HC Deb 23 November 1999 vol 339 cc76-7W
Mr. Baker

To ask the Secretary of State for the Home Department (1) in the applications leading to existing OECD guideline 401 licences issued(a) before 5 September 1998 and (b) since that date approximately how many animals it was envisaged would be used; [99140]

(2) what steps he is taking to encourage other EU states to adopt the UK position on LD50 tests; [99131]

(3) by what date he proposes to review Guideline 401 licences; and what the outcome was of reviews already carried out; [99143]

(4) against what criteria he proposes to review existing OECD guideline 401 licences issued before 5 September 1998; [99142]

(5) what legal advice he has received in respect of OECD guideline 401 licences granted (a) before and (b) since 5 September 1998; [99144]

(6) of the existing OECD guideline 401 licences issued before 5 September 1998, how many, taking into account any renewal already granted, are due to expire in (a) 2000, (b) 2001, (c) 2002 and (d) 2003; [99141]

(7) how many existing project licences authorising the use of the LD50 test, as defined in OECD guideline 401, were issued (a) before 5 September 1998 and (b) since that date; [99139]

(8) how many animals were used in LD50 tests as set out in OECD guideline 401 in the UK in (a) 1996, (b) 1997 and (c) 1998, listed by species. [99132]

Mr. Mike O'Brien

We have accepted that Section 5 (5) of the Animals (Scientific Procedures) Act 1986, as amended in September 1998, does not allow licensing of the Lethal Dose 50 (LD50) test for the purpose of meeting international regulatory requirements. The general principle is that a test will be licensed only where there is not a scientifically valid and reasonably practicable and accepted alternative.

One licence, issued since September 1998, has been varied. This was the point at which changes on the face of the Animals (Scientific Procedures) Act 1986 became effective. Authorities to use the LD50 test on a project due to expire in 2004 have been withdrawn, but alternative tests (Organisation for Economic Co-operation and Development (OECD) Guidelines 420, 423 or 425) are likely to be used instead. A total of 467 rats have been used under this licence and an earlier one for the same purpose, which it succeeded.

We have undertaken to review relevant licences issued before September 1998. All project licences authorising acute toxicity testing using protocols based upon OECD Guideline 401 will be reviewed and amended to prohibit the use of the protocols where suitable alternative methods are available. Amendments will be subject to the standard processes of representation. We accept there may be cases where no exact alternative is available and Guideline 401 (the LD50 test) can be lawfully licensed.

The review should be completed by mid-December 1999 on approximately 50 existing licences, issued before 5 September 1998. It has not, at this stage, been possible to make an assessment of the expiry dates of those licences or the number of animals affected.

Information relating to the numbers of animals used in LD50 tests each year is not available. Changes to data collection introduced in January 1999—for reporting in 2000—will separately identify different forms of acute toxicity tests.

We are pressing the European Commission to follow our lead in interpreting Article 7 of European Directive 86/609/European Economic Community. The Commission has formally urged the OECD to withdraw Guideline 401 on the basis that alternative acute toxicity tests have been accepted for most situations.

Mr. Baker

To ask the Secretary of State for the Home Department if he will make it his policy to repeal section 24 of the Animals (Scientific Procedures) Act 1986. [99122]

Mr. Mike O'Brien

Under the proposals for the Freedom of Information Bill, we will review all statutory bars on the disclosure of information, including section 24 of the Animals (Scientific Procedures) Act 1986. No decision has yet been taken on whether to repeal or amend section 24.