excel sheet semifinal housing and care...

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Question IV.Aa.

Question text:

Introduction IV.a) Current provisions of Directive 86/609/EEC Annex II of Directive 86/609/EEC contains non-binding guidelines for the housing and care of laboratory animals which are identical to that of Appendix A in the Council of Europe Convention for the protection of vertebrate animals used for experimental and other scientific purposes (ETS 123). The Directive requires full regard to be paid to these guidelines. IV.b) Current situation in Member States The Member States have implemented the non-binding guidelines in a varying manner. In some Member States they are considered as minimum compulsory, in others they maintain the non-binding status of guidelines. 10 Member States have ratified the Europe Convention 123 covering 91% of animal use in the EU. The preliminary findings have demonstrated that 22% of private establishments and 20% of public establishments have already upgraded their facilities to meet with the revised guidelines. IV.c) Trends and implications In 1998 the EU became a Party to Council of Europe Convention ETS 123. The Council of Europe is currently revising Appendix A to this Convention to better reflect the scientific developments in animal welfare and to implement current best practice in the field. The revised guidelines have significant increases to the cage sizes and emphasis on group housing and enrichment.

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enrichment. The revised Appendix A will apply to those countries who are parties to the Convention, currently only 12 out of the 25 Member States. After the adoption, however, also the Community would need to update these guidelines. Therefore, those Member States who are not Parties to the Convention would need to pay regard to the revised guidelines. IV.d) Problem dimension Since the current, and the revised guidelines, are non-binding, there is no assurance for minimum animal welfare requirements to be met, e.g. in terms of space allowance. This is not in line with the requirement to take into account animal welfare requirements as per the Animal Welfare Protocol to the Treaty. Some Member States consider these guidelines as a compulsory minimum whereas others use them purely as guidance. This places establishments (breeding, supply and user establishments) into a significantly different cost environment depending on the Member State in which they are located, consequently distorting the internal market. IV.e) Potential solutions The revision of the Directive could envisage elements of the revised Appendix A as the minimum standard with a transitional period for implementation. This would bring the Directive in line with current scientific and technical knowledge, increase animal welfare and create a competitive level playing field within the EU (and between EU and non-EU countries who are Parties to the Convention). Many of the general provisions and recommendations of the revised Appendix A for health, transport, quarantine, acclimatisation, isolation, watering, feeding, cleaning, records and identification are procedures that are already in place in many establishments, as these are integral parts of good scientific/laboratory practice to obtain reliable and reproducible scientific results. Major changes required are mostly related to the new cage sizes, the mandatory use of environmental enrichment, and the mandatory group housing and socialising of animals. Do you support this overall analysis?

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Statistics:

162 respondents stated that they support the preliminary analysis.

17 respondents stated that they have no opinion in relation to this question.

43 respondents stated that they do not support the preliminary analysis or components of it. To justifydisagreement, they were asked to provide arguments, facts and figures and if possible indicate the source of information. However, a number of respondents opted for the "No" reply only to supply additional arguments in support of the preliminary analysis.

Comments received:

Name of the expert or organisation

Type of organisation

Activity level of the organisation

Representative- ness

IV.Aa.

(Name confidential - Respondent 006)

User of animals -public sector

National representative I object to the wording “required”; I agree to the analysis that changes related to the new cage sizes, the mandatory use of environmental enrichment, and the mandatory group housing and socialising of animals will be the one which will affect establishments whereas the other mentioned provisions and recommendations are already in place.



National Yes, we are representing all physiological researchers in the Netherlands; we have about 300 members

It should be recognized that even in the more “developed” member states, significant costs have to be made to upgrade cage sizes. Because research budgets are not likely to be increased, a slow implementation is warranted, using a term of 10 rather than 5 years. And, again, it seems important to realize that cage sizes for laboratory animals are in most cases already larger than for the same animals in bioindustry.

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Worldwide One of several global pharmaceutical companies

There is no general impact of having guidelines for housing and conditions on the quality of scientific results and the mental wellbeing of personnel. This obviously assumes that housing and care standards are very poor, which is not necessarily the case.



National yes see detailed answers below

Bayer HealthCare

User of animals -private sector

Worldwide organisation is representative for the field

The statements do not seem to be based on evidence. Experience of major pharmaceutical companies shows that these figures could apply in Northern Europe, but not in all member states and certainly not in academia and public research establishments. Many companies already comply or will shortly comply with requirements for rodents. However, adaptation of facilities for larger animals, such as dogs or NHPs (but also guinea pigs), will require more time (minimum 5 years, sometimes longer). Initial estimate is that the proposed by CoE transitional period of 3 years will not be enough. If 3-year transitional period is maintained, the changes could not be made smoothly without seriously disrupting companies’ ongoing work.

GlaxoSmithKline User of animals -private sector

Worldwide Thre are other international pharamceutical companies. We produce 25% of the worlds vaccines

We would not agree with the implication that the European Treaty obligation dictates that standards should be mandatory; neither would it appear does the Commission: http://ec.europa.eu/food/animal/welfare/work_doc_strategic_basis230106_en.pdf It should be recognised that CoE appendix A is based both on science but also substantially on expert opinion which can change. Therefore Appendix A should be neither a minimum requirement, nor a non mandatory guideline. It should be the formal basis on which national authorities inspect, and based on their science-based judgement, implement with the ability to apply discretion and implement new knowledge. Also many institutions outside major industry or national research centres have not yet fully implemented the existing Appendix A.

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Protherics Medicines Development Ltd.


Worldwide No - ABPI and EFPIA repesent the pharmaceutical industry in UK/EU

Standards of old Appendix A are met or exceeded in all the old EU MS and the new MS only recently had to implement them. The statements do not seem to be based on evidence. Many companies already comply or will shortly comply with requirements for rodents. However, adaptation of facilities for larger animals, such as dogs or NHPs (but also guinea pigs), will require more time (minimum 5 years, sometimes longer). Therefore, the transitional period proposed by CoE (3 years) will not be enough, If 3-year transitional period is maintained, the changes could not be made smoothly without seriously disrupting companies’ ongoing work. This assessment is based on contributions from 12 major R&D companies having their research facilities in Europe.

sanofi pasteur R&D


Worldwide Vaccine field Most of the changes are not scientifically justified and jeopardize European Biomedical Research by decreasing competitiveness ans increasing public expenses.



National yes The recommendations of the old Appendix A are met or outperformed in all MS, old and new MS. The new Appendix A includes good proposals but sometimes the regulation is not based on evidence (see guinea pigs and height of the cages). As the experiences in several MS show the introduction of the requirements is costly, time, space consuming and expensive in purchasing. It facilitates cage and equipment industries.



National; European; Worldwide

Sanofi aventis is the largest pharmaceutical company in Europe and ranks third worldwide

The statements do not seem to be based on evidence. Experience of major pharmaceutical companies shows that these figures could apply in Northern Europe, but not in all member states and certainly not in academia and public research establishments. Many companies already comply or will shortly comply with requirements for rodents. However, adaptation of facilities for larger animals, such as dogs or NHPs (but also guinea pigs), will require more time (minimum 5 years, sometimes longer). If 3-year transitional period is maintained, the changes could not be made smoothly without seriously disrupting companies’ ongoing work.



Worldwide Yes Paragraphs a) to d) are acceptable. Paragraph e is inaccurate in suggesting that complete implementation of the revised Appendix A will be easy. The capital investment needed to meet new cage sizes in particular, is significant - it should not be forgotten that it is not simply a matter of buying new cages, but in many cases the lower stocking densities will reduce the capacity of an existing building and require new buildings to be constructed.

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Worldwide Research and development

Most of countries applied the old appendix A. The changes required by the revision will induce very important changes in laboratory building or will decrease significantly capacities of European laboratories. Consequences will be costs and/or studies will be subcontracted in other contries (outside Europe for example). For public research and academia , it would be very difficult to follow the new appendix (cost? ) These changes will required lot of times to be put in place (costs and to avoid disrupting ongoing work: it is not possible to modify all buildings at the same time). In addition, procedures for manipulation of some species would be changed and required training for the staff.



Worldwide yes it's representative

Standards of new ETS123 are not already in place in many establishments and countries and compliance will take much more time than directive revision and application



National; Worldwide

yes The "original" Appendix A is already implemented in most E.U. countries. Only the recent E.U. member states still have to do it.The figures can be accepted for most pharmaceutical companies but one should be very careful with other institutions, particularly some public research establishments. For rodents, it should be "easier" to comply with the revised Appendix A requirements. An exception could be the breeding establishments that may have to modify, redesign or even extend the rodent building for rodents, especially for guinea pigs. For large animals, the process will be much time and budget consuming, and will generally involve major modification of existing infrastructure and organization. A 5 year-period seems to be a minimum to address all related issues (capital investment, facility renovation or new working procedures and organization…) One should be aware that this transition has to be carried out without jeopardizing the research activity.

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Worldwide other relevant organisations

Most of countries applied the old appendix A. The changes required by the revision will induce very important changes in laboratory building or will decrease significantly capacities of European laboratories. Consequences will be costs and/or studies will be subcontracted in other contries (outside Europe for example). For public research and academia , it would be very difficult to follow the new appendix (cost? ) These changes will required lot of times to be put in place (costs and to avoid disrupting ongoing work: it is not possible to modify all buildings at the same time). In addition, procedures for manipulation of some species would be changed and required training for the staff.




representative for MD&D

Standards of the old Appendix A are met or exceeded in all the old EU MS and the new MS recently had to implement them. The statements do not seem to be based on evidence. Experience of major pharmaceutical companies shows that these figures could apply in Northern Europe, but not in all member states and certainly not in academia and public research establishments.



Worldwide There are many other such organisations in Europe

The overall analysis cannot be supported as it lacks an assessment of the impact of ETS123 on facilities in those countries where it currently does not apply and, furthermore, does not indicate the very significant increase in housing requirements with the version of Appendix A approved in June 2006. For some species such as rodents existing facilities will accommodate many fewer animals and for other species such as dog and primate, existing facilities will require significant capital investment. The overall analysis should include and acknowledge that the capital planning cycles in both the private and public sector have prolonged timelines. The lag time between planning, building and commissioning new facilities is very significant and the analysis is not complete without this being stated in the problem dimension.



Worldwide pharmaceutical YES, at least for rodents, the major pharmaceutical companies are already in compliance with the new appendix, but NO for many academic and public institutions. NO for dogs and primates, where a transitional period of at least 5 years will be necessary to comply to the new Appendix, because there are major capital investment involved and major adaptations needed to older buildings or even new constructions needed.

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Worldwide YES (Safety Assessment)

An assessment by EFPIA, our trade association, of contributions from 12 major R&D companies having their research facilities in Europe (UK, France, Germany, Switzerland, Denmark, Hungary, Croatia, Belgium, Italy) shows that many companies already comply or will shortly comply with requirements for rodents. However, adaptation of facilities for larger animals, such as dogs or NHPs but also guinea pigs), as well as for those not complying yet with requirements for rodents, will require more time (minimum 5 years, sometimes longer). This also applies to our academic collaborators. 3 years will not be enough because of the need to apply for funding for new cages and in many instances, new buildings; time for specification and planning of new facilities; the building and setting up of new operations and processes, especially with respect to human health and safety ( eg manual handing issues). 10 years would be a realistic period for this, but the absolute minimum is 5 years.



Worldwide Global pharmaceutical research and development

The statements do not seem to be based on evidence. Experience of major pharmaceutical companies shows that these figures could apply in Northern Europe, but not in all member states and certainly not in academia and public research establishments. Many companies already comply with requirements for rodents. Adaptation of facilities for larger animals, such as dogs or minipigs will require more time.



Worldwide yes New Appendix A = approved 06/06. Countries(C) must introduce within 1 year,but can decide on implement. timeframe for instit.Transitional period must be harmonized in Europe.Otherwise:Possible shift to C w/ longer timeframes or weaker laws. Standards of old Appendix A:met or exceeded in all old EU MS, new MS:only recent implementation. No evidence for statements.Figures do not apply in all MS nor in academia&public research establishments. We mostly comply w/ new requirements for rodents.But adaptation of facilities for larger animals:more time needed(>5 y.). Proposed CoE transitional period (3 years)=too short for - capital invest. cycle&renewal of material - allow. design&construction of adapted facilities - expanding animal facilities area - adapting proced. to new occup. health requirements (bigger&hence heavier&less mobile material) - adapting organis. of work w/in labs. 3-year transitional period:changes would seriously disrupt our work(our experience in CH&D).

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National Yes Experience of pharmaceutical companies shows that these figures could apply in Northern Europe, but not in all member states and not in academia and public research establishments. Many companies already comply with requirements for rodents. However, adaptation of facilities for larger animals, such as dogs or NHPs (but also guinea pigs), will require more time (minimum 5 years, sometimes longer). Initial estimate is that the proposed by CoE transitional period of 3 years will not be enough for the capital investment cycle and renewal of material. Changes could not be made smoothly in a 3-year transitional period without seriously disrupting our ongoing work.



Worldwide yes An assessment by EFPIA, our trade association, on contributions from 12 major R&D companies having their research facilities in Europe (UK, France, Germany, Switzerland, Denmark, Hungary, Croatia, Belgium, Italy) shows that many companies already comply or will shortly comply with requirements for rodents. However, adaptation of facilities for larger animals, such as dogs or NHPs but also guinea pigs), will require more time (minimum 5 years, sometimes longer). This also applies to our academic collaborators. 3 years will not be enough because it is necessary to provide justifications to obtain funding ( the new requirements will mean new buildings may be needed in some cases – not just cages); time specification and planning of new facilities, building and the setting up of new operations and processes, especially with respect to human health and safety ( eg manual handing issues). 10 years would be a realistic period for this, but a minimum of 5 years is needed.



Worldwide yes Many companies already comply or will shortly comply with requirements for rodents. However, adaptation of facilities for larger animals, such as dogs or NHPs (but also guinea pigs), will require more time (minimum 5 years, sometimes longer). Initial estimate is that the proposed by CoE transitional period of 3 years will not be enough for - the capital investment cycle and renewal of material - allowing design and construction of adapted facilities - expanding animal facilities area- adapting procedures to new occupational health requirements (bigger and hence heavier and less mobile material)- adapting organisation of work within the laboratory. If 3-year transitional period is maintained, the changes could not be made smoothly without seriously disrupting companies’ ongoing work.

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Worldwide The bquestionaire will be completed for the German sites. Other site head in other countries will reply individually

We fully support the following industry assessment which is based on contributions from 12 major R&D companies having their research facilities in Europe (UK, France, Germany, Switzerland, Denmark, Hungary, Croatia, Belgium): It is posted under 1.10



National representative Many companies already comply or will shortly comply with requirements for rodents. However, adaptation of facilities for larger animals, such as dogs or NHPs (but also guinea pigs), will require more time (minimum 5 years, sometimes longer). Initial estimate is that the proposed by CoE transitional period of 3 years will not be enough for - the capital investment cycle and renewal of material - allowing design and construction of adapted facilities - expanding animal facilities area - adapting procedures to new occupational health requirements (bigger and hence heavier and less mobile material) - adapting organisation of work within the laboratory.



Worldwide Don't understand this question

Paragraphs a to d are acceptable. Paragraph e is inaccurate in suggesting that complete implementation of the revised Appendix A will be easy. The capital investment needed to meet new cage sizes in particular, is significant - it should not be forgotten that it is not simply a matter of buying new cages, but in many cases the lower stocking densities will reduce the capacity of an existing building and require new buildings to be constructed.

Prof. Dr. Bernd Hoffmann, Justus-Liebig-Universität Giessen

Public authority National; European

similar to other universities

no, bot yes for rodents only

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Public authority National Yes There needs to be greater consistency in practice across the Community we remain to be convinced that minimum cage and pen sizes are the best or only way to do this. The TEXT of the revised Appendix A, containing the principles to be applied and the performance standards to be implemented, are in many ways more important than the tables of cage sizes. We believe animal welfare would be done a disservice be making the engineering standards mandatory and under-valuing the more important performance standards. The revised Appendix has been deliberately crafted as provisions combining both text and tables, as to separate one from the other is an essential is an obstacle to ensuring high standards.


Public authority Local; Regional; National; European; Worldwide

Yes I have no idea about the upgrading costs for user establishments regarding small and large animals. Concerning health, transport, quarantine, acclimatisation, isolation, I am not sure that the current guidelines are correctly applied in most establishments. In fact, directive 86/609/EEC don’t give clear guidelines and many people are not well trained on these subjects. Moreover, many establishments have no budget (which can be high) for the health monitoring program. The new cage sizes can make handlings of animals more difficult particularly for NHP or for animals breeding in isolators. The mandatory use of environmental enrichment, and the mandatory group housing and socialising of animals will change the physiological standard data obtained with the previous housing conditions (according to directive 86/609/EEC). So, it will probably lead to the short-term increase in the number of animals used in order to correct these data.


Public authority National We are the National Competent Authority

Whilst we agree that there needs to be greater consistency in practice across the Community we remain to be convinced that minimum cage and pen sizes are the best way to do this. The TEXT of the revised Appendix A, containing the principles to be applied and the performance standards to be implemented, are in many ways more important than the tables of cage sizes (that is the view of the President of the Council of Europe Working Party and Multilateral Meeting). We believe animal welfare would be done a disservice be making the engineering standards mandatory and at the expense of the more important commentary and performance standards. The revised CoE Appendix has been deliberately crafted as provisions combining both text and tables, as to separate one from the other would be an obstacle to ensuring high standards.

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Public authority National; European; Worldwide

Although we are a smaller University, about half of the research groups involving animal experiments belong to leading institutions in their field.

Mandatory use of environmental enrichment is a serious pitfall. It is known, that enrichment increases the variability of experimental data. This in turn demands higher numbers of animals to statistically demonstrate treatment effects. Taken further this also increases costs on housing and personal.

The Association for the Study of Animal Behaviour

Other Worldwide yes see 1.10 below


Other National I am the chair of the Hungarian Scientific Ethical Committeeon Animal Experimentation

IV.e. Critical review of the revised Appendix A is necessary before implementing it in EU law. Rendering environmental enrichment and social housing mandatory and the modified cage dimensions often lack enough scientific support; many times these are anthropocentric requirements. Appendix A should remain a non-binding guideline or if it is set as mandatory minimum requirements a minimum of 10 year transitional period (for preparation by the establishments and for scientific validation of the requirements) is necessary before its entering into force.


Other National Yes New Member States only recently had to implement the old Appendix A. In addition, many institutions outside major industry or national research centres have not yet fully implemented it. A transition period of sufficient length (e.g. ten years) and significant funding would therefore be needed.

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Other European yes The new Member States only recently had to implement the old Appendix A. Furthermore, many institutions outside major industry or national research centres have not yet fully implemented it. Therefore, a transition period of sufficient length (ten years) and major funding would be needed.

Eurogroup for Animal Welfare/EWLA

Non-governmental organisation

European Eurogroup/EWLA is made up of animal welfare Member Organisations and Observers in all Member States

We agree regarding the overall importance of obtaining harmonised housing and care standards in accordance with the revised Appendix A to the Council of Europe’s Convention ETS 123. However we disagree that only “elements” of the revised Appendix A should be incorporated into the Directive. Instead, the entire text of Appendix A of ETS 123 should be adopted as an Annex to the revised EU Directive and should become a legally binding minimum standard. This will ensure harmonisation of housing and care requirements between Member States. We also totally disagree that a general transitional period is either necessary or acceptable.



Worldwide - -



National yes Harmonization in this area seems to be essential. But we can not follow the comment, that the proposal is still fulfilled in most cases or that facilities have already upgraded their environment. For rodents this may be the case, but in housing and handling of large animals or non human primates this statement seems to be unfounded. The implementation of binding guidelines will lead to high financial burden for industry and academia. Changes could not be made smoothly without seriously disrupting ongoing scientific work.

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Breeder of animals

Worldwide We are representative for the field and constitute about 50 percent of the activity

The analysis does not take into account the size of the institutions currently in compliance nor the number of animals being housed under the new standards. True costs for compliance are not known but are not as simple as the cost of new cages or enrichment devices. The additional space and labor which all have reoccurring costs components need to be factored into the calculation. Our institution’s estimate of such costs exceeds 35 percent of current levels, not including the other previously mentioned costs. Statement 1.2 is without any scientific evidence to support it, and Statement 1.5 while perhaps true for competition within Europe does not consider the obvious competitive disadvantage that is placed upon Europe with respect to conducting studies with laboratory animals in countries outside of Europe.



Yes Not entirely, I can imagine that standards are lower in new European countries. Although certain standards are highly desired, one should also consider whether the costs of implementation can be carried by specific establishments in such countries. Nevertheless, long term, uniform minimal standards should be achievable.


Local representative Harmonization in this area seems to be essential. But we can not follow the comment, that the proposal is still fulfill in most cases or that facilities have already upgraded their environment. For rodents this may be the case, but in housing and handling of large animals or non human primates this statement seems to be unfounded. The implementation of binding guidelines will lead to high financial burden for industry and academia. Changes could not be made smoothly without seriously disrupting ongoing scientific work.



Yes, we are representarive for the field

Harmonization in this area seems to be essential. But we can not follow the comment, that the proposal is still fulfill in most cases or that facilities have already upgraded their environment. For rodents this may be the case, but in housing and handling of large animals or non human primates this statement seems to be unfounded. The implementation of binding guidelines will lead to high financial burden for industry and academia. Changes could not be made smoothly without seriously disrupting ongoing scientific work.

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Question IV.1.1.

Question text:

Statistics:




Comments received:





IV.1.1a.

Compliance with ETS 123 guidelines would increase animal welfare through better housing and care standards thus leading to better and more reliable scientific results as well as to improvements in the mental wellbeing of personnel. Preliminary findings indicate that 22% of establishments in private sector and 20% in public sector have already adapted, thus the impact would be borne by around 80% of user establishments in both sectors.

Do you support this overall analysis? Yes/No/No opinion

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National XXX are representative of our scientifi activity (basic research)

I really doubt that 20% of public sector, uniformally across EU countries, have already adapted to new standard. In fact, a significant number are still working to reach present standard, due to the difficulty to raise funds for purchasing equipment. Impact of group housing on science is under debate. It cannot be concluded that any aspect of revised ETS 123 guidelines will lead to more reliable scientific results.



Not applicable yes Tthe impact on welfaret of the current guidelines for housing and care of animas is overestimated. Many of the current guidelines lack sufficient scientific support and are often based on emotional reasoning and anthropomorphic reasoning. Moreover, the guidelines are a strange mixture of welfare measures and measures to improve the conditions of work of the animal caretakers. In general, one can say that animal welfare research is scientifically weak and has very low scientific impact values. Given that notion, it is strange that such a weak scientific discipline affects the full range of scientific disciplines working with laboratory animals.



National yes Larger cages or enclosures with enrichment tools lead to an increase of the workload for animal caretakers with more time for the cleaning or and less time with animals. It seems unclear that increase in workload for animal caretaker and the stress to miss an animal hide in a burrow will induce improvments in their mental wellbeing.



Local; Regional; National; European; Worldwide

yes, we are a major EU HEI for biomedical research

There is no evidence advanced about the mental well-being of personnel. The main adverse effect on mental well-being has been the poltical failures at the highest levels to defend the important role of animal experiments in medical advances.



National yes 1.1 compliance with ETS guidelines would not necessarily lead to better and more reliable scientific results. For example if an experiment is designed to test the effect of various feeding procedures, one needs to be able to compare with current farm conditions (i.e. housing, handling…)




yes I am not aware of any data supporting wellbeing of personel

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Worldwide Yes, representative

The sums of money devoted to so-called appropriate housing are disproportionate and often higher than for human habitation! Housing should be guaged to be adequate for the holding time envisgaed and to ensure the animals do not harm each other. In addition, in my experience, only the scientists know their animals well enough (and this includes veterinary staff of assessment boards!!) to know the appropriate holding conditions and care.

Bayer HealthCare



1.1 The figure could be questions since no source is provided. It is assumed that the standards in these 80% are bad simply because there is no legislation on this.



Changes in practice comes about not only through governmental regulation, for example GSK published work that showed the benefits of solid bottomed cages for rats, or through non governmental systems, for example AAALAC International (www.aaalac.org)




The figure could be questioned since no source is provided. It is assumed that the standards in these 80 % is bad simply because there is no legislation on this. As industry is often in compliance with other standards (company own, AAALAC etc) the improvement re this would be much less visible

sanofi pasteur R&D


Worldwide Vaccine field But usually the first 20% were the easiest to be implemented: new facilities, models with no constraints, private companies... New scope fields should be also including with a result of dropping down the 20%



National yes May be this figures are correct, there is no reference basis, the introduction of the requirements will not lead automatically to better scientific results. Group housing of animals – a good emphasis in the point animal welfare -could smear single results. Bigger and heavier cage material does not improve the wellbeing of personnel.

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Industry in the major EU areas have already started to implement ETS 123. I question the 80% figure as being applicable to Industry. If this is applicable to the public sector it will have a major impact.



Worldwide Yes The basis for the figures provided is not clear and hence cannot be supported.



Worldwide Yes No source is provided for these figures




No source is provided to support these data. Some guidelines follows states regulations, etc … and not new ETS123



National; Worldwide

yes Again, the relevance of these figures should be questioned… The situation is very heterogeneous between industry and public research, between countries, institutions and their affiliation, the existence of an internal animal care policy or not, AAALAC accredited sites or not…



European Representitive We house a lot of older rats, and so although we spent £1/2million on new cages 4 years ago, and have the largest rat cage available to us to use, it would not be big enough for 4 of our current animals (it is 2065cm squared). We would have to increase our cage sizes by 25%, and do not see that this is required when we observe our own animals, and we would have to reduce our experimental output. We would also need to re-validate all our existing group housed experimental models.

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The impact might be lower as the 20% are just “preliminary findings” and it is unclear how these numbers were generated). Many establishments even meet the requirements of institutions like AAALAC.



Worldwide yes Not in general, in some cases yes, sometimes no




The overall analysis cannot be supported as the statement relating to mental well-being of personnel is highly prejudiced. The personnel currently providing routine animal care are extremely motivated as animal care roles are vocational. Also it is likely that the percentage of establishments already implementing Appendix A proposals reflects current standards in a small number of Member States, for example, the United Kingdom.



Worldwide pharmaceutical Although this is likely to be the case for most rodents in some pharmaceutical companies, we really question these figures apply for academic and public institutions neither for many companies and institutions regarding dogs and primates.



Worldwide Global pharmaceutical research and development

The figure could be questions since no source is provided. It is assumed that the standards in these 80 % is bad simply because there is no legislation on this. As industry e.g. is in compliance with other standards (company own, AAALAC etc) the improvement re this would be much less visible.



Worldwide yes The figure could be questioned since no source is provided. It is assumed that the standards in these 80 % is bad simply because there is no legislation on this. We, like many other companies= in compliance with other standards (company own, AAALAC) the improvement re this would be much less visible.



National Yes Simply because there is no legislation on this does not mean that the conditions are substandard.

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Worldwide Representative Above figures are not supported by any technical Report.



Worldwide no Better housing conditions will improve animal welfare but not necessarily lead to better scientific results. The use of enrichment might increase the variability of the data.



Worldwide Many organisations

The figure could be questions since no source is provided. It is assumed that the standards in these 80 % is bad simply because there is no legislation on this. As industry e.g. is in compliance with other standards (company own, AAALAC etc) the improvement re this would be much less visible.



National representative The figure could be questions since no source is provided. It is assumed that the standards in these 80 % are bad simply because there is no legislation on this.




The basis for the figures provided is not clear and hence cannot be supported.




The assesment is only partially true. For example it is more difficult to catch animals in larger cages, which imposes mor sress to them (and to the animal care takers). Some animals like to be lonely and devoid of sociel stress.

1.Animal Aid Other National Other organisations do exist

While we can accept the prospect that minimum standards will improve welfare for some animals, we do not accept the supposition that it will lead to increased reliability of the experimental data obtained from animal experiments.

Cris Iles-Wright Other Not applicable Not applicable This implied that reasonable standards are met by oganisations that 'comply'. This is clearly contrary to all evidence.

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Other National Yes We are not able to support this as we cannot verify these figures. We would make the point, however, that standards already exist even where legislation may not exist, such as the Association for Assessment and Accreditation of Laboratory Care International (AAALAC).


Other Not applicable not applicable The figure could be questions since no source is provided. It is assumed that the standards in these 80 % is bad simply because there is no legislation on this. As industry e.g. is in compliance with other standards (company own, AAALAC etc) the improvement re this would be much less visible.


Other European yes We are not able to respond as we cannot verify these figures. It should be noted, however, that there are already standards even where there may not be legislation, e.g. the Association for Assessment and Accreditation of Laboratory Care International (AAALAC).



National NO OTHER RELEVANT ORGANISATION

The impact of group housing on reliability of scientific results is under debate. It cannot be concluded that any aspect of revised ETS 123 guidelines will lead to more reliable scientific results.



Worldwide - -



National yes Harmonization in this area seems to be essential. But we can not follow the statistics and the conclusion. It is assumed that the standards in 80% of the establishments is bad simply because there is no legislation on this. This is not true.

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Worldwide yes From an global acting company point of view and experiences due to several merges in the past an 3 Year transitional period could be far to short. Due to enhanced cages sizes facility space has to be increased as well, which is often not possible without additional Construction measures. 5 years or even moren would be better.


Breeder of animals



giacomo Ri(olatti


it is represntative

The present situation of animal housing is quite satisfactory in most labs and such as to render perfectly happy the people working with them. A transitional period of 5 years is not sufficient. The allocation of a large amount of money on useless improvements would drainsmoney from research rendering EU research non competitive with that of US and Japan.


National; European

There are other organisations

The transition period proposed would be particularly problematic for academic and public sector institutions, and it should be noted that many institutions have yet to fully implement Appendix A. Moreover, national authorities should be permitted to implement Appendix A as using their judgement as appropriate, and incorporating new developments in science. In industry, adaptation for larger animals such as dogs will certainly require at least 5 years. The timing factors in design, construction, expansion of facilities, and restructuring of work patterns, including different occupational health requirements, for staff.

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Local representative of national pharmacological research institutions

Introducing the ETS 123 standards will create a considerable financial burden for universities and researchers. If implemented it would be indispensable to provide EU-wide funding programmes for setting up the required infrastructure


Local representative Harmonization in this area seems to be essential. But we can not follow the statistics and the conclusion. It is assumed that the standards in 80% of the establishments is bad simply because there is no legislation on this. This is not true.




Harmonization in this area seems to be essential. But we can not follow the statistics and the conclusion. It is assumed that the standards in 80% of the establishments is bad simply because there is no legislation on this. This is not true.

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Question IV.1.2.

Question text:

Statistics:




Comments received:





IV.1.2a.

Animal welfare: Adaptation to the revised guidelines has positive animal welfare effects. This can be observed in reduced stress levels, increased tranquillity, and consequently easier and faster handling of animals. Do you support the preliminary findings? Yes/No/ No opinion

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Timo Nevalainen User of animals -public sector

Local Yes This is not so straightforward. For instance, items mentioned to have enrichment value may not. The real impact depends on whether the item has been shown to be beneficial to the species, and not to interfere with the study. If the first scenario fails, then the item has no or perhaps negative effect, and if there is interference, the study should not have done at all. This can only be solved with more funding to Refinement and Reduction alternatives.




Impact depends whether enrichment will be beneficial to the species, but also will minimize variability and response to tests. This is indeed crucial since increased variability means more animals per group. Group housing commonly induces more stress and sometimes dominance and fighting. It needs a close survey.



National representative Increased cage size and enriched environment does not make animals more tranquil but actually increases motor activity (Physiol Behav.62:1253, 1997; Physiol Behav. 84:429, 2005) and consequently does not make handling of animals easier and faster.



Not applicable yes See comment above. Several of the guidelines even have negative welfare consequences.



Local yes No, because this is very much depending of the detailed aspect. There are cases where this is true and cases where not. Especially the use of environmental enrichment (of course depending on the type) can cause adverse effects on the animals. There is much more research necessary in this field.



National yes Animal caretaker will spend more time in searching animals or cleaning enrichment device and less time with animals. It seems unclear that increase in workload for animal caretaker and the stress to miss an animal during cage changing will induce improvments in their mental wellbeing.



National yes 1.2 more information is needed to be able to answer Yes on the positive effects of the revised guidelines

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Bayer HealthCare



1.2 Larger cages do not make it easier to catch and handle animals. Considerable skill is needed to do this and there is increased risk of damaging animals and people. Furthermore, it is not comprehensible why guinea pigs should have the new higher cages. This species does not stand up like rats and from our view there is no physiological need for these cages. They are really difficult to handle for the animal keepers.



Changes in practice comes about not only through governmental regulation, for example GSK published work that showed the benefits of solid bottomed cages for rats, or through non governmental systems, for example AAALAC International (www.aaalac.org)




In principle yes, but not always. This is true for some modifications. Larger cages do not make it easier to catch and handle animals. Considerable skill is needed to do this and there is increased risk of damaging animals and people.

sanofi pasteur R&D


Worldwide Vaccine field In general yes, but no evidence in some species and in some research models.



National yes This statement is not correctly, you cannot say bigger cages allow easier and faster handling of the animals. These points mainly depend on trained and well orientated people. Rodents and Guinea pigs in bigger cages without human contact and handling will have more stress, for example.

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In principle this could apply but bigger is not always better. Larger cages can make it difficult to catch and restrain animals and there is a risk of injury to staff and animal – particularly in the case of Primates.



Worldwide Yes In general larger cages allow for a better environment, but they do not necessarily make it easier to handle animals. More time spent on cage changes – less time for other animal care, might cause more strain injuries on animal care personnel.




no comment



Worldwide Yes actually yes but: Better housing and care standards may reduce stress level at least for part of the animals (in group housing, there may also be animals with more stress), but there is no reason to assume easier and faster handling of animals, since enrichment and group housing could also result in more difficult handling




Having animals in larger space does not lead to faster and easier handling ! Furthermore there are no evidence about stress levels related to these guidelines



National; Worldwide

yes Ultimately when all housing / caging concepts and related procedures are almost perfectly defined and has been duly assessed… and only for projects that are compatible with the full requirements. Like any change, group housing and enrichment have positive and negative aspects. Aggression and group stability have to be managed, animal inspection, handling, cage cleaning, husbandry procedures… are sometimes much more complex to manage and some revised practices appear to be less efficient and may require specific skills or training... The list of direct and indirect impact is very long and cannot be summarized in this type of consultation.

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European Representitive Our group housed rats do not show any signs of stress in our current cage sizes. I think the depth of the bedding assists with this, along with environmental enrichment items, and regular human to animal interaction.




OK with the principle but: The increase of the size of cages should induce difficulties to catch the animals ; socialisation might be responsible for fighting and difficulties for dominated animals (difficult access to food…) Procedures of manipulations should be changed with increase risk for the staff and animals







This preliminary finding is largely correct but it should also reflect that management systems and expertise of the personnel providing routine animal care are crucial factors. For many species there is no evidence to support this statement.



Worldwide pharmaceutical Increased cage sizes may indeed have positive animal welfare effects considering group housing and enrichment. However, in some cases, handling may be more difficult. YES for most part, but NO for faster handling.



Worldwide yes In principle yes, but not always. Although there might be several limitations.e.g. introduction of enrichment is discussed controversially because it might increase deviations in some biological parameters which might result in increase in animal numbers for certain studies. Increasing of space provisions per animal sometimes also might increase stress for animalsor the risk of damaging animals or people e.g. during catching. The same can be true for group housing which sounds good in theory but very often results in aggressiveness, biting wounds etc. in animals.

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National Yes In principles yes, but lager cages do not make it easier to catch and handle animals. Considerable skill is needed to do this and there is increased risk of damaging animals and people.



Worldwide Representative The Appendix has been too often revised on the basis of the "the larger is the better" criteria, that does not correctly apply to all the animal species most frequently used for scientific purposes (ie rabbit)



Worldwide no Group housing and the use of cage enrichment might slow down the handling of the animals and cages.




This is truth with some modification. Lager cages do not make it easier to catch and handle animals. Considerable skill is needed to do this and there is increased risk of damaging animals and people.



Worldwide Yes Yes, but handling can also be more difficult in larger cages, group housing etc.



National representative Larger cages do not make it easier to catch and handle animals. Considerable skill is needed to do this and there is increased risk of damaging animals and people. Furthermore, it is not comprehensible why guinea pigs should have the new higher cages. This species does not stand up like rats and from our view there is no physiological need for these cages. They are really difficult to handle for the animal keepers.




In general larger cages allow for a better environment, but they do not necessarily make it easier to handle animals.

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Coordination group for laboratory animal activities

Public authority National Yes This is not so straightforward. For instance, items mentioned to have enrichment value may not. The real impact depends on whether the item has been shown to be beneficial to the species, and not to interfere with the study. If the first scenario fails, then the item has no or perhaps negative effect, and if there is interference, the study should not have done at all. This can only be solved with more funding to Refinement and Reduction alternatives.

Francois Lachapelle INSERM

Public authority National BEA du CNRS, de l'INRA, du CEA

there are many clear evidence that mots decision are based on shalow science and that few if any part of the studies have been adapted to the specific situation of lab animals




see 1.1a


Public authority National Yes Not all aspects of new guidelines have been assessed - for example, although reduced stress levels in the new housing may be anticipated, catching/handling may be more stressful due to the increased difficulties of capture in larger enclosures.



yes In general the new guidelines are a good thing. The bird cage sizes do not allow faster or easier handling, in fact the converse. There is littleif any evidence to support the contention that stress levels are reduced although this seems likely.

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We lack practical experience of the new provisions – any of the above problems, if present, should nevertheless be identified and remedied. As the new provisions were only published 3 months ago, it is not known what evidence there is to support the statement that benefits have already been seen.


Public authority National Ministry of VWS is also involved

Some provisions are fact-based but not all of them. It is what we anticipate what might be beneficiary. which is no garantuee


As with much of this questionnaire, a number of propositions – some contentious, some supportable – are rolled up together. Adaptation to the revised guidelines could have positive welfare benefits for some, but the element of stress and unnatural confinement will continue to be present throughout.

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COST Action B24 “Laboratory Animal Science Welfare” - http://biomedicum.ut.ee/costb24

Other European No This is not so straightforward. For instance, items mentioned to have enrichment value may not. The real impact depends on whether the item has been shown to be beneficial to the species, and not to interfere with the study. If the first scenario fails, then the item has no or perhaps negative effect, and if there is interference, the study should not have done at all. This can only be solved with more funding to Refinement and Reduction alternatives.

Cris Iles-Wright Other Not applicable Not applicable Standards are routinely ignored and there is no meaningful effort to enforce them. They are also extremely low-standard and as such do not have the effect of bringing animals close to their natural requirements.




Other National Yes We agree, but feedback from companies indicates that this is not always the case. For example, it can be harder to catch and handle animals in larger cages, which can increase the risk of damage to both the animals and the handlers.


Other European yes We do agree, but - feedback from companies indicates that this may not always be the case. For example, it can be harder to catch and handle animals in larger cages, which can increase the risk of damage to both the animals and the handlers.

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Gesellschaft für Versuchstierkunde - Society for Laboratory Animal Science (GV-SOLAS)


National; European

Yes No, because this is very much depending of the detailed aspect. There are cases where this is true and cases where not. Especially the use of environmental enrichment (of course depending on the type) can cause adverse effects on the animals. There is much more research necessary in this field.

Stichting EDEV - Een DIER Een VRIEND


National; European

We cooperate with animal organisations within the ECEAE

Who is getting these findings? The animal testers. They have all to win by giving these results. Not transparant.




Group housing commonly induces more stress and sometimes dominance and fighting. It needs a close survey, but all negative effects cannot be eliminated.



Worldwide No other organisations

Whilst we broadly accept the principles behind this statement, there is a lack of evidence to back it up. It must be noted that the effects on variability of experimental design from changes introduced by ETS123 guidelines are not fully known yet.



National yes Overall this comment is true with some modification. But for example larger cages do not make it easier to catch and handle animals and can lead to stress and an increased risk of damaging animals and people. Social stress within group housed animals can also contribute to reduced welfare of individual animals.

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Breeder of animals




National; European


See AAALAC International publication, www.aaalac.org


Local representative Overall this comment is true with some modification. But for example larger cages do not make it easier to catch and handle animals and can lead to stress and an increased risk of damaging animals and people. Social stress within group housed animals can also contribute to reduced welfare of individual animals.




Overall this comment is true with some modification. But for example larger cages do not make it easier to catch and handle animals and can lead to stress and an increased risk of damaging animals and people. Social stress within group housed animals can also contribute to reduced welfare of individual animals.

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Question IV.1.3.

Question text:

Statistics:




Comments received:





IV.1.3a.

Science: Increased animal welfare leads to animals suffering less from birth until death, and experiments with more precise and reliable results. Also, the variability of results of animal experiments may decrease, which in turn might lead to a reduction in the number of animals used. Do you support the preliminary findings? Yes/No/ No opinion

36

Dept. Laboratory Animal Science, Utrecht University, The Netherlands


Worldwide chair of lab. animal sci. recognized by national authorities/responsable for national coordination education and training in lab. animal sci./ leading role in international laboratory animal science

There are as yet insufficient data to support this statement. In particular, the impact of environmental enrichment upon variability has yet to be fully assessed and could lead to some increase in animal use.

KTL (National Public Health Institute)


National yes, in occupational health there is the Finnish Institute of Occupational Health

Your questions automatically assume that animals always suffer. Why? Do you have any evidence that this is the rule and not an exception?

P A Brennan User of animals -public sector

Worldwide I am not an organisation

If higher standards of housing mean closely controlled temperature, humidity and light levels then I don't agree that these necessarily improve animal welfare. They can effectively lead to an artificial reduction in environmental enrichment. Animals have physiological adaptations to enable them to cope with a range of environmental conditions given suitable housing that allows them some control over their environment due to behavioural choices. Allowing a controlled level of environmental variability would be likely to benefit animal welfare.

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Local Yes Variation part is not this simple. Variation may go up, which contradicts the aim, but in case it really goes down it leads to true Reduction, and better science.




XXX “Improved husbandry” is to be welcomed but “improvements” are not always obvious. For instance “environmental enrichment” reduces the visibility of animals to carers, which can adversely affect animals undergoing procedures that need constant care. It is therefore vital that there is some flexibility in the implementation of the ETS123 proposals that are dependent upon the needs of a particular project.




It remains to be demonstrated that new guidelines lead to more precise and reliable results. Group housing leads to increased variability in experimental results. That might lead to an increase in the number of animals used.



National representative Enriched environment does not necessarily reduce variability of results, it actually makes environmental differences between animals within one experimental group more likely



Local; National There are several central laboratory animal facilities at Austrian universities

The effect of e.g. environmental enrichment on variabilty is are contradictory, depending on the type of enrichment, cage and group size, sex, strain, etc.



National yes. There are other academic medical centres

Introduction of environmental enrichment and its impact on experimental variation is a major issue of debate among scientists. There is a great necessity of (additional) scientific data being generated in order to make evidence based decisions

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Local yes No, because this is very much depending of the detailed aspect. There is also a risk that due to the changes variation of results obtained with the animals is increasing, which means that more animals are then necessary to statistically valid results.



National yes THe assumption that variability will decrease is erroneous. When increasing animal welfare correspond to environmental enrichment, the variability of animal increase leading to an increase of the number of animals needed.



National yes in some cases (group housing/individual housing) revised guidelines application will increase variability, this is the case when studying feeding behaviour

Bayer HealthCare



1.3 In some cases enrichment might even affect various response pattern in terms of increased coefficients of variance so the number of animals needed is to be increased. Reference: J Neuroendocrinol. 2004 May;16(5):423-31.



In general this is correct, but as the submissions to the Commission’s Technical Expert Working Group showed the impact of changes can be increases in variation. This may or may not be acceptable; the important point is that validation and awareness of changes is needed, and it may not be possible to implement all proposals in every case




In principle this is correct. However, in some cases enrichment might even affect various response patterns in terms of increased coefficients of variance so the number of animals needed is to be increased. Enrichment and group housing can introduce issues such as potential for contamination, and reduced ability to collect individual animal data, that can reduce the sensitivity of some experiments

39

sanofi pasteur R&D


Worldwide Vaccine field No evidence of “suffering less”; this notion is anthropomorphic. In some models, enrichment or new caging system increase inter-individual differences.



National yes Increased animal welfare will lead to animals suffering less, that is try. But the variability of results do not depend only on animal welfare, in contrast there are results published that enrichment can increase the variety between experiments and results.





In principle this is correct. The proposition is not clearly stated. Enrichment can lead to increased variance in experiments and thus an increase in the number of animals. Individual welfare may be enhanced but at the cost of using more animals per study.



Worldwide Yes The statement includes many assumptions and because of the complexity of the issue, it's impossible to draw a single conclusion. Adding of enrichment has for example shown both increased and decreased variability in results. Laboratory Animals. 37(4):314-327, 2003 Oct.Laboratory Animals. 36(4):411-419, 2002 Oct. Animal Welfare. 15(1):31-38, 2006 Feb. Applied Animal Behaviour Science. 76(1):65- 81, 2002 Feb 22.




no comment

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Worldwide Yes The impact of altered housing conditions on variability and stress level of animals is oversimplified. For species living in hierarchic groups, group housing may result in more stress for the inferior animals, as they are attacked and dominated by other animals. Also, enrichment may result in more variability, since a diverse and variable response by different animals is considered physiological and may be reduced by stress. The changed housing conditions can have a positive or negative impact on experiments. They can also imply a repetition of earlier experiments. The variability in experiments and the animal numbers may increase, as more control data are needed because of the unknowns related to changed housing conditions. Overall, the impact on quality of science is considered rather small and the effect on animal numbers is unknown.




Problem of enrichment which increase variability and thus number of animals used



National; Worldwide

yes It is NOT an automatic benefit! It is now clearly demonstrated in numerous publications that enrichment can also negatively affect the experimental variability and / or the outcome of the studies. It is critical to assess the optimal enrichment on a case per case basis, depending on the type of study and the study requirements, the sex, the species, the strain, the age, the type of caging…




Socialisation will induced difficulties for data collection (clinical changes, feces/vomit appearance); social group will increase variability of the response (dominated/dominant animals will not have the same response in one dose level group, food consumption will be different)





Yes and no. Sometimes an increase in welfare (e.g. enrichment and outdoor housing) causes variability of results thereby not reducing the number of animals needed.




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Worldwide pharmaceutical We need to be very careful before implementing enrichment. The choice for a kind of enrichment depends on the animal, even the strain, kind of research wherein it is used, and so on, since there may be an impact with the study, or the variability of the results may even increase in some type of (e.g. behavioral) research.



Worldwide yes In principle this is correct. However, in some cases enrichment might even affect various response pattern in terms of increased coefficients of variance so the number of animals needed is to be increased. Reference: ….



National Yes Usually, yes, but in some cases enrichment might even affect various response patterns in terms of increased coefficients of variance.



Worldwide Representative There is a scientific debate still ongoing for what concerns housing, enrichment, and increased variability in experimental results.



Worldwide yes In principle this is correct. However, in some cases enrichment might even affect various response pattern in terms of increased coefficients of variance so the number of animals needed is to be increased.



Worldwide no The use of enrichment might increase the variability of the results and might even result in an increase of the number of animals.




In principle this is correct. However, in some cases enrichment might even affect various response pattern in terms of increased coefficients of variance so the number of animals needed is to be increased

42



Worldwide Yes This is dependent on the individual experiment. Variability, e.g. in behavioural studies can also be increased by environmental enrichment, group housing etc.



National representative In some cases enrichment might even affect various response pattern in terms of increased coefficients of variance so the number of animals needed is to be increased. Reference: J Neuroendocrinol. 2004 May;16(5):423-31.




The evidence in this area is too weak to support this assertion so strongly.


Public authority National Yes Variation part is not this simple. Variation may go up, which contradicts the aim, but in case it really goes down it leads to true Reduction, and better science.


Public authority National Yes Agree improved science, but not necessarily a reduction in nyumbers.


Animal experimentation is fundamentally bad science. The results obtained through experimentation on one species cannot be reliably applied to another species.

Biosciences Federation

Other National; European

There are other relevant organisations

The effects of the husbandry and housing changes mandated by ETS123 guidelines on the variability of experimental results are not known. For example, the assumption that bigger caging or lower stocking densities lead to less variability has not been tested experimentally.

43


Other European No No, because this is very much depending of the detailed aspect. There is also a risk that due to the changes variation of results obtained with the animals is increasing, which means that more animals are then necessary to statistically valid results. Or the opposite, which leads to true Reduction, and better science.





The relation between animal welfare and variability and reliability of experimental results is not so straightforward. Variability may even increase because of the increased variability in the environment. The impact is rather neutral (0).


Other National Yes The effect of the ETS123 changes on husbandry and housing on the variability of results is not yet known.


Other European yes It is not yet known what effect of the ETS123 changes on husbandry and housing will have on the variability of results.

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European Biomedical Research Association


European Yes The effects of the husbandry and housing changes that will be introduced by the ETS123 guidelines on the variability of experimental results is not known. The assumption that bigger caging or lower stocking densities lead to less variability has not been tested experimentally and there are several factors that suggest that it may be overly simplistic.

FELASA (Federation of European Laboratory Animal Science Associations)


European FELASA represents 13 European lab animal sci associations and therefore some 3-4000 members of those associations (scientists, veterinary surgeons, technicians etc.). See www.felasa.org

There are as yet insufficient data to support this statement. In particular, the impact of environmental enrichment upon variability has yet to be fully assessed and could lead to some increase in animal use.



National; European

Yes No, because this is very much depending of the detailed aspect. There is also a risk that due to the changes variation of results obtained with the animals is increasing, which means that more animals are then necessary to statistically valid results.

45



National; European


Only real scientific experiments thus without animals will give the disered result of real scientific results.

The Physiological Society


Worldwide Many other Learned Societies aer also representative

“Improved husbandry” is to be welcomed but “improvements” are not always obvious. For instance “environmental enrichment” reduces the visibility of animals to carers, which can adversely affect animals undergoing procedures that need constant care. It is therefore vital that there is some flexibility in the implementation of the ETS123 proposals.

The Royal Society


National Yes. The Royal Society is the independent scientific academy of the UK dedicated to promoting excellence in science. The Society plays an influential role in national and international science policy

There is currently no evidence on how the housing conditions in the ETS123 guidelines affect the variability of scientific experiments.

Universities Federation for Animal Welfare


Worldwide There are others [Providing animals with environments that meet their needs can often result in better science, as well providing better animal welfare. There are data to show that enrichment can either reduce, increase or have no effect on variability. Much depends on species, strain, husbandry conditions, etc. see http://www.lal.org.uk/pdffiles/FELASA_Enrichment_2006.pdf .

46




Monotony does not call for increased variability. Group housing leads to increased variability in experimental results. That might lead to an increase in the number of animals used.



National YES At the moment, there are not enough scientific data to support this statement. In addition, the impact of environmental enrichment upon result variability has yet to be fully assessed and could lead to an increased used of animals necessary to a valid statistic analysis.



Local; Regional; National; European

One other This question implies that there exist no alternative to animal experimentation.



National yes In some cases enrichment might even affect various response patterns in terms of increased coefficients of variance. This will lead to an increase in the number of animals


Local representative of national pharmacological research institutions

To reduce variability is a research issue; if animal welfare in any sense could contribute researchers would strive to increase welfare. Therefore if the standards of good science require appropriate housing facilities they will be installed. Since the research standards are permanently evaluated the housing facilities have to be adapted in line with the scientific requirements.



Yes The outcome of animal experiments is variable indeed. I never observed any correlation with animal housing conditions.


Local representative In some cases enrichment might even affect various response patterns in terms of increased coefficients of variance. This will lead to an increase in the number of animals.

47




In some cases enrichment might even affect various response patterns in terms of increased coefficients of variance. This will lead to an increase in the number of animals.


European all universities are relevant

This is probably true for most experiments. Improved housing can reduce variation between institutes but research in this area is limited so far to a handful of papers e.g. by Wuerbel at University of Giessen. Further work is needed to be sure of the generality of these effects

48

Question IV.1.4.

Question text:

Statistics:




Comments received:





IV.1.4a.




Present European guidelines give yet this positive impact on research teams. On the contrary, demand for group housing will increase stress and discomfort to research team, as more survey will be needed and fight behaviour will happen.

Societal concerns: Increased animal welfare due to the revised guidelines has a positive impact on animal care takers’, technicians’ and scientists’ mental well being. Do you support the preliminary findings? Yes/No/ No opinion

49




This obviously assumes that housing and care standards are very poor, with negative impacts on mental well-being. This is in contrast to my personal experience and there are no scientifically sound studies showing such negative impact.



Not applicable yes Several of the guidelines go against the professional opinion of animal caretakers leading to frustration.



National yes Good animal welfare have positive impact on animal caretakers mental well being. Increase workload have negative impact on animal caretakers mental well being. The final results is still unclear.




yes I am not aware data supporting this

Bayer HealthCare



1.4 It is true that increased animal welfare improves mental well-being of staff. However, this must be balanced against the health problems caused by the manual handling of an increased number of heavier cages (e.g. back problems). The increase in cage size, and floor housing must be weighed up against ergonomic constraints in handling and cleaning. If there is a negative effect on staff, there is a risk that animals will not be group housed in an effort to use small and easily handled cages.

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Whilst it is reasonable to assume that animal welfare in any area can be improved, we are not aware of data that shows that those performing animal experimentation ‘feel bad; about this, and so need help to ‘feel better’ These assumptions are an illustration of unsubstantiated information and poor policy analysis in this questionaire. It has also been postulated that larger cages and more manual handling from group housed larger species may have adverse ergonomic implications for staff: http://dels.nas.edu/ilar_n/ilarjournal/44_1/v4401KERST.pdf




It is true that increased animal welfare improves mental well-being of staff. However, this must be balanced against the health problems caused by the manual handling of an increased number of heavier cages (e.g. back problems), and in some cases, the increased difficulty of catching group-housed animals for procedures. Caging for group housing is often more difficult and time-consuming to clean, increasing workload for animal room staff. Therefore, the increase in cage size, and group/floor housing must be weighed up against ergonomic constraints in handling and cleaning. If there is a negative effect on staff, there is a risk that animals will not be group housed in an effort to use small and easily handled cages.

sanofi pasteur R&D


Worldwide Vaccine field Yes for mental well-being, but this had the negative impact of increasing occupational risks: ergonomics, handling the animals, weight of cages, …



National yes See answer point B, the requirements demand bigger and heavier cages and so there is more labour to do.

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The proposal is not clear. Increased welfare can have a positive impact on staff. This must be weighed up against ergonomic constraints that arise form having to handle larger cages. There is risk in catching animals in large enclosures leading to possible injury to staff. Difficult working practices wil sonn negate any positive impact.



Worldwide Yes Any positive impact on mental wellbeing caused by better living conditions for the animals must be weighed against possibly worse working conditions for staff due to having to handle larger cages and spend more time on cleaning tasks. Ergonomic issues from handling large numbers of big cages should not be underestimated - we have already encountered issues with this. The implication that the mental wellbeing is impaired with current standards is in our opinion not a reality. On the contrary, the most suitable personnel are persons with a true interest in animal welfare and are happy to work with animals.




no comment




Some guidelines have large impact on workload or difficulties for working and safety (i.e. handling in large enclosures or within grouped animals)



National; Worldwide

yes Improved animal welfare practices do influence very positively the staff "mental well being" and motivation, but it can also generate new issues such as increased manual handling or heavy equipments, exposure to allergens or to bites and scratches (example with NHP), etc. NO change is providing exclusively benefits!



European Representitive The cages will be too large for the technicians to lift.

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OK with the increase in mental well-being of staff in medium term; in short-term, as procedures of manipulation must be changed, staff is slightly stressed and try to find solutions to the practical problems (other method of identification of animals to decrease the risk of errors, increase in weight of the cage, risk for catching monkeys,





Yes and no. Mental well-being will take a back seat if health problems increase (e.g. injuries of the spine and lower back)




The preliminary finding appears to be based on a highly prejudiced assumption that the mental well-being of colleagues involved in laboratory animal care and welfare is somehow in doubt. The individuals who work with animals in laboratory settings are highly motivated due to the vocational nature of the work. The preliminary finding might be more accurate if it stated that improvements in housing standards would be welcomed by animal care takers, technicians and scientists as these people are continuously working to improve welfare.



Worldwide pharmaceutical Agreed, but larger cages may cause some ergonomics problems that need to be carefully considered.



Worldwide yes It is true that increased animal welfare improves mental well-being of staff. However, this must be balanced against the health problems caused by the manual handling of an increased number of heavier cages (e.g. back problems): The increase in cage size, and floor housing must be weighed up against ergonomic constraints in handling and cleaning. If there is a negative effect on staff, there is a risk that animals will not be group housed in an effort to use small and easily handled cages. There are two aspects: increase of welfare of animals (with some potential disadvantages as described above) opposes potential increase in working load for animal technicians during routine procedures. Furthermore, also the risk for injuries to the employees might increase.

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National Yes In principles yes, but increased animal welfare improves mental well being of staff, but this must be balanced against the health problems caused by the manual handling of an increased number of heavier cages (e.g. back problems).



Worldwide Representative Although the mental well being might benefit, the overall well being of personnel should be reconsidered once potential health issues related to increased physical activity and handling of larger or heavier equipments will be mandatory.




In principle yes, but improved mental well being of staff must be balanced against increasing health (especially) back problems of staff caused by the manual handling of an increased number of heavier cages. Automation of handling might be a solution here, but it would reduce social contacts with humans and thus decrease animal welfare.




It is true that increased animal welfare improves mental well-being of staff. However, this must be balanced against the health problems caused by the manual handling of an increased number of heavier cages (e.g. back problems). Agree. The increase in cage size, and floor housing must be weighed up against ergonomic constraints in handling and cleaning. If there is a negative effect on staff, there is a risk that animals will not be group housed in an effort to use small and easily handled cages.



Worldwide Yes Yes, but some conditions like larger cages, floor and group housing will increase individual workload and physical stress (e.g. weight of cages to move)

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National representative It is true that increased animal welfare improves mental well-being of staff. However, this must be balanced against the health problems caused by the manual handling of an increased number of heavier cages (e.g. back problems). The increase in cage size, and floor housing must be weighed up against ergonomic constraints in handling and cleaning. If there is a negative effect on staff, there is a risk that animals will not be group housed in an effort to use small and easily handled cages.




Any positive impact on mental wellbeing caused by better living conditions for the animals must be weighed against possibly worse working conditions for staff due to having to handle larger cages and spend more time on cleaning tasks. Ergonomic issues from handling large numbers of big cages should not be underestimated - we have already encountered issues with this.



yes This does not address societal concerns. These should also be alleviated by the consistent adoption of the revised guidelines.


Public authority Local; Regional no probably no impact

Cris Iles-Wright Other Not applicable Not applicable Staff feel that increased welfare standards means more work, more tedious routines and more unwanted responsibilities.



1.1 and 1.4. The text implies as if the mentioned persons felt uncomfortable about their work, had a guilty conscience because of poor animal welfare. This is an unjustified prejudice. The questionnaire should refrain from making this kind of predictions.

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Other National Yes We agree that increased animal welfare improves the mental well being of staff. However, it is worth noting that increased cage sizes result in cages being heavier to handle, which could lead to health problems for staff moving them.


Other National representative See under III.A.B.1.5.


Other European yes We agree that increased animal welfare improves the mental well being of staff. However, increased cage sizes also mean that cages are heavier to handle, which could lead to staff health problems.



National; European


I think the mental well being of the animals is more important. Animal testers leave for home every day, lab animals leave dead with the garbage.




Present European guidelines give yet this positive impact on research teams. On the contrary, demand for group housing will increase stress and discomfort to research team, as more survey will be needed and fight behaviour will happen.


National; European


This is countered by possible negative impact on occupational health and ergonomics due to larger heavier equipment and cages.



Yes Only if animal treatment was inhumane, which is usually not the case

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Question IV.1.5.

Question text:

Statistics:




Comments received:





IV.1.5a.



National representative They may actually have a negative effect on level playing field if establishments in poorer countries will be confronted with unaffordable costs for increased cage sizes etc.

Level playing field: Minimum standards would ensure a level playing field by reducing unfair competitive advantages for establishments in countries which are not bound by the same standards. Do you support the preliminary findings? Yes/No/ No opinion

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There is no evidence that competitive advantages are being exploited.

sanofi pasteur R&D


Worldwide Vaccine field The new standards jeopardized European Research by increasing the husbandry costs, by requiring large amount of investments, by decreasing the research capacity… North-american countries and Asiatic countries are far from Europe requirements. This lack of competitiveness is also true within private companies with multiple research sites.




The preliminary finding cannot be supported as the standards outlined in Appendix A will not be applied outside the EU by their adoption through the revision of the Directive.



Worldwide Yes This will be true for Member States and countries which are party to the treaty but not to other parts of the world


Public authority National Yes These would certainly improve competitiveness , but not everyone would apply minimum standards + there must be flexibility to adapt/adopt novel innovative strategies which may enhance welfare - there are a number of examples which could be quoted - eg pig housing - welfare can be enhanced in some novel systems, in which space is below minima suggested in revised guidelines.



Minimum standards are minimum standards – not common harmonised requirements. They provide a baseline – but there must be scope to innovate, and thus improving welfare at the expense of uniformity.

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Other European No It is not correct to use here the word “unfair”. Improving animal welfare standards is accepted. If this also create a competitive level playing field within the EU (and between EU and non-EU countries who are Parties to the Convention) it is a positive side effect.



The statement "unfair competitive advantage" is unfair. Those member states which installed stricter standards did it voluntarily! Then who is or what is unfair here? Myself, as one coming from a country which falls below the standards of the revised Appendix A, accept the need of increasing the requirements if/because they are for improving animal welfare, but do not accept them if they are for reducing the "unfair" competitive advantage.




Be careful at new EU countries who have years before coming under compliance.



National YES It is not correct to define “unfair” what depends on legislative evaluations and decisions of Member States, which might have been taken accordingly to the reality of that country.

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Breeder of animals



60

Question IV.1.6.

Question text:

Statistics:




Comments received:





IV.1.6a.

Public accountability and ethical concerns: Standards based on current best practice and latest scientific knowledge on the welfare of animals would help in improving the public perception of animal experiments. Do you support the preliminary findings? Yes/No/ No opinion

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Augusto Vitale User of animals -public sector

National There are other relevant organisation

The main public perception about animal experiments is that animals should not be used at all. Improving housing conditions and aiming at a higher level of welfare would surely help, but it would not the main problem of communication. What is needed, first of all, is a correct and persistent flow of information, from scientists to general public, on the importance of using animals for biomedical experimentation



Regional; National

yes Public opinion of animal experiments will not improve with better housing of the animals. The public is concerned with animal suffering and simply putting an animal into a cage is enough for the public to disapprove. Better housing is not going to sway the public into support of caging, experimenting on, and killing of animals.

Bayer HealthCare



1.6 In principle this is correct, but industry has established similar or higher standards already by introducing global company standards or AAALAC accreditation, etc.



This makes the assumption that regulation is the only option for this output. As stated already this can also be achieved with increased openness from institutions and scientists: http://www.rds-online.org.uk/pages/page.asp?i_ToolbarID=5&i_PageID=2228 http://www.medicalprogress.org/animalhouse/index.cfm http://www.gsk.com/responsibility/cr_report_2005/research/animal-research.htm




In principle this is correct, but industry has established similar or higher high standards already by introducing global company standards or AAALAC accreditation, etc.



National yes In principle yes, but improving public perception demands more activities. On the other side there are countries with higher demands in keeping some species, like dog housing in Germany with no big impact on public perception.

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In principle the proposition is correct. Industry has however already introduced similar or even higher standards nationally or globally and has in many cases used independent verification of excellence by means of AAALAC accreditation. Sanofi-aventis is on track to have all sited AAALAC accredited by 2012.



Worldwide Yes Only if the imorivements in welfare are properly communicated to th public and where you can reach an understanding in the public standing for animal protection. The persons advocating for animal rights might difficultly or never be reached by these arguments.



National; Worldwide

yes It is always possible to get improved but most industry and some public institutions have already adopted high animal care and welfare standards such as AAALAC accreditation and / or benefited from international benchmarking exercises




The public perception of animal experiments is unlikely to be influenced through the adoption of new standards as there is such a poor understanding of the existing standards. It is our experience that when the public see the current welfare standards in animal facilities they are impressed anyway as they have been so negatively influenced by misrepresentations in the media.



Worldwide yes Industry has established similar or higher high standards already by introducing global company standards or AAALAC accreditation, etc. Morover, most of the public are certainly not aware of those more technical details. Their opinion is usually built on articles in boulevard newspapers and not on scientific facts.



Worldwide Representative See responses under 1.2

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Worldwide yes In principle this is correct, but industry has established similar or higher standards already by introducing global company standards or AAALAC accreditation, etc.




In principle this is correct, but industry has established similar or higher high standards already by introducing global company standards or AAALAC accreditation, etc



National representative In principle this is correct, but industry has established similar or higher high standards already by introducing global company standards or AAALAC accreditation, etc.


Public authority Local; Regional no this does not have any effect. Those who are against animal experimentation do not change their minds


Public authority Regional this organisation is representative for the field at the respective activity level

the public pinion is not based on facts.

Cris Iles-Wright Other Not applicable Not applicable A large proportion of the public appreciate that animal experiments are not a rational scientific method for research into human method and feel such action is akin to rearranging deckchairs on a sinking ship.



National; European


The public understands all too well the suffering of animals in laboratories. We do not need animal testers to decide what the needs of animals are.

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UK Laboratory Animal Science Association (LASA)


National LASA represents animal user community in academic, government & industry sectors.

This is correct in principle, but within the UK industry has established similar or higher standards already by introducing global company standards or AAALAC accreditation, etc.




One other Again, why should General Public accept animal experiments when alternatives exist.



Worldwide - In principle this is correct, but industry has established similar or higher high standards already by introducing global company standards or AAALAC accreditation, etc. but without having a positive impact on public perception on animal experiments.


National; European


Industry has its own published guidelines with high standards of welfare which companies adopt.



Yes see other answers concerning public image

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Question IV.1.7.

Question text:

Statistics:




Comments received:





IV.1.7a.

Upgrading costs for establishments regarding smaller animals: Evidence from European establishments which have already adapted to the revised guidelines indicates that the implementation has permanently increased the daily housing costs for rodents by about € 0.02 per animal. Do you support the preliminary findings? Yes/No/ No opinion

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C. Norman Scholfield


Regional; National; European; Worldwide

yes the daily cost for rats is far higher than this

Prof. Dr. R. Nobiling, University of Heidelberg



Biomed research at Univ. Heidelberg is Top - ranked

Cost are underestimated




XXX The costs suggested are far less than the “full economic costs” of implementing the revised ETS123, particularly with RH control requiring new equipment and ongoing high energy consumption at ever increasing energy prices and associated damage to the environment. Larger caging means more housing for the same number of animals, and new housing to new standards is extremely expensive. It is highly likely in public sector research that the high costs would cause some institutions to abandon all animal research.



Local; Regional; National

Yes This is likely to be an underestimate of the ongoing costs and that it ignores the main one-off costs. The changes in stocking densities will mean that, to accommodate the same number of animals, more housing will have to be constructed. The environmental control requirements in ETS123 (and previous guidelines) make animal housing extremely expensive to build. It has been estimated that the total one-off cost of upgrading to meet the ETS123 standards across the EU will exceed €1 billion. This estimate is based upon the costings produced by the UK universities when they had to upgrade in 1990.




But what about the initial cost for replacing equipment ? No one can believe the figure mentioned above.

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Estimate seems very low



National yes, competitive in the field of small animal research

animal rooms for small animals are usually fully occupied in universities and other research institutes. Increasing the space needed for each animal would require an upgrading of housing facilities and heavy investments



National yes Assuming that compliance with ETS123 have low cost for rodent only on per diem increase of 0.02 €/day/animal do not take into account that it is a 10% increase. This evaluation do not take in account that since many years laboratories upgraded their installations in prevision of the modification.



Local Not applicable, I am not an organisation

This will depend on the level of increase and also the level to which the establishment has upgraded e.g. conventional facility to individual ventilated racking, which is where animal research will end.



Industry does not usually cost animal care on a ‘per diem’ basis, but this is common on academia. In countries where full cost recovery is practiced an accurate figure might be obtained.

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This may be the case in industry in which the increase is seen in relation to the much larger development cost of getting a drug to market. I doubt whether this is the case for universities in which the cost will have to be borne by the user and grants – private or governmental.

sanofi pasteur R&D


Worldwide Vaccine field Our estimate is about 0.1 € increase per mice and 0.5 € per rabbit. But it also lead to a decrease of housing capacity. Consequences of the latter are either building new premises or externalization of research.





This may be the case in industry where the costs of the animal component of drug development are indeed very small. This does not apply to Universities in which the costs have to be carried by grants.



Worldwide Yes No evidence for this figure is give. Does it include capital costs to build new buildings due to reduced capacity (see IVe). Nearly impossible to calculate cost in a complex and constantly changing environment.




Not possible to answer as long as the cost was not calculated , cost likely different for a large company or for a small public lab



European Representitive We would have to increase our housing capacity by about 25%. This would be more than £0.02. Is this per day or per week, per month or a lifetime staement?

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Not possible to answer as long as the cost was not calculated, cost likely different for a large company or for a small public lab




This figure does not reflect the depreciation linked to the capital costs which will be required to be spent in adapting the new standards. Likewise this preliminary finding fails to represent the loss in efficiencies as fewer animals can be accommodated in existing facilities.



Worldwide pharmaceutical Not sure about the figure of 0.02 EUR per animal, but there may be a huge difference between the drug development, where the cost is spread over the long development cost of a drug and the academic research where the money needs to be used from one particular research project.



Worldwide yes Actually yes, but: No hard figures exist on this, but we assume that this increase in costs might be too low.The new requirements mean that the space demands will increase. This will result in increased work load for lab. animal caretakers. Sometimes, this will result in the fact that facilities will be too small to house the number of animals housed so far. This would mean either decreasing the number of experiments or building new facilities.



Worldwide Representative Although a permanent increase in the cost is expected following the implementation of the revised Appendix, this need to be properly calculated and might vary significantly from one Institution to another.




This may be the case in industry in which the increase is seen in relation to the much larger development cost of getting a drug to market. I doubt whether this is the case for universities in which the cost will have to be borne by the user and grants – private or governmental.




No evidence for this figure is given. Does it include capital costs to build new buildings due to reduced capacity (see IVe)?

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Animal Procedures Committee (APC)

Public authority National The APC provide independent advice to UK Government on the use of animals in scientific procedures. The APC consider science, industry and animal welfare. Members are from a variety of backgrounds.

We have not seen the evidence for these seemingly very conservative costings.


Public authority National Yes That sum is large in e.g. mouse per diem, and not knowing what has been upgraded renders the exact sum presented worthless.


Public authority National Yes What is a small animal? Strongly disagree . No – bearing in mind the new provisions for space requirements for breeding rodents this seems too low. FELABA have indicated – huge cost implications – 25% more buildings to keep same nos of animals. Where did these figures come from – these seem fictional – rats; hamsters; guinea pigs; gerbils; rabbits; dogs; cats propose significant changes from existing EU spec to new COE (UK is not nearly so badly affected).

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yes This seems very small increase but only discusses rodents. Birds will be very much increased costs due to space allowances.


Public authority National Regulatory authority in UK

Where are these figures derived from? (see also 1.10)




See comment 1.9


Public authority Worldwide yes it will require change of equippment and may put a great burden on Universities. The EU should support this




This is likely to be an underestimate of the ongoing costs and it ignores the main one-off costs. We estimated that the total one-off cost of upgrading to meet the new ETS123 standards across the EU will exceed €1 billion. This estimate is based upon the costings produced by the UK universities when they had to upgrade in 1990.

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The intitial one-time investment is missing! New cages, new racks, occasionally new equipments or buildings are needed.


Other Not applicable other Can have high initial infrastructure costs, for which money is often lacking


Other National Yes EBRA has estimated that the total cost of upgrading across the EU would be more than €1 billion.


Other Worldwide The Institute of Animal Technology is the prfessional body representing animal technologists

Evidence indicated that costs may be higher but this is outweighed by improvements in animal welfare, science and public attitude.


Other European yes We note that EBRA has estimated that the total cost of upgrading across the EU would be more than €1 billion.

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There is no data to support the figures presented so these cannot be verified. It is not possible to support the findings without knowing how the figures were calculated and what factors were taken into account. An increase in costs should not preclude improved housing conditions from being implemented because of the benefits to both animal welfare and science of so doing.



European Yes This is likely to be an underestimate of the ongoing costs and that it ignores the main one-off costs. The changes in stocking densities will mean that, to accommodate the same number of animals, more housing will have to be constructed. The environmental control requirements in ETS123 (and previous guidelines) make animal housing extremely expensive to build. We estimated that the total one-off cost of upgrading to meet the ETS123 standards across the EU will exceed €1 billion. This estimate is based upon the costings produced by the UK universities when they had to upgrade in 1990.




The costs suggested are far less than the “full economic costs” of implementing the revised ETS123, particularly with RH control requiring new equipment and ongoing high energy consumption at ever increasing energy prices and associated damage to the environment. Larger caging means more housing for the same number of animals, and new housing to new standards is extremely expensive. It is highly likely in public sector research that the high costs would cause some institutions to abandon all animal research.

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The Royal Society



We believe the costs have been underestimated (both in terms of one-off and ongoing costs), and do not take into consideration the ‘full economic costs’ of conducting animal research. Further increases in the cost of research using animals will reduce EU competitiveness.




No opinion. These estimates are out of the world!




We believe these costings are very conservative and do not take into consideration the full costs of conducting animal research (both at EU level and national level). The introduction of TRAC (Transparent Approach to Costing) methodology in UK universities has meant that universities are getting a clearer understanding of the full economic costs of animal research. As a result in some universities in the UK, costs of biological services are increasing by 50 – 80%.

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Question IV.1.8.

Question text:

Statistics:




Comments received:





IV.1.8a

Upgrading costs for establishments regarding larger animals: Evidence from European establishments which have already adapted or plan to adapt to the revised guidelines indicate, that for larger animals (non-human-primates and other larger mammals) on average a one-time investment of Euro 4,500 per animal was required to plan, design, and adapt their facilities to the new guidelines resulting in an increase of daily housing cost of about € 1,- per animal. Do you support the preliminary findings? Yes/No/ No opinion

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C. Norman Scholfield



yes what larger animals rabbits or pigs or what?




XXX Copy of 1.7. The costs suggested are far less than the “full economic costs” of implementing the revised ETS123, particularly with RH control requiring new equipment and ongoing high energy consumption at ever increasing energy prices and associated damage to the environment. Larger caging means more housing for the same number of animals, and new housing to new standards is extremely expensive. It is highly likely in public sector research that the high costs would cause some institutions to abandon all animal research.




Yes see comments to 1.7




No opinion these estimates are unbelievable





Real figures from real changes to adjust to revised guidelines suggest much higher figures. Worst-case scenarios must be worked out and presented transparently before this is approved.

Covance Laboratories GmbH


Worldwide yes We are currently upgrading our facilities and costs are 10000-15000 EUR per animal.

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Worldwide Yes Se above. Depending on how many years new facilities are depreciated over, we consider it will add £4 to £5 per day per dog for the new facilities that we might require.












The figure presented here appears to be an underestimate by a factor of 10 when capital investments and on-going depreciation are considered. Also given that many of the facilities which will have adapted to the new Appendix A proposals are located in the UK, smaller modifications will have been required in comparison to many other Member States which have must less generous guidelines for minimum housing standards.



Worldwide pharmaceutical A recent new dog building gave us the following figures: - 2880 sqm vivarium à 2600 EUR/sqm = 7.5 Mo EUR - 270 dog pens à 3800 EUR/pen = 1 Mo EUR => total cost 8.5 Mo EUR for a dog building for 270 dogs = 31.500 EUR/dog place



Worldwide yes We estimate that the costs will be higher, at least Euro 2 per animal. Moreover, also the annual maintenance costs will increase.



Worldwide Representative Increase in the costs need to be properly calculated and might vary significantly from one Institution to another.

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Depending on how many years new facilties are depreciated over, we consider it will add 6 to 8 Euros per day per dog for the new facilities that we might require.



We have not seen the evidence for these seemingly very conservative costings.

Francois Lachapelle INSERM

Public authority National BEA du CNRS, de l'INRA, du CEA

the avergae cost for primates is more important


Public authority National Yes No basis for figures. Costs will be increased significantly. Why are birds not mentioned, despite the fact that the new recommendations provide the biggest increases.

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yes Large one off, but low ongoing costs. I suspect these are not correct.



Where are costs derived from? see comments in 1.10




See comment 1.9.




This is likely to be an underestimate of the ongoing costs and it ignores the main one-off costs. We estimated that the total one-off cost of upgrading to meet the new ETS123 standards across the EU will exceed €1 billion. This estimate is based upon the costings produced by the UK universities when they had to upgrade in 1990.

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Evidence indicated that costs may be higher but this is outweighed by improvements in animal welfare, science and public attitude.




The figures presented by the Commission cannot be verified and it is not possible to have an opinion without knowing how these figures were calculated and what factors were taken into account. Nevertheless, an increase in costs should not preclude improved housing conditions from being implemented because of the benefits to both animal welfare and science of so doing. The cost is a one-time investment, and so in the long term the investment per animal diminishes.



European Yes See comments at 1.7 above




The costs suggested are far less than the “full economic costs” of implementing the revised ETS123, particularly with RH control requiring new equipment and ongoing high energy consumption at ever increasing energy prices and associated damage to the environment. Larger caging means more housing for the same number of animals, and new housing to new standards is extremely expensive. It is highly likely in public sector research that the high costs would cause some institutions to abandon all animal research.

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The Royal Society



We believe the costs have been underestimated (both in terms of one-off and ongoing costs), and do not take into consideration the ‘full economic costs’ of conducting animal research. Further increases in the cost of research using animals will reduce EU competitiveness.




No opinion. These estimates are out of the world!




We believe these costings are very conservative and do not take into consideration the full costs of conducting animal research (both at EU level and national level). The introduction of TRAC (Transparent Approach to Costing) methodology in UK universities has meant that universities are getting a clearer understanding of the full economic costs of animal research. As a result in some universities in the UK, costs of biological services are increasing by 50 – 80%.

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Question IV.1.9.

Question text:

Statistics:




Comments received:





IV.1.9a.

Length of transitional period: 0 If existing facilities and equipment do not conform to the revised guidelines, these should be upgraded within a reasonable period of time, taking into account animal welfare priorities and financial and practical concerns. Preliminary findings suggest that more than 70% of all establishments are able to comply with the revised guidelines within 48 months. A transitional period of 5 years from now would therefore allow all public and private establishments, including small- and medium-sized establishments, to comply. Do you support the preliminary findings? Yes/No/ No opinion

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Regarding 1.9, the imposition of a fixed transitional period such as 5 years would be of considerable concern. Although facilities should be upgraded to the new standards as quickly as possible, this has to take account of the individual situation, which can only be assessed by the national authority. Upgrading of facilities within 5 years could prove highly problematic, particularly within the academic/public sector and where new building/refurbishment to current standards has taken place within recent years.

Gesellschaft zur Förderung der biomedizischen Forschung


National The organisation is representative for the field at the respective activity level.

Compliance with the new ETS 123, App. A standards for caging will cause a substantially increase in costs in nearly all Member States, a 10 year phase -in period is needed as minimal time for compensation of that burden. Because of the high quality of existing housing conditions in rats and mice and other laboratory animals which guarantees health and welfare of them. The delay of an only moderate increase of welfare of these animals should balanced against the heavy burden which it causes in medical and basic research..

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Hannover Medical School



Hannover Medical School currently ranks highest with respect to research activities and aquired research grants

Compliance with the new ETS 123, App. A standards for caging will cause a substantially increase in costs in nearly all Member States, a 10 year phase -in period is needed as minimal time for compensation of that burden. Because of the high quality of existing housing conditions in rats and mice and other laboratory animals which guarantees health and welfare of them. The delay of an only moderate increase of welfare of these animals should balanced against the heavy burden which it causes in medical and basic research.

Hans J. Hedrich User of animals -public sector


I am currently President of the European College of Laboratory Animal Medicine (ECLAM) and Vicepresident Gesellschaft zur Förderung der Biomedizinischen Forschung

No; Compliance with the new ETS 123, App. A standards for caging will cause a substantial increase in costs in nearly all Member States, a 10 year phase-in period is needed as minimal time for compensation of that burden. Because of the high quality of existing housing conditions in rats and mice and other laboratory animals health and welfare is already guaranteed. The delay of only a moderate increase of welfare should be balanced against the heavy burden imposed on medical and basic research.





The high quality of existing housing conditions in rats and mice and other laboratory animals which guarantees health and welfare of them. The delay of an only moderate increase of welfare of these animals should balanced against the heavy burden which it causes in medical and basic research.

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Prof.Dr. Günter Klima


Not applicable yes medical university

Should be in the hand of the local governments




yes Upgrading costs may be a problem in both the academic and private areas, so a longer transition period is likely necessary in the case of some establishments. But this should be the task of national governments and companies.




XXX Planning and completing new building works to achieve close environmental control usually takes at least 4 years, even when funding is identified, which in most cases it is not. Moreover there can be serious delays/disruption due to extremist objections and protest, with resulting security difficulties during construction. A 5 year implementation period is therefore not realistic; 10 years would be necessary.




Yes Based on the time taken to upgrade UK facilities after the 1990 change in guidelines, the above preliminary findings are surprisingly low. There is particular concern about the ability of universities to find the money to pay for the necessary upgrading, since they will need to make a special case to their national governments for the extra funding. Experience has shown that governments can slow to meet such requests for funding and do not always give the full amount required. Accordingly, we recommend a 10 year transitional period.




Facilities that have been recently built in accordance with present guidelines cannot obtain investment for renewing before 5 to 10 years, especially, but not only, in public research. Then the 48 months delay begins running. As a consequence, 15 years is a realistic transitional period.



Worldwide there are others Compliance with the new ETS 123, App. A standards for caging will cause a substantially increase in costs in nearly all Member States, a 10 year phase -in period is needed as minimal time for compensation of that burden. Because of the high quality of existing housing conditions in rats and mice and other laboratory animals which guarantees health and welfare of them. The delay of an only moderate increase of welfare of these animals should balanced against the heavy burden which it causes in medical and basic research.

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National representative All public and private establishments can only comply if introduction of ETS123 standards will be accompanied by respective EU-wide programs for support.



Local; National; European; Worldwide

representative of a research university

I would go for 7 years as planning may be in 5 year blocks




GIven the very significant costs involved, even for the "old" MS, a 5 year transition period seems too short; a minimum of 10 years is necessary, unless the EU gemnerates special funds to improve the housing quality quickly.




Potentially not sufficient.



Not applicable we are a medical university.

longer transition period is needed.



National yes I think this period should be 10 years, to allow the financial burden to be more easily distributed

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Local; National There are several central laboratory animal facilities at Austrian universities

Funding of transition may be a problem in the academic area, so a longer transition period may be necessary for some establishments.




No opinion: this is all dependent on how far behind the 30% of establishments are. They may be concentrated in certain regions, hence setting those regions back, impairing their (scientific) development.




No The new Member States have only recently implemented the old ETS123 standards and the academic sector has significant problems finding the funding to meet new capital requirements, the minimum sensible phase-in period should be 5 years, and the ideal period should be 10 years



Local yes No, a transitional period of 5 to 10 years is necessary depending on the establishment.



National no Compliance with the new ETS 123, App. A standards for caging will cause a substantially increase in costs in nearly all Member States, a 10 year phase -in period is needed as minimal time for compensation of that burden. Because of the high quality of existing housing conditions in rats and mice and other laboratory animals which guarantees health and welfare of them. The delay of an only moderate increase of welfare of these animals should balanced against the heavy burden which it causes in medical and basic research

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YES A transitional period of 5 years is not sufficient.



National yes mandatory application of the revised guidelines should not be decided especially considering agricultural research in which one has to compare to farming practices



National Some smaller institutes exist in the Netherlands

In view of the very high costs necessary to implement the revised guidelines, a transitional period of 10 years would be preferable, as it allows better spreading of the costs.



National yes Compliance with the new ETS 123, App. A standards for caging will cause a substantially increase in costs in nearly all Member States, a 10 year phase -in period is needed as minimal time for compensation of that burden. Because of the high quality of existing housing conditions in rats and mice and other laboratory animals which guarantees health and welfare of them. The delay of an only moderate increase of welfare of these animals should balanced against the heavy burden which it causes in medical and basic research..



Local organisation is representative

this question was not in the questionnaire when I printed it out

Bayer HealthCare



1.9 Many companies already comply or will shortly comply with requirements for rodents. However, adaptation of facilities for larger animals, such as dogs or NHPs (but also guinea pigs), will require more time (minimum 5 years, sometimes longer). In case of too short transitional periods (less than 5 to 10 years), the changes could not be made smoothly without seriously disrupting companies’ ongoing work.

Covance Laboratories GmbH


Worldwide yes A 5 year period is considered too short given the financial impact of upgrading. For public and academic institutions longer periods may be required than for private sectors.

89



Many institutions outside major industry or national research centres have not yet fully implemented the existing Appendix A. Given the investment cycle, the time for construction and commissioning, the need for extra staff, and the fixed research budgets from the public sector it seems unrealistic to consider any period of less than 10 years




Many companies already comply or will shortly comply with requirements for rodents. However, adaptation of facilities for larger animals, such as dogs or NHPs (but also guinea pigs), will require more time (minimum 5 years, sometimes longer). Initial estimate is that the proposed by CoE transitional period of 3 years will not be enough for - the capital investment cycle and renewal of material - allowing design and construction of adapted facilities - expanding animal facilities area - adapting procedures to new occupational health requirements (bigger and hence heavier and less mobile material) - adapting organisation of work within the laboratory.

sanofi pasteur R&D


Worldwide Vaccine field Yes for large private companies, not for biotech companies which are quite young and already invested in new equipment, and not possible at all for public research. 15 years seems more reasonable in order not to jeopardize European public research funds.



National yes No, experiences in companies and universities show that the time period should be 5 years and longer. The time of 48 months could be realised if there are no obstacles in the meantime.





See the overall analysis

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Worldwide Yes In large establishments, with several animal facilities, a 10 year period will most certainly of practical and financial reason be needed to refurbish all facilities, if necessary.




For rodents, it would be easier and shorter to comply but for large animals, adaptation of facilities would take lot of time and moneys (at least 5 years) to avoid to be obliged to stop all the activity in the lab. Cost and construction/modifications of building should be diluted on several years. Training of staff and changes in the organisation of the lab also required times In addition, suppliers of cages (very specific activity) should be overbooked if all labs need to buy materials at the same time



Worldwide Yes Adaptation of facilities for larger animals to the intended changes require longer than five years.




For public establishment or for large animals, 5 years isn’t enough to comply ! due to cost, scientific justifications, …



National; Worldwide

yes The "original" Appendix A is already implemented in most E.U. countries. Only the recent E.U. member states still have to do it.The figures can be accepted for most pharmaceutical companies but one should be very careful with other institutions. For rodents, it should be "easier" to comply . An exception could be the breeding establishments that may have to modify, redesign or even extend the rodent building for rodents, especially for guinea pigs. For large animals, the process will be much time and budget consuming, .A 3 year transition period in too short to manage the transition. A 5 year-period seems to be a minimum to address all related issues (capital investment, facility renovation or adaptation or expansion, new working procedures and organization…) One should be aware that this transition has to be carried out without jeopardizing the research activity.This observation is based on practical experience from several research sites having already initiated the process.

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For rodents, it would be easier and shorter to comply but for large animals, adaptation of facilities would take lot of time and moneys (at least 5 years) to avoid to be obliged to stop all the activity in the lab. Cost and construction/modifications of building should be diluted on several years. Training of staff and changes in the organisation of the lab also required times In addition, suppliers of cages (very specific activity) should be overbooked if all labs need to buy materials at the same time





Many companies already comply or will shortly comply with requirements for rodents. However, adaptation of facilities for larger animals, such as dogs or NHPs (but also guinea pigs), will require more time (minimum 5 years, sometimes longer). Initial estimate is that the proposed by CoE transitional period of 3 years will not be enough for -the capital investment cycle and renewal of material -allowing design and construction of adapted facilities -expanding animal facilities area -adapting procedures to new occupational health requirements (bigger and hence heavier and less mobile material) -adapting organisation of work within the laboratory. If 3-year transitional period is maintained, the changes could not be made smoothly without seriously disrupting companies’ ongoing work. This assessment is based on contributions from 12 major R&D companies having their research facilities in Europe (UK, France, Germany, Switzerland, Denmark, Hungary, Croatia, Belgium).



Worldwide yes 5 years is maybe too short

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A 5 year transition period is very short given that any capital planning cycle in the public/private sector is prolonged. In some cases facilities can be adapted through internal building modifications. However in other cases, new buildings or external modifications may be required and this involves planning permission from local or national authorities. The commissioning of new facilities is a very complex process and may involve troubleshooting over a period of one year or more. Implicit in the preliminary finding is that 30% of establishments require more than 4 years to make modifications. Simultaneous modification of buildings throughout Europe would tie up all the specialist architectural firms available for the work and the productivity of the research sector would decline. Therefore there is a risk that work would move out of the EU due to reduced capacity and this factor alone should require the Commission to consider a phase in period of > 10 years.



Worldwide No Adaptation of facilities can take a long time to budget and plan for, and needs to be achievable within the business plan of an organisation – there is no point in spending a lto of money to meet a five year targert if by doing so the company would be driven out of business. The likely end result in such cases would be a decision to relocate work out of the EU rather than meet a too-tight timescale. Suggest 7 years minimum.



Worldwide pharmaceutical A transitional period of at least 5 years may eventually be feasible for major companies, although we doubt this would be feasible for academic and public research.

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An assessment by EFPIA, our trade association, of contributions from 12 major R&D companies having their research facilities in Europe (UK, France, Germany, Switzerland, Denmark, Hungary, Croatia, Belgium, Italy) shows that many companies already comply or will shortly comply with requirements for rodents. However, adaptation of facilities for larger animals, such as dogs or NHPs but also guinea pigs), as well as for those which do not comply with requirements for facilities, will require more time (minimum 5 years, sometimes longer). This also applies to our academic collaborators. 3 years will not be enough because of the need to apply for funding for new cages and in many instances, new buildings; time for specification and planning of new facilities; the building and setting up of new operations and processes, especially with respect to human health and safety ( eg manual handing issues). 10 years would be a realistic period for this, but the absolute minimum is 5 years



Worldwide yes We comply or will shortly comply with requirements for rodents. But adaptation of facilities for larger animals (dogs, NHPs, guinea pigs), will require more time (min. 5 years). Proposed CoE transitional period of 3 years will not be enough for - capital investment cycle & renewal of material - allowing design & construction of adapted facilities - expanding animal facilities area - adapting procedures to new occupational health requirements (bigger & hence heavier & less mobile material) -adapting organisation of work within the laboratory. Too short transitional periods (less than 5 to 10 years) mean: changes could not be made smoothly without seriously disrupting companies’ ongoing work (our experience in CH & Germany).



National Yes Please see 1.0



Worldwide Representative Adaptation of facilities for larger animals (dogs and NHPs) may require fundamental upgrading at some Institutions, taking even more than 5 years. Costs and time should be reconsidered, ensuring adequate time and progression of ongoing activities.Timelines may finally be even longer for public institutions and for Facilities located in specific geografic areas (ie Eastern EU).

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Worldwide yes An assessment by EFPIA, our trade association, on contributions from 12 major R&D companies having their research facilities in Europe (UK, France, Germany, Switzerland, Denmark, Hungary, Croatia, Belgium, Italy) shows that many companies already comply or will shortly comply with requirements for rodents. However, adaptation of facilities for larger animals, such as dogs or NHPs but also guinea pigs), will require more time (minimum 5 years, sometimes longer). This also applies to our academic collaborators. 3 years will not be enough because it is necessary to provide justifications to obtain funding ( the new requirements will mean new buildings may be needed in some cases – not just cages); time specification and planning of new facilities, building and the setting up of new operations and processes, especially with respect to human health and safety ( eg manual handing issues). 10 years would be a realistic period for this, but a minimum of 5 years is needed.



Worldwide yes Many companies already comply or will shortly comply with requirements for rodents. However, adaptation of facilities for larger animals, such as dogs or NHPs (but also guinea pigs), will require more time (minimum 5 years, sometimes longer). Initial estimate is that the proposed by CoE transitional period of 3 years will not be enough for - the capital investment cycle and renewal of material - allowing design and construction of adapted facilities - expanding animal facilities area- adapting procedures to new occupational health requirements (bigger and hence heavier and less mobile material)- adapting organisation of work within the laboratory. If 3-year transitional period is maintained, the changes could not be made smoothly without seriously disrupting companies’ ongoing work.



Worldwide no The adaption of facilities for larger animals (dogs) might need longer than 5 years if a completely new building has to be constructed.

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For the majority of companies a 5 year transitional period will be sufficient, with difficulties maybe in some Eastern European companies. However, this will create major problems for the European academia which are often depending on grants to cover costs.




Many companies already comply or will shortly comply with requirements for rodents. However, adaptation of facilities for larger animals, such as dogs or NHPs (but also guinea pigs), will require more time (minimum 5 years, sometimes longer). Initial estimate is that the proposed by CoE transitional period of 3 years will not be enough for - the capital investment cycle and renewal of material - allowing design and construction of adapted facilities - expanding animal facilities area - adapting procedures to new occupational health requirements (bigger and hence heavier and less mobile material) - adapting organisation of work within the laboratory. In case of too short transitional periods (less than 5 to 10 years), the changes could not be made smoothly without seriously disrupting companies’ ongoing work. This assessment is based on contributions from 12 major R&D companies



Worldwide Yes From my experience adaptation for large animals will take up to 10 years.



National representative Many companies already comply or will shortly comply with requirements for rodents. However, adaptation of facilities for larger animals, such as dogs or NHPs (but also guinea pigs), will require more time (minimum 5 years, sometimes longer). In case of too short transitional periods (less than 5 to 10 years), the changes could not be made smoothly without seriously disrupting companies’ ongoing work.

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If new facilities are required, this timeline of 4-5 years is inadequate. A typical new building project takes around 2 years to plan and find funding, 2 years to build and 6 months to bring into use - this is the best case scenario. A timeline of 10 years is much more realistic.



Five years is generally regarded as a minimum period to make significant changes in academic institutions because many large research grants have a five year life, as have most project licences. Upgrading would not be a major problem for the UK, but might be for other member states.




Some experiments are designed for more than 5 years and the transitionalperiod should be extended or there should be place for specialregulations.

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Public authority National Yes There would be legitimate exceptions. Much can be done by adjusting stocking densities but some cage/enclosure lives will significantly exceed 5 years.


Public authority Local yes Compliance with the new ETS 123, App. A standards for caging will cause a substantially increase in costs in nearly all Member States, a 10 year phase -in period is needed as minimal time for compensation of that burden. Because of the high quality of existing housing conditions in rats and mice and other laboratory animals which guarantees health and welfare of them. The delay of an only moderate increase of welfare of these animals should balanced against the heavy burden which it causes in medical and basic research..


Public authority Local yes Compliance with the new ETS 123, App. A standards for caging will cause a substantially increase in costs in nearly all Member States, a 10 year phase -in period is needed as minimal time for compensation of that burden. Because of the high quality of existing housing conditions in rats and mice and other laboratory animals which guarantees health and welfare of them. The delay of an only moderate increase of welfare of these animals should balanced against the heavy burden which it causes in medical and basic research..



yes This timing would not be able to be complied with in all establishments. Some work would stop. It is however, a good timeline to work with. Exemptions to this could then be accepted where a valid arguement is accepted AND where a reasonable time frame for compliance is in place.




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We believe there would be legitimate exceptions and that the focus should be to invest in the short term where the greatest welfare gains are to be had. In some circumstances the life-cycle of facilities may make a five year transitional period impractical.




A standards for caging will cause a substantially increase in costs in nearly all Member States, a 10 year phase -in period is needed as minimal time for compensation of that burden. Basic research requires stress-free animals. Tthe existing housing conditions in rats and mice and other laboratory animals is therefore usually high quality already because it guarantees health and welfare of the animals. An only moderate increase of welfare of these animals should balanced against the heavy financial burden which it causes in medical and basic research.


Public authority National representative Compliance with the new ETS 123, App. A standards for caging will cause a substantially increase in costs in nearly all Member States, a 10 year phase -in period is needed as minimal time for compensation of that burden. Because of the high quality of existing housing conditions in rats and mice and other laboratory animals which guarantees health and welfare of them. The delay of an only moderate increase of welfare of these animals should balanced against the heavy burden which it causes in medical and basic research..


If conditions are unsatisfactory, then the transition period must be swifter.




Even when funding is identified planning and completing new building works to achieve close environmental control usually takes at least 4 years, A 5 year implementation period is therefore not realistic. We recommend a 10 year transitional period.

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Other European No No, a transitional period of 5 to 10 years is necessary depending on the establishment.

Medical University of Vienna

Other Local; Regional; National; European; Worldwide

Research in Medicine

Upgrading costs may be a problem in both the academic and private areas, so a longer transition period is likely necessary in the case of some establishments. But this should be the task of national governments and companies

Royal Netherlands Akademie of Arts and Sciences

Other National Yes, representative of the scientific community

Costs for user establishments can be very high, compared to the annual budgets; therefore we recommend allowing a transitional period of 5-10 years.



Considering the costs and the scarsity of funding for this purpose a minimum of 10 year transitional period is necessary. Alternatively, if the transitional period is 5 years then the EU should provide sufficient funding for this purpose.

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Other Not applicable other Upgrading costs may be a problem in both the academic and private areas, so a longer transition period is likely necessary in the case of some establishments. But this should be the task of national governments and companies.


Other National Yes Feedback from companies indicates that a minimum of five years -possibly longer – would be needed to adapt facilities for larger animals.


Other European yes Based on the feedback from companies, adaptation of facilities for larger animals would require a minimum of five years, but possibly longer.

Austrian Society of Toxicoloy (ASTOX)


National Yes a transitional period of 5 to 10 years is necessary depending on the establishment. Compliance with the new ETS 123, App. A standards for caging will cause a substantially increase in costs in nearly all Member States, a 10 year phase -in period is needed as minimal time for compensation of that burden. Because of the high quality of existing housing conditions in rats and mice and other laboratory animals which guarantees health and welfare of them. The delay of an only moderate increase of welfare of these animals should balanced against the heavy burden which it causes in medical and basic research.

British Heart Foundation


National We are a medical research charity, of which there are many in the UK

No comment.

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On animal welfare grounds, a transitional period of 5 years is totally unacceptable. Though not adopted until June 2006, details of the revised ETS123 Appendix A were published on the Council of Europe website in June 2003. Establishments throughout Europe were therefore aware of the husbandry and care standards agreed as required to ensure good animal welfare. As stated in (IV)b, almost a quarter of establishments have already adjusted their facilities to meet these new standards. The revised Appendix A will not come into force until July 2007, allowing a further year for establishments to upgrade facilities. An additional transitional period is therefore completely unacceptable. If individual establishments consider a transitional period to be essential, then this should be considered on a case by case basis, taking account of: the current standards of husbandry and care; how far these differ from the revised standards; and what adverse effects this has on animal welfare.



European Yes Based on the time taken to upgrade UK facilities after the 1990 change in guidelines, we find the above preliminary findings surprising and assume that they are not based on a representative sample. There is particular concern about the ability of universities to find the money to pay for the necessary upgrading, since they will need to make a special case to their national governments for the extra funding. Experience has shown that governments can slow to meet such requests for funding and do not always give the full amount required. Accordingly, we recommend a 10 year transitional period.

European Coalition to End Animal Experiments (ECEAE)


Worldwide Representative (the only EU coalition focusing on animal experiments)

Given that 10 Member States have ratified the Europe Convention 123 covering 91% of animal use in the EU and many of the general provisions are already in place, and given that the revised Appendix A of ETS123 will only comeinto force in mid 2007, we are not prepared to accept any additional transitional periods. Given that the ETS guidelines are a minimum it is not morally acceptable to fail to implement these immediately.

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Regarding 1.9, the imposition of a fixed transitional period such as 5 years would be of considerable concern. Although facilities should be upgraded to the new standards as quickly as possible, this has to take account of the individual situation, which can only be assessed by the national authority. Upgrading of facilities within 5 years could prove highly problematic, particularly within the academic/public sector and where new building/refurbishment to current standards has taken place within recent years.



National; European

Yes No, a transitional period of 5 to 10 years is necessary depending on the establishment.

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PETA Europe Ltd.


Worldwide both The transition period suggested is inconsistent with animal welfare needs and cannot be justified. The extreme boredom of inadequate housing induces some animals to overeat and others to undereat, leading to obesity and severe weight loss (Gunn-Dore 1997). Resulting physical problems include degenerative changes in the spine and hip joints of rabbits (Wieser 1986). Poor housing can affect the results of experiments as well as impacting badly on animal welfare. When deprived of companionship for extended periods, primates develop unmistakable signs of depression and frustration. Some 10% of single-caged monkeys develop the serious behavioural pathology of self-injurious biting (Jorgensen et al. 1998). Behavioural assessment of 362 singly housed rhesus monkeys found that 321 exhibited at least one abnormal behaviour (Lutz et al. 2003).



National; European


These periodes to comply with a set of minimum rules are a scandal. We are not even talking about housing that animals would need/deserve.

The National Anti-Vivisection Society



The NAVS is the leading and oldest anti-vivisection organisation in the world. There are a number of other relevant anti-vivisection organisations around the world with expertise in this field.

The NAVS do not consider the suggested transitional period to be satisfactory, given that 91% of animal use in the EU is said to comply with the guidelines in the Appendix A in the Council of Europe Convention for the protection of vertebrate animals used for experimental and other scientific purposes (ETS 123). The NAVS reports “Access Denied” (1996) and “Labs unlocked” (1994) show how very significant welfare problems can arise rapidly even when minimum standards are met (suffering through attack/injury, boredom, accidents such as cage flooding etc). We therefore suggest that the transitional period is shortened to two years, and that efforts are made to exceed the legal minima, as outlined below. References: Access denied (1996) NAVS report http://www.navs.org.uk/publications/reports/c=1 Labs unlocked (1994) NAVS report

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Planning and completing new building works to achieve close environmental control usually takes at least 4 years, even when funding is identified, which in most cases it is not. Moreover there can be serious delays/disruption due to extremist objections and protest, with resulting security difficulties during construction. A 5 year implementation period is therefore not realistic; 10 years would be necessary.

The Royal Society



Raising the required investment, obtaining planning permission and completing new building works to upgrade facilities to meet the standards required by ETS123 is likely to take longer than five years, particularly in new Member States. Therefore we believe that a five year implementation period is not realistic and at least a ten year transition period is required.




both This long period cannot be justified, neither from an animal welfare point of view, nor from a human point of view. The extreme boredom and under stimulation of lab animals, as well as the stress lead to many physical problems and stereotypical behaviour. Please refer to Balcombe JP. 2006, Laboratory Environments and Rodents' Behavioural Needs: A Review. Laboratory Animals 40: 217–235.



National yes Upgrading costs may be a problem in both the academic and private areas, so a longer transition period is likely necessary in the case of some establishments. But this should be the task of national governments and companies.

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Facilities that have been recently built in accordance with present guidelines cannot obtain investment for renewing before 5 to 10 years, especially, but not only, in public research. Then the 48 months delay begins running. As a consequence, 15 years is a realistic transitional period.



National YES Although facilities should be upgraded to the new standards as quickly as possible, the transitional period should be decided by the national authorities taking into account the reality of the country and individual situations. Upgrading of facilities within 5 years could prove highly problematic, particularly within the academic/public sector and where new building/refurbishment to current standards has taken place within recent years.



National The Danish Society of Pharmacology and Toxicology represents Danish pharmacologists and toxicologists.

See 1.10.




Whilst we broadly support the introduction of these new provisions, which largely represent existing best practice in the UK, we support a minimum phase in period of 5 years and an optimum transition period of 10 years. Universities and institutions across Europe (especially those based in new Member States) will require this amount of time to raise the investment required to pay for the necessary upgrading of animal facilities.



National yes In case of too short transitional periods, the changes could not be made smoothly without seriously disrupting ongoing work, especially for academia.

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Worldwide yes Mandatory compliance with the new ETS 123 Appendix A standards for caging will cause a substantial increase in costs in nearly all Member States, a 10 year phase-in period is needed as a minimal time for compensation of that burden. The high quality of existing housing conditions in rats and mice and other laboratory animals currently guarantees health and welfare to them. The moderate increase in welfare that is to be expected should be balanced against the heavy burden, which it causes on medical and basic research.



Worldwide yes From an global acting company point of view and experiences due to several merges in the past an 5 Year transitional period could be to short. Due to enhanced cages sizes facility space has to be increased as well, which is often not possible without additional Construction measures.


National; European


See above. Academic institutions in particular will have difficulty raising the required funding and capital.


Local representative In case of too short transitional periods, the changes could not be made smoothly without seriously disrupting ongoing work, especially for academia.




In case of too short transitional periods, the changes could not be made smoothly without seriously disrupting ongoing work, especially for academia.

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Question IV.1.10.

Question text:Justification (open text box)

Statistics:(no numbers registered as this was not a closed question)

Comments received:





IV.1.10. Justification

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N.B. A.IV.b refers to 10 Member States, A.IV.c to 12. Which is correct?

Dr ICH Smith User of animals -public sector

National I am not an organisation

Use same fundamental rules for farmstock and pets.

KTL (National Public Health Institute)


National yes, in occupational health there is the Finnish Institute of Occupational Health

Again there is a matter of justice. How do you ascertain that the conditions for pets are even close to the requirements set for experimental animals? Education in this field is far more important than detailed regulations.





Compliance with the new ETS 123, App. A standards for caging will cause a substantially increase in costs in nearly all Member States.

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Local Yes 1.1. Percentages cannot be correct, compliance in most countries must be considerably higher. There will be improvement in facilities where these minimum criteria are not met. 1.7. That sum is large in e.g. mouse per diem, and not knowing what has been upgraded renders the exact sum presented worthless.

Torgny Jeneskog, Umeå University, Sweden



Yes, guess so ... My "Yes" to 1.6 is my sincere hope, but ....




yes There are very high standards in housing and animal care not only for ethical but also for scientific reasons. However, a distinction between regular animal housing and experimental requirements is necessary. The optimal conditions for animals and experiments depend on the scientific question and have to be individually defined for each project. Thus, at times, adaptations to experimental necessities may be in conflict with environmental enrichment. Concerning animal welfare more attention should be paid to the hierarchical stress during the formation of new animal groups caged together in the course of the randomization process during experiments.




XXX Section A omits the considerable costs of close control of temperature and relative humidity within the revised ETS123. Compliance 98% of the time saves considerably on 100% compliance on both capital costs and ongoing energy requirements, as equipment does not need to manage occasional extreme weather conditions that have no impact on welfare. As pointed out during ETS123 discussions, fine RH control involves complex and costly equipment, and the increased risks of equipment failure causing major temperature fluctuations (that can have significant welfare impact) are greater than the disadvantages of incompletely controlled RH. Why is RH signalled for control when, for instance, dietary vitamin levels, which have far greater welfare impact, are not?



Local; National; European; Worldwide

representative of a research university

This requires some detailed analyses and cost are relative depending on what is counted as a ‘cost’ e.g. scientists’ salaries and time, utilities, building replacement, depreciation of equipment etc. I would also go for a 5 year review by the competent authority and a 7 year compliance.

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This transition phase appears to be very short, especially for academic institutions with the danger that they cannot continue their research. Funding for the implementation may cause difficulties in academic institutions.




Other organisations in Austria: Karl-Franzens-University; Medical University Vienna; Medical University Innsbruck

A transition period is essential, the transitional period should be at least 5, preferably 10 years. Introducing ETS 123 standards for animal caging will bring considerable financial burdens to European Universities and Researchers. It has to be accompanied by respective EU-wide programs for supporting the build up of such infrastructures.




Yes Mandatory group housing is a fine thing in some instances but impracticable and even inhumane (see below) in other instances. Therefore, exemptions must be allowed. For instance, males of certain mouse strains kept in groups do fight with each other to an extent that some of the males are killed. Certain behavioural experiments make it also necessary to keep animals temporarily in isolation to avoid that handling of one animal causes measurable stress to the companion animals. Inplementation of standard housing conditions is welcome, but the compulsory introduction of ETS 123 standards for animal caging will cause considerable costs to European universities and researchers which/who are notoriously short of money. This measure has to be supported financially on an European level, by a redirection of budget from non-science matters.



Regional yes A transition period is essential, the transitional period should be at least 5, preferably 10 years. Introducing ETS 123 standards for animal caging will bring considerable financial burdens to European Universities and Researchers. It has to be accompanied by respective EU-wide programs for supporting the build up of such infrastructures.

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Yes 5 years is insufficient for major building work which will be required in some places.




Ad Introduction: there seems to be a discrepancy between the numbers of member states that are parties to the Convention. In IVb. you refer to 10 member states, whereas in IVc. a figure of 12 member states is mentioned.




Yes 5 years transitional period may not be sufficient.



Local yes At IV. e) In principle yes but with some changes of the Appendix A of the Europe Convention ETS 123 and with a period for adaptation for the establishments up to 10 years. At 1.6 In principle yes but experience in some Member States shows that this is not always the case.




Yes Stocking densities may cause problems and be difficult to manage - necessity to split social groups with a risk of housing some animals singly because of weight limits (potentially causing other welfare and impact issues)




YES The present situation of animal housing is quite satisfactory in most labs and such as to render happy the people working with them. The allocation of a large amount of money on useless improvements drains money from research rendering EU research non competitive with that of US and Japan.

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National; Worldwide

yes, major UK research organisation for aquatic organisms and environment

One qualification to support is that improving and enriching the environment must take account of health and hygiene, so must be manageable without excessive staff. (A local example is that sea-horses are kept in fairly spartan tanks because they have to be cleaned out twice every day.)



Local organisation is representative

The transitional period should be no longer than 2 years.

Bayer HealthCare



Currently, the Directive contains non-mandatory guidelines identical to the old Appendix A. These standards are met or exceeded in all the old Member States and many establishments in these countries have started to implement the standards in the new Appendix A. It is unlikely to make much difference whether the new Appendix A is implemented in the revised Directive as guidelines or made mandatory. In either case, the vast majority of EU establishments will implement them in the next few years. However, this will produce a very significant cost (estimated to be in excess of a €1 billion) and a substantial increase in ongoing costs, to meet the lower stocking densities in the revised Appendix A. Making the Appendix A standards mandatory will mean that all establishments have to implement them sooner than if they were only guidance, but this will be formalised with a defined phase-in period.



The assumption here appears to be that unless housing and care guidelines are mandatory they will not be observed. What will happen if they are mandatory is that change to better practice will be obstructed, and costs will rise unreasonably for compliance. http://www.bsf.ac.uk/responses/Davidson.pdf

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National yes As mentioned in the analysis the revised Appendix A is in several MS the basis for animal housing, the status as a non-binding guideline for the housing and care of laboratory animals will prolonged time for implementing the requirements in an adequate time. Time pressure of 5 years is not mandatory. I think the revised Appendix A could be now tested in practised and before it is binding for all MS. The practical experiences can show what demands are useful and are changes necessarily.





Seen from an Industry viewpoint, the implementation of ETS 123 Rev A is a process that has commenced and is ongoing albeit at considerable cost. EBRA estimates this to be in excess of €1 billion. There will also vbe significant ongoing costs due to reduced stocking densities in the event of institutions not being able to rebuild to allow for the same numbers of animals in existing spaces. Making Appendix A mandatory will place unacceptable restraints on establishments that will have to seek funding. Bearing in mind that the new member states have only recently started implementing the pre-revision standards, and that Universities will have significant funding deficits, the implementation period should be at least 5 to preferably 10 years.



Worldwide Yes Overall, we support the revised Appendix A. However, the cost and time taken to implement it across the EU must not be underestimated. Nor should one underestimate the likelihood that companies may choose to make capital investments outside the EU, where the environment for research is becoming more supportive than within the EU.




no comment



National; Worldwide

yes The original Appendix A requirements are implemented met or exceeded in most western E.U. and the revision is already used as the new reference document. This means that most establishments in the E.U. will start implementing them in over the next few years, initiating a very expensive and time consuming process. The implementation of the revised Appendix A will take minimum 5 years in the best situations. In some countries or institutions, it could be necessary to extend the period of time up to 10 years. During the transition period, it is however possible to follow up the evolution towards this objective.

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no comment



Worldwide There are other relevant organisations

1.2. Benefits of enrichment on animal welfare and quality of results are still controversial and need to be further investigated.





Bearing in mind that the new Member States have only recently had to implement the old Appendix A standards and that the academic sector has significant problems finding the funding to meet new capital requirements, the minimum sensible phase-in period should be 5 years, and the ideal period should be 10 years.



Worldwide No Re 1.7 & 1.8 - unable to agree or disagree with the figure, but no doubt that there are initial and on-going costs associated with improved animal housing.




It is unlikely to make much difference whether the new Appendix A is implemented in the revised Directive as guidelines or made mandatory. In either case, the vast majority of EU establishments will implement them over time. However, this will produce a very significant one-off cost (estimated to be in excess of a €1 billion – figure advised by EBRA) and a substantial increase in ongoing costs, to meet the lower stocking densities in the revised Appendix A. Making the Appendix A standards mandatory will mean that all establishments have to implement them sooner than if they were only guidance, but this will be formalised with a defined phase-in period. Bearing in mind that the new Member States have only recently had to implement the old Appendix A standards and that the academic sector has significant problems finding the funding to meet new capital requirements, the minimum sensible phase-in period should be 5 years, and the realistic period should be 10 years.

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Worldwide yes It is unlikely to make much difference whether the new Appendix A is implemented in the revised Directive as guidelines or made mandatory. In either case, the vast majority of EU establishments will implement them in the next few years. However, this will produce a very significant one-off cost (estimated to be in excess of a €1 billion) and a substantial increase in ongoing costs, to meet the lower stocking densities in the revised Appendix A. Making the Appendix A standards mandatory will mean that all establishments have to implement them sooner than if they were only guidance, but this will be formalised with a defined phase-in period. Bearing in mind that the new Member States have only recently had to implement the old Appendix A standards and that the academic sector has significant problems finding the funding to meet new capital requirements, the minimum sensible phase-in period should be 5 years, and the ideal period should be 10 years.



Worldwide Yes 5 yeras transitional period is the minimum since high investments are needed




there are multiple independent Contract Research Organisations in UK and EU

No comments



National Yes Experience of pharmaceutical companies shows that these figures could apply in Northern Europe, but not in all member states and not in academia and public research establishments. Many companies already comply with requirements for rodents. However, adaptation of facilities for larger animals, such as dogs or NHPs (but also guinea pigs), will require more time (minimum 5 years, sometimes longer). Initial estimate is that the proposed by CoE transitional period of 3 years will not be enough for the capital investment cycle . Changes could not be made smoothly in a 3-year transitional period without seriously disrupting our ongoing work.

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Worldwide Representative The implementation of the revised Appendix A will generate a very significant increase in research costs and potential negative effects on the ongoing research activities. Attention should be paid to avoid outsourcing of strategical activities to non-EU destinations.



Worldwide yes Currently, the Directive contains non-mandatory guidelines identical to the old Appendix A.These standards are met or exceeded in all the old Member States and many establishments in these countries have started to implement the standards in the new Appendix A.It is unlikely to make much difference whether the new Appendix A is implemented in the revised Directive as guidelines or made mandatory. In either case, the vast majority of EU establishments will implement them in the next few years. However, this will produce a very significant one-off cost (ca €1 billion) and a substantial increase in ongoing costs, to meet the lower stocking densities in the revised Appendix A.Making the Appendix A standards mandatory will mean that all establishments have to implement them sooner than if they were only guidance, but this will be formalised with a defined phase-in period.The minimum sensible phase-in period should be 5 years, and the ideal period should be 10 years.




“ Experience of major pharmaceutical companies shows that these figures could apply in Northern Europe, but not in all member states and certainly not in academia and public research establishments. Many companies already comply or will shortly comply with requirements for rodents. However, adaptation of facilities for larger animals, such as dogs or NHPs (but also guinea pigs), will require more time (minimum 5 years, sometimes longer). Initial estimate is that the proposed by CoE transitional period of 3 years will not be enough for -the capital investment cycle and renewal of material -allowing design and construction of adapted facilities -expanding animal facilities area -adapting procedures to new occupational health requirements (bigger and hence heavier and less mobile material) -adapting organisation of work within the laboratory.

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General comments provided by EBRA: Since the EU has made itself a Party of European Convention ETS123 and since the revised Appendix A will be adopted by the Council of Europe at some time in the near future, it is inevitable that these standards will become part of the revised Directive. Currently, the Directive contains non-mandatory guidelines identical to the old Appendix A. These standards are met or exceeded in all the old Member States and many establishments in these countries have started to implement the standards in the new Appendix A.



National representative It is unlikely to make much difference whether the new Appendix A is implemented in the revised Directive as guidelines or made mandatory. In either case, the vast majority of EU establishments will implement them in the next few years. However, this will produce a very significant cost (estimated to be in excess of a €1 billion) and a substantial increase in ongoing costs, to meet the lower stocking densities in the revised Appendix A. Making the Appendix A standards mandatory will mean that all establishments have to implement them sooner than if they were only guidance, but this will be formalised with a defined phase-in period. Bearing in mind that the new Member States have only recently had to implement the old Appendix A standards and that the academic sector has significant problems finding the funding to meet new capital requirements, the minimum sensible phase-in period should be 5 years, and the ideal period should be 10 years.




Overall, we support the revised Appendix A. However, the cost and time taken to implement it across the EU must not be underestimated. Nor should one underestimate the likelihood that companies may choose to make capital investments outside the EU, where the environment for research is becoming more supportive than within the EU.

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With reference to the adoption of Appendix A of ETS 123, compliance with these guidelines would on the whole improve animal welfare. However, there needs to be flexibility, and mandatory changes with possibly significant cost implications need to be firmly evidence based. There must also be provision for swift amendments where developing science indicates changes are required. Animal behaviour and welfare is often counter-intuitive – for example, larger cages for pigeons in compliance with ETS123 might result in them being communally housed, instead of pair-housed, resulting in bullying.

Coenraad F.M.Hendriksen

Public authority National at the national level: yes

ad.1.3. There is hardly any data that could substantiate this conclusion as there also is hardly any data to reject the conclusion.


Public authority National Yes 1.1. Percentages cannot be correct, compliance in most countries must be considerably higher. There will be improvement in facilities where these minimum criteria are not met.

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Swedish Animal Welfare Agency

Public authority National yes The Swedish Animal Welfare Agency is very positive to the implementation of the revised Appendix A into the Directive as minimum standards. The revised Appendix A contains provisions and recommendations based on current scientific and technical knowledge and is a result of co-operation between many countries within and outside of the EU. Parts of the revised Appendix A are already in place as part of the Swedish regulatory system, as well as already in use in establishments as best practice.

UK Medical Research Council


The MRC is the UK's leading publicly funded biomedical research organisation

With regard to 1.4: Concern has been expressed about the ergonomics of handling larger cages e.g. potential for back strain in animal husbandry staff. The answers to 1.7 and 1.8 are because we feel unable to comment on the reliability of the evidence offered. With regard to 1.9: Five years should be the minimum.


Public authority National Yes Adoption of revised ETS123 guidelines would benefit science and welfare. Care needs to be taken to ensure that reasonable and defensible implementation periods are agreed at local level, but single timeframe at EU level would be impossible .


Public authority National XXX is central conpetent authority for approvel for the experiments and inspections animal protection

The Slovak Republic does not have ratified the Europe Convention ETS 123

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Public authority Local; Regional no Better animal housing is essential for the food industry. THAT would reduce animal suffering.



We believe there would be legitimate exceptions and that the focus should be to invest in the short term where the greatest welfare gains are to be had. In some circumstances the life-cycle of facilities may make a five year transitional period impractical.


Public authority National yes Ad mandatory group housing: exceptions should be considered (e.g. for adult males of certain species and strains).



Overall supportive of the principle. Focus should be on performance standards which can be related to improved animal welfare standards rather than just cage sizes and engineering targets that may not necessary lead to improvements in animal welfare. Source and reliability of the figures quoted in Q1 is questioned. Q2 Handling of animals may be more problematic and stressful if larger enclosures are used therefore overall statement may not be totally correct. Q3 Although there is potential for better quality research using quality animals in better conditions there may not be a direct correlation. If minimum standards are set some national bodies may implement higher than this and therefore the argument that a level playing field is assured may not be true. The figures quoted in Q8 seem very general and cannot be true costs. A target time for implementation is reasonable but exemptions should be allowed or in some cases adjustments to stocking density may work as an interim solution.


Public authority National Ministry of VWS is also involved

transitional period depends on species, requirements to be met. some equipment has a longer economic lifetime than other

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Invariably, animals cannot be institutionalised and remain healthy. Significant fear and stress are predictable consequences of routine laboratory procedures. These phenomena have substantial scientific and humane implications for the use of animals in laboratory research (ref. Balcombe J, Barnard N, Sandusky C. Laboratory routines cause animal stress. Contemporary Topics in Laboratory Animal Science Nov. 2004;43(6):42-51).

Arun Kumar, UCC, Cork

Other National; European; Worldwide

yes not now


Other European No At IV.e) In principle yes but with some changes of the Appendix A of the Europe Convention ETS 123 and with a period for adaptation for the establishments up to 10 years. At 1.6 In principle yes but experience in some Member States shows that this is not always the case. At 1.7 Numbers, such as this, are worthless unless specified what exactly has been done.

Medical University of Vienna

Other Local; Regional; National; European; Worldwide

Research in Medicine

There are very high standards in housing and animal care not only for ethical but also for scientific reasons. However, a distinction between regular animal housing and experimental requirements is necessary. The optimal conditions for animals and experiments depend on the scientific question and have to be individually defined for each project. Thus, at times, adaptations to experimental necessities may be in conflict with environmental enrichment. Concerning animal welfare more attention should be paid to the hierarchical stress during the formation of new animal groups caged together in the course of the randomization process during experiments.

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Other Worldwide yes The idea of regulatory cage sizes and environmental enrichment is problematic because, as they currently exist, they are based on simplistic and inaccurate perceptions of welfare impact. The issue is vastly more complicated than providing a certain amount and/or of space and/or environmental diversity per animal. For example, research on laboratory rodents shows that the welfare impact of different stocking densities in cages depends not so much on the space per animal but the individual mix of animals housed together, and that environmental enrichment in terms of the provision of refuges and elevated surfaces can heighten aggression and depress immunity by providing a focus for resource defence by dominant individuals. Different individuals respond differently to the same conditions and any realistic approach to welfare regulation needs to take this into account


Other Not applicable other There are very high standards in housing and animal care not only for ethical but also for scientific reasons. However, a distinction between regular animal housing and experimental requirements is necessary. The optimal conditions for animals and experiments depend on the scientific question and have to be individually defined for each project. Thus, at times, adaptations to experimental necessities may be in conflict with environmental enrichment or cage size.


Other Not applicable not applicable Since the EU has made itself a Party of European Convention ETS123 and since the revised Appendix A will be adopted by the Council of Europe at some time in the near future, it is inevitable that these standards will become part of the revised Directive. Currently, the Directive contains non-mandatory guidelines identical to the old Appendix A. These standards are met or exceeded in all the old Member States and many establishments in these countries have started to implement the standards in the new Appendix A. It is unlikely to make much difference whether the new Appendix A is implemented in the revised Directive as guidelines or made mandatory. In either case, the vast majority of EU establishments will implement them in the next few years. However, this will produce a very significant one-off cost (estimated to be in excess of a €1 billion) and a substantial increase in ongoing costs, to meet the lower stocking densities in the revised Appendix A.

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It is incumbent on competent authorities in member states to identify funds to improve the standards of animal housing and care to meet the needs of the animals, science and the expectations of the general public.




Because of its importance in improving the welfare of animals used in research and testing, the entire revised ETS 123 Appendix A should become a legally binding part of the EU Directive. This is the only means of ensuring that minimum housing and care standards will be harmonised, and that the same level of economic investment is required of research facilities in all Member States. The provisions should be legally binding because this ensures that compliance can be enforced. The improvements for animal welfare resulting from the revised guidelines are sufficiently high to justify the increased cost. Re 1.2. The revised Appendix A guidelines should lead to reduced stress levels for animals. Handling may therefore be easier, but there was no suggestion that it should be “faster”. Animals require sympathetic handling by competent personnel, however long this takes.

European Coalition to End Animal Experiments (ECEAE)


Worldwide Representative (the only EU coalition focusing on animal experiments)

We support the implementation of ETS 123, however we think that compliance with this should be made compulsory. Since the aim of these guidelines is to ensure a minimum standard of animal welfare, failure to comply with this should be unacceptable. As an animal protection group we have experienced many failures in provision of minimum standards within laboratories but experienced considerable difficulty in seeking appropriate disciplinary action. There is a wealth of evidence that good welfare standards also reduce variability and increase the validity of research findings (see SCAHAW 2002 European Commission, Health and Consumer Protection DG). Wider societal concerns about animals and the wellbeing of a society that looks after its animals properly is not covered here – we are surprised that the benefits are limited only to the wellbeing of researchers (1.4) and image of the industry (1.6).

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N.B. A.IV.b refers to 10 Member States, A.IV.c to 12. Which is correct?



National; European

Yes At IV. e) In principle yes but with some changes of the Appendix A of the Europe Convention ETS 123 and with a period for adaptation for the establishments up to 10 years. At 1.6 In principle yes but experience in some Member States shows that this is not always the case.

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PETA Europe Ltd.


Worldwide both As outlined above, improvements to animal housing and husbandry conditions are important from both animal welfare and scientific perspectives (see Lab Anim. 2006;40:215-35; Contemp Topics in Lab Anim Sci. 2004;43:42-51; Comp Psychol. 1995;109:368-83; Am J Primatol. 2000;52:63-80; Comfortable Quarters for Laboratory Animals. Washington, DC: Animal Welfare Institute, 2002). As such, compliance with minimal standards (e.g. ETS 123) should be compulsory and subject to unannounced inspections with reporting of all breaches and both internal and external reviews.

PROFESSOR RD COMBES - FRAME


Worldwide THERE ARE OTHERS

Provisions for husbandry, housing, care, experimentally applied procedures and euthanasia and killing should be of the highest possible standards in all authorised establishments both in the EU and in countries from which animals are obtained for use in the EU. This should be enforced by a system of regular inspections.

The National Anti-Vivisection Society



The NAVS is the leading and oldest anti-vivisection organisation in the world. There are a number of other relevant anti-vivisection organisations around the world with expertise in this field.

NAVS agrees that Annex II needs to incorporate the considerable developments in animal welfare science since 1986. Environments that do not meet the physical and behavioural of animals cause abnormal behaviour and changes in physiology, severely compromising welfare and scientific results. Annex II should be implemented as a set of minimum standards, with emphasis on exceeding the legal minima to allow animals to perform the widest range of species-typical behaviour. In view of the cost and time of implementing these changes it is crucial the revisions to Annex II are well considered and take account of the unique ethological and physiological requirements of each species, unlike the current guidelines which e.g. group all non-human primates in one category, and fail to make any provision for many species e.g. fish. The revisions must also consider the animal's age, health and reproductive status, and the impact of scientific procedures, which influence housing and husbandry needs.

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Section A omits the considerable costs of close control of temperature and relative humidity within the revised ETS123. Compliance 98% of the time saves considerably on 100% compliance on both capital costs and ongoing energy requirements, as equipment does not need to manage occasional extreme weather conditions that have no impact on welfare. As pointed out during ETS123 discussions, fine RH control involves complex and costly equipment, and the increased risks of equipment failure causing major temperature fluctuations (that can have significant welfare impact) are greater than the disadvantages of incompletely controlled RH. Why is RH signalled for control when, for instance, dietary vitamin levels, which have far greater welfare impact, are not?

The Royal Society



We broadly support the implementation of the revised ETS123 guidelines which largely represent existing best practice in the UK. However, some of the standard housing conditions, such as fixed levels of relative humidity, are not supported by recent scientific evidence and may result in unnatural conditions which may adversely affect welfare.




both Please refer to statements given by ECEAE and PETA.

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National yes There are very high standards in housing and animal care not only for ethical but also for scientific reasons. However, a distinction between regular animal housing and experimental requirements is necessary. The optimal conditions for animals and experiments depend on the scientific question and have to be individually defined for each project. Thus, at times, adaptations to experimental necessities may be in conflict with environmental enrichment. Concerning animal welfare more attention should be paid to the hierarchical stress during the formation of new animal groups caged together in the course of the randomization process during experiments.



National YES Regarding 1.7, 1.8, 1.9, data and quantification presented are meaningless since there is no reference to the method and the sample used to obtain them.



National Represents all Finnish pharmacologists

It is essential that animals are housed in appropriate conditions if the research work is to be of any value. No more than 5 years should be given to bring sub-standard establishments up to scratch.



National The Danish Society of Pharmacology and Toxicology represents Danish pharmacologists and toxicologists.

5 years is probably too short for orderly transition].




1.3 It must also be noted that the effects on variability of experimental design from changes introduced by ETS123 guidelines are not fully known yet.

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Regional Yes A transition period is essential, the transitional period should be at least 5, preferably 10 years. Introducing ETS 123 standards for animal caging will bring considerable financial burdens to European Universities and Researchers. It has to be accompanied by respective EU-wide programs for supporting the build up of such infrastructures.



Worldwide - -



National yes Making the Appendix A standards mandatory will mean that all establishments have to implement them sooner than if they were only guidance. However, this will produce a very significant one-off cost and a substantial increase in ongoing costs, to meet the lower stocking densities in the revised Appendix A of ETS123. Bearing in mind that the new Member States have only recently had to implement the old Appendix A standards and that the academic sector has significant problems finding the funding to meet new capital requirements.



Worldwide Representative An appropriate transition period of at least 5 and preferably 10 years is essential.


Breeder of animals

Worldwide yes We agree with the directives concerning the space allowance and its positive impact. Yet, provision should be made to allow for a smaller space allowance in exceptional and temporary circumstances such as veterinary care and medical treatment.

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Breeder of animals



Biotechnology and Biological Sciences Research Council

National Representative BBSRC supports the principle of this proposal and suggests a minimum of 5 years as a transition period to comply with any new legislation. Better enrichment will lead to higher standards of welfare and should be supported on that basis alone; research into the effects on scientific data and validity are on-going and it is too early to say that high standards of housing will lead to experiments with more precise and reliable results.

giacomo Ri(olatti


it is represntative

The present situation of animal housing is quite satisfactory in most labs and such as to render happy the people working with them. A transitional period of 5 years is not sufficient. The allocation of a large amount of money on useless improvements drains money from research rendering EU research non competitive with that of US and Japan.


Regional; Worldwide

also others Mandatory group housing may be a good thing in some instances but impracticable and even inhumane (see below) in other instances. Therefore, exemptions must be allowed. E.g., males of certain mouse strains kept in groups fight with each other to an extent that some of the males are killed. Certain behavioural experiments make it also necessary to keep animals temporarily in isolation to avoid handling of one animal causing measurable stress to the companion animals. Implementation of standard housing conditions is welcome, but the compulsory introduction of ETS 123 standards for animal caging will cause considerable - and continuing - costs to European universities and researchers which/who are notoriously short of money. This measure has to be supported financially on an European level, by a redirection of budget from non-science matters.

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Yes Over the last decade, I saw no major changes with respect to animal (read: mouse) housing that seemed to improve welfare. Nevertheless, increased costs probably mainly arise through increased administrative burdens (which require extra staff) and upscaling of housing conditions from standard to SPF, and not so much due to increased cage size etc.


Local representative Making the Appendix A standards mandatory will mean that all establishments have to implement them sooner than if they were only guidance. However, this will produce a very significant one-off cost and a substantial increase in ongoing costs, to meet the lower stocking densities in the revised Appendix A of ETS123. Bearing in mind that the new Member States have only recently had to implement the old Appendix A standards and that the academic sector has significant problems finding the funding to meet new capital requirements.




Making the Appendix A standards mandatory will mean that all establishments have to implement them sooner than if they were only guidance. However, this will produce a very significant one-off cost and a substantial increase in ongoing costs, to meet the lower stocking densities in the revised Appendix A of ETS123. Bearing in mind that the new Member States have only recently had to implement the old Appendix A standards and that the academic sector has significant problems finding the funding to meet new capital requirements.

excel sheet semifinal housing and care...

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