9 CFR 113.207 - Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus.

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§ 113.207 Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus.
Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus, shall be prepared from virus-bearing cell culture fluids. Each serial or subserial shall meet the requirements prescribed in this section and the general requirements prescribed in § 113.200, except those in § 113.200(d). Any serial or subserial found unsatisfactory by a prescribed test shall not be released.
(a) Safety test. Bulk samples of completed product from each serial shall be tested for encephalomyelitis virus inactivation.
(1) Each of at least ten 6 to 12 hour old chickens shall be injected subcutaneously with 0.5 ml of the product and the chickens observed each day for 10 days.
(2) If unfavorable reactions attributable to the product occur in the chickens during the observation period, the serial is unsatisfactory. If unfavorable reactions not attributable to the product occur, the test is 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 from each serial shall be tested for potency in accordance with the two-stage test provided in this paragraph. For each fraction contained in the product—Eastern type, Western type, or Venezuelan type—the serological interpretations required in this test shall be made independently. A serial or subserial found unsatisfactory for any of the fractions shall not be released.
(1) For this test, a guinea pig dose shall be one-half the amount recommended on the label for a horse and shall be administered as recommended for a horse. Each of 10 healthy guinea pigs (vaccinates) shall be injected with two guinea pig doses with an interval of 14 to 21 days between doses. Two additional guinea pigs from the same source shall be held as controls.
(2) Fourteen to 21 days after the second injection, serum samples from each vaccinate and each control shall be tested by a plaque reduction, serum neutralization test using Vero 76 cells.
(3) If the control serum samples show a titer of 1:4 or greater for any fraction, the test is inconclusive for that fraction and may be repeated: Provided, That, if four or more of the vaccinate serum samples show a titer of less than 1:40 for the Eastern type fraction, less than 1:40 for the Western type fraction, or less than 1:4 for the Venezuelan type fraction, the serial or subserial is unsatisfactory without further testing.
(4) If two or three of the vaccinate serum samples show a titer of less than 1:40 for the Eastern type fraction, less than 1:40 for the Western type fraction, or less than 1:4 for the Venezuelan type fraction, the second stage of the test may be used for the relevant fraction(s): Provided, That, if a fraction is found acceptable by the first stage of the test, the second stage need not be conducted for that fraction.
(5) If the second stage is used and four or more of the vaccinate serum samples show a titer of less than 1:40 for the Eastern type fraction or the Western type fraction, or less than 1:4 for the Venezuelan type fraction, the serial or subserial is unsatisfactory.
(6) The results shall be evaluated according to the following table:
Cumulative Totals
Stage Vaccinates Failures for acceptance Failures for rejection
1 10 1 or less 4 or more.
2 20 3 or less Do.
[39 FR 44714, Dec. 27, 1974, as amended at 40 FR 14084, Mar. 28, 1975; 42 FR 45284, Sept. 9, 1977. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66786, Dec. 26, 1991; 61 FR 67930, Dec. 26, 1996]

Title 9 published on 2014-01-01

The following are only the Rules published in the Federal Register after the published date of Title 9.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-05-30; vol. 79 # 104 - Friday, May 30, 2014
    1. 79 FR 31021 - In Vitro Tests for Serial Release
      GPO FDSys XML | Text
      DEPARTMENT OF AGRICULTURE, Animal and Plant Health Inspection Service
      Final rule.
      Effective May 30, 2014.
      9 CFR Part 113

Title 9 published on 2014-01-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 9 CFR 113 after this date.

  • 2014-05-30; vol. 79 # 104 - Friday, May 30, 2014
    1. 79 FR 31021 - In Vitro Tests for Serial Release
      GPO FDSys XML | Text
      DEPARTMENT OF AGRICULTURE, Animal and Plant Health Inspection Service
      Final rule.
      Effective May 30, 2014.
      9 CFR Part 113