f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 297 [Entry Date] 04/20/2011 at 04:32:25 PM [Affiliation] Organization [Organization Name] Medical College of Wisconsin [Organization City and State] Milwaukee, WI [Comments] 
Comment 1: The Medical College of Wisconsin (MCW) acknowledges the 8th edition of the Guide offers improved programmatic guidance in many respects, including expanded reliance upon peer-reviewed scientific literature as the basis for many recommendations. However, MCW has serious concerns about the potential impact of this document and cannot recommend its adoption by OLAW unless those concerns are addressed. Although the Guide contains several new recommendations that likely would result in additional programmatic costs, of preeminent concern to this institution are the new recommendations for minimum animal space, particularly for breeding rodents. Strict implementation of the new space recommendations would result in significant new start-up and recurring costs to this institution and its federal grant recipients. While such costs might be warranted if there was sound evidence demonstrating improved scientific outcomes or enhanced animal welfare, the new space recommendations are not based on any scientific investigations nor any data indicating the 1996 recommendations are inadequate. As such, the costs to implement the recommendations would be incurred for no proven benefit to science or animals. Like MCW, many academic institutions maintain large mouse breeding colonies, and we are confident many respondents will address concerns about the affects of the recommendations on investigations involving mice. However, MCW also maintains one of the largest academic research rat colonies in the world. We currently maintain more than 2,000 active breeding pairs and over 350 different inbred, transgenic, knockout, and consomic/congenic strains. These animals represent a unique, critically important resource for research conducted at MCW and around the country. Therefore, we chose to specifically illustrate the potential impact of the recommendations on this enterprise and the investigations it supports. In recent years MCW has invested more than $4 million to purchase individually ventilated cages (IVC) specifically to accommodate our growing breeding colonies of both rats and mice using the space recommendations of the 7th edition of the Guide. Each rat IVC provides approximately 140 sq. in. floor space. Nearly all of our rat breeders are set up as continuously co-housed monogamous pairs, and litters are raised in the cage with both parents. Implementation of the new space recommendations for a female rat with litter (table 3.2, page 57) would preclude this practice because our caging would not be big enough for a monogamous breeding pair plus a litter. This would necessitate separating each breeding pair prior to parturition and only re-pairing the animals after the litter has been weaned. Because separating the breeders like this would not permit mating during the female rat's postpartum estrus, the number of litters produced by each female would be reduced by nearly 50% per year. Subsequently, we would have to significantly increase the number of breeding animals and cages in order to maintain the current breeding colony production. We estimate this would cost the institution between $340,000 and $680,000 just for purchase of additional IVC caging. Furthermore, additional animal holding rooms would need to be freed up to accommodate the added caging, which may not be feasible. In addition to the cost to this institution for additional rat caging, the direct charges to grants for animal care also would increase markedly. Based on our current animal care costs/rates, the projected increase in the average daily census of rat cages needed to support the current level of research activity would translate to an additional $397,000 to $794,000 per year in animal care charges to investigators due to the change in housing density. And those charges would be compounded by the added personnel costs needed to separate and then re-pair breeders nearly 11,000 extra times per year. In the face of such increases in charges, especially in light of the current funding climate, investigators may be forced to cut back on or even abandon research projects involving rats, which would jeopardize the public investment already made in important projects. Although we detail above the perceived impact on research involving rat resources, MCW anticipates a similar, albeit somewhat less dramatic, impact on projects involving mouse breeding programs. We note the Guide does indicate that adjustments to the space recommendations may be reviewed and approved by the IACUC "based on performance indices related to animal well-being and research quality." However, from a practical perspective, the text on page 55 providing guidance on such indices illustrates several situations in which more space than that which is listed should be provided, but offers little in terms of situations in which less space would be acceptable. As such, it appears inevitable that the interpretation of the statement on page 56 that the listed space recommendations "should be considered the minimum" will result in their implementation as hard, engineering standards, and that any justification for providing less space than the "minimum" will be met by a high bar indeed. As a matter of precedent, OLAW's current guidance on whether IACUC's may approve deviations from the cage density recommendations states in part, "Blanket, program-wide deviations from the Guide for reasons of convenience, cost, facility capacity, and other non animal welfare considerations are not acceptable." In summary, MCW does not recommend OLAW's adoption of the 8th edition of the Guide for the following reasons: a. The new recommended space for breeding rodents will result in significant additional costs to institutions and research programs. b. There is no scientific basis to support the recommended increase in space; therefore, the added costs to implement the recommendations would be for no demonstrable benefit. Comment 2: It will be feasible for the Medical College of Wisconsin to complete a semiannual program and facility evaluation using the 8th edition of the Guide by March 31, 2012. By that date, this institution will be able to determine the extent to which its animal care and use program conforms to the new Guide recommendations. However, we do not think it feasible to have implemented all of the new recommendations contained in the 8th edition of the Guide in that time frame. In particular, it would be unreasonable to expect that institutions could implement the new space recommendations for breeding rats and mice by the end of March next year without simply culling breeding stock and thus cutting back or curtailing research projects.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals