Minutes of Meetings - February 2000

Animal Procedures Committee  APC (2000) 1st Meeting
Minutes of the meeting held on 9 February 2000

Opening the meeting, the Chairman and members thanked Professor McNeilly and his staff for their help in arranging the Committee's stay in Edinburgh and the meeting facilities at MRC.

1. Apologies for absence

1.1 Apologies from Mr Baker, Professor Broom, Professor Martin, Mr McCracken, Professor Purchase and Dr Southee.

1.2 The Chairman announced that the Secretary, Mr Bone, was to leave the Committee. The new Secretary would be Mr Richard West.

2. Minutes of the previous meeting (8 December)

2.1 Para 9.5 should record that Mr Ward had agreed to write to the Chief Inspector about the use of goats in underwater defence experiments.

2.2 Mr McCracken, who was unable to attend the meeting, had sent in a suggested correction to paragraph 9.7. The Committee decided against his suggestion.

2.3 The minutes were then agreed.

3. Matters arising

3.1 World Trade Organisation talks (para 3.5) Paper INF(00)5 contained the Chairman's correspondence with the Minister about the fate of the Committee's suggestion that the Government raise laboratory animal welfare during the WTO talks. Mr Evans told the Committee that the recently signed United Nations biosafety protocol allows states to restrict imports of organisms on grounds either of evidence that they would have a harmful effect or of concerns that they might. The protocol allowed for labelling procedures and had equal status with WTO agreements.

3.2 Accident cover for members of the APC (para 3.7) Mr Bone informed members that the rules under which Committees such as the APC operate mean that they are covered for any accident or mishap that might happen while they were on APC business - either at a meeting, or on their way to or from a meeting, or on an APC visit.

3.3 Primate applications (para 4) The Chairman had written to the Minister (INF(00)4) and he was considering the Committee's advice.

3.4 Follow-up to the review of the Act (para 6) Mr Bone reported that the Committee's website would soon be put on a stand-alone basis, outside the Home Office site where it was currently found. Along with the material it already contained, the website would include the Committee's workplan.

3.5 Committee visits (para 8.2) After the meeting the Committee visited animal facilities in the Edinburgh area. The Secretariat had developed plans for several further Committee visits over the year and Mr Bone outlined these.

3.6 The Chairman reminded members that Committee visits are by invitation and are not inspections.

3.7 It was agreed that the Committee and its members would make no public comments on visits made by the Committee.

4. Committee's annual report for 1999 - Paper APC(00)1

4.1 Members discussed the draft of the report which was contained in the paper. They agreed to pass minor drafting points to the Secretary in time to allow him to prepare a revised version of the report for circulation to the next meeting on April 12. Members hoped to be able to agree a final text for publication at that meeting.

4.2 Members suggested a number of detailed changes, and the secretariat noted them. In more general discussion, members commented that the level of detail contained in the report marked a departure from previous editions - this was generally welcomed, but there were concerns that the wording might be unnecessarily graphic in places. Providing a higher level of detail meant that the Committee would be widening the scope for possible misinterpretation of its report, but that was outweighed by the need for openness.

4.3 Members suggested that the report should explain more fully why the Committee had agreed to advise the Home Secretary to allow particular animal experiments. The draft report did not mention the introduction of the ethical review process during 1999. This was not something that the Committee had specifically talked about during the year, but it had been a background issue in a number of its discussions and members agreed that the report should mention it.

4.4 The Secretary reminded members that the report would contain the Committee's register of interests and a note of their attendance at meetings during 1999. He would write to them to check these things.

5. Revision to the Home Office Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 - Paper APC(00)2

5.1 Mr Evans introduced the Home Office's draft revision of their main guidance on implementing the 1986 Act. He had tabled copies at the December APC meeting. The Committee Secretariat had since sent a further copy to every member, and had received the comments set out in paper APC(00)2. The Home Office planned to lay the revised guidance before Parliament on 15 March, and were obliged by section 21(3) of the Act to consult the Committee before doing so. The formal period for public consultation ended on 11 February.

5.2 The draft was significantly longer and more detailed than the original version of the Guidance which it was intended to replace. One member had already commented to the Home Office to the effect that it was difficult to follow and seemed to need a user's guide.

5.3 There was discussion of the role of the ethical review process and of the concept of severity limits. On the former, it was not clear whether the ethical review was simply a process to which each project application was subject or whether it was something which a project application had to pass. Paragraph 4.17 of the draft - which requires a senior person at the establishment from which a new project licence application comes to sign that it has been through the process - was ambiguous on this point. The Home Office would look at it again.

5.4 On severity limits, members commented that it was not clear whether the wording of the draft guidance would rule out the grant of a licence allowing an animal to be subject - for reasons thought to be justifiable - to 'severe pain, distress or suffering'. The parts of the document in question were para 5.39, et seq, and 19C in Appendix E.

5.5 The Home Office said that the ambiguity stemmed from a European document which posed certain translation difficulties. They acknowledged that there could be a contradiction between Appendix E and the main text on this point - it was important that there should not be any ambiguity and they would look at the issue again. Members discussed whether there was an upper limit to the pain, distress or suffering that licences under the 1986 Act would allow. The Home Office believed that there was - as defined in the 'substantial' classification – and agreed to make that quite clear in the document as laid before Parliament.

5.6 The Chairman would write to the Home Office making these points, and those contained in paper APC(00)2, as the Committee's formal response to consultation on the revised Guidance.  Action: Chairman

6. Microsurgery project licence application - paper APC(00)3)

6.1 Opening discussion, the Chairman explained that the Home Office routinely refers licence applications for microsurgery training to the Committee. The pre-1986 legislation prohibited surgical training on animals (section 3(6) of the Cruelty to Animals Act 1876). The modern, 1986, legislation allows it under licence, but the then Government promised that all such applications would be sent to the APC for advice before a licence was granted. The current Government is maintaining that commitment.

6.2 The Chief Inspector said that there were 6 to 8 microsurgery training licences currently in existence. They lasted four years. Most of them had originally been issued at around the same time and - assuming that their holders intended to renew - the APC would be asked for their views on them over the next year or two. The current application was to renew one such licence. Fairly typical of the other microsurgery licences, it would allow training on terminally anaesthetised rats in non-recovery procedures.

6.3 The training would form the second part of a two-part microsurgery course approved by the Royal College of Surgeons. In the first part, candidates - all experienced surgeons - would study theory and do in vitro work using tissues from dead animals. They would only move on to the second part of the course and work on terminally anaesthetised rats if they had passed through the first part and demonstrated the necessary aptitude for microsurgery. Not all surgeons have this aptitude.

6.4 In answer to questions from members the Chief Inspector said that the Royal College had reviewed these courses within the last five years and concluded that the use of anaesthetised rats remained the only way for surgeons to perfect micro techniques. Adult rats were ideally sized animals for work of this kind - their vessels were closely similar to those which surgeons would encounter in their human patients. Artificial alternatives such as the PVC rat model or the Sharp Point Practice Rat did not fully mimic all the features of living tissue or the effects of clotting and other surgical error.

6.5 Each trainee would use no more than one rat per day during the 5-day course. The Chief Inspector believed that there was sufficient demand for microsurgery courses nationally to justify allowing the application. Places on the course would be fully subscribed. The consequence of the Minister refusing the application would be that waiting lists for plastic surgery would get longer, or that some patients or intending microsurgeons would go overseas.

6.6 Members queried the forms of anaesthesia which the application proposed (gas, followed by a terminal injection into the peritoneum). A single non-peritoneal injection would be safe and satisfactory, but it might be more difficult to administer. At an earlier meeting the Committee had heard that injection via the peritoneum was a potentially distressing procedure - the Chief Inspector assured the Committee that this was not an issue in this case as the animals would be deeply anaesthetised before their terminal peritoneal injection.

6.7 The Chairman commented, and members agreed, that the need to elicit basic information of this kind from the Chief Inspector showed the inadequacy of the Home Office's licence application documents. On the basis of the Chief Inspector's assurances, and in particular his confirmation that no alternative was available for training in the techniques in question, the Committee was minded that the Chairman write to the Minister suggesting that he approve the application. The Chairman would so do.  Action: Chairman

7. The APC's research funding strategy - paper APC(00)4

7.1 Professor Anderson, chair of the Research and Alternatives sub-Committee, introduced the paper and sought the Committee’s endorsement of its proposals. The extended brief which the main Committee had given the sub-Committee had substantial implications for how they should conduct their business. He and his sub-Committee colleagues had taken these into account in producing the revised strategy document, which also set out the practicalities of the procedure for administering the research grants, in which the sub-Committee’s role was to advise the Home Office on how the money should be spent. He expressed the sub-Committee's thanks to Dr Navaratnam of the Inspectorate for the help he had given in producing the document.

7.2 The sub-Committee had placed an advertisement for research proposals in the New Scientist in January 1998 and received many expressions of interest. It had shortlisted the main candidates for grants and interviewed them personally, assisted by outside experts. Other significant recent activity had included the presentation of a poster at the ECVAM convention in Bologna in September 1999.

7.3 The main change which the sub-Committee proposed to the funding strategy was to split the money between research on the 3R’s, the development and promotion of awareness and use of alternatives, and research into the operation of the 1986 Act in respective proportions of 60%, 20% and 20%.

7.4 The sub-Committee had placed a further advertisement for research proposals in New Scientist (and elsewhere) in January 2000. This had mentioned an upper limit of £20,000 on possible awards, and members pointed to the disparity between that and that statement in the strategy document that grants could be up to £40,000. The sub-Committee explained that the grant funds were already heavily committed for the next year – at present the money left over would allow only smaller grants to be made, but the sub-Committee anticipated that it would be possible to be more ambitious in future years as had been the case in the past.

7.5 There was a disparity between the preliminary guidelines for applicants at Appendix 1, which said that ‘any proposal which involves protected animals must justify their use carefully’ and the formal terms and conditions at Appendix 3, which did not say that. The sub-Committee thought this might not be a difficulty - the terms and conditions would only apply once a project had been agreed, and projects which did not carefully justify any use they made of protected animals would not be agreed. But they would reconsider this point.

7.6 T he sub-Committee had received 3 formal applications following its January 2000 advertisement and around 20 expressions of interest (note – more applications came in after the meeting – cb). Members voiced concern about the size of the annual budget, especially given that the Committee seemed to be the only body which funded research into the operation of the 1986 Act, and about the way in which Treasury rules forced the sub-Committee to run its budget on a yearly basis when research grants were often made over 3 years. There would need to be something about this in the Committee’s 1999 annual report.

7.7 Mr Evans told members that the Government funded alternatives research in a number of different ways. The APC’s research budget was by no means the whole picture. The exact details were hard to discern, but it seemed clear that the Government put considerably more money into this area in other ways. It helped to fund ECVAM (an EU body) and it seemed likely that expenditure in Departments other than the Home Office was of the order of $2 million a year.

7.8 Concluding the discussion the Chairman thanked the Research & Alternatives sub-Committee for their work in taking up their revised remit and producing the strategy document. The Committee was content.

8. Harlan-Hillcrest - Home Office investigation

8.1 Before discussion began Dr Langley declared a personal and business interest as the author of the report by the British Union for the Abolition of Vivisection (BUAV) about conditions at Harlan Hillcrest.

8.2 Mr Evans reminded the Committee that the Home Office had received BUAV’s report at the end of June 1999, followed by more allegations in July. The Minister had commissioned an investigation by the Inspectorate, and had received its report in December. The investigation had concluded that most of BUAV’s allegations were not substantiated. There had been one infringement meriting a formal letter of admonition to the company, and the letter had been sent. The company had given the Home Office assurances about staffing levels at the establishment.

8.3 A Parliamentary reply in July had said that the Home Office would inform the Committee of the outcome of the Inspectorate’s investigation. But the Minister wanted to go further than that, by providing the Inspectorate’s report to members and eventually publicising it more generally. Mr Evans had copies with him to give to members.

8.4 He explained however that the document had for the time being to be treated as restricted. Having received it members should not discuss it with anybody outside the Committee. Much of the information on which it was based had come from Harlan Hillcrest, and their customers, in confidence. The company and the other parties were currently content for the Committee to see it but section 24 of the 1986 Act prohibited its wider disclosure without their consent.

8.5 The version of the report available for members contained some blankings out. Mr Evans explained that these passages contained confidential information which the company or its customers had not agreed could be released to the Committee. There were also some shaded (but legible) passages containing confidential information which BUAV, the company or its customers had agreed could be released to the Committee only. He said that this position in which it was possible for the Home Office to show members the great majority of the Inspectorate’s report had only been reached after prolonged negotiations with the various parties. But it was possible that they might allow more material to be released later.

8.6 The Chairman summarised the position. The Home Office proposed to show members a version of the Inspectorate report with some details missing. The report was a 40-page document and it would be impossible for members to discuss it sensibly at the meeting when they had just seen it. The Minister might make it public at some stage, but he (Chairman) had written to the Home Office to say that it would be regrettable if it became public before the Committee had had a chance to consider it. He hoped that there would be the opportunity for a proper discussion in the Committee before its publication – the next Committee meeting, however, was in April.

8.7 Asked what the Minister expected the Committee to do with the Inspectorate’s report, the Chairman said that this was a matter for the Committee itself to decide – it might simply note the report, or take a view as to its adequacy in dealing with the BUAV’s criticisms, or use it to consider wider issues that might arise. There was comment that the Committee might find it difficult to challenge the report and could therefore find itself being used as cover for any inadequacies in it. The Chairman thought that many members might share that concern.

8.8 Members were concerned as to whether the confidential status of the report might prevent them taking action if it shed light on a particular research project which was being funded by the Home Office on the Committee’s behalf. Mr Evans said that it did not – the Committee’s role as regards the project was to provide advice to the Department. It could make its own enquiries and was free to offer whatever advice it thought necessary.

8.9 The Chairman then authorised Mr Evans to give copies of the report to members present at the meeting (the Secretary later posted a copy to all those members who were not present). The Chairman would write to the Minister to thank him for providing the report. Action: Chairman

8.10 The Committee would discuss the Inspectorate’s report at a later meeting. The Committee were content to have received it. But receiving it did not in any way imply that the Committee endorsed its conclusions.

8.11 Dr Langley observed that if the Minister announced the Inspectorate’s conclusions without publishing their report, members who wanted to comment on what he said would be unable to refer to it. Mr Evans said that negotiations as to the confidential status of the report were continuing, and the position might change. He would ensure that the Minister was aware of this and the Committee’s other concerns.  Action: Home Office

9. Other business

9.1 The Institute of Animal Technology had held a weekend meeting for named animal care & welfare officers (NACWO’s). The event was very useful and would be repeated annually.

9.2 There was discussion of the Committee’s consultation paper on openness, circulated as INF(00)1. It seemed somewhat abrupt in tone and to miss out on some of the disclosure issues which the Committee had marked up for discussion in its 10-year review of the 1986 Act. Professor Atterwill, who chairs the openness working group, confirmed that the group had these issues under consideration and members agreed to pursue any concerns about the paper outside the meeting.

9.3 The US National Institute of Health had issued a press release indicating that they would accept lymph node assay work in mice rather than more invasive tests on guinea pigs. The Chief Inspector said that the Home Office was aware of this development, but matters were not yet at a stage where licence applications for guinea pig work would fall to be refused under section 5(5) of the 1986 Act. The Chairman instructed the Secretary to circulate material about this for discussion at a later meeting.  Action: Home Office

10. Next meeting

April 12, 10.30, Room 1027 Home Office (on the 10^th floor - not the previous meeting room).

• Minutes of Meetings
• Reports and Publications
• Consultation Letters
• Press Releases

• Animals (Scientific Procedures) Act 1986 (available on the Home Office website)

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