Enforcement Pertaining to Unauthorized Users and Unauthorized Materials

HPPOS-026 PDR-9111210144

See the memorandum from D. Thompson to G. Snyder (and others) dated December 24, 1980. This memo provides enforcement guidance for medical and small industrial licensees when unauthorized users are determined to be qualified. It also provides guidance applicable to the use of materials not authorized in the license.

Supplement VII of 45 FR 66754 establishes the conduct of licensed activities by a technically unqualified or unauthorized person as a Severity III Violation, a violation that normally results in a civil penalty on the first offense. The use of materials not on the license would also warrant a penalty under the criteria.

The routine inspection program discloses many cases of unauthorized or unqualified users or unauthorized materials not included in the license for medical programs and for small industrial licenses such as users of certain gauges and gas chromatographs. In many of these cases, a civil penalty is not appropriate when, in reality, the person (s) is appropriately qualified to use the materials.

The enforcement guidance for medical and small industrial licenses is as follows. An inspector will request the licensee to explain whether or not the current unauthorized user (s) is qualified. If the licensee or inspector and his/her supervisor determine that the user (s) is not qualified, then a Severity III Violation will exist and a civil penalty or order should be processed.

If the licensee concludes that the user (s) is qualified and the inspector and his/her supervisor reach the same conclusion, the violation will be categorized as a Severity IV Violation and handled with a Regional Notice of Violation (NOV).

In addition, an Immediate Action Letter (IAL) will be issued requiring the licensee to promptly request a license amendment to resolve the problem of unauthorized user or unauthorized materials for which the person is qualified to use.

Should the NRC subsequently determine that the user (depending on the type of licensed program) is not qualified, the NOV will be rescinded and an appropriate enforcement package prepared.

In such cases, an order suspending the license until an authorized, qualified user (s) is obtained or materials for which the user is qualified is placed on the license may be more appropriate than civil penalties. A suspension or a modification order appears to be more appropriate in those cases, where more hazardous materials are used, since a civil penalty may not ensure that unknowledgeable users immediately desist for operations. For example, this action would be more applicable to users in medical programs than to users of gas chromatograph or licensed gauges where the radiation hazards are minimal.

For materials where radiation hazards are minimal, such as materials of gas chromatograph, stationary liquid level gauges, or thickness measuring gauges, the unauthorized user (s) should be the subject of an IAL "suspending" the user until he/she becomes qualified or another qualified user is found. If the IAL is ineffective, an order suspending the user would be appropriate.

Generally, these kinds of radioactive materials are inspected only for cause, except initially, since they fall into priorities VI and VII. Because cases involving unauthorized users and unauthorized materials will most likely be different, the regional offices should consult with appropriate cognizant individuals in EI:HQ.

Regulatory references: 10 CFR 2, License Conditions

Subject codes: 1.3, 3.8, 12.7

Applicability: Byproduct Material

Page Last Reviewed/Updated Monday, October 02, 2017