[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR113.40]

[Page 667]
 
                  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. 113.40  Dog 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 dogs. Serials 
which are not found to be satisfactory when tested pursuant to the 
procedures in this section may not be released for shipment.
    (a) The dog 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 by a method acceptable to the Animal and Plant Health 
Inspection Service.
    (2) Each of at least 10 susceptible dogs shall be administered a 
sample of the Master Seed Virus equivalent to the amount of virus to be 
used in one dog dose of the vaccine, by the method recommended on the 
label, and the dog shall be observed each day for 14 days.
    (3) If unfavorable reactions attributable to the virus occur in any 
of the dogs during the observation period, the Master Seed Virus is 
unsatisfactory. If unfavorable reactions occur which are not 
attributable to the Master Seed Virus, the test shall be declared 
inconclusive and may be repeated: Provided: That, if the test is not 
repeated, the Master Seed Virus shall be considered unsatisfactory.
    (b) The dog 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 dogs shall be administered 10 dog doses by 
the method recommended on the label and the dogs shall be 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 biological 
product, the test shall be declared inconclusive and may be repeated: 
Provided, That, if the test is not repeated, the serial shall be 
considered unsatisfactory.

[60 FR 14358, Mar. 17, 1995]