[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.

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

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]
BILLING CODE 7590-01-P