[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR113.100]

[Page 630-631]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 113--STANDARD REQUIREMENTS--Table of Contents
 
Sec. 113.100  General requirements for inactivated bacterial products.

    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 Sec. 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 Sec. 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 Sec. 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 
Sec. 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

[[Page 631]]

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 Sec. 113.50. Ingredients of animal origin shall 
meet the applicable requirements provided in Sec. 113.53.
    (e) Only serials tested for viricidal activity in accordance with 
the test provided in Sec. 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 shall be 
tested for residual free formaldehyde content using the Basic Fuchsin 
Test.
    (1) The residual free formaldehyde content of biological products 
containing Clostridial antigens shall not exceed the equivalent of 0.5 
percent formaldehyde solution (1,850 parts per million formaldehyde.)
    (2) The residual free formaldehyde content of bacterins, bacterin-
toxoids, and toxoids other than those containing Clostridial antigens, 
shall not exceed the equivalent of 0.2 percent formaldehyde solution 
(740 parts per million formaldehyde.)

[39 FR 16862, May 10, 1974. Redesignated at 55 FR 35562, Aug. 31, 1990, 
as amended at 60 FR 14355, Mar. 17, 1995]