f6098d8b__and_Use_of_Laboratory_Animals__Comments
[ID] 97 [Entry Date] 04/15/2011 at 03:40:02 PM [Affiliation] Self [Comments] 
Comment 1: NIH should not adopt the 8th edition of The Guide. In 2003, an ILAR document was published titled "The Development of Science-based Guidelines for Laboratory Animal Care" that presented the concept of using research and scientific principles to guide our policies on the use and care of animals, with utmost consideration on animal wellbeing. However, the 8th edition of The Guide does not advance the field of animal welfare by inclusion of scientific principles. It introduces policy that is based on philosophical arguments lacking basis on scientific findings. One policy that illustrates this is the new section on "Pharmaceutical Grade" reagents used in animal research (Ch. 2). What this section says is that "pharmaceutical grade" substances should be used, and if they are not used, this has to be justified, including a consideration of grade, purity, sterility, pH, pyrogenicity, osmolality, stability, site and route of administration, formulation, compatibility, and pharmacokinetics. This philosophy is not a new one, however, until now, it has not appeared in a policy document that would have a real impact on research institutions. There are several problems with this addition regarding "Non-Pharmaceutical Grade Chemicals and Other Substances." 1. The term "pharmaceutical grade" is not defined. 2. There are no scientific citations to reinforce this policy. Where is the evidence that non-pharmaceutical grade compounds, whatever they may be, are harming animal welfare or disturbing research results? 3. There is a misconception that this policy is actually part of the Animal Welfare Act. The paragraph cites a reference to USDA 1997b. This citation is a USDA Animal Care Resource Guide (www.aphis.usda.gov/animal_welfare/downloads/policy/policy3.pdf) that is not part of the Animal Welfare Act. It is a policy adopted by USDA to guide interpretation of the Animal Welfare Act, but it is not, in and of itself, part of the Animal Welfare Act. This USDA policy has language about non-pharmaceutical grade substances that is now showing up in The Guide. Again, the problem with this is that it's actually not part of the Animal Welfare Act, so it's not technically a federal law. It's simply the guidance USDA is providing in interpreting the Animal Welfare Act. Other groups could come up with alternative interpretations. Furthermore, this guidance provided by USDA still does nothing to define what is meant by "pharmaceutical grade". 4. The paragraph also cites Wolff et al 2003. This is a FAQ document that was published in Lab Animal in 2003. In the FAQ's specifically question 3 dealt with non-pharmaceutical grade compounds. This FAQ document was written by a group of veterinarians at OLAW. They are providing the argument that the use of non pharmaceutical grade compounds should be justified in an IACUC protocol. However, this response to an FAQ is not official public policy. It represents the opinion of veterinarians at OLAW. 5. The paragraph ends with a citation to NIH 2008. It is suggestive that this policy is part of NIH public policy. However, this is a reference document provided by the NIH to guide NIH internal research programs, and it does not apply to institutions funded by NIH. It is contains essentially the same verbiage found in the FAQ's cited above and the USDA guidance policy. (http://oacu.od.nih.gov/ARAC/documents/Pharmaceutical_Compounds.pdf) It does however provide some definitions, so it is a bit more helpful. A very important note: this document is not part of the Public Health Service Policy on Humane Care and Use of Laboratory Animals. To the best of my knowledge, the term "pharmaceutical grade" does not even appear in the PHS Policy on Humane Care and Use of Laboratory Animals. In fact, this reference to the NIH document appears to have been inadvertently left in the published form of the Guide, as a note in the "Addendum: List of Editorial Changes from the Prepublication Version" of The Guide indicates that this reference was removed from an earlier position in the paragraph: In summary The Guide relating to pharmaceutical grade compounds is misleading and confusing. It does not explain what is meant by pharmaceutical grade compounds, and it also suggests that using non-pharmaceutical grade compounds without justification goes against the Animal Welfare Act and PHS policy, of which it does neither. There has been an emphasis on the application of "science-based" guidelines to develop policies for the care and use of laboratory animals (e.g. see ILAR publication "The Development of Science-based Guidelines for Laboratory Animal Care, National Academies Press 2003). However, this policy on pharmaceutical grade compounds in research is not based on scientific principles, but rather a philosophical argument that, for some reason, non-pharmaceutical grade compounds (whatever that means) are inferior to pharmaceutical grade compounds (whatever they are). If the PHS adopts version 8 of The Guide, this policy will become PHS policy. We still don't even really know what this means. The PI would have to consider grade, purity, sterility, pH, pyrogenicity, osmolality, stability, site and route of administration, formulation, compatibility, and pharmacokinetics. Much of this already gets considered when preparing to administer a reagent to an animal. However, some information may not even be available. Do we have to send out research compounds to a compounding pharmacy or characterization lab? Will the PI have to do these characterizations in house? Does this policy apply to common practices such as administering sucrose in drinking water or using any chemical from Sigma or other reagent suppliers? How will drug dosage be adjusted? What about drug vehicles? Version 8 of The Guide should not be adopted by NIH. If a new version of The Guide is to be adopted, it should be based on scientific principles that will benefit animal welfare, and key terms should be defined. Comment 2: NIH should not adopt the 8th edition of The Guide. If implemented, facilities should not be required to use it in their semiannual inspections prior to March 31, 2015. It will take substantial time and effort to revise internal policies and procedures to meet the recommendation of the 8th edition of The Guide. This would be a multi-year process.
Listing of Public Comments on Proposed Adoption and Implementation of the Eighth Edition of the Guide for the Care and Use of Laboratory Animals