f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 218 [Entry Date] 04/19/2011 at 06:01:25 PM [Affiliation] Self [Organization Name] Johns Hopkins University [Organization City and State] Baltimore Maryland [Comments] 
Comment 1: I am an NIH-funded behavioral researcher and I am concerned by several aspects of the new Guide for the Care and Use of Laboratory Animals (new Guide) that I see as compromising scientific research with little if any demonstrated benefit for laboratory animal welfare. My concerns are that a) the new Guide contains recommendations that will, in effect, function like regulations, rather than guidelines for the care and use of research animals, b) the arecommendations are based on little scientific evidence in some cases, and c) the additional provisions will have a significant ecomomic impact on PHS-assured institutions. For these reasons, I believe the 1996 Guide should remain PHS policy and that the new Guide be used as a reference document. If the OLAW decides to adopt the new Guide as PHS policy, it should extend the unrealistic deadline from 2012. I believe 4-5 years would be necessary to full phase in the changes. Of significant concern to me are the increased cost and regulatory and paperwork burden, in terms of justifications, requests for exception, and additional recordkeeping that will occur if the new Guide is adopted. Much of this will result from recommendations that lack empirical evidence of enhanced laboratory animal welfare. Of particular concern are a) Housing - detailed specifications for cage sizing and recommended use of solid bottom cages particularly for rats and mice is based on weak to nonexistent evidence. Required social housing for all species does not recognize practical constraints on institutions; (b) IACUC responsibilities – new requirements for post-approval monitoring and formal review of "unexpected outcomes" will require additional staffing and recordkeeping; (c) Surgery -- the caution against multiple major survival surgical procedures not only increases costs because of the increase in number of animals required, but also interferes with the scientific integrity of the study by not allowing the use of within-subject and single subject designs that are particularly powerful for behavioral research; (d) Food/fluid regulation – a new requirement to keep written records of both daily food and fluid consumption for animals under either restriction precludes the use of commonly used automatic watering devices, even when water is not restricted. Further, the recommendation that "a highly preferred food or fluid be used as positive reinforcement, instead of restriction" for "conditioned-response research protocols" is made despite information provided in the cited papers that such strategies do not work well to train behaviors – one of many examples of guidance that is inappropriate, both scientifically and for ensuring appropriate use of laboratory animals; (e) Use of Non-Pharmaceutical Grade Chemicals and Other Substances – this new policy is based on false premises. For example, not only do very few commercially available preparations exist that are suitable as tools for experimental research but they are also subject to formulation errors. Also, in behavioral research with drugs, including studies such as those I conduct, the commercially available preparations would need to be altered (diluted to particular dose concentrations), increasing rather than decreasing the margin of error. I concur with the National Association for Biomedical Research (NABR) that the new Guide represents a significant "guidance document," as defined by the Office of Management and Budget (OMB). Therefore, an opportunity for comment in greater detail from the research community on the substance of the new Guide and its financial consequences is necessary before a decision on the adoption of the new Guide as PHS Policy is made and an implementation strategy instituted. Comment 2: In my comments above I noted taht I think 2012 is unrealistic to fully implement the extensive set of recommendations listed in the new Guide.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals