[Federal Register Volume 87, Number 250 (Friday, December 30, 2022)]
[Proposed Rules]
[Pages 80474-80479]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28356]


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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; consideration in the rulemaking 
process.

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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) will consider in 
its rulemaking process issues raised in a petition for rulemaking 
(PRM), PRM-35-22, submitted by Ronald K. Lattanze on behalf of Lucerno 
Dynamics, LLC. The petitioner requested that the NRC amend its 
regulations to require reporting of certain nuclear medicine injection 
extravasations as medical events.

DATES: The docket for the petition for rulemaking, PRM-35-22, is closed 
on December 30, 2022.

ADDRESSES: 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. Address 
questions about NRC dockets to Dawn Forder; telephone: 301-415-3407; or 
email: [email protected]. For technical questions, contact the 
individual listed in the FOR FURTHER INFORMATION CONTACT section of 
this document.
     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, at 301-415-4737, 
or by email to [email protected]. For the convenience of the reader, 
instructions about obtaining materials referenced in this document are 
provided in the ``Availability of Documents'' section.
     NRC's PDR: You may examine and purchase copies of public 
documents, by appointment, at the NRC's Public Document Room (PDR), 
Room P1 B35, One White Flint North, 11555 Rockville Pike, Rockville, 
Maryland 20852. To make an appointment to visit the PDR, please send an 
email to [email protected] or call 1-800-397-4209 or 301-415-4737, 
between 8:00 a.m. and 4:00 p.m. (ET), Monday through Friday, except 
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Andrew Carrera, Office of Nuclear 
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555-0001; telephone: 301-415-1078, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. The Petition
    A. Background
    B. Issues Raised in the Petition
II. Public Comments on the Petition
    A. Overview of Public Comments
    B. Comments Received to Specific Questions in the Docketing 
Request for Comment
    C. NRC Response to Additional Public Comments
III. Reasons for Consideration
IV. Availability of Documents
V. Conclusion

I. The Petition

    The NRC received and docketed a PRM (ADAMS Accession No. 
ML20157A266) dated May 18, 2020, filed by Ronald K. Lattanze on behalf 
of Lucerno Dynamics, LLC. On September 15, 2020, the NRC published a 
notice of docketing and request for public comment on the petition (85 
FR 57148). The petitioner requested that the NRC amend its regulations 
in part 35 of title 10 of the Code of Federal Regulations (10 CFR), 
``Medical Use of Byproduct Material,'' to require reporting of certain 
nuclear medicine injection extravasations as medical events. 
Extravasation is the infiltration of

[[Page 80475]]

injected fluid into the tissue surrounding a vein or artery. 
Extravasation is not limited to the administration of 
radiopharmaceuticals.

A. Background

    In 1980, the Commission amended the medical use regulations in 10 
CFR part 35 to require the reporting of medical misadministrations 
(later renamed medical events) (45 FR 31701; May 14, 1980). 
Misadministration reporting allowed the NRC to investigate 
misadministrations for possible violations, evaluate licensee 
corrective actions, inform other licensees of potential problems, and 
take generic corrective actions. In this 1980 rulemaking, the 
Commission stated in a comment response that it did not consider 
extravasation to be a misadministration because extravasation 
frequently occurs in otherwise normal intravenous or intraarterial 
injections and that extravasations are virtually impossible to avoid.
    The misadministration reporting requirements were updated in 1991 
(56 FR 34104; July 25, 1991) with dose criteria based on the National 
Council on Radiation Protection and Measurements dose levels. These 
dose criteria were added to clarify the definition of misadministration 
and to exclude events involving diagnostic procedures, which the 
Commission considered low-risk. The next major update of 10 CFR part 35 
was completed in 2002 (67 FR 20250; April 24, 2002). The term 
``misadministration'' was replaced with ``medical event,'' the existing 
dose reporting criteria for patient exposures from medical events was 
retained, and a dose threshold of 0.5 Sv (50 rem) shallow dose 
equivalent to the skin was added. The extravasation exemption was not 
addressed.

B. Issues Raised in the Petition

    The NRC identified two issues in the petition as follows:
    Issue 1: The exemption of radiopharmaceutical extravasations from 
medical event reporting is based on the incorrect assertion that 
radiopharmaceutical extravasations are virtually impossible to avoid 
and therefore does not protect the public from unsafe irradiation. The 
petitioner requested that the NRC amend Sec.  35.2, ``Definitions,'' to 
include a definition of ``extravasation'' as follows: ``Extravasation 
means the inadvertent injection or infusion of some or all of a 
radiopharmaceutical dosage into the tissue surrounding a vein or 
artery.''
    Issue 2: Exemption of extravasations from medical event reporting 
requirements results in a lack of transparency to patients, the public, 
and the NRC. The petitioner also requested that the NRC amend Sec.  
35.3045(a)(1), ``Report and Notification of a Medical Event,'' by 
adding a new paragraph (iv) as follows: ``(iv) An extravasation that 
leads to an irradiation resulting in a localized dose equivalent 
exceeding 0.5 Sieverts (Sv) (50 rem).''

II. Public Comments on the Petition

A. Overview of Public Comments

    On September 15, 2020, the NRC requested comments from the public 
on the petition and posed eight specific questions to gain information 
on the scope of and basis for the issues raised by the petitioner. The 
comment period closed on November 30, 2020. The NRC received 488 public 
comment submissions, including late-filed submissions. All the comment 
submissions received on this petition are available on https://www.regulations.gov under Docket ID NRC-2020-0141. A comment submission 
is a communication or document submitted to the NRC by an individual or 
entity, with one or more individual comments addressing a subject or 
issue. Eighty-eight submissions (from the Association for Vascular 
Access, Organization of Agreement States, congressional 
representatives, and private citizens) generally supported the 
petition, 396 submissions (from 11 medical communities and private 
citizens) generally opposed the petition, and two submissions were 
duplicates. The NRC reviewed and considered all comments in its 
evaluation of the petition.

B. Comments Received in Response to Specific Questions in the Docketing 
Request for Comment

    The following is a summary of the feedback that the NRC received 
from the public on the eight specific questions posed in the notice of 
docketing and request for public comment on the petition.
    Question 1: How frequently does radiopharmaceutical extravasation 
occur?
    Comments Received: Twenty-five comments provided at least one of 
the following replies to the frequency of radiopharmaceutical 
extravasations: (1) there is clinical evidence that extravasation rates 
are greater than 1 percent of all administrations; (2) the frequency 
rate is unknown because extravasations are not reported; or (3) some 
groups are understating the frequency and potential harm to patients.
    Four comments stated that the extravasation frequencies cited in 
the petition--average of 15 percent and a range of 2 to 23 percent of 
all administrations--are misleading and biased. Twenty-one additional 
comments stated that the frequency of either therapeutic or diagnostic 
extravasations is very rare, typically less than 1 percent of 
injections. Some of the 21 comments stated that this information is 
based on their own clinical observations, which these comments further 
stated is consistent with the results from peer-reviewed manuscripts.
    Question 2: Do you know of any extravasations that have resulted in 
harm to patients? If so, what were the circumstances, the type of 
effect or harm, and the impacts.
    Comments Received: Thirty-nine comments provided at least one of 
the following responses related to patient harm due to extravasations: 
(1) it is difficult to know if extravasations have resulted in patient 
harm because they are not tracked and rarely studied; (2) it can take 
months or years for the effects to become evident; (3) there are over 
50 peer-reviewed papers that list the following adverse biological 
effects of extravasations--local pain, erythema, swelling, lesions, wet 
and dry desquamation, severe tissue damage, and radiation necrosis; (4) 
even diagnostic extravasations can lead to high radiation doses to 
injection site tissue; and (5) extravasations can hinder the ability to 
deliver therapeutic applications of nuclear medicine.
    Forty-nine comments provided at least one of the following 
responses related to patient harm due to extravasations: (1) despite 
millions of nuclear medicine injections, there have been no serious 
cases of patient harm; (2) no instances of patient harm have been 
observed during decades on the job; and (3) there is a lack of clinical 
and research studies demonstrating instances of harm.
    Question 3: For medical use licensees, does your facility currently 
monitor for radiopharmaceutical extravasations? If so, why and how do 
you monitor? If not, why not?
    Comments Received: Sixteen comments stated that they are currently 
monitoring for extravasations through scans or other methods. Ten 
comments stated they have capabilities to monitor for and minimize 
extravasations but some clinics are doing a better job of monitoring 
than others. The same ten comments stated that requiring monitoring of 
extravasations would

[[Page 80476]]

hold all clinics to a higher bar and increase injection quality and 
patient health. Four comments agreed that not all institutions monitor 
extravasations probably because they do not need to report 
extravasations.
    Question 4: Do you expect that monitoring for extravasations and 
reviewing the results would improve radiopharmaceutical administration 
techniques at medical use licensee facilities? If so, how? If not, why 
not?
    Comments Received: Thirty-six comments stated that monitoring 
extravasations would improve injection quality. The same comments 
stated that tracking would lead to a better understanding of how often 
extravasations occur, which would lead to better training to reduce the 
frequency of occurrence. In addition, the same comments noted that 
there is plenty of evidence in clinical observations and peer-reviewed 
literature that the frequency of extravasations can be reduced.
    Twelve comments stated that monitoring and reviewing extravasations 
would not improve injection quality because highly trained 
professionals are already doing their best to prevent extravasations 
from occurring, so monitoring would only cause unnecessary burdens. 
Three comments stated that monitoring extravasations would not improve 
injection quality because extravasations occur largely as a result of 
patients having poor vascular structure. In addition, the same comments 
noted that, in particular, pediatric, geriatric, and chemotherapy 
patients often have compromised vascularity.
    Question 5: Do you believe an NRC regulatory action requiring 
monitoring and review of extravasations would improve patient 
radiological health and safety? If so, how? If not, why not?
    Comments Received: Fourteen comments stated that they had concerns 
about the health of patients for both therapeutic and diagnostic 
extravasations. The same comments stated that reporting of 
extravasations would lead to a better understanding of their frequency 
and severity, which could reduce how often they occur and lead to 
better patient health. One comment supported the petition because 
extravasations then could be tracked and their frequencies reduced to 
the benefit of patients.
    Four comments stated that there would not be improvements to 
patient health due to monitoring and reporting of extravasations 
because they are not preventable. Seven comments stated that there 
would be no health benefits but there would be additional burdens to 
medical licensees. Two comments stated that monitoring for 
extravasations would negatively impact patient health because any 
manipulation of the injection site or addition of sensors could 
decrease blood flow, resulting in radioactive material remaining in the 
injection site for a longer period of time.
    Question 6: 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?
    Comments Received: Forty-two comments stated that there would be 
considerable burdens to monitoring and reporting extravasations without 
much, if any, benefit. One commenter provided the example that 14 
million diagnostic procedures are performed annually and if there is a 
1 percent extravasation rate, then the result would be 140,000 medical 
events annually. The commenters stated that the main burdens they are 
concerned about are (1) reporting with minimal or no benefit, (2) 
considerable increase in paperwork, (3) considerable financial costs 
for practitioners and the entire medical field--possibly hundreds of 
millions of dollars, (4) the total time for extra monitoring and the 
frequency of nuclear medicine injections would allow for fewer patients 
to be seen, and (5) it may create false radiation safety concerns in 
patients and increase public fear concerning nuclear medicine.
    Eight comments listed the following benefits to monitoring and 
reporting extravasations: (1) patients will know when an extravasation 
occurs, (2) it will lead to better diagnostics, (3) it will lead to 
better data for tracking, and (4) it will reduce medical workload and 
costs. Ten comments stated that those in opposition are overstating the 
burdens to the medical community. The comments also stated that the new 
detection methods are more cost effective for detecting extravasations 
than traditional computed tomography (CT) scans. Lastly, the comments 
noted that while there could be additional costs, it would increase the 
incentive to provide quality injections.
    Question 7: If the NRC were to require that licensees report 
certain extravasations as medical events, what reporting criteria 
should be used to provide the NRC data that can be used to identify 
problems, monitor trends, and ensure that all licensees take corrective 
action(s)?
    Comments Received: Nine comments were in favor of the petitioner's 
proposed 0.5 Sv (50 rem) reporting level because it is consistent with 
the level used for nuclear medicine both domestically and 
internationally. In addition, the same comments stated that the 
petitioner's proposed reporting level will lead to better monitoring 
and reduce the frequency of extravasations.
    Eight comments stated the following concerns with the petitioner's 
proposed reporting level of 0.5 Sv (50 rem): (1) the criterion is 
arbitrary and does not harm the skin or tissue; (2) it takes more than 
2 Gray (Gy) (200 rad) to cause impacts to skin in fluoroscopy 
procedures, which is much higher than the proposed criterion; and (3) 
if an extravasation does occur, the nuclear agents end up in the 
intended part of the body similar to a non-extravasated injection 
(i.e., extravasations migrate from the lymphatic system and end up in 
the venous system). Nine comments did not support the petitioner's 
proposed criteria of 0.5 Sv (50 rem) because there is not a good or 
technically sound way to evaluate the dose to the tissue. Two comments 
stated that there should not be any criteria because there should be no 
reporting of extravasation.
    Question 8: 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?
    Comments Received: Eighteen comments stated that there should not 
be a distinction between diagnostics and therapeutics for 
classification of medical events because (1) if you exceed 0.5 Sv (50 
rem), you could be causing harm regardless of the method, (2) 
diagnostic extravasations can cause harm or compromise scans, and (3) 
few facilities monitor diagnostic injections, but monitoring tools now 
exist that could lead to a better understanding of the frequency and 
help reduce the occurrence of extravasations. One comment supported the 
classification of therapeutic injection extravasations as medical 
events; explaining, however, that some diagnostic doses are used as 
``test doses'' to determine injection quality; and stated that 
classifying these ``test doses'' as extravasations would be 
contradictory since they are meant to improve patient safety.
    Twenty-five comments expressed concerns regarding classification of 
diagnostic extravasations as medical events because they are of such 
low dose that they do not cause harm or compromise scans. The same 
comments also noted that while therapeutic extravasations can cause 
tissue damage, they are extremely rare events that are dealt with under 
existing regulations. Lastly, most of these 25 comments do

[[Page 80477]]

not support the classification of diagnostic or therapeutic 
extravasations as medical events, with an especially strong position 
against the classification of diagnostic extravasations as medical 
events.

C. NRC Response to Additional Public Comments

    The NRC received thirty-three additional comments related to the 
petition that did not provide a direct response to the specific 
questions in the notice of docketing and request for public comment on 
the petition. In addition, the NRC received three comments that were 
out of scope. The NRC has binned these additional comments related to 
the petition into two categories. The following discussion provides a 
summary of each category and the NRC's response to the grouped 
comments, including--if appropriate--a summary of the basis for the 
response.
1. Comments Supporting the Petition
    Comment: The NRC received nine comments supporting the proposed 
criteria of 0.5 Sv (50 rem) because the dose to the skin from 
extravasation can be estimated and this limit is 500 times higher than 
the dose from an ``ideal injection.''
    NRC Response: The NRC disagrees with this comment. The NRC's 
medical event reporting dose threshold criteria (0.05 Sv [5 rem] 
effective dose equivalent, 0.5 Sv [50 rem] to an organ or tissue, or 
0.5 Sv [50 rem] shallow dose equivalent to the skin) are conservative 
dose levels that would not be expected to cause patient harm. The 
criteria were implemented in part to screen out medical events 
involving diagnostic procedures because, as stated by the Commission, 
the NRC agrees that routine doses from diagnostic procedures represent 
a small amount of risk to the patient. On the dose levels, the 
Commission further commented that these levels correspond to a 
threshold well below the onset of acute, clinically detectable adverse 
effects that may be caused by exposure to ionizing radiation. Reporting 
extravasations at 0.5 Sv (50 rem) would result in many extravasation 
events of low radiation safety significance being reported. However, 
the NRC agrees that the topic of extravasation is important and 
therefore is considering the issues raised in the petition and 
assessing a more risk-informed reporting requirement in the rulemaking 
process.
    Comment: The NRC received a comment stating that reporting 
extravasations is within the purview of the NRC. While administration 
of radiopharmaceuticals is a practice of medicine, misadministration of 
radiopharmaceuticals should be reported and this will not intrude on 
the practice of medicine.
    NRC Response: The NRC agrees with this comment. Requiring medical 
event reporting of radiation-safety-significant extravasations is 
within the purview of the NRC's regulatory authority and supports the 
NRC's public health and safety mission.
    Comment: The NRC received one comment concerning the lack of 
rationale explaining why extravasation of diagnostic injections should 
be exempted from medical event reporting.
    NRC Response: The NRC agrees with this comment. The NRC questions 
whether excluding diagnostic administrations from an extravasation 
reporting requirement is supportable. Due to the smaller amounts of 
radioactivity used in diagnostic procedures, extravasation of 
diagnostic radiopharmaceuticals would rarely be expected to result in 
adverse tissue effects. However, while rare, significant extravasations 
of diagnostic radiopharmaceuticals with longer half-lives (such as 
thallium-201) could result in adverse tissue effects (Van der Pol et 
al., 2017) and would be considered a safety-significant medical event.
2. Comments Opposing the Petition
    Comment: The NRC received four comments stating that extravasation 
is a generic medical issue outside the NRC's regulatory authority and 
is best managed at the institutional level.
    NRC Response: The NRC disagrees with this comment. The radiation 
safety impact of some extravasations can be severe enough to warrant 
regulatory action, and reporting and tracking these incidents is of 
interest to the NRC.
    Comment: The NRC received three comments concerning diagnostic 
extravasations. The comments state that minor diagnostic extravasations 
occur frequently but can be detected by scans and do not reduce scan 
quality or affect patient health. The comments further state that 
concerns regarding diagnostic extravasations are overstated and 
extravasation should be managed at the institutional level.
    NRC Response: The NRC partially disagrees with this comment. While 
diagnostic extravasations of safety significance are rare, significant 
extravasations of certain diagnostic radiopharmaceuticals can cause 
adverse tissue effects, such as prolonged erythema and even skin 
necrosis (Van der Pol et al., 2017). The NRC is interested in medical 
event reporting of radiation-safety-significant extravasations, 
regardless of whether they involve diagnostic or therapeutic 
radiopharmaceuticals.
    Comment: The NRC received 11 comments stating that the NRC's 
extravasation exemption is outdated.
    Response: The NRC agrees with this comment. In 1980 the use of 
injectable radiopharmaceuticals involved diagnostic dosages of lower 
energy gamma emitting radionuclides. Since then, nuclear medicine has 
evolved to include use of higher energy positron-emitting diagnostic 
radiopharmaceuticals (for positron emission tomography imaging) and 
therapeutic radiopharmaceuticals, which use higher doses of 
radioactivity to treat certain cancers and diseases. The NRC is 
revisiting the exclusion of extravasation from medical event reporting 
in light of intervening changes in radiopharmaceuticals in the 
rulemaking process.

III. Reasons for Consideration

    Although the petitioner requested that the NRC require the 
reporting of radiopharmaceutical extravasations exceeding 0.5 Sv (50 
rem) localized dose equivalent, the NRC considered the issue more 
broadly and evaluated whether to require reporting of certain 
radiopharmaceutical extravasations of radiation safety significance as 
medical events. The NRC evaluated whether (1) the radiation safety risk 
from extravasations merits medical event reporting, (2) extravasations 
are preventable, (3) including extravasations in medical event 
reporting would align with the objectives of the NRC's medical event 
reporting regulations, and (4) regulating extravasations would align 
with the NRC's Medical Use Policy Statement (65 FR 47654; August 3, 
2000). The staff recommends further evaluating, within the NRC's 
rulemaking process, medical event reporting of extravasations that 
require medical attention for a suspected radiation injury. The 
remaining paragraphs of Section III summarize the NRC's evaluation of 
the two issues identified in the petition.

Evaluation of Petition Issues

    Issue 1: The exemption of radiopharmaceutical extravasations from 
medical event reporting is based on the incorrect assertion that 
radiopharmaceutical extravasations are virtually impossible to avoid 
and therefore does not protect the public from unsafe irradiation.
    The petitioner stated that recent evidence demonstrates that 
extravasations are avoidable, invalidating the NRC's 1980

[[Page 80478]]

determination and subsequent exemption of extravasations from medical 
event reporting requirements. The petitioner asserted that reporting 
extravasations as medical events would reduce the amount of 
extravasations and protect patients from harmful injections. In 
addition, the petitioner asserted that diagnostic and therapeutic 
extravasations can result in significant radiation doses to injection 
site tissue, potentially causing adverse tissue reactions and cancer. 
The petitioner stated that diagnostic extravasations can also affect 
the accuracy of imaging study results, affect the patient's care, and 
may lead to unnecessary radiation dose due to repeat imaging studies. 
Lastly, the petitioner asserted that, per the NRC's Medical Use Policy 
Statement, the NRC has the obligation to regulate extravasations as 
necessary to provide for the radiation safety of workers and the 
general public.
    NRC Evaluation: The NRC believes that the Commission's 1980 
decision to exclude extravasations from medical event reporting should 
be reconsidered in the rulemaking process given the evolution of 
nuclear medicine since then. However, the NRC does not agree with the 
petitioner that the 1980 decision is invalidated because extravasations 
are avoidable. Although there have been many advancements in nuclear 
medicine since 1980, there is still no technology or technique that can 
fully prevent an extravasation. While monitoring technology could help 
identify extravasations earlier and improvements in training, skill, 
and tools could help reduce the prevalence of extravasations, there is 
no way to fully prevent extravasations from occurring. Even the most 
skilled clinician may infiltrate an injection due to many factors 
outside of the control of the clinician. Patient anatomy, age, body 
habitus, hydration, and prior medical treatment are all factors that 
may impact an intravenous administration.
    The NRC agrees with the petitioner that medical event reporting of 
extravasations may focus some medical licensees on reducing their 
extravasation rate through implementation of quality improvement 
programs for intravenous administration of radiopharmaceuticals, and 
reducing the extravasation rate would improve radiation safety for 
patients.
    The NRC agrees that certain extravasations can result in radiation-
safety-significant doses to the tissue around the administration site, 
which could result in adverse tissue effects. However, published 
studies (Van der Pol et al., 2017; Hall et al., 2006) and input from 
the medical community and the Advisory Committee on the Medical Uses of 
Isotopes (ACMUI) indicate that due to the smaller amounts of 
radioactivity used in diagnostic procedures, extravasations of 
diagnostic radiopharmaceuticals are typically of low radiation safety 
significance and would rarely be expected to result in adverse tissue 
effects. The NRC agrees that extravasations of therapeutic 
radiopharmaceuticals, which deliver larger amounts of radioactivity to 
treat cancer and other ailments by killing cells, may cause tissue 
damage around the administration site (Van der Pol et al., 2017; Bonta 
et al., 2011; Tylski et al., 2018; Benjegerdes et al., 2017).
    The NRC's Medical Use Policy Statement says, in part, that the NRC 
will not intrude into medical judgments affecting patients, except as 
necessary to provide for the safety of workers and the general public. 
The policy also states that the NRC will regulate radiation safety, 
when justified by the risk to the patient, primarily to assure the use 
of radionuclides is in accordance with the physician's directions. The 
NRC agrees that medical event reporting of certain extravasations would 
support these patient safety objectives of the Medical Use Policy 
Statement by potentially reducing the occurrence of radiation-safety-
significant extravasations. Therefore, the NRC is considering the 
issues raised by the petitioner in a rulemaking process that will 
assess risk-informed reporting requirements for extravasations.
    Issue 2: Exemption of extravasations from medical event reporting 
requirements results in a lack of transparency to patients, the public, 
and the NRC.
    The petitioner asserted that the exemption of extravasations from 
medical event reporting requirements results in a lack of transparency 
to the patients, the public, and the NRC as the 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. The petitioner asserted that this may result in 
patients and clinicians being unaware that the diagnostic image or 
intended therapy may have been compromised, and the NRC remains unaware 
when licensees misadminister radiopharmaceuticals resulting in doses 
that exceed medical event reporting limits.
    NRC Evaluation: Under the NRC's current practice of excluding 
extravasations from medical event reporting, extravasations that result 
in suspected radiation injury, or even those that meet the NRC's public 
health and safety significance criteria for an abnormal occurrence, are 
not required to be reported to the NRC. The NRC agrees that reporting 
radiation-safety-significant extravasations would increase transparency 
between patients, physicians, and the NRC. If certain extravasations 
were required to be reported under Sec.  35.3045, this would enhance 
transparency through medical event reporting requirements for notifying 
the patient, referring physician, and the NRC within 24 hours of 
discovering the event and through event notification reports published 
by the NRC. These event notifications would be publicly available on 
the NRC website. These extravasation events would be shared with and 
evaluated by the ACMUI on an annual basis. Additionally, the reporting 
and analysis of safety-significant extravasation events would allow the 
NRC to identify similarities in reports from multiple facilities and 
issue generic communications to share information that may help 
licensees to reduce the occurrence of radiation-safety-significant 
extravasations and mitigate their consequences.

IV. Availability of Documents

    The documents identified in the following table are listed in the 
order in which they are cited in this notice and are available to 
interested persons through one or more of the following methods, as 
indicated.

------------------------------------------------------------------------
                                                   ADAMS accession No./
                    Document                         web link/Federal
                                                     Register citation
------------------------------------------------------------------------
Petition for Rulemaking (PRM-35-22)--Lucerno      ML20157A266.
 Dynamics, LLC, Petition to Amend 10 CFR
 35.3045, May 18, 2020.
Notice of Docketing and Request for Comment on    85 FR 57148.
 Petition for Rulemaking, Reporting Nuclear
 Medicine Injection Extravasations as Medical
 Events, September 15, 2020.
Final Rule, Medical Use of Byproduct Material,    67 FR 20250.
 April 24, 2002.
Final Rule, Quality Management Program and        56 FR 34104.
 Misadministrations, July 25, 1991.

[[Page 80479]]

 
Final Rule, Misadministration Reporting           45 FR 31701.
 Requirements, May 14, 1980.
Medical Use of Byproduct Material; Policy         65 FR 47654.
 Statement, Revision, August 3, 2000.
Van der Pol, J., S. Voo S, J. Bucerius, and F.M.  https://
 Mottaghy, ``Consequences of Radiopharmaceutical   pubmed.ncbi.nlm.nih.g
 Extravasation and Therapeutic Interventions: A    ov/28303300.
 Systematic Review.'' European Journal of
 Nuclear Medicine and Molecular Imaging, Vol.
 44, No. 7, July 2017.
Hall, N., J. Zhang, R. Reid, D. Hurley, and M.    https://
 Knopp, ``Impact of FDG Extravasation on SUV       jnm.snmjournals.org/
 Measurements in Clinical PET/CT. Should we        content/47/suppl_1/
 routinely scan the injection site? '' The         115P.2.
 Journal of Nuclear Medicine, Vol. 41,
 Supplement 1, Pg. 115, May 2006.
Bonta, D.V., R.K. Halkar, and N. Alazraki,        https://
 ``Extravasation of a Therapeutic Dose of 131I-    pubmed.ncbi.nlm.nih.g
 Metaiodobenzylguanidine: Prevention, Dosimetry,   ov/21795365.
 and Mitigation.'' The Journal of Nuclear
 Medicine, Vol. 52, No. 9, September 2011.
Tylski, P., A. Vuillod, C. Goutain-Majorel, and   https://doi.org/
 P. Jalade, ``Dose Estimation for an               10.1016/
 Extravasation in a Patient Treated with \177\     j.ejmp.2018.09.071.
 Lu-DOTATATE.'' Journal of Medical Physics, Vol.
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------------------------------------------------------------------------

V. Conclusion

    For the reasons cited in this document, the NRC will consider the 
issues raised in the petition in the rulemaking process. The NRC will 
evaluate the current requirements and guidance for reporting of certain 
nuclear medicine injection extravasations as medical events. The NRC 
tracks the status of all rules and PRMs on its website at https://www.nrc.gov/about-nrc/regulatory/rulemaking/rules-petitions.html. The 
public can monitor further NRC action on the rulemaking titled, 
``Reporting Nuclear Medicine Injection Extravasations as Medical 
Events,'' that will address the issues in this petition by searching 
for Docket ID NRC-2022-0218 on the Federal rulemaking website, https://www.regulations.gov. In addition, the Federal rulemaking website allows 
members of the public to receive alerts when changes or additions occur 
in a docket folder. To subscribe: (1) navigate to the docket folder 
(NRC-2022-0218); (2) click the ``Subscribe'' link; and (3) enter an 
email address and click on the ``Subscribe'' link. Publication of this 
document in the Federal Register closes Docket ID NRC-2020-0141 for 
PRM-35-22.

    Dated December 22, 2022.

    For the Nuclear Regulatory Commission.
Brooke P. Clark,
Secretary of the Commission.
[FR Doc. 2022-28356 Filed 12-29-22; 8:45 am]
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