[Federal Register Volume 68, Number 76 (Monday, April 21, 2003)]
[Proposed Rules]
[Pages 19466-19470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-9602]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 35

RIN 3150-AH08


Medical Use of Byproduct Material: Clarifying and Minor 
Amendments

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its 
regulations regarding the medical use of byproduct material. This 
action would clarify the definitions of authorized users, authorized 
medical physicists, authorized nuclear pharmacists, and radiation 
safety officers; clarify the notification requirements if the patient 
is in a medical emergency or dies; clarify the recordkeeping 
requirements for calibration of brachytherapy sources; correct the 
title for the National Institute of Standards and Technology; clarify 
that prior to October 24, 2004, individuals who meet the training and 
experience requirements in Subpart J may undertake responsibilities 
specified in certain sections in Subparts B and D-H; and eliminate a 
restriction that training for ophthalmic use of strontium-90 can only 
be conducted in medical institutions. These amendments are necessary to 
clarify certain inconsistencies within the regulations and to allow 
training in ophthalmic treatment to be conducted in eye clinics or 
private practices, in addition to medical institutions.

DATES: Comments on the proposed rule must be received on or before May 
21, 2003.

ADDRESSES: You may submit comments by any one of the following methods. 
Please include the following number (RIN 3150-AHO8) in the subject line 
of your comments. Comments on rulemakings submitted in writing or in 
electronic form will be made available

[[Page 19467]]

to the public in their entirety on the NRC rulemaking Web site. 
Personal information will not be removed from your comments.
    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) 415-1966. You may also submit comments via the NRC's 
rulemaking Web site at http://ruleforum.llnl.gov. Address questions 
about our rulemaking Web site to Carol Gallagher (301) 415-5905; email 
[email protected].
    Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 
20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. (Telephone 
(301) 415-1966).
    Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 
(301) 415-1101.
    Publicly available documents related to this rulemaking may be 
examined and copied for a fee at the NRC's Public Document Room (PDR), 
Public File Area O1 F21, One White Flint North, 11555 Rockville Pike, 
Rockville, Maryland. Selected documents, including comments, can be 
viewed and downloaded electronically via the NRC rulemaking Web site at 
http://ruleforum.llnl.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/NRC/ADAMS/index.html. From this 
site, the public can gain entry into the NRC's Agencywide Document 
Access and Management System (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 NRC Public Document Room (PDR) Reference staff at 1-800-
397-4209, (301) 415-4737 or by email to [email protected].

FOR FURTHER INFORMATION CONTACT: Dr. Anthony N. Tse, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001, telephone (301) 415-6233, email: 
[email protected].

SUPPLEMENTARY INFORMATION: For additional information see the direct 
final rule published in the Rules and Regulations section of this 
Federal Register.
    Because the 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 July 7, 2003. 
However, if the NRC receives significant adverse comments on the direct 
final rule, by May 21, 2003, the NRC will publish a document that 
withdraws 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 staff to reevaluate (or reconsider) its 
position or conduct additional analysis;
    (B) The comment raises an issue serious enough to warrant a 
substantive response to clarify or complete the record; or
    (C) The comment raises a relevant issue that was not previously 
addressed or considered by the 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 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).

    2. In Sec.  35.2, the definitions for authorized medical physicist, 
authorized nuclear pharmacist, authorized user, and radiation safety 
officer, are amended by revising paragraph (1) of each definition to 
read as follows:


Sec.  35.2  Definitions.

* * * * *
    Authorized medical physicist means an individual who--
    (1) Meets the requirements in Sec. Sec.  35.51(a) and 35.59; or, 
before October 24, 2004, meets the requirements in Sec. Sec.  
35.961(a), or (b), and 35.59; or
* * * * *
    Authorized nuclear pharmacist means a pharmacist who--
    (1) Meets the requirements in Sec. Sec.  35.55(a) and 35.59; or, 
before October 24, 2004, meets the requirements in Sec. Sec.  35.980(a) 
and 35.59; or
* * * * *
    Authorized user means a physician, dentist, or podiatrist who--
    (1) Meets the requirements in Sec. Sec.  35.59 and 35.190(a), 
35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), or 
35.690(a); or, before October 24, 2004, meets the requirements in 
Sec. Sec.  35.910(a), 35.920(a), 35.930(a), 35.940(a), 35.950(a), or 
35.960(a) and 35.59; or
* * * * *
    Radiation Safety Officer means an individual who--
    (1) Meets the requirements in Sec. Sec.  35.50(a) and 35.59; or, 
before October 24, 2004, meets the requirements in Sec. Sec.  35.900(a) 
and 35.59; or
* * * * *
    3. In Sec.  35.51, the second sentence of paragraph (b)(2) is 
revised to read as follows:


Sec.  35.51  Training for an authorized medical physicist.

* * * * *
    (b) * * *
    (2) * * * The written certification must be signed by a preceptor 
authorized medical physicist who meets the requirements in Sec.  35.51, 
or, before October 24, 2004, Sec.  35.961, 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.
    4. In Sec.  35.100, paragraph (b) is revised to read as follows:

[[Page 19468]]

Sec.  35.100  Use of unsealed byproduct material for uptake, dilution, 
and excretion studies for which a written directive is not required.

* * * * *
    (b) Prepared by:
    (1) An authorized nuclear pharmacist;
    (2) A physician who is an authorized user and who meets the 
requirements specified in Sec. Sec.  35.290, 35.390, or, before October 
24, 2004, Sec.  35.920; or
    (3) An individual under the supervision, as specified in Sec.  
35.27, of the authorized nuclear pharmacist in paragraph (b)(1) of this 
section or the physician who is an authorized user in paragraph (b)(2) 
of this section; or
* * * * *
    5. In Sec.  35.190, paragraph (b), 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.

* * * * *
    (b) Is an authorized user under Sec. Sec.  35.290, 35.390, or, 
before October 24, 2004, Sec. Sec.  35.910, 35.920, or 35.930, or 
equivalent Agreement State requirements; or
* * * * *
    (c) * * *
    (1) * * *
    (ii) Work experience, under the supervision of an authorized user 
who meets the requirements in Sec. Sec.  35.190, 35.290, 35.390, or, 
before October 24, 2004, Sec. Sec.  35.910, 35.920, or 35.930, or 
equivalent Agreement State requirements, involving--
* * * * *
    (2) Has obtained written certification, signed by a preceptor 
authorized user who meets the requirements in Sec. Sec.  35.190, 
35.290, 35.390, or, before October 24, 2004, Sec. Sec.  35.910, 35.920, 
or 35.930, or equivalent Agreement State requirements, that the 
individual has satisfactorily completed the requirements in paragraph 
(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.  35.200, paragraph (b) is revised to read as follows:


Sec.  35.200  Use of unsealed byproduct material for imaging and 
localization studies for which a written directive is not required.

* * * * *
    (b) Prepared by:
    (1) An authorized nuclear pharmacist;
    (2) A physician who is an authorized user and who meets the 
requirements specified in Sec. Sec.  35.290, 35.390, or, before October 
24, 2004, Sec.  35.920; or
    (3) An individual under the supervision, as specified in Sec.  
35.27, of the authorized nuclear pharmacist in paragraph (b)(1) of this 
section or the physician who is an authorized user in paragraph (b)(2) 
of this section;
* * * * *
    7. In Sec.  35.290, paragraph (b), 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.

* * * * *
    (b) Is an authorized user under Sec.  35.390, or, before October 
24, 2004, Sec.  35.920, or equivalent Agreement State requirements; or
    (c) * * *
    (1) * * *
    (ii) Work experience, under the supervision of an authorized user, 
who meets the requirements in Sec. Sec.  35.290, 35.390, or, before 
October 24, 2004, Sec.  35.920, or equivalent Agreement State 
requirements, involving --
* * * * *
    (2) Has obtained written certification, signed by a preceptor 
authorized user who meets the requirements in Sec. Sec.  35.290, 
35.390, or, before October 24, 2004, Sec.  35.920, or equivalent 
Agreement State requirements, that the individual has satisfactorily 
completed the requirements in paragraph (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.
    8. In Sec.  35.300, paragraph (b) is revised to read as follows:


Sec.  35.300  Use of unsealed byproduct material for which a written 
directive is required.

* * * * *
    (b) Prepared by:
    (1) An authorized nuclear pharmacist;
    (2) A physician who is an authorized user and who meets the 
requirements specified in Sec. Sec.  35.290, 35.390, or, before October 
24, 2004, Sec.  35.920; or
    (3) An individual under the supervision, as specified in Sec.  
35.27, of the authorized nuclear pharmacist in paragraph (b)(1) of this 
section or the physician who is an authorized user in paragraph (b)(2) 
of this section; or
* * * * *
    9. In Sec.  35.310, paragraph (a)(5) is revised to read as follows:


Sec.  35.310  Safety instruction.

    (a) * * *
    (5) Notification of the Radiation Safety Officer, or his or her 
designee, and an authorized user if the patient or the human research 
subject has a medical emergency or dies.
* * * * *
    10. In Sec.  35.315, paragraph (b) is revised to read as follows:


Sec.  35.315  Safety precautions.

* * * * *
    (b) A licensee shall notify the Radiation Safety Officer, or his or 
her designee, and an authorized user as soon as possible if the patient 
or human research subject has a medical emergency or dies.
    11. 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.  35.390(a), 35.390(b), or, 
before October 24, 2004, Sec.  35.930, or equivalent Agreement State 
requirements. A supervising authorized user, who meets the requirements 
in Sec.  35.390(b) or, before October 24, 2004, Sec.  35.930(b), must 
also have experience in administering dosages in the same dosage 
category or categories (i.e., Sec.  35.390(b)(1)(ii)(G)(1), (2), (3), 
or (4)) as the individual requesting authorized user status. The work 
experience must involve--
* * * * *
    (2) Has obtained written certification that the individual has 
satisfactorily completed the requirements in paragraph (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 certification must be signed by a 
preceptor authorized user who meets the requirements in Sec. Sec.  
35.390(a), 35.390(b), or, before October 24, 2004, Sec.  35.930, or 
equivalent Agreement State requirements. The preceptor authorized user, 
who meets the requirements in Sec.  35.390(b) or, before October 24, 
2004, Sec.  35.930(b), must also have experience in administering 
dosages in the same dosage category or categories (i.e., Sec.  
35.390(b)(1)(ii)(G)(1), (2), (3), or (4)) as the individual requesting 
authorized user status.
    12. In Sec.  35.392, paragraph (b), the introductory text of 
paragraph (c)(2), and paragraph (c)(3) are revised to read as follows:

[[Page 19469]]

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 Gigabecquereis (33 millicuries).

* * * * *
    (b) Is an authorized user under Sec. Sec.  35.390(a), 35.390(b) for 
uses listed in Sec.  35.390(b)(1)(ii)(G)(1) or (2), Sec.  35.394, or, 
before October 24, 2004, Sec. Sec.  35.930, 35.932, or 35.934, or 
equivalent Agreement State requirements; or
    (c) * * *
    (2) Has work experience, under the supervision of an authorized 
user who meets the requirements in Sec. Sec.  35.390(a), 35.390(b), 
35.392, 35.394, or, before October 24, 2004, Sec. Sec.  35.930, 35.932, 
or 35.934, 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)(1) or (2). The work experience must involve--
* * * * *
    (3) Has obtained written certification 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 certification must be 
signed by a preceptor authorized user who meets the requirements in 
Sec. Sec.  35.390(a), 35.390(b), 35.392, 35.394, or, before October 24, 
2004, Sec. Sec.  35.930, 35.932, or 35.934, 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.  35.390(b)(1)(ii)(G)(1) or 
(2).
    13. In Sec.  35.394, paragraph (b), 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 
Gigabecquereis (33 millicuries).

* * * * *
    (b) Is an authorized user under Sec. Sec.  35.390(a), 35.390(b) for 
uses listed in Sec.  35.390(b)(1)(ii)(G)(2), or, before October 24, 
2004, Sec. Sec.  35.930 or 35.934, or equivalent Agreement State 
requirements; or
    (c) * * *
    (2) Has work experience, under the supervision of an authorized 
user who meets the requirements in Sec. Sec.  35.390(a), 35.390(b), 
35.394, or, before October 24, 2004, Sec. Sec.  35.930 or 35.934, 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 certification 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 certification must be 
signed by a preceptor authorized user who meets the requirements in 
Sec. Sec.  35.390(a), 35.390(b), 35.394, or, before October 24, 2004, 
Sec. Sec.  35.930 or 35.934, 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).
    14. In Sec.  35.432, paragraph (b) is revised to read as follows:


Sec.  35.432  Calibration measurements of brachytherapy sources.

* * * * *
    (b) Instead of a licensee making its own measurements as required 
in paragraph (a) of this section, the licensee may use measurements 
provided by the source manufacturer or by a calibration laboratory 
accredited by the American Association of Physicists in Medicine that 
are made in accordance with paragraph (a) of this section.
* * * * *
    15. In Sec.  35.490, the introductory text of paragraph (b)(1)(ii), 
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.  35.490, or, before 
October 24, 2004, Sec.  35.940, or equivalent Agreement State 
requirements at a medical institution, involving--
* * * * *
    (2) Has obtained 3 years of supervised clinical experience in 
radiation oncology, under an authorized user who meets the requirements 
in Sec.  35.490, or, before October 24, 2004, Sec.  35.940, 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 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 certification, signed by a preceptor 
authorized user who meets the requirements in Sec.  35.490, or, before 
October 24, 2004, Sec.  35.940, or equivalent Agreement State 
requirements, that the individual has satisfactorily completed the 
requirements in 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.
    16. In Sec.  35.491, paragraph (a), the introductory text of 
paragraph (b)(2), and paragraph (b)(3) are revised to read as follows:


Sec.  35.491  Training for ophthalmic use of strontium-90.

* * * * *
    (a) Is an authorized user under Sec.  35.490, or, before October 
24, 2004, Sec. Sec.  35.940 or 35.941, or equivalent Agreement State 
requirements; or
    (b) * * *
    (2) Supervised clinical training in ophthalmic radiotherapy under 
the supervision of an authorized user at a medical institution, clinic, 
or private practice that includes the use of strontium-90 for the 
ophthalmic treatment of five individuals. This supervised clinical 
training must involve--
* * * * *
    (3) Has obtained written certification, signed by a preceptor 
authorized user who meets the requirements in Sec. Sec.  35.490, 
35.491, or, before October 24, 2004, Sec. Sec.  35.940 or 35.941, or 
equivalent Agreement State requirements, that the individual has 
satisfactorily completed the requirements in paragraphs (a) and (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.
    17. In Sec.  35.630, paragraph (a)(1) is revised to read as 
follows:


Sec.  35.630  Dosimetry equipment.

    (a) * * *
    (1) The system must have been calibrated using a system or source 
traceable to the National Institute of Standards and Technology (NIST) 
and published protocols accepted by nationally recognized bodies; or by 
a

[[Page 19470]]

calibration laboratory accredited by the American Association of 
Physicists in Medicine (AAPM). The calibration must have been performed 
within the previous 2 years and after any servicing that may have 
affected system calibration; or
* * * * *
    18. 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.

* * * * *
    (b) * * *
    (1) * * *
    (ii) 500 hours of work experience, under the supervision of an 
authorized user who meets the requirements in Sec.  35.690, or, before 
October 24, 2004, Sec.  35.960, 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.  35.690, or, before October 24, 2004, Sec.  35.960, 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 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 certification that the individual has 
satisfactorily completed the requirements in 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 each type 
of therapeutic medical unit for which the individual is requesting 
authorized user status. The written certification must be signed by a 
preceptor authorized user who meets the requirements in Sec.  35.690, 
or, before October 24, 2004, Sec.  35.960, 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.
    19. In Sec.  35.2432, paragraph (b)(5) is revised to read as 
follows:


Sec.  35.2432  Records of calibration measurements of brachytherapy 
sources.

* * * * *
    (b) * * *
    (5) The name of the individual, the source manufacturer, or the 
calibration laboratory that performed the calibration.

    Dated at Rockville, Maryland, this 31st day of March, 2003.

    For the Nuclear Regulatory Commission.
William D. Travers,
Executive Director for Operations.
[FR Doc. 03-9602 Filed 4-18-03; 8:45 am]
BILLING CODE 7590-01-P