HEADLINE SUMMARY OF CONSULTATION RESPONSES ON LEGISLATION TRANSPOSING THE FOOT AND MOUTH DISEASE DIRECTIVE
The key pieces of draft legislation transposing the FMD Directive were published for a full twelve week public consultation from 9 June to 1 September 2005. We received 35 external responses of which none raised fundamental objections to the legislation as a whole. They generally raised a series of detailed issues with the legislation or relating to its practical implementation. These are highlighted below. For further detail, please see the detailed summary at Annex A.
Responses and Outcomes
· There was widespread support for our intention to include measures from existing legislation that proved useful in dealing with the 2001 outbreak;
· Some questioned the need to amend the Secretary of State’s discretion to slaughter susceptible animals kept on infected premises only to a duty. However, this is a requirement of the Directive and does not change UK policy;
· Most supported proposals not to impose additional controls on the domestic trade of vaccinated animals. There was widespread support for a vaccination strategy and Defra is working with retailers and consumers representatives to avoid any discrimination against products from vaccinated animals during an outbreak;
· Most supported a similar approach to cleansing and disinfection to that used in 2001. Defra will ensure that the legislation enables a local, flexible approach. Who meets the costs of cleansing and disinfection will be addressed separately;
· Most agreed with the approach to common land used in 2001. Defra will create flexible powers to gather animals on such land and apply controls that are necessary and appropriate to local circumstances;
· There were concerns that economic losses may arise from treatments required for animal products for those caught in disease-affected areas or where their animals were vaccinated. Defra aims to strike a balance between effective disease control and enabling the industry to function and will seek EC agreement to remove these treatments after the early stages of an outbreak;
· Concerns were also raised on the effective operation of the dairy industry under the new licensing requirements. Defra has agreed with the EC to remove the ban on milk hygiene testing and will ensure that licensing is carried out effectively;
· Some asked that Polymerase Chain Reaction (PCR) testing be used to diagnose FMD, rather than clinical examination. At present, the standard of PCR tests is not as stringent as required. Should they reach this standard, the legislation would allow us to use them;
· There was a request that camelids should not be classed as FMD susceptible animals. Defra is unable to do so due to the requirements of the Directive. However, should the Directive change, we will amend the legislation accordingly;
· The meat treatment requirements were criticised for being overly complicated and we have attempted to simplify them where possible and produce clear guidance;
· It was felt that the role of local authorities was not clear enough and we have changed the legislation to bring out their important role.
DETAILED SUMMARY OF CONSULTATION RESPONSES ON LEGISLATION TRANSPOSING THE FOOT AND MOUTH DISEASE DIRECTIVE
1. The EU Foot and Mouth Disease (FMD) Directive sets out the measures to be adopted in the event of a suspected or confirmed outbreak of FMD within the EU. It replaces the previous EU measures to control and eradicate FMD, taking account of recent scientific developments and the experience gained in eradicating FMD during the 2001 outbreak.
2. In particular, the Directive moves emergency vaccination to the forefront of FMD control strategies, alongside the basic policy of slaughter of susceptible animals on infected premises and those identified as dangerous contacts.
3. The draft legislation transposing the Directive was published for a full twelve week public consultation from 9 June to 1 September 2005. A further draft amendment to the Animal Health Act was published on 25 August. The deadline for commenting on this piece of legislation was extended to 15 September due to the short length of the document (3 pages) and the fact that its effect had been spelt out in the consultation letter.
4. Defra will transpose the Directive fully, so fulfilling the UK’s obligations under European law. However, the consultation set out the limited areas where we have national discretion and asked for views on how we should implement them. The consultation also sought economic data on the costs of the control measures to inform our Regulatory Impact Assessment (RIA), which we have revised as a result and will publish shortly, and on the impact of the controls, particularly regarding treatments of animal products from vaccinated animals or those in disease affected areas.
5. During the consultation period, we also held a series of meetings with a wide variety of stakeholder groups including representatives of the farming industry, the veterinary profession, meat and milk processors, retailers, consumers and other interested groups. This summary also reflects relevant issues raised in those meetings, full notes of which are available online at www.defra.gov.uk/footandmouth/disease/strategies/minutes.htm.
6. We received 35 external responses to the consultation. No respondent raised fundamental objections to the legislation as a whole but generally a series of detailed issues where either we do have national discretion or relating to the practical implementation of the legislation. Many of these points have been very useful in developing robust and practical legislation. We aim to set out here those more significant issues raised and how Defra is taking account of them. A full list of respondents and where you can obtain the responses themselves is at the end of this summary.
Summary of responses and outcomes
Issue A: Measures retained from existing legislation to supplement the Directive where veterinary advice was that they were essential in controlling the 2001 outbreak.
Discussion: These measures include control of rodents, dogs and poultry, closure of land including footpaths, control of mobile sheep shearing, scanning and dipping and controls of gatherings of people and animals. This represented the recommended option 3 of the RIA and received broad support from respondents. Some respondents questioned why dogs in particular needed to be controlled, rather than other non-susceptible animals. One asked how rodents would be controlled. Others asked for details of how widespread footpath closures would be.
Outcome: Defra will retain all of these measures in the draft legislation. Their application will be proportionate to the risk of disease spread and will not necessarily be limited to matters with a rural focus. The controls on dogs relate to the fact that they are common on farms and often make contact with livestock so represent a significant risk of disease spread if they are allowed to run free in areas which have disease. The requirement to keep dogs under control only applies in Protection and Surveillance Zones which could simply be keeping them on a lead. Rodent control creates a particular disease risk if the inhospitable environment of an infected premises, subject to slaughter and cleansing and disinfection, causes rodents to move off those premises onto neighbouring farms. In such cases, rodents would be controlled humanely by professional contractors. Footpaths would only be closed in Protection Zones (PZs) which would be a minimum of 3km around an infected premises and only larger if necessary for disease control purposes. Furthermore, although local authorities would normally be responsible for closing footpaths in these areas, this can only be done with prior written consent from the Secretary of State.
Issue B: The amendment to the Animal Health Act 1981 to change the Secretary of State’s discretion to slaughter susceptible animals to a duty to slaughter such animals on infected premises, with certain exemptions.
Discussion: Some respondents questioned the need to change the discretion to slaughter to a duty, while a similar number supported the change as necessary to fight disease. One respondent had a particular concern that this duty would be imposed on premises that were epidemiologically linked to an infected premises without a need for further testing.
Outcome: Defra will seek to amend the 1981 Act as proposed to fulfil the legal requirement of the FMD Directive that all susceptible animals on infected premises must be slaughtered. However, the amendment will include exemptions, such as for infected premises that are laboratories, zoos, wildlife parks or similar institutions, and for rare breeds on infected premises and for separate production units (those which are sufficiently separate from the rest of the premises to pose no threat of disease spread). In these cases, we would retain the discretion to slaughter and would still do so except in exceptional veterinary circumstances where these animals did not pose a significant risk of disease spread. This amendment does not reflect any change in UK policy which has always been to slaughter all susceptible animals on infected premises to control disease. The duty to slaughter does not apply to premises where disease has not been confirmed (such as dangerous contacts, suspect or contiguous premises) where we would retain full discretion to cull, vaccinate or place under observation as is justified by the scientific and veterinary risk of disease spread. Although the duty may be applied to epidemiologically linked premises that had not been tested, this is also a requirement of the Directive and would similarly not impose a duty on any premises where our policy would not be to slaughter.
Issue C: Defra does not intend to impose additional controls on domestic trade in vaccinated animals once the UK is FMD free.
Discussion: Most respondents agreed that additional domestic controls were not necessary, over and above the ban on export of live vaccinated animals required by the Directive. In particular, those respondents who commented on this issue unanimously stressed the fact that products from vaccinated animals do not pose any risk to human health. Animals are already vaccinated against a number of diseases and then go into the human food chain with no consequences. Many respondents also emphasised the need for clear communication of this fact to the public to enable the success of a vaccination campaign. However, concerns were raised over the possibility of a two-tier market where vaccinated animals, which would need to be tagged to prevent live export, might command a lower price. One respondent felt that the UK’s international trade would suffer if vaccinated animals were not tracked domestically.
Outcome: Defra’s intention is to restore trading conditions to as close to normal as soon as possible following an outbreak, therefore we will not be introducing any domestic controls on the trade in vaccinated animals. These animals will be tracked through ear-tagging and marks in cattle passports so there should not be any detrimental effects on the UK’s long term international trading status of ‘FMD free without routine vaccination’. Defra also agrees strongly with the Food Standards Agency (FSA) which has repeatedly stated that there is no risk to human health from products from animals vaccinated against FMD. The treatments required for products from vaccinated animals and animals from disease affected areas are solely intended to prevent virus spread to susceptible animals. Defra is working with organisations at every point in the food chain to promote this message.
We are also engaging in continued dialogue with retailers and consumers’ representatives to prevent discrimination against products from vaccinated animals and therefore remove any justification for price differentials. In consultation meetings it was generally accepted that vaccination is a vital part of the options available in fighting an FMD outbreak. Its implications are now seen as practical ones regarding the treatments required rather than the acceptability of treated products to retailers and consumers. Much obviously depends on the scale of any future outbreak and the market reaction at that time. Defra has recently issued a statement in co-operation with consumer organisations supporting the use of vaccination as part of the FMD control strategy. Defra is also seeking to agree a similar statement with major retailers.
Issue D: Defra intends to repeat the cleansing & disinfection (C & D) requirements in place during the 2001 outbreak but sought views on how flexibly to do this.
Discussion: The majority of respondents supported this approach, with some proposing a flexible system to take into account local needs, such as listed farm buildings. Some respondents suggested that Defra should meet the cost of C & D during the next outbreak. One respondent felt that the disinfection regime was a waste of money. Others felt that the C & D regime used in 2001 was successful because there was no recrudescence of disease.
Outcome: Defra will ensure that the C & D requirements of the draft legislation are generally limited to the minimum requirements of the Directive and existing legislation and made as flexible as possible. We will create a power for local requirements to be added on a more flexible basis, through licence conditions and directions by local inspectors. This will allow local knowledge and circumstances to inform the approach taken. The draft legislation allows Defra either to pay the costs of C & D itself or to require the occupier to do so. In the wider context, Defra expects to publish its Farming Regulation and Charging Strategy which will set out the Government's intention to work in partnership with the farming industry in exploring risk sharing mechanisms in tackling animal disease, including future financing options and simplifications in the regulatory burdens on the farming industry.
Issue E: Defra also intends to retain the controls over common and unenclosed land used in 2001 but again sought views on this.
Discussion: The majority of respondents supported a similar approach to that taken in 2001. One area of concern was whether we would define commons as a single premises.
Outcome: As the Directive and existing legislation is largely silent on controls on common and unenclosed land, Defra will include in the draft legislation general powers for veterinary inspectors to gather animals on such land and apply any controls they deem necessary to limit the spread of disease in each zone of control. This would allow the response to be proportionate and suited to local circumstances in the unique situation of common and unenclosed land.
Issue F: Treatment of products from animals in Protection and Surveillance Zones and vaccinated animals.
Discussion: We asked specific questions on the likely cost implications, practical issues and level of demand for products from vaccinated animals that have to be subject to various treatments to reduce the risk of disease spread, such as heat treatment (cooking) or deboning and maturation. During subsequent discussions with the industry, we reached a consensus that these treatments are no more and no less than those required for animals in PZs and Surveillance Zones (SZs). Although the use of vaccination would be based largely on the veterinary and scientific circumstances of the outbreak, its success would depend on its acceptability to, and the preparedness of, the wider stakeholder community including the farming industry, processors, retailers and the general public as consumers. Some respondents expressed concern that treated meat would not be a commercially viable alternative to untreated, possibly imported, meat or other sources of protein. Others suggested that Defra should investigate deboning and maturing as a treatment for pig meat and the use of electrical stimulation in place of maturation. Some respondents questioned why derogations from treatment were not set out in the draft legislation.
Outcome: Defra has gathered some useful data on the costs associated with the treatments which has informed the development of the RIA. It is clear that many of these treatments may add significant costs to some sectors if they are caught in an outbreak or vaccinated. This is especially the case for pig meat from PZs and VZs which can only be cooked before marketing. The Directive does not recognise deboning and maturing as an effective method of destroying FMD virus in pigmeat, on the basis of veterinary advice. We will keep this issue, and electrical stimulation, under review with our veterinary advisors and if the European Commission decides to allow deboning and maturation of pig meat, we will amend the legislation accordingly.
This would not be so serious an issue for beef where the carcase is more suited to being deboned and matured. Some cuts of sheepmeat (eg leg and shoulder) can also be treated in this way. However, the effect on the industry as a whole, and therefore the market, will depend critically on such variables as the size, geographical spread, seasonality and the species affected in any future outbreak. New control measures, such as the six day movement standstill, decrease the likelihood that a future outbreak would be of the scale and spread of 2001 so these additional costs should be limited compared to the overall benefit of increased disease control that the treatments would give. Defra aims to strike a balance between effective disease control and enabling the industry to function and we will continue to work closely with the industry where possible to mitigate the impact of these treatments.
During an outbreak, Defra will also seek all available derogations from the European Commission from the treatments for all animal products. These derogations apply 30 days after the establishment of the latest PZ or SZ that applies and in Phase 3 of a Vaccination Zone (VZ). These derogations are not set out in the legislation as we cannot refer in law to a derogation which has not yet been granted. At the time these derogations are granted, we will amend the legislation accordingly to set out the precise terms of the decision.
Issue G: Practical operation of the dairy Industry.
Discussion: Milk testing is banned by the Directive other than at laboratories testing for FMD. The Dairy Industry responded that if compositional and hygiene testing cannot occur, the industry would not be able to operate effectively. The Industry also requested that the necessary authorisation required in disease affected areas for the transport of milk and premises treating milk be granted in advance of an outbreak and any route specified for milk tankers be as flexible as possible.
Outcome: Defra and the dairy industry have contacted the Commission which has now agreed to amend the Directive to allow milk testing under hygiene and quota rules. Defra will pre-emptively reflect this change in the draft legislation and will allow sampling and testing under conditions which prevent disease spread. Defra is not able to give authorisation for milk treatment and transport in PZs and SZs in advance of any outbreak as such authorisation must depend on the circumstances at the time and the risk of disease spread. However, Defra will continue to work closely with the dairy industry and the FSA to set out clearly the conditions expected of dairies and tankers and to carry out routine inspections so as to minimise the amount of time needed to give such authorisation. The route specified for milk tankers will be as flexible as possible depending on the discretion of a local veterinary inspector.
Issue H: Polymerase Chain Reaction (PCR) testing.
Discussion: Some respondents suggested that PCR testing should be mandatory in confirming disease rather than relying on clinical grounds alone.
Outcome: The FMD Directive requires that diagnostic tests and standards must be at least as stringent as those in the OIE manual. The Directive also allows the EU Commission to adopt more stringent tests and standards than those in the OIE manual. This has not been done but, if it was, the Commission tests would become the new benchmark and replace the OIE standard. Tests not in the OIE manual or adopted Community standard are explicitly allowed, but only if they are shown to match or exceed the sensitivity and specificity standards in the manual or Community standards, whichever is the most stringent. Defra is working with its veterinary advisors to study the efficacy of PCR testing and should it be concluded that it meets these standards we could use it under the new legislation. However, the Directive also permits us to confirm disease by a link to an existing outbreak on clinical grounds alone, in order to fully control disease in a fast-moving situation.
Issue I: Whether camelids (eg llamas and alpacas) are susceptible species.
Discussion: There was a request that camelids be excluded from the definition of FMD susceptible animals and not subject to the controls imposed on such animals, including the new duty of compulsory slaughter on infected premises.
Outcome: Camelids are clearly stated to be susceptible animals in the Directive on the precautionary basis that the available evidence does not conclusively prove that camelids are not capable of passing on FMD. Therefore the UK is legally obliged to define camelids as susceptible species. Should the Commission change this position in the Directive, Defra will amend the legislation accordingly.
Issue J: Complexity of treatment requirements.
Discussion: One respondent felt that the transposition of the requirement to treat meat was overly complex and did not accurately reflect the requirements of the Directive.
Outcome: Defra accepts many of these comments in what is a particularly complex area of the Directive. Defra has reviewed these provisions and will re-draft them on the basis of these comments to make them fully reflective of the Directive and easier to follow. Such treatments will also be described clearly in accompanying guidance for the industry.
Issue K: Role of local authorities in a disease outbreak.
Discussion: Some respondents felt that the role of local authorities, and in particular trading standards officers, should be reflected in the legislation through explicit duties to ensure consistent application across the country.
Outcome: Defra accepts these comments and welcomes the important role of local authorities in a disease outbreak. We will amend the legislation to place a duty on local authorities to carry out certain functions, such as signage around zones, and also expand areas which are currently reserved to Defra officials to include local authority officers as well, to ensure a consistent approach and maximum flexibility.
List of respondents
- Animal Health Resources Ltd
- British & Irish Association of Zoos and Aquariums
- British Cattle Veterinary Association
- British Meat Processors Association
- British Retail Consortium
- British Veterinary Association
- Captain Bryn Wayt
- Central Association of Agricultural Valuers
- Colchester Zoo
- Compassion in World Farming
- Country Land and Business Association
- Dairy UK
- Devon County Council
- East of England Trading Standards Association
- Elm Farm Research Centre
- Kennel Club
- Lake District National Park Authority
- Local Authorities Coordinators of Regulatory Services
- Meat and Livestock Commission
- Mrs J H Wilson
- Mrs Suzanne Greenhill
- Ms Pat Innocent
- National Farmers Union
- National Foot and Mouth Group
- National Milk Laboratories
- National Pig Association
- National Sheep Association
- National Trust
- Outdoors Industries Association
- Rare Breeds Survival Trust
- Royal Society for the Prevention of Cruelty to Animals
- Society for General Microbiology
- Specialist Cheesemakers Association
Copies of the responses are available from Defra’s Information Resource Centre at Ergon House, Horseferry Road, London, SW1P 2AL