f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 144 [Entry Date] 04/18/2011 at 03:02:18 PM [Affiliation] Self [Comments] 
Comment 1: This letter is submitted in response to the National Institutes of Health's solicitation of comments concerning the Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals (Guide) that appeared in Federal Register on February 24, 2011 (76 Federal Register 10379 – 80). While I support the use of the Guide as a document that promotes animal welfare while supporting the needs of the research community, I cannot support adoption of the Guide in its present form. The emphasis on performance based standards and professional judgment in much of the text is commendable, but I am concerned about new recommendations for rodent housing that 1) are not supported by scientific literature, 2) as presented appear to be fixed engineering standards, and 3) will have a significant financial impact on animal care and use programs that will be passed on to the investigators thereby limiting their ability to successfully complete research aims. During pre-publication review, the American College of Laboratory Animal Medicine commented that minimal cage size requirements for rodents presented in Table 3.2 of the Guide appear to be adopted from Annex II of the European Directive with a modification. In the European Directive an analogous table stipulates that mouse cages should provide 330 cm2 for each breeding pair with the qualification that a breeding pair is a "...monogamous pair (inbred/outbred) or trio (inbred)." Table 3.2 in the Guide however, calls for a minimum of 330 cm2 for a female with a liter plus 96.7 cm2 for each additional average sized adult mouse. Consequently, standard mouse cages used by facilities throughout the country are not large enough to house some rodent pairs (male and female) and all trios (one male, 2 females) typically maintained together for breeding purposes. In the final version an asterisk was added to Table 3.2 with the related note: "* The interpretation of this table should take into consideration the performance indices described in the text beginning on page 55." However, this edit lacks the desired clarity since the discussion on performance standards that begin on page 55 continues to page 56 with a statement that reads, "space recommendations presented here….should be considered the minimum for animals housed under conditions commonly found in laboratory animal facilities". Moreover, one "frequently asked question" published on OLAW's website leads us to believe that the flexibility of institutions to use performance based standards to develop and implement a policy to house mice in configurations that result in less space than stipulated in the Guide is limited. The text of that posting appears below: May the IACUC approve deviations from the Guide for rodent (mice and rats) cage density? - OLAW supports the Guide's approach to applying performance standards to achieve specified outcomes, and expects institutions to use the Guide's engineering standards as a baseline. The Guide clearly states that the need for adjustments to the recommendations for primary space enclosures should be made at the institutional level by the Institutional Animal Care and Use Committee (IACUC) and should be based on performance outcomes. The Guide further identifies examples of performance indices to assess adequacy of housing, including health, reproduction, growth, behavior, activity, and use of space (Guide, pages 25-26). IACUC determinations of the need for adjustments in the space recommendations should be based on veterinary considerations or scientific justification relative to the nature of the protocol and its requirements. Blanket, program-wide deviations from the Guide for reasons of convenience, cost, facility capacity, and other non animal welfare considerations are not acceptable. IACUC approved deviations from the Guide must be clearly documented and reflect the scientific or veterinary justification relevant to the action. It is important to note the authors provide no scientific justification for the increased cage size requirement and in fact describe as insufficient the information that's available to delineate space and housing needs of laboratory species. By implementing the standards in the new Guide PHS-assured institutions will be forced to purchase additional cages or larger cages for breeding pairs and trios, which may required the purchase of additional racks, and in many instances, the construction of additional rooms to accommodate the increases. Alternatively, researchers would be forced to scale back breeding populations of inbred mice, thereby limiting research. Either way, NIH funded research facilities will incur substantial costs that could easily run into the hundreds of millions of dollars. It is with great reluctance that I have decided that I cannot support the adoption of the Guide. If the Guide were adopted by the NIH, PHS-assured institutions would be forced to spend hundreds of millions of dollars to fully comply. These costs would be in large part be passed on to the investigators in the form of increased charges which would negatively impact their ability to maintain their currently level of productivity. Increasing the cost of doing animal based research without solid scientific evidence that such increases are needed is not consistent with the NIH's goal "to expand the knowledge base in medical and associated sciences in order to enhance the Nation's economic well-being and ensure a continued high return on the public investment in research."
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals