ML24252A004
| ML24252A004 | |
| Person / Time | |
|---|---|
| Issue date: | 06/05/2024 |
| From: | Office of Nuclear Material Safety and Safeguards, Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| References | |
| NRC-2843 | |
| Download: ML24252A004 (1) | |
Text
Official Transcript of Proceedings
NUCLEAR REGULATORY COMMISSION
Title:
Meeting of the Advisory Committee on the Medical Uses of Isotopes
Docket Number: (n/a)
Location: teleconference
Date: Wednesday, June 5, 2024
Work Order No.: NRC-2843 Pages 1-83
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
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ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES
+ + + + +
VIDEOCONFERENCE
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WEDNESDAY,
JUNE 5, 2024
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The meeting was convened via
Videoconference, at 1:00 p.m. EDT, Richard L. Green,
ACMUI Vice Chairman, presiding.
MEMBERS PRESENT:
HOSSEIN JADVAR, M.D., Ph.D., Chairman
RICHARD L. GREEN, Vice Chairman
REBECCA ALLEN, Member
ANDREW J. EINSTEIN, M.D., Ph.D., Member
JOANNA FAIR, M.D., Ph.D., Member
MICHAEL FOLKERT, M.D., Ph.D., Member
RICHARD HARVEY, Dr.PH, Member
JOSH MAILMAN, Member
MELISSA C. MARTIN, Member
MICHAEL D. O'HARA, Ph.D., Member
ZOUBIR OUHIB, Member 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
MEGAN L. SHOBER, Member
HARVEY B. WOLKOV, M.D., Member
JOHN F. ANGLE, M.D., Member
NRC STAFF PRESENT:
BRIAN ALLEN, NRC
LILLIAN ARMSTEAD, NMSS, Designated Federal
Officer
KEN BRENNEMAN, NMSS
DANIEL DIMARCO, NMSS
LISA DIMMICK, NRC
CYNTHIA M. FLANNERY, NMSS
TRAVIS JONES, NRC
DANIEL SHAW, NMSS
SARAH SPENCE, NMSS
KATHERINE TAPP, Ph.D., NMSS
CELIMAR VALENTIN-RODRIGUEZ, Ph.D., NMSS,
Designated Federal Officer
CHRISTIAN EINBERG, NMSS, Designated Federal
Officer
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AGENDA
Opening Remarks
Dr. Valentin-Rodriguez.......................4
Implementation of Part 35 T&E Subcommittee Report
Dr. Folkert.................................12
Closing and Adjournment
Mr. Richard Green...........................83
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P-R-O-C-E-E-D-I-N-G-S
1:01 p.m.
DR. VALENTIN-RODRIGUEZ: So, we'll get
started with today's meeting. Again, good afternoon.
As the designated Federal Officer for this meeting,
I am pleased to welcome you to this public meeting of
the Advisory Committee on the Medical Uses of
Isotopes.
I am Celimar Valentin-Rodriguez, and I am
the Medical Radiation Safety Team Leader and I have
been designated as the federal officer for this
Advisory Committee in accordance with 10 CFR Part
7.11.
This is an announced meeting of the
Committee. It has been held in accordance with the
rules and regulations of the Federal Advisory
Committee Act, and the Nuclear Regulatory Commission.
This meeting is being transcribed by the
NRC, and it may also be transcribed or recorded by
others.
The meeting was announced in the May 7th,
2024, addition of the Federal Register, Volume 89,
Page 38197. On May 21st, 2024, NRC publish a
correction to the original Federal Register in Volume
89, Page 44714 to correct the Teams meeting link.
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The purpose of this meeting today is to
discuss the ACMUI's Subcommittee report on the NRC
staff's draft interim staff guidance for the
implementation of training and experience
requirements in 10 CFR Part 35. The function of the
ACMUI is to advise the staff on issues and questions
that arise on the medical use and byproduct material.
The Committee provides counsel to the
staff but does not determine or direct the actual
decisions for the staff or the Commission. The NRC
solicits the views of the Committee and values their
opinions.
I request that whenever possible we try
to reach a consensus on the issue that we will discuss
today. But I also recognize there may be minority
or dissenting opinions. If you have such opinions,
please allow them to be read into the record.
At this point I would like to perform a
roll call of the ACMUI Members participating today.
Dr. Hossein Jadvar?
DR. JADVAR: Present.
DR. VALENTIN-RODRIGUEZ: Mr. Richard
Green?
VICE CHAIR GREEN: Present.
DR. VALENTIN-RODRIGUEZ: Ms. Rebecca 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 7
Allen?
MS. ALLEN: Present.
DR. VALENTIN-RODRIGUEZ: Dr. Michael
Folkert?
DR. FOLKERT: Here.
DR. VALENTIN-RODRIGUEZ: Mr. Josh
Mailman?
MR. MAILMAN: Here.
DR. VALENTIN-RODRIGUEZ: Ms. Melissa
Martin?
MS. MARTIN: Here.
DR. VALENTIN-RODRIGUEZ: Dr. Michael
O'Hara? Mr. Zoubir Ouhib?
MR. OUHIB: Present.
DR. VALENTIN-RODRIGUEZ: Ms. Megan
Shober?
MS. SHOBER: Present.
DR. VALENTIN-RODRIGUEZ: Dr. Harvey
Wolkov?
DR. WOLKOV: Present.
DR. VALENTIN-RODRIGUEZ: Dr. Richard
Harvey?
DR. HARVEY: Present.
DR. VALENTIN-RODRIGUEZ: Dr. Andrew
Einstein?
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DR. EINSTEIN: Present.
DR. VALENTIN-RODRIGUEZ: Dr. Joanna
Fair? I think I did see her join through Teams.
Okay, so I can confirm --
DR. O'HARA: Sorry --
DR. VALENTIN-RODRIGUEZ: No, you're
fine.
DR. O'HARA: This is Michael O'Hara. My
mic was off so, I'm here.
DR. VALENTIN-RODRIGUEZ: No worries.
Thank you, Dr. O'Hara. Okay, so with that I can
confirm that we have a quorum of at least six members
present.
All members of the ACMUI are subject to
federal ethics laws and regulations and received
annual training on these requirements. If a member
believes that they may have a conflict of interest,
as that term is broadly used within 5 CFR 2635 with
regards to an agenda item to be addressed by the
ACMUI, this member should divulge it to the Chair and
the designated federal officer as soon as possible
before the ACMUI discusses it as an agenda item.
ACMUI members must recuse themselves from
participating in any agenda item in which they may
have a conflict of interest unless they receive a 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 9
waiver or prior authorization from the appropriate
NRC official.
Mr. Richard Green, ACMUI Vice Chair, will
conduct today's meeting. Although I see that Dr.
Jadvar, our Chair, is also present.
Dr. Joanna Fair recently selected as the
diagnostic radiologist representative, who I see has
joined us today, is pending her security clearance
and will not have voting rights for any actions
requiring a vote but may participate in the
discussion during today's meeting.
Dr. John F. Angle, interventional
radiologist consultant to the ACMUI, may also
participate in today's discussion but does not have
voting rights for any actions requiring a vote.
Today's meeting is being transcribed by
a court reporter. We are utilizing Microsoft Teams
for the audio/video of today's meeting, and to view
presentation material in real time. The meeting
materials and agenda for this meeting can be accessed
from the NRC's public meeting schedule. And the
ACMUI's public website.
The phone number for the meeting is 301-
576-2978. And is currently being shown on the
screen. The phone conference ID is 652827577.
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For the purposes of this meeting, the
chat feature in Microsoft Teams has been disabled so
that we can capture all comments as part of the
official transcript. Mr. Green, at his discretion,
may entertain comments or questions from the members
of the public who are participating today.
Comments and questions are typically
addressed by the Committee near the end of the
presentation, after the Committee has fully discussed
the topic. We will announce when we are ready for
the public portion of the meeting. And we will
assist in facilitating public comments.
Individuals who have joined us via
Microsoft Teams, please use the raised hand function
to signal to our Microsoft Teams host that you wish
to speak.
If you have called in to the Microsoft
Teams using your phone, please ensure you have
unmuted your phone pressing star-6. When you begin
your comment, please clearly state your first and
last name for the record.
At this time, we have disabled all of the
attendees' mics. We will enable them during the
meeting. And at that point you can all use, press,
or press star-6 to unmute your phone if you're on the 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 11
phone and want to provide a comment.
Members of the public who notified Ms.
Lillian Armstead that they would be participating via
Teams will be captured as participants in the
transcript meeting summary. Those of you who did not
provide prior notification or who have called into
the Microsoft Teams meeting through a phone, please
contact Ms. Armstead by email at lxa5@nrc.gov at the
conclusion of this meeting.
At this time, I ask that everyone who is
not speaking please mute your Teams microphones, or
your phone. And I will now turn over the meeting to
Mr. Richard Green.
VICE CHAIR GREEN: Thank you, Dr.
Valentin-Rodriguez. Again, we're here as the
Advisory Committee on the Medical Use of Isotopes to
hear the report out from this Subcommittee on the
Training and Experience Requirements Draft Interim
Guidance. And we'll hear from the Chair of this
Subcommittee, Dr. Michael Folkert to present their
report.
DR. FOLKERT: Mr. Green, I think you have
to unmute.
(Pause.)
VICE CHAIR GREEN: Dr. Folkert, the 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 12
chair, the floor is now yours.
(Pause.)
DR. VALENTIN-RODRIGUEZ: Dr. Folkert,
can you hear us?
DR. FOLKERT: I can hear you. I couldn't
hear, yes, Richard Green as he muted the entire time.
VICE CHAIR GREEN: Dr. Folkert, I just
announced you and your subcommittee. Are you able
to hear me now?
DR. FOLKERT: I'm not hearing Richard
Green at all.
DR. VALENTIN-RODRIGUEZ: He just jumped
through the agenda, and he just passed on the meeting
to you, Dr. Folkert, so you can go ahead with the
meeting slides. We'll try to figure out on the back
end if there is something going on with Mr. Green's
presentation.
DR. FOLKERT: Yes, I hear you fine, but
I don't hear -- I didn't hear anything from him.
All right. I'm sorry about the delay on
that. That's probably technical issues on my side.
I apologize.
So, I am Dr. Folkert. I am the
subcommittee chair for the Training and Experience
Subcommittee. And I am going to be presenting on the 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 13
comments from the Advisory Committee on the Medical
Use of Isotopes.
I'd like to thank the other members of my
subcommittee, as well as the rest of the ACMUI for
their feedback, the NRC for the summary on this
guidance and providing the platform for discussion.
And thank the members of the public for joining today,
which it looks like there is at least 60 so far. So,
thank you very much.
So next slide, please. This is the
membership of the subcommittee. The T&E
Subcommittee, including Dr. Harvey, Dr. Jadvar, Ms.
Martin, Ms. Shober. And we were advised by the NRC
staff resource Cindy Flannery. Okay, thank you.
Next slide. Okay. So, on February 2nd
the ACMUI Chair expanded the charge of the T&E for
all modality subcommittee to include a review of the
NRC's draft training and experience implementation
guidance. A joint NRC and agreement state working
group drafted this guidance in accordance with the
Commission direction.
I want to emphasize that with this
guidance the NRC is not recommending or instituting
any changes in the current training and experience
requirements in 10 CFR Part 35. This guidance is to 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 14
provide a roadmap and a resource for helping us,
helping people meet those requirements.
So next slide, please. As background,
so for the Commission direction and the staff
requirements memorandum to SECY-20-0005, staff
requirements. The rulemaking plan for T&E
requirements for unsealed byproduct material in 10
CFR Part 35. The staff developed this guidance for
implementing the T&E requirements in 10 CFR Part 35
medical use of byproduct material.
The NRC staff utilized information from
a number of different resources, including the NUREG-
1556 from the frequently asked questions on the NRC's
medical tool kit. And from information based on
questions received from stakeholders to develop the
guidance.
Next slide, please. Next slide, please.
Okay, I think the slides aren't advancing. The next
slide, if you could show it, please? Unless it's
frozen.
DR. VALENTIN-RODRIGUEZ: What, Dr.
Folkert, what slide do you see, because I see them
advancing on my end. I can see Slide 10 right now
on the screen.
DR. FOLKERT: Let me see. I am on Slide 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 15
- 5. And so,it's what it should be. The background
where this guidance aims to clarify the roles and
responsibilities of individuals subject to T&E
requirements.
It seems to be, at least on mine, I
apologize, it's frozen on Slide Number 4. There, now
it's moved to, let's see, the one that's popped up
right now is slide --
VICE CHAIR GREEN: Dr. Folkert, as a
suggestion you might turn off your camera.
DR. FOLKERT: I see Slide 8 is on the
screen now.
VICE CHAIR GREEN: You may have limited
bandwidth.
MR. MAILMAN: Yes, we're seeing Slide 10.
This is Josh. So may be on your end.
DR. FOLKERT: Okay. I'm still only
seeing slide, you have both said Slide 10, so. Oh,
it's Slide 10 in your dataset, but not Slide 10
presentation.
DR. VALENTIN-RODRIGUEZ: Yes.
DR. FOLKERT: If you -- I don't know if
it's possible to go back and -- because it should be
-- I believe it should be Slide 7 in your presentation
stack.
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DR. VALENTIN-RODRIGUEZ: Yes, we'll get
to Slide 7.
DR. FOLKERT: Yes, because you're
showing Slide 10.
DR. VALENTIN-RODRIGUEZ: Dr. Folkert, I
advise maybe turning your camera off. It might be a
bandwidth issue on your end.
DR. FOLKERT: Okay.
DR. VALENTIN-RODRIGUEZ: So that might
help with you seeing --
DR. FOLKERT: All right. I'll do that.
DR. VALENTIN-RODRIGUEZ: -- yes, the
slides that we see.
DR. FOLKERT: Can we go back to slide --
DR. VALENTIN-RODRIGUEZ: It should be on
Slide 7 on our side.
DR. FOLKERT: Yes. That is the correct
slide.
All right. So, this guidance aims to
clarify the roles and responsibilities that
individuals subject to T&E requirements outlines the
information needed to demonstrate the necessary
training and experience for individuals who are being
listed on the license and explains expectations for
how these individuals are to fulfill the T&E 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 17
requirements.
Next slide, please. It also importantly
provides criteria for the NRC staff and agreement
state regulators to evaluate the applications for
licensees and applicants who are seeking to add
individuals to their license as authorized
individuals, including authorized users, radiation
safety officers, associate radiation safety officers,
authorized nuclear pharmacists, authorized medical
physicists or ophthalmic physicists.
Next slide, please. And we have to note
that due to ongoing medical rulemakings, this
guidance is serving as an interim staff guidance as
some, or many training experience requirements could
change in the near future. So once the NRC is closer
to distributing and promulgating these medical
rulemakings, the NRC staff will then decide on the
best way to transmit this guidance, whether it's
through NUREG-1556 or through a standalone guidance
document, which will also have additional review.
Next slide, please. So overall I said
that members of the ACMUI Subcommittee on T&E found
that the submitted document was very thorough and
helpful. The general opinion of the Committee was
that the guidance was well developed and did 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 18
effectively outline the process to list individuals
as AUs, RSOs, ARSOs, ANPs, AMPs and OPs on an NRC
license.
So next slide, please. However, to make
things more approachable to simplify and to make this
a more accessible resource, one recommendation was
that presentation of the required hours, which are
generally divided into classroom and laboratory
hours, supervised work experience hours and/or the
number of cases/supervised clinical casework required
to meet the regulatory requirements for each T&E
element should be presented clearly in a tabular
format, perhaps as an appendix, to increase
accessible.
Next slide, please. And also, to make
it even more approachable, the recommendation was to
create case scenarios to outline comment situations.
Many of us learned by case descriptions, by example,
and use those to inform our processes.
Some suggestions that were made by the
Subcommittee were to create a case scenario, such as
an interventional radiologist, who is seeking to be
listed as an AU for liver microsphere applications.
Or medical physicists taking on the role of a
radiation safety officer at a new institution, a 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 19
radiation oncologist who is ten years out of training
seeking to be listed as an authorized user for seed
implant brachytherapy or radiopharmaceutical
therapy.
Or a community radiologist who previously
only worked in the diagnostic realm as the diagnostic
nuclear medicine practitioner who now wanted to
participate in theranostics, the application of a
therapeutic and diagnostic applications of
radiopharmaceuticals.
Next slide, please. And then also
specifically, Section 4.1.2, roles of
responsibilities, Page 6. Under the radiation safety
committee, we requested to add a statement about how
and when 35.1000 technologies, emerging technologies,
are required to have radiation safety committee
participation. Whether one could represent multiple
technologies or if you need individual
representatives, so on and so forth.
Next slide, please. And in Section
4.3.2.4, device-specific training, Page 17, we noted
that guidance stated that training is not required to
be specific to the model of the device. This is
inconsistent with other guidance that require
specific training for new devices and applications.
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So even though an authorized user or an
authorized medical physicist may be otherwise
qualified in a device, they should have training in
the use of an emergency procedures for the model of
device or byproduct material for which the
authorization is sought.
Next slide, please. In the same section
it was noted that model specific training may be
required under some cases under 10 CFR 35.610. But
this only applies to sealed sources and remote
afterloader units, teletherapy units or gamma
stereotactic radiosurgery units. And there is many
byproduct material uses/devices that are not covered
under 10 CFR 35.610.
Now in Section 5.1 of the microsphere
licensing guidance, for example, also requires
authorized users to have training with the specific
microsphere product for which the AUs is seeking
authorization. So, a clarification of these training
requirements is recommended.
Next slide, please. And again, the same
section, the guidance also noted the device training
must be completed in person with the device. We
requested that the sentence be removed. This element
must be completed in person with the device. And for 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 21
the NRC to provide specific guidance as to when and
what devices or applications require both in-person
and hands on training.
Next slide, please. So those were our
specific questions and comments. The next slide has
the acronyms used in our report. Abbreviations and
acronyms used in the report.
All right, thank you very much.
VICE CHAIR GREEN: Thank you, Dr.
Folkert, and the care and diligence exercise by the
subcommittee on preparing this report.
Are there any questions from the ACMUI on
this report? Go ahead and use the raise your hand
feature. Mr. Ouhib?
MR. OUHIB: Yes. Thank you, Mr. Green.
I actually have one, two, three, four, five questions
regarding the report itself.
So, my first question is on Page 6 of the
document. It says, like if, however, if the licensee
has a radiation safety committee the RSO is
prohibited by 10 CFR 35.24(f) from serving as the
management representative on the committee.
And I was just wondering if there was any
exception in the event that the management
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that might be. Are there any exceptions that the RSO
can actually serve as the management representative?
DR. FOLKERT: I apologize, I still cannot
hear any audio from anyone else other than the NRC
Members. I am going to exit out and try to join back
in. I apologize again.
DR. VALENTIN-RODRIGUEZ: Okay. Thank
you, Dr. Folkert.
MR. OUHIB: Can you hear me now, Dr.
Folkert?
DR. VALENTIN-RODRIGUEZ: Dr. Folkert is
going to call in. Trying to see if his audio is
fixed, Dr. Zoubir. But you can go ahead with your
comments, we can hear you.
MR. OUHIB: You can hear me, okay.
DR. VALENTIN-RODRIGUEZ: Yes.
MR. OUHIB: Should I move on to the next
question until he, there is an opportunity to answer
those or how do you want me to proceed?
VICE CHAIR GREEN: The court reporter
will be recording these. Let's move on to your
question number two. The rest --
MR. OUHIB: Okay.
VICE CHAIR GREEN: -- of the Subcommittee
can assist.
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MR. OUHIB: Absolutely. Thank you. My
next question is on Page 7 of the document. What it
says, the RSO duties and responsibility include
ensuring radiological safety, security and compliance
with both the NRC and the U.S. Department of
Transportation regulations and the conditions of the
license.
I was just curious if the word conditions
can be explicit? In other words, what is meant
behind the conditions of a license? Okay.
And along that line, in that same
section, there was no, nothing mentioned regarding
pregnant staff, you know, recommendations or policies
or whatever. There are several things that are being
discussed there but none related to what should be
done about pregnant staff.
Move on to Page 9. If I can get to it.
Okay. This is regarding the RSO. The associate
radiation safety officer. And it says the ARSO
cannot assume any RSO responsibility unless the
licensee designates, in writing, the ARSO as a
temporary RSO.
And my question on that is, is that to be
submitted to the regulation, to regulators, that
state or NRC, whatever, or is that just a document 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 24
that's available in-house?
My, oops. My next question is on Page
- 10. This is regarding the atomic physicist, Item 2
there. Where it says, an OP is responsible for
assisting the licensee in developing, implementing
and maintaining written procedure to provide high
confidence that the administration is in accordance
with the written directives.
I think it would be great if the word
procedures, written procedures, are defined in that
paragraph. What is meant about that.
And my last question is on Page 16 of the
document. And allow me to get to that section.
Okay. Where it says, in order for the regulatory
body to determine whether the classroom and
laboratory training requirement are met, the
applicant may need to provide information such as a
transcript, completion certificate, course
description, syllabus, outline and learning
objectives. I was just curious whether there is a
need of providing the instructors credentials?
My worry is that somebody who is not
qualified to provide all that might be providing
that. That is documented that, well yes, they had
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that kind of training and education and so on.
And that concludes my questions. Thank
you.
VICE CHAIR GREEN: Thank you, Mr. Ouhib.
Has Dr. Folkert rejoined us via telephone?
DR. FOLKERT: Let's see, I was able to
get back on.
VICE CHAIR GREEN: Okay.
DR. FOLKERT: Now I hear you at least.
VICE CHAIR GREEN: Dr. Folkert, I don't
know how many of those questions you were able to
catch, but I believe Dr. Ouhib had about five, five
questions for the subcommittee.
DR. FOLKERT: See, the first one that I
head mentioned had to do with clarifying the
conditions of the license on Page 7.
MR. OUHIB: Page 6.
DR. FOLKERT: And so, it would have had
-- oh. Radiation safety officer, okay.
MR. OUHIB: Yes.
DR. FOLKERT: Okay. Okay, it's 6, not
- 7. So, purpose of the authorized individual. And
so. And in any events, now I think this is a very
reasonable request to make, and so to clarify what
conditions of the license means.
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And I had assumed that condition of the
license would be whether or not it was active or
currently under review at the state level. And so,
if the NRC can clarify what the conditions for license
are I think that would be a good addition to the
guidance.
The second question that I heard was
about including direction about pregnant workers. I
believe that was what he said.
VICE CHAIR GREEN: Ms. Shober, a member
of the Subcommittee, has raised her hand.
MS. SHOBER: Hi. Yes, this is Megan
Shober. I just wanted to provide a little
clarification on the conditions of the license.
So that is referring to the actual
license document itself and the conditions that are
listed on the license document. So that's standard
regulatory language that licensees need to be
compliant with the regulations and the conditions of
their license because those licensed conditions are
also legally binding requirements.
DR. FOLKERT: So, clarify --
VICE CHAIR GREEN: Thank you, Dr.
Shobert.
(Simultaneously speaking.)
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DR. FOLKERT: --within the document.
Oh, thanks. Sorry about that. Just for
interrupting.
Okay. So, I do think it would be helpful
to include some clarification of that in the document
to make it generally understandable what exactly is
meant by the condition to the license.
So, and then the next question about
training for workers who are pregnant or seeking to
become pregnant. I do believe that's included in one
of the referenced regulatory requirements of --
listed on Page 3 of the document.
My question for Mr. Ouhib would be, what
aspects of that training, like the training guidance
for what their dose limitations are or what they're
reporting requirements are? Is that what he wanted
to have expanded in the document?
MR. OUHIB: No. It is more like the RSO,
basically define the role of the RSO. The duties of
the RSO and all that. But there is nothing mentioned
regarding, you know, pregnancy issues. What the role
of the RSO is to monitor these situations.
DR. HARVEY: Dr. Folkert, if I may? It's
Dr. Richard Harvey. I don't think that's something
that would be included in the scope of this. I think 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 28
that that's clearly defined in regulations, NUREGs
and other guidance documents so I don't think that's
intended to be included here, but that's just my
opinion.
DR. FOLKERT: Yes. And the radiation
officer, the radiation safety officer is in charge of
tracking dose limits and requirements for pregnant
workers or workers seeking to be become pregnant, so
perhaps adding the line in there just specifying that
that is one of their charges in the section under RSO
responsibilities on Pages 7 through 8 of the docs, 7
through 9 of the document. As it is one of their
specific duties. I think that would be reasonable.
MR. OUHIB: Yes, I was just curious
because it defines and lists all the responsibilities
of the RSO in here. And then I notice that the
pregnancy issue was simply omitted there, which is a
very important one in my opinion.
DR. FOLKERT: Okay.
DR. HARVEY: Dr. Richard Harvey. Mr.
Ouhib, I agree with you, it's a very important one.
I don't think every duty is listed there. I don't
think it's completely encompassing. So, I wouldn't
expect every single duty responsibility to be listed
within this report presentation.
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DR. FOLKERT: So,I'm looking to see now,
this is Mike Folkert, I'm looking to see if there is
a comment that this list has not exhausted. So,
okay. It just says, typically these duties and
responsibilities including the following.
And so, we can say include, but are not
limited to the following. That would be on Page 7
under the paragraph labeled, the RSO is responsible
for the day-to-day oversight of the entire radiation
safety program.
Because I completely agree, this is not
meant to be an exhausted list.
MR. OUHIB: That is not.
DR. FOLKERT: Yes. It's supposed to be
spelled out in other documents.
All right, the next question that I heard
had to do with, let's see. It was on --
MR. OUHIB: Page 9.
DR. FOLKERT: Page 9. And sir, would
you be so kind as to repeat the question?
MR. OUHIB: I'm sorry, I couldn't hear
you?
DR. FOLKERT: Would you be so kind as to
repeat the question?
MR. OUHIB: Yes. On Page 9 it talks 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 30
about the associate radiation safety officer. And
on Bullet number, one, two, three, three it says, the
ARSO cannot assume any responsibility unless the
licensee designates, in writing, the ARSO as a
temporary RSO. And my question was that, does that
have to be submitted to the regulators or it's just
a statement that is kept basically in house?
DR. FOLKERT: For that one I would defer
to our NRC staff. Are you able to give feedback as
to where the responsibility designation statement
goes to?
VICE CHAIR GREEN: Ms. Shober has her
hand raised.
MS. SHOBER: Thank you. Megan Shober.
The regulations allow licensees to name temporary
RSOs for up to 60 days without a licensing amendment.
So, when that phrase, temporary RSO, is used, it means
that up to 60-day designation that happens locally.
MR. OUHIB: Locally. Okay, thank you.
DR. FOLKERT: Like in locally, as within
the institution itself?
MS. SHOBER: Correct.
DR. FOLKERT: Okay.
MR. OUHIB: Thank you, Ms. Shober.
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from the NRC. And Megan beat me to it. So,Megan
is correct. The correct regulations for the
temporary RSO does allow the licensee to name someone
as a RSO temporarily. The designation, in writing,
is for in-house for the licensee to keep. And for
us to review, if necessary, if we need to or during
inspection.
VICE CHAIR GREEN: To improve clarity of
this guidance document should we ask the guidance
document to be edited to clearly show that this is
submitted to the local management chain of the
institution, not the regulator?
DR. FOLKERT: It's Mike Folkert. I
would agree. And also, in part to add a reference
to the regulation that states this. Okay.
VICE CHAIR GREEN: Dr. Ouhib, have we
answered your questions?
MR. OUHIB: Yes, thank you. Thank you.
DR. FOLKERT: All right.
MR. OUHIB: I think that that clarifies
that so there would be no confusion.
DR. FOLKERT: Yes.
VICE CHAIR GREEN: Any other member of
the ACMUI that has questions regarding the report or
the draft interim guidance?
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DR. FOLKERT: Well so this is Michael.
His next question that was relevant to Page 16, about
including the credentials of those providing the
training.
And so, I do think it would be, I mean,
for any course CME, educational program that the
credentials are vetted for CME applications,
continued medical education applications, all of the
credentials, the conflicts of interest, the review of
the presented material is all required. So, I would
say for this that policing the credentials the
individual educational activity would certainly be
out of the scope of the NRC.
It's, but as far as looking to see if
they are CME credentialed, if they're a part of a
collegiate force that I think looking to see the
source I think does make sense as part of the review
of the training and the hours done. But going into
the credentials of the presenters I think would be
far beyond the scope of the NRC.
VICE CHAIR GREEN: Thank you, Dr.
Folkert. Do we have any other comments, questions
from Members of the ACMUI?
MR. OUHIB: Mr. Green, if I may? This
is Zoubir Ouhib.
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VICE CHAIR GREEN: Yes.
MR. OUHIB: Two items of the one, the
first one on Page 6 and the last one on Page 16 that
we did not address. And on Page 16 that's under
4.3.2.1. It's the last paragraph.
What it says, in order for the regulatory
body to determine whether the classroom and
laboratory training requirement are met, the
applicant may need to provide information such as
transcript, completion certificate, course
description, et cetera, et cetera.
I guess my question in there, should
there be a need of qualified instructors and
credentials to avoid having training provided by a
non-qualified person?
And, for that matter, who should that be?
Who should what requirements be needed for that
person providing the training, qualifications, et
cetera?
DR. FOLKERT: All right, it's Mike
Folkert. I think that was the point that I had been
trying to -- I was addressing just right before you
joined in there.
So, I mean, I think policing the
credentials I do think would be far out of the scope 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 34
of anything the NRC can do. I hope you can hear me.
For any sort of policy course, any continuing
education course, CME course, all of those presenters
do have to have their credentials reviewed. They
have to disclose their conflict of interest, they
have to present their course materials for approval
in advance.
So, I think that the responsibilities on
the source of the education, whether it's like an
ASTRO CME course of an SNMMI CME course, so on,
because of, I mean, if you go down to things like the
radiation biology education, radiation biology is
taught by people who have no authorized user status,
or not clinicians. You know, they're often
laboratory-based scientists so who are not, who don't
have a credential for radiation biology, but they
have a deep and fundamental knowledge of the subject
and are providing educational training.
And so, I don't see how the NRC on any
level could review that level of training that review
their credentials. But the offering institutions
that, so are supervised by the ACGME, by the graduate
medical education groups, they review them. And
ultimately, it's going to be their responsibility to
assess the quality of core education and things like 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 35
radiation biology, core physics, so on and so forth.
MR. OUHIB: Okay. All right, thank you.
DR. FOLKERT: And if you could, your
first on that I wasn't able to hear, the one on Page
6, or was --
MR. OUHIB: I think it was on Page 6
where, on the one before last bullet point. Let see
what section that is. Give me a second here. Under
radiation safety officer. RSO.
And I think it says, if the RSO is placed
in the license management structure and meets the
criteria of management as defined in the regulation
in 10 CFR 35.2, then action of the RSO may be
considered action of management. And my question is
on the last sentence there.
However, if the licensee has a radiation
safety committee, the RSO is prohibited by 10 CFR
35.24(f) from serving as the management
representative on the committee. My question to that
is, could there be any exception in the event that
the management representative cannot be available and
that RSO can act as the management representative?
DR. HARVEY: This is Dr. Richard Harvey.
We keep those roles completely separate. I don't
know how the NRC feels about it. If there could be 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 36
an exception to Mr. Ouhib's point, but we keep those
roles completely separate for many reasons.
And it's nice to have the management
representative there to help mediate situations
between an RSO, and maybe other members of the
committee. And, you know, its just better, in my
opinion, to clearly keep those roles separate.
Segregated. That's just my feeling.
MR. OUHIB: I guess my question is that
let's just say something prevented the management
representative from attending at the very last
minute. And you have a radiation safety committee
meeting. Now you know that you're supposed to have
that person present during radiation safety
committee, but here you are, you don't have that
person. Could there be an exception that somebody
like the RSO can assume those functions? And that's
all.
DR. HARVEY: Yes. This is Richard
Harvey again. And so, I mean, our approach is we
have a management alternate in case of situations
like that. But again, there is nothing to say that
the management representative and their alternate
can't make the meeting as well.
So, your point is well taken. I think 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 37
it's the NRC's decision to say if they would allow
that exception. So, I think your point is very
important and well taken and would be very interested
to hear an answer. Thank you.
MR. OUHIB: Thank you.
VICE CHAIR GREEN: Do any members of the
NRC staff wish to address that last portion of Mr.
Ouhib's question?
DR. AYOADE: Hi, Dr. Folkert, this is
Maryann Ayoade from the NRC. So, as it relates to
that situation, you know, 10 CFR 35 clearly has a
definition for management in 35.2. And I believe
that was included in the guidance. But as Dr. Harvey
said, we tried to keep, the intent was to keep the
roles of management and the RSO separate, except for
situations where the RSO does meet the criteria of
management.
And so, for the case that Dr. Ouhib has
presented, it would have to be, you know, an
exception, and that would have to mean, you know, or
an exemption. And so, it would have to come in
separately from what, to request that separate from
what you currently authorize. Or allow.
DR. FOLKERT: Yes, this is Michael
Folkert. That makes sense. And most of this 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 38
discussion I think actually would pertain more to
that regulation rather than this guidance document.
DR. AYOADE: Agreed.
VICE CHAIR GREEN: Thank you. Are there
any additional questions from Members of the ACMUI?
I see no hands raised.
Let's open it up to any questions from
Members of the NRC staff? Dr. Valentin-Rodriguez, I
see your hand raised.
DR. VALENTIN-RODRIGUEZ: Thank you, Mr.
Green. I had one question for Dr. Folkert. When you
were, when you and Shober were discussing the
temporary RSO, the ARSO, one of those bullets in the
implementation guidance, you mentioned that it might
be worthwhile for the NRC to clarify the regulation
as well. Is that something that the Subcommittee is
considering as a recommendation or, and do you all
think that you can provide language at this time or
is that something for further consideration for the
Committee?
I just want to make sure that whatever
action the ACMUI wants to recommend that it's
captured as part of the report.
DR. FOLKERT: This is Michael Folkert.
Yes, I wouldn't expect any full discussion on that 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 39
right now this just came up. I was merely pointing
out that this, like the purpose for today's
discussion is to go over the guidance document. If
there are concerns about a separate regulation, I
think that is a separate conversation and that should
be taken up at a different time.
DR. VALENTIN-RODRIGUEZ: Okay. Yes, I
just wanted to make sure if I understood the comment
correctly. That's all.
Mr. Green, I was going to suggest, if
there are any changes that the Committee, in full,
wants to make to the draft report based on Mr. Ouhib's
questions, now might be the time for the ACMUI to
discuss those changes so we can capture them as part
of the final report when we issue that. I don't know
if you wanted to do that now. I think we have time.
VICE CHAIR GREEN: I agree. As I recall
it was one recommendation to clarify that the
internal designation of the alternate RSO is
submitted to the institutional leadership, not to a
regulator. Were there any other things that we
thought required clarification?
DR. FOLKERT: This is Michael Folkert.
On the section under the radiation safety officer,
with the conditions of the license. And so, the, 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 40
right there we would look for language for clarifying
what conditions of the license means. Because it has
to do with --
DR. VALENTIN-RODRIGUEZ: Yes.
DR. FOLKERT: Oh, sorry.
DR. VALENTIN-RODRIGUEZ: No, I was just
going to say, I capture that. And I think the plan
would be to include that as a specific comment in
that section of the report, and we would just add it
as Number 7.
DR. FOLKERT: Okay.
DR. VALENTIN-RODRIGUEZ: Thank you.
DR. FAIR: Just to clarify, I may have
misheard. I thought what I had just heard was that
the alternate RSO would be designated at the
institution. I think it was actually that the
temporary RSO, that if the alternate RSO becomes the
temporary RSO that that's internal. I don't think
alternate RSO's are strictly internal.
VICE CHAIR GREEN: Thank you for catching
that.
DR. HARVEY: This is Richard Harvey. I
think it's for associate RSOs to be the temporary
RSO, correct?
DR. FAIR: Yes.
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DR. FOLKERT: Yes. ARSO to RSO. Yes.
So, again, this is Michael Folkert again. So, in
that same area there was just the clarification, the
duties and responsibilities include the following.
Just because it did not specifically state anything
about the documentation or special considerations for
pregnant workers, to make the last line of that
paragraph that the RSO is responsible for daily
oversight of the entire radiation safety program. To
say typically these duties and responsibilities
include, but are not limited to, the following.
Just to make it very explicit that this
is not the exhausted sum of the list of all
responsibilities of an RSO.
MR. OUHIB: I like that suggestion very
much.
VICE CHAIR GREEN: Is there anything else
we need to capture, Mr. Folkert?
DR. AYOADE: Hi, this is Maryann Ayoade
from the NRC. Just wanted to, again, clarify that,
a question about the ARSO being able to function as
a temporary RSO. Again, as I mentioned before, that
designation in writing is for, you know, within the
institution or for the licensee.
But I also wanted to clarify that the NRC 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 42
does require that the licensee notify us when they
made the change, or they want to appoint an individual
as an RSO. And the notification is separate from a
license amendment where they would have to submit
something or information that we would have to
actually amend the license to include that
individual's name.
So as Megan said, for up to 60 days they
have to notify us. That licensee designation in
writing is for in-house with the licensee.
DR. FOLKERT: So, this is Michael
Folkert. So that would be, so the specific line then
we're looking at is on Page 9. The ARSO cannot assume
any RSO responsibilities unless the licensee
designates in writing the ARSO is a temporary RSO.
So, we should add, so it seems like the
suggestion would be then, unless the designee, unless
the licensee designates in writing the ARSO as a
temporary RSO, and then comma, and notifies the NRC.
And then I would recommend providing a link or a
reference to the appropriate regulation that states
this.
VICE CHAIR GREEN: Melissa, I see your
hand raise.
MS. MARTIN: One question. Yes, this is 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 43
Melissa Martin, a member of the ACMUI Subcommittee on
this project.
One question that has been raised is, in
today's world with such a shortage of qualified
radiation safety officers, is it permissible to do
more than 60, in other words, if you designate your
ARSO for 60 days, at the end of that 60 days you still
do not have another person to be named RSO, can you
do those multiple times?
DR. HARVEY: This is Richard Harvey. I
can't speak for the NRC, but I think 60 days is a
timeframe for you to, you know, try to make some
arrangements other than extended that multiple times.
And I could be incorrect on that, but I think there
would have, I would think there would be able, the
NRC and the agreement states would want somebody
specifically designated after 60 days. But I cannot
speak for them whether they would grant additional
occurrences of that. Thank you.
MS. MARTIN: Thank you, Richard.
VICE CHAIR GREEN: Ms. Shober?
MS. SHOBER: Yes. Again, Megan Shober.
I won't speak for the NRC either, but in my state, we
require a license amendment if it's a temporary
situation that's going to extend beyond the 60 days.
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VICE CHAIR GREEN: Dr. Ayoade?
DR. AYOADE: Yes, this Maryann Ayoade
from the NRC. So yes, for as far our regulations it
is 60 days, and so it would require them submitting
an amendment.
Now the regulations also allow for more
than one ARSO, or more than one, I mean, temporary
RSO. So, it could be another individual that
qualifies, that meets the qualification to be a
temporary RSO.
But if it's beyond the 60 days it would
have to be an amendment. And so, they would have to
submit information of the individuals, or the
proposed individuals, training and experience to be
named on the license as an RSO.
MS. MARTIN: Thank you very much.
VICE CHAIR GREEN: Have we succeeded in
capturing all the thoughts and recommendations that
you've come up with?
DR. VALENTIN-RODRIGUEZ: Mr. Green, I
have captured I think all of them. They are also
captured in the transcript. So, what we'll do is
we'll go back to the draft report, incorporate the
comments from the transcript, and we'll send the
ACMUI a copy of the final draft report before we issue 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 45
it as final to ensure that we captured the appropriate
changes based on the transcript.
VICE CHAIR GREEN: So, for today's
purposes we still want to entertain a motion to accept
this report, as amended.
DR. WOLKOV: Move we accept the report
as amendment. This is Harvey Wolkov.
VICE CHAIR GREEN: Thank you, Dr. Wolkov.
DR. HARVEY: This is Richard Harvey; I'd
be happy to second that.
VICE CHAIR GREEN: Thank you, Dr. Harvey.
Now we'll ask all members of the ACMUI if they support
the report as amendment, say aye?
(Chorus of ayes.)
VICE CHAIR GREEN: There are any opposed?
Any abstentions? Hearing none, it is in the
affirmative.
Now we have some time to open up the phone
lines to see if there are any comments from members
of the public. Can we go ahead and do that now?
What's the process?
DR. VALENTIN-RODRIGUEZ: Yes. Thank
you, Mr. Green. So right now, I've, I'm pretty sure
I've enabled everyone's mics who have joined us
through the Microsoft Teams meeting. I see there is 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 46
some hands raised already. So,I will go and call
on those hands raised in the order that they appear.
And you should be able to enable your mics to come
off mute.
So, the first person I have is Laura
Evans. Laura, you can take yourself off mute if you
want to comment. Okay, maybe Laura is having some
issues.
The next person I see is Ralph Lieto.
Ralph, can you take yourself off mute?
(Pause.)
DR. VALENTIN-RODRIGUEZ: Mr. Lieto, I
see you're off mute so you can go ahead with your
comment.
It might be some issues on our side with
the unmute function, so let me go back and try to
unmute everybody so that you all can control your own
mics and come off mute. Let's try this again. Mr.
Lieto, are you able to speak into your mic or are you
unable to unmute yourself?
DR. FOLKERT: It's Mike Folkert. And in
order for me to be able to hear anybody I had to
completely close out and exit the Teams program and
restart it again. I'm on a trunk line so it's not a
-- and it's definitely not a bandwidth issue.
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(Simultaneously speaking.)
DR. VALENTIN-RODRIGUEZ: Let's see.
I've tried something else. Laura Evans, can you come
off mute now? Or Ralph Lieto. I have promoted you
to presenter so I think you should be able to control
your mics now. Let's try that.
(Pause.)
DR. VALENTIN-RODRIGUEZ: Okay, let's try
this a different way. So, please stand by while I
try to figure out what's going on in the back end.
Because I can hear everyone else, and I see the mics
being turned on, but I can't hear if anyone is
talking.
(Pause.)
DR. VALENTIN-RODRIGUEZ: Okay, let's try
this again. Let's see. Laura Evans, can you unmute
your mic and see if you can make a comment? You
should be able to unmute your mic.
So, I'll go down the list. Ralph Lieto,
can you unmute your mic?
(No response.)
MR. OUHIB: As a last resort --
DR. VALENTIN-RODRIGUEZ: Okay, let's try
this again.
MR. OUHIB: -- can we use the chat box 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 48
by any chance?
DR. VALENTIN-RODRIGUEZ: Yes. So, I
just enabled the chat. I am so sorry about that.
I'm not sure what's happening on the back end. But
I have just enabled the chat so what I'll try to do
is, if you have a comment, thank you for your
patience.
The chat feature should be enabled, so if
you can write your comment or you're in the chat,
we'll be able to read it for the transcript. The
chat is turned on for the duration of the meeting.
So, I really apologize. I'll keep trying on my end
to see if there is anything we can do to resolve the
audio issues.
In the meantime, if you can type your
comments on the chat that should be enabled for
everyone. And so, we'll be looking for comments
there while I try to figure out if there is any other
way I can fix this. So, I apologize for that.
MR. MITCHELL: Hello, this is Chris
Mitchell. I was the next one on your list. I don't
know if --
DR. VALENTIN-RODRIGUEZ: Okay. Yes, we
can hear you, Chris. Go ahead.
MR. MITCHELL: Okay. So, if it's okay 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 49
I'll go ahead and ask my, make my comment and
questions.
DR. VALENTIN-RODRIGUEZ: Yes, please.
Thank you.
MR. MITCHELL: Okay. Chris Mitchell. I
am the radiation safety officer at Kettering Health
in Dayton, Ohio. My question and comment really are
regarding the discussion that was had regarding the
temporary RSO and the associate RSO.
Since the associate RSO really is, has to
undergo the same training and experience requirements
as the RSO, would they not be the more logical choice
for, as a temporary RSO, maybe not for the 60 days,
but in those situations where maybe the RSO is on
leave or medical leave or whatever RSO leaves, you
have an assistant RSO that's in the process. But
would they not fit that bill, and would you have to
submit an amendment for them to do that? Thank you.
DR. FOLKERT: This is Michael Folkert.
This is definitely a question for the NRC staff to
answer.
DR. AYOADE: Hi, Dr. Folkert, this is
Maryann Ayoade from NRC. So, again, the regulations
would only allow for an associate radiation safety
officer to become a temporary RSO if that ARSO meets 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 50
the qualifications of the RSO, right?
And so, in some cases licensees are
appointing multiple associate RSOs to do specific
duties and tasks. So, they may not be fully
qualified to do everything that that licensee is
licensed for. And so again, the licensee can
designate an individual, but again, the individual
has to be, has to meet the qualifications of an RSO
even to be listed as a temporary RSO. And I hope
that clarifies the question at hand.
MR. MITCHELL: Thank you very much.
That does I appreciate that.
DR. VALENTIN-RODRIGUEZ: Thanks,
Maryann. Let's see. From the chat Mr. Ralph Lieto
asked for the, if the document is available for public
comment?
So, Mr. Lieto, the draft that the ACMUI
reviewed is available on the ACMUI website. I put
the link to the direct document, and to the materials
for today's meeting on today's chat.
The plan is to provide this interim staff
guidance for a 60-day public comment in the next few
months. So, the public will have an opportunity to
provide comments on this document.
And then, Ralph, I don't know if you can 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 51
come off mute now? I've tried toggling some of our
audio settings, but I see your question in the chat.
Last slide of the report is confusing.
What is the difference between in-person and hands
on, I'm assuming training, if hands on you are in
person, is this terms of different authors? His
suggestion is to just use the hands-on term.
Let's see. For the folks that have their
hands raised, maybe we can try for you to leave the
call and then come back in. I think everyone's audio
should be enabled so when you come back in you should
be able to unmute yourself, and then go ahead and
raise your hands and I will come on your names. I
apologize for that, but hopefully that will ease that
audio settings issue and we can have folks get their
questions on the transcript.
Dr. Folkert, go ahead?
DR. FOLKERT: Oh yes. So, it's Michael
Folkert. And so, this has to do with Ralph Lieto's
comment about the in-person hands on. So, there were
a couple of points within the draft guidance where
they mention hands on training, in-person training.
And it is a little confusing that's one of the reasons
why we want to clarify.
So, hands on training you could be 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 52
practicing with a syringe for an injection, you could
be practicing with a Mick applicator for LDR
brachytherapy, you could be practicing with an HDR
afterloader, so on and so forth. But you may or may
not have a trained licensed, otherwise authorized
individual like with you for the training.
And like in-person training is you've got
a trained authorized user who is there with you going
through the training rather than Zoom or Teams
meeting, so on and so forth. So, kind of clarifying
these, like when do you have to physically manipulate
the device as part of the training, when do you have
to have an authorized user or, you know, other
specified professional trainer physically with you on
site for the training? I think that was what we
wanted to have clarified.
MR. OUHIB: This is Zoubir Ouhib from the
ACMUI. I guess my question is, should there be, like
right underneath that, a very quick short definition
of the two terms basically? What is meant about in-
person, what is meant about hands on.
DR. VALENTIN-RODRIGUEZ: Zoubir, I think
your comment was for the Committee to make such a
recommendation, correct? If I capture that
correctly. To suggest to the NRC, clarify --
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MR. OUHIB: That is correct. Yes.
DR. VALENTIN-RODRIGUEZ: Okay.
MR. OUHIB: Yes, that is correct. Since
it was clarified, you know, it would be good to have
that clarification right underneath that.
DR. FOLKERT: So, Mike Folkert. And so,
part of the concern about that is that this, this is
kind of mirrored in many, many, many different
specific guidances for other devices. So, it's
something where it actually is going to have to be
addressed on other guidances. Guidances for the use
of microspheres, guidance on the use for the beta-
Cath device, so on and so forth.
So specifically, to this document, I
mean, if we want to add something in there it would
be under Section 4.3.2.4, and that's on Page 17 of
the document. And let's see.
So, we had actually asked to remove the
line stating, this element must be completed in
person with the device. And so, because it's not
really spelled out anywhere in here. It has to be
in other regulations. So that's why we recommended
removing the sentence from the guidance document.
So, but if we want to clarify it there,
we could state something, let's see. For this, so 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 54
under scope of training, reach device we could say,
so after that line that we suggest removing, this
element must be completed in person with device, we
could say, aspects of training could include hands on
training where the perspective authorized user
directly works with the device or a mock injectable.
And another possible, and another type of
training is in-person training where the regulation
specified authorized user or trainer who is
physically present in the same room as the
perspective authorized user as part of the training.
That might be a bit clunky and overly worded.
VICE CHAIR GREEN: Dr. Folkert, it sounds
like that suggestion would require us to go back and
DR. FOLKERT: Wordsmith.
VICE CHAIR GREEN: -- wordsmith. And
again, for a motion to approve the report as amended,
including this last recommendation. A second vote.
DR. FOLKERT: Yes. So, Michael Folkert
again. I mean, that was the reason why we asked for
this to be removed. And so, the, you know, because
we did not, because there are multiple other guidance
out there that do spell out requirements. This was,
this was a request for the NRC to clarify this in 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 55
their other regulations. We asked to remove this
from the document.
VICE CHAIR GREEN: So that's the issue
with other documents, not this document. We can let
this document remain as the report recommends.
DR. FOLKERT: Yes. I mean, that was our,
that's why we asked for that line to be removed.
VICE CHAIR GREEN: Okay.
DR. VALENTIN-RODRIGUEZ: So, Dr.
Folkert, I think based on your discussion with Mr.
Green there is no need to amend the report further
because I think you've captured that already in your
report, correct?
VICE CHAIR GREEN: I agree.
DR. VALENTIN-RODRIGUEZ: Okay.
DR. FOLKERT: Yes.
DR. VALENTIN-RODRIGUEZ: Okay. Let's
see. Are there any folks with their hands raised who
can unmute themselves and let, and try and speak?
Otherwise, I'll go to the chat that I see a question
or two.
DR. RAZMARIA: Hi there. Can you hear
me?
DR. VALENTIN-RODRIGUEZ: Yes, we can
hear you.
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DR. RAZMARIA: Hi, how are you? This is
Ali Aria Razmaria. I'm calling in from, I'm a
nuclear medicine physician from Memorial Sloan
Kettering Cancer Center.
Yes, again, thank you for the ACMUI
Members on the Subcommittee for the report. And I
just want to kind of bring up a topic here that, kind
of reading through the regulations that has caught my
eyes, and also pertains the training and experience
requirements. And I wanted to share that at this
opportunity with my comment and the ACMUI in general.
So, again, that goes along the lines of
what Mr. Ouhib, he has mentioned regarding insuring
quality. How that can be maintained in terms of what
training and experience requirements.
And again, it's clear that obviously NRC
cannot police the requirements and have the standards
of training that has been provided, but thinking
there are measures in place in terms of, you know,
the medical field we rely on which pertains to like
residency trainings that are created by bodies that
basically have accreditation and instruments in place
that we rely in the medical field on.
So again, in that regard I just want to
kind of point out that we have a discrepancy that is 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 57
kind of apparent in the regulations. And again, I
wish I could, because I have the regulations, NRC
regulations, up here. I wish we could have shared
that. Is it possible to share those? I know I will
try --
DR. VALENTIN-RODRIGUEZ: We can try to
pull up the regulations --
DR. RAZMARIA: Okay.
DR. VALENTIN-RODRIGUEZ: -- if you let
us know what the --
DR. RAZMARIA: Yes. So, I think --
DR. VALENTIN-RODRIGUEZ: -- number --
DR. RAZMARIA: Because if I could try if
that's possible. Can you see those? I mean, this
is not pulled up as NRC website, this is kind of --
DR. VALENTIN-RODRIGUEZ: Okay.
DR. RAZMARIA: -- foreign material.
Kind of we see here, obviously this is about Part 35,
medical use of byproduct materials. Particularly
we're interested in training and experience
requirements.
And I just want to kind of point out, in
terms of the Subpart E, which kind of pertains to
unsealed byproduct material and the corresponding
training and experience requirements. And I just 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 58
wanted to kind of point that out. And kind of
different tabs here.
So, if you read here, we see, in terms of
what is needed in order to be able to basically
confidently administer or use those products is
successfully complete residency training in radiation
therapy and nuclear medicine training program and
other related specialties.
But I just want to put that in contrast,
what we have in place in subpart for, if we go back,
it's Subpart, basically in 35.494, brachytherapies.
You kind of see there really explicitly mentioned in
the regulations, successfully complete minimum three
years of residency training in a radiation oncology
program approved by the residency review committee of
accreditation counsel for graduate medical education.
So, your kind of relying here, the NRC is
relying here on a third-party established
accreditation body, so, which kind of oversees all
the practice of medical field. It gets started from
family medicine, surgery, radiology, et cetera.
So, we are relying on an external body to
basically, to keep that accreditation. So, we need
to police the educators, but these are kind of the
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by.
So, the same thing applies to like
training for user remote after loading units,
teletherapy units, and gamma stereotactic
radiosurgery. Again, we see the same thing for
radiation oncology has been kind of very proactive in
kind of having those requirements explicitly
mentioned in the regulation.
So here again, successfully complete a
minimum of three years of residency training. And
this is kind of the first point. So, there are
subsequent points that point out like alternative
pathways. But again, you're relying here heavily on
kind of medical bodies, accreditation bodies that are
kind of giving us their assurance, this is quality
training that has been pursued by people who are kind
of using these devices.
So, three years of residency training in
a radiation therapy program approved by the residency
review committee, accreditation costs for grad
medical education.
So, again, going back to the training for
use of on unsealed byproduct material, again, by no
means less dangerous or less prone to side effects,
if you will, but we have the kind of rudimentary 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 60
mention of what training is, so basically
successfully complete residency training in radiation
therapy or nuclear medicine.
Again, we know that unsealed byproduct
materials have been kind of traditionally used by
nuclear medicine as a field and a program-related
medical specialty, again, not really kind of going
into the details as we have it in the other two
training and experience requirements.
So, again, a very clear disparity in
terms of how to maintain or assure quality in terms
of training for people who pursue this or people who
are providing the training for people that are
interested in becoming authorized users.
Again, you see here that, again, this
goes hand-in-hand with having an examination, again,
in Part 4 the brachytherapy, examinations have to be
passed by the candidates.
That kind of provides the board
certification, specialty board, and this applies for
like, you know, teletherapy units as well. Again,
not as clearly stated for unsealed byproduct
materials.
So, yes, again, since we are at the point
where we are discussing what are, you know, what is 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 61
the quality of training, you know, what it should
look like going into future, again, very well worded
out or kind of spelled out for radiation oncology
applications, brachytherapy, teletherapy, but not so
much for nuclear medicine application, which kind of
this area has been traditionally within the nuclear
medicine field, again not that specific language.
Again, I think that's kind of, you know,
at this point, I just want to kind of bring up this
disparity in regulation, the wording of the
regulation, and kind of towards the point of how we
can in the future improve or maintain, establish the
quality that we want to see these products being used
by -- for the people who are candidates where people
providing the training.
So, I just wanted to kind of bring that
up at this point and, you know, have kind of, you
know, a response or comments from the ACMUI or NRC
staff.
DR. VALENTIN-RODRIGUEZ: Thank you for
your comment, Dr. Razmaria. Let's see. I think
there was some back and forth in the chat. Let's
see, looking at the next comment.
Mr. Bryant, if you want to come off mute,
otherwise I will share your question and read through 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 62
it. I think Dr. Folkert responded to it, but your
question was "Can a proposed authorized physician
user be added without considering recentness of
training to an NRC RAM license if the proposed
individual was previously but not currently listed on
an NRC RAM license for all uses applied for?"
Dr. Folkert responding, "Yes, they would
use NRC Form 313A, Authorized User Requesting
Authorization for Use of Seal Sources Defined Under
10 CFR 35.400 or 35.600. Instructions are in Section
4.6 of the proposed guidance."
Mr. Bryant, I don't know if you wanted to
come off mute to add anything.
(Simultaneous speaking.)
DR. FOLKERT: This is Michael Folkert.
Just to -- Oh, sorry. Yes, okay.
MR. BRYANT: Yes, so perfect. It sounds
like my microphone is working now.
DR. FOLKERT: Yes.
MR. BRYANT: So that was the question.
I just wanted to make sure there wasn't like a time
bar that existed as far as on the time that would
have elapsed from the time that the proposed
authorized user would apply to be added to a RAM
license and the time that they were last listed on an 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 63
active radioactive materials license.
So, let's say that it was ten years ago
when the individual was last employed and working in
the field and was on a byproduct license as an
authorized user?
DR. VALENTIN-RODRIGUEZ: Dr. Folkert, I
think that's something that the NRC could consider as
a potential scenario --
MR. BRYANT: Yes.
DR. VALENTIN-RODRIGUEZ: -- to add to the
guidance if I think I understood Mr. Bryant's
question correctly.
DR. FOLKERT: Yes, this is Michael
Folkert again. Yes, that's -- I mean he captured --
That's exactly one of the ones that we specifically
requested.
And so, as a case example, a 10-year out
radiation oncologist who wanted to, you know, get set
up, because you could do one of the standard pathways
or you could do the preceptor attestation. That is
the one that is listed under Section 4.7, and it
explains the preceptor attestation method of getting
on the license.
So, but, yes, we should -- I mean
providing an explicit case example for some of these 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 64
very common scenarios I think is absolutely a need
and clearly wanted by the public.
DR. VALENTIN-RODRIGUEZ: Thank you, Dr.
Folkert. Ralph Lieto, I think you can unmute
yourself now. Let's see if this works.
MR. LIETO: Can you hear me?
DR. VALENTIN-RODRIGUEZ: Yes. I
apologize for all the issues, but we can hear you
now.
MR. LIETO: It's probably not on your
end. I ended up changing computers.
DR. VALENTIN-RODRIGUEZ: Okay.
MR. LIETO: My name is Ralph Lieto. I
am a retired RSO, and medical physicist and I am
asking this on behalf of myself.
I had a couple of questions. My main one
has to do with the last slide where it talks about
"in person" versus "hands on." I am trying to
understand what that difference is.
Was that just maybe different authors of
the document using their respective terms or is there
some difference between "in person" and "hands on"
that I just don't fathom? So, it's directed not only
to the Committee, the subcommittee, but also NRC.
DR. FOLKERT: Hi. It's Mike Folkert.
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So,I think maybe while you were switching computers,
we had a discussion about that as well. I apologize
if it was confusing in the presentation.
We actually did not want that to be
discussed at all in the guidance. We actually asked
for it to be removed from the guidance, because there
are elements of -- there is definitions of these
aspects of training in specific guidance that are
more in line with specific applications,
radiopharmaceutical applications, device
applications, so on and so forth, and so it was a
request to the NRC to address when devices and
applications require both in person and hands on
training.
The general thinking that hands on
training means that you train with the device or a
mock version of the device yourself, whereas in
person is you have a qualified person with you,
physically with you in a room, not on a Teams chat or
a Zoom chat or anything like that, going over the use
of the device or the application.
But as far as the guidance was concerned,
we had actually asked for it to be removed from the
guidance so it would not be part of this draft.
MR. LIETO: But -- Okay. But then you 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 66
are asking that just from that respective section but
wherever it's used in the document, is that correct,
because the terms are used about four or five times
throughout the document?
So, some cases there is "hands on," the
term is used, and in other places, in a couple other
instances the term "in person" is used. So, I am
still not clear in terms of the way you described "in
person," how that does not mean that the person is
actually hands on with the device or some mock of it.
So --
(Simultaneous speaking.)
MR. LIETO: I think this is something
that needs to be fixed in the document and also in
terms of with NRC, but I think the term, it should be
just one term and not two terms.
I think "hands on" is used in other NRC
documents if my memory serves me right.
DR. FOLKERT: Yeah, I think it is.
MR. LIETO: Like in the regulatory
guidance documents.
DR. FOLKERT: Yeah.
MR. LIETO: So that was my one point.
The other is I think Maryann mentioned a comment about
that you could have more than one temporary RSO 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 67
designated during some type of transition, especially
in larger programs.
I don't -- I'm pretty sure that's not
common knowledge and I would recommend to the writing
committee that they clarify and maybe even specify
that point in a discussion about temporary RSOs, or
excuse me, the associate RSOs becoming temporary,
because I think that's a very important point and
could aid licensees very much. Thank you.
DR. VALENTIN-RODRIGUEZ: Thank you,
Ralph. Again, thanks for putting up with our audio
issues. Let's see. I am looking for more hands
raised. Any other attendees who would like to
comment.
I think the audio now is working so you
can go ahead and unmute yourself or raise your hand
and I'll call on you.
(Pause.)
DR. VALENTIN-RODRIGUEZ: Okay. William
Hinchcliffe, go ahead.
MR. HINCHCLIFFE: Hi. William
Hinchcliffe. I am the radiation safety officer for
Yale New Haven Hospital. Actually, on this point for
the temporary radiation safety officer I just wanted
to clarify Ms. Ayoade's comments for 35.24(c), that 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 68
the 60 days a licensee makes for an individual
qualified radiation safety officer, the 60 days is
specific to the individual and not the licensee.
I was looking and there is a little bit
between 35.24(c) and 35.24(d) and whether it can be
multiple individuals longer than 60 days or is the 60
days tied to the licensee in an annual year, in a
year?
DR. AYOADE: This is Maryann Ayoade from
the NRC. I can clarify that some more because I
believe that's what you are asking for, some more
clarification.
So, as you mentioned the regulations in
35.24 does allow for the temporary RSO to serve in
that role for up to 60 days each year, right, and
then it is in I believe 10 CRF 35.14 the notification
where the licensee has to notify NRC within 30 days
of any changes, including that of the temporary RSO.
I hope that clarifies your question.
MR. HINCHCLIFFE: I think the actual
clarification was whether the 60 days is for the
individual or the 60 days is the maximum for a
licensee to have any temporary RSO. So --
(Simultaneous speaking.)
DR. AYOADE: The 60 days is for the 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 69
individual to function as a temporary RSO on the
license, or for the licensee.
MR. HINCHCLIFFE: Okay. So --
DR. AYOADE: So, to function as a
temporary RSO.
MR. HINCHCLIFFE: For that individual.
So, if you had two individuals you could have a
temporary RSO for 60 days and then you could in
writing have a new individual be a temporary RSO for
60 additional days as long as you notified the NRC
per 35.14?
DR. AYOADE: Yes. I believe from what
you said, yes, that's correct.
MR. HINCHCLIFFE: Okay. Thank you.
DR. VALENTIN-RODRIGUEZ: Thanks,
William. Matt Barrett, I think you can come off
mute. I see your question in the chat. If you can't
unmute yourself then I can go ahead and read it, but
I figured I'd give you the chance to come off mute.
MR. BARRETT: Yes. Let me try to clarify
(audio interference) --
DR. VALENTIN-RODRIGUEZ: See, I think
your connection is coming in and out, Matt, so maybe
I can read the question and if that's fixed on your
end you can come off mute.
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Your question is "Would this be
acceptable, 10 CFR 35.24(d), a licensee may
simultaneously or sequentially appoint more than one
temporary radiation safety officer in accordance with
Paragraph C of this section if needed to ensure that
the licensee has a temporary radiation safety officer
that satisfied the requirements to be a radiation
safety officer for each of the different types of
uses of byproduct material permitted by the license?"
So, I don't know, maybe you can come off
mute now. Is that what the NRC is allowing? I think
based on your quoting of regulations I think, yes, it
would be allowed, but I don't know.
Maryann, maybe you can -- I think that's
what you were speaking to earlier.
DR. AYOADE: Yes. Hi, Celimar, this is
Maryann Ayoade. So, it looks like in is quote of
35.24(d) he included the language "or sequentially,"
right.
DR. VALENTIN-RODRIGUEZ: Yes.
DR. AYOADE: And currently the
regulation says "simultaneously."
DR. VALENTIN-RODRIGUEZ: Right.
DR. AYOADE: And so currently the
regulation's intention is not for that to be the case.
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But, again, on the case-by-case basis, you know, as
you notify us and you present the information to the
NRC or the agreement states, you know, we would have
to evaluate it on a case-by-case basis.
DR. VALENTIN-RODRIGUEZ: Let's see. I
think he added something. The chat says "I am just"
-- Okay. "I am just trying to clarify is that what
we are verbally saying?" And I think Maryann
clarified that. Okay.
I don't see any other hands raised.
Anyone else from the public who would like to make a
comment feel free to come off mute or raise your hand
and I'll call on you.
It looks like the enabling mic feature
for all of you should be active so you can come off
mute. Dr. Carol Marcus, I see your hand raised. Go
ahead.
(Pause.)
DR. MARCUS: Can you hear me now?
DR. VALENTIN-RODRIGUEZ: Yes, we can
hear you.
DR. MARCUS: Oh, okay. You'll have to
forgive me, but the first hour and a quarter of this
meeting I couldn't hear because there was some
speaker issue, but it's resolved now, so I don't know 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 72
if this was discussed at all.
I was concerned that preceptor
attestation in nuclear medicine now does not include
assurance of clinical competence but only radiation
safety competence.
The NRC has a statement that it's the job
of the Board of Medicine to regulate clinical
competence. Number one, it's not the job of the
Board of Medicine, they don't do that.
Once you pass Part 1, 2, and 3 of the
National Board Exams as long as you pay your fee you
get a license. In the very, very unlikely event that
somebody makes a complaint to the Board of Medicine
about your performance they will appoint a board-
certified person in nuclear medicine to look at what
went on and to decide if you are competent, if that's
the question, but that hardly ever happens.
I think it would really be important that
the preceptor attest to the clinical competence of
the physician because the physician is not board
certified in a field, you know, that is recognized by
the NRC.
If you just -- You know, radiation safety
is pretty simple and almost anybody can learn it
pretty fast, but clinical competence is something 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 73
else.
When I was teaching radiation oncology
residents to do radiopharmaceutical therapy, they,
you know, satisfied the case numbers and things like
that, but that wasn't enough.
I had, you know, extensive discussions of
all the cases from a medical point of view and I had
a comprehensive written examination for each resident
and a passing grade was a 100. If you didn't get
something right, you had to do it over till you got
it right.
So that my criteria for clinical
competence was more than what was set out in the
regulations because I simply wouldn't attest to that
unless I thought these residents could actually do
the job.
So, I basically am asking the ACMUI how
you are going to assure that the people you license
to do radiopharmaceutical therapy, for example, are
clinically competent, you know.
If, you know, the Board of Radiology says
that the requirements of their residency program no
longer meet the NRC requirements -- Actually, it
hasn't met the NRC requirements in 20 years, but they
finally realized that they were lying so they stopped 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
this nonsense.
But what are we going to do about this
preceptor thing? Somebody has to decide that the
person is competent and usually it's the boards, the
specialty boards, but now you're talking about
licensing people who don't have specialty boards and,
you know, you better make sure they are competent.
I mean if the NRC has any job at all, you
know, you certainly don't want to license people who
aren't competent to do radiopharmaceutical therapy
and then shrug your shoulders when they screw up and
say, oh, well, it was the Board of Medicine's fault,
not ours.
That just does not fly at least in my
thinking. Well, I'm done. Anyone like to talk about
this?
DR. FOLKERT: It's Mike Folkert from the
ACMUI. I mean my personal opinion on this is that
it should be the responsibility of the specialty
board and the professional groups.
I know, for example, for radiation
oncology they are taking a very active role in this
through ASTRO. They are developing training
curriculum that is specific to radiopharmaceuticals.
The ACGME requirements have been expanded 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 75
to require increased numbers of cases for performance
of radiopharmaceuticals even in order to just to
graduate regardless of the NRC requirements.
It's actually currently above the old NRC
requirements, the number of cases that radiation
oncology residents are required to finish in order to
graduate now.
So, you know, my opinion is that it is
the responsibility of the specialty board and of the
professional societies that oversee the education of
radiation oncologists, in all areas, but I am most
aware of the radiation oncology residents, and so to
make sure that they are up to speed and clinically
competent for these.
I know they have also included
radiopharmaceutical questions into our oral boards,
which is a direct one-on-one, you know, testing of
knowledge.
So that's where I think the clinical
competency should be for the, at least for the board
areas. From the clarification that we had seen back
in 2018, they do still require attestation for folks
who are not trained by a specialty board, and so
preceptor attestation.
So that is still requiring the 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 76
attestation, but I know that the professional
societies are taking an active role in making sure
that clinical competency is met.
DR. MARCUS: Well, if that's the case
then I would expect the American Board of Radiology
to say that the requirements for radiopharmaceutical
therapy are now met by accepted radiation oncology
residency programs, but they haven't said that yet,
have they?
The last thing I heard was that neither
diagnostic radiology residency programs nor radiation
oncology residency programs, neither of them meet the
requirements for radiopharmaceutical therapy.
I mean I like the idea of the residency
programs being altered to really establish
competence, but then it's up to the Board to ask the
NRC to then recognize their Board as competent, like
we have for the American Board of Nuclear Medicine,
but that hasn't happened yet as far as I know.
DR. VALENTIN-RODRIGUEZ: Thank you, Dr.
Marcus. Dr. Einstein, did you want to make a
comment?
DR. EINSTEIN: Yes. I would second Dr.
Folkert's thoughts about this as well. I appreciate
Dr. Marcus' concerns in ensuring quality of care, but 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 77
it doesn't seem to me to be the bailiwick of the
Nuclear Regulatory Commission to ensure clinical
competence, which is really more the bailiwick of
organizations which are approved by the American
Board of Medical Specialties and smaller
organizations which are affiliated with organizations
that are affiliated with the American Board of
Medical Specialties.
You know, fundamentally the NRC is not a
clinical competency accrediting or a credentialing
organization. So, while, you know, your comments are
very valid, I think to a certain degree you may be
barking up the wrong tree, as the expression goes.
Like I think you'll have ACMUI members
who are sympathetic to your concern, but NRC is
probably not the mechanism through which to ensure
such clinical competency.
DR. MARCUS: I agree with you completely.
The NRC is completely non-competent in clinical
anything.
What I am just pointing out is that the
only group that was providing assurance of clinical
competence was these preceptors and now the preceptor
only attests to radiation safety competence, which is
pretty simple and pretty basic, but not the clinical 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 78
competence.
So, if the person is not board certified,
you know, board recognized by the NRC for its
competence in this area and the preceptor is not
attesting to clinical competence nobody is attesting
to clinical competence, and I think that's a problem.
I think that until the American Board of
Radiology says, okay, now our boards in radiation
oncology are consistent with clinical competency in
radiopharmaceutical therapy and they get the NRC to
recognize them, fine, we let the American Board of
Radiology determine clinical competence, but we don't
have that. We don't have anything.
DR. EINSTEIN: It's a problem as you
point out and it's a problem with the system, but
it's not a problem, you know, for the NRC. That's
not NRC's part of the system as I understand it.
So, I encourage you to move forward with
these concerns, but I don't know that moving forward
through ACMUI is the right way to do that.
DR. MARCUS: Well unless you have a
situation where the person can be called clinically
competent by the board that he has taken, if you would
say that the -- I mean your last chance of
establishing clinical competence is the preceptor 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 79
and, you know, it's been a joke for many years because
most nuclear medicine people are in a radiology
department and if they don't declare the residents
clinically competent they're not going to have a job.
So, for years and years and years the
preceptors declared clinical competence when they
were really were very uncomfortable with that. When
the NRC said we no longer need these preceptor
statements in diagnostic and therapeutic radiology
they were very happy because then they didn't have to
be responsible for determining clinical competence,
but that -- And now that you've put the preceptors
back in here, and I think maybe we shouldn't have it.
Unless you are Board certified in nuclear
medicine or nuclear radiology, which I assume now
includes therapy, it originally just included
diagnostic nuclear medicine, why do you need an
alternate pathway?
I mean the radiation oncologists to
practice radiation oncology you have to be board
certified in radiation oncology period. There isn't
any alternative thing.
It would seem to me if the
radiopharmaceutical therapy should require that you
be boarded in a Board that is recognized by the NRC 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 80
as establishing clinical competence.
DR. EINSTEIN: Again, I agree that you
should be boarded by such a board, but I don't know
that it's the NRC's role to establish that, which
fundamentally is a check of clinical competency.
This is not a clinical organization.
DR. FOLKERT: So, Michael Folkert, if
it's okay to join in again on that one.
DR. VALENTIN-RODRIGUEZ: Yes.
DR. FOLKERT: I mean we are very
sympathetic to the needs of ascertaining and
confirming clinical competency and this is an entire
area of focus for me as a former residency program
director and constantly involved in education and
safety training, and so for radiation therapy,
brachytherapy, and radiopharmaceuticals.
I mean this is actively being worked on
by the professional societies. One of the big
programs that is being developed, SNMMI has it, ASTRO
has it, the accreditation programs that look at
centers of excellence for radiopharmaceutical
administration.
They are taking a deep dive into
competency, into safety, into how well these patients
are being taken care of, and people are going to be 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 81
applying for these accreditations and in the end, you
know, patients will have the choice to go to places
that are accredited that have that stamp of approval
for high quality care in terms of
radiopharmaceuticals.
So, this is, you know, so this venue for
looking at safety is very critical for the Nuclear
Regulatory Commission, but in the areas that are
looking at clinical competency and for high quality
deliver of care with radiopharmaceuticals, these are
established and growing right now.
There are multiple accreditation
programs through ACR, ASTRO, and SNMMI, that are
looking specifically at this area and, you know, it's
going to be very obvious to patients which places
have satisfied this, which places have received these
marks of approval, and which have not.
DR. VALENTIN-RODRIGUEZ: Thank you, Dr.
Folkert. This is Celimar. I just wanted to step in
for the interest of time. It is 2:52 and our meeting
is scheduled to end at 3:00.
I just wanted to give Mr. Green and Dr.
Jadvar enough time to summarize the meeting as well
as put in a vote for the amendments to the report.
So, I appreciate everyone's interest in 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 82
this topic. I know that we'll have more public
meetings once we issue this document for public
comment, and so the public will have an opportunity
to weigh in with their own comments.
So, Mr. Green, if I can go ahead and
summarize the discussions for the meeting so you can
call for a vote on the amended report.
VICE CHAIR GREEN: Yes, please do.
DR. VALENTIN-RODRIGUEZ: Thank you, Mr.
Green. So, for today besides the report that was
included as a handout I have the following amendments
that will be done to the draft report before it is
issued as final.
One is to clarify what the NRC means by
"conditions of a license." The next is to clarify
and add more detail to the section on assistant and
temporary RSOs, associate RSOs, and how that can be
and the difference between notification and
especially to clarify the 60-day requirement in
35.24.
The next issue that will be amended in
the report is to clarify that RSO responsibilities
are inclusive but not limited to the list that is
already included in the draft implementation staff
guidance.
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So those are the changes that I noted.
Was there anything I missed before Mr. Green you can
call on the vote?
DR. JADVAR: Wasn't there a definition
of "hands on" and "in person" clarification?
VICE CHAIR GREEN: There was no
definition. There was an ask to remove that
language.
DR. JADVAR: Remove, yes.
PARTICIPANT: Okay.
VICE CHAIR GREEN: And that's in the
report.
DR. VALENTIN-RODRIGUEZ: Do you want to
-- Is the ACMUI asking to amend that comment in the
report, or should we keep it as is?
DR. FOLKERT: Let's see. So, this is
Michael Folkert. Looking at the report and as was
mentioned that there were a couple points where "in
person" or "hands on" was mentioned besides that one
spot, so there are two mentions of "in person" and
let's see, and then "hands on" I believe there were
two other mentions of it.
DR. VALENTIN-RODRIGUEZ: Okay. I'm good
with that.
DR. FOLKERT: And so, we just have to be 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 84
thorough for getting those. So, yes, so it has
training and -- So, for example, on Page 26 where it
says, "hands on device operation" we could remove
"hands on" and have "training in device operation."
And then overall the NRC though does have
to be, has to have a definition of "in person" versus
"hands on" and where the crossover is because it's
critical for the training and certification for
different devices and applications throughout all the
different applications that we have.
DR. VALENTIN-RODRIGUEZ: So, from your
comment what I understand is you want to keep the
current recommendation but maybe propose a second one
to clarify "hands on" versus "in person?"
DR. FOLKERT: No. Yes, so this is not
for the report.
DR. VALENTIN-RODRIGUEZ: Okay.
DR. FOLKERT: Specifically for the
report to remove these comments of "hands on" versus
"in person."
DR. VALENTIN-RODRIGUEZ: Okay.
DR. FOLKERT: But outside of the report
I mean the NRC needs to have a policy for what is
hands on and what is in person.
DR. VALENTIN-RODRIGUEZ: Okay. So, I'll 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 85
take that back as an action for the NRC staff then.
I just wanted to clarify that. Thank you, Dr.
Folkert.
If there is nothing else, I think Mr.
Green I can turn the meeting back to you so you can
call on the vote.
VICE CHAIR GREEN: Okay. I believe we
do need to have a second vote. We have amended the
report from our previous vote. So, are there any
votes to accept the report as amended?
DR. HARVEY: I can make a motion. This
is Richard Harvey. I will make the motion to accept
the report with the revisions and clarifications.
VICE CHAIR GREEN: Thank you, Doctor.
Any seconds?
DR. EINSTEIN: Second.
PARTICIPANT: Second.
VICE CHAIR GREEN: Thank you, Andrew
Einstein. Okay, all in favor say aye.
(Chorus of ayes.)
VICE CHAIR GREEN: Any opposed?
And any abstentions?
Hearing none, the vote is unanimous.
Well, that concludes our time this
afternoon and I would like to thank you for 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 86
participating and for the Subcommittee for their
excellent work and report. We will now stand
adjourned.
(Whereupon the above-entitled matter
went off the record at 2:57 p.m.)
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 COMMENTS FOR JUNE 5TH ACMUI MEETING
Carol S. Marcus, Ph.D., M.D.
May 31, 2024
Thank you for the opportunity to comment on NRCs interim guidance on medical Training and Experience (T&E) requirements. I am surprised that the ACMUI has not commented on the fact that preceptor attestation no longer requires the preceptor to attest to the clinical competence of the recipient of his preceptoring, but only to his radiation safety competence. The NRC states that medical competence is the responsibility of the applicable state medical board.
This represents a huge change. For many years, licensed Nuclear Medicine physicians were expected to provide preceptor attestation for residents in Diagnostic Radiology and in Radiation Oncology that included clinical competence. This caused a problem because the Nuclear Medicine physician often did not think that the resident was competent to practice Nuclear Medicine, but could lose his job if he/she did not provide preceptor attestation. Many nuclear medicine physicians were happy when preceptor attestation was no longer required for Diagnostic Radiology and Radiation Oncology residency programs. Board certification was all that was required. Now that the American Board of Radiology no longer claims that its residency programs in Diagnostic Radiology and Radiation Oncology meet NRCs T&E requirements, there is no requirement that preceptors attest to clinical competence, only radiation safety competence. There is no one to judge clinical competence. State medical boards do not do this, except in the unlikely event of a malpractice accusation.
I think that the ACMUI and its subcommittee need to address this. Some entity has to assure clinical competence to keep patients safe.
Thank you for your attention and consideration.