ML23257A263
| ML23257A263 | |
| Person / Time | |
|---|---|
| Issue date: | 08/29/2023 |
| From: | NRC/NMSS/DMSST/MSEB |
| To: | |
| Shared Package | |
| ML23257A262 | List: |
| References | |
| NRC-2481 | |
| Download: ML23257A263 (78) | |
Text
Official Transcript of Proceedings
NUCLEAR REGULATORY COMMISSION
Title:
Public Meeting on the Regulatory Basis for the Part 35 Rulemaking on Rubidium-82 Generators, Emerging Technologies, and Other Medical Use of Byproduct Material
Docket Number: (n/a)
Location: teleconference
Date: Tuesday, August 29, 2023
Work Order No.: NRC-2481 Pages 1-73
NEAL R. GROSS AND CO., INC.
Court Reporters and Transcribers 1716 14th Street, N.W.
Washington, D.C. 20009 (202) 234-4433 1
UNITED STATES OF AMERICA
NUCLEAR REGULATORY COMMISSION
+ + + + +
PUBLIC MEETING ON THE REGULATORY BASIS FOR THE PART
35 RULEMAKING ON RUBIDIUM-82 GENERATORS, EMERGING
TECHNOLOGIES, AND OTHER MEDICAL USE OF BYPRODUCT
MATERIAL
+ + + + +
TUESDAY
AUGUST 29, 2023
+ + + + +
The meeting was convened via
Videoconference, at 2:00 p.m. EDT, Sarah Lopas
facilitating.
PRESENT:
Francis O'Neill
Elizabeth Tindle-Englemann
NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com 2
ALSO PRESENT:
Max Amurao
Peter Crane
Willie Crawford
Scott Fuller
Tianliang Gu
Stanley Hampton
Roxanna Kimes
Koressa Lee
Bryan Lemieux
Ralph Lieto
Prasad Neti
Harrison Redman
Jerry Thomas
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P-R-O-C-E-E-D-I-N-G-S
2:00 p.m.
MS. LOPAS: So good afternoon, everybody.
Welcome to today's NRC public meeting on the
regulatory basis for the Part 35 Rulemaking on
Rubidium-82 Generators, Emerging Medical Technologies,
and Other Medical Use of Byproduct Material. My name
is Sarah Lopas. I'm going to be facilitating today's
meeting.
As a facilitator, I want to welcome you
all to this meeting regarding the Federal Register
notice that was published on July 3rd, 2023 announcing
the availability of the reg basis for this rulemaking
to amend 10 CFR Part 35 to establish requirements for
Rubidium-82 generators, emerging medical technologies,
and also accommodate developments in the medical field
related to new radiopharmaceuticals and EMTs. During
this meeting today, staff intend to provide
clarification to the information in the July 3rd, FRN
and associated regulatory basis document and also
explain the process of providing feedback to the NRC.
Next slide. And I'm going to take a moment to record
today's meeting.
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So I'm going to start that now. Just a
warning for everybody, we are recording today's
meeting. We aren't going to be making the recording
available to the public. It's more just a backup for
our court reporter.
So I'm going to start that now. Okay.
All right. And I'm going to try to stop the
transcript. Maryann, I wonder if you can -- I'm going
to close out the transcript. Okay.
All right. So just a couple of
housekeeping items. So as I mentioned, today's
meeting is being transcribed. But we are not
collecting comments on the reg basis today.
The purpose of today's meeting is to
encourage attendees and stakeholders to submit your
comments through the formal comment submission process
that Maryann and Andy will be going over later today.
Those comments need to be submitted by October 31st,
Halloween. So they're going to encourage you to
submit comments using the means discussed in the FRN,
and they're going to answer clarifying questions,
basically help you inform those comments.
In just a moment, I'm going to take the
links that are on this slide here and put them into
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the chat. Our chat is open today for your questions
and comments. You can go ahead and put questions and
comments in the chat at any time, but we are going to
hold off on addressing those until we get to the
designated points in time during the staff's
presentations where we're going to be taking questions
and comments.
So that'll be three periods throughout the
meeting where we'll stop, we'll all stop for
questions, stop for Q&A. And I'll read what's in the
chat as applicable. So we aren't going to be
responding directly back to you in the chat for your
questions, but we will be reading them aloud as
applicable.
If you have technical issues with today's
Teams, put that in the chat and I will do my best to
be responding to that and trying to help you out with
any technical issues in the chat once I stop talking
right here. I do want to note that all of the things
that we're mentioning today, the reg basis, the
Federal Register notice, and the slides are -- if
you're on the phone right now and you can't get to
these links that I'm posting in Teams, you can just go
to the NRC public meeting notice website and find the
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notice for this meeting. And there's all those links
are in the meeting notice, including these slides.
So the slide ML number if you're somebody
that's familiar with ADAMS, the slides, you can find
them in ADAMS at ML23122A356. So that's where you can
pull up today's slides if you'd rather have them open.
And you'd be able to click on the links directly
there too.
Let's see. So you'll notice that
everybody has their mics enabled. So please just keep
an eye that you are muted. We'll do our best to keep
you muted too.
When we get to the Q&A portion of today's
meeting, we'll be using the raise hand function. So
you'll go ahead and click that raised hand icon up
top. And I'll call on you, and you will unmute
yourself.
So you are in control of your own
microphone. We aren't enabling attendee cameras.
You'll notice that. If you are on the phone, you'll
press *5 to raise your hand. And then I'll instruct
you how to unmute yourself on your phone.
And you'll need to make sure that your
phone is unmuted as well, like, your personal phone.
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If you have yourself, like, double muted, I often do
that on the meetings to be extra safe. So you'll need
to hit unmute on your phone in addition to pressing *6
on your phone to unmute. But *5 to raise your hand if
you're on your cell phone.
Let's see. So I will repeat those
instructions when we get to the Q&A. And I just want
to note that -- let's see. Like I mentioned, we do
have the chat function open. And I think that's
basically it for now.
I'll have more kind of facilitator-esque
instructions when we get to the Q&A. But basically,
we'll start with a couple presentations. We'll stop
for a break. Do a little bit more presentation. Stop
for break, a little bit more, and then we'll end up --
we'll conclude with questions.
So if we don't get to your questions
during one of the first two Q&A rounds, we'll get to
it at the end. So with that, I'm going to hand over
the meeting to really officially kick us off to
Theresa Clark who's going to give our opening remarks.
Theresa is our deputy director her at the Division of
Material Safety, Security, State and Tribal Program in
the NRC's Office of Nuclear Material Safety and
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Safeguards. Theresa?
MS. CLARK: Hi, thanks, Sarah. And so
welcome, everyone. Good afternoon to you if you're on
the eastern side of the U.S. Good morning if you're
on the West Coast. We're pleased to have you here
with us today to discuss a really important rulemaking
and one that's been a lot of work for our working
group. So I truly appreciate all of their support in
developing this regulatory basis that we've been
talking about today.
These medical technologies that are the
subject of this rulemaking are very important for
lifesaving and life sustaining activities nationwide.
And so the information that goes into this regulatory
basis really affects a lot of people. And we find it
to be really important.
So appreciate everyone who's taken the
time to participate in this meeting today. Like I
said, I want to acknowledge all the major efforts of
the working group. There's a lot of work that goes on
behind the scenes to prepare a regulatory basis
document, to do the cost analysis that helps inform
some of the options, and then to do some of the
outreach like this meeting. So thanks, everyone, for
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their participation.
Like was mentioned before, this regulatory
basis is out for public comment right now. It was
published in July. And we've been working on this
rulemaking for about a year and a half or so,
developing the content that you see in the regulatory
basis. So we're really looking forward to sharing it
with you and getting more feedback through that formal
comment process.
Today's meeting as Sarah mentioned is
designed to help you shape those comments. We put a
lot of questions into the regulatory basis in specific
areas for comment. So that should help you give us
the information that will really help us make a great
product when we prepare the rulemaking on this.
So any comments that you want to submit in
response to the Federal Register notice please feel
free to do so. If we missed any questions that you
think are important to helping us inform the proposed
rule that we'll be developing, please feel free to
make those comments and provide any new information we
should consider as we progress in this rulemaking. So
we'll consider all of that information as we develop
the proposed rule which is the next step in our
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rulemaking process.
Maryann Ayoade is going to take us through
the background that helps set up the topic for this
meeting. She and other members of our joint working
group between the NRC and Agreement States are going
to go over all the information provided in the
regulatory basis document. They'll tell you how to
submit comments specifically, and we will have some
time as Sarah mentioned for questions and answers
using the various features of this Teams meeting.
So I want to thank everyone for
participating in this important meeting. This is a
special project and a lot of work that goes into it.
And we look forward to your thoughts on that work.
And now I'll turn it over to Ms. Ayoade.
MS. AYOADE: Thank you, Ms. Clark. Good
afternoon, everyone. My name is Maryann Ayoade, and I
am a member of the medical radiation safety team at
the NRC and also a member of the NRC agreement state
working group for this rulemaking effort as Ms. Clark
mentioned.
Before we begin, I would like to
acknowledge and thank all of the working group members
for your contribution in the development of the
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regulatory basis as this project has been a major
effort and also for your support in this meeting
today. So for today's presentation -- next slide,
please. For today's presentation, I will be providing
some information on the background of the rulemaking
that's associated with this regulatory basis and where
we are in the rulemaking process, a quick overview of
the regulatory basis document and what you can expect
to see, and a general overview of the proposed changes
with the highlight on the major proposed changes and
the questions that the NRC is seeking additional
comments and feedback on to better inform the next
phase of the rulemaking.
I will then be turning it over to the
other members of the working group to go over the
proposed changes in more detail by technology,
including those NRC questions for feedback. And then
you will hear about the early feedback that we
received from our regulatory counterparts in the
Agreement States as well as our NRC advisory committee
on the medical uses of isotopes as this is a part of
our rulemaking process. And then finally, you will
hear from our rulemaking and cost analyst experts on
the preliminary cost analysis and the estimates for
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NRC, the estimates for Agreement States, and also for
our licensees and all that was considered for this
rulemaking as well as the next steps in the rulemaking
process and what you can expect as we move forward.
I do want to point out that in the
presentation for today we have included some reference
guide slides after each proposed section. And they're
meant to help guide you to the existing sections of
the regulations where we're proposing to make changes
and where we have added new sections with proposed
changes. We do not plan to speak to those slides in
detail for the sake of time today, but I just want to
note that they will be included in the presentation
file that will be made publicly available. And I
believe that link has been shared in the chat for
today. Next slide.
Okay. So moving forward with the
rulemaking background, what exactly are the issues
that we're considering and hoping to address in this
rulemaking? There are two primary issues under
consideration. We're hoping to first address the
ongoing challenges that are associated with licensing
Rubidium generators under Part 35 by proposing changes
to include requirements that will address the
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calibration and dosage measurements for the Rubidium
generators.
And then we're also hoping to address the
challenges that are associated with licensing the
existing and future emerging medical technologies
under the current medical use regulations in Part 35
by establishing more risk informed and performance-
based requirements which will also create more
flexibility in the regulations for existing and future
technologies. Now in addition to these two primary
areas, we're also proposing to make revisions to other
sections of Part 35 that are not associated with any
one technology. And this is because we want to be
able to accommodate the development that we continue
to see in the medical field that are related to new
radiopharmaceuticals and emerging technologies.
And that will also allow for added
flexibility and more risk informed and performance-
based requirements. So you will notice in the title
of this rule, it also states and other medical use of
byproduct material. And so that's what I'm referring
to there. Next slide.
Okay. So this slide gives some
information as far as the initial timeline for this
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rulemaking up until where we are today. We will cover
the next steps in the rulemaking process timeline a
little later on towards the end of the presentation.
And so as Ms. Clark mentioned, this rulemaking was
initiated with the NRC staff recommendation for
rulemaking to the Commission through a rulemaking
plan.
And that was issued in February of 2021.
That plan was then approved the following year in
January of 2022. And our NRC agreement state working
group was formed right after that in February of last
year.
And so the working group was formed to
develop the regulatory basis for the rule. And the
regulatory basis which is what has been issued for
comment is what serves as a precursor to the proposed
rule which is the next phase of this rulemaking. And
then late last year in the November-December time
frame, as part of our rulemaking process, a draft
version of the regulatory basis was reviewed by our
regulatory counterparts in the Organization of
Agreement States as well as the NRC's advisory
committee on the medical uses of isotopes.
So I want to point out that a summary of
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their comments and recommendations as well as the
NRC's responses to the comments are included in the
regulatory basis document. And their overall feedback
has been considered as a part of this regulatory basis
that you're reviewing. We have also included links to
a copy of the draft regulatory basis, the ACMUI
recommendations report, and the transcript of
discussion during the public meeting that occurred
last December.
And so all of those can be found using the
links that are provided on this slide. You'll also
hear from another working group member later on about
the type of feedback and the comments that we received
from these two groups. And so this brings us to where
we are today with the issuance of the regulatory basis
document for public comment that was issued in July.
Next slide.
So this slide provides a quick overview of
what to expect in the regulatory basis document. So
when you review this document, you will find
information on the background for this rulemaking and
the current regulatory framework, including the
policies, the regulations, and the guidance
surrounding this rule. You will also see that it
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covers an explanation of the regulatory issues and the
proposed changes of the regulations and how those
changes could resolve the issues.
And then you'll find sections on the NRC's
evaluation of the type of approaches and also the
alternatives that we considered in support of the
regulatory basis as well as cost and benefit analysis
for the rulemaking and the different alternatives.
You will also see in there that we have included an
explanation of some of the limitations that were
considered, including any uncertainties in the data or
the methods of analysis for this rule. Next slide.
So this slide gives a quick overview of the proposed
changes that are being considered in this rulemaking.
And you will find some more detailed
descriptions of the changes that are currently under
consideration in Appendix A of the document. So
Appendix A is where you will find the proposed
changes. And they've been organized by technology.
And we've also included a section that
provides information on other Part 35 proposed changes
that I mentioned earlier that are not necessarily
associated with any one technology. You'll also find
that we have included a series of NRC questions that
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we're seeking additional feedback on as I mentioned
earlier. These questions are alongside the proposed
changes in Appendix A, and we've highlighted those in
bold italic font in the reg basis document to draw
your attention to it. But you will also find them in
the Federal Register notice as well.
So what else do we need to know about the
proposed changes? We want you to know that the
changes are primarily based on the existing criteria
in the guidance document. So that is the existing
criteria in the emerging medical technologies
licensing guidance documents and of course in the
enforcement guidance memorandum for the use of
Rubidium generators which are not characterized as
emerging medical technologies.
And so as you may be aware, the NRC uses
existing emerging medical technologies licensing
guidance documents as a pathway under the current
regulations in 35.1000. And we use this to license
certain types of new medical use. And when a licensee
commits to following the guidance in these documents,
then they are also committing to following the
conditions and the criteria that are set forth in
those documents. So that was sort of our baseline for
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the proposed changes for this rulemaking. Next slide.
So this slide was added to highlight some
of the major changes that you will find in this
rulemaking. You will see that we have proposed
changes to the current requirements for use of
unsealed byproduct material to account for calibration
and dose measurements for Rubidium generators. You
will also see that we've created a new subpart for the
regulation of microspheres which would be referred to
as Microsource Manual Brachytherapy.
And then you'll find that we are proposing
to require the device specific training for some
generators and emerging medical technologies. And
then there are proposed changes that are requirements
primarily for the regulations that are associated with
gamma stereotactic radiosurgery. And there we're
proposing criteria that will shift the focus from more
specific device components to more of the functional
element of the technologies.
This slide also includes a note about a
couple of new emerging medical technologies that this
rulemaking would not establish regulations for but
were considered. And so we have the NorthStar
RadioGenix Mo-99/Tc-99m Generator System and the
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diffusing brachytherapy sources like the Alpha DaRT
technology. And this is because these are newer
technologies, and we determined that they are not as
well -- or they're not well established and that
additional operating experience is still needed in
order for us to consider codifying or moving it into
the existing licensing criteria for these technologies
into Part 35.
Also for technologies like the NorthStar
Generator, we determined that because they are more
complex and they have a higher radiation risk as
compared to the traditional Mo-99/Tc-99m generators
and the other generators that we currently license in
Part 35, the working group determined that maintaining
licensing under 35.1000, the licensing guidance would
be the most practical and cost effective regulatory
approach. So you will see that noted in the
regulatory basis document. Next slide. This slide
provides information on the NRC questions for feedback
that I mentioned are included in the regulatory basis
document.
You'll find a series of questions that
have been included throughout Appendix A because we're
trying to get additional stakeholder input on certain
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regulatory issues or proposed regulatory approaches to
an issue. And NRC is particularly interested in
feedback on the topics that you see on the slide. So
we want to hear from you about whether there's enough
operating experience to inform regulations for
diffusion brachytherapy.
We want to know whether the effort to
establish regulations for less widely used emerging
medical technologies is warranted. We also want to
get your feedback on the proposed regulatory framework
for the new microsource manual brachytherapy for the
new microsource brachytherapy subpart. And also we
want to know whether there should be any changes to
the training and experience requirements that we
currently have for emerging medical technologies. So
you'll see these questions for feedback in the
regulatory basis document. Next slide.
Also we have included in the questions for
feedback some additional stakeholder feedback
questions in Appendix A. And these are Commission
directed questions that are related to training and
experience for the use of emerging medical
technologies. So these questions came from a separate
effort that was related to the training and experience
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unsealed byproduct material that was issued by the
Commission early last year, so January of last year.
And as part of the Commission's response
to that separate effort, we were directed -- our staff
was directed to reconsider the full complement of the
training and experience requirements within our
current regulatory framework. And we were asked to
also obtain stakeholder comments in the following
areas that you see listed on this slide. So the first
is on the knowledge topics that surround the safety-
related characteristics of emerging medical
technologies that are required for authorized users to
be able to fulfill their radiation safety-related
duties and supervision roles.
The second is on the methods, so what
methods and how should the knowledge topics be
acquired. Finally, we have questions that are related
to continuing education, vendor training for new
medical uses, and then training on NRC's regulatory
requirements in Part 35. So again, I want to point
out that all of these stakeholder questions are in
Appendix A of the regulatory basis and also in the
Federal Register notice.
And they'll be covered during the rest of
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the presentation by other members of the working
group. I also want to emphasize that the stakeholder
feedback that we receive on the regulatory basis is
just as important as these questions. And we want to
be able to use them to help to better inform as we
move into the proposed rule phase where we'll move
into writing and revising rule language.
And we ask that you please provide your
feedback on these questions in addition to your
feedback on the regulatory basis as a whole. So I
will now turn over to the other members of our working
group to go over the proposed changes and the
questions for feedback in more detail, starting with
Mr. Francis O'Neill. Thank you. Next slide,
Christine. Great.
MR. O'NEILL: Thank you, Maryann.
Appendix A-1 focuses on radionuclide generators,
strontium-rubidium generators, is not considered --
lost my slide here -- is not considered an EMT
emerging medical technology. And its use is currently
licensed under Subpart D for material that does not
require a written directive.
So it is licensed under Subpart D along
with the enforcement guidance memorandum that has been
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used since 2013 for outstanding technical issues
related to the generator. These generators are
different from other generators license under subpart
because of a short half-life, 76 seconds of Rubidium-
82, and the generator's automated elution and patient
infusion system. Because of this, licensees cannot
meet the requirements of 10 CFR 35.60 of a calibration
of the sites of radiation detectors and these
generators that function dynamically as fluid moves
past each sector in the tube as opposed to in a static
well counter.
Additionally, they cannot meet the
requirements of 10 CFR 35.63 to determine the activity
of each dose administered prior to medical use.
There's also the Germanium/Gallium Generators which is
currently utilized under 10 CFR 35.1000 because of the
risk of a specific specified permissible concentration
limit for the parent radionuclide and the regulations
and the potential for breakthrough and unnecessary
high radiation exposure to patients.
The proposed changes made in this section
would allow Rubidium generators to continue to be
licensed under Subpart D but without the need for
enforcement discretion. The changes would also allow
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for Germanium/Gallium Generators to be licensed under
Subpart D by including an established limit for the
allowable concentration of Germanium-68 in each eluate
of the generator. The first set of questions that
we're looking for, feedback on are related to
generator device specific training and dose
measurements.
We want feedback on whether the RSOs need
device-specific training for generator systems or
whether the general awareness training on generators
and their function of risk is enough. We are seeking
feedback on whether and how the NRC should allow the
completion of doses of measurements as a beginning of
an increment administration for radionuclides other
than Rubidium-82. Next slide, please. This slide is
a reference guide that Ms. Ayoade referred to earlier.
This slide has been included to show you
sections of regulations that we're proposing to make
changes to that are related to the use of the
generators. These are the generator changes. I will
now turn it over to my other member, Monica Ford, from
the NRC, to go over the next set of changes. Thank
you. Next slide, please.
MS. FORD: Thank you, Francis. Next we
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will discuss intravascular brachytherapy which is
noted as Appendix A.2 and is currently regulated under
10 CFR 35.1000. Intravascular brachytherapy is a type
of brachytherapy in which the sources are placed
within blood vessels for treatment.
The current 10 CFR 35.1000 licensing
guidance is for the best vascular beta-cath
intravascular brachytherapy system which is manually
controlled and uses a Strontium-90 source to deliver
high doses of beta radiation. To incorporate
intravascular brachytherapy into 10 CFR Part 35, the
NRC is proposing revisions be made to 10 CFR Part 35,
Subpart F, manual brachytherapy, as the current
guidance for the intravascular brachytherapy uses
references for several requirements of this subpart.
Several regulatory changes are being proposed to
Subpart F.
These include adding training and
experience requirements similar to those outlined in
10 CFR 35.690 for physicians wishing to become
authorized users and additionally including a
requirement that all members of the care team receive
device-specific training related to hands-on device
operation, safety procedures, and clinical use
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commensurate with the specific care team members role.
Additional regulatory changes will include
requirements for physical presence, operating and
emergency procedures, servicing of the device by
qualified individuals, surveys of patients and human
research subjects before release to confirm the source
has been removed, and radiation survey requirements
similar to those described in 10 CFR 35.652. Lastly,
the written directive requirements currently reflected
in 10 CFR 35.40 would need to be updated to include
criteria specific to intravascular brachytherapy.
Along with these changes, the NRC has
posed one question related to intravascular
brachytherapy that we are seeking feedback on.
Question A.2.1 asks stakeholders to please provide
comments on the sufficiency of the training and
experience requirements for authorized users outlined
in the current licensing guidance documents for
intravascular brachytherapy, liquid brachytherapy, and
eye applicators. Specifically, the NRC is seeking
feedback on the knowledge topics encompassing the
safety-related characteristics that are required for
authorized users to fulfill their radiation safety-
related duties and supervision roles, the methods for
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acquiring knowledge topics in consideration for
continuing education, vendor training for new medical
uses, and training on NRC regulatory requirements.
Next slide, please.
This slide reflects the list of
regulations that the NRC is proposing to amend in
order to incorporate intravascular brachytherapy into
our regulatory framework. Next slide, please. This
next slide is discussing Appendix A.3, which focuses
on liquid brachytherapy sources and devices currently
licensed under 10 CFR 35.1000. Liquid brachytherapy
is a type of manual brachytherapy that treats cancer
with devices that are implanted temporarily.
The current licensing guidance is for the
GliaSite radiation therapy system. The system
delivers intracavity radiation therapy to patients
with malignant brain tumors following tumor resection
surgery. Liquid brachytherapy has use characteristics
similar to the existing medical uses in 10 CFR Part
35, Subpart F.
However, the current regulations in
Subpart F do not cover all the safety concerns
associated with use of liquid brachytherapy. These
safety concerns include removal of all liquid from the
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device, leak testing of the device before use, and the
need for an authorized user with experience in
radiopharmaceutical procedures to be on call to
provide guidance in case of a leak. Regulatory
changes being proposed will allow for this use to be
regulated under 10 CFR Part 35, Subpart F.
These changes include revising the
definition of manual brachytherapy to include liquid
sources, updating the definition of prescribed dose,
and adding a definition for source leakage.
Additional changes include those for written directive
requirements specific to liquid brachytherapy,
requirements for leak testing prior to the start of
the procedure, labeling requirements for vials and
syringes associated with the procedure, contamination
control, safety instructions for the safe handling of
contaminated items, and the addition of the new
section specific to training and experience
requirements for authorized users of these devices.
In addition to Question A.2.1 which I previously
discussed which asked for comments on the sufficiency
of training and experience requirements for authorized
users for intravascular brachytherapy, liquid
brachytherapy, and eye applicators, the NRC is seeking
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feedback on three additional topics specifically
focusing on liquid brachytherapy.
The first two questions are shown on this
slide. Question A.3.1 requests comments on whether
the current definition of manual brachytherapy as
shown in 10 CFR 35.2 should be revised to include
liquid brachytherapy and exclude microsources or if
liquid brachytherapy should be included in the newly
proposed Subpart I for microsources. Question A.3.2
is seeking input on whether a new requirement on
contamination control is needed.
Specifically, we are asking for comments
on this proposed requirement and your thoughts on if
it should apply to all medical licensees or to a
certain subset and why. Next slide, please. The
third question we are seeking feedback on is shown as
Question A.3.3. This question relates to the
definition of source leakage as it relates to liquid
Specifically, we are asking for your
comments on whether the limit being proposed is
appropriate and an explanation supporting that
position. We are also seeking your insights on what
types of limits for liquid brachytherapy device
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leakage should be considered by the NRC. Next slide,
please. This slide reflects the list of regulations
that the NRC is proposing to amend in order to
incorporate liquid brachytherapy into our regulatory
framework. Next slide, please.
Appendix A.4 focuses on radioactive seed
localization which is currently regulated under 10 CFR
35.1000. Radioactive seed localization procedures
involve using decayed radioactive seeds that were
previously approved for use or treatment under 10 CFR
Part 35, Subpart F or with low activity seeds approved
specifically for radioactive seed localization use.
Therefore, there are currently challenges in
regulating this modality under 10 CFR Part 35,
Subparts D, F, and G.
The NRC is proposing changes to the
regulations that would allow for this use to be
regulated under 10 CFR Part 35, Subpart G. The
proposed changes would allow for use of sources
specifically approved in a sealed source and device
registry for this use and those sources that were
previously approved for therapeutic use that have
decayed to less than or equal to 300 microcuries.
There would also be changes for requirements for
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supervision, new training and experience requirements
specific to this modality, record keeping
requirements, and medical event reporting
requirements.
Additionally, we're proposing changes to
Subpart G that are similar to the requirements that
are currently in Subparts F and H related to patient
surveys, source accountability procedures, operating
and emergency procedures, and emergency response
equipment. Additionally, we are looking to add
requirements to verify source activity before
implantation. Unlike the first two sections that I
presented on, the NRC does not have any specific
questions for feedback related to radioactive seed
localization. However, we would be very appreciative
of any feedback you wish to share related to the
proposed regulatory changes for this use. Next slide,
please.
This slide reflects the list of
regulations that the NRC is proposing to amend in
order to incorporate radioactive seed localization
into our regulatory framework. And at this time, I
will turn the presentation back over to Sarah to open
it up for questions. Thank you.
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MS. LOPAS: Thank you, Monica. All right.
So now we've reached the first break in the
presentation for any questions. You can go ahead and
click on the hand icon on the top of your Teams
meeting. And that'll indicate to me that you want to
ask a question.
I'll call on you. You will unmute
yourself. Everybody does have their microphones
enabled. But you do have to unmute them in order to
be heard. But we're going to do it by raising hands.
You can also submit comments or questions
in the chat. If you prefer that I read out your
question, that's fine too. And if you have called in
which I see there are several people who called in,
just press *5 on your phone and that will raise your
hand. I'll be able to see that you have your hand
raised, and you can then -- I'll call on you and
you'll press *6 to unmute your phone -- your Teams
line on your phone.
So *5 if you're on the phone. Hit the
hand icon if you're here joining us on Teams. I'll
keep an eye out for that. Or go ahead and just put
your question or comment in the chat if you'd prefer
that. And also let me know if some of you that joined
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late, I'll probably repost the links to the FRN and
the reg basis and today's slide because I think when
you join late, you don't see all the links -- excuse
me, all the chat.
Okay. So here we are. We have a chat
question from Ralph Lieto. The question is, is the
GliaSite device still available? Never came off IND
if I remember correctly. After more than 20 years, if
not FDA approved, is there new data of increased use?
A start is for NRC to establish how many licensees
are using the device seems not even on the horizon for
regulatory interest or need.
So that's a good comment, medical group.
I remember when I was working with you all, we talked
a little bit about this and whether we thought it was
useful to codify regs for something like this. So I
wonder if you all -- if anybody can talk to that
maybe.
MS. AYOADE: Monica, I don't know if you
wanted to take this. But that's correct, Ralph. We
do have note in the document speaking to this, and we
acknowledge that the GliaSite technology is no longer
being distributed. And so we do account for that in
this rulemaking, yeah.
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MS. LOPAS: All right. Let's see. I
don't see any hands raised. I'll give you just a
couple more seconds to click on the raised hand icon
or press *5 if you're on the phone. If you're calling
in, you just press *5 and that shows me that your hand
is raised if you're on the phone.
There's only two callers. Or pop it in
the chat. We are going to have a couple more breaks
for questions. So if we don't have any questions
right now, I guess we'll just keep moving forward.
Maryann, I do want to encourage people.
If you hear something that you have a question on as
we're going through, go ahead and pop it in the chat
and we'll get to it when we break. But if you don't
want to forget about it.
Let's see. All right. I think we're set.
Everybody is -- oh, we got one unmuted. Willie
Crawford, I see you're unmuted. Did you have a
question?
MR. CRAWFORD: I did not. Sorry.
MS. LOPAS: Oh, no worries. Apologize for
calling you out. All right. I think we'll keep
moving then Maryann. Does that work?
MR. CRAWFORD: Called you out. Attendance
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verified. Got it.
MS. LOPAS: Got it.
MS. AYOADE: Yes, Sarah. That's correct.
Thank you.
MS. LOPAS: Oh, and I do want to know one
thing for verifying attendance. For the people that
have called in if you want your name to be kind of on
our attendance list, we ask that you email Maryann or
Andy to note your name and that you attended because
we only see your phone number. Okay. That's it.
MS. CENDER: All right. Thank you, Sarah.
My name is Laura Cender, and I'm a health physicist
out of NRC's Region 3 office. This next session
focuses on eye applicator sources and devices.
Currently, Subpart F provides pathways for
use of traditional, superficial Strontium-90 eye
applicators. As the structure of Subpart F is limited
to only these traditional eye applicators, licensing
guidance has been increasingly relied on to
accommodate next generation ophthalmic applicators and
to address the unique safety considerations associated
with their new designs and methods of use. Today,
licensing guidance has been issued for the Neovista
EPI-RAD Ophthalmic System and is in development for
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the Liberty Vision Yttrium-90 Disc Source Ophthalmic
System.
The proposed changes here are primarily to
address training and experience requirements under
Subpart F including additional pathways for physicians
to become authorized users. Other proposed changes
you'll see are related to written directive
requirements, device-specific training, safety
precautions, and changes promoting the use of Yttrium-
90 for ophthalmic treatments. The question here as
seen on previous slides, it's requesting comments on
the training and experience requirements and our
existing licensing guidance and if those requirements
are sufficient for the use of these eye applicator
sources and devices. Next slide, please.
And here we have the full list of
references for proposed changes associated with
ophthalmic applicator sources and devices. Next
slide, please. Now we're moving on to the gamma
stereotactic radiosurgery and photon emitting
teletherapy units. The proposed changes described
here in Appendix A.6 encompass one of the major items
for this rulemaking, and that is due in part to the
many significant technology advancements in this area
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since Subpart H was last revised.
Advanced gamma stereotactic radiosurgery
units or GSRs have undergone many major design and
engineering changes as you see described in current
licensing guidance documents for the different units
such as the Elekta Leksell Gamma Knife Perfexion and
Icon Units and Xcision GammaPod. So with the proposed
changes, you'll see a shift in the regulations from
referencing individual components to technologies and
prescriptive quality assurance requirements that are
now mostly updated to instead focusing on the
regulations around the actual functional elements of
the technologies that we're interested. So for
example, outdated requirements to test help
microswitches, trunnions, hydraulic backups, and other
components that no longer exist in newer GSR units
will no longer be included in Subpart H.
Instead, these proposed changes will see
replacement of these outdated requirements with
testing for the actual functional items of interest
such as dose delivery accuracy and positional accuracy
along with other functional aspects such as source
output, columniation positioning and attenuation with
the focus always on patient facility safety. The
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proposed changes here would also include new and
revised definitions related to GSR and teletherapy
units to be better align the definitions used in the
medical community. As you review the reg basis,
you'll see changes to requirements for a licensee,
including procedural submission requirements.
You'll also see revised requirements for
written directives, training and experience, models
with specific training and requirements for authorized
users. You'll also see proposed changes and
requirements for safety procedures and instructions
and precautions. Full calibration measure, periodic
spot checks, and records are also part of the changes
that we are seeking.
We're looking forward to hearing your
thoughts on these many proposed changes. And we also
have some questions of our own seeking specific
feedback. This first question here is seeking
feedback relating to model-specific training on
Subpart H devices for radiation safety officers and
how the NRC should define the types of Subpart H
devices that would require model-specific training, if
any. Next slide, please.
As I discussed earlier, the proposed
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changes to Subpart H would result in requirements
focused on the functional elements and objectives of
the technologies authorized under the Subpart. These
three questions seek to understand if there are any
additional functional elements critical to safety that
should be addressed in this rulemaking. Similarly,
comments were requested for considerations into the
types of objective tests that the NRC should consider
from calibration and spot check requirements.
Again, this is what we consider to be one
of the major proposed changes in this rulemaking, and
we're very interested in your feedback here. Next
slide, please. This slide captures the full list of
references for proposed changes associated with GSR
and teletherapy units. Next slide. Just like the
last section, the proposed changes here are another
major item in this rulemaking.
These microspheres has increased
significantly since the original licensing guidance
was issued. And we're anticipating that additional
new related technologies such as microparticles, new
microsphere systems will need to be authorized in the
years to come. The proposed changes you'll see here
include the creation of a new subpart in Part 35 which
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is Subpart I.
As you can see, we have introduced a new
title for the type of use which is now microsource
manual brachytherapy. These changes will include the
creation of a new definition for these types of
sources to be called microsources. Creating this new
subpart means making several revisions throughout all
of Part 35 to distinguish between current manual
brachytherapy technologies and microsource manual
The new Subpart I would mirror the
structure of Subparts F and H for manual
brachytherapy, HGR, GSR, and teletherapy use. Other
requirements would be specific to these microsource
brachytherapy. In the interest of time rather trying
to touch on all the proposed changes associated with
this section, I'll go over the many questions for
comments and feedback that we have instead as they
closely follow the most significant proposed changes.
So with this first question, we are
requesting feedback and comments on the proposed
definition of microsource and how that definition
should be loaded by radiation and energy type and what
sealed source and device registry considerations
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should be in place. Additionally, this question seeks
comments on any additional changes that may be
required to ensure appropriate flexibility in Subpart
I and Part 35 generally for future microsource manual
brachytherapy uses. Next slide, please. The first
question here, we are requesting comments on defining
physiological equilibrium as well as inputs to other
physiological stop points that should be taken into
consideration.
And moving on, microsphere manual
brachytherapy is usually performed by using a multi-
disciplinary team approach. The second question is
requesting feedback on the fundamentals of a
successful team-approach program would look like as we
consider changes to be made to the supervision
requirements in 10 CFR 35.27. And our final two
questions on the slide are requesting comments on
microsource manual brachytherapy specific inputs and
should be considered for pre-and post-implant
directives -- excuse me, written directives. Next
slide, please.
These first two questions are related to
changes proposed to 10 CFR 35.41, procedures for
administrations requiring a written directive.
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Specifically, the NRC is requesting comments on
whether the NRC should require documentation of
activity administered and activity to the treatment
site as well the required timeline that should be in
place for making this determination. Additionally,
comment is request on requirements for post-treatment
imaging or alternative mechanisms for confirming the
treatment was delivered in accordance with a written
directive.
And for a final question on this slide,
it's referencing authorized medical physicist. The
current licensing guidance in place for use of
microspheres does not define specific roles for AMPs.
This last question is requesting comments as to
whether there are any tasks for this category that
would require an authorized medical physicist. And if
so, what revised requirements should be considered for
10 CFR 35.51. Next slide, please.
Now we're getting into the questions
directly related to the new proposed Subpart I. These
first two questions request input into the basic
boundaries for this new subpart, the types of uses to
be permitted, whether uses under the section should be
limited to permanent implant only, and requirements
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should be considered for sealed source and the device
registry of microsources, both with and without unique
delivery systems. And the last question on the slide
is relating to the proposed new section of 10 CFR
35.710.
This section is intended to be analogous
in structure to the other sections in Part 35 such as
35.410 and 35.610, setting requirements for safety
procedures and instructions specific to microsources.
This question is seeking feedback on proposed
procedural requirements and input on any additional
aspects that should be considered. Next slide,
please. This leads to the last question. Here we're
seeking feedback on a proposed new section, 35.715,
that will address safety precautions for use of
microsources.
This question is seeking feedback on
proposed items intended to establish the minimum
requirements for safety precautions and any additional
aspects that should be considered for inclusion. Next
slide. This question is the first of several relating
to training and experience requirements for authorized
users that will be captured in the newly proposed 10
CFR 35.790. This is a long question essentially
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asking for feedback on the currently permitted
conditional authorization pathway for AUs in the
licensing guidance that allows AUs to be named on a
license and the limited capacity prior to completion
of all three of their hands-on patient cases.
The context for originally allowing this
conditional pathway stems from limited use and
training opportunities for physicians at the time that
the guidance was first issued. This question is
seeking comment if these conditions still persist or
if there are any other reasons why the NRC should or
should not allow this pathway to continue. Next
slide, please. This question is focused on training
and experience requirements for interventional
radiologists seeking to become authorized users.
With respect to classroom and laboratory
training, this question is seeking comment on whether
80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> is an appropriate training threshold.
Additionally, this question seeks input on the types
of individuals that should be permitted to supervised
direct working experience. Next slide, please. The
current licensing guidance also provides pathways for
physicians that meet the training requirements
described in 10 CFR 35.390 or 10 CFR 35.490 to become
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authorized users for Yttrium-90 microsphere use by
only completing the vendor training for delivery
system operation, procedural training, and the
clinical use portion, including their three hands-on
patient cases.
This question is requesting feedback on
whether additional training and work experience
requirements should be considered and why. Next
slide, please. This first question is asking if
additional pathways to becoming a microsource manual
brachytherapy authorized user should exist aside from
the current pathways permitted in the licensing
guidance for interventional radiologists and
physicians that meet the training requirements of 10
CFR 35.390 or 35.490. And our final question for this
section is asking about the circumstances of use for
Yttrium-90 microspheres and whether the authorized
users are primarily the individuals the administering
the microspheres.
This question seeks comment on whether it
is appropriate for other individuals to administer
microspheres under the supervision of an authorized
user. Next slide, please. This slide summarizes the
many sections of Part 35 including the addition of the
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new proposed Subpart I that would receive revision
under these proposed changes. And at this point, I
believe we're pausing for questions again.
MS. LOPAS: Well, Maryann, are we going a
little bit further with Elizabeth.
MS. AYOADE: A little bit.
MS. CENDER: I'm sorry for that.
MS. LOPAS: No, no worries.
MS. TINDLE-ENGLEMANN: No worries.
Thanks, Laura. And my name is Elizabeth Tindle-
Engelmann. I'm a health physicist in our NRC Region
III office. And I'm not going to talk about any
specific technologies today, but I'm going to talk
about a group of other changes to Part 35.
So if you remember, Maryann, the
Commission directed us to look at ways to make Part 35
more flexible for future technologies that we don't
currently have on our radar or things that we've heard
about might be headed our way but we don't really know
about in full detail yet. This is the group of things
I'm going to talk about, so we might be a little bit
all over the place. So if you have questions, feel
free to pop them in the chat.
But we'll be covering a couple different
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areas. Based on this directive to make Part 35 more
flexible for future EMTs, we came up with a couple of
different areas that we believe may allow future
technologies to move into the applicable subpart of
Part 35 without landing in 35.1000 and then requiring
rulemaking. Obviously, rulemaking is time consuming
and can be quite expensive. So if we can clear the
pathway for some of those now, that's obviously
advantageous.
So that's what I'm going to be talking
about today and that's what you're going to see in
Appendix A.8. And on this side, you can see one of
our proposed changes is to create a requirement for
licensees to develop a procedure for breakthrough
testing and reporting of breakthrough for novel
radionuclide generators. We also have a specific
question on there.
And so we're proposing that licensees
develop, implement, maintain a procedure for
breakthrough testing and reporting of novel -- a
breakthrough for novel radionuclide generators. There
are generators on the horizon that are not Moly-99 or
Strontium-82 based. And they may not have
breakthrough limits that have been established by USP
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or FDA.
So we're looking for feedback on whether
this approach sounds sufficient or any perspectives
you have on another participant might take in this
area. Next slide, please. So another topic related
to the novel radionuclides is a proposal for training
and experience for authorized users and authorized
nuclear pharmacists working with these novel
radionuclide generators. We're interested in
understanding what your thoughts are and if you have
any specific ideas on the training and experience that
should be required for these authorized users working
with these novel radionuclide generators as well as
the authorized nuclear pharmacists.
At this point in time, they're probably
not going to be at all of our licensees' facilities.
And so we're interested in how we should tackle that
training and experience requirement for those types of
generators. You'll also see that we're looking to
determine if there are other changes that are needed
for authorized medical physicist involvement in manual
Currently, there is a requirement for
authorized medical physicists to be involved in some
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Subpart F manual brachytherapy procedures. We're
looking for your input as to whether that's sufficient
and whether these authorized medical physicists should
be involved in additional tasks or skills that are
part of these manual brachytherapy procedures that we
currently have in Subpart F. We're looking for your
feedback there as well. Next slide, please.
And then here you're going to see a bunch
of different little things. And kind of like Laura
mentioned, I'm not going to go through each of them
here. But there are lots of details in the proposed
changes that you'll find in Appendix A.8.
But I am going to talk about some of the
specific questions. So in general, we're looking at
some changes to the definition of physician. We're
looking at defining a treatment regimen for patient
release criteria.
We're looking at revising the requirements
for radiation safety committees. We're looking at
revising the requirements for supervision. We're
looking at amending the requirements for written
directives, looking at amending T&E requirements as it
relates to recentness of training and continuing
education.
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We're looking at amending various
recordkeeping requirements based on these other
changes as well as medical event reporting
requirements and safety procedures instructions and
precautions for Subpart H devices. So I'm going to go
through a couple of questions related to these. And
if any of them spark your interest, definitely take a
look at the full section in Appendix A.8 on the
topics.
So the first question that you'll see on
this slide is that we're looking for your thoughts as
to whether we should require continuing education for
authorized users. We're all familiar with the
recentness of training criteria. But we're interested
in understanding if we should have a continuing
education requirement for authorized users.
And if so, what should be required? What
should it entail? What frequency should it be
acquired at? And what are the knowledge topics that
should be encompassed in that continuing education
element?
On this slide, you'll also see that we're
looking to understand if all AUs for 35.200 need to
have device-specific training on radionuclide
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generators. Obviously, they supervise the use of
these units on a regular basis. But they may not be
regularly working with them.
In light of the discussion we had
previously on novel radionuclide generators, we're
interested in your thoughts on whether authorized
users need training on general generators, specific
types of generators, or how we should handle that.
And so that's what this question is aiming to
understand. Next slide, please. This one is looking
at how we've seen a bit of a shift in 35.300
procedures.
So we've seen a large number of complex
emerging therapeutic radiopharmaceuticals come out.
And they've been able to safely go to 35.300. But
we're interested in looking at whether the T&E
requirements are sufficient.
And if additional training is needed, what
should the scope be? How should that be acquired?
And literally, this is with the intent of allowing
things to land in 35.300 immediately rather than going
to 35.1000 in the future based on the training gap.
Next slide, please.
On this slide, you'll see that we're
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looking for some training and experience insights for
35.500 devices. We previously talked about how we're
proposing to put one of our emerging technologies into
the section. And so we would like to understand if
you think the eight hours of classroom and laboratory
training for the 35.500 devices is sufficient, if we
have other types of devices that are going to land in
this section as well.
We'd like to consider how we can make this
a little bit broader for future emerging technologies
that we might not have on the horizon. So in light of
that, if we need additional training, what types of
training should be covered, frequency, such as that.
Next slide, please. We're also looking for your input
on specific changes that are needed to secure consoles
for keys, consoles, keys, and passwords for HDRs,
teletherapy units, and GSRs.
We've obviously seen a lot of changes in
technology. The treatment console looks much
different today than it did 5 years ago, 10 years ago,
20 years ago. So we're interested in input on some of
those specific requirements that are in Subpart H as
it relates to the security of the consoles, keys, and
passwords for those units.
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And you'll also see that we're looking for
your input on the types of entry controls that are
acceptable for these Subpart H devices. So we've
heard about licensees that may be interested in lasers
or some sort of entry control that is not a physical
door. So we're interested in your perspectives on why
a physical door should or shouldn't be required. And
if it shouldn't be required, what other types of
controls may be acceptable.
So I believe this is the last of our
proposed changes in Appendix A. So you've made it
through all of the different technologies as well as
this group of other changes that we're proposing.
Here you'll see the reference slide that you've seen
for the other sections. And now before our next
break, we're going to hit on some of the feedback
we've gotten from other stakeholders so far. Next
slide, please.
So I'm going to first talk about the
Organization of Agreement States feedback to us. When
we previously mentioned -- Maryann went over the
schedule. So we issued a draft regulatory basis to
the Organization of Agreement States.
If you're unfamiliar with them, they
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actually represent all of the Agreement States in the
U.S. And they provided feedback to us on the
regulatory basis. And they responded to many of our
questions which was really helpful.
It helped us not only make some changes to
the regulatory basis but make edits to the questions
to make sure we're asking the question in a way that
we're getting the information we're looking for. In
general, Organization of Agreement States indicated
support of our training requirements which was great
to hear. They also recommended that we consider
scaling back some of the regulatory development for
this rulemaking effort.
Based on this feedback, we actually had a
section that we've reviewed since then. And that was
for alpha diffusion manual brachytherapy. And I'll
talk about this again because ACMUI also had a similar
comment.
OAS recommended that we consider
developing a training and experience pathway for
individuals who administer radioactive materials. We
didn't take any action on this item since the
Commission previously instructed us to stick to the
status quo while evaluating training and experience as
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it comes to EMTs. So we tried to strike a balance
there.
And so you'll see many questions on the
T&E topic without creating that additional pathway.
And then finally, OAS recommended that we consider
developing a structured pathway to define metrics for
determining when a type of medical use is no longer an
emerging medical technology. I'd say everybody on the
working group believes this is a good idea. But it's
something that belongs in policy, not in regulation.
So we can go to the next slide.
So now I'm going to talk about the
feedback that we got from ACMUI. ACMUI is our
Advisory Committee on the Medical Uses of Isotopes.
They reviewed the same draft that OAS reviewed.
They established a subcommittee. And this
subcommittee prepared a report. They provided lots of
feedback on our approach. They also responded to many
of the questions that we're seeking. And much like
OAS, their input was extremely valuable to us and
helped us shape the current basis that you're getting
the opportunity to review.
In general, they communicated that our
scope was very ambitious which I think everybody on
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the working group, it was good to hear that they
agreed because it does feel quite ambitious. But they
thought it was reasonable. They said that we should
limit our efforts to the projects that are in broader
use, have clinical experience, and are technologies
that we understand.
So based on this feedback, we took the
opportunity as a working group to actually look at all
of the technologies we were proposing to move from
35.1000 into Part 35. We looked at each of them in
light of their operating experience that we have the
breadth of use as well as the associated scope of
regulatory changes that would be needed to move that
into Part 35, one of the applicable subparts. They
also suggested that we don't move the diffusing
brachytherapy sources into Part 35.
This was the same comment that OAS
provided to us. So we took that section out of the
regulatory basis so that draft actually had nine
sections in the appendix. Now you only see eight
because we did remove this and are no longer seeking
to move that into the bulk of Part 35.
Kind of along those lines is they
recommended that we don't move Gammapod or ViewRay
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into Subpart H, Part 35. As Laura mentioned, we're
seeking to not have specific technology-based
requirements. We're trying to take the approach of
having a technology neutral regulatory requirement
that is based on the outcome of a certain task.
And so based on this and the work that is
required to make the changes for Gammaknife, we
believe that the Gammapod and the ViewRay would
automatically be able to be brought into Subpart H
based on this new approach. They also recommended
creating a contamination control requirement for IVB
and diffusing sources if we maintain those in the
regulatory basis. So Monica talked about earlier a
requirement for contamination control and the
questions there that was based on this recommendation
from ACMUI.
They also recommended that we take a
wholesale reevaluation for ophthalmic applicators.
That is a relatively complex framework to navigate,
and the proposed changes do bring in some new types of
eye applicators which could make that a little bit
more complex to navigate with some different criteria
to consider. At this point in time, we have not taken
a wholesale reevaluation.
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We're still continuing with our proposal
to bring in those sources while not changing the
current regulatory framework for the currently
authorized sources that are in Subpart F. We don't
believe the burden and impact to licensees for those
current applicators is really worth the justification
for a wholesale reevaluation. But you will see some
questions in that section that are really targeted to
get information to help us make this determination.
And we could before the proposed rule make
a shift there. And you may see some changes based on
feedback that you guys provide on the topic. And I
believe that's all I wanted to talk about there. So
we can go to the next slide which I think we'll be
ready for a break.
MS. LOPAS: Yeah.
MS. TINDLE-ENGLEMANN: Thanks.
MS. LOPAS: All right. So before we get
to the cost analysis, I'll go ahead and remind
everybody just click on the raised hand icon if you
want to speak your question aloud. And I'll call on
you, and you can unmute yourself, *5 if you're on the
phone or enter it in the chat. So we'll start with
the chat questions if that's okay with the working
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group.
The first question we have here is, would
the current guidelines for Germanium-68, Gallium-68
breakthrough testing be maintained? Currently,
breakthrough testing is performed weekly on each
generator and not on every elution. Due to the energy
and amount of Gallium-68 in each elution, we are not
able to discern the minute amount of Germanium-68
energy until the bulk of the Gallium-68 energy has
decayed down.
So the question is, would the current
guidelines for Germanium-68/Gallium-68 breakthrough
testing be maintained? And Fran, I don't know if
you're able to answer that or any of the other working
group members. And you're muted, Fran. Oh, there you
go.
MR. O'NEILL: We need the guideline for
the Germanium. So thats the main issue here, because
it's a long half-life and we do need that.
MS. LOPAS: So it would be maintained. Go
ahead, Elizabeth. You want to --
MS. TINDLE-ENGLEMANN: Yeah, I can add to
that. So the current breakthrough testing
requirements are not handled through a Part 35
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regulation. And so we're not proposing any changes
there.
You'll see that the changes that we're
calling out are very clearly highlighted as to what's
applicable to the different generator systems in that
Appendix A.
MS. LOPAS: Okay. All right, great.
Thank you, Fran. Thank you, Elizabeth. The next
question is from Judi Buckalew. What is the source of
your statement that interventional radiologists only
receive 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of training to use microspheres?
Does this track back to the June 2012 NRC guideline
that set 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br />? This was an NRC guidance document
-- microsphere guidance document revised back in June
2012 staffed by former NRC staff Ashley Cockerham.
(Simultaneous speaking.)
MS. AYOADE: Okay. Go ahead.
MS. CENDER: Oh, go ahead. Oh, okay.
Yes, that 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> is referring to the classroom and
laboratory training portion of the experience in the
guidance only. And yes, I went back through and it
does seem that 2012 is where that first delineation
for interventional radiologists came in and is
formatted a little differently in the most recent
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guidance. But yes, that's the source.
MS. LOPAS: Okay, great.
MS. AYOADE: And I can add to that. We
have also included a question for feedback about
whether the 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> is appropriate. And so I think
it's in the A.7 section.
I couldn't pull up the number right now,
but it's in there. And so we want your feedback on
whether the hours is appropriate or not. And I
believe Laura went over that question as well during
her talk.
MS. LOPAS: Okay. All right. Let's see.
I don't see any other chats. So we'll just keep
moving forward. Just a reminder, keep putting your
questions in the chat as you think of them. We'll
stop for questions again. We're going to do one last
portion of the presentation, then we'll close out with
additional questions.
So raise your hand right now or just put
it in the chat and we will get to it at the end. If
you are on the phone, it's *5. Let me just take a
quick look. I don't see any raised hands. So we'll
just keep moving forward, and I think we're going to
Tony, correct?
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MR. GOMEZ: Thank you very much, Sarah.
My name is Antonio Gomez, and I am the cost analyst on
this rulemaking. I am part of the regulatory analysis
and rulemaking support branch in the Division of
Rulemaking, Environmental, and Financial Support.
Let's go ahead and move on to the slide,
rulemaking cost analysis. The NRC staff developed a
preliminary cost analysis for the rulemaking and the
options. We looked at NRC rulemaking costs. We also
looked at agreement state and licensee rulemaking
participation costs.
And we also looked at NRC agreement state
and licensee implementation of the rule. And that is
developing the compatible regulations, submitting and
reviewing revised procedures. And we also looked at
averted costs related to the inspection of Rubidium-82
generators and emerging medical technology licensing
actions.
I would like to add that after the
Alternative 4 rule is effective, the Agreement States
have three years to adopt compatible regulations.
Agreement States will need to implement their new
regulations which is assumed will be similar to the
NRC implementation, that is processing licensee
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amendments for affected licensees. The agreement
state rulemaking cost may be lower if the Agreement
States choose to incorporate the regulatory changes by
reference.
Now most costs for the Alternative 4 are
borne by the affected licensees for updating certain
safety procedures for gamma stereotactic radiosurgery,
teletherapy, or high dosage rate afterloader devices.
Alternative 4 results in averted costs for the NRC,
the Agreement States, and potentially also for the
licensees. And that is through the increased
licensing efficiency of existing and future emerging
medical technologies.
The NRC would save resources by minimizing
the need to develop new or update existing 10 CFR
35.1000 licensing guidance documents. Now when you
review this document, you will find information on the
background for this rulemaking and the current
regulatory framework to include policies, regulations,
and guidance. You will also see that this covers an
explanation of regulatory issues and the proposed
changes to the regulations and how those changes could
resolve those issues.
You will find sections of the NRC's
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evaluation of different approaches and alternatives
that have been considered in support of the regulatory
basis as well as the costs and benefits of the
rulemaking and the different alternatives. And this
also explains the limitations including the
uncertainties and the data or methods of analysis.
Next slide, please.
MS. LOPAS: Actually, Christine, can you
go back one slide. I think you were one slide ahead
of Tony. So yeah, go one more forward now. Yeah,
just stay on that slide for now. Thank you. Are you
finished up, Tony? I'm sorry if I interrupted you.
MR. GOMEZ: No, this is what I was going
to cover next.
MS. LOPAS: Okay, perfect.
MR. GOMEZ: This was next slide.
MS. LOPAS: Okay. We're set. Thank you.
MR. GOMEZ: So we're where I think we need
to be. Okay. Now what do I want to call out on this?
There are close to 40 tables in Appendix C. And
these tables show the calculations for the net cost
and averted costs associated with each alternative by
the stakeholders, that is the NRC, the Agreement
States, and the licensees.
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Now if we looked at what we have here, in
Section 8, we have cost impact considerations. This
contains the assumptions and descriptions of the
Agreement States costs and averted costs. Table 5
includes a summary of the costs for each of the four
alternatives.
Table 6 will have a breakdown of the
Alternative 4 rulemaking and operating costs for the
NRC, the Agreement States, and the licensees. Then we
go ahead and move to Appendix B which we call the data
tables. Table 7 is an emergency medical technology
licensing assumptions.
And here we looked at how many emerging
medical technologies the NRC has licensed to date, how
many similar technologies we can expect to license in
the future, and how many hours we could save on
initial license and supplemental applications. And
Table 8 shows data for each alternative. It is
extremely important to add requirements for
calibration and dosing instruments for Strontium-82,
Rubidium-82 generators, and establish performance-
based requirements for existing and future emerging
medical technologies.
Even though Rubidium is highly toxic by
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ingestion, a catastrophic generator failure could end
lives and disrupt businesses and societies. So in
addition, this rule would ensure that researchers to
the medical field will have the required knowledge to
adequately handle Rubidium when treating future
medical technologies. And in contrast, it's important
to understand the economic impact of this rule.
We should consider how this rule will
affect already existing researchers handling Rubidium
in a medical setting and the necessary cost to train
this workforce. And this is one of the major reasons
why we are looking for feedback. That concludes my
presentation. Take it away, Andy.
MR. CARRERA: Hi, thank you, Tony. And
Christine, may have the next slide, please? Thank
you. And good afternoon, everyone. My name is Andy
Carrera, and I'm in the Division of Rulemaking,
Environmental and Financial Support in the Office of
Nuclear Material Safety and Safeguards at the NRC.
So this next session is really to drive
that point home about how you can prepare and submit
the comments. So we've got some -- seen some good
questions and have some good discussion in the meeting
so far. But even though we are transcribing this
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meeting for our public meeting summary, the formal way
of getting those comments on the record outlined in
the July 3rd Federal Register notice which I will go
through that shortly.
But before we get there, I just wanted to
provide some quick tips on preparing the comments.
Now regulations.gov has a great document on their
website that includes tips for submitting effective
comments. And you should be able to click on the
links provided on the slides to access the document.
You can also access the document when you
are going into regulations.gov and submit your
comments. Now I really urge you all to really go
through the questions that we ask in the Federal
Register notice and the regulatory basis document and
look to answer those questions. Also, please feel
free to provide comments on the preliminary cost
estimate provided in the regulatory basis document
which Tony just went over.
And as Theresa previously mentioned, we
also welcome your thoughts and any questions that we
may have missed and new information that we should be
considering that wasn't part of the regulatory basis
for this rulemaking. And that really helps us as we
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move forward in developing the proposed rule. So may
I have the next slide, please.
So all right. So I know you heard this
mentioned all over already. But I'm going to repeat
it anyway. So we've got three methods for submitting
comments, right, the three methods for submitting
comments to the NRC either through regulations.gov and
go to our specific docket which is on the screen but
I'll read it anyway.
It's Docket ID NRC-2018-0297. So you can
submit a comment that way. And you can also email the
NRC with your comments to the address
rulemaking.comments@nrc.gov.
And lastly if you prefer, you can always
mail your comments to the NRC at the address provided
on the slide and also listed in the July 3rd Federal
Register notice. And again, I'll just try to drive
this home just one more time. So we really appreciate
hearing all of your feedback and questions and
discussion during this meeting.
But again, since this meeting isn't the
venue for collecting comments to get on the official
record. So please formally submit your comments using
the methods that are on the slides and in the Federal
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Register notice. And just a quick reminder, the
comment period for the regulatory basis will end on
October 31st. Next slide, please.
Okay. So far, next step, what are we
going to do next? So the NRC will consider all
comments assembled on the regulatory basis to inform
the developer of the proposed rule. And what comes
next is the staff plans to submit a draft proposed
rule to the Commission for approval in late 2025 time
frame.
Assuming if the Commission approves the
staff's draft proposed rule, the NRC will publish the
proposed rule in the Federal Register for public
comment. Now the NRC, we've also published a draft
regulatory analysis with cost benefit analysis and
also a draft environmental analysis for public comment
concurrently with the proposed rule. And we'll also
be making available for comment the implementation
guidance as well.
So the NRC also plans to conduct a public
meeting similar to this public meeting during the
comment period of the proposed rule to facilitate
stakeholders' feedback, input, and comments on the
proposed rule. And that will happen some time in mid-
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2026. So the NRC would then consider all the comments
received and the proposed rule to inform the
development of the final rule which the staff plans to
provide to the Commission for review and approval by
mid-2027. Okay. So that's the end of my
presentation.
I believe we have some time open for
questions. So Sarah, I'm turning this meeting back to
you. And thanks again, everyone, for your feedback
and your comments on the draft regulatory basis
document.
MS. LOPAS: All right, great. Thank you,
Andy. Thanks for the overview of the rulemaking. So
go ahead and raise your hand. Hit the raise hand icon
if you want to make a -- ask a question over your
microphone or make a comment.
Or if you have any questions about
anything you heard today, how to submit comments, the
schedule of the rulemaking, the process of the
rulemaking, any kind of clarifying details that would
help you submit comments on the reg basis, *5 if
you're on the phone. Or just enter it in the chat.
The chat has been working well today for questions, so
that's great and I'll read that aloud.
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I did put a bunch of links in there.
Again, I reposted links so we have a link to the
regs.gov website where you would go ahead and submit
your comments. Again, the Federal Register notice is
linked there. The actual reg basis document is linked
there directly. And today's slides are linked there
too.
And I will go ahead and read Ralph's
question. So Ralph Lieto asks, a common issue across
these proposed issues is waste disposal. I know
numerous RSOs have tried to get approval to allow DIS
radionuclides greater than 120 days. So that's decay-
in-storage of radionuclides greater than 120 days. Is
this a consideration for changes of this rulemaking?
Is this being considered at all in this rulemaking?
Maryann?
MS. AYOADE: Yeah. Hey, Sarah. I can
take that. We are aware of this issue on the medical
team. Because this rulemaking was specifically
focused on new technologies and things related to new
technologies, we have it included in here. But it's
something that you can provide information on as part
of our feedback -- I mean, as part of your feedback to
us. I see Elizabeth has her hand up.
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MS. TINDLE-ENGLEMANN: Yeah, I was going
to add one of the things that we talked about as a
working group was, do all of the emerging technologies
have a disposal pathway for some of those things above
120 days? So that was one of the things that we did
talk about. We weren't aware of anything that didn't
have disposal pathway. So if you have other
information on that, that'd be helpful to us, I think.
MS. LOPAS: Okay. Pop any other questions
or clarifying questions or comments in the chat or
raise your hand. Because if we don't have anything,
I'll probably send it back to the working group to
close us out. But let's -- I'm going to keep pushing
you. Now is your chance to ask your questions, to
inform your comments on the reg basis.
And just a reminder that you have until
Halloween. Scary spooky, to submit your scary
comments on the reg basis, Halloween is the deadline.
Now you won't forget that date because you'll think
about I'm going to give the NRC some scary comments on
the reg basis. Halloween is the deadline to get those
written comments in via regs.gov or the email or any
way that Andy went over in submitting your comments on
the reg basis.
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And Andy, I have a clarifying question
that maybe some people would be interested in, I'm
interested in. What happens with comments on the reg
basis? Do we republish the reg basis? Or how do
folks see, like, what we did with their comments on
the reg basis?
MR. CARRERA: Yeah, so after we receive a
comment, we look at the comments and review the
comments and kind of work out a way to work on a path
forward for the reg guide for the proposed rule. But
we won't be issuing a document where we are responding
to each of those comments. And then these comments
will be -- I mean, aggregation or bins of these
comments will be summarized in the preamble of the
proposed rule.
MS. LOPAS: Perfect, okay. That's where
we'll kind of discuss what we heard at the reg basis
space. Okay. Maryann.
MS. AYOADE: Yeah. And Andy said it
correctly. I just wanted to add to that. Again, the
regulatory basis gives the public an early look at our
thoughts and what we're considering. This is the
first time in medical rulemaking that we're issuing a
regulatory basis that includes our proposed changes
NEAL R. GROSS COURT REPORTERS AND TRANSCRIBERS 1716 14th STREET, N.W., SUITE 200 (202) 234-4433 WASHINGTON, D.C. 20009-4309 www.nealrgross.com 74
and gives the members of the public a really early
look, right?
Before we get into the next phase where we
are actually revising rule language and connecting it
to how it will be implemented later on after the rule
is issued. And so as Andy mentioned, we're just going
to be summarizing the comments. They are going to be
part of what we consider as we move forward. And then
the next phase is what people may be used to seeing
where we will actually respond to -- after we issue a
proposed rule and we receive those comments, we'll be
responding to the comments at that phase.
MS. LOPAS: All right. Very good,
Maryann. Thank you. Okay. I will -- maybe I'll just
put out one last call for any comments or questions.
And while we're waiting for that, I don't know,
Maryann, if you had any -- or anybody in the group or
Theresa have any last closing items or anything along
those lines.
(Simultaneous speaking.)
MS. CLARK: Thanks everyone for their
participation.
MS. LOPAS: Go ahead, Maryann.
MS. AYOADE: Yeah, no, thanks. Just again
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I wanted to thank everybody for participating. We
look forward to receiving feedback and comments. We
want to hear from you. Like I said, this is the first
time we're doing this out in the public forum in the
regulatory basis phase. And we're hoping that this
will help us as we move forward and give you all an
early look because this is such a major rulemaking.
It touches pretty much every single
section in Part 35. I know it's a lot to chew on
today. But I hope that this meeting serves to help
you all in, like, starting to receive information for
what it is that we're looking to change and what it is
that we are looking for to help better inform us as we
move forward with rule language for this rulemaking.
Thank you.
MS. LOPAS: Okay. And Maryann, let me
just follow up with one thing. If folks have
additional questions after this meeting, they hang up,
they're thinking later on, can they reach out to you
directly if they have questions? Or is there another
point of contact that you would prefer?
MS. AYOADE: It's just myself and Andy.
MS. LOPAS: Okay. All right. I'll put
those -- I'll put your emails into the chat. So
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everybody has those, carrera@nrc.gov. There's Andy's
email and maryann.ayoade@nrc.gov. Okay, great. I
think with that, we can close out the meeting.
Appreciate everybody's participation, and that
concludes today's meeting. Get your comments in by
October 31st. Thank you very much.
(Whereupon, the above-entitled matter went
off the record at 3:32 p.m.)
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