General requirements for inactivated bacterial products.

CFR · 2024-01-01 · US · Title 9

Unless otherwise prescribed in an applicable Standard Requirement or in the filed Outline of Production, an inactivated bacterial product shall meet the applicable requirements in this section. (a) (2) Each lot of Master Seed Bacteria shall be tested for the presence of extraneous viable bacteria and fungi in accordance with the test provided in § 113.27(d). (b) (1) The product contains material which is inherently lethal for mice. In such instances, the guinea pig safety test provided in § 113.38 shall be conducted in place of the mouse safety test. (2) The product is recommended for poultry. In such instances, the product shall be safety tested in poultry as defined in the specific Standard Requirement or Outline of Production for the product. (3) The product is recommended for fish, other aquatic species, or reptiles. In such instances, the product shall be safety tested in fish, other aquatic species, or reptiles as required by specific Standard Requirement or Outline of Production for the product. (c) (1) Cultural characteristics, (2) Staining reaction, (3) Biochemical reactivity, (4) Fluorescent antibody tests, (5) Serologic tests, (6) Toxin typing, (7) Somatic or flagellar antigen characterization, and (8) Restriction endonuclease analysis. (d) (e) Only serials tested for viricidal activity in accordance with the test provided in § 113.35 and found satisfactory by such test shall be packaged as diluent for desiccated fractions in combination packages. (f) If formaldehy

official document · source cfr-2024 · id 9:§ 113.100