Information Notice 2002-28, Appointment of Radiation Safety Officers and Authorized Users Under 10 CFR Part 35

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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)
v • d • e


UNITED STATESNUCLEAR REGULATORY COMMISSIONOFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDSWASHINGTON, D.C. 20555 September 27, 2002NRC INFORMATION NOTICE 2002-28:APPOINTMENT OF RADIATION SAFETYOFFICERS 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 informlicensees 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 whoappointed 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 implementingthe 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. The revised Part 35 also requires that the AU provide supervision to individuals using licensedmaterial. 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 theinformation 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, NMSSRoberto Torres, NMSS(301) 415-8152(301) 415-8112 E-mail: imc1@nrc.govE-mail: rjt@nrc.gov

Attachments:1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

ML022660312ADAMS DOCUMENT TITLE:OFFICEMSIBMSIBNMSS/EditorMSIBIMNSNAMEICabreraFBrownEKraus/faxTEssigDCoolDATE 9/6/029/9/02 9/10/02 9/10/029/ /02

______________________________________________________________________________________OL = Operating License

CP = Construction PermitAttachment 1 LIST OF RECENTLY ISSUEDNMSS INFORMATION NOTICES

_____________________________________________________________________________________InformationDate of

Notice No. SubjectIssuanceIssued to

_____________________________________________________________________________________2002-23Unauthorized Administration ofByproduct Material for Medical

Use07/16/2002All medical licensees.2002-19Medical MisadministrationsCaused By Failure to Properly

Perform Tests on Dose

Calibrators for Beta- and Low- Energy Photon-Emitting

Radionuclides06/14/2002All nuclear pharmacies andmedical licensees.2002-17Medical Use of Strontium-90Eye Applicators: New

Requirements for Calibration

and Decay Correction05/30/2002All U.S. Nuclear RegulatoryCommission medical licensees

that use strontium-90 (Sr-90) eye

applicators.2002-16Intravascular BrachytherapyMisadministrations05/01/2002All Medical Licensees.2001-18Degraded and FailedAutomatic Electronic

Monitoring, Control, Alarming,

Response, and

Communications Needed for

Safety and Safeguards12/14/2001All uranium fuel conversion,enrichment and fabrication

licenses and certificate holders

authorized to receive safeguards

information. Information notice is

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 bysubscribing to the NRC listserver as follows:To subscribe send an e-mail to <listproc@nrc.gov >, no subject, and the following command in themessage portion:subscribe gc-nrr firstname lastname

______________________________________________________________________________________OL = Operating License

CP = Construction PermitAttachment 2 LIST OF RECENTLY ISSUEDNRC INFORMATION NOTICES

_____________________________________________________________________________________InformationDate of

Notice No. SubjectIssuanceIssued to_____________________________________________________________________________________2002-27Recent Fires at CommercialNuclear Power Plants in the

United States09/20/2002All holders of operating licensesfor nuclear power reactors, except those who have

permanently ceased operations

and have certified that fuel has

been permanently removed from

the reactor.2002-26Failure of Steam Dryer CoverPlate After a Recent Power

Uprate09/11/2002All holders of operating license orconstruction permits for nuclear

power reactors, except those that

have permanently ceased

operations and have certified that

fuel has been permanently

removed from the reactor.2002-25Challenges to Licensees

'Ability to Provide Prompt

Public Notification and

Information During an

Emergency Preparedness

Event08/26/2002All holders of operating licensesfor nuclear power reactors, except those who have

permanently ceased operations

and have certified that fuel has

been permanently removed from

the reactor vessel.2002-24Potential Problems With HeatCollectors on Fire Protection

Sprinklers07/19/2002All holders of licenses for nuclearpower, research, and tests

reactors and fuel cycle facilities.2002-02,Supplement 1Recent Experience WithPlugged Steam Generator

Tubes07/17/2002All holders of operating licensesfor pressurized-water reactors

(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 bysubscribing to the NRC listserver as follows:To subscribe send an e-mail to <listproc@nrc.gov >, no subject, and the following command in themessage portion:subscribe gc-nrr firstname lastname


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