[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: 9CFR113.70]

[Page 682-683]
 
                  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. 113.70  Pasteurella Multocida Vaccine, Avian Isolate.

    Pasteurella Multocida Vaccine, Avian Isolate, shall be prepared as a 
desiccated live culture of an avirulent or modified strain of 
Pasteurella multocida. Only Master Seed which has been established as 
pure, safe, and immunogenic shall be used for vaccine production.
    (a) The Master Seed shall meet the applicable general requirements 
prescribed in Sec. 113.64 and the requirements in this section.
    (b) Each lot of Master Seed used for vaccine production shall be 
tested for immunogenicity in each species and for each serotype for 
which the Master Seed is claimed to give protection.
    (1) Thirty Pasteurella multocida susceptible birds shall be used as 
test animals (20 vaccinates and 10 controls) for each bird species, 
route of administration, and serotype for which protection is claimed on 
the label.
    (2) An arithmetic mean count of colony forming units from vaccine 
produced from the highest passage of Master Seed shall be established 
before the immunogenicity test is conducted. The 20 birds to be used as 
vaccinates shall be inoculated, as recommended on the label with a 
predetermined quantity of vaccine bacteria. The 10 control birds shall 
be held separately from the vaccinates. To confirm the dosage 
calculation, an arithmetic mean count shall be established by conducting 
five replicate titrations on a sample of the bacterial vaccine used. 
Only plates containing between 30 and 300 colonies shall be considered 
in a valid test.
    (3) Not less than 14 days after vaccination, each of 20 vaccinates 
and each of 10 unvaccinated controls shall be challenged intramuscularly 
or by other methods acceptable to the Animal and Plant Health Inspection 
Service with a virulent Pasteurella multocida strain, for which 
protection is claimed, and observed daily for a 14 day post-challenge 
period.
    (4) Eight or more of the unvaccinated controls must die for the test 
to be valid. If at least 16 of 20 of the vaccinates do not survive the 
14-day postchallenge period, the Master Seed is unsatisfactory at the 
selected bacterial count.
    (5) The Master Seed shall be retested for immunogenicity in 3 years 
and shall meet the criteria prescribed in paragraph (b)(4) of this 
section.
    (c) Test requirements for release. Each serial and subserial shall 
meet the applicable requirements in Sec. Sec. 113.8 and 113.64 and the 
requirements in this paragraph. Any serial or subserial found 
unsatisfactory by a prescribed test shall not be released.
    (1) Safety test. Samples of completed product from each serial or 
first subserial shall be tested for safety.
    (i) Ten birds of a species for which the vaccine is recommended 
shall be given the equivalent of 10 doses each of the vaccine and 
observed for 10 days. If the vaccine is recommended for more than one 
species, only one species needs to be tested.
    (ii) If unfavorable reactions attributable to the vaccine occur 
during the observation period in two or more of the test birds, the 
serial is unsatisfactory.

[[Page 683]]

    (iii) If unfavorable reactions occur which are not attributable to 
the test vaccine, the test is inconclusive and may be repeated. If the 
results of the next test are not satisfactory, or if the test is not 
repeated, the serial shall be considered unsatisfactory.
    (2) Bacterial count requirements. Final container samples of 
completed product shall be tested for bacterial count using the method 
used in paragraph (b)(2) of this section. Two replicate titrations shall 
be conducted on each serial and subserial. Each sample shall be 
rehydrated with accompanying sterile diluent to the volume indicated on 
the label. To be eligible for release, each serial and subserial shall 
have a bacterial count sufficiently greater than that of the vaccine 
used in the immunogenicity test count per dose established to assure 
that, when tested at any time within the expiration period, each serial 
and subserial shall have a bacterial count at least two times greater 
than that used in the immunogenicity test.

[55 FR 35560, Aug. 31, 1990, as amended at 59 FR 19633, Apr. 25, 1994; 
64 FR 43044, Aug. 9, 1999]