[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR113.67]

[Page 624-626]
 
                  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. 113.67  Erysipelothrix Rhusiopathiae Vaccine.

    Erysipelothrix Rhusiopathiae Vaccine shall be prepared as a 
desiccated

[[Page 625]]

live culture of an avirulent or modified strain of Erysipelothrix 
rhusiopathiae. 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 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. The selected bacterial count from the lot of 
Master Seed shall be established as follows:
    (1) Thirty Erysipelothrix rhusiopathiae susceptible swine shall be 
used as test animals (20 vaccinates and 10 controls) for each route of 
administration recommended on the label.
    (2) An arithmetic mean count of the colony forming units from 
vaccine produced from the highest passage of the Master Seed shall be 
established before the immunogenicity test is conducted. The 20 swine to 
be used as vaccinates shall be injected as recommended on the label with 
a predetermined quantity of vaccine bacteria. The 10 control swine 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 dilution 
used. Only plates containing between 30 and 300 colonies shall be 
considered in a valid test.
    (3) The vaccinates and controls shall be examined and their average 
body temperature determined prior to challenge. Fourteen to twenty-one 
days postvaccination, the vaccinates and controls shall be challenged 
with a virulent Erysipelothrix rhusiopathiae culture and observed for 7 
days. The challenge culture and instructions for preparation and use 
shall be obtained from Animal and Plant Health Inspection Service.
    (4) A satisfactory challenge shall be evidenced in the controls by a 
high body temperature or clinical signs including, but not limited to 
acute illness with hyperemia of the abdomen and ears, possibly 
terminating in sudden death; moribundity, with or without metastatic 
skin lesions; depression with anorexia, stiffness, and/or joint 
involvement; or any combination of these symptoms and lesions.
    (5) If at least 80 percent of the controls do not show 
characteristic signs during the observation period including, but not 
limited to a body temperature of 105.6 [deg] F or higher on at least 2 
consecutive days, the test shall be considered inconclusive: Provided, 
That control pigs which meet the criteria requirements for 
susceptibility except for high body temperature shall be considered 
susceptible if sacrificed and organisms identified as Erysipelothrix 
rhusiopathiae can be isolated from the blood, spleen, or other organs.
    (6) To demonstrate immunity after challenge, the vaccinates shall 
remain free of clinical signs and the body temperature shall not exceed 
104.6 [deg] F on 2 or more consecutive days. If at least 90 percent of 
the vaccinates do not remain free from clinical signs and high body 
temperature throughout the observation period, the Master Seed is 
unsatisfactory.
    (7) The Master Seed shall be retested for immunogenicity in 3 years. 
Only five vaccinates and five controls need to be used in the retest: 
Provided, That at least four of five vaccinates and four of the five 
controls shall meet the criteria prescribed in paragraphs (b)(5) and 
(b)(6) of this section.
    (8) An Outline of Production change shall be made before authority 
for use of a new Master Seed shall be granted by Animal and Plant Health 
Inspection Service.
    (c) Test requirements for release. Each serial and subserial shall 
meet the applicable requirements in Sec. 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 in young adult mice as 
prescribed in Sec. 113.33(b) and in swine as prescribed in Sec. 113.44.
    (2) Bacterial count requirements. Final container samples of 
completed product from each serial and each subserial 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

[[Page 626]]

sample. 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 to assure that, when tested at any time within 
the expiration period, each serial and subserial shall have a bacterial 
count two times greater than that used in such immunogenicity test.

[50 FR 23795, June 6, 1985, as amended at 56 FR 66784, Dec. 26, 1991]