U.S. Nuclear Regulatory Commission

Enforcement Pertaining to Unauthorized Users and Unauthorized Materials

HPPOS-026 PDR-9111210144

Title: Enforcement Pertaining to Unauthorized Users and

Unauthorized Materials

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program) is not qualified, the NOV will be rescinded and an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