f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 351 [Entry Date] 04/21/2011 at 02:47:26 PM [Affiliation] Organization [Organization Name] Charles River Laboratories [Organization City and State] Wilmington, Massachusetts [Comments] 
Comment 1: Charles River Laboratories recommends that OLAW not accept the 2011 Guide in its present form. The Guide to be valuable must be clear in its recommendations, recommend practices that have a robust scientific base in the peer-reviewed literature, minimize or eliminate unintended consequences, take into account the myriad of confounding variables that may make recommendations inappropriate, and consider the impact on limited research resources. While the 2011 Guide has many positive aspects particularly in providing detailed explanations of recommended practices as well as the rationale behind them, in certain sections its guidance is unclear. The strength of some recommendations appear to exceed the robustness of the available data, and difficulties in practical application of the guidance appear not to have been appropriately considered. Previous editions, as well as the 2011 edition, 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 frequently sets forth as minimum recommendations new engineering standards, new strong recommendations, and certain new prohibitions. These new standards while similar to ETS 123 do not include the same caveats as that guidance and like the standards in ETS 123 are not not adequately 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. Charles River does not believe that the 2011 Guide meets this standard in several key areas. 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 substantial unintended consequences in terms of costs for compliance, on adherence to the principles of the three Rs, and depending upon how compliance is achieved, on animal welfare. In Charles River's analysis, even if the substantial costs for implementing these new space recommendations were set aside, there is no scientifically supported proportionate benefit to the welfare of these animals that warrants these new recommendations to be considered as minimum. In some cases, not only is guidance not supported by scientific evidence, it is contradictory to other guidance such as is the case in requiring that floor space occupied by enrichment items be subtracted from the total floor area—a clear disincentive to using floor mounted rodent enrichment devices. Other unintended consequences will occur by tightening the relative humidity ranges for animal areas that is worded as a strong recommendation and is not support 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 impact. 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, engineering considerations, and professional judgment. Overall, Charles River recommends that OLAW gathers more detailed information on issues associated with changes in the 2011 Guide than allowed by this comment mechanism before making the final decision on acceptance. Based upon these concerns, an analysis of both scientific justification and the financial impact of new guidance should be undertaken, especially if it is to be applied as a minimum standards or strong recommendations. The decision 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: Charles River Laboratories believes that it is appropriate that each institution should begin to make an assessment of areas of compliance and noncompliance with new guidance as set forth in the 2011 Guide. The deadline for this evaluation as suggested by OLAW seems to be appropriate. However, Charles River strongly urges that OLAW requests that the evaluation include, in addition to a time table for compliance, a feasibility and economic impact statement for correcting areas of noncompliance. Certainly such an evaluation is in keeping with Charles River's recommendation for a more robust analysis of the 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; and where significant economic impact is identified, should guidance be provided outlining reasonable and perhaps institutional-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 sound science and must consider the amount of resources that will be required to implement them. If such recommendations are limited or are uncertain in their established ability 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. Moreover, they do not warrant wide spread application or the expenditure of disproportional amounts of the ever decreasing resources available for the research community that will be required to implement them. Charles River has calculated its additional costs for implementing some of the recommendations within the Guide and has found them to conservatively exceed $100 million. Charles River believes that this level of expenditure coupled with the estimate from other rodent and rabbit breeders, as well as the costs from the research community, merits 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