UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555 

September 27, 2002

NRC INFORMATION NOTICE 2002-28: APPOINTMENT OF RADIATION SAFETY

OFFICERS AND AUTHORIZED USERS UNDER 

10 CFR PART 35

Addressees:

All medical licensees.

Purpose:

The U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice (IN) to inform

licensees of the importance of ensuring that Radiation Safety Officers (RSOs) and Authorized

Users (AUs) are appointed with the individuals’ knowledge and consent. This IN is also being

issued to inform licensees of the new requirement affecting the appointment of RSOs under the

revised 10 CFR Part 35, “Medical Use of Byproduct Material.” It is expected that recipients will

review the information for applicability to their facilities and consider actions, as appropriate, to 

ensure compliance with the new NRC requirement. However, no specific action nor written

response is required.

Description of Circumstances:

Several recent NRC inspections have identified cases involving medical licensees who

appointed an RSO or AU without this individual’s knowledge or consent. As a result, licensed

activities were performed without the oversight of an RSO and dosages were administered to

human patients without the supervision of an AU. 

Discussion:

The current Part 35 states that a licensee shall appoint an RSO responsible for implementing

the radiation safety program, but there is no explicit regulatory requirement for written

acceptance by the RSO. The revised Part 35, which becomes effective October 24, 2002,

provides a new requirement for appointment of the RSO for medical facilities. Specifically,

10 CFR 35.24(b) states that a licensee’s management shall appoint an RSO, who agrees, in

writing, to be responsible for implementing the radiation protection program. A clear written

agreement between licensee management and the RSO can prevent confusion about the

RSO’s role and responsibilities. Licensees appointing RSOs after the effective date of the

revised rule are required to adhere to this new requirement.

ML022660312
IN 2002-28

Page 2 of 2

The revised Part 35 also requires that the AU provide supervision to individuals using licensed

material. Specifically, 10 CFR 35.27(a)(2) requires the supervised individual to follow the

instructions of the supervising AU for medical uses of byproduct material. Although there is no 

requirement for a written agreement between the AU and management, licensees are expected

to ensure that AUs are aware of their respective roles and responsibilities. 

This IN requires no specific action nor written response. If you have any questions about the

information in this notice, please contact one of the technical contacts listed below, or the

appropriate regional office.

/RA/

Donald A. Cool, Director 

Division of Industrial and Medical 

 Nuclear Safety 

Office of Nuclear Material 

 Safety and Safeguards 

Technical contacts: Ivelisse Cabrera, NMSS Roberto Torres, NMSS

(301) 415-8152 (301) 415-8112

E-mail: imc1@nrc.gov E-mail: rjt@nrc.gov

Attachments:

1. List of Recently Issued NMSS Information Notices 

2. List of Recently Issued NRC Information Notices