[Federal Register Volume 73, Number 152 (Wednesday, August 6, 2008)]
[Proposed Rules]
[Pages 45635-45644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-18014]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 /
Proposed Rules
[[Page 45635]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 35
RIN 3150-AI26
[NRC-2008-0071]
Medical Use of Byproduct Material--Amendments/Medical Event
Definitions
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend
its regulations that govern medical use of byproduct material related
to reporting and notifications of medical events (MEs) to clarify
requirements for permanent implant brachytherapy. The proposed
amendments would change the criteria for defining an ME for permanent
implant brachytherapy from dose-based to activity-based; add a
requirement to report, as an ME, any administration requiring a written
directive (WD) if a WD was not prepared; clarify requirements for WDs
for permanent implant brachytherapy; and make certain administrative
and clarification changes.
These amendments regarding permanent implant brachytherapy are
being proposed in response to several incidents involving therapeutic
use of byproduct material. The proposed changes are based in part on
recommendations from NRC's Advisory Committee on the Medical Use of
Isotopes (ACMUI) and the NRC's Medical Radiation Safety Team. This
proposed rule would affect all medical licensees that perform
procedures using byproduct material that require completion of a WD.
DATES: The comment period expires October 20, 2008. Comments received
after this date 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 this date.
ADDRESSES: Please include the following number RIN 3150-AI26 in the
subject line of your comments. Comments on rulemakings submitted in
writing or in electronic form will be made available to the public in
their entirety on the NRC's Web site in the Agencywide Documents Access
and Management System (ADAMS) and at http://www.regulations.gov.
Personal information, such as your name, address, telephone number, e-
mail address, etc., will not be removed from your submission. You may
submit comments by any one of the following methods.
Electronically: Via the Federal eRulemaking Portal (Docket ID NRC-
2008-0071) and follow instructions for submitting comments. Address
questions about this docket to Carol Gallagher 301-415-5905; e-mail
[email protected].
Mail comments to: Secretary, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.
E-mail comments to: [email protected]. If you do not
receive a reply e-mail confirming that we have received your comments,
contact us directly at 301-415-1966.
Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland
20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. (Telephone
301-415-1966).
Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at
301-415-1101.
You may submit comments on the information collections by the
methods indicated in the Paperwork Reduction Act Statement.
Publicly available documents related to this rulemaking may be
viewed electronically on the public computers located at the NRC's
Public Document Room (PDR), Room O-1 F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland. The PDR reproduction contractor
will copy documents for a fee.
Publicly available documents created or received at the NRC after
November 1, 1999, are available electronically at the NRC's Electronic
Reading Room at http://www.nrc.gov/reading-rm/adams.html. From this
site, the public can gain entry into ADAMS, which provides text and
image files of NRC's public documents. If you do not have access to
ADAMS or if there are problems in accessing the documents located in
ADAMS, contact the PDR Reference staff at 1-800-397-4209, 301-415-4737
or by e-mail to [email protected].
FOR FURTHER INFORMATION CONTACT: Edward M. Lohr, Office of Federal and
State Materials and Environmental Management Programs, U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, telephone 301-415-
0253, e-mail, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
II. Discussion
A. What Action Is the NRC Taking?
B. Who Would This Action Affect?
C. What Steps Did NRC Take To Involve the Public in This
Proposed Rulemaking?
D. Why Change the ME Criteria for Permanent Implant
Brachytherapy?
E. Would All MEs for Permanent Implant Brachtheryapy Be Assessed
in Terms of Activity?
F. Why Add an ME Criterion for Failure To Prepare a WD When
Required?
G. Can the Authorized User (AU) Modify the Preimplantation WD
During the Administration of Brachythrapy?
H. Where Does the 20 Percent Deviation From the Preimplantation
WD Originate?
I. Would One Sealed Source Implanted Beyond the 3 cm Boundary
Constitute an ME?
J. What Are the New Information Requirements for a Brachytherapy
WD?
K. Has NRC Prepared a Cost-Benefit Analysis of the Proposed
Actions?
L. Has NRC Evaluated the Paperwork Burden to Licensees?
M. What Should I Consider as I Prepare My Comments to NRC?
III. Discussion of Proposed Amendments by Section
IV. Criminal Penalties
V. Agreement State Compatibility
VI. Plain Language
VII. Voluntary Consensus Standards
VIII. Environmental Impact: Categorical Exclusion
IX. Paperwork Reduction Act Statement
X. Regulatory Analysis
XI. Regulatory Flexibility Certification
XII. Backfit Analysis
I. Background
MEs are events that meet the criteria in 10 CFR 35.3045(a) or (b).
These events are incidents in which the end result of a medical use of
radioactive material is significantly different from what was planned.
The ME could be a result of an error in calculating or
[[Page 45636]]
delivering a radiation dose, administering the wrong radionuclide or
the wrong amount of the correct radionuclide, or other factors that are
described in 10 CFR 35.3045.
Medical licensees are required to report MEs to the NRC and to
notify the referring physician and the individual who is the subject of
the ME so that: (1) NRC is aware of the events that led to the
unplanned outcome, to determine what actions, if any, need to be taken
to prevent recurrence; (2) other medical use licensees can be made
aware of generic problems that result in MEs; and (3) patients and
their physicians can make timely decisions regarding remedial and
prospective health care.
For all medical uses, the variance criterion threshold for licensee
submission of an ME report is an administered total dose (or dosage)
that differs from the prescribed dose (or dosage), as defined in the
WD, by more than 20 percent. The basis for this ME criterion reporting
threshold is that variances of this magnitude may reflect quality
assurance (QA) problems with the licensees' programs and also have the
potential to result in harm to the patient. This 20 percent criterion,
and others relating to reporting of MEs, appears in 10 CFR 35.3045. 10
CFR 35.40 establishes the requirements for a WD.
Several medical use events in 2003 involving therapeutic use of
byproduct material, as well as advice from ACMUI, prompted the NRC to
reconsider the appropriateness and adequacy of the regulations for MEs
and WDs with regard to use of byproduct material that require
completion of a WD. These medical use events included the implantation
of brachytherapy sources in the wrong treatment site by several
licensees. Other medical use events were not reportable as MEs because
a WD was not prepared for use of byproduct material when a WD was
required, and under current regulations such events are not reportable
as MEs. In addition, there is no basis for determining whether an ME
has occurred.
Another issue identified from these medical use events was that
criteria for MEs for permanent implant brachytherapy are dose-based.
Under current regulations, determining whether an ME has occurred for
permanent implant brachytherapy is not done until the dose to the
treatment site is determined, and often this is not done for some time
after the procedure. ACMUI recommended that the criteria for defining
most MEs for permanent implant brachytherapy be based on activity,
which allows for a determination if an ME has occurred at the end of
the procedure. Activity-based criteria allows for earlier recognition
by the licensee that an ME has occurred and allows corrective actions
to be taken sooner, resulting in an increase in the health and safety
of the patient. Additionally, because the AU can control where the
brachytherapy sources are implanted, activity-based ME criteria would
result in fewer occurrences of MEs for permanent implant
brachytherapies.
ACMUI, in considering the issue of defining MEs involving permanent
implant brachytherapy, concluded that the 20 percent variance from the
prescription criterion in the existing rule continued to be appropriate
for permanent implant brachytherapy if both the prescription and the
variance could be expressed in units of activity, rather than in units
of dose, because there is no suitable clinically used dose metric
available for judging the occurrence of MEs. The NRC staff agrees that,
for permanent implant brachytherapy, total source strength (activity-
based) is an acceptable alternative to total dose (dose-based) for the
purpose of determining the occurrence of most MEs.
In March 2004, the NRC staff began its interactions with the ACMUI
on issues relating to the adequacy of ME criteria for permanent implant
brachytherapy. ACMUI established a Medical Event Subcommittee (MESC) in
October 2004 to develop ACMUI recommendations on these issues. In June
2005, ACMUI received and approved, with modification, the
recommendations prepared by the MESC.
The ACMUI recommendations included:
1. For all permanent implants, most MEs should be defined in terms
of the total source strength implanted in the treatment site, not in
terms of absorbed dose.
2. Any implant in which the total source strength implanted in the
treatment site deviates from the WD by more than 20 percent (in either
direction) should be classified as an ME.
3. Implants in which more than 20 percent of the total source
strength documented in the preimplantation WD is implanted in tissue or
organs adjacent to the treatment site [within 3 centimeters (cm) (1.2
in.) of the treatment site boundary] should be classified as MEs.
4. Implants should be classified as MEs if:
a. Sealed radioactive sources (seeds) are implanted in distant
[beyond 3 cm (1.2 in.) from the treatment site boundary] tissue or
organs;
b. The excess dose to the distant tissue or organ exceeds 0.5 Sv
(50 rem); and
c. The excess dose to the tissue or organ is at least 50 percent
greater than the dose that would have been delivered if the seeds had
been implanted in the correct tissue volume.
5. An implant is an ME if the dose calculations used to determine
the total source strength documented in the WD, to achieve the
authorized user's intention for absorbed dose to the treatment site,
are in error by more than 20 percent in either direction.
6. The AU is to complete any revisions (to the WD for permanent
implants) to account for any medically necessary plan adaptations
before the patient is released from licensee control after the
implantation procedure and immediate post-operative period.
7. Seeds that were correctly implanted but subsequently migrated
are excluded as grounds for any ME.
ACMUI meetings on these issues were noticed in the Federal Register
and open to the public. Members of the public participated in
discussions of these matters during the meetings.
Based on the ACMUI and NRC staff recommendations, the Commission
directed the NRC staff in a Staff Requirements Memorandum (SRM-SECY-05-
0234, February 15, 2006) to:
(1) Retain the 20 percent delivered dose variation in 10 CFR
35.3045(a) as an appropriate threshold for ME reporting for all medical
use modalities except permanent implant brachytherapy; and
(2) Develop a proposed rule to modify both the WD requirements in
10 CFR 35.40 and the ME reporting requirements in 10 CFR 35.3045 for
permanent implant brachytherapy medical use to convert from dose-based
to activity-based.
II. Discussion
A. What Action Is the NRC Taking?
The NRC is proposing to modify 10 CFR 35.40 and 35.3045 to
establish separate ME criteria and WD requirements for permanent
implant brachytherapy. This proposed amendment would add as an ME a
criterion for the failure to prepare a WD when required. Additionally,
the proposed rule would make minor administrative and clarification
changes.
Section 35.3045 would be restructured to create separate paragraphs
specific to ME criteria for permanent implant brachytherapy (such as
seeds and microspheres). Regulations for all other uses of byproduct
material
[[Page 45637]]
requiring a WD (such as temporary implant brachytherapy and
radiopharmaceuticals) would be left combined. Additionally, minor
changes would also be made to the language in the regulations to
accommodate this proposed revision.
B. Who Would This Action Affect?
This proposed rule would affect all NRC and Agreement State medical
licensees who perform procedures using byproduct material that require
completion of a WD.
C. What Steps Did NRC Take To Involve the Public in This Proposed
Rulemaking?
The NRC took several initiatives to enhance stakeholder involvement
and to improve efficiency during the rulemaking process. Public input
was solicited on the preliminary draft rule language via http://www.regulations.gov (Docket ID NRC-2008-0071) on February 8,
2008, and noticed in the Federal Register on February 15, 2008.
Additionally, the preliminary draft rule language and information on
how to provide input was sent out on the NRC's Medical List Server on
February 8, 2008. All public input on the preliminary draft rule
language received was considered in formulating this proposed rule.
After consideration of public input on the preliminary language,
the NRC revised the proposed language related to information required
on a preimplantation WD and made other clarifications to the proposed
regulations. The NRC also received comments that concerned the
technical basis for this rulemaking. These comments will be considered
with all other public comments received during the comment period on
this proposed rule.
In addition, this proposed rule is based partly on recommendations
from ACMUI. The issues were addressed in ACMUI's briefing to the
Commissioners on March 2, 2004, and discussed in its March 2004
meeting. As a result of ACMUI's briefing, the Commission directed the
NRC staff in SRM-M040302B, dated March 16, 2004, to provide
recommendations concerning the current ME definition.
A MESC was established by ACMUI at its October 2004 meeting to
develop recommendations on these issues. ACMUI subsequently considered
these issues: (1) As the principal subject of its mid-cycle
teleconference in January 2005 and during a March 2005 teleconference;
(2) during the ACMUI spring meeting in April 2005; and (3) as the
principal subject of a teleconference in June 2005. MESC's
recommendations were accepted by ACMUI and forwarded to the NRC on July
19, 2005.
ACMUI meetings on these issues were noticed in the Federal Register
and open to the public. Members of the public participated in
discussions of these matters during the meetings.
D. Why Change the ME Criteria for Permanent Implant Brachytherapy?
Currently, the ME criteria for permanent implant brachytherapy are
dose-based. The proposed rule would define ME criteria in terms of the
total source strength (activity-based) rather than dose or dosage
(dose-based). This change focuses on what the AU can control; namely,
into which organ or treatment site the sources are implanted, instead
of the absorbed dose distribution, over which AU control is limited.
Additionally, for the most commonly practiced forms of image-guided
source implantation, definitive dose distributions may not be available
until several weeks after completion of the procedure. On the other
hand, the number of sources implanted in the treatment site (and hence
total source strength) can be assessed before releasing the patient
from licensee control (e.g., via intraoperative imaging for prostate
implants).
Criteria for defining an ME for permanent implant brachytherapy
would address situations that are specific to permanent implant
brachytherapy. Currently, the criteria for defining an ME for permanent
implant brachytherapy are incorporated into requirements for temporary
implant brachytherapy and therapeutic use of unsealed byproduct
materials.
E. Would All MEs for Permanent Implant Brachytherapy Be Assessed in
Terms of Activity?
The proposed rule would allow for a limited situation in which a
dose-based criterion is retained in assessing if an ME occurred in
permanent implant brachytherapy. Specifically, prior to implantation,
an AU prescribes his or her treatment intention in units of absorbed
dose to the treatment site, and the intended dose along with the
corresponding calculated total source strength is documented in the
preimplantation WD. However, an error may be made in the calculations
used to determine the total source strength that will deliver the
desired dose. As a result, although the prescribed total source
strength is delivered, the intended dose to the treatment site is not
achieved. If an ME were assessed solely in terms of whether the correct
source strength specified in the preimplantation WD was implanted,
treatment planning errors, many of which could adversely affect the
patient's clinical outcome, would not be subject to regulatory
oversight. Therefore, as recommended by ACMUI, the proposed rule would
provide in Sec. 35.3045(a)(3) that an administration is an ME if an
error in the calculations used to determine the total source strength
documented in the preimplantation WD results in a delivered dose
differing by more than 20 percent from the intended dose to the
treatment site.
F. Why Add an ME Criterion for Failure To Prepare a WD When Required?
Under current regulations, a WD must be dated and signed by an AU
before the administration of I-131 sodium iodine greater than 1.1
megabecquerels (30 microcuries), any therapeutic dosage of unsealed
byproduct material, or any therapeutic dose of radiation from byproduct
material. Prescribed dosage and dose are defined differently in Sec.
35.2.
The NRC has determined that all therapeutic and certain diagnostic
procedures involving radioactive material, sealed or unsealed, must
have WDs to ensure that the health and safety of the patient is
protected. Unintended events have occurred at licensed facilities in
which therapeutic doses requiring a WD have been administered to
patients without a WD. These incidents were not reportable or subject
to the requirements of the current regulations for determining if an ME
has occurred because a WD was not prepared. Under the current
regulations, if a WD is not prepared for therapeutic procedures that
prescribe dose or dosage, then licensees do not have a basis for
determining if an ME has occurred, nor is there a requirement to report
such an event as an ME to the NRC. Adding a criterion that an incident
must be reported as an ME if there has been a failure to prepare a WD
when required would ensure that the health and safety of medical
patients are protected.
G. Can the AU Modify the Preimplantation WD During the Administration
of Brachytherapy?
No. Making changes to the preimplantation WD would constitute
revising the WD. As is also provided by the current regulations,
revisions to the WD must be made before implantation begins. The reason
the preimplantation WD cannot be changed is that the preimplantation WD
serves as the basis for determining if an ME has occurred.
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However, the current regulations specify that after implantation
but before completion of the procedure, certain information required by
the regulations must be added to the WD. The current regulations do not
clearly define ``completion of the procedure'' for permanent implant
brachytherapy. As a result, there has been confusion as to when the
required information must be added to the WD. The proposed rule would
clarify that this information must be added after administration, but
before the patient leaves the post-treatment recovery area.
The requirement in the current regulation to document the treatment
site and nuclide on the WD after administration for permanent implant
brachytherapy would be removed because this information is already
required by the preimplantation WD and modifying these two items after
the procedure has begun would constitute a revision of the WD. A
requirement for the AU to sign the WD after administration but before
the patient leaves the post-treatment recovery area would be added to
ensure that the information added to the WD has been reviewed and
approved by the AU. This change would clarify the intent of the current
regulation that the AU must approve all required information on the WD.
H. Where Does the 20 Percent Deviation From the Preimplantation WD
Originate?
ACMUI, in its recommendations to the NRC, stated that ``any implant
in which the total source strength implanted in the treatment site
deviates from the written directive by more than 20 percent (in either
direction) should be classified as an ME.'' The rationale for this
recommendation was that the AU should be afforded the option of
positioning up to 20 percent of the total source strength for seed
implantation into tissue or organs adjacent to the treatment site. For
example, in treating the prostate with permanent implant brachytherapy,
a small number of radioactive seeds need to be placed 2-10 millimeters
outside the prostate in order to provide adequate dosimetric coverage.
In addition, the 20 percent latitude also accounts for variations in
treatment-site definition, difficulties in visualizing the target organ
by intraoperative imaging, and other phenomena that contribute to
uncertainty in estimating the fraction of seeds implanted in the
treatment site.
The 20 percent dose threshold is comparable to the variation
encountered in normal medical practice, due mainly to the limited
control the AU has over the positioning of seeds and hence the dose
delivered by permanent implants. Raising the relative absorbed dose
threshold (e.g., to 50 percent), would reduce the number of clinically
acceptable implants deemed to be MEs, but would not take into
consideration implants that constitute technical errors with quality
assurance (QA) significance that could relate to health issues.
I. Would One Sealed Source Implanted Beyond the 3 cm Boundary
Constitute an ME?
Yes, with the exception of sealed sources that migrate after
implantation, a single brachytherapy source implanted beyond 3 cm from
the outside boundary of the treatment site would constitute an ME. In
its recommendations to the NRC (SECY-05-0234, December 27, 2005,
Enclosure 2), ACMUI distinguished between two scenarios for defining
MEs for implants outside the treatment site.
The first scenario relates to sealed sources permanently implanted
in tissue or organs adjacent to the treatment site. In this case, ACMUI
recommended that up to 20 percent of the total source strength
documented in the preimplantation WD be allowed in the adjacent area
before being considered an ME. ACMUI concluded that ``a 20 percent
threshold strikes a reasonable balance between permitting seed
implantation outside of the target to boost peripheral doses [a
medically legitimate objective] and detecting gross mispositioning of
seeds into an adjacent organ rather than the intended treatment site.''
ACMUI recommended that 3 cm from the outside boundary of the treatment
site be used to define the adjacent area.
The second scenario relates to sealed sources permanently implanted
in tissue or organs beyond the adjacent area (3 cm) of the treatment
site. In this case, ACMUI concluded that tissues and organs that are
more than 3 cm from the outside treatment site boundary would be
considered distant sites and that any sealed source implanted beyond
the 3 cm boundary would constitute an ME. Both of ACMUI's
recommendations have been incorporated into this proposed rule.
J. What Are the New Information Requirements for a Brachytherapy WD?
Information that is required in a WD is crucial to ensuring that a
patient receives the appropriate treatment. Therefore, based on
recommendations from ACMUI, the specific WD requirements for permanent
implant brachytherapy would be changed from dose-based to activity-
based.
The permanent implant brachytherapy WD requirements would include
specifying at what point a permanent implant brachytherapy procedure is
considered to be complete. ACMUI, in its recommendations to the NRC,
noted that ``completion of the procedure'' is not currently defined in
Part 35.
Requiring the AU to sign the WD after administration but before the
patient leaves the post-treatment area would ensure that the
information added to the WD has been reviewed and approved by the AU.
This change would clarify the intent of the current regulation that the
AU approve all required information on the WD.
K. Has NRC Prepared a Cost-Benefit Analysis of the Proposed Actions?
The NRC staff has prepared a draft Regulatory Analysis for this
rulemaking. This analysis shows a reduction in cost by approximately
$5,211 annually from this proposed rule. More detailed information on
this subject is in Section XI of this document.
L. Has NRC Evaluated the Paperwork Burden to Licensees?
This proposed rule would contain new or amended information
collection requirements that are subject to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.). The NRC staff has estimated the
impact this proposed rule would have on reporting and recordkeeping
requirements of NRC and Agreement State licensees. The NRC seeks public
comment on these estimates of reduced burden to licensees from the
proposed rule. More information on this subject is in section IX,
Paperwork Reduction Act Statement, of this document.
M. What Should I Consider as I Prepare My Comments to NRC?
Commenters may wish to consider the following in providing their
comments:
(1) Identify the rulemaking (RIN 3150-AI26);
(2) Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes;
(3) Describe any assumptions and provide any technical information
and/or data that you used;
(4) If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced;
(5) Provide specific examples to illustrate your concerns, and
suggest alternatives;
(6) Explain your views as clearly as possible;
[[Page 45639]]
(7) Make sure to submit your comments by the comment period
deadline identified; and
(8) See Section VI of the Supplemental Information for the request
for comments on the use of plain language, Section IX for the request
for comments on the information collection, and Section XI for the
request for comments on the draft regulatory analysis.
III. Discussion of Proposed Amendments by Section
1. Section 35.40 Written Directives
This section would be amended to create specific requirements for a
WD for permanent implant brachytherapy. The section would be
restructured to accommodate the specific requirements for a WD for
permanent implant brachytherapy. Additionally, there would be an
administrative change to the paragraph numbering.
2. Section 35.3045 Report and Notification of a Medical Event
This section would be amended to separately establish the criteria
for MEs involving permanent implant brachytherapy. The proposed
amendment would change the requirements for defining most MEs for
permanent implant brachytherapy from dose-based to activity-based. A
requirement would be added to report, as an ME, any administration
requiring a WD if a WD was not prepared. In addition, the NRC is
proposing to make certain administrative and clarification changes
including an update to reflect the new NRC Operations Center phone
number.
IV. Criminal Penalties
For the purpose of section 223 of the Atomic Energy Act (AEA), the
Commission is proposing to amend 10 CFR Part 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.
V. Agreement State Compatibility
Under the ``Policy Statement on Adequacy and Compatibility of
Agreement State Programs'' approved by the Commission on June 30, 1997
(62 FR 46517), specific requirements within this rule should be adopted
by Agreement States for purposes of compatibility or because of health
and safety significance. Implementing procedures for the Policy
Statement establish specific categories which have been applied to
categorize the requirements in Part 32 and 35. A Compatibility Category
``A'' designation means the requirement is a basic radiation protection
standard or deals with related definitions, signs, labels, or terms
necessary for a common understanding of radiation protection
principles. Compatibility Category ``A'' designated Agreement State
requirements should be essentially identical to those of the NRC. A
Compatibility Category ``B'' designation means the requirement has
significant transboundary implications. Compatibility Category ``B''
designated Agreement State requirements should be essentially identical
to those of the NRC. A Compatibility Category ``C'' designation means
the essential objectives of the requirement should be adopted by the
State to avoid conflicts, duplications, or gaps. The manner in which
the essential objectives are addressed in the Agreement State
requirement need not be the same as NRC provided the essential
objectives are met. A Compatibility Category ``D'' designation means
the requirement does not have to be adopted by an Agreement State for
purposes of compatibility. The Compatibility Category Health & Safety
(H&S) identifies program elements that are not required for purposes of
compatibility, but have particular health and safety significance.
States should adopt the essential objectives of such program elements
in order to maintain an adequate program.
Summary of NRC Rules With Compatibility or Health and Safety
Designations Under the Proposed Rule Covering 10 CFR Part 35
------------------------------------------------------------------------
Section and paragraph Section title
------------------------------------------------------------------------
Category C
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Sec. 35.3045......................... Report and notification of a
medical event.
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Category D
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Sec. 35.40(c)........................ Written directives.
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Category H&S
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Sec. 35.40(b)........................ Written directives.
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VI. Plain Language
The Presidential Memorandum ``Plain Language in Government
Writing'' published June 10, 1998 (63 FR 31883), directed that the
Government's documents be in clear and accessible language. The NRC
requests comments on this proposed rule specifically with respect to
the clarity and effectiveness of the language used. Comments should be
sent to the address listed under the ADDRESSES heading.
VII. 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 10
CFR 35.40 and 35.3045 to revise the criteria for defining MEs and
clarify requirements for WDs for permanent implant brachytherapy. This
action does not constitute the establishment of a standard that
establishes generally applicable requirements.
VIII. Environmental Impact: Categorical Exclusion
The NRC has determined that this proposed rule is the type of
action described in categorical exclusion 10 CFR 51.22(c)(3). Therefore
neither an environmental impact statement nor an environmental
assessment has been prepared for this proposed rule.
IX. Paperwork Reduction Act Statement
This proposed rule contains new or amended information collection
requirements that are subject to the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.). This proposed rule has been submitted to the
Office of Management and Budget for review and approval of the
information collection requirements.
Type of submission, new or revision: Revision.
The title of the information collection: Part 35 Medical Use of
Byproduct Material--Amendments/Medical Event Definitions.
The form number if applicable: N/A.
How often the collection is required: As events occur.
Historically, the number of MEs reported from the NRC and Agreement
State medical licensees have averaged 35 annually.
Who will be required or asked to report: NRC and Agreement State
medical licensees who perform therapeutic procedures using byproduct
material.
An estimate of the number of annual responses: -2 (reduction of one
from NRC medical licensees and one from Agreement State licensees).
The estimated number of annual respondents: -2 (reduction of one
from NRC medical licensees and one from Agreement State licensees).
[[Page 45640]]
An estimate of the total number of hours needed annually to
complete the requirement or request: Reduction of -20.2 hours (10.1
hours per response).
Abstract: The NRC is proposing to amend 10 CFR 35.40 and 35.3045 to
revise the criteria for defining MEs and clarify requirements for WDs
for permanent implant brachytherapy. The proposed amendments would
change the criteria for defining an ME for permanent implant
brachytherapy from dose-based to activity-based; add a requirement to
report, as an ME, any administration requiring a WD if a WD was not
prepared; clarify requirements for WDs for brachytherapy; and would
make certain administrative and clarification changes.
These proposed amendments regarding permanent implant brachytherapy
are based in part on ACMUI recommendations and on the NRC's Medical
Radiation Safety Team recommendations in response to several incidents
involving therapeutic use of byproduct material. This proposed rule
would affect all medical licensees that perform therapeutic procedures
using byproduct material.
The NRC is seeking public comment on the potential impact of the
information collections contained in this proposed rule and on the
following issues:
1. Is the proposed information collection necessary for the proper
performance of the functions of the 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?
A copy of the OMB clearance package may be viewed free of charge at
the NRC Public Document Room, One White Flint North, 11555 Rockville
Pike, Room O-1 F21, Rockville, Maryland 20852. The OMB clearance
package and rule are available at the NRC worldwide 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 September 5, 2008 to the Records and FOIA/Privacy
Services Branch (T-5 F52), U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001, or by Internet electronic mail to
[email protected] and to the Desk Officer, Nathan J. Frey,
Office of Information and Regulatory Affairs, NEOB-10202, (3150-0010),
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 e-mail comments to [email protected] or comment by telephone at (202) 395-7345.
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.
X. Regulatory Analysis
The Commission has prepared a draft regulatory analysis on this
proposed regulation and has included it in this document. The analysis
examines the costs and benefits of the alternatives considered by the
Commission.
1. Introduction
The NRC proposes to amend its regulations to revise the criteria
for defining MEs and clarify requirements for WDs for permanent implant
brachytherapy. The rule would amend 10 CFR 35.40 and 35.3045. The
proposed amendments would change the criteria for defining an ME for
permanent implant brachytherapy from dose-based to activity-based;
would add a requirement to report, as an ME, any administration
requiring a WD if a WD was not prepared; would clarify requirements for
WDs for brachytherapy, and would make certain administrative and
clarification changes.
This proposed rule regarding permanent implant brachytherapy is
based in part on the recommendations from ACMUI and the NRC's Medical
Radiation Safety Team in response to several incidents involving
brachytherapy. The issues raised by these incidents were discussed in
several ACMUI public meetings. Public input was solicited during the
development of the proposed rule language.
Several medical use events involving therapeutic use of byproduct
material in 2003, as well as advice from ACMUI, prompted the NRC to
reconsider the appropriateness and adequacy of the regulations for MEs
and WDs with regard to therapeutic use of byproduct material.
1.1 Description of the Proposed Action
The proposed rule would amend Sec. 35.3045 to change the criteria
for defining an ME for permanent implant brachytherapy in terms of
total source strength implanted rather than in terms of absorbed dose.
The proposed rule does retain a limited dose-based ME criterion as
recommended by ACMUI. This criterion applies if the calculations used
to determine the total source strength documented in the WD are in
error by more than 20 percent. As in the current regulations, source
migration would be specifically excluded as grounds for treatment-site-
accuracy MEs. One additional ME criterion would be added that would
require a medical licensee to report, as an ME, any administration
requiring a WD if a WD was not prepared.
Section 35.40 would be amended to clarify requirements for WDs
required for permanent implant brachytherapy for before and after
administration. A detailed analysis of this amendment is included in
Section 4 of this Regulatory Analysis.
The proposed rule would also make certain administrative and
clarification changes. These changes include updating the phone number
for the NRC Operations Center, revising the numbering of various
paragraphs in Sec. Sec. 35.40 and 35.3045, and other minor
clarifications.
1.2 Need for the Proposed Action
The change from a dose-based to an activity-based criterion for
establishing criteria for MEs for permanent brachytherapy implants is
proposed because the current dose-based criteria do not adequately
address MEs for permanent brachytherapy implants.
Several medical use events involving therapeutic use of byproduct
material in 2003, as well as advice from ACMUI, prompted the NRC to
reconsider the appropriateness and adequacy of the regulations for MEs
and WDs with regard to use of byproduct material that require
completion of a WD. These medical use events included the implantation
of brachytherapy sources in the wrong treatment site by several
licensees. Other medical use events were not reportable as MEs because
a WD was not prepared for use of byproduct material when a WD was
required, and under current regulations such events are not reportable
as MEs. In addition, there is no basis for determining whether an ME
has occurred.
Another issue identified from these medical use events was that
criteria for MEs for permanent implant
[[Page 45641]]
brachytherapy are dose-based. Under current regulations, determining
whether an ME had occurred for permanent implant brachytherapy was not
done until the dose to the treatment site was determined and often was
not done for some time after the procedure. ACMUI recommended that the
criteria for defining most MEs for permanent implant brachytherapy be
based on activity which allows for a determination if an ME has
occurred at the end of the procedure. Activity-based criteria allow for
earlier recognition by the licensee that an ME has occurred and allow
corrective actions to be taken sooner, which results in an increase in
the health and safety of the patient. Additionally, because the AU can
control where the brachytherapy sources are implanted, activity-based
ME criteria would result in less occurrences of MEs for permanent
implant brachytherapies.
Information required on a WD is crucial to ensure that a patient
receives the appropriate administration. Changing from a dose-based to
activity-based criteria for defining most MEs for permanent implant
brachytherapy would also entail changing the information required in a
WD.
2. Technical Basis for the Proposed Rule
For all medical uses, the variance criterion threshold for licensee
submission of an ME report is an administered total dose (or dosage)
that differs from the prescribed dose (or dosage), as defined in the
WD, by more than 20 percent. The basis for this ME criterion reporting
threshold is that variances of this magnitude may reflect quality
assurance (QA) problems with a licensee's program and also have the
potential to harm the patient. This 20 percent criterion, and others
relating to reporting of MEs, appears in 10 CFR 35.3045. 10 CFR 35.40
defines the requirements for a WD.
Several medical use events involving therapeutic use of byproduct
material that require completion of a WD in 2003, as well as advice
from the ACMUI, prompted the NRC to reconsider the appropriateness and
adequacy of the regulations for MEs and WDs. ACMUI, in considering the
issue of defining MEs involving permanent implant brachytherapy,
concluded that the 20 percent variance from the prescription criterion
in the existing rule continued to be appropriate for permanent implant
brachytherapy if both the prescription and the variance could be
expressed in units of activity, rather than in units of dose, because
there is no suitable clinically used dose metric available for judging
the occurrence of MEs. The NRC staff agreed that, for permanent implant
brachytherapy, total source strength (activity-based) is an acceptable
alternative to total dose (dose-based) for the purpose of determining
the occurrence of most MEs.
In March 2004, the NRC staff began its interactions with the ACMUI
on the issues related to the adequacy of ME definitions. ACMUI
established a MESC in October 2004 to develop ACMUI recommendations on
these issues. In June 2005, ACMUI received and approved, with
modification, the recommendations prepared by the MESC. ACMUI meetings
on these issues were noticed in the Federal Register and open to the
public. Members of the public participated in discussions of these
matters during the meetings.
Based on the ACMUI and NRC staff recommendations, the Commission
directed the NRC staff in a Staff Requirements Memorandum (SRM-SECY-05-
0234, February 15, 2006) to (1) retain the 20 percent delivered dose
variation in 10 CFR 35.3045(a), as an appropriate threshold for ME
reporting for all medical use modalities except permanent implant
brachytherapy; and (2) develop a proposed rule to modify both the WD
requirements in 10 CFR 35.40 and the ME reporting requirements in 10
CFR 35.3045 for permanent implant brachytherapy medical use to convert
from dose-based to activity-based.
3. Identification of Alternative Approaches
The NRC considered two alternatives for the proposed rule:
Alternative 1: No-Action
Under this alternative, the Commission would make no changes to
current regulations. This could result in the continued delay in
recognizing MEs related to implant brachytherapy by medical licensees.
Corrective actions based on MEs might not be taken in a timely manner
which could affect the health and safety of patients.
Alternative 2: Revise the Criteria for Defining MEs and Clarify
Requirements for WDs for Permanent Implant Brachytherapy
This alternative would amend the regulations as described in
section 1.1 and 1.2 of this Regulatory Analysis and is the preferred
alternative for reasons stated in section 1.2.
4. Analysis of Values and Impacts
This section examines the values (benefits) and impacts (costs)
expected to result from NRC's proposed rule.
Report and Notification of a Medical Event (Sec. 35.3045)
The NRC staff, based on a review of historic reporting of MEs,
anticipates a decrease in reported MEs from the use of the new ME
criteria for permanent implant brachytherapy by approximately four per
year. This would result in a reduction of cost by approximately
$10,423.
Based on NRC staff estimates, the number of MEs would increase by
approximately two per year from the new reporting requirements when a
WD is not prepared when required. This would result in an increase of
cost by approximately $5,211.
The net result is that the proposed amendment to Sec. 35.3045
would decrease cost to medical licensees by $5,211.
Written Directives (Sec. 35.40)
Information Required To Be Documented on a Written Directive for Permanent Implant Brachytherapy
----------------------------------------------------------------------------------------------------------------
Current regulations Proposed rule change
----------------------------------------------------------------------------------------------------------------
(Before Implantation) (Before Implantation *)
----------------------------------------------------------------------------------------------------------------
Date &signature of the Authorized User..... Date & signature of the Authorized User
Treatment site............................. Treatment site
Radionuclide............................... Radionuclide
Dose....................................... Intended dose
Calculated total source strength
----------------------------------------------------------------------------------------------------------------
(After Implantation) (After Implantation *)
----------------------------------------------------------------------------------------------------------------
Total source strength...................... Total source strength
Number of sources implanted................ Date & signature of the Authorized User
[[Page 45642]]
Treatment site
Radionuclide
----------------------------------------------------------------------------------------------------------------
* The proposed rule language uses ``administration'' in lieu of ``implantation.''
As noted in the table above, the information required on a WD for
permanent implant brachytherapy under the proposed rule does not differ
greatly from the current regulatory requirements. The proposed rule
would add the requirement of documenting the calculated total source
strength in the WD before implantation. Source strength must be known
before a dose can be calculated; therefore this requirement is not a
new burden on the medical licensee. Also, requiring the source strength
to be documented in the WD would be an insignificant change. The term
``dose'' in the current language means ``intended dose'' and is a
clarification in the proposed rule language and would not constitute a
new requirement.
Under both the current regulations and the proposed rule the WD
must be completed after implantation. The requirement under the
proposed rule to have the AU sign and date the WD when the post
implantation information is documented would be an insignificant change
for the medical licensee.
The result of the proposed amendment to Sec. 35.40 is that there
would be a negligible increase of burden or cost to the medical
licensees.
The characteristics, in both the public and private sectors that
would be affected by the proposed rule, are listed below. These are
called ``attributes,'' and are based on the list of potential
attributes provided by NRC in Chapter 5 of its Regulatory Analysis
Technical Evaluation Handbook. Only the following attributes would be
impacted by this proposed rule:
Industry Implementation. The NRC anticipates that there would be a
reduction in the number of MEs reported under the new criteria for
permanent implant brachytherapy and an increase in the number of MEs
reported from the new reporting requirement when a WD is not prepared
when required, resulting in a decrease in the total number of MEs
reported. The change in information required to be documented in the WD
for permanent implant brachytherapy would not place any significant
additional burden on the medical licensees. Therefore, the industry
would have a decrease in expenses from implementation of this proposed
rule.
NRC Implementation. NRC would incur one-time costs to support
development of the rule following publication in the Federal Register
through publication of the final rule. NRC may also need to revise
guidance documentation during the implementation time period.
Other Government. Agreement State governments may incur a one-time
cost for adopting this proposed rule, if it becomes a final rule, into
their State regulations governing the use of radioactive material.
Under the ``Policy Statement on Adequacy and Compatibility of Agreement
State Programs'' approved by the Commission on June 30, 1997 (62 FR
46517), specific requirements within this rule should be adopted by
Agreement States for purposes of compatibility or because of health and
safety significance. Implementing procedures for the Policy Statement
establish specific categories which have been applied to categorize the
requirements in Parts 35. The proposed rule would amend the following
sections and paragraphs that are covered under the Policy Statement:
1. Sec. 35.3045, which has a Compatibility Category C designation
under the Policy Statement. A Compatibility Category ``C'' designation
means the essential objectives of the requirement should be adopted by
the State to avoid conflicts, duplications, or gaps. The manner in
which the essential objectives are addressed in the Agreement State
requirement need not be the same as NRC provided the essential
objectives are met.
2. Sec. 35.40(c), which has a Compatibility Category D designation
under the Policy Statement. A Compatibility Category ``D'' designation
means the requirement does not have to be adopted by an Agreement State
for purposes of compatibility.
3. Sec. 35.40(b), which has a Compatibility Category Health &
Safety (H&S) designation under the Policy Statement. The Compatibility
Category H&S identifies program elements that are not required for
purposes of compatibility, but have particular health and safety
significance. States should adopt the essential objectives of such
program elements in order to maintain an adequate program.
Each Agreement State had its own unique procedure it must follow to
amend its State regulations governing the use of radioactive material.
The NRC recognizes that there is a cost for Agreement States to amend
their State regulations to adopt this proposed rule if it becomes a
final rule. On average each State would expend 0.1 FTE to amend their
State regulation, which, based on $76,000 per FTE, would equal $7,600
per State. With 34 Agreement States, the total cost would be $258,400.
The Agreement States are required to report MEs that occur under
their license jurisdiction to the NRC. As noted in Section 4 of this
Regulatory Analysis, the proposed amendment to Sec. 35.3045 would
decrease the cost to the medical licensees and the proposed amendment
to Sec. 35.40 would have a negligible increase of burden or cost to
the medical licensees. Also, there would be no additional burden to the
Agreement States for licensing or inspections.
Other Considerations. Public confidence in NRC may be affected
positively by the rule. The public may have more confidence in NRC's
program for protection of patient health and safety as a result of
clarifying the specific criteria for MEs resulting from permanent
implant brachytherapy.
5. Decision Rationale and Implementation
The assessment of costs and benefits discussed previously leads the
NRC to the conclusion that the proposed rule, if implemented, would not
have a significant economical impact on medical licensees who are
performing therapeutic procedures using byproduct material. The
proposed rule would make it easier for AUs to determine if MEs have
occurred, thereby facilitating timely reporting and other appropriate
actions and therefore, increase patient health and safety. Requiring
licensees to report, as an ME, when a WD is not prepared when required
would increase
[[Page 45643]]
patient health and safety as well as ensure the proper documentation of
the procedure.
The revised requirements for a WD for permanent implant
brachytherapy would make determining if an ME has occurred during the
procedure easier, therefore improving the reliability of ME recognition
and reporting. Requiring the AU to sign and date the WD at the end of
the procedure would ensure that any changes made during the procedure
were authorized by the AU.
The Commission requests public comment on the draft regulatory
analysis. Comments on the draft regulatory analysis may be submitted to
the NRC as indicated under the ADDRESSES heading.
After publication of this proposed rule in the Federal Register and
consideration and resolution of public comments, a final rule will be
published.
XI. 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.
XII. Backfit Analysis
The NRC has determined that the backfit rule (Sec. Sec. 50.109,
70.76, 72.62, or 76.76) does not apply to this proposed rule because
this amendment would not involve any provisions that would impose
backfits as defined in 10 CFR Chapter I. Therefore, a backfit analysis
is not required.
List of Subjects in 10 CFR Part 35
Byproduct material, Criminal penalties, Drugs, Health facilities,
Health professions, Medical devices, Nuclear materials, Occupational
safety and health, Radiation protection, Reporting and recordkeeping
requirements.
For 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. 553; the NRC is proposing to
adopt the following amendments to 10 CFR part 35.
PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
1. The authority citation for part 35 continues to read as follows:
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954,
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat.
1242, as amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 (44
U.S.C. 3504 note); sec. 651(e), Pub. L. 109-58, 119 Stat. 806-810
(42 U.S.C. 2014, 2021, 2021b, 2111).
2. In Sec. 35.40, paragraphs (b)(5) and (c) are revised, paragraph
(b)(6) is redesignated as paragraph (b)(7), and a new paragraph (b)(6)
is added to read as follows:
Sec. 35.40 Written directives.
* * * * *
(b) * * *
(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 administration (preimplantation): the treatment site,
the radionuclide, the intended dose to the treatment site and other
sites as necessary, and the corresponding calculated total source
strength required; and
(ii) After administration but before the patient leaves the post-
treatment recovery area: the total source strength implanted, the date,
and signature of AU; or
* * * * *
(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 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.
* * * * *
3. In Sec. 35.3045, paragraph (a) and the footnote to paragraph
(c) are revised 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 if a written directive was not prepared
or any event, 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 or by use of the wrong
applicator in a brachytherapy procedure;
(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 0.5 Sv (50 rem) and by 50 percent or
more the dose expected to that site if the administration had been
carried out as specified in the written directive.
(2) The administration of byproduct material or radiation from
byproduct material for permanent implant brachytherapy (excluding
sources that were implanted in the correct site but migrated outside
the treatment site) results in--
(i) The total source strength administered differing by 20 percent
or more from the total source strength documented in the
preimplantation written directive.
(ii) The total source strength administered outside the treatment
site and within 3 cm (1.2 in) of the boundary of the treatment site
exceeding 20 percent of the total source strength documented in the
preimplantation written directive.
(iii) Brachytherapy source(s) implanted beyond 3 cm (1.2 in) from
the outside boundary of the treatment site, except for brachytherapy
source(s) at
[[Page 45644]]
other sites noted in the preimplantation written directive.
(iv) A dose to the skin or an organ or tissue other than the
treatment site exceeding by 0.5 Sv (50 rem) and by 50 percent or more
the dose expected to that site if the administration had been carried
out as specified in the preimplantation written directive.
(v) 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 the wrong radionuclide;
(B) An administration by the wrong route of administration;
(C) An administration to the wrong individual or human research
subject;
(D) An administration delivered by the wrong mode of treatment; or
(E) A leaking sealed source.
(3) An error in calculating the total source strength for permanent
implant brachytherapy documented in the preimplantation written
directive that resulted in an administered total source strength that
delivered a dose differing by more than 20 percent from the intended
dose to the treatment site.
* * * * *
(c) * * *
\3\ The commercial telephone number of the NRC Operations Center
is (301) 816-5100.
* * * * *
Dated at Rockville, Maryland, this 31st day of July 2008.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. E8-18014 Filed 8-5-08; 8:45 am]
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