Asked by: Virendra Sharma (Labour - Ealing, Southall)
Question to the Home Office:
To ask the Secretary of State for the Home Department, what assessment she has made of the effectiveness of the Animals in Science Regulation Unit; and what assessment she has made of the compatibility of her Department’s change programme with the UK's animal welfare responsibilities.
Answered by Damian Hinds - Minister of State (Education)
The Animals in Science Regulation Unit has undertaken a change programme to benchmark itself against leading regulatory practice. The aim of the programme has been to improve its effectiveness.
Under the Change Programme the Regulator has strengthened its regulatory oversight and published its process of full system audits at: www.gov.uk/guidance/animal-research-technical-advice#process-and-standards-for-establishment-full-system-audits.
At audits the Regulator requires evidence for assessment of compliance against all legal licence conditions, including those for animal welfare, which is available at: www.gov.uk/guidance/animal-research-technical-advice#process-and-standards-for-establishment-full-system-audits.
Asked by: Jonathan Edwards (Independent - Carmarthen East and Dinefwr)
Question to the Home Office:
To ask the Secretary of State for the Home Department, what recent discussions she has had with representatives of animal rights charities on the potential impact on animal welfare of the proposed changes set out in the Animals in Science Regulation Unit’s Change Programme.
Answered by Tom Pursglove - Minister of State (Minister for Legal Migration and Delivery)
The Animals in Science Regulation Unit public engagement framework ensures balanced representation and input. The regulator has engaged in stakeholder meetings with animal rights charities, among others, on four occasions since October 2021. Each of the four meetings were held to specifically describe and discuss the regulator’s change programme.
Asked by: Kate Osamor (Labour (Co-op) - Edmonton)
Question to the Home Office:
To ask the Secretary of State for the Home Department, what steps her Department has taken to ensure that the Animals in Science Regulation Unit provides appropriate regulatory oversight in the context of fewer in-person inspections to view animals and meet with staff.
Answered by Tom Pursglove - Minister of State (Minister for Legal Migration and Delivery)
In July 2021 the regulator initiated a new operating model that delivers a structured and integrated framework aligned with leading regulatory practice. In October of last year the regulator commenced a new system of audits that form part of an integrated system to assess compliance across the regulated community. The audit process and the evidence for assessment of compliance against the Animals (Scientific Procedures) Act 1986, and associated licence conditions, are available here: www.gov.uk/guidance/animal-research-technical-advice#process-and-standards-for-establishment-full-system-audits.
Asked by: Catherine West (Labour - Hornsey and Wood Green)
Question to the Home Office:
To ask the Secretary of State for the Home Department, what recent assessment she has made of the impact of the Change Programme on the welfare of animals, including the reduction of in-person inspections on animals and staff.
Answered by Tom Pursglove - Minister of State (Minister for Legal Migration and Delivery)
Each establishment licence holder has the responsibility at all times for the welfare of the animals within their establishment. Establishment licence holders are required to have governance systems in place to ensure all personal and project licence holders comply with the requirements of the Animals (Scientific Procedures) Act 1986 (ASPA) and to maintain compliance with the conditions on their own establishment licence. These requirements are defined in the Standard Conditions of licences.
In July 2021 the regulator initiated a new operating model that delivers a structured and integrated framework aligned with leading regulatory practice. In October of this year the regulator commenced a new system of full system audits that form part of an integrated system to assess compliance across the regulated community. The audit process and the evidence for assessment of compliance against the Animals (Scientific Procedures) Act 1986, and associated licence conditions, are available at: www.gov.uk/guidance/animal-research-technical-advice#process-and-standards-for-establishment-full-system-audits.
Asked by: Henry Smith (Conservative - Crawley)
Question to the Home Office:
To ask the Secretary of State for the Home Department, how many inspectors were in post in the Animals in Science Regulation Unit as at 25 February 2022; and how that figure compares to the inspectors in post in (a) 2019, (b) 2020 and (c) 2021.
Answered by Kit Malthouse
The number of inspectors in post within the Animals in Science Regulation Unit is as follows. On 25 February 2022 the number of Inspectors in post was 19 individuals. At the end of 2019, 2020 and 2021, the number of Inspectors in post was 24, 25 and 20 individuals, respectively.
Asked by: Caroline Lucas (Green Party - Brighton, Pavilion)
Question to the Home Office:
To ask the Secretary of State for the Home Department, how many establishments licensed under the Animals (Scientific Procedures) Act 1986 are planned to receive full audits carried out in person by Inspectors from the Animals in Science Regulation Unit during 2022.
Answered by Kit Malthouse
For the first quarter of 2022, five full systems audits will have been completed.
Further audits will be undertaken in 2022 and will be undertaken announced or unannounced, on-site or remotely, depending on their purpose. The schedule for future quarters has not been finalised.
Asked by: Kenny MacAskill (Alba Party - East Lothian)
Question to the Home Office:
To ask the Secretary of State for the Home Department, with reference to the 2020 statistics on scientific procedures on living animals, what the purpose was of the (a) 46,918 uses of sheep, ( b) 10,396 uses of horses under routine production (blood-based products) and (c) 96,737 uses of domestic fowl under routine production (other products); and what assessment she has made of the availability of opportunities to replace these with non-animal based products.
Answered by Rachel Maclean
The Home Office publishes data on the use of animals in scientific procedures annually at: https://www.gov.uk/government/collections/statistics-of-scientific-procedures-on-living-animals.
The data collected from establishments for the production of the Annual Statistics of Scientific Procedures on Living Animals in Great Britain does not include information which would allow a further breakdown on the purposes of the use of sheep, horses, and domestic fowl in 2020 beyond that which is provided.
The Home Office Animals in Science Regulation Unit will only authorise applications where there is robust, legitimate scientific justification for the use of animals through the harm benefit analysis (HBA) process required under the Animals (Scientific Procedures) Act 1986.
The UK’s rigorous regulatory system requires that no testing takes place if there is a validated non-animal alternative that would achieve the scientific outcomes sought. Licence proposals for research on animals for which there is no non-animal alternative must comply fully with the principles of the 3Rs: replacement, reduction and refinement.
Asked by: Kenny MacAskill (Alba Party - East Lothian)
Question to the Home Office:
To ask the Secretary of State for the Home Department, what her policy is on approving licences for the use of live animals for the routine production of antibodies; and how many animals were used for this purpose in 2020.
Answered by Tom Pursglove - Minister of State (Minister for Legal Migration and Delivery)
The data from establishments used for the production of the Annual Statistics of Scientific Procedures on Living Animals in Great Britain does not include information on how many animals were used for the purpose for the routine production of antibodies in 2020.
The Home Office Animals in Science Regulation Unit will only authorise applications that include animals used for the production of monoclonal and/or polyclonal antibodies where there is robust, legitimate scientific justification through the harm benefit analysis (HBA) process required under the Animals (Scientific Procedures) Act 1986.
From a regulatory perspective the position for the use of animals for antibody production is subject to the same standards as for any other application to use animals in science as follows:
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Asked by: Beth Winter (Labour - Cynon Valley)
Question to the Home Office:
To ask the Secretary of State for the Home Department, whether the harm-benefit analysis process for retrospective assessments of PPLs required by the Animal (Scientific Procedures) Act 1986 record deaths of animals; and whether that data is routinely published.
Answered by Kit Malthouse
All project licence (PPLs) applications are subject to the harm–benefit analysis (HBA) process required under the Animals (Scientific Procedures) Act 1986. This process is undertaken by the Home Office Animals in Science Regulation Unit to ensure that any harm that may be caused to the animals is justified by the expected benefits for humans, animals or the environment and evaluates whether a project licence application can be legally authorised.
The retrospective assessment process which applies to a subsection of project licences does not include a harm-benefit analysis.
A project licence retrospective assessment does not routinely record the deaths of animals.
Asked by: Ruth Jones (Labour - Newport West)
Question to the Home Office:
To ask the Secretary of State for the Home Department, when the Animals in Science Regulation Unit annual reports for 2019 and 2020 will be published.
Answered by Kit Malthouse
The Home Office will publish the Animals in Science Regulation Unit annual reports for 2019 and 2020 in due course.