[Federal Register Volume 74, Number 133 (Tuesday, July 14, 2009)]
[Proposed Rules]
[Pages 33925-33928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-16656]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 74, No. 133 / Tuesday, July 14, 2009 /
Proposed Rules
[[Page 33925]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 35
[NRC-2009-0098]
RIN 3150-AI59
Medical Use of Byproduct Material--Authorized User Clarification
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing to
amend its regulations to clarify that individuals who do not need to
comply with the training and experience requirements as described in
the applicable regulations for the medical use of byproduct material (
i.e., are ``grandfathered'') may serve as preceptors and work
experience supervisors for individuals seeking recognition on NRC
licenses for the same medical uses of byproduct material. The
regulations that govern the medical use of byproduct material were
amended in their entirety in 2002 and again in 2005. Currently,
individuals who were identified on an NRC or Agreement State license or
permit before the regulations were amended do not need to requalify by
meeting the training and experience requirements of the applicable
regulations. When the regulations were revised, the NRC intended that
those authorized individuals would also be able to serve as preceptors
and work experience supervisors. However, the regulations as they are
currently written do not specifically state that grandfathered
individuals can be work experience supervisors and preceptors.
This proposed rule would amend the regulations to clarify that all
individuals grandfathered under the applicable regulations may serve as
preceptors and work experience supervisors for individuals seeking
recognition on an NRC license for the same uses. Additionally, several
minor administrative changes are included in this proposed rulemaking.
DATES: Comments on the proposed rule must be received on or before
August 13, 2009.
ADDRESSES: Please include the number RIN 3150-AI59 in the subject line
of your comments. Comments on rulemakings submitted in writing or in
electronic form will be made available to the public in their entirety
on the NRC's Web site in the Agencywide Documents Access and Management
System (ADAMS) and at http://www.regulations.gov. Personal information,
such as your name, address, telephone number, e-mail address, etc.,
will not be removed from your submission. You may submit comments by
any one of the following methods:
Federal e-Rulemaking portal: Go to http://www.regulations.gov and
search for documents filed under Docket ID NRC-2009-0098 and follow
instructions for submitting comments. Address questions about NRC
dockets to Carol Gallagher 301-492-3668; e-mail
[email protected].
Mail comments to: Secretary, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
E-mail comments to: [email protected]. If you do not
receive a reply e-mail confirming that we have received your comments,
contact us directly at 301-415-1677.
Hand-deliver comments to: 11555 Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. (Telephone
301-415-1677).
Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at
301-415-1101.
Publicly available documents related to this rulemaking may be
viewed electronically on the public computers located at the NRC's
Public Document Room (PDR), Room O-1 F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland. The PDR reproduction contractor
will copy documents for a fee. Selected documents, including any
comments, may be viewed and downloaded via the e-Rulemaking Portal at
http://www.regulations.gov.
Publicly available documents created or received at the NRC after
November 1, 1999, are available electronically at the NRC's Electronic
Reading Room at http://www.nrc.gov/reading-rm/adams.html. From this
site, the public can gain entry into ADAMS, which provides text and
image files of NRC's public documents. If you do not have access to
ADAMS or if there are problems in accessing the documents located in
ADAMS, contact the PDR Reference staff at 1-800-397-4209, 301-415-4737
or by e-mail to [email protected].
FOR FURTHER INFORMATION CONTACT: Edward M. Lohr, Office of Federal and
State Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, telephone 301-415-
0253, e-mail, [email protected].
SUPPLEMENTARY INFORMATION: For additional information see the Direct
Final Rule published in the final rules section of this Federal
Register.
Procedural Background
Because NRC considers this action noncontroversial and routine, we
are publishing this proposed rule concurrently as a direct final rule.
The direct final rule will become effective on September 28, 2009.
However, if the NRC receives a significant adverse comment on the
proposed rule by August 13, 2009, then the NRC will publish a document
to withdraw the direct final rule. If the direct final rule is
withdrawn, the NRC will address the comments received in response to
the proposed revisions in a subsequent final rule. Absent significant
modifications to the proposed revisions requiring republication, the
NRC will not initiate a second comment period for this action if the
direct final rule is withdrawn.
A significant adverse comment is a comment where the commenter
explains why the rule would be inappropriate, including challenges to
the rule's underlying premise or approach, or would be ineffective or
unacceptable without a change. A comment is adverse and significant if:
(1) The comment opposes the rule and provides a reason sufficient
to require a substantive response in a notice-and-comment process. For
example, a substantive response is required when:
(a) The comment causes the NRC staff to reevaluate (or reconsider)
its position or conduct additional analysis;
(b) The comment raises an issue serious enough to warrant a
substantive
[[Page 33926]]
response to clarify or complete the record; or
(c) The comment raises a relevant issue that was not previously
addressed or considered by the NRC staff.
(2) The comment proposes a change or an addition to the rule, and
it is apparent that the rule would be ineffective or unacceptable
without incorporation of the change or addition.
(3) The comment causes the staff to make a change (other than
editorial) to the rule.
List of Subjects in 10 CFR Part 35
Byproduct material, Criminal penalties, Drugs, Health facilities,
Health professions, Medical devices, Nuclear materials, Occupational
safety and health, Radiation protection, Reporting and recordkeeping
requirements.
For the reasons set out in the preamble and under the authority of
the Atomic Energy Act of 1954, as amended; the Energy Reorganization
Act of 1974, as amended; and 5 U.S.C. 553; the NRC is proposing to
adopt the following amendments to 10 CFR part 35.
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
1. The authority citation for part 35 continues to read as follows:
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954,
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat.
1242, as amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 (44
U.S.C. 3504 note); sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810
(42 U.S.C. 2014, 2021, 2021b, 2111).
2. In Sec. 35.50, paragraph (a)(2)(ii)(B) is revised to read as
follows:
Sec. 35.50 Training for Radiation Safety Officer.
* * * * *
(a) * * *
(2) * * *
(ii) * * *
(B) In clinical nuclear medicine facilities providing diagnostic
and/or therapeutic services under the direction of physicians who meet
the requirements for authorized users in Sec. Sec. 35.57, 35.290, or
35.390;
* * * * *
3. In Sec. 35.51, paragraphs (a)(2)(ii) and (b)(2) are revised to
read as follows:
Sec. 35.51 Training for an authorized medical physicist.
* * * * *
(a) * * *
(2) * * *
(ii) In clinical radiation facilities providing high-energy,
external beam therapy (photons and electrons with energies greater than
or equal to 1 million electron volts) and brachytherapy services under
the direction of physicians who meet the requirements in Sec. Sec.
35.57, 35.490, or 35.690; and
* * * * *
(b) * * *
(2) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraphs (c) and (a)(1)
and (a)(2), or (b)(1) and (c) of this section, and has achieved a level
of competency sufficient to function independently as an authorized
medical physicist for each type of therapeutic medical unit for which
the individual is requesting authorized medical physicist status. The
written attestation must be signed by a preceptor authorized medical
physicist who meets the requirements in Sec. Sec. 35.51, 35.57, or
equivalent Agreement State requirements for an authorized medical
physicist for each type of therapeutic medical unit for which the
individual is requesting authorized medical physicist status; and
* * * * *
4. In Sec. 35.57, a new paragraph (c) is added to read as follows:
Sec. 35.57 Training for experienced Radiation Safety Officer,
teletherapy or medical physicist, authorized medical physicist,
authorized user, nuclear pharmacist, and authorized nuclear pharmacist.
* * * * *
(c) Individuals who need not comply with training requirements as
described in this section may serve as preceptors for, and supervisors
of, applicants seeking authorization on NRC licenses for the same uses
for which these individuals are authorized.
5. In Sec. 35.190, the introductory text of paragraph (c)(1)(ii)
and paragraph (c)(2) are revised to read as follows:
Sec. 35.190 Training for uptake, dilution, and excretion studies.
* * * * *
(c)(1) * * *
(ii) Work experience, under the supervision of an authorized user
who meets the requirements in Sec. Sec. 35.57, 35.190, 35.290, 35.390,
or equivalent Agreement State requirements, involving--
* * * * *
(2) Has obtained written attestation, signed by a preceptor
authorized user who meets the requirements in Sec. Sec. 35.57, 35.190,
35.290, or 35.390, or equivalent Agreement State requirements, that the
individual has satisfactorily completed the requirements in paragraph
(a)(1) or (c)(1) of this section and has achieved a level of competency
sufficient to function independently as an authorized user for the
medical uses authorized under Sec. 35.100.
6. In Sec. 35.290, the introductory text of paragraph (c)(1)(ii)
and paragraph (c)(2) are revised to read as follows:
Sec. 35.290 Training for imaging and localization studies.
* * * * *
(c)(1) * * *
(ii) Work experience, under the supervision of an authorized user
who meets the requirements in Sec. Sec. 35.57, 35.290, or 35.390 and
35.290(c)(1)(ii)(G), or equivalent Agreement State requirements,
involving--
* * * * *
(2) Has obtained written attestation, signed by a preceptor
authorized user who meets the requirements in Sec. Sec. 35.57, 35.290,
or 35.390 and 35.290(c)(1)(ii)(G), or equivalent Agreement State
requirements, that the individual has satisfactorily completed the
requirements in paragraph (a)(1) or (c)(1) of this section and has
achieved a level of competency sufficient to function independently as
an authorized user for the medical uses authorized under Sec. Sec.
35.100 and 35.200.
7. In Sec. 35.390, the introductory text of paragraph (b)(1)(ii)
and paragraph (b)(2) are revised to read as follows:
Sec. 35.390 Training for use of unsealed byproduct material for which
a written directive is required.
* * * * *
(b)(1) * * *
(ii) Work experience, under the supervision of an authorized user
who meets the requirements in Sec. Sec. 35.57, 35.390, or equivalent
Agreement State requirements. A supervising authorized user, who meets
the requirements in Sec. 35.390(b), must also have experience in
administering dosages in the same dosage category or categories (i.e.,
Sec. 35.390(b)(1)(ii)(G)) as the individual requesting authorized user
status. The work experience must involve--
* * * * *
(2) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraphs (a)(1) and
(b)(1)(ii)(G) or (b)(1) of this section, and has achieved a level of
competency sufficient to function independently as an authorized user
for the medical uses authorized under Sec. 35.300. The written
attestation must be signed by a preceptor authorized user who meets the
requirements in Sec. Sec. 35.57, 35.390, or equivalent Agreement State
requirements. The preceptor authorized user, who meets the requirements
in Sec. 35.390(b) must have experience in
[[Page 33927]]
administering dosages in the same dosage category or categories (i.e.,
Sec. 35.390(b)(1)(ii)(G)) as the individual requesting authorized user
status.
8. In Sec. 35.392, the introductory text of paragraph (c)(2) and
paragraph (c)(3) are revised to read as follows:
Sec. 35.392 Training for the oral administration of sodium iodide I-
131 requiring a written directive in quantities less than or equal to
1.22 gigabecquerels (33 millicuries).
* * * * *
(c) * * *
(2) Has work experience, under the supervision of an authorized
user who meets the requirements in Sec. Sec. 35.57, 35.390, 35.392,
35.394, or equivalent Agreement State requirements. A supervising
authorized user who meets the requirements in Sec. 35.390(b) must also
have experience in administering dosages as specified in Sec. Sec.
35.390(b)(1)(ii)(G)(1) or 35.390(b)(1)(ii)(G)(2). The work experience
must involve--
* * * * *
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraphs (c)(1) and
(c)(2) of this section, and has achieved a level of competency
sufficient to function independently as an authorized user for medical
uses authorized under Sec. 35.300. The written attestation must be
signed by a preceptor authorized user who meets the requirements in
Sec. Sec. 35.57, 35.390, 35.392, 35.394, or equivalent Agreement State
requirements. A preceptor authorized user, who meets the requirement in
Sec. 35.390(b), must also have experience in administering dosages as
specified in Sec. Sec. 35.390(b)(1)(ii)(G)(1) or
35.390(b)(1)(ii)(G)(2).
9. In Sec. 35.394, the introductory text of paragraph (c)(2) and
paragraph (c)(3) are revised to read as follows:
Sec. 35.394 Training for the oral administration of sodium iodide I-
131 requiring a written directive in quantities greater than 1.22
gigabecquerels (33 millicuries).
* * * * *
(c) * * *
(2) Has work experience, under the supervision of an authorized
user who meets the requirements in Sec. Sec. 35.57, 35.390, 35.394, or
equivalent Agreement State requirements. A supervising authorized user,
who meets the requirements in Sec. 35.390(b), must also have
experience in administering dosages as specified in Sec.
35.390(b)(1)(ii)(G)(2). The work experience must involve--
* * * * *
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraphs (c)(1) and
(c)(2) of this section, and has achieved a level of competency
sufficient to function independently as an authorized user for medical
uses authorized under Sec. 35.300. The written attestation must be
signed by a preceptor authorized user who meets the requirements in
Sec. Sec. 35.57, 35.390, 35.394, or equivalent Agreement State
requirements. A preceptor authorized user, who meets the requirements
in Sec. 35.390(b), must also have experience in administering dosages
as specified in Sec. 35.390(b)(1)(ii)(G)(2).
10. In Sec. 35.396, the introductory text of paragraph (d)(2) and
paragraph (d)(3) are revised to read as follows:
Sec. 35.396 Training for the parenteral administration of unsealed
byproduct material requiring a written directive.
* * * * *
(d) * * *
(2) Has work experience, under the supervision of an authorized
user who meets the requirements in Sec. Sec. 35.57, 35.390, 35.396, or
equivalent Agreement State requirements, in the parenteral
administration, for which a written directive is required, of any beta
emitter, or any photon-emitting radionuclide with a photon energy less
than 150 keV, and/or parenteral administration of any other
radionuclide for which a written directive is required. A supervising
authorized user who meets the requirements in Sec. 35.390 must have
experience in administering dosages as specified in Sec. Sec.
35.390(b)(1)(ii)(G)(3) and/or 35.390(b)(1)(ii)(G)(4). The work
experience must involve--
* * * * *
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraph (b) or (c) of
this section, and has achieved a level of competency sufficient to
function independently as an authorized user for the parenteral
administration of unsealed byproduct material requiring a written
directive. The written attestation must be signed by a preceptor
authorized user who meets the requirements in Sec. Sec. 35.57, 35.390,
35.396, or equivalent Agreement State requirements. A preceptor
authorized user, who meets the requirements in Sec. 35.390, must have
experience in administering dosages as specified in Sec. Sec.
35.390(b)(1)(ii)(G)(3) and/or 35.390(b)(1)(ii)(G)(4).
11. In Sec. 35.490, the introductory text of paragraph (b)(1)(ii)
and paragraphs (b)(2) and (b)(3) are revised to read as follows:
Sec. 35.490 Training for use of manual brachytherapy sources.
* * * * *
(b)(1) * * *
(ii) 500 hours of work experience, under the supervision of an
authorized user who meets the requirements in Sec. Sec. 35.57, 35.490,
or equivalent Agreement State requirements at a medical institution,
involving--
* * * * *
(2) Has completed 3 years of supervised clinical experience in
radiation oncology, under an authorized user who meets the requirements
in Sec. Sec. 35.57, 35.490, or equivalent Agreement State
requirements, as part of a formal training program approved by the
Residency Review Committee for Radiation Oncology of the Accreditation
Council for Graduate Medical Education or the Royal College of
Physicians and Surgeons of Canada or the Committee on Postdoctoral
Training of the American Osteopathic Association. This experience may
be obtained concurrently with the supervised work experience required
by paragraph (b)(1)(ii) of this section; and
(3) Has obtained written attestation, signed by a preceptor
authorized user who meets the requirements in Sec. Sec. 35.57, 35.490,
or equivalent Agreement State requirements, that the individual has
satisfactorily completed the requirements in paragraph (a)(1), or
paragraphs (b)(1) and (b)(2), of this section and has achieved a level
of competency sufficient to function independently as an authorized
user of manual brachytherapy sources for the medical uses authorized
under Sec. 35.400.
12. In Sec. 35.491, paragraph (b)(3) is revised to read as
follows:
Sec. 35.491 Training for ophthalmic use of strontium-90.
* * * * *
(b) * * *
(3) Has obtained written attestation, signed by a preceptor
authorized user who meets the requirements in Sec. Sec. 35.57, 35.490,
35.491, or equivalent Agreement State requirements, that the individual
has satisfactorily completed the requirements in paragraph (b) of this
section and has achieved a level of competency sufficient to function
independently as an authorized user of strontium-90 for ophthalmic use.
13. In Sec. 35.690, the introductory text of paragraph (b)(1)(ii)
and paragraphs (b)(2) and (b)(3) are revised to read as follows:
Sec. 35.690 Training for use of remote afterloader units, teletherapy
units, and gamma stereotactic radiosurgery units.
* * * * *
[[Page 33928]]
(b)(1) * * *
(ii) 500 hours of work experience, under the supervision of an
authorized user who meets the requirements in Sec. Sec. 35.57, 35.690,
or equivalent Agreement State requirements at a medical institution,
involving--
* * * * *
(2) Has completed 3 years of supervised clinical experience in
radiation therapy, under an authorized user who meets the requirements
in Sec. Sec. 35.57, 35.690, or equivalent Agreement State
requirements, as part of a formal training program approved by the
Residency Review Committee for Radiation Oncology of the Accreditation
Council for Graduate Medical Education or the Royal College of
Physicians and Surgeons of Canada or the Committee on Postdoctoral
Training of the American Osteopathic Association. This experience may
be obtained concurrently with the supervised work experience required
by paragraph (b)(1)(ii) of this section; and
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraph (a)(1) or
paragraphs (b)(1) and (b)(2), and paragraph (c), of this section, and
has achieved a level of competency sufficient to function independently
as an authorized user of each type of therapeutic medical unit for
which the individual is requesting authorized user status. The written
attestation must be signed by a preceptor authorized user who meets the
requirements in Sec. Sec. 35.57, 35.690, or equivalent Agreement State
requirements for an authorized user for each type of therapeutic
medical unit for which the individual is requesting authorized user
status; and
* * * * *
Dated at Rockville, Maryland, this 26th day of June 2009.
For the Nuclear Regulatory Commission.
R.W. Borchardt,
Executive Director for Operations.
[FR Doc. E9-16656 Filed 7-13-09; 8:45 am]
BILLING CODE 7590-01-P