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e-CFR data is current as of August 12, 2020

Title 9Chapter ISubchapter EPart 113 → §113.55


Title 9: Animals and Animal Products
PART 113—STANDARD REQUIREMENTS


§113.55   Detection of extraneous agents in Master Seed Virus.

Unless otherwise prescribed in a Standard Requirement or in a filed Outline of Production, each Master Seed Virus (MSV) shall be tested as prescribed in this section. A MSV found unsatisfactory by any prescribed test shall not be used. A serial of biological product shall not be released if produced from a MSV that is found unsatisfactory by any prescribed test.

(a) At least a 1.0 ml aliquot per cell culture of MSV shall be dispensed onto monolayers (at least 75 cm2 in area) of:

(1) Vero (African green monkey kidney) cell line;

(2) Embryonic cells, neonatal cells, or a cell line of the species for which the vaccine is recommended; and

(3) Embryonic cells, neonatal cells, or a cell line of the species of cells in which the MSV is presently being propagated if different than prescribed in paragraphs (a)(1) and (a)(2) of this section. Cell lines used shall have been found satisfactory when tested as prescribed in §113.52 and primary cells used shall have been found satisfactory when tested as prescribed in §113.51. If the MSV is cytopathic for or causes hemadsorption in the cells in which it is to be tested, the MSV shall be neutralized with monospecific antiserum supplied or approved by Animal and Plant Health Inspection Service (APHIS) or counteracted by a method approved by APHIS.

(b) At least one monolayer of each cell type used in the test shall be maintained as an uninoculated control.

(c) Each monolayer shall be maintained at least 14 days.

(d) Cells shall be subcultured at least once during the maintenance period. All but the last subculture shall result in at least one new monolayer at least 75 cm2. The last subculture shall meet the minimum area requirement specified in §§113.46 and 113.47.

(e) Monolayers shall be examined regularly throughout the 14-day maintenance period for evidence of cytopathogenic agents. If evidence of a cytopathogenic agent is found, the MSV is unsatisfactory.

(f) At the conclusion of the 14-day maintenance period, monolayers shall be tested for:

(1) Cytopathogenic and/or hemadsorbing agents as prescribed in §113.46;

(2) Extraneous agents by the fluorescent antibody technique as prescribed in §113.47.

[50 FR 444, Jan. 4, 1985, as amended at 56 FR 66784, Dec. 26, 1991]

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