Comment on FR Doc # 2010-32922

I work for a company that distributes a diagnostic test for Tuberculosis in NHP's, which can be performed on the same blood sample that is drawn during a health exam, providing results in minutes rather than days and without subjecting the animal to additional injections. The sales of this test are hampered because the CDC will will only recognize the intradermal Tuberculin Skin Test (TST) to release animals from quarantine because the TST is the only one cited in the 1980 LABORATORY ANIMAL MANAGEMENT: Nonhuman Primates. In 30 years, other diagnostic devices and methods have been developed, but remain limited in use. The TST measures only one aspect of the animal's ability to respond to Tb, specifically cell-mediated immunity, which can be suppressed in latent infections. Performing the TST, 3 or 5 times, on a latent infected animal does not assure they are free. To combine the TST with other methods that may measure the humoral immune response, would increase diagnostic power and may reduce the possibility of latent infected animals escaping detection during quarantine. This is also a position advocated in 2008 by Lerche etal, ILAR Journal vol. 49 #2 pg 176-177. This strategy would also be in keeping with the statement in the proposed rule, "...improved surveillance and testing procedures are essential in NHP quarantine and research facility settings." Furthermore, the TST has not been proven to detect TB in each and every species of NHP. In fact, the code of Federal Regulations does not require serial release testing of new production batches of the TST on any primate, but rather, it is tested for potency on sensitized guinea pigs. Therefore, imposing the same testing requirements on all NHP's as are conducted for macaques and African green monkeys would be based upon tradition and not scientific merit and thus may be an unnecessary and unjustified expense that would create a false sense of security, and condemn some animals that produce false positive reactions