f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 461 [Entry Date] 04/23/2011 at 01:18:53 PM [Affiliation] Self [Comments] 
Comment 1: My primary reaction is that this would take us a giant step forward toward consuming so much of an investigator's time in compliance, that there will be little time left for actual conduct of the research. As an initial comment, let me state that our IACUC already views every 'should' as a 'must' in the Guide, and that the paperwork and regulatory burden is already much higher than needed with the current Guide. I have made the statement at my institution that there have been enormous increases in paperwork burden and compliance requirements, without a single increase in actual animal welfare. I stand by this statement, and, at my institution, this would hold for the proposed new Guide. There are a number of particulars, a few of which include: Design considerations,which a number of older institutions cannot comply with, but IACUCs will mightily attempt to do so. At my institution, the transition zones between animal housing, animal testing, and student offices are murky, and we had a very long battle with the IACUC over whether personnel must wear booties, with many changes per day and enormous cost, when transition zones are not clear. Many older, smaller facilities, cannot comply with new requirements, which are clearly geared toward very large, centralized facilities. A net effect of the new Guide would be to drive many smaller facilities, and their investigators, out of business. A new mandate for PPE. Availability, training, and choice should be sufficient. Many rodent researchers judge that they do not require much in the way of PPE. Under the guide, all would be required to wear what the IACUC judges. Much more in the way of paperwork requirements, such as a disaster plan, etc. Extension of the requirements to fish; not my issue, but for investigators with a few aquaria, this is hugely burdensome. The issue of 'pharmaceutical grade' chemicals for use in animals. A huge number of investigational drugs are not available in this formulation, and the paperwork requirements for review would be burdensome. Elaboration of requirements for enrichment, food/water restriction, etc. And the list goes on. I strongly urge that the proposed Guide be scrapped, and that a new effort, not piggybacking on earlier versions and adding more restrictions, be initiated. The focus of the new version should be on actually protecting the welfare of animals, WITHOUT adding tons of additional compliance burden which does little for animal welfare. It should also differentiate MUCH more clearly between primates, for which a good bit of the current Guide may be appropriate, and species such as rodents. leaving the differentiation to an IACUC imposes primate-level requirements on rodent researchers. As a final comment, let me give you a single example of the impact of existing guidelines and implementation. For context, I chaired our IACUC for 20 years, and I am at what has recently become a Carnegie I institution. For me, the burden of compliance has already become so great that I just announced that I am discontinuing funding efforts and leaving animal research, and that is only partly as a result of our IACUC's imposition of a three month salary fine upon me for 'unauthorized transport of a rat'. IACUCs already have [and use] the power to make life miserable for researchers and students. The improvement in animal welfare [noted above as negligible], is simply not worth the enormous investment in compliance time and associated aggravations. A likely effect of adoption of the much-expanded Guide would be to drive many researchers out of animal research. Comment 2: I am fine with the notion of semiannual program and facility evaluation, but I am NOT fine with using the proposed revision of the Guide as the basis for that.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals