DEFRA's Q and A on its current foot and mouth policy (and dithering on vaccination)

FMD DIRECTIVE

Q1. Why is there a new Directive?

A. This Directive replaces the previous EU measures, taking account of

the most recent scientific developments in the field of disease control; the

experience gained in eradicating FMD during the 2001 outbreak; and

technical developments in laboratory diagnosis of FMD and vaccines.

Q2. Are we prepared for an outbreak?

A. Existing legislation would allow us to control the disease substantially

in accordance with the Directive. We have drafted legislation covering

vaccination (which is the main area were we lack some provisions in the

current legislation) and this could be brought into force immediately at the

start of an outbreak. However, we wish to ensure that stakeholders are given

a chance to comment on our plans and that the implications are fully and

maturely considered well before any outbreak.

Q3. Is the Animal Health Act itself being amended?

There is one small technical amendment which does not change the

Government's stated policy. The Animal Health Act 1981 enables the

Secretary of State to cause slaughter, but the Directive requires slaughter in

certain circumstances.

Q4. Why is Defra imposing a duty on itself to slaughter animals?

The EU Directive requires all member states to introduce the duty to slaughter

susceptible animals on infected premises only. This ensures a common

approach to disease control across the European Union. The UK intends to

comply with this requirement by amending the existing Animal Health Act

1981 by changing the current discretion to slaughter to a duty on infected

premises only. This change will not make any practical difference as Defra's

policy is to slaughter all susceptible animals on infected premises to control

disease spread. There are various exemptions to this duty such as for rare

breeds, zoos, wildlife parks, laboratories and separate production units where

we might not slaughter such animals on infected premises in exceptional

veterinary circumstances where there is no risk of disease spread.

Q5. How does the Directive differ from what we did in 2001?

A. Greater prominence is given to the potential use of emergency

vaccination. The disease control framework provided by the Directive is

consistent with the policies outlined in the Government's Response to the

FMD Inquiries, and embodied in the published Contingency Plan.

Q6. Does this Directive change your policy on vaccination?

A. No. The Government's position on emergency vaccination was set out

in the Government Response to the FMD Inquiries in 2002: that animals on

infected premises and their dangerous contacts would be culled but that

emergency vaccination should now be considered as part of the control

strategy from the start of any outbreak of FMD. The greater prominence given

to the potential use of emergency vaccination in the Directive is consistent

with this settled policy.

Q7. Does this mean we will/will not vaccinate next time?

A. A decision to vaccinate in a future outbreak will depend on a range of

factors. The FMD Contingency Plan includes a Decision Tree which sets out

the factors that would be taken into account, including those listed in the EU

Directive. Veterinary and scientific advice, and modelling of the outbreak will

be key to any decision. The lessons from our recent detailed cost benefit

analysis of using vaccination would also help to inform the decision.

Q8. What is the Directive's policy on contiguous cull?

A. The EU Directive anticipates that such a policy may be pursued and

specifically provides for a 'preventive eradication programme'. However, the

use of such control measures is not automatic. Our policy is first and foremost

culling of animals within the infected Premise and their Dangerous contacts.

In addition, emergency vaccination would also be considered as part of the

control strategy from the start of any outbreak. This does not rule out the

possibility of a contiguous cull if circumstances and our modelling showed it to

be necessary.

Q9. Why is there no mention of a contiguous cull or preventive

eradication programme in the Order?

A. It is not necessary to refer specifically to a preventive eradication

programme in the Order, because the powers necessary to implement one

already exist in the Animal Health Act 1981.

Q10. Will rare breeds be exempt from slaughter?

A. This depends on the precise circumstances of an outbreak, but Article

15 of the Directive allows such animals to be exempted from compulsory

slaughter. This power is discretionary and conditional on all necessary

measures being in place to prevent any risk of spreading disease. We are

working closely with the Rare Breeds Survival Trust to draw up a database of

rare breed animals to qualify for that exemption in time for when the

legislation comes into force.

Q11. How will this Directive impact on the farming industry?

A. The requirements of the Directive generally only apply when FMD is

suspected or confirmed in the UK. The aim of the EU Directive is that the

disease is controlled and eradicated as quickly as possible to the benefit of

the farming industry and the whole rural economy. In order to meet that aim it

is necessary to have stricter biosecurity measures and movement restrictions

in place as well as other requirements, such as the treatment of vaccinated

meat, which may well impose a cost on livestock producers. We will work with

the industry during the consultation period to quantify these costs in a

Regulatory Impact Assessment. However, it is clear that the extent of these

costs will be far exceeded by the impact of a prolonged disease outbreak.

Q12. What are the Devolved Administrations doing on transposition?

A. The consultation period for England and Wales began on 9 June 2005,

ending on 1 September 2005. Scotland and Northern Ireland will similarly be

consulting soon afterwards. The legislation will then be finalised and

presented to the respective legislatures to allow us to fully transpose the

Directive in England, Scotland and Wales by December 2005, and in Northern

Ireland by January 2006.

Q & A ON SPECIFIC DETAILED ISSUES ONTHE DIRECTIVE

Q13. What is a Protection Zone?

A. A Protection Zone (PZ) is the geographical area immediately

surrounding a confirmed case of FMD. The strictest biosecurity measures

apply there. Every PZ would be centred on an infected premises and cover a

three kilometres minimum radius.

Q14. What movement controls are there in a Protection Zone?

A. Nobody is allowed to move any susceptible animal from premises in a

PZ. However, movement is permitted for transporting susceptible animals to

emergency slaughter under a licence granted from premises in a PZ direct to

a slaughterhouse. The slaughterhouse should be in the same PZ, but where

this is not possible, it may be outside.

These restrictions do not apply to movement within premises;

movement of pet animals which are not susceptible; movement of horses

under a licence; transport through the PZ along a railway, motorway or trunk

road or transport from outside the PZ for immediate slaughter within it under a

licence.

Q15. What are the restrictions on meat, milk and animal products from

a PZ?

A. Meat, milk and animal products produced in a PZ are required to be

treated as set out in Annex 7 of the Directive for animal products; Annex 8 for

meat; and Annex 9 for milk (these requirements are transposed in Schedule 4

of the FMD Order). The treatments include heat treatment, deboning and

maturing of meat and meat products and pasteurisation of milk. However, the

Directive provides an exemption from these treatments once the PZ has been

in place for more than 30 days, subject to specific conditions laid down by the

Standing Committee on the Food Chain and Animal Health (SCOFCAH).

Q16. When will the Protection Zone end?

A. The conditions for termination of a PZ are: at least 15 days have

elapsed since completion of any preliminary cleansing and disinfection

measures in that PZ; and a survey has been carried out of all susceptible

animals in that PZ with negative results, to ensure the absence of infection.

Full cleansing and disinfection does not need to be completed before lifting

the PZ, only the preliminary C&D. On termination of a PZ, the area within its

boundaries becomes part of the associated Surveillance Zone.

Q17. What is a Surveillance Zone?

A. A Surveillance Zone (SZ) is the geographical area immediately

surrounding a protection zone. Slightly less strict biosecurity measures apply

there. Every SZ would be centred on infected premises and cover a ten

kilometres minimum radius.

Q18. What movement controls are there in a Surveillance Zone?

A. Animals of susceptible species cannot be removed from holdings within

the SZ. However, livestock can be moved from premises in the SZ to an

abattoir for slaughter under a specific movement licence. Before movement, a

representative sample of the animals must have been clinically examined and

the rest should have been clinically inspected and certified free of suspicion of

FMD. The animals must be transported to and slaughtered in a

slaughterhouse within, or as close as possible to, the SZ.

Q19. What are the restrictions on meat, milk and animal products from

a Surveillance Zone?

A. Meat, milk and animal products produced in a SZ are required to be

treated as set out in Annex 7 of the Directive for animal products; Annex 8 for

meat; and Annex 9 for milk (these requirements are transposed in Schedule 4

of the FMD Order). The treatments include heat treatment, deboning and

maturing of meat and meat products and pasteurisation of milk. However, the

Directive provides an exemption from these treatments once the SZ has been

in place for more than 30 days, subject to specific conditions laid down by the

Standing Committee on the Food Chain and Animal Health (SCOFCAH).

Q20. When does the Surveillance Zone end?

A. The conditions for termination of an SZ are: at least 30 days have

elapsed since completion of any cleansing and disinfection measures within

the boundaries of that SZ; its associated Protection Zone has been

terminated; and a survey has been carried out of all susceptible animals in

that SZ with negative results, to ensure the absence of infection.

Q21. What is a Vaccination Zone?

A. A Vaccination Zone (VZ) is the geographical area within which a

programme of protective vaccination (vaccination to live) will take place.

Increased biosecurity requirements will apply there. If protective vaccination

(to live) takes place, a VZ will be declared around the site of vaccination. The

declaration will specify the boundaries of the VZ, and the boundaries of a

Vaccination Surveillance Zone surrounding it. The size of the geographical

zone in which vaccination is carried out would depend on

veterinary/epidemiological judgement and other considerations including the

virulence of the strain and seasonal farm management factors.

Q22. What is a Vaccination Surveillance Zone?

A. If protective vaccination were adopted, each VZ would be surrounded

by a Vaccination Surveillance Zone (VSZ) of at least 10km. In this area,

vaccination would be prohibited, intensified surveillance would be carried out

and movements of susceptible animals would be controlled. This would

ensure that the vaccination campaign in the VZ was working and that the

disease was not spreading further.

Q23. What are the three phases in a Vaccination Zone during a

Vaccination campaign?

A. There are three phases in a vaccination campaign.

PHASE 1: Measures applicable from the beginning of emergency

vaccination until at least 30 days after completion of vaccination

During this phase, vaccination is carried out, and the geographical area for

vaccination and the species to be vaccinated are identified. This phase lasts

until 30 days after completion of vaccination in the zone.

PHASE 2: Measures applicable during the period of emergency

vaccination until the survey and classification of holdings are

completed.

This phase starts after all vaccination has been carried out (plus 30 days

minimum as above), and is the phase during which holdings are tested and

surveyed to classify them as either (i) infected (ii) containing reactors (called a

depopulation holdings in the SI) or (iii) free of infection. It finishes once all

holdings are classified and any action taken to deal with reactors.

PHASE 3: Measures applicable after the completion of the survey and

the classification of holdings until FMD and infection free status is

recovered.

This phase is after completion of the survey to check for infected animals

amongst the vaccinated population. It lasts until FMD-free status has been

regained. This may be either regional, or for the UK as a whole, depending on

the circumstances.

Q24. Are there any movement controls on vaccinated animals?

A. PHASE 1: Movement of live animals of susceptible species is

prohibited between holdings and out of the vaccination zone, except under

licence and for slaughter.

PHASE 2: Movement of live animals of susceptible species is prohibited

between holdings and out of the vaccination zone except under licence and

for slaughter.

PHASE 3: Movement of live animals of susceptible species out of the

vaccination zone is prohibited, except under licence and for slaughter.

Movement of susceptible animals between holdings can be authorised.

Unvaccinated animals can move outside the vaccination zone.

Q25. How are vaccinated animals identified?

A. The person carrying out the vaccination will need to affix an eartag,

and apply an indelible mark to a vaccinated animal, and also make a written

record of the vaccination.

Q26. Are there any controls on the products from vaccinated animals?

A. Yes. The products from vaccinated animals have to be treated and the

treatments vary according to the phase of the vaccination campaign.

Q27. Why do products from vaccinated animals have to be treated

before being placed on the market?

A. This is done for animal health and disease control reasons ? to prevent

the virus accidentally being spread. There are no implications of

vaccination for human health.

Q28. What is the required treatment of milk from vaccinated animals?

A. During all three phases of a vaccination campaign, milk from

vaccinated animals has to be heat treated (pasteurised) at a dairy within the

vaccination zone or transported outside the vaccination zone for treatment,

subject to strict biosecurity rules e.g. on transport.

Q29. What is the required treatment for meat from vaccinated animals?

A. PHASE 1: all meat from vaccinated animals has to be heat treated

or deboned and matured before it is placed on the market.

PHASE 2: fresh meat from vaccinated pigs would still be subject to

heat treatment. Meat from vaccinated cattle and sheep would have to be

deboned and matured before being placed on the market,

PHASE 3: meat from vaccinated animals would have to be treated

as in Phase 2. However, during this Phase, untreated meat from vaccinated

cattle and sheep can be placed on the domestic market only. Untreated meat

from vaccinated pigs can be placed on the domestic market and can also be

exported to another Member State if requested by them.

Q30. Can we export any products from vaccinated animals to the EU?

A. Yes, provided products from vaccinated animals have been treated in

line with the above requirements, they can be exported to the EU. During

Phase 3, untreated meat from vaccinated pigs can be exported, to other

Member States, at their request. Such meat would have to bear a special

mark. Once FMD free status is regained, no treatment is required.

Q31. Can we export products from vaccinated animals to third

countries?

A. Provided products from vaccinated animals have been treated in line

with requirements, they can be exported to third countries. Once FMD free

status is regained, no treatment is required.

Q32. What about the export of live vaccinated animals?

A. Vaccinated live animals will not be eligible for export. They are,

however, permitted on the domestic market without restrictions

Q33. What is a Restricted Zone?

A. . The Restricted Zones (RZ) is intended to tighten biosecurity

measures to prevent disease spread following confirmation of disease. An RZ

may cover the whole of England and possibly the whole of Great Britain [or

United Kingdom?].

Q34. Are there any movement controls in a Restricted Zone?

A. The movement of a susceptible animal is not permitted from premises

within an RZ, or into or out of an RZ, except under a licence.

Q35. What is a Wild Animal Infected Area?

A. A Wild Animal Infected Area (WAIA) is the geographical area

surrounding an outbreak of FMD in wild animals. Extra biosecurity measures

apply there, but these are not as strict as those which apply when the

outbreak is in farmed animals. This is because of the obvious difficulty of

controlling the movements of wild animals or imposing biosecurity measures

on them

Q36. Are there any movement controls in a Wild Animal Infected Area?

A. The movement of any susceptible animal on or off a holding in a WAIA

is not permitted, except under a licence.

Q37. What is a Temporary Control Zone?

A. A Temporary Control Zone (TCZ) is the geographical area immediately

surrounding a premises with only a suspected case of FMD or premises which

may have had relevant contact with a suspected or confirmed case. Extra

biosecurity measures apply to premises within a TCZ. The Secretary of State

has discretion over whether or not to declare one.

Q38. Are there any movement controls in a Temporary Control Zone?

A. The movement of any susceptible animal into or out of a TCZ is not

permitted, except where the movement is through the zone by road or rail, or

necessary to complete a journey started before the creation of the zone.

Movement of susceptible animals from premises in a TCZ is prohibited except

from contact premises under licence or from infected premises where

(exceptionally) it is necessary to slaughter animals off the premises.

Q39. What is a Supplementary Movement Control Zone?

A. A Supplementary Movement Control Zone (SMCZ) is a geographical

area attached to a TCZ within which there are further movement controls (but

no other restrictions).

Q40. Are there any movement controls in a Supplementary Movement

Control Zone?

A. The movement of any susceptible animal into or out of a SMCZ is not

permitted, except where the movement is through the zone by road or rail, or

necessary to complete a journey started before the creation of the zone. It is

also possible to prohibit movement of non-susceptible animals, but only

during the first 72 hours of the zone.

Q41. Is it really necessary to have so many different types of zone,

areas and premises?

A. Yes. In order to fulfil our legal obligations and properly implement the

Directive it is necessary to use the same concepts, which have the benefit of

being common across the EU. The draft legislation contains no more and no

less in the way of zones, areas and premises than the Directive requires, but

it has been necessary to name some of the concepts where names do not

appear in the Directive, to improve clarity. The number of different zones and

the different levels of controls within them also reflect the complexity of a

disease situation, the need for controls to be proportionate depending on the

degree of risk in an area and the need to facilitate vaccination.