On October 26^th 2022, the Animals in Science Regulation Unit released its annual report for 2019-2021. The Animals in Science Regulation Unit is part of the Home Office and is responsible for enforcing the Animals (Scientific Procedures) Act 1986 in Great Britain. The annual report outlines the work carried out by the Animals in Science Regulation Unit, and below we highlight the key points and main concerns from the report.

Summary

• Replacement must be prioritised in the implementation and regulation of the Animals (Scientific Procedures) Act (1986)
• Inspector visits need to return to in person where possible
• The number of cases of non-compliance and avoidable suffering is unacceptable. More needs to be done urgently to prevent future incidents

Key points from the report

The 3Rs

Section 6 of the annual report outlines ‘promoting the principles of replacement, reduction and refinement of animals in research’, and the work that is conducted in collaboration with the National Centre for the 3Rs.

In 2019, themed inspection activities were carried out on 3Rs areas, including avoiding the reuse of hypodermic needles, and using more refined mouse handling procedures. Both of these areas focus on refinement and improving animal welfare and data collection in scientific studies. In 2019 are the only areas mentioned relating to collaborative projects between the Animals in Science Regulation Unit and the National Centre for the 3Rs, with no further information on 2020 or 2021, or on specific work towards reduction or replacement.

Whilst refinement is vital in animal research to minimise pain, suffering and distress in the animals used, it should not be the only focus of the Home Office based, Animals in Science Regulation Unit when enforcing the 3Rs legislative requirements. It is already a legal requirement to look for Replacements under the Animals (Scientific Procedures) Act (1986) when submitting a license application. Replacement is the top priority, and this should be reflected and highlighted in all strands of work and reporting across NC3Rs and the Animals in Science Regulation Unit.

Inspector visits

In 2019, 470 inspections took place. 2020 and 2021 were affected by the COVID-19 pandemic national lockdowns, meaning inspections began taking place remotely. In 2020, 712 inspections were remote and 78 were in person. In 2021, 170 inspections were remote and 41 were onsite. The on-site inspections took place to evaluate serious cases of non-compliance or serious animal welfare concerns.

In 2021 the Animals in Science Regulation Unit launched the ‘Bridging Ways of Working’ model, which introduced on-site auditing processes alongside inspections. These involve teams of the Animals in Science Regulation Unit officials assessing selected establishments in depth. These were selected based on their previous non-compliance data. This is a great step in ensuring establishments that have had high numbers of non-compliance cases in the past are checked more thoroughly, but there is still a concern that not every establishment that conducts research is being checked as thoroughly as it could be.

It is understandable that during 2020 and the start of 2021 remote inspections were the only option due to national lockdowns. However, moving forward, in-person inspections must be prioritised again and used as standard rather than being conducted only when a serious non-compliance or animal welfare concern has arisen.

Non-compliance and avoidable suffering

Non-compliance is where there has been either a breach of the legislation (Animals in (Scientific Procedures) Act (1986)), or a breach of the specific conditions applied to a license. The report covers cases of non-compliance in different categories including:

• Failure to comply with project license conditions
• Failure to provide food and/or water
• Failure to provide adequate care
• Regulated procedures being carried out by correct license or authorisation to do so

The annual report covers 2019, 2020 and 2021, the below section outlines non-compliance cases from each year in turn.

In 2019, there were 115 cases of non-compliance across 44 establishments. 52 cases were related to failure to adhere to license authorities whilst the remaining 63 related to failure to provide appropriate care. Of the 115 cases, 105 involved a total of 21,242 animals including fish, mice, rabbits, rats, unhatched birds, dogs, and non-human primates. 92% of these animals were involved in cases of overbreeding for genetic altering purposes. In the remaining 10 of the 115 cases, the total number of animals involved were not reported. 1160 animals experienced adverse welfare outcomes due to non-compliance. 50 out of 115 (43%) non-compliance cases were due to a failure to provide sufficient food and/or water.

Some of the most significant cases of non-compliance that resulted in adverse welfare outcomes in 2019 included:

• 500 zebrafish larvae being allowed to develop further than the conditions of the establishment were prepared for
• 120 fish killed due to failure to close a tank value after flushing
• 112 rats crushed when boxes containing them were moved to a compactor
• Rodents being trapped in food hoppers or lids, on two separate occasions

In 2020, there were 92 cases of non-compliance however the number of establishments was not disclosed. 51 cases were related to failure to adhere to license authorities whilst the remaining 41 related to failure to provide appropriate care. Of the 92 cases, 73 involved a total of 2692 animals including fish, mice, rats, non-human primates, birds, cattle, and rabbits. In the remaining 19 cases, the total number of animals involved were not reported. 1068 animals experienced adverse welfare outcomes due to non-compliance. 23 out of 92 (25%) non-compliance cases were due to a failure to provide sufficient food and/or water.

Some of the most significant cases of non-compliance that resulted in adverse welfare outcomes in 2020 included:

• A non-human primate being killed after being trapped behind a restraint device and not being noticed as missing from their main enclosure
• Animals being injured when head restraints were applied too forcefully while taking blood, on two separate occasions
• 16 animals being killed after an isolator fan and alarm were accidently switched off
• 4 separate occasions in which the authorised method or the most humane killing methods were not used

In 2021, there were 122 cases of non-compliance however the number of establishments was not disclosed. 68 cases were related to failure to adhere to license authorities whilst the remaining 54 related to failure to provide appropriate care. Of the 122 cases, 114 involved a total of 4519 animals including fish, mice, rats, non-human primates, dogs, sheep, horses, guinea pigs and cattle. In the remaining 8 cases, the total number of animals involved were not reported. 2328 animals experienced adverse welfare outcomes due to non-compliance. This is particularly high in comparison to the previous two years due to 2 cases of draining fish tanks leading to the death of 740 fish in total, and an incident involving a chlorine tablet being added to the wrong tank during cleaning, leading to the death of 1300 fish. 14 out of 122 (11%) non-compliance cases were due to a failure to provide sufficient food and/or water.

Some of the most significant cases of non-compliance that resulted in adverse welfare outcomes in 2020 included:

• 2040 fish being killed across 3 separate occasions in which water was drained from tanks or a toxic substance was added to a tank
• Rats being provided with inadequate analgesia after surgery, on two separate occasions
• The most refined method of conducted a regulated procedure was not used, on two separate occasions
• Animals exceeding the weight loss of their humane endpoints, on two separate occasions

Improvements to be made

Significant improvement in how the Animals in Science Regulation Unit enforces and administers the Animals (Scientific Procedures) Act (1986) is vital to uphold the protective provisions given to laboratory animals. The amount of unnecessary and avoidable suffering that took place between 2019 and 2021 is completely unacceptable and must be prevented. None of these animals should have experienced any avoidable suffering, particularly considering that their basic needs are covered by law in the Animals (Scientific Procedures) Act (1986). Many of the cases listed in the annual report were avoidable, seemingly small mistakes at the time, that led to animals being injured or killed on multiple occasions. Whilst many of the examples above may have resulted from human error, we are particularly concerned about non-compliance related to systemic failings within establishments which result for example, in humane end points not being adhered to, animals being left without food or water, or suffering caused as a result of personal or project license conditions being breached. These areas must be reviewed regularly as a priority and addressed within establishments and within the regulatory system itself.

Establishment policies and training for license holders and other staff involved with the animals must robustly prioritise the 3Rs to help prevent mistakes that cause suffering. Safeguarding measures must be put in place to ensure the animals are monitored appropriately and their needs are met. Increasing the number of in-person inspections, as opposed to remote inspections, particularly now national lockdowns are no longer an issue, would aid in establishments being checked more thoroughly, and would allow inspectors to find and resolve issues more efficiently. In 2019 50 cases of non-compliance related to a failure to provide adequate water/food. After the Animals in Science Regulation Unit addressed this through education for establishments, this dropped to 23 cases in 2020, and 14 cases in 2021. Whilst the COVID pandemic, and the corresponding drop in scientific research may affect these figures, it reflects the importance of direct contact with inspectors for establishments to obtain advice, and the need for more in-person inspections to support this.

In future, the Animals in Science Regulation Unit must ensure they continue to publish their annual report annually. The information in this report concerning 2019 should have been released in 2020 making this release over two years late, and the 2020 information over a year late. This is especially concerning considering the high number of non-compliance cases that occurred during these years. We cannot effectively provide advice or act upon matters that happened 3 years ago.

Finally, the government must start prioritising replacement as the first of the 3Rs, as it is enshrined in the letter, and the spirit, of the law. Refinement is important in terms of improving the welfare of the animals currently used in research, but it should not be the primary focus of the Animals in Science Regulation Unit or the National Centre for the 3Rs and should not be the only one of the 3Rs discussed in this report, especially when replacement and reduction are legally required under the Animals (Scientific Procedures) Act (1986). There is an opportunity here to include some form of reporting on license considerations of alternative approaches and how they are being assessed, reviewed and reported, alongside specific replacement or reduction initiatives that have been addressed in collaboration with the National Centre for the 3Rs. The government has a huge opportunity for the UK to become a world leader in scientific research by focussing on replacement and redirecting funding into the development and promotion of non-animal methods. This must be the priority.

To find out more

You can read the Animals in Science Regulation Unit annual report for 2019 to 2021 here.

Animal-Free Research UK responds to the Animals in Science Regulation Unit Report

Cruelty Free International “Sharp rise in cases of non-compliance with laws protecting animals in UK laboratories”

The Independent, Sunday 30th October, 2022 “Primate died after becoming trapped in UK animal testing laboratory, dossier of blunders reveals”