Great Eastern University's IACUC is overly sensitive to the need to classify these rats into pain and distress category E. The use of such categories is required on Annual Reports for the USDA but is not required by OLAW. Assuming Subaraman's rats are of the genus Rattus and are bred for use in research1, they are not covered by the USDA. There is no requirement to include information about these rats on the Annual Report to the USDA, and Great Eastern University would be foolish to do so. The report indicating unalleviated pain or distress would be posted on the USDA's website and would be subject to disclosure under the Freedom of Information Act (http://www.aphis.usda.gov/animal_welfare/efoia/7023.shtml). This could attract unwanted attention from animal rights activists and protestors.

Great Eastern University should retroactively classify USDA-covered animals into pain category E depending upon their response to experimental treatment. They must carry out this classification effectively each year for the period October 1 through September 30 and accurately report it on their Annual Report to USDA. There is no requirement by either USDA or OLAW to classify animals prospectively into pain category E if only a small number of animals will reach that state and they cannot be identified in advance.

Subaraman has already described the manipulations on the rats in detail, and the treatment he is testing will minimize pain and distress if successful. He has proposed withholding of any other treatment for pain or distress based on scientific justification and has fulfilled the requirement of the Public Health Service Policy on Humane Care and Use of Laboratory Animals2. Subaraman has a plan to identify and count any rats that develop clinically apparent neuropathy and to report them to the IACUC for categorization into pain category E. This plan leaves the rats without clinically apparent neuropathy in pain category D, as appropriate.

Because these are not USDA-covered animals, annual reporting of animals in pain categories to any agencies is not required. The IACUC may require an annual accounting as the study progresses, and it should require re-evaluation of endpoint criteria when the protocol is resubmitted after three years.

The ability of the stimulation by heat or cold to elicit hypersensitivity early in the project is irrelevant and should not be considered by the IACUC. Application of heat or cold to the area of concern is not part of the normal husbandry of the rats. This IACUC is hypersensitive!

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