[Federal Register Volume 72, Number 155 (Monday, August 13, 2007)]
[Rules and Regulations]
[Pages 45147-45151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-3976]


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NUCLEAR REGULATORY COMMISSION

10 CFR Parts 32 and 35

RIN 3150-AI14


Medical Use of Byproduct Material--Minor Corrections and 
Clarifications

AGENCY: Nuclear Regulatory Commission.

ACTION: Direct final rule.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending its 
regulations to correct or clarify the rule language in several sections 
in the regulations that govern specific domestic licenses to 
manufacture or transfer certain items containing byproduct material and 
medical use of byproduct material. The regulations that govern medical 
use of byproduct materials were amended in their entirety on April 24, 
2002 (67 FR 20249). Subsequently, these regulations were amended again 
to revise the training and experience requirements for the medical use 
of byproduct material on March 30, 2005 (70 FR 16336). Through 
implementation of these revised regulations, the NRC has identified 
additional changes that need to be made to these regulations. This 
action is necessary to clarify certain provisions and to make certain 
conforming changes to the regulations.

DATES: The final rule is effective on October 29, 2007, unless 
significant adverse comments are received by September 12, 2007. 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. If the rule is withdrawn due to significant adverse 
comments, timely notice will be provided in the Federal Register.

ADDRESSES: You may submit comments by any one of the following methods. 
Please include the following number (RIN 3150-AI14) 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 rulemaking Web site. Personal information, such as name, 
address, phone, e-mail address, etc., will not be removed from your 
submission.
    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; e-mail 
[email protected]. Comments can also be submitted via the Federal eRulemaking 
Portal http://www.regulations.gov.
    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 viewed electronically on the public computers 
located at the NRC's Public Document Room (PDR), O1 F21, One White 
Flint North, 11555 Rockville Pike, Rockville, Maryland. The PDR 
reproduction contractor will copy documents for a fee. Selected 
documents, including comments, may

[[Page 45148]]

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/reading-rm/adams.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 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:

Background

    The purpose of these amendments is to amend 10 CFR Parts 32 and 35 
to clarify and make certain conforming changes related to the NRC's 
requirements for the medical use of byproduct material.

Discussion

    This direct final rule revises several sections in 10 CFR Parts 32 
and 35 to correct or clarify rule language. It also includes 
conformatory changes that should have been incorporated in the 
regulations but were inadvertently left out. The changes and 
clarifications are minor in nature and noncontroversial. The following 
changes are being made to the regulations:

Section by Section Analysis

1. Section 32.72 Manufacture, Preparation, or Transfer for Commercial 
Distribution of Radioactive Drugs Containing Byproduct Material for 
Medical Use Under Part 35

    During the rulemaking completed in 2005, conforming changes to 
Sec.  32.72, to reflect the changes made in Sec.  35.55, were 
inadvertently omitted. The 2005 revision of the training and experience 
requirements for an authorized nuclear pharmacist (ANP) in Sec.  35.55 
removed the requirement for a preceptor statement as a condition for 
recognition of a specialty board's certification process. Instead, an 
individual seeking ANP status on an NRC license must provide a 
preceptor statement, in addition to documentation of the board 
certification. This amendment makes the necessary conforming changes to 
Sec.  32.72.
    Additionally, certification by the Board of Pharmaceutical 
Specialties is removed from Sec.  32.72 because specialty boards 
recognized by the Commission or Agreement States are posted on the 
NRC's web page and are no longer listed in NRC regulations.

2. Section 32.74 Manufacture and Distribution of Sources or Devices 
Containing Byproduct Material for Medical Use

    Section 32.74(a) states that an application will be approved for a 
specific license to manufacture and distribute sources and devices 
containing byproduct material to persons licensed under Part 35 of this 
chapter for use as a calibration or reference source or for the uses 
listed in Sec. Sec.  35.400, 35.500, and 35.600 if certain conditions 
are met. When Part 35 was amended on April 24, 2002 (67 FR 20249), a 
new section, Sec.  35.1000, ``Other medical uses of byproduct material 
or radiation from byproduct material,'' was added to address radiation 
safety issues associated with new modalities. A conforming change 
should have been made in Sec.  32.74(a) to reference Sec.  35.1000, but 
was inadvertently left out. This change amends this section by adding 
Sec.  35.1000 after Sec. Sec.  35.400, 35.500, 35.600.

3. Section 35.2 Definitions

    The definitions in this section include both medium-dose rate 
remote afterloader and high-dose rate remote afterloader. The medium-
dose rate remote afterloader is defined as a device that remotely 
delivers a dose rate of greater than 2 gray (200 rads), but less than 
12 gray (1200 rads) per hour at the point or surface where the dose is 
prescribed. The high-dose rate remote afterloader is defined as 
delivering a dose rate in excess of 12 gray (1200 rads) per hour at the 
point or surface where the dose is prescribed. The dose rate of equal 
to 12 gray (1200 rads) per hour was inadvertently excluded. This 
section is being amended to revise the definition of medium dose-rate 
remote afterloader to include ``equal to'' 12 gray. In addition, for 
clarification, the phrase ``per hour'' will be added after the phrase 
``delivers a dose rate of greater than 2 gray (200 rads)'' to read as 
``delivers a dose rate of greater than 2 gray (200 rads) per hour.''

4. Section 35.41 Procedures for Administrations Requiring a Written 
Directive

    Section 35.41(b)(4) requires a licensee to have procedures 
verifying that any computer-generated dose calculations are correctly 
transferred into the consoles of therapeutic medical units authorized 
by Sec.  35.600. When Part 35 was amended on April 24, 2002 (67 FR 
20249), a new section, Sec.  35.1000, ``Other medical uses of byproduct 
material or radiation from byproduct material,'' was added to address 
radiation safety issues associated with new modalities. A conforming 
change should have been made in Sec.  35.41(b)(4) to reference Sec.  
35.1000, but was inadvertently left out. This changes this section by 
adding Sec.  35.1000 after Sec.  35.600.

5. Section 35.75 Release of Individuals Containing Unsealed Byproduct 
Material or Implants Containing Byproduct Material

    In Sec.  35.75(a), the footnote states that NUREG-1556, Vol. 9, 
``Consolidated Guidance About Materials Licenses: Program-Specific 
Guidance About Medical Licenses,'' describes methods for calculating 
doses to other individuals and contains tables of activities not likely 
to cause doses exceeding 5 mSv (0.5 rem). NUREG-1556, Vol. 9, is not 
the current version of this NUREG. The current version, ``Revision 1,'' 
is expected to be revised. Thus, the footnote is revised to add the 
phrase ``The current version of'' before the phrase ``NUREG-1556, Vol. 
9.''

6. Section 35.92 Decay-in-Storage

    This section permits decay-in-storage by medical use licensees for 
radionuclides with half-lives of less than 120 days. This section 
inadvertently excluded radionuclides with half-lives equal to 120 days. 
This change revises this section to include ``equal to'' 120 days.

7. Section 35.190 Training for Uptake, Dilution, and Excretion Studies

    Section 35.190(a)(1) provides that in order for a specialty board's 
certification process to be recognized, the board must require all 
candidates for certification to complete 60 hours of training and 
experience ``that includes the topics listed in paragraphs (c)(1)(i) 
and (c)(1)(ii) of this section.'' The intent of the regulation is that 
candidates must obtain their work experience involving the topics 
listed in (c)(1)(ii) under the supervision of a specified authorized 
user. The change of the phrase to ``as described in paragraphs 
(c)(1)(i) through (c)(1)(ii)(F) of this section,'' clarifies that all 
of the requirements in

[[Page 45149]]

Sec.  35.190(c)(1)(ii), including that candidates must obtain their 
work experience under the supervision of a specified authorized user, 
are also applicable to the board certification pathway.

8. Section 35.290 Training for Imaging and Localization Studies

    Section 35.290(a)(1) provides that in order for a specialty board's 
certification process to be recognized, the board must require all 
candidates for certification to complete 700 hours of training and 
experience ``that includes the topics listed in paragraphs (c)(1)(i) 
and (c)(1)(ii) of this section.'' The intent of the regulation is that 
candidates must obtain their work experience involving the topics 
listed in (c)(1)(ii) under the supervision of a specified authorized 
user. The change of the phrase to ``as described in paragraphs 
(c)(1)(i) through (c)(1)(ii)(G) of this section,'' clarifies that all 
of the requirements in Sec.  35.290(c)(1)(ii), including that 
candidates must obtain their work experience under the supervision of a 
specified authorized user, are also applicable to the board 
certification pathway.

Procedural Background

    This rulemaking will become effective on October 29, 2007. However, 
if the NRC receives significant adverse comments by September 12, 2007, 
then the NRC will publish a document that withdraws the direct final 
rule and will address the comments received in a final rule as a 
response to the companion proposed rule published elsewhere in this 
issue of the Federal Register. Absent significant modifications to the 
proposed revisions requiring republication, the NRC will not initiate a 
second comment period on this action.
    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 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.

Voluntary Consensus Standards

    The National Technology Transfer Act of 1995 (Pub. L. 104-113) 
requires that Federal agencies use technical standards that are 
developed or adopted by voluntary consensus standards bodies unless the 
use of such a standard is inconsistent with applicable law or otherwise 
impractical. In this final rule, the NRC corrects and clarifies the 
rule language in several sections in 10 CFR Parts 32 and 35. This 
action does not constitute the establishment of a standard that 
contains generally applicable requirements.

Issues of Compatibility for Agreement States

    Under the ``Policy Statement on Adequacy and Compatibility of 
Agreement State Programs'' approved by the Commission on June 30, 1997 
(62 FR 46517), specific requirements within this rule should be adopted 
by Agreement States for purposes of compatibility or because of health 
and safety significance. Implementing procedures for the Policy 
Statement establish specific categories which have been applied to 
categorize the requirements in Parts 32 and 35. A Compatibility 
Category ``A'' designation means the requirement is a basic radiation 
protection standard or deals with related definitions, signs, labels, 
or terms necessary for a common understanding of radiation protection 
principles. Compatibility Category ``A'' designated Agreement State 
requirements should be essentially identical to those of the NRC. A 
Compatibility Category ``B'' designation means the requirement has 
significant transboundary implications. Compatibility Category ``B'' 
designated Agreement State requirements should be essentially identical 
to those of the NRC. A Compatibility Category ``C'' designation means 
the essential objectives of the requirement should be adopted by the 
State to avoid conflicts, duplications, or gaps. The manner in which 
the essential objectives are addressed in the Agreement State 
requirement need not be the same as NRC provided the essential 
objectives are met. A Compatibility Category ``D'' designation means 
the requirement does not have to be adopted by an Agreement State for 
purposes of compatibility. The Compatibility Category Health and Safety 
(H&S) identifies requirements that are not required for compatibility, 
but which have particular health and safety significance. Agreement 
States should adopt the essential objectives of such requirements in 
order to maintain an adequate program.

      Summary of NRC Rules With Compatibility or Health and Safety
Designations Under the Direct Final Rule Covering 10 CFR Parts 32 and 35
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    Section and paragraph                    Section title
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                               Category B
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Sec.   32.72(b)(5)...........  Manufacture, preparation, or transfer for
                                commercial distribution of radioactive
                                drugs containing byproduct material for
                                medical use under Part 35.
Sec.   32.74(a)..............  Manufacture and distribution of sources
                                or devices containing byproduct material
                                for medical use.
Sec.   35.190................  Training for uptake, dilution, and
                                excretion studies.
Sec.   35.290................  Training for imaging and localization
                                studies.
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                               Category C
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Sec.   35.75(a)..............  Release of individuals containing
                                unsealed byproduct material or implants
                                containing byproduct material.
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[[Page 45150]]

 
                               Category D
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Sec.   35.2..................  Definitions--Medium dose-rate remote
                                afterloader.
Sec.   35.41(b)(4)...........  Procedures for administrations requiring
                                a written directive.
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                              Category H&S
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Sec.   35.92.................  Decay-in-storage is an ``H&S'' for States
                                authorizing this activity and ``D'' for
                                States that do not authorize this
                                activity.
------------------------------------------------------------------------

Plain Language

    The Presidential Memorandum dated June 1, 1998, entitled, ``Plain 
Language in Government Writing'' directed that the Government's writing 
be in plain language. The NRC requests comments on this direct final 
rule specifically with respect to the clarity and effectiveness of the 
language used. Comments should be sent to the address listed under the 
heading ADDRESSES above.

Environmental Impact: Categorical Exclusion

    The NRC has determined that this final rule is the type of action 
described in the categorical exclusion at 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 direct 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 3150-0001 and 3150-
0010.

Public Protection Notification

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

Regulatory Analysis

    A regulatory analysis has not been prepared for this direct final 
rule because this rule is considered a minor nonsubstantive amendment 
and it has no economic impact on NRC licensees or the public.

Regulatory Flexibility Certification

    Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the 
Commission certifies that this rule does not have a significant 
economic impact on a substantial number of small entities. This rule 
merely corrects or clarifies the rule language in several sections in 
10 CFR parts 32 and 35.

Backfit Analysis

    The NRC has determined that the backfit rule (Sec. Sec.  50.109, 
70.76, 72.62, or 76.76) does not apply to this final rule and 
therefore, a backfit analysis is not required because these amendments 
do not involve any provisions that would impose backfits as defined in 
10 CFR Chapter I.

Congressional Review Act

    Under the Congressional Review 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

10 CFR Part 32

    Byproduct material, Criminal penalties, Labeling, Nuclear 
materials, Radiation protection, Reporting and recordkeeping 
requirements.

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 parts 32 and 35.

PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER 
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL

0
1. The authority citation for part 32 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), Energy Policy Act of 2005, Pub. L. 109-58, 119 
Stat. 594 (2005).

0
2. In Sec.  32.72, paragraph (b)(5) is revised to read as follows:


Sec.  32.72  Manufacture, preparation, or transfer for commercial 
distribution of radioactive drugs containing byproduct material for 
medical use under part 35.

* * * * *
    (b) * * *
    (5) Shall provide to the Commission a copy of each individual's:
    (i)(A) Certification by a specialty board whose certification 
process has been recognized by the Commission or an Agreement State as 
specified in Sec.  35.55(a) of this chapter with the written 
attestation signed by a preceptor as required by Sec.  35.55(b)(2) of 
this chapter; or
    (B) The Commission or Agreement State license; or
    (C) The permit issued by a licensee of broad scope; and
    (ii) State pharmacy licensure or registration, no later than 30 
days after the date that the licensee allows, under paragraphs 
(b)(2)(i) and (b)(2)(iii) of this section, the individual to work as an 
authorized nuclear pharmacist.
* * * * *

0
3. In Sec.  32.74, the introductory text of paragraph (a) is revised to 
read as follows:


Sec.  32.74  Manufacture and distribution of sources or devices 
containing byproduct material for medical use.

    (a) An application for a specific license to manufacture and 
distribute sources and devices containing byproduct material to persons 
licensed under part 35 of this chapter for use as a calibration, 
transmission, or reference source or for the uses listed in Sec. Sec.  
35.400, 35.500, 35.600, and 35.1000 of this chapter will be approved 
if:
* * * * *

[[Page 45151]]

PART 35--MEDICAL USE OF BYPRODUCT MATERIAL

0
4. 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
5. In Sec.  35.2, the definition of Medium dose-rate remote afterloader 
is revised to read as follows:


Sec.  35.2  Definitions.

* * * * *
    Medium dose-rate remote afterloader, as used in this part, means a 
brachytherapy device that remotely delivers a dose rate of greater than 
2 gray (200 rads) per hour, but less than or equal to 12 gray (1200 
rads) per hour at the point or surface where the dose is prescribed.
* * * * *

0
6. In Sec.  35.41, paragraph (b)(4) is revised to read as follows:


Sec.  35.41  Procedures for administrations requiring a written 
directive.

* * * * *
    (b) * * *
    (4) Verifying that any computer-generated dose calculations are 
correctly transferred into the consoles of therapeutic medical units 
authorized by Sec. Sec.  35.600 or 35.1000.
* * * * *

0
7. In Sec.  35.75, the text of paragraph (a) is republished and 
footnote 1 is revised to read as follows:


Sec.  35.75  Release of individuals containing unsealed byproduct 
material or implants containing byproduct material.

    (a) A licensee may authorize the release from its control of any 
individual who has been administered unsealed byproduct material or 
implants containing byproduct material if the total effective dose 
equivalent to any other individual from exposure to the released 
individual is not likely to exceed 5 mSv (0.5 rem).\1\

* * * * *
    \1\ The current revision of NUREG-1556, Vol. 9, ``Consolidated 
Guidance About Materials Licenses: Program-Specific Guidance About 
Medical Licenses'' describes methods for calculating doses to other 
individuals and contains tables of activities not likely to cause 
doses exceeding 5 mSv (0.5 rem).


0
8. In Sec.  35.92, the introductory text of paragraph (a) is revised to 
read as follows:


Sec.  35.92  Decay-in-storage.

    (a) A licensee may hold byproduct material with a physical half-
life of less than or equal to 120 days for decay-in-storage before 
disposal without regard to its radioactivity if it--
* * * * *

0
9. In Sec.  35.190, paragraph (a)(1) is revised to read as follows:


Sec.  35.190  Training for uptake, dilution, and excretion studies.

* * * * *
    (a) * * *
    (1) Complete 60 hours of training and experience in basic 
radionuclide handling techniques and radiation safety applicable to the 
medical use of unsealed byproduct material for uptake, dilution, and 
excretion studies as described in paragraphs (c)(1)(i) through 
(c)(1)(ii)(F) of this section; and
* * * * *

0
10. In Sec.  35.290, paragraph (a)(1) is revised to read as follows:


Sec.  35.290  Training for imaging and localization studies.

* * * * *
    (a) * * *
    (1) Complete 700 hours of training and experience in basic 
radionuclide handling techniques and radiation safety applicable to the 
medical use of unsealed byproduct material for imaging and localization 
studies as described in paragraphs (c)(1)(i) through (c)(1)(ii)(G) of 
this section; and
* * * * *

    Dated at Rockville, Maryland, this 31st day of July, 2007.

    For the Nuclear Regulatory Commission.
Martin J. Virgilio,
Acting Executive Director for Operations.
[FR Doc. 07-3976 Filed 8-10-07; 8:45 am]
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