Further memorandum submitted by the Department for Environment, Food and Rural Affairs

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1 Further memorandum submitted by the Department for Environment, Food and Rural Affairs Follow-up to the evidence session on 5 November 2008: [Bee research] I am writing in response to your letter of 10 November to provide you with the additional information requested by the Committee during the evidence session held on 5 November. The Committee asked for further information on the number of herds, and number of cattle, that had been identified through slaughterhouse surveillance (meat inspection) rather than skin tests as having TB. The proportion of confirmed new TB incidents (CNI) first disclosed by slaughterhouse cases was 15.8% (391 out of 2,479) of all CNIs in The remaining 84.2% were detected by routine and targeted skin testing. Between 1997 and 2004, the overall proportion of CNIs disclosed by slaughterhouse cases in GB steadily increased, but the trend has stabilised since The more frequently testing is carried out, the smaller the contribution of slaughterhouse surveillance to the detection of new TB breakdowns. I attach a table which gives figures for animals and herds from 2003 to By way of explanation, on-farm TB surveillance by skin testing of cattle herds is supplemented by meat inspection of cattle carcases during commercial slaughter, followed by traceback of any carcases that present with suspect TB lesions positive to Mycobacterium bovis (the bovine TB bacillus). A proportion of the infected animals listed in the table as detected during meat inspection may have been identified in herds already under TB restrictions and thus do not generate a new TB incident. In other cases, more than one infected animal will originate from the same herd. Therefore, the number of infected herds detected will be less than the number of infected animals detected by meat inspection. I am also enclosing a note which sets out details on the availability of medicines for bees and issues surrounding the authorisation of medicines together with information on Defra s funding at Rothamsted Research. I hope this is helpful. Rt Hon Hilary Benn MP Secretary of State for Environment, Food and Rural Affairs 27 November Environment, Food and Rural Affairs Committee, Sixth Special Report of Session , Badgers and cattle TB: Government response to the Committee's Tenth Report of Session , HC 1178, Ev 56.

2 BEE RESEARCH Rothamsted Research 1. Defra funded a series of fixed term projects carried out by Brenda Ball at Rothamsted Research on bee diseases and in particular varroa mites and bee viruses. These projects all came to their natural end, the most recent in Rothamsted Research subsequently carried out an internal reorganisation of their research departments and the decision regarding the staffing of their Bee Health unit was taken by the Research Institute management, not Defra. Nevertheless, there are still researchers with expertise in bee health working at Rothamsted Research. 2. During the projects carried out by Rothamsted Research, antibodies were developed which could detect some of the bee viruses. The collection of antibodies has been shared with an academic collaborator, Prof Fries in the Swedish University of Agricultural Sciences. Prof Fries will maintain the collection and will respond to requests to supply antisera from individuals and academics from across Europe, including the UK. 3. Some of the results from Rothamsted Research s work have been published in academic and bee-keeping journals. Availability of veterinary medicines for bees 4. Under EU legislation veterinary medicinal products must be authorised in a Member State before they can be placed on the market. The authorisation procedure consists of the scientific assessment of data on the quality, safety and efficacy of the product in relation to a given species. For medicines which are to be used in food-producing animals, including bees, additional information has to be provided to ensure that the produce obtained from the animals are safe for consumers and a Maximum Residue Limit (MRL) (Annex 1) has to be set for the active ingredient in the produce. 5. Veterinary medicine is private medicine so decisions on whether to apply for a marketing authorisation for a veterinary medicinal product are commercially based on the likelihood of sufficient return on the investment necessary to produce the data to support an application. The market for bee products, as for other minor species, is small and the pharmaceutical companies are reluctant to invest in the work for applications for veterinary medicinal products for bees. Recognising situations such as this, the Commission recently agreed a reduction in the data required to support applications for use in minor species. Also, the EU legislation permits veterinary surgeons to use products in a species for which they have not been authorised under the prescribing cascade (see Annex 2). Unfortunately, the

3 use of the cascade for bees is limited because it requires input from a veterinary surgeon but vets are rarely involved in beekeeping. 6. There are currently four products authorised for the control of bee diseases in the UK: Apiguard Gel, Apistan and Bayvarol Strips (for the control of varroa) and Fumidil B Power (for the control of nosema). All these products are exempt from prescription and are available over-the-counter (AVM-GSL products). 7. The following measures have been put in place by the VMD to improve the availability of medicine for bees: allowed Apivar, a product authorised elsewhere in the EU to control varroosis to be imported and used in the UK under the VMD s Special Import Scheme (SIC). We have also contacted the French Authorities to establish if a Mutual Recognition Procedure might be possible so that Apivar could be fully authorised in the UK; allowed substances such as oxalic acid, formic acid and lactic acid to be used in the UK to control varroosis although they are not authorised in the UK. Our reassurance on the safety of these products is that they are entered into Annex II of European Council Regulation 2377/90 laying down the Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin and they are tolerated in other member states. We have also advised BBKA on how to approach manufacturers to get these products authorised in the UK; negotiated with a manufacturer to agree an extension to their application to authorise a bee product for the control of varroa in other member states to include the UK; identified a substance that might be beneficial for the control of nosema and are about to initiate dialogue with research laboratories to investigate its potential use. If the substance does control nosema we will need to get a pharmaceutical company to apply for its authorisation; commissioned a project to investigate experimental protocols to determine MRLs in honey, using oxalic acid as a model compound. The objective is to help bee keepers to choose the best possible time to treat their hives whilst minimising the risks of having undesirable residues in honey; proposed a change to the EU regulations on the cascade to allow nationally qualified bee experts to decide on the use of medicines in bees, in place of veterinary surgeons.

4 waived fees to animal test certificates (field trials) intended to develop data to support Marketing Authorisation applications for products intended for use minor species including bees; arranged for the BBKA to give a presentation to staff to increase their knowledge and understanding of bee keeping. 8. Following Jane Kennedy MP s meeting with representatives of bee keeping organisations on 3 November 2008, the VMD initiated discussions with the Bee Unit to look the possibility of adapting the SIC scheme to simplify the importation of Apivar into the UK. MAXIMUM RESIDUE LIMITS AND WITHDRAWAL PERIOD ANNEX 1 A Maximum Residue Limit (MRL) is the maximum concentration of a residue of a pharmacologically active substance that can legally be present in food. MRLs are set by international bodies of scientific experts. Following consideration by the experts, the substances are listed in annexes of Regulation 2377/90: Annex I substances where MRLs have been set: Annex II substances where on toxicological grounds, no MRL is necessary if a substance is used as directed; Annex III substance for which a provisional MRL has been set; Annex IV substances for which no safety limit can be set. These substances are banned from use in food-producing animals. The withdrawal period is the interval between the time of the last administration of a medicinal product to an animal and the time when the level of residues in the tissues (muscles, liver, kidney, skin/fat) or products (milk, eggs, honey) is lower than or equal to the MRL. Until the withdrawal period has elapsed, the animal or its products must not be used for human consumption. Farmers are required by law to observe the withdrawal period. The withdrawal period is indicated in the label or in the leaflet that accompanies veterinary medicinal products. A veterinary surgeon prescribing for, or administering a medicine to, food-producing animals under the cascade is required to specify an appropriate withdrawal period. Unless the medicine indicates a withdrawal period for the species concerned, this should not be less than:

5 7 days for eggs and milk; 28 days for meat from poultry and mammals; 550 degree days for meat from fish. Currently no standard withdrawal period has been established for honey. Annex 2 THE PRESCRIBING CASCADE The prescribing cascade provisions are set out in the Veterinary Medicines Regulations and are summarised below. If there is no medicine authorised in the UK for a condition affecting an animal species, the veterinary surgeon responsible for treating the animal(s) may, in particular to avoid unacceptable suffering, treat the animal(s) in accordance with the following sequence: 1. a veterinary medicine authorised in the UK for use in another animal species or for a different condition in the same species; or, if there is no such product, use 2. either: a medicine authorised in the UK for human use; or a medicine authorised for veterinary use in accordance with Directive 2001/82 (as amended) in another Member State or Third Countries, 3. a medicine prepared extemporaneously, by a veterinary surgeon, a pharmacist or a person holding an appropriate manufacturer s authorisation, as prescribed by the veterinary surgeon responsible for treating the animal. If the animal is to be treated is a food-producing species, any medicine imported to be used under the cascade must be authorised for use in a food-producing species. A medicine prescribed in accordance with the cascade may be administered by the prescribing veterinary surgeon or by a person acting under their direction. Responsibility for the prescription, the use of the medicine and for setting the withdrawal period remains with the prescribing veterinary surgeon.

6 Letter from the Chairman of the Committee to the Secretary of State, 10 November 2008 Follow-up to the evidence session on 5 November 2008 Thank you for giving evidence to the Committee last week on the Government Response to the Committee s Tenth Report on Badgers and Cattle TB. On behalf of the Committee, I am writing to request further information based on the evidence that you gave to us. You agreed to provide the Committee with further information on the number of herds, and number of cattle, that had been identified through slaughterhouse observations rather than skin tests as having TB. You also agreed to provide the Committee with a separate note on the availability of medicines for bees and issues surrounding the licensing of medicines. I would be grateful if the note could include information on Government funding of the research into bee health at Rothamsted Research, which I referred to during the evidence session. 2 Rt Hon Michael Jack MP Chairman of the Committee 2 See The Times, The plight of the honey bee, 31 October 2008,

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