f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 56 [Entry Date] 04/07/2011 at 03:51:19 PM [Affiliation] Self [Comments] 
Comment 1: After reading the Eighth Edition of the Guide for the Care and Use of Laboratory Animals, we feel strongly that it should not be adopted as it is, but should be sent back for revision and clarification. While some necessary updates are included, several statements within the Guide are ambiguous and others are not appropriate for the use of species such as rodents and fish. We think that the lack of discussion of species-specific requirements for optimal care and management is a major problem with the Guide as written. If adopted in its present form, the Guide is likely to be interpreted variably by readers at different institutions and increase the regulatory burden on those who work with animals. Of great relevance, it appears that the committee that wrote the Guide included minimal representation from the scientific community who actually use animals in their research. We believe that having a balanced committee is key to having a clear and useful document and that this unbalanced committee structure may underlie the specific issues listed below. 1. Guide page 27-"Experimental and Humane endpoints". We believe that this distinction is false and will be interpreted to mean that some procedures in IACUC-approved documents are inhumane. Before any proposal is submitted by the investigator or approved by an IACUC, alternatives are considered fully. In approved protocols, IACUC-approved experimental and human endpoints are identical. During the course of studies, investigators continually re-evaluate the endpoint criteria necessary to meet the scientific goals and the necessity of any adverse affects that have been previously approved. This change in the Guide may directly hamper research efforts by raising questions about "inhumane" endpoints. 2. Guide page 25-"A clear and concise sequential description of the procedures involving the use of animals that is easily understood by all members of the committee." This addition to the Guide does not affect animal welfare, but increases the regulatory burden on investigators. Description of Study Objectives in lay terms is already required (and often difficult); any procedures that are not easily understood can be discussed at committee meeting. If necessary, investigators could be asked for additional clarification for those few cases in which procedures are not clear or adequately justified. 3. Guide page 64-"Social environment"-The concerns raised about social housing apply minimally to mice, rats or fish. Mice, rats and fish should be exempt from these social pairing requirements. The Guide should state that while mice and rats are social animals and single housing is discouraged, they are exempt from the need for provision of scientific justification and review of social housing requirements. Appropriate environmental enrichment for mice and rats is encouraged. 4. Guide pages 29 and 64-Restraint devices. It is unreasonable to broadly apply the information in the physical restraint section, which describes requirements for training and habituation, to laboratory mice, rats and fish. Training and habituation is generally not feasible due to the numbers of animals involved and average length of experiments. Training and habituation should not be required for the restraint of rodents for acute and transient procedures. Only prolonged restraint or restraint used as an experimental stressor for rodents should require description and justification. Listing the restraint methods to be used on the animal study proposal is appropriate in all cases. It should be clarified that animals that fail to adapt should be removed from the study when the failure poses a reasonable risk to the animal or personnel, or adversely affects the animal's health and welfare or study objectives. Finally, fish should be excluded from the physical restraint and training section. 5. Guide page 30-Food and fluid regulation. The requirement that written records of daily food and fluid intake be maintained for individual animals in experiments involving food or fluid restriction should be waived for mice, rats and fish. Measuring intake is virtually impossible for mice or rats unless they are singly housed, which is not recommended elsewhere in the Guide. The IACUC should decide when records are required, unless adverse effects are observed during daily monitoring. 5. Guide page 115-Surgery-"The IACUC, together with the AV, is responsible for determining that personnel performing surgical procedures are appropriately qualified and trained in the procedures (Anderson 2007)." The IACUC should be responsible for supervision. The AV should provide guidance but there will be a potentially adversarial relationship if the AV is also responsible for determining whether personnel are appropriately qualified. 6. Guide page 123-Euthanasia-"Standardized methods of euthanasia that are predictable and controllable should be developed and approved by the AV and IACUC."This is the same issue as in item #5. The IACUC should have the final authority in all areas of euthanasia. 7. Guide page 15: Interinstitutional Collaborations - . "In cases of such collaboration involving animal use (beyond animal transport), the participating institutions should have a formal written understanding…" This creates an unnecessary regulatory burden. OLAW should clarify that the Guide is concerned with animal care and services and not with typical scientific collaborations between investigators at institutions with PHS assurances.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals