[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 If the rule is withdrawn due to significant adverse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.
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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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