f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 58 [Entry Date] 04/12/2011 at 06:06:27 PM [Affiliation] Self [Comments] 
Comment 1: Chapter 4, pp 114 ...investigator and veterinary staff cannot reach consensus on treatment, the veterinarian must have the authority, delegated by senior administration (see Chapter 2, Institutional Official and Attending Veterinarian) and the IACUC, to treat the animal, remove it from the experiment, institute appropriate measures to relieve severe pain or distress, or perform euthanasia if necessary. This is in direct conflict with 21 CFR 58.33 The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control. In addition, 9 CFR 2.31 empowers the IACUC committee to resolve differences in opinion between SD and Veterinarian. It would be a violation of the USDA regulations for the Veterinarian to act unilaterally and intervene against SD opinion, without IACUC consideration and approval. Endpoints and pain/morbidity level plans are a required part of the IACUC protocol approval process. If the Veterinarian is concerned about endpoints or pain management plans, the time to voice those concerns are prior to start of study. Interference can result in biased data and skew endpoints required for FDA decision making and ultimately endanger human health where such endpoints are ignored in favor of animal comfort. Critical data can be lost or obscured under the guise of protecting the test subject. FDA regulations are designed to create studies which per 21 CFR 58.120 reduce bias and per 21 CFR 58.33 capture all data including unanticipated results which may point to future human safety issues thereby saving lives in future clinical trials. The Veterinarian having the authority to act unilaterally without IACUC consideration and approval is unacceptable and violates FFDCA and the regulatory authority of the FDA. Currently the Federal Register Vol 76 March 29, 2011 list April 24, 2011 as the final date for comment. In addition to the problem with the Study Director – Vet conflict there are a number of revisions of cage dimensions which are virtually unavailable in the market making cage sizes obsolete and creating a rather unreasonable financial burden on all research organizations.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals