[Federal Register Volume 69, Number 179 (Thursday, September 16, 2004)]
[Rules and Regulations]
[Pages 55736-55739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-20856]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 35

RIN 3150-AH47


Medical Use of Byproduct Material Minor Amendments: Extending 
Expiration Date for Subpart J

AGENCY: Nuclear Regulatory Commission.

ACTION: Final rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its 
regulations governing the medical use of byproduct material to extend 
the expiration date for training and experience requirements that will 
be superseded (Subpart J) for 1 year, from October 24, 2004, to October 
24, 2005. The rulemaking is necessary to allow sufficient time for 
implementation of the forthcoming final rule that amends the training 
and experience requirements, including new requirements for recognition 
of specialty board certifications.

EFFECTIVE DATE: October 22, 2004.

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, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

The 2002 Final Rule

    On April 24, 2002 (67 FR 20249), the NRC published a final rule 
amending its regulations regarding the medical use of byproduct 
material. The final rule addressed, among other things, new training 
and experience (T&E) requirements for radiation safety officers, 
authorized medical physicists, authorized nuclear pharmacists, and 
authorized users. This rule also addressed the requirements for 
recognition of medical and other specialty boards whose certifications 
may be used to demonstrate the adequacy of the T&E of individuals 
mentioned above. This final rule was effective on October 24, 2002. In 
addition, NRC retained the existing T&E requirements, designated as 
subpart J in 10 CFR part 35, for a 2-year period. Therefore, subpart J 
remains effective until October 24, 2004.

Statements in the Preamble of the 2002 Final Rule

    In the preamble, NRC stated that during an NRC's Advisory Committee 
on the Medical Uses of Isotopes (ACMUI) briefing of the Commission on 
February 19, 2002, the issue of recognition of medical and other 
specialty boards was discussed. In that meeting, two committee members 
expressed concern that some boards did not qualify for recognition and 
might not be ready to apply for recognition within 6 months after 
publication of the final rule. Therefore, implementation of the new 
part 35, without Subpart J, could disrupt the current license 
authorization process for new medical personnel because many license 
authorizations are granted based on recognition of board certification.
    The preamble further stated that NRC had considered this matter and 
decided to retain the training requirements in subpart J for a 2-year 
period after the effective date of the final rule. During this 
transition period, the NRC would continue working with the ACMUI and 
the medical community to resolve any concerns about the training and 
experience requirements. The NRC would consider changes to the T&E 
requirements, as appropriate.

The T&E Proposed Rule

    After the publication of the 2002 final rule, the NRC worked with 
the ACMUI and other stakeholders to consider what changes were 
necessary to the T&E requirements. Several public meetings were held to 
discuss the changes. On December 9, 2003 (68 FR 68549), a proposed rule 
on T&E requirements was published for a 75-day public comment period. 
The NRC is currently considering public comments and developing the T&E 
final rule.
    One commenter stated that the current transition period for subpart 
J, which ends on October 24, 2004, must be extended to allow time for 
boards to

[[Page 55737]]

prepare applications and for NRC to process applications, including 
ACMUI review. The NRC agrees that additional time for implementation of 
the changes to T&E should be allowed beyond October 24, 2004.

Actions Taken in This Final Rule

    NRC is amending part 35 to extend the expiration date of subpart J 
for 1 year, from October 24, 2004, to October 24, 2005. The NRC 
believes that it is prudent to extend the expiration date of subpart J 
at this time to allow affected stakeholders (i.e., medical and other 
specialty boards, and medical use licensees) to effectively plan their 
implementation.
    The following sections are revised by changing the date from 
October 24, 2004, to October 24, 2005: Sec.  35.2, paragraph (1) of the 
definitions of ``Authorized medical physicist,'' ``Authorized nuclear 
pharmacist,'' ``Authorized user,'' and ``Radiation Safety Officer''; 
Sec. Sec.  35.10(b) and (c); 35.51(b)(2); 35.100(b)(2); 35.190(b), 
(c)(1)(ii) and (c)(2); 35.200(b)(2); 35.290(b), (c)(1)(ii), and (c)(2); 
35.300(b)(2); 35.390(b)(1)(ii) and (b)(2); 35.392(b), (c)(2), and 
(c)(3); 35.394(b), (c)(2), and (c)(3); 35.490(b)(1)(ii), (b)(2), and 
(b)(3); 35.491(a) and (b)(3); and 35.690(b)(1)(ii), (b)(2), and (b)(3).
    Because these amendments constitute minor administrative changes to 
the regulations, the notice and comment provisions of the 
Administrative Procedure Act do not apply, pursuant to 5 U.S.C. 
553(b)(B).

Environmental Impact: Categorical Exclusion

    NRC has determined that this final rule is the type of action 
described in categorical exclusion 10 CFR 51.22(c)(2). Therefore, 
neither an environmental impact statement nor an environmental 
assessment has been prepared for this final rule.

Paperwork Reduction Act Statement

    This final rule does not contain new or amended information 
collection requirements subject to the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.). Existing requirements were approved by the 
Office of Management and Budget, approval numbers 3150-0010 and 3150-
0120.

Public Protection Notification

    The NRC may not conduct or sponsor, and a person is not required to 
respond to, a request for information of an information collection 
requirement unless the requesting document displays a currently valid 
OMB control number.

Backfit Analysis

    The NRC has determined that the backfit rule does not apply to this 
final rule; and therefore, a backfit analysis is not required for this 
final rule because these amendments do not involve any provisions that 
would impose backfits as defined in 10 CFR Chapter 1.

Small Business Regulatory Enforcement Fairness Act

    In accordance with the Small Business Regulatory Enforcement 
Fairness Act of 1996, the NRC has determined that this action is not a 
major rule and has verified this determination with the Office of 
Information and Regulatory Affairs of OMB.

List of Subjects for 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.


0
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. 552 and 553; the NRC is adopting the 
following amendments to 10 CFR part 35.

PART 35-MEDICAL USE OF BYPRODUCT MATERIAL

0
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).


0
2. In Sec.  35.2, the definitions of ``authorized medical physicist,'' 
``authorized nuclear pharmacist,'' ``authorized user,'' and ``Radiation 
Safety Officer'' are amended by republishing the introductory text and 
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, 2005, 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, 2005, 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, 2005, 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, 2005, meets the requirements in Sec. Sec.  35.900(a) 
and 35.59; or
* * * * *

0
3 In Sec.  35.10, paragraph (b) and the introductory text of paragraph 
(c) are revised to read as follows:


Sec.  35.10  Implementation.

* * * * *
    (b) A licensee shall implement the training requirements in 
Sec. Sec.  35.50(a), 35.51(a), 35.55(a), 35.59, 35.190(a), 35.290(a), 
35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), and 35.690(a) on 
or before October 25, 2005.
    (c) Prior to October 25, 2005, a licensee shall satisfy the 
training requirements of this part for a Radiation Safety Officer, an 
authorized medical physicist, an authorized nuclear pharmacist, or an 
authorized user by complying with either:
* * * * *

0
4. In Sec.  35.51, paragraph (b)(2) is revised to read as follows:


Sec.  35.51  Training for an authorized medical physicist.

* * * * *
    (b) * * *
    (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 medical physicist for each type of 
therapeutic medical unit for which the individual is requesting 
authorized medical physicist status. The written certification must be 
signed by a preceptor authorized medical physicist who meets the 
requirements in Sec.  35.51, or, before October 24, 2005, 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.

[[Page 55738]]


0
5 In Sec.  35.100, paragraph (b)(2) is revised to read as follows:


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

* * * * *
    (b) * * *
    (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, 2005, Sec.  35.920; or
* * * * *

0
6. 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, 2005, 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, 2005, 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, 2005, 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.

0
7. In Sec.  35.200, paragraph (b)(2) 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) * * *
    (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, 2005, Sec.  35.920; or
* * * * *

0
8. 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, 2005, 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, 2005, 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, 2005, 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.

0
9. In Sec.  35.300, paragraph (b)(2) is revised to read as follows:


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

* * * * *
    (b) * * *
    (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, 2005, Sec.  35.920; or
* * * * *

0
10. 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.  35.390(a), 35.390(b), or, before 
October 24, 2005, 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, 2005, 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, 2005, 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, 
2005, 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.

0
11. In Sec.  35.392, paragraph (b), 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).

* * * * *
    (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, 2005, 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, 2005, 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, 
2005, Sec. Sec.  35.930, 35.932, or

[[Page 55739]]

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).

0
12. 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 
gigabecquerels (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, 
2005, 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, 2005, 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, 2005, 
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).

0
13. 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.  35.490, or, before 
October 24, 2005, 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, 2005, 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, 2005, 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.

0
14 In Sec.  35.491, paragraphs (a) and (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, 2005, Sec. Sec.  35.940 or 35.941, or equivalent Agreement State 
requirements; or
    (b) * * *
    (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, 2005, 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.

0
15 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, 2005, 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, 2005, 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, 2005, 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.

    Dated at Rockville, Maryland, this 10th day of September, 2004.

    For the Nuclear Regulatory Commission.
Annette Vietti-Cook,
Secretary of the Commission.
[FR Doc. 04-20856 Filed 9-15-04; 8:45 am]
BILLING CODE 7590-01-P