f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 416 [Entry Date] 04/22/2011 at 12:09:00 PM [Affiliation] Self [Comments] 
Comment 1: I am against the adoption of the new edition of the Guide. The 2011 Guide introduces new policies that constrain the exercise of scientific and professional judgment for both investigators and laboratory animal veterinarians. Mandatory requirements, including 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 (without leeway for practical constraints) will require large expenditures of funds to accomplish. Newly introduced requirements for post-approval monitoring of IACUC-approved protocols (e.g., direct observation of "laboratory practices and procedures and comparisons with approved protocols") and formal review of "unexpected outcomes" of research are examples of items that require additional IACUC staffing to accomplish as well as require additional time from research team members. A major change in the Guide is the introduction of language cautioning against multiple survival surgical procedures per se on the same animal, in addition to cautioning against multiple major survival surgical procedures. This echos a caution in which investigators are strongly discouraged from advocating animal reuse as a "reduction" strategy. Restrictions against using animals in multiple procedures most certainly will increase the number of animals needed in research, thus increasing costs, but also indirectly hampers the use of within-subject and single subject designs that are particularly powerful for behavioral research. The section on "Food and Fluid Regulation" requires that food and fluid consumption be recorded daily for all animals on either type of restriction, which requires abandoning automated watering systems for food-restricted, as well as water-restricted, animals; and that food consumption for fluid-restricted, as well as for food-restricted, animals be recorded daily despite the fact that each type of restriction makes the other commodity freely available. This may represent only imprecision in drafting, but is only one example of guidance that is inappropriate. The newly added section "Use of Non-Pharmaceutical Grade Chemicals and Other Substances" is of particular concern. This section 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. The statements in this section are out of touch with the realities of drug abuse research as well as research in numerous other fields. Comment 2: I am against the adoption of the new edition of the Guide. The 2011 Guide represents a significant "guidance document," as defined by the Office of Management and Budget (OMB), which "may reasonably be anticipated to lead to an annual effect on the economy of $100 million or more. . ." Therefore, an opportunity for 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