[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: 9CFR113.36]

[Page 611-612]
 
                  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. 113.36  Detection of pathogens by the chicken inoculation test.

    The test for detection of extraneous pathogens provided in this 
section shall be conducted when such a test is prescribed in an 
applicable Standard Requirement or in the filed Outline of Production 
for the product.
    (a) The biological product to be tested shall be prepared for use as 
recommended on the label, or in the case of desiccated vaccine to be 
used in poultry, rehydrated with sterile distilled water at the rate of 
30 ml per 1,000 doses.
    (b) At least 25 healthy susceptible young chickens, properly 
identified and obtained from the same source and hatch, shall be 
immunized at least 14 days prior to being put on test. The immunizing 
agent shall be the same as the product to be tested but from a serial 
previously tested and found satisfactory.
    (c) At least 20 of the previously immunized birds shall be 
inoculated with 10 label doses of the vaccine being tested by each of 
the following routes: Subcutaneous, intratracheal, eye-drop, and comb 
scarification (1 cm\2\). Twenty birds may be used for each route or 
combination of routes.
    (d) At least five birds shall be isolated as control birds.
    (e) All birds shall be observed for 21 days for signs of septicemic 
diseases,

[[Page 612]]

respiratory diseases, or other pathologic conditions.
    (f) If the controls remain healthy and unfavorable reactions 
attributable to the product occur in the vaccinates, the serial or 
subserial tested is unsatisfactory. If the controls do not remain 
healthy or if unfavorable reactions not attributable to the product 
occur in the vaccinates, or both, the test shall be declared 
inconclusive and may be repeated: Provided, That, if the test is not 
repeated, the serial of subserial tested shall be considered 
unsatisfactory.

[38 FR 29889, Oct. 30, 1973, as amended at 39 FR 21042, June 18, 1974; 
43 FR 7610, Feb. 24, 1978]