f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 423 [Entry Date] 04/22/2011 at 01:54:32 PM [Affiliation] Organization [Organization Name] University of Texas at El Paso [Organization City and State] El Paso, Texas [Comments] 
Comment 1: The new section "Use of Non-Pharmaceutical Grade Chemicals and Other Substances" is of particular concern. This section essentially bans researchers from using standard source drugs for research,(e.g., compounds from the NIDA drug supply program; reliable private vendors; chemists) or requires additional paperwork burden to justify and detail their use if a version of that same drug is available in a human clinical or veterinary formulation. There are several problems with this request. First, there is a lack of a definition of pharmaceutical grade. As with other sections, the contradictions in guidance are problematic. Reconciling definitions is one obstacle to interpretation, but the clear requirement that investigators justify the use of certain types of compounds and provide elaborate detail on their preparation and characteristics for IACUC review. Second, it is unclear that this provision will be an improvement over currently used practices. Given that it is a costly suggestion, I worry that a careful cost/benefit analysis has not been done. I personally contacted Sigma INC on this matter when our last veterinarian was encouraging us to purchase Nembutal, over pentobarbitol which wee were purchasing from Sigma. When I called Sigma, they were unclear what this definition meant, especially given that they are a pharmaceutical company. They did describe the careful provisions that they took to ensure the quality of their compounds. They also save portions of lots of their drugs to enable them to go back and re-evaluate the purity of lots. Related to this, is cost and whether it is a valuable use of our research dollars. As an example, a vial of nembutal (or animal sacrifice) is at least 5 times the cost of the same drug that can be purchased and prepared in our own laboratories---using pure compounds purchased from well known pharma compainies. This seems to be an unwarranted request that is difficult to accept given the cuts in NIH funding that we are all experiencing. On a final note, the 8th edition departs significantly from the 7th, which has served us well since 1996. Of particular concern is the extent to which the 8th edition introduces new policies that go beyond the earlier edition. Many of these new policies constrain the exercise of scientific and professional judgment and add significantly to the paperwork burden for investigators and IACUCs. They require additional staffing and or time from researchers who want to stay focused on advancing science while still taking quality care of research animals. Many of these will result in higher costs to grants and to institutions, and importantly, it is not clear that the changes will improve the quality of the animals lives and of the research findings. Comment 2: It is unclear whether this revision will improve the quality of animal research over what is currently done. These provisions are potentially costly in money and time and require additional staffing that many institutions cannot afford. A more careful cost/benefit analysis is needed to ensure that this major change is truly warranted.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals