f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 429 [Entry Date] 04/22/2011 at 02:29:33 PM [Affiliation] Organization [Organization Name] The American Association of Immunologists [Organization City and State] Bethesda, Maryland [Comments] 
Comment 1: The American Association of Immunologists (AAI), a professional association of more than 7,200 of the world's leading research scientists and physicians who are dedicated to elucidating the immune system through basic research, appreciates having this opportunity to express its views on whether the NIH Office of Laboratory Animal Welfare (OLAW) should adopt the recently published 8th edition of the Guide for the Care and Use of Laboratory Animals (Guide). In their research, AAI members use and depend on rodents, and in particular laboratory mice, and therefore have a deep interest in all matters governing their care and use. Although AAI recognizes, and agrees with, the goal of updating the former Guide – to ensure the humane care of laboratory animals – AAI believes that the revised Guide will have a substantial negative impact on NIH-funded biomedical research. AAI is confident that the Guide can be updated in a way that addresses the humane care of animals, a goal which we strongly endorse, without unnecessarily or inadvertently reducing scientific research capacity or disrupting, impeding, or burdening the research scientists who spend their careers in search of answers and cures. Unfortunately, the revised Guide does not accomplish this objective. As a result, AAI urges OLAW not to adopt or implement the 8th edition of the Guide. AAI is aware that OLAW has received comments regarding the adoption of the 8th edition of the Guide from the National Association for Biomedical Research (NABR). AAI wholly endorses NABR's comments and shares its substantive concerns. AAI underscores the following points of major concern: 1) The new Guide has not been sufficiently vetted by the scientific community it is meant to serve. The new Guide is a quantum change from the previous version. The AAI community is one of many that looked forward to a new, modernized Guide that balances the needs of laboratory experimentation with humane animal care. However, the new Guide falls far short of our expectations: in too many cases changes have been mandated without scientific justification. And too often, the new Guide makes generalizations and creates ambiguities both in lines of responsibility and logical application to specific laboratory organisms. AAI will not address specific granular concerns in this solicitation for Public Comment, but AAI would be happy to comment in greater detail at a later date or to meet with OLAW to discuss our detailed concerns. The impact of these concerns is magnified because some language in the new Guide might be construed to prohibit the use of animals in certain experiments that are currently considered humane. Moreover, AAI does not believe that these problems can be solved by OLAW's publication of its interpretation of the new Guide via FAQs. Instead, the problem is with the new Guide itself because reasonable interpretations in the FAQs could, at best, confuse matters further, and at worst, directly contradict what is written in the Guide. 2) New rodent cage space restrictions are not based on substantiated scientific data. The new restrictive cage space policy, unjustified by scientific data, would have far-reaching scientific and financial impact on a breath of Public Health Service supported biomedical research. A strict interpretation of the new Guide would have tremendous adverse effect and appears to be inconsistent with best, healthy breeding practices. For example, duo (1 male and 1 female) and trio (one male and 2 females) of laboratory mice within the recommendations of the 7th Guide are shown by years of experience to be the most beneficial configurations for litters to survive and thrive. There are no substantiated data that merit a change from the former time-tested policy. This new policy, if adopted, would require a doubling to tripling of breeding colony to even approach the same productivity. It would also require the dismantlement of caging systems, including racks, designed to comply with the 7th Guide recommendations, and would cost hundreds of millions of dollars and time lost to retrofit caging systems and to expand current animal facilities (including continually incurring husbandry costs). The impact of this scientifically unjustified change is far-reaching because it would not only negatively impact organizations that perform rodent breeding but also drive up the costs for all organizations that purchase laboratory rodents to an unsustainable level. Most importantly, this new restrictive policy is inconsistent with data from multiple peer-reviewed publications evaluating the effects of cage density. Furthermore, data in peer-reviewed papers published since the 7th edition show that a number of common mouse strains can be housed at twice the density recommended by 7th edition of the Guide, in some cases with apparent benefits to health. Therefore, it is troubling from both animal health and financial perspectives that maximum recommended caging densities were not relaxed to reflect this new information. In conclusion, AAI urges OLAW not to adopt or implement the 8th edition of the Guide until it has been revised, following the solicitation of detailed comments by the scientific community and after careful consideration of the concerns that working scientists have raised. AAI respectfully requests that in the meantime, OLAW continue to use and rely upon the 7th edition of the Guide. Comment 2: Because AAI urges OLAW not to adopt or implement the 8th edition of the Guide until it has been revised, following the solicitation of detailed comments by the scientific community and after careful consideration of the concerns that working scientists have raised, AAI does not support NIH's proposed implementation plan. If NIH does adopt the 8th edition of the Guide, despite the many concerns raised, AAI recommends that NIH delay implementation at least until March 31, 2013, except for life- threatening issues (e.g., cage washer safety).
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals