f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 149 [Entry Date] 04/18/2011 at 05:29:21 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). First, I would like to commend the Committee responsible for the 8th edition of the Guide on their significant effort in revising and updating the document to ensure that animal based research is conducted at the highest standard. With that said, I feel there is one significant change in the 8th edition of the Guide that has the potential to negatively impact animal based research, and as a result I cannot in good conscious recommend that OLAW adopt the Guide in its current format. More specifically, I am referring to the recommended cage sizes for female mice and rats with litters for which there is no scientific justification to support the recommendations. To put things in perspective, the average mouse box provides approximately 66 sq. in. of floor space whereas the Maxi-cage made by some companies provides approximately 75 sq. in. of space. In either case, the current caging systems available for mice would only support a monogamous pair based on the floor space recommendations in the 8th edition of the Guide. Though the Guide does indicate that "the interpretation of this table (space recommendations for group housed rodents) should take into account consideration the performance indices described in the text beginning on page 55", I have significant reservations that OLAW, which tends to be prescriptive in nature, will be able to use performance standards, in lieu of the recommendations in Table 3.2. In my opinion, the table could work for AAALAC; however, I am not confident it will work for OLAW. As a result, I truly believe that this issue needs to be resolved prior to OLAW adopting the Guide and/or that OMB be asked to look at the impact of the new Guide on the research enterprise in the U.S. The impact of the new recommendations for a female mouse with litter is significant. To move from a trio breeding system to a monogamous breeding system would have the following direct impact on the program for which I am associated: 1) the need to purchase an additional 6000 microisolator boxes; 2) the need to add 3 FTEs to the staff; 3) the need to add 5000 sq.ft. of animal housing space to the animal care program. The estimated cost to accommodate the new recommendations and go from a trio to a monogamous housing system would be approximately $2.2 million, of which a portion (new FTEs) would be recurring costs. The indirect impact would be greater cost to investigators for maintaining unique genetically engineered animals and a decrease in breeding indices. It is my belief, having worked in the field for over 23 years, that mice in trio breeding groups (1male/2females) have higher breeding indices, which may be attributed to a number of factors including: pheromone effects, social effects and shared parenting. In conclusion, I would recommend that OLAW not adopt the Guide until the issue related to cage sizes for female mice and rats with litters is resolved. If OLAW and NRC cannot resolve this issue then I would also recommend that the document be made available for public comment and that OMB be asked to review the economic impact of the new Guide on the nation's animal based research enterprise. Comment 2: Institutions should be given 1 year from the date the 8th edition of the Guide is adopted by OLAW to complete at least one semiannual program and facility evaluation. Since March 31, 2011 has passed, I would recommend that March 31, 2012 not be used and that it be tied to the date (1 year following) approval by OLAW of the 8th edition of the 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