f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 499 [Entry Date] 04/25/2011 at 12:44:40 PM [Affiliation] Self [Comments] 
Comment 1: Although it includes much new information, the new Guide also incorporates new policies in a number of areas. Of particular concern is the extent to which the 2011 Guide introduces new policies that constrain the exercise of scientific and professional judgment for both investigators and laboratory animal veterinarians. Mandatory requirements, including requirements for new cage sizes for some species (particularly for rodent breeding, apparently to conform to European standards) and mandatory requirements for social housing of all species (without leeway for practical constraints) will require large expenditures of funds to accomplish. Newly introduced requirements for post-approval monitoring of IACUC-approved protocols (e.g., direct observation of "laboratory practices and procedures and comparisons with approved protocols") and formal review of "unexpected outcomes" of research are examples of items that require additional IACUC staffing to accomplish as well as require additional time from research team members. A major change in the Guide is the introduction of language cautioning against multiple survival surgical procedures per se on the same animal, in addition to cautioning against multiple major survival surgical procedures. This echoes a caution in which investigators are strongly discouraged from advocating animal reuse as a "reduction" strategy. Restrictions against using animals in multiple procedures most certainly will increase the number of animals needed in research, thus increasing costs, but also indirectly hampers the use of within-subject and single subject designs that are particularly powerful for behavioral research. The section on "Food and Fluid Regulation" requires that food and fluid consumption be recorded daily for all animals on either type of restriction, which requires abandoning automated watering systems for food-restricted, as well as water-restricted, animals; and that food consumption for fluid-restricted, as well as for food-restricted, animals be recorded daily despite the fact that each type of restriction makes the other commodity freely available. This may represent only imprecision in drafting, but is only one example of guidance that is inappropriate. The newly added section "Use of Non-Pharmaceutical Grade Chemicals and Other Substances" is of particular concern. This section essentially bans researchers from use of drugs provided by suppliers of high-quality drugs for research and from using such compounds provided through the NIDA drug supply program if a version of that same drug is available in a human clinical or veterinary formulation. It also fails to acknowledge the critical importance of collaborations by chemists with behavioral researchers to develop new therapeutic drugs. The statements in this section are out of touch with the realities of drug abuse research as well as research in numerous other fields. Although OLAW has published a similar set of statements on its website in recent years, the status as enforceable PHS Policy has been controversial due to their de novo introduction of the topic as an answer to a "Frequently Asked Question," (i.e., no previously published PHS Policy nor the Guide had addressed use of drugs in research). No definition of "pharmaceutical grade" is given, but two conflicting definitions are implied by citation of, first, the USDA/APHIS Policy 3, an interpretive rule for use of pharmaceutical grade "medications" to prevent pain/distress in the conduct of research; and second, the NIH policy for its intramural program on "non-pharmaceutical grade drugs." Experience with USDA/APHIS enforcement has made clear that Policy 3 is interpreted to require use of commercially prepared solutions, rather than those prepared by investigators; the first sentence of the new Guide section on this topic is consistent with this view. Yet the NIH policy defines "pharmaceutical grade" drugs as those manufactured according to USP standards, thus accommodating the practice of preparation of drug solutions in the laboratory. Yet even that intramural NIH Policy ignores the fact that the NIDA drug supply program, which has been operating to supply compounds to funded researchers for decades, does not prepare to USP standards, because they are unnecessary for research purposes. To require that they do so would result in significant increases in costs to NIH, for no valid reason, at a time when NIH funding is shrinking. Yet, as with other sections, the contradictions in guidance were not recognized by those who published the 2011 Guide. Reconciling definitions is one obstacle to interpretation, but the clear requirement that investigators justify their use of certain types of compounds and provide elaborate detail on their preparation and characteristics for IACUC review is only one example of the intrusion of the new Guide into second-guessing scientific and professional judgment of experts in their fields of research. This represents only one of many examples of greater burdens on the IACUC, and by extension staff, imposed by new requirements. Comment 2: I concur with NABR that the 2011 Guide represents a significant "guidance document," as defined by the Office of Management and Budget (OMB), which "may reasonably be anticipated to lead to an annual effect on the economy of $100 million or more. . ." Therefore, an opportunity for 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.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals