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) Purity tests.

(1) Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in §113.26.

(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) Safety tests. Bulk or final container samples of completed product from each serial shall be tested for safety in young adult mice in accordance with the test provided in §113.33(b) unless:

(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) Identity test. Methods of identification of Master Seed Bacteria to the genus and species level by laboratory tests shall be sufficient to distinguish the bacteria from other similar bacteria according to criteria described in the most recent edition of “Bergey's Manual of Systematic Bacteriology” or the American Society for Microbiology “Manual of Clinical Microbiology”. If Master Seed Bacteria are referred to by serotype, serovar, subtype, pilus type, strain or other taxonomic subdivision below the species level, adequate testing must be used to identify the bacteria to that level. Tests which may be used to identify Master Seed Bacteria include, but are not limited to:

(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) Ingredient requirements. Ingredients used for the growth and preparation of Master Seed Bacteria and of final product shall meet the requirements provided in §113.50. Ingredients of animal origin shall meet the applicable requirements provided in §113.53.

(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 formaldehyde is used as the inactivating agent, and the serial has not been found satisfactory by the viricidal activity test, bulk or final container samples of completed product from each serial must be tested for residual free formaldehyde content using the ferric chloride test.1 Firms currently using tests for residual free formaldehyde content other than the ferric chloride test have until July 14, 2004 to update their Outline of Production to be in compliance with this requirement.

(1) The residual free formaldehyde content of biological products containing clostridial antigens must not exceed 1.85 grams per liter (g/L).

(2) The residual free formaldehyde content of bacterins, bacterin-toxoids, and toxoids, other than those containing clostridial antigens, must not exceed 0.74 grams per liter (g/L).

[39 FR 16862, May 10, 1974. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 60 FR 14355, Mar. 17, 1995; 68 FR 35283, June 13, 2003; 79 FR 31021, May 30, 2014]