[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: 9CFR113.301]

[Page 726-727]
 
                  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. 113.301  Ovine Ecthyma Vaccine.

    Ovine Ecthyma Vaccine shall be prepared from tissue culture fluids 
or virus-bearing tissues obtained from sheep that have developed ovine 
ecthyma following inoculation with virulent ovine ecthyma virus. Ovine 
Ecthyma Vaccine is exempt from the requirements prescribed in Sec. Sec. 
113.27 and 113.300(a), (b), and (c). Each serial shall meet the moisture 
requirements in Sec. 113.300(e) and the special requirements prescribed 
in this section. Any serial found unsatisfactory by a prescribed test 
shall not be released.
    (a) Safety tests. (1) Bulk or final container samples of completed 
product from each serial shall be tested for safety as prescribed in 
Sec. 113.38.
    (2) The prechallenge period of the potency test shall constitute a 
safety test. If unfavorable reactions attributable to the vaccine occur 
in either of the vaccinates during the observation period, the serial is 
unsatisfactory.
    (b) Potency test. Final container samples of completed product from 
each serial and each subserial shall be tested for potency using 
susceptible lambs. The vaccine shall be prepared as recommended for use 
on the label.
    (1) Each of two lambs (vaccinates) shall be vaccinated by 
application of the vaccine to a scarified area on the medial surface of 
the thigh and observed each day for 14 days.
    (2) The immunity of the two vaccinates and one or more unvaccinated 
lambs (controls) shall be challenged in

[[Page 727]]

the same manner as for vaccination, using the opposite thigh.
    (3) If typical signs of ovine ecthyma, such as hyperemia, vesicles, 
and pustules do not develop on the controls during the first 2 weeks 
following challenge and persist for approximately 30 days, the test is 
inconclusive and may be repeated.
    (4) If the vaccinates do not show a typical immune reaction, the 
serial is unsatisfactory: Provided, That, an initial active reaction 
with hyperemia which resolves progressively and disappears within 2 
weeks, may be characterized as a typical immune reaction.

[39 FR 27430, July 29, 1974. Redesignated at 55 FR 35562, Aug. 31, 1990, 
as amended at 56 FR 66786, Dec. 26, 1991]