ML062550222
| ML062550222 | |
| Person / Time | |
|---|---|
| Issue date: | 12/07/2006 |
| From: | Schlueter J NRC/FSME/DMSSA |
| To: | |
| References | |
| RIS-06-026 | |
| Download: ML062550222 (7) | |
See also: RIS 2006-26
Text
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF FEDERAL AND STATE MATERIALS
AND ENVIRONMENTAL MANAGEMENT PROGRAMS
WASHINGTON, D.C. 20555
December 07, 2006
NRC REGULATORY ISSUE SUMMARY 2006-26
TRAINING AND EXPERIENCE AND GRANDFATHER PROVISIONS FOR
AUTHORIZED MEDICAL PHYSICISTS UNDER 10 CFR PART 35.
ADDRESSEES
All NRC medical-use licensees and Radiation Control Program Directors.
INTENT
The U.S. Nuclear Regulatory Commission (NRC) is issuing this regulatory issue summary (RIS)
to clarify the provisions for recognizing and grandfathering authorized medical physicists
(AMPs) under 10 CFR 35.2, 35.14, 35.51 and 35.57. The regulatory use of the term authorized
medical physicist includes only medical physicists for the following medical uses: Strontium-90
(Sr-90) eye applicators, remote afterloader units, teletherapy units, and gamma stereotactic
radiosurgery (Gamma Knife) units. Therefore, this RIS applies only to licensees with these
devices. No specific action nor written response is required.
BACKGROUND
On March 30, 2005, the Commission published a final rule, in the Federal Register, amending
specific sections in 10 CFR Part 35 (70 FR 19336). The rule revised regulations for the
recognition of specialty boards, whose certification processes can demonstrate the training and
experience of individuals for serving as radiation safety officers, authorized nuclear
pharmacists, AMPs, or authorized users. The rule also included additional revisions to other
training and attestation requirements for these individuals. Subpart J, of prior 10 CFR Part 35
(Training and Experience Requirements), remained in effect for a transition period, and expired
on October 25, 2005. Agreement States have until April 29, 2008, three years from the
effective date of the final rule, to establish regulations compatible with the revised rule.
All specialty boards listed in former 10 CFR Part 35, Subpart J, were contacted about
application for NRC recognition of one or more of their certification processes, under the
boards recognition requirements, in the revised training and experience sections of Part 35,
Subparts B, and D through H. Each specialty board was requested to supply NRC with an
effective date for when its certification process met, or would meet, the revised training and
experience requirements in 10 CFR Part 35. The procedures for NRC recognition of board
certifications and the recognized certification processes, with the associated effective dates, are
listed on NRCs medical-use tool kit web site under Other Guidance at:
http://www.nrc.gov/materials/miau/med-use-toolkit.html.
Page 2 of 4
The revised Part 35 offers four methods for individuals seeking to be recognized as AMPs at
NRC licensed medical-use facilities. The regulations in 10 CFR 35.51 specify two of these
methods: (1) Approval of an individual who is certified by a specialty board whose certification
process has been recognized by the NRC or an Agreement State as meeting the NRCs
requirements for training and experience, referred to as the certification pathway; or (2)
Approval by NRC, an NRC master materials licensee (MML), an NRC broad-scope medical-use
licensee, or an MML broad-scope medical-use permittee, based on an evaluation of an
individuals training and experience, against the requirements described in 10 CFR 35.51(b),
referred to as the alternate pathway.
The third method is described in the provisions of 10 CFR 35.57. Under this section,
teletherapy or medical physicists identified on existing Commission or Agreement State licenses
or permits before October 24, 2002, or AMPs identified on Commission or Agreement State
licenses or permits between October 24, 2002, and April 29, 2005, are exempt from the
requirements in 10 CFR 35.51. The intent of 10 CFR 35.57 is to grandfather those individuals
named on existing Commission or Agreement State licenses or permits, so that they may
continue functioning as AMPs for those uses for which they have been previously approved.
The fourth method is implemented through the definition of an AMP in 10 CFR 35.2 and
10 CFR 35.14, medical physicists who are listed as AMPs or teletherapy physicists on
Commission or Agreement State medical-use licenses or permits may work as AMPs without
the licensee needing to apply for a license amendment. The limited-specific medical-use
licensee or permittee only has to notify the NRC or the NRC MML that the individual is working
as an AMP, and provide documentation required in 10 CFR 35.14. Some Agreement States
have not adopted the notification provisions in 10 CFR 35.14. Accordingly, this method may not
be available to medical physicists moving to a new licensee in a particular Agreement State.
There are approximately 109 Gamma Knife units, 765 remote afterloader units, 12 teletherapy
units, and 100 Sr-90 eye applicators licensed in the U.S. NRC licenses about 260 of these
devices, and approximately 725 devices are licensed by Agreement States.
SUMMARY OF ISSUE
For many years, NRC has listed medical physicists on licenses for remote afterloader units,
teletherapy units, Sr-90 eye applicators, and Gamma Knife units. In the 2002 revision of
10 CFR Part 35, NRC began identifying these medical physicists as AMPs. However, not all
the Agreement States list medical physicists on medical-use licenses. Based on a recent NRC
survey, 28 of the 34 Agreement States indicated that they have been or are now listing AMPs
on their limited-specific medical-use licenses. The remaining six States indicated they did not
previously list AMPs on their licenses, but they will list them by the April 29, 2008, deadline for
establishing regulations compatible with the revised rule.
A medical physicist moving from an Agreement State to an NRC licensed medical facility, who
was named on a Commission or Agreement State medical-use license or permit that was valid
on April 29, 2005, is eligible to use the grandfather provision, in 10 CFR 35.57, to be named as
an AMP on the new facilitys NRC license. If the medical physicist is listed as a teletherapy
physicist, medical physicist, or AMP on an Agreement State license issued subsequent to
Page 3 of 4
April 29, 2005, the new NRC licensed medical facility can permit the individual to work as an
AMP under the provisions of 10 CFR 35.2 and 35.14.
Medical physicists for whom the grandfather provisions do not apply, but who are professionally
active in Agreement States that do not list medical physicists on their limited-specific medical-
use licenses, must apply by either the board certification pathway or the alternate pathway,
described in 10 CFR Part 35.51, when seeking AMP recognition on an NRC license or a license
in another Agreement State. A board certified medical physicist may not be able to use the
board certification pathway to obtain recognition as an AMP if his or her certification board and
certification year are not listed on NRCs web site. Furthermore, medical physicists applying for
recognition as AMPs by either the board certification pathway or the alternate pathway are
subject to the recentness-of-training provisions in 10 CFR 35.59.
Therefore, a medical physicist to whom the grandfather provisions and the notification
provisions do not apply and who is practicing in an Agreement State licensed limited-specific
medical-use facility is strongly encouraged to request being identified as an AMP listed on the
Agreement State license for his or her present facility if the medical physicist may in the future
seek to be listed as an AMP on an NRC license or on a license in another Agreement State.
Once listed on an Agreement State license, the medical physicist can seek recognized status
via the notification provisions described in 10 CFR 35.2 and 10 CFR 35.14, or equivalent
regulations in the particular Agreement State.
Even if an Agreement State does not identify teletherapy physicists, medical physicists, or
AMPs on limited-specific medical-use licenses, a medical physicist located at a broad-scope
medical-use facility licensed in such an Agreement State is encouraged to have the licensee
name the physicist on a permit. This will enable the medical physicist to use the notification
provisions described in 10 CFR 35.2 and 10 CFR 35.14, if he or she seeks to be listed as an
AMP on an NRC license, or a license in another Agreement State.
FEDERAL REGISTER NOTIFICATION
A notice of opportunity for public comment on this RIS was not published in the Federal
Register because this RIS is informational and does not represent a departure from current
regulatory requirements.
SMALL BUSINESS REGULATORY ENFORCEMENT FAIRNESS ACT
NRC has determined that this action is not subject to the Small Business Regulatory
Enforcement Fairness Act of 1996.
PAPERWORK REDUCTION ACT STATEMENT
This RIS does not contain information collections and, therefore, is not subject to the
requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq.).
Page 4 of 4
CONTACT
This RIS requires no specific action nor written response. If you have any questions about this
summary, please contact the individual listed below or the appropriate regional office.
/RA/
Janet R. Schlueter, Director
Division of Materials Safety
and State Agreements
Office of Federal and State Materials
and Environmental Management Programs
Technical Contact: Ronald Zelac, FSME
(301) 415-7635
(301) 415-6272
E-mail: rez@nrc.gov
E-mail: dew2@nrc.gov
Enclosure: List of Recently Issued NMSS
Generic Communications
Page 4 of 4
CONTACT
This RIS requires no specific action nor written response. If you have any questions about this
summary, please contact the individual listed below or the appropriate regional office.
/RA/
Janet R. Schlueter, Director
Division of Materials Safety
and State Agreements
Office of Federal and State Materials
and Environmental Management Programs
Technical Contact: Ronald Zelac, NMSS
(301) 415-7635
(301) 415-6272
E-mail: rez@nrc.gov
E-mail: dew2@nrc.gov
Enclosure: List of Recently Issued NMSS
Generic Communications
DISTRIBUTION:
DMSSA r/f
RZelac
DWhite
CHawes
OFFICE IMNS/MSIB
IMNS/MSIB
IMNS/MSIB
IMNS/MSIB
IMNS/MSIB
NAME
DWhite
AMcIntosh
RZelac
CFlannery
SWastler
DATE
09 / 06 / 06
09 / 07 / 06
09 / 25 / 06
09 / 22 / 06
09 / 25 / 06
OFFICE OIS
TechEd
FSME/MSSA
NAME
ESt.Mary
EKraus
STreby
JSchlueter
DATE
09 /14 / 06
09 / 13 / 06
11 / 21 /06
12 / 1 /06
OFFICIAL RECORD COPY
Enclosure
Page 1 of 2
Recently Issued FSME/NMSS Generic Communications
Date
GC No.
Subject
Addressees
Guidance for Receiving
09/14/06
Concentrating Uranium at
Community Water Systems
All community water systems (CWSs), in
U.S. Nuclear Regulatory Commission
(NRC) non-Agreement States, that during
the treatment of drinking water, may
accumulate and concentrate naturally-
occurring uranium in media, effluents,
and other residuals, above 0.05 percent
by weight.
08/15/06
Transfer of the Management
Oversight Of Certain NRC Region I
Licensees in Mississippi
To the NRC Region IV Office
All NRC materials licensees.
09/14/06
Availability of Guidance on
Radioactive Seed Localization
All NRC medical licensees.
08/31/06
Requesting Exemption from the
Public Dose Limits for Certain
Caregivers of Hospital Patients
All NRC medical licensees.
09/22/06
Enforcement Discretion for Facility
Changes Under 10 CFR 70.72(c)(2)
All fuel cycle licensees regulated under
Title 10 of the Code of Federal
Regulations (10 CFR) Part 70, Subpart H.
07/20/06
Requesting Quality Assurance
Program Approval Renewals
Online by Electronic Information
Exchange
All 10 CFR Part 71 quality assurance
program and certificate holders.
04/23/06
Use of Concentration Control for
Criticality Safety
All licensees authorized to possess a
critical mass of special nuclear material.
01/26/06
Rev. 1
NRC Approval of Commercial Data
Encryption Products For the
Electronic Transmission Of
Safeguards Information
All authorized recipients and holders of
sensitive unclassified safeguards
information (SGI).
01/24/06
Expiration Date for NRC-Approved
Spent Fuel Transportation Routes
The U.S. Nuclear Regulatory Commission
(NRC) licensees who transport, or deliver
to a carrier for transport, irradiated
reactor fuel (spent nuclear fuel (SNF)).
01/13/06
Rev. 1
NRC Timeliness Goals,
Prioritization of Incoming License
Applications and Voluntary
Submittal of Schedule for Future
Actions for NRC Review
All 10 CFR Parts 71 and 72 licensees
and certificate holders.
Enclosure
Page 2 of 2
Date
GC No.
Subject
Addressees
07/10/06
Ground-W ater Contamination
Due to Undetected Leakage of
Radioactive W ater
All holders of operating licenses for
nuclear power and research and test
reactors including those who have
permanently ceased operations and
have certified that fuel has been
permanently removed from the
reactor and those authorized by Title
10 of the Code of Federal Regulations
(10 CFR) Part 72 licenses to store
spent fuel in water-filled structures.
07/06/06
Exercising Due Diligence W hen
Transferring Radioactive
Materials
All materials licensees.
06/12/06
Applicability of Patient Intervention
in Determining Medical Events for
Gamma Stereotactic Radiosurgery
and Other Therapy Procedures
All medical licensees.
03/31/06
Inappropriate Use of a Single-
parameter Limit as a Nuclear
Criticality Safety Limit
All licensees authorized to possess a
critical mass of special nuclear material.
03/21/06
Supl. 1
Unauthorized Administration of
Byproduct Material for Medical Use
All medical licensees.
01/19/06
Use of Galvanized Supports and
Cable Trays with Meggitt Si 2400
Stainless- Steel-jacketed Electrical
Cables
All holders of operating licenses for
nuclear reactors except those who have
permanently ceased operations and have
certified that fuel has been permanently
removed from the reactor vessel; and fuel
cycle licensees and certificate holders.
Note: NRC generic communications may be found on the NRC public website at http://www.nrc.gov, under Electronic
Reading Room/Document Collections.