Sheep safety test.

§ 113.45 Sheep safety test. The sheep safety test provided in this section shall be conducted when prescribed in a Standard Requirement or in the filed Outline of Production for a product. (a) Test procedure. (1) Inject each of two sheep of the minimum age for which the product is recommended with the equivalent of two doses of bacterial vaccine or 10 doses of viral vaccine. (2) Administer vaccine in the manner recommended on the label. (3) Observe sheep each day for 21 days. (b) Interpretation. If unfavorable reactions attributable to the product occur in either of the sheep during the observation period, the serial or subserial is unsatisfactory. If unfavorable reactions which are not attributable to the product occur, the test shall be declared a No Test and may be repeated; Provided, That, if the test is not repeated, the serial or subserial shall be declared unsatisfactory. [48 FR 33476, July 22, 1983]