9 CFR 113.36 - Detection of pathogens by the chicken inoculation test.
The test for detection of extraneous pathogens provided in this section shall be conducted when such a test is prescribed in an applicable Standard Requirement or in the filed Outline of Production for the product.
(a) The biological product to be tested shall be prepared for use as recommended on the label, or in the case of desiccated vaccine to be used in poultry, rehydrated with sterile distilled water at the rate of 30 ml per 1,000 doses.
(b) At least 25 healthy susceptible young chickens, properly identified and obtained from the same source and hatch, shall be immunized at least 14 days prior to being put on test. The immunizing agent shall be the same as the product to be tested but from a serial previously tested and found satisfactory.
(c) At least 20 of the previously immunized birds shall be inoculated with 10 label doses of the vaccine being tested by each of the following routes: Subcutaneous, intratracheal, eye-drop, and comb scarification (1 cm 2). Twenty birds may be used for each route or combination of routes.
(e) All birds shall be observed for 21 days for signs of septicemic diseases, respiratory diseases, or other pathologic conditions.
(f) If the controls remain healthy and unfavorable reactions attributable to the product occur in the vaccinates, the serial or subserial tested is unsatisfactory. If the controls do not remain healthy or if unfavorable reactions not attributable to the product occur in the vaccinates, or both, the test shall be declared a No Test and may be repeated: Provided, That, if the test is not repeated, the serial of subserial tested shall be considered unsatisfactory.
Title 9 published on 2015-12-04
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 9 CFR Part 113 after this date.
- 9 CFR 113.325 — Avian Encephalomyelitis Vaccine.
- 9 CFR 113.212 — Bursal Disease Vaccine, Killed Virus.
- 9 CFR 113.331 — Bursal Disease Vaccine.
- 9 CFR 113.326 — Avian Pox Vaccine.
- 9 CFR 113.327 — Bronchitis Vaccine.
- 9 CFR 113.330 — Marek's Disease Vaccines.
- 9 CFR 113.328 — Fowl Laryngotracheitis Vaccine.
- 9 CFR 113.329 — Newcastle Disease Vaccine.
- 9 CFR 113.332 — Tenosynovitis Vaccine.