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.
Asked by: Ruth Jones (Labour - Newport West)
Question to the Home Office:
To ask the Secretary of State for the Home Department, how many and what proportion of non-compliance cases reported in each of the last five years under the Animal Scientific Procedures Act 1986 were for the failure to provide food and/or water; and if she will make a statement.
Answered by Kit Malthouse
The Home Office Regulator’s annual reports from 2016 to 2018 are available at: www.gov.uk/government/collections/animals-in-science-regulation-unit-annual-reports.
From these reports, the Home Office can confirm that in 2016, eight cases (18% of total non-compliance cases) were related to the failure to provide appropriate care (including food, water and suitable facilities).
In 2017, eight cases (20% of total non-compliance cases) were related to the failure to provide appropriate care (including food, water and suitable facilities).
In 2018, eight cases (29% of total non-compliance cases) were related to the failure to provide appropriate care (including food, water and suitable facilities).
The data for 2019 and 2020 will soon be published in the Home Office Regulator’s annual report.
Failing to provide sufficient food and/or water to animals, as part of basic husbandry and care, is unacceptable. Establishments must have robust procedures in place to ensure the adequate provision of food and water at all times to animals kept under the protection of ASPA.
The Home Office take any allegations regarding potential non-compliance with ASPA, the Code of Practice or individual licence conditions very seriously. The published Compliance Policy, found here: (https://www.gov.uk/guidance/animal-testing-and-research-compliance-with-aspa) explains how the Regulator identifies and investigates potential incidents of non-compliance and decides on appropriate and proportionate measures and remedies aimed to minimise the risk of recurrence.
Asked by: Kerry McCarthy (Labour - Bristol East)
Question to the Home Office:
To ask the Secretary of State for the Home Department, what recent discussions she has had with the Animals in Science Regulation Unit and other stakeholders on granting licences for the use of the forced swim test for screening of antidepressant drugs or as a model of human depression in response to the recommendations of the Medicines and Healthcare Products Regulatory Agency and the National Centre for the Replacement, Refinement & Reduction of Animals in Research, published 29 July 2021.
Answered by Damian Hinds - Minister of State (Education)
The Animals in Science Regulation Unit were involved in contributing to and reviewing the paper cited and it thus aligns to the regulatory approach taken by the Unit.
The Home Office through the Animals in Science Regulation Unit assures that, in every research proposal animals are replaced with non-animal alternatives wherever possible; the number of animals are reduced to the minimum necessary to achieve the result sought; and that, for those animals which must be used, procedures are refined as much as possible to minimise their suffering.
Asked by: Henry Smith (Conservative - Crawley)
Question to the Home Office:
To ask the Secretary of State for the Home Department, with respect to Section 18, 2(b) of the Animals (Scientific Procedures) Act 1986, how many and what proportion of inspection visits carried out by officials of her Department to establishments designated as breeding, supplying or using animals during (a) 2017, (b) 2018 and (c) 2019 were without notice; and whether she has plans to increase those type of inspection visits.
Answered by Victoria Atkins - Secretary of State for Health and Social Care
Inspections are conducted by the Home Office in accordance with the requirements of ASPA and according to risk. In 2017, 59% of inspection visits were unannounced, 2018 63% and 2019 36%. Full details are published in the Regulator’s annual reports available at: Animals in Science Regulation Unit annual reports - GOV.UK (www.gov.uk).
The Home Office inspects establishments at a frequency that is compliant with the requirements of the Animals (Scientific Procedures) Act (1986). Both announced and unannounced inspections are undertaken, depending on the regulatory outcomes required. No plans have been made to change the frequency of unannounced visits.
Asked by: Alex Sobel (Labour (Co-op) - Leeds North West)
Question to the Home Office:
To ask the Secretary of State for the Home Department, for what reasons the number of inspections of animal testing establishments carried out between 2011 and 2018 decreased.
Answered by Victoria Atkins - Secretary of State for Health and Social Care
The number of Inspections of licensed animal testing establishments between 2011 and 2018 would be expected to vary dependent on the baseline number of inspections, risk profiling and thematic inspections. Inspections are conducted by the Home Office according to risk-based criteria and as required by the legislation. Full details are given in the 2018 Regulators annual report available at: Animals in Science Regulation Unit Annual Report 2018 (publishing.service.gov.uk).
The Home Office inspects all establishments at a frequency that is fully compliant with the requirements of the Animals (Scientific Procedures) Act (1986).
Asked by: Lisa Cameron (Conservative - East Kilbride, Strathaven and Lesmahagow)
Question to the Home Office:
To ask the Secretary of State for the Home Department, whether the Animals in Science Regulation Unit has recommenced on-site inspections of animal testing facilities following their suspension in 2020; for how long inspections were carried out by telephone or email; and whether the Government plans to carry out additional on-site inspections.
Answered by Victoria Atkins - Secretary of State for Health and Social Care
The Animals in Science Regulation Unit (ASRU) assesses the compliance of the regulated community in a variety of ways, including on site and remote inspections, investigation of potential non-compliance cases and reviewing of reports. Throughout the pandemic ASRU have conducted on site visits for the investigation of significant cases of potential non-compliances or as needed. ASRU also implemented a system of remote inspections. ASRU resumed routine on-site inspection of animal testing facilities on 7 September 2020.
During 2020, 712 remote inspections were conducted and 78 on-site inspections where there were animal welfare concerns or cases of non-compliance that could not be investigated remotely. ASRU will continue to undertake remote and on-site inspection activity as required as part of its overall programme of assessing the compliance of the regulated community.