f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 199 [Entry Date] 04/19/2011 at 03:03:54 PM [Affiliation] Organization [Organization Name] American College of Neuropsychopharmacology [Organization City and State] Brentwood, Tennessee [Comments] 
Comment 1: The American College of Neuropsychopharmacology (ACNP), founded in 1961, is the nation's premier professional society in brain, behavior, and psychopharmacology research. The field of neuropsychopharmacology involves the evaluation of the effects of natural and synthetic compounds upon the brain, mind, and human behavior. ACNP welcomes this opportunity to comment on the question of whether the recently published 8th edition of the "Guide for the Care and Use of Laboratory Animals" should supplant the 7th edition as Public Health Service (PHS) Policy to govern all PHS-Assured institutions. Although the 8th edition contains useful new information (e.g., on the care of aquatic species), it otherwise represents a significant departure from the 7th edition in ways that impose new constraints, paperwork burdens, and costs on investigators and institutions receiving federal funds for research without a concomitant increase in animal welfare. ACNP therefore supports the position of the National Association for Biomedical Research (NABR) in its letter to Francis Collins urging that the NIH not adopt the new Guide until and unless concerns regarding new regulatory burdens are addressed. Although there are numerous new requirements in the 8th edition of the Guide that would impose substantial new paperwork burdens and expense, ACNP will focus in its comments on one issue of particular concern for its members. The new section on "Use of Non-Pharmaceutical Grade Chemicals and Other Substances" adds a policy that, on the surface, may sound reasonable, but is inappropriate for basic research. Its apparent premise (based on the citation of an interpretive rule guiding USDA inspectors regarding adequate veterinary care) that the use of commercial drug solutions sold for clinical use in human or veterinary practice "ensures that toxic and unwanted effects are not introduced into studies conducted with experimental animals" is false. Not only do very few commercially available preparations exist that are suitable as tools for experimental research, but also, commercial solutions themselves are subject to formulation errors, as evidenced by recent recalls. Even with solutions that may be useful for a particular project, the need to conduct dose-effect evaluations inevitably means the commercial solution would need to be diluted or concentrated in the laboratory to accomplish this purpose. In addition, many commercial formulations, such as those in pill or capsule form, contain filler material that could confound experimental effects, especially when used by alternative routes of administration. For ACNP members, the ultimate goal of neuropsychopharmacology research is to find new treatments for neuropsychiatric illnesses. A critical step in much of this research is to give drugs with novel mechanisms of action to laboratory animals. Most of these drugs are, by definition, unavailable from commercial sources and must be prepared by the investigator. The requirement in this new section of the Guide that "The use of non-pharmaceutical-grade chemicals or substances should be described and justified in the animal use protocol and be approved by the IACUC," inappropriately presumes the accuracy of the premise that any preparation of drug solutions by the researcher can be assumed to be inferior to commercial preparation. The further requirement that "In such instances, consideration should be given to the grade, purity, sterility, pH, pyrogenicity, osmolality, stability, site and route of administration, formulation compatibility, and pharmacokinetics of the chemical or substance to be administered, as well as animal welfare and scientific issues relating to its use. . " inappropriately defers the scientific judgment of the researcher to the IACUC. This recommendation also presumes that the IACUC has expertise, or retains someone with such expertise, to evaluate the details of formulations planned by the researcher. Review of the Guide indicates that this new section uniquely micromanages pharmacological research. In conclusion, the section on "non-pharmaceutical grade drugs" and multiple other sections of the new Guide preempt scientific and professional judgment on the design and conduct of research. This section seems especially inappropriate for a document that will govern the research of scientists whose funding has been granted based to a significant degree on the peer-reviewed determination of their expertise and ability to carry out specialized research. It goes significantly beyond the traditional value of the Guide for setting standards for animal housing, husbandry, and veterinary care of research animals. Comment 2: ACNP concurs 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, setting a date by which PHS-Assured institutions must comply with the new Guide prior to an OMB analysis of its financial impact on those institutions and NIH itself is premature.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals