[Federal Register Volume 82, Number 68 (Tuesday, April 11, 2017)]
[Notices]
[Pages 17465-17467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-07276]
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NUCLEAR REGULATORY COMMISSION
[NRC-2017-0094]
Patient Release Program
AGENCY: Nuclear Regulatory Commission.
ACTION: Request for comment.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is requesting
comment from the general public on its patient release programs.
Specifically, the NRC would like input from the public on whether
additional or alternate criteria are needed and whether to clarify the
NRC's current patient release requirements. The information will be
used to determine whether significant regulatory changes to the NRC's
patient release requirements are warranted.
DATES: Submit comments by June 12, 2017. 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: You may submit comments by any of the following methods
(unless this document describes a different method for submitting
comments on a specific subject):
Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0094. Address
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: [email protected]. For technical questions, contact
the individual listed in the FOR FURTHER INFORMATION CONTACT section of
this document.
Mail comments to: Cindy Bladey, Office of Administration,
Mail Stop: OWFN-12-H08, U.S. Nuclear Regulatory Commission, Washington,
DC 20555-0001.
For additional direction on obtaining and submitting comments, see
``Obtaining Information and Submitting Comments'' in the SUPPLEMENTARY
INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Donna-Beth Howe, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001; telephone: 301-415-7848; email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Obtaining Information and Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC-2017-0094 when contacting the NRC
about the availability of information for this action. You may obtain
publicly-available information related to this action by any of the
following methods:
Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0094.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly-available documents online in the
ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``ADAMS Public Documents'' and
then select ``Begin Web-based ADAMS Search.'' For problems with ADAMS,
please contact the NRC's Public Document Room (PDR) reference staff at
1-800-397-4209, 301-415-4737, or by email to [email protected]. The
ADAMS accession number for each document referenced (if it is available
in ADAMS) is provided the first time that it is mentioned in the
SUPPLEMENTARY INFORMATION section.
NRC's PDR: You may examine and purchase copies of public
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555
Rockville Pike, Rockville, Maryland 20852.
B. Submitting Comments
Please include Docket ID NRC-2017-0094 in your submission.
The NRC cautions you not to include identifying or contact
information that you do not want to be publicly disclosed in your
comment submission. The NRC posts all comment submissions at http://www.regulations.gov and enters the comment submissions into ADAMS. The
NRC does not routinely edit comment submissions to remove identifying
or contact information.
If you are requesting or aggregating comments from other persons
for submission to the NRC, then you should inform those persons not to
include identifying or contact information that they do not want to be
publicly disclosed in their comment submission. Your request should
state that the NRC does not routinely edit comment submissions to
remove such information before making the comment submissions available
to the public or entering the comment submissions into ADAMS.
II. Background
In a March 10, 2014, Commission Action Memorandum (COMAMM-14-0001/
COMWDM-14-0001, ``Background and Proposed Direction to NRC Staff to
Verify Assumptions Made Concerning Patient Release Guidance'' (ADAMS
Accession No. ML14072A112), then NRC Chairman MacFarlane and then
Commissioner Magwood brought into question, among other things, whether
significant regulatory changes to the patient release program are
warranted. They asked whether different criteria should be used to
determine when patients should be released, whether the application of
the current dose release standard needed to be clarified, whether all
exposed members of the public should be subject to the same patient
release dose limit, and whether new release requirements are needed for
patients who are likely to expose young children and pregnant women.
In the Staff Requirements Memorandum (SRM) to COMAMM-14-0001/
COMWDM-14-0001 (ADAMS Accession No. ML14118A387), the Commission, among
other things, directed the NRC staff to evaluate whether regulatory
changes are necessary to clarify the NRC's current release criteria and
whether additional or alternate criteria are needed. As a result of
earlier public comments on other elements of the SRM (November 16,
2015; 80 FR 70843), the staff identified two additional questions to
consider. These are whether a requirement is needed to ensure the
discussion between the licensee and patient concerning patient
isolation occurs in sufficient time for licensees or patients to make
necessary arrangements for holding or releasing the patient and whether
patients required to receive instructions on minimizing dose to others
should be provided with these instructions before the administration.
The NRC is interested in obtaining input from as many stakeholders
as possible, including the NRC's Advisory
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Committee on the Medical Use of Isotopes, professional organizations,
physicians, patients, patient advocacy groups, licensees, Agreement
States, and other interested individuals. The focus of this request is
to gather information that will permit the NRC staff to determine
whether significant regulatory changes to the patient release program
are warranted.
During the comment period on April 25, 2017 and May 23, 2017, the
NRC will have two public meeting at the NRC's Headquarters that will
explain and clarify the information requested with members of the
public. These meetings will be webcast.
The NRC does not intend to provide any responses to comments
received during the public meeting(s). The public meeting(s) will be
noticed on the NRC's public meeting Web site at least 10 calendar days
before the meeting. Members of the public should monitor the NRC's
public meeting Web site at http://www.nrc.gov/public-involve/public-meetings/index.cfm.
The NRC will also post the meeting notices on the Federal
rulemaking Web site at http://www.regulations.gov under Docket ID NRC-
2017-0094. The NRC may post additional materials related to this
document, including public comments, on the Federal rulemaking Web
site. The Federal rulemaking Web site allows you to receive alerts when
changes or additions occur in a docket folder. To subscribe: (1)
Navigate to the docket folder (NRC-2017-0094); (2) click the ``Sign up
for Email Alerts'' link; and (3) enter your email address and select
how frequently you would like to receive emails (daily, weekly, or
monthly).
III. Requested Information and Comments
A. Development of an Activity-Based Patient Release Threshold
The NRC is asking the public to comment on whether the NRC should
develop an activity-based patient release threshold under which
patients would be required to be maintained in a clinic-sponsored
facility (e.g., a medical facility or facility under the licensee's
control) until the standard for release is met.
Question: Should the NRC develop an activity-based patient release
threshold?
1. If so, explain why and provide a potential activity-based
criterion.
2. If not, explain why the regulations should remain as is.
3. In either case, describe the resulting health and safety
benefits, or lack of benefits, to the individual being released and to
individual members of the public.
B. Clarification of the Time Covered by the Current Dose Limit in 10
CFR 35.75(a) for Releasing Individuals
Currently, under section 35.75(a) of title 10 of the Code of
Federal Regulations (10 CFR), allows a licensee to release a patient if
the dose to any other individual is not likely to exceed 5
milliSieverts (mSv) (0.5 rem). The NRC staff determined in the NRC'
Regulatory Issue Summary 2008-07, ``Dose Limit for Patient Release
Under 10 CFR 35.75'' (ADAMS Accession No. ML063030572) that, as written
the regulation is ambiguous and the dose to any other individual from
the released individual does not reflect the NRC's intent of a per-year
limit and that this limit has been interpreted by others to be per
release. The NRC staff explained that a ``per release'' interpretation
does not consider the cumulative dose received in a year from the same
released individual or repeated exposure to different released
individuals. The Commission has asked the NRC staff to clarify this
issue.
Question: Should the NRC amend the regulations to clarify the time
frame for the current dose limit in 10 CFR 35.75(a) for releasing
Individuals? For example, should the regulations explicitly state that
the criterion is a per year limit? If not, is there a different
criterion that the NRC should consider? In either case, describe the
resulting health and safety benefits, or lack of benefit, to the
individual being released and to individual members of the public as a
result of the proposed clarification.
C. Appropriateness of Applying the Same Limit on Dose From Patient
Exposure to All Members of the General Public
In the current NRC patient release dose criterion, the NRC does not
distinguish between family members, young children, pregnant women,
caregivers, hotel workers, and other members of the public. Further,
the NRC patient release dose criterion is above the 10 CFR part 20
public dose limit.
Question: Should the NRC continue to apply the same dose criteria
of 5 mSv (0.5 rem), to all members of the general public, including
family members, young children, pregnant women, caregivers, hotel
workers, and other members of the public when considering the release
of patients?
1. If so, explain why.
2. If not, what criterion should the NRC use for an individual
group or groups? Specify the group (e.g., family members, young
children, pregnant women, caregivers, hotel workers, or others) for
each criterion.
3. In either case, describe the resulting health and safety
benefits, or lack of benefits, to the individual being released and to
individual members of the public.
D. Requirements for Releasing Individuals Who Are Likely To Expose
Young Children and Pregnant Women
The current NRC patient release program requires the licensee to
provide the released individual with instructions if the dose to any
individual is likely to exceed 1 mSv (0.1 rem). The NRC does not have
specific requirements for releasing patients who are likely to expose
young children or pregnant women to doses above the public dose limit.
Question: Should the NRC include a specific requirement for the
release of a patient who is likely to expose young children or pregnant
women to doses above the public dose limit?
1. If so, explain why and describe what the requirement should
include.
2. If not, explain why the requirement is not needed.
3. In either case, describe the resulting health and safety
benefits, or lack of benefits, to the individual being released and to
a young child or to pregnant woman.
E. Requirement for Timely Discussion With the Patient About Patient
Isolation to Provide Time for Licensee and Patient Planning
The current NRC patient release program permits the licensee to
authorize the release from its control of any individual who has been
administered unsealed byproduct material or implants containing
byproduct material if the total effective dose equivalent to any other
individual from exposure to the released individual is not likely to
exceed 5 mSv (0.5 rem). In some common procedures (e.g., Iodine-131
procedures), the patients must isolate themselves for the licensee to
meet this dose release requirement. In other cases, the patient cannot
be released and the licensee must make arrangements to isolate the
patient. The requirements are silent on when the licensee should
discuss patient isolation with the patient. As a result, both patients
and licensees may not have time to make appropriate isolation
arrangements prior to the planned administration. Some patients
reported that they were unaware of a need to isolate themselves from
others prior to the administration.
Question: Should the NRC have a specific requirement for the
licensee to have a patient isolation discussion with patients in
sufficient time prior to the
[[Page 17467]]
administration to provide the patient time to make isolation
arrangements or the licensee to make plans to hold the patient, if the
patient cannot be immediately released?
1. If so, explain why and describe what the requirement should
include.
2. If not, explain why the requirement is not needed.
3. In either case, describe the resulting health and safety
benefits, or lack of benefits, to individual being released, the
licensee, and to the public.
F. Requirement To Ensure Patients Are Given Instructions Prior to the
Procedure
The current NRC patient release regulations require the licensee to
provide the released individual with instructions if the dose to any
individual is likely to exceed 1 mSv (0.1 rem). The requirements are
silent on when the required instructions should be given to the
patient. Some patients are given instructions along with other medical
release paperwork and may not be aware of the instructions.
Question: Should the NRC explicitly include the time frame for
providing instructions in the regulations (e.g., the instructions
should be given prior to the procedure)?
1. If so, explain why and provide a recommended time period for the
instructions to be provided.
2. If not, explain why the requirement is not needed.
3. In either case, describe the resulting health and safety
benefits, or lack of benefits, to the individual being released, the
licensee, and to the public.
Dated at Rockville, Maryland, this 3rd day of April, 2017.
For the Nuclear Regulatory Commission.
Daniel S. Collins,
Director, Division of Material Safety, State, Tribal and Rulemaking
Programs, Office of Nuclear Material Safety and Safeguards.
[FR Doc. 2017-07276 Filed 4-10-17; 8:45 am]
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