[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: 9CFR113.204]

[Page 713]
 
                  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. 113.204  Mink Enteritis Vaccine, Killed Virus.

    Mink Enteritis Vaccine, Killed Virus, shall be prepared from virus-
bearing cell culture fluids or tissues obtained from mink that have 
developed mink enteritis following inoculation with virulent mink 
enteritis virus. Each serial shall meet the applicable requirements 
prescribed in Sec. 113.200 and special requirements prescribed in this 
section. Any serial found unsatisfactory by a prescribed test shall not 
be released.
    (a) Safety test. Vaccinates used in the potency test in paragraph 
(b) of this section shall be observed each day prior to challenge. If 
unfavorable reactions attributable to the vaccine occur, the serial is 
unsatisfactory. If unfavorable reactions not attributable to the vaccine 
occur, the test shall be declared inconclusive and may be repeated: 
Provided, That, if the test is not repeated, the serial is 
unsatisfactory.
    (b) Potency test. Bulk or final container samples of completed 
product shall be tested for potency using 10 mink enteritis susceptible 
mink (five vaccinates and five controls) as follows:
    (1) Vaccination. Each of the five vaccinates shall be injected with 
one dose of vaccine as recommended on the label and observed each day 
for 14 days.
    (2) Challenge. At least 2 weeks after the last inoculation, the five 
vaccinates and the five controls shall be challenged with virulent mink 
enteritis virus and observed each day for 12 days. Fecal material shall 
be collected on one day between days 4-8 (inclusive) postchallenge from 
each test animal that remains free of enteric signs and tested for the 
presence of mink enteritis virus by cell culture with fluorescent 
antibody examination.
    (3) Interpretation. A serial is satisfactory if at least 80 percent 
of the vaccinates remain free of enteric signs and do not shed virus in 
the feces, while at least 80 percent of the controls develop clinical 
signs of mink enteritis or shed virus in the feces. If at least 80 
percent of the vaccinates remain free of enteric signs and do not shed 
virus in the feces, while less than 80 percent of the controls develop 
clinical signs of mink enteritis or shed virus in the feces, the test is 
considered inconclusive and may be repeated: Provided, That, if at least 
80 percent of the vaccinates do not remain well and free of detectable 
virus in the feces, the serial is unsatisfactory.

[39 FR 27428, July 29, 1974. Redesignated at 55 FR 35562, Aug. 31, 1990, 
as amended at 56 FR 66786, Dec. 26, 1991; 60 FR 14361, Mar. 17, 1995]