[Federal Register Volume 79, Number 139 (Monday, July 21, 2014)]
[Proposed Rules]
[Pages 42410-42447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16753]
[[Page 42409]]
Vol. 79
Monday,
No. 139
July 21, 2014
Part III
Nuclear Regulatory Commission
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10 CFR Parts 30, 32, and 35
Medical Use of Byproduct Material--Medical Event Definitions, Training
and Experience, and Clarifying Amendments; Proposed Rule
Federal Register / Vol. 79 , No. 139 / Monday, July 21, 2014 /
Proposed Rules
[[Page 42410]]
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NUCLEAR REGULATORY COMMISSION
10 CFR Parts 30, 32, and 35
[NRC-2008-0175]
RIN 3150-AI63
Medical Use of Byproduct Material--Medical Event Definitions,
Training and Experience, and Clarifying Amendments
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is proposing to
amend its regulations related to the medical use of byproduct material.
In this action the NRC addresses three ongoing rulemaking projects and
several other related topics. First, this rule proposes amendments to
the reporting and notification requirements for a medical event for
permanent implant brachytherapy. Second, the rule proposes changes to
the training and experience (T&E) requirements for authorized users,
medical physicists, Radiation Safety Officers, and nuclear pharmacists;
to the requirements for measuring molybdenum (Mo) contamination and
reporting of failed technetium and rubidium generators; and to allow
Associate Radiation Safety Officers to be named on a medical license.
Third, the rule proposes changes to address a request filed in a
petition for rulemaking (PRM), PRM-35-20, to exempt certain board-
certified individuals from certain T&E requirements (i.e.,
``grandfather'' these individuals) so they may be identified on a
license or permit for materials and uses that they performed on or
before October 24, 2005, the expiration date of the prior T&E
requirements.
DATES: Submit comments by November 18, 2014. Submit comments specific
to the information collections aspects of this proposed rule by August
20, 2014. Comments received after these dates will be considered if it
is practical to do so, but the NRC is able to assure consideration only
for comments received on or before these dates.
ADDRESSES: You may submit comments by any one of the following methods
(unless this document describes a different method for submitting
comments on a specific subject):
Federal rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2008-0175. Address
questions about NRC dockets to Carol Gallagher, telephone: 301-287-
3422, email: [email protected]. For technical questions, contact
the individual listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
Email comments to: [email protected]. If you do
not receive an automatic email reply confirming receipt, then contact
us directly at 301-415-1677.
Fax comments to: Secretary, U.S. Nuclear Regulatory
Commission at 301-415-1101.
Mail comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and
Adjudications Staff.
Hand deliver comments to: 11555 Rockville Pike, Rockville,
Maryland 20852, between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal
workdays; telephone: 301-415-1677.
For additional direction on accessing information and submitting
comments, see ``Obtaining Information and Submitting Comments'' in the
SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Neelam Bhalla, Office of Federal and
State Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-
0978, email: [email protected].
SUPPLEMENTARY INFORMATION:
Executive Summary
A. Need for the Regulatory Action and Legal Authority
The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend
its regulations related to the medical use of byproduct material. These
regulations were last amended in their entirety in 2002. Over the last
12 years, stakeholders and members of the medical community have
identified certain issues in implementing these regulations. As a
result, the NRC is proposing changes to update its regulations to
address technological advances and changes in medical procedures. The
proposed rule would also enhance patient safety. The NRC is proposing
to revise parts 30, 32, and 35 of Title 10 of the Code of Federal
Regulations (10 CFR) under the legal authority granted to the NRC by
the Atomic Energy Act of 1954, as amended; the Energy Reorganization
Act of 1974, as amended; and 5 U.S.C. 552 and 553.
B. Major Provisions
The proposed rule would establish separate requirements
for identifying and reporting medical events (ME) involving permanent
implant brachytherapy programs. These new regulations would require
reporting of an event in which there is actual or potential harm to a
patient resulting from an ME. Additionally, licensees would be required
to develop, implement, and maintain procedures for determining if an ME
has occurred, including, for permanent implant brachytherapy,
procedures for making certain assessments within 60 days from the date
the treatment was performed;
Training and experience requirements would be amended in
multiple sections to remove the requirement to obtain a written
attestation for an individual who is certified by a specialty board
whose certification process has been recognized by the NRC or an
Agreement State. This requirement is being removed because the NRC has
determined that certification by a specialty board, coupled with
meeting the recentness of training requirements, is sufficient to
demonstrate that an individual seeking authorization on a license has
met the training and experience (T&E) requirements and has the
requisite current knowledge and that additional attestation by a
preceptor is therefore unnecessary. Individuals who are not board
certified would still need to obtain a written attestation; however,
the language of the attestation would be modified. Additionally,
residency program directors would be able to provide these written
attestations;
The requirements for measuring the Mo-99 concentration for
elutions of Mo-99m/Tc generators would be changed and reporting
requirements added for failed Mo-99/Tc-99m and strontium-82 (Sr-82)/Rb-
82 generators. The current requirement to measure the Mo-99
concentration after the first eluate would be changed to require that
the Mo-99 concentration be measured in each eluate because of several
incidents reported to the NRC of breakthrough; and
Licensees would be allowed to appoint a qualified
individual with expertise in certain uses of byproduct material to be
named on a license to serve as an Associate Radiation Safety Officer
(ARSO). This would make it easier for an individual to become a
Radiation Safety Officer (RSO) on other medical licenses and would
increase the number of individuals who would be available to serve as
preceptors for individuals seeking to be appointed as RSOs or ARSOs.
Additionally, the proposed rule would address the issues raised in
a petition for rulemaking (PRM-35-20) that was submitted to the NRC in
2006. The petition requested that experienced board-certified RSOs and
medical
[[Page 42411]]
physicists not named on a license who had practiced certain modalities
prior to October 24, 2005, be exempt from the specific T&E requirements
in 10 CFR 35.50 and 35.51, respectively. In effect, they would be
``grandfathered'' for these training requirements for the modalities
that they practiced as of October 24, 2005. This petition is discussed
in detail in Section III, Petition for Rulemaking, PRM-35-20, of this
document.
C. Costs and Benefits
The NRC has not established a quantitative cutoff for defining an
economically significant regulatory action. The NRC assumes
``significant'' impact if the ratio of annualized costs to estimated
annual gross revenues for a licensee exceeds 1 percent. The proposed
rule would have an estimated $8.3 million implementation cost for the
medical community. This cost would be spread over the 7,845 impacted
licensees for an average implementation cost of approximately $1,100
per licensee. The NRC assumes that all affected licensees have annual
revenues greater than $110,000. Therefore, the estimated cost impacts
do not exceed the 1 percent criterion for ``significant'' impacts, and
the proposed rule appears not to be an economically significant
regulatory action. It would cost the NRC approximately $400,000 to
implement this rule.
The benefits of this proposed rule are associated with potentially
reducing unnecessary radiation exposure to patients, potentially
reducing requirements for T&E, and potentially affording more latitude
to licensees. The proposed rule would also update, clarify, and
strengthen the existing regulatory requirements, and thereby promote
public health and safety.
A draft regulatory analysis has been developed for this proposed
rulemaking and is available for public comment (see Section XVI,
Regulatory Analysis, of this document).
Table of Contents
I. Obtaining Information and Submitting Comments
II. Background
III. Petition for Rulemaking, PRM-35-20
IV. Discussion
A. What action is the NRC proposing to take?
B. When would these actions become effective?
C. Are there any cumulative effects of regulation associated
with this rule?
D. Is the NRC requesting comments on other specific issues?
E. What should I consider as I prepare my comments to the NRC?
V. Discussion of Proposed Amendments by Section
VI. Criminal Penalties
VII. Coordination With NRC Agreement States
VIII. Agreement State Compatibility
IX. Coordination With the Advisory Committee on the Medical Uses of
Isotopes
X. Plain Writing
XI. Consistency With Medical Policy Statement
XII. Voluntary Consensus Standards
XIII. Environmental Impact: Categorical Exclusion
XIV. Finding of No Significant Environmental Impact: Availability
XV. Paperwork Reduction Act Statement
XVI. Regulatory Analysis
XVII. Regulatory Flexibility Certification
XVIII. Backfitting and Issue Finality
I. Obtaining Information and Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC-2008-0175 when contacting the NRC
about the availability of information for this proposed rule. You may
access publicly-available information related to this proposed rule by
any of the following methods:
Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2008-0175.
NRC's Agencywide Documents Access and Management System
(ADAMS):
You may access publicly-available documents online in the ADAMS Public
Documents collection at http://www.nrc.gov/reading-rm/adams.html. To
begin the search, select ``ADAMS Public Documents'' and then select
``Begin Web-based ADAMS Search.'' For problems with ADAMS, please
contact the NRC's Public Document Room (PDR) reference staff at 1-800-
397-4209, 301-415-4737, or by email to [email protected]. The ADAMS
accession number for each document referenced in this document (if that
document is available in ADAMS) is provided the first time that a
document is referenced.
NRC's PDR: You may examine and purchase copies of public
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852.
B. Submitting Comments
Please include Docket ID NRC-2008-0175 in the subject line of your
comment submission, to ensure that the NRC is able to make your comment
submission available to the public in this docket.
The NRC cautions you not to include identifying or contact
information that you do not want to be publicly disclosed in your
comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into
ADAMS. The NRC does not routinely edit comment submissions to remove
identifying or contact information.
If you are requesting or aggregating comments from other persons
for submission to the NRC, then you should inform those persons not to
include identifying or contact information that they do not want to be
publicly disclosed in their comment submission. Your request should
state that the NRC does not routinely edit comment submissions to
remove such information before making the comment submissions available
to the public or entering the comment submissions into ADAMS.
II. Background
The NRC published a final rule in the Federal Register on April 24,
2002 (67 FR 20250), that revised the medical use regulations in part 35
of Title 10 of the Code of Federal Regulations (10 CFR) in their
entirety. The training and experience (T&E) requirements in 10 CFR part
35 were further revised through an additional rulemaking, ``Medical Use
of Byproduct Material--Recognition of Specialty Boards,'' published in
the Federal Register on March 30, 2005 (70 FR 16336).
In implementing the current regulations in 10 CFR part 35, the NRC
staff, stakeholders, and the Advisory Committee on the Medical Uses of
Isotopes (ACMUI) have identified numerous issues that need to be
addressed through the rulemaking process.
As a result, the NRC is proposing to amend its regulations in 10
CFR part 35 to address these issues. The proposed rule would modify the
written directive (WD) requirements in 10 CFR 35.40 and the medical
event (ME) reporting in 10 CFR 35.3045 to establish separate ME
reporting criteria for permanent implant brachytherapy. The proposed
rule would accordingly also modify the requirements for procedures for
administrations requiring a WD in 10 CFR 35.41 to require licensees to
develop written procedures for determining if an ME has occurred as a
result of any administrations requiring a WD, including permanent
implant brachytherapy.
Currently, the ME criteria for brachytherapy implants in 10 CFR
35.3045, ``Report and Notification of a Medical Event,'' are based on
the dose administered to the patient. The proposed amendment would
establish separate ME criteria for permanent implant brachytherapy in
terms of the
[[Page 42412]]
total source strength administered (activity-based) rather than the
dose delivered (dose-based). The ME criteria would also include
absorbed doses to normal tissues located outside of the treatment site
as well as within the treatment site. The proposed amendments are based
on the staff recommendations contained in SECY-12-0053,
``Recommendations on Regulatory Changes for Permanent Implant
Brachytherapy Programs'' (ADAMS Accession No. ML12072A306).
The NRC previously published a proposed rule, ``Medical Use of
Byproduct Material--Amendments/Medical Event Definitions,'' to revise
ME definitions for permanent implant brachytherapy in the Federal
Register on August 6, 2008 (73 FR 45635), for public comment. The
majority of commenters were in agreement to convert the ME criteria
from dose-based to activity-based. However, during late summer and
early fall of 2008, a substantial number of MEs involving permanent
implant brachytherapy were reported to the NRC. Based on the
circumstances involving the MEs reported in 2008, the staff re-
evaluated the previously published proposed rule and developed a
reproposed rule.
In SECY-10-0062, ``Reproposed Rule: Medical Use of Byproduct
Material--Amendments/Medical Event Definitions,'' dated May 18, 2010
(ADAMS Accession No. ML100890121), the staff requested the Commission
to approve for publication the revised proposed rule for public
comment. Prior to Commission voting on the reproposed rule, a
Commission briefing was held on the reproposed rule on July 8, 2010
(ADAMS Package Accession No. ML101930532). The presenters included a
member of the ACMUI, a representative from the Organization of
Agreement States (OAS), a physician from the American Brachytherapy
Society, the National Director of the Radiation Oncology Program of the
Department of Veterans Affairs, a representative from the American
Association of Physicists in Medicine (AAPM), and a representative from
Us-TOO (a support group for prostate cancer patients). The presenters
urged the Commission not to publish the reproposed rule as developed.
They believed that MEs should be based on events of potential clinical
significance and recommended that the NRC seek stakeholder input in
revising this rule.
In Staff Requirements Memorandum (SRM) SECY-10-0062, dated August
10, 2010 (ADAMS Accession No. ML102220233), the Commission disapproved
the staff's recommendation to publish the reproposed rule and directed
the staff to work closely with the ACMUI and the broader medical and
stakeholder community to develop ME definitions that would protect the
interests of patients and allow physicians the flexibility to take
actions that they deem medically necessary, while continuing to enable
the agency to detect failures in process, procedure, and training, as
well as any misapplication of byproduct materials by AUs. The NRC is
addressing the issues in the reproposed rule (RIN 3150-AI26) in this
proposed rulemaking; for more information, including public comments
submitted on the earlier rule, see Docket ID NRC-2008-0071 on
www.regulations.gov. The SRM also directed the staff to hold a series
of stakeholder workshops to discuss issues associated with the ME
definition.
Following Commission direction, the NRC conducted two workshops in
the summer of 2011. These facilitated workshops were held in New York,
New York, in June 2011 (ADAMS Accession No. ML111930470), and in
Houston, Texas, in August 2011 (ADAMS Accession No. ML112900094). The
NRC staff also requested the ACMUI to prepare a report on ME
definitions for permanent implant brachytherapy. In February 2012, the
ACMUI submitted its final revised report to the NRC (ADAMS Accession No
ML12038A279). The staff used the recommendations in the ACMUI revised
final report, along with the substantial input from stakeholders, to
develop the recommendations in SECY-12-0053, which provided the
regulatory basis for the ME definitions in this proposed rule.
In addition to revising the ME definitions for permanent implant
brachytherapy, the NRC is proposing to amend its regulations in 10 CFR
part 35 to revise the preceptor attestation requirements, require
increased frequency of testing for measuring Mo-99 concentration in a
Mo-99/Tc-99m generator, require reporting of failed tests of a Mo-99/
Tc-99m generator and failed strontium-82 (Sr-82) and strontium-85 (Sr-
85) tests of a Rb-82 generator, allow ARSOs to be named on a medical
use license, extend the 5-year inspection frequency for a gamma
stereotactic radiosurgery unit to 7 years, and to make several
clarifying amendments.
Finally, the proposed rule would address issues that were raised in
PRM-35-20 (ADAMS Accession No. ML062620129) filed by E. Russell
Ritenour, Ph.D., on behalf of the AAPM on September 13, 2006. The
petition requested that the training requirements for experienced RSOs
and medical physicists in 10 CFR 35.57 be amended to recognize board
certified physicists and RSOs as ``grandfathered'' for the modalities
that they practiced as of October 24, 2005. The following section
discusses the petition in detail.
III. Petition for Rulemaking, PRM-35-20
The NRC has incorporated into this proposed rulemaking the
resolution of PRM-35-20 filed by E. Russell Ritenour, Ph.D. (the
petitioner), dated September 10, 2006, on behalf of the AAPM. A notice
of receipt and request for comments on this petition was published in
the Federal Register on November 1, 2006 (71 FR 64168).
The petitioner requested that 10 CFR 35.57, ``Training for
experienced Radiation Safety Officer, teletherapy or medical physicist,
authorized medical physicist, authorized user, nuclear pharmacist, and
authorized nuclear pharmacist,'' be revised to: (1) Recognize medical
physicists certified by either the American Board of Radiology or the
American Board of Medical Physics on or before October 24, 2005, as
``grandfathered'' for the modalities that they practiced as of October
24, 2005, independent of whether or not a medical physicist was named
on an NRC or an Agreement State license as of October 24, 2005; and (2)
recognize all diplomates certified by the named boards in former
subpart J of 10 CFR part 35, which was removed from 10 CFR part 35 in a
rulemaking dated March 30, 2005 (70 FR 16336), as RSOs who have
relevant timely work experience (even if they have not been formally
named as an RSO). The petitioner requested that experienced board-
certified RSOs and medical physicists not named on a license who had
practiced certain modalities prior to October 24, 2005, be exempted
from the specific T&E requirements in 10 CFR 35.50, and 35.51,
respectively. In effect, they would be ``grandfathered'' for these
training requirements for the modalities that they practiced as of
October 24, 2005. The petitioner was concerned that as a result of the
amendments to the T&E regulations in 2005, an individual could become
authorized on a license only if he or she had been certified by a
specialty board whose certification process was recognized under the
new regulations by the NRC or an Agreement State or was already
identified on an existing NRC or Agreement State license. If the
individual had been certified prior to the effective date for
recognition of the certifying board but had not been listed on a
license, he or she would not be ``grandfathered,'' and would have to
obtain training through
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the so-called ``alternate pathway,'' which establishes the specific
training requirements for the non-certified individuals. The petitioner
did not believe that it was the intent of the Commission to deny
recognition to individuals currently practicing or to minimize the
importance of certification by a certifying board. The NRC received 168
comments from professional organizations and individuals on the
petition. The majority of the commenters supported the petition.
The NRC reviewed the petitioner's request and comments received on
the petition and concluded that revisions made to the regulations in
2005 may have inadvertently affected a group of board certified
professionals insofar as they may now have to use the alternate pathway
option to demonstrate that they meet the T&E requirements in 10 CFR
part 35 rather than the certification pathway for recognition on an NRC
license as an RSO or an authorized medical physicist (AMP) (73 FR
27773; May 14, 2008). Therefore, the NRC concluded that the issues
raised in the petition would be considered in the rulemaking process if
a regulatory basis could be developed to support a rulemaking.
In October 2008, the NRC staff sent letters to all of the
certifying boards whose certification processes are currently
recognized by the NRC and to certifying boards previously named in the
former 10 CFR part 35, subpart J, whose certification processes
currently are not recognized by the NRC. To determine the scope of the
medical community that might be negatively impacted by the T&E
grandfathering provisions of the regulations, the NRC asked each
organization to provide the number and percentage of its currently
active diplomates who are not grandfathered under 10 CFR 35.57 by
virtue of not being named on a license or permit. The organizations
were asked to include individuals who are now or may in the future be
seeking to be named as an RSO, AMP, AU, or authorized nuclear
pharmacist (ANP) on an NRC or an Agreement State medical use license.
Based on the responses, the NRC estimates that as many as 10,000 board
certified individuals may have been affected by the 2005 T&E
rulemaking.
Accordingly, the NRC believes that these individuals should be
eligible for grandfathering for the modalities that they practiced as
of October 24, 2005, and that their previously-acceptable
qualifications for authorized status should continue to be adequate and
acceptable from a health and safety standpoint such as to allow them to
continue to practice using the same modalities. This proposed rule, in
response to the petition, would amend Sec. 35.57 to recognize all
individuals that were previously certified by boards recognized under
the previous 10 CFR part 35, subpart J, as RSOs, teletherapy or medical
physicists, AMPs, AUs, nuclear pharmacists, and ANPs for the modalities
that they practiced as of October 24, 2005.
The petitioner, in his support for ``grandfathering'' the RSOs who
have relevant work experience and were not formally named on an NRC or
an Agreement State license or permit as an RSO, stated that these
individuals will be required to provide preceptor attestations. In this
proposed rulemaking, the NRC would eliminate the requirement for
preceptor attestations for all individuals certified by NRC recognized
boards. The NRC believes that attestations are not necessary in this
particular situation because the provisions of Sec. 35.59,
``Recentness of training,'' require that the T&E must have been
obtained within the 7 years preceding the date of application, or the
individual must have had related continuing education and experience
since the required T&E was completed. The ``grandfathered'' individuals
would fall under the provisions of Sec. 35.59 and would need to
provide evidence of continued education and experience. Therefore, the
NRC believes that preceptor attestations are not warranted for these
``grandfathered'' individuals so long as the provisions of Sec. 35.59
are met and the individual requests authorizations only for the
modalities the individual practiced as of October 24, 2005.
IV. Discussion
A. What action is the NRC proposing to take?
In implementing the current regulations in 10 CFR part 35, the NRC
staff, stakeholders, and the ACMUI identified numerous issues that need
to be addressed through the rulemaking process. The proposed revisions
would clarify the current regulations, and provide greater flexibility
to licensees without compromising patient, worker, and public health
and safety. The proposed amendments include:
a. Adding separate ME definitions for permanent implant
brachytherapy.
b. Amending preceptor attestation requirements.
c. ``Grandfathering'' certain board-certified individuals (PRM-35-
20) discussed in Section III, Petition for Rulemaking, PRM-35-20, of
this document.
d. Requiring increased frequency of testing to measure Mo-99
breakthrough.
e. Requiring reporting and notification of failed Mo-99/Tc-99m and
Sr-82/Rb-82 generators.
f. Allowing ARSOs to be named on a medical use license.
g. Additional issues and clarifications.
Early public input on this proposed rule was solicited through
various mechanisms. For certain amendments the NRC posted preliminary
draft rule text (ADAMS Accession No. ML111390420) for a 75-day comment
period on www.regulations.gov. The availability of the draft rule
language was noticed in the Federal Register on May 20, 2011 (76 FR
29171). The NRC received 10 comment letters, which are also posted on
www.regulations.gov under Docket ID NRC-2008-0175. The NRC staff
reviewed the comments and considered them in developing the proposed
rule text.
The proposed amendments and preliminary draft rule text were also
discussed at the two transcribed facilitated public workshops that were
conducted in New York City, New York, on June 20-21, 2011, and in
Houston, Texas, on August 11-12, 2011. The purpose of the workshops was
to solicit key stakeholder input on topics associated with definition
of an ME, including the requirements for reporting and notifications of
MEs for permanent implant brachytherapy, and on other medical issues
that are being considered in the proposed rulemaking. These workshops
were initiated as a result of the Commission's direction to staff in
SRM-SECY-10-0062 to work closely with the ACMUI and the medical
community to develop event definitions that would protect the interests
of patients. The Commission also directed that these definitions should
allow physicians the flexibility to take actions that they deem
medically necessary, while preserving the NRC's ability to detect
misapplications of radioactive material and failures in processes,
procedures, and training. The panelists for the workshops included
representation from the ACMUI, Agreement States, professional
societies, and a patients' rights advocate.
The major proposed revisions are:
a. Adding Separate ME Definitions for Permanent Implant Brachytherapy
The proposed rule would establish separate ME definitions and
reporting requirements for permanent implant brachytherapy programs. As
explained in Section II, Background, of this document, the proposed
amendments are based on the recommendations developed in close
cooperation with the
[[Page 42414]]
ACMUI, as well as with substantial input from various stakeholders.
During its meeting in March 2004, the ACMUI recognized the existing
inadequacy of defining MEs with regard to permanent implant
brachytherapy. The ACMUI explained that for these implants, the plus or
minus 20 percent variance from the prescription criterion in the
existing rule was only appropriate if both the prescription and the
variance could be expressed in units of activity, rather than in units
of dose, as there is no suitable clinically used dose metric available
for judging the occurrence of MEs. In June 2005, the ACMUI recommended
that new language should be developed to define MEs related to
permanent implant brachytherapy.
In SECY-05-0234, ``Adequacy of Medical Event Definitions in 10 CFR
35.3045, and Communicating Associated Risks to the Public,'' dated
December 27, 2005 (ADAMS Accession No. ML053180408), based on
recommendations received from the ACMUI, the staff recommended that for
permanent implant brachytherapy the Commission approve the staff's plan
to revise the ME definitions and the associated requirements for WDs to
be activity-based, instead of dose-based. In SRM-SECY-05-0234, dated
February 15, 2006 (ADAMS Accession No. ML060460594), the Commission
directed the staff to proceed directly with the development of a
proposed rule to modify both the WD requirements in 10 CFR 35.40(b)(6)
and the ME reporting requirements in 10 CFR 35.3045 for permanent
implant brachytherapy medical use, to convert from dose-based to
activity-based ME criteria.
As discussed in Section II, Background, of this document, a
proposed rule was published in the Federal Register on August 6, 2008
(73 FR 45635). Due to the substantial number of MEs reported in 2008,
the staff submitted a reproposed rule to the Commission for
consideration in May of 2010. However, the Commission disapproved the
staff's recommendations and directed the staff to work closely with the
ACMUI and the broader medical and stakeholder community to develop ME
definitions and to hold a series of stakeholder workshops to discuss
issues associated with the MEs.
The ACMUI Permanent Implant Brachytherapy Subcommittee (PIBS)
issued a report, with recommendations, which was unanimously approved
by the ACMUI at its October 20, 2010, meeting (ADAMS Accession No.
ML103540385). The PIBS report included the caveat that it was to be
considered an interim report and that it might be revised in response
to additional stakeholder input. The ACMUI meeting in April 2011 was
devoted to issues associated with the ME definition. The meeting was
webcast, providing an opportunity for further public involvement on
this issue.
The ACMUI final report (ADAMS Accession No. ML11292A139), which
revised the earlier interim report on prostate brachytherapy
regulation, was provided to the NRC following the ACMUI October 18,
2011, teleconference public meeting. The final report reflected the
principal positions and recommendations provided by participants during
the NRC public workshops; in particular, the report included the
recommendation to change from dose-based ME criteria for the treatment
site to source-strength based criteria. The final report included a
quantitative metric, the ``octant approach,'' for determining that a
distribution of implanted sources was irregular enough (i.e.,
demonstrating ``bunching'') to consider the procedure as an ME. The
final report also included a dose-related ME criterion for the
treatment site.
However, in a letter to the Chairman of the ACMUI dated November
30, 2011 (ADAMS Accession No. ML11341A051), the American Society for
Radiation Oncology (ASTRO) expressed criticism of the ACMUI final
report. The ASTRO considered the ME definition recommended by the ACMUI
to be complex, difficult to regulate, and likely to cause confusion in
practice. Consequently, a revised final report (ADAMS Accession No.
ML12038A279) that simplified the ME criteria for the treatment site,
and removed the ``octant approach'' and direct reference to absorbed
dose, was issued by the PIBS. The revised final report was, with minor
modification, approved by the ACMUI during its February 7, 2012,
teleconference public meeting and was subsequently, in a letter to the
Chairman of the ACMUI (ADAMS Accession No. ML12044A358), characterized
as an improvement by ASTRO.
The staff used the recommendations in the ACMUI revised final
report, along with the substantial input from stakeholders gathered in
the two facilitated public workshops and the three ACMUI public
meetings in 2011 and early 2012, to develop the recommendations
conveyed to the Commission on April 6, 2012, in SECY-12-0053. In a
Commission meeting held April 24, 2012 (ADAMS Accession No.
ML12116A294), participating representatives from ACMUI, ASTRO, and
American Brachytherapy Society (ABS) endorsed the recommendations for
modification of the requirements in 10 CFR 35.40 and 35.3045 that are
contained in SECY-12-0053. The NRC notes that ASTRO and ABS
representatives suggested eliminating the criterion for ME reporting,
which requires reporting of excessive dose to normal tissue structures
within the treatment site. However, this ACMUI-recommended ME reporting
criterion for normal tissue structures located within the treatment
site was retained in SECY-12-0053 because ACMUI and the staff
determined there needs to be some form of ME reporting criterion for
overdosing of normal tissue structures located within the treatment
site.
The ACMUI recommendations, as approved by the Commission in SRM-
SECY-12-0053, ``Recommendations on Regulatory Changes for Permanent
Implant Brachytherapy Programs'' (ADAMS Accession No. ML122260211), are
applicable to all permanent implant brachytherapy procedures using
radioactive sources for all treatment sites.
Consistent with the ACMUI recommendations, all of the proposed ME
criteria reflect circumstances in which there is actual or potential
harm to a patient resulting from an ME. The proposed ME criteria are
primarily source-strength based for the treatment site, and dose-based
for the absorbed dose to normal tissues. The proposed ME criteria for
permanent implant brachytherapy are:
(1) For the treatment site (documented in the pre-implantation
portion of the WD), an ME has occurred if 20 percent or more of the
implanted sources documented in the post-implantation portion of the WD
are located outside of the intended implant location.
In supporting this recommendation, the NRC believes that source
strength/positioning is the measurable metric/surrogate for dose, as
related to harm/potential harm for permanent brachytherapy implant MEs.
The 20 percent variance limit (from physician intention) is consistent
with the recommendation of the ACMUI for all medical uses of byproduct
material as described in SECY-05-0234.
(2) For normal-tissue structures, an ME has occurred if: (a) For
structures located outside of the treatment site (for example the
bladder or rectum for prostate implant treatments), the dose to the
maximally exposed 5 contiguous cubic centimeters of tissue exceeds 150
percent of the absorbed dose prescribed to the treatment site in the
pre-implantation portion of the WD; or (b) for intra-target normal
structures, the
[[Page 42415]]
maximum absorbed dose to any 5 contiguous cubic centimeters of tissue
exceeds 150 percent of the dose the tissue would have received based on
the approved pre-implant dose distribution.
The size of the normal tissue, 5 cubic centimeters, is based on
ACMUI's recommendation in its report. In its recommendation, the ACMUI
stated that the 5 contiguous cubic centimeters dose-volume
specification avoids the high variation in dose sometimes seen in point
doses and has cited literature to support that as being a relevant
quantity for toxicity. In this proposed rule, the NRC is specifically
inviting comments on the selection of the specified volume of the
normal tissues located both outside and within the treatment site in
defining MEs.
The proposed rule specifies that these dose determinations must be
made within 60 days from the date the treatment was administered unless
accompanied by written justification about patient unavailability after
treatment. The NRC believes that 60 days provides adequate time to make
implanted source location and dose assessments to determine if an ME
has occurred. The AAPM, in its Task Group Report 137, entitled, ``AAPM
recommendations on dose prescription and reporting methods for
permanent interstitial brachytherapy for prostate cancer,'' recommends
that post-implant dosimetry for iodine-125 implants should be performed
at 1 month (plus or minus 1 week) after the procedure. For palladium-
103 and cesium-131 implants, it recommends that post-implant dosimetry
be performed at 16 (plus or minus 4) days and 10 (plus or minus 2)
days, respectively. The 60-day time limit is also consistent with the
ACMUI recommendation. The NRC recognizes that some patients may not be
able to return to the treatment center for the dose assessment, and the
proposed rule addresses that concern by adding ``unless accompanied by
written justification about patient unavailability.''
Because of this dose-based ME criterion for organs and tissues
other than the treatment site, there is an implicit operational
requirement for post-implant imaging, as strongly recommended during
the public workshops and as practiced in most clinical facilities.
(3) An ME has occurred if a treatment involves: (a) Using the wrong
radionuclide; (b) delivery to the wrong patient or human research
subject; (c) source(s) implanted directly into the wrong site or body
part, i.e., not in the treatment site identified in the WD; (d) using
leaking sources; or (e) a 20 percent or more error in calculating the
total source strength documented in the pre-implantation WD (plus or
minus 20 percent is used for the ME threshold for source strength
variance because plus or minus 10 percent is considered too close to
the actual variance associated with this quantity in clinically
acceptable implant procedures).
The proposed criterion related to sources implanted directly into
the wrong site or body part (i.e., not in the treatment site identified
in the WD) directly reflects an ACMUI recommendation. Note that the
proposed criterion would require that even a single sealed source
directly delivered to the wrong treatment site would constitute an ME
that must be reported. However, this proposed criterion is not more
restrictive than the current regulation, which requires reporting of a
dose of 0.5 sievert (50 rem) to an organ or tissue, since the localized
dose associated with even one misplaced source would far exceed the
current 0.5 sievert (50 rem) dose threshold.
The current WD requirements for manual brachytherapy in Sec.
35.40(b)(6) primarily reflect requirements associated with temporary
implant brachytherapy medical use. The WD requirements in Sec. 35.40
would be amended to establish separate WD requirements appropriate for
permanent implant brachytherapy. The WD for permanent implant
brachytherapy would consist of two portions: The first portion of the
WD would be prepared before the implantation, and the second portion of
the WD would be completed after the procedure, but before the patient
leaves the post-treatment recovery area. For permanent implant
brachytherapy, the WD portion prepared before the implantation would
require documentation of the treatment site, the radionuclide, the
intended absorbed dose to the treatment site, and the corresponding
calculated source strength to deliver that dose. If the treatment site
has normal tissues located within it, the WD would also allow
documentation of the expected absorbed dose to normal tissue as
determined by the AU. The post-implantation portion of the WD would
require the documentation of the number of sources implanted, the total
source strength implanted, the signature of an AU for Sec. 35.400 uses
for manual brachytherapy, and the date. It would not require the
documentation of dose to the treatment site.
Based on ACMUI input and information gained at public workshops,
the NRC understands that the final WD documentation related to these
Sec. 35.40 permanent implants must reflect the medical situation
encountered during the surgical procedure. Therefore, in defining an ME
involving the treatment site for permanent implants, the NRC based the
criterion for an ME on the percentage of implanted sources that are
outside the treatment site as documented in the post-implantation
portion of the WD rather than defining an ME based on a comparison of
the implanted total source strength to the calculated total source
strength documented in the pre-implantation portion of the WD. This
proposed definition differs from the ME definition for all other
brachytherapy procedures where the dose comparisons are made with what
was prescribed in the WD prepared/revised before the procedure.
Conforming changes would be made to Sec. 35.41, ``Procedures for
administrations requiring a written directive,'' to include permanent
implant brachytherapy. Although the current Sec. 35.41(a)(2) requires
licensees to determine if the administration is in accordance with the
written directive, there is no specific requirement that a licensee
determine that an administered dose or dosage has met an ME criterion
defined in Sec. 35.3045. The ME reporting criteria are defined in
Sec. 35.3045, but the current regulations do not require that a
licensee have procedures to make that determination. Section 35.41
would be amended to require that a licensee include procedures for
determining if an ME has occurred. For all permanent implant
brachytherapy, this section would also be amended to require that a
licensee develop additional procedures to include an evaluation of the
placement of sources as documented in the completion portion of the WD,
dose assessments to maximally exposed 5 contiguous cubic centimeters of
normal tissue located both inside and outside of the treatment site,
and to include that these assessments be made within 60 days from the
date the treatment was performed.
Currently Sec. 35.3045, Report and notification of a medical
event, is designated as Compatibility Category C for the Agreement
States. Input provided at the public meetings conducted in New York
City, New York, on June 20-21, 2011, and in Houston, Texas, on August
11-12, 2011, and from the ACMUI prompted the NRC to revisit
compatibility category. The Commission, after considering the issue, is
proposing that the compatibility for reporting MEs for the Agreement
States be designated as a Compatibility Category B.
Additional information on Agreement State compatibility
designations can be
[[Page 42416]]
found in Section VIII, Agreement State Compatibility, of this document.
b. Amending Preceptor Attestation Requirements
The current regulations in 10 CFR part 35 provide three pathways
for individuals to satisfy T&E requirements to be approved as an RSO,
AMP, ANP, or AU. These pathways are: (1) Approval of an individual who
is certified by a specialty board whose certification process has been
recognized by the NRC or an Agreement State (certification pathway);
(2) approval based on an evaluation of an individual's T&E (alternate
pathway); or (3) identification of an individual's approval on an
existing NRC or Agreement State license.
Under both the certification and the alternate pathway, an
individual seeking authorization for medical byproduct material must
obtain written attestation signed by a preceptor with the same
authorization. The attestation must state that the individual has
satisfactorily completed the necessary T&E requirements and has
achieved a level of competency sufficient to function independently in
the position for which authorization is sought.
During a briefing held on April 29, 2008 (ADAMS Accession No.
ML12116A294), with the Commission, the ACMUI recommended that the
attestation requirements be revised. The ACMUI expressed concern that
the existing requirements have had unintended consequences that, if not
corrected, would impact the availability of authorized individuals;
i.e., there would likely be a shortage of authorized individuals to
provide medical care as a result of the reluctance of preceptors to
sign attestations. The ACMUI recommended that attestations be
eliminated for the board certification pathway. In the ACMUI's view, by
meeting the board requirements, a curriculum and a body of knowledge
can be defined, and progress toward meeting defined requirements can be
measured. Further, the ACMUI asserted that a board certification
indicates that the T&E requirements have been met, and the Maintenance
of Certification provides ongoing evidence of current knowledge.
Therefore, the ACMUI argued that an additional attestation for the
board certified individuals was not needed.
The ACMUI also recommended that the attestation requirements
associated with the alternate pathways be modified to delete the
requirement for an attestation of an individual's radiation safety-
related competency being sufficient to function independently as an
authorized person for the medical uses being requested. The reason for
the recommendation was that the ACMUI believed that signing an
attestation of competence results in a perceived risk of personal
liability on the part of the individual signing the attestation and
that preceptors are reluctant to accept this risk.
In addition, the ACMUI recommended that the attestation submitted
under the alternate pathway be considered acceptable if provided by a
residency program director representing a consensus of an authoritative
group, irrespective of whether the program director personally met the
requirements for authorized user status. The ACMUI advised that
training of residents is a collective process and entails the
collective judgment of an entire residency program faculty, whereas
preceptor attestation is an individual process, and an individual
preceptor typically would provide only a small portion of the T&E.
Following the April 29, 2008, meeting of the ACMUI, in an SRM dated
May 15, 2008 (ADAMS Accession No. ML081360319), the Commission directed
the staff to work with the ACMUI and the Agreement States to provide
recommendations to the Commission with regard to amending the NRC's
requirements for preceptor attestation for both board certified
individuals and for individuals seeking authorization via the alternate
pathway. The staff was also directed to consider additional methods,
such as the attestation being provided by consensus of an authoritative
group.
Following both consideration of the position of the ACMUI, which
the staff determined was clear and consistent with its long-held
position on this issue, and interactions with regional NRC staff and
the Agreement States, the staff provided its recommendations on this
issue to the Commission on November 20, 2008, in SECY-08-0179,
``Recommendations on Amending Preceptor Attestation Requirements in 10
CFR part 35, Medical Use of Byproduct Material'' (ADAMS Accession No.
ML083170176). The staff recommended that the Commission approve
development of the following modifications to the 10 CFR part 35
attestation requirements: (1) Eliminate the attestation requirement for
individuals seeking authorized status via the board certification
pathway; (2) retain the attestation requirement for individuals seeking
authorized status via the alternate pathways; however, replace the text
stating that the attestation demonstrates that the individual ``has
achieved a level of competency to function independently'' with
alternative text such as ``has demonstrated the ability to function
independently'' to fulfill the radiation safety-related duties required
by the license; and (3) accept attestations from residency program
directors, representing consensus of residency program faculties as
long as at least one member of the residency program faculty is an
authorized individual in the same category as that requested by the
applicant seeking authorized status.
In an SRM dated January 16, 2009, to SECY-08-0179 (ADAMS Accession
No. ML090160275), the Commission approved these recommendations and
directed the staff to develop the proposed rule language for the
attestation requirements for the alternate pathway in concert with the
ACMUI and the Agreement States.
The proposed changes to remove the attestation requirement for
board certified individuals were broadly supported during the public
workshops conducted in the summer of 2011. The panelists (which
included members of the ACMUI and the Agreement States) at the
workshops recommended that the NRC should remove the requirement for
attestation for board certified individuals. They believed that board
certification coupled with the recentness of training requirements
should be sufficient for the regulator's needs. With regard to the
language of attestation (for the alternate pathway), they believed that
the preceptors should not be attesting to someone's competency; rather,
they should be attesting to the individual's T&E necessary to carry out
one's responsibility independently. At the April 2011 ACMUI meeting,
the ACMUI advised that the attestation language should be revised to
say that the individual has received the requisite T&E to fulfill the
radiation safety-related duties required by the license. The proposed
rule language reflects this approach.
The proposed rule would amend T&E requirements in multiple sections
of 10 CFR part 35 with regard to the attestation requirements in
accordance with the staff's recommendations in SECY-08-0179.
c. Extending Grandfathering to Certain Certified Individuals (PRM-35-
20)
The petition is discussed in Section III, Petition for Rulemaking
(PRM-35-20), of this document.
[[Page 42417]]
d. Requiring Increased Frequency of Testing To Measure Mo-99
Breakthrough
Current regulations in Sec. 35.204(a) prohibit a licensee from
administering a radiopharmaceutical to humans that exceeds 0.15
microcuries of Mo-99 per millicurie of Tc99m. Section 35.204(b)
requires that a licensee that uses Mo-99/Tc-99m generators for
preparing a Tc-99m radiopharmaceutical measure the Mo-99 concentration
of the first eluate to demonstrate compliance with the specified
concentrations; however a generator can be eluted several times to
obtain Tc-99m for formulating radiopharmaceuticals for patient use.
The Mo-99 breakthrough, which exceeds the permissible concentration
listed in Sec. 35.204(a), may cause unnecessary radiation exposures to
patients. The administration of higher levels of Mo-99 could
potentially affect health and safety, as well as have an adverse effect
on nuclear medicine image quality and medical diagnosis.
Generator manufacturers have always recommended testing each
elution prior to use in humans. Before 2002, Sec. 35.204 required a
licensee to measure the Mo-99 concentration of each eluate. However,
the NRC revised Sec. 35.204 in April 2002 because the medical and
pharmaceutical community considered frequency of Mo breakthrough to be
a rare event. Therefore, the Commission decided that measuring only the
first elution was necessary to detect manufacturing issues or
generators that may have been damaged in transport.
From October 2006 to February 2007, and again in January 2008,
medical licensees reported to the NRC that numerous generators had
failed the Mo-99 breakthrough tests. Some licensees reported the failed
tests in the first elution, while some reported an acceptable first
elution but failed subsequent elutions. One generator manufacturer
voluntarily reported 116 total elution test failures in 2008. Based
upon the numerous reports of failed Mo-99 breakthrough measurements
noted in the subsequent elutions, the NRC proposes to amend Sec.
35.204 to return to the pre-2002 performance standard, which required
licensees to measure the Mo-99 concentration for each elution of the
Mo-99/Tc-99m generator.
e. Requiring Reporting and Notification of Failed Mo-99/Tc-99m and Sr-
82/Rb-82 Generators
The regulations do not currently require reporting to the NRC when
an elution from a Mo-99/Tc-99m or Sr-82/Rb-82 generator exceeds the
regulatory limit in Sec. 35.204(a). As discussed in this section,
eluates from generators for making Tc-99m radioactive drugs exceeded
the permissible concentration listed in Sec. 35.204(a) on numerous
occasions in 2006, 2007, and 2008. Additionally, in 2011, contamination
issues with Sr-82/Rb-82 generators were discovered when several
individuals were identified with unexpected levels of Sr-82 and Sr-85.
These individuals had undergone Rb-82 chloride cardiac scanning
procedures several months before and had received these radionuclides
in levels greatly in excess of the administration levels permitted in
Sec. 35.204 for Sr-82/Rb-82 generators. Further investigations showed
that at least 90 individuals at one facility and 25 at another facility
received levels of Sr-82 or Sr-85 that exceeded the levels permitted in
Sec. 35.204. Of these patients, at least three had levels of Sr-82 and
Sr-85 high enough to result in reportable MEs as defined in Sec.
35.3045.
Because the reporting of a failed generator is voluntary, the NRC
had difficulty determining the extent of the problem. Reporting of
results in excess of the levels in Sec. 35.204 for the Sr-82/Rb-82
generators could have alerted users and regulators to issues associated
with these generators and possibly reduced the number of patients
exposed to excess Sr-82 and Sr-85 levels. Breakthrough of Mo-99, Sr-82
and Sr-85 contamination can lead to unnecessary radiation exposure to
patients.
The NRC proposes to add a new reporting requirement related to
breakthrough of Mo-99, and Sr-82 and Sr-85 contamination. This new
reporting requirement in Sec. 35.3204(a) would require a licensee to
report to the NRC and the manufacturer or distributor of medical
generators within 30 days any measurement that exceeds the limits
specified in Sec. 35.204(a).
f. Allowing ARSOs To Be Named on a Medical Use License
Currently, Sec. 35.24(b) requires a licensee's management to
appoint an RSO who, in writing, agrees to be responsible for
implementing the radiation protection program. However, the regulations
in 10 CFR part 35 do not allow the naming of more than one permanent
RSO on a license.
During an ACMUI meeting in June 2007 (ADAMS Accession No.
ML072060526), concern was expressed that this restriction has been
contributing to a shortage of available RSOs to serve as preceptors.
The ACMUI stated that the restriction has been creating a situation in
which an individual who is qualified and performing the same duties as
an RSO cannot be recognized or listed as an RSO, and that it has been
creating a situation in which an individual working as a contractor RSO
at several hospitals or other licensed locations is unable to have
actual day-to-day oversight at the various facilities.
The proposed rule would amend the regulations in 10 CFR part 35 to
allow a licensee to appoint a qualified individual with expertise in
certain uses of byproduct material to serve as an ARSO. This individual
would be required to complete the same T&E requirements as the named
RSO for the individual's assigned sections of the radiation safety
program. The ARSOs would have oversight duties for the radiation safety
operations of their assigned sections, while reporting to the named
RSO. The proposed regulation would continue to allow a licensee to name
only one RSO on a license. The RSO would continue to be responsible for
the day-to-day oversight of the entire radiation safety program.
Similarly, a licensee with multiple operating locations could appoint a
qualified ARSO at each location where byproduct material is used;
however, the named RSO would remain responsible for the overall
licensed program. Under the proposed rule, the ARSO would be named on
the license for the types of use of byproduct material for which this
individual has been assigned duties and tasks by the RSO.
The NRC believes that allowing an ARSO to be named on a license
would increase the number of individuals who would be available to
serve as preceptors for individuals seeking to be appointed as RSOs or
ARSOs. Also, by being named on a license, an ARSO could more easily
become an RSO on other licenses for the types of uses for which the
ARSO is qualified.
In addition, the current regulations allow AUs, AMPs and ANPs to
serve as the RSO only on the license for which they are listed. Because
AUs, AMPs and ANPs must meet the same requirements to serve as the RSO
regardless of which Commission medical license they are identified on,
the NRC believes that it is overly restrictive to not allow them to
serve as an RSO on any Commission medical license. Therefore, a
modification is proposed that would allow an AU, AMP, or ANP listed on
any license or permit to serve as an RSO or ARSO. This proposed change
would increase the number of individuals available to serve as RSOs and
ARSOs on NRC medical licenses. Additionally, these ARSOs and RSOs could
serve as preceptors for an individual seeking to be named as the RSO.
The proposed change to allow an ARSO to be named on a license was
[[Page 42418]]
broadly supported during the public workshops conducted in the summer
of 2011. The T&E requirements for an ARSO were discussed, and
stakeholders strongly supported the NRC's position that the ARSOs must
meet the same qualifications as the RSO for their assigned sections of
the radiation safety program.
The proposed rule would amend multiple sections of 10 CFR part 35
to accommodate the new ARSO position.
g. Additional Issues and Clarifications
There are additional amendments, which are discussed in Section V,
Discussion of Proposed Amendments by Section, of this document.
B. When would these actions become effective?
Generally, the NRC allows an adequate time (30 to 180 days) for a
final rule to become effective. The time for the final rule to become
effective depends on the scope of the rulemaking, availability of the
conforming guidance, and the complexity of the final rule. With regard
to this proposed rule, the NRC proposes that the final rule would
become effective 180 days from its publication in the Federal Register.
C. Are there any cumulative effects of regulation associated with this
rule?
Cumulative effects of regulation (CER) describes the challenges
that licensees, certificate holders, States, or other entities may
encounter while implementing new regulatory requirements (e.g., rules,
generic letters, orders, backfits, inspection findings). The CER is an
organizational effectiveness challenge that results from a licensee or
impacted entity implementing a significant number of new and complex
regulatory actions stemming from multiple regulatory actions, within a
limited implementation period and with available resources (which may
include limited available expertise to address a specific issue). The
CER can potentially distract licensee or entity staff from executing
other primary duties that ensure safety or security. The NRC is
specifically requesting comment on the cumulative effects of this
rulemaking. In developing comments on CER, consider the following
questions:
(1) In light of any current or projected CER challenges, does the
proposed rule's effective date, compliance date, or submittal date(s)
provide sufficient time to implement the proposed requirements,
including changes to programs, procedures, and the facility?
(2) If current or projected CER challenges exist, what should be
done to address this situation (e.g., if more time is required to
implement the new requirements, what period of time would be
sufficient)?
(3) Do other (NRC, Agreement States, or other agency) regulatory
actions (e.g., orders, generic communications, license amendment
requests, and inspection findings of a generic nature) influence the
implementation of the proposed requirements?
(4) Are there unintended consequences? Does the proposed rule
create conditions that would be contrary to the proposed rule's purpose
and objectives? If so, what are the consequences and how should they be
addressed?
(5) Please comment on the NRC's cost and benefit estimates in the
regulatory analysis that supports this proposed rule. The draft
regulatory analysis is available in ADAMS under Accession No.
ML14184A620.
D. Is the NRC requesting comments on other specific issues?
(1) Volume for determining an absorbed dose to normal tissue for
MEs under Sec. 35.3045, Report and notification of a medical event.
Two new criteria for determining if a licensee must report an ME
involving permanent implant brachytherapy have a dose-volume
specification for an absorbed dose to normal tissue. One proposed
criterion is for normal tissue within the treatment site (such as the
urethra in prostate implants) and the other proposed criterion is for
normal tissue outside the treatment site (such as the bladder or the
rectum in prostate implants).
The proposed volume, 5 contiguous cubic centimeters of normal
tissue, is based on the recommendations from the ACMUI (ADAMS Accession
No. ML12038A279). In its recommendation, the ACMUI stated that the 5
contiguous cubic centimeters dose-volume specification avoids the high
variation in dose sometimes seen in point doses and has literature to
support it being a relevant quantity for toxicity to an organ at risk.
Because the majority of permanent implants are performed to treat
prostate cancer, examples and guidance for the ACMUI recommendations
related extensively to that procedure. However, the proposed rule is
intended to apply generally to all forms of permanent implants.
The NRC is seeking specific comments, in defining MEs, on the
proposed volume of 5 contiguous cubic centimeters dose-volume
specification for an absorbed dose to normal tissue located both
outside and within the treatment site.
The NRC is also seeking specific comments on whether the
application of the proposed medical event definition for normal tissue
based on the absorbed dose to the maximally exposed 5 contiguous cubic
centimeters during permanent implant brachytherapy is appropriate for
all potential treatment modalities, or whether it may result in
unintended consequences for tissues or organs adjacent to the treatment
site.
(2) Implementation Period.
In Section IV.B of this document, the NRC is proposing the
effective date of the final rule to be 180 days from the date it is
published in the Federal Register. The NRC is seeking specific comments
on whether a 180 day effective date for the final rule is sufficient to
communicate the changes to all practitioners, revise procedures, train
on them, and implement the changes.
(3) Impact on Clinical Practice.
The NRC is seeking comments on whether any of the proposed changes
in this rulemaking are likely to discourage licensees from using
certain therapy options or otherwise adversely impact clinical
practice, and if so, how.
(4) Compatibility Category for the Agreement States on Sec.
35.3045, Report and notification of a medical event.
Currently Sec. 35.3045, Report and notification of a medical
event, is designated as Compatibility Category C for the Agreement
States. This 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 requirements need not be the same as
NRC requirements, provided the essential objectives are met. Under
Compatibility Category C, Agreement States may require the reporting of
MEs with more restrictive criteria than those required by the NRC.
Some medical licensees have multiple locations, some of which are
NRC-regulated and some which are Agreement State-regulated. These
licensees would prefer a Compatibility Category B designation for
uniformity of practice and procedures among their different locations.
A Compatibility Category B designation is for those program elements
that apply to activities that have direct and significant effects in
multiple jurisdictions.
The OAS has expressed a strong desire to retain a dose-based ME
reporting criterion for the treatment site if NRC regulations are
revised to include
[[Page 42419]]
source-strength based criteria for determining MEs for permanent
implant brachytherapy. The OAS has no objection to the introduction of
the source-strength based criteria, as long as the dose-based criteria
can be retained by the Agreement States, which requires Sec. 35.3045
to remain as Compatibility Category C. With a Compatibility Category C
designation, the Agreement States could require both the dose-based
criterion and source-strength based criterion, as long as the Agreement
State reports to the NRC only include the information required by the
NRC.
For some Agreement States, Compatibility Category B is difficult to
achieve because their regulations have to also meet specific state
requirements based on the state agencies in which the radiation control
regulators reside. Also, Agreement States may have existing laws
requiring the collection of additional information on medical
diagnostic and therapy procedures.
If the level of compatibility for Sec. 35.3045 were to be raised
to Compatibility Category B, Agreement State requirements would need to
be essentially identical to those of the NRC. Compatibility Category B
is applied to requirements that have significant direct transboundary
health and safety implications. A Compatibility Category B designation
would prevent the Agreement State requirements from including any
additional requirements, such as diagnostic reports, shorter reporting
times, or lower dose limits for reporting.
The ACMUI in its report to the NRC (ADAMS Accession No.
ML13071A690), recommended that MEs related to permanent implant
brachytherapy be designated as Compatibility Category B. The ACMUI was
concerned with proposed designation as Compatibility Category C which
would allow the Agreement States to retain the dose-based criteria for
definition of an ME for permanent implant brachytherapy. The ACMUI
asserted that a Compatibility Category C would continue to result in
clinically insignificant occurrences being identified as MEs by
Agreement States and thereby perpetuate the confusion associated with
the current dose-based criteria. The ACMUI stated that the most
important component of the rationale for conversion from dose-based to
activity-based criteria is the failure of dose-based criteria to
sensitively and to only specifically capture clinically significant MEs
in permanent implant brachytherapy.
Because of these divergent positions (the OAS favoring
Compatibility Category C and some medical use licensees and the ACMUI
favoring Compatibility Category B), the NRC invites comments on the
appropriate compatibility category for ME reporting under Sec.
35.3045.
In responding to these issues, please use one of the methods
described in Section I, Obtaining Information and Submitting Comments,
of this document.
E. What should I consider as I prepare my comments to the NRC?
Tips for preparing your comments. When submitting your comments,
remember to:
i. Identify the rulemaking (RIN 3150- AI63; NRC-2008-0175).
ii. Explain why you agree or disagree with the proposed rule;
suggest alternatives and substitute language for your requested
changes.
iii. Describe any assumptions and provide any technical information
and/or data that you used.
iv. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
v. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vi. Explain your views as clearly as possible.
vii. Make sure to submit your comments by the comment period
deadline identified.
viii. The NRC is particularly interested in your comments
concerning the following issues: Sections IV.C and D. of this document
request comment on the cumulative effects of regulation, Whether the
proposed volume for determining an absorbed dose to normal tissue for
MEs is appropriate and applicable for all potential treatment
modalities related to permanent implant brachytherapy, the proposed
180-day effective date for the final rule, the proposed rule's impact
on clinical practice, and Compatibility Category for the Agreement
States on Sec. 35.3045, Report and notification of a medical event;
Section X of this document requests comment on the use of plain
writing; Section XIV requests comment on the draft environmental
assessment; Section XV of this document requests comment on the
information collection requirements; Section XVI of this document
requests comment on the draft regulatory analysis; and Section XVII of
this document requests comment on the impact of the proposed rule on
small businesses.
V. Discussion of Proposed Amendments by Section
Section 30.34 Terms and Conditions of Licenses
Paragraph (g). A new requirement would be added requiring
radiopharmacy licensees to report to the NRC the results of testing of
generator elutions for Mo-99 breakthrough or Sr-82 and Sr-85
contamination that exceed the permissible concentration listed in Sec.
35.204(a). Reporting would be in accordance with the reporting and
notifications in Sec. 35.3204. While the proposed reporting
requirement as well as the requirement to test every elution is new,
the testing by licensees of the first elution to ensure that it does
not exceed the permissible concentration listed in Sec. 35.204(a) and
recording the results of these tests is already required by this
paragraph.
This change is being proposed to provide the information to allow
the NRC to assess a potential situation quickly and efficiently when
issues occur with generators that may cause unwarranted radiation
exposure to patients. This issue is discussed further in Section IV,
Discussion, of this document.
Section 32.72 Manufacture, Preparation, or Transfer for Commercial
Distribution of Radioactive Drugs Containing Byproduct Material for
Medical Use Under 10 CFR Part 35
Paragraph (a)(4). This paragraph would be modified to clarify that
the applicant ``commits to'' rather than ``satisfies'' the label
requirements. Committing to the prescriptive labeling requirements in
the regulation in the license application would remove ambiguity
related to what must appear on the label.
Paragraph (b)(5)(i). This paragraph would be amended to remove the
requirement to obtain a written attestation for individuals seeking to
be named as an ANP and who are certified by a specialty board whose
certification process has been recognized by the NRC or an Agreement
State to be an ANP. This is a conforming change in support of the
removal of the attestation requirement in Sec. 35.55(a) of this
chapter for a board certified ANP.
Paragraph (d). The existing requirements in paragraph (d) would be
redesignated as (e), and a new paragraph (d) would be added to clarify
that the labeling requirements that applicants commit to in paragraph
(a) of this section are also applicable to current licensees.
[[Page 42420]]
Section 35.2 Definitions
New definitions for Associate Radiation Safety Officer and for
Ophthalmic physicist would be added to this section and the definition
for Preceptor would be amended.
The new definition for Associate Radiation Safety Officer would
identify the requirements an individual would need to meet to be
recognized as an ARSO. These requirements include that the individual
must meet the specified T&E criteria and that the individual be
currently listed as an ARSO on a medical license or permit for the
types of use of byproduct material for which the individual had been
assigned tasks and duties by the RSO. Additional information on ARSOs
is located in Section IV, Discussion, of this document.
The new definition for Ophthalmic physicist would identify the
requirements an individual would need to meet to be recognized as an
ophthalmic physicist. These requirements include that the individual
must meet the specified T&E criteria in Sec. 35.433(a)(2) and that the
individual must be currently listed as an ophthalmic physicist on a
specific medical use license issued by the Commission or an Agreement
State or a medical use permit issued by a Commission master material
licensee. A written attestation would not be required for this
individual.
The definition for Preceptor would be amended to add ARSO to the
list of individuals who provide, direct, or verify T&E required for an
individual to become an AU, an AMP, an ANP, or an RSO. This is a
conforming change in support of the new definition for Associate
Radiation Safety Officer.
Section 35.12 Application for License, Amendment, or Renewal
This section would be amended to remove the requirement to submit
copies of NRC Form 313, Application for Material License, or a letter
containing information required by NRC Form 313 when applying for a
license, an amendment, or renewal. This section would clarify what
information should be submitted and add a requirement to submit
information on an individual seeking to be identified as an ARSO or as
an ophthalmic physicist.
Paragraph (b)(1). As part of the application for a medical use
license, this paragraph would be amended to remove the requirement to
submit an additional copy of NRC Form 313. This change would relieve
the burden on the applicant by requiring less paperwork to be
submitted. It would also require the applicant to submit the T&E
qualifications for one or more ARSOs and ophthalmic physicists that are
to be identified on the license.
Paragraph (c). For license amendments or renewals, this paragraph
would be amended to remove the requirement to submit a copy of NRC Form
313 or a letter containing information required by NRC Form 313. This
change would relieve the burden on the licensee by requiring less
paperwork to be submitted. Additionally, it would clarify that the
letter submitted in lieu of NRC Form 313 must contain all the
information required by NRC Form 313.
Paragraph (d). This paragraph would be amended and restructured to
clarify what information must be included in an application for a
license or amendment for medical use of byproduct material as described
in Sec. 35.1000.
Section 35.13 License Amendments
This section would be amended by revising paragraph (b),
redesignating paragraphs (d) through (g) as paragraphs (e) through (h),
revising redesignated paragraphs (g) and (h), and adding new paragraphs
(d) and (i).
Paragraph (b). The paragraph would be amended to allow a licensee
to permit an individual to work as an ophthalmic physicist before
applying for a license amendment, provided that the individual is
already listed on a medical license or permit. The definition of an
Ophthalmic physicist in Sec. 35.2 would allow the ophthalmic physicist
to be named only on a specific medical use license and not on a broad
scope medical license. This limitation is to ensure that individuals
seeking to be named as an ophthalmic physicist have their T&E reviewed
by a regulatory authority as the position is new and unfamiliar to the
medical community. Additionally, broad scope licensees already have
ready access to AMPs to perform the requirements listed in Sec.
35.433.
Paragraph (d). This new paragraph would be added to require a
licensee to apply for and receive a license amendment before permitting
an individual to work as an ARSO or before the RSO assigns different
tasks and duties to an ARSO currently authorized on the license.
Paragraph (i). This new paragraph would be added to this section to
allow a licensee to receive sealed sources from a new manufacturer or a
new model number for a sealed source listed in the Sealed Source and
Device Registry (SSDR) used for manual brachytherapy for quantities and
isotopes already authorized by its license without first seeking a
license amendment. This change is proposed to provide manual
brachytherapy licensees greater flexibility in obtaining the sealed
sources necessary for patient treatments in a timely manner.
Section 35.14 Notifications
Paragraph (a). The paragraph would be restructured to separate the
notification requirements for an individual who is certified by a board
that is recognized by the NRC or an Agreement State from the
requirements for an individual who is not certified by a board that is
recognized by the NRC or an Agreement State but is listed on a license.
Additionally, the requirement to provide a written attestation is
removed for an individual who is certified by a board that is
recognized by the NRC or an Agreement State. Further discussion on
removing the written attestation requirement can be found in Section
IV, Discussion, of this document. Licensees may not permit an
individual who is not certified by a board that is recognized by the
NRC or an Agreement State or does not meet the requirements in Sec.
35.13(b) to work under their license without first obtaining an
amendment to their license.
Paragraph (a)(1). This paragraph would be restructured to more
clearly identify the verification that a board certified individual
would need to provide along with a copy of the individual's board
certification. This proposed change does not impose any new
requirements.
Paragraph (a)(2). This paragraph would retain the notification
requirements for individuals who are authorized to work under Sec.
35.13(b) who are not certified by a board that is recognized by the NRC
or an Agreement State but are listed on a license. These individuals
would be only authorized for the materials and uses for which they were
previously authorized. This proposed change does not impose any new
requirements.
Paragraph (b)(1). This paragraph would be amended to require a
licensee to notify the Commission within 30 days after an ARSO or
ophthalmic physicist has a name change or discontinues performance of
their duties under the license.
Paragraph (b)(6). This new paragraph would require a licensee to
notify the NRC no later than 30 days after receiving a sealed source
from a new manufacturer or a new model number listed in the SSDR for
manual brachytherapy for quantities and
[[Page 42421]]
isotopes already authorized by the license.
Section 35.24 Authority and Responsibilities of the Radiation
Protection Program
This section would be amended to allow licensees to appoint
qualified individuals with expertise in certain uses of byproduct
material to be named as ARSOs on a license or permit.
Paragraph (b). This paragraph would be modified to specify that a
licensee's management may appoint one or more ARSOs. These appointed
ARSOs would have to be named on a medical license or permit for the
types of use of byproduct material for which the RSO, with the written
agreement of the licensee's management, would assign tasks and duties.
The licensee's management would still be limited to naming one RSO
who would remain responsible for implementing the entire radiation
protection program. The RSO would be prohibited from delegating
authority and responsibilities for implementing the radiation
protection program. Each ARSO would have to agree in writing to the
tasks and duties assigned by the RSO.
Paragraph (c). An administrative change would be made to this
paragraph to remove the phrase ``an authorized user or'' as it is
redundant with ``an individual qualified to be a Radiation Safety
Officer under 35.50 and 35.59'' in the same sentence.
The proposed position of ARSO is discussed further in Section IV,
Discussion, of this document.
Section 35.40 Written Directives
Paragraph (b) of this section would be restructured and amended to
accommodate specific requirements for a WD for permanent implant
brachytherapy. Existing paragraph (b)(6) would be redesignated as
paragraph (b)(7) and a new paragraph (b)(6) would be added to specify
the information that must be included in the pre-implantation (before
implantation) and post-implantation (after implantation) portions of
the WD for permanent implant brachytherapy.
Paragraph (b)(6). This new paragraph would detail the specific WD
requirements for permanent implant brachytherapy. Specifically, it
would clarify that the WD is divided into two portions, i.e., the pre-
implantation portion and the post-implantation portion. The pre-
implantation WD portion would require documentation of the treatment
site, the radionuclide, the intended absorbed dose to the treatment
site, and the corresponding calculated source strength to deliver that
dose. If the treatment site has normal tissues located within it (such
as the urethra in prostate implants), the WD would also allow
documentation of the expected absorbed dose to normal tissue as
determined by the AU. The information required by the pre-implantation
portion of the WD must be documented prior to the start of the
implantation and cannot be modified once the implantation begins. The
proposed rule would retain the current provision that an AU could
revise an existing WD in writing or orally before the implantation
begins.
The post-implantation portion of the WD would require the
documentation of the number of sources implanted, the total source
strength implanted, the signature of an AU for Sec. 35.400 uses for
manual brachytherapy, and the date. It would not require the
documentation of dose to the treatment site. The information required
by the post-implantation portion of the WD must be documented before
the patient leaves the post-treatment recovery area. The term ``post-
treatment recovery area,'' as used in paragraph (b)(6)(ii), means the
area or place where a patient recovers immediately following the
brachytherapy procedure before being released to a hospital room or, in
the case of an outpatient treatment, released from the licensee's
facility.
Paragraph (c) of this section would be restructured for clarity.
Section 35.41 Procedures for Administrations Requiring a Written
Directive
This section would be amended by adding two new paragraphs with
requirements that the licensee must address when developing,
implementing, and maintaining written procedures to provide high
confidence that each administration requiring a WD is in accordance
with the WD.
Paragraph (b)(5). This new paragraph would require that the
licensee's procedures for any administration requiring a WD must
include procedures for determining if an ME, as defined in Sec.
35.3045 of this part, has occurred.
Paragraph (b)(6). This new paragraph would require the licensee to
develop specific procedures for permanent implant brachytherapy
programs. At a minimum, the procedures would include determining post-
implant source position verification and normal tissue dose assessment
within 60 calendar days from the date the implant was performed. If the
licensee cannot make these determinations within the 60 calendar days
because the patient is not available, then the licensee would have to
provide written justification that these determinations could not be
made due to patient unavailability.
The determinations that would be required include: (1) The total
source strength administered outside of the treatment site compared to
the total source strength documented in the post-implantation portion
of the WD; (2) the absorbed dose to the maximally exposed 5 contiguous
cubic centimeters of normal tissue located outside of the treatment
site; and 3) the absorbed dose to the maximally exposed 5 contiguous
cubic centimeters of normal tissue located within the treatment site.
The NRC is proposing this change because the current regulations do
not have a defined time within which the licensee must determine if the
implantation of radioactive sealed sources was done as prescribed in
the WD. The occurrence of a substantial number of MEs in 2008
underscored the need to add this requirement to the regulations, as
post-implant source position verifications and normal tissue dose
assessments for some of these MEs were not determined for more than a
year after the patient was treated. The NRC believes that these
determinations must be made in a timely manner to ensure that patients
and their physicians have information upon which to base decisions
regarding remedial and prospective health care.
A 60-calendar-day time frame is proposed to ensure that the
licensee has ample time to make arrangements for the required
determinations. These determinations would be used to partially assess
if an ME, as defined in Sec. 35.3045, has occurred.
Section 35.50 Training for Radiation Safety Officer
Multiple changes to this section are proposed. They include
amending the title of the section to add ``and Associate Radiation
Safety Officer'' as the T&E requirements for this new position would
also be made applicable to the ARSO. Other changes proposed are: (1)
Removing the requirement to obtain a written attestation for
individuals qualified under paragraph (a) of this section; (2) adding a
provision that would allow individuals identified as an AU, AMP, or ANP
on a medical license to be an RSO or an ARSO not only on that current
license but also on a different medical license; (3) adding a provision
to allow an individual to be named simultaneously both as the RSO and
AU on a new license application; and 4) certain administrative
clarifications.
[[Page 42422]]
Paragraph (a). The requirement for individuals seeking to be named
as an RSO or ARSO to obtain a written attestation would be removed for
those individuals who are certified by a specialty board whose
certification process has been recognized by the NRC or an Agreement
State. Individuals seeking to be named as RSOs or ARSOs via the
certification pathway would still need to meet the training
requirements in the new paragraph (d) of this section. Further
discussion on removing the written attestation requirement can be found
in Section IV, Discussion, of this document.
Paragraph (b)(1)(ii). This paragraph is amended to allow an ARSO,
in addition to the RSO, to provide supervised work experience for
individuals under the alternate pathway. The ARSO would be limited to
providing supervised work experience in those areas for which the ARSO
is authorized on a medical license or permit.
Paragraph (b)(2). Reserved paragraph (b)(2) would be revised to
contain the requirements for an RSO or ARSO under the alternate pathway
to obtain a written attestation signed by either an RSO or ARSO. The
language that is required in the written attestation would be amended
to state that the individual ``is able to independently fulfill the
radiation safety-related duties as an RSO or ARSO,'' rather than that
the individual ``has achieved a level of radiation safety knowledge to
function independently'' as an RSO or ARSO.
Paragraph (c)(1). This paragraph would be modified to allow medical
physicists who have been certified by a specialty board whose process
has been recognized by the Commission or an Agreement State under Sec.
35.51(a) to be named as ARSOs. Additionally, the requirement for a
written attestation for these medical physicists is removed. A medical
physicist seeking to be named as an RSO or an ARSO would still need to
meet the training requirements in paragraph (d) of this section.
Paragraph (c)(2). This paragraph would be modified to allow AUs,
AMPs, and ANPs identified on a Commission or an Agreement State medical
license or permit to be an RSO or ARSO on any Commission or an
Agreement State license or Commission master material permit provided
that the AU, AMP, or ANP has experience with the radiation safety
aspects of similar types of use of byproduct material. The current
regulations limit AUs, AMPs and ANPs to serve as an RSO only on the
license on which they are listed.
The AUs, AMPs and ANPs must meet the same requirements to serve as
the RSO regardless of which Commission medical license they are
identified on; therefore, not allowing them to serve as an RSO on any
Commission medical license is overly restrictive. This change would
increase the number of individuals available to serve as RSOs and ARSOs
on NRC medical licenses.
Paragraph (c)(3). This new paragraph would allow an individual who
is not named as an AU on a medical license or permit, but is qualified
to be an AU, to be named simultaneously as the RSO and the AU on the
same new medical license. Current regulations, under Sec. 35.50(c)(2),
do not permit an individual who is not an AU on a license, but
qualified to be an AU, to be an RSO. The individual must have the
experience with the radiation safety aspects of the byproduct material
for which the authorization is sought. An individual may meet the
qualifications of an AU via the board certification or alternate
pathway. An individual who is using the alternate pathway to be named
simultaneously as the RSO and the AU on the same new medical license
must obtain a written attestation.
The provision would provide flexibility for an individual to serve
as both an AU and as the RSO on a new medical license and would make
medical procedures more widely available, especially in rural areas.
Paragraph (d). This paragraph would be amended to include ARSOs as
individuals who can provide supervised training to an individual
seeking recognition as an RSO or ARSO.
Section 35.51 Training for an Authorized Medical Physicist
Paragraph (a). The requirement for individuals seeking to be named
as an AMP to obtain a written attestation would be removed for those
individuals who are certified by a specialty board whose certification
process has been recognized by the NRC or an Agreement State. Further
discussion on removing the written attestation requirement can be found
in Section IV, Discussion, of this document.
Paragraph (a)(2)(i). This paragraph would be amended to clarify
that an AMP who provides supervision for meeting the requirements of
this section, be certified in medical physics by a specialty board
whose certification process has been recognized under this section by
the Commission or an Agreement State.
Current regulations allow a medical physicist with any board
certification in diagnostic or therapeutic medical physics to serve as
a supervising medical physicist in therapeutic procedures. The NRC
believes that the supervision for therapeutic procedures must be
provided by a medical physicist who is certified in medical physics by
a specialty board recognized under Sec. 35.51 by the Commission or an
Agreement State.
Paragraph (b)(2). The wording in this paragraph would be revised to
conform to the removal of the attestation requirement in paragraph (a)
of this section. It would also be amended to incorporate the new
language that the written attestation would verify that the individual
is able to independently fulfill the radiation safety-related duties,
rather than has achieved a level of competency to function
independently, as an AMP.
Section 35.55 Training for an Authorized Nuclear Pharmacist
Paragraph (a). The requirement for individuals seeking to be named
as an ANP to obtain a written attestation would be removed for those
individuals who are certified by a specialty board whose certification
process has been recognized by the NRC or an Agreement State.
Paragraph (b)(2). The wording in this paragraph would be revised to
conform to the removal of the attestation requirement in paragraph (a)
of this section. It would also be amended to incorporate the new
language that the written attestation would verify that the individual
is able to independently fulfill the radiation safety-related duties,
rather than has achieved a level of competency to function
independently, as an ANP.
Section 35.57 Training for Experienced Radiation Safety Officer,
Teletherapy or Medical Physicist, Authorized Medical Physicist,
Authorized User, Nuclear Pharmacist, and Authorized Nuclear Pharmacist
Multiple changes to this section are proposed. Most of the proposed
changes are to the T&E requirements in response to the requested
amendments in the Ritenour petition. This includes recognizing the
board certifications of individuals certified by boards recognized
under subpart J, which was removed from 10 CFR part 35 in a rulemaking
dated March 30, 2005 (70 FR 16336), and making administrative
clarifications. Additional information on the Ritenour petition, as it
relates to this rulemaking, is located in Section IV, Discussion, of
this document.
Paragraph (a)(1). This paragraph would be modified to add AMPs and
ANPs identified on a Commission or an Agreement State license or a
permit issued by a Commission or an Agreement State broad scope
licensee or master material license permit or by a
[[Page 42423]]
master material license permittee of broad scope on or before October
24, 2005, as individuals that would not need to comply with the
training requirements of Sec. Sec. 35.50, 35.51, or 35.55,
respectively. In addition, the date is changed for individuals named on
a license as RSOs, teletherapy or medical physicists, AMPs, nuclear
pharmacists, or ANPs from October 24, 2002, to October 24, 2005,
because during the 3-year time frame applicants could have qualified
under the now removed subpart J or the new T&E requirements under
Sec. Sec. 35.50, 35.51, or 35.55.
However, under the proposed rule, RSOs and AMPs identified by this
paragraph would have to meet the training requirements in Sec. Sec.
35.50(d) or 35.51(c) as appropriate, for any materials or uses for
which they were not authorized prior to the effective date of the rule.
This is not a new training requirement. Current regulations require
individuals qualifying under Sec. Sec. 35.50 and 35.51 as RSOs and
AMPs to meet the training requirements in Sec. 35.50(e) and Sec.
35.51(c). Individuals excepted by this paragraph would still need to
meet the recentness-of-training requirements in Sec. 35.59.
Paragraph (a)(2). This paragraph would recognize individuals
certified by the named boards in the now-removed subpart J of 10 CFR
part 35 on or before October 24, 2005, who would not need to comply
with the training requirements of Sec. 35.50 to be identified as an
RSO or as an ARSO on a Commission or an Agreement State license or
Commission master material license permit for those materials and uses
that these individuals performed on or before October 24, 2005.
Individuals excepted by this paragraph would still need to meet the
recentness-of-training requirements in Sec. 35.59 and, for new
materials and uses, the training requirements in Sec. 35.50(d).
Paragraph (a)(3). This paragraph would recognize individuals
certified by the named boards in the now-removed subpart J of 10 CFR
part 35 on or before October 24, 2005, who would not need to comply
with the training requirements of Sec. 35.51 to be identified as a AMP
on a Commission or an Agreement State license or Commission master
material license permit for those materials and uses that these
individuals performed on or before October 24, 2005. Removal of subpart
J from 10 CFR part 35 was effective on October 24, 2005. These
individuals would be exempted from these training requirements only for
those materials and uses these individuals performed on or before
October 24, 2005. Individuals excepted by this paragraph would still
need to meet the recentness-of-training requirements in Sec. 35.59
and, for new materials and uses, the training requirements in Sec.
35.51(c).
Paragraph (a)(4). This paragraph would be renumbered from current
paragraph (a)(3) and not be revised.
Paragraph (b)(1). This paragraph would be amended to change the
date an individual named on a license as an AU from October 24, 2002,
to October 24, 2005, because during that 3-year time frame, an
applicant could have qualified as an AU either under the former subpart
J or the revised T&E requirements in subparts D through H of 10 CFR
part 35.
Additionally, the paragraph would be amended to clarify that an
individual authorized before, rather than just on, October 24, 2005,
would not be required to comply with the T&E requirements in subparts D
through H of 10 CFR part 35 for those materials and uses that they
performed on or before that date.
Paragraph (b)(2). This paragraph would be restructured and expanded
to recognize a physician, dentist, or podiatrist who was certified by
the named boards in the now-removed subpart J of 10 CFR part 35 on or
before October 24, 2005, and who would not need to comply with the
training requirements of subparts D through H of 10 CFR part 35 to be
identified as an AU on a Commission or an Agreement State license or
Commission master material license permit for those materials and uses
that the individual performed on or before October 24, 2005. Removal of
subpart J from 10 CFR part 35 was effective on October 24, 2005. An
individual excepted from the T&E requirements by this paragraph would
still need to meet the recentness-of-training requirements in Sec.
35.59.
Section 35.65 Authorization for Calibration, Transmission, and
Reference Sources
This section would be restructured and amended to include two new
paragraphs.
Paragraph (b)(1). This new paragraph would require that medical use
of any byproduct material authorized by this section can only be used
in accordance with the requirements in Sec. 35.500. This is a
clarification that all of the specified byproduct material for medical
use must be under the supervision of an AU.
Paragraph (b)(2). This new paragraph would prohibit the bundling or
aggregating of single-sealed sources to create a sealed source with an
activity larger than authorized by Sec. 35.65. Sources that consist of
multiple single sources (bundling) that exceed the limits authorized by
Sec. 35.65 would no longer be regulated under Sec. 35.65, would be
treated as one single source, and would have to meet all of the
regulatory requirements for that single source including, if
appropriate, listing on a specific medical license, leak testing, and
security requirements.
Paragraph (c). This new paragraph would clarify that a licensee
using calibration, transmission, and reference sources in accordance
with the requirements in paragraphs (a) or (b) of this section need not
list these sources on a specific medical use license.
Section 35.190 Training for Uptake, Dilution, and Excretion Studies
Paragraph (a). For a physician seeking to be named as an AU of
unsealed byproduct material for uses authorized under Sec. 35.100, the
requirement to obtain a written attestation would be removed for an
individual who is certified by a specialty board whose certification
process has been recognized by the NRC or an Agreement State. Further
discussion on removing the written attestation requirement can be found
in Section IV, Discussion, of this document.
Paragraph (c)(2). This paragraph would be restructured and expanded
to allow certain residency program directors to provide written
attestations for a physician seeking to be named as an AU of unsealed
byproduct material for uses authorized under Sec. 35.100. The
residency program director must represent a residency training program
approved by the Residency Review Committee of the Accreditation Council
for Graduate Medical Education, the Royal College of Physicians and
Surgeons of Canada, or the Committee on Post-Graduate Training of the
American Osteopathic Association. The residency training program must
include T&E specified in Sec. 35.190.
The residency program director who provides written attestations
does not have to be an AU who met the requirements in Sec. Sec. 35.57,
35.190, 35.290, or 35.390, or equivalent Agreement State requirements.
However, the director must affirm in writing that the attestation
represents the consensus of the residency program faculty where at
least one faculty member is an AU who meets the requirements in
Sec. Sec. 35.57, 35.190, 35.290, or 35.390, or equivalent Agreement
State requirements, and that the AU concurs with the attestation.
Additionally, the paragraph would be amended to incorporate the new
language that the written attestation would verify that the physician
is able to independently fulfill the radiation safety-related duties,
rather than has
[[Page 42424]]
achieved a level of competency to function independently, as an AU.
Section 35.204 Permissible Molybdenum-99, Strontium-82, and Strontium-
85 Concentrations
Paragraph (b). The current requirement to measure the Mo-99
concentration after the first eluate would be changed to require that
the Mo-99 concentration be measured after each elution. A generator can
be eluted several times to obtain Tc-99m for formulating
radiopharmaceuticals for human use. Current regulations require
licensees to measure the Mo-99 concentration only the first time a
generator is eluted.
Paragraph (e). This new paragraph would add a requirement that
licensees report any measurement that exceeds the limits specified in
Sec. 35.204(a) for Mo-99/Tc-99m and Sr-82/Rb-82 generators.
Further discussion on this issue can be found in Section IV,
Discussion, of this document.
Section 35.290 Training for Imaging and Localization Studies
Paragraph (a). For physicians seeking to be named as an AU of
unsealed byproduct material for uses authorized under Sec. 35.200, the
requirement to obtain a written attestation would be removed for those
individuals who are certified by a specialty board whose certification
process has been recognized by the NRC or an Agreement State. Further
discussion on removing the written attestation requirement can be found
in Section IV, Discussion, of this document.
Paragraph (c)(1)(ii). This paragraph would be amended to allow an
ANP who meets the requirements in Sec. Sec. 35.55 or 35.57 to provide
the supervised work experience specified in paragraph (c)(1)(ii)(G) of
this section for individuals seeking to be named as an AU of unsealed
byproduct material for uses authorized under Sec. 35.200. Paragraph
(c)(1)(ii)(G) of this section requires supervised work experience in
eluting generator systems. Many medical facilities no longer elute
generators and receive unit doses from centralized pharmacies;
therefore, training on eluting generators is not available at these
facilities. ANPs have the T&E to provide the supervised work experience
for AUs on the elution of generators.
Paragraph (c)(2). This paragraph would be restructured and expanded
to allow certain residency program directors to provide written
attestations for individuals seeking to be named as an AU of unsealed
byproduct material for uses authorized under Sec. Sec. 35.100 and
35.200. The residency program director must represent a residency
training program approved by the Residency Review Committee of the
Accreditation Council for Graduate Medical Education, the Royal College
of Physicians and Surgeons of Canada, or the Committee on Post-Graduate
Training of the American Osteopathic Association. The residency
training program must include T&E specified in Sec. 35.290.
The residency program directors who provide written attestations do
not have to be AUs who meet the requirements in Sec. Sec. 35.57,
35.290, or 35.390 and 35.290(c)(1)(ii)(G), or equivalent Agreement
State requirements. However, they must affirm in writing that the
attestation represents the consensus of the residency program faculty
where at least one faculty member is an AU who meets the requirements
in Sec. Sec. 35.57, 35.290, or 35.390 and 35.290(c)(1)(ii)(G) or
equivalent Agreement State requirements, and that the AU concurs with
the attestation.
Additionally, the paragraph would be amended to incorporate the new
language that the written attestation would verify that the individual
is able to independently fulfill the radiation safety-related duties,
rather than has achieved a level of competency to function
independently, as an AU.
Sec. 35.300 Use of Unsealed Byproduct Material for Which a Written
Directive Is Required
The introductory paragraph would be amended to clarify that a
licensee may only use unsealed byproduct material identified in Sec.
35.390(b)(1)(ii)(G) under this section. Currently, Sec. 35.300 states
that ``A licensee may use any unsealed byproduct material. . ..'' This
change is proposed to clarify that a licensee's authorization of the
radiopharmaceuticals requiring a WD is only for those types of
radiopharmaceuticals for which the AU has documented T&E. An AU may be
authorized for one or more of the specific categories described in
Sec. 35.390(b)(1)(ii)(G), but not for all unsealed byproduct material.
Section 35.390 Training for Use of Unsealed Byproduct Material for
Which a Written Directive Is Required
Paragraph (a). For physicians seeking to be named as an AU of
unsealed byproduct material for uses authorized under Sec. 35.300, the
requirement to obtain a written attestation would be removed for those
individuals who are certified by a specialty board whose certification
process has been recognized by the NRC or an Agreement State. Further
discussion on removing the written attestation requirement can be found
in Section IV, Discussion, of this document.
Paragraph (b)(1)(ii)(G). This paragraph would be amended to expand
and clarify the categories of parenteral administrations of
radionuclides in which work experience is required for an individual
seeking to be an AU for uses under Sec. 35.300. Most radionuclides
used for parenteral administrations have more than one type of
radiation emission. Under the proposed change, the type of radiation
emissions of parenteral administrations would be based on the primary
use of the radionuclide radiation characteristics. The proposed changes
to this paragraph would also further expand the parenteral
administration categories to include radionuclides that are primarily
used for their alpha radiation characteristics.
The current regulations include a broad category for parenteral
administrations of ``any other'' radionuclide. This broad category
would be removed, as any new parenteral administration of radionuclides
not listed in this paragraph would be regulated under Sec. 35.1000.
This approach would allow the NRC to review each new proposed
radionuclide for parenteral administration and determine the
appropriate T&E for its use.
Current regulations require physicians requesting AU status for
administering dosages of radioactive drugs to humans (including
parenteral administration) to have work experience with a minimum of
three cases in each category for which they are requesting AU status.
This requirement would be retained in the proposed rule with regard to
all categories in this paragraph.
Paragraph (b)(2). This paragraph would be restructured and expanded
to allow certain residency program directors to provide written
attestations for physicians seeking to be named as an AU of unsealed
byproduct material for uses authorized under Sec. 35.300. The
residency program director must represent a residency training program
approved by the Residency Review Committee of the Accreditation Council
for Graduate Medical Education or the Royal College of Physicians and
Surgeons of Canada or the Committee on Post-Graduate Training of the
American Osteopathic Association. The residency training program must
include T&E specified in Sec. 35.300.
The residency program directors who provide written attestations do
not have
[[Page 42425]]
to be AUs who meet the requirements in Sec. Sec. 35.57, 35.390, or
equivalent Agreement State requirements, or have experience in
administering dosages in the same dosage category or categories as the
individual requesting AU status. However, they must affirm in writing
that the attestation represents the consensus of the residency program
faculty where at least one faculty member is an AU who meets the
requirements in Sec. Sec. 35.57, 35.390, or equivalent Agreement State
requirements, has experience in administering dosages in the same
dosage category or categories as the physicians requesting AU status,
and that the AU concurs with the attestation.
Additionally, the paragraph would be amended to incorporate the new
language that the written attestation would verify that the physician
is able to independently fulfill the radiation safety-related duties,
rather than has achieved a level of competency to function
independently, as an AU.
Paragraph (c). This new paragraph is added to clarify that if an
individual is a user of any of the parenteral administrations specified
in Sec. 35.390(b)(1)(ii)(G) or equivalent Agreement State requirements
that individual would be only authorized for that use and not for all
of the parenteral administrations. If an individual is seeking
authorization for any new type of parenteral administrations then the
supervised work experience requirements in paragraph (b)(1)(ii)(G)
would have to be met.
Section 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)
Paragraph (a). For physicians seeking to be named as an AU for the
oral administration of sodium iodide I-131 requiring a WD in quantities
less than or equal to 1.22 gigabecquerels (33 millicuries), the
requirement to obtain a written attestation would be removed for those
individuals who are certified by a specialty board whose certification
process has been recognized by the NRC or an Agreement State. Further
discussion on removing the written attestation requirement can be found
in Section IV, Discussion, of this document.
Paragraph (c)(3). This paragraph would be restructured and expanded
to allow certain residency program directors to provide written
attestations for physicians seeking to be named as an AU of unsealed
byproduct material for the oral administration of sodium iodide I-131
requiring a WD in quantities less than or equal to 1.22 gigabecquerels
(33 millicuries) authorized under Sec. 35.300. The residency program
director must represent a residency training program approved by the
Residency Review Committee of the Accreditation Council for Graduate
Medical Education or the Royal College of Physicians and Surgeons of
Canada or the Committee on Post-Graduate Training of the American
Osteopathic Association. The residency training program must include
T&E specified in Sec. 35.392.
The residency program directors who provide written attestations do
not have to be AUs who meet the requirements in Sec. Sec. 35.57,
35.390, 35.392, 35.394, or equivalent Agreement State requirements, or
have experience in administering dosages as specified in Sec. Sec.
35.390(b)(1)(ii)(G)(1) or 35.390(b)(1)(ii)(G)(2). However, they must
affirm in writing that the attestation represents the consensus of the
residency program faculty where at least one faculty member is an AU
who meets the requirements in Sec. Sec. 35.57, 35.390, 35.392, 35.394,
or equivalent Agreement State requirements, and has experience in
administering dosages as specified in Sec. Sec. 35.390(b)(1)(ii)(G)(1)
or 35.390(b)(1)(ii)(G)(2) and that the AU concurs with the attestation.
Additionally, the paragraph would be amended to incorporate the new
language that the written attestation would verify that the physician
is able to independently fulfill the radiation safety-related duties,
rather than has achieved a level of competency to function
independently, as an AU.
Section 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)
Paragraph (a). For physicians seeking to be named as an AU for the
oral administration of sodium iodide I-131 requiring a WD in quantities
greater than 1.22 gigabecquerels (33 millicuries), the requirement to
obtain a written attestation would be removed for those individuals who
are certified by a specialty board whose certification process has been
recognized by the NRC or an Agreement State. Further discussion on
removing the written attestation requirement can be found in Section
IV, Discussion, of this document.
Paragraph (c)(3). This paragraph would be restructured and expanded
to allow certain residency program directors to provide written
attestations for physicians seeking to be named as an AU of unsealed
byproduct material for the oral administration of sodium iodide I-131
requiring a WD in quantities greater than 1.22 gigabecquerels (33
millicuries) authorized under Sec. 35.300. The residency program
director must represent a residency training program approved by the
Residency Review Committee of the Accreditation Council for Graduate
Medical Education or the Royal College of Physicians and Surgeons of
Canada or the Committee on Post-Graduate Training of the American
Osteopathic Association. The residency training program must include
T&E specified in Sec. 35.394.
The residency program directors who provide written attestations do
not have to be AUs who meet the requirements in Sec. Sec. 35.57,
35.390, 35.394, or equivalent Agreement State requirements, or have
experience in administering dosages as specified in Sec.
35.390(b)(1)(ii)(G)(2). However, they must affirm in writing that the
attestation represents the consensus of the residency program faculty
where at least one faculty member is an AU who meets the requirements
in Sec. Sec. 35.57, 35.390, 35.394, or equivalent Agreement State
requirements, and has experience in administering dosages as specified
in Sec. 35.390(b)(1)(ii)(G)(2) and that the AU concurs with the
attestation.
Additionally, the paragraph would be amended to incorporate the new
language that the written attestation would verify that the physician
is able to independently fulfill the radiation safety-related duties,
rather than has achieved a level of competency to function
independently, as an AU.
Section 35.396 Training for the Parenteral Administration of Unsealed
Byproduct Material Requiring a Written Directive
Proposed amendments to this section include conforming changes to
support the new categories for parenteral administration in Sec.
35.390(b)(1)(ii)(G), changes to allow residency program directors to
provide written attestations, and the change to the attestation
language. Additionally, the section would be renumbered to accommodate
the proposed changes.
Paragraph (a). This paragraph would be amended to revise the
categories for parenteral administration of radionuclides listed in
Sec. 35.390(b)(1)(ii)(G). The AUs authorized to use any of the
categories for parenteral administration of radionuclides in Sec.
35.390(b)(1)(ii)(G) would also have to meet the supervised work
experience requirements in paragraph (d)(2) of this section for each
new parenteral administration listed in
[[Page 42426]]
Sec. 35.390(b)(1)(ii)(G) for which the individual is requesting AU
status.
Paragraph (d)(1). This paragraph would be amended to conform with
the new categories for parenteral administration in Sec.
35.390(b)(1)(ii)(G).
Paragraph (d)(2). This paragraph would be amended to conform with
the new categories for parenteral administration in Sec.
35.390(b)(1)(ii)(G) and to clarify that a supervising AU must have
experience in administering dosages in the same category or categories
as the individual requesting AU status.
Paragraph (d)(2)(vi). This paragraph would be amended to conform
with the new categories for parenteral administration in Sec.
35.390(b)(1)(ii)(G).
Paragraph (d)(3). This paragraph would be restructured and expanded
to allow certain residency program directors to provide written
attestations for physicians seeking to be named as an AU of unsealed
byproduct material for the parenteral administration requiring a WD.
The residency program director must represent a residency training
program approved by the Residency Review Committee of the Accreditation
Council for Graduate Medical Education or the Royal College of
Physicians and Surgeons of Canada or the Committee on Post-Graduate
Training of the American Osteopathic Association. The residency
training program must include T&E specified in Sec. 35.396.
The residency program directors who provide written attestations do
not have to be AUs who meet the requirements in Sec. Sec. 35.57,
35.390, 35.396, or equivalent Agreement State requirements, or have
experience in administering dosages in the same category or categories
as the individual requesting AU status. However, they must affirm in
writing that the attestation represents the consensus of the residency
program faculty where at least one faculty member is an AU who meets
the requirements in Sec. Sec. 35.57, 35.390, 35.396, or equivalent
Agreement State requirements, and concurs with the attestation. An AU
who meets the requirements in Sec. Sec. 35.390, 35.396, or equivalent
Agreement State requirements, must have experience in administering
dosages in the same category or categories as the individual requesting
AU user status.
Additionally, the paragraph would be amended to incorporate the new
language that the written attestation would verify that the physician
is able to independently fulfill the radiation safety-related duties,
rather than has achieved a level of competency to function
independently, as an AU.
Section 35.400 Use of Sources for Manual Brachytherapy
This section would be expanded to allow sources that are listed in
the SSDR for manual brachytherapy to be used for other medical uses
that are not explicitly listed in the SSDR.
Paragraph (a). This paragraph would be amended to allow sources
that are listed in the SSDR for manual brachytherapy medical uses to be
used for other manual brachytherapy medical uses that are not
explicitly listed in the SSDR provided that these sources are used in
accordance with the radiation safety conditions and limitations
described in the SSDR. These radiation safety conditions and
limitations described in the SSDR may apply to storage, handling,
sterilization, conditions of use, and leak testing of radiation
sources.
The NRC recognizes that the medical uses specified in the SSDR may
not be all inclusive. The proposed revision would permit physicians to
use manual brachytherapy sources to treat sites or diseases not listed
in the SSDR. For example, the SSDR may specify that the sources are for
interstitial uses, but the proposed change would allow the physician to
use the sources for a topical use. The NRC has determined this latitude
should be afforded to physicians to use at their discretion in the
practice of medicine.
Section 35.433 Decay of Strontium-90 Sources for Ophthalmic Treatments
The section title would be modified to delete ``Decay of'' at the
beginning of the title. The new title would reflect the expanded
information and requirements in the section.
Paragraph (a). This paragraph would be amended and expanded to
allow certain individuals who are not AMPs to calculate the activity of
strontium-90 (Sr-90) sources that is used to determine the treatment
times for ophthalmic treatments. These individuals, defined in Sec.
35.2 as ophthalmic physicists, would have to meet the T&E requirements
detailed in the new paragraph (a)(2) of this section to perform the
specified activities but would not require an attestation. These
requirements are similar to the T&E requirements for an AMP, but
include only the requirements related to brachytherapy programs.
This amendment is proposed to increase the number of qualified
individuals available to support the use of Sr-90 sources for
ophthalmic treatments. Often, AUs who work in remote areas do not have
ready access to an AMP to perform the necessary calculation to support
the ophthalmic treatment. This proposed change would make the procedure
involving use of Sr-90 sources for ophthalmic treatments available to
more patients located in remote areas.
Paragraph (b). This new paragraph would establish the tasks that
individuals qualified in paragraph (a) of this section would be
required to perform in supporting ophthalmic treatments with Sr-90. The
first task is based upon the requirements in Sec. 35.432 for
calculating the activity of each Sr-90 source used for ophthalmic
treatments. This is not a new requirement, as it is required in the
current regulation under Sec. 35.433(a).
The second task is related to the requirements in Sec. 35.41 and
is included in this proposed rule to ensure the safe use of Sr-90 for
ophthalmic treatments. Both the AMP and the individuals identified
under paragraph (a)(2) of this section would be required to assist the
licensee in developing, implementing, and maintaining written
procedures to provide high confidence that the dose administration is
in accordance with the WD. Under this paragraph, the licensee would
have to modify its procedures required under Sec. 35.41 to specify the
frequencies that the AMP and/or the individuals identified under
paragraph (a)(2) of this section would observe treatments, review the
treatment methodology, calculate treatment time for the prescribed
dose, and review records to verify that the treatment was administered
in accordance with the WD.
Paragraph (c). This new paragraph would be unchanged from the
recordkeeping requirements in the current regulation under Sec.
35.433(b).
Section 35.490 Training for Use of Manual Brachytherapy Sources
Paragraph (a). For a physician seeking to be named as an AU of a
manual brachytherapy source for the uses authorized under Sec. 35.400,
the requirement to obtain a written attestation would be removed for an
individual who is certified by a specialty board whose certification
process has been recognized by the NRC or an Agreement State. Further
discussion on removing the written attestation requirement can be found
in Section IV, Discussion, of this document.
Paragraph (b)(1)(ii). This paragraph would be amended to require
that the work experience required by this section must be received at a
medical facility authorized to use byproduct materials under Sec.
35.400 rather than at a medical institution. The current term
[[Page 42427]]
``medical institution'' in this paragraph is defined in Sec. 35.2 as
an organization in which more than one medical discipline is practiced.
This definition unnecessarily limits where the work experience must be
obtained. Moreover, the fact that an organization practices more than
one medical discipline does not ensure that one of the medical
disciplines will be related to uses authorized under Sec. 35.400. The
proposed change would allow the work experience to be received at a
stand-alone single discipline clinic and also ensure that the work
experience is related to the uses authorized under Sec. 35.400.
Paragraph (b)(3). This paragraph would be restructured and expanded
to allow certain residency program directors to provide written
attestations for physicians seeking to be named as an AU of a manual
brachytherapy source for the uses authorized under Sec. 35.400. The
residency program directors must represent a residency training program
approved by the Residency Review Committee of the Accreditation Council
for Graduate Medical Education or the Royal College of Physicians and
Surgeons of Canada or the Committee on Post-Graduate Training of the
American Osteopathic Association. The residency training program must
include T&E specified in Sec. 35.400.
The residency program directors who provide written attestations do
not have to be AUs who meet the requirements in Sec. Sec. 35.57,
35.490 or equivalent Agreement State requirements. However, they must
affirm in writing that the attestation represents the consensus of the
residency program faculty where at least one faculty member is an AU
who meets the requirements in Sec. Sec. 35.57, 35.490, or equivalent
Agreement State requirements, and that the AU concurs with the
attestation.
Additionally, the paragraph would be amended to incorporate the new
language that the written attestation would verify that the physician
is able to independently fulfill the radiation safety-related duties,
rather than has achieved a level of competency to function
independently, as an AU.
Section 35.491 Training for Ophthalmic Use of Strontium-90
Paragraph (b)(3). This paragraph would be amended to incorporate
the new language that the written attestation would verify that the
physician is able to independently fulfill the radiation safety-related
duties, rather than has achieved a level of competency to function
independently, as an AU.
Section 35.500 Use of Sealed Sources for Diagnosis
The section would be restructured and expanded to include the use
of medical devices to allow sealed sources and medical devices that are
listed in the SSDR for diagnostic medical uses to be used for
diagnostic medical uses that are not explicitly listed in the SSDR, and
to allow sealed sources and medical devices to be used in research in
accordance with an active Investigational Device Exemption (IDE)
application accepted by the FDA. The section title would be modified to
add ``and medical devices'' as the use of medical devices is added to
this section.
Paragraph (a). This paragraph would be amended to clarify that
sealed sources not in medical devices for diagnostic medical uses
approved in the SSDR can be used for other diagnostic medical uses that
are not explicitly listed in an SSDR provided that they are used in
accordance with radiation safety conditions and limitations described
in the SSDR. These radiation safety conditions and limitations
described in the SSDR may include storage, handling, sterilization,
conditions of use, and leak testing of radiation sources.
Paragraph (b). This paragraph would be added to allow diagnostic
devices containing sealed sources to be used for diagnostic medical
uses if both are approved in the SSDR for diagnostic medical uses that
are not explicitly listed in an SSDR, provided that they are used in
accordance with radiation safety conditions and limitations described
in the SSDR. These radiation safety conditions and limitations
described in the SSDR may include storage, handling, sterilization,
conditions of use, and leak testing of radiation sources.
Paragraph (c). This new paragraph would allow sealed sources and
devices for diagnostic medical uses to be used in research in
accordance with an active IDE application accepted by the FDA, provided
the requirements of Sec. 35.49(a) are met.
Section 35.590 Training for Use of Sealed Sources and Medical Devices
for Diagnosis
This section would be restructured and expanded to clarify that
both diagnostic sealed sources and devices authorized in Sec. 35.500
are included in the T&E requirements of this section.
Paragraph (b). This new paragraph would recognize the individuals
who are authorized for imaging uses listed in Sec. 35.200, or
equivalent Agreement State requirements, for use of diagnostic sealed
sources or devices authorized under Sec. 35.500.
Section 35.600 Use of a Sealed Source in a Remote Afterloader Unit,
Teletherapy Unit, or Gamma Stereotactic Radiosurgery Unit
The section would be amended to separate the uses of photon-
emitting remote afterloader units, teletherapy units, or gamma
stereotactic radiosurgery units from the uses of the sealed sources
contained within these units. The amended section would allow only
sealed sources approved in the SSDR in devices to deliver therapeutic
medical treatments as provided for in the SSDR; however, the units
containing these sources could be used for therapeutic medical
treatments that are not explicitly provided for in the SSDR, provided
that they are used in accordance with radiation safety conditions and
limitations described in the SSDR. The purpose of this amendment is to
allow physicians flexibility to exercise their medical judgment and to
use these devices for new therapeutic treatments that may not have been
anticipated when the devices were registered.
Paragraph (a). This paragraph would require that a licensee use
only sealed sources approved in the SSDR for therapeutic medical uses
in photon-emitting remote afterloader units, teletherapy units, or
gamma stereotactic radiosurgery units as provided for in the SSDR or
for research in accordance with an active IDE application accepted by
the FDA, provided the requirements of Sec. 35.49(a) are met.
Paragraph (b). This paragraph would continue to require that a
licensee only use photon emitting remote afterloader units, teletherapy
units, or gamma stereotactic radiosurgery units approved in the SSDR or
for research in accordance with an active IDE application accepted by
the FDA provided the requirements of Sec. 35.49(a) are met. However,
this paragraph would be amended to provide that these units may be used
for medical uses that are not explicitly provided for in the SSDR,
provided that these units are used in accordance with the radiation
safety conditions and limitations described in the SSDR.
Section 35.610 Safety Procedures and Instructions for Remote
Afterloader Units, Teletherapy Units, and Gamma Stereotactic
Radiosurgery Units
Paragraph (d)(1). This paragraph would be amended and restructured
to add a new training requirement for the
[[Page 42428]]
use of remote afterloader units, teletherapy units, and gamma
stereotactic radiosurgery units. This proposed amendment would require
all individuals who would operate these units to receive vendor
operational and safety training prior to the first use for patient
treatment of a new unit or an existing unit with a manufacturer upgrade
that affects the operation and safety of the unit. This training must
be provided by the device manufacturer or by an individual certified by
the device manufacturer to provide the training.
Currently, Sec. 35.610(d) requires that an individual who operates
these units be provided safety instructions initially, and at least
annually; however, there is no requirement for this individual to
receive instructions when the unit is upgraded. In addition, the
proposed amendment would require an individual who operates these new
or upgraded units to receive training prior to first use for patient
treatment.
Paragraph (d)(2). This paragraph would be restructured and amended
to clarify that the training required by this paragraph on the
operation and safety of the unit applies to any new staff who will
operate the unit or units at the facility. This requirement would be
added to enhance the safety of patients by eliminating the potential
for training of new staff to be delayed until the required annual
training, which could lead to having undertrained individuals operating
the unit.
Paragraph (g). This paragraph would be amended to conform with the
restructuring of paragraph (d)(2) of this section.
Section 35.655 Five-Year Inspection for Teletherapy and Gamma
Stereotactic Radiosurgery Units
The section title would be modified to delete ``Five-year
inspection'' and insert ``Full-inspection servicing'' to more
accurately reflect the requirements in the section of inspection and
servicing of teletherapy unit and gamma stereotactic radiosurgery
units.
Paragraph (a). This paragraph would be amended to extend the full
inspection and servicing interval between each full inspection
servicing for gamma stereotactic radiosurgery units from 5 years to 7
years to assure proper functioning of the source exposure mechanism.
The interval between each full inspection and servicing of teletherapy
units would remain the same (not to exceed 5 years). For gamma
stereotactic radiosurgery units, the full inspection and servicing to
assure proper functioning of the source exposure mechanism is performed
when the sources are taken out of the unit and before the new sources
are placed in the unit (source replacement). Since the cost to replace
the decaying sources in a gamma stereotactic radiosurgery unit can be
exorbitant, licensees have requested that the intervals between each
full inspection servicing for these units be extended beyond 5 years.
The NRC finds that the 6-month routine preventive maintenance that is
performed on these units is adequate to assure the proper functioning
of the source exposure mechanisms and that therefore this extension may
be granted. Additionally, the paragraph would require that the full
inspection and servicing of these units be performed during each source
replacement regardless of the last time that the units were inspected
and serviced.
The full inspection and servicing interval of a teletherapy unit
has not been extended from the current interval of 5 years to help
prevent potentially serious radiation exposure of teletherapy operators
and patients in the event that the source exposure mechanism failed.
The radioactive source contained in a teletherapy unit produces
radiation fields on the order of hundreds of rads per minute in areas
accessible to patients and operators. In the event of a source exposure
mechanism failure, the exposed source could result in overexposure of a
patient or operating personnel in a short period of time.
Section 35.690 Training for Use of Remote Afterloader Units,
Teletherapy Units, and Gamma Stereotactic Radiosurgery Units
Paragraph (a). For a physician seeking to be named as an AU for
sealed sources for uses authorized under Sec. 35.600, the requirement
to obtain a written attestation would be removed for an individual who
is certified by a specialty board whose certification process has been
recognized by the NRC or an Agreement State. Further discussion on
removing the written attestation requirement can be found in Section
IV, Discussion, of this document.
Paragraph (b)(1)(ii). This paragraph would be amended to require
that the work experience required by this section must be received at a
medical facility authorized to use byproduct materials under Sec.
35.600 rather than at a medical institution. The current term ``medical
institution'' in this paragraph is defined in Sec. 35.2 as an
organization in which more than one medical discipline is practiced.
This definition unnecessarily limits where the work experience must be
obtained. Moreover, the fact that an organization practices more than
one medical discipline does not ensure that one of the medical
disciplines will be related to uses authorized under Sec. 35.600. The
proposed change would allow the work experience to be received at a
stand-alone single discipline clinic for the uses authorized under
Sec. 35.600.
Paragraph (b)(3). This paragraph would be restructured and expanded
to allow certain residency program directors to provide written
attestations for physicians seeking to be named as an AU for sealed
sources for uses authorized under Sec. 35.600. The residency program
directors must represent a residency training program approved by the
Residency Review Committee of the Accreditation Council for Graduate
Medical Education, the Royal College of Physicians and Surgeons of
Canada, or the Committee on Post-Graduate Training of the American
Osteopathic Association. The residency training program must include
T&E specified in Sec. 35.690.
The residency program directors who provide written attestations do
not have to be AUs who meet the requirements in Sec. Sec. 35.57,
35.690, or equivalent Agreement State requirements, for the type(s) of
therapeutic medical unit(s) for which the individual is requesting AU
status. However, they must affirm in writing that the attestation
represents the consensus of the residency program faculty where at
least one faculty member is an AU who meets the requirements in
Sec. Sec. 35.57, 35.690, or equivalent Agreement State requirements,
for the type(s) of therapeutic medical unit(s) for which the individual
is requesting AU status and that the AU concurs with the attestation.
Additionally, the paragraph would be amended to incorporate the new
language that the written attestation would verify that the physician
is able to independently fulfill the radiation safety-related duties,
rather than has achieved a level of competency to function
independently, as an AU.
Section 35.2024 Records of Authority and Responsibilities for Radiation
Protection Programs
Paragraph (c). This new paragraph would require the licensee to
keep records of each ARSO assigned under Sec. 35.24(b) for 5 years
after the ARSO is removed from the license. These records would have to
include the written document appointing the ARSO signed by the
licensee's management and each agreement signed by the ARSO listing the
duties and tasks assigned by the RSO under Sec. 35.24(b).
[[Page 42429]]
Section 35.2310 Records of Safety Instruction
This section would be amended to conform to the changes proposed in
Sec. 35.610 by adding a requirement to maintain the operational and
safety instructions required by Sec. 35.610.
Section 35.2655 Records of 5-Year Inspection for Teletherapy and Gamma
Stereotactic Radiosurgery Units
The section title would be modified to delete ``5-year inspection''
and insert ``full-inspection servicing'' to reflect the proposed
changes to Sec. 35.655 requiring full inspection and servicing of
teletherapy units and gamma stereotactic radiosurgery units.
Section 35.3045 Report and Notification of a Medical Event
Paragraph (a) of this section would be restructured and amended to
specify separate specific criteria for reporting an ME involving
permanent implant brachytherapy. These new criteria would be different
from the criteria for reporting an ME for other administrations that
require a WD.
Paragraph (a)(1). This new paragraph would have criteria for
reporting an ME for administrations that require a WD other than
permanent implant brachytherapy. Criteria for reporting an ME involving
permanent implant brachytherapy would be in a new paragraph (a)(2) in
this section. The criteria used to determine if an ME has occurred for
administrations that require a WD other than permanent implant
brachytherapy would be unchanged except (1) the current paragraph
(a)(3) related to the dose to the skin or an organ or tissue other than
the treatment site would be restructured for clarity as the new
paragraph (a)(1)(iii); and (2) a criterion would be added in the new
paragraph (a)(1)(ii)(A) of this section for reporting as an ME an
administration involving the wrong radionuclide for a brachytherapy
procedure.
Paragraph (a)(2). This new paragraph would be added to establish
separate criteria for reporting MEs involving permanent implant
brachytherapy. These new criteria are designed to ensure reporting of
situations where harm or potential harm to the patient may occur. The
new criteria for reporting an ME involving permanent implant
brachytherapy include:
(1) The total source strength administered differing by 20 percent
or more from the total source strength documented in the post-
implantation portion of the WD. An example of a situation that would
meet this criterion would be if the sealed sources, which were
implanted, had a different source strength than what was intended. This
situation could occur from ordering, or a vendor shipping, sealed
sources with the wrong activity;
(2) The total source strength administered outside of the treatment
site exceeding 20 percent of the total source strength documented in
the post-implantation portion of the WD. An example of a situation that
would meet this criterion would be if sealed sources are
unintentionally implanted outside of the treatment site. This situation
would be identified by the licensee when determinations are made that
are related to 10 CFR 35.41;
(3) An absorbed dose to the maximally exposed 5 contiguous cubic
centimeters of normal tissue located outside of the treatment site that
exceeds by 50 percent or more of the absorbed dose prescribed to the
treatment site by an AU in the pre-implantation portion of the WD. The
ACMUI recommended that for this criterion the absorbed dose to normal
tissue should be measured in a volume large enough such that small
fluctuations, such as a single source out of place, would not result in
an ME. The ACMUI's recommendation for selecting 5 contiguous cubic
centimeters volume related to organ at risk toxicity is based on an
article entitled, ``Proposed guidelines for image-based intracavitary
brachytherapy for cervical carcinoma: Report from Image-Guided
Brachytherapy Working Group,'' by S. Nag, H. Cardenes, S. Chang, I.
Das, B. Erickson, G. Ibbott, J. Lowenstein, J. Roll, B. Thomadsen, M.
Varia, in the International Journal of Radiation Oncology and Bio
Physics 60:1160-1172, 2004.
An example of a situation that would meet this criterion would be
if sealed sources are not implanted in the treatment site in a
spatially distributed manner, i.e., they are bunched or grouped rather
than spatially distributed. This could result in a higher dose than was
expected or desired to normal tissues that are located close to the
treatment site.
(4) An absorbed dose to the maximally exposed 5 contiguous cubic
centimeters of normal tissue located within the treatment site that
exceeds by 50 percent or more of the absorbed dose to that tissue based
on the pre-implantation dose distribution approved by an AU. The ACMUI
recommended with regard to this criterion that the absorbed dose to
normal tissue should be measured in a volume large enough such that
small fluctuations, such as a single source out of place, would not
result in an ME. The 5 contiguous cubic centimeters proposed is the
largest volume related to organ at risk toxicity in the literature
referenced in criterion 3.
An example of a situation that would meet this criterion would be
if sealed sources are not implanted in the treatment site as intended.
The unintended higher dose could be from the sealed sources being
bunched or grouped close to the normal tissue rather than spatially
distributed or from sealed sources being unintentionally implanted into
the normal tissue. This could result in a higher dose than was expected
or desired to normal tissues that are located within the treatment
site.
(5) An administration that includes the wrong radionuclide; the
wrong individual or human research subject; sealed sources directly
delivered to the wrong treatment site; a leaking sealed source
resulting in a dose that exceeds 0.5 Sv (50 rem) to an organ or tissue;
or a 20 percent or more error in calculating the total source strength
documented in the pre-implantation portion of the WD. Only the proposed
criteria for a leaking sealed source retains the dose threshold in
current regulations because the NRC determined the leaking sealed
source delivering a dose below this threshold does not need to be
reported as a medical event.
Several situations that would meet this criterion are self-evident,
i.e., wrong patient, wrong treatment site, or leaking sealed source. An
error of 20 percent or more in calculating the total source strength
could lead to implanting the wrong number of sealed sources, which
could result in an under- or over-dosing of the treatment area and
possibly a higher dose to normal tissue than was expected.
Section 35.3204 Report and Notification for an Eluate Exceeding
Permissible Molybdenum-99, Strontium-82, and Strontium-85
Concentrations
This new section would be added to require reporting and
notification of an elution from a Mo-99/Tc-99m or Sr-82/Rb-82 generator
that exceeds the regulatory requirements in Sec. Sec. 30.34 and
35.204(a). Further discussion on reporting failed generators can be
found in Section IV, Discussion, of this document.
Paragraph (a). This new section would require a licensee to notify
both the NRC Operations Center and the manufacturer/distributor of the
generator by telephone within 30 calendar days after discovery that an
eluate exceeds the permissible concentration listed in Sec. 35.204(a).
This
[[Page 42430]]
notification would include the manufacturer, model number, and serial
number (or lot number) of the generator; the results of the
measurement; the date of the measurement; whether dosages were
administered to patients or human research subjects; whether the
manufacturer/distributor was notified; and the action taken.
Paragraph (b). This new section would require a licensee to submit
a written report to the appropriate NRC Regional Office listed in Sec.
30.6 within 45 days after discovery of an eluate exceeding the
permissible concentration. The report would have to be submitted by an
appropriate method listed in Sec. 30.6(a). The report would include
the action taken by the licensee, patient dose assessments, the
methodology used in making the patient dose assessment if the eluate
was administered to patients or human research subjects, probable cause
and assessment of failure in the licensee's equipment, procedures or
training that contributed to the excessive readings if an error
occurred in the licensee's breakthrough determination, and the
information in the telephone report as required by paragraph (a) of
this section.
Administrative Changes to Authority Citations
The authority citations for 10 CFR parts 30, 32, and 35 would be
revised to make editorial changes that are administrative in nature,
including inserting missing parentheses and punctuation. The proposed
revisions would not change the statutory authority.
VI. Criminal Penalties
For the purpose of Section 223 of the Atomic Energy Act of 1954, as
amended (AEA), the Commission is proposing to amend 10 CFR parts 30,
32, and 35 under one or more of Sections 161b, 161i, or 161o of the
AEA. Willful violations of the rule would be subject to criminal
enforcement.
VII. Coordination With NRC Agreement States
The Agreement States have been involved throughout the development
of this proposed rule. Agreement State representatives have served on
the rulemaking working group that has developed the proposed amendments
to 10 CFR part 35 and on the steering committee for the rulemaking.
Through an All Agreement State Letter (FSME-11-044, dated May 20,
2011, ADAMS Accession No. ML111400231), the Agreement States were
notified of the availability of preliminary rule text for comments
posted on www.regulations.gov and noticed in the Federal Register (76
FR 29171; May 20, 2011). The Federal Register notice also invited the
Agreement States to participate at the two public workshops that were
held in New York City, New York, and Houston, Texas, during the summer
of 2011. Finally, in preparing the proposed amendments, the rulemaking
working group considered the comments provided by the Agreement States.
VIII. Agreement State Compatibility
Under the ``Policy Statement on Adequacy and Compatibility of
Agreement State Programs'' approved by the Commission on June 30, 1997,
and published in the Federal Register (62 FR 46517; September 3, 1997),
this proposed rule would be a matter of compatibility between the NRC
and the Agreement States, thereby providing consistency among the
Agreement States and NRC requirements. The NRC staff analyzed the
proposed rule in accordance with the procedure established within Part
III, ``Categorization Process for NRC Program Elements,'' of Handbook
5.9 to Management Directive 5.9, ``Adequacy and Compatibility of
Agreement State Programs'' (a copy of which may be viewed at http://www.nrc.gov/reading-rm/doc-collections/management-directives/). The
Agreement States have 3 years from the effective date of the final rule
in the Federal Register to adopt compatible regulations.
The NRC program elements (including regulations) are placed into
four compatibility categories (See the Draft Compatibility Table for
Proposed Rule in this section). In addition, the NRC program elements
can also be identified as having particular health and safety
significance or as being reserved solely by the NRC. Compatibility
Category A contains those program elements that are basic radiation
protection standards and scientific terms and definitions that are
necessary to understand radiation protection concepts. An Agreement
State should adopt Category A program elements in an essentially
identical manner to provide uniformity in the regulation of agreement
material on a nationwide basis. Compatibility Category B contains those
program elements that apply to activities that have direct and
significant effects in multiple jurisdictions. An Agreement State
should adopt Category B program elements in an essentially identical
manner. Compatibility Category C contains those program elements that
do not meet the criteria of Category A or B, but provide the essential
objectives, which an Agreement State should adopt to avoid conflict,
duplication, gaps, or other conditions that would jeopardize an orderly
pattern in the regulation of agreement material on a nationwide basis.
An Agreement State should adopt the essential objectives of the
Category C program elements. Compatibility Category D contains those
program elements that do not meet any of the criteria of Categories A,
B, or C, and, therefore, do not need to be adopted by the Agreement
States for purposes of compatibility.
The Health and Safety (H&S) category contains program elements that
are not required for compatibility but are identified as having a
particular health and safety role (i.e., adequacy) in the regulation of
agreement material within the State. Although not required for
compatibility, the State should adopt program elements in this H&S
category based on those of the NRC that embody the essential objectives
of NRC program elements because of particular health and safety
considerations. Compatibility Category NRC are those program elements
that address areas of regulation that cannot be relinquished to the
Agreement States under the Atomic Energy Act, as amended, or provisions
of 10 CFR. These program elements are not adopted by the Agreement
States. The following table lists the parts and sections that would be
revised and their corresponding categorization under the ``Policy
Statement on Adequacy and Compatibility of Agreement State Programs.''
A bracket around a category means that the section may have been
adopted elsewhere, and it is not necessary to adopt it again.
The NRC invites comment on the compatibility category designations
in the proposed rule and suggests that commenters refer to Handbook 5.9
of Management Directive 5.9 for more information. The NRC notes that,
like the rule text, the compatibility category designations can change
between the proposed rule and final rule, based on comments received
and Commission decisions regarding the final rule. The NRC encourages
anyone interested in commenting on the compatibility category
designations in any manner to do so during the comment period.
Discussion on changing the Compatibility Category for Sec. 35.3045,
Report and notification of a medical event, can be found in Section IV,
Discussion, of this document.
[[Page 42431]]
Draft Compatibility Table for Proposed Rule
----------------------------------------------------------------------------------------------------------------
Compatibility
Section Change Subject -----------------------
Existing New
----------------------------------------------------------------------------------------------------------------
Part 30
----------------------------------------------------------------------------------------------------------------
30.34(g)............................. Amend................... Terms and conditions of B B
licenses.
----------------------------------------------------------------------------------------------------------------
Part 32
----------------------------------------------------------------------------------------------------------------
32.72(a)(4).......................... Amend................... Manufacture, B B
preparation, or
transfer for
commercial
distribution of
radioactive drugs
containing byproduct
material for medical
use under 10 CFR part
35.
32.72(b)(5)(i)....................... Amend................... Manufacture, B B
preparation, or
transfer for
commercial
distribution of
radioactive drugs
containing byproduct
material for medical
use under 10 CFR part
35.
32.72(d)............................. New..................... Manufacture, .......... B
preparation, or
transfer for
commercial
distribution of
radioactive drugs
containing byproduct
material for medical
use under 10 CFR part
35.
----------------------------------------------------------------------------------------------------------------
Part 35
----------------------------------------------------------------------------------------------------------------
35.2................................. New..................... Definitions--Associate .......... B
Radiation Safety
Officer.
35.2................................. New..................... Definitions--Ophthalmic .......... B
physicist.
35.2................................. Amend................... Definitions--Preceptor. D D
35.12(b)(1).......................... Amend................... Application for D D
license, amendment, or
renewal.
35.12(c)(1).......................... Amend................... Application for D D
license, amendment, or
renewal.
35.12(c)(1)(ii)...................... Amend................... Application for D D
license, amendment, or
renewal.
35.12(d)............................. Amend................... Application for D D
license, amendment, or
renewal.
35.12(d)(1).......................... New..................... Application for .......... D
license, amendment, or
renewal.
35.12(d)(2).......................... New..................... Application for .......... D
license, amendment, or
renewal.
35.12(d)(3).......................... New..................... Application for .......... D
license, amendment, or
renewal.
35.12(d)(4).......................... Amend................... Application for D D
license, amendment, or
renewal.
35.13(b)............................. Amend................... License amendments..... D D
35.13(d)............................. New..................... License amendments..... .......... D
35.13(i)............................. New..................... License amendments..... .......... D
35.14(a)............................. Amend................... Notifications.......... D D
35.14(b)(1).......................... Amend................... Notifications.......... D D
35.14(b)(2).......................... Amend................... Notifications.......... D D
35.14(b)(6).......................... New..................... Notifications.......... .......... D
35.24(b)............................. Amend................... Authority and H&S H&S
responsibilities for
the radiation
protection program.
35.24(c)............................. Amend................... Authority and D D
responsibilities for
the radiation
protection program.
35.40(b)(6).......................... Amend................... Written directives..... H&S H&S
35.41(b)(5).......................... New..................... Procedures for .......... H&S
administrations
requiring a written
directive.
35.41(b)(6).......................... New..................... Procedures for .......... H&S
administrations
requiring a written
directive.
35.50................................ Amend................... Training for Radiation B B
Safety Officer and
Associate Radiation
Safety Officer.
35.50(a)............................. Amend................... Training for Radiation B B
Safety Officer and
Associate Radiation
Safety Officer.
35.50(a)(2)(ii)(B)................... Amend................... Training for Radiation B B
Safety Officer and
Associate Radiation
Safety Officer.
35.50(b)(1)(ii)...................... Amend................... Training for Radiation B B
Safety Officer and
Associate Radiation
Safety Officer.
35.50(b)(2).......................... New..................... Training for Radiation .......... B
Safety Officer and
Associate Radiation
Safety Officer.
35.50(c)(1).......................... Amend................... Training for Radiation B B
Safety Officer and
Associate Radiation
Safety Officer.
35.50(c)(2).......................... Amend................... Training for Radiation B B
Safety Officer and
Associate Radiation
Safety Officer.
35.50(c)(3).......................... New..................... Training for Radiation .......... B
Safety Officer and
Associate Radiation
Safety Officer.
35.50(d)............................. Amend................... Training for Radiation B B
Safety Officer and
Associate Radiation
Safety Officer.
35.51(a)............................. Amend................... Training for an B B
authorized medical
physicist.
35.51(a)(2)(i)....................... Amend................... Training for an B B
authorized medical
physicist.
35.51(b)(2).......................... Amend................... Training for an B B
authorized medical
physicist.
35.55(a)............................. Amend................... Training for an B B
authorized nuclear
pharmacist.
35.55(b)(2).......................... Amend................... Training for an B B
authorized nuclear
pharmacist.
35.57(a)(1).......................... Amend................... Training for B B
experienced Radiation
Safety Officer,
teletherapy or medical
physicist, authorized
medical physicist,
authorized user,
nuclear pharmacist,
and authorized nuclear
pharmacist.
35.57(a)(2).......................... New..................... Training for .......... B
experienced Radiation
Safety Officer,
teletherapy or medical
physicist, authorized
medical physicist,
authorized user,
nuclear pharmacist,
and authorized nuclear
pharmacist.
[[Page 42432]]
35.57(a)(3).......................... New..................... Training for .......... B
experienced Radiation
Safety Officer,
teletherapy or medical
physicist, authorized
medical physicist,
authorized user,
nuclear pharmacist,
and authorized nuclear
pharmacist.
35.57(b)(1).......................... Amend................... Training for B B
experienced Radiation
Safety Officer,
teletherapy or medical
physicist, authorized
medical physicist,
authorized user,
nuclear pharmacist,
and authorized nuclear
pharmacist.
35.57(b)(2).......................... Amend................... Training for B B
experienced Radiation
Safety Officer,
teletherapy or medical
physicist, authorized
medical physicist,
authorized user,
nuclear pharmacist,
and authorized nuclear
pharmacist.
35.57(b)(2)(i)....................... New..................... Training for .......... B
experienced Radiation
Safety Officer,
teletherapy or medical
physicist, authorized
medical physicist,
authorized user,
nuclear pharmacist,
and authorized nuclear
pharmacist.
35.57(b)(2)(ii)...................... New..................... Training for .......... B
experienced Radiation
Safety Officer,
teletherapy or medical
physicist, authorized
medical physicist,
authorized user,
nuclear pharmacist,
and authorized nuclear
pharmacist.
35.57(b)(2)(iii)..................... New..................... Training for .......... B
experienced Radiation
Safety Officer,
teletherapy or medical
physicist, authorized
medical physicist,
authorized user,
nuclear pharmacist,
and authorized nuclear
pharmacist.
35.57(b)(2)(iv)...................... New..................... Training for .......... B
experienced Radiation
Safety Officer,
teletherapy or medical
physicist, authorized
medical physicist,
authorized user,
nuclear pharmacist,
and authorized nuclear
pharmacist.
35.65(b)............................. New..................... Authorization for .......... D
calibration,
transmission, and
reference sources.
35.65(b)(1).......................... New..................... Authorization for .......... D
calibration,
transmission, and
reference sources.
35.65(b)(2).......................... New..................... Authorization for .......... D
calibration,
transmission, and
reference sources.
35.65(c)............................. New..................... Authorization for .......... D
calibration,
transmission, and
reference sources.
35.190(a)............................ Amend................... Training for uptake, B B
dilution, and
excretion studies.
35.190(c)(2)......................... Amend................... Training for uptake, B B
dilution, and
excretion studies.
35.190(c)(2)(i)...................... New..................... Training for uptake, .......... B
dilution, and
excretion studies.
35.190(c)(2)(ii)..................... New..................... Training for uptake, .......... B
dilution, and
excretion studies.
35.204(b)............................ Amend................... Permissible molybdenum- H&S H&S
99, strontium-82, and
strontium-85
concentrations.
35.204(e)............................ New..................... Permissible molybdenum- .......... H&S
99, strontium-82, and
strontium-85
concentrations.
35.290(a)............................ Amend................... Training for imaging B B
and localization
studies.
35.290(c)(1)(ii)..................... Amend................... Training for imaging B B
and localization
studies.
35.290(c)(2)......................... Amend................... Training for imaging B B
and localization
studies.
35.290(c)(2)(i)...................... New..................... Training for imaging .......... B
and localization
studies.
35.290(c)(2)(ii)..................... New..................... Training for imaging .......... B
and localization
studies.
35.300............................... Amend................... Use of unsealed B B
byproduct material for
which a written
directive is required.
35.390(a)............................ Amend................... Training for use of B B
unsealed byproduct
material for which a
written directive is
required.
35.390(b)(1)(ii)(G)(3)............... Amend................... Training for use of B B
unsealed byproduct
material for which a
written directive is
required.
35.390(b)(1)(ii)(G)(4)............... New..................... Training for use of .......... B
unsealed byproduct
material for which a
written directive is
required.
35.390(b)(1)(ii)(G)(5)............... New..................... Training for use of .......... B
unsealed byproduct
material for which a
written directive is
required.
35.390(b)(2)......................... Amend................... Training for use of B B
unsealed byproduct
material for which a
written directive is
required.
35.390(b)(2)(i)...................... New..................... Training for use of .......... B
unsealed byproduct
material for which a
written directive is
required.
35.390(b)(2)(ii)..................... New..................... Training for use of .......... B
unsealed byproduct
material for which a
written directive is
required.
35.390(c)............................ New..................... Training for use of .......... B
unsealed byproduct
material for which a
written directive is
required.
35.392(a)............................ Amend................... Training for the oral B B
administration of
sodium iodide I-131
requiring a written
directive in
quantities less than
or equal to 1.22
gigabecquerels (33
millicuries).
35.392(c)(3)......................... Amend................... Training for the oral B B
administration of
sodium iodide I-131
requiring a written
directive in
quantities less than
or equal to 1.22
gigabecquerels (33
millicuries).
35.392(c)(3)(i)...................... New..................... Training for the oral .......... B
administration of
sodium iodide I-131
requiring a written
directive in
quantities less than
or equal to 1.22
gigabecquerels (33
millicuries).
35.392(c)(3)(ii)..................... New..................... Training for the oral .......... B
administration of
sodium iodide I-131
requiring a written
directive in
quantities less than
or equal to 1.22
gigabecquerels (33
millicuries).
[[Page 42433]]
35.394(a)............................ Amend................... Training for the oral B B
administration of
sodium iodide I-131
requiring a written
directive in
quantities greater
than 1.22
gigabecquerels (33
millicuries).
35.394(c)(3)......................... Amend................... Training for the oral B B
administration of
sodium iodide I-131
requiring a written
directive in
quantities greater
than 1.22
gigabecquerels (33
millicuries).
35.394(c)(3)(i)...................... New..................... Training for the oral .......... B
administration of
sodium iodide I-131
requiring a written
directive in
quantities greater
than 1.22
gigabecquerels (33
millicuries).
35.394(c)(3)(ii)..................... New..................... Training for the oral .......... B
administration of
sodium iodide I-131
requiring a written
directive in
quantities greater
than 1.22
gigabecquerels (33
millicuries).
35.396(a)............................ Amend................... Training for the B B
parenteral
administration of
unsealed byproduct
material requiring a
written directive.
35.396(b)............................ Amend................... Training for the .......... B
parenteral
administration of
unsealed byproduct
material requiring a
written directive.
35.396(c)............................ Amend................... Training for the B B
parenteral
administration of
unsealed byproduct
material requiring a
written directive.
35.396(d)(1)......................... Amend................... Training for the B B
parenteral
administration of
unsealed byproduct
material requiring a
written directive.
35.396(d)(2)......................... Amend................... Training for the B B
parenteral
administration of
unsealed byproduct
material requiring a
written directive.
35.396(d)(2)(iv)..................... Amend................... Training for the B B
parenteral
administration of
unsealed byproduct
material requiring a
written directive.
35.396(d)(3)......................... Amend................... Training for the B B
parenteral
administration of
unsealed byproduct
material requiring a
written directive.
35.396(d)(3)(i)...................... New..................... Training for the .......... B
parenteral
administration of
unsealed byproduct
material requiring a
written directive.
35.396(d)(3)(ii)..................... New..................... Training for the .......... B
parenteral
administration of
unsealed byproduct
material requiring a
written directive.
35.400(a)............................ Amend................... Use of sources for C C
manual brachytherapy.
35.400(b)............................ Amend................... Use of sources for C C
manual brachytherapy.
35.433(a)............................ Amend................... Strontium-90 sources H&S B
for ophthalmic
treatments.
35.433(b)............................ New..................... Strontium-90 sources .......... H&S
for ophthalmic
treatments.
35.433(b)(1)......................... New..................... Strontium-90 sources .......... H&S
for ophthalmic
treatments.
35.433(b)(2)......................... New..................... Strontium-90 sources .......... H&S
for ophthalmic
treatments.
35.433(c)............................ Redesignated............ Strontium-90 sources .......... H&S
for ophthalmic
treatments (Previously
35.433(b)).
35.490(a)............................ Amend................... Training for use of B B
manual brachytherapy
sources.
35.490(b)(1)(ii)..................... Amend................... Training for use of B B
manual brachytherapy
sources.
35.490(b)(3)......................... Amend................... Training for use of B B
manual brachytherapy
sources.
35.490(b)(3)(i)...................... New..................... Training for use of .......... B
manual brachytherapy
sources.
35.490(b)(3)(ii)..................... New..................... Training for use of .......... B
manual brachytherapy
sources.
35.491(b)(3)......................... Amend................... Training for ophthalmic B B
use of strontium-90.
35.500(a)............................ Amend................... Use of sealed sources [C] C
and medical devices
for diagnosis
(Previously 35.500).
35.500(b)............................ New..................... Use of sealed sources .......... C
and medical devices
for diagnosis.
35.500(c)............................ New..................... Use of sealed sources .......... C
and medical devices
for diagnosis.
35.590(a)............................ Amend................... Training for use of B B
sealed sources for
diagnosis.
35.590(b)............................ New..................... Training for use of .......... B
sealed sources for
diagnosis.
35.590(c)............................ Redesignated............ Training for use of B B
sealed sources for
diagnosis (Previously
35.590(b)).
35.590(d)............................ Redesignated............ Training for use of B B
sealed sources for
diagnosis (Previously
35.590(c)).
35.600(a)............................ Amend................... Use of a sealed source C C
in a remote
afterloader unit,
teletherapy unit, or
gamma stereotactic
radiosurgery unit.
35.600(b)............................ Amend................... Use of a sealed source C C
in a remote
afterloader unit,
teletherapy unit, or
gamma stereotactic
radiosurgery unit.
35.610(d)(1)......................... New..................... Safety procedures and .......... H&S
instructions for
remote afterloader
units, teletherapy
units, and gamma
stereotactic
radiosurgery units.
35.610(d)(2)......................... Amend................... Safety procedures and H&S H&S
instructions for
remote afterloader
units, teletherapy
units, and gamma
stereotactic
radiosurgery units.
35.610(g)............................ Amend................... Safety procedures and H&S H&S
instructions for
remote afterloader
units, teletherapy
units, and gamma
stereotactic
radiosurgery units.
35.655(a)............................ Amend................... Full-inspection H&S H&S
servicing for
teletherapy and gamma
stereotactic
radiosurgery units.
35.690(a)............................ Amend................... Training for use of B B
remote afterloader
units, teletherapy
units, and gamma
stereotactic
radiosurgery units.
35.690(b)(1)(ii)..................... Amend................... Training for use of B B
remote afterloader
units, teletherapy
units, and gamma
stereotactic
radiosurgery units.
35.690(b)(3)......................... Amend................... Training for use of B B
remote afterloader
units, teletherapy
units, and gamma
stereotactic
radiosurgery units.
[[Page 42434]]
35.690(b)(3)(i)...................... New..................... Training for use of .......... B
remote afterloader
units, teletherapy
units, and gamma
stereotactic
radiosurgery units.
35.690(b)(3)(ii)..................... New..................... Training for use of .......... B
remote afterloader
units, teletherapy
units, and gamma
stereotactic
radiosurgery units.
35.2024(c)........................... New..................... Records of authority .......... D
and responsibilities
for radiation
protection programs.
35.2024(c)(1)........................ New..................... Records of authority .......... D
and responsibilities
for radiation
protection programs.
35.2024(c)(2)........................ New..................... Records of authority .......... D
and responsibilities
for radiation
protection programs.
35.2310.............................. Amend................... Records of safety D D
instruction.
35.2655(a)........................... Amend................... Records of full- D D
inspection servicing
for teletherapy and
gamma stereotactic
radiosurgery units.
35.3045(a)(1)........................ Amend................... Report and notification C B
of a medical event.
35.3045(a)(2)........................ New..................... Report and notification .......... B
of a medical event.
35.3204(a)........................... New..................... Report and notification .......... C
for an eluate
exceeding permissible
molybdenum-99,
strontium-82, and
strontium-85
concentrations.
35.3204(b)........................... New..................... Report and notification .......... C
for an eluate
exceeding permissible
molybdenum-99,
strontium-82, and
strontium-85
concentrations.
----------------------------------------------------------------------------------------------------------------
IX. Coordination With the Advisory Committee on the Medical Uses of
Isotopes
The NRC staff consults with the ACMUI whenever it identifies an
issue with implementation of 10 CFR part 35 regulations. Accordingly,
issues leading to these proposed amendments have been discussed at
ACMUI meetings over the past 9 years. The ACMUI meetings are
transcribed. Full transcripts of the ACMUI meetings can be found online
in the NRC Library at http://www.nrc.gov/reading-rm/doc-collections/acmui/tr. In addition, in SRM-SECY-10-0062, the Commission specifically
directed the staff to engage the ACMUI in developing the ME definition
criterion for permanent implant brachytherapy. Further, the proposals
to revise T&E requirements to eliminate preceptor attestation for
board-certified individuals, change the language of the attestation,
and allow a residency director to provide preceptor attestations were
initiated by the ACMUI in its briefing to the Commission held on April
29, 2008 (discussed in detail in item b in Section IV, Discussion, of
this document). Similarly, the issue of naming more than one RSO was
initiated by the ACMUI at the June 2007 ACMUI meeting (discussed in
detail in item d in Section IV, Discussion, of this document). Finally,
the entire ACMUI meeting held on April 20-21, 2011, was devoted to
discussion of the rulemaking issues addressed in this proposed rule, so
that the staff would be better able to understand ACMUI's position and
views on the issues raised.
In December 2012, the NRC provided the preliminary draft proposed
rule to the ACMUI for a 90-day review. The draft (ADAMS Accession No.
ML13014A487) was made public to facilitate the ACMUI review in a public
forum. The ACMUI discussed the draft proposed rule at two publicly held
teleconferences on March 5 and March 12, 2013 (conference transcripts
are available in ADAMS at ML13087A474 and ML13087A477, respectively),
and provided a final report to the NRC on April 9, 2013 (ADAMS
Accession No. ML13071A690).
While the ACMUI was supportive of most of the proposed amendments,
it expressed concerns on some issues and provided its recommendations
on those issues. Several comments resulted in revisions to the
discussion section of this document to provide additional emphasis or
clarity. However, the NRC did not accept all of the ACMUI
recommendations. The recommendations that the staff did not accept are
discussed in a document entitled, ``NRC Staff Responses to the ACMUI
Comments on the draft Part 35 Proposed Rule'' (ADAMS Accession No.
ML13179A073).
In addition, in the report, the ACMUI recommended that for
permanent implant brachytherapy procedures, licensees be allowed to use
total source strength as a substitute for total dose for determining
MEs until the 10 CFR part 35 rulemaking is completed. In response, on
July 9, 2013, the Commission issued an interim enforcement policy (78
FR 41125) that addresses this issue.
X. Plain Writing
The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal
agencies to write documents in a clear, concise, and well-organized
manner. The NRC has written this document to be consistent with the
Plain Writing Act as well as the Presidential Memorandum, ``Plain
Language in Government Writing,'' published June 10, 1998 (63 FR
31883). The NRC requests comment on the proposed rule with respect to
the clarity and effectiveness of the language used.
XI. Consistency With Medical Policy Statement
The proposed amendments to 10 CFR part 35 are consistent with the
Commission's Medical Use Policy Statement published August 3, 2000 (65
FR 47654). This proposed rule is consistent with the Commission's
statement because it balances the interests of the patient with the
flexibility needed by the AU to take the actions that he or she deems
medically necessary, while continuing to enable the NRC to detect
deficiencies in processes, procedures, and training, as well as any
misapplication of byproduct materials.
XII. Voluntary Consensus Standards
The National Technology Transfer and Advancement 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 proposed rule, the NRC would amend its
medical use
[[Page 42435]]
regulations related to ME definitions for permanent implant
brachytherapy; T&E requirements for AUs, medical physicists, RSOs, and
nuclear pharmacists; consideration of the Ritenour Petition (PRM-35-20)
to ``grandfather'' certain experienced individuals; measuring Mo
contamination for each elution and reporting of failed breakthrough
tests; naming ARSOs on a medical license; and several minor
clarifications.
The NRC is not aware of any voluntary consensus standards that
address the proposed subject matter of this proposed rule. The NRC will
consider using a voluntary consensus standard if an appropriate
standard is identified. If a voluntary consensus standard is identified
for consideration, the submittal should explain why the standard should
be used.
XIII. Environmental Impact: Categorical Exclusion
The NRC has determined that the following actions in the proposed
rule are the types of actions described in categorical exclusions in 10
CFR 51.22(c)(2) and (c)(3)(i-v):
(1) The amendments to the general administrative requirements and
general technical requirements meet the categorical exclusion criteria
under Sec. 51.22 (c)(2).
(2) The amendments to sealed sources usage provide clarifications
to the current regulations and meet the categorical exclusion criteria
under Sec. 51.22(c)(2).
(3) The amendments to the requirements for reporting MEs and
reporting failed generator tests meet the categorical exclusion
criteria under Sec. 51.22(c)(3)(iii).
(4) The amendments related to the record-keeping requirements meet
the categorical exclusion criteria under Sec. 51.22(c)(3)(ii).
(5) The amendments related to the T&E requirements meet the
categorical exclusion criteria under Sec. 51.22(c)(3)(iv).
There are two proposed amendments that do not meet the categorical
exclusions in Sec. 51.22. Therefore, a draft environmental assessment
has been prepared for this proposed rule for the two proposed actions
that do not meet the categorical exclusions in Sec. 51.22 and is
discussed in Section XIV, Finding of No Significant Environmental
Impact: Availability, of this document. The proposed amendments that do
not meet the categorical exclusions in Sec. 51.22 are: (1) Increase
frequency of measuring Mo-99 tests required in Sec. 35.204, and (2)
increase the full inspection time interval for a gamma stereotactic
radiosurgery unit from 5 years to 7 years in Sec. 35.655.
XIV. Finding of No Significant Environmental Impact: Availability
The Commission has determined under the National Environmental
Policy Act of 1969, as amended, and the Commission's regulations in
subpart A of 10 CFR part 51, not to prepare an environmental impact
statement for this proposed rule because the Commission has concluded
on the basis of a draft environmental assessment that this proposed
rule, if adopted, would not be a major Federal action significantly
affecting the quality of the human environment. The amendments would
relax certain requirements and eliminate other procedural restrictions
associated with the medical use of byproduct material. The Commission
believes these amendments would provide greater flexibility in the
medical use of byproduct material while continuing to adequately
protect public health and safety. It is expected that this rule, if
adopted, would not cause any significant increase in radiation exposure
to the public or radiation release to the environment beyond the
exposures or releases currently resulting from the medical use of
byproduct material.
The determination of this draft environmental assessment is that
there will be no significant impact to the public from this action.
However, the general public should note that the NRC welcomes public
participation and comments on any aspect of the Environmental
Assessment.
The NRC has sent a copy of the Draft Environmental Assessment and
this proposed rule to every State Liaison Officer and requested their
comments on the Draft Environmental Assessment. The Draft Environmental
Assessment is available in ADAMS under Accession No. ML14184A621.
XV. Paperwork Reduction Act Statement
This proposed rule amends information collection requirements that
are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.). The rule would reduce the burden for existing information
collection requirements. This rule has been submitted to the Office of
Management and Budget for review and approval of the paperwork
requirements.
Type of submission, new or revision: Revision.
The title of the information collection: 10 CFR parts 30, 32, and
35, Medical Use of Byproduct Material--Medical Event Definitions,
Training and Experience, and Clarifying Amendments, Proposed Rule.
The form number if applicable: NRC Form 313A Series, ``Authorized
User Training and Experience and Preceptor Attestation.''
How often the collection is required: The information is collected
as needed. Reports required under the proposed rule are based on events
that exceed limits stipulated by various sections of the proposed rule.
The NRC Form 313A Series or equivalent is required when an applicant or
licensee applies to have a new individual identified as an AU, RSO,
ARSO, ANP, or an AMP on a medical use license during a new license, a
renewal, or an amendment request.
Who will be required or asked to report: Persons licensed under 10
CFR parts 30, 32, and 35 who possess and use certain byproduct material
for medical use.
An estimate of the number of annual responses: 28,049 (4,095 NRC
licensees/23,954 Agreement State licensees).
The estimated number of annual respondents: 7,845 (1,085 NRC/6,401
Agreement State medical use licensees) and (52 NRC and 307 Agreement
State radiopharmacy licensees).
An estimate of the total number of hours needed annually to
complete the requirement or request: 6,671 hours (963.75 NRC licensees/
5,739.75 Agreement State licensees/-32.5 third-party burden).
Abstract: The NRC is proposing to amend its regulations related to
the medical use of byproduct material. In this action the NRC addresses
three ongoing rulemaking projects and several other related topics.
First, this rule proposes amendments to the reporting and notification
requirements for a ME for permanent implant brachytherapy. Second, the
rule proposes changes to the T&E requirements for AUs, medical
physicists, RSOs, and nuclear pharmacists; changes to the requirements
for measuring Mo contaminations and reporting of failed Tc and Rb
generators; and changes that would allow ARSOs to be named on a medical
license, as well as other clarifying and conforming amendments. Third,
the NRC is considering a request filed in a petition for rulemaking
(PRM-35-20) to ``grandfather'' certain board-certified individuals.
The NRC is seeking public comment on the potential impact of the
information collections contained in the proposed rule and on the
following issues:
1. Is the proposed information collection necessary for the proper
performance of the functions of the
[[Page 42436]]
NRC, including whether the information will have practical utility?
2. Is the estimate of burden accurate?
3. Is there a way to enhance the quality, utility, and clarity of
the information to be collected?
4. How can the burden of the information collection be minimized,
including the use of automated collection techniques?
The public may examine and have copied, for a fee, publicly
available documents, including the draft supporting statement, at the
NRC's PDR, One White Flint North, 11555 Rockville Pike, Room O-1 F21,
Rockville, MD 20852. The OMB clearance package and rule are available
at the NRC's Web site: http://www.nrc.gov/public-involve/doc-comment/omb/index.html for 60 days after the signature date of this notice.
Send comments on any aspect of these proposed information
collections, including suggestions for reducing the burden and on the
above issues, by August 20, 2014 to the FOIA, Privacy, and Information
Collections Branch (T-5 F53), U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, or by Internet electronic mail to
[email protected] and to the Desk Officer, Danielle Y.
Jones, Office of Information and Regulatory Affairs, NEOB-10202, (3150-
AI63), Office of Management and Budget, Washington, DC 20503. Comments
received after this date will be considered if it is practical to do
so, but assurance of consideration cannot be given to comments received
after this date. You may also email comments to [email protected] or comment by telephone at (202) 395-1741.
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.
XVI. Regulatory Analysis
The Commission has prepared a draft regulatory analysis on this
proposed regulation. The analysis examines the costs and benefits of
the alternatives considered by the Commission.
The Commission requests public comment on the draft regulatory
analysis. The draft regulatory analysis is available in ADAMS under
Accession No. ML14184A620
XVII. Regulatory Flexibility Certification
In accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C.
605(b)), the Commission certifies that this rule would not, if
promulgated, have a significant economic impact on a substantial number
of small entities. An estimate is provided in Appendix A of the draft
Regulatory Analysis for this proposed regulation (ADAMS Accession No.
ML14184A620). The NRC is seeking public comment on the potential impact
of the proposed rule on small entities. The NRC particularly desires
comment from licensees who qualify as small businesses, specifically as
to how the proposed regulation will affect them and how the regulation
may be tiered or otherwise modified to impose less stringent
requirements on small entities while still adequately protecting the
public health and safety and common defense and security. Comments on
how the regulation could be modified to take into account the differing
needs of small entities should specifically discuss--
(a) The size of the business and how the proposed regulation would
result in a significant economic burden upon it as compared to a larger
organization in the same business community;
(b) If the proposed regulation could be further modified to take
into account the business's differing needs or capabilities;
(c) The benefits that would accrue, or the detriments that would be
avoided, if the proposed regulation was modified as suggested by the
commenter;
(d) How the proposed regulation, as modified, would more closely
equalize the impact of the NRC's regulations as opposed to providing
special advantages to any individuals or groups; and
(e) How the proposed regulation, as modified, would still
adequately protect the public health and safety and common defense and
security.
XVIII. Backfitting and Issue Finality
The backfitting rule and issue finality provisions of 10 CFR part
52 (which are found in the regulations at Sec. Sec. 50.109, 70.76,
72.62, 76.76, and in 10 CFR part 52) do not apply to this proposed
rule. Title 10 of the CFR parts 30, 32, and 35 do not contain a
backfitting requirement. Therefore, a backfitting analysis is not
required.
List of Subjects
10 CFR Part 30
Byproduct material, Criminal penalties, Government contracts,
Intergovernmental relations, Isotopes, Nuclear materials, Radiation
protection, Reporting and recordkeeping requirements.
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.
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 proposing
to adopt the following amendments to 10 CFR parts 30, 32, and 35.
PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF
BYPRODUCT MATERIAL
0
1. The authority citation for part 30 is revised to read as follows:
Authority: Atomic Energy Act secs. 81, 82, 161, 181, 182, 183,
186, 223, 234 (42 U.S.C. 2111, 2112, 2201, 2231, 2232, 2233, 2236,
2273, 2282); Energy Reorganization Act secs. 201, 202, 206 (42
U.S.C. 5841, 5842, 5846); Government Paperwork Elimination Act sec.
1704 (44 U.S.C. 3504 note); Energy Policy Act of 2005, Pub. L. 109-
58, 119 Stat. 549 (2005).
Section 30.7 also issued under Energy Reorganization Act sec.
211, Pub. L. 95-601, sec. 10, as amended by Pub. L. 102-486, sec.
2902 (42 U.S.C. 5851). Section 30.34(b) also issued under Atomic
Energy Act sec. 184 (42 U.S.C. 2234). Section 30.61 also issued
under Atomic Energy Act sec. 187 (42 U.S.C. 2237).
0
2. In Sec. 30.34, add a third sentence to paragraph (g) to read as
follows:
Sec. 30.34 Terms and conditions of licenses.
* * * * *
(g) * * * The licensee shall report the results of any test that
exceeds the permissible concentration listed in Sec. 35.204(a), in
accordance with Sec. 35.3204 of this chapter.
* * * * *
PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
0
3. The authority citation for part 32 is revised to read as follows:
Authority: Atomic Energy Act secs. 81, 161, 181, 182, 183, 223,
234 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 2282); Energy
[[Page 42437]]
Reorganization Act sec. 201 (42 U.S.C. 5841); Government Paperwork
Elimination Act sec. 1704 (44 U.S.C. 3504 note); Energy Policy Act
of 2005, sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810 (42 U.S.C.
2014, 2021, 2021b, 2111).
0
4. In Sec. 32.72, revise paragraphs (a)(4) and (b)(5)(i), redesignate
paragraph (d) as paragraph (e), and add a new paragraph (d) 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.
(a) * * *
(4) The applicant commits to the following label requirements:
* * * * *
(b) * * *
(5) * * *
(i) A copy of each individual's 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; or
* * * * *
(d) A licensee shall satisfy the labeling requirements in (a)(4) of
this section.
* * * * *
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
0
5. The authority citation for part 35 is revised to read as follows:
Authority: Atomic Energy Act secs. 81, 161, 181, 182, 183, 223,
234 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 2282); Energy
Reorganization Act sec. 201, 206 (42 U.S.C. 5841, 5842, 5846);
Government Paperwork Elimination Act sec. 1704 (44 U.S.C. 3504
note); Energy Policy Act of 2005, sec. 651(e), Pub. L. No. 109-58,
119 Stat. 806-810 (42 U.S.C. 2014, 2021, 2021b, 2111).
0
6. In Sec. 35.2, add, in alphabetical order, the definitions for
Associate Radiation Safety Officer and Ophthalmic physicist and revise
the definition for Preceptor to read as follows:
Sec. 35.2 Definitions.
* * * * *
Associate Radiation Safety Officer means an individual who--
(1) Meets the requirements in Sec. Sec. 35.50 and 35.59; and
(2) Is currently identified as an Associate Radiation Safety
Officer for the types of use of byproduct material for which the
individual has been assigned duties and tasks by the Radiation Safety
Officer on--
(i) A specific medical use license issued by the Commission or an
Agreement State; or
(ii) A medical use permit issued by a Commission master material
licensee.
* * * * *
Ophthalmic physicist means an individual who meets the requirements
in Sec. 35.433(a)(2) and is identified as an ophthalmic physicist on a
specific medical use license issued by the Commission or an Agreement
State or a medical use permit issued by a Commission master material
licensee.
* * * * *
Preceptor means an individual who provides, directs, or verifies
training and experience required for an individual to become an
authorized user, an authorized medical physicist, an authorized nuclear
pharmacist, a Radiation Safety Officer, or an Associate Radiation
Safety Officer.
* * * * *
0
7. In Sec. 35.12, revise paragraphs (b)(1), (c), and (d) to read as
follows:
Sec. 35.12 Application for license, amendment, or renewal.
* * * * *
(b) * * *
(1) Filing an original NRC Form 313, ``Application for Material
License,'' that includes the facility diagram, equipment, and training
and experience qualifications of the Radiation Safety Officer,
Associate Radiation Safety Officer(s), authorized user(s), authorized
medical physicist(s), ophthalmic physicist(s), and authorized nuclear
pharmacist(s); and
* * * * *
(c) A request for a license amendment or renewal must be made by--
(1) Submitting an original of either--
(i) NRC Form 313, ``Application for Material License''; or
(ii) A letter containing all information required by NRC Form 313;
and
(2) Submitting procedures required by Sec. Sec. 35.610, 35.642,
35.643, and 35.645, as applicable.
(d) In addition to the requirements in paragraphs (b) and (c) of
this section, an application for a license or amendment for medical use
of byproduct material as described in Sec. 35.1000 must also include:
(1) Any additional aspects of the medical use of the material that
are applicable to radiation safety that are not addressed in, or differ
from, subparts A through C, L, and M of this part;
(2) Identification of and commitment to follow the applicable
radiation safety program requirements in subparts D through H of this
part that are appropriate for the specific Sec. 35.1000 medical use;
(3) Any additional specific information on--
(i) Radiation safety precautions and instructions;
(ii) Methodology for measurement of dosages or doses to be
administered to patients or human research subjects; and
(iii) Calibration, maintenance, and repair of instruments and
equipment necessary for radiation safety; and
(4) Any other information requested by the Commission in its review
of the application.
* * * * *
0
8. In Sec. 35.13, revise paragraph (b), redesignate paragraphs (d)
through (g) as paragraphs (e) through (h), revise redesignated
paragraphs (g) and (h), and add new paragraphs (d) and (i) to read as
follows:
Sec. 35.13 License amendments.
* * * * *
(b) Before it permits anyone to work as an authorized user,
authorized medical physicist, ophthalmic physicist, or authorized
nuclear pharmacist under the license, except--
(1) For an authorized user, an individual who 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), and 35.690(a);
(2) For an authorized nuclear pharmacist, an individual who meets
the requirements in Sec. Sec. 35.55(a) and 35.59;
(3) For an authorized medical physicist, an individual who meets
the requirements in Sec. Sec. 35.51(a) and 35.59;
(4) An individual who is identified as an authorized user, an
authorized nuclear pharmacist, authorized medical physicist, or an
ophthalmic physicist--
* * * * *
(d) Before it permits anyone to work as an Associate Radiation
Safety Officer, or before the Radiation Safety Officer assigns duties
and tasks to an Associate Radiation Safety Officer that differ from
those for which this individual is authorized on the license;
* * * * *
(g) Before it changes the address(es) of use identified in the
application or on the license;
(h) Before it revises procedures required by Sec. Sec. 35.610,
35.642, 35.643, and 35.645, as applicable, where such revision reduces
radiation safety; and
(i) Before it receives a sealed source from a different
manufacturer or of a different model number than authorized by its
license unless the sealed source is used for manual brachytherapy, is
listed in the Sealed Source and Device Registry, and is in a quantity
and for an isotope authorized by the license.
0
9. In Sec. 35.14, revise paragraphs (a) and (b) to read as follows:
[[Page 42438]]
Sec. 35.14 Notifications.
(a) A licensee shall provide the Commission, no later than 30 days
after the date that the licensee permits an individual to work under
the provisions of Sec. 35.13(b) as an authorized user, authorized
medical physicist, ophthalmic physicist, or authorized nuclear
pharmacist--
(1) A copy of the board certification and as appropriate,
verification of completion of:
(i) Training for the authorized medical physicist under Sec.
35.51(c);
(ii) Any additional case experience required in Sec.
35.390(b)(1)(ii)(G) for an authorized user under Sec. 35.300; or
(iii) Device specific training in Sec. 35.690(c) for the
authorized user under Sec. 35.600; or
(2) A copy of the Commission or Agreement State license, the permit
issued by a Commission master material licensee, the permit issued by a
Commission or Agreement State licensee of broad scope, the permit
issued by a Commission master material license broad scope permittee,
or documentation that only accelerator-produced radioactive materials,
discrete sources of radium-226, or both, were used for medical use or
in the practice of nuclear pharmacy at a Government agency or Federally
recognized Indian Tribe before November 30, 2007, or at all other
locations of use before August 8, 2009, or an earlier date as noticed
by the NRC for each individual that the licensee permits to work under
the provisions of this section. The licensee shall only permit the
individual to work with materials and uses previously authorized as an
authorized user, an authorized medical physicist, ophthalmic physicist,
or an authorized nuclear pharmacist under Sec. 35.13(b).
(b) A licensee shall notify the Commission no later than 30 days
after:
(1) An authorized user, an authorized nuclear pharmacist, a
Radiation Safety Officer, an Associate Radiation Safety Officer, an
authorized medical physicist, or ophthalmic physicist permanently
discontinues performance of duties under the license or has a name
change;
(2) The licensee permits an individual qualified to be a Radiation
Safety Officer under Sec. Sec. 35.50 and 35.59 to function as a
temporary Radiation Safety Officer and to perform the functions of a
Radiation Safety Officer in accordance with Sec. 35.24(c);
(3) The licensee's mailing address changes;
(4) The licensee's name changes, but the name change does not
constitute a transfer of control of the license as described in Sec.
30.34(b) of this chapter;
(5) The licensee has added to or changed the areas of use
identified in the application or on the license where byproduct
material is used in accordance with either--
(i) Sec. 35.100 or Sec. 35.200 if the change does not include
addition or relocation of either an area where PET radionuclides are
produced, or
(ii) A PET radioactive drug delivery line from the PET
radionuclide/PET radioactive drug production area; or
(6) The licensee obtains a sealed source for use in manual
brachytherapy from a different manufacturer or with a different model
number than authorized by its license for which it did not require a
license amendment as provided in section 35.13(i). The notification
must include the manufacturer and model number of the sealed source,
the isotope, and the quantity per sealed source.
* * * * *
0
10. In Sec. 35.24, revise paragraphs (b) and (c) to read as follows:
Sec. 35.24 Authority and responsibilities for the radiation
protection program.
* * * * *
(b) A licensee's management shall appoint a Radiation Safety
Officer who agrees, in writing, to be responsible for implementing the
radiation protection program. The licensee, through the Radiation
Safety Officer, shall ensure that radiation safety activities are being
performed in accordance with licensee-approved procedures and
regulatory requirements. The Radiation Safety Officer may delegate
duties and tasks but shall not delegate the authority or
responsibilities for implementing the radiation protection program. A
licensee's management may appoint, in writing, one or more Associate
Radiation Safety Officers to support the Radiation Safety Officer. The
Radiation Safety Officer, with written agreement of the licensee's
management, must assign the specific duties and tasks to each Associate
Radiation Safety Officer. The Associate Radiation Safety Officer must
agree, in writing, to the list of the specific duties and tasks. These
duties and tasks are restricted to the types of use for which the
Associate Radiation Safety Officer has radiation safety training.
(c) For up to 60 days each year, a licensee may permit an
individual qualified to be a Radiation Safety Officer, under Sec. Sec.
35.50 and 35.59, to function as a temporary Radiation Safety Officer
and to perform the functions of a Radiation Safety Officer, as provided
in paragraph (g) of this section, if the licensee takes the actions
required in paragraphs (b), (e), (g), and (h) of this section and
notifies the Commission in accordance with Sec. 35.14(b).
* * * * *
0
11. In Sec. 35.40, revise paragraphs (b) and (c) to read as follows:
Sec. 35.40 Written directives.
* * * * *
(b) The written directive must contain the patient or human
research subject's name and the following information--
(1) For any administration of quantities greater than 1.11 MBq (30
[micro]Ci) of sodium iodide I-131: The dosage;
(2) For an administration of a therapeutic dosage of unsealed
byproduct material other than sodium iodide I-131: The radioactive
drug, dosage, and route of administration;
(3) For gamma stereotactic radiosurgery: The total dose, treatment
site, and values for the target coordinate settings per treatment for
each anatomically distinct treatment site;
(4) For teletherapy: The total dose, dose per fraction, number of
fractions, and treatment site;
(5) For high dose-rate remote afterloading brachytherapy: The
radionuclide, treatment site, dose per fraction, number of fractions,
and total dose;
(6) For permanent implant brachytherapy:
(i) Before implantation: The treatment site, the radionuclide, the
intended absorbed dose to the treatment site and the corresponding
calculated total source strength required, and if appropriate, the
expected absorbed doses to normal tissues located within the treatment
site; and
(ii) After implantation but before the patient leaves the post-
treatment recovery area: The number of sources implanted, the total
source strength implanted, the signature of an authorized user for
Sec. 35.400 uses for manual brachytherapy, and the date; or
(7) For all other brachytherapy, including low, medium, and pulsed
dose rate remote afterloaders:
(i) Before implantation: Treatment site, the radionuclide, and
dose; and
(ii) After implantation but before completion of the procedure: The
radionuclide, treatment site, number of sources, total source strength
and exposure time (or the total dose), the signature of an authorized
user for Sec. 35.400 uses for manual brachytherapy, and the date.
(c)(1) A written revision to an existing written directive may be
made if the revision is dated and signed by an authorized user before
the administration of the dosage of unsealed
[[Page 42439]]
byproduct material, the brachytherapy dose, the gamma stereotactic
radiosurgery dose, the teletherapy dose, or the next fractional dose.
(2) If, because of the patient's condition, a delay in order to
provide a written revision to an existing written directive would
jeopardize the patient's health, an oral revision to an existing
written directive is acceptable. The oral revision must be documented
as soon as possible in the patient's record. A revised written
directive must be signed by the authorized user within 48 hours of the
oral revision.
* * * * *
0
12. In Sec. 35.41, revise paragraph (b) to read as follows:
Sec. 35.41 Procedures for administrations requiring a written
directive.
* * * * *
(b) At a minimum, the procedures required by paragraph (a) of this
section must address the following items that are applicable to the
licensee's use of byproduct material--
(1) Verifying the identity of the patient or human research
subject;
(2) Verifying that the administration is in accordance with the
treatment plan, if applicable, and the written directive;
(3) Checking both manual and computer-generated dose calculations;
(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;
(5) Determining if a medical event, as defined in Sec. 35.3045,
has occurred; and
(6) Determining, for permanent implant brachytherapy, within 60
calendar days from the date the implant was performed unless
accompanied by a written justification related to patient
unavailability:
(i) The total source strength administered outside of the treatment
site compared to the total source strength documented in the post-
implantation portion of the written directive;
(ii) The absorbed dose to the maximally exposed 5 contiguous cubic
centimeters of normal tissue located outside of the treatment site; and
(iii) The absorbed dose to the maximally exposed 5 contiguous cubic
centimeters of normal tissue located within the treatment site.
* * * * *
0
13. Revise Sec. 35.50 to read as follows:
Sec. 35.50 Training for Radiation Safety Officer and Associate
Radiation Safety Officer.
Except as provided in Sec. 35.57, the licensee shall require an
individual fulfilling the responsibilities of the Radiation Safety
Officer or an individual assigned the duties and tasks as an Associate
Radiation Safety Officer as provided in Sec. 35.24 to be an individual
who--
(a) Is certified by a specialty board whose certification process
has been recognized by the Commission or an Agreement State and who
meets the requirements in paragraph (d) of this section. (The names of
board certifications that have been recognized by the Commission or an
Agreement State will be posted on the NRC's Web page.) To have its
certification process recognized, a specialty board shall require all
candidates for certification to:
(1)(i) Hold a bachelor's or graduate degree from an accredited
college or university in physical science or engineering or biological
science with a minimum of 20 college credits in physical science;
(ii) Have 5 or more years of professional experience in health
physics (graduate training may be substituted for no more than 2 years
of the required experience) including at least 3 years in applied
health physics; and
(iii) Pass an examination administered by diplomates of the
specialty board, which evaluates knowledge and competence in radiation
physics and instrumentation, radiation protection, mathematics
pertaining to the use and measurement of radioactivity, radiation
biology, and radiation dosimetry; or
(2)(i) Hold a master's or doctor's degree in physics, medical
physics, other physical science, engineering, or applied mathematics
from an accredited college or university;
(ii) Have 2 years of full-time practical training and/or supervised
experience in medical physics--
(A) Under the supervision of a medical physicist who is certified
in medical physics by a specialty board recognized by the Commission or
an Agreement State; or
(B) In clinical nuclear medicine facilities providing diagnostic
and/or therapeutic services under the direction of physicians who meet
the requirements for authorized users in Sec. Sec. 35.57, 35.290, or
35.390; and
(iii) Pass an examination, administered by diplomates of the
specialty board, that assesses knowledge and competence in clinical
diagnostic radiological or nuclear medicine physics and in radiation
safety; or
(b)(1) Has completed a structured educational program consisting of
both:
(i) 200 hours of classroom and laboratory training in the following
areas--
(A) Radiation physics and instrumentation;
(B) Radiation protection;
(C) Mathematics pertaining to the use and measurement of
radioactivity;
(D) Radiation biology; and
(E) Radiation dosimetry; and
(ii) One year of full-time radiation safety experience under the
supervision of the individual identified as the Radiation Safety
Officer on a Commission or an Agreement State license or permit issued
by a Commission master material licensee that authorizes similar
type(s) of use(s) of byproduct material. An Associate Radiation Safety
Officer may provide supervision for those areas for which the Associate
Radiation Safety Officer is authorized on a Commission or an Agreement
State license or permit issued by a Commission master material
licensee. The full-time radiation safety experience must involve the
following--
(A) Shipping, receiving, and performing related radiation surveys;
(B) Using and performing checks for proper operation of instruments
used to determine the activity of dosages, survey meters, and
instruments used to measure radionuclides;
(C) Securing and controlling byproduct material;
(D) Using administrative controls to avoid mistakes in the
administration of byproduct material;
(E) Using procedures to prevent or minimize radioactive
contamination and using proper decontamination procedures;
(F) Using emergency procedures to control byproduct material;
(G) Disposing of byproduct material; and
(2) This individual must obtain a written attestation, signed by a
preceptor Radiation Safety Officer or Associate Radiation Safety
Officer who has experience with the radiation safety aspects of similar
types of use of byproduct material for which the individual is seeking
approval as a Radiation Safety Officer or an Associate Radiation Safety
Officer. The written attestation must state that the individual has
satisfactorily completed the requirements in paragraphs (b)(1) and (d)
of this section, and is able to independently fulfill the radiation
safety-related duties as a Radiation Safety Officer or as an Associate
Radiation Safety Officer for a medical use license; or
(c)(1) Is a medical physicist who has been certified by a specialty
board whose certification process has been
[[Page 42440]]
recognized by the Commission or an Agreement State under Sec. 35.51(a)
and has experience in radiation safety for similar types of use of
byproduct material for which the licensee is seeking the approval of
the individual as Radiation Safety Officer or an Associate Radiation
Safety Officer and who meets the requirements in paragraph (d) of this
section; or
(2) Is an authorized user, authorized medical physicist, or
authorized nuclear pharmacist identified on a Commission or an
Agreement State license, a permit issued by a Commission master
material licensee, a permit issued by a Commission or an Agreement
State licensee of broad scope, or a permit issued by a Commission
master material license broad scope permittee and has experience with
the radiation safety aspects of similar types of use of byproduct
material for which the individual has Radiation Safety Officer
responsibilities or Associate Radiation Safety Officer duties and tasks
and who meets the requirements in paragraph (d) of this section; or
(3) Has experience with the radiation safety aspects of the types
of use of byproduct material for which the individual is seeking
simultaneous approval both as the Radiation Safety Officer and the
authorized user on the same new Commission or Agreement State license;
and
(d) Has training in the radiation safety, regulatory issues, and
emergency procedures for the types of use for which a licensee seeks
approval. This training requirement may be satisfied by completing
training that is supervised by a Radiation Safety Officer, an Associate
Radiation Safety Officer, authorized medical physicist, authorized
nuclear pharmacist, or authorized user, as appropriate, who is
authorized for the type(s) of use for which the licensee is seeking
approval.
0
14. In Sec. 35.51, revise the introductory text of paragraph (a), and
revise paragraphs (a)(2)(i) and (b)(2) to read as follows:
Sec. 35.51 Training for an authorized medical physicist.
* * * * *
(a) Is certified by a specialty board whose certification process
has been recognized by the Commission or an Agreement State and who
meets the requirements in paragraph (c) of this section. (The names of
board certifications that have been recognized by the Commission or an
Agreement State will be posted on the NRC's Web page.) To have its
certification process recognized, a specialty board shall require all
candidates for certification to:
* * * * *
(2) * * *
(i) Under the supervision of a medical physicist who is certified
in medical physics by a specialty board whose certification process has
been recognized under this section by the Commission or an Agreement
State; or
* * * * *
(b) * * *
(2) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraphs (b)(1) and (c)
of this section, and is able to independently fulfill the radiation
safety-related duties as an authorized medical physicist for each type
of therapeutic medical unit for which the individual is requesting
authorized medical physicist status. The written attestation must be
signed by a preceptor authorized medical physicist who meets the
requirements in Sec. Sec. 35.51, 35.57, or equivalent Agreement State
requirements for an authorized medical physicist for each type of
therapeutic medical unit for which the individual is requesting
authorized medical physicist status; and
* * * * *
0
15. In Sec. 35.55, revise the introductory text of paragraph (a) and
revise paragraph (b)(2) to read as follows:
Sec. 35.55 Training for an authorized nuclear pharmacist.
* * * * *
(a) Is certified by a specialty board whose certification process
has been recognized by the Commission or an Agreement State. (The names
of board certifications that have been recognized by the Commission or
an Agreement State will be posted on the NRC's Web page.) To have its
certification process recognized, a specialty board shall require all
candidates for certification to:
* * * * *
(b) * * *
(2) Has obtained written attestation, signed by a preceptor-
authorized nuclear pharmacist, that the individual has satisfactorily
completed the requirements in paragraph (b)(1) of this section and is
able to independently fulfill the radiation safety-related duties as an
authorized nuclear pharmacist.
0
16. Revise Sec. 35.57 to read as follows:
Sec. 35.57 Training for experienced Radiation Safety Officer,
teletherapy or medical physicist, authorized medical physicist,
authorized user, nuclear pharmacist, and authorized nuclear pharmacist.
(a)(1) An individual identified on a Commission or an Agreement
State license or a permit issued by a Commission or an Agreement State
broad scope licensee or master material license permit or by a master
material license permittee of broad scope as a Radiation Safety
Officer, a teletherapy or medical physicist, an authorized medical
physicist, a nuclear pharmacist or an authorized nuclear pharmacist on
or before October 24, 2005, need not comply with the training
requirements of Sec. Sec. 35.50, 35.51, or 35.55, respectively. After
January 20, 2015, Radiation Safety Officers and authorized medical
physicists identified in this paragraph must meet the training
requirements in Sec. 35.50(d) or Sec. 35.51(c), as appropriate, for
any material or uses for which they were not authorized prior to this
date.
(2) Any individual certified by the American Board of Health
Physics in Comprehensive Health Physics; American Board of Radiology;
American Board of Nuclear Medicine; American Board of Science in
Nuclear Medicine; Board of Pharmaceutical Specialties in Nuclear
Pharmacy; American Board of Medical Physics in radiation oncology
physics; Royal College of Physicians and Surgeons of Canada in nuclear
medicine; American Osteopathic Board of Radiology; or American
Osteopathic Board of Nuclear Medicine on or before October 24, 2005,
need not comply with the training requirements of Sec. 35.50 to be
identified as a Radiation Safety Officer or as an Associate Radiation
Safety Officer on a Commission or an Agreement State license or
Commission master material license permit for those materials and uses
that these individuals performed on or before October 24, 2005.
(3) Any individual certified by the American Board of Radiology in
therapeutic radiological physics, Roentgen ray and gamma ray physics,
x-ray and radium physics, or radiological physics, or certified by the
American Board of Medical Physics in radiation oncology physics, on or
before October 24, 2005, need not comply with the training requirements
for an authorized medical physicist described in Sec. 35.51, for those
materials and uses that these individuals performed on or before
October 24, 2005.
(4) A Radiation Safety Officer, a medical physicist, or a nuclear
pharmacist, who used only accelerator-produced radioactive materials,
discrete sources of radium-226, or both, for medical uses or in the
practice of nuclear pharmacy at a Government agency or Federally
recognized Indian Tribe before November 30, 2007, or at all other
locations of use before August 8, 2009, or an earlier date as noticed
by the NRC, need not comply with the
[[Page 42441]]
training requirements of Sec. 35.50, Sec. 35.51 or Sec. 35.55,
respectively, when performing the same uses. A nuclear pharmacist, who
prepared only radioactive drugs containing accelerator-produced
radioactive materials, or a medical physicist, who used only
accelerator-produced radioactive materials, at the locations and time
period identified in this paragraph, qualifies as an authorized nuclear
pharmacist or an authorized medical physicist, respectively, for those
materials and uses performed before these dates, for purposes of this
chapter.
(b)(1) Physicians, dentists, or podiatrists identified as
authorized users for the medical use of byproduct material on a license
issued by the Commission or an Agreement State, a permit issued by a
Commission master material licensee, a permit issued by a Commission or
an Agreement State broad scope licensee, or a permit issued by a
Commission master material license broad scope permittee before October
24, 2005, who perform only those medical uses for which they were
authorized on or before that date need not comply with the training
requirements of subparts D through H of this part.
(2) Physicians, dentists, or podiatrists not identified as
authorized users for the medical use of byproduct material on a license
issued by the Commission or an Agreement State, a permit issued by a
Commission master material licensee, a permit issued by a Commission or
an Agreement State broad scope licensee, or a permit issued by a
Commission master material license of broad scope before October 24,
2005, need not comply with the training requirements of Subparts D
through H of this part for those materials and uses that these
individuals performed before October 24, 2005, as follows:
(i) For uses authorized under Sec. 35.100 or Sec. 35.200, or oral
administration of sodium iodide I-131 requiring a written directive for
imaging and localization purposes, a physician who was certified on or
before October 24, 2005, in nuclear medicine by the American Board of
Nuclear Medicine; diagnostic radiology by the American Board of
Radiology; diagnostic radiology or radiology by the American
Osteopathic Board of Radiology; nuclear medicine by the Royal College
of Physicians and Surgeons of Canada; or American Osteopathic Board of
Nuclear Medicine in nuclear medicine;
(ii) For uses authorized under Sec. 35.300, a physician who was
certified on or before October 24, 2005, by the American Board of
Nuclear Medicine; the American Board of Radiology in radiology,
therapeutic radiology, or radiation oncology; nuclear medicine by the
Royal College of Physicians and Surgeons of Canada; or the American
Osteopathic Board of Radiology after 1984;
(iii) For uses authorized under Sec. 35.400 or Sec. 35.600, a
physician who was certified on or before October 24, 2005, in
radiology, therapeutic radiology or radiation oncology by the American
Board of Radiology; radiation oncology by the American Osteopathic
Board of Radiology; radiology, with specialization in radiotherapy, as
a British ``Fellow of the Faculty of Radiology'' or ``Fellow of the
Royal College of Radiology''; or therapeutic radiology by the Canadian
Royal College of Physicians and Surgeons; and
(iv) For uses authorized under Sec. 35.500, a physician who was
certified on or before October 24, 2005, in radiology, diagnostic
radiology, therapeutic radiology, or radiation oncology by the American
Board of Radiology; nuclear medicine by the American Board of Nuclear
Medicine; diagnostic radiology or radiology by the American Osteopathic
Board of Radiology; or nuclear medicine by the Royal College of
Physicians and Surgeons of Canada.
(3) Physicians, dentists, or podiatrists who used only accelerator-
produced radioactive materials, discrete sources of radium-226, or
both, for medical uses performed at a Government agency or Federally
recognized Indian Tribe before November 30, 2007, or at all other
locations of use before August 8, 2009, or an earlier date as noticed
by the NRC, need not comply with the training requirements of subparts
D through H of this part when performing the same medical uses. A
physician, dentist, or podiatrist, who used only accelerator-produced
radioactive materials, discrete sources of radium-226, or both, for
medical uses at the locations and time period identified in this
paragraph, qualifies as an authorized user for those materials and uses
performed before these dates, for purposes of this chapter.
(c) Individuals who need not comply with training requirements as
described in this section may serve as preceptors for, and supervisors
of, applicants seeking authorization on NRC licenses for the same uses
for which these individuals are authorized.
0
17. Revise Sec. 35.65 to read as follows:
Sec. 35.65 Authorization for calibration, transmission, and reference
sources.
(a) Any person authorized by Sec. 35.11 for medical use of
byproduct material may receive, possess, and use any of the following
byproduct material for check, calibration, transmission, and reference
use:
(1) Sealed sources, not exceeding 1.11 GBq (30 mCi) each,
manufactured and distributed by a person licensed under Sec. 32.74 of
this chapter or equivalent Agreement State regulations;
(2) Sealed sources, not exceeding 1.11 GBq (30 mCi) each,
redistributed by a licensee authorized to redistribute the sealed
sources manufactured and distributed by a person licensed under Sec.
32.74 of this chapter or equivalent Agreement State regulations,
providing the redistributed sealed sources are in the original
packaging and shielding and are accompanied by the manufacturer's
approved instructions;
(3) Any byproduct material with a half-life not longer than 120
days in individual amounts not to exceed 0.56 GBq (15 mCi);
(4) Any byproduct material with a half-life longer than 120 days in
individual amounts not to exceed the smaller of 7.4 MBq (200 micro Ci)
or 1000 times the quantities in appendix B of part 30 of this chapter;
or
(5) Technetium-99m in amounts as needed.
(b) Byproduct material authorized by this provision shall not be:
(1) Used for medical use as defined in Sec. 35.2 except in
accordance with the requirements in Sec. 35.500; or
(2) Combined to create (i.e., bundled or aggregated) an activity
greater than the maximum activity of any single sealed source
authorized under this section.
(c) A licensee using calibration, transmission, and reference
sources in accordance with the requirements in paragraphs (a) or (b) of
this section need not list these sources on a specific medical use
license.
0
18. In Sec. 35.190, revise the introductory text of paragraph (a) and
revise paragraph (c)(2) to read as follows:
Sec. 35.190 Training for uptake, dilution, and excretion studies.
* * * * *
(a) Is certified by a medical specialty board whose certification
process has been recognized by the Commission or an Agreement State.
(The names of board certifications that have been recognized by the
Commission or an Agreement State will be posted on the NRC's Web page.)
To have its certification process recognized, a specialty board shall
require all candidates for certification to:
* * * * *
(c) * * *
(2) Has obtained written attestation that the individual has
satisfactorily
[[Page 42442]]
completed the requirements in paragraph (c)(1) of this section and is
able to independently fulfill the radiation safety-related duties as an
authorized user for the medical uses authorized under Sec. 35.100. The
attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in
Sec. Sec. 35.57, 35.190, 35.290, or 35.390, or equivalent Agreement
State requirements; or
(ii) A residency program director who affirms in writing that the
attestation represents the consensus of the residency program faculty
where at least one faculty member is an authorized user who meets the
requirements in Sec. Sec. 35.57, 35.190, 35.290, or 35.390, or
equivalent Agreement State requirements, and concurs with the
attestation provided by the residency program director. The residency
training program must be approved by the Residency Review Committee of
the Accreditation Council for Graduate Medical Education or the Royal
College of Physicians and Surgeons of Canada or the Committee on Post-
Graduate Training of the American Osteopathic Association and must
include training and experience specified in Sec. 35.190.
0
19. In Sec. 35.204, revise paragraph (b) and add a new paragraph (e)
to read as follows:
Sec. 35.204 Permissible molybdenum-99, strontium-82, and strontium-85
concentrations.
* * * * *
(b) A licensee that uses molybdenum-99/technetium-99m generators
for preparing a technetium-99m radiopharmaceutical shall measure the
molybdenum-99 concentration in each eluate after receipt of a generator
to demonstrate compliance with paragraph (a) of this section.
* * * * *
(e) The licensee shall report any measurement that exceeds the
limits in paragraph (a) of this section, in accordance with Sec.
35.3204.
0
20. In Sec. 35.290, revise the introductory text of paragraphs (a) and
(c)(1)(ii), and paragraph (c)(2) to read as follows:
Sec. 35.290 Training for imaging and localization studies.
* * * * *
(a) Is certified by a medical specialty board whose certification
process has been recognized by the Commission or an Agreement State.
(The names of board certifications that have been recognized by the
Commission or an Agreement State will be posted on the NRC's Web page.)
To have its certification process recognized, a specialty board shall
require all candidates for certification to:
* * * * *
(c)(1) * * *
(ii) Work experience, under the supervision of an authorized user
who meets the requirements in Sec. Sec. 35.57, 35.290, or 35.390 and
35.290(c)(1)(ii)(G), or equivalent Agreement State requirements. An
authorized nuclear pharmacist who meets the requirements in Sec. Sec.
35.55 or 35.57 may provide the supervised work experience for paragraph
(c)(1)(ii)(G) of this section. Work experience must involve--
* * * * *
(2) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraph (c)(1) of this
section and is able to independently fulfill the radiation safety-
related duties as an authorized user for the medical uses authorized
under Sec. Sec. 35.100 and 35.200. The attestation must be obtained
from either:
(i) A preceptor authorized user who meets the requirements in
Sec. Sec. 35.57, 35.290, or 35.390 and 35.290(c)(1)(ii)(G) or
equivalent Agreement State requirements; or
(ii) A residency program director who affirms in writing that the
attestation represents the consensus of the residency program faculty
where at least one faculty member is an authorized user who meets the
requirements in Sec. Sec. 35.57, 35.290, or 35.390 and
35.290(c)(1)(ii)(G), or equivalent Agreement State requirements, and
concurs with the attestation provided by the residency program
director. The residency training program must be approved by the
Residency Review Committee of the Accreditation Council for Graduate
Medical Education or the Royal College of Physicians and Surgeons of
Canada or the Committee on Post-Graduate Training of the American
Osteopathic Association and must include training and experience
specified in Sec. 35.290.
0
21. In Sec. 35.300, revise introductory text to read as follows:
Sec. 35.300 Use of unsealed byproduct material for which a written
directive is required.
A licensee may use any unsealed byproduct material identified in
Sec. 35.390(b)(1)(ii)(G) prepared for medical use and for which a
written directive is required that is--
* * * * *
0
22. In Sec. 35.390, revise the introductory text of paragraph (a), and
revise paragraphs (b)(1)(ii)(G) and (b)(2), and add a new paragraph (c)
to read as follows:
Sec. 35.390 Training for use of unsealed byproduct material for which
a written directive is required.
* * * * *
(a) Is certified by a medical specialty board whose certification
process has been recognized by the Commission or an Agreement State and
who meets the requirements in paragraphs (b)(1)(ii)(G) of this section.
(The names of board certifications that have been recognized by the
Commission or an Agreement State will be posted on the NRC's Web page).
To be recognized, a specialty board shall require all candidates for
certification to:
* * * * *
(b)(1) * * *
(ii) * * *
(G) Administering dosages of radioactive drugs to patients or human
research subjects from the four categories in this paragraph.
Radioactive drugs in categories not included in this paragraph are
regulated under Sec. 35.1000. This work experience must involve a
minimum of three cases in each of the following categories for which
the individual is requesting authorized user status--
(1) Oral administration of less than or equal to 1.22
gigabecquerels (33 millicuries) of sodium iodide I-131, for which a
written directive is required;
(2) Oral administration of greater than 1.22 gigabecquerels (33
millicuries) of sodium iodide I-131; \2\
(3) Parenteral administration of any radionuclide that is primarily
used for its electron emission, beta radiation characteristics, or for
its photon energy of less than 150 keV, for which a written directive
is required;
(4) Parenteral administration of any radionuclide that is primarily
used for its alpha radiation characteristics, for which a written
directive is required; and
(2) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraph (b)(1) of this
section and is able to independently fulfill the radiation safety-
related duties as an authorized user for the medical uses authorized
under Sec. 35.300 for which the individual is requesting authorized
user status. The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in
Sec. Sec. 35.57, 35.390, or equivalent Agreement State requirements
and has experience in administering dosages in the same dosage category
or categories as the individual requesting authorized user status; or
(ii) A residency program director who affirms in writing that the
attestation
[[Page 42443]]
represents the consensus of the residency program faculty where at
least one faculty member is an authorized user who meets the
requirements in Sec. 35.57, 35.390, or equivalent Agreement State
requirements, has experience in administering dosages in the same
dosage category or categories as the individual requesting authorized
user status, and concurs with the attestation provided by the residency
program director. The residency training program must be approved by
the Residency Review Committee of the Accreditation Council for
Graduate Medical Education or the Royal College of Physicians and
Surgeons of Canada or the Committee on Post-Graduate Training of the
American Osteopathic Association and must include training and
experience specified in Sec. 35.390; or
(c) Is an authorized user for any of the parenteral administrations
specified in Sec. 35.390(b)(1)(ii)(G) or equivalent Agreement State
requirements. This individual must meet the supervised work experience
requirements in (b)(1)(ii) of this section for each new parenteral
administration listed in Sec. 35.390(b)(1)(ii)(G) for which the
individual is requesting authorized user status.
* * * * *
\2\ Experience with at least three cases in Category (G)(2) also
satisfies the requirement in Category (G)(1).
0
23. In Sec. 35.392, revise paragraphs (a) and (c)(3) 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).
* * * * *
(a) Is certified by a medical specialty board whose certification
process includes all of the requirements in paragraphs (c)(1) and
(c)(2) of this section and whose certification process has been
recognized by the Commission or an Agreement State. (The names of board
certifications that have been recognized by the Commission or an
Agreement State will be posted on the NRC's Web page.); or
* * * * *
(c) * * *
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraphs (c)(1) and
(c)(2) of this section, and is able to independently fulfill the
radiation safety-related duties as an authorized user for oral
administration of less than or equal to 1.22 gigabecquerels (33
millicuries) of sodium iodide I-131 for medical uses authorized under
Sec. 35.300. The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in
Sec. Sec. 35.57, 35.390, 35.392, 35.394, or equivalent Agreement State
requirements and has experience in administering dosages as specified
in Sec. Sec. 35.390(b)(1)(ii)(G)(1) or 35.390(b)(1)(ii)(G)(2); or (ii)
A residency program director who affirms in writing that the
attestation represents the consensus of the residency program faculty
where at least one faculty member is an authorized user who meets the
requirements in Sec. Sec. 35.57, 35.390, 35.392, 35.394, or equivalent
Agreement State requirements, has experience in administering dosages
as specified in Sec. Sec. 35.390(b)(1)(ii)(G)(1) or
35.390(b)(1)(ii)(G)(2), and concurs with the attestation provided by
the residency program director. The residency training program must be
approved by the Residency Review Committee of the Accreditation Council
for Graduate Medical Education or the Royal College of Physicians and
Surgeons of Canada or the Committee on Post-Graduate Training of the
American Osteopathic Association and must include training and
experience specified in Sec. 35.392.
0
24. In Sec. 35.394, revise paragraphs (a) and (c)(3) 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).
* * * * *
(a) Is certified by a medical specialty board whose certification
process includes all of the requirements in paragraphs (c)(1) and
(c)(2) of this section, and whose certification has been recognized by
the Commission or an Agreement State. (The names of board
certifications that have been recognized by the Commission or an
Agreement State will be posted on the NRC's Web page.); or
* * * * *
(c) * * *
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraphs (c)(1) and
(c)(2) of this section, and is able to independently fulfill the
radiation safety-related duties as an authorized user for oral
administration of greater than 1.22 gigabecquerels (33 millicuries) of
sodium iodide I-131 for medical uses authorized under Sec. 35.300. The
attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in
Sec. Sec. 35.57, 35.390, 35.394, or equivalent Agreement State
requirements, and has experience in administering dosages as specified
in Sec. 35.390(b)(1)(ii)(G)(2); or
(ii) A residency program director who affirms in writing that the
attestation represents the consensus of the residency program faculty
where at least one faculty member is an authorized user who meets the
requirements in Sec. Sec. 35.57, 35.390, 35.394, or equivalent
Agreement State requirements, has experience in administering dosages
as specified in Sec. 35.390(b)(1)(ii)(G)(2), and concurs with the
attestation provided by the residency program director. The residency
training program must be approved by the Residency Review Committee of
the Accreditation Council for Graduate Medical Education or the Royal
College of Physicians and Surgeons of Canada or the Committee on Post-
Graduate Training of the American Osteopathic Association and must
include training and experience specified in Sec. 35.394.
0
25. Revise Sec. 35.396 to read as follows:
Sec. 35.396 Training for the parenteral administration of unsealed
byproduct material requiring a written directive.
Except as provided in Sec. 35.57, the licensee shall require an
authorized user for the parenteral administration requiring a written
directive, to be a physician who--
(a) Is an authorized user under Sec. 35.390 for uses listed in
Sec. 35.390(b)(1)(ii)(G)(3) or (b)(1)(ii)(G)(4), or equivalent
Agreement State requirements. This individual must meet the supervised
work experience requirements in (d)(2) of this section for each new
parenteral administration listed in Sec. 35.390(b)(1)(ii)(G) for which
the individual is requesting authorized user status;
(b) Is an authorized user under Sec. Sec. 35.490, 35.690, or
equivalent Agreement State requirements and who meets the requirements
in paragraph (d) of this section;
(c) Is certified by a medical specialty board whose certification
process has been recognized by the Commission or an Agreement State
under Sec. Sec. 35.490 or 35.690, and who meets the requirements in
paragraph (d) of this section; or
(d)(1) Has successfully completed 80 hours of classroom and
laboratory training, applicable to parenteral administrations listed in
Sec. 35.390(b)(1)(ii)(G). The training must include--
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics pertaining to the use and measurement of
radioactivity;
(iv) Chemistry of byproduct material for medical use; and
[[Page 42444]]
(v) Radiation biology; and
(2) Has work experience, under the supervision of an authorized
user who meets the requirements in Sec. Sec. 35.57, 35.390, 35.396, or
equivalent Agreement State requirements, in the parenteral
administrations listed in Sec. 35.390(b)(1)(ii)(G). A supervising
authorized user who meets the requirements in Sec. Sec. 35.390,
35.396, or equivalent Agreement State requirements, must have
experience in administering dosages in the same category or categories
as the individual requesting authorized user status. The work
experience must involve--
(i) Ordering, receiving, and unpacking radioactive materials
safely, and performing the related radiation surveys;
(ii) Performing quality control procedures on instruments used to
determine the activity of dosages, and performing checks for proper
operation of survey meters;
(iii) Calculating, measuring, and safely preparing patient or human
research subject dosages;
(iv) Using administrative controls to prevent a medical event
involving the use of unsealed byproduct material;
(v) Using procedures to contain spilled byproduct material safely,
and using proper decontamination procedures; and
(vi) Administering dosages to patients or human research subjects,
that include at least three cases in each category of the parenteral
administrations as specified in Sec. 35.390(b)(1)(ii)(G) for which the
individual is requesting authorized user status; and
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraph (d)(1) and
(d)(2) of this section, and is able to independently fulfill the
radiation safety-related duties as an authorized user for the
parenteral administration of unsealed byproduct material requiring a
written directive. The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in
Sec. Sec. 35.57, 35.390, 35.396, or equivalent Agreement State
requirements. A preceptor authorized user who meets the requirements in
Sec. 35.390, 35.396, or equivalent Agreement State requirements, must
have experience in administering dosages in the same category or
categories as the individual requesting authorized user status; or
(ii) A residency program director who affirms in writing that the
attestation represents the consensus of the residency program faculty
where at least one faculty member is an authorized user who meets the
requirements in Sec. Sec. 35.57, 35.390, 35.396, or equivalent
Agreement State requirements, has experience in administering dosages
in the same dosage category or categories as the individual requesting
authorized user status, and concurs with the attestation provided by
the residency program director. The residency training program must be
approved by the Residency Review Committee of the Accreditation Council
for Graduate Medical Education or the Royal College of Physicians and
Surgeons of Canada or the Committee on Post-Graduate Training of the
American Osteopathic Association and must include training and
experience specified in Sec. 35.396.
0
26. Revise Sec. 35.400 to read as follows:
Sec. 35.400 Use of sources for manual brachytherapy.
A licensee must use only brachytherapy sources:
(a) Approved in the Sealed Source and Device Registry to deliver
therapeutic doses for medical use. The manual brachytherapy sources may
be used for manual brachytherapy uses that are not explicitly listed in
the Sealed Source and Device Registry, but must be used in accordance
with the radiation safety conditions and limitations described in the
Sealed Source and Device Registry; or
(b) In research to deliver therapeutic doses for medical use in
accordance with an active Investigational Device Exemption (IDE)
application accepted by the FDA provided the requirements of Sec.
35.49(a) are met.
0
27. Revise Sec. 35.433 to read as follows:
Sec. 35.433 Strontium-90 sources for ophthalmic treatments.
(a) Licensees who use strontium-90 for ophthalmic treatments must
ensure that certain activities as specified in paragraph (b) of this
section are performed by either:
(1) An authorized medical physicist; or
(2) An individual who holds a master's or doctor's degree in
physics, medical physics, other physical sciences, engineering, or
applied mathematics from an accredited college or university and has
successfully completed 2 years of full-time practical training and/or
supervised experience in medical physics and has documented training
in:
(i) The creating, modifying, and completing of written directives;
(ii) Procedures for administrations requiring a written directive;
and
(iii) Performing the calibration measurements of brachytherapy
sources as detailed in Sec. 35.432.
(b) The individuals who are identified in paragraph (a) of this
section must:
(1) Calculate the activity of each strontium-90 source that is used
to determine the treatment times for ophthalmic treatments. The decay
must be based on the activity determined under Sec. 35.432; and
(2) Assist the licensee in developing, implementing, and
maintaining written procedures to provide high confidence that the
administration is in accordance with the written directive. These
procedures must include the frequencies that the individual meeting the
requirements in paragraph (a) of this section will observe treatments,
review the treatment methodology, calculate treatment time for the
prescribed dose, and review records to verify that the administrations
were in accordance with the written directives.
(c) Licensees must retain a record of the activity of each
strontium-90 source in accordance with Sec. 35.2433.
0
28. In Sec. 35.490, revise the introductory text of paragraphs (a) and
(b)(1)(ii), and paragraph (b)(3) to read as follows:
Sec. 35.490 Training for use of manual brachytherapy sources.
* * * * *
(a) Is certified by a medical specialty board whose certification
process has been recognized by the Commission or an Agreement State.
(The names of board certifications that have been recognized by the
Commission or an Agreement State will be posted on the NRC's Web page.)
To have its certification process recognized, a specialty board shall
require all candidates for certification to:
* * * * *
(b)(1) * * *
(ii) 500 hours of work experience, under the supervision of an
authorized user who meets the requirements in Sec. Sec. 35.57, 35.490,
or equivalent Agreement State requirements, at a medical facility
authorized to use byproduct materials under Sec. 35.400, involving--
* * * * *
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraphs (b)(1) and
(b)(2) of this section and is able to independently fulfill the
radiation safety-related duties as an authorized user of manual
brachytherapy sources for the medical uses authorized under Sec.
35.400. The attestation must be obtained from either:
(i) A preceptor authorized user who meets the requirements in
Sec. Sec. 35.57, 35.490, or equivalent Agreement State requirements;
or
[[Page 42445]]
(ii) A residency program director who affirms in writing that the
attestation represents the consensus of the residency program faculty
where at least one faculty member is an authorized user who meets the
requirements in Sec. Sec. 35.57, 35.490, or equivalent Agreement State
requirements, and concurs with the attestation provided by the
residency program director. The residency training program must be
approved by the Residency Review Committee of the Accreditation Council
for Graduate Medical Education or the Royal College of Physicians and
Surgeons of Canada or the Committee on Post-Graduate Training of the
American Osteopathic Association and must include training and
experience specified in Sec. 35.490.
0
29. In Sec. 35.491, revise paragraph (b)(3) to read as follows:
Sec. 35.491 Training for ophthalmic use of strontium-90.
* * * * *
(b)(1) * * *
(3) Has obtained written attestation, signed by a preceptor
authorized user who meets the requirements in Sec. Sec. 35.57, 35.490,
35.491, or equivalent Agreement State requirements, that the individual
has satisfactorily completed the requirements in paragraph (b) of this
section and is able to independently fulfill the radiation safety-
related duties as an authorized user of strontium-90 for ophthalmic
use.
0
30. Revise Sec. 35.500 to read as follows:
Sec. 35.500 Use of sealed sources and medical devices for diagnosis.
(a) A licensee must use only sealed sources not in medical devices
for diagnostic medical uses that are approved in the Sealed Source and
Device Registry for diagnostic medicine. The sealed sources may be used
for diagnostic medical uses that are not explicitly listed in the
Sealed Source and Device Registry. The sealed sources must be used in
accordance with the radiation safety conditions and limitations
described in the Sealed Source and Device Registry.
(b) A licensee must only use diagnostic devices containing sealed
sources for diagnostic medical uses if both the sealed sources and
diagnostic devices are approved in the Sealed Source and Device
Registry for diagnostic medical uses. The diagnostic medical devices
may be used for diagnostic medical uses that are not explicitly listed
in the Sealed Source and Device Registry but must be used in accordance
with the radiation safety conditions and limitations described in the
Sealed Source and Device Registry.
(c) Sealed sources and devices for diagnostic medical uses may be
used in research in accordance with an active Investigational Device
Exemption (IDE) application accepted by the FDA provided the
requirements of Sec. 35.49(a) are met.
0
31. Revise Sec. 35.590 to read as follows:
Sec. 35.590 Training for use of sealed sources and medical devices
for diagnosis.
Except as provided in Sec. 35.57, the licensee shall require the
authorized user of a diagnostic sealed source or a device authorized
under Sec. 35.500 to be a physician, dentist, or podiatrist who--
(a) Is certified by a specialty board whose certification process
includes all of the requirements in paragraphs (c) and (d) of this
section and whose certification has been recognized by the Commission
or an Agreement State. (The names of board certifications that have
been recognized by the Commission or an Agreement State will be posted
on the NRC's Web page.);
(b) Is an authorized user for imaging uses listed in Sec. 35.200
or equivalent Agreement State requirements; or
(c) Has completed 8 hours of classroom and laboratory training in
basic radionuclide handling techniques specifically applicable to the
use of the device. The training must include--
(1) Radiation physics and instrumentation;
(2) Radiation protection;
(3) Mathematics pertaining to the use and measurement of
radioactivity; and
(4) Radiation biology; and
(d) Has completed training in the use of the device for the uses
requested.
0
32. Revise Sec. 35.600 to read as follows:
Sec. 35.600 Use of a sealed source in a remote afterloader unit,
teletherapy unit, or gamma stereotactic radiosurgery unit.
(a) A licensee must only use sealed sources:
(1) Approved and as provided for in the Sealed Source and Device
Registry in photon emitting remote afterloader units, teletherapy
units, or gamma stereotactic radiosurgery units to deliver therapeutic
doses for medical uses: or
(2) In research involving photon-emitting remote afterloader units,
teletherapy units, or gamma stereotactic radiosurgery units in
accordance with an active Investigational Device Exemption (IDE)
application accepted by the FDA provided the requirements of Sec.
35.49(a) are met.
(b) A licensee must use photon-emitting remote afterloader units,
teletherapy units, or gamma stereotactic radiosurgery units:
(1) Approved in the Sealed Source and Device Registry to deliver a
therapeutic dose for medical use. These devices may be used for
therapeutic medical treatments that are not explicitly provided for in
the Sealed Source and Device Registry, but must be used in accordance
with radiation safety conditions and limitations described in the
Sealed Source and Device Registry; or
(2) In research in accordance with an active Investigational Device
Exemption (IDE) application accepted by the FDA provided the
requirements of Sec. 35.49(a) are met.
0
33. In Sec. 35.610, revise paragraphs (d) and (g) to read as follows:
Sec. 35.610 Safety procedures and instructions for remote afterloader
units, teletherapy units, and gamma stereotactic radiosurgery units.
* * * * *
(d)(1) Prior to the first use for patient treatment of a new unit
or an existing unit with a manufacturer upgrade that affects the
operation and safety of the unit, a licensee shall ensure that vendor
operational and safety instructions are provided to all individuals who
will operate the unit. The vendor operational and safety instructions
must be provided by the device manufacturer or by individuals certified
by the device manufacturer.
(2) A licensee shall provide operational and safety instructions
initially and at least annually to all individuals who operate the unit
at the facility, as appropriate to the individual's assigned duties.
The instructions shall include instruction in--
(i) The procedures identified in paragraph (a)(4) of this section;
and
(ii) The operating procedures for the unit.
* * * * *
(g) A licensee shall retain a copy of the procedures required by
paragraphs (a)(4) and (d)(2)(ii) of this section in accordance with
Sec. 35.2610.
0
34. In Sec. 35.655, revise the section heading and paragraph (a) to
read as follows:
Sec. 35.655 Full-inspection servicing for teletherapy and gamma
stereotactic radiosurgery units.
(a) A licensee shall have each teletherapy unit and gamma
stereotactic radiosurgery unit fully inspected and serviced during each
source replacement to assure proper functioning of the source exposure
mechanism and other safety components. The interval between each full-
inspection servicing shall not exceed 5 years for each teletherapy unit
[[Page 42446]]
and shall not exceed 7 years for each gamma stereotactic radiosurgery
unit.
* * * * *
0
35. In Sec. 35.690, revise the introductory text of paragraphs (a) and
(b)(1)(ii), and paragraph (b)(3) to read as follows:
Sec. 35.690 Training for use of remote afterloader units, teletherapy
units, and gamma stereotactic radiosurgery units.
* * * * *
(a) Is certified by a medical specialty board whose certification
process has been recognized by the Commission or an Agreement State and
who meets the requirements in paragraph (c) of this section. (The names
of board certifications that have been recognized by the Commission or
an Agreement State will be posted on the NRC's Web page.) To have its
certification process recognized, a specialty board shall require all
candidates for certification to:
* * * * *
(b)(1) * * *
(ii) 500 hours of work experience, under the supervision of an
authorized user who meets the requirements in Sec. Sec. 35.57, 35.690,
or equivalent Agreement State requirements, at a medical facility that
is authorized to use byproduct materials in Sec. 35.600, involving--
* * * * *
(3) Has obtained written attestation that the individual has
satisfactorily completed the requirements in paragraphs (b)(1) and
(b)(2), and paragraph (c), of this section, is able to independently
fulfill the radiation safety-related duties as an authorized user of
each type of therapeutic medical unit for which the individual is
requesting authorized user status. The attestation must be obtained
from either.
(i) A preceptor authorized user who meets the requirements in
Sec. Sec. 35.57, 35.690, or equivalent Agreement State requirements
for the type(s) of therapeutic medical unit for which the individual is
requesting authorized user status; or
(ii) A residency program director who affirms in writing that the
attestation represents the consensus of the residency program faculty
where at least one faculty member is an authorized user who meets the
requirements in Sec. Sec. 35.57, 35.690, or equivalent Agreement State
requirements, for the type(s) of therapeutic medical unit for which the
individual is requesting authorized user status and concurs with the
attestation provided by the residency program director. The residency
training program must be approved by the Residency Review Committee of
the Accreditation Council for Graduate Medical Education or the Royal
College of Physicians and Surgeons of Canada or the Committee on Post-
Graduate Training of the American Osteopathic Association and must
include training and experience specified in Sec. 35.690;
* * * * *
0
36. In Sec. 35.2024, add a new paragraph (c) to read as follows:
Sec. 35.2024 Records of authority and responsibilities for radiation
protection programs.
* * * * *
(c) For each Associate Radiation Safety Officer appointed under
Sec. 35.24(b), the licensee shall retain, for 5 years after the
Associate Radiation Safety Officer is removed from the license, a copy
of:
(1) The written document appointing the Associate Radiation Safety
Officer signed by the licensee's management; and
(2) Each agreement signed by the Associate Radiation Safety Officer
listing the duties and tasks assigned by the Radiation Safety Officer
under Sec. 35.24(b).
0
37. Revise Sec. 35.2310 to read as follows:
Sec. 35.2310 Records of safety instruction.
A licensee shall maintain a record of safety instructions required
by Sec. Sec. 35.310, 35.410, and the operational and safety
instructions required by Sec. 35.610 for 3 years. The record must
include a list of the topics covered, the date of the instruction, the
name(s) of the attendee(s), and the name(s) of the individual(s) who
provided the instruction.
0
38. In Sec. 35.2655, revise the section heading and paragraph (a) to
read as follows:
Sec. 35.2655 Records of full-inspection servicing for teletherapy and
gamma stereotactic radiosurgery units.
(a) A licensee shall maintain a record of the full-inspection
servicing for teletherapy and gamma stereotactic radiosurgery units
required by Sec. 35.655 for the duration of use of the unit.
* * * * *
0
39. In Sec. 35.3045, revise paragraph (a) to read as follows:
Sec. 35.3045 Report and notification of a medical event.
(a) A licensee shall report as a medical event any administration
requiring a written directive, except for an event that results from
patient intervention, in which--
(1) The administration of byproduct material or radiation from
byproduct material, except permanent implant brachytherapy, results
in--
(i) A dose that differs from the prescribed dose or dose that would
have resulted from the prescribed dosage by more than 0.05 Sv (5 rem)
effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or
0.5 Sv (50 rem) shallow dose equivalent to the skin; and
(A) The total dose delivered differs from the prescribed dose by 20
percent or more;
(B) The total dosage delivered differs from the prescribed dosage
by 20 percent or more or falls outside the prescribed dosage range; or
(C) The fractionated dose delivered differs from the prescribed
dose for a single fraction, by 50 percent or more.
(ii) A dose that exceeds 0.05 Sv (5 rem) effective dose equivalent,
0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem) shallow dose
equivalent to the skin from any of the following--
(A) An administration of a wrong radioactive drug containing
byproduct material or the wrong radionuclide for a brachytherapy
procedure;
(B) An administration of a radioactive drug containing byproduct
material by the wrong route of administration;
(C) An administration of a dose or dosage to the wrong individual
or human research subject;
(D) An administration of a dose or dosage delivered by the wrong
mode of treatment; or
(E) A leaking sealed source.
(iii) A dose to the skin or an organ or tissue other than the
treatment site that exceeds by:
(A) 0.5 Sv (50 rem) or more the expected dose to that site from the
procedure if the administration had been given in accordance with the
written directive prepared or revised before administration; and
(B) 50 percent or more the expected dose to that site from the
procedure if the administration had been given in accordance with the
written directive prepared or revised before administration.
(2) For permanent implant brachytherapy, the administration of
byproduct material or radiation from byproduct material that results
in--
(i) The total source strength administered differing by 20 percent
or more from the total source strength documented in the post-
implantation portion of the written directive;
(ii) The total source strength administered outside of the
treatment site exceeding 20 percent of the total source strength
documented in the post-implantation portion of the written directive;
(iii) An absorbed dose to the maximally exposed 5 contiguous cubic
[[Page 42447]]
centimeters of normal tissue located outside of the treatment site that
exceeds by 50 percent or more the absorbed dose prescribed to the
treatment site in the pre-implantation portion of the written directive
approved by an authorized user;
(iv) An absorbed dose to the maximally exposed 5 contiguous cubic
centimeters of normal tissue located within the treatment site that
exceeds by 50 percent or more the absorbed dose to that tissue based on
the pre-implantation dose distribution approved by an authorized user;
or
(v) An administration that includes any of the following--
(A) The wrong radionuclide;
(B) The wrong individual or human research subject;
(C) Sealed source(s) directly delivered to the wrong treatment
site;
(D) A leaking sealed source resulting in a dose that exceeds 0.5 Sv
(50 rem) to an organ or tissue; or
(E) A 20 percent or more error in calculating the total source
strength documented in the pre-implantation portion of the written
directive.
* * * * *
0
40. Add a new Sec. 35.3204 to read as follows:
Sec. 35.3204 Report and notification for an eluate exceeding
permissible molybdenum-99, strontium-82, and strontium-85
concentrations.
(a) The licensee shall notify by telephone the NRC Operations
Center and the manufacturer/distributor of the generator within 30
calendar days after discovery that an eluate exceeded the permissible
concentration listed in Sec. 35.204(a). The telephone report to the
NRC must include the manufacturer, model number, and serial number (or
lot number) of the generator; the results of the measurement; the date
of the measurement; whether dosages were administered to patients or
human research subjects, whether the manufacturer/distributor was
notified: And the action taken.
(b) By an appropriate method listed in Sec. 30.6(a) of this
chapter, the licensee shall submit a written report to the appropriate
NRC Regional Office listed in Sec. 30.6 of this chapter within 45 days
after discovery of an eluate exceeding the permissible concentration.
The written report must include the action taken by the licensee; the
patient dose assessment; the methodology used to make this dose
assessment if the eluate was administered to patients or human research
subjects; and probable cause and assessment of failure in the
licensee's equipment, procedures or training that contributed to the
excessive readings if an error occurred in the licensee's breakthrough
determination, and the information in the telephone report as required
by paragraph (a) of this section.
Dated at Rockville, Maryland, this 10th day of July, 2014.
For the Nuclear Regulatory Commission.
Richard J. Laufer,
Acting, Secretary of the Commission.
[FR Doc. 2014-16753 Filed 7-18-14; 8:45 am]
BILLING CODE 7590-01-P