§ Mr. Baker
To ask the Secretary of State for the Home Department (1) what criteria are used to classify a project 1 procedure under the Animals (Scientific Procedures) Act 1986 as being likely to be of substantial severity; and if he will make a statement; 
(2) how many procedure 1 projects under the Animals (Scientific Procedures) Act 1986, as a proportion of the total, were in the substantial severity category for each of the last 10 years. 
§ Mr. Mike O'Brien
The Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 sets out the criteria for determining severity levels. Two different types of severity levels are set on project licences; a severity limit for each protocol authorised in the licence and an overall severity banding for the project.
The severity limit for each protocol is determined by the upper limit of the expected adverse effects that may be encountered by a protected animal, taking into account the measures specified in the licence for avoiding and controlling these effects. It represents the worst potential outcome for any animal subjected to the protocol, even if it may only be, and often is, experienced by a small number of the animals to be used. Indeed, it may never be encountered.
Protocols of substantial severity may result in a major departure from the animal's usual state of health or well-being. These include: acute toxicity procedures where significant morbidity is an endpoint; some efficacy tests of anti-microbial agents and vaccines; major surgery; and some models of disease, where welfare may be seriously compromised. If it is expected that even one animal would suffer substantial effects, the procedure would merit a substantial severity limit. The Secretary of State will not license any procedure likely to cause severe pain or distress that cannot be alleviated. Licence holders are required by conditions in both project and personal licences to minimise any pain, suffering, distress or lasting harm and to approach the set severity limit only when absolutely necessary.
The assessment of the overall severity of a project reflects the cumulative effect of each procedure. This assessment is used to weigh the likely adverse effects on 254W all the animals to be used against the benefit likely to accrue. It takes into account not just the level of suffering that might be reached, but also such factors as the number of animals involved; the frequency of use of each procedure; the proportion of animals that are expected to be exposed to the upper severity limits; and the length of time that animals will experience such adverse effects.
The severity bandings of project licences were introduced into the Statistics of Scientific Procedures on Living Animals in 1998 at Appendix B. Figures before that date were not published in the annual statistics, but were generally included as part of the Annual Report of the Animal Procedures Committee.
Figures are as follows:
Number Project Licences issued during 1991 Substantial 11 Total 685 Project Licences issued during 1992 Substantial 33 Total 1,257 Project Licences issued during 1993 Substantial 21 Total 1,444 Project Licences in force on 31 December 1994 Substantial not readily available Total 4,013 Project Licences in force on 31 December 1995 Substantial 72 Total 3,977 Project Licences in force on 31 December 1996 Substantial 66 Total 3,869 Project Licences in force on 31 December 1997 Substantial 66 Total 3,765 Project Licences in force on 31 December 1998 Substantial 66 Total 3,650 Project Licences in force on 31 December 1999 Substantial 66 Total 3,481