Medical Use of Byproduct Material-Authorized User Clarification, 33925-33928 [E9-16656]

Agencies

• NUCLEAR REGULATORY COMMISSION

[Federal Register Volume 74, Number 133 (Tuesday, July 14, 2009)]
[Proposed Rules]
[Pages 33925-33928]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16656]


========================================================================
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.

========================================================================


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.

-----------------------------------------------------------------------

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 https://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 https://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 
Carol.Gallagher@nrc.gov.
    Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
    E-mail comments to: Rulemaking.Comments@nrc.gov. 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 
https://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 https://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 pdr.resource@nrc.gov.

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, Edward.Lohr@nrc.gov.

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