[Federal Register Volume 78, Number 131 (Tuesday, July 9, 2013)]
[Notices]
[Pages 41125-41128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16435]
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NUCLEAR REGULATORY COMMISSION
[NRC-2013-0114]
Interim Enforcement Policy for Permanent Implant Brachytherapy
Medical Event Reporting
AGENCY: Nuclear Regulatory Commission.
ACTION: Policy statement; revision.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing an
interim Enforcement Policy that allows the staff to exercise
enforcement discretion for certain violations of regulations for
reporting medical events occurring under an NRC licensee's permanent
implant brachytherapy program. This interim policy affects NRC
licensees that are authorized to perform permanent implant
brachytherapy.
DATES: This policy revision is effective July 9, 2013. The NRC is not
soliciting comments on this revision to its Enforcement Policy at this
time.
ADDRESSES: Please refer to Docket ID NRC-2013-0114 when contacting the
NRC about the availability of information regarding this document. You
may access information related to this document, which the NRC
possesses and is publicly available, using any of the following
methods:
Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2013-0114. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-492-
3668; email: [email protected]. For technical questions, contact
the individual listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may access publicly available documents online in the NRC
Library 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. The Enforcement Policy is available in ADAMS under
Accession No. ML12340A295.
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.
The NRC maintains the Enforcement Policy on its Web site at http://www.nrc.gov; select ``Public Meetings and Involvement,'' then
``Enforcement,'' and then ``Enforcement Policy.''
FOR FURTHER INFORMATION CONTACT: Kerstun Day, Office of Enforcement,
U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001;
telephone: 301-415-1252; email: [email protected].
SUPPLEMENTARY INFORMATION:
Background
In SECY-05-0234, ``Adequacy of Medical Event Definitions in 10 CFR
[Title 10 of the Code of Federal Regulations] 35.3045, and
Communicating Associated Risks to the Public,'' (ADAMS Accession No.
ML041620583), dated December 27, 2005, the staff recommended that the
Commission approve the staff's plan to revise the medical event
definition and the associated requirements for written directives to be
source strength-based instead of dose-based. The Commission directed
the staff to proceed directly with the development of a proposed rule
to modify both the written directive requirements in Sec. 35.40(b)(6)
and the medical event reporting requirements in Sec. 35.3045 for
permanent implant brachytherapy. The modified medical event reporting
requirements would allow the medical event criteria to be based on
source strength as opposed to dose. In SRM-SECY-08-0080, ``Proposed
Rule: Medical Use of Byproduct Material--Amendments/Medical Events
Definitions'' (ADAMS Accession No. ML082100074), dated July 25, 2008,
the Commission approved publication of a proposed rule to (1) amend
sections in 10 CFR part 35 involving medical event reporting and (2)
clarify requirements for permanent implant brachytherapy programs.
The proposed rule was published for public comment in the Federal
Register on August 6, 2008 (73 FR 45635). The vast majority of
commenters offered no objection to converting the medical event
criteria from dose-based to source strength-based. However, following
an evaluation of a number of medical events in 2008, the staff
recognized that an unintended effect of the proposed rule would have
been that some significant events would not be identified, categorized,
and reported as medical events, which would have been contrary to the
original regulatory intent. Therefore, in SECY-10-0062, ``Reproposed
Rule: Medical Use of Byproduct Material--Amendments/Medical Event
Definitions'' (ADAMS Accession No. ML100890121), dated May 18, 2010,
the staff recommended that the NRC publish a revised proposed rule to
retain dose-based criteria. However, following a Commission meeting in
which members of the NRC's Advisory Committee on the Medical Use of
Isotopes (ACMUI) and certain stakeholders opposed this approach, the
Commission disapproved the staff's recommendation and directed the
staff to work closely with the ACMUI and stakeholders to develop a
revised medical event definition that would protect patients' interests
and allow physicians necessary flexibility, while enabling the agency
to detect failures and misapplication of byproduct materials. The staff
worked closely with the ACMUI and held stakeholder workshops to discuss
issues associated with the medical event definition. The meeting
summaries from the stakeholder workshops are available in ADAMS under
Accession Nos. ML111930470 and ML112510385.
Following these outreach efforts, the NRC staff developed
recommendations
[[Page 41126]]
in SECY-12-0053, ``Recommendations on Regulatory Changes for Permanent
Implant Brachytherapy Programs'' (ADAMS Accession No. ML12072A306),
dated April 5, 2012, defining separate medical event reporting criteria
exclusively for permanent implant brachytherapy and, for permanent
implant brachytherapy, changing from a dose-based criterion to a hybrid
definition using primarily source-strength based criteria but also
retaining certain dose-based criteria for assessing whether a medical
event occurred. In SRM-SECY-12-0053, ``Recommendations on Regulatory
Changes for Permanent Implant Brachytherapy Programs,'' issued on
August 13, 2012 (ADAMS Accession No. ML122260211), the Commission
approved these recommendations and directed that modifications be
developed as part of a so-called ``expanded'' rulemaking that had begun
in July 2010 to amend 10 CFR part 35. The NRC staff is currently
revising the regulations in 10 CFR part 35 for permanent implant
brachytherapy programs which may eliminate dose-based medical event
reporting requirements for treatment sites. In the interim, the NRC has
developed this policy with regard to permanent implant brachytherapy
for the reasons explained below in the Discussion section of this
document.
Discussion
Section 35.40, Written directives, provides that for permanent
implant brachytherapy, the written directive must contain, before
implantation, the treatment site, radionuclide, and dose; and after
implantation but before completion of the procedure, the radionuclide,
treatment site, number of sources, and total source strength and
exposure time or the total dose.
Section 35.41, Procedures for administrations requiring a written
directive, requires that a licensee performing medical administrations
must develop, implement, and maintain written procedures to provide
high confidence that, among other things, each administration is in
accordance with the treatment plan, if applicable, and the written
directive.
Section 35.3045, Report and notification of a medical event,
provides the criteria that must be met for a medical administration to
be reported as a medical event. Among the criteria, there is a
criterion for reporting a medical event involving dose to the treatment
site in Sec. 35.3045(a)(1) which specifies a threshold based on
absorbed dose variance (i.e., a comparison of the dose delivered as a
result of the medical administration with the prescribed dose) as
measured in sieverts (Sv) or in rem, and a threshold for percent
variance (i.e., the difference between delivered dose and prescribed
dose measured as a percentage). Section 35.3045(a)(1) includes limits
for both of these dose thresholds. If both limits are exceeded, a
medical administration would be required to be reported as a medical
event, based on an evaluation of the dose to the treatment site.
With regard to these criteria, Sec. 35.3045(a)(1) does not
currently provide separate criteria for permanent implant
brachytherapy, and does not explicitly state whether, for permanent
implant brachytherapy, the comparison of delivered dose to prescribed
dose can be done with doses expressed as total source strength and
exposure time for determining percent dose variance for the treatment
site. The definition of prescribed dose for manual brachytherapy in
Sec. 35.2, Definitions, permits the doses to be expressed as total
source strength and exposure time as well as absorbed dose. However,
Sec. 35.3045(a)(1) specifies the threshold for delivered absorbed dose
variance from prescribed dose in sieverts (Sv) or in rem. Therefore,
Sec. 35.3045(a)(1) requires that this comparison of delivered absorbed
dose to prescribed dose must be performed in terms of absorbed dose to
determine whether a medical event has occurred. Section 35.3045(a)(1)
therefore does not provide licensees with the option to use total
source strength and exposure time instead of absorbed dose when
evaluating the difference between the delivered absorbed dose and the
prescribed dose.
When completing the written directive after permanent implant
brachytherapy implantation, the delivered dose (for the treatment site)
may be expressed as total source strength and exposure time. In such a
situation, in order to allow a comparison to be made between the
delivered dose and the dose prescribed in the written directive, the
preimplantation entry in the written directive for prescribed dose must
also have been expressed as total source strength and exposure time.
However, in accordance with Sec. 35.3045(a)(1), medical use licensees
must currently perform a treatment site medical event evaluation with
both the delivered dose and the prescribed dose expressed in sieverts
or rem for determination of absorbed dose variance. Therefore, if the
licensee specifies treatment site doses in the written directive as
total source strength and exposure time, then the licensee must also
provide enough information to allow for the absorbed dose calculation
(in sieverts or rem) to ensure compliance with Sec. 35.3045(a)(1).
This creates an unnecessary burden for licensees.
The treatment site doses for therapeutic uses are large enough that
if the percent variance of delivered dose from prescribed dose for the
treatment site exceeds the threshold for reporting a medical event
(i.e., 20 percent), then the threshold for absorbed dose variance for
the treatment site (i.e., 0.5 Sv (50 rem)), will also be exceeded.
Hence, the two linked criteria for a treatment site medical event in
Sec. 35.3045(a)(1) will both have been met. Therefore, the staff
recognizes the need to provide regulatory relief to licensees from the
current requirement, so a comparison of delivered dose to prescribed
dose for determination of absorbed dose variance, with both doses
expressed in sieverts or rem, is not necessary.
This interim enforcement policy provides enforcement discretion for
both existing and future violations of the current Sec. 35.3045(a)(1)
requirement relating to treatment site dose comparisons for permanent
implant brachytherapy. Under this interim enforcement policy, the staff
will typically exercise enforcement discretion and not cite a violation
for failure to use a dose-based calculation if the authorized treatment
mode is permanent implant brachytherapy and licensees use total source
strength and exposure time for evaluating the existence of a medical
event. This approach will allow for an effective and objective
criterion for medical event reporting. In order for enforcement
discretion to be exercised, however, the event cannot result in the
misapplication of byproduct material. This policy does not provide
regulatory relief from complying with any other aspect of Sec.
35.3045, including the requirements for evaluation of dose to normal
tissue.
Enforcement discretion would only apply in this situation if the
licensee had entered both the prescribed dose and the delivered dose
into the written directive in terms of total source strength and
exposure time. Also, this dose comparison could only be made if the
licensee's documented procedures required under Sec. 35.41 specify use
of total source strength and exposure time as the basis for the
required treatment site dose comparison.
In addition, the NRC will normally exercise enforcement discretion
for violations of current Sec. 35.3045(a)(1) when the total dose to
the permanent implant brachytherapy treatment site equals or exceeds
120 percent of the
[[Page 41127]]
prescribed dose. This enforcement discretion would only apply if: (1)
The licensee used absorbed dose to compare the dose delivered to the
treatment site with the prescribed dose; (2) doses to normal tissues
and structures did not exceed the regulatory dose limits for reporting
medical events specified in current Sec. 35.3045(a)(3); and (3) the
total dose for the treatment site was expressed in the written
directive as absorbed dose. Section 35.3045(a)(1)(i) limits the
variance of delivered dose from prescribed dose to less than 20
percent, so if the delivered dose variance from prescribed dose equals
20 percent or more, the delivered dose equals 120 percent or more of
the prescribed dose.
As part of the ongoing 10 CFR part 35 proposed rulemaking,
stakeholders have informed the NRC that variables in post-implant
dosimetry studies cause calculated absorbed dose to be an unreliable
metric for regulatory purposes; however, licensees have more control
over delivery of the prescribed dose when using source strength and
exposure time. As a result, this enforcement discretion will not apply
if the total dose for the treatment site was expressed in the written
directive as total source strength and exposure time. This does not
change the physician's current ability to make intraoperative
adjustments in the quantity of source strength implanted based on the
conditions encountered during the surgical procedure and to document
such adjustments in the portion of the written directive required after
implantation but before completion of the procedure.
This regulatory relief does not pose a safety concern because the
NRC recognizes that the overall clinical objective of permanent implant
therapies is to deliver as much radiation dose as possible to the
treatment site without exceeding medically-recognized dose limits for
nearby normal tissues and structures (i.e., organs at risk). Licensees
using this regulatory relief must evaluate dose to nearby normal
tissues and structures in accordance with the requirements in Sec.
35.3045(a)(3) to determine if a medical event has occurred. In
addition, this policy is not intended to grant discretion for doses
less than 80 percent of the prescribed dose. The intent of permanent
implant brachytherapy is to deliver at least a minimum dose in
accordance with the physician's direction; therefore, exercising
enforcement discretion for an underdose would not further this intent.
Licensees shall comply with all other requirements, as applicable,
unless explicitly replaced or amended in this interim policy.
The NRC will keep this interim policy in place until the
implementation date of a final rule associated with the medical event
reporting requirements.
Accordingly, the NRC has revised its Enforcement Policy to read as
follows:
Interim NRC Enforcement Policy
9.3 Enforcement Discretion for Permanent Implant Brachytherapy Medical
Event Reporting (10 CFR 35.3045)
This section sets forth the interim policy that the NRC will use
for medical event reporting violations under current 10 CFR 35.3045.
Enforcement discretion will typically be exercised for reporting
violations in the following scenarios, subject to criteria specified
below, when the authorized treatment mode is permanent implant
brachytherapy: (1) the licensee uses total source strength and exposure
time for evaluating the existence of a treatment site medical event; or
(2) the total absorbed dose to the treatment site equals or exceeds 120
percent of the prescribed dose. This policy does not provide regulatory
relief from complying with any other aspect of Sec. Sec. 35.41 or
35.3045, including the requirements related to the evaluation of dose
to normal tissue.
The interim policy applies to violations that result from an
otherwise appropriate use of total source strength and exposure time
when determining the existence of a medical event and when the use of
these values does not result in the misapplication of byproduct
material by the licensee.
Specifically, under this interim Enforcement Policy, the NRC will
normally not take enforcement action for using total source strength
and exposure time to compare the dose delivered to the treatment site
with the prescribed dose when evaluating whether a medical
administration is a medical event under Sec. 35.3045(a)(1) if the
authorized treatment mode is permanent implant brachytherapy and all of
the following criteria are met:
a. The licensee's documented procedures required under Sec. 35.41
specify total source strength and exposure time as the regulatory
evaluation values for treatment site dose comparisons;
b. The licensee entered both the prescribed dose and the delivered
dose into the written directive as total source strength and exposure
time; and
c. Per Sec. 35.3045, the licensee timely reported the event based
on that treatment site dose comparison, if applicable.
In addition, the NRC will normally not take enforcement action
against a licensee for not submitting a medical event report when the
permanent implant brachytherapy treatment site total dose equals or
exceeds 120 percent of the prescribed dose. This enforcement discretion
would only apply if: (1) The licensee used absorbed dose to compare the
dose delivered to the treatment site with the prescribed dose; (2)
doses to normal tissues and structures did not exceed the regulatory
dose limits for reporting medical events specified in current Sec.
35.3045(a)(3); and (3) the total dose for the treatment site was
expressed in the written directive as absorbed dose.
This discretion will not be exercised for licensees using source
strength and exposure time to compare the dose delivered to the
treatment site with the prescribed dose, since it is expected that the
licensee has more control over delivery of the prescribed dose when
using source strength and exposure time. However, this is not intended
to limit the physician's current ability to make intraoperative
adjustments in the quantity of source strength to be implanted based on
the conditions encountered during the surgical procedure and to
document such adjustments in the portion of the written directive
required after implantation but before completion of the procedure.
Licensees shall comply with all other requirements, as applicable,
unless explicitly replaced or amended in this interim policy.
This interim policy will remain in place until the implementation
date of a final rule associated with the medical event reporting
requirements.
Procedural Requirements
Paperwork Reduction Act Statement
This policy statement does not contain new or amended information
collection requirements subject to the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.). Existing requirements were approved by the
Office of Management and Budget, approval numbers 3150-0010 and 3150-
0136.
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.
Congressional Review Act
In accordance with the Congressional Review Act of 1996, the NRC
has
[[Page 41128]]
determined that this action is not a major rule and has verified this
determination with the OMB Office of Information and Regulatory
Affairs.
Dated at Rockville, MD, this 3rd day of July, 2013.
For the Nuclear Regulatory Commission.
Rochelle C. Bavol,
Acting Secretary of the Commission.
[FR Doc. 2013-16435 Filed 7-8-13; 8:45 am]
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