Middle Campscott Farm

Lee

Ilfracombe

Devon EX34 8LS

Tel/Fax 01270 864621

e-mail mcampscott@aol.com

To Mr John Fitzgerald

Director of Policy

Veterinary Medicines Directorate

Woodham Lane

New Haw

Addlestone

Surrey KT15 3LS.

10th July 2001

Dear Mr Fitzgerald,

Request to use FMD vaccine for our sheep, goats, cattle and pig in North Devon.

I request permission to use vaccination to protect my sheep, goats, cattle and sow from foot and mouth disease (FMD). I would like to carry out the vaccination as soon as possible in view of the imminent Summer Holiday period. Here in Devon, Devon County Council, pressed to do so by central government, are seeking to re-open the public rights of way. We and our neighbours wish to open our farms to visitors. Our farms are to a large extent dependent on tourists and summer visitors for their income and we are an important part of the attraction which brings holiday visitors to North Devon. At the same time it is clear from the application of common sense and from the advice issued by DEFRA (for example in the Guidance for Growers of Crops and Grass - which is dealing with access to farmland by persons not necessarily involved in livestock handling - see ACD/FMD 1, DEFRA 22^nd June2001) that access to our farms by visitors and members of the public who are able to walk unsupervised from farm to farm through fields overstocked with separate flocks and herds of susceptible grazing animals must significantly increase the risk of the spread of FMD. The Governments and Devon County Councils wish to open the countryside and our need to bring visitors onto our farms is incompatible with the precautions advised to prevent spread of FMD. The solution to this problem is to ensure that our stock is not susceptible to FMD. Consequently, I ask permission to vaccinate my stock and I request permission likewise for others in the same position as myself.

In making this request, I take note that the Minister has the power, under Section 16 of the Animal Health Act 1981 to cause to be treated with serum or vaccine, or both, any animal which has been in contact with a diseased animal or which appears to have been in any way exposed to infection or is in an infected area (we are in an Infected Area); and that the reproduction factor for this outbreak, having previously fallen, has recently risen towards 1.

Before making this request, I have read and understood the submission for permission to use vaccination by Dr Ruth Watkins and to support my application I have attached a note which she has compiled on the properties and efficacy of the vaccine (see enclosure A). Dr Watkins has used her knowledge as a clinical virologist to assemble information from a number of sources expert in FMD, such as Professor Fred Brown, Dr Paul Kitching, Dr Simon Barteling, Dr Paul Sutmoller, Dr Noel Mowat and Dr Gareth Davies. I note that discussion with Dr John Beale has confirmed her conviction that vaccination is the logical and effective way to control this outbreak of FMD and eradicate the virus from our country again.

I understand that the FMD vaccine is available commercially from Merial (Merial supply the antigen to Pirbright to manufacture their high potency vaccine) and is licensed for use in the UK: that it appears to be a highly efficacious vaccine and that there appears to be no veterinary reason to slaughter vaccinated animals.

Notes on the local circumstances are summarised in enclosure B. I have nine years experience of livestock farming and have vaccinated my flock against clostridial diseases. Vaccination and the administering of injectables is a technique familiar to me and to all livestock farmers. I and my neighbouring farmers would be able to assist our vets in administering vaccination and in marking, tagging and numbering all vaccinated sheep. My own sheep and lambs are all tagged and individually numbered, as are my cattle.

In the absence of any formal way to make my application to use the FMD vaccine, I trust you will find it acceptable to consider my letter and the enclosures sent with it. I look forward to your considered reply.

Yours sincerely ,

Lawrence Wright MA (Cantab), MA Hons (UCL), Dip TP.

Copy sent to Dr David Byrne, European Commissioner for Health and Consumer Protection.

Enclosed:

A: information supplied by Dr Ruth Watkins about the Foot and Mouth vaccine licensed for use in the UK

B: notes on the local circumstances in North Devon.

Enclosure A: The FMD Vaccine

FMD serotype-O vaccine

The current epidemic of FMD is caused by a serotype-O virus, subtype Pan Asia, that emerged from the Indian subcontinent in the early 1990s. This virus has spread out from its origin, across continents both east and west, replacing other circulating serotypes and strains of FMD virus. The epidemic virus in Britain was sequenced at an early stage in the epidemic and was shown to be very closely related to other presently circulating strains of the serotype-O Pan Asia virus in other parts of the world. The serotype-O vaccine, using a Manisa strain because the Pan Asia strain has not yet been adapted for vaccine production, is so similar to the Pan Asia strain that it is expected to give rise to a protective immune response. Indeed this was proven to be so in Holland 2001. Vaccination was highly effective there; no further FMD outbreaks occurred 5 days after ring vaccination was completed around the identified cases, infected farms. It is necessary only to use vaccine containing the single serotype, that of the epidemic virus.

The serotypes of FMD are stable (quite unlike influenza virus for example). The serotype O vaccine in use has been shown to protect against all field isolates of the Pan Asia subtype to date.

Safety

The killed (inactivated) vaccine for FMD has been used since the 1950s. Billions of animals have been vaccinated and humans have consumed these animals and drunk their milk with no adverse effect. Humans continue to consume the products of these animals all over the world wherever the vaccine is used. The modern vaccine is safer to use than that manufactured in the 1980s because the inactivation step is quicker and more complete than that used for the first 30 years the vaccine was made. Binary-ethylene-imine (BEI) is used now to inactivate FMD virus in vaccine manufacture in preference to formaldehyde. This, together with modern quality control guarantees that the vaccine does not contain live (infectious) virus. The FMD vaccine is licensed for use in the UK providing the relevant authorities in the UK and Europe allow it to be given. Permission has already been obtained from the EU for Cumbria and Devon.

A vaccinated animal is not infected with FMD virus by vaccination. There is no veterinary reason to slaughter out vaccinated animals.

Efficacy

The killed FMD vaccine is efficacious. If oil-based vaccine is used virtually 100% of domestic animals respond, this applies to pigs, sheep, goats and cattle. The vaccine protects against disease. An animal responds to vaccine by making antibodies, some of which are neutralising antibodies to the coat proteins of the serotype in the vaccine and these are protective. Vaccination, in the case of FMD, is the inoculation of the animal with viral protein to elicit a protective immune response.

You may say a vaccinated animal can be infected if exposed to a very large dose of virus, such as shed from pigs with acute FMD lesions. This could happen with any vaccine that is used, in animals and humans, yet vaccines have had spectacular success in controlling and eradicating virus infections such as smallpox, measles, hepatitis B, and polio for example in humans, and rinderpest in animals. The infection in this case is modified by the possession of prior immunity and disease is prevented. Also in these cases the titre of virus shed is low and the virus is coated in neutralising antibody and thus not able to infect another animal, whether vaccinated or not.

The vaccinated animal, subsequently exposed to and infected by a large dose of virus, may not clear the infection within three weeks but become persistently infected, remain a carrier. This has been shown to occur in the case of vaccinated cattle but has not been shown to be the case in sheep as yet. FMD research has demonstrated that generalisations cannot be safely made for different serotypes or subtypes of virus between different species of animal. Virus is shed from the upper respiratory tract and mouth from a persistently infected animal. Unlike the acute infection, virus is not present in the blood, nor in other parts of the body such as muscle, nor in secretions such as milk. However the period of persistent infection in vaccinated cattle is shorter overall when compared to naturally infected carrier cattle. Carrier animals, and specifically cattle, that have arisen due to infection subsequent to successful vaccination, have never been shown to be the source of infection for another animal, whether that other animal has been vaccinated or not. There is some historical evidence linking natural carriers to a small number of outbreaks in unvaccinated animals (the rare occurrence that is quoted as a one in a million chance). There is no historical evidence to link vaccinated carrier animals, infected subsequent to vaccination, with the occurrence of any outbreak in unvaccinated animals. Under experimental conditions neither vaccinated nor unvaccinated (natural) carriers can be proven to spread infection.

The FMD vaccine has been and is currently used to control epidemics of FMD infection and to eradicate the virus both from populations of animals and from countries (the most recent example is Holland where pigs, sheep, goats, and cattle were vaccinated). Vaccination in Europe allowed FMD-free status to be regained in 1991. The FMD virus used to cause 100,000s outbreaks annually in Europe. Latterly slaughter was used as an adjunct to vaccination when outbreaks were localised in the 1970s and 1980s. These were epidemics arising from the reintroduction of virus. In a few instances this was caused by the administration of improperly inactivated vaccine with formaldehyde, or by poor quality control allowing subsequent contamination of vaccine with live virus, or escape of virus from laboratories. The current production of FMD vaccine provides a safe product.

Use

The vaccine is normally given in two doses about one month apart to induce a good level of protective antibody. A booster may be required 6 months later in order to sustain a good level of antibody for at least one year. There are vaccines that can give protection after one dose because they contain a high payload of inactivated virus, viral antigen, and these are held in stock by Pirbright. There are two formulations licensed in the UK, each with different adjuvants to suit either pigs or cattle, goats and sheep. The inoculation is made intramuscularly in the case of oil based vaccines (~100% of vaccinees respond to oil based vaccines). Other types of adjuvant vaccine can be given subcutaneously as well.

The vaccine can be used on young animals, from the first week of life. Both vaccines are effective if there are no maternal antibodies passed to the offspring. If the mother has antibodies then the oil-based vaccine is preferable, as it is most likely to stimulate the immune system in the presence of low levels of antibodies (maternal antibodies last a few months only before they disappear completely). The special vaccine product from Pirbright, the high potency formulation, can induce a good level of protective antibody after one dose. This is useful when required in emergency for the quickest possible protection. The commercially available vaccine can be used as part of a measured response to control or eradicate FMD infection. The latter is the substance of my application for the hill flock in the Brecon Beacons National Park.

Vaccine non-responders are very infrequent to oil based vaccine. A 90% response rate to vaccination in a population of animals would be more than sufficient to ensure that further spread of virus is prevented. It has been estimated that the number of immune animals need be only 70-80% in order for the virus to die out, in other words to fail to find any receptive animal to cause an acute infection. Acute infections cease where there is high herd immunity. The epidemic is halted.

Dr RPF Watkins 20/6/2001

Enclosure B

Vaccination of sheep, goats, cattle and pig at Middle Campscott Farm in Devon.

Middle Campscott Farm is a small farm of about 17 hectares. (In February, we had agreed to buy a further 16 hectares but the transaction has been delayed as a result of side effects of foot and mouth disease). It is within the North Devon Area of Outstanding Natural Beauty and Coastal Heritage Area above the village of Lee, between Ilfracombe and Mortehoe. Apart from a small area of steep woodland, the farm consists of permanent pasture: and all our enterprises are based on our own livestock. We have a flock of milking sheep, a flock of coloured Shetland sheep ( normally, all told about 130 sheep), five dairy goats, a small herd of polled Devon cattle (registered with the Devon Cattle Breeders Association), normally about 15 beasts including followers, and a pet Oxford Sandy and Black sow. All our farm animals are unusual and would be very difficult to replace by reason of their rarity and the requirements of organic licencing. In particular, our sheep are the product of nine years breeding; in the case of the milking sheep, we have included British Friesland, Poll Dorset and Shetland strains to develop a flock which is suited to milk production under organic management in our local conditions. In the case of our Shetlands, we have bred to produce a variety of natural colours in the wool.

Our business depends on adding value to our farm products and processing our produce for retail sale and we have been developing it for nine years. We are licenced by the Soil Association (UK5) as Organic producers and processors; and are one of very few producers of organic ewes milk in the UK (we were aware of only about three others before the outbreak of FMD). We use our own production of milk exclusively to make one of the few organic ewes milk cheeses in the UK. We also produce organic goats cheese and organically farmed wool, processed to be sold as naturally coloured knitting wool and woven blankets under organic licence. Our cheeses are distinctive and well received; having had success in the British Cheese Awards, the World Cheese Awards and the Organic Food Awards. We are members of the Specialist Cheesemakers Association and the Exmoor Producers Association.

All our products are unusual and contribute to the variety of local produce. In normal circumstances we sell as much as possible locally, from our own farm gate and through the traditional pannier markets in Barnstaple and Bideford. We also sell our products from local farmers markets and local Agricultural Shows (North Devon Show, Dunster Show, etc.) We are at the same time, farmers and part of the rural attraction of North Devon, producing some of the speciality foods and craft products which make North Devon an interesting and enjoyable place for residents and visitors. In particular our cheeses have achieved success in the British Cheese Awards and the Organic Food Awards and you may have heard them praised in a recent BBC Radio 4 'Food Programme'. We depend on and contribute to the rural economy here, including the tourist industry.

In normal circumstances we welcome visitors onto our farm: for their enjoyment and recreation and to buy products from us. We normally have a sign on the farm gate inviting people to visit, we have two public rights of way which cross our land and we are participating in the Country Stewardship scheme, restoring traditional features of the landscape and providing educational access and a permissive right of way.

The policy for the eradication of foot and mouth disease by culling presents us with irreconcilable difficulties. On the one hand, we are obliged to exercise the most rigorous biosecurity and exclude visitors and external contacts from our farm; on the other, we need to open the farm in order to earn our income - and survive.

Since the announcement of the first cases of foot and mouth disease, we have implemented the tightest biosecurity on our farm. If our animals were to be killed as a result of contracting FMD the effect on our business (not to mention our chosen lifestyle) would be catastrophic. We would be out of production for at least two years and would probably not recover. Thus, because I deal with the animals, milking the sheep daily, I have hardly left the farm since the first cases of the disease were reported; and no visitors have been allowed near our animals. We have ceased attending the local markets and the local Agricultural Shows have been cancelled. We have noted that the Government Chief Vet continues to reiterate his exhortation to farmers not to relax their biosecurity measures - particularly in light of the recent, new and virulent outbreaks here in North Devon/Somerset and in the Brecon Beacons. Our conduct in this context is also important because if we became a contiguous farm to an outbreak on any of the five livestock farms neighbouring ours, our defence against the culling of our animals would be in the standard of biosecurity we have maintained.

The effect on our income has been devastating. Our income for the quarter up to the end of May this year was 25% of that for the equivalent period last year. We cannot remedy our situation while we are obliged to keep our animals susceptible to FMD and threatened by the culling policy. We are forced to keep our farm closed or risk losing it entirely.

We wish to vaccinate our animals, rendering them no longer susceptible to FMD, in order that we can open again for business and for the enjoyment of our customers, friends and neighbours.

In this matter, we share a common interest with the whole local community in this part of North Devon. The driving force behind the local economy is tourism. Those businesses which are not directly involved in tourism are employed by those which are; in a complex network of interdependence. Almost all our farming neighbours are to some extent participants in the tourist industry. One near neighbour has a large, well established camping and caravan site. Another, a Caravan Club certified location; another normally gives very impressive and skilled sheepdog handling demonstrations; another has holiday cottages, bed and breakfast guests and serves cream teas. All are confronted with the same dilemma and all are suffering as a result of the need to protect susceptible livestock.

Even the non farming businesses are threatened by the situation. Our tiny village of Lee boasts two teashops, a craft shop and public house and shop. All are aware that if one farm were to succumb, the resultant scenes of slaughter would drive all holidaymakers away, probably for ever; and the resultant closures would destroy us all. A cluster of cases like that at Clayhanger would probably close Ilfracombe and Woolacombe too.

Devon County Council, coerced by the Government, are confronted by the same dilemma. They seem, however, to be casting prudence aside by proposing to open local public rights of way. This action will undermine all our protective measures. We, and all other local farms are currently carrying more stock than usual, as a result of the movement restrictions: so more fields have higher densities of stock than normal. Most local footpaths run through these fields overcrowded with susceptible animals and users of the paths will cross from farm to farm and flock to herd to flock. Common sense and DEFRA advice indicates that it is a recipe for disaster. The effectiveness of the biosecurity measures available to us in practice is very questionable: it is for this reason that I have avoided outside contact as far as I am able. It is unlikely that a casual walker will be aware of what may and may not represent dangerous contact with animals.

DEFRA advises for all farms, all areas that:

in order to safeguard all types of farming operations and to ensure movements can be traced, should this become necessary as a result of subsequent developments, all farmers are advised to observe the following basic precautions:

it is imperative that you only allow access to your farm with prior permission. It is strongly recommended that visits are arranged in advance by telephone, fax or e-mail and that you advise any contractors or suppliers accordingly;

keep the number of visitors to the farm to the minimum necessary to do the job. Do not let children to come on the farm unless absolutely necessary;

keep any visitors away from fields where susceptible livestock have been, are or will be;

if people or machinery coming on to your farm (particularly contractors) are visiting more than one farm in a day, it is in your interest to ensure that they leave visits to holdings with susceptible livestock until last and that you are aware of other visits they may have made;

diaries should be kept recording details of all visitors, where possible noting the time of visit, which fields were entered, the route taken to the farm and the fields and operations carried out. The proximity to susceptible livestock should be noted. Anyone who visits different farm premises during the course of their work should be encouraged to keep similar records;

None of these common sense precautions can be applied to the unregulated, unobserved and unrecorded users of footpaths. We are informed that no outbreak has ever been recorded as being caused by a walker: but since the passage of walkers is generally unobserved and unrecorded and their past and future movements are likewise unrecorded and untraced it is practically impossible that an outbreak could ever be thus linked. It is, however patently apparent that the user of a footpath which crosses farm boundaries and passes through different flocks and herds in succession, will carry fresh dung and possibly other means of transmission of disease from one group of susceptible animals to another.

I note that the infecting Pan Asia strain of virus is 'adapted to sheep' in comparison with other strains and serotypes of FMD virus. It frequently causes asymptomatic infection and therefore spreads silently in sheep flocks as an acute infection. Also this strain is shed in lower titre than other virus strains and serotypes so that aerosol infection over any distance has not occurred in this epidemic, certainly not in the case of sheep which anyway shed lower titres of virus in acute infection than cattle or pigs. Thus the most important routes of spread have been direct and indirect contact between acutely infected animals particularly between sheep.

The virus has spread widely amongst sheep, and there is evidence that it can exist undetected even by regular veterinary inspection as at Clapperdown Farm, Bondleigh, North Tawton - and that it has spread outside the immediate areas where outbreaks have been published: as occurred at Clayhanger.

With the opening of footpaths the flocks and herds in this part of Coastal North Devon will become interlinked and any FMD infection, existing or introduced, is likely to be spread throughout the area. The only safe solution is to vaccinate the animals and thus render them no longer susceptible.

In summary: I would like to vaccinate the animals on my farm, in order that I can safeguard against the effects of the opening of the local footpaths, reopen my farm to visitors (including tourists) and re-commence trading and playing my part in the local community. I would like permission for my neighbours to do likewise.

Lawrence Wright. 5/7/2001