f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 435 [Entry Date] 04/22/2011 at 03:00:37 PM [Affiliation] Self [Comments] 
Comment 1: I strongly oppose adoption of the new Guide for the Care and Use of Laboratory Animals as the 8th edition. The new guide has doubled in size. There is no need for additional rules and regulations. Animal care is already overly regulated. In particular, I cite the following issues as poorly thought out. Several will require enormous added expense and result in no increase in animal welfare. 1. I am opposed to the new mandatory requirements for new cage sizes for some species (particularly for rodent breeding, apparently to conform to European standards) and mandatory requirements for social housing of all species. Implementation of these requirements will require large expenditures of funds to accomplish. 2. I oppose the newly introduced requirements for post-approval monitoring of IACUC-approved protocols and formal review of "unexpected outcomes" of research. Such requirements are examples of items that require additional IACUC staffing to accomplish as well as require additional time from research team members and are unnecessary. 3. I oppose the new requirement that food and fluid consumption be recorded daily for all animals on either type of restriction, which requires abandoning automated watering systems. This is only one example of guidance that is inappropriate. 4. I oppose the newly added section titled "Use of Non-Pharmaceutical Grade Chemicals and Other Substances". This section is particularly problematic because it essentially bans researchers from use of drugs provided by suppliers of high-quality drugs for research and from using such compounds provided through the NIDA drug supply program if a version of that same drug is available in a human clinical or veterinary formulation. It also fails to acknowledge the critical importance of collaborations by chemists with behavioral researchers to develop new therapeutic drugs. To require that they do so would result in significant increases in costs to NIH, for no valid reason, at a time when NIH funding is shrinking. Comment 2: I believe that the 2011 Guide represents a significant "guidance document," as defined by the Office of Management and Budget which "may reasonably be anticipated to lead to an annual effect on the economy of $100 million or more. . ." Therefore, a meaningful opportunity to comment in greater detail on the substance of the new Guide and its financial consequences is necessary before a decision on Guide adoption and implementation strategy can be made.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals