f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 45 [Entry Date] 03/18/2011 at 12:38:20 PM [Affiliation] Organization [Organization Name] National Biodefense Analysis and Countermeasures Center [Organization City and State] Frederick, MD [Comments] 
Comment 1: We fully support the adoption of the 8th edition of the Guide for the Care and Use of Laboratory Animals (Guide) by the National Institutes of Health (NIH) and the proposed implementation plan. While the vast majority of the changes to the 8th edition of the Guide provide much needed improvements and clarifications on the standards for research animal care and use programs and facilities, there are a small number of issues that could be misinterpreted by either oversight agencies or research facilities using the Guide as a standard. While most comments apply directly to NIH funded research, a few comments do not but still could result in significant confusion across biomedical research facilities in the United States. These issues are provided as follows: Page 25 Topic: Frequency of Program Review and Facilities Inspections The new Guide states "Program review and facilities inspections should occur at least annually or more often as required (e.g., by the Animal Welfare Act and PHS Policy)." While the Animal Welfare Act and PHS Policy both require semiannual program review and facility inspection, not all research entities, even in the United States, are subject to these regulatory requirements. This will lead to a disparity in requirements for those research entities who utilize the Guide as a guidance document but not the other documents cited. The IACUC is a mechanism of self-regulation and conducting annual reviews of the animal care and use program and facilities is not of a sufficient frequency to identify and resolve program and facility issues in a timely manner. Page 26 Topic: Protocol Review A new requirement for protocol review states that the protocol should include a "method of euthanasia or disposition of animals, including planning for care of long-lived species after study completion." The latter part of this statement is very ambiguous and should be clearly defined as to what constitutes "care" and what are considered "long-lived species." This could easily be interpreted by oversight agencies as the need to establish retirement funds designed to maintain animals in sanctuaries for the remainder of their natural life. While this is currently done for chimpanzees, this would result in a phenomenal increase in the cost for research if the intent of this guidance was to include more commonly used nonhuman primates such as Old World macaques. Page 26 Topic: Protocol Review While the new Guide advises that the responsibility for scientific merit review normally lies outside the IACUC, it states "in the absence of evidence of a formal scientific merit review, the IACUC may consider conducting or requesting such a review (Mann and Prentice 2004)." This statement has considerable implications for programs not utilizing the NIH grant review system and leaves the question of "formal review" open to interpretation by oversight agencies. Clarification should be provided as to whether a formal scientific merit review can be performed internally or if the expectation is that it be performed by an external, independent group of scientists. Pages 59 and 61 Topic: Minimum Space Tables 3.3 and 3.5 The title of the tables prescribing minimum space requirements for rabbits, cats, and dogs (Table 3.3) and nonhuman primates (Table 3.5) changed from "minimum space requirements for individual animals" in the old Guide to "individual space requirements for animals housed in pairs or groups" in the new Guide. While there are some differences in floor space and height requirements, the space requirements are similar in both versions of the Guide. The change with the greatest impact involves the addition of the statement to both tables that states "singly housed animals may require more space per animal than recommended for pair- or group-housed animals." Caging manufacturers have produced cages with dimensions based on the minimum space required for individually housed animals as specified in the 7th edition of the Guide. An implication, and possible expectation, that individually housed animals should now have more space will cause confusion not only to the cage manufacturers on how large to make cages for these species, but could result in all the existing cages in use for these species to now be unusable when housing animals individually, which is often needed due to veterinary care or experimental requirements (e.g., quarantine, infectious disease research). Depending on how this new requirement is interpreted by regulatory agencies, this could have a huge economic impact if new caging must now be procured whenever the single housing of animals is required. Without solid scientific evidence that single housed animals benefit from having larger amounts of space over the stated individual space requirement for group housed animals, this requirement will result in the unnecessary diversion of funds from science and confusion among animal care and use programs. Page 139 Topic: Heating, Ventilation, and Air Conditioning (HVAC) With regard to animal room humidification, the new Guide states "Ideally relative humidity should be maintained within ±10% of set point; however, this may not be achievable under some circumstances." While the Guide recognizes that this may not be achievable, the sentence sets a standard that is unachievable by most all older facilities and many new ones. Even with the caveat, the stated preference of no more than a 10% variation of humidity levels from set point will be used by regulators and oversight agencies as an engineering standard. It should be made clear by regulatory and oversight agencies that this is an unrealistic goal and that as long as humidification levels remain between Guide recommended parameters (i.e., 30-70%), and there are no adverse health effects, that the 10% variation requirement will not be used as a standard when evaluating animal facilities. Comment 2: The implementation plan is reasonable and provides sufficient time for programs to incorporate changes to the Guide.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals