Animal Aid

Animal Aid's Suggested Response to Vivisection Consultation

Posted 15 August 2011

Question 1: Is there scientific evidence that suggests that the UK should continue to protect mammals from half way through gestation using Article 2 to the Directive?

Suggested answer: Yes

The UK currently protects foetal mammals from halfway through their gestation period, this compares to Directive 201063/EU, which protects these same animals for the last third of their gestation. It is acknowledged that all animals develop at different rates. To treat all mammals the same, and to err on the side of less protection is to underestimate the differences between species. The different degrees of sentience and cognition for the multitude of different species means that it is difficult to protect all animals with one time point. For this reason, and also to give animals the benefit of the doubt in the absence of clear scientific evidence to the contrary – as well as to uphold the stricter measures in the UK's Animals (Scientific Procedures) Act 1986 (ASPA) – the UK should continue to protect foetal mammals from halfway through their gestation period.

Question 2: Is there scientific evidence to support the continued protection of foetal forms of birds and egg laying reptiles using Article 2 to the Directive?

Suggested answer: Yes

Chicks are fully formed and can be heard cheeping in the egg up to three days before hatching. Reducing the scope of protection for chicks in the egg could lead to avoidable suffering. UK legislation should ensure that the use of birds and reptiles is regulated from halfway through their incubation period.

Question 5: Should the UK retain its current special protection for dogs, cats and equids?

Suggested answer: Yes

The current UK Animals (Scientific Procedures) Act 1986 (ASPA) goes beyond the European Directive on the scope of protection for certain animals such as birds, foetal forms of mammals or reptiles from halfway through the gestation or incubation period (section 1.2), vertebrates of endangered species (section 10.3), dogs and cats and equines (section 5.6) and feral and stray animals (section 10.3). The Home Office also publishes detailed annual statistics of animal use under the ASPA, which contributes to public access to information about animal experiments. The EU Directive (Article 2) allows EU Member States to go beyond the provisions of the Directive, therefore the UK must maintain these higher standards. The special protection which is afforded to these animals, alongside primates, is a reflection of the public concern about their use. There must be special clearance to use these animals. To revoke the special protection which is extended to these animals is a retrograde step and should be resisted.

Question 6: Should we retain our current requirements exempting only those methods of marking (used for scientific purposes) which cause no more than momentary pain or distress, and no lasting harm?

Suggested answer: Yes.

Exempting practices undertaken for the primary purpose of identification, with no reference to pain, suffering, distress or lasting harm could allow methods of marking to be used without regulation when they cause more than transient pain, suffering and lasting harm.

Question 7: Should the UK retain its current restrictions on the use of endangered species using Article 2? What implications would adoption of the provisions of Article 7 of the Directive have for the use of endangered species in the UK?

Suggested answer: Yes.

The Directive would permit endangered species to be used for a wide range of non-essential purposes, including toxicology testing of common and innocuous household products. The stricter requirements of ASPA should be retained.

Question 8: Are there any further issues to consider when transposing these provisions relating to the use of non-human primates?

Suggested answer: Yes

The probability that Article 8 of the Directive will affect research, which is currently being conducted using non-human primates, depends very heavily upon the exact definition of 'debilitating condition'. If this definition is taken in its strictest sense, then the number of primates and the research that can be conducted with them, will be minimised, which is in the spirit of the Directive. If almost any condition can be considered to be 'debilitating', then the number of permissible procedures and protocols will increase. For this reason, it is imperative that a comprehensive, exclusive list of conditions and diseases considered to be debilitating is drafted and then strictly adhered to, without the use of any safeguard clauses.

The use of non-endangered non-human primates in basic research should not be allowed. Although restrictions notionally apply to the use of primates in applied research there are no restrictions at all to the use of most species of primates in basic research. This is entirely disproportionate, given that basic research does not aim at finding cures, and there is a strong risk that tests prohibited under paragraph 1 of the Directive might be allowed under the basic research category. The Government should close this loophole and ensure that primate research unrelated to 'areas essential for the benefit of human beings' (Recital 17) is not permitted.

Question 10: Do you agree that the UK should continue to operate a policy ban on the use of great apes? Are there any further issues we should consider relating to the use of great apes?

Suggested answer: Yes.

The UK should reaffirm its commitment not to license great ape use and transposition of the Directive should take account of the concern for primates expressed in its recitals. The Article 55 safeguard clause should not be transposed into UK law.

Question 11: Are there any issues we should consider relating to the prohibition on the use of animals taken from the wild? What impact will the more limited derogation provided in Article 9 have on the conduct of research in the UK?

Suggested answer: The UK should never allow any exemptions to a ban on the use of animals taken from the wild.

Question 12: What criteria should be applied to ensure the competence of persons capturing animals in the wild?

Suggested answer: This question is irrelevant. The capturing of wild animals for experimentation should cease forthwith.

Question 13: Is there a case for retaining the current UK requirement that quail and ferrets should be purpose bred?

Suggested answer: Yes

The ASPA (schedule 2) lists the animals who must be obtained from designated breeding or supplying establishments. This means that the animals are bred under codes of practice and government guidance and that the establishments where they are bred can be inspected by the UK's Animals Scientific Procedures Inspectorate (ASPI). Whilst this system is far from perfect, buying animals only from designated establishments does confer a degree of protection on these animals, and allows the public to check that inspections are being carried out. Article 2 of the Directive allows Member States to maintain higher standards, and this is an instance where this should happen.

Question (not numbered, between 13 and 14): What impact will this have on UK breeders, suppliers and users? Will opening up the ability to supply animals have any animal welfare impact?

Suggested answer: Opening up the ability to supply laboratory animals to any breeder across Europe could have a seriously detrimental impact on animal welfare, in an area already recognised to cause immense suffering.

For example, the UK Home Office currently appraises overseas non-human primate breeding centres, and animals can only be obtained from those deemed acceptable. Laboratories would not longer be compelled to use these approved centres if other suppliers across Europe are also importing primates.

Question 14: What impact will these requirements have on UK breeders, suppliers and users? What impact, if any, is there likely to be on animal welfare?

Suggested answer: The use of F1 primates should end within five years after the date of entry into force of the Directive.

A feasibility study has already been completed by the independent consultancy Prognos, on behalf of the European Commission, which concluded in its preliminary assessment that 'a transitional period of five years should allow most breeding facilities to raise their production and provide enough F2 animals to users' and that 'additional costs should not be significantly high'.

Question 15: Is there a case on animal welfare grounds for retaining the current UK prohibition on the use of stray and feral animals, as permitted by Article 2?

Suggested answer: Yes.

Experience from the US shows that any relaxation of protection for stray and feral animals could lead to companion animals being stolen and sold to research establishments.

Question 19: We propose to transpose these provisions relating to the use of anaesthesia as they stand. Are there any further issues we should consider relating to the use of anaesthesia?

Suggested answer: A list of procedures should be drawn up, in association with all key stakeholders including animal welfare groups, of the procedures judged to be incompatible with either local or general anaesthesia.

It is not currently clear from the statistics published by the Home Office how many animals receive local or general anaesthesia. This may mask the fact that animals are undergoing procedures under local anaesthesia that are more appropriately performed under general. This would represent avoidable suffering and should be legislated against.

Question 20: Should UK restrictions on neuromuscular blocking agents in mammals be retained?

Suggested answer: Yes

The ASPA does not allow the use of neuromuscular blocking agents (NMBAs) without an anaesthetic (ASPA section 17), whereas the Directive would allow their use with analgesics. This would be to the serious detriment of animal welfare given that NAVS research clearly shows that their use will induce fear and distress. NMBAs stop the ability to move, but do not affect consciousness – a terrifying prospect for animals who have been given an NMBA without anaesthesia, as it would not prevent them feeling pain, but they would be in a helpless state of paralysis.

Question 21: Are there any further issues relating to re-use we should consider?

Suggested answer: None. Animals should not be re-used.

Historically, the re-use of laboratory animals has been responsible for considerable suffering. For example an animal may be allowed to recover from anaesthetic following a procedure in order that he or she can be used again, when otherwise he or she would have been euthanased while still unconscious. There are also scientific concerns about the impacts of multiple procedures. It is acknowledged that the animal's welfare has an impact on the outcome of the experiment, and re-use adds an additional factor. It is misleading to assume that re-use reduces the amount of suffering because fewer animals may be involved, since a single animal simply endures twice as much suffering. The current provision of the Directive would allow animals, in exceptional circumstances, to be re-used after a severe procedure has taken place and does not explicitly require prior authorisation for re-use. The UK should maintain its stricter standards and not take up the same position as the Directive.

Question 22: Should we retain current stricter UK requirements relating to the welfare of animals at the end of a regulated procedure?

Suggested answer: Yes.

Question 24: Do you agree with our analysis of Article 6 and Annex IV? Should the UK retain some methods listed in ASPA Schedule 1 using Article 2? Which methods should be retained?

Suggested answer: Annex IV must not go into UK legislation as it is. The existing UK Schedule of methods of humane killing, updated and suitably amended, should be used instead.

Annex IV includes techniques that would concern the public and cause avoidable suffering. For example, very young puppies and kittens could be killed by a blow to the head, and an adult bird the size of a sparrow could be decapitated.

Question 28: Are there any further issues relating to avoidance of duplication of procedures?

Suggested answer: Create a UK database of experiments being conducted to share information and make it a legal requirement to consult it.

Laboratories must be held accountable, and sharing of data is part of this. Data sharing and detailed and regular statistical reporting are essential to avoid duplication of experiments and to assess progress made in the promotion of alternatives. According to the data of the European Commission, 'approximately 160,000 animals are subject to duplication in regulatory testing each year'. These could be avoided by creating a UK database collecting information on animal experiments and sharing data, as with the European chemicals regulations. Compulsory data sharing is vital for the reduction of animal testing. This will also contribute to transparency of animal testing and accountability of licence holders.

Question 29: Are there any issues we should consider in relation to the provision for alternatives approaches set out in Article 47?

Suggested answer: More emphasis is needed on replacement techniques. These are advanced scientific methods to replace animal use. Establish a UK co-ordinating body for the development and validation of non-animal methods and ensure their implementation. This needs to be wider than the scope of the present National Centre for the 3Rs, and needs to include participation of specialist organisations.

Advanced scientific techniques that replace animals are at the forefront of scientific developments, but these are not being implemented quickly enough. There is a lack of coordination especially on replacements. The National Centre for the 3Rs (Reduction, Refinement, Replacement) is still focussed on animal research techniques, rather than advanced replacements.

Question 31: Are there any additional examples of severity that might be included in guidance?

Suggested answer: Yes. A 'severe and prolonged' category – which has a list of procedures that are prohibited - must be created. This must be compiled and adhered to without safeguard clauses.

To function effectively and meet its objectives, severity classification needs to have clarity, consistency, and be easily understood by researchers and those processing and authorising applications. The system needs to clearly link common procedures and practices to categories of pain and suffering which are readily understood by the public. Grouping procedures, which cause both severe and prolonged suffering within a single 'severe' category, should be eliminated. Such ambiguities mislead the public, are detrimental to standards of accountability and represent poor scientific planning. An upper limit of pain and suffering must be set for scientific and ethical reasons. In modern scientific procedures, animals should not suffer severe and prolonged pain, neither should death be an acceptable end-point. Without this category to report non-authorised prolonged suffering, the 'severe' category has the potential to be open-ended and the suffering animals endure without limits. This would be reprehensible.

Question 39: We propose to transpose the provisions of Article 33 as they stand. Are there any further issues we should consider relating to the issues covered by Article 33?

Suggested answer: Article 33(3) would allow exemptions from utterly basic care and accommodation standards, such as the provision of food and water, or prompt elimination of avoidable suffering, for 'scientific' reasons. It is unacceptable to allow any such exemptions and this legislation should not be transposed unamended.

Question 41: Should the UK retain its current system of personal licensing or adopt a simplified version of that system with greater local accountrability?

Suggested answer: The UK should retain its full licensing system to maintain animal welfare standards.

The UK should retain a strict three tier licensing system (for establishments, personnel and projects) administered by the Home Office. Even competent handling will cause stress in laboratory animals. Therefore it is fundamental that, throughout their entire lifetime, animals are handled by competent personnel. Numerous investigations have shown that mishandling animals can lead to severe suffering, especially during and after scientific procedures. This has been shown to happen under the current licensing regime, and was clearly demonstrated by a NAVS expose of work at Huntingdon Life Sciences only recently. Therefore, all personnel carrying out experiments on animals should hold a personal licence issued by the UK authorities. This system should not be simplified as it would compromise animal welfare.

Question 45: What type of information should be placed in the public domain about the project evaluation process to ensure transparency of the process?

Suggested answer: All information about the project evaluations should be made public to ensure accountability and public confidence. This can be achieved with online access.

Publication of technical details of project licence applications (with private information excluded) would allow wider scientific scrutiny of proposals to use animals and consideration of non-animal alternatives or other sources of the information required. Ethical evaluation reports and retrospective reviews should also be made available to the public.

Question 46: Should the UK extend the requirement for retrospective assessment to some or all projects involving procedures classified as 'mild' or 'non-recovery'?

Suggested answer: All projects must be retrospectively assessed.

Animal Aid strongly supports the implementation of retrospective reviews of all projects, where a review is conducted to see what actually happened to the animals, as opposed to what the researchers predicted might happen when they applied for permission to use animals. These can be very useful to establish whether animal procedures have been conducted within the terms of the project licence and they are useful to inform future cost-benefit assessments and define priorities for replacement techniques. Animals suffer in all experiments and this suffering should be acknowledged and quantified at all times.

Question 49: Should the UK adopt a simplified administrative procedure for relevant categories of project?

Suggested answer: The UK should not simplify the current administrative procedures.

There should not be a simplification of the current administrative procedures. To fast track or in any way speed up or simplify the scrutiny to which these projects are subjected would give researchers the impression that the procedures are less serious. All procedures that are undertaken on animals, with the animals bearing the cost of the procedure, should undergo a rigorous and robust assessment. This is important not only to maintain scientific robustness, but also to ensure that public transparency and accountability is ensured for each and every aspect of procedures involving animals.

Question 50: Should the UK aim to publish non-technical summaries for all authorised projects?

Suggested answer: Yes

Waiving requirements for non-technical summaries for mild or moderate procedures, not only implies to the public and researchers that these procedures are of less concern, but also that less information is required – this is incorrect on both counts. All non-technical summaries must be published in order to ensure the highest level of public confidence, transparency and accountability. In addition, if there are different rules for different severities of procedure, this may lead researchers to categorise their work into the categories that undergo the least amount of scrutiny – this is unacceptable.

Question 52: Is there a case for animal welfare bodies to have more extensive membership and functions than the minimum requirement set out in Articles 26 and 27? If so, what additional members and functions should be required or recommended in guidance? Might animal welfare bodies play a role in advising on training and competence?

Suggested answer: Yes, animal welfare bodies should have more extensive membership and functions than the minimum requirement. The UK should maintain a requirement for a local ethical review process, in order to ensure adequate scrutiny of animal research proposals and stimulation of ethical reflection within industry.

The Ethical Review Board (ERB) system has been in existence for more than 10 years and, whilst not perfect, has contributed positively to animal welfare. It is frequently referenced by the Home Office, major research funders and individual research establishments when answering questions regarding public accountability with respect to the use of animals. There is much support for the current ERB system within the research community. Whilst some users, breeders and suppliers may opt to model their Animal Welfare Bodies (AWB) on their current ERBs, this would not be mandatory. Some establishments will decide to implement the lower AWB requirements and inconsistent standards will develop across the UK.

Question 53: Should the Animal Procedures Committee form the basis for the new National Committee? Are there any models other than the APC on which the National Committee might be based? What should be its membership and what range of expertise will the National Committee require to enable it to meet the requirements set out in Article 49? How might this expertise be accessed?

Suggested answer: The broader role of the current APC must be preserved in any new legislation.

The current body, under ASPA, is tasked, alongside other roles, with balancing the interests of science and industry with animal welfare, with a broader ethical remit, and with providing independent advice to the Secretary of State. It must be a key requirement of the new legislation that there is a body to provide independent advice to the government on matters relating to the care and use of animals in scientific procedures, and to act as a channel for public concern.

Question 54: What aspects of the current UK inspection system should be retained? How might it be improved?

Suggested answer: Yes, all aspects should be retained, and the proportion of unannounced visits and the frequency of visits should increase.

The system of inspections currently in place, although far from perfect, is much stronger than that proposed under the Directive. Two ways to increase the strength of the current inspection system would be to increase both the frequency of visits and the proportion of these that are unannounced.

A detailed, more formal approach would not be favoured by the establishments as, under the current process, they are able to see inspectors frequently and to gain information and feedback from them. In addition, the frequency of visits will enable an inspector to spot if things have changed over a shorter period of time. The Home Office has suggested that there may be periods of three to five years between inspections for some establishments. This is far too long and would allow controls, procedures and facilities at establishments to deteriorate without regular inspections and guidance. In addition, generations of animals may live, be used and die in between inspections of this frequency, which is unacceptable. Public confidence would, quite rightly, be seriously undermined by less frequent inspections, irrespective of how 'detailed' these are intended to be, compared with the current process.

Question 55: Should the UK continue to publish a full range of statistics as in the current annual statistics report?

Suggested answer: Yes

The current UK law (ASPA) goes beyond the European Directive on the scope of protection for certain animals such as birds, foetal forms of mammals or reptiles from halfway through the gestation or incubation period (section 1.2), vertebrates of endangered species (section 10.3), dogs and cats and equines (section 5.6) and feral and stray animals (section 10.3). The Home Office also publishes detailed annual statistics of animal use under the ASPA, which contributes to public access to information about animal experiments. The EU Directive (Article 2) allows EU Member States to go beyond the provisions of the Directive, therefore the UK must maintain these higher standards.

Question 58A (not in the original document but added after pressure from animal protection groups – so please include in your response): The UK will introduce thematic review – would you like to see thematic review include all stakeholders and allow them to submit at least five animal experiments a year for review?

Suggested answer: Yes

We have lobbied for 'thematic reviews'. A system which allows groups of experiments to be reviewed and scheduled for replacement with non-animal methods is essential to ensure progress on this issue. The thematic review process must involve all stakeholders (including Animal Aid). The weight of importance placed on certain experiments will be of more or less concern or value to different stakeholders. Consideration by the stakeholders and then the submission of five specific procedures for review is a manageable number for an annual review. The thematic review process, allowing the gradual removal of the procedures of most concern, is essential to the spirit of the Directive, as outlined in its Recital 10 – 'this Directive represents an important step towards achieving the final goal of full replacement of procedures on live animals for scientific and educational purposes as soon as it is scientifically possible to do so'.

The following answer applies to Questions 64-72:

UK standards should be retained where they are higher than the Directive. The UK Codes of Practice on Husbandry and Care, which are more than 20 years old, need to be revised and updated to include additional guidance on providing for animals' physical and behavioural needs.

Additionally, essential text information that sets the Tables in context and provides information on how to provide a good environment for the animals has not been included.

Question 64: Is there a welfare need/benefit for retaining 20cm cage height for rats that are >250g and that are post-weaned stock or being used?

Question 65: Is there a welfare need/benefit for retaining 15cm cage height?

Question 66: Is there a welfare need/benefit for retaining current UK CoP minimum floor areas for some weights of rabbits over 10 weeks of age? Is there a welfare need/benefit for retaining current UK CoP minimum enclosure sizes for does without litters?

Question 67: Is there a welfare need/benefit for retaining the larger minimum enclosure size? Is there a welfare need/benefit for retaining the larger minimum enclosure size?

Question 68: Is there a welfare need/benefit to retaining the slightly larger minimum floor area for breeding pairs of marmosets?

Question 69: Is there a welfare need/benefit to retaining current minimum trough space allocations for ad libitum feeding of individual polled cattle?

Question 70: Is there a welfare need/benefit to retaining current space allocations for most weights of sheep and goats?

Question 71: Is there a welfare need/benefit to retaining the current minimum floor area per animals and are there likely to be welfare issues if minimum water flow rates and trough space allowances are not specified?

Question 72: Is there a welfare need/benefit to retaining the current space allocations for equines?

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