f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 133 [Entry Date] 04/18/2011 at 11:52:46 AM [Affiliation] Self [Comments] 
Comment 1: NO. This is an emphatic NO. The new guide was originally supposed to be an "update" of the 1996 Guide--however the final product is 2x as long and contains a great deal of NEW "policy" that has not been properly vetted and is not supported by data. Compliance with these NEW "policy" statements undoubtedly will greatly increase the expense of conducting public health research to both institutions (e.g., new requirements for cage size) and investigators (e.g., new constraints on the use of experimental drugs) without need. The scientific data justifying these expensive changes are non-existent. The policy changes laid out in the new Guide, if implemented, represent regulatory mischief that results in no real enhancement of animal welfare. Adherence to the proposed 2011 Guide also will require large increase in paperwork (e.g., all deviations from "should" statements contained in the new Guide will need to be justified). Adoption of the new Guide may also negate the opportunity to diminish the burden resulting from previous over-reactions to issues for which institutions already have "overregulated." Moreover, the new "Guide" policies will unduly increase infringement on scientific decision-making by PHS grantees, contractors and IRGs. Some specific examples of recommendations that are unwarranted by data include: constraints on multiple procedures in experimental subjects, constraints on multiple surgeries (per se), new requirements for food- or fluid-restriction, naïve and constraining section on choices of "chemicals and other substances" that can be given to subjects under study, and specific guidance on "post-approval" monitoring (e.g., observation of procedures). Finally, the new "Guide" requires an increased level of intra and post-operative surgical procedures--again, without data indicating need. Comment 2: OLAW should require institutional compliance with the new Guide no sooner than March, 2015 to allow for the collection of relevant data. Those data alone should guide policy decisions.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals