[Federal Register Volume 85, Number 179 (Tuesday, September 15, 2020)]
[Proposed Rules]
[Pages 57148-57149]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19903]
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Proposed Rules
Federal Register
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This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 85, No. 179 / Tuesday, September 15, 2020 /
Proposed Rules
[[Page 57148]]
NUCLEAR REGULATORY COMMISSION
10 CFR Part 35
[Docket No. PRM-35-22; NRC-2020-0141]
Reporting Nuclear Medicine Injection Extravasations as Medical
Events
AGENCY: Nuclear Regulatory Commission.
ACTION: Petition for rulemaking; notification of docketing and request
for comment.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has received a
petition for rulemaking from Ronald K. Lattanze on behalf of Lucerno
Dynamics, LLC, dated May 18, 2020. The petitioner requests that the NRC
revise its regulations to require reporting of certain nuclear medicine
injection extravasations as medical events. The NRC docketed the
petition on June 5, 2020, and assigned it Docket No. PRM-35-22. The NRC
is examining the issues raised in PRM-35-22 to determine whether they
should be considered in rulemaking. The NRC is requesting public
comment on this petition at this time.
DATES: Submit comments by November 30, 2020. 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:
Federal Rulemaking Website: Go to https://www.regulations.gov and search for Docket ID NRC-2020-0141. 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.
Email comments to: [email protected]. If you do
not receive an automatic email reply confirming receipt, then contact
us at 301-415-1677.
Mail comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, ATTN: Rulemakings and
Adjudications Staff.
For additional direction on obtaining information and submitting
comments, see ``Obtaining Information and Submitting Comments'' in the
SUPPLEMENTARY INFORMATION section of this document.
FOR FURTHER INFORMATION CONTACT: Pamela Noto, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001; telephone: 301-415-6795; email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Obtaining Information and Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC-2020-0141 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 website: Go to https://www.regulations.gov and search for Docket ID NRC-2020-0141.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly-available documents online in the
ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, 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.
Attention: The Public Document Room (PDR), where you may
examine and order copies of public documents, is currently closed. You
may submit your request to the PDR via email at [email protected] or
call 1-800-397-4209 between 8:00 a.m. and 4:00 p.m. (EST), Monday
through Friday, except Federal holidays.
B. Submitting Comments
Please include Docket ID NRC-2020-0141 in your comment 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 will post all comment submissions at
https://www.regulations.gov as well as enter 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 into ADAMS.
II. The Petitioner
The petition for rulemaking (PRM) was filed by Ronald K. Lattanze,
on behalf of Lucerno Dynamics, LLC. Ronald K. Lattanze is the Chief
Executive Officer of Lucerno Dynamics, LLC. Lucerno Dynamics, LLC, is a
North Carolina-based company that specializes in the design and
development of systems that detect the presence of radiolabeled
biomarkers in patients.
III. The Petition
The petitioner requests that the NRC amend part 35 of title 10 of
the Code of Federal Regulations to require the reporting of certain
nuclear medicine injection extravasations as medical events.
Extravasation is the infiltration of injected fluid into the tissue
surrounding a vein or artery. The petition may be found in ADAMS at
Accession No. ML20157A266.
IV. Discussion of the Petition
The petition states that, in 1980, the NRC exempted extravasations
from medical event reporting with the understanding that extravasations
are virtually impossible to avoid. The petition further states that,
since that time, ample evidence has been published demonstrating that
nuclear medicine extravasations are avoidable and are capable of
causing considerable harm to patients. Referencing literature research
and case studies, the petition asserts that extravasations can result
in
[[Page 57149]]
patient tissue doses that exceed existing NRC medical reporting limits
and can harm patients in many ways. In light of this evidence, the
petition requests that the NRC revisit the policy established in 1980
and require the reporting of medical events of extravasations that
result in a localized dose equivalent exceeding 50 rem (0.5 Sv). The
petition asserts that the reporting of certain extravasations as
medical events will not only alert the NRC to instances of serious
misuse of byproduct material, but also will incentivize practitioners
to improve injection and infusion quality. The petition states that
this is intended to ensure that diagnostic and therapeutic nuclear
medicine patients are protected from avoidable irradiation and given
access to vital information to understand when and how medical events
impact their care.
V. Request for Public Comment
The NRC's Medical Use Policy Statement (65 FR 47654) states, in
part, that the NRC will not intrude into medical judgments affecting
patients, except as necessary to provide for the radiation safety of
workers and the general public. It also states that the NRC will, when
justified by the risk to patients, regulate the radiation safety of
patients primarily to assure the use of radionuclides is in accordance
with the physician's directions. Considering these policy objectives
and how they may relate to radiopharmaceutical extravasations, the NRC
is requesting public comment on the following specific questions.
Injection Quality Monitoring
The NRC encourages licensees to use quality assurance tools and
available technology to ensure that the licensee delivers the
administration that the physician intended. The NRC requires certain
quality assurance procedures--such as calibrating instruments used to
measure patient dosages and recording dosages administered--but there
are other procedures that the NRC does not require that could be
relevant to extravasation. The NRC is seeking information on use of
quality assurance tools and technologies for radiopharmaceutical
injection quality monitoring and extravasation.
1. How frequently does radiopharmaceutical extravasation occur?
2. Do you know of any extravasations that have resulted in harm to
patients? If so and without including information that could lead to
the identification of the individual, describe the circumstances, type
of effect harm, and the impacts.
3. For medical use licensees, does your facility currently monitor
for radiopharmaceutical extravasation? If so, why and how do you
monitor? If not, why not?
4. Do you expect that monitoring for extravasation and reviewing
the results would improve radiopharmaceutical administration techniques
at medical use licensee facilities? If so, how? If not, why not?
5. Do you believe an NRC regulatory action requiring monitoring and
review of extravasation would improve patient radiological health and
safety? If so, how? If not, why not?
Medical Event Classification and Reporting Criteria
Currently, the NRC excludes extravasation of radiopharmaceuticals
from its medical event reporting regulations. Medical events may not
necessarily result in harm to the patient, but they can indicate a
potential problem in a medical facility's use of radioactive materials
or in administration as directed by the physician. Because licensees
are not required to report extravasations to the NRC, extravasation
events are not documented in the NRC's Nuclear Material Events Database
(NMED), which contains records of events involving nuclear material
reported to the NRC.
1. Are there any benefits, not related to medical techniques, to
monitoring and reporting certain extravasations as medical events? What
would be the burden associated with monitoring for and reporting
certain extravasations as medical events?
2. If the NRC were to require that licensees report certain
extravasations as medical events (recorded in NMED), what reporting
criteria should be used to provide the NRC data that can be used to
identify problems, monitor trends, and ensure that the licensee takes
corrective action(s)?
3. If the NRC requires reporting of extravasations that meet
medical event reporting criteria, should a distinction be made between
reporting extravasations of diagnostic and therapeutic
radiopharmaceuticals? If so, why? If not, why not?
VI. Conclusion
The NRC has determined that the petition meets the sufficiency
requirements for docketing at Sec. 2.803. The NRC will examine the
issues raised in PRM-35-22 and any comments received on this document
to determine whether these issues should be considered in rulemaking.
Dated: September 3, 2020.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2020-19903 Filed 9-14-20; 8:45 am]
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