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The following extract contains information taken from the register of the above Title Number. A full copy of the register accompanies this document and you should read that in order to be sure that these brief details are complete. This extract shows information current on 22 JUN 2014 at 20:46:13 and does not take account of any application made after that time.
The following extract contains information taken from the register of the above Title Number. A full copy of the register accompanies this document and you should read that in order to be sure that these brief details are complete. This extract shows information current on 22 JUN 2014 at 20:46:13 and does not take account of any application made after that time.
The following extract contains information taken from the register of the above Title Number. A full copy of the register accompanies this document and you should read that in order to be sure that these brief details are complete. This extract shows information current on 22 JUN 2014 at 20:46:13 and does not take account of any application made after that time.
This title is dealt with by Land Registry, Weymouth Office.
The following extract contains information taken from the register of the above title number. A full copy of the register accompanies this document and you should read that in order to be sure that these brief details are complete. Neither this extract nor the full copy is an 'Official Copy' of the register. An official copy of the register is admissible in evidence in a court to the same extent as the original. A person is entitled to be indemnified by the registrar if he or she suffers loss by reason of a mistake in an official copy. This extract shows information current on 22 JUN 2014 at 20:46:13 and so does not take account of any application made after that time even if pending in the Land Registry when this extract was issued. REGISTER EXTRACT Title Number : IW79155 Address of Property : Land lying to the south of Main Road, Wellow, Yarmouth Price Stated : 40,000 Registered Owner(s) : WILLIAM SACKVILLE GWYNNE LAWRENCE and MICHELLE FLORENCE REINE LAWRENCE of Wellow House, Main Road, Wellow, Yarmouth PO41 0SZ. Lender(s) : None 1 of 3 This is a copy of the register of the title number set out immediately below, showing the entries in the register on 22 JUN 2014 at 20:46:13. This copy does not take account of any application made after that time even if still pending in the Land Registry when this copy was issued. This copy is not an 'Official Copy' of the register. An official copy of the register is admissible in evidence in a court to the same extent as the original. A person is entitled to be indemnified by the registrar if he or she suffers loss by reason of a mistake in an official copy. If you want to obtain an official copy, the Land Registry web site explains how to do this. A: Property Register This register describes the land and estate comprised in the title. ISLE OF WIGHT 1 (31.05.2013) The Freehold land shown edged with red on the plan of the above title filed at the Registry and being Land lying to the south of Main Road, Wellow, Yarmouth. 2 (07.01.2014) The Transfer dated 12 December 2013 referred to in the Charges Register contains a provision as therein mentioned. B: Proprietorship Register This register specifies the class of title and identifies the owner. It contains any entries that affect the right of disposal. Title absolute 1 (07.01.2014) PROPRIETOR: WILLIAM SACKVILLE GWYNNE LAWRENCE and MICHELLE FLORENCE REINE LAWRENCE of Wellow House, Main Road, Wellow, Yarmouth PO41 0SZ. 2 (07.01.2014) The price stated to have been paid on 12 December 2013 was 40,000. 3 (31.05.2013) RESTRICTION: No disposition by the proprietor of the registered estate (other than a charge) or by the proprietor of any registered charge prior to the expiration of 80 years from 3rd May 2013 is to be registered without a certificate of a conveyancer that the disposition is not made in breach of the provisions of the Schedule to a Transfer dated 3rd May 2013 and made between Ian Lister Kelly and Patricia Mary McCowen (1) and Neil Robert Payne and Michelle Payne(2) C: Charges Register This register contains any charges and other matters that affect the land. 1 (31.05.2013) The land is subject to the rights granted by a Deed of Grant dated 9 May 2002 made between (1) Ian Lister Kelly and Patricia Mary McGowen and (2) Southern Water Services Limited. The said Deed also contains restrictive covenants by the grantor. NOTE: Copy filed under IW78009. 2 (31.05.2013) A Transfer of the land in this title and other land dated 3 May 2013 made between (1) Ian Lister Kelly and Patricia Mary McCowen and (2) Neil Robert Payne and Michelle Payne contains restrictive covenants. NOTE:-Copy filed under IW78248. 3 (07.01.2014) A Transfer of the land in this title dated 12 December 2013 made between (1) Neil Robert Payne and Michelle Payne and (2) Title number IW79155 2 of 3 C: Charges Register continued William Sackville Gwynne Lawrence and Michelle Florence Reine Lawrence contains restrictive covenants. NOTE: Copy filed. 4 (07.01.2014) The land is subject to the rights reserved by the Transfer dated 12 December 2013 referred to above. End of register Title number IW79155 3 of 3 Preventing or controlling ill health from animal contact at visitor attractions Industry Code of Practice Version 1 published June 2012 CONTENTS Page INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Part 1: PRINCIPLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Chapter 1: What is risk? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Chapter 2: Guiding principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Part 2: PRACTICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Chapter 3: Planning and organising . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Chapter 4: Risk assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Part 3: SUPPORTING INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Chapter 5: The role of information in risk control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Chapter 6: Advice to teachers and others who organise visits for children . . . . . . . . . . . . . . . . . . . . . 45 Chapter 7: Incident reporting and investigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Chapter 8: Dealing with a major incident . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Chapter 9: The law and visitor safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 Appendix 1: Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Appendix 2: Sources of advice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 1 Every year millions of people visit premises where members of the public, particularly children, are encouraged to view or touch animals. The purpose of this Code of Practice is to help ensure visitor health and safety by providing sensible, practical and proportionate guidance on preventing or controlling ill health at visitor attractions. This Code of Practice has been produced by the industry and is aimed at the owners, operators and managers of such visitor premises. It provides guidance, including pictures and real-life case studies, of practical measures that you can apply at your premises to help you comply with the law and keep visitors safe. The examples are from businesses, ranging from conventional farms that open to the public for one day a year to attractions that may cater for hundreds of thousands of visitors each year. The code is modelled on Managing Visitor Safety in the Countryside, principles and practice published by the Visitor Safety in the Countryside Group (www.vscg.co.uk). Context INTRODUCTION The Health and Safety Executive was consulted in the production of this publication. It endorses the sensible, proportionate, reasonable and balanced advice to owners on managing visitor health and safety set out in the industry Code of Practice. Health and Safety Executive The Chartered Institute of Environmental Health supports the adoption and promotion of this Industry Code of Practice and believes that compliance with these standards will be the means to minimise risks to health from visitor contact with animals. The Chartered Institute of Environmental Health The Code of Practice is based on guidance from the Health and Safety Executive (HSE) Agriculture Information Sheet No 23(rev2) Preventing or controlling ill health from animal contact at visitor attractions (AIS23), which has been withdrawn. AIS23 was revised following the outbreak of Escherichia coli O157 at a visitor attraction in Surrey in 2009. The Health Protection Agency (HPA) set up an Independent Investigation Committee chaired by Professor Grifn the report of which, Review of the major outbreak of E. coli O157 in Surrey, 2009 was published in June 2010 and can be found at: http://www.grifninvestigation.org.uk/ The proposal to develop the Code of Practice to replace existing HSE guidance was discussed with Professor Grifn and the Advisory Committee on Dangerous Pathogens. The Code of Practice has been produced by the Access to Farms partnership which includes representatives of a number of organisations whose members encourage visitors, especially children, to visit their farm attraction, farm or other attraction to view, touch or pet animals. 2 Access to Farms members 3 Visits to these attractions have increased signicantly over recent years and every year millions of people go to these attractions. These visits play a valuable part in the education and development of children and young adults, and provide an enjoyable experience for many people. It is uncommon for members of the public to become ill as a result of such visits. However, there have been a relatively small number of cases of serious ill health involving members of the public resulting from exposure to micro-organisms such as E. coli O157 and Cryptosporidium carried by animals. As with most activities, visits to farms and farm attractions can never be considered free from risk. However, we believe it is possible to reduce the levels of risk and still provide a valuable and enjoyable recreational and educational experience. Premises covered by the Code of Practice These include: Farm attractions such as open farms and farm parks. Animal contact enclaves within other attractions, including those at zoos. City farms or other educational establishments. Working farms with livestock that occasionally open to the public, e.g. for school visits or to participate in Open Farm Sunday or similar events. Rare breed and rescue centres. Agricultural shows or country fairs where livestock are present. Travelling menageries or mobile petting enterprises. Other similar visitor attractions at which the public have contact with animals. Whilst the general principles covered in this document are equally applicable to zoos, specic guidance on managing zoonotic disease (disease passed from animals to humans) in zoos is contained in Managing zoonotic risk in zoos and wildlife parks. This can be found at: http://www.biaza.org.uk/uploads/Animal%20Management/zoonoticrisk.pdf This Code of Practice does not apply to the following destinations except where they may have an animal contact enclave: Moors and mountains Historic properties Forests Way marked trails Waterways Open countryside Visitor centres Nature reserves Footpaths Country parks Archaeological remains For these settings, guidance in the Managing Visitor Safety in the Countryside: Principles and Practice booklet is applicable. 4 There are several reasons for managing visitor safety: Moral: First and foremost we want our visitors to return home happy and satised with their experiences. We have a moral obligation to consider their health and safety and protect them from unnecessary or unreasonable risk. Legal: We have legal duties to ensure the safety of those we do not employ but who are affected by our workour visitors. These duties are explained in more detail in Chapter 9. Financial: We need to demonstrate that all reasonable and practicable steps have been taken to reduce the risks, thereby reducing unnecessary costs arising from implementing inappropriate or disproportionate health and safety measures. Reputation and authority: We cannot create an environment that is free from all risk. However, we must demonstrate to the public, regulators and government that we have done all that is reasonably practicable and within our powers to control or minimise the risks down to acceptable levels. If there is a zoonotic outbreak, we are then in a much better position to defend our position and retain public trust. Business: Attracting and satisfying visitors is fundamental to many of our businesses. Creating a healthy and safe environment is essential to attract visitors and therefore makes good business sense. Education: There is an educational benet from demonstrating how good practice results in healthy and safe visitor experiences, with potential transferable learning value to our visitors. This Code of Practice covers the building blocks of visitor risk management and aims to improve standards across the industry whilst promoting consistent enforcement by the regulators. The principles contained within the Code of Practice provide a framework to guide management decisions and ensure that the experiences of visitors are memorable for the right reasons. Subsequent chapters deal with specic areas of risk management. The headings will be familiar to readers with a background in occupational safety or knowledge of the HSEs Guide to Successful Health and Safety Management (HSG 65). The Code of Practice describes the measures that need to be taken to protect visitors. It does not address the health and safety of staff, including employees, volunteers and helpers. Nor is it aimed at premises that offer work experience where children come to carry out work activities. It is also not intended to address premises where agricultural or horticultural activities are undertaken by members of the public, such as allotments on city farms and similar premises. We still have a duty to comply with our legal obligations to protect these people and risk assessments for the activities they undertake will need to be carried out. 5 CHAPTER 1: WHAT IS RISK? Consideration of risk is important at several levels: Potential risk to society Reduction of educational and development opportunities. Many children and young adults derive great educational and developmental benet from visiting our sites, learning through experience. Potential risk to the individual: Personal illness or death Long term effects of illness Loss of employment, income, or educational opportunities Impoverished experience Increased costs Passing disease onto relations and friends. It is important to understand how people view and accept risks. People are likely to be less tolerant of risk when: They are exposed to the risk whether they want to be or not (involuntary exposure). They have no control over the outcome. There is uncertainty about what could happen and its likelihood of happening. They have no personal experience of the risks involved (fear of the unknown). It is difcult to imagine the level of exposure to risk. There is potential for a major catastrophe (even though the risk of it happening may be low, should it come about the consequences would be severe). The benets of taking the risks are not clear. They are exposed to the risks but others get the benets. The potential illness would result from human failure. It involves vulnerable groups including children. Some of these factors account for peoples common misconceptions when asked to rank the relative safety of road, rail and air travel. There is often a mismatch between an individuals perception of risk and that deduced from risk assessment. Part 1: PRINCIPLES 6 Potential risk to your organisation: Damage to reputation. Loss of income if visitors dont come because they perceive that the risk of harm is too great. Civil claims arising from visitor illness, leading to nancial loss. Prosecution and penalties for breaches of criminal law. Impact on the morale and esteem of employees. Adverse outcomes like these arise from either a failure to recognise and deal with a hazard or through making the wrong response. Our aim is to have the best of both worldsto introduce risk control measures that are sufcient to safeguard visitors, but do not lessen the attraction. What are the animal-related ill health risks at visitor attractions? All animals naturally carry a range of micro-organisms, some of which cause no illness in the animal but can be transmitted to humans. Diseases passed from animals to humans are known as zoonoses. Some zoonotic diseases may cause ill health; in some cases the diseases may be severe or life threatening. Equally, some are more amenable than others to treatment, and some may leave lasting ill health. A range of zoonotic diseases can be acquired from animal contact at visitor attractions including: Verocytotoxigenic Escherichia coli or VTEC of which E. coli O157 is one Cryptosporidium parvum Chlamydophilia abortus (formally called Chlamydia psittaci) Toxoplasmosis Salmonella spp. How do people become infected? People can become infected with micro-organisms through consuming contaminated food or drink, through direct contact with contaminated animals, by contact with an environment contaminated with animal faeces or by being bitten. Very low numbers of micro-organisms can cause human infection. How safe is a visit to an attraction? Given an estimated 10 million people visit such attractions each year, we consider the risk of infection to be low. A review by the Health Protection Agency, published in 2010, found that there were 55 outbreaks of gastrointestinal disease linked to petting farms between 1992 to 2009 in England and Wales. An HPA press release said: Although the overall risk of infection is low in light of the millions of farm visits each year, these outbreaksover a 17-year periodled to 1,328 people becoming infected, of whom 113 were hospitalised. Illness ranged from mild through to severe diarrhoea and occasionally more serious conditions. The majority of these outbreaks were caused by E. coli O157 (55 per cent) or Cryptosporidium (42 per cent). http://www.hpa.org.uk/NewsCentre/ NationalPressReleases/2010PressReleases/101215Handwashingkeytoreduceriskfromfarmvisits/ 7 We acknowledge that zoonotic disease can be very serious for those affected, particularly young children and the elderly. However, the risk needs to be seen in the context of an historically very low incidence of infection at visitor attractions where the public are encouraged to view or touch animals. Although the number of reported cases of zoonotic diseases varies from year to year, there is no evidence to suggest a substantive increase in the prevalence or incidence of infection in Britain. 8 CHAPTER 2: GUIDING PRINCIPLES This chapter sets out the principles that we use to guide us when deciding what actions to take to reduce the risk of zoonotic diseases to visitors. Subsequent chapters expand on these principles. AWARENESS Ensure that your visitors know the risks they face. Visitors should be aware of the risks they face and have the chance to decide whether or not to accept them. Inform and educate your visitor about the nature and extent of hazards, the risk control measures in place, and the precautions that they themselves should take. Risk can be controlled through information and education as well as physical measures. People on organised visits, e.g. school trips, can be made aware of hazards in advance through their organisers. Information can be included on the attractions website and on site maps/plans given to visitors on arrival. Signs and notices at entrances and around the site are also an important means of communicating information. RESPONSIBILITY It is reasonable to expect visitors to exercise some degree of personal responsibility. It is reasonable to expect visitors to follow simple instructions made known to them by staff or on leaets and signs - such as washing hands before eating, drinking or smoking and washing hands after leaving contact areas. Visitors should be expected not to touch or approach animals they may be allergic to, or where signs specically prohibit contact. It is reasonable to expect parents, guardians and leaders to supervise people in their care. Parental/carer responsibility should include, for example, supervising children when washing their hands and preventing young children sucking their ngers immediately after handling animals or their environment. RISK CONTROL Assess risks Every attraction should carry out a site risk assessment. A risk assessment would typically involve: identifying how the public could be exposed to micro-organisms; the likelihood of it happening; the possible consequences, and what measures need to be taken to reduce the risks to an acceptable level. The risk assessment would indicate the need to carry out further assessment after a specied interval, or when there is a change in the activities provided. It should be reviewed regularly to verify risk mitigation strategies are in place and are working. 9 Risk control measures should be consistent. Consistency is important within a particular site and between organisations. Note that consistency is not the same as uniformity. Monitor the behaviour and experiences of visitors to review visitor safety plans. Learn from experience of incidents and near misses. Add questions about accidents to visitor surveys. Have systems in place for accident reporting and investigation, and for letting others know what lessons you have learned. Monitor changes in the number and type of visitor to ensure risk controls remain valid. 10 CHAPTER 3: PLANNING AND ORGANISING This chapter introduces a framework for planning your approach to visitor safety, ensuring that it integrates with other management activities. We build on the general principles set down in recognised management systems. 1 Whilst some of this chapter may be familiar to those in occupational health and safety, it is intended to help the wider range of people involved in visitor safety management. Elements of an organisations Visitor Safety Plan Whatever the size of organisation and resources available, establish a policy for visitor safety and have a strategy for its implementation. Set clear objectives and have a good management plan to achieve them. Learning from experience is important. You should review the outcomes and, if necessary, make changes to improve things. Visitor safety management is no different to other management processes that demand a systematic approach, as shown in the diagram below. Part 2: PRACTICE Plan Do Check Act Review Policy and Planning Implementation and Operation Performance Monitoring Learn and Improve Refer to Guiding Principles 11 1. Plan Policy and strategy development Developing a policy for visitor safety management and promoting a strategy for its achievement will ensure effective use of your organisations resources as well as ensuring visitor safety. An effective policy will: Demonstrate the commitment of senior management to visitor safety. Integrate visitor safety management with other relevant organisational policies and management activities throughout the organisation. An effective strategy will: Clearly set out how your organisation is structured to deal with visitor safety issues. Show where you are now, where you want to be, and set out the steps to get there. Identify the resources, in money and staff time, necessary to achieve the objectives. Planning and organising Develop plans for visitor safety management at appropriate levels, depending on the size and structure of the organisation. The types of organisation involved with visitor attractions are varied, ranging from small farms that open to the public one day a year to large enterprises attracting 250,000+ visitors each year. It is reasonable to expect a large attraction to have a detailed safety plan. For a small farm open one day a year a risk assessment would sufce. 2. Do Implementation and operation How will you communicate relevant information to visitors? See Chapter 5 for further information on communication. Dene clear roles. State who is responsible for carrying out each task, producing overall visitor safety plans, undertaking individual risk assessments and acting on their ndings. Be clear who will audit the process and review progress. List the hazards that your visitors might encounter and assess the risk that they might be harmed. Risk assessment is central to visitor safety management and is covered in more detail in Chapter 4. Take care when using generic risk assessments or guidance. They may need adapting to take account of local circumstances. It is essential to use the knowledge of staff and users who are familiar with the site. 12 3. Check Performance monitoring Plan a programme of inspection and keep clear records of your risk assessments and actions. It helps to follow a written programme of priorities, keeping a record of what has been done and where and listing work planned for the future. You will then be able to demonstrate progress and ensure that the investigation and resolution of any outstanding issues is put into your work programme. Learn from incidents and near misses. Incident and accident data is a valuable indicator of risk and provides a measure of performance. Do not ignore near misses, encourage staff to report them and treat them as an opportunity to learn from something that did not quite happen, this time. 4. Act Learn and improve Learn from the information that you have gathered and act to make improvements. Incorporate mechanisms into routine work that allow feedback to be used to improve services and safety for visitors, or to explain why no changes are being made. 5. Review Review against guiding principles Review is a key part of a management process. Check at each stage that decisions are consistent with the guiding principles. You should measure progress against plans, identify problems and instigate any corrective actions that may be necessary. 1. References and further information Recognised Management Systems: BS 8800Guide to occupational health and safety management systems OHSAS 18001Health and safety HSG65Successful health and safety management (HSE) 13 CHAPTER 4: RISK ASSESSMENT This chapter sets out the steps necessary for successful risk assessment. This includes the information required, a suggested methodology and lists what should be recorded. We also look at the relative merits of different ways of controlling risks and the need to consider controls that reduce risk. Assessing risks to visitors There is no universally accepted format for carrying out risk assessments. The HSE recommends a ve-step approach for risk assessment in the work place. We have used this model as a basis for assessing risks facing visitors to our premises. 1. Identify the hazards. 2. Consider who might be harmed and how. 3. Evaluate the risks and decide whether the existing risk control measures are adequate or whether more should be done. 4. Record your ndings and implement them. 5. Review your assessment and update if necessary. Hazard is anything with the potential to cause harm. Risk is the likelihood, high or low, that somebody will be harmed by the hazard, the severity of the harm and the number of people who might be hurt. Risk control measures are precautions to make an incident less likely to occur and/or the results less severe. Further information on risk management can be found on the HSE website at: http://www.hse.gov.uk/risk/index.htm Step 1 Identify the hazards All animals naturally carry a range of micro-organisms, some of which can be transmitted to humans, in whom they may cause ill health, which in some cases may be severe or life threatening. VTEC (including E. coli O157) One organism that may be present is the verocytotoxin-producing bacterium E. coli O157. E. coli O157 can cause serious illness, especially in young children and the elderly in whom symptoms may include bloody diarrhoea and kidney failure. The illness may occasionally be fatal. 14 You should assume that your animals carry E. coli O157 even though they have no signs of this. Cattle, sheep and goats are the main recognised carriers of E. coli O157. The organism may occasionally be found in other animals, especially amongst the mixed species often present at visitor attractions. These include pigs, chickens, horses, donkeys, deer, llamas and alpacas. Farm dogs and wild rabbits can pick up the infection from an infected environment. Infection can also occur in birds such as wild geese. The organism is primarily transmitted through contact with animal faeces (dung). It may also be transmitted by contact with saliva derived from animal grooming activities. Cryptosporidium parvum Cr yptosporidium par vum is a microscopic parasite predominantly carried by calves, lambs, deer and goats that can cause severe diarrhoea in young children and the elderly. It is capable of surviving for a long time in the environment. Chlamydophilia abortus Visitors may also be exposed to Chlamydia abortus (formally called Chlamydia psittaci), the agent of enzootic abortion and ovine chlamydiosis in humans. This bacterium is carried by sheep and possibly goats. In humans, it may cause abortion or u-like illnesses. Other zoonoses that may be present at visitor attractions include: Salmonella spp. Orf Q fever Ringworm Campylobacter spp. Leptospirosis Toxoplasmosis Step 2 Consider who might be harmed and how People can become infected with micro-organisms by consuming contaminated food or drink, through direct contact with infected animals, by contact with an environment contaminated with animal products such as faeces, or by contact with saliva. Very low numbers of micro-organisms can cause human infection. Anyone can be infected, but children and the elderly are the most vulnerable. Young children are particularly at risk because they are most likely to put contaminated ngers or items in their mouths (including thumb sucking, nail biting and dummies/toys). Women who are, or may be pregnant, and people with weakened immune systems, are also at risk. Only small numbers of the organism are required to cause illness, so just because something (an animal or an object) is not visibly contaminated with faeces, this does not necessarily mean it is free from risk. 15 Infection can occur when people come into contact with animal faeces or saliva by: Touching or kissing animals in petting areas or during bottle-feeding. Feeding, stroking or touching animals through gates or pens. Touching gates, or animal pen divisions, or other structures contaminated with faeces. Picking up contaminated feed from the oor. Removing contaminated footwear or clothing. Eating, drinking and smoking with contaminated hands. Using contaminated play equipment. Touching personal items taken on to the premises that have become contaminated e.g. dropped toys or dummies and pushchair wheels. Being bitten. Step 3 Evaluate the risks and decide whether the existing precautions are adequate or whether more should be done The Code of Practice contains a number of case studies outlining how different types of visitor attraction have identied risks and come up with solutions to them. In some cases, the solutions have not only ensured control but lead to an increase in visitor numbers. The level of overall risk depends on a combination of factors: the likelihood of harm arising; the severity of the harm, and the number of people who might be affected. Sign advising women about possible health risks 16 When undertaking your assessment you should be aware that: All animals (including birds) carry micro-organisms such as E. coli O157 that could represent a hazard to human health. Animals carrying infection can still appear healthy. Ruminants (e.g. cattle, sheep and goats) carry E. coli O157. E. coli O157 is also found in a range of other animals and birds. Although tests are available to detect the presence of E. coli O157 and other micro-organisms, a negative test result does not guarantee the animal is free of infection. E. coli O157 may be introduced to your premises at any time by new stock, wild birds and animals, or by visitors. Young stock, stock under stress, pregnant stock or stock that are unfamiliar with people are more likely to excrete micro-organisms such as E. coli O157. Other animals on the premises, including pets, may acquire the bacterium through contact with faeces etc. Control measures Control measures are actions that need to be taken to prevent or reduce exposure to a substance hazardous to health, in this case micro-organisms. Such measures include the layout of the premises (including giving regard to topography); the cleaning of the premises; provision and use of washing facilities; supervision; information, and signage. A combination of control measures will be necessary to protect the health of visitors. To be effective, these measures should be practical, workable and sustainable. They should be reviewed on a regular basis. Controlling the risk In order to minimise and control the risk you should concentrate on the following: Establishing premises layout and routes, including areas to which visitors should not have access. Dening, segregating and clearly identifying animal contact areas. Dening, segregating and clearly identifying non-animal contact areas. Dening, segregating and clearly identifying eating and play areas. Providing adequate and suitable washing facilities. Providing visitor information and signage. Providing training and supervision of staff. Establishing livestock management procedures including management of bedding, sick/pregnant/stressed animals and veterinary input. Controlling manure/run-off and compost heaps. These are discussed in more detail in the following sections. The diagram below shows the risk pathway for micro-organisms such as E. coli O157 and demonstrates how the pathway can be broken by control measures. The risk pathway for micro-organisms Clean site & avoidance of faecal contact Effective handwashing/hygeine Denotes point where pathway can be broken Micro-organism e.g. E. coli O157 in faeces/saliva Contamination of environment Contamination of hands Ingestion of micro-organism Infection in some individuals Infected animal Contact prevented e.g. by double fencing X X X X 17 18 Premises layout and routes You should: Decide which areas you want visitors to have access to. Make sure routes around the premises prevent visitors from entering non-access areas, e.g. places where work is going on or where manure is stored. Consider how you will prevent entry to non-access areas. For example, providing suitable fencing and warning signs; Direct visitors to washing facilities as they leave any animal contact area, before they access eating and play areas and before leaving the premises. Avoid directing visitors across tracks or routes regularly used by stock and farm vehicles. If this is not possible, make sure visitors do not have to walk through any build up of faeces, liquid efuent, or soiled bedding material. For example, regularly clear or clean routes used by livestock or when cleaning out pens etc, and provide duckboards or similar so that visitors avoid contaminating their footwear. Keep the premises as clean as practicable and ensure areas to which visitors have access are free from any build-up of faeces. Clear sign on locked gate Well signed entrance to animal feeding area Take the following precautions if you intend to use elds that have been used for grazing or keeping stock for recreational activities e.g. picnicking, camping or play area. : Keep farm animals off the elds for at least three weeks prior to use. Remove any visible droppings, ideally at the beginning of the period. Mow the grass, keep it short and remove the clippings before the elds are used for recreation. Keep farm animals off elds during use. Always wash hands before eating, drinking and smoking. Ensure adequate supervision of children, particularly those aged under ve. 19 Animal contact You should: Decide on suitable contact areas where visitors will be able to pet or feed animals. Decide which animals are suitable for contact areas. Sick or injured animals should be excluded from contact with the public. Not allow the public to enter pens where animals are housed (this is because faeces or contaminated bedding will be underfoot and visitors may themselves carry infections on their footwear that could put your animals at risk). Do not allow visitors to enter pens where animals are housed Visitors can be allowed to enter pens or enclosures specically designed for the handling of animals, such as pens which lambs are brought into for feeding. These should be closely supervised and be near to washing facilities. Staff should remind visitors to wash their hands after animal contact e.g. feeding the lambs. The staff should also remove faecal contamination from the pen as soon as possible. Ensure adequate and suitable washing facilities are available and are used by visitors when leaving contact areas. Ensure fencing and other barriers are regularly inspected and properly maintained. Ensure that animal contact areas where visitors stand or walk are as free as possible from any faeces, and put in place measures to prevent contamination from liquid manure or surface run- off where necessary. Regularly clean and disinfect pen divisions and gates in animal contact areas where visitors are able to touch them. A variety of cleaning methods are available. Not all disinfectants are suitable so take advice from your vet. Dont allow faeces to remain on and contaminate walkways or other areas used by the visitors. Dont allow contaminated bedding or run-off material to contaminate walkways or other areas used by visitors. Solid boarding at the base of pens can be used to prevent spillage onto walkways. Retain all bedding and faecal material within the pens Ensure that eating (including sweets, gum and ice cream), drinking, putting contaminated items in mouths (including dummies, pens and pencils) are discouraged and smoking is prohibited in animal contact areas. Signs should be displayed instructing visitors of this requirement. Ensure an adequate number of trained staff for contact areas. Where eating and play areas are adjacent to areas containing animals, ensure that measures are provided to prevent members of the public touching the animals, e.g. by providing double fencing. This should be positioned at a distance that will prevent visitors reaching through to touch the animals and to prevent animals reaching over or through the fence to contact people. Do not allow run-off to contaminate walkways Example of double fencing, stock and electric fences used together Single fencing can be acceptable on farm trails Example of double fencing, high and low stock fences 20 In some non-contact areas, it will not be reasonably practicable to provide double fencing along enclosures where animals are kept. Examples include livestock farms that open occasionally, such as on Open Farm Sunday, or along a farm walk/trail through elds. In such cases, the areas should be clearly signed to inform visitors they are entering a non-contact area and touching, petting and feeding of animals is not allowed. Eating and play areas should be located within non-contact areas. Any decision to rely on single fencing and signage rather than double fencing must be justied in your risk assessment. Food is allowed to slide down the pipes into the pen for the pigs Food is placed in the trailer and by turning a handle the tractor and trailer back out and the food is tipped from the trailer for the cattle Problem 1 Animal paddocks were not double fenced and play areas and picnic benches were nearby. Solution I did not want double fence with stock fencing and rails because this made the animals seem too far away. So, we used high tensile wire with three strands and electried it far enough away from the main fence so no one could touch it or the animals. We also put standpipes in all the gateways so we can pressure wash the paddock sweeper to avoid contamination of walkways. Cost: Labour 1,500 Materials 2,195 Outcome The result is exactly what we wanted. The whole area is now a clean area for picnics and play. And we dont get any goats heads stuck in the fencing! Problem 2 Stopping contamination of walkways. Solution The solution was easy. We put sleepers along the bottom of the gates and in some places we have put sheep hurdles in front of the gates as well to create an area where no one walks. Cost: Sleepers 2.4mts 18.99 Sheep hurdles 21.00 each. Outcome We now have animal areas with no faecal material in the walkways. This has reduced the risk of contamination of footwear. Case study: Mead Open Farm, Billington, Bedfordshire This is a commercial attraction with approximately 160,000 visitors each year. 21 Children can still enjoy feeding animals in non-contact areas 22 Eating areas You should: Site eating or picnic facilities away from areas where animals can be contacted, or where wind blown contaminated material (e.g. straw from muck heaps) might be present, and preferably at the end of any farm trail, walk or tour, or outside the main areas of the premises. Ensure that visitors have to pass through or by washing facilities before entering eating areas. Ensure visitors are advised, e.g. by adequate signage, to wash their hands before eating. Exclude animals including captive birds from eating areas. They could contaminate eating areas with faeces. Consider wing clipping, double gates into eating areas and adequate fencing to exclude them. Where eating areas are adjacent to animal contact areas, prevent animal contact, e.g. by providing double fencing. This should be positioned at a distance that will prevent visitors reaching through to touch the animals and to prevent animals reaching over or through the fence to contact people. Provide adequate waste bins and clear discarded food from eating areas to discourage wild birds and rodents from feeding and contaminating the area. Locate ice cream and sweet kiosks in the non-contact areas of the premises, such as the eating areas or at the exit where visitors have passed washing facilities. Remind visitors using the kiosks, by notices or verbally, to wash their hands before touching or eating purchased food or sweets. This is not acceptable. Where eating areas are situated next to animal contact areas, animal contact must be prevented. Double fencing to prevent contact with animals 23 Play areas You should: Site play areas away from areas where animals can be contacted, and preferably at the end of any farm trail, walk or tour, or outside the main areas of the premises. Ensure that visitors are advised, e.g. by adequate signage, to wash their hands before and after using play areas. Exclude animals including captive birds from play areas. They could contaminate play areas and equipment with faeces. Consider wing clipping, double gates into play areas and adequate fencing to exclude them. Where play areas are adjacent to animal contact areas, prevent animal contact, e.g. by providing double fencing. This should be positioned at a distance that will prevent visitors reaching through to touch the animals and to prevent animals reaching over or through the fence to contact people. Ensure that play areas and equipment are designed so they can be cleaned on a regular basis to remove any contamination.
Washing facilities on side of food kiosk Sign reminding visitors to wash hands before eating or drinking Double fence between play and animal area 24 Washing facilities While the primary control measures should focus on reducing and eliminating faecal contamination, the most effective method of removing dirt and contamination remains hand washing with soap and running hot and cold, or warm water followed by hand drying. Soap bars can easily be dropped onto the oor. Liquid soap is a better solution. Washing facilities should be provided at or near the exits from any area/premises where visitors are encouraged to have animal contact. Cleansing wipes or anti bacterial gels are not an acceptable substitute for proper hand washing. At temporary events, such as agricultural shows, where suitable permanent washing facilities are provided (e.g. a purpose built toilet and washing block), it is acceptable practice for animal exhibitors or others to provide information and signs to indicate that visitors should use these facilities after contact with the animals. If such general visitor washing facilities do not exist or are not situated close by, it will be necessary to provide suitable temporary washing facilities. Washing facilities should be positioned close to areas where animal contact is allowed. Further guidance on the provision of washing facilities at agricultural shows is being developed with the industry. The provision of adequate numbers of washing facilities and their location is crucial to preventing ill health. Facilities can be individual taps and basins, and/or long sinks with a number of running water outlets. They need to be provided and easily accessible at or near: Areas where visitor contact with animals is allowed, such as petting barns. If there is a one-way system for visitors through the contact area they should be provided immediately adjacent to the exit. If there is a two-way ow of visitors they should be provided immediately adjacent to entrances and exits. A one- way system may help to ensure that washing facilities are properly used; Entrances to eating areas. Exits from the premises. Signage or other means of public communication should state this 25 Washing facilities An acceptable way to estimate the capacity of washing facilities is to: Estimate the maximum number of visitors expected or permitted at one time. Consider how many visitors will be in animal contact areas at any timeyou may already limit numbers in these areas to allow visitors time to enjoy the experience with the animals. Assess the rate at which visitors will leave contact areas, e.g. in large groups such as school parties or a few at a time. Estimate the time taken to wash hands effectively, remembering that a thorough hand wash may take up to two minutes. If you estimate that, for instance, 30 people will leave a contact area every 15 minutes, and each person will take two minutes to wash their hands, you should provide enough washing facilities for four people to use at one time (30 x 2 divided by 15 = 4). Make similar calculations for other locations around the premises, such as the main exits or entrances to eating areas.
You can supplement permanent facilities with temporary ones at busy times, e.g. just before the summer holidays, in remote areas of the premises, or for short duration events such as country shows or fairs. Portable units can be hired which have heating, lighting and running water. Portable hand wash stations All washing facilities should be/have: Accessible by all visitors, i.e. at the right heights for both children and adults or with raised standing areas provided for children. Check these do not create tripping or falling hazards. Running hot and cold, or warm water (e.g. mixer taps). It is easier to create soap lather with warm water, and it may encourage visitors, especially children, to wash more thoroughly particularly in cold weather. Warm water supplies should be tted with a means of restricting the temperature to no more than 43C to avoid scalding. Liquid soap as soap bars can be dropped on the oor. Bactericidal soaps are not necessary. Paper towels in and near animal contact areas, as they provide an additional opportunity to remove contamination. Elsewhere, hot-air hand-dryers are suitable but may lead to queues that discourage visitors from washing their hands. Reusable hand towels are not suitable. Properly maintained and cleaned regularly as required, at least daily. Replenished with paper towels and soap as necessary. Open or pedal operated waste bins that are emptied as necessary. Arranged so that visitor throughput and/or water overows etc. do not make the immediate vicinity muddy and put people off using the washing facilities. Case study: Dairy farm hosting four school visits a year (50 children) Problem HSE issued an improvement notice relating to hand washing and the use of gels. Solution Two additional hand wash basins with warm water, liquid soap dispensers, paper towel dispensers and bins were installed. The position adjacent to the calf feeding area was agreed with the inspector. Signage was put up advising people to wash hands. The location was noted in the teacher information pack. Outcome More schools are asking to visit since the farm advertised improved washing facilities 26 27 Case study: Ouseburn City Farm, Newcastle (in excess of 20,000 visitors each year) Problem1 Environmental Health would not allow the attraction to open its main pedestrian gates because no hand washing facilities were nearby. Solution Money was raised through Newcastle City Council Access Fund to install an external hand washing trough. This is accessible to children, adults and wheelchair users. Installation included a hand washing trough with three sets of hot and cold water taps, water feed, hand towel dispenser and tiling. Cost: approximately 1500 Outcome The main pedestrian gates can now be opened, allowing the public to enter the farm without having to go through the visitor centre. The farm entrance is more welcoming and there has been an increase in visitors who all see the external hand washing facilities and use them. Problem 2 The signage for hand washing was unclear. Solution The hand washing toolkit of the Federation of City Farms and Community Gardens was used to produce some A4 laminated signs. Outcome There is now clear signage throughout the site, advising visitors to wash hands after touching the animals and showing the location of hand washing. Visitors (including children) are regularly overheard telling each other to wash their hands. Only in exceptional circumstances, such as premises that open on an occasional basis in the summer, it may be acceptable to provide cold running water only, soap and disposable towels. This must be justied in your risk assessment. 28 Case study: Molescroft Farms Ltd This is a large arable farm with environmental stewardship. When there are group visits, neighbouring farms bring cattle and sheep. During school visits, 30 children attend. Open Farm Sunday can attract up to 250 people. In addition, 300 primary school children visit the Friday before Open Farm Sunday. Problem The new toilets and sinks (with hot water) are ne for most visits. However, on the Friday before Open Farm Sunday the hand washing facilities are not adequate to cope with 300 children. Solution They made troughs out of clean unused sheet foot troughs and tted these under a line of taps. Cold water was supplied from two different taps to ensure sufcient water pressure. Liquid hand wash was provided under each tap. Outcome Children like it. It is only used during summer so cold water is adequate. During the rest of the year the normal facilities are adequate for the reduced number of visitors. Although it is temporary, the hooks have been left in position so it can easily be put back whenever there are large numbers of visitors (probably every summer now). Do not provide buckets or troughs of standing water that are shared or reused by several people. They do not allow effective hand washing and reusing water can spread micro-organisms among those using it. Adding a disinfectant to the water does not make the practice acceptable. 29 It is important to encourage your staff, parents, teachers and others who have responsibility for visitors to make sure that children and other visitors wash their hands properly. This is not acceptable. Dirty water will be contaminated Parents should ensure children wash their hands properly 30 Case study: South of England Agricultural Society Countryside Day for Schools (2,500 pupils) Problem Ensuring pupils do not eat or drink in the livestock area and wash their hands before visiting the food hall and prior to lunch. Making sure teachers have all the information and take responsibility. Solution At the pre-event brieng for teachers, the importance of hand washing was emphasised and a copy of HSE guidance was given to all teachers. A map of the site highlighted the location of hand washing facilities. The existing hand washing facilities were checked for adequacy. As a result, lower hand towel dispensers were tted to ensure children could reach them. Extra control measures put in place. A one-way system was introduced in the livestock building so that children exited past the toilets. This was pointed out at the brieng and highlighted by signage at the event. Signs were put up to remind visitors about no eating and drinking in the livestock area, wash hands before touching food etc. Directional signs to toilets were put up on the day. The refreshment area for animal exhibitors was moved to outside the livestock building. Outcome Apart from the lower hand towel dispensers, the actual facilities were not improved. However, organisation was improved and measures put in place to make the event as safe as possible. Example of a hand wash station on mobile petting attraction. 31 Cleaning footwear, pushchairs, wheel chairs etc The layout of the premises should be planned to minimise the likelihood of contamination of footwear, pushchairs, wheel chairs etc. Where this unavoidably occurs, you will need to consider providing suitable facilities to allow visitors to clean contaminated footwear and wheels on pushchairs and wheelchairs. The facilities should be arranged to reduce the risk of personal contamination from manure, liquid run off etc. during the cleaning process and be located so that people can easily wash their hands after this has been done. Visitor information and signage Information should be provided to visitors covering the: Risks to health. Precautions taken to minimise risks. Personal responsibility of visitors to minimise risks, including complying with hygiene precautions and carrying out hand washing. Site plan, map, route directions or other information as necessary. The information should be included on the: Attractions website. Site maps/plans or other handouts given to visitors on arrival. Leaets DVDs, website links or pre-visit packs for schools and other organised groups should be provided to help teachers and others to plan their visit and educate children on safety, prevention of illness and hand washing. Remember the following: Information should include notices at all entrances to the premises to remind visitors of the need for good personal hygiene and to inform them that they should only eat or drink in the designated areas. Consider handouts for visitors and stickers etc. about hand washing. Signs should be erected in appropriate places reminding visitors to wash their hands when leaving animal contact areas, before eating, before entering and after leaving play areas, and when leaving the premises. Washing facilities should have signs showing how to wash hands properly. This leaet from the Health Protection Agency, Department of Health and Defra provides advice for the public on avoiding infection from animals when visiting farms. It may photocopied and distributed free of charge. It is available from: http://www.hpa.org. uk/webc/HPAwebFile/ HPAweb_C/1270122184581 32 Remember that young children may have dummies or toys that they put in their mouths. You should remind accompanying adults not to put dummies that have fallen to the ground back into their childrens mouths. Pictograms, audio devices, continuous loop videos or other media may be useful. Information should be clearly legible and may be required in languages other than English. Sign at entrance to animal feeding area Sign at farm attraction entrance Signage at the entrance to a visitor attraction Case study: Odds Farm Park, Wooburn Common, High Wycombe This is a commercial visitor attraction with approximately 170,000 visitors per annum. Problem 1 Visitors were not taking notice of hand washing or rules for the animal area. Solution To stop children rushing into the animal contact area, a simple picket fence and wooden gate with a high latch was installed to prevent small children from entering without adults. Secondly, to get visitors to take the animal area rules on board, we made a very basic PowerPoint slideshow using our own photos. This runs silently and continuously on a 50-second loop. Costs: Picket fence and gate 200 + labour Old PC and screen 11 + time Outcome The new gathering area slows the children down and ensures that they have an adult with them when they enter the animal contact area. The moving pictures get everyones attention in this same gathering area and they take on board far more of the rules before they enter. HSE, Environmental Health and the customers are all pleased with the efforts. Chapter 5 contains more detail about the role of information. Case study: Royal Cornwall Showground, Wadebridge, Cornwall This agricultural show attracts 127,000 people over three days. Problem Public access to livestock areas (cattle, sheep, pigs & goats). Solution Numerous permanent and mobile toilet blocks were available on site. Signage advising the use of nearby hand washing facilities within these toilet facilities was erected in livestock areas for those touching livestock. Outcome These facilities have been available for a great number of years and therefore no specic improvement can be regarded as having taken place. However, signage increases public perception of the advisability of good hygiene. 33 34 Training and supervision You should: Ensure staff are trained and instructed about the human health risks associated with animals and the necessary control measures. Dont forget that training should also be provided for temporary or seasonal staff. Ensure staff are trained and instructed on what visitors should or should not do. Provide guidance to staff on how to explain the hygiene message to visitors including the importance of thorough hand washing, particularly for children. Arrange adequate and appropriate levels of supervision in contact areas. The number of supervisors will depend on the size of the animal contact area and the number of visitors permitted or expected in that area at one time. Ensure that children are supervised while they wash their hands. Although this is the responsibility of parents or teachers, in some cases staff may need to help in supervision. Remind supervisors in animal contact areas (who may also be there to protect the animals) to ensure that visitors do not eat, drink or put items in their mouths while in these areas and until they have washed their hands on leaving the contact area. Ensure supervisors discourage visitors (especially children) from putting their ngers in their mouths, or kissing the animals. Stress to your own staff the importance of setting a good example and following good personal hygiene, e.g. thoroughly washing their own hands when necessary, and not eating or drinking in animal contact areas. Staff should discourage kissing of animals 35 Livestock management procedures You should: Consider producing an animal or farm health plan in consultation with your vet to help reduce the risks from zoonoses. Assess whether animals are healthy before moving them to animal contact areas, but remember that animals carrying VTEC do not necessarily show signs of illness. Ensure that animals that have just given birth, or been born, are not put in contact areas. Immediately remove any animals showing signs of ill health, such as diarrhoea or stress, from animal contact areas until they have recovered and seek veterinary attention and advice promptly. Keep animals and their housing clean. Consider whether replacement stock can come from within the premises rather than being brought in (this would reduce the likelihood of new infections being inadvertently brought on to the premises). Where possible, source replacement livestock (especially young animals for bottle-feeding) from a reputable supplier with known health status where the stock-keeper will have ensured that they have received an adequate supply of colostrum after being born. Try to minimise movement and mixing of animals from different groups. This is particularly important to minimise the shedding of VTEC by ruminants such as cattle, sheep and goats. Regularly check all animals on display for evidence of illness, consulting your vet as appropriate. Regularly empty and clean water troughs and provide the animals with clean drinking water. Manure and compost heaps You should: Position manure or compost heaps well away from areas that visitors can access, or fence them off. Prevent or contain any liquid run-off where this might contaminate visitor areas or routes. Prevent dried contaminated material (e.g. bedding) being blown onto clean non-contact areas. Not allow visitors to collect and bag their own compost or manure. Keep visitors away from manure and compost heaps Case study: Heeley City Farm, Shefeld This city farm hosts children and adults with learning disabilities on daytime placements and has approximately 100,000 visitors per annum. Problem 1: Faeces on paths Solution All paths are swept down and disinfected before being opened to the public. A gate was put on the stable entrance with a sorry we are closed for cleaning sign. A poster of a clean and unclean path was displayed to give staff/volunteers a pictorial reference of acceptable practice. (Visitors can be unreasonable about not being allowed in to the stables or having to wait.) Costs - Gate made from recycled wood, printing and laminating sheet. Outcome This has improved the facility because all staff work to the same standard. It is good for adults with learning disabilities and children with English as second language. Problem 2: Animal bedding spilling out Solution Solid fronts(1/2 height so children can still look through) have been put on to the front of gates and pens in the stables to stop bedding spilling on to clean paths and to stop little children reaching through the bars and touching dirty bedding. It also discourages laddering, where people stand on rails to look at animals with dirty shoes then little children touch the rails and get muck on their hands. Outcome Solid fronts have reduced the spillage from pens. Problem 3: Hand washing facilities needed improving Solution Extra sinks are to be installed outside with hot running water. They will be in the form of taps over a trough to catch the water. Bigger groups of children will be able to wash their hands and staff will nd it easier to stand and supervise correct hand washing. Groups of people in wheel chairs, i.e. nursing home residents, can easily wash hands whilst still sat in chairs with staff helping. Costs - Expensive. The work is part of new 100,000 toilet facilities. Outcome This will make us more attractive to visiting groups and individuals. We can expand sensory/ reminiscence tours for dementia patients. Problem 4: Attending festivals Solution We no longer attend events that cannot provide running hot water for hand washing. If we do attend events, animals have to be double fenced and no contact with public is allowed. The cost of a portable hot water washing unit is out of our price range. Outcome We lose some bookings. People are cross and disappointed not to touch the animals. Problem 5: Recording Outcome New recording sheets, daily recording, weekly and monthly deep cleaning schedule. Costs - Extra staff time for new cleaning system. 36 37 Problem 6: Training Outcome Extra E. coli training for staff by a health and safety ofcer. Costs - Staff time for the trainer and staff taking time out of normal duties. Problem 7: Play area Solution New cartoon signs to prevent eating in the playground. They explain that muck from footwear on play equipment can be transferred to childrens hands and so eating is not allowed. Costs - Staff time to design poster and printing. Case study: New Forest & Hampshire County Show, New Park, Brockenhurst, Hampshire This agriculture show attracts 95,000 visitors. Problem1: Risk of infection through contact with animals. Solution A full risk assessment on infection control is completed prior to the event. Visitors are kept to a specic route, minimising the direct contact with animals. All animals are kept in pens. Visitors are not allowed in the car parks and only see the animals once in their pens. Visitors are removed from the area when the animals are moved from their pen to the judging rings. Outcome Identies risks. It ensures that the visitors stay away from animals outside of their pens. This reduces contact with the public whilst allowing good viewing. It reduces the risk of visitors touching animals whilst outside of their pens. Problem 2: Risk of infection from dirty bedding. Solution Each pen is cleaned and disinfected daily. Fresh straw is then put into the empty pen. The dirty straw is removed from the site. Stockman and stewards are responsible for the removal of faeces produced in the transport of animals. This is especially important when occurring in the walkways. Outcome It has reduced the risk of infection. Problem 3: Insufcient knowledge about the need to wash hands Solution Signage in the livestock marquees informs the public to wash hands after touching animals. Stewards are trained to inform the public that there is a need to wash hands after direct contact with animals. Exhibitors are written to prior to the event informing them of the importance of infection control at the show. Directional signage moves the public from the livestock to the nearest hand wash facilities. These facilities are located close to the marquees to ensure that no one gets lost. Information sheets in schedules and the show programme emphasise the need to use hand wash facilities after touching animals. Outcome Increased knowledge of the need to wash hands after touching an animal. Ensures that the public know where the nearest facilities are. Problem 4: Visitors eat food without washing hands. Solution All food units on site identify the need to wash hands before consuming food. These units are always located next to the hand wash facilities. Outcome Increased knowledge of the need to wash hands after touching an animal. The risk of infection is reduced. Problem 5: Facilities are not maintained. Solution Hand wash facilities are monitored throughout the event with one person for every nine sinks. Outcome This reduces the risk of facilities becoming unusable. 38 39 Step 4 Record your ndings and implement them You must be able to demonstrate that you have a system in place to spot hazards, but you are not required to record every possible type. Concentrate on the signicant hazards that could result in serious harm, or affect several people. You should keep a record of your assessment where any signicant risk is identied, whether or not any further precautions are proposed. This will be useful for later review and for sharing the ndings with your site staff. When writing down your results, keep it simple. A risk assessment is not expected to be perfect, but it must be suitable and sufcient. You need to be able to show that: A proper check was made. You considered who might be affected. You dealt with all the obvious signicant hazards, taking into account the number of people who could be affected. The precautions are reasonable, and the remaining risk is low. You involved your staff or their representatives in the process. If, like many businesses, you nd that there are quite a lot of improvements that you could make, big and small, dont try to do everything at once. Make a plan of action to deal with the most important things rst. Health and safety inspectors acknowledge the efforts of businesses that are clearly trying to make improvements. A good plan of action often includes a mixture of different things such as: A few cheap or easy improvements that can be done quickly, perhaps as a temporary solution until more reliable controls are in place. Long-term solutions to those risks most likely to cause accidents or ill health. Long-term solutions to those risks with the worst potential consequences. Arrangements for training employees on the main risks that remain and how they are to be controlled. Regular checks to make sure that the control measures stay in place. Allocating clear responsibilities who will lead on what action and by when. Remember, prioritise and tackle the most important things rst. As you complete each action, tick it off your plan. 40 Step 5 Reviewing risk assessments You should regularly review risk assessments as a matter of course. In addition, they should be reviewed immediately after any signicant incident or near miss and following signicant changes to visitor activities or working practices on site. Such changes may necessitate additional and/or alternative risk control measures. The revised ndings should be recorded and retained for future reference. In summary: Identify the hazards on your site. Know who is using your site and what they are doing there. Think about what accidents could happen (or have happened) and how they might be caused Decide if current risk control measures are adequate or more needs to be done. When introducing new risk controls choose the most effective ones that are practicable bearing in mind their impact on benets. Record your ndings and review your risk assessments on a regular basis. 41 CHAPTER 5: THE ROLE OF INFORMATION IN RISK CONTROL This chapter considers the role of information and education in risk control. We emphasise the need to give visitors the knowledge to consider their behaviour so they can take responsibility for their own health and safety. The management of safety should be an integral part of your overall system to meet all the needs of your visitors. There are opportunities at different stages of the process. Well-designed safety information should: Alert visitors to the nature and severity of hazards and risks and provide information about restrictions. Give visitors the information to understand risks to which they are likely to be exposed, and the precautions they should adopt. Give information about the nature and extent of risk control measures provided by the site operator. Make clear to visitors what is expected of them, on the understanding that they share responsibility for their own safety. Our aim should not be to disclaim responsibility. Signs and leaets that state visitors enter at their own risk have little validity in civil law. However, providing safety information that ensures visitors are made aware of hazards should help to prevent accidents and ill health. It may also help to demonstrate that you have acted reasonably in the event of a claim against you if an accident does occur. Good information can help visitors to develop the skills and condence to take appropriate responsibility for their own safety. Different ways of providing information Leaets, posters, tickets and booklets Signs (including pictorial), notices and information boards Audio and/or video messages Use of signs with themed characters/colour coding along the route Verbally Websites Recorded telephone information lines Part 3: SUPPORTING INFORMATION 42 You should identify any partners to your visitor attraction and work with them to achieve a common information strategy. Diversity and social inclusion Think about the needs of different types of visitor. Ensure that any information you publish is accessible for all. Consider different formats, sizes, typefaces, colours and languages. Communications strategy checklist Who is the audience you want the information to reach? Consider specic audiences, e.g. people new to the site or particular age/ability groups Dont forget even regular visitors need reminders. How is the information going to reach the audience? Consider information given prior to the visit on a website and at the location through maps, leaets and signs. Have you met the needs of people with varying levels of skill and ability? Can your signs be understood by all visitors or their parent/carer/guardian? Have you reached your intended audience? This is hard to assess without research or survey work, but you may get some idea from hits on a webpage. Has the information been effective? Monitor the behaviour of your visitors to see if you have achieved your objectives SIGNAGE Advisory, warning and prohibition signs You may need advisory, warning or prohibition signs to tell visitors about things that have an impact on their visit. However, do not put up signs unless your risk assessment indicates that they are the most appropriate measure for risk control. You may be able to use a better option such as creating a route that avoids the hazard. 43 When you decide to use signs you must give thought to their content, design, location and maintenance, if they are to be effective. Advantages: Concise means of conveying information. Simple pictorial information widely understood. Relatively cheap to produce and install. Can be used to warn visitors of hazards that are not readily obvious. Limitations: Prone to damage and deterioration so require ongoing maintenance or investment in more expensive versions. Can be ignored by intended audience especially if there are too many. Limited effectiveness for children. Limited value for foreign language speakers. Limited value for the visually impaired. Visually intrusive in places of beauty or historical signicance. Some additional points should be noted: Poorly designed or badly positioned signs are not effective. Signs can be used together with other physical measures, such as fencing. They can explain why access is restricted. There is no need to provide warning signs where the hazard is obvious. Overuse of signs or leaving old signs in place after the hazard has gone undermines their effectiveness. The use of signs to disclaim responsibility or liability is not usually appropriate. Safety advice can often be incorporated into the content of general information panels. Signs must be regularly inspected and maintained. Sign design Be consistent in your use of signs. Otherwise the visitor is likely to be misled. Safety signs fall into ve categories: Prohibitory Mandatory Warning Safe condition Fire-ghting 44 When you are certain that a sign is needed, decide which category is appropriate. There are standard designs and colours for each category. These are prescribed by the Health and Safety (Safety Signs and Signals) Regulations 1996. Although these regulations apply to the safety of employees in work situations, there is great merit in applying them, as far as is practicable, to visitor safety signs. You can use an information board to give a fuller explanation and incorporate other information about, for example, emergency procedures, management strategy, nature conservation, or environmental protection. Examples of hand washing signage are available at: http://www.farmgarden.org.uk/publications/856-clean-hands-zone-toolkit Sign location Give careful consideration to the position of signs. General warning notices need to be seen on arrival by as many visitors as possible. They are usually located at the main points of access to a property. Signs in car parks are best placed at the point where visitors exit on foot to the place of interest. Warn visitors about hazards in time for them to take in and act on the information before being exposed to the risk. This can be particularly important for controlling children. Sometimes small repeat signs are necessary for hazards that recur along a route. Monitoring and review Observe how people react to signs and notices to ensure that they are in the correct location, understood and acted upon. Check them regularly for damage and deterioration. Remove signs as soon as they become out of date. The role of education If your organisation has an education strategy, include visitor safety within the wider educational objectives, particularly when preparing guidance for site visits. Educational opportunities include: Direct work with schools and communities. Indirect work, for example, via website information. Work with school and community groups that organise activities in the countryside. Use the opportunity for local staff to explain the guiding principles and emphasise how visitors have some responsibility for their own safety. 45 CHAPTER 6 ADVICE TO TEACHERS AND OTHERS WHO ORGANISE VISITS FOR CHILDREN This advice is for teachers and others who organise visits by children on the precautions necessary to reduce the risk of ill health arising from contact with animals. All animals naturally carry a range of micro-organisms, some of which can be transmitted to humans, where they may cause ill health. Some of these, such as Escherichia coli O157 (E. coli O157) or Cryptosporidium parvum (a microscopic parasite), present a serious health hazard and have the potential to cause serious illness and health problems which may be particularly severe in young children. As with many other educational or recreational activities, visits can never be considered free from all risk. However, while the hazards are real, the risk of infection in children can be readily controlled by simple everyday measures. The following practical steps will help make your visit even more safe, healthy and enjoyable. Before your visit, you should: Read and understand the advice in the industry Code of Practice, and discuss arrangements for the visit with the management at the site. Conrm that the control measures provided at the site match the recommendations in the industry Code of Practice. Seek advice from your local authority or organisation on what the appropriate ratio of pupils to teachers/leaders/assistants/parents should be. Discuss and agree with the supervisors, parents or staff of the school, crche leaders of youth organisations etc. their roles and responsibilities during the visit. In particular, they must understand the need to make sure that the children wash, or are helped to wash, their hands thoroughly after contacting animals and before eating. Key points to cover with the children should include: explaining the rules for the visit, stressing that they must not eat, drink or chew anything (including sweets) outside the areas in which you permit them to do so; explaining why they must wash their hands thoroughly after contact with the animals, and before eating or drinking anything; demonstrating how to wash their hands properly; discussing the requirements for appropriate clothing, including suitable footwear. You should liaise with the attraction to ascertain what this is; checking that cuts, grazes etc on childrens hands are covered with a waterproof dressing. 46 During and after the visit, make sure that the children: Are reminded of the rules/precautions to take upon arrival at the site. Do not kiss animals. Always wash their hands thoroughly before and after eating, after any contact with animals and again before leaving the site. Eat only food that they have brought with them or food for human consumption that they have bought on the premises, in designated areas. Never eat food that has fallen to the ground. Never taste animal foods. Do not suck ngers or put hands, pens, pencils or crayons etc. in mouths. Where practical and possible, clean or change their footwear before leaving. Wash their hands after changing their footwear. Check that the children stay in their allocated groups during the visit, and that they: Do not use or pick up tools (e.g. spades and forks) or touch other work equipment unless permitted to do so by site staff. Do not climb on to walls, fences, gates or animal pens etc. Listen carefully and follow the instructions and information given by the site staff. Approach and handle animals quietly and gently. Do not chase, frighten or torment the animals. Do not wander off into unsupervised or prohibited areas e.g. manure heaps. Remember the children are your responsibility during the visit: You should supervise them during the visit, especially during hand washing to make sure that each child washes thoroughly. Site staff may be able to help with this supervision. Allow plenty of time for hand washing before eating or leaving the site so that the children do not have to rush. If a member of your group shows signs of illness (e.g. sickness or diarrhoea) after a visit, advise them or their parent/guardian to visit the doctor and explain that they have had recent contact with animals. Please also contact the attraction you visited and inform them of the illness. Additional advice Further advice on E. coli O157 including a video on hand washing is available at: http://www.hse.gov.uk/campaigns/farmsafe/ecoli.htm Other advice is available from a number of other government websites including: http://www.hse.gov.uk/ www.hpa.org.uk/ www.hps.scot.nhs.uk/ www.dh.gov.uk/en/index.htm http://www.defra.gov.uk/ http://vla.defra.gov.uk/ 47 CHAPTER 7: INCIDENT REPORTING AND INVESTIGATION Incident reporting is an important element in managing visitor safety. We want our visitors to enjoy their experience and return home unharmed. It is essential to learn from incidents and near misses that do occur. Why investigate incidents? To help manage the incident. To prevent future similar incidents. To check whether your risk control measures are sufcient and effective. It may be a statutory requirement. Some cases of ill health to the public must be reported, usually to the environmental health department of your local authority, or to the Health and Safety Executive. To provide information in case there is a claim for compensation, or a need to defend a legal action. To identify trends in the pattern of incidents or accidents. To measure whether your safety record is improving or worsening. Common obstacles to investigations Difculty in collecting information. Fear of blame. To counteract this it helps to create a management culture in which staff and visitors are encouraged to report accidents and near misses. Over-complicated reporting systems. Introduce simple and clear systems that minimise paperwork. Staff being unaware of the value of the information they supply. It is essential to give feedback and show how things have changed as a result of incident investigations. Visitors may not know how or where to report incidents. Incident reporting procedures It is important to have a clear process for reporting and investigating incidents. This should include consideration of the need to inform insurers or involve legal advisors if claims are likely to result. You should also consider whether the incident could give rise to media enquiries and how these would be handled. You are legally bound under the Reporting of Injuries Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR) to report certain accidents, dangerous occurrences and types of ill health to the enforcing authority You must also ensure that the person who investigates an incident has the necessary skills, knowledge and experience. Many organisations have specic forms to report incidents and record investigations. Often the two are combined. They typically gather the following information: 48 Basic facts Where the incident happened What happened Date and time Who was involved Physical site characteristics Facilities or equipment involved Activities of those involved The weather at time of incident (you may also wish to consider details of clothing and footwear worn at the time) The nature of actual or potential exposure to possible infection Damage to property or environment (actual or potential) What control measures, if any, were in place. Gathering evidence Evidence is critical to establish the facts and determine the causes of incidents and it should be gathered before any changes are made to the site (other than those necessary to prevent any recurrence), and whilst the events are fresh in peoples minds. Information to be gathered should include: Photographs or video recordings of the incident/site. Witness statements written or recorded. Any equipment or infrastructure damaged or otherwise, implicated in the incident. Be careful when asking for statements at the time of the event from witnesses who may be distressed. It might be more sensitive to ask for an address and telephone number in order to make contact later. Incident history The investigator needs to establish whether: A similar incident has happened before. Recommendations had previously been made to prevent a recurrence. If so, were the recommendations carried out? Causes If there is not an obvious direct cause to the incident, it is necessary to look beyond the immediate cause of an incident to see if there are important underlying reasons. Often there are several inter-related causes. 49 Recommendations Recommendations are actions to lessen the possibility of a similar incident occurring in the future or to mitigate its effect to an acceptable level. Where recommendations are made they should be given a timescale for implementation and responsibility should be allocated for carrying it out. Review There should be a review to see if the recommended actions have been taken and to assess whether they were adequate and appropriate. Responsibility for carrying out the review should be allocated to a person with an appropriate level of authority. 50 CHAPTER 8: DEALING WITH A MAJOR INCIDENT A number of zoonotic diseases are notiable under veterinary and/or human health legislation. However, not all zoonotic diseases in animals or humans are notiable. The primary purpose of the notication system is to identify possible outbreaks and epidemics and initiate appropriate action as soon as possible. Accuracy of diagnosis is secondary, and generally clinical suspicion is all that is required. If the diagnosis later proves incorrect, the notication can be changed or cancelled. In April 2010, new Health Protection Regulations for England came into force. These include The Health Protection (Notication) Regulations 2010, which made changes to the requirement for notications of infectious disease. An Incident or Outbreak Control Team (OCT) will be formed for signicant outbreaks of zoonotic disease. Standard principles for managing incidents/outbreaks apply. Depending on the individual situation and disease, membership of the OCT may include representatives from the: HPAs local Health Protection Unit, for example, the Consultant in Communicable Disease Control. Local authority (Environmental Health Ofcer). Primary Care Trust. Local acute trust (Microbiologist or Virologist, Infection Control Nurse). Other agencies as necessary may also be included, for example, the Health & Safety Executive or the Food Standards Agency. Veterinary involvement may be provided by the Animal Health Veterinary Laboratory Agency. Further information regarding the investigation of zoonotic disease can be found in Guidelines for the Investigation of Zoonotic Disease (England and Wales) issued in April 2009 at: www.hpa.org.uk/Topics/InfectiousDiseases/InfectionsAZ/Zoonoses/Guidelines/ 51 CHAPTER 9: THE LAW AND VISITOR SAFETY This chapter looks at the legislation and court judgements that affect visitor safety and outlines your responsibilities under the law. References in this chapter are to legislation for England and Wales. There are differences in the legislation in Scotland. Someone injured through your negligence can bring an action for damages against you in a civil court of law. If you are found negligent, you may be ordered to pay compensation for loss of earnings, medical expenses, pain, suffering and the like. Claims for damages after accidents are perceived to be on the increase, with solicitors and accident claim practitioners touting for new business by offering no win no fee terms. Concern about the growth of the compensation culture led to the introduction of the Compensation Act in 2006. This brought in changes to the law on liability and breach of statutory duty aimed at tackling perceptions that can lead to a disproportionate fear of litigation and risk-averse behaviour. Despite this, Lord Young states in his 2010 report Common Sense, Common Safety, the problem of the compensation culture prevalent in society today is one of perception rather than reality. The number of claims for damages due to an accident or disease has increased slowly but nevertheless signicantly over recent years. Furthermore, there is clear evidence that the public believes that the number of claims and the amount paid out in damages have also risen signicantly. Not only organisations but also individuals can face prosecution in a criminal court for not complying with legal duties imposed by government legislation. You can be ned, or even face imprisonment if found guilty in a criminal court. Criminal law Health and Safety Legislation Health and Safety at Work etc. Act 1974 A criminal offence will arise from a failure to comply with legal duties imposed by the Health and Safety at Work etc. Act 1974 (HSWA) and regulations made under it. This legislation places a duty on employers to ensure, as far as is reasonably practicable, that in the course of conducting their undertaking, members of the public are not put at risk. The phrase conducting their undertaking also includes cleaning, maintenance and repair of the plant, machinery and buildings necessary for carrying on the business. The employer cannot delegate responsibility for this duty. Therefore, in effect, you need to consider the consequences of the actions of contractors as well as your employees. You need to consider the cost and effectiveness of any precautions that you can take to minimise risk of harm. If a precaution is cheap, easy to take and is very effective, then it is reasonable to implement it even if the risk of harm is small. If the risk of harm is great, then more expensive precautions may be reasonable. These decisions need to be balanced against the benets arising from the site or the activity, as we have considered in earlier chapters. 52 Enforcement of health and safety legislation Responsibility for the enforcement of health and safety legislation rests with the Health and Safety Executive (HSE) and local authorities. Their inspectors have powers to investigate incidents and complaints or carry out routine inspections. When there has been a breach of health and safety law the enforcing authority can serve improvement or prohibition notices or prosecute. The local authority will be the enforcing authority for most visitor attractions. Where an offence is committed with the consent, connivance or neglect of any director, manager, secretary or other similar ofcer, that person may be guilty of an offence along with the organisation. If the breach in the law results in death, the police are involved and they may refer the case to the Crown Prosecution Service. The Corporate Manslaughter and Corporate Homicide Act 2007 created a criminal offence of corporate manslaughter in England, Wales and Northern Ireland and corporate culpable homicide in Scotland. This Act applies to all companies, most government bodies, partnerships, trade unions, employers associations and incorporated charities. Crown immunity has been largely abolished. The Act does not apply to unincorporated bodies such as some charities, friendly societies etc. or individuals. Corporate manslaughter and corporate homicide investigations are led by the police. They can be lengthy and intrusive. The existing provisions of the HSWA still apply. Control of Substances Hazardous to Health Regulations 2002 (as amended) (COSHH) E. coli O157 and other micro-organisms that may cause ill health are subject to the Control of Substances Hazardous to Health (COSHH) Regulations 2002 (as amended). These Regulations require an employer or self-employed person to: Assess the risks to employees, self-employed people and the public from exposure to hazardous substances, including micro-organisms. Prevent, or, where this is not reasonably practicable, adequately control exposure to the hazardous substances. Introduce and maintain control measures. Inform, instruct and train employees about the risks and precautions to be taken. Inform visitors about the risks and precautions to be taken. Regularly review the assessment and the effectiveness of control measures. Guidance on COSHH can be obtained from the HSE website http://www.hse.gov.uk/coshh/index.htm 53 Management of Health and Safety at Work Regulations 1999 as amended The Management of Health and Safety at Work Regulations 1999 require you to carry out risk assessments to identify hazards and take any necessary steps to reduce the risk of an incident. Regulation 3(1)(b) states that: Every employer shall make a suitable and sufcient assessment of the risks to the health and safety of persons not in his employment arising out of or in connection with the conduct by him of his undertaking. In effect this means that your risk assessments should consider the risks to visitors you invite onto your property, or other people who might be affected by your undertaking or your activities. Regulation 5 states: Every employer shall make and give effect to such arrangements as are appropriate, having regard to the nature of his activities and the size of his undertaking, for the effective planning, organisation, control, monitoring and review of his preventive and protective measures. Where the employer employs ve or more employees, the arrangements should be recorded. (We discuss how you can meet these requirements in Chapter 4.) Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1999 (RIDDOR) You are legally bound under RIDDOR to report certain accidents, dangerous occurrences and types of ill health to the enforcing authority. They may well send an inspector to investigate. The authority will also investigate complaints made by members of the public. It is essential that you are able to demonstrate that you have effective procedures in place to identify and manage risk Independent Regulatory Challenge Panel An Independent Regulatory Challenge Panel has been established to handle complaints about advice given by either the HSE or local authority inspectors and will seek the expert advice of assessors in reaching a conclusion. Any case where someone believes the enforcing authority is incorrect or has gone beyond what is required to control the risk adequately is eligible for consideration by the panel. The panel will not consider issues where other independent appeals processes exist, such as enforcement notices or prosecutions. Further information is available at: http://www.hse.gov.uk/contact/challenge-panel.htm Public Health legislation Application of the Health Protection Regulations 2010 (England & Wales) These health protection powers are for use where voluntary cooperation to avert a health risk cannot be secured and where other methods of control are ineffective, unsuitable or disproportionate to the risk involved. The Department of Health has published Guidance that was written by the Health Protection Agency and the Chartered Institute of Environmental Health, which describes how these powers should be used. Powers that impose restrictions or requirements are conditional on strict criteria being met. The local authority makes an application to a JP who must be satised that the relevant criteria are met. The criteria cover evidence of infection or contamination, assessment of the potential for signicant harm to human health, risk of spread to others and necessity for action to be taken in order to reduce or remove that risk. The legislation also contains various safeguards for people who might be subject to the legal measures. 54 The measures are contained in the Public Health (Control of Disease) Act 1984 (as amended) together with the Health Protection (Local Authority Powers) Regulations 2010 and the Health Protection (Part 2A Orders) Regulations 2010. For further information see: Health Protection Legislation (England) Guidance 2010 Information about Public Health legislation in Scotland is available at: http://www.legislation.gov.uk/asp/2008/5/contents Civil law The foundation of most personal injury actions is in proving negligence under common law. An action for damages is brought in the civil courts. To win an action and be awarded compensation the injured person must be able to demonstrate that they were owed a duty of care, and there was a breach of that duty leading to the injury. A civil case can also be brought for breach of statutory duty that results in injury or ill health. Common law duties essentially derive from decisions made by judges over the years. Under common law you owe someone a duty of care if there is: sufcient proximity between you and the person injured, and it was reasonable to foresee that harm may result from your actions, and it is fair, just and reasonable to impose a duty of care on you. Proximity can be geographical, contractual, or through a care situation (for example between teacher and child). If you breach that duty of care, and foreseeable physical or psychological damage results, then you are liable to negligence. An employer may be held liable for the negligence of his employees (this is called vicarious liability). The visitor must take reasonable care for his own safety. If he doesnt and comes to harm, then his contributory negligence would lessen any claim against you. Note that children cannot be expected to appreciate dangers in the same way as adults. It is highly unlikely that contributory negligence could be attributed to the actions of a very young child. Adults, however, will be expected to exercise responsibility for children in their care. In civil law, the duty of care has been further dened by legislation. Under the Occupiers Liability Acts of 1957 (OLA57) and 1984 (OLA84), the occupier of premises owes a duty of care to lawful visitors (OLA57) and trespassers (OLA84), by reason of the state of the premises and things done or omitted to be done on them. In Scotland, a similar duty of care is owed under the Occupiers Liability (Scotland) Act 1960. The occupier is the person or body that has sufcient control over the premises to be in a position to take the steps necessary to protect people who otherwise may be at risk. If there is more than one occupier, each owes a duty of care that is in relation to the degree of control each has over the premises. An occupier has the duty of care and cannot delegate this duty to someone else. So, in effect, you may be responsible for the actions of contractors working on your behalf. 55 Visitors Under Section 2(2) of the OLA57, the occupier has: A duty to take such care as in all the circumstances of the case is reasonable to see that the visitor will be reasonably safe in using the premises for the purposes for which he is invited or permitted by the occupier to be there. You must consider the particular needs of people you invite onto your property. You must be able to demonstrate that your precautions are reasonable in the circumstances. You must be prepared for children to be less careful than adults. Furthermore, a warning sign, however clear in itself, cannot warn if the child is unable to read. However, in some circumstances, particularly in the case of a young child, the parent may hold the primary duty of care. Warning a visitor of dangers might be sufcient to absolve you from liability, but only if it was sufcient to enable the visitor to be reasonably safe. Under OLA57, you can choose to restrict or exclude your liability by imposing entry conditions. However, the Unfair Contract Terms Act 1977 says that: A person cannot by reference to any contract term or to a notice exclude or restrict his liability for death or personal injury resulting from negligence. In the case of other loss or damage, liability can only be excluded or restricted if the terms are reasonable. 56 CHECKLIST Use the checklist to ensure that you are addressing issues that will help to keep your customers safe from exposure to microbiological contaminants and zoonoses. This document may help you record your COSHH assessment. It can be printed on A3 paper. PREMISES LAYOUT AND ROUTES Current standard Action required By whom Date Are the public access areas segregated from the main farm work areas? Areas of the farm to which members of the public have access need to be dened and segregated in order to implement the control measures. Are the visitor routes around and through the attraction clearly dened? Are the visitor routes kept reasonably clean and free from build-up of animal faeces? Sensible hygiene practices indicate that trafc routes should be clean to minimise risks of contamination of hands and footwear and reduce transfer of faecal matter to non-animal areas. ANIMAL CONTACT Are adequate washing facilities provided adjacent to areas of animal contact? The primary control measure is good hygiene. Are non-contact animals segregated from the public? Access to animals that have been designated as non-contact should be managed in accordance with the guidance. APPENDIX 1 57 PREMISES LAYOUT AND ROUTES Current standard Action required By whom Date Are the public prevented from entering animal pens (except in staff supervised specic contact areas)? You need to prevent the public entering animal living pens, as faeces or contaminated bedding will be underfoot. Are visitors prohibited from eating, drinking and smoking in the animal contact areas? Permitting these activities in areas with recent faecal contamination is unacceptable. Is contaminated bedding or run-off prevented from contaminating walkways or other visitor areas? Faeces should not be allowed to remain on and contaminate walkways or other areas used by visitors. Also contaminated bedding or run-off material should not be allowed to contaminate walkways or other areas used by visitors. EATING AREAS Are visitors in eating areas prevented from contact with animals in adjacent areas? (Remember temporary eating areas such as ice cream vans and sweet kiosks.) Eating in areas where contact is possible should not be permitted and in all cases thorough hand washing is a primary control measure. Are visitors advised to wash their hands before eating or drinking? Hand washing after contact with animals or animal faeces is a primary control. 58 PREMISES LAYOUT AND ROUTES Current standard Action required By whom Date PLAY AREAS Are children prevented from reaching and touching animals in areas adjacent to play areas? Where play areas are adjacent to animal areas, animal contact should be prevented, e.g. by double fencing. Are visitors advised to wash their hands before and after using play areas? Visitors should be advised to wash their hands before and after using play areas. WASHING FACILITIES Have sufcient numbers of washing facilities been provided? Thorough hand washing is a primary control measure. Are washing facilities provided immediately adjacent to petting areas, eating areas, or areas where contact with animals or their faeces likely, including exits? Thorough hand washing is a primary control measure. Is clean running hot and cold or warm water provided? Thorough hand washing is a primary control measure. If only cold water facilities are provided, has a justication by risk assessment been completed? In exceptional circumstances, such as premises that open on an occasional basis in the summer, providing cold running water soap and paper towels only may be acceptable. This must be justied in a risk assessment. 59 PREMISES LAYOUT AND ROUTES Current standard Action required By whom Date Is liquid soap provided? Thorough hand washing is a primary control measure. Depending on type and method in which they are used, bars of soap may not be effective and may present additional microbiological risks Are personal means of drying hands thoroughly provided? Drying by paper towel or hot-air dryer forms part of the thorough hand washing as a primary control measure. Are cleansing wipes or anti bacterial gels prohibited as a substitute for proper hand washing? Thorough hand washing is a primary control measure. Anti bacterial wipes and gels are not an effective means of preventing exposure to E. coli O157 or cryptosporidium. . Is the water used in hand washing allowed to drain away quickly? Re-using used hand washing water must not be possible. Are the segregated/clean picnic and eating areas co-located with suitable washing facilities? Permitting eating in areas where there is the potential for recent faecal contamination is unacceptable and in all cases thorough hand washing prior to eating is a primary control measure. 60 PREMISES LAYOUT AND ROUTES Current standard Action required By whom Date VISITOR INFORMATION & SIGNAGE Is information available for visitors about the risks to health, the precautions taken to minimise risk and on the need for good hygiene? Information should be available on the attractions website, on site maps and other handouts given to visitors on arrival. Leaets or pre-visit packs should be provided to schools and other organised groups to aid planning. Are washing stations clearly signposted on the route around premises? Are there signs to instruct on hand washing techniques? TRAINING AND SUPERVISION Are employees/staff sure about what visitors can and cannot do? The concern is that staff may not appreciate the risk and thus not prevent members of the public from e.g. eating in animal handling areas. Are employees/staff sure of how to explain the hygiene message to visitors? Are employees/staff sure how to manage difcult and uncooperative visitors? Are there arrangements in place to determine and apply adequate and appropriate levels of supervision? 61 PREMISES LAYOUT AND ROUTES Current standard Action required By whom Date LIVESTOCK MANAGEMENT PROCEDURES Are there procedures for managing the health of the livestock? New animals introduced to the farm, newly born and newly birthed animals and sick animals, may present a broad range of zoonotic illnesses. They are no more likely to have E. coli O157 than any other animals, but their state may mean that they are more likely to shed this organism into the environment. The current guidance provides advice on good livestock management practice and of cleanliness of livestock quarters (see below). Are animals reasonably clean and their pens without a build-up of faecal material? Cross contamination risks increase where animals are dirty. MANURE & COMPOST HEAPS Are manure and compost heaps and their liquid run-off managed and segregated? Is the spread of faecal matter prevented? Sensible hygiene practices indicate that trafc routes should be clear and methods of segregation, typically fences or channels, set to minimise risks of contamination of hands and footwear and reduce transfer of faecal matter to non-animal areas. 62 SOURCES OF ADVICE There are a number of organisations that offer advice and guidance, some of which is freely available and some which is only available to members. The National Farm Attraction Network http://www.farmattractions.net The Federation of City Farms and Community Gardens http://www.farmgarden.org.uk Farming and Countryside Education http://www.face-online.org.uk/ Farms for Schools http://www.farmsforschools.org.uk/ The National Farmers Union http://www.nfuonline.com/ The National Farmers Union Cymru http://www.nfu-cymru.org.uk/ The National Farmers Union Scotland http://www.nfus.org.uk/ The Association of Show and Agriculture Organisations http://www.asao.co.uk/ Linking Environment and Farming http://www.leafuk.org/leaf/home.eb The Royal Highland Education Trust http://www.rhet.org.uk APPENDIX 2 63
www.gov.uk/defra Consultation on tuberculosis (TB) animal disease controls for deer and camelids.
April 2014
Crown copyright 2014 You may re-use this information (not including logos) free of charge in any format or medium, under the terms of the Open Government Licence. To view this licence, visit www.nationalarchives.gov.uk/doc/open-government-licence/ or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or e-mail: psi@nationalarchives.gsi.gov.uk This document/publication is also available online at: http://www.gov.uk/defra Any enquiries regarding this document/publication should be sent by e-mail to bTBengage@defra.gsi.gov.uk, or by post to: Deer/Camelid Consultation TB Programme Department for Environment, Food and Rural Affairs Area 5D, Nobel House 17 Smith Square London SW1P 3JR
Contents Chapter 1: Introduction ........................................................................................................ 4 Purpose of the consultation .............................................................................................. 4 Who will the proposals affect? .......................................................................................... 4 Why changes are needed? .............................................................................................. 4 Defras Policy Intention ..................................................................................................... 5 How these proposals will be taken forward ...................................................................... 5 Consultation ..................................................................................................................... 5 Disclosure ........................................................................................................................ 6 Confidentiality and Freedom of Information ...................................................................... 6 Responding to the consultation document ....................................................................... 6 Chapter 2: Background to the Policy and Legislation and Proposed Changes .................... 8 General Background to TB Policy in non-bovine domestic species ................................. 8 Question 1: Do you have evidence to support a different approach to TB in non-bovine farmed species? (please specify) ................................................................................. 8 Deer: Background to the Legislation ................................................................................ 8 Question 2: Does the current deer legislation provide a satisfactory framework of essential controls on TB in deer? If not, why not and what is missing? ..................... 9 Question 3: Does the current legislation create unnecessary burdens on deer farmers? What is your evidence; and what would you do about it? ......................... 10 Camelids: Background to the policy ............................................................................... 10 Proposed legislative changes: The changes we propose to make: ................................ 10 Question 4: Are the safeguards proposed (para 2.10(b)) the right ones and are there others that should be put in place to protect the public? ............................................. 11 Question 5: How can we best ensure that all camelid owners are aware of these proposed new powers? ............................................................................................... 11 Legislative changes that we do not propose to make at this time but will keep under review ............................................................................................................................. 12
Question 6: Are there any other comments you wish to make about these proposals? (Please provide evidence in support of further changes you are proposing) .............. 12 Administrative changes to the current arrangements for TB testing of camelids ............ 12 Question 7: Do these administrative changes in TB testing of SAC go: too far, far enough, not far enough? Explain why......................................................................... 13 Annex A: List of consultees ................................................................................................ 14 Annex B: Response Form .................................................................................................. 15 Annex C: Consultation criteria ........................................................................................... 18 Annex D: Economic analysis for a statutory compensation scheme for South American Camelids (SAC) ................................................................................................................. 19 Question 8 Do you know of any further sources on camelid numbers, herd sizes and businesses in England? .............................................................................................. 20 Question 9 Do you have any information on how long it takes farmers to gather and present camelids for testing? ...................................................................................... 21 Question 10 Do you know any further sources on the sale values of camelids, particularly llamas, in England? .................................................................................. 21 Question 11 Do you know any sources of information on the economic returns of different camelid enterprises in England? ................................................................... 21 Question 12 Do you know of any evidence on the economic impact of TB in camelid herds in England? ....................................................................................................... 21
1 Summary of Proposals A consultation issued by the Department of Environment, Food and Rural Affairs Scope of the consultation Topic of this consultation This consultation sets out proposals: (i) to consolidate the two current Tuberculosis (TB) Deer Orders into a single new Order without further alteration in England. This consolidation would streamline the regulatory framework in England and in particular reduce the burden on deer keepers and their veterinary advisers. For information on relevant Orders please see: www.legislation.gov.uk/uksi/1989/878/article/9/made www.legislation.gov.uk/uksi/1989/1316/contents/made www.legislation.gov.uk/uksi/1993/2010/contents/made (ii) for a statutory compensatory payment for positive tested camelids (in particular llamas and alpacas) to keepers for animals that the Secretary of State decides to remove as TB reactors or suspect animals together with proposals for the marking of camelids that react to the TB test; and prohibition of vaccination and therapeutic treatment for TB in camelids. We also propose to introduce statutory powers similar to those already applied in the case of deer to test and slaughter camelids suspected of being affected by TB. (iii) for revised administrative arrangements for testing camelids in TB breakdown situations. See Chapter 2 Scope of this consultation The main purpose of the consultation is to set out proposals and seek your views on the consolidation of the various Deer Orders, and the inclusion of provisions relating to statutory compensation of camelid keepers for the removal of TB infected animals in England. The consultation also includes proposals for changes to the administrative arrangements concerning the testing of camelids in TB breakdown situations. The outcome of the consultation will assist the Department in drafting the replacement Order; and the drawing up of administrative guidance for handling TB breakdown situations.
Subject to the outcome of the consultation, it is proposed that an Order is laid before Parliament in summer 2014. The three existing GB-wide Deer Orders will remain in force in Scotland. The administrative changes are proposed to be introduced concurrently with the replacement Order coming into effect. See Chapter 2 Geographical scope The changes only apply to England.
2 Economic Analysis The proposed changes have been supported by economic analysis. Further information is sought from consultees. See Annex D
Basic information To This consultation will be of particular interest to deer and camelid keepers and vets in England and those bovine and non-bovine animal keepers that farm nearby to such kept animals.
Body/Bodies responsible for the consultation This consultation is being carried out by the Department for Environment, Food and Rural Affairs.
Duration Consultation starts: 9th April 2014 Consultation closes: 6th May 2014
Enquiries During the consultation, if you have any enquiries, or wish to receive hard copies of the consultation documents, please contact:
Camelid/Deer Consultation TB Programme Department for Environment, Food and Rural Affairs Area 5D, Nobel House Smith Square London SW1P 3JR
Email: bTBengage@defra.gsi.gov.uk
How to respond Any comments on the proposals and the economic analysis (Annex D) in this consultation document can be communicated to Defra by responding to an on-line survey on the Citizen Space website. The survey is accessed via the following address: https://consult.defra.gov.uk/bovine- tb/consultation-on-tb-controls-for-deer-and-camelids. The deadline for comments is 6th May 2014.
Alternatively, comments can be e-mailed. To do this, you can either copy the response form (Annex B) into a separate attachment, or copy the questions into an e-mail message, and send - with your answers - to:- bTBengage@defra.gsi.gov.uk
You may wish to print off the response form and send your comments by post to:
Camelid/Deer Consultation TB Programme Department for Environment, Food and Rural Affairs Area 5D, Nobel House Smith Square London SW1P 3JR
3 After the consultation When this consultation ends, we will send respondents a summary of the responses received and our proposed way forward and publish the results on the GOV.UK website. If you do not want your response - including your name, contact details and any other personal information to be publicly available, please tick the box in the on-line survey or (if youre replying by e-mail or by post) on the response form or otherwise say so clearly in writing when you send your response to the consultation. Please note, if your computer automatically includes a confidentiality disclaimer that will not count as a confidentiality request. Please explain why you need to keep details confidential. We will take your reasons into account if someone asks for this information under freedom of information legislation. But, because of the law, we cannot promise that we will always be able to keep those details confidential.
The summary of responses will be put on GOV.UK at https://www.gov.uk/government/publications?publication_filter _option=consultations This summary will include a list of names of organisations that responded but not individual contact details.
Compliance with the Consultation Principles This consultation is being conducted in accordance with the terms of the Governments Consultation Principles see:- https://www.gov.uk/government/uploads/system/uploads/attac hment_data/file/60937/Consultation-Principles.pdf See Annex C
4 Chapter 1: Introduction Purpose of the consultation 1.1 This consultation sets out the Governments proposals for consolidating the provisions of the GB-wide Tuberculosis (Deer) Orders in England. These Orders have already been revoked in Wales by Tuberculosis (Wales) Order S.I. 2011/692. Scottish Governments intention for these Orders is to revoke and replace these Orders in due course. They comprise: The Tuberculosis (Deer) Order 1989 SI 1989 No 878; The Tuberculosis (Deer) Notice of Intended Slaughter and Compensation Order 1989 SI 1989 No 1316; and The Tuberculosis (Deer) (Amendment) Order 1993 SI 1993 No 2010 1.2 This consolidation also provides an opportunity to look across the piece in England at tuberculosis (TB) regulation of non-bovine animals generally (particularly goats, pigs and sheep). We have concluded that the current approach to the disease in non-bovines is proportionate, but we will continue to keep the situation under close review. Nevertheless, this consolidation of the three Deer Orders in England does create an opportunity to introduce a statutory TB compensation scheme for camelids (in particular alpacas and llamas) and other statutory measures similar to those that already apply to deer. This proposal for a statutory compensation scheme replaces the present non-statutory TB payment where keepers agree to hand over reactors for slaughter in return for Government TB testing their animals. 1.3 This consultation on a statutory compensation scheme for camelids is also an opportunity to consult widely on proposals for improved testing of these animals in TB breakdown situations. Who will the proposals affect? 1.4 Those owning or keeping deer or camelids on land in England that may be affected or suspected of being affected by TB caused by Mycobacterium bovis (M. bovis), the bacterium that causes TB in cattle and other animals. Why changes are needed? 1.5 English deer farmers and their vets have to consult three separate Orders to understand what they need to do when TB affects a deer herd. This proposal consolidates these Orders into one document without making any substantive change to the present arrangements. 1.6 The non-statutory slaughter arrangements with payment made to camelid keepers to remove animals suspected to be infected with TB was introduced in 2008 as a
5 temporary measure. There is an ongoing need to remove animals suspected of having TB in order to prevent the spread of this disease that can devastate small businesses. This consolidation of the deer Orders provides an opportunity to establish statutory compensation and to introduce other measures where camelids are tested positive or suspected of TB. 1.7 Research has shown that the tuberculin skin test used on camelids is only moderately successful in detecting animals infected with the bovine TB bacterium M.bovis, but that sensitivity of detection of the bacterium can be dramatically increased (to approximately 80 percent by using a combination of two antibody (blood) tests in parallel interpretation It is proposed to introduce administrative changes in the testing regime of TB-infected camelid herds and other at-risk herds to reflect this new situation. Defras Policy Intention 1.8 The policy objectives for these changes are to- o reduce administrative burdens for deer farmers vets and relevant external stakeholders by consolidating old Animal Health Act 1981 Orders; o increase certainty about the basis on which compensatory payments are made to camelid keepers for the removal of their TB-affected animals; while providing better safeguards for the public; and o administratively deploy better, mandatory, tests and improve the clarity over roles and responsibilities. How these proposals will be taken forward 1.9 We propose to revoke the Deer Orders in England in line with the Departmental commitment to the Governments Red Tape Challenge; and to use the opportunity to utilise this non-bovine TB Order to introduce: statutory testing of camelids; a power to slaughter animals testing positive; a compensation scheme; and other measures regarding marking, and the prohibition of vaccination and therapeutic treatments for camelids. Alongside the legislative changes the main administrative change on camelid testing (mandatory antibody testing along with the existing skin test) will be delivered by the Animal Health and Veterinary Laboratories Agency (AHVLA) following a suspicion of exposure of animals to the M.bovis bacterium. Consultation 1.10 The list of consultees, including the devolved administrations, to which this document has been sent, is at Annex A. 1.11 Comments are invited from all interested parties, and not just from those to whom the document has been sent.
6 1.12 This consultation document follows the format recommended by Better Regulation Executive for such proposals. The criteria applicable to all UK public consultations under the Consultation Principles are set out in Annex C. Disclosure 1.13 Normal practice will be for details of representations received in response to this consultation document to be disclosed, and for respondents to be identified. 1.14 You should note that: If you request that your representation is not disclosed, the Minister will not be able to disclose the contents of your representation without your express consent and, if the representation concerns a third party, their consent too. Alternatively, the Minister may disclose the content of your representation but only in such a way as to anonymise it. In all cases where your representation concerns information on a third party, the Minister is not obliged to pass it on if he considers that disclosure could adversely affect the interests of that third party and he is unable to obtain the consent of the third party. 1.15 Please identify any information which you or any other person involved do not wish to be disclosed. You should note that many facsimile and e-mail messages carry, as a matter of course, a statement that the contents are for the eyes only of the intended recipient. In the context of this consultation such appended statements will not be construed as being requests for non-inclusion in the post consultation review unless accompanied by an additional specific request for confidentiality, such as an indication in the tick-box provided for that purpose in the on-line survey or in the response form at Annex B, or if you choose to send an e-mail make it clear in your message. Confidentiality and Freedom of Information 1.16 It is possible that requests for information contained in consultation responses may be made in accordance with access to information regimes (these are primarily the Freedom of Information Act 2000, the Data Protection Act 1998 and the Environmental Information Regulations 2004). If you do not want your response to be disclosed in response to such requests for information, you should identify the information you wish to be withheld and explain why confidentiality is necessary. Your request will only be acceded to if it is appropriate in all the circumstances. An automatic confidentiality disclaimer generated by your IT system will not of itself be regarded as binding on the Department. Responding to the consultation document 1.17 As mentioned under Basic Information on page 2, any comments on the proposals and the economic analysis (Annex D) in this consultation document should be submitted to
7 Defra by 6th May 2014. This can be done in a variety of ways: o By responding to an on-line survey on the Citizen Space website. The survey is accessed via the following address: https://consult.defra.gov.uk/bovine- tb/consultation-on-tb-controls-for-deer-and-camelids. o Alternatively, comments can be e-mailed. To do this, you can either complete the response form (Annex B) and copy into a separate attachment or copy the questions into an e-mail message and send - with your answers - to: bTBengage@defra.gsi.gov.uk o We should also be grateful for any comments on the economic analysis which accompanies the consultation document. o You may wish to print off the response form and send your comments, or any requests for further copies of this document, to:
Camelid/Deer Consultation TB Programme Department for Environment, Food and Rural Affairs Area 5D, Nobel House 17 Smith Square London SW1P 3JR Tel: 020 7238 6735
8 Chapter 2: Background to the Policy and Legislation and Proposed Changes General Background to TB Policy in non-bovine domestic species 2.1 The TB Strategy published on 3 rd April 2014 1 explains that many species of non- bovine farmed South American Camelids (SAC), captive deer, goats, pigs and sheep, companion animals (e.g. cats, dogs and ferrets), zoo and wild mammals are susceptible to M. bovis infection. Only a relatively small number of such animals are identified as infected each year through scanning surveillance and the evidence suggests that, with the exception of the badger, these species are generally spillover hosts and appear to pose a very small risk of spreading M. bovis to cattle and badgers. 2.2 Defra keeps the evidence under ongoing review but the current policy approach to surveillance and TB testing of non-bovines is a proportionate one. Now that the TB Strategy has been published we will revisit the matter of TB in non-bovine species generally but, as a first step, the Government is proposing to consolidate the existing Deer Orders in England. We are also proposing to introduce statutory testing and slaughter of camelids testing positive; a statutory compensation scheme; a power to mark animals that are to be removed and a statutory prohibition on vaccination and therapeutic treatments that may adversely affect TB testing. We also plan to update administrative TB testing arrangements. Question 1: Do you have evidence to support a different approach to TB in non-bovine farmed species? (please specify) Deer: Background to the Legislation 2.3 The Tuberculosis (Deer) Order 1989 contains provisions relating to tuberculosis in deer and, in particular, provides for a. the compulsory notification of tuberculosis in deer and in carcasses of deer (articles 5 and 6); b. the investigation by a veterinary inspector into the existence of tuberculosis in deer and the examination by him of deer and their carcasses for this purpose (article 6(1), (2) and (3));
9 c. the imposition (by notice in Form A served by a veterinary inspector) of certain requirements in respect of deer which are affected or suspected of being affected with tuberculosis, including the isolation of such deer from all other deer and from cattle (article 6(4), (5) and (6)); d. the testing of deer (if required by notice) and the reporting of the results of such tests (article 7); e. the prohibition of the vaccination and treatment of deer for tuberculosis (article 8); f. precautions which may be required (by notice) to be taken against the spread of tuberculosis in deer, including the isolation of deer and the cleansing and disinfection of premises (articles 9 and 10); g. the marking and identification of deer (article 13); h. the prohibition of the exposure for sale in a market of a deer by its owner unless it is marked or identified in accordance with the provisions of the Order and the mark or identification is clearly legible (article 14); and i. offences (article 17). We intend to make minor changes to the notice provisions (f) above to tailor them more closely to comparable provisions in Article 18 of the Tuberculosis Order (England) 2007 2
which mainly deals with TB in bovine animals. 2.4 The Tuberculosis (Deer) Notice of Intended Slaughter and Compensation Order 1989 prescribes the amount of compensation payable for deer slaughtered by the appropriate Minister due to tuberculosis infection under section 32 of the Animal Health Act 1981. The compensation payable is 600 or 50 per cent of its market value (calculated in accordance with the provisions of the Order), whichever is the less (article 4). Compensation payable for the slaughter of deer which are required to serve as controls during the quarantine of imported deer is limited to their carcass value, less reasonable expenses (article 5). The Order also requires the appropriate Minister, where he intends to cause a deer to be slaughtered under section 32, to serve a notice of intended slaughter on the owner or person in charge of the deer requiring him to detain and isolate the deer pending such slaughter (article 3 and Schedule). 2.5 The Tuberculosis (Deer) (Amendment) Order 1993 amends the Tuberculosis (Deer) Order 1989 to remove the general requirement for marking or identifying farmed deer. Marking is required for deer carcasses (other than wild deer) and live deer which are to be moved on or off premises, and deer which are to be tested for tuberculosis. Question 2: Does the current deer legislation provide a satisfactory framework of essential controls on TB in deer? If not, why not and what is missing?
10 Question 3: Does the current legislation create unnecessary burdens on deer farmers? What is your evidence; and what would you do about it? Camelids: Background to the policy 2.6 Camelid keepers have since 2008 received a non-statutory payment when agreeing to the testing and slaughter of a TB confirmed or suspect animal. The non-statutory payment was always seen as a temporary measure to meet an immediate need; and that a statutory payment scheme should be introduced in due course. This consolidation of the Deer Orders provides just such an opportunity. 2.7 The proposed statutory compensation scheme is being introduced alongside administrative changes to AHVLAs TB testing regime, the details of which are set out below. To safeguard the public interest, as in the case of deer, we propose to introduce statutory controls to mark animals that are to be removed for slaughter as TB reactors and to prohibit vaccination and the use of therapeutic or prophylactic TB treatment as these may affect TB testing results. With the introduction of the statutory compensation scheme we propose that the new Order should contain explicit provisions in one piece of legislation to make it clear what keepers can expect in terms of testing of their animals and the removal of TB reactors. 2.8 Because of the low sensitivity of the tuberculin skin test in camelids an antibody (blood) test has been used to supplement the skin test on a research basis since 2006. As a piece of research it was reasonable to seek the voluntary agreement of keepers to its deployment. In 2011 antibody tests for TB in camelids were validated by AHVLA, since when discussions with the industry have taken place regarding their wider deployment. Separately the industry has sought to develop proposals for a voluntary health surveillance scheme on which discussions are continuing but Defra reserves its position to look again at options for statutory surveillance if the voluntary industry scheme cannot deliver the desired results. With all the necessary research complete the Government proposes for now to continue to pay for skin and blood testing in herds in which TB has been identified or is suspected, and compensate keepers for the removal of their affected animals for slaughter. Proposed legislative changes: The changes we propose to make: (i) Deer 2.9 Taken together, we believe the current Deer Orders made under the Animal Health Act 1981 set out a sensible and proportionate structure for controlling TB in the farmed and park deer sector. There has been no major pressure for change since their introduction in 1989. For that reason we are proposing in England to consolidate all of the current provisions into a single Order which will make it easier for the deer keeper, their vet and other stakeholders to establish their duties and legislative requirements.
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(ii) Camelids 2.10 We propose to: (a). Introduce statutory payment of compensation to camelid keepers for the slaughter of affected animals under section 32(3) of the Animal health Act 1981 at the same fixed rate as currently paid under the non-statutory arrangement (750 per animal). (b). Also introduce safeguards: i. that provide for the marking of animals that are to be removed for slaughter and prohibition of vaccination, and ii. prohibit the use of therapeutic or prophylactic TB treatments of camelids since these may affect TB testing results and increase the risk of developing M. bovis strains that are resistant to drugs used to treat TB in humans. Question 4: Are the safeguards proposed (para 2. 10(b)) the right ones and are there others that should be put in place to protect the public?
(c). Introduce statutory powers of testing and removal of TB reactors alongside the statutory compensation. We propose in addition that where a keeper: - fails to co-operate with the AHVLA testing requirements then they will under the proposed new Order be responsible to reimburse the Government for any testing costs and expenses reasonably incurred by the Secretary of State for the purpose of making good the keepers default (similar to the position under article 8(4) of the bovine TB Order S.I. 2007/740). - refuses to allow their animals to be tested the keeper will be committing an offence under the Animal Health Act 1981 and the herd will be placed under movement restriction until such time as the disease risk is determined to have ended. The proposed Order is made under the Animal Health Act 1981 and therefore inspector powers of entry, testing, seizure and slaughter are all contained in the parent Act and therefore are not replicated in the Order. As with other 1981 Act Orders this proposed Order will be enforced by local authorities. Obstruction of inspectors in the exercise of their duties and non-compliance with any requirements of the Order will be prosecuted under the 1981 Act. Question 5: How can we best ensure that all camelid owners are aware of these proposed new powers?
12 Legislative changes that we do not propose to make at this time but will keep under review (i) Deer 2.11 From our conversations with stakeholders we are aware that some in the deer farming industry would like changes made: to the level of TB compensation; to arrangements for the TB testing of deer to allow for blood testing; and to remove the requirement for deer farmers to pay for TB tests. 2.12 The Animal Health and Welfare Board for England (AHWBE) has been reviewing compensation generally and we propose to revisit compensation for deer when that review has completed its work. 2.13 The tuberculin skin test is currently the only internationally recognised standard for TB testing of deer. We have encouraged the deer industry to consider carrying out their own research to validate blood tests as supplementary ante-mortem diagnostic tools for TB in captive deer, and if that happens successfully we will look again at whether to provide for such additional validated tests. 2.14 The costs of TB testing of deer are currently borne by deer farmers and we propose to look again at the whole issue of who pays for testing as part of a wider consultation on TB in non-bovine animals. (ii) Camelids 2.15 From our conversations with stakeholders we are aware that some in the industry would like changes made to the level of TB compensation. 2.16 AHWBE has been reviewing compensation generally and we propose to revisit this when that review has completed its work. Question 6: Are there any other comments you wish to make about these proposals? (Please provide evidence in support of further changes you are proposing) Administrative changes to the current arrangements for TB testing of camelids 2.17 Based on all the available evidence the Government does not propose to change the current arrangements and introduce a statutory surveillance scheme for TB in camelids like the one we have for cattle. But the Government is proposing to deploy better tests to identify disease and to do this within a statutory framework similar to that which has successfully been used for deer for more than 20 years. To date AHVLA staff have in many cases been prepared to invest extra time and effort to persuade keepers to have their animals TB tested only to find some keepers change their minds about testing or the removal of reactors when the results are known. We intend that with the introduction of
13 statutory compensation the present voluntary form of agreement should be replaced by a notice requiring camelid keepers to test animals, and those that test positive to TB will be subject to a notice of intended statutory slaughter. 2.18 We propose the new testing regime for known infected herds will comprise a tuberculin skin test with injection of bovine tuberculin only (i.e. a more severe interpretation than that currently used) followed by two antibody blood tests in parallel interpretation (i.e. with animals positive to either or both tests being considered infected and removed). The Government will continue to pay for this skin and blood testing and compensate keepers for the removal of their affected animals with the same level of payment for animals that are culled until the outcome of the AHWBE review of compensation is known. By making these more sensitive tools available the Department will expect keepers to cooperate with veterinary inspectors carrying out the timely testing of their animals. 2.19 At present TB screening of any animal that may have been moved out of a TB- infected herd before the infection was diagnosed on the premises of origin is by comparative skin testing only. With the availability of validated antibody TB tests, the Government proposes that any spread-tracings instigated by AHVLA from herds with confirmed M. bovis TB will be subject to the same TB testing regime as the infected herd of origin. In other words, animals identified as TB spread-tracings will have to pass a single (bovine tuberculin only) intradermal test followed by two antibody blood tests in parallel interpretation, at the Governments expense. 2.20 There are other cases where M. bovis infection is only suspected in a camelid herd, but not confirmed by laboratory culture, or where a herd are identified by AHVLA as being at risk of TB because of their proximity or epidemiological links (known as back- tracing) to infected, cattle, deer, goats or other camelids. In those situations, the Department proposes to use the current comparative skin test followed by the dual antibody test with serial interpretation (i.e. removing only SAC that are positive on both antibody tests) at the Departments expense. 2.21 As llamas and alpacas are traded internationally and any TB breakdowns abroad caused by undetected TB-infected animals exported from the UK could have serious implications for the reputation of UK plc, particularly in Europe. The Department is proposing that the guidance for exporters is amended so that they should undertake (and pay for) private pre-export TB testing using the existing skin and an antibody TB test of their choice in the 30 days prior to date of export. If exporters fail to act in accordance with the revised guidance the Department will consider other actions, including regulation, to protect the UKs export market. 2.22 The changes proposed here will be complemented by revised guidance on the TB testing of camelids, to ensure that keepers of these animals have the best available information to inform the important decisions that they may be called upon to make. Question 7: Do these administrative changes in TB testing of camelids go: too far, far enough, not far enough? Explain why
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Annex A: List of consultees
British Alpaca Society British Deer Farms and Parks Association British Llama Society British Veterinary Association British Veterinary Camelid Society Camelid TB Support & Research Group Country Land and Business Association National Farmers Union Scottish Government Veterinary Deer Society Welsh Government
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Annex B: Defra Consultation on tuberculosis (TB) animal disease controls for deer and camelids - Response Form
Questions
Question 1: Do you have evidence to support a different approach to TB in non-bovine farmed species? Yes/No* (*delete as appropriate)
(If yes, please specify)
Question 2: Does the current deer legislation provide a satisfactory framework of essential controls on TB in deer? Yes/No* If not, why not and what is missing?
Question 3: Does the current legislation create unnecessary burdens on deer farmers? Yes/No* If yes, what is your evidence; and what would you do about it?
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Question 4: Are the safeguards proposed (para 2.10(b)) the right ones and are there others that should be put in place to protect the public? Yes/No*
Question 5: How can we best ensure that all camelid owners are aware of these proposed new powers?
Question 6: Are there any other comments you wish to make about these proposals? Yes/No* (Please provide evidence in support of further changes you are proposing)
Question 7: Do these administrative changes in TB testing of SAC go: too far/far enough/not far enough?* Explain why.
Question 8: Do you know of any further sources on camelid numbers, herd sizes and businesses in England? Yes/No* (If yes, please specify)
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Question 9: Do you have any information on how long it takes farmers to gather and present camelids for testing? Yes/No* (If yes, please specify)
Question 10: Do you know any further sources on the sale values of camelids, particularly llamas, in England? Yes/No* (If yes, please specify)
Question 11: Do you know any sources of information on the economic returns of different camelid enterprises in England? Yes/No* (If yes, please specify)
Question 12: Do you know of any evidence on the economic impact of TB in camelid herds in England?
If you do not want your response - including your name, contact details and any other personal information to be publicly available, please tick the box or otherwise say so clearly in writing when you send your response.
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Annex C: Consultation criteria The criteria in the "Consultation Principles" (http://www.cabinetoffice.gov.uk/resource- library/consultation-principles-guidance) apply to all UK national public consultations on the basis of a document in electronic or printed form. Though they have no legal force, and cannot prevail over statutory or other mandatory or external requirements (e.g. under European Community law) they should otherwise generally be regarded as binding on UK Departments and their agencies unless Ministers conclude that exceptional circumstances require a departure. The key Consultation Principles are: departments will follow a range of timescales rather than defaulting to a 12-week period, particularly where extensive engagement has occurred before; departments will need to give more thought to how they engage with and consult with those who are affected; consultation should be digital by default, but other forms should be used where these are needed to reach the groups affected by a policy; and the principles of the Compact between government and the voluntary and community sector will continue to be respected. Defra believes that in relation to this particular consultation that we have followed the criteria. If you have any comments in relation to Defras approach to consultation then they may be contacted at: consultation.coordinator@defra.gsi.gov.uk. Please do not send specific responses to this consultation to the consultation co-ordinator. We will be happy to receive those at: BTBengage@defra.gsi.gov.uk.
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Annex D: Economic analysis for a statutory compensation scheme for South American Camelids (SAC) Rationale for intervention and intended effects Bovine TB (TB, caused by Mycobacterium bovis) is a serious infectious, often fatal, bacterial disease of cattle and other mammals, including South American camelids: alpacas and llamas. In England, around 9 camelid herds per year are identified by Animal Health & Veterinary Laboratories Agency (AHVLA) with confirmed new TB infections caused by M. bovis. The government intervenes generally because actions taken by one animal keeper in relation to TB on his or her premises may allow onward spread that causes losses and costs to others (including keepers of other susceptible species). Such interventions are in proportion to the risks involved. Current government intervention with herds of camelids that have TB is partly based on voluntary agreement with keepers. The law does not specify the flat 750 public-funded non-statutory payment that is currently offered for each animal identified as affected and culled. Section 32(3) of the Animal Health Act 1981 requires compensation to be set down in an Order and the lack of a statutory compensation scheme leaves the government unable to invoke other statutory control measures (powers of entry, testing and removal of animals) in a limited number of cases. Defra lawyers have advised that a statutory compensation scheme must be placed in law. The primary aim is to improve disease management by ensuring all camelid keepers with animals affected by TB undergo a new enhanced testing regime (comprising compulsory skin and double blood testing); and for those who currently refuse to have their herd tested to comply. TB blood testing of infected camelid herds has been voluntary. Camelid keepers could get their animals de-restricted on the back of negative skin test results alone, thus increasing the risk of leaving infected animals undetected in the herd compared with the far more sensitive combined skin and blood TB testing regime. Policy options Defra has considered the risks of retaining the current (business as usual) arrangements as well as those associated with withdrawing all government support for TB in camelids. On balance Defras preferred option is to establish a statutory compensation scheme with compensation at the current non-statutory payment level of 750 per animal culled.
The introduction of a statutory scheme will enable AHVLA to invoke other statutory powers to enter premises and test when there is a suspicion of TB, and remove animals where necessary.
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Benefits from the preferred option
a) Improved control of TB. b) Reducing the potential spread of TB as infected animals could further spread the disease in the herd, or even off the premises, particularly in the final stages of the disease. c) A possible welfare gain of quickly culling infected animals rather than leaving them to die of TB.
Risks and Uncertainties
Future levels of TB in camelids are uncertain, as is the future number of camelids slaughtered due to additional testing along with their potential value given the wide range of infection prevalence within affected herds. There is a risk of non-cooperation when mandatory blood testing is rolled out, as some in industry are known to be sceptical of blood testing.
Economic analysis
South American Camelids in England
We have limited evidence of the impact of TB and the controls on the camelid industry. As a result, a number of assumptions have been made to estimate the economic impact of introducing a statutory compensation scheme for camelid keepers.
Based on advice from the British Llama Association (BLA) and British Alpaca Society (BAS) we estimate there are between 28,000 and 34,000 camelids in England, a third of which are kept by 250-300 commercial businesses. This suggests an average business herd size of 37. These businesses are mainly breeders plus fleece producers, meat producers, and trekking establishments.
Question 8: Do you know of any further sources on camelid numbers, herd sizes and businesses in England?
Defra statistics
show that around 65 camelid businesses were affected by TB in England in 2012 and there have been on average 9 new breakdowns confirmed by culture in England per year. Per breakdown, around 8 animals are slaughtered with 74 slaughtered in total per year on average. This has led to 55,500 paid in compensation per year.
Impacts on businesses of TB controls
TB controls in camelids include: testing for disease; movement restrictions on premises that are found to have disease or refuse testing; and, the removal and slaughter of TB affected animals. These controls, whilst they are designed to control and prevent further disease, will impose costs on keepers.
The majority of the costs of testing are currently paid by AHVLA including vet fees, transport of samples and culture. However, we recognise that keepers face costs in
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gathering and presenting animals for testing. This has been estimated at an average of 2 hours per test, monetised using standard farm labour wage rates from Nix 2013.
Question 9: Do you have any information on how long it takes farmers to gather and present camelids for testing?
Early identification and culling of camelids that are infected with TB may impose costs on keepers where they could have gained further enjoyment and economic value from them. This will depend upon the length of time a camelid could live undetected with TB and the economic value of the animal over that time. Whilst the current non-statutory payment takes some account of the replacement value of camelids, the true economic loss is measured by their economic potential.
We have limited information on the economic returns for different camelid enterprises. We have used the sales values of cria (young camelids) from www.alpacaseller.co.uk and production costs from Nix to estimate the potential economic value for breeding stock.
Question 10: Do you know any further sources on the sale values of camelids, particularly llamas, in England?
Question 11: Do you know any sources of information on the economic returns of different camelid enterprises in England?
Any costs need to be viewed against the benefits of earlier disease detection, prevention of onward spread within the herd or into neighbouring farms/wildlife and the possible welfare gain of culling infected animals sooner.
Question 12: Do you know of any evidence on the economic impact of TB in camelid herds in England?
Sources of evidence
Defra stats: https://www.gov.uk/government/statistical-data-sets/other-tb-statistics Nix (2014) John Nix Farm Management Pocketbook, 44 th Edition, Agro Business Consultants. Sensitivity of combined skin and blood testing: Veterinary advice, based on AHVLAs report of TB blood test evaluation study in alpacas (Rhodes et al. 2012)
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and peer-reviewed published research: http://cvi.asm.org/content/19/10/1677 and http://cvi.asm.org/content/18/12/2143 Dean et al. (2009) Use of serological techniques for diagnosis of Mycobacterium bovis infection in a llama herd http://www.ncbi.nlm.nih.gov/pubmed/19749210 Alpaca sale value: www.alpacaseller.co.uk
60 Chapter 4: The Regulatory Framework for Open Farms 61 Chapter 4: The Regulatory Framework for Open Farms Chapter 4: The Regulatory Framework for Open Farms 4.1 Regulatory Control of Open Farms 4.2 Current UK Legislation 4.3 Main Regulatory Bodies 4.4 Inspection Procedures 4.5 Standards for Farms including Open Farms 4.6 References Key Points The legal and institutional framework for protection of human health and the prevention of disease outbreaks in Great Britain is complex. The prevention of an outbreak involves different laws and combinations of regulatory authorities from those involved in the control of an outbreak of disease Separate regimes have been set up by Parliament for animal health including zoonoses, public health, food safety and occupational health and safety. Each regime is the responsibility of a different Government Department, with separate agencies and different mechanisms for delivery of the intended outcomes Four separate streams of legislation apply to health hazards that may be present at Open Farms, covering: Public health Food safety Animal health Health and safety at work Prevention of risks to human health arising at Open Farms is governed principally by food safety, and by health and safety law which covers risks to visitors and depends primarily on compliance by farm operators with statutory duties There is a wide range of regulatory and enforcement options for the control of risks to health and safety. Options include prohibition, licensing, regulations, approved codes of practice and non-statutory guidance Responsibility for enforcing the law at farms is shared between the Health and Safety Executive (HSE) and the local authorities (LAs), depending on the kind of activity at each farm. Inspectors have powers to serve improvement or prohibition notices and to prosecute International comparisons show that there is no European Directive for Open Farms but we found some regulations and guidance in individual European countries, plus North American and Australian States. The Netherlands is currently strongly considering replacing its current guidance system with an enforceable statute in view of the risk of zoonotic infection. 62 4.1 Regulatory Control of Open Farms Different kinds of farm-related activity are regulated in different ways and by different authorities, as set out in detail in a paper by Weightmans Solicitors commissioned by the Health Protection Agency (HPA) (i). Prevention of outbreaks of disease at Open Farms involves laws and a combination of regulatory authorities that differ from those involved in investigation and control of an outbreak. Prevention depends on compliance by farm operators with duties laid down in food safety, and in health and safety laws. Food safety law is enforced by LAs whereas responsibility for enforcing health and safety law is shared between LAs and the national health and safety regulator, the HSE, depending on the kind of activity at each farm. The HSE inspects the vast majority of agricultural premises but enforcement of health and safety law at Open Farms is the responsibility of LAs, for the reasons described below. The HSE and LAs maintain a joint liaison committee (HELA) (1), set up in 1975 to provide effective liaison between enforcing authorities. HELA seeks to ensure that health and safety legislation is enforced consistently among LAs and between LAs and the HSE. It provides a national forum for discussion and exchange of information, and issues guidance on enforcement of legislation to the HSEs inspectors and LAs, whose Environmental Health Offcers (EHOs) carry out health and safety inspections as well as performing other functions such as food hygiene inspections at Open Farms. The allocation of enforcement responsibilities under the Health and Safety (Enforcing Authority) Regulations 1998 in respect of farm-related activities is fragmented, as can be seen below in an extract from an administrative circular (2) interpreting the 1998 regulations. Issued to LAs by HELA, it contains an A-Z guide explaining the allocation of responsibility for enforcement at various kinds of premises including agricultural, entertainment and leisure activities (see extracts in Table 4.1). Chapter 4: The Regulatory Framework for Open Farms 63 Table 4.1: Responsibility for health and safety enforcement at premises for agricultural, entertainment and leisure activities Type of activity Agency responsible Scope of responsibility Agricultural activities HSE Reg.2(1)(a) defnes this as including horticulture, fruit growing, seed growing, dairy farming, livestock breeding and keeping, including the management of livestock up to the point of slaughter or export from Great Britain, forestry, the use of land as grazing land, market gardens and nursery grounds and the preparation of land for agricultural use. (Sch 2 para 7). But these activities are not defned as agricultural activities when carried out at a garden centre or other shop. (Reg. 2(1)(b)). LA enforced. For this purpose livestock breeding and keeping does not include activities the main purpose of which is entertainment. (Reg 2(1)). Thus Open Farms visited by the general public would be LA enforced. Agricultural shows HSE Any activity at an agricultural show which involves the handling of livestock or the working of agricultural equipment. (Sch 2 para 7). Horses do not fall within defnition of livestock unless used for any agricultural activity, eg, ploughing. LA where no agricultural activity, unless part of a farm and not a separate legal entity. Animals, birds or other creatures LA In connection with the care, treatment, accommodation or exhibition except as below. HSE Where the main activity is horse breeding or horse training at a stable, or is an agricultural activity or veterinary surgery (Sch 1 para 11). Handling of livestock (Sch 2 para 7), fsh, maggot and game breeding except in a zoo (Sch 2 para 10). Research. Education HSE Entertainment (public) LA HSE has responsibilities where the LA is the duty holder and for specifc Sch 2 activities in premises, eg, fairgrounds, broadcasting, recording, flming, and any activity at an agricultural show which involves the handling of livestock or the working of agricultural equipment. Leisure/cultural activities LA Sch 1 para 9 allocates a wide range of premises to LAs, for example sports facilities, cinemas, circuses, racecourses, riding schools, etc. Cultural activities will include non-educational pursuits such as dance schools, other than those attached to schools. HSE Where the main purpose of the premises is educational or vocational training similar to that provided in the mainstream educational system, such premises will remain with HSE including their evening use for leisure purposes.
Pony trekking LA/ HSE The enforcing authority will depend on the main activity. May be subject to the Adventure Activities Licensing Regulations 1996. Zoos LA (Sch 1 para 11). Source: HELA administrative circular LAC 23/15 64 Open Farms are not specifcally defned by the 1998 Regulations but as their main purpose has been identifed by HELA as entertainment they are the responsibility of LAs (Table 4.1). These arrangements mean that the national health and safety regulator is responsible for, say, 100,000 agricultural holdings throughout Great Britain (3), including farms that open only occasionally to the public, whereas a few hundred Open Farms are inspected by LAs. In practice, most LAs will each have only one or two Open Farms to inspect. Regulation 5 of the Regulations allows enforcement responsibility for any particular premises or activity to be transferred from the HSE to the LA, or vice versa. 4.2 Current UK Legislation The legal and institutional frameworks for protection of human health and the prevention of outbreaks are complex. Over time, separate regimes have been set up by Parliament for animal health (including zoonoses), public health, food safety and occupational health and safety. Each regime is the responsibility of a different Government Department, with separate agencies and different mechanisms for delivery of the intended outcomes. England and the devolved administrations in Scotland, Wales and Northern Ireland have each established their own regulatory institutions and pursue their own policies for public health, animal health and food safety, whereas health and safety at work has not been devolved but remains reserved to the Westminster Parliament. These complicating factors have relevance to the issues we have been asked to address. 4.2.1 Prevention Health and Safety Law There is no European or international regulatory standard for Open Farms. Thus health and safety law applies for the prevention of risks to human health from activities at Open Farms in Great Britain. Health and safety law was reformed in the early 1970s after Parliament decided that Britains performance in preventing work-related injuries and ill health was unsatisfactory. The Health and Safety at Work etc Act 1974 (HSWA), based on the common law duty of care, has replaced the previous prescriptive and outdated requirements that had accumulated over the years in the Factories Acts. HSWA applies across the whole of Great Britain. It is goal-setting in the sense that it requires an outcome to be achieved rather than being prescriptive in setting out rigidly what has to be done. Sections 2 to 7 of the Act contain the so-called general duties of employers and others for ensuring the protection of human health and safety. These general duties always apply, whether or not additional measures are specifed. Essentially, they require employers to ensure the health and safety of employees so far as is reasonably practicable (SFAIRP). The term so far as is reasonably practicable has been the subject of interpretation by the Courts. In the decided case of Edwards v National Coal Board (4), Lord Asquith said: Reasonably practicable is a narrower term than physically possible and seems to me to imply a computation must be made by the owner in which the quantum of risk is placed on one scale and the sacrifce involved in the measures necessary for averting the risk (whether in money, time or trouble) is placed in the other, and that, if it be shown that there is a gross disproportion between them the risk being insignifcant in relation to the sacrifce the defendants discharge the onus on them. Chapter 4: The Regulatory Framework for Open Farms 65 Section 3 of the Act is particularly relevant to businesses such as Open Farms or fairgrounds which invite members of the public into their premises, as it requires every employer to conduct his undertaking in such a way as to ensure, so far as is reasonably practicable, that persons not in his employment who may be affected thereby are not thereby exposed to risks to their health or safety. Risks to the health of visitors from activities such as arise in the running of an Open Farm are thus clearly covered by Section 3. In addition to these general duties, the Act allows a range of other regulatory options. These may be described as a hierarchy of regulatory controls that may be applied to risks ranging from high to low as illustrated by Figure 4.1. Figure 4.1: The hierarchy of regulatory controls that may be applied to risks Risk Tolerability Regulatory options Extremely high Intolerable Bans, proscriptions High Licensing, permits Notifcation, registration Special regulations Medium Approved Codes of Practice (ACoPs) Low Guidance Very low Insignifcant Ignore A very dangerous substance or activity may be banned. However bans are unusual as much can often be done technically or through safe systems of work to eliminate or considerably reduce the hazard and so remove or reduce the risk. For high risks which are not banned the law expects the maximum effort in terms of time, trouble and expense in order to reduce them to a level as low as reasonably practicable. A licence to operate may be required to which conditions may be attached (eg, for the safe operation of nuclear power stations, for stripping of asbestos from buildings or for businesses running adventure activities). Alternatively a safety case might have to be submitted for acceptance by the regulator before operations may begin (as in the case of offshore oil and gas installations). 66 Special regulations may be made under the Act to deal with a particular hazard (eg, lead, asbestos, electricity) and may apply either to all or certain industries. Many apply to Open Farms and some with particular relevance to this Investigation are: The Management of Health and Safety at Work Regulations 1999 (5) which make more explicit the general duties contained in HSWA, require among other fundamental provisions that employers appoint a competent person and carry out a risk assessment and (if more than fve persons are employed) record signifcant fndings The Health and Safety (Enforcing Authority) Regulations 1998 (6) which allocate responsibility for enforcement of health and safety legislation (HSE) at different kinds of premises and activities between HSE and LAs. These are set out in Schedules to the regulations The Control of Substances Hazardous to Health Regulations 2002 (COSHH) (7) extends to microbiological risks. The regulations impose duties on employers and require among other things that they do not carry out work which is liable to expose any employees to any hazardous substance unless they have made a suitable and suffcient assessment of the risk and of the steps that need to be taken to meet the (other) requirements of the regulations. The duties on employers extend to other persons (including members of the public) who may be affected by their work activities. 4.2.2 Great Britains National Strategies for Health and Safety In 2000 the HSE agreed a strategy (8) with the Government for Revitalising health and safety at work, in which targets were set to reduce the incidence of injury and ill health and the number of days lost from work; to be achieved by 2010. A key element of this strategy was to reduce the incidence of ill health at work. Following a review, HSE announced in September 2004 that delivery of these targets would in future be addressed by two strategic programmes Fit for work, ft for life, ft for tomorrow (9) and Major Hazards. Subsequently, HSE and the local authorities entered into a Partnership Agreement through which they committed to working more closely together in future. In June 2009 and following a public consultation exercise, HSE launched a new strategy, The Health and Safety of Great Britain: Be part of the solution (10) and a joint Statement of Commitment, agreed by HSE and the Local Authorities Co-ordinators of Regulatory Services (LACORS) to further embed and consolidate partnership working, see: www.hse.gov.uk/lau/statement.htm. Chapter 4: The Regulatory Framework for Open Farms 67 4.3 Main Regulatory Bodies It is not only the legal framework that is complex. A multifaceted administrative network exists, comprising several separate departments, agencies and authorities with responsibilities or interests touching on Open Farms to a greater or lesser extent. Principal among these in England and Wales are the following: For public health: Department of Health (DH) HPA reports to DH LAs Department for Environment, Food and Rural Affairs (Defra) and Veterinary Laboratories Agency (VLA), an agency of Defra For animal health: Defra Animal Health (AH), an agency of Defra VLA LAs For food safety: Food Standards Agency (FSA) LAs Defra For health and safety at work Department of Work and Pensions (DWP) HSE LAs. LACORS is part of the Local Government Association Group. It is not a regulatory body or authority but regards itself as part of the regulatory structure, being a council funded organisation that has a long established role in supporting various council regulatory services including health and safety, food safety and animal health. Northern Ireland has its own arrangements for the above functions. Scotland and Wales have made their own arrangements under devolved powers with the exception of health and safety at work (the HSEs remit covers Great Britain but not Northern Ireland). We heard evidence from devolved administrations about their approaches to prevention and control of outbreaks of E. coli O157 and took this into account in our analyses in Parts C and D. 68 Figure 4.2 The regulatory framework as it relates to Open Farms D E P A R T M E N T S D E L I V E R Y A G E N C I E S D E P A R T M E N T S D E L I V E R Y A G E N C I E S INDUSTRY National Farm Attractions Network National Farmers Union etc EDUCATORS ACCREDITORS Farming and Countryside Education Countryside Educational Visits Accreditation Scheme etc PUBLIC Visitors Haemolytic Uraemic Syndrome Help etc LACORS PROFESSIONAL BODIES Chartered Institute of Environmental Health Trading Standards Institute V e t e r i n a r y
L a b o r a t o r i e s
A g e n c y V e t e r i n a r y
M e d i c i n e s
D i r e c t o r a t e L o c a l
A u t h o r i t i e s H e a lt h a nd Safety Exe c u t iv e L o cal Authoritie s H e a lth and Safety Execu tiv e D e partment o f H e a lth Protection Ag e n c y F o o d
S t a n d a r d s
A g e n c y L o cal Authoritie s H e a lth Protection U n it s E n vironmental Health Farms F a r m s Farms F a r m s E n v i r o n m e n t a l
H e a l t h E n v ironmental Hea lth T r a d i n g
s t a n d a r d s Officers O f f i c e r s Officers O f f i c e r s L o c a l
A u t h o r i t i e s A n i m a l
H e a l t h
A g e n c y D e f r a D e p a rtment of H e a lt h H e a l t h
+
D e f r a W o rk and Pensio n s D e p a r t m e n t
o f Open farms PUBLIC HEALTH ANIMAL HEALTH FOOD SAFETY HEALTH AND SAFETY AT WORK Chapter 4: The Regulatory Framework for Open Farms Figure 4.2 illustrates the main departmental bodies and layers of administration involved in regulating public health, food safety, animal health and human health and safety at Open Farms. Some of the principal stakeholder groups are also shown, for example those representing industry, professions, public, and local authority interests. Major delivery agencies such as the Health Protection Agency, Food Standards Agency, Animal Health and the Health and Safety Executive and their enforcement arms are included but for the sake of simplicity other elements of the system are not, such as advisory committees discussed elsewhere in the report. 69 4.4 Inspection Procedures Since the 19 th Century independent regulatory inspection of how businesses are complying with their legal duties and meeting their responsibilities has been a fundamental part of the UKs health and safety system. Regimes for public health, food safety and animal health and welfare have developed in parallel but separately. Each has its own procedures and standards for inspection. Some years ago the HSE developed a method to enable its inspectors to prioritise health and safety inspections of businesses according to the degree of risk and managements competence to control it. Known as the Inspection Rating System, it was described in a circular LAC 67/1 (Revised 3) issued to LAs in July 2003. Enforcement decisions under health and safety legislation are made by reference to the HSEs Enforcement Policy Statement (11) which is consistent with the principles set out in the Crown Prosecution Services code for Crown Prosecutors, ie, principles of consistency, transparency, targeting and proportionality. Further information on the code can be found at: www.cps.gov.uk/publications/code_for_crown_prosecutors/index.html In support of the statement, HSE has developed an Enforcement Management Model (EMM) which helps inspectors decide on what would be appropriate enforcement action in the particular circumstances. The EMM is not intended to fetter inspectors discretion when making enforcement decisions or direct enforcement in any particular case. Rather, it seeks to promote consistency and proportionality in enforcement by confrming the parameters that need to be considered and the risk-based criteria against which decisions are made. In 2004 the HSE and LACORS on behalf of LAs entered into a formal partnership agreement (12) and a joint report in 2009 (13) includes consideration of the progress made in joint planning and joint working that followed an independent evaluation conducted by PA Consulting in May 2008 (14). The HSE developed and shared with LAs an Enforcement Management Model (EMM) in 2003 to help inspectors make decisions about taking actions that will be in line with the policy and proportionate to risks. Depending on what they fnd, inspectors may decide to exercise their enforcement powers under HSWA (15). Actions may range from prosecution to giving oral advice during an inspection, and include serving an improvement notice if in the inspectors opinion a person is contravening a legal requirement. The notice may require the contravention to be remedied and will usually include a schedule setting out what needs to be done. There is an appeal procedure. A prohibition notice may be served where the inspector is of the opinion that activities being carried on (or likely to be carried on) involve or will involve a risk of serious personal injury. The notice may stop the activity immediately or at the end of a specifed period. Again, there is an appeal procedure. Prosecutions are few in number compared with notices served. They may follow egregious breaches of law, particularly if death or injury has been caused. Under their Partnership arrangements, further efforts have been made by the HSE and LAs to work together and to record enforcement procedures in instructions shared by their inspectors. The HSE and LAs have a duty under Section 18 of HSWA to make adequate arrangements for enforcement. In 2008 they developed a Section 18 Standard (16) setting these out, including common measures to ensure their inspectors are competent to undertake regulatory activities. An Annex to the circular LAC 70 67/1 (Rev 3) contained guidance to the HSEs staff and LAs about actions that may be appropriate in different circumstances. That circular was under review at the time of the Godstone outbreak and was replaced in October 2009 by new Priority Planning Guidance. The guidance is described as providing the necessary detail to help LAs comply with the S18 Standard on Priorities and Planning and Targeting Interventions and is consistent with priority planning guidance used by HSEs own inspectors. 4.5 Standards for Farms including Open Farms 4.5.1 Approved Codes of Practice Practical advice on compliance may be given by a regulator in the form of an approved code of practice (ACoP). For example, an ACoP may explain the meaning of a suffcient and suitable risk assessment in the COSHH regulations (17). An ACoP may be produced for microbiological hazards as is the case for control of legionella (18). ACoPs have a special legal status under HSWA. If employers are prosecuted for a breach of health and safety law and it is proved that they have not followed relevant provisions of an applicable ACoP, a court may fnd them at fault unless they can show compliance in some other way. There is no ACoP specifcally for E. coli O157. We noted that since 2007, some Codes of Practice have been approved to do with gas installation, construction, asbestos and work equipment (see www.hse.gov.uk). 4.5.2 Accreditation Schemes Self-regulation and voluntary accreditation are recognised as playing a part for setting standards. Accreditation schemes, whereby a business or individual can seek a badge from an independent expert organisation with competence to carry out inspections and audits, offer assurance to the public that the business is meeting any relevant standards. The Access to Farms Farm Inspected scheme is an accreditation scheme for farms where educational activities are undertaken. 4.5.3 HSE Guidance on Open Farms Agriculture remains one of the most hazardous industrial sectors, with a fatal injury incidence rate in 2008/09 (19) of 5.7 per 100,000 workers (compared with 2.4 per 100,000 workers in construction and a national average of 0.6 per 100,000 workers). Approximately 530,000 people work in agriculture (source: Defra Census 2008) which includes a range of sectors including arable, dairy, livestock and mixed farming, the growing of fruit and vegetables, arboriculture, forestry, production horticulture, agricultural and animal husbandry services. HSEs strategy for addressing the poor health and safety performance of the industry has changed over time. For many years, the interventions chosen were based on inspection. Latterly, greater resource has been directed to promoting and raising awareness among much greater number of farmers through a variety of communications methods, including direct marketing, Safety and Health Awareness Days (SHADs) and working with key industry infuencers and stakeholders. This approach has resulted from a regulatory decision that an inspection based approach was neither effective nor cost effective in tackling an industry characterised by micro-businesses, self employment and family enterprises. This analysis has continued to underpin HSEs strategic approach to the industry. Chapter 4: The Regulatory Framework for Open Farms 71 The current strategy (Agriculture Revisited) agreed by the HSE Board in May 2008 is set out in Board paper 08/24 which can be accessed from the HSE website. The Investigation noted the Prevention of Accidents to Children in Agriculture Regulations 1998 (PACAR) and the associated ACoP (20) introduced in April 1999. The regulations apply to farmers or persons responsible for agricultural activities and prohibit children from driving or riding on certain classes of vehicle or agricultural plant and machinery. They do not address the health risks to children from agricultural activities and were not brought to our attention by any witnesses. There is also advice and guidance for farmers (21) that includes how to reduce the risk of accidents to children and young people whether residents or visitors and refers to risks from animals including (briefy) E. coli O157 infection. To assist Open Farms with risk assessments the HSE published free information sheets setting out advice to farmers on practical steps to ensure the health and safety of visitors, including one aimed specifcally at Open Farms and the risk of E. coli O157 infection (Agricultural Information Sheet AIS23 [discussed in Chapter 8]). LA Inspectors are expected by HELA to make reference to this when inspecting Open Farms. The leafet contains a supplement designed to help teachers and others who organise visits to farms (AIS23 Supplement) (see Appendix 5). Another information sheet Common Zoonoses in Agriculture (AIS2) gives general guidance for farmers on the range of diseases carried by animals that can also affect humans and the precautionary measures that should be put in place on working farms and also if the farm is open to the public (see Appendix 6). The advice contained in published guidance such as AIS23 is non-statutory, and is usually accompanied by this legal disclaimer: This leafet contains notes on good practice which are not compulsory but which you may fnd helpful in considering what you need to do. Employers are thus free to take other action, but the HSE takes the view that if they do follow guidance they will normally be doing enough to comply with the law. In 2003 the HSE produced a four-minute video (22) containing advice about the risk at farms from E. coli O157. This can still be viewed on the HSE website. The HSE issued guidance (23) to inspectors in 2003 on applying the principles of the EMM to risks to health and the standards expected in AIS23 (Rev) on Open Farms (see Appendix 7). In 2005 HELA also launched a secure intranet website called HELex where HSE and LAs enforcement offcers can communicate with one another by uploading, downloading and exchanging relevant information and data. This site is not publicly accessible. After the Godstone outbreak, and following a request by the HPA to the HSE and LAs that all Open Farms should be visited, HELA issued another circular (24) to LAs on 21 October 2009 entitled E. coli O157 outbreak August/September 2009. This contained revised advice from the HSE about inspections of Open Farms, reaffrming LAC 61/1 general guidance on application to health risks with an annex explaining how to apply the EMM to various scenarios they might fnd. The circular contained a statement: HSEs Biological Agents Unit (BAU) is satisfed that the guidance in AIS23 (Rev) is proportionate and ft-for-purpose providing sensible, practical advice, consistent with that provided in other countries, eg, USA. It is aimed at farmers and through the supplement at teachers or others in charge of visits as a work activity, not at members of the public generally. 72 4.5.4 International Standards for Open Farms Chapter 1 identifes that agricultural and environmental exposures are a well recognised cause of E. coli O157 outbreaks across the world. During the Investigation we searched on the internet and also sought information from expert authorities for more detail on international standards and legislation relevant to Open Farms. In the USA, a number of outbreaks of E. coli O157 have been associated with animal contact, but there is no Federal US law that specifcally addresses the issue of preventing disease associated with animals in public settings. The Animal Welfare Act (9CFR Ch.1, Section 2.131) administered by the US Department of Agriculture (USDA) requires petting zoos to hold a licence and is aimed principally at assuring humane treatment of animals, not the protection of human health. However the licensing requirements demand supervision at all times by a trained and competent person if the animals are being handled. Suitable barriers must be in place to protect both the animals and the public from harm. In 2009, Centers for Disease Control and Prevention (CDC) issued a Compendium of Means to Prevent Disease Associated with Animals in Public Settings (25). This was because of the inadequate understanding of disease transmission among visitors, especially children to Open Farm-type premises and also because of instances in which numerous persons became ill. The report, which includes petting farms (ie, Open Farms) provides recommendations for public health offcials, veterinarians, animal venue staff members, exhibitors, visitors, physicians and others concerned with minimising risks associated with animals in public settings. Pennsylvania enacted legislation that specifcally regulates petting zoos (26) and North Carolina enacted legislation in July 2005 that requires petting zoos to obtain permits and undergo inspections (27); the bill is called Aedins Law in honour of two-year-old Aedin Gray whose exposure led to life-threatening haemolytic uraemic syndrome (HUS) and its purpose is to control public contact with animals, inform the public of risks related to animal contact, provide transition areas, regulate animal care and license petting zoos. Massachusetts and Washington State have available brief recommendations (28,29). The South Australian Governments Department of Human Services has also issued guidelines for control of infections at petting zoos and in Canada the Ontario Farm Animal Council has issued a single page guideline (30). In Europe, while we are aware of the EUs strategy for improving health and safety at work generally, there is no European Directive that sets out standards or controls over the E. coli O157 risk for Open Farms. However, we understand that in Sweden there is legislation that requires Open Farms to be registered and the owners are required to develop a hygiene plan with veterinary input. We understand that in Denmark, the Danish Ministry of Food, Agriculture and Fisheries (Animal Health Division) is responsible for certifcation of zoological gardens and farms open to visitors and that there is requirement that: children under fve years of age are only in exceptional circumstances allowed into animal areas; the person who is responsible for the farm is also responsible for people who have been in contact with animals or their faecal products to ensure they wash their hands afterwards; that visitors are not allowed access to unpasteurised milk or products and all animals must be registered in the equivalent of a County Parish Holding (CPH). Generic advice is similar to AIS23 but it and other information additionally suggest: 1. Only wearing clothes and footwear (eg, Wellington boots) which are washable, when on farms 2. Wash all clothes and footwear immediately after any visit to a farm or leave it on the farm 3. Wash all equipment etc, used on the farm 4. Dont kiss the animals, but please pet them and then wash your hands Chapter 4: The Regulatory Framework for Open Farms 73 5. No dummies are allowed on farms 6. No toys are allowed to be brought onto farms 7. No ordinary shoes allowed 8. An anteroom to change clothes is recommended as a lock for people entering and leaving to encourage/remind people to change clothes and wash hands 9. Wash all clothes at 60 degrees 10. Information on how to wash hands. Visitors are also recommended to check the health status of any farm before visiting it and this information is openly available on the internet in Denmark. We have received, via VLA, information from the Dutch Food and Consumer Product Safety Authority. The Dutch recognised human infections with E. coli O157 as the result of Open Farm visits in 2000. To date, the measures adopted in the Netherlands have been to concentrate on improving the hygiene on farms (a safe farm environment) and teaching the visitors. The Dutch organisation representing Open Farms has also worked on a quality/certifcation system to provide information and to motivate the Open Farm owners to invest in providing a hygienic farm environment. The certifcation is currently voluntary, but it may become compulsory and if so, public farms not having the basic certifcate (there are different levels) will be closed to the public. Farms with a certifcate will be inspected on a regular basis. Furthermore, we have been told that the Offce for Risk Assessment in the Netherlands is currently proposing a stronger regulatory framework regarding Shiga-toxin (VTEC)-producing and other relevant zoonotic pathogens such that enforcement will be possible. This proposal is in the context of the ascending recognition of the importance of zoonotic infection to the human population, especially for visitors to Open Farms (personal communication, Dr RAA van Oosterom). 4.6 References 1. HELA, the Health and Safety Executive/Local Authority Enforcement Liaison Committee www.hse.gov.uk 2. HELA administrative circular LAC 23/15 www.hse.gov.uk 3. Defra, December Survey of Agriculture, 1 December 2009 www.defra.gov.uk 4. Edwards v National Coal Board (1949) All ER 743 (CA) 5. Statutory Instrument 1999/3242 www.opsi.gov.uk 6. Statutory Instrument 1998/494 www.opsi.gov.uk 7. Statutory Instrument 2002/2677 (amended 2003) www.opsi.gov.uk 8. Revitalising Health and Safety, 2000 www.hse.gov.uk/revitalising/strategy.pdf 9. Strategy for workplace health and safety in Great Britain to 2010 and beyond, 2004 www.hse.gov.uk/consult/condocs/strategycd.pdf 10. The Health and Safety of Great Britain: Be part of the solution June 2009 www.hse.gov.uk 11. HSE Enforcement Policy Statement updated September 2009 www.hse.gov.uk 74 12. HSE/LACORS Partnership 2004 www.hse.gov.uk 13. HSE/LACORS Partnership Report 2008/2009 www.hse.gov.uk/lau/pdfs/lacors08ar.pdf 14. HSE and Local Authorities in Partnership: an evaluation RR680, HSE 15. See HSWA Sections 2025 16. HSE: www.hse.gov.uk/section18/index.htm 17. COSHH: Approved Code of Practice L5 www.hse.gov.uk 18. Approved Code of Practice Legionnaires disease the control of legionella bacteria in water systems L8 www.hse.gov.uk 19. Health and Safety Statistics 2008/09 www.hse.gov.uk 20. Approved Code of Practice Preventing accidents to children in agriculture L116 www.hse.gov.uk 21. HSE Farmwise. The essential guide to health and safety in agriculture. www.hse.gov.uk/pubns/indg427.pdf 22. www.hse.gov.uk/press/e03092.htm 23. OC 130/5, LAC 61/1www.hse.gov.uk 24. LAC 41/5 www.hse.gov.uk 25. Centers for Disease Control and Prevention. Compendium of measures to prevent disease associated with animals in public settings. MMWR Morb Mortal Wkly Rep 2009, 58(No.RR-5): 1-21 www.cdc.gov/mmwr/PDF/rr/rr5805.pdf 26. Pennsylvania Animal Exhibition Sanitation Act 211 of 2002 http://law.onecle.com/pennsylvania/agriculture/00.025.001.000.html 27. North Carolina Session Law 2005-191, Senate Bill 268. www.ncleg.net/sessions/2005/bills/senate/html/S268v4.html 28. Recommendations for Petting Zoos, Petting Farms, Animal Fairs, and Other Events and Exhibits where Contact between Animals and People is Permitted www.mass.gov/Eeohhs2/docs/dph/cdc/rabies/reduce_zoos_risk.pdf 29. Recommendations to Reduce the Risk of Disease Transmission from Animals to Humans at Petting Zoos, Fairs and Other Animal Exhibits http://kitsap.wsu.edu/4h/fair/recommendationspettingzoo.pdf 30. Petting Zoo Guidelines, see www.ofac.org Independent Investigation Documents available at www.griffninvestigation.org.uk i The Statutory framework and the roles and responsibilities of relevant public bodies concerned with protecting public health in relation to visits to Open Farms and when investigating an outbreak of E. coli O157 a paper by Weightmans Solicitors. Chapter 4: The Regulatory Framework for Open Farms 75 ACDP/96/P6/Annex 1 HSE information sheet
Preventing or controlling ill health from animal contact at visitor attractions with supplement for teachers and others who organise visits for children
Introduction
1 This information sheet provides advice for those responsible for premises where members of the public, including children, are encouraged to view, touch or pet animals. Visits to these sites are primarily for recreational or educational purposes.
Premises covered by this guidance include: farm attractions e.g. open farms/farm parks; petting enclaves within other attractions (including those at zoos etc); city farms or other educational establishments; working farms with livestock that occasionally open to the public e.g. for school visits or to participate in Open Farm Sunday or similar events; rare breed and rescue centres; agricultural shows or country fairs where livestock are present; travelling menageries or mobile petting enterprises; other similar visitor attractions at which the public have contact with animals.
Whilst the general principles covered in this document are equally applicable to zoos, specific guidance on managing zoonotic disease (disease passed from animals to humans) in zoos is contained in Managing zoonotic risk in zoos and wildlife parks hyperlink to be added idc This guidance is issued by The Health and Safety Executive. Following the guidance is not compulsory and you are free to take other action. But if you do follow the guidance you will normally be doing enough to comply with the law. Health and Safety Inspectors seek to secure compliance with the law and may refer to this guidance as illustrating good practice. ACDP/96/P6/Annex 1 2. The information contained within this guidance is aimed at owners and managers of visitor attractions who have legal duties under health and safety law (duty holders). It describes the measures duty holders should take to protect visitors. Duty holders will also need to ensure that they comply with their legal obligations to protect the health and safety of their staff, including their employees, volunteers, helpers etc.
3. Teachers and others who organise visits should read the separate supplementary sheet which forms part of this advice, to help them make sure that children do not become ill as a result of visits. It may be useful to assist with the process of risk assessment which should be carried out before the visit takes place.
4. Visits to premises covered by this guidance play a valuable part in the education and development of children and young adults, and provide an enjoyable experience for many people. It is unusual for members of the public to be made ill as a result of such visits. However, there have been a relatively small number of serious cases of ill health reported as a consequence of visits to premises.
Background
5 All animals naturally carry a range of micro-organisms, some of which can be transmitted to humans, where they may cause ill health, which in some cases may be severe or life threatening. Much of this guidance refers specifically to the verocytotoxin producing bacterium E. coli O157 because it poses a serious hazard to the health of people visiting such premises. E. coli O157 can potentially cause serious illness, especially in young children in whom symptoms may include bloody diarrhoea and kidney failure.
6 Cattle and sheep are the main recognised carriers of E. coli O157. The organism may occasionally be found in other animals, especially amongst the mixed species often present at visitor attractions. These include goats, pigs, chickens, horses, deer, llamas and alpacas. Farm dogs and wild rabbits can pick up the infection from an infected environment. Infection can also occur in birds such as wild geese. The organism is primarily transmitted through contact with their faeces (dung)
7 Another harmful micro-organism is Cryptosporidium parvum. This is a parasite carried by calves, lambs, deer and goats and can cause severe diarrhoea in young children and the elderly. It is capable of surviving for a long time in the environment.
8 People can become infected with E. coli O157 or Cryptosporidium parvum through consuming contaminated food or drink, through direct contact with contaminated animals, or by contact with an environment contaminated with animal faeces.
As with many other activities, visits to such premises can never be considered free from all risk. However, implementing the control measures in this guidance will help ensure that the risk of infection from Escherichia coli O157 (E coli O157), from contact with animals is low. Hazard and risk Throughout this guidance the term hazard is used to describe anything with the potential to cause harm and risk used to describe the chance or probability of harm occurring coupled with its severity. It should be assumed that animals at visitor attractions carry harmful micro-organisms such as Eschericha coli O157 (commonly known as E. coli O157 or VTEC) and Cryptosporidium parvum. Therefore, as with many other activities, visits to such premises can never be considered free from all risk. However implementing the control measures in this guidance will help ensure that the risk of infection from contact with animals is low. ACDP/96/P6/Annex 1
9 Very low numbers of micro-organisms can cause human infection and so it is important that those responsible for the premises control the risks to visitors.
10 A number of essential control measures can help reduce the risk of people especially children, becoming infected through contact with faeces and faecal material. These include: good general cleanliness around the premises; including prevention of animal soiling on paths and walkways; containing animal bedding material within pens; the careful transporting and storage of manure; good animal husbandry; separating animal contact and non- contact areas; provision of adequate hand-washing facilities; information for staff and visitors; and proper supervision of animal contact and hand-washing.
11 Controlling the risks from E. coli O157 and Cryptosporidium parvum will also control the risks from most other organisms, which are transmissible to humans by the hand to mouth route. Precautions against other types of zoonoses are covered by HSE Agriculture Information Sheet 2 (rev2) Common zoonoses in agriculture.
The law 12 The Health and Safety at Work etc Act 1974, and associated health and safety regulations, place duties on a wide range of people (duty holders). If you open your premises to the public, including for charity events, you will have duties under health and safety law.
Assessing the risk
13 When undertaking your COSHH assessment you should: assume that all animals (including birds) carry micro-organisms such as E. coli O157 that could represent a hazard to human health. Animals carrying infection can still appear healthy; remember that ruminants (e.g. cattle, sheep, and goats) carry E. coli O157; take into account E. coli O157 is also found in a range of other animals including pigs, horses, donkeys, deer, alpacas, llamas, cats, dogs, wild rabbits, chickens and other birds; recognise that although tests are available to detect the presence of E. coli O157 and other micro-organisms a negative test result does not guarantee the animal is free of infection as infected animals do not shed the micro-organism all the Animals which have previously tested negative may begin to excrete the organism at a later date; acknowledge E. coli O157 may be introduced to your premises at any time by new stock, wild birds and animals, or by visitors; COSHH E. coli O157 and other micro organisms that may cause ill health are subject to The Control of Substances Hazardous to Health (COSHH) Regulations 2002 (as amended). These Regulations require an employer or self-employed person to: assess the risks to employees, self-employed people and the public from exposure to hazardous substances, including micro-organisms; prevent, or, where this is not reasonably practicable, adequately control exposure to the hazardous substances; introduce and maintain control measures; inform, instruct and train employees about the risks and precautions to be taken; inform visitors about the risks and precautions to be taken; regularly review the assessment and the effectiveness of control measures.
Guidance on COSHH can be obtained from the HSE website http://www.hse.gov.uk/coshh/index.htm ACDP/96/P6/Annex 1 bear in mind when selecting animals for petting areas that young stock, stock under stress, or stock unfamiliar with people etc are more likely to excrete E. coli O157; accept that other animals on the premises, including pets, may acquire the bacterium through contact with faeces etc.
Exposure to E coli O157
14 You should assume that your animals carry E. coli O157 even though they have no symptoms. The organism can be spread to humans by hand to mouth contact, e.g. hands contaminated with E. coli O157 from faecal sources coming into contact with the mouth. Children, especially those under 5 years old, are particularly at risk as they are most likely to put contaminated fingers or items in their mouths (including thumb sucking, nail biting and dummies/toys). Only small numbers of the bacterium are required to cause illness, so just because something (an animal or an object) is not visibly contaminated with faeces, this does not necessarily mean it is free from risk.
15 People may become infected when they come into contact with animal faeces or saliva by: touching or kissing animals in petting areas or during bottle feeding; feeding, stroking or touching animals through gates or pens; touching gates, or animal pen divisions, or other structures contaminated with faeces; picking up contaminated feed from the floor: removing contaminated footwear or clothing; eating, drinking and smoking with contaminated hands; using contaminated play equipment; touching personal items taken on to the premises that have become contaminated e.g. dropped toys or dummies and pushchair wheels.
Controlling the risk
16 In order to minimise and control the risk you should concentrate on the following: establishing premises layout and routes, including areas to which visitors should not have access; defining, segregating and clearly identifying animal contact areas; defining, segregating and clearly identifying non-animal contact areas; defining, segregating and clearly identifying eating and play areas; providing adequate and suitable washing facilities; providing visitor information; providing information and signs for visitors; providing training and supervision of staff establishing livestock management procedures; including management of bedding and sick/pregnant/stressed animals; controlling manure/run-off and compost heaps. Control measures Control measures are actions that need to be taken to prevent or reduce exposure to a substance hazardous to health in this case micro organisms. Such measures include: the layout of the premises; the cleaning of the premises; provision and use of washing facilities; supervision; information; signage; etc. In practice, a combination of control measures will be necessary to protect the health of visitors. To be effective these measures should be practical, workable and sustainable. They should be reviewed on a regular basis. ACDP/96/P6/Annex 1
These are discussed in more detail in the following sections.
17 Premises layout and routes
You should: decide which areas you want visitors to have access to; make sure that routes around the premises prevent visitors from entering non-access areas, e.g. parts of the premises where work is going on, or where manure is stored etc.; consider how you will prevent entry to non-access areas. For example, providing suitable fencing and warning signs; direct visitors to washing facilities as they leave any animal contact area, before they access eating and play areas and before leaving the premises; avoid directing visitors across tracks or routes used regularly by stock and farm vehicles. If this is not possible then make sure visitors do not have to walk through any build up of faeces, liquid effluent, or soiled bedding material. For example, regularly clear or clean routes used by livestock or when cleaning out pens etc, and provide duckboards or similar so that visitors avoid contaminating their footwear; keep the premises as clean as practicable and ensure areas to which visitors have access are free from any build-up of faeces.
18 Animal contact
You should: decide on suitable contact areas where visitors will be able to pet and feed animals: decide which animals are suitable for contact areas; not allow the public to enter animal pens (as faeces or contaminated bedding will underfoot and visitors may themselves carry infections on their footwear that could put your animals at risk; ensure adequate and suitable washing facilities are available and are used by visitors when leaving contact areas; ensure fencing and other barriers are regularly inspected and properly maintained; ensure that animal contact areas where visitors stand or walk are as free as possible from any faeces, and put in place measures to prevent contamination from liquid manure or surface run-off where necessary; regularly clean and disinfect pen divisions and gates as required in animal contact areas where visitors are able to touch them; not allow faeces to remain on and contaminate walkways or other areas used by the visitors; not allow contaminated bedding or run-off material to contaminate walkways or other areas used by visitors; ensure that eating (including sweets and ice cream), drinking, putting contaminated items in mouths (including dummies) and smoking are prohibited in animal contact areas (signs should be displayed instructing visitors of this requirement); ensure an adequate number of trained staff for contact areas; ensure where eating and play areas are adjacent to areas containing animals, measures are provided to prevent members of the public touching the animals, e.g. by providing double fencing. This should be positioned at a distance that will prevent visitors reaching through to touch the animals and to prevent animals reaching over or through the fence to contact people.
In some non-contact areas, it will not be reasonably practicable to provide double fencing along enclosures where animals are kept. Examples would be: livestock farms that open occasionally e.g. Open Farm Sunday; and along a farm walk/trail through fields. In such cases the areas should be clearly signed to inform visitors they are entering a non-contact ACDP/96/P6/Annex 1 area and touching, petting and feeding of animals is not allowed. Eating and play areas should not be located within non-contact areas. Any decision to rely on single fencing and signage rather than double fencing must be justified in your risk assessment.
19 Eating areas
You should: site eating or picnic facilities away from areas where animals can be contacted, and preferably at the end of any farm trail, walk or tour, or outside the main areas of the premises; make sure that visitors have to pass through or by washing facilities before going to eating areas; ensure visitors are advised, e.g. by adequate signage to wash their hands before eating; exclude your animals including captive birds from eating areas. They could contaminate eating areas with faeces. Consider wing clipping, double gates into eating areas and adequate fencing to exclude them; ensure where eating areas are adjacent to animal contact areas, animal contact must be prevented e.g. by providing double fencing. This should be positioned at a distance that will prevent visitors reaching through to touch the animals and to prevent animals reaching over or through the fence to contact people; provide adequate waste bins and clear discarded food from eating areas to discourage wild birds and rodents from feeding and contaminating the area; position ice-cream and/or sweet kiosks etc in the non-contact areas of the premises, such as the eating areas or at the exit where visitors have passed washing facilities, and remind visitors using the kiosks, by notices or verbally, to wash their hands before touching or eating purchased food or sweets.
20 Play areas
You should: where possible site play areas away from areas where animals can be contacted, and preferably at the end of any farm trail, walk or tour, or outside the main areas of the premises; ensure visitors should be advised e.g. by adequate signage to wash their hands before and after using play areas; exclude your animals including captive birds from play areas. They could contaminate play areas and equipment with faeces. Consider wing clipping, double gates into play areas and adequate fencing to exclude them; ensure where play areas are adjacent to animal contact areas, animal contact is prevented e.g. by providing double fencing. This should be positioned at a distance that will prevent visitors reaching through to touch the animals and to prevent animals reaching over or through the fence to contact people; ensure play areas are cleaned on a regular basis to remove any contamination
Washing facilities
21 While the primary control measures should focus on reducing and eliminating faecal contamination, the most effective method of removing dirt and contamination remains handwashing with soap and hot and cold or warm running water.
22 Washing facilities i.e. soap and running water should be provided at or near the exits from any area/premises where visitors are encouraged to have animal contact. Cleansing wipes or anti bacterial gels are not an acceptable substitute for proper hand washing.
ACDP/96/P6/Annex 1 23 At temporary events, such as agricultural shows where there are suitable permanent washing facilities provided e.g. a purpose built toilet and washing block, it is acceptable practice for animal exhibitors or others to provide information and signs to indicate that visitors should use these facilities after contact with the animals. If such general visitor washing facilities do not exist or are not situated close by, then it will be necessary to provide suitable temporary washing facilities. Ideally washing facilities should be positioned close to areas where animal contact is permitted.
Further guidance on the provision of washing facilities at agricultural shows is being discussed with the industry.
24 The provision of adequate numbers of facilities and their location is crucial to preventing ill health. Facilities can be individual taps and basins, and/or long sinks with a number of running water outlets. They need to be provided and easily accessible at or near: areas for intentional contact (petting barns etc). If there is a one-way system for visitors through the contact area they should be provided immediately adjacent to the exit; if there is a two-way flow of visitors they should be provided immediately adjacent to entrances and exits. A one-way system may help to ensure that washing facilities are properly used; entrances to eating areas; the exit from the premises.
25 All washing facilities should: be accessible by all visitors, i.e. at the right heights for both children and adults or with raised standing areas provided for children. Check these do not create tripping or falling hazards; have running hot and cold or warm water (e.g. mixer taps). It is easier to create soap lather with warm water, and it may encourage visitors, especially children, to wash more thoroughly particularly in cold weather. Warm water supplies should be fitted with a means of restricting the temperature to no more than 43C to avoid scalding; have liquid soap. Bactericidal soaps are not necessary; have paper towels. Hot-air hand-dryers are suitable but may lead to queues which discourage visitors from washing their hands. Reusable hand towels are not suitable; Washing facilities An acceptable way of estimating the capacity of the washing facilities is to: estimate the maximum number of visitors expected or permitted at one time; consider how many visitors will be in animal contact areas at any time - you may already limit numbers of visitors in these areas to allow them time to enjoy the experience with the animals; assess the rate at which visitors will leave contact areas, e.g. in large groups such as school parties or a few at a time; estimate the time taken to wash hands effectively, remembering that a thorough hand wash may take up to two minutes.
If you estimate that, for instance, 30 people will leave a contact area every 15 minutes, and each person will take two minutes to wash their hands, you should provide enough washing facilities for four people to use at one time (30 x 2 divided by 15 = 4). Make similar calculations for other locations around the premises, e.g. at main exits or entrances to eating areas.
You can supplement permanent facilities with temporary ones at busy times e.g. just before the summer holidays, in remote areas of the premises, or for short duration events e.g. country shows or fairs. Portable units can be hired which have heating, lighting and running water. ACDP/96/P6/Annex 1 be properly maintained and cleaned regularly as required, at least daily; be replenished with paper towels and soap as necessary; include open or pedal operated waste bins which are emptied as necessary; be arranged so that visitor throughput and/or water overflows etc do not make the immediate vicinity muddy and so put people off using the washing facilities.
26 In exceptional circumstances, such as premises that open on an occasional basis in the summer providing cold running water only, soap and disposable towels may be acceptable. This must be justified in your risk assessment.
27 Do not provide buckets or troughs of standing water which are shared or reused by several people - they do not allow effective hand washing, and reusing water can spread micro- organisms among those using it. Adding a disinfectant to the water does not make the practice acceptable.
28 It is important to encourage your staff, parents, teachers and others who have responsibility for visitors to make sure that children and other visitors wash their hands properly.
You should ensure your planned layout will prevent contamination of footwear, pushchairs, wheel chairs etc, Where this unavoidably occurs you will need to consider providing suitable facilities to allow visitors to clean contaminated footwear and wheels on pushchairs and wheelchairs. The facilities should be arranged to reduce the risk of personal contamination from manure, liquid run off etc during the cleaning process.
30 Visitor information
Information should be provided to visitors covering:
risks to health; precautions taken to minimise risks; personal responsibilities of visitors to minimise risks including hygiene precautions; site plan, map, route directions or other information as necessary.
The information should be included:
on the attractions website; and on site maps/plans or other handouts given to visitors on arrival.
Leaflets or pre-visit packs for schools and other organised groups should be provided to help teachers and others plan the visit.
31 Information and signs
Information should include notices at all entrances to the premises to remind visitors of the need for good personal hygiene, and to inform them that they should only eat or drink in the designated areas. Consider handouts for visitors and stickers etc about hand washing. Signs should be erected in appropriate places reminding visitors to wash their hands when leaving animal contact areas, before eating, and when leaving the premises. Washing facilities should have signs showing how to wash hands properly. ACDP/96/P6/Annex 1 Remember that young children may have dummies or toys that they put in their mouths. You should remind accompanying adults not to put dummies that have fallen to the ground back into their childrens mouths. Pictograms, audio devices, continuous loop videos or other media may be useful. Information should be clearly legible and may be required in languages other than English.
32 Training and supervision
You should: ensure staff are trained and instructed about the human health risks associated with animals and the necessary control measures. Dont forget that training should also be provided for temporary or seasonal staff taken on during busy periods; ensure staff are trained and instructed on what visitors should or should not do; provide guidance to staff on how to explain the hygiene message to visitors including the importance of thorough hand washing, particularly for children; arrange adequate and appropriate levels of supervision in contact areas. The number of supervisors will depend on the size of the animal contact area and the number of visitors permitted or expected in that area at one time; make sure that children are supervised while they wash their hands. Although this is the responsibility of parents or teachers, in some cases staff may need to help in supervising; remind supervisors in animal contact areas (who may also be there to protect the animals) to ensure that visitors do not eat, drink or put items in their mouths while in these areas; ensure supervisors discourage visitors (especially children) from putting their fingers in their mouths, or kissing the animals; stress to your own staff the importance of following good personal hygiene, e.g. thoroughly washing their own hands when necessary, and not eating or drinking in animal contact areas.
33 Livestock management procedures
You should: consider producing an animal or farm health plan in consultation with your vet to help reduce the risks from zoonoses; assess whether animals are healthy before moving them to animal contact areas, but remember that animals carrying E coli O157 do not suffer ill-health effects; ensure that animals that have just given birth, or been born, are not put in contact areas; immediately remove any animals showing signs of ill health, such as diarrhoea, or stress from animal contact areas until they have recovered; keep animals and their housing clean; consider whether replacement stock can come from within the premises rather than being brought in (this would avoid new infections being inadvertently brought on to the farm); where possible, source replacement livestock (especially young animals for bottle feeding) from a reputable supplier with known health status where the stock-keeper will have ensured that they have received an adequate supply of colostrum after being born; try to minimise movement and mixing of animals from different groups (this is particularly important to minimise the shedding of E. coli O157 by ruminants such as cattle and sheep); check all animals on display regularly for evidence of illness, consulting your vet as appropriate; regularly empty and clean water troughs and provide the animals with clean drinking water.
ACDP/96/P6/Annex 1 34 Manure and compost heaps
You should: position manure or compost heaps well away from areas that visitors can access, or fence them off; prevent or contain any liquid run-off where this might contaminate visitor areas not allow visitors to bag their own compost or manure.
Additional advice
Further advice on E. coli O157 including a video on handwashing is available at: http://www.hse.gov.uk/campaigns/farmsafe/ecoli.htm
Sources of advice
The National Farm Attraction Network (http://www.farmattractions.net), the Federation of City Farms and Community Gardens (http://www.farmgarden.org.uk) Farming and Countryside Education (http:www.face-online.org.uk), and Farms for Schools (http:www.farmsforschools.org.uk) all provide advice and other services. Consider using the assurance or inspection schemes run by some of these organisations.
Where the premises are part of a commercial farm this will normally be HSE (http:www.hse.gov.uk); in other cases it will be the local authority for your area http://www.direct.gov.uk/en/Dl1/Directories/Localcouncils/index.htm
Other advice is available from a number of other government websites including:
Advice can also be provided by veterinary surgeons (see telephone books for contacts)
Further information HSE priced and free publications are available by mail order from HSE Books, PO Box 1999, Sudbury, Suffolk CO10 2WA Tel: 01787 881165 Fax: 01787 313995 Website: www.hsebooks.co.uk (HSE priced publications are also available from bookshops.)
This publication may be freely reproduced, except for advertising, endorsement or commercial purposes. First published 3/11. Please acknowledge the source as HSE. AIS23(rev3) C100
ACDP/96/P6/Annex 1
Avoiding ill health from animal contact at visitor attractions Advice to teachers and others who organise visits for children
This supplement advises teachers and others who organise visits by children on the precautions necessary to reduce the risk of ill health arising from contact with animals.
All animals naturally carry a range of micro-organisms, some of which can be transmitted to humans, where they may cause ill health. Some of these, such as the bacterium Escherichia coli O157 (E coli O157) or Cryptosporidium parvum, present a serious health hazard and have the potential to cause severe illness and health problems which may be particularly acute in young children.
As with many other educational or recreational activities, visits can never be considered free from all risk. However, while the hazards are real, the risk of infection in children can be readily controlled by simple everyday measures. The following practical steps will help make your visit even more safe, healthy and enjoyable.
Before your visit, you should:
read and understand the advice in the main AIS23 information sheet, and discuss arrangements for the visit with the management at the site; confirm that the control measures provided at the site match the recommendations in AIS23; seek advice from your local authority or organisation on what the appropriate ratio of pupils to teachers/leaders/assistants/parents etc. should be; discuss and agree with the supervisors, parents or staff of the school, creche, leaders of youth organisations etc, their roles and responsibilities during the visit. In particular, they must understand the need to make sure that the children wash, or are helped to wash, their hands thoroughly after contacting animals. Key points to cover with the children should include: o explaining the rules for the visit, stressing that they must not eat, drink or chew anything (including sweets) outside the areas in which you permit them to do so; o explaining why they must wash their hands thoroughly after contact with the animals, and before eating or drinking anything; o demonstrating how to wash their hands properly; ACDP/96/P6/Annex 1 o discussing the requirements for appropriate clothing, including suitable footwear. You should liaise with the attraction to ascertain what this is; o checking that cuts, grazes etc on childrens hands are covered with a waterproof dressing.
During and after the visit, make sure that the children: are reminded of the rules/precautions to take upon arrival at the site; do not kiss animals; always wash their hands thoroughly before and after eating, after any contact with animals and again before leaving the site; eat only food that they have brought with them, or food for human consumption they have bought on the premises, in designated areas, and never eat food which has fallen to the ground, or taste animal foods; do not suck fingers or put hands, pens, pencils or crayons etc in mouths; where practical and possible, clean or change their footwear before leaving; wash their hands after changing their footwear. . Check that the children stay in their allocated groups during the visit, and that they: do not use or pick up tools (e.g. spades and forks) or touch other work equipment unless permitted to do so by site staff; do not climb on to walls, fences, gates or animal pens etc; listen carefully and follow the instructions and information given by the site staff; approach and handle animals quietly and gently; do not chase, frighten or torment the animals; do not wander off into unsupervised or prohibited areas e.g. manure heaps.
Remember: the children are your responsibility during the visit; you should supervise them during the visit, especially during hand washing to make sure that each child washes thoroughly. Site staff may be able to help with this supervision; allow plenty of time before eating or leaving so that the children do not have to rush.
If a member of your group shows signs of illness (e.g. sickness or diarrhoea) after a visit, advise them or their parent/guardian to visit the doctor and explain that they have had recent contact with animals.
Additional advice
Further advice on E. coli O157 including a video on handwashing is available at: http://www.hse.gov.uk/campaigns/farmsafe/ecoli.htm
Further information Extra copies of this information sheet and supplement are available free from HSE Books, PO Box 1999, Sudbury, Suffolk CO10 2WA. Tel: 01787 881165 Fax: 01787 313995 or can be downloaded fromhttp://www.hsebooks.co.uk
Printed and published by the Health and Safety Executive Reprinted 3/11 AIS23(rev3)supp C100
www.defra.gov.uk The Strategy for achieving Officially Bovine Tuberculosis Free status for England April 2014
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PB 14088
Contents Secretary of States foreword: Achieving a bovine tuberculosis free England ..................... 6 I. The Strategy for achieving Officially Bovine Tuberculosis Free status for England ........ 10 Objective ........................................................................................................................ 10 Rationale for intervention ............................................................................................... 10 The problem of bTB........................................................................................................ 11 Defining the solution ....................................................................................................... 11 Implementing the solution .............................................................................................. 13 Low Risk Area (LRA) .................................................................................................. 15 Edge Area ................................................................................................................... 16 High Risk Area (HRA) ................................................................................................. 16 Research .................................................................................................................... 16 Governance ................................................................................................................ 17 II. Background .................................................................................................................... 21 Bovine tuberculosis ........................................................................................................ 21 History of bovine tuberculosis in England ....................................................................... 21 Evidence ........................................................................................................................ 28 Strategy aim ................................................................................................................... 29 Rationale for intervention ............................................................................................... 31 Strategy approach .......................................................................................................... 33 Targets and timeline ....................................................................................................... 34 Targets ....................................................................................................................... 34 Timeline ...................................................................................................................... 35 Key elements ................................................................................................................. 37 Developing our risk-based approach .............................................................................. 37 Introduction ................................................................................................................. 37
Existing bTB control measures applied in England ..................................................... 41 Developing cross-cutting bTB control measures in all risk areas ................................ 48 Developing area risk-based strategies ........................................................................ 53 Low Risk Area (LRA) strategy .................................................................................... 53 Edge Area strategy ..................................................................................................... 55 High Risk Area (HRA) strategy ................................................................................... 56 Next steps to develop our risk-based approach .......................................................... 58 Developing new tools ..................................................................................................... 58 Introduction ................................................................................................................. 58 Defras Evidence and Investment Strategy ................................................................. 58 The bTB research programme .................................................................................... 59 Governance, delivery and funding .................................................................................. 66 Governance ................................................................................................................ 67 Delivery ....................................................................................................................... 68 Funding ....................................................................................................................... 68 Monitoring and evaluation of the Strategy ...................................................................... 70 Glossary ......................................................................................................................... 72 Annexes ......................................................................................................................... 77 Annex A Badger controls and population ................................................................. 77 Annex B Enhancements of cattle measures since 2011 .......................................... 80 Annex C Sources of evidence ................................................................................. 82 Natural science ........................................................................................................... 82 Socio-economic science ............................................................................................. 82 Surveillance reports .................................................................................................... 82 Statistical reports ........................................................................................................ 82 Annex D Bovine tuberculosis in Europe ................................................................... 83
Annex E Defras bovine tuberculosis research programme ..................................... 84 Background ................................................................................................................ 84 Research spend by scientific area .............................................................................. 84
6 Secretary of States foreword: Achieving a bovine tuberculosis free England Bovine tuberculosis (bTB) is the most pressing animal health problem in the UK. The crisis facing our cattle farmers, their families and their communities cannot be overstated. It is a devastating zoonosis that threatens our cattle industry and presents risks to other livestock, wildlife species such as badgers, domestic pets and humans. This was once a disease isolated to small pockets of the country; in 1979 only 0.01 percent of British cattle tested as infected. It has now spread extensively northwards and eastwards from infected pockets in the south west of England and Wales. The number of new herd breakdowns has doubled every nine years and in the last decade we have slaughtered 314,000 otherwise healthy cattle across Great Britain in our attempt to control this disease. In 2013 over 6.2 million bTB tests were performed in England leading to the slaughter of over 26,000 cattle. One quarter of herds in the South West and West Midlands were placed under movement restrictions at some point; bTB causes misery for affected farmers. In the last decade it has cost the taxpayer 500 million. In 2014 it will cost the taxpayer nearly 100 million with costs to farmers estimated to run to tens of millions of pounds. If we do not get on top of the disease we will see a continued increase in the number of herds affected, further geographical spread and a taxpayer bill over the next decade exceeding 1 billion. It is therefore vital that farmers, vets, non-government organisations and politicians work together to free England of bTB. We want to build a thriving cattle sector which maintains our countryside, trades internationally and delivers economic growth. The current surveillance and control scheme is based on the traditional approach applied across Europe: routine skin testing of cattle, removal and slaughter of test reactors combined with post-mortem surveillance at slaughter and movement controls placed on infected herds. In the absence of a major wildlife reservoir, this approach has been successful in allowing many EU countries and regions, for example Scotland, to achieve Officially bTB Free (OTF) Status. It has also been successful at preventing the establishment of disease in many counties in the north and east of England, areas we believe do not yet have a significant reservoir of infection in wildlife. The same approach has reduced the spread of the disease in the areas where bTB is established but on its own it is not enough. Where there is a reservoir of disease in wildlife, tackling this disease will require long-term solutions and considerable national resolve. Half measures are simply not enough. I intend to pursue policies which will reverse this trend well before the end of this decade, achieve OTF status for parts of England on the same timescale and thereafter progressively rid the whole of the country of bTB. So we need a control and eradication strategy with these
7 clear aims at its heart. It must be dynamic, tailored to the sources of disease and the potential for eliminating it. It must adapt as new tools become available. In achieving these aims, we must learn the lessons from those countries that have succeeded in tackling bTB where there has been a reservoir of the disease in wildlife. I have visited Australia, New Zealand, the Republic of Ireland and the USA. I have talked to the Ministers, farmers and officials involved and I intend to apply the lessons of their success here in England: Australia achieved official freedom from bTB in 1997 after a sustained campaign over nearly three decades. Michigan has reduced the prevalence of TB in white-tailed deer by 60 per cent since the mid-1990s and reduced the average annual number of livestock herds affected with bTB to single figures since 2005. New Zealand achieved a reduction in the number of infected herds from 1,700 in the mid-1990s to 66 in 2011/12. The Republic of Ireland reduced the proportion of herds affected from 9.6 percent in 1995 to 7.4 percent in 2010. In the same period it increased from 0.8 percent to 9 percent in England and from 5.5 to 7.9 percent in Northern Ireland. The number of bTB reactors in the Republic of Ireland fell by over 65 percent between 1999 and 2013, from 44,903 to 15,612, the lowest level since the eradication programme started in the 1950s. The vital lesson I have taken from these countries is the importance of stringent cattle control measures in combination with tackling the primary wildlife reservoir, be it the water buffalo in Australia, the white-tailed deer in Michigan, the brush-tailed possum in New Zealand or, closer to home the badger in the Republic of Ireland. An additional factor which has contributed to their success is the fact that their programmes are either led by industry or delivered by industry and government working in partnership, with both parties contributing to the cost. No two countries are the same, so we will need to be smart in how we adapt and apply the key elements of others eradication strategies to our countryside. However, the common thread is undoubtedly the sustained and adaptive application of a control programme that addresses significant reservoirs of infection in cattle and wildlife as well as pockets of infection in other species such as camelids, deer and goats, through a partnership approach. I am delighted to publish the Governments bTB Strategy for England following a public consultation and extensive dialogue in 2013. For the first time it: brings together all the tools we need to address the disease including those currently available and those under development such as cattle vaccine, explicitly rejects the one size fits all approach, recognising the need to apply different tools in different herds depending on local circumstances and disease risk,
8 sets targets by which we can measure progress towards achieving OTF status for England. The Strategy is comprehensive using all available tools to: contain bTB in the high risk area and progressively reduce its spread, thereby increasing the number of bTB-free herds, maintain the commercial viability of herds in the high risk area, maintain consumer confidence and exports without undermining the detection and control of bTB, reduce the risk of spread of the bTB to currently free areas, rapidly find and eliminate bTB wherever it occurs, reduce and eliminate the spread of TB from badgers, identify and apply management practices that minimise transmission risk within herds, deploy market measures, regulation, incentives and deterrents to reduce the risk of disease spread due to movements. The Strategy will simply not work without addressing the reservoir of TB infection in badgers. The option of using injectable badger vaccine has been available since 2010. However, we estimate that a third of badgers in endemic areas are infected with TB; we know that the vaccine does not cure them and that they remain free to spread TB. Despite the fact that injectable badger vaccination does not entail all the licensing criteria landowners must meet to carry out culling, there has been no widespread deployment either by farmers or NGOs. Based on first veterinary principles and supported by modelling, one would expect culling to be more effective than a badger vaccination programme; that is why I have decided to continue the policy of badger culling in endemic areas learning lessons from the pilots in 2013. As well as using available tools, I am determined to develop new ones to support the Strategy. Over this Parliament, we are investing 24.6 million in the development of effective TB vaccines for both cattle and badgers. Our scientists are leading the world in the development of a deployable cattle vaccine. I secured a clear programme from Commissioner Tonio Borg (DG-SANCO) on the work necessary to bring a cattle vaccine to the market. We are making progress in designing the large scale field trials necessary to take this forward. Subject to an assessment of costs and benefits, I am committed to meeting the earliest deadline for its implementation, but the need for the field trials and changes in the law mean that a usable cattle vaccine is still many years away. In the future, an oral badger vaccine might address some of the deployment issues with injectable vaccine deployment and serve as a targeted control measure. Although some progress has been made, we have not yet identified a candidate vaccine to take forward for authorisation. We will also continue to invest in the development of improved diagnostic tests for both cattle and badgers such as DNA-based technologies. My goal is to move to a position whereby we have the tools to enable us to deploy a targeted approach, identifying and removing only TB-infected badgers either at individual or sett level. In the meantime we will not sit on our hands and let the problem get worse.
9 A key point drawn from other countries is the need for a partnership approach to governance, delivery, and funding of eradication programmes with farmers making the key implementation decisions and significantly contributing to the costs. The New Zealand government has commissioned an independent, farmer-led body, jointly funded by industry and government with responsibility for oversight and implementation of the eradication strategy. It has been a great success. I am absolutely clear that if we are to tackle this disease successfully, we need a different way of working together in England, which acknowledges the respective responsibilities for government and industry both in terms of what we do and how we pay for it. I intend to continue discussions with the industry as to how we might achieve this new way of working. I accept that the right approach is not always the popular approach. The House of Commons gave its view in J une 2013, when it endorsed by a majority of 61 votes a motion reflecting our strategic approach. This includes drawing on international experience which demonstrates the importance of bearing down on bTB in cattle and wildlife. It also stresses the need to employ every available tool to deal effectively with the disease, researching and investing in the development and deployment of new technologies. I am extremely grateful for the work of the Animal Health and Welfare Board for England, the Bovine TB Eradication Advisory Group for England and to all those who responded to our public consultation or took part in stakeholder and public dialogue events. The Strategy, which they have all played a part in developing, recognises that achieving OTF status for England will be a long haul. I am however confident that it is not beyond industry and government to achieve it for England within the timescales we envisage. My aim is for England to be free of bTB by 2038 with healthy livestock living alongside healthy badgers. Our livestock industry, our badgers and our countryside deserve no less.
The Rt Hon Owen Paterson MP Secretary of State for Environment, Food and Rural Affairs
10 I. The Strategy for achieving Officially Bovine Tuberculosis Free status for England Objective The objective of the Government is to achieve Officially Bovine Tuberculosis Free (OTF) status for England by 2038. It also has an interim objective of achieving OTF status for large parts of the north and east of England as soon as possible but most likely by 2025. This will be achieved by three key actions: a) establishing three bovine tuberculosis (bTB) management regions or zones (a High Risk Area, a Low Risk Area and a buffer zone (Edge Area) in between); b) applying a range of measures to control the disease within these zones that is practical and proportionate to the disease risk while maintaining an economically sustainable livestock industry; c) ensuring that there is shared governance of the delivery process between the main beneficiaries including the food and farming industry and the taxpayer. This activity will be led increasingly by the farming industry and other stakeholders, and their responsibilities will include the effective application of disease control measures in cattle, securing best practice in livestock farming including on-farm methods for preventing the spread of disease, and addressing the reservoir of bTB in wildlife 1 whilst maintaining biodiversity. We explicitly recognise the need to adapt our approach as the epidemic evolves and new evidence and technology becomes available and to embrace partnership working with a range of stakeholders, as well as working effectively in the European Union (EU). Rationale for intervention Bovine tuberculosis (bTB) is an increasing social and economic problem in England. There is a strong social and economic case for controlling the disease in order to support a thriving and sustainable livestock sector and the United Kingdom (UK)s statutory bTB eradication programme is designed to comply with international standards for trade. The fact that the bTB situation in the UK (excluding Scotland) is the worst by far in the EU and
1 While Mycobacterium bovis has been found in wildlife other than badgers, evidence from surveillance and modelling indicates that the badger remains the principal and possibly the only wildlife maintenance host in England. However, we will continue to review the potential role of other wildlife species in the epidemiology of bTB.
11 probably the worst in the developed world, poses an increasing risk to intra-EU and international trade. Additionally, bTB can pose a risk to human health. The problem of bTB Over the past three decades, the incidence of bTB in England has continued to increase and the disease has spread from parts of the South West. Although most of the north and east of England has had a very low incidence of bTB herd incidents (breakdowns) there has been a much higher disease incidence in the West and South West. Parts of Wales have had a similar problem but Scotland achieved OTF status in 2009. The epidemiology of bTB is complex and, despite considerable investment in the evidence base over the last 20 years, much remains highly uncertain. While the evidence that is available needs to be used and weighted appropriately according to its relevance and reliability, there is a need to pursue an adaptive approach to policy development, particularly as the evidence base grows and new interventions are tried and tested. We will deploy a package of interventions, flexibly informed by scientific and veterinary advice, to address all likely routes of disease transmission. Due to the biology of bTB and its complex epidemiology, most effects of interventions will only be seen several years after their introduction and, even then, it will be difficult to assign cause and effect to any particular intervention. As a result, each of these interventions is open to challenge by those with different perceptions of where the real problem lies. Consequently, success is measured through the combined impacts of a national system of intervention, rather than looking at individual control measures in isolation. Defining the solution There is no single intervention that will on its own achieve control of the bTB epidemic. Disease control needs to be constructed around controlling all routes of transmission of the disease. These are principally cattle-cattle, but will also include cattle-badger, badger- badger and badger-cattle as well as spillover into other susceptible species. The different contribution made by these routes will vary with circumstances. This approach means using all the available interventions in proportion to their likely contributions to the aim of achieving reduced disease incidence in cattle, and as part of the national framework. Therefore we need to: bear down on the highest impact risks using the latest and most relevant evidence; ensure that future interventions are designed to minimise these risks and that they are applied proportionately to the circumstances; and
12 ensure that those who are responsible for managing the behaviours that change the risks are aware of their responsibilities and are incentivised to deliver effective disease control. Improved application of epidemiological techniques has the capacity to refine our understanding of the risk factors determining the probability of infection with bTB and to design interventions in ways that are increasingly effective. This is a key priority and we are committed to developing this by strengthening our application of epidemiology at local, regional and national scales. Additional data collection and epidemiological analysis conducted alongside implementation of integrated controls will lead to improvement in modelling and risk assessments and in turn to improvement in the design of cost-effective interventions to reduce disease. This approach to risk assessment, enabling interventions to be tailored to specific circumstances, has the greatest probability of success if it is shared with the farming community and implemented in a partnership between farmers, veterinarians and regulators. We intend to adapt compulsory surveillance and control measures, and the way in which compensation funding is used, both to improve the implementation of control measures and incentivise risk reduction actions at the scale of individual farms. It is widely accepted that no single intervention has the capacity to control the disease. Each intervention has strengths and weaknesses, which will vary depending upon local circumstances. Therefore an integrated approach to controlling bTB will require the use of a range of disease surveillance and control interventions, including statutory and non- statutory controls. Current statutory controls include continued surveillance for disease within cattle herds and at slaughter, pre-movement testing, removal of bTB test reactors and other cattle suspected of being infected with bTB from the national herd, and additional measures in bTB breakdown herds such as movement restrictions, disinfection, and more sensitive tests to increase the chances of removing infection from affected herds and to reduce the probability of spread between herds. Non-statutory controls include a range of measures that are expected to reduce the likelihood of introducing infection into cattle herds. These include: the risk-based trading scheme introduced in 2013 in response to the recommendations of an industry-led Risk- Based Trading Group to enable farmers to better understand and act on the risk of introducing disease when buying cattle; post-movement testing; biosecurity measures on farms against both cattle-cattle and badger-cattle transmission; reduction in badger populations; and BCG vaccination of badgers against bTB by injection. BCG is not a very effective vaccine. Notable potential interventions that are either not currently available or not deployable on an operational scale are cattle TB vaccination, oral TB vaccination of badgers, the identification and removal of TB-infected badgers and alternative approaches to badger population control ideally focussed on removing from the population only those badgers infected with TB. A combination of scientific and technical challenges means that each of
13 these approaches requires further work before they can be implemented but we will look to deploy them to best effect as they become available. Ongoing research and pilots are examining ways in which some of these interventions can be turned into operational tools. Implementing the solution The approach to controlling bTB ultimately aims to tackle the disease nationally. However, achieving this will require us to apply different sets of interventions according to circumstances because the problem is different in different parts of the country. In practice, interventions take place mainly at the scale of individual farms but it is important to see a coherent link between the application of these interventions and the wider national objective of achieving OTF status by 2038. Regional variation will be addressed by different generic control policies in three management regions or zones. These zones are defined as the High Risk (HRA) the Edge, and the Low Risk (LRA) Areas (Figure 1).
14 Figure 1 Geographical location of the three risk areas in 2013
Local variation in disease characteristics can be addressed, for example, by more frequent surveillance testing of local herds in response to emerging problems and where the epidemiological evidence shows that bTB herd breakdowns detected by testing or by slaughterhouse surveillance are in some way geographically and temporally associated. This kind of intervention is already a standard approach within the LRA and Edge Area. As our epidemiological knowledge improves, it may signal new ways of controlling the disease at these local levels and we will introduce new measures to achieve this whenever feasible and cost-effective. The strategic disease control principles used in implementation are set out in Table 1. This builds upon the interventions that we know from past experience are effective. Applying Low Risk Area: - Crude herd prevalence ~0.1% - Has remained stable since 2006 Edge Area: - Crude herd prevalence ~1% - Is steadily increasing High Risk Area: - Crude herd prevalence ~9% - Increased from ~1.5% in 1995
15 these in proportion to the risk will improve their effectiveness. It also uses the information we have from surveillance, epidemiology and local knowledge to greatest effect. It will lead to a step change in the effectiveness of our approach to control bTB because it will focus the resources in those places and situations where the problem is most profound. Table 1 Strategic disease control principles
Define areas of the country on the basis of risk (Figure 1). Focus disease control measures on those risks, to contain the disease in the HRA and progressively reduce its size. Establish a risk rating system for herds and incentivise actions by farmers to reduce their risk. Reduce the risk of spread of the disease to currently free geographic areas and to unaffected cattle herds in affected areas. Rapidly find and eliminate disease in cattle when it occurs in areas previously free of disease. Reduce the spread of TB between cattle both within and between herds. Minimise the exposure of cattle to infected badgers (a key risk factor for its introduction to cattle) and other possible wildlife vectors. Deal promptly with any other epidemiologically significant reservoirs of TB infection that are discovered. Move towards an increasingly farmer-led control and eradication process, with farmers significantly contributing to the costs of implementing the practical decisions they are taking to eradicate the disease. Improving bio-security is a priority. This focuses attention on the processes involved in disease transmission. Early interventions to improve bio-security include developing the voluntary risk-based trading scheme introduced in 2013, deploying measures at the farm level to reduce cattle-cattle and wildlife-cattle transmission, providing the necessary incentives to farmers to achieve risk-reduction, improving advice for farmers, improving compliance and enforcement, and tackling TB in non-bovine species such as South American camelids. The intention is to progress region-by-region towards OTF status. Consequently a key development to achieve this is the introduction of a risk-based approach to disease control applied to three management regions or zones. The differing approaches being adopted in these zones are set out in Table 2. Zoning will allow the system of disease management to be proportionate to the impact upon the industry and be flexible to the different circumstances of evolving disease risk in each zone. Low Risk Area (LRA) The LRA covers large parts of the north and east of England (Figure 1). It has a low incidence of bTB and no recognised significant reservoir of the disease in wildlife. Consequently, the objective in the LRA is to continue to protect it from the ingress of disease through the movement of cattle and the possible resulting infection of wildlife vectors. This will continue to involve testing of cattle before being introduced from other
16 areas, as well as improving risk-based surveillance and incentivising risk-based approaches such as risk-based trading and the testing of cattle after being introduced as happens in Scotland. Isolated outbreaks will be controlled using the most sensitive tests to remove infected cattle and by testing neighbouring herds for disease. This approach is designed to achieve early OTF status for this geographical area. Edge Area The Edge Area is the buffer zone between the HRA and the LRA (Figure 1) which contains local disease fronts advancing from the HRA towards the LRA. The incidence of bTB in the Edge Area is much lower than that in the HRA, but higher than that in the LRA. Additional evidence is needed to determine the respective role of cattle and wildlife in the spread of the disease in the Edge Area. The Edge Area will be managed to contain and reverse the spread of bTB from the HRA to the LRA, with the aim of obtaining OTF status for this geographical area as soon as possible. This will incorporate strict cattle measures similar to those applied to the LRA with the additional focus on surveillance to identify the role of wildlife vectors. Management of these wildlife vectors will include vaccination and possibly culling where the evidence supports its deployment. High Risk Area (HRA) This zone covers the South West, West Midlands and East Sussex (Figure 1) and it is where a relatively high proportion of herds are infected by bTB. It is also where there is a high proportion of repeat cases among herds, and there is a recognised reservoir of infection in badgers. Even against this background, some herds and areas remain bTB- free, and we want to do all we can to maintain this position. This will include applying the methodology currently used in the LRA and Edge Area where it is cost-effective to do so. The objective is to halt and then reverse the increasing prevalence of bTB and ultimately to achieve OTF status for this geographical area. Because of the greater challenge in this area, and recognising the need for proportionality of the impact of disease control on the capacity of the industry to operate, we need to develop a more complex set of interventions that address the specific local needs. This includes incentivising risk-based approaches, such as risk-based trading and farm management measures, to reduce the likelihood of both cattle-cattle and badger-cattle infection. Management of the latter will include vaccination and culling. Research Research into the development of new interventions to control the disease is an essential part of the Governments strategy. This includes continuation of our search for affordable and effective vaccines for both cattle and badgers, more effective diagnostic tests and the development of the capacity to provide near-real-time epidemiological intelligence to inform how disease can be controlled in specific circumstances. It also includes new research into more effective ways of controlling the routes of transmission of disease between wildlife and cattle. An essential component of future research capacity will continue to be the collection of information about the nature of bTB risk, including
17 effectiveness of different sets of interventions and the ways in which these provide benefits for farm businesses. This will contribute to an approach involving adaptive learning; as we implement new ideas we will learn from them and make them incrementally better. Governance Experience in other countries has shown that governance is key to addressing successfully the control and elimination of bTB. For example, in New Zealand delegating responsibility for the control of bTB to an independent organisation with strong representation from the farming industry has been an important feature of their strategy. The Government will work with stakeholders to develop an enhanced partnership approach to the delivery of OTF status. Within the context of such an approach the role of government will be to review delivery and provide the necessary support to ensure that delivery is efficient and effective and that operational decisions are taken at the most appropriate level. This recognises that tackling bTB carries significant costs to farmers and other taxpayers and that these costs are not sustainable, but also that additional investment will be required over the short term to bring the disease under control and reduce the costs in the long term. We will develop proposals for a sustainable funding model for this governance structure in partnership with stakeholders. The experiences of both New Zealand and the Republic of Ireland provide evidence of the success of innovative delivery and co-financed bTB disease control. Table 2 Summary of current measures and additional future measures or options Risk area Type of measure Current measures Additional future measures or options 2
All Risk Areas Surveillance -Slaughterhouse surveillance -TB surveillance in non- bovines -Enhance the sensitivity of slaughterhouse surveillance -Enhance the sensitivity of TB surveillance in non- bovines Breakdown management -Movement restrictions -Isolation and rapid removal of suspected infected animals/contacts -Increased testing in -Phase out the practice of lifting restrictions on different parts of bTB holdings at different times -Introduce more sensitive testing of cattle traced
2 Subject to change in the light of new evidence and experience
18 Risk area Type of measure Current measures Additional future measures or options 2
infected and surrounding herds -Epidemiological investigations/reports from breakdown herds -Introduce stricter measures for bTB breakdown herds on a risk basis -Extend the time between short-interval herd tests to reduce the risk of test de- sensitisation and increase detection of residual infection -Improve epidemiological investigation/ reporting -Introduce stricter measures for TB breakdowns non-bovine -Enhance the management of persistent and recurrent breakdowns Other disease prevention -Voluntary risk-based trading -Advice and guidance -Sanctions -Public health protection measures -Improve advice and guidance -Improve local information on bTB -Review pre-movement testing exemptions -Review compensation to encourage risk-reduction -Improve biosecurity on and off farm -Encourage voluntary local eradication boards -Work with industry to support risk-based trading -Consider interferon- gamma assay for private pre- and post- movement testing -Pilot bTB enforcement
19 Risk area Type of measure Current measures Additional future measures or options 2
team - Support the introduction of bTB risk accreditation standards Low Risk Area Surveillance Four-yearly herd testing (except higher risk herds on annual testing)
-Improve risk-based testing by reviewing current approach to identifying higher risk herds and based on recommendations from research Breakdown management - Interferon-gamma assay of higher risk breakdown herds -Surveillance skin testing of herds within 3km radius
Other disease prevention -Biosecure (non-grazing) Approved Finishing Units -Regional epidemiology reporting -Introduce compulsory post-movement testing into LRA -Encourage improved biosecurity in other finishing units receiving cattle into the LRA Edge of High Risk Area Surveillance -Annual herd testing Breakdown management - Interferon-gamma assay of higher risk breakdown herds -Skin testing of contiguous herds -Surveillance skin testing of herds within 3km radius (some counties)
Reduce risk of TB from badgers -Biosecurity -Injectable badger vaccination -Increase surveillance for TB in badgers -Deploy oral badger vaccination (R&D)
20 Risk area Type of measure Current measures Additional future measures or options 2
Other disease prevention -Compulsory pre- movement testing -Biosecure Approved Finishing Units -Regional epidemiology reporting -Deploy cattle vaccination (R&D) High Risk Area Surveillance -Annual herd testing Breakdown management -Skin testing of contiguous herds -Additional use of interferon-gamma assay in some herds e.g. where the risk of TB infection from badgers is under control -Improve field epidemiological investigation of breakdowns (including use of genetic sequencing) Reduce risk of TB from badgers -Biosecurity -Injectable badger vaccination -Badger culling pilots -Badger culling -Deploy oral badger vaccination (R&D) Other disease prevention -Compulsory pre- movement testing -Biosecure Approved Finishing Units -Deploy cattle vaccination (R&D) -Regional and cluster based epidemiological reporting Notes: 1. Measures in all areas are deployed in addition to measures in specific risk areas. 2. R&D indicates areas in which the Government is funding multi-million pound research projects to develop operational tools.
21 II. Background Bovine tuberculosis Bovine tuberculosis (bTB) is a chronic infectious disease of cattle caused by the bacterium Mycobacterium bovis (M. bovis). While cattle are particularly susceptible to infection, M. bovis can also infect a range of other mammalian species. bTB is primarily a respiratory disease. Infection most often happens when moisture droplets containing M. bovis are inhaled but there are other routes of infection e.g. eating or drinking contaminated material. The risk posed by M. bovis to human health in the UK is considered very low. The European Food Safety Authority (EFSA) and the European Centre for Disease Prevention and Control (ECDC) 3 have advised that the main transmission routes of M. bovis to humans are through drinking raw milk or eating raw milk products from bTB-infected cows. Historically, before the introduction of milk pasteurisation and tuberculin testing of cattle herds, M. bovis infection in humans was much more common. M. bovis can also be transmitted through direct contact with infected animals; if bTB is left unchecked, we could potentially see more cases of M. bovis infection in humans associated with spillover of infection into non-bovine species that have close contact with humans. EFSA 4 has also advised that there is no evidence suggesting that M. bovis is a meat-borne hazard for humans in the EU. The vast majority of cases of TB in humans in the United Kingdom (UK) are caused by human-to-human transmission of M. tuberculosis. History of bovine tuberculosis in England Efforts to eradicate bTB from Great Britain (GB) were initially driven by public health concerns and the desire to increase the productivity and welfare of the national cattle herd. The voluntary herd schemes up to the 1950s were replaced by compulsory schemes. The whole of GB became 'attested' on 1st October 1960 i.e. each cattle herd was certified as being subject to regular tuberculin skin testing with immediate slaughter of any reactors.
3 EFSA (European Food Safety Authority) and ECDC (European Centre for Disease Prevention and Control), 2014. The European Union Summary Report on Trends and Sources of Zoonoses, Zoonotic Agents and Food-borne Outbreaks in 2012. EFSA J ournal 2014;12(2):3547, 312 pp. doi:10.2903/j.efsa.2014.3547 http://www.efsa.europa.eu/en/efsajournal/pub/3547.htm 4 EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards), 2013. Scientific Opinion on the public health hazards to be covered by inspection of meat (bovine animals). EFSA J ournal 2013;11(6):3266, 261 pp. doi:10.2903/j.efsa.2013.3266 http://www.efsa.europa.eu/en/efsajournal/pub/3266.htm
22 For the next two decades there was a steady decline in the incidence of reactor cattle, clinical cases and infected herds detected and every year new counties would be designated bTB-free areas in which the herd testing frequency could be gradually relaxed to reflect the improved situation. In 1979 the lowest bTB prevalence was recorded in GB, with 0.49 percent of all herds tested having a reactor, which equated to 0.018 percent of all cattle tested. While the frequent testing of cattle herds and the removal of reactors to limit cattle-to-cattle spread of M. bovis remained the cornerstone of bTB control, a high prevalence of bTB persisted in parts of south west England despite enhanced herd control measures. In the early 1970s the badger was first identified as a possible wildlife reservoir of infection for cattle in this area. A series of different strategies were developed throughout the 1970s, 1980s and 1990s to tackle this wildlife source of bTB alongside further cattle-based measures in the area. Gassing (1975-1982) and clean ring (1982-1986) strategies were used prior to an interim badger culling strategy in place between 1986 and 1997, whereby badgers were removed only from farms where a bTB incident had been confirmed by M. bovis culture and where, following investigation, it was thought that badgers were the most likely source. Annex A provides further information. The progressive reduction in bTB incidence stalled in the mid-1980s and subsequently the incidence progressively increased with new breakdowns extending eastwards and northwards (Figure 2). Prior to this, bTB herd incidence in south west England had remained about three times higher than in the rest of GB despite the retention of an annual (and occasionally more frequent) tuberculin skin testing regime for herds in this area. The Krebs report published in 1997 concluded that the sum of evidence strongly supports the view that, in Britain, badgers are a significant source of infection in cattle. The main recommendation was to set up a controlled field experiment (the Randomised Badger Culling Trial (RBCT)) overseen by the Independent Scientific Group on cattle TB (ISG) to quantify the impact of culling badgers on bTB incidence in cattle. Immediately after the publication of the Krebs report, the Government suspended all badger removal operations outside the RBCT pending its outcome. Statutory compensation for bTB reactor cattle was increased from 75 percent to 100 percent of the individual market value of a normal animal from 1998.
23 Figure 2 Number of skin and interferon-gamma test reactors and slaughterhouse cases found between 1986 and 2010 in cattle holdings experiencing bovine TB breakdowns with officially TB-free status withdrawn per km 2 per year
In 2001 the national bTB testing programme was severely disrupted due to a major outbreak of Foot and Mouth Disease, which led to anomalous bTB statistics from 2001 to early 2003. This led to a marked fall in the number of bTB breakdowns and reactors detected in 2001, followed by a sharp increase in 2002 as tuberculin skin testing of herds resumed (Figure 3). Another consequence of the outbreak was the geographical spread of bTB to new areas of England through the restocking of depopulated herds.
24 Figure 3 The evolution of the bTB epidemic in Great Britain
The Final Report of the ISG published in 2007 included the findings of the RBCT (1998- 2005). Using data from the start of the RBCT, it has been estimated that badgers contributed to some 50 percent of cattle herd bTB breakdowns in high incidence areas, either directly (badger-to-cattle spread of M.bovis) or indirectly (badger-to-cattle, followed by cattle-to-cattle spread of M.bovis). This is why any successful bTB control and eradication strategy must use all available tools to address effectively all the different routes of spread of M. bovis (Figure 4). Figure 4 Different routes of spread of M. bovis between cattle and badgers
25 From 2006 a range of additional cattle surveillance testing and movement controls were introduced in England, including compulsory pre-movement tuberculin testing of cattle moving out of herds in high risk areas and the use of the interferon-gamma test to supplement the skin test in certain circumstances e.g. in culture and/or lesion positive breakdowns in non-endemic areas. In 2006 a new statutory compensation system for bTB reactor cattle was introduced, using monthly tables of values that reflect the average sales price of different categories of cattle. By 2008 England reached a historical peak of 6.4 percent of herds experiencing new culture and/or lesion positive (formerly known as Officially bTB Free status withdrawn or OTFW) bTB breakdowns. There was no clear trend in the number of cattle movements in GB between 2002 and 2009 5 . Between 2009 and 2012, the herd incidence remained below 6.4 percent but the geographical spread of the endemic area continued. In 2010 an injectable TB vaccine for badgers was authorised and this has been deployed in local projects funded by government and by non-government organisations. Multi-million pound government-funded research to develop a deployable cattle bTB vaccine and an oral TB vaccine for badgers is ongoing. In 2011 the Government published a comprehensive Bovine Tuberculosis Eradication Programme for England 6 . In 2012 most bTB breakdowns in England were in the South West and West Midlands (Figure 5). By contrast the north and east of England had a very low and sporadic incidence of breakdowns. Less than 1.5 percent of bTB breakdowns in previously unaffected herds occurred in the areas of the country at low risk of the infection (Low Risk Area). Of these, at least half could be traced directly to the movement of infected cattle from the area at high risk of the infection (High Risk Area) into herds in the Low Risk Area. The other half represented cases where the likelihood of spread with cattle movements was high but this could not be established as the index animal had moved on or been slaughtered without being detected as bTB-infected. These isolated cases in the low risk area created individual breakdowns with occasional but limited subsequent secondary spread.
5 Vernon, M.C. (2011) Demographics of cattle movements in the UK. BMC Veterinary Research 2011, 7:31 6 Defra (2011) Bovine Tuberculosis Eradication Programme for England, J uly 2011 (PB 13601)
26 Figure 5 Map showing the uneven geographic distribution of bTB in England. New bTB herd breakdowns, or clusters of breakdowns, with Officially bTB Free status withdrawn that were identified in England during 2012 are shown as yellow dots. Counties shown in red correspond to the current annual testing area of England that has been in force from 1 January 2013. (Source: AHVLA)
27 Additional packages of cattle measures came into effect between 2012 and 2014 (Annex B). These included changes to cattle bTB compensation, the removal of some pre- movement bTB testing exemptions, the removal of higher risk links between holdings on the Cattle Tracing System (CTS) and a ban on new or enlarged Sole Occupancy Authorities (SOAs) from 2012. This was followed in 2013 by a tightening of cattle movement controls and a move from parish to county-based bTB testing intervals, further expanding the area in which cattle herds are tested annually. In October 2013 the Government began deploying a package of measures as part of a new strategy for the Edge Area a defined area on the eastern and northern border of the High Risk Area (see later). This package included advice to farmers, improved information management, stricter bTB breakdown management and prevention measures, and extension of access to government financial support for vaccination projects in the Edge Area. Additionally research projects were set up to estimate likely locations of badger populations in the Edge Area and to assess how useful post mortem examinations of badgers killed in road traffic accidents would be in estimating TB levels in local badgers. In November 2013 the Government launched a voluntary risk-based trading scheme to encourage farmers to share details of the bTB disease history of cattle they sell and buyers to act on this information. Since J anuary 2014 farmers with overdue bTB surveillance or check tests have faced a reduction of their Common Agricultural Policy Scheme payments. In February 2014 AHVLA announced an enhanced approach to managing long-term bTB breakdown herds in partnership with the farmers private veterinary surgeons. In March 2014 Defra announced new powers to cull cattle unable to be tested for bTB and the removal of further pre-movement bTB testing exemptions. In 2012 Natural England issued badger control licences in the HRA in Somerset and Gloucestershire. Each licence has a four-year term authorising control operations to be conducted each year with no control operations permitted during specified close seasons. Two pilot culls were completed in 2013 and an Independent Expert Panel assessed the humaneness, effectiveness (in terms of badger removal) and safety of controlled shooting of free-ranging badgers to inform decisions on a wider roll out of the policy. Analysis of the bTB epidemic to 2012 showed that since the beginning of 2003, the relative rate of increase of new culture and/or lesion positive (formerly known as OTF status withdrawn or OTFW) bTB breakdowns in England fell by more than half compared with 1986-2000 (Figure 6). This was despite a year-on-year increase in the annual number of herd and animal tests carried out. However, the rolling average proportion of live cattle herds under restriction as a result of culture and/or lesion confirmed positive bTB breakdowns rose from just under one percent in 2000 to just over five percent in 2012. Further information is available in AHVLAs bTB surveillance reports 7 .
7 Bovine TB surveillance reports are available at http://www.defra.gov.uk/ahvla-en/publication/pub- survreport-tb/
28 Figure 6 Quarterly numbers of total and OTFW new bovine TB breakdowns detected in England between January 1986 and December 2012
Evidence The Government will develop approaches to deliver the Strategy based on the best available evidence, scientific advice and veterinary advice. The term evidence encompasses material from multi-disciplinary science research, statistics, economics, social or operational research and geographical information. Annex C includes links to components of the bTB evidence base, which is constantly evolving. This includes independent Natural Science and Socio-Economic Evidence Statements, and bTB surveillance reports and statistical reports compiled by Government. In some areas, the Government recognises that further research is required to strengthen the evidence base. Further information on Defras Evidence and Investment Strategy and the Bovine Tuberculosis Evidence Plan to strengthen the evidence base is provided in the section on Developing New Tools. As well as developing new tools for controlling bTB, the Government will also address the continuing need to improve the understanding of the epidemiology of bTB. This includes strengthening field epidemiology to improve incorporation of local information into the national picture of the epidemic. It also includes the development and use of mathematical
29 models to inform the development, application, assessment, monitoring and evaluation of bTB control tools and policy options. Strategy aim The aim of the Strategy is to eradicate bTB, achieving Officially bTB Free (OTF) Status 8 for England incrementall y, whilst maintaining an economically sustainable livestock industry 9 . The Strategy sets out how the aim will be achieved through greater partnership working, increasingly non-government-led implementation and a fair sharing of the associated costs. It draws upon the demonstratively successful approaches taken elsewhere in the world, for example in: Australia, where the national eradication programme spanning almost three decades achieved official freedom from bTB in 1997 through a comprehensive package of measures to tackle the disease in domestic cattle and wildlife. This included rigorous culling of feral water buffalo, which were introduced into Australia in the nineteenth century; Scotland, which successfully applied a package of conventional cattle measures in the absence of a significant reservoir of TB in wildlife, to achieve OTF status in 2009; Michigan in the United States of America, where the bTB eradication project includes cattle and wildlife controls. Since the mid-1990s, Michigan State has made significant progress in lowering the apparent prevalence of M. bovis in free ranging white-tailed deer in the endemic area by over 60 percent through reduction of deer densities by hunting and restrictions on public feeding and baiting of deer. This strategy has been implemented with the cooperation of local hunters. Livestock herd breakdowns averaged 3-4 per year from 2005 to 2011; New Zealand, where a farmer-led management agency has delivered an effective national bTB eradication plan comprising cattle and wildlife controls co-financed by government and industry. The primary wildlife reservoir of M. bovis is in brush-tailed possums, introduced into New Zealand in the nineteenth century. Wildlife control
8 For a Member State or region to achieve OTF status as defined in Council Directive 64/432/EEC, at least 99.9 percent of the herds within it must have been or remained OTF for at least six consecutive years. OTF status allows for residual levels of the infection to remain, whereby less than 0.1 percent of herds experience the infection annually in a region defined as OTF, whilst eradication would represent elimination of the infection 9 The Strategys aim complements Defras strategic objectives of supporting and developing British farming and encouraging sustainable food production, enhancing the environment and biodiversity, and managing the risk of animal disease. These support Governments overarching objective of achieving economic growth.
30 measures include aerially- or ground-deployed poison bait and trapping. The number of M. bovis infected cattle and deer herds has reduced from over 1700 in the mid-1990s to less than 100 (0.13 percent of herds) in 2012/13; The Republic of Ireland, where there has been a comprehensive bTB eradication programme including cattle controls and since 2000 10 an increasingly coordinated reactive cull of badgers in response to epidemiologically linked bTB breakdowns in cattle. The current badger culling strategy involving up to 30 percent of agricultural land has been in place since 2004 11 . The Irish programme has seen the proportion of bTB herd breakdowns fall from 9.6 percent (i.e. percentage of annual active herds with at least one TB reactor or slaughterhouse case) in 1995 to 7.4 percent in 2010, compared to increases from 0.8 percent to 9.0 percent in England and from 5.5 percent to 7.9 percent in Northern Ireland over the same period. 12 Cattle bTB testing and compensation in the Republic of Ireland are co-funded by government and industry; France, which achieved OTF status in 2000 and is working to eradicate bTB through a comprehensive eradication programme which includes cattle controls and culling of infected wildlife species (badgers, wild boar and deer). One of the most heavily infected dpartements used local trappers to catch and kill some 10,000 badgers over a large area between 2010 and 2013. Cattle bTB testing is co-funded by government and industry. Achieving the aim will be dependent upon: Effective application of disease control measures in cattle; Best practice in livestock farming achieved through advice and appropriate, evidence- based use of rewards and penalties; Addressing the reservoir of M. bovis in wildlife whilst maintaining biodiversity to enable a healthy cattle population to live alongside a healthy wildlife population; and Ensuring a fair balance of costs falling to the general taxpayer, the food and farming industry and other stakeholders. The Strategy focuses on keeping the Low Risk Area free of bTB, halting and then reversing the spread of bTB in the Edge Area, and radically reducing the prevalence of bTB in the High Risk Area, progressively achieving OTF status for England.
10 Good, M. et al (2011) Impact of the full herd depopulation policy on the recurrence of bovine tuberculosis in Irish herds, 2003 to 2005. Veterinary Record (2011) doi: 10.1136/vr.d4571 11 Sheridan, M. (2011) Progress in tuberculosis eradication in Ireland. Veterinary Microbiology 151 (2011) 160-169 12 Standardised annual herd prevalence as defined in Abernethy, D.A. et al (2013) Bovine tuberculosis trends in the UK and the Republic of Ireland, 1995-2010. Veterinary Record (2013) doi: 10.1136/vr.100969
31 Rationale for intervention The Government wants to see a thriving and sustainable livestock sector in England, one that, along with the rest of the agricultural sector, helps to support the resilience of the entire food chain. In 2012, 481 thousand people worked on UK farms. The value of UK production was 3.8 billion for dairy products and 2.8 billion for beef. The value of UK exports was 1.2 billion for dairy products and 389 million for beef 13 . In 2013, the total number of cattle and calves in England was just under 5.4 million. The female breeding herd, which steadily decreased from just over 2.0 million in 2005 to 1.8 million in 2013, accounted for just over a third of this total; the dairy herd accounted for 61 percent of the breeding herd and remained at 1.1 million animals between 2010 and 2013; the beef herd decreased from 742 thousand in 2012 to 720 thousand in 2013 14 . bTB is one of the most pressing challenges facing the industry today; it has social and economic impacts. In 2012 the estimated average cost of a bTB breakdown in the High Risk Area was 14,000 to farmers and 20,000 to taxpayers; in 2011/12 the average cost of a routine bTB test was 350 to farmers and 770 to taxpayers. Based on current expenditure, the forecast cost to taxpayers alone without additional intervention will exceed 1 billion over the next decade; this level of expenditure is unsustainable. If bTB is left unchecked we risk impacting the productivity and capability of the industry threatening our ability to trade and grow our exports into new and emerging markets. We also risk undermining confidence in our food and more cases of human infection. bTB can spread from animal to animal and from farm to farm. Whilst there are a number of measures that individuals can and should take to help reduce the risk of bTB, achievement of OTF status and then eradication of bTB in England requires collective action. Individuals are unlikely to consider the potential costs and benefits to others when deciding how and when to invest to limit the spread of the disease. For this reason their decisions are unlikely to be optimal from the perspective of the industry or society. Certain activities can actually worsen the spread of infection, so a coordinated and strategic approach is essential if we are to prevent the spread, bear down on, and ultimately eradicate the infection. The Governments responsibility is to set out how the disease can be tackled holistically. In doing so it needs to ensure that the UK meets its legal obligations and reduce the financial strain on public finances and industry through increased partnership working, industry-led
13 Source: Agriculture in the United Kingdom 2012, UK Rural Affairs Departments https://www.gov.uk/government/publications/agriculture-in-the-united-kingdom-2012 14 Source: Farming Statistics, Final Crop Areas and Cattle, Sheep and Pig Populations at 1 J une 2013 - England, Defra https://www.gov.uk/government/publications/farming-statistics-final-crop-areas-yields- livestock-populations-and-agricultural-workforce-at-1-june-2013-uk
32 delivery and a fair sharing of the costs involved. In so doing it will help put the sector and public financing of disease control on a more sustainable footing. The UK programme for accelerating the eradication of bTB 15 is designed on the basis of Council Directives 64/432/EEC, 77/391/EEC and 78/52/EEC with a view to enabling the UK to benefit from an EU financial contribution for the programme and mitigating the risk of infraction proceedings, financial penalties and trade sanctions. Achieving OTF status for England will provide tangible benefits for the cattle industry, rural communities and Government. These include significant savings in combating the disease both to Government and to industry, increasing the ability to trade within the EU and internationally 16 and alleviating the social impacts. While Scotland achieved OTF status in 2009, the prevalence of bTB infection in England contributes to an unacceptably high prevalence of bTB in the UK herd as a whole (Figure 7). Many other EU Member States are already OTF. A map showing the OTF status of EU Member States can be found at Annex D.
15 Working document on eradication of bovine tuberculosis in the EU accepted by the Bovine tuberculosis subgroup of the Task Force on monitoring animal disease eradication (SANCO/10067/2013) http://ec.europa.eu/food/animal/diseases/eradication/tb_workingdoc2006_en.pdf 16 The World Organisation for Animal Healths (OIE) Terrestrial Animal Health Code lays down animal health standards for international trade. These include requirements for qualifying for official freedom from bTB. http://www.oie.int/
33 Figure 7: National herd prevalence 17 for bovine TB in EU member states 18
The Government does not envisage disadvantages arising from the achievement of OTF status for England in a staged manner. Nevertheless, it proposes working with the Agricultural and Horticultural Development Board to assess any regional market impacts which might arise as a consequence of pursuing a staged approach (i.e. by counties or groups of counties) to achieving OTF regional status for England. Strategy approach The Strategy reflects the Governments commitment to tackle bTB in a comprehensive and balanced way, with achievement of OTF status for England. The approach will be: Comprehensive and adaptive: tackling M. bovis infection in cattle, other farmed animals and wildlife, addressing all transmission routes to tackle bTB in cattle, making best use of all available evidence and tools whilst funding research to address evidence gaps and develop new tools;
17 Prevalence proportions have been calculated as the percentage of cattle herds infected with or positive for M. bovis during 2010. The red symbol size is proportional to the prevalence of M. bovis in cattle herds 18 Source: Ru,G. et al (2013) Bovine TB Control: valuable insights from countries on steps toward eradication. Veterinary Record 2013 172: 310-311 doi: 10.1136/vr.f1347 citing EFSA & ECDC (2012) The European Union Summary Report on Trends and Sources of Zoonoses, Zoonotic Agents and Food-borne Outbreaks in 2010. EFSA J ournal 10, 2597
34 Risk-based: with controls targeted according to risk of infection and based on scientific and veterinary advice; and Staged: to provide the means to stop the spread of infection, bring it under control, and bear down on it to achieve and maintain OTF. To achieve a balanced approach, the Strategy embraces: Partnership working: Many individuals and groups have a direct involvement in controlling the disease and will benefit from England achieving OTF status. The Government, the farming and food industries, the veterinary profession, local authorities, wildlife interest groups and other stakeholders will need to collaborate effectively to deliver the Strategys aim. Government will maintain open dialogue on bTB policy development guided by the Strategy. It will work closely with devolved administrations, particularly in the context of the evolution of the UKs bTB eradication programme. Fair balance of costs and supported responsibility: Government will work with those at the forefront of the disease to support farm businesses in taking more responsibility for disease control, for example by appropriate use of rewards and penalties to encourage best practice. Government will explore innovative governance arrangements and delivery models. Working effectivel y i n the EU: Government, as the competent authority, will ensure that England complies with EU bTB legislation, while pushing for a more flexible, risk- based EU legal framework under a new Animal Health Regulation 19 . Government will work closely with the European Commission in the context of the evolution of the UKs bTB eradication programme and in presenting evidence for OTF status for regions of England. Government will also work through the EU to ensure that the World Organisation for Animal Health (OIE) animal health standards for international trade are aligned as far as possible with rules for intra-EU trade. Targets and timeline Targets The initial Strategy targets are set out in Table 3, below. The targets will be used to monitor and evaluate the Strategy (see Monitoring and Evaluation of the Strategy) and further targets may be developed.
19 On 6 May 2013, the European Commission adopted a package of measures to strengthen the enforcement of health and safety standards for the whole agri-food chain. The main elements include Animal Health and Official Controls. The package is subject to consideration by the European Parliament and the Council with possible entry into force in 2016, followed by a proposed three-year transition period. http://europa.eu/rapid/press-release_IP-13-400_en.htm
35 Table 3 Initial targets Basic measures of performance Targets Delivery scale Indicators of success Annual proportion of Officially bTB-Free (OTF) herds
Progressive attainment of OTF status for individual counties (or groups of counties) within the current low risk area 20
Between 2018 and 2025 1. The achievement of OTF status for individual counties in England 2. The reduction in the geographical coverage of the High Risk and Edge Areas in England 3. In longer term, the achievement of OTF status for England
Achievement of OTF status for all counties in the current low risk area By 2025 Maintain herd prevalence below 2% overall in the edge area 21
By 2019 Reduce herd prevalence below 1% overall in the edge area By 2025 Achieve OTF status for the lowest prevalence counties in the edge area By 2025 The Government will set targets for individual counties within the high risk area
Achieve OTF status for England By 2038 Timeline Figure 8 illustrates the tentative timeline for potential deployment of measures to achieve the targets in the preceding section.
20 Cumbria, Durham, Lancashire, Northumberland, Yorkshire, Humberside, Lincolnshire, Cambridgeshire, Norfolk, Suffolk, Essex, Hertfordshire, Bedfordshire, Greater London, Surrey, Kent, West Sussex and Isle of Wight 21 As defined in 2013
36 Figure 8 Tentative timeline of activity
2015 2020 2025 2030 2035 2038 Ongoing monitoring and evaluation will be carried out (see Monitoring and Evaluation of the Strategy). 2013: Deploy pilot badger cull From 2013: Deploy Edge Area strategy From 2013: Deploy Risk-Based Trading Scheme From 2013: Ongoing research and development
From 2014: Further development of area risk-based strategies and cross-cutting measures
Earliest 2019: (Subject to research breakthrough and authorisation) Possible deployment of authorised oral badger TB vaccination Earliest 2015: (Subject to research breakthrough) Start regulatory work to authorise oral badger TB vaccination Earliest 2017: (Subject to successful field trials) Start EU negotiations and regulatory work to permit use of cattle TB vaccination with validated DIVA test Earliest 2023: (Subject to successful field trials, legal change and authorisation) Possible deployment of authorised cattle TB vaccination with intra-EU trade 2038: Achieve OTF status for whole of England 2025: Achieve OTF status for current low risk area Earliest 2018: Start EU negotiations to secure OTF status for parts of England Earliest 2015: (Subject to research, Animal Test Certificate, trial design and cost: benefit assessment) Cattle TB vaccination/DIVA test field trials Earliest 2019: (Subject to successful field trials, legal change and authorisation) Possible deployment of authorised cattle TB vaccination without intra-EU trade
37 Key elements Developing our risk-based approach Introduction This section sets out the Strategys risk-based approach. Since J anuary 2013, geographical areas of England have been assigned one of three bTB risk-based classifications: Low Risk, High Risk or Edge. The Low Risk Area (LRA) is demarcated by the four yearly cattle herd testing counties in the North and East of England. The annual cattle herd testing zone includes the High Risk Area (HRA) and the Edge Area. The inner boundary of the Edge Area has been determined based on research and surveillance data, and local knowledge. Figure 9 shows the trend in bTB and the relative risk in each of the three risk areas. Figure 1 illustrates the coverage of each risk area in England in 2013 with crude herd prevalence (bTB incidents as a proportion of live herds) in each area. The herd prevalence varies across each area, particularly in the HRA and the Edge Area and specific county prevalence figures are shown in Figure 10. Table 4 provides details of the land coverage and the number of herds in each risk area in 2012. Figure 9 - Variation in the number of culture and/or lesion positive new bovine TB breakdowns per 100 herd years at risk between 2003 and 2012, in the High Risk Area, Edge Area, Low Risk Area and whole of England (based on identical geographical areas throughout)
38 Figure 10 Proportion of live herds with Officially bTB Free status withdrawn by county between January and December 2012: number of OTFW new bTB breakdowns per 100 live herds
39 Table 4 Land coverage and number of herds (and percentage of total) in each risk area in 2012 High Risk Area Edge Area Low Risk Area Land area (km 2 ) 38,570 (29%) 21,574 (16%) 72,621 (55%) Number of cattle herds in 2012 ~24,800 (46%) ~7,800 (15%) ~21,000 (39%) The aim of the Strategy is incrementally to extend the LRA to the whole of England and eventually to achieve OTF status. The boundaries of all three zones will be subject to regular review and will change over time as we move towards achieving this aim. The Strategy includes sub-strategies for each risk area. Cross-cutting tools such as biosecurity, advice, compliance and enforcement underpin the approaches. The Government also needs to ensure that proportionate measures are in place to address the risk posed by TB in non-bovine species. The underlying approach is common for all risk areas, i.e. prevent bTB breakdowns, detect bTB breakdowns early, and deal with bTB breakdowns rigorously. Whilst some control measures apply across all risk areas, others are tailored as part of individual packages to suit the disease profile of each area. For example, in the HRA particular emphasis is placed on addressing the reservoir of M. bovis in badgers alongside conventional cattle-based measures. Table 5 summarises the objectives for each of the area risk-based strategies.
40 Table 5 - Summary of objectives of area risk-based strategies For ALL areas of England
Ai m to eradicate bTB, achieving Officially bTB Free (OTF) status for England incrementally, whilst maintaining an economically sustainable livestock industry
For the LOW RISK AREA
For the EDGE AREA
For the HIGH RISK AREA
General characteristi cs Low level of bTB Breakdowns linked to cattle movements relatively short duration; low recurrence No significant reservoir of TB in wildlife North and East of England General characteristi cs Levels of bTB variable; higher than Low Risk Area but lower than High Risk Area Infection spreading north and east Role of cattle and badgers uncertain Buffer zone east and north of High Risk Area General characteristi cs High level of bTB Breakdowns relatively long duration; high recurrence Significant reservoir of TB in wildlife (badgers)
South West and West of England and East Sussex Objectives To expand current area Short to Medium Term Maintain or further reduce very low level of bTB Achieve OTF status for area Objectives To move current area west and south Short to Medium Term Stop geographical spread of bTB Begin to reduce level of bTB Longer Term Reduce level of bTB and secure OTF status for area Objectives To contract current area Short Term Stabilise level of bTB Medium Term Begin to reduce level of bTB Longer Term Reduce level of bTB and secure OTF status for area The level of bTB risk and incidence within each risk area is not uniform and stable. For example, forty percent of herds in the HRA in the ten years to 2012 did not have a bTB breakdown in this period; in the LRA, some individual herds may pose greater risks of infection than others because of their size, bTB history, cattle husbandry and trading practices. To reflect this, the Government wants to move towards a better definition of bTB risk on an individual herd basis rather than defining risk simply by geography. AHVLA has completed work that can generate a bTB risk rating for every herd in the country, which could be used to support risk-based trading decisions and potentially to enable the application of the principle of earned recognition whereby best practice is rewarded with fewer burdens. Alternatively, there is scope for industry to develop an accreditation scheme to support risk-based trading decisions.
41 The remainder of this section explains: Existing bTB control measures applied in England Developing bTB control measures applicable in all risk areas Developing the LRA strategy Developing the Edge Area strategy Developing the HRA strategy Existing bTB control measures applied in England The existing bTB control measures in England are directed primarily to controlling M. bovis infection in cattle 22 . Some measures address the disease in other animals, such as badgers, deer and South American camelids (SAC) in order to reduce the risk of TB transmission to cattle. The measures include a mixture of: measures that fulfil the minimum legislative requirements established by the EU in order a) to entitle herds and regions of a country to be OTF and to be able to trade with other Member States and b) to entitle the UK to EU co-financing of certain bTB control measures (testing, laboratory analysis, compensation); measures that are statutory (in domestic legislation) and apply to all keepers, irrespective of a particular situation; measures that are statutory (in domestic legislation) but are only applied on a discretionary basis, depending on a particular situation; and voluntary measures such as private deployment of badger vaccines. They can be categorised under the following headings: surveillance; breakdown management, dealing with the risk of TB from badgers; and other disease prevention (Figure 11). The measures, both statutory and non-statutory, are applied in a tailored manner across the different disease risk zones reflecting the value of each measure in a particular disease situation.
22 Cattle includes farmed buffalo and bison
42 Figure 11 Summary of existing bTB control measures applied in England
The existing measures which may be applied in England are: (1) Surveillance for bTB infection In cattle, surveillance for bTB is based on using the comparative tuberculin skin test (the single intradermal comparative cervical test (SICCT)) and slaughterhouse Measures applied across England -Combination of statutory and voluntary - Applied according to bTB risk in different areas Surveillance Find infection early Key measures include: For cattle: - Statutory testing -Slaughterhouse surveillance For other domestic animals: - Scanning surveillance - Slaughterhouse inspection - Targeted testing of at risk animals For wildlife: - Scanning surveillance and occasional targeted surveillance in low risk areas
Breakdown Management Reduce risk of spread of infection; Eliminate infection quickly Key measures include: - Movement restrictions - Isolation and rapid removal of suspected infected animals - Occasional partial or complete herd depopulation - Increased testing in infected herds and surrounding herds - Tracing source and spread of infection - Epidemiological investigations - Notification of public and environmental health authorities
Dealing with risk of TB from Badgers Reduce risk of badger-to-cattle and cattle-to-badger infection Key measures include: - Scope for privately funded licensed culling projects in areas with high and persistent levels of bTB in cattle - Scope for privately funded local projects involving licensed use of injectable badger vaccine - Voluntary on farm biosecurity measures to limit cattle and badger contact Other Disease Prevention Reduce risk of infection spread
Key measures include: - Advice and guidance on best practice including statutory obligations - Sanctions - Statutory pre- movement testing - Biosecure Approved Finishing Units -Voluntary risk-based trading - Public health protected through milk pasteurisation, TB reactor milk ban, and slaughterhouse inspection
43 surveillance. In areas that have endemic bTB or are otherwise considered to be at high risk of bTB spread, there is annual whole herd tuberculin skin testing of cattle. In the low risk area (LRA) of the country, four-yearly testing of breeding stock (routine herd testing) is carried out by default. This herd-based surveillance is statutory, EU law sets out minimum frequency levels for surveillance testing, depending on disease prevalence (lower prevalence =less frequent testing). It is not possible to reduce the surveillance testing frequency below the four-yearly pattern until a country or a region has gained OTF status. In the LRA, individual herds may be subject to annual whole herd testing (a discretionary statutory measure) for public (e.g. producer-retailers of raw milk, or open farms) or animal health (e.g. herds regularly purchasing cattle from higher risk areas) reasons. Zero-tolerance is applied to the timing of statutory tuberculin skin testing in cattle: overdue tests trigger movement restrictions and, since 2014, a reduction in Common Agricultural Policy Scheme payments for overdue bTB surveillance or check tests. All commercially slaughtered cattle are surveyed throughout the country for signs of bTB at slaughter (a statutory measure) and this is of critical importance in detecting herd infection, especially in the LRA, where more than 50 percent of all bTB incidents are disclosed at slaughterhouse. Statutory scanning surveillance via compulsory notification and investigation of suspect clinical cases applies to cattle but such cases are very rare now as active surveillance tends to remove infected animals before clinical signs appear; Surveillance in other livestock and in captive deer is carried out by statutory slaughterhouse and non-statutory scanning surveillance and with occasional targeted surveillance of at risk herds/flocks (e.g. contiguous or co-located animals); Surveillance in South American camelids (SAC) and pets is carried out by non- statutory scanning surveillance. Reporting of confirmation of bTB in private laboratories is a statutory requirement; and Surveillance of wildlife is not statutory and is only carried out as part of research or specific projects/initiatives (e.g. localised deer surveys in 2006, Road Traffic Accident surveys of badgers in the past; current research by AHVLA/Fera in Gloucestershire; investigations of unknown breakdown origins in the LRA). However, if there is a strong suspicion of wildlife spread in an area of low cattle incidence, enhanced wildlife surveillance is initiated. (2) Breakdown management Bovine TB breakdowns in cattle herds are managed with the aim of preventing further spread of disease and clearing the infection from the herd as quickly as possible. The following controls are applied uniformly across the country: (i) preventing movements from the herd (statutory; EU) other than movements to slaughter or to other herds in some specific circumstances subject to AHVLA licence; (ii) restrictions on movements into the herd subject to AHVLA veterinary risk assessment and licence (statutory; EU)
44 (iii) short interval testing with the SICCT (at not less than 60-day intervals) until one or two clear tests dependent on the risk status of the herd (statutory; EU) and (iv) tracing and testing both the potential source and spread of the infection (statutory; under domestic legislation). Statutory use of interferon-gamma assay as an additional breakdown test has been applied to all breakdowns where OTF status has been withdrawn in the LRA and to some breakdowns in the Edge Area. Since 2014, use of gamma-interferon testing has been extended throughout the Edge Area where it is compulsory for TB culture and/or lesion positive breakdowns and discretionary for lower risk breakdowns based on AHVLA veterinary risk assessment; Cattle suspected of being infected with bTB, on the basis of the results of the tuberculin test or the gamma-interferon test must be removed from the herd and slaughtered within 30 days (EU). Farmers have the option of arranging the removal and sale of the animal to the slaughterhouse themselves. However, most farmers opt for AHVLA to arrange the removal and sale of the animal to the slaughterhouse with statutory compensation payable to the farmer. Statutory compensation is determined primarily using monthly table values, which reflect 100 percent of the average sale prices of bovine animals in 51 different categories. The categories are based on the animal's age, gender, type (dairy or beef) and status (pedigree or non-pedigree). The default position is to use table valuation although individual valuations may be used in defined circumstances (e.g. buffalo or bison). Statutory compensation is reduced on a sliding scale if bTB reactors are detected in overdue tests. The Government retains the revenue generated from selling the animal to the slaughterhouse (the salvage value) which takes account of transport, handling and disposal costs. Following the removal of animals suspected of being infected with bTB, the farmer is responsible for any statutory cleansing and disinfection of the premises that is required by AHVLA. Statutory depopulation of a cattle herd can be applied in cases where repeated testing does not, or is suspected not, to clear a herd of infection, although it is rarely applied in practice on a whole herd basis; partial depopulation is more commonly used. Contiguous risk in breakdown situations is addressed: in the HRA and parts of the Edge Area, by testing of contiguous herds on a discretionary basis; in the LRA and the remainder of the Edge Area, by surveillance testing of all herds within a 3 km radius of the index farm. All testing relating to local risk from a breakdown is enforced under domestic legislation; Laboratory confirmation of M. bovis infection in all other livestock species, such as captive deer, pigs, goats, sheep and SAC normally triggers statutory movement restrictions and repeat TB testing (or, in the case of animals reared for their meat, depopulation) of the remaining animals on the infected premises in order to lift the restrictions. AHVLA also instigates spread and source tracings, as well as testing of any cattle herds that may be co-located with (or contiguous to) the infected premises. In the LRA, any incidents of TB in non-bovine species caused by M. bovis infection
45 result in enhanced bTB surveillance (targeted testing) of cattle herds situated within a 3 km radius of the index premises; and In pets and wildlife, confirmed cases of M. bovis are reported to AHVLA (statutory) and private deer stalkers are trained and encouraged to submit suspect samples from deer. The confirmed cases are epidemiologically assessed in terms of potential links to local disease situation in livestock, deer or camelids and the need for additional surveillance. (3) Dealing with the risk of TB from badgers Badgers are not an endangered species in the UK (see Annex A) but they are protected by UK legislation. The Protection of Badgers Act 1992 and the Wildlife and Countryside Act 1981 protect badgers and their setts, but make provision for licences to be granted to kill or trap badgers or to interfere with their setts for the purpose of preventing the spread of disease, provided the methods of capture and dispatch are humane. Unlicensed taking, possession, selling, or killing of badgers, or interference with their setts, is illegal. Badgers are also a protected species under the Convention of European Wildlife and Natural Habitats (1979) (known as the Bern Convention). The Convention requires contracting parties, including the UK, to take appropriate legislative and administrative measures to ensure the protection of badgers. Article 9 of the Convention allows parties to make exceptions to this for various purposes, but only provided that the exception will not be detrimental to the survival of the population concerned. Licensed methods of culling badgers may be cage trapping and shooting and controlled shooting of free ranging badgers. Determining the size of badger populations is challenging and the efficiency of cage trapping and of controlled shooting is variable. Culling can be deployed subject to land access and a licence from Natural England. Evidence shows that carefully managed badger culling to achieve a substantial reduction of the badger population over a sufficiently large geographic area leads to an overall net reduction in cattle herd bTB breakdowns over a defined period relative to a similar un-culled area. Small-scale or short term culling may exacerbate the disease situation through perturbation (see Glossary). The Government considers that licensed badger culling, delivered effectively, is an important bTB control measure in areas with high and persistent levels of bTB in cattle epidemiologically linked to endemic TB infection in badgers. On the basis of historical evidence an estimated one third of the badger population in endemic areas is infected with M. bovis. The Government believes that any licensed badger culling projects should be coordinated, delivered and funded privately. Culling projects should be deployed strategically to help deliver the aim of staged achievement of OTF status for England. Two licensed four-year badger culls started in Somerset and Gloucestershire in 2013. The Government will consult Natural England on revised criteria for licensing culling. Subject to available resources, the Government will also consider transitional financial support for private sector-led deployment of the policy.
46 An injectable TB vaccine for badgers (BadgerBCG) has been available on veterinary prescription since 2010. Injectable vaccine can be deployed subject to land access, a licence from Natural England, and the vaccine being administered by a veterinary surgeon or by a trained and competent lay person 23 . Trapping and injecting badgers is not believed to cause perturbation. BCG is not a very effective vaccine. Evidence shows that while BCG vaccination of adult badgers can reduce the risk of infection in unvaccinated cubs in a social group, the vaccine is not totally effective; a spectrum of protective immunity is seen in uninfected vaccinated badgers with no known benefit in animals infected with M. bovis (estimated at around one third of the badger population in endemic areas). Annual cage trapping programmes are required to target newly emerged badger cubs and maximise immunity in a social group; the annual turnover of the British badger population is estimated to be 30 percent. Determining the size of badger populations is challenging and the efficiency of cage-trapping is variable. A Food and Environment Research Agency (Fera) model 24 suggests that it could take over forty years to eradicate TB in badgers using vaccination. The effects of injectable badger vaccine deployment on bTB in cattle are not known. While it is reasonable to expect it to reduce the incidence of bTB in cattle in endemic areas, there has been no trial to assess the magnitude and timing of these effects. However, modelling 25
suggests that culling can reduce bTB levels in cattle more quickly than vaccination alone. In its response to the Environment, Food and Rural Affairs (EFRA) Committees report on bTB vaccination in 2013, the Government 26 said that badger vaccination must form part of any strategy to eradicate bovine TB, though badger vaccines cannot cure diseased badgers. These diseased animals will continue to infect cattle herds. The Government believes that any licensed badger vaccination projects should be coordinated, delivered and funded privately. Vaccination projects should be deployed strategically to help deliver the aim of staged achievement of OTF status for England. Injectable badger vaccine has been used in a government-funded, five-year Badger Vaccine Deployment Project (BVDP) in Gloucestershire, established to learn practical lessons about vaccinating badgers and to train lay badger vaccinators. The Government has also provided financial support for private vaccination projects through the Badger Vaccination Fund, a competitive grant scheme which has provided match- funded grants of up to fifty percent of the first year costs, although uptake to date has
23 Veterinary Surgery (Vaccination of Badgers Against Tuberculosis) Order 2010 (SI 2010 No.510) 24 Final Report of Project SE3294: Further numerical analyses of the badger vaccine study (BVS) http://randd.defra.gov.uk/Default.aspx?Menu=Menu&Module=More&Location=None&Completed=0&ProjectI D=16715 25 Smith GC, McDonald RA, Wilkinson D (2012) Comparing Badger (Meles meles) Management Strategies for Reducing Tuberculosis Incidence in Cattle. PLoS ONE 7(6): e39250. doi:10.1371/journal.pone.0039250 26 Government Response to Environment, Food and Rural Affairs Committee Report on vaccination against bovine tuberculosis (October 2013) http://www.publications.parliament.uk/pa/cm201314/cmselect/cmenvfru/705/70504.htm
47 been limited 27 . In 2013, priority access to the Badger Vaccination Fund was extended to vaccination projects in the Edge Area. In its response to the EFRA Committee, the Government acknowledged the enthusiasm among voluntary organisations for deploying badger vaccine but noted that while it was starting to see voluntary groups working in partnership with farmers to vaccinate badgers, the prospect of vaccination being carried out over a significant proportion of the endemic area in England remained remote adding that social research, carried out as part of the BVDP, suggests that there is little interest from landowners and farmers partly because of the costs involved and partly because of the limited confidence many have in the ability of badger vaccination to reduce the incidence of TB in cattle. Nevertheless, the Government said it would continue to offer to work with other organisations to ensure that their collective efforts yield maximum benefit. Subject to available resources, the Government will consider transitional financial support for private sector-led strategic projects, for example those focussed on maximising the immunity of badgers in locations at greatest risk of advancing infection. The role of badger vaccination in endemic areas could develop further as the number of TB-infected badgers is reduced through culling. (4) Other disease prevention measures AHVLA provides biosecurity advice to keepers supplementing other sources of information (e.g. from farming organisations and private vets). Defra funds various initiatives to provide such advice to keepers and substantial research effort into biosecurity measures, particularly to address spread from badgers to cattle. Whilst some biosecurity measures are statutory, many on-farm biosecurity measures are voluntary; All surveillance and breakdown testing (including tracing and contiguous testing) must be carried out within a given time window. Overdue tests trigger movement restrictions and, since 2014, a reduction in Common Agricultural Policy Scheme payments for overdue bTB surveillance or check tests; All cattle over 42-days of age, moving from annually tested herds to live on another holding must have a valid pre-movement bTB test (statutory) at the farmers expense. In order to support farmers, there are exemptions to this requirement for movements to slaughter (including indirect routes approved by AHVLA) veterinary treatment, artificial insemination centres, shows, common land and between holdings in the same Sole Occupancy Authority (SOA) located wholly within the annual testing area. These exemptions are subject to review. As well as potentially detecting bTB breakdowns, the main benefit of pre-movement bTB testing lies in preventing geographic spread and many new herd breakdowns. In the seven years since the Government introduced pre- movement bTB testing in 2006, some 2500 pre-movement bTB test reactors were
27 In 2013, 58 percent of badger vaccination (834 vaccinations out of a total of 1429) in England was carried out and paid for directly by government. Across England and Wales, this figure rises to 78 per cent (2186 vaccinations out of total of 2781)
48 removed in England, i.e. potentially preventing up to 2500 new breakdowns and all herds where pre-movement testing disclosed reactors were put under movement restrictions, potentially preventing even further disease spread. Keepers are encouraged voluntarily to isolate and post-movement test any new stock they bring into their herd; Cattle from restricted herds may be moved under AHVLA licence directly to slaughter. In order to support farmers, cattle from restricted herds may be moved indirectly to slaughter under licence via biosecure Approved Collection Centres or Approved Finishing Units (AFUs). Non-grazing AFUs are permitted in all areas, and stock must be kept in badger-proof buildings. In the HRA, where there is already a reservoir of M. bovis in badgers, grazing AFUs are permitted on double-fenced land. Since 2013, the Government has applied a risk-based, proportionate approach to bTB testing in AFUs with no routine or breakdown testing (other than in exceptional circumstances) in non- grazing AFUs; Cattle keepers are no longer allowed to establish links between holdings in different risk areas so all movements of cattle between such holdings must be reported to the Cattle Tracing System (CTS). This enables AHVLA to monitor compliance with pre- movement testing; Since 2012, new Sole Occupancy Authorities (SOAs) have not been permitted and new holdings can no longer be added to existing SOAs. Developing cross-cutting bTB control measures in all risk areas Cross-cutting measures which may be applicable to all risk areas are explained below. (1) Biosecurity Risk-based trading The way in which livestock are traded can have a direct impact on the risk of spreading disease as well as implications for surveillance. Incomplete information in decision making is a well-established form of market failure that can sometimes require Government intervention, and this is no less true for controlling bTB in cattle. Introducing cattle from higher risk herds (e.g. herds which have recently experienced a bTB breakdown) increases the disease risks for the importing herd. Achieving OTF status for the LRA and expanding it into the current HRA is a key aim of the Strategy; actions which jeopardise this need to be discouraged with the costs of consequences of risky decisions falling on those who take them. Making more bTB history information available to buyers would enable them to make informed decisions on the disease risk of purchased stock and would enable farmers to take appropriate action to reduce the risk of spreading bTB.
49 The industry-led Risk-Based Trading Group 28 recommended the development and introduction of a comprehensive, accessible database as the ideal solution to support a successful risk-based trading scheme. This would be used by farmers, veterinary surgeons and auctioneers to inform purchasing decisions and post-purchase behaviour. As the development of such a database (or interface) is not a quick or simple task, the group recommended a phased introduction of risk-based trading measures whilst the requirements and costs of the database can be scoped. In the shorter term, the group recommended the introduction of other measures such as making an animals bTB history available at the point of sale; the production of buyer and seller best-practice guidance; and the development of an accreditation scheme for assigning a risk status to cattle herds. Since the publication of the Groups report in May 2013, the Government has been working with the industry to act on all of its recommendations. The Group strongly favoured the voluntary approach to the introduction of risk-based trading, and emphasised that the Government and industry working in partnership was the way forward. However, it cautioned that if this was not successful, a mandatory approach must be considered to ensure the adoption of risk-based trading and to facilitate informed decision making by farmers when they trade cattle to help minimise the risk of spreading the disease by riskier trading practices. There are other tools (e.g. compensation levels) that can be used to encourage farmers to take advantage of risk-based trading. On-farm and off-farm biosecurity Biosecurity measures aim to prevent cattle-to-cattle, cattle-to-badger and badger-to-cattle spread of bTB 29 . For example, the risk of cattle-to-cattle spread of bTB may be tackled through timely herd bTB testing, pre- and post-movement testing, isolation of new animals prior to their introduction into a herd and separating cattle from neighbouring cattle herds. Other biosecurity measures are aimed at doing everything practical to keep badgers and cattle apart. There may be an opportunity for farmers to apply for Rural Development Programme for England funding towards biosecurity tools such as cattle handling facilities and badger-proof feed troughs. Many biosecurity measures are voluntary, but there is scope to build on the approach introduced in 2012 which reduced statutory compensation for bTB reactors disclosed in significantly overdue herd tests. The Government intends to undertake an evidence-based review of biosecurity measures both on farm and off farm, and will consider measures that would encourage improved uptake. Using compensation to encourage risk-reduction
28 Defra (2013) Bovine TB Risk-Based Trading: Empowering Farmers to Manage TB Trading Risks (PB 13911) https://www.gov.uk/government/publications/bovine-tb-risk-based-trading-empowering-farmers-to- manage-tb-trading-risks 29 Further information on general biosecurity measures is available on the AHVLA website at http://www.defra.gov.uk/ahvla-en/disease-control/bovine-tb/protecting-herd/. Further information on badger exclusion measures is provided in Badgers and bovine tuberculosis: on-farm biosecurity and badger exclusion measures (TIN106) available on the Natural England website at http://publications.naturalengland.org.uk/publication/970479
50 It is important to consider the extent to which compensation levels influence farmers approach to managing their bTB risks. For example, in some countries with successful control strategies such as New Zealand and Spain, cattle compensation is paid at 65 percent and 75 percent of market value respectively. The Government plans to review bTB compensation with the objective of encouraging risk-reduction, for example by ensuring that animal (e.g. cattle, South American camelids, farmed deer) keepers observing defined best practice on biosecurity benefit over those who do not. (2) Improving advice and guidance to farmers The Government is committed to exploring ways to provide evidence-based, effective advice and guidance to farmers, in partnership with the food and farming industry, levy bodies and the veterinary profession. Previous examples of biosecurity advice and guidance include films funded jointly by Defra, the National Farming Union, the Welsh Government and the National Animal Disease Information System, AHVLA leaflets, and biosecurity workshops for farmers in the HRA. Previous examples of compliance advice include bTB Information Notes summarising details of changes to bTB rules, and guidance produced by AHVLA. The Government will continue to work in partnership with stakeholder representatives to ensure that such advice is fit for purpose and is disseminated effectively. The Government has provided funding for and worked with the Farming Community Network to ensure that its volunteers are kept up to date with bTB policy developments so that they can provide effective support and business advice to those farmers most in need. There may be an opportunity for industry to apply for Rural Development Programme for England funding towards training and information exchange activities. In November 2013, the Government sought views on proposals compatible with data protection and other legislation, to provide farmers with sufficient information on the bTB status of neighbouring herds to enable them to manage any risks to their own herds. (3) Improving compliance and enforcement It is crucial that the currently high levels of farmer compliance with bTB controls are maintained. The small minority of farmers that contravene or ignore disease control rules jeopardise their own business and undermine the efforts of others. The Government recognises that non-compliance is not always deliberate, but can be due to the complexity of the rules and/or poor guidance. Therefore a high priority is to help farmers to comply by obtaining a clearer understanding of what guidance material they need. The Government has commissioned a review to consider the multiple sources of available guidance on bTB rules, find out what works well and not so well, and act on recommendations made. It also plans to work with industry partners to publicise the importance of compliance. The Government will work with the farming industry and delivery partners (including local authorities) to monitor compliance levels and find practical, proportionate and effective ways to improve them. A project board comprising industry and government
51 representatives is in place to oversee and direct bTB-related compliance and enforcement activity. In J anuary 2014 the Government built on the existing approach whereby owners of bTB affected herds that fail to test on time receive reduced compensation for bTB reactors, by tightening the Common Agricultural Policy Scheme rules for overdue bTB surveillance or check tests; maximising existing levers to encourage timely testing is more effective than penalising those that have already increased the risk of spreading bTB through late testing. Resources will be focused on areas where non-compliance could be most damaging. Where significant, damaging and deliberate breaches of bTB controls are identified the Government will encourage and support robust enforcement action by local authorities. (4) Tackling TB in non-bovine species Many species of non-bovine farmed (e.g. South American camelids (SAC), captive deer, goats, pigs and sheep) companion (e.g. cats, dogs and ferrets) zoo and wild mammals are susceptible to M. bovis infection. Only a relatively small number of animals are identified as infected each year through scanning surveillance. Evidence suggests that non-bovine species other than the badger are generally spillover hosts and appear to pose a very small risk of spreading M. bovis to cattle and badgers. All confirmed cases in SAC are investigated by AHVLA to assess epidemiological links and disease links to cattle or other SAC premises. The evidence from this work suggests that they often act as sentinel species to local cattle or badger infection; there are no known cases where a cattle bTB breakdown has been caused directly by transmission from SACs. Wild mammals other than badgers can act as maintenance hosts for M. bovis and vectors of the infection for cattle, as illustrated by the experiences of New Zealand (brush-tailed possum) Australia (Asiatic water buffalo) Michigan (white-tailed deer) South Africa (Cape buffalo) the Central and Southern Iberian Peninsula (wild boar and red deer) and some dpartements of France (wild boar and red deer in addition to badgers). However, the existing evidence from wildlife surveys and quantitative risk models carried out by Fera in GB indicates that in this country the badger remains the principal and possibly the only wildlife maintenance host of M. bovis. Whilst M. bovis infection has been found in other wild mammals in England (notably deer and more rarely wild boar, fox and some rodents) the data on the prevalence of infection, pathology, abundance and ecology suggest that fallow deer and possibly muntjac and red deer are the only other wild mammals that could act as potential sources of M. bovis for cattle in the South West of England and Wales. Even in these deer species the effect is localised and the risk of transmission to cattle much lower than that posed by badgers, primarily due to differences in behaviour and contact levels with cattle. Additionally, once detected, deer infection is often controlled locally by additional culling. 30
31
32
30 Delahay et al. (2002) The status of Mycobacterium bovis infection in the UK wild mammals: a review. The Veterinary J ournal, 164, 90-105
52 The Governments response to M. bovis infection in non-bovine species will be evidence- driven and proportionate to the risk, in order to target efforts in areas where risk management will make a real impact on bTB. Additional measures for badgers are discussed elsewhere. Any additional measures proposed for other non-bovine species are explained below: South American camelids The tuberculin skin test has limited sensitivity in SACs. As a result of research undertaken for the SAC sector, the Government intends to introduce mandatory single intradermal tuberculin testing supplemented by a combination of two antibody tests (in parallel interpretation) as a condition for lifting movement restrictions from all SAC herds with confirmed M. bovis infection. The Government intends to consult with a view to making TB surveillance mandatory in SACs. In the meantime, it is working with the sector to encourage voluntary pre and post-movement testing and surveillance of SAC herds using skin and blood tests. Sharing of these voluntary surveillance results is essential for disease control purposes. There are no compulsory registration and identification requirements for SACs. As SACs are considered spillover hosts for M. bovis, the Governments position remains that these arrangements are proportionate to the risk. There are therefore no plans to introduce compulsory identification and registration requirements for the control of TB in SACs in the short term. In the longer term, however, it is possible that a new EU Animal Health Regulation may include a requirement for Member States to regulate the registration and identification of SACs. The Government will review the case for including SAC within such a requirement in the context of negotiations on the European Commissions Animal Health Regulation proposal published in 2013. Other farmed mammals (e.g. captive deer, goats, pigs and sheep) M. bovis infection in other farmed mammals is a relatively rare occurrence and improved slaughterhouse surveillance introduced in 2011 has helped identify new TB outbreaks, which will continue to be handled on a case by case basis using the tuberculin skin test as required. All confirmed holdings will be placed under movement restrictions until testing or slaughter surveillance has demonstrated absence of infection. Contiguous or radial surveillance around these cases will continue. The Government will also continue to work with the various sectors to raise awareness among farmers of the risks of M. bovis
31 Delahay et al. (2007) Bovine tuberculosis infection in wild mammals in the South West region of England: a survey of prevalence and semi quantitative assessment of the relative risk to cattle. The Veterinary J ournal, 173, 287-301 32 Ward et al. (2009) Estimating the risk of cattle exposure to tuberculosis posed by wild deer relative to badgers in England and Wales. J ournal of Wildlife Disease, Vol. 45 No. 4,1104-20
53 infections in non-bovine species and the measures that can be taken to reduce these risks. Companion and zoo mammals M. bovis infection in companion and zoo mammals is a relatively rare occurrence and AHVLA and Public Health England will continue to monitor the results of scanning surveillance and work with the sectors to raise awareness of the risks and of the measures that can be taken to reduce these risks. AHVLA will continue to carry out epidemiological investigations into all companion animal cases to assess any connection with local cattle epidemics. Zoos and animal collections with confirmed incidence will continue to be placed under movement restrictions until considered free of disease. Wild mammals (other than badgers) Wild deer surveillance is carried out by private stalkers who are aware of the need to submit suspicious lesions for bacteriological examination. Where there is a suspicion of deer-related infection in cattle, this surveillance can be intensified and additional radial surveillance of cattle in an area can be initiated by AHVLA when considered appropriate. AHVLA will continue to monitor the results of scanning surveillance in wild mammals. Developing area risk-based strategies The epidemiological rationale for, and the objectives of, sub-strategies tailored to specific risk areas are explained below. These sub-strategies will be deployed geographically to deliver the aim of staged achievement of OTF status for England. For example, we could anticipate a movement in the deployment of Edge strategy westwards and southwards if existing strategies are successful in reversing the geographical distribution of the disease. Low Risk Area (LRA) strategy Epidemiological rationale The rationale for the LRA strategy is based on the following evidence and assumptions: The area has a low bTB incidence. Where bTB does occur, it tends to result from infected cattle that have been brought in from other parts of the UK. An analysis of the prevalence of culture and/or lesion positive bTB breakdowns over the past six years (up to 2012) demonstrated that, if only the indigenous breakdowns of bTB are included in the calculation, the crude annual herd prevalence for the area remained below or equal to 0.1 percent throughout the period. The proportion of OTF herds remained above 99.9 percent throughout the period. These figures demonstrate that the area has great potential to gain OTF status as defined in Council Directive 64/432/EEC. There is evidence to support the non-endemic nature of bTB in the LRA: o The analysis of the genotypes of the mycobacteria involved in herd breakdowns in England carried out on a continuous basis since 1996 by AHVLA, shows that there are no established areas of specific genotypes of M. bovis isolated from cattle within the LRA or near it;
54 o There is little evidence of local spread between cattle herds (this analysis continues and is strengthened by the radial surveillance measures implemented in the LRA from 2013); o Recurrence figures are low and associated with re-introduction of disease by stock brought in from the endemic area (a total of four recurrent breakdowns, within a three year retrospective window, in 2009-2011; three of these were attributable to a new genotype introduced by new stock purchased from the endemic area; one had an unknown origin); o Breakdown duration is shorter than in the endemic areas (14 percent of LRA breakdowns ending in 2011 lasted more than 240 days; the same figure for GB was 33 percent and for Wales 53 percent); and o Whilst previous, very limited road traffic accident based surveillance has found occasional badgers infected with M. bovis in the LRA in the past, there is little evidence of a significant reservoir of M. bovis in badgers in the area. AHVLA has carried out badger surveillance measures around unexplained bTB incidence in the LRA (1-2 surveillance zones established annually). In the seven years to 2013, this surveillance has not yielded any positives results. With the non-endemic nature of the disease in the LRA, it is considered important to maintain the status quo, seek further and sustained reduction in breakdown incidence and to seek OTF status for the whole or parts of the area as soon as this can be justified within the current EU legislation. The target in the Strategy is to achieve OTF status progressively starting in 2018. This would allow the LRA to be better protected from disease occurrence, to align its cattle movements and marketing with other OTF regions of the UK and to reduce the surveillance burden on cattle keepers and Government. The resultant resource or financial savings could then be directed to achieving OTF status for other areas. The creation of the uniform four-yearly testing area in 2013 removed pockets of more frequently tested areas. Farmers may not therefore be aware of disease levels occurring in this area and we need to guard against a perception that there is no disease threat in this area. Low risk does not mean no risk and the impact of an increase in breakdowns could lead to whole counties being placed on more frequent testing. Objecti ves To maintain or further reduce the very low incidence of sporadic culture and/or lesion positive bTB breakdowns in the counties of the north and east of England (LRA) and deal quickly and effectively with any incursions of disease in these areas, through the application of proactive, risk-based surveillance and breakdown management; To expand the current OTF region of the UK by moving towards similar OTF status recognition for those counties (or groups of counties) in the north and east of England
55 that have maintained over a six-year period a very low incidence of indigenous (not clearly introduced) culture and/or lesion positive bTB breakdowns, which is below the threshold set out in Council Directive 64/432/EEC (0.1 percent annual herd incidence); and To continue to protect the LRA of England, by introducing additional measures to halt the spatial spread of the disease (see below) and by introducing risk based cattle trading strategies. Edge Area strategy Epidemiological rationale The rationale for the Edge area strategy is based on the following evidence and assumptions: There are advancing disease fronts where bTB is spreading spatially across the entire annually tested area of England, including within the HRA. The Edge Area strategy focuses on those disease fronts that face the non-endemic areas of England. The disease fronts, or areas where geographic spread of bTB has occurred, threaten areas of high cattle density in the north west and north of England. It makes good disease control sense and is cost effective to apply additional disease control measures and increase farmer awareness of the disease spread risk in the Edge Area in order to: o identify where disease is emerging and publicise this information locally; o take effective measures to stamp out the disease when found; and o prevent the disease from re-emerging by addressing the causes of breakdowns. The Edge Area strategy applies to areas where the infection is potentially spreading geographically and to areas that are at short term risk from such spread. It is important to define the Edge Area where the control measures are applied in order to deploy the measures and to measure their success in halting the spread. The outer boundary of the Edge Area is a county boundary for administrative and EU legal reasons. The inner boundary of the Edge Area is set based on previous research work, surveillance data and knowledge of the local situation provided by the AHVLA staff working within the Edge Area. This boundary will be subject to change, reflecting the changing disease situation in the area. While there are local differences in the disease occurrence in the Edge Area, it differs from the LRA and the HRA in disease prevalence. Between 2006 and 2011 there was an increasing number of culture and/or lesion positive bTB breakdowns in the Edge Area and the crude prevalence of herd breakdowns reached just over 1 percent. As the rate of disease movement is not uniform across the Edge Area and the areas affected differ in their characteristics, a successful strategy to target disease spread needs to be tailored to the local conditions. This flexibility can be achieved by using a
56 mixture of compulsory and discretionary control measures which can be applied with local evidence-based veterinary discretion. We currently know very little about the TB-infection status of badgers in the Edge Area. Further research is needed to determine the respective roles of cattle and wildlife in the spread of bTB in the Edge Area and whether or not the badgers there represent a significant wildlife reservoir of M. bovis and/or drive the spread of the edge. This will involve gathering information on the badger population density and prevalence of TB infection in badgers in the Edge Area to inform future control measures. Objecti ves The short to medium term objectives for the Edge Area are to: stop the geographic spread of the HRA; and begin to reduce the incidence rate within the Edge Area. The longer term objectives are to: reverse the spread of disease; and reduce the incidence rate of the Edge Area, working towards an OTF status for the counties involved. High Risk Area (HRA) strategy Epidemiological rationale The rationale for the HRA strategy is based on the following evidence and assumptions: The South West and West Midlands have been recognised as a HRA for bTB. A separate and epidemiologically distinct HRA is located in East Sussex. There is evidence to indicate that bTB is endemic and that residual infection in breakdown herds, cattle movements and the badger reservoir of M. bovis infection play a key role in bTB epidemiology in these areas; Due to the limitations of any single disease control measure, a multiple approach to disease control in both the major hosts of bTB infection in the area, the cattle and the badger, is required; The epidemic in the HRA can be defined by home ranges of different genotypes of M. bovis, suggesting a pattern of clusters that tend to expand and overlap and cannot be explained by cattle movement alone; Recurrence of herd breakdowns is a key epidemiological feature of the epidemic in the HRA. In England and Wales, herds with a 36-month history of breakdowns were 6.3- 8.5 times more likely to have a breakdown in 2011 than herds without such a history.
57 Around 56 percent of herds with culture and/or lesion positive bTB breakdowns in 2011 had a history of a breakdown in the previous 36 months 33 ; There is evidence to suggest that a substantial proportion of herds have residual infection left in the herd at the end of a breakdown. Data indicate that, in the worst-case scenario, up to 21 percent of cattle herds may be harbouring at least one infected animal when movement restrictions are lifted 34 . Furthermore, depending on the modelling assumptions, the researchers estimated that 50 percent (3367, 95 percent confidence interval) or 24 percent (1142, 95 percent confidence interval) of recurrent bTB breakdowns could be attributed to infection missed by the short-interval skin testing regime. This is likely to play a substantial role in the epidemiology of bTB in the HRA, contributing to the high recurrence rate. This suggests improved breakdown management will be important for disease eradication; Whilst the contribution of cattle movements to the epidemiology of bTB in the HRA is not quantified in the same manner as in the LRA, it must be assumed that it contributes to disease spread in the HRA as well. Ninety-eight percent of movements of cattle from holdings in the HRA to live on other holdings take place within the HRA. Thus there is a need to apply risk-based trading practices in the HRA, perhaps even more so than between the different risk areas; In spite of the relatively high county level herd prevalence across the HRA, there is a marked variation in this prevalence (0.7-15.7 percent of herds affected with culture and/or lesion confirmed breakdowns in 2011). Forty percent of cattle herds in the HRA in the ten years to 2012 did not have a bTB breakdown in this period. It is important that the status of these herds is recognised and protected as part of the strategy, particularly in terms of their potential contribution to risk-based trading practices in the HRA; A small proportion of often prolonged breakdowns with high numbers of reactors are responsible for a disproportionate share of breakdown costs in the HRA. Evidence suggests that, in any one year, 40 percent of breakdown costs arise in 10 percent of breakdowns. Addressing these breakdowns more rigorously is an important part of the strategy. AHVLA will launch a project in 2014 to tackle persistent breakdowns; and As OTF status in the HRA will take decades to achieve, it is important to ensure that the epidemic is closely monitored, the approach to eradication is flexible and short and medium term targets are in place. It is also important that a flexible and adaptive approach to the management of the strategy is adopted.
33 AHVLA (2013) Bovine tuberculosis, infection status of cattle in GB, Annual Surveillance Report for the period of J an 2011 to Dec 2011 http://www.defra.gov.uk/ahvla-en/publication/pub-survreport-tb/ 34 Conlan et al. (2013) Estimating the Hidden Burden of bovine tuberculosis in Great Britain. PLoS Comput Biol 8(10): e1002730. doi:10.1371/journal.pcbi.1002730.
58 Objecti ves The short term objectives for the HRA are to: maintain a stable incidence rate within this area; and establish an improved understanding of the epidemiology of bTB in the area in order to introduce a more tailored approach to control measures. The medium term objectives for the HRA are to: turn the current trend of increasing herd incidence into a decline by addressing cattle movement related spread, the residual infection and the wildlife reservoir, strengthening and targeting cattle control measures and moving towards greater stakeholder engagement on all control fronts; and introduce targeted and localised strategies with clear prevalence targets. In the longer term, the objectives are to: achieve a continuous and sustained reduction in both herd and animal incidence of bTB in all areas of the HRA, and ultimately, to achieve OTF status. Next steps to develop our risk-based approach Table 2 provides a summary of the current measures applied in each area and the additional future measures or options to develop our risk-based approach. Developing new tools Introduction This section outlines the research programme and new tools under development, with a view to deployment as part of the ongoing implementation of the Strategy. It also explains why the Government is not developing therapeutics for treating bTB. Defras Evidence and Investment Strategy Defras Evidence and Investment Strategy 35 summarises the work that it is doing to develop research programmes to support the development of policy. Defras Evidence Plans provide a clear reasoning as to why Defra invests in evidence and how it makes best use of all available evidence.
35 Defra Evidence and Investment Strategy 2010 to 2013 and beyond (PB 13471) https://www.gov.uk/government/publications/defra-s-evidence-investment-strategy-2010-to-2013-and- beyond-2011-update
59 The bTB research programme The Government has spent a significant amount (over 155 million since 1991/92) on an ongoing and wide-ranging bTB research programme. The content and direction of the research programme is described in further detail in the Bovine Tuberculosis Evidence Plan 2013/14 2017/18. 36 Further information is available in Annex E. The portfolio comprises projects to increase understanding of the disease epidemic and to support the development of new tools such as vaccination and diagnostics that can be used to tackle the disease. Evidence needs to be multidisciplinary to provide a comprehensive understanding of the disease epidemic. The research programme will continue to bring together epidemiology, veterinary science, modelling, statistics and the social sciences to generate integrated and innovative approaches to tackling the disease. Developing new diagnostics tests for surveillance (i) Tests to detect bTB in cattle Tuberculin skin test Under Council Directive 64/432/EEC, the cervical (i.e. applied to the neck) tuberculin skin test is the only official EU standalone test for bTB in live cattle (i.e. for the purposes of granting and retaining OTF herd status). No diagnostic test for bTB is perfect and the tuberculin skin test is no exception. However, if performed correctly it remains the most practical and cost-effective tool for detecting bTB. In areas (e.g. Scotland) where there is no significant reservoir of M. bovis in wildlife, traditional cattle herd test and slaughter strategies using the tuberculin skin test have proven efficacy in achieving OTF status. For the routine programme of surveillance testing of cattle herds, we have used the comparative tuberculin skin test (the single intradermal comparative cervical test (SICCT)) which measures the animals immune reaction to injections of both avian and bovine tuberculin. At standard interpretation, fewer than 1 in 1,000 bTB-free cattle give a false positive result (over 99.9 percent specific if the test is performed correctly) but the test misses around 1 in 5 bTB-infected cattle (at best, 80 percent sensitive at herd level if the test is performed correctly). Using a severe interpretation of the comparative tuberculin skin test marginally reduces the likelihood of false negatives (i.e. increases the sensitivity) whilst slightly increasing the likelihood of false positives (i.e. decreases the specificity). A further option is to use the bovine tuberculin skin test (the single intradermal cervical test (SICT)) which measures the animals immune reaction to injections of bovine tuberculin only. The bovine tuberculin skin test increases the likelihood of detecting bTB-infected cattle and the Government has therefore taken the decision to use it for pre-export testing to safeguard trade. However cattle are exposed to a wide range of (non-M. bovis) environmental mycobacteria which can potentially interfere with the assessment of
60 reactions to the bovine tuberculin skin test so use of the bovine tuberculin skin test for routine or whole herd testing would be at the expense of a high proportion of false positives. For example, a retrospective analysis carried out by AHVLA of 1 million cattle tested in 2005 concluded that only one in every twenty-one additional cattle which would have been removed by applying the bovine tuberculin skin test, would have progressed to develop detectable bTB in the following four years; this would have resulted in the slaughter of 24,100 cattle in addition to the 30,000 cattle slaughtered for bTB control in 2005. While some countries (e.g. New Zealand) apply the bovine tuberculin skin test in the caudal fold of the tail (rather than in the neck) which allows for a quicker and safer application of tuberculin, this technique is not permitted for trade purposes under EU law. Interferon-gamma (IFNg) assay Since 2002, Council Directive 64/432/EEC has allowed the more sensitive interferon- gamma assay (a blood test which also uses tuberculin) to be used in parallel with the tuberculin skin test to detect and remove additional infected cattle. Between 2002 and 2006, the Government used the interferon-gamma assay in the context of a field trial in OTF status withdrawn herds and on an ad hoc basis elsewhere. Since October 2006, the Government has deployed mandatory parallel interferon-gamma assay in OTF status withdrawn herds in four-yearly testing (Low Risk) areas of England to supplement the tuberculin skin test and improve the detection of infected animals. In 2011, the Government adopted mandatory parallel interferon-gamma assay in OTF status withdrawn herds in two-yearly testing parishes; in 2013 the test continued to be mandatory in OTF status withdrawn herds in these areas after they had been incorporated into the Edge Area as annual testing zones. Since J anuary 2014, the Government has deployed parallel interferon-gamma assay across the Edge Area to supplement the tuberculin skin test and improve the detection of infected animals; interferon-gamma assay is mandatory for culture and/or lesion positive bTB breakdowns and discretionary for lower risk bTB breakdowns, based on an AHVLA veterinary assessment of the herd. The Government is considering making the interferon-gamma assay available for private pre- and post- movement testing of tuberculin skin test-negative cattle moving between OTF herds. A European Food Safety Authority (EFSA) scientific opinion 37 on the use of the interferon- gamma assay for the diagnosis of bTB published in 2012 concluded that the tuberculin- based interferon-gamma assay could be included among the official tests for the purpose of granting and retaining OTF herd status, but protocols for use should first be harmonised across the EU. This opinion may result in EU negotiations on the future approval of the
37 EFSA Panel on Animal Health and Welfare (AHAW); Scientific Opinion on the use of a gamma interferon test for the diagnosis of bovine tuberculosis. EFSA J ournal 2012;10 (12):2975 [63 pp.] doi:10.2903/j.efsa.2012.2975 http://www.efsa.europa.eu/en/efsajournal/pub/2975.htm
61 tuberculin-based-interferon-gamma assay as a second official EU standalone test for bTB in live cattle although no changes are envisaged before 2017. Other tests In the opinion cited above, EFSA advised that other tests reviewed (e.g. antibody detection tests) should not yet be considered for use as official tests for the purpose of granting official bTB-free herd status. Given the limitations of current cattle diagnostic tests and the need to develop improved tests, the Government will consider funding research when potentially useful new methods become available. As new diagnostic tests become available, the Government will make an assessment of their costs and benefits before deciding whether or not to deploy them. (ii) Tests to detect M. bovis infected badgers Ongoing research aims to develop additional diagnostic tests for use in potential surveillance programmes. This includes tests to detect M. bovis either in individual infected badgers or in their environment. Such tests could have many potential applications including measuring TB prevalence in badgers, monitoring the effect of interventions such as vaccination, and increasing understanding of the epidemiology of the disease and the relative importance of different routes of transmission. Additionally, the availability of suitable tests to identify M. bovis infection in badgers will inform the development of new strategies for dealing with the risk of TB in badgers ideally focussed on removing from the population only those badgers infected with TB. Detection of infected, individual badgers can be done by post mortem examination of dead badgers (identification of lesions and/or culture of M. bovis from lesions or of certain predilection site organs). These techniques are highly developed and moderate to high sensitivity and specificity of testing can be achieved. However, healthy badgers would need to be killed for this methodology to be used for surveillance and representative meaningful sampling is not straightforward. In live badgers, testing for an immune response associated with exposure to M. bovis, such as the BrockTB StatPak 38 or interferon gamma assay testing can be carried out. The former test could be carried out in field conditions allowing animals to be restrained until results are available, but it misses around 1 in 2 infected badgers (around 50 percent sensitive). The latter test misses around 1 in 5 infected badgers (around 80 percent sensitive) but requires laboratory analysis. Both these immunological tests require blood sampling of live, captured badgers which can currently only be done under sedation by trained and licensed staff. Defra has funded a research project which aims to develop methods of taking clinical samples such as blood and urine from badgers without the need for sedation. This would simplify the sampling of trapped badgers and could be used in
38 Commercial name for M. bovis serology test for badgers
62 conjunction with new serological diagnostic 39 methods and methods for testing urine samples that are being developed. In the Republic of Ireland, polymerase chain reaction (PCR) methodology is being tested to assess its sensitivity in detecting infection in faeces samples from individual culled badgers. Results are expected in 2014/15. Efforts to develop a suitable tool for testing badger setts have concentrated on developing tests which can detect M. bovis in environmental samples taken in the vicinity of setts, including from latrines. The analysis and interpretation of environmental sampling is challenging. Infected badgers shed M. bovis intermittently. The presence of M. bovis in latrines, soil or air depends on whether infected badgers have been shedding the bacteria in the sample type collected, in the location being sampled from, and in the sample that is taken. The methods which have been assessed include PCR and immuno-magnetic separation (IMS) 40 coupled with a lateral flow device. Defra started funding the development of a PCR-based test to detect M. bovis in environmental samples at Warwick University in 2007. While the test performs well at identifying spiked samples in the laboratory and is reproducible, it has been less sensitive at detecting known infected social groups from faecal samples collected in the field. Warwick University has led on Defra-funded research to optimise the sampling regime with the aim of improving the performance of the PCR test in the field. The IMS technique has the potential to increase the sensitivity of environmental sampling strategies. Defra has funded a project at Queens University in Belfast to develop this method. Defra is planning an inter-laboratory study (ring-trial) applying different PCR tests and the IMS technique to badger faecal samples to identify which test shows most promise for field use. Developing deployable bTB vaccines We have an authorised injectable vaccine for badgers. There are no bTB vaccines authorised for use in other animals. Vaccination of cattle to control bTB is prohibited under EU law (Council Directive 78/52/EEC) as it is not compatible with the provisions for testing and herd qualification for OTF status (Council Directive 64/432/EEC). (i) Cattle vaccination A cattle bTB vaccine is likely to be a valuable additional tool in the fight to eradicate bTB but vaccination of cattle with a vaccine such as BCG (Bacillus Calmette-Guerin) will reduce but never eradicate bTB from the national herd, particularly if there remains an ongoing spread of M. bovis from badgers.
39 Serological diagnostics is testing for antibodies in serum (serum is a component of blood) 40 Using antibody-coated magnetic particles to separate microbe cells from the rest of the sample in order to concentrate them for better detection
63 The current best candidate vaccine to protect against TB in cattle is based on BCG. BCG does not offer complete protection from infection with M. bovis. Research to date suggests that the proportion of cattle protected or partially protected may be in the order of only 50- 70 percent although further research is needed to verify this. Vaccination of cattle with BCG can cause them to test positive to the tuberculin skin test, the backbone of our bTB control policy. This is the main reason for the EU ban on bTB vaccination in cattle. EU law meets OIE standards for international trade. The OIE Terrestrial Manual 2012 41 advises that cattle vaccination should not be used in countries where control or trade measures based on tuberculin skin tests are in operation. To use such a vaccine, a diagnostic test is required that can detect infected among vaccinated animals (DIVA). Development of this DIVA test forms part of the ongoing Defra-funded research programme and candidate diagnostic tests have been developed. The most advanced is a modified version of the currently used interferon-gamma assay. Following approaches from the Government, the European Commission acknowledged in J anuary 2013 that the UK had invested considerable resources in developing a candidate vaccine and accompanying DIVA test. The European Commission set out a tentative timeline 42 of the steps to be able eventually to deploy a cattle bTB vaccine and associated DIVA; cattle vaccination could only be deployed if it is demonstrably safe. These steps include a field trial of the vaccine and DIVA test under EU conditions. Government scientists are leading the world in developing a deployable cattle vaccine and have been considering the design of a trial that will deliver the European Commissions objectives and deliver the evidence necessary to secure a licensed cattle bTB vaccine and a validated DIVA test. In 2013, EFSA published a scientific opinion 43 providing advice relating to the design of field trials to test the performance of a cattle bTB vaccine along with a DIVA test. Based partly on that advice, the Government has awarded a contract for field trial design and is expecting this work to be completed by August 2014. The trial design work and ongoing research is necessary to provide evidence to support an application for an Animal Test Certificate to permit field trials of an otherwise unauthorised vaccine. Extensive field trials are not expected to start until 2015. The cost of such trials is likely to amount to tens of millions of pounds. The European Commission estimated that it was unlikely that the EU ban on intra-EU trade in bTB-vaccinated cattle would be lifted within ten years of successful trials starting;
41 Chapter 2.4.7, Bovine tuberculosis (version adopted May 2009) Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 2013 http://www.oie.int/international-standard-setting/terrestrial-manual/access-online/ 42 Letter from European Commissioner for Health and Consumer Protection to the Secretary of State for Environment, Food and Rural Affairs, 14 J anuary 2013 https://www.gov.uk/government/publications/bovine- tb-eradication-programme-letter-from-the-european-commission-to-owen-paterson 43 EFSA AHAW Panel (EFSA Panel on Animal Health and Welfare) 2013. Scientific Opinion on field trials for bovine tuberculosis vaccination. EFSA J ournal 2013; 11 (12): 3475, 35pp. doi:10.2903/j.efsa.2013.3475 http://www.efsa.europa.eu/en/efsajournal/pub/3475.htm
64 the European Commissions tentative timeline included the need to amend OIE animal health standards for international trade. The European Commission indicated that it might be possible to allow the vaccine to be used under controlled conditions in the UK four to five years after successful trials started but that bTB-vaccinated cattle would not be able to be traded within the EU until the wider ban was lifted. Research to develop other cattle vaccines (i.e. that are better than BCG or that do not sensitise cattle to the tuberculin skin test) to improve the sensitivity of the DIVA test, and to develop DIVA tests using alternative methods is ongoing but these are long-term goals and will require scientific breakthroughs to achieve. (ii) Badger vaccination The Veterinary Medicines Directorate issued a marketing authorisation for an injectable BCG-based TB vaccine for badgers (BadgerBCG) in 2010. There is scope to use data from the English Badger Vaccination Deployment Project and the Badger Vaccination Project in the Welsh Intensive Action Area 44 to understand better the long-term costs and benefits of deploying injectable badger vaccination. The Government has also invested considerable resources in ongoing research to identify an effective and affordable oral badger TB vaccine which could make the vaccine much simpler to deploy than the currently available injectable vaccine. Government scientists have made progress in identifying a candidate edible bait. Further progress is dependent on ensuring a consistent immune response to orally administered vaccine so it is not yet possible to predict with any certainty when there will be a candidate vaccine which can be taken forward for marketing authorisation. However, in the best case scenario an oral badger TB vaccine might be deployable in the field by 2019. The Governments independent vaccines advisory group (comprising vaccines experts from the human and animal fields) has advised that additional investment would not accelerate the development process. Research into alternati ve strategies for dealing with risk of TB from badgers In parallel to research to develop diagnostic tests to detect infected badgers and/or their environment, consideration is being given to how such tests might best be used to support the development, delivery and monitoring of strategies for dealing with the risk of M. bovis from badgers, e.g. targeted culling, understanding local epidemiology, and monitoring the effectiveness of badger vaccination at reducing infection. This work will inform where future research and implementation effort should be targeted.
44 The Intensive Action Area in south west Wales is approximately 288 km 2 primarily located in north Pembrokeshire but also including small parts of Ceredigion and Carmarthenshire. The five-year injectable badger vaccination project is running alongside additional surveillance and controls for cattle and non- bovines, and enhanced biosecurity. The project started in 2012.
65 Further research into alternative methods for dealing with the risk of M. bovis from badgers (e.g. sett-based culling methods and non-lethal methods) has been considered. This includes investigations into the use of gases such as carbon monoxide or anoxic gas-filled foam as a sett-based means of humane culling. Anoxic gases are used humanely to cull farmed animals such as pigs and poultry. The use of hydrogen cyanide gas to cull badgers will not be considered. The Government has also funded research into the application of fertility control using contraceptives to manage badger populations. Two studies have looked at injectable contraceptive, one in captive badgers and one in free-living urban badgers, and one study has examined the potential to develop an oral contraceptive. This research is at an early stage and it is not yet possible to assess the likely scale on which such an approach might be deployed in future or the likely timescale. The Government will continue to review evidence emerging from badger control strategies and research in place elsewhere. For example, the Republic of Ireland Government has operated focussed badger culling since 2000. Badgers are captured under licence by trained contractors using specially designed body restraints and then killed, in areas where serious outbreaks of bTB have been detected in cattle herds and an epidemiological investigation has found that badgers are the likely cause of infection. In Northern Ireland, the Department for Agriculture and Rural Development is proposing a five-year Test, Vaccinate and Remove (TVR) research project starting in summer 2014. The research would involve trapping and testing badgers in one or more 100 km 2 areas: badgers testing positive for TB would be killed; badgers testing negative would be vaccinated and released. A further 100 km 2 area would serve as a control. The limitations of tests on live badgers and of the injectable badger vaccine are discussed elsewhere. Research into genetic resistance of cattle to bTB In the UK there is no clear evidence of differences between breeds in terms of susceptibility to bTB. While there is evidence that dairy farms are more likely to experience a breakdown than beef farms, this is not necessarily due to breed differences. Pedigree analysis funded by Defra has shown evidence of genetic variation to bTB susceptibility within Holsteins in the UK. Another study identifying genetic markers linked to susceptibility saw no significant differences in the distribution of these markers across UK breeds. Dairy Co has advised that it expects to be able to select Holstein bulls with resistant genes in 2015 so their daughters would enter the milking herd from 2018. While Dairy Co expects this to improve the resistance of the Holstein herd to bTB over the next decade, it notes that it is unlikely that any animal has full genetic resistance so genetic selection would need to be combined with other measures in order to achieve OTF status. The Government believes that it is for cattle farmers to make business decisions on which bulls they choose to use, taking into account genetic merit for resistance to diseases and other desirable traits which may or may not be correlated with bTB susceptibility. Why we do not use therapeutics to treat bTB in cattle
66 Therapeutic treatment of cattle to control bTB is prohibited under EU law as it is not compatible with the provisions for testing and herd qualification for OTF status. There are no drugs licensed in the UK for the treatment of bTB in animals. To date, antimicrobial therapy of cattle believed to be infected with M. bovis has not been a realistic option for the reasons set out below. Treatment of TB with antibiotics is not universally successful, even in humans receiving multiple drug therapy for several months. M. bovis is naturally resistant to one of the first-line drugs used for the treatment of TB in humans. In order to eliminate the risk of antibiotic-resistant strains of M. bovis infecting the human population, where multiple-drug resistant strains of M. tuberculosis are already a significant public health problem, it is critical to ensure that such strains of M. bovis are not artificially selected in animal populations. Most drugs used to treat TB in humans are inherently toxic and are poorly tolerated by animals. Therapeutic treatment of cattle for bTB would interfere with the detection of infected animals, by suppressing the immunological reactions that are measured by the tuberculin skin and interferon-gamma tests. During treatment it would be necessary to consider infected cattle contagious for the duration of treatment and to observe milk and meat withdrawal times during and following treatment. Governance, delivery and funding The Government will develop proposals for governance, delivery and funding of the Strategy in partnership with stakeholders. It will consult further on detailed proposals and carry out impact assessments as appropriate. Any changes to governance or delivery would need to comply with EU 45 and national law and take account of government policies on public bodies 46 and wider impacts on the governments capability to respond to animal
45 Regulation (EC) No.882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules. On 6 May 2013, the European Commission adopted a proposal to amend this legislation. The package is subject to consideration by the European Parliament and the Council with possible entry into force in 2016, followed by a proposed three-year transition period. http://europa.eu/rapid/press-release_IP-13-400_en.htm
46 Cabinet Office (2012) The approval process for the creation of non-departmental public bodies https://www.gov.uk/government/publications/public-bodies-information-and-guidance
67 disease outbreaks. Any changes to funding would need to comply with HM Treasury rules on managing public money 47 . Governance Defra Ministers have policy responsibility for bTB policy in England. In 2011, the Government established the Animal Health and Welfare Board for England (AHWBE) in response to the recommendations of the England Advisory Group on Responsibility and Cost Sharing 48 . The AHWBE is the principal source of Departmental advice to Defra Ministers on all strategic health and welfare matters relating to kept animals in England 49 . It comprises appointed external members with the confidence and support of major stakeholder interests, and senior government officials. The AHWBE is an innovative approach to bringing those affected by government decisions into the heart of the process in order to create a more direct link between those making Defra policy and those experiencing the delivery of that policy. Establishing the AHWBE marked an important step in sharing responsibility for animal health and welfare with animal keepers and other interested parties. It aims to build trust between government and animal keepers and strengthen arrangements for working together to develop a true partnership. Agreement on how best to achieve practices that collectively and cost effectively reduce disease risk leads to greater adherence to responsible practices and then to reduced animal disease risk and improved standards of health and welfare. This benefits government, the public and animal keepers. The Bovine Tuberculosis Eradication Advisory Group (TBEAG) is an AHWBE sub-group, which brings together a range of interested parties who share the desire to tackle bTB. This Strategy has been developed in partnership and discussion with TBEAG.
The New Zealand experience shows that alternative governance and delivery models can enhance bTB control. The New Zealand government has delegated management of the National bTB Pest Management Plan, which is defined in law, to an industry-led management agency 50 under the Biosecurity Act 1993. The management agency supports a number of TBfree Committees to maintain effective links with the farming community and stakeholders at a regional level. The TBfree Committees promote the programme in their regions and are a source of feedback and advice to the management agency on policy and operational issues. The National bTB Pest Management Plan budget has been co-
47 HM Treasury (2013) Managing Public Money (PU 1513) https://www.gov.uk/government/publications/managing-public-money 48 Defra (2010) Responsibility and Cost Sharing for Animal Health and Welfare Final report (PB 13450)
49 Further information about the Animal Health and Welfare Board for England is available at https://www.gov.uk/government/policy-advisory-groups/animal-health-and-welfare-board-for-england-ahwbe
50 On 1 J uly 2013, the role of management agency for New Zealands National Bovine Tuberculosis Pest Management Plan transferred to a limited-liability company, TBfree New Zealand Limited http://www.biosecurity.govt.nz/media/14-06-2013/new-agency-national-tb-management-plan
68 financed by industry and government with funding from central and local government, statutory beef and dairy sector levies and deer sector grants 51 . The Government will develop proposals for an enhanced partnership approach to the governance of the Strategy in England. Delivery Delivery of bTB controls rests with government agencies such as AHVLA, local authorities and the private and voluntary sectors e.g. veterinary and farming businesses, and wildlife interest groups. Delivery approaches include services funded and provided by Government, services funded by government and procured from the private and voluntary sectors, and services funded and provided by the private and voluntary sectors. The Government will continue to review delivery of bTB controls, ensuring a partnership approach with government (i) delivering those services that only it can deliver, building on the efficiency savings delivered to date whilst ensuring quality; and (ii) ensuring that any services provided by the private sector and funded by government are procured in line with legal requirements with robust contracts and effective audit to deliver value for money and ensure quality services. The veterinary profession is a key delivery partner for bTB controls. The Government will develop a modern commercial relationship with private veterinary businesses delivering bTB testing and controls. The Government will explore ways in which private veterinary businesses can deliver local services currently delivered by government (the so-called TB Plus model) in line with AHVLAs Veterinary and Technical Strategy 52 and mindful of the outcome of the Welsh Governments Cymorth TB pilots due for completion in April 2014. Funding Tackling bTB carries significant costs to farmers and other taxpayers. These costs are not sustainable. At the same time, it is clear that additional investment is required to bring the disease under control and reduce the costs in the longer term. Furthermore, the Government must demonstrate value for money in public funding as well as acting where there are clear advantages and a need for government intervention to overcoming market failure. Table 6 provides the breakdown of state-funded and privately funded areas in 2013/14.
51 Further information is available at http://tbfree.org.nz/ 52 AHVLA (2013) Veterinary and Technical Strategy Securing a healthy future http://www.defra.gov.uk/ahvla-en/publication/vet-tech-strategy/
69 Table 6 Breakdown of state-funded and privately-funded areas in 2013/14 State-funded areas Privatel y-funded areas Routine bTB surveillance testing and breakdown testing, mainly delivered by veterinary businesses Laboratory testing (e.g. bacterial culture and gamma-interferon blood testing) bTB breakdown investigations Procuring transport and disposal of bTB reactors Statutory compensation for bTB reactors (above the minimum carcase salvage value) Badger Vaccination Deployment Project and Badger Vaccination Fund bTB research and development Advice and guidance Competent Authority functions (including policing) Handling facilities, staff and time away from business for bTB testing Pre-movement testing and export testing TB testing of deer Consequential losses (e.g. from movement restrictions and compulsorily slaughtered cattle) Biosecurity measures (e.g. badger proofing or double fencing) Local badger vaccination deployment Advice and guidance Deployment of badger culling licensed by Natural England Costs of slaughter of TB infected non-bovine animals (e.g. goats) without compensation For the costs which fall to government, the budgetary pressure is expected to increase through a combination of increasing costs and declining budgets; EU financial support at current levels is not guaranteed to continue indefinitely. Most of the Governments bTB budget is spent on bTB testing, breakdown management and compensation. Almost 80 percent of testing and compensation costs are related to managing bTB breakdowns. The cost of breakdowns is concentrated in a minority of affected herds: about 40 percent of breakdown costs arise in 10 percent of breakdown herds. Actions that significantly reduce the likelihood, duration and extent of these breakdowns would have a major effect in reducing the overall cost of bTB management. Farmers also bear financial costs of bTB both in terms of taking steps to minimise risk and also when a breakdown occurs. These financial costs can be significant to individuals. The Government aims to build a framework of modelling tools which could support the production of a reliable estimate of cost of achieving OTF status for England; this will require a credible assessment of the impact of policy options some of which are many years away.
70 The Government will develop proposals for a sustainable model for funding the Strategy in partnership with stakeholders. The experiences of both New Zealand and the Republic of Ireland provide evidence of the success of co-financed bTB control strategies. Irish farmers are responsible for arranging annual herd bTB tests with their veterinary practitioners and for payment of testing fees. They also contribute towards 50 percent of the cost of the bTB compensation via statutory Bovine Disease Levies collected in respect of each animal slaughtered or exported from the country, and in respect of each unit of milk delivered to creameries. Funding options for the Strategy could include stakeholders paying more for bTB measures such as bTB testing and deployment of cattle and badger vaccination; government reducing its intervention in the market in terms of levels of compensation payable; developing insurance options in partnership with the insurance sector; and the establishment of a mutual bTB control fund co-financed by government and industry. While any new compulsory contribution (i.e. charge) would need to ensure commensurate benefits for those paying, access to additional services could provide an incentive for farmers to contribute to a mutual fund. The Government will keep bTB compensation and the funding of bTB testing under review; savings to government could be redistributed to fund preventative measures, e.g. transitional financial support for measures to reduce the risk of TB from badgers. Failure to ensure a sustainable funding model will limit the future development and deployment of full range of new tools. Monitoring and evaluation of the Strategy Figure 12 illustrates the monitoring and evaluation that can be applied to various strands of the Strategy. It is a critical part of measuring progress made towards the stated aim (and the various targets, outputs and activities that lead toward it) and allows action to be taken as and when the disease situation changes and alternative approaches become available. The Government will monitor and evaluate the progress of the Strategy in line with best practice 53 . In particular, focus will be placed on progress and delivery of the specified targets and outputs that work toward the overall aim of OTF status for England. The correct tools must be used to monitor and evaluate the effectiveness of the Strategy, including epidemiological, economic and social analyses. The use of epidemiological expertise is particularly important to inform ongoing decisions on tackling disease appropriately at national, regional and local levels.
53 HM Treasury (2011) The Magenta Book - Guidance for evaluation (PU 1120) https://www.gov.uk/government/publications/the-magenta-book
71 Figure 12 Logic chain RESOURCES / INPUTS Includes: Key documents Organisations, partners and stakeholders Defra and Agency resources MONITORING EVALUATION SUMMARY OF LOGIC CHAIN FOR MONITORING AND EVALUATION OF STRATEGY ACTIVITIES Includes: Surveillance activities Control measures Other interventions Monitoring, for example of disease, costs, behaviours OUTPUTS Includes: Targeted, area and risk based strategies Compliance with EU law Delivery of control and other measures to required amounts Delivery of other interventions Sustainable funding base Up to date data and information IMPACTS Includes: Environmental e.g. Sustained reduction in disease (to achieve OTF status) Economic e.g. reduction in overall costs and a sustainable industry Social e.g. public understanding OUTCOMES Delivery of stated aim i.e. OTF for England For example: What impact has the delivery of the policy had? Has the policy delivered its stated aim? Was the actual impact and outcome as expected? Does anything else need to happen? What lessons are learnt? For example: Monitoring who is involved in delivering the policy Tracking progress against targets and the health of the industry Monitoring progress with the implementation and delivery of activities and measures Collection, analysis and review of data and information Monitoring the outputs that are produced Monitoring costs on affected parties
Key tools include using the best available data to review the impact in terms of: The health and sustainability of the sector Media coverage and social impacts Behaviours and attitudes of farmers and the public Trade patterns, for example the number of cattle exported Monthly laboratory testing result reports M. bovis genetic typing home range alert system Quarterly and annual epidemiological reports from regions Monthly publication and analysis of national bTB statistics Quarterly publication and analysis of non-bovine TB statistics Annual surveillance reporting and associated analysis of outcomes The Strategy will be carefully monitored and fully evaluated and the approach and forward use of the tools will be adapted based on experience in the field and as new tools become available. The Strategy will be regularly reviewed and refreshed accordingly.
72 Glossary AFU Approved Finishing Unit, a biosecure unit used to channel cattle from bTB restricted herds to slaughter AHVLA Animal Health and Veterinary Laboratories Agency, an executive agency of Defra AHWBE Animal Health and Welfare Board for England BCG Bacillus Calmette-Gurin, which is used to manufacture tuberculosis vaccines Biosecurity security from transmission of infectious diseases Bovine tuberculosis an infectious disease in cattle caused by Mycobacterium bovis Breakdown detection of exposure to M. bovis infection in a herd (e.g. detection of a bTB reactor or signs of possible bTB at post mortem). This is followed by breakdown control procedures; the duration of a breakdown depends on the successfulness of the breakdown measures to clear the infection from the herd bTB bovine tuberculosis Check tests cattle herd tuberculin skin tests carried out for a number of reasons, including determining the herd disease status when there is a suspicion of infection, within potential hotspot areas which have previously been free of TB, and for new or re-formed herds. CTS Cattle Tracing System, the national cattle identification and movements database Defra Department for Environment, Food and Rural Affairs Depopulation slaughtering all the animals in a herd for disease control purposes DIVA a test used to detect infected among vaccinated animals ECDC European Centre for Disease Prevention and Control Edge Area the edge of the HRA where the disease is not yet considered to be endemic and disease prevalence is lower than in the HRA but there is a great likelihood of further geographical spread of bTB out of the HRA EFSA European Food Safety Authority Endemic a disease which is typically present in a specific geographical area Epidemiology a study of disease in a population
73 EU European Union Fera Food and Environment Research Agency, an executive agency of Defra. Feras Wildlife Team transferred to AHVLA in April 2013 FSA Food Standards Agency GB Great Britain, comprising England, Wales and Scotland Genotype a genetically distinct strain of a specimen or species Herd prevalence can be expressed in different ways but depicts the proportion of herds that are affected by a disease/condition in a defined area High Risk Area for bTB an area defined geographically in which cattle herds have a greater likelihood of experiencing a bTB breakdown. It includes geographical areas in which there is a relatively high herd prevalence of bTB Home range the specific geographic area where a specific genotype of M. bovis is typically detected Host animals which can routinely become infected with M. bovis if exposed HRA see High Risk Area Incidence reflects the number of cases of infection or disease. Inconclusive reactor an animal which gives an inconclusive reaction to the tuberculin skin test as defined in Council Directive 64/432/EEC Index the first infection in a herd or area. Interferon Gamma Assay - a rapid (24 hour) whole blood in-vitro assay to detect immune response to M. bovis infection for the diagnosis of bTB IR see Inconclusive reactor ISG Independent Scientific Group, which supervised the Randomised Badger Culling Trial Lesions Characteristic tubercles or larger abscess-like structures typically found in lymph nodes and organs such as the lungs, liver and spleen. Low Risk Area - An area defined geographically in which cattle herds have a lower likelihood of experiencing a bTB breakdown. It includes geographic areas with very low herd prevalence of bTB and where the disease is not believed to be maintained by badgers and is primarily caused by cattle movements LRA see Low Risk Area
74 MAFF Ministry of Agriculture, Food and Rural Affairs, replaced by Defra in 2001 Mycobacteria a family of bacteria which includes Mycobacterium bovis Mycobacterium bovis (M. bovis) the bacterium which causes bovine tuberculosis Mycobacterium tuberculosis (M. tuberculosis) one of the bacteria which causes tuberculosis in humans Natural England - an executive non-departmental public body responsible to Defra, which administers applications for licences under the Protection of Badgers Act 1992 OIE World Organisation for Animal Health OTF Officially Bovine Tuberculosis Free as defined in Council Directive 64/432/EEC. OTF status may apply to herds, regions or Member States OTFS Officially Bovine Tuberculosis Free status of herd suspended as defined in Council Directive 64/432/EEC. This definition has been used for cattle herds where the laboratory culture result is not positive for M. bovis but there is an increased likelihood that the animal was infected OTFW Officially Bovine Tuberculosis Free status of herd withdrawn as defined in Council Directive 64/432/EEC. This definition has been used for cattle herds where typical lesions of TB are found in a carcase of an animal and/or the laboratory culture result is positive for M. bovis OV Official Veterinarian, a private veterinarian permitted to undertake official controls such as tuberculin skin testing PCR See Polymerase Chain Reaction Perturbation - disruption of badger social groups causes badgers to range more widely than they would normally and come into contact more often with other animals (including both cattle and other badgers). This is called perturbation Pol ymerase Chain Reaction - technology to amplify a single of a few copies of a piece of DNA in order to allow easier detection of a particular pathogen by its DNA Post Movement Test a tuberculin skin test applied to an animal after it has moved between premises Pre Movement Test a tuberculin skin test applied to an animal before it has moved between premises Prevalence see Herd Prevalence R&D research and development
75 RBCT Randomised Badger Culling Trial, a scientific study carried out from 1998-2005 to quantify the impact of culling badgers on TB incidence in cattle Reactor an animal which gives a positive reaction to the tuberculin skin test as defined in Council Directive 64/432/EEC Reservoir Host animals which can routinely harbour M. bovis infection Routine herd testing the programme of routine surveillance testing of breeding cattle in herds using the tuberculin skin test in line with Council Directive 64/432/EEC. Routine herd testing is applied to four-yearly tested herds RTA road traffic accident SAC South American camelids, for example alpacas and llamas Severe interpretation a more rigorous interpretation of the tuberculin skin test (than the standard interpretation) in line with Council Directive 64/432/EEC Short interval test the intensive testing of all cattle in breakdown herds using the tuberculin skin test in line with Council Directive 64/432/EEC SICT single intradermal cervical test. See tuberculin skin test SICCT single intradermal comparative cervical test. See tuberculin skin test SOA Sole Occupancy Authorities approved by AHVLA consist of a group of holdings under the same farm management and control. Movements among holdings within a SOA are not subject to the standstill restrictions that normally apply to livestock movements. Spillover Host animals which do not normally become infected with M. bovis unless they are exposed to relatively high levels of infection Standard interpretation the routine interpretation of the tuberculin skin test in line with Council Directive 64/432/EEC Surveillance an effort to detect disease in a population by using diagnostic or clinical methods. For bTB in England, formal surveillance is carried out with frequent whole or routine herd testing, by pre-movement testing of all cattle over 42-days of age leaving premises in the HRA and by inspecting all cattle carcases slaughtered commercially for post mortem signs of bTB TBEAG Bovine Tuberculosis Eradication Advisory Group for England, a sub-group of AHWBE Test Interval the period of time between tuberculin skin tests Therapeutics pharmaceutical agents (drugs) licensed for use in treating human or animal diseases
76 Tuberculin mycobacterial proteins used in tests to detect bovine tuberculosis Tuberculin skin test measuring an animals reaction to injections of tuberculin carried out in line with Council Directive 64/432/EEC. The single intradermal cervical test involves a single injection of bovine tuberculin in the neck; the single intradermal cervical comparative test involves single injections of bovine and avian tuberculin in the neck UK United Kingdom, comprising Great Britain and Northern Ireland VMD Veterinary Medicines Directorate, an agency of Defra Whole herd testing the testing of all cattle in herds using the tuberculin skin test in line with Council Directive 64/432/EEC. Whole herd testing is applied routinely to annually tested herds and to breakdown herds
77 Annexes Annex A Badger controls and population Table 7 A chronology of badger controls 1971 M. bovis first isolated in badgers M. bovis first isolated in a badger in Gloucestershire. 1973 The Badgers Act Made it an offence to take, injure or kill badgers and commit offences of cruelty. 1975-82 Gassing strategy By 1975 there were concerns about the lack of controls on who could kill badgers, so MAFF decided that only its own staff, or people under its control, could cull. Gassing using hydrogen cyanide was permitted under The Conservation of Wild Creatures and Wild Plants Act 1975. 1980 Zuckerman Review Concluded badgers were probably a significant source of bTB infection and that high density and close proximity of cattle and badgers in parts of South West England made disease spread easy. Because disease seemed to have spread since controls stopped at the start of the review, it advised that control measures start again. As gassing was considered inhumane, cage trapping, followed by shooting, became the culling method. 1982-86 Clean-ring strategy Zuckerman advised that areas should be cleared of infected badgers and kept clear. Under this strategy, social groups of badgers on and around breakdown farms were identified, trapped and a sample of carcases from these groups were examined. Where infection was found, all badgers in the social group were removed. The ring extended out until groups with uninfected badgers were found. Trapping took place in the cleared area for a further six months to keep the area clean. 1986 Dunnet Review Concluded that some form of badger control was unavoidable. Recommended the use of an interim strategy until there was sufficient data from research and badger removal operations for a further substantive review, and development
78 of a reliable live diagnostic test for TB in badgers. 1986-96
Interim strategy Removal and culling of badgers only from farms where a bTB incident had been confirmed and where, following investigation, it was thought that badgers were the most likely cause of the disease. During the operation of the interim strategy, the annual incidence of bovine TB increased in south west England and occurred in other areas with no recent history of infection, including the West Midlands and south Wales. 1991 The Badgers (Further Protection) Act Conferred additional powers on a Court, where a dog had been used in or was present at the commission of certain offences under the Badgers Act 1973. 1992 The Protection of Badgers Act Consolidated and built on the 1973 & 1991 Acts. Made it a serious offence to kill, injure or take a badger, or to damage or interfere with a sett unless a licence is obtained from a statutory authority. 1994-96
Live test strategy Trial of live badger diagnostic test, stopped due to poor sensitivity of test and problems with trial. 1997 Krebs Review Concluded that despite there being compelling evidence badgers were involved in transmitting M. bovis to cattle, the development of a control policy was made difficult because the effectiveness of badger culling could not be quantified with the data available. Recommended a large-scale field trial be set up to quantify the impact of culling badgers on incidence of TB in cattle, and to determine the effectiveness of strategies to reduce the risk of a TB cattle herd breakdown. 1998-2005 Randomised Badger Culling Trial (RBCT) Saw both beneficial and detrimental effects of culling during culling period. Hypothesised that culling disrupts badger behaviour to increase ranging and therefore potential for infectious contact (perturbation) increasing disease prevalence in badgers and subsequently that in cattle (the perturbation effect). On-going post-trial analysis showed that once culling stopped, the detrimental effects diminished quickly. 2013 Pilot of Badger Control Policy Licensed badger culling pilots in Somerset and Gloucestershire to assess the
79 humaneness, effectiveness (in terms of badger removal) and safety of controlled shooting of free-ranging badgers in year one. Licences also permit cage trapping and despatch. Each licence has a four-year term. No control operations can take place during specified close seasons. Changes in the British badger population Harris et al (1992) 54 concluded that there were approximately 250,000 adult badgers in Britain in the 1980s with 172,000 cubs born each year. Annual adult mortality was estimated to be approximately 61,000 animals, annual cub mortality 64,500 pre- emergence and 41,500 post-emergence. The greatest single known cause of badger mortality was road deaths (about 50,000 animals a year) with approximately 10,000 killed illegally and 1,000 killed each year to control bTB. Defra funded a badger sett survey of England and Wales in 2011-2013 (Defra Project SE3129) and a project to generate estimates of typical badger social group size in different landscapes (Defra Project SE3132). The badger sett survey estimated that the number of badger social groups in England had more than doubled (from 31,500 +/- 3,900 to 64,000 +/- 5,000) since the previous comparable survey was carried out in 1985-1988 55 . The social group size survey will report results in summer 2014, allowing updated estimates of the total population of badgers in England and Wales to be made. J udge et al (2014) concluded that the implications of increasing badger populations are numerous as badgers are the largest terrestrial carnivore in the British Isles. They eat mainly soil invertebrates but will also prey upon ground nesting birds, hedgehogs and other vertebrates. Evaluation of the ecological impact of badger culling during the RBCT identified an increase in fox abundance associated with reductions in badger density while reciprocal relationships between hedgehog and badger distributions suggest that increasing badger numbers might have had a negative impact on hedgehogs.
54 Harris, S., Cresswell, W., Reason, P. and Cresswell, P. (2001) An integrated approach to monitoring badger (Meles Meles) population changes in Britain. Wildlife 2001: Populations. Special Session 9. Pages 945-953. DOI: 10.1007/978-94-011-2868-1_72 55 J udge, J ., Wilson, G.J ., Macarthur, R., Delahay, R.J . & McDonald, R.A. Density and abundance of badger social groups in England and Wales in 20112013. Sci. Rep. 4, 3809; DOI:10.1038/srep03809 (2014).
80 Annex B Enhancements of cattle measures since 2011 Table 8 Enhancements of cattle measures since 2011 2011 Introduced DNA tagging of bTB reactors to ensure they are removed from farms. 2012 Reduced statutory bTB compensation for owners of herds with overdue tests. Tightened pre-movement testing rules including amendments to exemption for movements to shows and movements between holdings within the same Sole Occupancy Authority (SOA). Banned new SOAs and applications to add new holdings to existing SOAs. Phased removal of Cattle Tracing System (CTS) links between holdings in one/two-yearly testing parishes and holdings in three/four-yearly testing parishes. Banned new Approved Quarantine Units which sourced calves from TB breakdown herds with existing Units closed by the end of 2013. 2013 Adopted county-based routine bTB surveillance testing with significant extension of annual testing to herds in High Risk/Edge Areas and four-yearly testing of herds in Low Risk Area. Introduced radial testing of all herds within 3km of a lesion/culture positive bTB breakdown herd in the Low Risk Area. Cattle movements into non-lesion/culture positive bTB breakdown herds only permitted after the first post-breakdown test and subject to a satisfactory veterinary risk assessment (to align with policy for lesion/culture positive bTB breakdown herds). Pre-movement testing window for movements from bTB restricted herds reduced from 60 to 30 days. Increased auditing of Approved Finishing Units (which send cattle to slaughter) and enhanced sanctions for non-compliance Introduced risk-based bTB testing in Approved Finishing Units with higher testing burden remaining in Units with grazing. Enhanced the quality assurance programme for Official Vets carrying out bTB testing. Phased removal of CTS links between High Risk and Edge Areas.
81 Rolled-out a voluntary risk-based trading scheme in livestock markets. Introduced requirement for two consecutive clear herd tests (rather than one) at severe interpretation for non-lesion/culture positive bTB breakdown herds in Edge Area before restrictions lifted. 2014 Introduced mandatory parallel interferon-gamma assay for lesion/culture positive bTB breakdown herds in Edge Area; discretionary for non-lesion/culture positive bTB breakdown herds in Edge Area. Introduced radial testing of all herds within 3km of a lesion/culture positive bTB breakdown herd in the Cheshire and Derbyshire Edge Area. Reduced Common Agricultural Policy Scheme payments for overdue bTB surveillance or check tests. Enhanced the approach for dealing with persistent bTB breakdowns. Introduced powers to remove cattle which are unable to be tested for bTB. Tightened pre-movement testing rules by removing exemption for movements to and from common land.
82 Annex C Sources of evidence Natural science The following paper describing a project to provide a succinct summary of the natural science evidence base relevant to the control of bTB is published in the Proceedings of the Royal Society Biology http://rspb.royalsocietypublishing.org/ Godfray, H.C.J. et al. (2013) A restatement of the natural science evidence base relevant to the control of bovine tuberculosis in Great Britain. Proc. R. Soc. B. 2013 280 1768 20131634; doi:10.1098/rspb.2013.1634 (published 7 August 2013) 1471- 2954 The project was commissioned and funded by the Oxford Martin School (part of the University of Oxford) and though many groups were consulted, the project was conducted completely independently of any stakeholder. Further information is available at http://www.futureoffood.ox.ac.uk/news/bTBevidence Socio-economic science The following paper was authored by Professor Richard Bennett and Ian MacFarlane at the University of Reading and Dr Gareth Enticott of Cardiff University. Bennett, R.M. et al. Socio-economic science relevant to the control of bovine tuberculosis in cattle. Report prepared for Defra, July 2013. Surveillance reports The Governments Bovine TB surveillance reports are available at http://www.defra.gov.uk/ahvla-en/publication/pub-survreport-tb/ Statistical reports The Governments Bovine TB statistical reports are available at https://www.gov.uk/government/collections/bovine-tb
83 Annex D Bovine tuberculosis in Europe Figure 13: Official bovine tuberculosis status of EU member states in April 2012
(Source: European Commission Annual Report Bovine and Swine Diseases 2012) Table 9 EU member states declared officially bovine tuberculosis free in Commission Decision 2003/467 (as amended) in 2014 Belgium Estonia Luxembourg Slovenia Czech Republic France Netherlands Slovakia Denmark Hungary Austria Finland Germany Latvia Poland Sweden Table 10 EU member states with specific regions (number) declared officially bovine tuberculosis free in Commission Decision 2003/467 (as amended) in 2014 Italy (12) Portugal (1) United Kingdom (1)
84 Annex E Defras bovine tuberculosis research programme Background Defra has funded a wide-ranging bTB research and development programme including: The development of a vaccine for bTB (for potential use either in cattle or badgers); Developing improved diagnostic techniques (both for bTB in cattle and badgers); Epidemiological studies on factors influencing the prevalence and persistence of the disease in cattle and wildlife; Analysis of data from the Randomised Badger Culling Trial & associated research; Investigating transmission routes between and within species; Investigating risk factors contributing to the development of the disease in cattle; and Economic, epidemiological and social scientific analyses of bTB control strategies and impact of the disease. Between 1991/92 and 2012/13 Defra and its predecessor MAFF, funded over 110 individual research projects and invested approx 108 million in its bTB R&D programme plus a further 49 million on the Randomised Badger Culling Trial (RBCT). Defras Animal Health and Welfare research budget covers England, Wales and Scotland. Research spend by scientific area Figure 14 shows the research expenditure in the following scientific areas (excluding the RBCT) since 1991. Ecology and Husbandry Epidemiology, Economics and Modelling Pathogenesis/Genomics/Immunology Cattle Vaccines Badger Vaccines Cattle Diagnostics Badger Diagnostics General Diagnostics (those projects which cover badgers and cattle and/or other species)
85 Figure 14: Defra bTB research spend by scientific area to 2012/13
Further information on Defra-funded research projects is available at http://randd.defra.gov.uk