All test animals shall be examined for clinical signs of illness, injury, or abnormal behavior prior to the start of a test and throughout the observation period specified in the test protocol.

All animals used for test purposes shall be identified either collectively or individually in a manner conducive to an accurate interpretation of the results of the test.

No test animals shall be given a biological product during the preconditioning period which would affect its eligibility according to the test requirements. No treatment, with a biological product or otherwise, shall be administered to a test animal during a test period which could interfere with a true evaluation of the biological product being tested.

During the course of a test, animals that are injured or show clinical signs of illness or unfavorable reactions that are not due to the test may be removed from the test and treated or humanely destroyed. If sufficient animals do not remain for the test to be evaluated, the test shall be declared inconclusive and may be repeated.

Test animals that show clinical signs of illness that are due to the test may be treated or humanely destroyed if the illness has progressed to a point (defined in the filed Outline of Production) when death is certain to occur without therapeutic intervention. When interpreting the results of the test, the animals that were treated or humanely destroyed because of illness due to the test and the animals that have died from illness due to the test prior to being humanely destroyed shall be combined into a common statistic of mortality due to the test.