[Federal Register Volume 78, Number 131 (Tuesday, July 9, 2013)]
[Notices]
[Pages 41125-41128]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16435]


-----------------------------------------------------------------------

NUCLEAR REGULATORY COMMISSION

[NRC-2013-0114]


Interim Enforcement Policy for Permanent Implant Brachytherapy 
Medical Event Reporting

AGENCY: Nuclear Regulatory Commission.

ACTION: Policy statement; revision.

-----------------------------------------------------------------------

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: Carol.Gallagher@nrc.gov. 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 pdr.resource@nrc.gov. 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: Kerstun.Day@nrc.gov.

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]
BILLING CODE 7590-01-P