[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR113.39]

[Page 637-638]
 
                  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. 113.39  Cat safety tests.

    The safety tests provided in this section shall be conducted when 
prescribed in a standard requirement or in the filed Outline of 
Production for a biological product recommended for use in cats.
    (a) The cat safety test provided in this paragraph shall be used 
when the Master Seed Virus is tested for safety.
    (1) The test animals shall be determined to be susceptible to the 
virus under test as follows:
    (i) Throat swabs shall be collected from each cat and individually 
tested on susceptible cell cultures for the presence of the virus. Blood 
samples shall also be drawn and individual serum samples tested for 
antibody to the virus.
    (ii) The cats shall be considered susceptible if swabs are negative 
for virus isolation and the serums are free of virus antibody at the 1:2 
final dilution in a 50 percent plaque reduction test or other serum-
neutralization test of equal sensitivity.
    (iii) When determining susceptibility to a virus which does not lend 
itself to the methods in paragraphs (a)(1)(i) and (ii) of this section, 
a method acceptable to Animal and Plant Health Inspection Service shall 
be used.
    (2) Each of at least 10 susceptible cats shall be administered a 
sample of the Master Seed Virus equivalent to the amount of virus to be 
used in one cat dose of the vaccine, by the method to be recommended on 
the label, and the cats observed each day for 14 days.
    (3) If unfavorable reactions attributable to the virus occur in any 
of the cats during the observation period, the Master Seed Virus is 
unsatisfactory. If unfavorable reactions occur which are

[[Page 638]]

not attributable to the Master Seed Virus, the test shall be declared 
inconclusive and repeated: Provided, That, if not repeated, the Master 
Seed Virus shall be unsatisfactory.
    (b) The cat safety test provided in this paragraph shall be used 
when a serial of vaccine is tested for safety before release.
    (1) Each of two healthy cats shall be administered 10 cat doses by 
the method recommended on the label and the cats observed each day for 
14 days.
    (2) If unfavorable reactions attributable to the biological product 
occur during the observation period, the serial is unsatisfactory. If 
unfavorable reactions occur which are not attributable to the product, 
the test shall be declared inconclusive and repeated: Provided, That, if 
not repeated, the serial shall be unsatisfactory.

[44 FR 58898, Oct. 12, 1979, as amended at 56 FR 66784, Dec. 26, 1991]