f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 501 [Entry Date] 04/25/2011 at 03:02:19 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 the Federal Register on February 24, 2011 (76 Federal Register 10379 – 80). Note that I am a Diplomate of the American College of Laboratory Animal Medicine (ACLAM) and make these comments as an individual. ACLAM is the AVMA-recognized veterinary specialty organization that represents veterinarians certified as Diplomates in laboratory animal medicine. I acknowledges that the Guide is the premier guidance document promoting animal welfare and compliance while supporting the animal-based research community. I do not support adoption of the new Guide in its present form. I is concerned that the new space recommendations for breeding mice are not supported by scientific literature, will have little-to-no measurable benefit on animal welfare, and yet will have a significant financial impact on animal care and use programs. These costs will be passed on to the investigators or will otherwise negatively impact research output. During the pre-publication review period, several organizations including ACLAM commented that minimal cage size requirements for rodents presented in Table 3.2 of the Guide appeared to be adopted from Annex II of the European Directive with a modification. The table in Annex II stipulates that mouse cages should provide 330 cm2 for "breeding," and clarifies breeding "for a monogamous pair (inbred/outbred) or a trio (inbred)." Table 3.2 in the new Guide however, calls for a minimum of 51 in2 (330 cm2) for a female plus litter plus 15 in2 (96.7 cm2) for each additional average sized adult mouse. The clarification language present in Annex II is absent in the Guide. Consequently, standard mouse cages used by facilities throughout the US 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. If language could somehow be added back to Table 3.2 in the Guide, to allow for mouse trio breeding using existing cage sizes, I would fully endorse NIH's adoption of the Guide. 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 indices does not provide any examples of trio paradigms and concludes 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" (FAQ) 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. Specifically, the FAQ states that, "Blanket, program-wide deviations from the Guide for reasons of convenience, cost, facility capacity, and other non animal welfare considerations are not acceptable (http://grants.nih.gov/grants/olaw/faqs.htm#f10). It is important to note the authors of the Guide provide no scientific justification for the increased cage size requirement and, in fact, describe as insufficient, the information that is available to delineate space and housing needs of laboratory species. Contrast this to the significant body of science supporting current breeding densities and paradigms in the US (see references below). By implementing the mouse breeding recommendations in the Guide, PHS-assured institutions will be forced to purchase additional cages or larger cages for breeding pairs and trios, which may require the purchase of additional racks, and in many instances, the construction of additional rooms to accommodate the increases. Bedding costs will increase and the number of males used in breeding programs will also increase because one male can no longer service two females. This last point runs counter to the 3Rs approach to animal welfare. According to data supplied to the National Association for Biomedical Research by the Laboratory Animal Breeders Association initial capital outlay to accommodate these change will cost ~500 million dollars, with annual increased operating expenses of ~150 million dollars. Alternatively, researchers would be forced to scale back breeding populations of mice, thereby limiting research. 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 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 or will benefit animal welfare 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." References J Whitaker, SS Moy, V Godfrey, J Nielsen. Effects of cage size and enrichment on reproductive performance and behavior in C57BL/6Tac mice. Lab Animal, 2009. Laber K, Veatch L, Lopez M, Lathers D. The Impact of Housing Density on Weight Gain, Immune Function, Behavior, and Plasma Corticosterone Levels in BALB/c and C57Bl/6 Mice." JAALAS, 2008. 47(2): 16-23. O'Malley J, Dambrosia JM, Davis JA. Effect of housing density on reproductive parameters and corticosteron levels in nursing mice. J Am Assoc Lab Anim Sci., 2008. Mar;47(2): 9-15. J Whitaker, SS Moy, BR Saville, V Godfrey. The effect of cage size on reproductive performance and behavior of C57BL/6 mice. Lab Animal, 2007 Smith, AL, et al. Effects of housing density and cage floor space on three strains of young adult inbred mice. Comp Med, 2005. Aug 55(4): 368-76. Smith, AL, et al. Effects of housing density and cage floor space on C57BL/6J mice. Comp Med, 2004. Dec 54(6): 656-63. McGlone et al. Floor space needs for laboratory mice: BALB/cJ males or females in solid-bottom cages with bedding. Contemporary Topics, 2001. C. K. Reeb-Whitaker, B. Paigen, W. G. Beamer, R. T. Bronson, G. A. Churchill, I. B. Schweitzer & D. D. Myers. The impact of reduced frequency of cage changes on the health of mice housed in ventilated cages. Laboratory Animals, 2001. (35): 58-73. Eveleigh JR. Murine cage density: cage ammonia levels during the reproductive performance of an inbred strain and two outbred stocks of monogamous breeding pairs of mice. Lab Anim., 1993 Apr; 27(2): 156-60
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals