f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 487 [Entry Date] 04/25/2011 at 09:32:04 AM [Affiliation] Self [Comments] 
Comment 1: I am AGAINST adoption of the new edition of the Guide for the Care and Use of Laboratory Animals (Guide). My objection stems from a number of new sections added to this version. 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) and mandatory requirements for social housing of all species (without leeway for practical constraints - animal fighting, illneess, etc.) will require large expenditures of funds to accomplish. In addition, 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 fails to acknowledge the critical importance of collaborations by chemists with researchers to develop new therapeutic drugs or formulations. It is written in a way that assumes that clinical preparations are available for most laboratory animal research, when this is seldom true. Furthermore, 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. Even the intramural Policy ignores that the NIDA drug supply program and other standard sources do not prepare to USP standards, as these have more to do with documenting drug manufacture than drug quality. As with other sections, the contradictions in guidance are problematic. Reconciling definitions is one obstacle to interpretation. This new regulation is burdensome and expensive without benefit to animal welfare or science. Comment 2: 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. We currently have annual renewals, repeated training sessions, and online continuing eduation. These new policies question professional judgment and add significantly to the paperwork burden for investigators and IACUCs.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals