f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 148 [Entry Date] 04/18/2011 at 05:24:19 PM [Affiliation] Organization [Organization Name] Washington University [Organization City and State] St. Louis, MO [Comments] 
Comment 1: Washington University in St. Louis is concerned about the substantive changes made to the Eighth Edition of the Guide for the Care and Use of Laboratory Animals. The 2011 Guide contains many recommendations that will, in effect, function like regulations, rather than guidelines. At over 200 pages (nearly double the size of its predecessor) the 2011 revision includes new and expanded coverage of the ethics of laboratory animal use; components of effective animal care and use programs (regulations, policies and principles; program management; program oversight; disaster planning and emergency preparedness); housing, environment, and enrichment for terrestrial and aquatic animals; veterinary and clinical care as well as physical plant characteristics. It contains more than 40 statements directing what institutions must do, including 29 newly-stated requirements. In addition, there are now approximately 660 "strong" recommendations. Although excellent new reference information from peer-reviewed scientific literature has been added in support of many subject areas, scientific evidence is lacking for changes in the recommended minimum housing space. In the Preface, the Committee acknowledges this deficiency, yet the new recommendations are still included. Of primary concern is the revision of minimum space for laboratory rodents: recommended space for a female and litter (mice) is 51 sq in and 124 sq in for rats. This would end the current practice of housing male/female rodent pairs and 1 male/2 female trios for breeding purposes in the standard cage used by most facilities. These recommendations pose significant operational, logistical, physical plant, personnel and financial obstacles. To follow all the Guide's provisions to qualify for NIH awards, PHS-assured institutions will likely spend a minimum of $100 million annually for increased costs of research animals, per diems, new caging and facility renovations. Some facilities will have no option but to reduce facility capacity to comply with new cage sizes. The limited opportunity for comment is insufficient in terms of both time and substance. A meaningful process for public input should be required. The current process limiting comments to 6,000 characters and requires comment submission by April 24, 2011 is simply insufficient to provide NIH with meaningful comments regarding the impact of this revision on institutional animal care and use programs. When comments are requested for the Guide under the requirements of OMB Bulletin No. 07-02: Final Bulletin for Agency Good Guidance Practices, no such limits should be in place. Washington University in St. Louis recommends that NIH not adopt the new Guide until these concerns are addressed.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals