82_FR_17533 82 FR 17465 - Patient Release Program

82 FR 17465 - Patient Release Program

NUCLEAR REGULATORY COMMISSION

Federal Register Volume 82, Issue 68 (April 11, 2017)

Page Range17465-17467
FR Document2017-07276

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.

Federal Register, Volume 82 Issue 68 (Tuesday, April 11, 2017)
[Federal Register Volume 82, Number 68 (Tuesday, April 11, 2017)]
[Notices]
[Pages 17465-17467]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

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



                                                                               Federal Register / Vol. 82, No. 68 / Tuesday, April 11, 2017 / Notices                                           17465

                                                the Renewed Facility Operating License                  Regulatory Commission, Washington,                      If you are requesting or aggregating
                                                and Technical Specifications.                           DC 20555–0001.                                        comments from other persons for
                                                  Date of initial notice in Federal                        For additional direction on obtaining              submission to the NRC, then you should
                                                Register: August 16, 2016 (81 FR                        and submitting comments, see                          inform those persons not to include
                                                54618).                                                 ‘‘Obtaining Information and Submitting                identifying or contact information that
                                                  The Commission’s related evaluation                   Comments’’ in the SUPPLEMENTARY                       they do not want to be publicly
                                                of the amendment is contained in a                      INFORMATION section of this document.                 disclosed in their comment submission.
                                                Safety Evaluation dated March 24, 2017.                 FOR FURTHER INFORMATION CONTACT:                      Your request should state that the NRC
                                                  No significant hazards consideration                  Donna-Beth Howe, Office of Nuclear                    does not routinely edit comment
                                                comments received: No.                                  Material Safety and Safeguards, U.S.                  submissions to remove such information
                                                  Dated at Rockville, Maryland, this 31st day           Nuclear Regulatory Commission,                        before making the comment
                                                of March 2017.                                          Washington, DC 20555–0001; telephone:                 submissions available to the public or
                                                  For the Nuclear Regulatory Commission.                301–415–7848; email: Donna-                           entering the comment submissions into
                                                Kathryn M. Brock,                                       Beth.Howe@nrc.gov.                                    ADAMS.
                                                Deputy Director, Division of Operating                  SUPPLEMENTARY INFORMATION:                            II. Background
                                                Reactor Licensing, Office of Nuclear Reactor                                                                     In a March 10, 2014, Commission
                                                Regulation.                                             I. Obtaining Information and                          Action Memorandum (COMAMM–14–
                                                [FR Doc. 2017–07279 Filed 4–10–17; 8:45 am]             Submitting Comments                                   0001/COMWDM–14–0001,
                                                BILLING CODE 7590–01–P
                                                                                                        A. Obtaining Information                              ‘‘Background and Proposed Direction to
                                                                                                                                                              NRC Staff to Verify Assumptions Made
                                                                                                           Please refer to Docket ID NRC–2017–
                                                                                                                                                              Concerning Patient Release Guidance’’
                                                NUCLEAR REGULATORY                                      0094 when contacting the NRC about
                                                                                                                                                              (ADAMS Accession No. ML14072A112),
                                                COMMISSION                                              the availability of information for this              then NRC Chairman MacFarlane and
                                                                                                        action. You may obtain publicly-                      then Commissioner Magwood brought
                                                [NRC–2017–0094]
                                                                                                        available information related to this                 into question, among other things,
                                                Patient Release Program                                 action by any of the following methods:               whether significant regulatory changes
                                                                                                           • Federal Rulemaking Web site: Go to               to the patient release program are
                                                AGENCY:  Nuclear Regulatory                             http://www.regulations.gov and search                 warranted. They asked whether
                                                Commission.                                             for Docket ID NRC–2017–0094.                          different criteria should be used to
                                                ACTION: Request for comment.                               • NRC’s Agencywide Documents                       determine when patients should be
                                                                                                        Access and Management System                          released, whether the application of the
                                                SUMMARY:   The U.S. Nuclear Regulatory                  (ADAMS): You may obtain publicly-
                                                Commission (NRC) is requesting                                                                                current dose release standard needed to
                                                                                                        available documents online in the                     be clarified, whether all exposed
                                                comment from the general public on its                  ADAMS Public Documents collection at
                                                patient release programs. Specifically,                                                                       members of the public should be subject
                                                                                                        http://www.nrc.gov/reading-rm/                        to the same patient release dose limit,
                                                the NRC would like input from the                       adams.html. To begin the search, select               and whether new release requirements
                                                public on whether additional or                         ‘‘ADAMS Public Documents’’ and then                   are needed for patients who are likely to
                                                alternate criteria are needed and                       select ‘‘Begin Web-based ADAMS                        expose young children and pregnant
                                                whether to clarify the NRC’s current                    Search.’’ For problems with ADAMS,                    women.
                                                patient release requirements. The                       please contact the NRC’s Public                          In the Staff Requirements
                                                information will be used to determine                   Document Room (PDR) reference staff at                Memorandum (SRM) to COMAMM–14–
                                                whether significant regulatory changes                  1–800–397–4209, 301–415–4737, or by                   0001/COMWDM–14–0001 (ADAMS
                                                to the NRC’s patient release                            email to pdr.resource@nrc.gov. The                    Accession No. ML14118A387), the
                                                requirements are warranted.                             ADAMS accession number for each                       Commission, among other things,
                                                DATES: Submit comments by June 12,                      document referenced (if it is available in            directed the NRC staff to evaluate
                                                2017. Comments received after this date                 ADAMS) is provided the first time that                whether regulatory changes are
                                                will be considered if it is practical to do             it is mentioned in the SUPPLEMENTARY                  necessary to clarify the NRC’s current
                                                so, but the NRC is able to assure                       INFORMATION section.                                  release criteria and whether additional
                                                consideration only for comments                            • NRC’s PDR: You may examine and                   or alternate criteria are needed. As a
                                                received on or before this date.                        purchase copies of public documents at                result of earlier public comments on
                                                ADDRESSES: You may submit comments                      the NRC’s PDR, Room O1–F21, One                       other elements of the SRM (November
                                                by any of the following methods (unless                 White Flint North, 11555 Rockville                    16, 2015; 80 FR 70843), the staff
                                                this document describes a different                     Pike, Rockville, Maryland 20852.                      identified two additional questions to
                                                method for submitting comments on a                                                                           consider. These are whether a
                                                                                                        B. Submitting Comments
                                                specific subject):                                                                                            requirement is needed to ensure the
                                                   • Federal Rulemaking Web site: Go to                   Please include Docket ID NRC–2017–                  discussion between the licensee and
                                                http://www.regulations.gov and search                   0094 in your submission.                              patient concerning patient isolation
                                                for Docket ID NRC–2017–0094. Address                      The NRC cautions you not to include                 occurs in sufficient time for licensees or
                                                questions about NRC dockets to Carol                    identifying or contact information that               patients to make necessary
                                                Gallagher; telephone: 301–415–3463;                     you do not want to be publicly                        arrangements for holding or releasing
                                                email: Carol.Gallagher@nrc.gov. For                     disclosed in your comment submission.                 the patient and whether patients
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                                                technical questions, contact the                        The NRC posts all comment                             required to receive instructions on
                                                individual listed in the FOR FURTHER                    submissions at http://                                minimizing dose to others should be
                                                INFORMATION CONTACT section of this                     www.regulations.gov and enters the                    provided with these instructions before
                                                document.                                               comment submissions into ADAMS.                       the administration.
                                                  • Mail comments to: Cindy Bladey,                     The NRC does not routinely edit                          The NRC is interested in obtaining
                                                Office of Administration, Mail Stop:                    comment submissions to remove                         input from as many stakeholders as
                                                OWFN–12–H08, U.S. Nuclear                               identifying or contact information.                   possible, including the NRC’s Advisory


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                                                17466                          Federal Register / Vol. 82, No. 68 / Tuesday, April 11, 2017 / Notices

                                                Committee on the Medical Use of                         B. Clarification of the Time Covered by                 3. In either case, describe the resulting
                                                Isotopes, professional organizations,                   the Current Dose Limit in 10 CFR                      health and safety benefits, or lack of
                                                physicians, patients, patient advocacy                  35.75(a) for Releasing Individuals                    benefits, to the individual being
                                                groups, licensees, Agreement States, and                   Currently, under section 35.75(a) of               released and to individual members of
                                                other interested individuals. The focus                 title 10 of the Code of Federal                       the public.
                                                of this request is to gather information                Regulations (10 CFR), allows a licensee               D. Requirements for Releasing
                                                that will permit the NRC staff to                       to release a patient if the dose to any               Individuals Who Are Likely To Expose
                                                determine whether significant                           other individual is not likely to exceed
                                                regulatory changes to the patient release                                                                     Young Children and Pregnant Women
                                                                                                        5 milliSieverts (mSv) (0.5 rem). The                     The current NRC patient release
                                                program are warranted.
                                                                                                        NRC staff determined in the NRC’                      program requires the licensee to provide
                                                   During the comment period on April
                                                25, 2017 and May 23, 2017, the NRC                      Regulatory Issue Summary 2008–07,                     the released individual with
                                                will have two public meeting at the                     ‘‘Dose Limit for Patient Release Under                instructions if the dose to any
                                                NRC’s Headquarters that will explain                    10 CFR 35.75’’ (ADAMS Accession No.                   individual is likely to exceed 1 mSv (0.1
                                                and clarify the information requested                   ML063030572) that, as written the                     rem). The NRC does not have specific
                                                with members of the public. These                       regulation is ambiguous and the dose to               requirements for releasing patients who
                                                meetings will be webcast.                               any other individual from the released                are likely to expose young children or
                                                   The NRC does not intend to provide                   individual does not reflect the NRC’s                 pregnant women to doses above the
                                                any responses to comments received                      intent of a per-year limit and that this              public dose limit.
                                                during the public meeting(s). The public                limit has been interpreted by others to                  Question: Should the NRC include a
                                                meeting(s) will be noticed on the NRC’s                 be per release. The NRC staff explained               specific requirement for the release of a
                                                public meeting Web site at least 10                     that a ‘‘per release’’ interpretation does            patient who is likely to expose young
                                                calendar days before the meeting.                       not consider the cumulative dose                      children or pregnant women to doses
                                                Members of the public should monitor                    received in a year from the same                      above the public dose limit?
                                                the NRC’s public meeting Web site at                    released individual or repeated                          1. If so, explain why and describe
                                                http://www.nrc.gov/public-involve/                      exposure to different released                        what the requirement should include.
                                                public-meetings/index.cfm.                              individuals. The Commission has asked                    2. If not, explain why the requirement
                                                   The NRC will also post the meeting                   the NRC staff to clarify this issue.                  is not needed.
                                                notices on the Federal rulemaking Web                      Question: Should the NRC amend the                    3. In either case, describe the resulting
                                                site at http://www.regulations.gov under                regulations to clarify the time frame for             health and safety benefits, or lack of
                                                Docket ID NRC–2017–0094. The NRC                        the current dose limit in 10 CFR                      benefits, to the individual being
                                                may post additional materials related to                35.75(a) for releasing Individuals? For               released and to a young child or to
                                                this document, including public                         example, should the regulations                       pregnant woman.
                                                comments, on the Federal rulemaking                     explicitly state that the criterion is a per
                                                                                                        year limit? If not, is there a different              E. Requirement for Timely Discussion
                                                Web site. The Federal rulemaking Web
                                                                                                        criterion that the NRC should consider?               With the Patient About Patient Isolation
                                                site allows you to receive alerts when
                                                                                                        In either case, describe the resulting                to Provide Time for Licensee and Patient
                                                changes or additions occur in a docket
                                                                                                        health and safety benefits, or lack of                Planning
                                                folder. To subscribe: (1) Navigate to the
                                                docket folder (NRC–2017–0094); (2)                      benefit, to the individual being released                The current NRC patient release
                                                click the ‘‘Sign up for Email Alerts’’                  and to individual members of the public               program permits the licensee to
                                                link; and (3) enter your email address                  as a result of the proposed clarification.            authorize the release from its control of
                                                and select how frequently you would                                                                           any individual who has been
                                                                                                        C. Appropriateness of Applying the                    administered unsealed byproduct
                                                like to receive emails (daily, weekly, or
                                                                                                        Same Limit on Dose From Patient                       material or implants containing
                                                monthly).
                                                                                                        Exposure to All Members of the General                byproduct material if the total effective
                                                III. Requested Information and                          Public                                                dose equivalent to any other individual
                                                Comments                                                  In the current NRC patient release                  from exposure to the released individual
                                                A. Development of an Activity-Based                     dose criterion, the NRC does not                      is not likely to exceed 5 mSv (0.5 rem).
                                                Patient Release Threshold                               distinguish between family members,                   In some common procedures (e.g.,
                                                  The NRC is asking the public to                       young children, pregnant women,                       Iodine-131 procedures), the patients
                                                comment on whether the NRC should                       caregivers, hotel workers, and other                  must isolate themselves for the licensee
                                                develop an activity-based patient release               members of the public. Further, the NRC               to meet this dose release requirement. In
                                                threshold under which patients would                    patient release dose criterion is above               other cases, the patient cannot be
                                                be required to be maintained in a clinic-               the 10 CFR part 20 public dose limit.                 released and the licensee must make
                                                sponsored facility (e.g., a medical                       Question: Should the NRC continue to                arrangements to isolate the patient. The
                                                facility or facility under the licensee’s               apply the same dose criteria of 5 mSv                 requirements are silent on when the
                                                control) until the standard for release is              (0.5 rem), to all members of the general              licensee should discuss patient isolation
                                                met.                                                    public, including family members,                     with the patient. As a result, both
                                                  Question: Should the NRC develop an                   young children, pregnant women,                       patients and licensees may not have
                                                activity-based patient release threshold?               caregivers, hotel workers, and other                  time to make appropriate isolation
                                                  1. If so, explain why and provide a                   members of the public when                            arrangements prior to the planned
                                                                                                        considering the release of patients?                  administration. Some patients reported
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                                                potential activity-based criterion.
                                                  2. If not, explain why the regulations                  1. If so, explain why.                              that they were unaware of a need to
                                                should remain as is.                                      2. If not, what criterion should the                isolate themselves from others prior to
                                                  3. In either case, describe the resulting             NRC use for an individual group or                    the administration.
                                                health and safety benefits, or lack of                  groups? Specify the group (e.g., family                  Question: Should the NRC have a
                                                benefits, to the individual being                       members, young children, pregnant                     specific requirement for the licensee to
                                                released and to individual members of                   women, caregivers, hotel workers, or                  have a patient isolation discussion with
                                                the public.                                             others) for each criterion.                           patients in sufficient time prior to the


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                                                                               Federal Register / Vol. 82, No. 68 / Tuesday, April 11, 2017 / Notices                                                    17467

                                                administration to provide the patient                   invites public comment, and takes other               projections of expected revenue.4 The
                                                time to make isolation arrangements or                  administrative steps.                                 Commission denied the request for
                                                the licensee to make plans to hold the                  DATES: Comments are due: April 26,                    exemption as premature, but noted that
                                                patient, if the patient cannot be                       2017.                                                 the Postal Service may resubmit its
                                                immediately released?                                                                                         request ‘‘once it collects sufficient data
                                                   1. If so, explain why and describe                   ADDRESSES:   Submit comments                          to calculate the total revenue received
                                                what the requirement should include.                    electronically via the Commission’s                   and estimate the additional revenue
                                                   2. If not, explain why the requirement               Filing Online system at http://                       anticipated for each fiscal year of the
                                                is not needed.                                          www.prc.gov. Those who cannot submit                  market test.’’ Order No. 2224 at 18.
                                                   3. In either case, describe the resulting            comments electronically should contact                   The Postal Service asserts that it now
                                                health and safety benefits, or lack of                  the person identified in the FOR FURTHER              has the data available to make the
                                                benefits, to individual being released,                 INFORMATION CONTACT section by                        calculations requested by the
                                                the licensee, and to the public.                        telephone for advice on filing                        Commission. Request at 3. The Postal
                                                                                                        alternatives.                                         Service states that if current demand for
                                                F. Requirement To Ensure Patients Are
                                                                                                        FOR FURTHER INFORMATION CONTACT:                      Customized Delivery continues, it
                                                Given Instructions Prior to the
                                                                                                        David A. Trissell, General Counsel, at                anticipates reaching the inflation
                                                Procedure
                                                                                                        202–789–6820.                                         adjusted $10 million revenue limitation
                                                   The current NRC patient release                                                                            for FY 2017 in early June 2017.5
                                                                                                        SUPPLEMENTARY INFORMATION: On April
                                                regulations require the licensee to                                                                              The Commission shall approve the
                                                                                                        4, 2017, the Postal Service filed a
                                                provide the released individual with                                                                          request for exemption if it determines
                                                                                                        request, pursuant to 39 U.S.C.
                                                instructions if the dose to any                                                                               that: (1) The product is likely to benefit
                                                                                                        3641(e)(2), for an exemption from the
                                                individual is likely to exceed 1 mSv (0.1                                                                     the public and meet an expected
                                                                                                        $10 million annual revenue limitation
                                                rem). The requirements are silent on                                                                          demand; (2) the product is likely to
                                                                                                        for the Customized Delivery market
                                                when the required instructions should                                                                         contribute to the financial stability of
                                                                                                        test.1 The Commission authorized the
                                                be given to the patient. Some patients                                                                        the Postal Service; and (3) the product
                                                                                                        market test to proceed in Order No.
                                                are given instructions along with other                                                                       is unlikely to result in unfair or
                                                                                                        2224 and authorized the extension of
                                                medical release paperwork and may not                                                                         otherwise inappropriate competition. 39
                                                                                                        the market test in Order No. 3543 until
                                                be aware of the instructions.                                                                                 U.S.C. 3641(e)(2). In its Request, the
                                                   Question: Should the NRC explicitly                  October 31, 2017.2
                                                                                                                                                              Postal Service discusses how the
                                                include the time frame for providing                       The Postal Service states that
                                                                                                                                                              Customized Delivery market test
                                                instructions in the regulations (e.g., the              ‘‘Customized Delivery is an
                                                                                                                                                              benefits the public and meets an
                                                instructions should be given prior to the               experimental package delivery service
                                                                                                                                                              expected demand, contributes to the
                                                procedure)?                                             that offers delivery of groceries and
                                                                                                                                                              Postal Service’s financial stability, and
                                                   1. If so, explain why and provide a                  other prepackaged goods within a
                                                                                                                                                              is unlikely to result in unfair or
                                                recommended time period for the                         customized delivery window.’’ Request
                                                                                                                                                              inappropriate competition. Request at
                                                instructions to be provided.                            at 4. The Postal Service states that the
                                                                                                                                                              5–7. The Commission’s regulations
                                                   2. If not, explain why the requirement               purpose of the market test is to test and
                                                                                                                                                              require the Postal Service to file cost
                                                is not needed.                                          develop a long-term, scalable solution to
                                                                                                                                                              and revenue information with its
                                                   3. In either case, describe the resulting            facilitate expansion to additional
                                                                                                                                                              request for exemption. 39 CFR
                                                health and safety benefits, or lack of                  markets. Id.
                                                                                                                                                              3035.16(f). The Postal Service asserts
                                                benefits, to the individual being                          Total revenues anticipated or received
                                                                                                                                                              that the financial documentation and
                                                released, the licensee, and to the public.              by the Postal Service from the
                                                                                                                                                              workpapers submitted under seal show
                                                                                                        Customized Delivery market test must
                                                  Dated at Rockville, Maryland, this 3rd day                                                                  actual and expected revenue and costs
                                                                                                        not exceed $10 million in any year
                                                of April, 2017.                                                                                               for the market test. Request at 1, 4.
                                                                                                        unless the Commission exempts the
                                                  For the Nuclear Regulatory Commission.                                                                         The Commission invites comments on
                                                                                                        market test from that limit.3 If the
                                                Daniel S. Collins,                                                                                            whether the Request complies with
                                                                                                        Commission grants an exemption, total
                                                Director, Division of Material Safety, State,                                                                 applicable statutory and regulatory
                                                                                                        revenues anticipated or received by the
                                                Tribal and Rulemaking Programs, Office of                                                                     requirements, including 39 U.S.C. 3641,
                                                                                                        Postal Service from Customized
                                                Nuclear Material Safety and Safeguards.                                                                       39 CFR part 3035, Order No. 2224, and
                                                                                                        Delivery may not exceed $50 million in
                                                [FR Doc. 2017–07276 Filed 4–10–17; 8:45 am]                                                                   Order No. 3543. Comments are due no
                                                                                                        any year, adjusted for inflation. Id. 39
                                                                                                                                                              later than April 26, 2017. The public
                                                BILLING CODE 7590–01–P                                  U.S.C. 3641(e)(2), (g). In its initial notice
                                                                                                                                                              portions of these filings can be accessed
                                                                                                        for the Customized Delivery market test,
                                                                                                                                                              via the Commission’s Web site (http://
                                                                                                        the Postal Service requested an
                                                POSTAL REGULATORY COMMISSION                                                                                  www.prc.gov).
                                                                                                        exemption from the $10 million revenue
                                                                                                                                                                 39 U.S.C. 505 requires the
                                                [Docket No. MT2014–1; Order No. 3849]                   limitation based on then-current
                                                                                                                                                              Commission to designate an officer of
                                                                                                                                                              the Commission to represent the
                                                Market Test of Experimental Product-                      1 Request of the United States Postal Service for
                                                                                                                                                              interests of the general public in all
                                                Customized Delivery                                     Exemption from Revenue Limitation on Market Test
                                                                                                        of Experimental Product—Customized Delivery,          public proceedings (Public
                                                AGENCY:   Postal Regulatory Commission.                 with Portions Filed Under Seal, April 4, 2017         Representative). The Commission
                                                                                                        (Request).                                            previously appointed Lauren A.
srobinson on DSK5SPTVN1PROD with NOTICES




                                                ACTION:   Notice.                                         2 See Order Authorizing Customized Delivery
                                                                                                                                                              D’Agostino to serve as the Public
                                                                                                        Market Test, October 23, 2014 (Order No. 2224); see
                                                SUMMARY:   The Commission is noticing a                 also Order Authorizing Extension of Customized        Representative in this proceeding. She
                                                recently-filed Postal Service request for               Delivery Market Test and Updating Data Collection
                                                an exemption from the $10 million                       Plan, September 28, 2016 (Order No. 3543).              4 Notice of the United States Postal Service of
                                                                                                          3 See 39 U.S.C. 3641(e). The $10 million annual     Market Test of Experimental Product—Customized
                                                annual revenue limitation for the                       limitation is adjusted by the change in the           Delivery, September 23, 2014, at 7.
                                                Customized Delivery market test. This                   consumer price index for all urban consumers (CPI–      5 Id. The Postal Service calculates an inflation

                                                notice informs the public of the filing,                U). Id. 39 U.S.C. 3641(g).                            adjusted revenue limitation of $11,170,163. Id. at 2.



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Document Created: 2017-04-11 00:48:52
Document Modified: 2017-04-11 00:48:52
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionRequest for comment.
DatesSubmit 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.
ContactDonna-Beth Howe, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-7848; email: Donna- [email protected]
FR Citation82 FR 17465 

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