f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 421 [Entry Date] 04/22/2011 at 12:56:28 PM [Affiliation] Self [Organization Name] New York State Psychiatric Insitute [Organization City and State] New York, NY [Comments] 
Comment 1: As chair of an IACUC at a large New York State research facility, I recommend that the 8th edition not be adopted as PHS Policy. There are numerous problems with the 8th edition as federal policy that will govern PHS-funded researchers. In addition the guide oversteps the bounds of its mandates by outlining policies and guidelines for other Executive Branch agencies (e.g., OSHA and DEA). It steps out of the PHS Policy to cover vertebrates used in research in stating "The Guide does not address in detail agricultural animals … or invertebrate animals (e.g., cephalopods) used in research, but establishes general principles and ethical considerations that are also applicable to these species and situations." Never-the-less, the 8th edition can function, as do other National Academy publications, as a useful reference volume on certain issues relating to animal husbandry. 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; policies that must be followed. The excessive use of the "must" term removes the traditional role of the IACUC in supervising animal work in accordance with locally-based knowledge of the complexities attendant to the specific types of research being conducted at an institution. Thus, the new policies constrain the exercise of scientific and professional judgment. Further any local variation away from the "must" list will entail massive amounts of tedious paperwork that will cost much in time and money and do nothing to improve animal welfare. Higher costs to institutions (not counting the time donated by IACUC members) will have to be passed on to grants through increased direct and indirect costs. What is challenging for scientists working with laboratory animals is the absence of data supported so many of the "must." Data we can work with, hunches and feelings that a change is good is a different matter entirely. I will focus on only a few specific concerns. 1) Mandatory requirements for new cage sizes for some species and for social housing of all species will require large expenditures. The increase in cage size for rodent breeding, based on no data, is particularly troubling. Our institution is modest with about 20,000 rodents but breeding is key especially for mouse work and the increased cost will decrease funding for the science part of the work. 2) Newly introduced requirements for post-approval monitoring of protocols (e.g., direct observation of "laboratory practices and procedures and comparisons with approved protocols") places a great burden on the IACUC and its members. Our current PAM practices address adequately address the issues, but the addition more specific review points is a burden. Likely the extra work will entail increasing IACUC size and staff. 3) The language cautioning against multiple survival surgery procedures in addition to the previous caution against multiple major survival surgeries ignores both studies that are best done with multiple survival surgeries and long-term studies that based on their length may require motile surgeries. Further restrictions against using animals in multiple procedures surely increases the number of animals needed, thus increasing research costs as well as the number of animals used in research. Finally, these restrictions fail to take into account the value of within-subject and single subject designs, which are particularly powerful for behavioral and psychiatric research. 4) The section on "Food and Fluid Regulation" now requires daily recording of food and fluid consumption for all animals on either type of restriction will increase burden without improving animal care. This requirement will necessitate use of calibrated water bottles or flow-meters rather than the now common automated watering systems, thus incurring additional equipment costs; and will require a method of weighing the unrestricted food given to fluid-restricted animals. Guidance to use "treats" for behavioral training with the assumption that this avoids food restriction is counter to the information in two of the scholarly reviews cited in that same Guide paragraph. These examples may represent only imprecise drafting, rather than intent, but this is only one example of how the 8th edition is unsuitable as federal policy. 5) The new section "Use of Non-Pharmaceutical Grade Chemicals and Other Substances" shows a complete lack of understanding research examining drug effects on behavior and studies that manipulate internal states with drugs as pharmacological probes of underlying mechanism. This section essentially bans researchers from using standard source drugs for research including compounds from the National Institute on Drug Abuse 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. It also is written in a way that assumes that clinical preparations are available for most laboratory animal research, when this is seldom true. Further, clinical formulations are generally bad choices for research as these can make dose manipulations and vehicle comparisons difficult. No definition of "pharmaceutical grade" is given, but two conflicting definitions are implied by citation of the USDA/APHIS Policy 3, an interpretive rule for use "medications" to prevent pain/distress and the intramural NIH program policy on "non-pharmaceutical grade drugs." Experience with USDA/APHIS enforcement makes clear that Policy 3 is interpreted as requiring use of commercially prepared solutions, rather than investigator-prepared;, and the first sentence of the new Guide section on this topic is consistent with this. Yet the intramural policy defines "pharmaceutical grade" as manufactured according to USP standards, thus accommodating investigator-prepared solutions. 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 is only one example of the new Guide's intrusion into the realm of the scientific and professional judgment of NIH-funded researchers. Again this is an intrusion into the scientific process without any data justifying the change. An issue not directly addressed by focusing on the human and financial burden of the new guide is the fact that increasing costs for housing and breeding will decrease money available for the science part of the project. An increase in both direct and indirect costs will decrease funds available to support investigators. Those hurt the most will be junior investigators just getting their careers started. This will put an entire generation of scientists at risk. This is not a minor issue. Recent cutbacks have already significantly disheartened the latest batch of individuals looking for their first research award at my institution. Further cut backs will be devastating in both the short and long terms for progress in medical and psychological science. Comment 2: I agree with the National Association for Biomedical Research that the 2011 Guide represents a significant "guidance document," as defined by the Office of Management and Budget which "may reasonably be anticipated to lead to an annual effect on the economy of $100 million or more. . ." Therefore, a meaningful opportunity to comment in greater detail on the substance of the new Guide and its financial consequences is necessary before a decision on Guide adoption and implementation strategy can be made. As chairman of my IACUC I can say with certainty that we will not be prepared to meet the new proposed standards if adopted in such a brief time frame. Physical space and financial restraints would make it impossible. Further the greater demands placed on IACUC membership will make serving on the IACUC an even greater strain on the ability to conduct one's own research and keep one's own funding tenable. I care deeply about the science our researchers conduct and in the proper care of our laboratory animals. What I've seen in the new guide will not improve substantially our animal care but will impede science.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals