Information Notice 2002-28, Appointment of Radiation Safety Officers and Authorized Users Under 10 CFR Part 35
| ML022660312 | |
| Person / Time | |
|---|---|
| Issue date: | 09/27/2002 |
| From: | Cool D NRC/NMSS/IMNS |
| To: | |
| References | |
| IN-02-028 | |
| Download: ML022660312 (7) | |
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 individuals 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 licensees 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
RSOs role and responsibilities. Licensees appointing RSOs after the effective date of the
revised rule are required to adhere to this new requirement.
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
ML022660312 ADAMS DOCUMENT TITLE:
OFFICE MSIB MSIB NMSS/Editor MSIB IMNS
NAME ICabrera FBrown EKraus/fax TEssig DCool
DATE 9/6/02 9/9/02 9/10/02 9/10/02 9/ /02
Attachment 1 LIST OF RECENTLY ISSUED
NMSS INFORMATION NOTICES
_____________________________________________________________________________________
Information Date of
Notice No. Subject Issuance Issued to
_____________________________________________________________________________________
2002-23 Unauthorized Administration of 07/16/2002 All medical licensees.
Byproduct Material for Medical
Use
2002-19 Medical Misadministrations 06/14/2002 All nuclear pharmacies and
Caused By Failure to Properly medical licensees.
Perform Tests on Dose
Calibrators for Beta- and Low- Energy Photon-Emitting
Radionuclides
2002-17 Medical Use of Strontium-90 05/30/2002 All U.S. Nuclear Regulatory
Eye Applicators: New Commission medical licensees
Requirements for Calibration that use strontium-90 (Sr-90) eye
and Decay Correction applicators.
2002-16 Intravascular Brachytherapy 05/01/2002 All Medical Licensees.
Misadministrations
2001-18 Degraded and Failed 12/14/2001 All uranium fuel conversion, Automatic Electronic enrichment and fabrication
Monitoring, Control, Alarming, licenses and certificate holders
Response, and authorized to receive safeguards
Communications Needed for information. Information notice is
Safety and Safeguards not available to the public
because it contains safeguards
information.
Note: NRC generic communications may be received in electronic format shortly after they are issued by
subscribing to the NRC listserver as follows:
To subscribe send an e-mail to <listproc@nrc.gov >, no subject, and the following command in the
message portion:
subscribe gc-nrr firstname lastname
______________________________________________________________________________________
OL = Operating License
CP = Construction Permit
Attachment 2 LIST OF RECENTLY ISSUED
NRC INFORMATION NOTICES
_____________________________________________________________________________________
Information Date of
Notice No. Subject Issuance
Issued to
_____________________________________________________________________________________
2002-27 Recent Fires at Commercial 09/20/2002 All holders of operating licenses
Nuclear Power Plants in the for nuclear power reactors, United States except those who have
permanently ceased operations
and have certified that fuel has
been permanently removed from
the reactor.
2002-26 Failure of Steam Dryer Cover 09/11/2002 All holders of operating license or
Plate After a Recent Power construction permits for nuclear
Uprate power reactors, except those that
have permanently ceased
operations and have certified that
fuel has been permanently
removed from the reactor.
2002-25 Challenges to Licensees 08/26/2002 All holders of operating licenses
Ability to Provide Prompt for nuclear power reactors, Public Notification and except those who have
Information During an permanently ceased operations
Emergency Preparedness and have certified that fuel has
Event been permanently removed from
the reactor vessel.
2002-24 Potential Problems With Heat 07/19/2002 All holders of licenses for nuclear
Collectors on Fire Protection power, research, and tests
Sprinklers reactors and fuel cycle facilities.
2002-02, Recent Experience With 07/17/2002 All holders of operating licenses
Supplement 1 Plugged Steam Generator for pressurized-water reactors
Tubes (PWRs), except those who have
permanently ceased operations
and have certified that fuel has
been permanently removed from
the reactor.
Note: NRC generic communications may be received in electronic format shortly after they are issued by
subscribing to the NRC listserver as follows:
To subscribe send an e-mail to <listproc@nrc.gov >, no subject, and the following command in the
message portion:
subscribe gc-nrr firstname lastname
______________________________________________________________________________________
OL = Operating License
CP = Construction Permit