Minutes of Meetings December 2002

At University College London

Present:

Professor Banner (Chairman)
Professor Atterwill
Professor Broom
Professor D Clark
Dr Festing
Mr Gregory
Professor Holland
Dr Hubrecht
Dr Jennings
Dr Langley
Professor Martin
Mr McCracken
Professor McNeilly
Mr Moore
Dr Morris
Professor Richardson

Home Office (AP&CU)

Mr Cobley
Mr Walsh
Mr Wood

Home Office (Inspectorate)

Dr Richmond (Chief Inspector)
Dr Anderson

Department of Health, Social Services and Public Safety for Northern Ireland

Mr Collins

Secretariat

Mr West (Secretary)
Mr Earle
Mr Brenner

Item 1: Welcome / Apologies for Absence

1.1 Professor Spyer, Vice-Provost for Biomedicine and Head of Medicine at UCL welcomed the Committee to University College London (UCL). The Chairman thanked Professor Spyer and Professor Martin for arranging the meeting at UCL. The Chairman opened the meeting at 10.31. Apologies for absence from the meeting had been received from Professor Bulfield, Professor S Clark and Professor Dunbar. The Chairman noted that Mr Moore was attending his first APC meeting and he welcomed him to the Committee. He also noted that Professor Atterwill, Professor Broom, Professor Bulfield, Professor S Clark, Professor Holland, Professor McNeilly and Professor Richardson had all been re-appointment to the Committee for a second four year period. The Chairman welcomed Mr Collins and thanked him for hosting a visit by the Chairman and Secretary to Northern Ireland earlier in the year.

Item 2: Minutes of the meetings held on 9 October 2002

2.1 The Committee agreed that subject to a minor drafting amendment in paragraph 8.1 the minutes could be ratified and posted on APC's website.

3.1 The Secretary stated that the Annual Report had been laid before Parliament on 14 November.

Item 3: Improving Experimental Design and Statistics

3.2 Dr Festing explained that the Medical Research Council's Centre for Best Practice in Animal Research had arranged a conference to be held in February, which would consider this issue. Some members of the Committee, including the Chairman, would receive invitations. It was noted that in the light of this initiative there was now no need for the APC itself to take this issue forward. However, there would be a continuing need for the Committee to keep abreast of developments in this area.

3.3 The Chairman has incorporated the comments he had received from members into a letter to the Minister, which asked for a more substantive reply to the recommendations of the APC's Biotechnology report. [Secretary's note: a copy of the Chairman's letter is at Annex A.]

3.4 The Chairman said that the report had been sent to the Minister on 4 December. It was agreed that for the report to reach as wide an audience as possible, it should be published in an eye-catching format and announced by means of a press release. The Secretary explained that the Committee was looking for support from the Home Office toward the publication costs.

3.5 This was a later agenda item.

3.6 The Chairman had written to the Home Office as agreed at the last meeting. [Secretary's note: a copy is at Annex B.]

3.7 The Chairman thanked those members who had attended the Committee's weekend conference on 22 and 23 November.

3.8 The Committee discussed the Home Office's reply to a request made at the previous meeting for more information regarding an infringement. Dr Langley considered that this was a helpful reply and asked whether some of the lessons learnt could be included in a circular to Certificate Holders, or reported on the Home Office website. Mr Cobley agreed to consider this proposal.

3.9 The Secretary and Chairman had met with Jane Smith, whom it was noted had been of great support in the preparation of the report. Further amendments had been made to the report and a revised version would be circulated to the other members of the Working Group and then, after any further revision, to all Committee members. The intention was to publish the report in January.

4.1 Paper APC(02)41 was a microsurgery application to train surgeons in microvascular techniques using terminally anaesthetised rats. In the light of its previous discussions about microsurgery applications the Committee agreed to recommend that the application should be approved.

5.1 The Chairman had written to Mr Cobley on 25 October offering the Committee's views on five of the House of Lords Select Committee's recommendations. The Committee now proposed to offer its views on whether farm animals were satisfactorily regulated under the Act; and whether visiting scientists and students should be allowed to work under the licences of established licence-holders. Although it was understood that it was too late to influence the Government's initial response to the House of Lords recommendations, it was agreed that the Committee should still offer its views on these two recommendations.

5.2 The Chairman advised the Committee that the draft paper on these issues before the Committee would be redrafted to remove typographical errors and be adapted to more adequately express the views of its members. The revised paper would be circulated to Committee members who had expressed an interest and then a final, approved version would be sent to the Home Office. [Secretary's note: Professor Broom has suggested two amendments to the committee's views on the farm animals recommendation. Paragraph 3, sentence 2 should be amended to read, "Whilst conditions on farms can be very different from those required under ASPA and it is sometimes necessary that typical farm conditions be used in licensed studies, that is no justification to allow lower overall standards for particular scientific procedures carried out on farm animals as compared with those permitted for laboratory animals." And in paragraph 3, sentence 4 the term "and proportionate" should be removed.]

6.1 Professor Banner thanked the Working Group for their work and invited Mr Gregory to introduce the paper.

6.2 Mr Gregory explained that the only emerging recommendation at this stage was for an amendment to Schedule 1 of ASPA to permit the euthanasia of neonatal rodents (up to the age of seven days) by decapitation. The decapitation of foetal rodents was already permitted under Schedule 1. Neonatal rodents were less physically developed, but there were no proven studies to support the theory that they suffered less pain from this method of euthanasia than juvenile or adult rodents. Indications were that immature animals might retain the potential for feeling pain for longer than mature animals, because immature animals had a greater tolerance of hypoxia. On the other hand, at birth rodents had little or no cerebral cortex, and therefore had a reduced ability to experience pain. Although it was illogical to take birth as the point at which decapitation ceased to be permitted, some members were concerned that there was no firm evidence to support the proposal to extend the point to seven days after birth. In conclusion, it was agreed that the case for the Working Group's recommendation had at the current stage not been made. Mr Gregory agreed that the Working Group would re-draft the document for future consideration by the Committee. It was noted that there would need to be wide consultation about this and any other proposal to amend Schedule 1. Given the nature of the subject the consultation paper would need to be written sensitively, with due reference to ethical and aesthetic issues.

7.1 The Chairman suggested that the Committee had not yet arrived at a consensus about a revised policy on the types of applications that it should see, and explained that he would not be writing to the Minister as envisaged by the paper. It was agreed that the issue required further discussion within the Applications Working Group and that this should include consideration of the logistical practicalities for applicants and the APC. It would also be helpful for the working group to have sight of the Government's response to the House of Lords' report, before deciding on an overall strategy. In response to a suggestion from the Chairman, the Committee agreed that Mr Moore should join the working group.

8.1 The Chairman asked whether the Home Office wished to add any comments to their paper, a summary of which is annexed to these minutes at Annex C.

8.2 House of Lords report Mr Walsh explained that the Minister had been provided with a draft response to the House of Lords report and this was now being discussed with other government departments.

8.3 Inter-departmental data sharing The Group had met most recently on 19 November. The topics discussed had included the options for the Government response to the House of Lords Select Committee recommendations regarding research into alternatives and the review of the joint guidance on the conduct of regulatory toxicology and safety evaluation studies. A further meeting was planned for January/February after which the Group expected to report back to Ministers. Dr Jennings asked if the Home Office could provide more information on data sharing, perhaps with a detailed paper or presentation on the subject. The Chief Inspector said that he was preparing a paper on data sharing for publication, which he would send to the Secretariat for distribution to the membership after publication.

8.4 Home Office publication scheme on Freedom of Information Mr Walsh explained that the Home Office publication scheme on Freedom of Information had been approved and had come into operation on 30 November. Relevant information relating to the 1986 Act could be accessed through the Home Office web-site. He agreed to provide a digest for the Committee, which was welcomed.

8.5 Requests for information under the Code of Practice on Access to Government Information Mr McCracken asked whether the Home Office would allow publication of its legal advice, advising that the disclosure of individual project licences granted before October 1998 could lead to breach of confidence actions. The Home Office replied that it was not practice to disclose such advice.

8.6 Two completed infringement cases A member declared an interest in one of the listed infringements, and his offer to withdraw from the meeting was accepted.

8.7 The first infringement had been self-reported, along with a number of other infringements (none of the others had significant animal welfare consequences). A rat had inadvertently been left in its home cage instead of being killed, and had remained undetected for five and half days without access to drinking water. The establishment concerned had responded with reorganised procedures to minimise the likelihood of re-occurrence. The licensees involved had received letters of admonition. The Certificate Holder had also received a letter of admonition, and the conditions attached to the certificate had been varied to require evidence of further administrative and procedural improvements within a specified period.

8.8 The second infringement involved a review of records at a designated establishment undertaken by the Inspectorate. This had revealed that two sheep undergoing regulated procedures had been found to have problems with abnormal horn growth. This had resulted in both cases in an immediate welfare problem and had prevented the continued use of the sheep under project licence authority. The local Inspector had considered that these problems could have been identified and dealt with at an earlier stage, and that proper provision had not been made for the care of these animals. The matter had been mistakenly categorised as a Class 1 infringement and dealt with locally rather than being referred up the line as a Class 3 infringement. Class 1 infringements are dealt with by letters drafted by the Inspectorate to those involved requiring that appropriate remedial action be taken and indicating that future similar lapses will be dealt with more severely. In this case written confirmation had also been obtained from the certificate holder of the improved local processes designed to prevent recurrences. Further action was not now deemed appropriate, but the Inspector had been reminded of the correct procedure for dealing with infringements that impacted adversely on animal welfare

8.9 Some Committee members thought that the first of the summarised infringements was of particular concern, and expressed surprise at the relative mild level of punishment of an admonishment. One member suggested that a pet owner who had deprived an animal of water for five days would have been prosecuted under the Protection of Animals Act 1911. The Chief Inspector said that he could not comment on why the infringement had not been the subject of a prosecution. The Committee noted that there would be an opportunity to review these and other infringements when the next annual infringement summary was provided by the Home Office in the New Year.

Item 9: Revisions to Sub-Committees and Working Groups (APC(02)46)

9.1 The Chairman introduced the self-explanatory paper and added that Mr Moore would join the Applications Working Group. All were content with the proposals. [Secretary's note: A breakdown of the agreed membership of all APC's sub-committees and working groups is at Annex D.]

10.1 [Secretary's note: the member who had left the meeting during the discussion of infringements rejoined the meeting at this point]. The Secretary explained that a further set of papers had been received from "Uncaged", which included many leaked documents previously unseen by the Committee. The Chairman was now proposing to reply to two letters from "Uncaged". At this point, another member offered to withdraw. This was noted but not accepted, as the Committee was not considering the specific allegations made by "Uncaged".

10.2 The Secretariat had enquired about the state of the injunction taken out by Novartis. The legal advice received was that the Committee were able consider the documents without risking a breach of the injunction. The Secretariat agreed to supply copies of the documents to any member who requested them.

Action: Secretariat

10.3 Dr Hubrecht stated that the allegations had already been considered by the APC and suggested that little would be learnt from revisiting this subject again. It was noted that the Committee's Working Groups and Sub-Committees had carried out work on several related subjects, which had addressed many of the issues stemming from the original allegations.

10.4 The Chairman asked the Secretariat to prepare a summary setting out what the Committee had done and was still doing in response to the allegations and to the Home Office response. That would be used as a final response to the letter from "Uncaged". It was agreed that the Secretariat would liaise with Professor Clark, Dr Jennings, and Professor Richardson to prepare the summary.

11.1 The Chairman introduced the revised appraisal paper, which reflected the concerns raised when the previous document had been discussed in February. The new format allowed for an opportunity to appraise the Committee, the Chairman and the Secretariat, although it had not been decided whether appraisals should be held annually or at the end of a member's first term. The Secretary added that the Minister needed information about a member's performance in order to inform the assessment of whether the member should be re-appointed. A copy of the appraisal would be sent to each member, allowing for the opportunity of a meeting with the Chairman, if required.

11.2 Given their experience of appraisal systems employed within industry and academia, it was agreed that Professor D Clark, Dr Morris and Professor Holland would consider a simplified appraisal system.

12.1. The Committee had submitted a draft syllabus for the mandatory training of Named Animal Care and Welfare Officers (NACWOs) in 2001, observing that the syllabus could be improved if it included more emphasis on welfare observations and a general introduction to ethics training. Angela Eagle, the then Minister had accepted in principle that some form of introductory training for NACWOs should be compulsory, and had said that the Home Office would take this forward as soon as the APC provided the finally recommended syllabus. The Committee agreed that the revised syllabus contained in APC(02)49 was satisfactory and could be forwarded to the Home Office. [Secretary's note: a copy of the syllabus to be sent to the Home Office is at Annex E]

Action: Secretariat

Action: Education and Training Sub-Committee

Revision of EU directive

12.3 It was agreed that the Chairman would write to the Minister asking him to confirm that the APC would be able to contribute at an early stage to the UK's thinking about the revision. Mr Moore said that the Committee would have to input its views quickly, as the work of revision was to begin early in 2003 with a report being produced in early 2004. Action: Chairman to write to Minister

12.4 After a short discussion the Committee agreed that this draft would be brought back to the February meeting after the Chairman had discussed the work plan with the chairs of the sub-committees and working groups.

Action: Secretariat

Cambridge BUAV allegations report

12.5 Mr Wood explained that the Inspectorate's report would shortly be sent to the Minister. He hoped that it would be published before the Committee's February meeting, by way of a Commons statement. The Committee asked to be notified when the statement was to be made.

12.6 The meeting ended at 12.27.

Item 13: Date of next meeting: 12 February 2003

APC Secretariat
January 2003

From the Chairman
Reverend Professor Michael Banner MA DPhil

Bob Ainsworth MP
Parliamentary Under Secretary of State
Home Office
50 Queen Anne's Gate
London SW1H 9AT

10 December 2002

Dear Minister

ANIMAL PROCEDURES COMMITTEE (APC): RECOMMENDATIONS ON BIOTECHNOLOGY

Thank you for your letter of 9 July giving the Home Office's response to the recommendations of the APC's report on biotechnology. The Committee discussed the Home Office's response at its meeting on 9 October, and I am now passing on our conclusions. I regret to say that the Committee was very disappointed with the brevity of the Home Office's response, not least in the light of the extensive expenditure of time and thought both by the respondents to our consultation exercise and by the members of our working group. I should like to comment on the response to our report as a whole and on certain specific recommendations.

2. The background to the Committee's examination of developments in biotechnology is that we recognised that the developments in biotechnology offered science a major advance in investigative technology. This was of course to be welcomed, but we also recognised that these developments posed particular challenges to the working of the Animals (Scientific Procedures) Act 1986. We considered that the responses to these challenges needed to be considered before, not after the event, as corrective action might otherwise be impossible.

3. We and many of the respondents to our consultation exercise recognised that the increasing opportunities to use genetically modified (GM) animals wond 22. It would be helpful if you could specifically endorse each of those recommendations.

5. When the Committee discussed your letter we thought that the Home Office should have gone much further than noting what was current practice. I do not think it unreasonable to ask for a more strategic response. For example, it would be helpful if you could comment on what can be now be done to re-emphasise and restate these points in the light of the increasing use of GM animals. Our working group on biotechnology included past and current licence holders, and it was certainly not apparent to them that certain of the recommendations reflected current practice. That indicates that there may be a gap between what the Home Office considers is current practice and perceptions in science and industry. You stated, in your response to recommendation 9, that you could confirm current practice about monitoring welfare consequences in one of the regular Home Office circulars. We suggest that many more of the recommendations which reflect current Home Office practice should also be brought to the attention of the user community and ERP committees by means of Home Office circulars. Our report provided detailed analysis and suggestions about cage-side assessments, databases etc, and we would look to the Home Office to take these forward proactively. It would be helpful if you could comment on these suggestions.

Recommendations about welfare assessments of GM animals

6. Many of our recommendations referred to efforts to improve and promulgate the welfare assessment of GM animals. In your response, you suggested that the APC or the Laboratory Animal Science Association (LASA) could take this forward. I am sure that you will be pleased to hear that earlier this year the APC convened a series of meetings with the major funding bodies to discuss these recommendations. The funding bodies have decided to establish an expert working group to develop welfare assessment schemes for GM mice. This working group will review potential welfare issues for GM animals and current practice and make recommendations on best practice for welfare assessments. The Home Office should consider incorporating any recommendations the working group may make into guidance notes for the user community. The Home Office should also keep in close and supportive contact with the working group. For example, we understand that the group has accepted that the establishment of a welfare database (our recommendations 10 and 19) would be valuable, but that there are real practical difficulties. It would be reassuring to know that the Home Office was actively engaging in taking this forward.

Comments on other individual recommendations

7. The Committee noted that DEFRA administers the regulations about transport of animals (recommendation 11). However, it would be helpful if you could describe how the particular welfare needs of animals being kept in germ-free or minimum disease-barriered conditions on long journeys are catered for. What advice with a view to minimising any untoward welfare effects of transport on such animals could the Home Office give the user community and/or to DEFRA on the treatment of genetically modified animals before, during and after transport?

8. We accept that there have been several recent examinations which have looked at licensing procedures (recommendation 21), not least the House of Lords Select Committee on Animal Experimentation. However, while there has been much anecdotal opinion recorded in those fora, there is a lack of independent research into the real impact of ASPA regulation. Indeed, the report of the Select Committee stated in this connection that "the reality is hard to discover". It would therefore be helpful if you could comment on our recommendation.

9. Recommendations 23 and 24 were for the AEBC. It would be helpful if you could confirm that these have been forwarded to that committee.

10. The APC looks forward to receiving a detailed response to each of the recommendations made in our report, and to what we hope are the further practical suggestions we make in this letter. I, with some of the APC members who served on the working group on biotechnology, would be pleased to attend a meeting with your officials if that would be helpful. The two of us might also discuss these issues at the meeting that officials have arranged on 12 December.

Yours sincerely

MICHAEL BANNER

From the Chairman
Reverend Professor Michael Banner MA DPhil

Trevor Cobley
Animal Procedures & Coroners Unit
Home Office
50 Queen Anne's Gate
London SW1H 9AT

25 October 2002

Dear Trevor

COMMENTS BY THE ANIMAL PROCEDURES COMMITTEE ON SOME ASPECTS OF THE REPORT OF THE HOUSE OF LORDS SELECT COMMITTEE ON ANIMAL EXPERIMENTATION

I understand that you are currently contributing to the Government's response to the report of the House of Lords Select Committee on Animal Experimentation. Several of the recommendations in the report would directly affect the Animal Procedures Committee (APC), and there are several other recommendations on which the APC might wish to comment. At some later stage the Committee will be having extensive discussions about all the recommendations in the Select Committee's report. However I hope it will be helpful if I offer the comments of the APC on aspects of some of the recommendations in the report which are of particular interest or concern to the Committee. I hope that our comments will assist in the preparation of the Government's response, although I recognise that it is of course for Ministers to respond to these recommendations.
Recommendation: the Animal Procedures Committee should invite submissions from the Royal College of Veterinary Surgeons, the Farm Animal Welfare Council and others to establish the appropriate application of the 1986 Act or the modification of its regulations for experimental farm animals (paragraph 3.17)

2. The Committee welcomes the opportunity to consider the efficacy of the Act and regulations as applied to experimental farm animals.
Recommendation: the Inspectorate should be subject to periodic review, by a body other than the Inspectorate itself (paragraph 5.13 )

3. The Committee already reviews and monitors the operation of the Act at the meetings of the main Committee and its sub-committees which take place throughout the year, and the work of the Inspectorate is included in that monitoring. For example, we are currently carrying out a detailed review of the Cost/Benefit assessment. The Committee believes that it has the potential to provide an informed, thorough and critical scrutiny of the Act and to play a key role in ensuring that this important area of public concern is subject to independent examination.

4. It is also the case that the Committee stands ready to take part in the "quality assurance" of any future investigation, as suggested by Mike O'Brien in connection with the allegations in 2000 about Harlan-Hillcrest. We have not discussed in depth the details of such an involvement by the Committee, but in principle a suitable scheme would strengthen our monitoring role.

5. The report suggests however that public confidence in the Inspectorate could be enhanced if there were an independent reviewing body, and that the APC might carry out such a role. However the report is silent on exactly what is envisaged. For example, such a body could

• examine allegations of malpractice by the Inspectorate;
• review the Inspectorate's work in general:
• review the efficacy of the regulations imposed; or
• do all of these.

The report suggests that the reviewing body "would need to have access to all the Inspectorate's records, including notes of what was seen and done during inspections of designated establishments." That suggests that an on-going, detailed and far ranging review is envisaged.

6. As currently constituted we do not believe that it would be possible for the APC to carry out the detailed inspectorial role which appears to be is envisaged. Our members do not have the time or the skills to carry out detailed audits of the Inspectorate's work, and we do not believe that it would be the best use of the expertise that we do possess.

7. I should draw your attention to one other matter. Paragraph 5.49 of the report states "We have also heard that the APC cannot always obtain all the papers it needs to carry out its scrutiny role effectively." A footnote indicates that this statement was based on Mr McCracken's evidence. It is unfortunate that the report does not refer to my subsequent letter to the Chairman of the Committee, where I clarified a matter where Mr McCracken may not have been entirely clear. In his evidence he had referred to the APC's examination of licence applications, and had suggested that the APC was hindered in its function of advising the Secretary of State because it did not see the analysis by the Inspectorate of the application. I was concerned that the Lords Committee might have gained the impression that the APC had been refused sight of these analyses. I explained that it was not the case that the Committee had asked for the Inspectorate's reports and been refused them, and I stated that I had no recollection of the Committee ever asking the Home Office for documents or information of any kind and being refused. It is unfortunate that the Lords Committee does not appear to have taken account of my clarification.

8. You will recall that I presented the Committee's arguments in favour of payment for all members of the APC in my letter to Angela Eagle of 25 September 2001. As I said in that letter, in recent years the APC has increased and widened its membership, and has, with Ministerial approval, taken a more active role. It has a professional, dedicated and authoritative position at the centre of the debate on animal experimentation. The Committee firmly believes that it should maintain this role. The time burden of meetings can be high. For example, in the year 2000 one member who was a member of two working groups had to attend more than twenty meetings. In addition, in order to carry out the Committee's enhanced role, individual members have to devote much more expense and effort to the APC than simply attending meetings. I hope you will take our reasoning into account when considering the Government's response to this recommendation of the Select Committee.

Recommendation: the APC Secretariat should be strengthened and separated from the regulators (paragraph 5.52)

9. Whether or not the Home Office asks the APC to take on additional work, I welcome the recommendation that the APC Secretariat should be strengthened. The current complement of one grade 7, one HEO and one AO has struggled to take forward all the work of the main Committee, its sub-committees and working groups, and this has been exacerbated by staff absences. This has meant that over the last two years we have made significantly slower progress than we hoped on several areas of work. As you know, we recently had the additional temporary help of a secondee from the Ministry of Agriculture and Forestry of New Zealand. The fact that that secondment was so very useful shows up a weakness in the current staffing complement despite the recent staff absences, and indicates that the Secretariat's staffing complement should be increased by one post. The scientific subject matter of most of our work indicates that the additional member of staff should be scientifically qualified.

10. I was grateful to hear from the APC Secretary that you had recently agreed in principle to another secondee from New Zealand, qualified in Applied Physiology and Animal Welfare Science, who we hope will start work in the new year. This further secondment will, I am sure, demonstrate the value of suitably qualified scientific support to the Committee. However, that should not be seen as a reason for delaying achieving adequate, permanent staffing of the Secretariat.

11. The report suggests that the Secretariat should be separated from the regulators. I do not understand precisely what is proposed, nor the reason for the proposal. I note however that in his evidence to the Select Committee, Mr Lyons of "Uncaged" asserted that "the independence of the APC was.. doubtful as its secretariat was based in the Home Office, and worked closely with the regulators."

12. As you know, until 1999 the function of APC Secretary and policy support to the Home Office on animal procedures was carried out by one post holder. It was recognised then that the two functions should be separated, and since then the APC Secretary and his staff have been a separate section of AP&CU. Staff in the Secretariat are answerable to the APC Chairman, although naturally and quite properly they liaise on a regular basis with AP&CU staff in other sections. I am satisfied that the Secretariat acts independently as the APC's support and executive arm, confidentially when necessary. The regular liaison between the Secretariat and the rest of AP&CU is handled sensitively by all those involved, and is of great practical assistance to the Committee.

Recommendation: the current APC research budget of £280,000 should be given to a Centre for the three Rs to disburse. (paragraph 7.23)

13. As you know, this research budget is administered by the Home Office on the advice of our Research and Alternatives sub-committee (RASC). The Committee believes that many worthwhile research projects have been funded by this budget, as RASC members have the expertise to identify useful projects. We would therefore be loath to relinquish our advisory role in this area. However, if the Government fully accepts the parallel recommendation - that a Centre for the three Rs be set up (paragraph 7.18) - we would not oppose the transfer of our research budget to such a centre. However, the Centre would need to have the means, experience and independence to administer the budget successfully. In connection with the Select Committee's recommendations on research, the Committee also welcomed recommendations 10 to 13, relating to initiatives by Government to increase research into alternatives to the use of animals.

14. I hope these comments are helpful. As I stated earlier, the Committee might wish to comment further when the Government's response to the Select Committee's report is published.

Yours sincerely

MICHAEL BANNER

It is now expected that the Government response will be published as a Command Paper in January 2003. The final deadline for a response, within the six months requested by the Chairman of the Select Committee, is 23 January.

Report of the Expert Group on Efficient Regulation (EGER)

2. A detailed Ministerial response to the recommendations in this report were sent to the EGER Chairman, Professor Purchase, on 15 October. A copy of the response is being sent to Committee members as an information paper, and can also be found on the Home Office website

Certificate Holders Forum

3. The Minister, Bob Ainsworth MP, addressed the Certificate Holders Forum in York on 24 October. Lord Smith of Clifton was also a guest speaker, and the focus of much of the event was on the report of the House of Lords Select Committee. The Minister's speech included an assurance that nothing would be done regarding section 24 of the 1986 Act without full consultation with the scientific research community. He also repeated his determination to continue to combat animal rights extremists, and pledged that efforts to streamline the licensing system would continue, provided animal welfare was not compromised. His attendance was appreciated and his speech well received.

Inter-Departmental Data Sharing/3Rs Group

4. The Group met for the third time on 19 November. The topics discussed included the options for the Government response to the House of Lords Select Committee recommendations regarding research into alternatives and the review of the guidance on the conduct of regulatory toxicology and safety evaluation studies. A further meeting is planned for January/February after which the Group expects to report back to Ministers.

Freedom of Information: Home Office publication scheme

5. The Home Office publication scheme has been approved by the Information Commissioner and became operational on 30 November. AP&CU/ASPI are committed to publishing "various guidance documents and other information relating to the use of animals in scientific procedures" through the Home Office website (and The Stationery Office, where appropriate).

6. The next phase of the Inspectorate expansion will take place in January with the appointment of 5 additional inspectors. Further appointments, to bring the staffing level to 33 professional staff are planned for April.

7. The AEBC published its report on 3 September. The Government response, which has been co-ordinated by DEFRA, is likely to be published later this month.

Request for information under the Code of Practice on Access to Government Information

8. The request for anonymised copies of licence applications received since the beginning of 2002 and for results of animal experiments passed to the Home Office over the same period remains under consideration.

9. We have responded to the separate request for disclosure of a specific project licence. The licence in question was granted before the assurance that all information provided by applicants would be treated in confidence was removed from the application form guidance notes in October 1998. On legal advice we therefore declined to disclose the licence, as to do so could amount to an actionable breach of confidence. This policy will apply to all licences and applications which pre-date the withdrawal of the assurance.

Appendix 1 to Council of Europe Convention ETS 123

10. It is unlikely that the preparatory work for a multilateral meeting to revise the current Council of Europe guidelines on care and accommodation of animals will be completed before the spring or summer of 2003.

Review of Directive 86/609/EEC

11. Formal proposals for the review are still awaited from the Commission. An own-initiative report prepared by Jillian Evans (rapporteur) was recently adopted by the Environment Committee.

12. The Chief Inspector has completed his report and it will shortly be submitted to the Minister. Subject to Ministerial approval, the report will be made public in the New Year. Copies will be provided for the Committee.

13. The Chief Inspector is looking into allegations recently sent to him by an animal protection organisation concerning a project at another licensed establishment. He expects to be able to report his findings to the Minister in the near future. The Committee will be informed of the outcome, and given details in the usual way if any infringements are discovered which have compromised animal welfare.

The four sub-committees and six working groups that are currently in existence as at December 2002 and their memberships are listed below. Where appropriate, the Inspectorate adviser (IA) is also shown.

Research and Alternatives sub-committee

Professor D Clark (chair)
Dr Jennings
Dr Festing
Mr Moore
IA Dr V Navaratnam

Dr Jennings (chair)
Dr Festing
Mr Gregory
IA Dr J Anderson

Primates sub-committee

Professor Dunbar (chair)
Professor Atterwill
Dr Hubrecht
Dr Jennings
Dr Langley
Professor McNeilly
IA Dr R Curtis

Accommodation and Care sub-committee

Dr Hubrecht (chair)
Professor Broom
Mr Gregory
Dr Jennings
Dr Morris

Cost/Benefit working group

Professor Banner (chair)
Professor D Clark
Professor Holland
Dr Jennings
Professor Martin

Professor McNeilly (chair)
Mr Gregory
IA Mr D Anderson

Professor Broom (chair)
Mr Gregory

Schedule 1 working group

Mr Gregory (chair)
Professor Broom
Dr Morris

One other co-opted member

IA Mr G Brouwer

"Applications" working group

Professor Banner (chair)
Dr Hubrecht
Dr Langley
Mr Moore
Professor Richardson

"Cambridge Primates - allegations by BUAV" working group

Professor Holland (chair)
Professor Atterwill
Dr Jennings

The course has been designed to provide information and some of the basic skills required by an individual who is to take on the role of Named Animal Care and Welfare Officer (NACWO). Completion of the course will enable participants to understand and begin to fulfil the responsibilities of the NACWO as detailed in the Guidance on the Operation of the Animals (Scientific Procedures) Act 1986. They will, however, need to supplement the information and learning derived during the course with experience from within their working environment, in addition to assistance and guidance gained by networking with others in similar positions in their own or other establishments.

Objectives of the Course

1. Develop an appreciation of the important role of the NACWO as an acknowledged expert in the care and welfare of laboratory animals.

2. Provide a forum for discussion of the ethical issues involved in the use of animals for biomedical research and describe how these are addressed within the framework of both UK and European legislation and by the UK Ethical Review Process.

3. Provide a clear understanding of the scope of the Animals (Scientific Procedures) Act 1986 and an appreciation of other legislation and guidelines appertaining to the care and use of laboratory animals.

4. Develop an understanding of the regulation, administration and spirit of the Act.

5. Develop an appreciation of the roles, responsibilities and interactions of those working within the Act, namely the HO Inspectorate, Named People, project and personal licence holders.

6. Develop an awareness of the Ethical Review Process and the role the NACWO is expected to play.

7. Provide a forum to discuss the concept of the Three Rs and to explore ways in which the NACWO is able to contribute towards their introduction.

8. Develop a process for assessing levels of pain or suffering in animals and create an awareness of the courses of action that may need to be taken.

9. Promote the exchange of ideas and experiences during the course but also later by networking with others in a similar position.

10. Develop an awareness of continuing developments within the field of laboratory animal science and the need to keep up to date with scientific advances.

11. Promote the concept of continuing professional development and life time learning.

Course Content

On completion of the course the trainee should be able to:

1. Demonstrate a sound knowledge of the legislation appertaining to the care and use of laboratory animals.

Animals (Scientific Procedures) Act 1986:

• Scope of the Act
• Regulation via Certificate of Designation, Project & Personal licences
• Roles, Responsibilities and interactions of those working under the Act - the Home Office Inspectorate, Animal Procedures Committee, named people, project and personal licensees
• Role and constitution of the Animal Procedures Committee
• Schedules to the Act and guidelines.

Other legislation impinging on laboratory animal work:

• Protection of Animals Act, 1911
• Protection of Animals (Anaesthetics) Act 1954, 1964
• Veterinary Surgeons Act, 1948, 1966
• Rabies Act 1974
• Balai Directive 92/65

2. Demonstrate an understanding of the ethical issues involved in the use of animals by society and have an appreciation of the wide range of views on animal use, in particular those used in biomedical research. Describe how these ethical issues are addressed within the framework of UK and European legislation and by the UK Ethical Review Process.

3. Be fully conversant with the NACWO role:

• legal and ethical responsibilities
• Codes of Practice
• interactions with others, to include potential confrontational situations
• promoting a culture of care
• infringements and how to deal with them

4. Demonstrate an understanding of the project licensing system to include:

• design of the licence
• the NACWO's contribution
• the mechanism for performing a cost benefit analysis

5. Demonstrate an understanding of the three Rs:

• their inception
• examples of reduction, refinement and replacement
• the role of the NACWO particularly in the fields of refinement and reduction

6. Describe the Ethical Review Process:

• the aims of the review
• membership and operation of the Ethical Review Group/Committee
• participating in the review, the likely role of the NACWO

7. Recognise and quantify pain, suffering and distress in animals:

• signs to look for
• scoring systems
• severity limits/bands, constraints upon adverse effects, humane endpoints
• actions to be taken

It is expected the course will take a minimum of twelve hours to deliver. Some of this time may be allocated to private study and take the form of published or specially prepared material to be read before attendance on the course. Prior learning eg attendance on Home Office modules 1 - 3 may also be taken into consideration. Assessment time, see later notes, is in addition to the twelve hours previously mentioned.

Whilst much of the course material may be delivered by overview lectures other methods may be incorporated including:

directed reading
discussions
case studies
syndicate exercises

Assessment Strategy

A tutor marked end of course assignment will be used to assess and reinforce the knowledge base. This will be expected to be of no less than forty-five minutes duration and consist of multi-choice and short answer questions. Delegates who achieve a 50% or higher mark will be issued with a Certificate of Successful Achievement.

Animal Procedures Committee

11 December 2002

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