Disposal of Byproduct Material Used for Certain In Vitro Clinical or Laboratory Testing

HPPOS-169 PDR-9111220186

See the memorandum from J. D. Kinneman to Materials Inspectors dated December 15, 1980.

Most waste generated from use of in vitro test kits under the general license of 10 CFR 31.11 can be disposed in non-radioactive trash. However, mock iodine-125 sources listed in 31.11 (a) (7) must be disposed of as required by 10 CFR 20.301. This health physics position also applies to "new" 10 CFR 20.2001.

Licensees performing certain in vitro tests that contain byproduct materials are authorized to dispose of the waste in non-radioactive trash. Under the provisions of 10 CFR 31.11, a general license may be issued to any physician, veterinarian, clinical laboratory or hospital to receive, acquire, possess, transfer or use certain byproduct materials in prepackaged form for in vitro clinical or laboratory testing.

The provisions of this paragraph exempt most byproduct materials used pursuant to the general license from the requirements of 10 CFR Parts 19, 20, and 21. Because of the exemption from the provisions of 10 CFR 20, most radioactive wastes generated in the use of these in vitro tests may be disposed of as ordinary waste (i.e., non-radioactive trash). Before these materials can be discarded in the trash, all radiation labels should be removed and destroyed. [Note: Mock iodine-125 sources listed in 10 CFR 31.11 (a) (7) must be disposed of as required by 10 CFR 20.301 and 10 CFR 20.2001.]

Regulatory references: 10 CFR 20.301, 10 CFR 20.2001, 10 CFR 31.11

Subject codes: 9.0, 9.7

Applicability: Byproduct material

Page Last Reviewed/Updated Monday, October 16, 2017