[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

[[Page 17466]]

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]
 BILLING CODE 7590-01-P