f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 315 [Entry Date] 04/21/2011 at 07:10:42 AM [Affiliation] Self [Comments] 
Comment 1: As a research psychologist involved in NIH-funded research, I am submitting comments on the proposed adoption and implementation of the 8th edition of the Guide for the Care and Use of Laboratory Animals (new Guide) as Public Health Service (PHS) Policy. I have carefully reviewed and compared the new Guide to existing PHS Policy, which is based on the 7th edition of the Guide (1996 Guide). Because research with laboratory animals is an integral component of my research, I strongly support efforts to improve laboratory animal welfare but, at the same time, believe that it is necessary to ensure that proposed policies or regulations are soundly based and do not compromise scientific research. As a result, while the new Guide appears to be a well-crafted resource that aims to strike a balance between the needs of research and the welfare of laboratory animals, at this time I cannot recommend that NIH adopt the 8th edition of Guide as PHS Policy. In particular, I am concerned that: 1) the new Guide contains many recommendations that will, in effect, function like regulations, rather than the "guidelines" for the care and use of research animals authorized by the Health Research Extension Act of 1985; 2) insufficient scientific evidence is presented regarding impact on animal welfare for some major revisions reflected in the new Guide; and 3) the additional provisions will have a significant economic impact on PHS-assured institutions. Therefore, I believe that the 1996 Guide should remain PHS policy and that the new Guide be used as a reference document. Given that the 6000 character limit for comments precludes the ability to provide a detailed response, this response will highlight areas of concern for my own research, as well as that of colleagues in the behavioral and psychological sciences who conduct research with laboratory animals. The new Guide contains more than 40 statements about what institutions "must" do (defined as "actions that are imperative and mandatory duty requirements"), including 29 newly-stated requirements. In addition, there are approximately 660 recommendations that researchers "should" do (defined as "a strong recommendation for achieving a goal" but noting that "individual circumstances might justify an alternative strategy"). Both sets of statements have the unintended consequence of being viewed and implemented as policy rather than guidance – policies that the research community has not had a chance to review and comment on in a substantive manner. Furthermore, some of these mandatory requirements are particularly problematic because they constrain the exercise of scientific and professional judgment for both investigators and laboratory animal veterinarians. The new Guide is extraordinarily prescriptive on a number of topics, without empirical evidence that the recommended action enhances the welfare of the lab animals. Compliance with these new standards will greatly increase the cost of conducting research with laboratory animals with no evidence of commensurate improvement in animal welfare. The increased cost will be further compounded by increased regulatory and paperwork burden, in terms of justifications, requests for exceptions, and additional recordkeeping. Areas of particular concern are: (a) IACUC responsibilities – new requirements for post-approval monitoring and formal review of "unexpected outcomes" will require additional staffing and recordkeeping; (b) 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; (c) 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; (d) 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 psychopharmacological research, including studies such as those I conduct, the commercially available preparations would need to be altered (diluted to particular dose concentrations and filtered), increasing rather than decreasing the margin of error. Given that these commercial preparations are also substantially more expense, this is an increased regulatory burden, with concomitant expense, but with no evidence of benefit. 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: If the Office of Laboratory Animal Welfare does decide to adopt the new Guide as PHS Policy, I strongly believe that the March 2012 deadline for compliance with the new standards is unrealistic and recommend a more gradual 4-5 year phase-in. Changes in requirements for cage sizes, watering systems, pharmaceuticals, etc. would require purchase of new equipment, all without concomitant changes in NIH funding for the projects affected. Given that budgets for currently funded projects were not developed with the new policies in mind, adoption by March 2012 would, in many cases, represent a substantial financial burden. Further, institutions would require time to prepare for the increased paperwork and regulatory burden, which may involve hiring of new personel and development of new accountability systems - burdens which the institutions will be required to bear without the opportunity for advance financial planning.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals