f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 295 [Entry Date] 04/20/2011 at 04:29:53 PM [Affiliation] Organization [Organization Name] Laboratory Animal Breeders Association [Organization City and State] Wilmington, Massachusetts [Comments] 
Comment 1: The Laboratory Animal Breeders Association recommends that OLAW not accept the 2011 Guide in its present form. We recognize the need for a guidance document for the US biomedical research community in order to set standards that take into consideration ethical responsibilities, animal welfare, and research concerns associated with the use of animals in research, teaching and testing. Such a document should leave room for professional judgment at an institutional level to apply performance standards in order to tailor practices and facilities to the needs of research animals. While the 2011 Guide acknowledges this principle, it sets forth, frequently as minimum standards, new engineering standards, new strong recommendations, and certain new prohibitions These standards, while similar to ETS 123, do not include the same caveats and hence, have more profound and costly unintended consequences. These stricter standards cannot be supported by peer-reviewed scientific studies. The level of specificity of guidance needs to be proportional to the robustness and specificity of the science supporting it. Such guidance should also still allow for the application of professional judgment and experience coupled with performance based measures applied at an institutional level using IACUC oversight to implement animal welfare based outcomes. In the case of the 2011 Guide, for example, the new cage space allocations for a mother with litter for rats and mice do not appear to be supported by robust science; yet, they will have an extreme negative impact in terms of costs, adherence to the principles of the three Rs, and depending upon how compliance is achieved, on animal welfare. If applied as a minimum standard, as suggested, they will have an extreme negative impact in terms of capital and operating costs, without commensurate benefit to the welfare of the animals. In some cases, not only is new guidance not supported by scientific evidence, it is contradictory to other guidance such as is the case in requiring that the floor space occupied by enrichment items be subtracted from the total floor area. Similarly, tightening of relative humidity ranges that is worded as a strong recommendation is not supported by scientific data yet will have a substantial operational and equipment cost impact on most facilities. In this case the strength of the recommendation is disproportionate to any theoretical positive animal welfare benefit. Clarification of the interpretation and application of this recommendation is not only needed but any strict application of this guidance should be justified at an institutional level based upon experience and professional judgment. Overall, we would recommend that OLAW gather more detailed information on issues associated with changes in the 2011 Guide before making a final decision. Based upon these concerns, an analysis of both the scientific justification for such additions and the financial impact of these additions should be undertaken especially if they are to be applied as minimum standards. Decisions on how the Guide will be used can then be made on a rational basis in proportion to the amount and strength of evidence supporting proposed changes in guidance. Comment 2: The Laboratory Animal Breeders Association agrees with OLAW that each institution should begin to make an assessment of areas of compliance and noncompliance with new guidance presented in the 2011 Guide. This evaluation should be completed by the deadline suggested. However, the evaluation should include, in addition to a timetable for compliance, a feasibility and economic impact statement for correcting areas of noncompliance. This is in keeping with our recommendation for a more robust analysis of new recommendations found within the 2011 Guide. Based upon this analysis, OLAW should decide if the Guide will be accepted as written and if so, should all recommendations be implemented; where significant economic impact is identified, should guidance be provided outlining reasonable and perhaps institution specific schedules for conformance or will certain recommendations require further scientific justification by an independent body such as the National Academy of Sciences perhaps using a group other than the Guide Committee assembled for this purpose. While animal welfare is an important component of biomedical research activities, recommendations for the care and use of laboratory animals need to be based on sufficient sound science and must consider the amount of resources that will be required to implement them. If such recommendations are limited or uncertain in their established ability for or level of improvement of animal welfare, if they are based principally on professional judgment, or if they do not consider all the variables that might impact their desired effect, they cannot be considered to be useful as universal guidance and certainly not be considered as minimum standards or strong recommendations. Moreover, they do not warrant wide spread application or the expenditure of disproportionate amounts of the ever decreasing resources available to the research community that will be required to implement them. The Laboratory Animal Breeders Association has calculated that at a minimum approximately $500 million in capital expenditures and $155 million dollars of increased operating expenses (not including amortization of capital expenses) will be required by its members to address some of the recommendations in the 2011 Guide. We feel that this level of expenditure when coupled with the estimates from the research community will merit more consideration of the strength of the scientific support for these recommendations before implementation should be considered.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals