[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR113.38]

[Page 570-571]
 
                  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. 113.38  Guinea pig safety test.

    The guinea pig safety test provided in this section shall be 
conducted when prescribed in a Standard Requirement or approved Outline 
of Production for a biological product. When desiccated products are 
tested, final container samples of completed product prepared for 
administration in the manner recommended on the label shall be used. 
When liquid products are tested, either bulk or final container samples 
of completed product shall be used.
    (a) Unless otherwise specified in the Standard Requirement or 
approved Outline of Production for the product, a 2 ml dose shall be 
injected either intramuscularly or subcutaneously into each of two 
guinea pigs and the animals observed for 7 days.
    (b) If unfavorable reactions attributable to the product occur in 
either of the guinea pigs during the observation period, the serial or 
subserial is unsatisfactory. If unfavorable reactions

[[Page 571]]

which are not attributable to the product occur, the test shall be 
declared inconclusive and may be repeated: Provided, That, if the test 
is not repeated, the serial or subserial shall be declared 
unsatisfactory.

[39 FR 16857, May 10, 1974; 39 FR 20368, June 10, 1974]