of the disease and ask whether this Annex has been peer reviewed, or subject to consultation with either IAH Pirbright or any of the authors of the reports in the Vet Record.

 

Page 106            Annex C    Disease Control (Slaughter) Protocol

 

Paras 1, 2 & 3

 

Response 1:             As detailed earlier in Section 3 and in response to Para 20-22 of the Decision Tree we remain extremely concerned as to the inclusion of this approach within the control measures.

 

We question the necessity of pre-emptive culling to be included in the UK FMD Contingency Plan when it has not been deemed necessary to provide for this method of disease control in the revised European Directive.  cf Article 8 of the EU Directive which only refers to “susceptible species likely to be contaminated and epidemiologically-linked production units or adjoining holdings.”

 

In addition we refer to our earlier comments that until the data from the 2001 FMD epidemic is subject to independent analysis and the results published we do not consider that the validity of pre-emptive and ‘firebreak’ culling has been proven. 

 

Once movement restrictions have been imposed and all other farm quarantine and bio-security measures implemented, including the effective enforcement of the ‘Blue Box’ schemes, the likelihood of being unable to control the disease are effectively nil.  Should preventative measures be needed then it would be far more effective to confer immunity by vaccination, rather than through the logistically difficult and far more risky approach of pre-emptive culling, with all its attendant socio-economic impact.

 

However, what needs to be made clear is that there will almost inevitably be a time delay from the imposition of these measures to the reduction in the number of FMD cases continuing to occur on a daily basis.   This is not because the disease is spreading, but because clinical symptoms will continue to appear on farms and holdings which had become infected before the standstill and other measures were imposed.  

 

This is exactly what happened in 2001.  Indeed by the time the Contiguous Cull was introduced on the 28 March 2001, the disease had already peaked and the number of new cases per day had begun to fall.   

 

We respectfully ask DEFRA and the Secretary of State to repeal this provision from the Animal Health Act, and from the FMD contingency plan.  Much trust and good will has been lost between the Department and the farming and rural communities through the 2001 FMD outbreak.

 

Such a gesture, coupled with clear and sound bio-security guidance and a workable vaccination protocol could go a long way to restoring the much needed trust and co-operation that must be re-established if we are to have a secure and workable future for UK farmers and the associated rural economy and society.

 

Response 2:            Notwithstanding our comments above we appreciate the consideration now to be given to vaccination prior to the decision to proceed with pre-emptive slaughter.

 

 

Page 106   Para 5

 

Response:   Again we stress that this approach should not be pursued unless and until the epidemiological  FMD data from 2001 has been independently assessed.

 

We refer again to the submissions by A Donaldson and P Kitching to the EU FMD Inquiry and also to the paper by Nick Wright – commissioned by Defra ,which also considered the efficacy of firebreak and contiguous culling.

 

Sadly we are of the opinion that the weight being attached to pre-emptive slaughter is based more on the need to justify what happened in 2001 – rather than on a science based risk assessment of disease control.  

 

Paras   9,  10  &  11

 

Response:   While maintaining our opposition to the principle of pre-emptive ‘firebreak’ culling we appreciate that an explanation would be given by the Veterinary Inspector to the livestock owner and allow evidence to be presented for exemption from the cull.   We welcome this procedure.

 

We also welcome that owners are to be made aware that they can ask the DVM to review the decision – and how this would be undertaken.

 

That this approach is detailed in the Plan is very much appreciated and endorsed.  We fully support Para 11 and its two sub paras.

 

However we urge that for all farmers and livestock holders should be fully briefed and kept updated on farm bio-security and effective farm quarantine – perhaps on a bi-ennial basis – so that should a future outbreak of FMD occur they know immediately how to isolate themselves, their farm, their animals and put in place all necessary measures to protect against infection.

 

 

Page 109            Annex D             Emergency Vaccination Arrangements

 

Response:            We welcome the detailing provided throughout this Annex.  It has gone some way to addressing the concerns we have been raising.  However we still submit that the processes from Day 1 of the outbreak being confirmed – through to the regaining of Disease Free Status needs to be detailed – perhaps in time line form – and covering the points we set out in Section 2 of our submission.  See Pages  2,3 and 4.

 

We also ask you to have regard to our recent letter to Simon Hewitt of 15 December 2003 as appended.

 

We also draw your attention to our earlier comments on number of vaccination teams, supplies, resources, equipment, ramping up, etc

 

Page 111        Para 4       Vaccine supplies and emergency vaccination                    

                                          arrangements

 

Response:     We are concerned that valuable time will be lost in the various stages

and visits which are proposed before vaccination actually takes place.  We are also

concerned that this may result in further spreading of disease.

 

Have any consultations taken place with those who have field experience in the use

of emergency vaccination in formulating the described processes?

 

What role is envisaged for the farmer and livestock owners?

 

 

Page 134        Annex L     Bio-security Advice and Guidance

 

Response :              This section has been much enlarged and detailed since we commented on Version 2.5 of the Contingency Plan and we appreciate the additional material that has now been incorporated.  However there are 2 issues which we feel should be addressed:

 

Issue 1            We submit that it would be very beneficial to have a separate section directed solely at farmers and livestock owners.  This should set out simply and clearly what the farmer must do to protect from the disease and its transmission (spread) and what provisions he must make on the farm.   Thus far we could not see clearly the instructions directed solely at livestock owners.

 

Issue 2            While welcoming an explicit and detailed list of recommended precautions we consider a major possible vector has not been addressed.  Namely the transmission of the disease by persons having had contact with infected animals and subsequently carrying the virus in the throat or nasal passages. 

 

Such persons may be unaware that they have been in contact with the disease – particularly in the early stages of infection.  We suggest that the use of appropriate face masks for personnel visiting the premises must also be included. 

 

Also disposable gloves should be used.

 

Additional Bio-security Advice – which we submit should be produced

 

May we suggest that the Bio-security Section should also provide a protocol for:

 

Effective farm quarantine – explicitly detailing how farms and holdings can isolate stock from possible infection,  via:

 

1          safe animal separation distances from neighbouring stock and possible housing to minimise risk of infection from airborne transmission.  

 

2          the measures to be used for all personnel and visiting service vehicles, eg, feed and milk tankers, etc.   The issue of milk is particularly important given the possibility of early virus circulation –  during the last outbreak detailed plans addressing this and the requisite air filter maintenance of milk tankers were issued.

 

3          Such measures should also detail how a vaccination plan would be delivered – and how vaccination would be applied without compromising the farm’s quarantine and bio-security.

 

In addition each farm/holding should have a bio-security/farm quarantine plan pre-agreed with DEFRA – via the local DVM – which should be put into place as soon as disease is confirmed in the country.

 

Such plans could be based on the effective and thorough approach which was implemented with the Blue Box protocols.

 

 

 

NFMG

February 2004

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

                                                                                                                  APPENDIX 1

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

 

 

 

Simon Hewitt, Head of AMED

DEFRA, 1a Page Street

London SW1P 4PQ

 

                                                                                                           9 December 2003

 

 

Dear Simon

 

FMD Stakeholder Meeting of 5 December 2003 & Issues Arising

 

Further to last Friday’s Stakeholder meeting I felt it might be useful to confirm some comments in writing.  Also could I suggest that it may be helpful to meet you to discuss how the various requirements of the EU Directive, Animal Health Act, etc relating to FMD vaccination can be met, and how the information could be conveyed to other stakeholders and to the wider public domain.  While we greatly appreciate our involvement in the Stakeholder meetings they are not always the best forum for undertaking detailed discussions

 

As I expressed at the meeting, our concerns are that without a published Vaccination Protocol or position statement setting out the Government’s stance on vaccination, what emergency vaccination is and how it would be implemented, we submit that confusion and uncertainty relating to FMD emergency vaccination will continue.  Such a document should also address the issues that have been resolved since 2001 and explain what will happen in relation to the process of vaccination, the use of vaccinated meat and milk, what testing will be used and what regime will be required to regain Disease free status.

 

The Communication Strategy we discussed at the meeting acknowledges the role of the Vaccination Protocol (see Page 10 and 16), also the EU Directive requires all Member States to prepare detailed plans for emergency vaccination and the Animal Health Act requires that vaccination be considered.  It therefore seems incumbent to ensure that appropriate information, explaining what FMD emergency vaccination is and how it would operate, is made publicly available as soon as possible.

 

I attach a list of some of the issues which we feel should be addressed by the Vaccination Protocol/Position Statement – and would very much welcome the opportunity to discuss these further – and how information relating to them could be conveyed to other stakeholders and the wider public.

 

Yours sincerely

 

 

Janet Bayley

NFMG Co-ordinator

 

 

 

ISSUES FOR DISCUSSION FOR INCLUSION IN FMD VACCINATION PROTOCOL / POSITION STATEMENT

 

 

1          The role and purpose of emergency, protective FMD vaccination

 

2          An explanation of how the process would operate – with reference to the phases specified in the EU Directive, what vaccines are available and the relevant NSP free tests that would be employed.

 

3          The testing regime which would be adopted and how this is designed to overcome the problem of carrier animals

 

4          How the testing regime would be used to demonstrate freedom from FMD and return to Disease Free Status in accordance with the OIE Code

 

5          The sale and use of vaccinated meat, milk and associated products

 

6          What market support/compensation may be needed/available

 

7          The role of a) farmers and b) vets in delivering vaccination

 

8          The implications of vaccination for food producers and retailers

 

9          What criteria will be taken into account in deciding whether to vaccinate or not

 

Inter alia clear communication is needed on the derogations that have been sought

and obtained relating to there being no need to differentiate between vaccinated and

un-vaccinated meat and milk for UK consumption, post vaccination and testing.

 

What market support will be needed/available for those reliant on exports post

vaccination

 

A clear exposition from the UK Govt of which matters still remain outstanding – and

unresolved with stakeholders - which will need to be overcome before the UK “is in a

position to trigger an emergency vaccination campaign” (with reference to Para 9 of

Annex B of UK Government’s FMD Contingency Plan – in both Version 3.0 and

Version 3.1  Page 88/89 and 90/91 respectively)

 

Consideration of what timescales are envisaged for the production of the above

information and how this will be conveyed to stakeholders and the wider public

 

Consideration of what resources are available for preparation of information and its

dissemination

 

 

 

NFMG

December 2003

 

 

 

                                                                                                               APPENDIX 2

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

 

 

 

Mr J Scudamore

Chief Veterinary Officer

Defra, 1A Page Street

London SW1P 4PQ

                                                                                                            15 January 2004

 

 

Dear Mr Scudamore

 

RE: FMD & THE VETERINARY JOURNAL  Volume 167 – January 2004

 

Further to your guest editorial in the above publication; “FMD – differentiating vaccinated from infected animals”, we would be very grateful for clarification on some of the issues you raise.

 

Since January 2003 we have been taking part in the Defra stakeholder meetings which have been considering FMD control.  Inter alia we have discussed the provisions of the revised Animal Health Act, the revised EU FMD Directive and Defra’s FMD Contingency Plan.  Discussions have also covered the treatments for meat, milk and their products during an FMD outbreak, the procurement of vaccines and the EU derogation sought and obtained by Defra relating to vaccinated products, post vaccination and NSP testing, destined for UK consumption.

 

Given the provisions of the EU Directive and Animal Health Act it is clear that emergency protective vaccination could be used to control FMD in a future outbreak.  Our concerns are that from reading your editorial in the Veterinary Journal it appears that the use of such vaccination is still dependent on several issues being resolved.

 

For example in Para 4 you state “If NSP tests are to be used as part of an FMD control strategy that includes “vaccination to live” as a component, it is vital that they are fully validated and internationally recognised”.  Also in the final Para “Therefore if NSP tests are to be used as a key component of an exit strategy following an outbreak where a policy of “vaccination to live” had been employed, more research is needed.”

 

While we understand and accept that full validation and international recognition of NSP tests is the most desirable situation, this may take several years to achieve.  From our perspective and from the EU Directive it does not appear that this must happen before emergency protective vaccination can be utilised as a form of FMD control.

 

The first point we therefore seek clarification on is:

 

“Is it the policy of Defra and the UK Government that full validation and international recognition of NSP tests must occur before the UK will utilise emergency, protective vaccination as a means of FMD control?”

 

Secondly; “If the UK is prepared to utilise emergency, protective vaccination to control FMD before full validation and international recognition of NSP tests is achieved, what provisions and procedures will be followed to overcome the existing limitations of the tests?”

 

It is our contention that NSP tests, applied on a herd/flock basis, could be used in conjunction with the existing tests used in sero-surveillance, as applied in the 2001 outbreak, to demonstrate freedom from disease.

 

While, ultimately, it would be best to have a situation where confidence in NSP tests alone enabled return to disease free status and full restoration of international trade this appears to be some years hence.  In the interim we have suggested that the temporary loss of some export markets may be the price payable if emergency, protective vaccination can be utilised as a form of FMD control as opposed to an extensive slaughter policy, with its attendant costs of compensation, disposal, etc.

 

As we advanced during our discussions in the Stakeholder meetings, there have been no fully proven cases that in the field vaccinated animals have caused introduction or recurrence of FMD.  Furthermore, can we be sure that the stamping out approach eliminated all sub-clinically infected animals and all potential carriers in 2001.

 

The EU derogation sought and obtained by Defra which has allowed the UK to treat vaccinated product no differently from non-vaccinated for the home market, post NSP testing, has been a major achievement and one which we fully welcome.

 

However, while there have been advances in the acceptability of the use of emergency, protective vaccination it seems that there is still some way to go before a coherent vaccination protocol emerges from Defra.  The document is still very much in draft form.  We consider that until such a document is compiled and in the public domain there will remain much confusion and misunderstanding about the principles of emergency, protective vaccination, how it will be applied and what procedures will be adopted.

 

It seems therefore paramount to ascertain:

 

1            whether Defra and UK Government is prepared to utilise emergency protective vaccination prior to the international validation and acceptance of NSP tests,

 

2          to determine a clear listing of what other matters relating to vaccination Defra considers still need resolution and the relevant timescales envisaged

 

3          and, if the UK Government is prepared to use emergency, protective vaccination at the current time, what procedures and testing regimes will be adopted to overcome the existing limitations of NSP testing.

 

We would be extremely grateful for your response to these queries.  For information I

also append our recent letter to Simon Hewitt relating to an FMD Vaccination Protocol and Position Statement.  If you have any queries please do not hesitate to contact me.

 

Yours sincerely

Janet Bayley, NFMG Co-ordinator