ML24269A153
| ML24269A153 | |
| Person / Time | |
|---|---|
| Issue date: | 08/29/2024 |
| From: | Office of Nuclear Material Safety and Safeguards, Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| References | |
| NRC-0019 | |
| Download: ML24269A153 (50) | |
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: Thursday, August 29, 2024
Work Order No.: NRC- 0019 Pages 1-47
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
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TELECONFERENCE
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THURSDAY, AUGUST 29, 2024
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The meeting was convened via
Teleconference, at 2:00 p.m. EDT, Hossein Jadvar,
ACMUI Chairman, presiding.
MEMBERS PRESENT:
HOSSEIN JADVAR, M.D., Ph.D., Chairman
RICHARD L. GREEN, Vice Chairman
REBECCA ALLEN, Member
ANDREW EINSTEIN, M.D., Ph.D., Member
MICHAEL R. FOLKERT, M.D., Ph.D., Member
JOANNA R. FAIR, M.D., Ph.D., Member
RICHARD HARVEY, Dr.PH., Member
JOSH MAILMAN, Member
MELISSA C. MARTIN, Member
MICHAEL D. O'HARA, Ph.D., Member
MEGAN L. SHOBER, Member
HARVEY B. WOLKOV, M.D., 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
John F. Angle, M.D., Consultant to ACMUI
NRC STAFF PRESENT:
CHRIS EINBERG, NMSS/MSST/MSEB, Designated
Federal Official
LILLIAN ARMSTEAD, NMSS
SARAH LOPAS, NMSS/MSST/MSEB
DANIEL SHAW, NMSS
KATHERINE TAPP, NMSS/MSST/MSEB
BRIAN ALLEN, NRC
DANIEL DIMARCO, NMSS
CYNTHIA M. FLANNERY, NMSS
TRAVIS JONES, NRC
DANIEL SHAW, NMSS
SARAH SPENCE, NMSS
TORI ROSZKOWSKI, NMSS
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P-R-O-C-E-E-D-I-N-G-S
2:03 p.m.
MR. EINBERG: Okay. Good afternoon. As
the designated federal officer for this meeting, I am
pleased to welcome you to this public meeting of this
Advisory Committee on the Medical Uses of Isotopes.
My name is Chris Einberg. I'm the chief
of the Medical Safety and Events Assessment Branch.
And I've 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 is being 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 July 12,
2024 edition of the Federal Register, Volume 89, Page
57173.
The function of the ACMUI is to advise
the staff on issues and questions that arise on the
medical use of byproduct material. The Committee
provides counsel to the staff but does not determine 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 5
or direct the actual decisions of 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
various issues 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 on the ACMUI members participating today.
Dr. Hossein Jadvar, Chair, nuclear
medicine physician.
CHAIRMAN JADVAR: Present.
MR. EINBERG: Mr. Richard Green, Vice
Chair, nuclear pharmacist.
VICE CHAIRMAN GREEN: Present.
MR. EINBERG: Michael Folkert, radiation
oncologist.
DR. FOLKERT: Present.
MR. EINBERG: Mr. Josh Mailman,
patients' rights advocate.
MR. MAILMAN: Present.
MR. EINBERG: Ms. Melissa Martin,
nuclear medicine physicist.
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MS. MARTIN: Present.
MR. EINBERG: Dr. Michael O'Hara, FDA
representative.
DR. O'HARA: Present.
MR. EINBERG: Mr. Zoubir Ouhib,
radiation therapy physicist. Okay. He's not
present.
Ms. Megan Shober, state government
representative.
MS. SHOBER: Present.
MR. EINBERG: Dr. Richard -- excuse me.
Dr. Harvey Wolkov, radiation oncologist.
DR. WOLKOV: Present.
MR. EINBERG: Dr. Richard Harvey,
radiation safety officer.
DR. HARVEY: Present.
MR. EINBERG: Dr. Andrew Einstein,
nuclear cardiologist.
DR. EINSTEIN: Present.
MR. EINBERG: Dr. Joanna Fair,
diagnostic radiologist. It doesn't appear she's
present. And then Ms. Rebecca Allen, health care
administrator. Okay. She also is not present.
We do have a quorum though of at least
six members. Dr. John Angle, interventional 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
radiologist consultant to the ACMUI may participate
in today's discussions but does not have voting
rights for any actions requiring a vote.
All members of the ACMUI are subject to
federal ethics laws and regulations and receive
annual training on these requirements.
If a member believes that they may have
a conflict of interest as the term is broadly used
within 5 CFR Part 2635 with regard to an agenda item
to be addressed by the ACMUI, this member should
divulge it to the chair and to the DFO 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
waiver or prior authorization from the appropriate
NRC official.
I would like to add that we are also using
Microsoft Teams so that members of the public and
other individuals can watch online or join via phone.
The phone number for the meeting is 301-576-2978.
The phone conference ID is 901692104#.
The handouts and agenda for this meeting
are available on NRC's ACMUI public website.
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Today's meeting is being transcribed by
a court reporter. We are utilizing Microsoft Teams
for the audio 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.
For the purpose of this meeting, the chat
featuring Microsoft Teams has been disabled. Dr.
Jadvar at his discretion may entertain comments or
questions from member of the public who are
participating today.
For those individuals in or on Microsoft
Teams, please use the raise hand function to signal
to our Microsoft Teams host, Ms. Armstead, that you
wish to speak. If you have called into the Microsoft
Teams using your phone, please ensure you have
unmuted your phone.
When you begin your comment, please
clearly speak your first and last name for the record.
Comments and questions are typically addressed by the
committee near the end of a presentation after the
committee has fully discussed the topic.
We will announce when we are ready for
the public comment period of the meeting. And Ms.
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Armstead or Ms. Lopas will assist in facilitating
public comments.
At this time, I ask that everyone who is
not speaking to please mute your Teams microphones or
phone. At this point, I would like to turn it over
to Dr. Jadvar.
CHAIRMAN JADVAR: Thank you very much,
Mr. Einberg. And welcome, everybody, good morning
or good afternoon as the case may be and welcome to
this ACMUI meeting.
At this meeting, I want to invite Mr.
Richard Green who is the nuclear pharmacist and the
vice chair of ACMUI who also chaired this
subcommittee to present the report of the
subcommittee on financial assurance requirements for
the disposition of Category 1 to 3 byproduct material
radioactive sealed sources. Mr. Green?
VICE CHAIRMAN GREEN: Thank you, Dr.
Jadvar. Hello. My name is Richard Green. I am the
chairperson of the ACMUI Subcommittee on Financial
Assurance Requirements for Disposition of Category 1
through 3 Byproduct Material Radioactive Sealed
Sources.
I'm pleased to be able to present our
subcommittee's final report today.
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Next slide, please. I would like to
acknowledge the outstanding efforts of the members of
the subcommittee that included Ms. Rebecca Allen, Dr.
Richard Harvey, Mr. Zoubir Ouhib and Dr. Harvey
Wolkov. Our efforts were assisted by Daniel Shaw as
the NRC staff resource.
Next slide, please.
The subcommittee's charge was to review
the U.S. Nuclear Regulatory Commission's staff draft
regulatory basis document on Financial Assurance
Requirements for Disposition of Category 1-3
Byproduct Material Radioactive Sealed Sources and to
provide feedbackand recommendations.
Next slide, please. First, we'll start
off by reviewing some of the regulatory concerns that
brought about this request for this regulatory basis
document.
Many licensees found themselves
unprepared for the costs associated with the
disposition of some Category 1-3 radioactive sealed
sources.
Some licensees had inadequate financial
assurance to support the disposition of Category 1B 3
radioactive sealed sources due to bankruptcy or other
unforeseen circumstances.
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There currently is no regulatory
incentive to provide the timely disposal of disused
Category 1 through 3 radioactive sealed sources. In
some cases, these sources are stockpiled and could
have less than adequate security.
When a licensee is unable to through
bankruptcy or because of abandonment, the disposition
costs for some Category 1 through 3 radioactive
sealed sources is borne by the federal government and
taxpayers instead of the licensees who obtained value
from the use of these sealed sources.
Next slide, please. Because of these
regulatory concerns, the U.S. Nuclear Regulatory
Commission is considering revising the requirements
in Title 10 of the Code of Federal Regulations 30.35,
Financial Assurance and Recordkeeping for
Decommissioning. Therulemaking would establish new
decommissioning financial assurance requirements for
the disposition of Category 1 through 3 byproduct
radioactive material sealed sources.
Next slide, please. When I personally
first read this proposed governance document
discussing Category 1, 2 and 3 radioactive sealed
sources, I really didn't know what these categories
were. I think it's worth pausing for a moment 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 12
familiarize ourselves with the definition for these
three classes of sealed sources.
If Category 1 sealed sources were not
safely or securely managed, they are likely to cause
permanent injury to a person who handles them or who
otherwise was in contact with them for more than a
few minutes.
It would probably be fatal to be close to
this amount of unshielded material for a period of a
few minutes to a few hours, and these sources are
typically used in radio thermal generators,
irradiators and radiation and teletherapy units.
Next slide, please. Category 2 sealed
sources, if not safely or securely managed, could
cause permanent injury to a person who handled them
or was otherwise in contact with them for a short
time of minutesto hours.
It could possibly be fatal to be close to
this amount of unshielded radioactive material for a
period of hours to days. These sources are typically
used in industrial gamma radiography, high-and
medium-dose rate brachytherapy and radiography.
Next slide, please. Category 3 sources,
if not safely or securely managed, could cause
permanent injury to a person who handled them or was 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
otherwise in contact with them for hours.
It could possibly, although it is
unlikely, be fatal to be close to this amount of
unshielded radioactive material for days to weeks.
These sources are typically used in fixed industrial
gauges such as level gauges, dredger gauges, conveyor
gauges, spinning pipe gauges and well-logging gauges.
Next slide, please. The NRC's current
regulations found in 10 CFR 30.35 require a fixed
dollar of financial assurance or a decommissioning
funding plan for licensees who possess byproduct
material with a half-life greater than 120 days and
at activity levels above certain thresholds.
However, these thresholds for sealed
byproduct material are such that many licenses
possessing Category 1 through 3 byproduct radioactive
material sealed sources are not required to provide
financial assurance for decommissioning.
Next slide, please. The Commission
approved the initiation of this rulemaking with Staff
Requirements Memorandum, or SECY-16-0115, entitled
Staff Requirements Rulemaking Plan on Financial
Assurance for Disposition of Category 1 and 2
Byproduct Material Radioactive Sealed Sources. And
this was dated on December 8, 2021.
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The next step in the NRC rulemaking
process is the development of a regulatory basis
document that serves as a precursor to a proposed
rule, which brings us to today's document that this
subcommittee has reviewed.
Next slide, please. This regulatory
basis document summarizes the current regulatory
framework, describes the regulatory issues and
evaluates alternatives for establishing financial
assurance requirements.
This regulatory basis also includes a
cost benefit analysis that considers impacts to the
NRC, to Agreement States, and to licensees for each
alternative.
This is a very extensive document. I
believe it was over 85 pages in length. Today, we
will be doing a brief review. And I would encourage
individuals to download and read the actual document.
Next slide, please. I would just point
out that licensees that are subject to 10 CFR Parts
50, 52, 72, 76 and 10 CFR Part 70, Subpart H, would
be exempt from this rulemaking for the facilities and
activities covered under those licenses.
These licensees are already required to
prepare a decommissioning plan and to demonstrate 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
sufficient financial assurance for decommissioning
those facilities, including the disposition of any
Category 1 through 3 byproduct radioactive material
sealed sources.
Next slide, please. In evaluating the
financial impact considerations, the following
entities were considered in these evaluations. the
cost to the NRC to implement. The cost to the NRC
operations staff. Cost to Agreement States to
implement proposed regulations. Cost to Agreement
States to operate the program. Cost for the industry
or licensees to implement the regulation. And the
cost that may be borne by other government
operations, such as the Department of Energy and the
National Nuclear Security Administration.
Next slide, please. So, in response to
SECY-16-0115, Rulemaking Plan on Financial Assurance
for the Decommissioning of Category 1, 2 Byproduct
Material Radioactive Sealed Sources, that was dated
December 8, 2021, the NRC staff has identified
several rulemaking alternatives.
We shall briefly discuss these
alternatives today. These can be referred to as
Alternatives 1, 2, 3, 4, 5, and there are three hybrid
approaches known as 6a, 6b and 6c.
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Next slide, please. Alternative 1 is
maintaining the status quo. This considers no
changes to the current process for assessing a
license= s decommissioning funding assurance
requirements. The status quo is the baseline from
which the staff evaluated the five other
alternatives.
Next slide, please. Alternative 2 is
financial assurance values that are based on device
type and disposition pathway.
Next slide, please. Some possible
advantages of this methodology include the following.
It leverages extensive information collected and
analyzed by the NRC staff to assign realistic
decommissioning for national assurance requirements
across a broad range of devices.
It links these DFA requirements to
radiological risk, as represented by the 10 CFR Part
37 and the IAEA Code of Conduct risk-based
categories.
It would be a simple implementation for
many licensees requiring sources or devices that are
assigned a fixed DFA financial amount.
It would provide a DFA estimate tailored
to the final disposition scenario for some devices, 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
for example the disposition through the DOE or the
NNSA or a commercial licensed low level disposal
facility.
It would reduce the risks associated with
under-or overpayment of DFA by tailoring these
required DFA amounts to estimated disposition costs.
It would more aggressively estimate DFA
requirements compared to Alternative 3, which assigns
a fixed DFA amount based on the source category alone.
It would impose less burden on licensees
and regulatory staff than Alternative 5, which
requires a DFP from each licensee.
Next slide, please. And there are some
potential disadvantages as well. It has greater
complexity than other alternatives and would result
in greater regulatory costs for the NRC, for
Agreement States and licensees compared to the staff= s
recommended alternative, which is Alternative 6b.
It would require additional education and
training efforts during the initial implementation
phase.
It includes fixed amounts and equations
used to calculate the DFA that would become outdated
over time and would require necessary periodic
updates.
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It bases fixed DFA amounts on averages
for groups of devices that may not accurately
represent the depositioning costs for all individual
cases.
Next slide, please. This brings us to
Alternative 3, Fixed Financial Assurance Based on
Source Category Alone.
Next slide, please. The advantages of
this methodology include the following. This would
tie the DFA requirements directly to the radiological
risk, as represented by the 10 CFR Part 35 and IAEA
Code of Conduct risk-based categories.
It would provide for simple
implementation. And licensees that elect to use the
fixed DFA amounts in Table 2 would result in less
regulatory burden for both licensees and regulatory
staff.
Next slide, please. And there are some
potential disadvantages as well. This methodology
does not link DFA requirements directly to the cost
of source depositioning. So, the specified DFA
amounts will significantly over-or underestimate
actual costs for many dispositioning scenarios.
It is expected that many licensees would
opt for a DFP in instances where the DFA amount 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 19
overestimated, increasing the burden on licensees as
well as regulators.
There is perhaps an increased regulatory
risk that the DFA amount will be inadequate to provide
for device disposition in cases where the fixed DFA
value is an underestimate.
This includes fixed DFA amounts that
would become outdated over time and will also require
periodic updating.
Next slide, please. Now Alternative 4,
Financial Assurance Determined by a Parametric
Formula. In my first read of the proposed regulatory
basis, I made a trip to the dictionary to look up the
word parametric. It is defined as of, or relating
to, a parameter, mathematical or statistical
variable.
Next slide, please. Advantages of this
methodology could include the following. This method
would tie the DFA requirements to radiological risk,
as represented by the 10 CFR Part 35 and the IAEA
Code of Conduct risk-based categories. It would
increase
parametric factors for sealed sources with increasing
radiological risk.
It has parametric factors based on key 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 20
variables that drive disposal costs. The methodology
is relatively simple to use and relies on source
activity and disposal options provided by the
applicant or licensee.
It has parametric factors based on recent
2023 disposal cost estimates that abet for a limited
group of Category 1 through 3 radioactive sealed
sources and devices.
The DFA requirements are adjustable over
time by adjusting their parametric factors, such as
the parameters that can be adjusted to increased
disposal costs based on changes in the consumer price
index or disposal rate schedules.
Next slide, please. Potential
disadvantages in Alternative 4 were evaluated. These
include the selection of parameter values that were
based on the limited data set, and the NRC staff was
unable to validate their parametric model for device
types that were dissimilar from those used to develop
this model. Consequently, their parametric formula
could significantly over-or underestimate
disposition costs for some types of devices.
It has greater complexity than other
alternatives, which would result in greater
regulatory costs for the NRC, for Agreement States 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
and licensees compared to the staff recommended
alternative, which is Alternative 6b.
It would require periodic review and
update of parametric factors by the regulator, such
as
labor, transportation and disposal costs that may
change frequently, which would result in an increased
burden on the licensees and regulators, as resources
would be needed to periodically review each license,
update the DFA calculation, and adjust the associated
DFA amounts.
It would require additional education and
training efforts during the initial implementation
period. This uses parameter values based on
commercial disposal estimates and limited actual
device disposal experience.
Next slide, please. Now Alternative 5,
Financial Assurance Based on a Decommissioning
Funding Plan. Next slide, please. The advantages
of this methodology could include the following.
This would provide an accurate assessment
of the DFA requirements for source and device
disposition that considers a license= s unique
circumstance.
It would be adaptable to the diverse 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 22
types of licensees that use for Category 1, 2 and 3
byproduct materials radioactive sealed sources.
This is adjustable over time and can be updated as
those licenses add or remove sources or devices from
their license or to account for changing disposition
costs.
It may provide a cost savings for some
licensees. For example, if a fixed DFA amount is
specified by the NRC, that represents an
overestimate.
Next slide, please. Potential
disadvantages were also evaluated. It would result
in the highest implementation costs for the NRC,
Agreement States and licensees compared to other
alternatives due to the need for internal preparation
or review and periodic updates to DFPs for all
affected licenses.
It imposes an unnecessary burden on
licensees and regulators if radioactive sealed
sources or device disposition costs can be adequately
estimated through another method, such as a fixed DFA
amount.
Next slide, please. Alternative 6a, 6b
and 6c are hybrid approaches that combine
Alternatives 2, 3 and 5.
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Next slide, please. Advantages of this
methodology include the following. For all
variations this would leverage extensive information
collected and analyzed by the NRC staff to assign
realistic fixed DFA amounts for many common
radioactive sealed sources and devices.
All variations link DFA requirements to
radiological risk, as represented by the 10 CFR Part
37 and IAEA Code of Conduct risk-based categories.
All variations provide a simple approach
using fixed DFA amounts for most affected licensees,
while requiring DFPs in more complex scenarios in
which disposition costs are expected to vary
significantly.
All variations result in lower costs for
licensees, the NRC, the Agreement States compared to
Alternatives 2 through 5.
Alternative 6c has the lowest cost
followed by 6b and Alternative 6a.
Alternative 6b is informed by
radiological risk by focusing on sources subject to
Part 37 physical protection requirements. And all
variations provide licensees that are eligible to use
a fixed DFA values with the flexibility to prepare a
DFP if they so choose.
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Next slide, please. Potential
disadvantages were also evaluated. This alternative
uses fixed DFA amounts that would become outdated
over time and requires periodic updates.
It does not include some features of
Alternative 2, such as a DFA estimates that are
tailored to the final disposition scenario for some
devices, for example disposal through the DOE or NNSA
or commercial low level waste disposal facilities.
There is a basis of fixed DFA amounts on
averages for groups of devices that may not
accurately represent the depositioning costs for all
individual cases.
Next slide, please. This regulatory
basis does not do the following. It does not provide
background information on policies, laws and
regulations that are related to the issue. It does
explain how a change in the regulations could resolve
the issue.
It identifies different approaches that
could address the regulatory issue and evaluates the
cost and benefits of the rulemaking and the
alternatives.
It provides scientific, policy, legal and
technical information used to support the evaluation.
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It explains limitations on the scope and
quality of the regulatory basis, such as known
uncertainties in the data or method of analysis and
discusses stakeholder interactions and views, to the
extent that they are known.
Next slide, please. Circling back to
something we discussed earlier, having a regulatory
basis that requires financial assurance for the
disposition of these Category 1-3 byproduct material
radioactive sealed sources would accomplish several
things.
It would help ensure that the affected
licensees are prepared for disposition of radioactive
sealed sources and will facilitate disposition of
unused sealed sources.
It would help ensure adequate financial
resources are available to support radioactive sealed
source disposal in the event of unforeseen
circumstances, such as licensee bankruptcy.
It would help ensure dispositioning costs
for Category 1 through 3 radioactive sealed sources
that are borne by those who receive the associated
economic benefit of source utilization, and it would
address recommendations on the issue provided by the
Government Accountability Office, the Interagency 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 26
Radiation Source Protection and Security Task Force
as well as other groups.
Next slide, please. In summary, the NRC
staff recommends Alternative 6b because the staff
determined that it provides the best balance of
managing these radiological, financial and regulatory
risks.
As described in Section 4.6, the staff
estimates that under Alternative 6b approximately 90
percent of licensees would be able to use a table of
fixed DFA amounts, which would limit the regulatory
burden for both licensees and the regulatory staff.
As explained in further detail in Section
4.6, the NRC staff developed these fixed DFA amounts
based on multiple sources of information to ensure
adequate funding would be available to disposition
sources without imposing an unnecessary burden on
licensees. Because staff sought to develop the best
estimates of the disposal costs, the staff expects
Alternative 6b should limit financial risks for both
regulators and licensees that could result from
significant variation between DFA amounts and actual
disposition costs.
Next slide, please. We have just
conducted a very brief review of an extensive 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 27
document. A document that is 85 pages in length that
is replete with financial data and other variables.
I would strongly encourage licensees and
professional societies and associations to read
through this document.
The subcommittee made several general
comments on the proposed regulatory basis document.
These include the general opinion that the regulatory
basis document was well-developed and effectively
outlined the regulatory alternatives.
The subcommittee supports the
recommendation that the Agency conduct a rulemaking
as described in Alternative 6b of this regulatory
basis document.
The subcommittee suggests that a
historical review of how financial assurance
requirements have changed prior to the current
regulations that are in place would be helpful.
And the subcommittee suggests that a
table of examples would be helpful to licensees as
well as regulators.
Specific comments include that a
definition should be provided for a self-shielded
irradiator.
Next slide, please. Members of 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 28
subcommittee feel that as representatives of the
medical community, we feel this regulatory basis will
assist licensees to plan ahead and to make full
weighted financial decisions as they contemplate
acquiring new technology and sealed sources.
All of us on the subcommittee thought of
our respective medical facilities where we work. We
spoke with our colleagues regarding this topic. We
all agree that our facilities had some initial work
prepared for disposition and cessation activities,
but
additional focus would be appropriate.
Next slide, please. Just a few notes on
the implementation time line and process.
The estimated compliance date for the
rule is 2028, by which time the NRC licensees must
comply.
Agreement States will have three years to
promulgate the rule. This assumes the implementation
will be spread evenly over the period of 2028 through
2030. These dates will be subject to the approval
of the proposed rule and final rule.
The public will have another opportunity
to comment after the proposed rule is issued.
Next slide, please. The following five 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 29
slides show all of the abbreviations and acronyms
used in this presentation as well as the draft
regulatory guide itself. Thank you very much for the
opportunity to present the subcommittee's report.
Dr. Jadvar, I will return it back to you.
CHAIRMAN JADVAR: Thank you very much,
Mr. Green for that very comprehensive report. I also
want to thank Ms. Allen, Mr. Ouhib and Drs. Harvey
and Wolkov for their participation and help with the
subcommittee and also Mr. Shaw as the NRC staff
liaison to this subcommittee.
So at this time, I want to ask the
subcommittee members if they have any questions or
comments regarding this report.
MR. EINBERG: Dr. Jadvar, before you get
into the discussion, I just wanted to note that Dr.
Fair and Ms. Rebecca Allen have joined the meeting,
and they are available for a conversation as well and
participation. Thank you.
DR. FAIR: Yes, thank you. I'm here.
CHAIRMAN JADVAR: Thank you. Thank you.
All right. So, again, any comments or questions from
the subcommittee members regarding this report?
Hearing None, I move to ask if there is any questions
or comments by the ACMUI members. I see Ms. Shober.
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MS. SHOBER: Yeah, I was wondering if,
Lillian, can you go back to the slide that had the
subcommittee recommendations on it?
VICE CHAIRMAN GREEN: I think that would
be Slide 34. No, it would be two more slides in your
deck, Lillian. Here we are.
MS. SHOBER: Thank you. My question for
the subcommittee is regarding GeneralComment Number
4, when you say a Table of Examples would be helpful,
what information were you wanting examples for --
examples of what? I guess I'm not sure what that
comment is referring to.
VICE CHAIRMAN GREEN: I think if we were
just to list some devices or some sealed sources,
industrial density gauge or a gamma knife, a make and
model, you know, just something that they can see and
say, yeah, that's similar to what we have and let
them easier work their way into the tables to look at
the information.
MS. SHOBER: So, I thought that
information was included already in Table 6. But if
you're looking for something else, that's great. I
just was trying to get clarity on what was missing.
VICE CHAIRMAN GREEN: Megan, I think it
might be possible to do an example of city-wide 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 31
hospital that has Device A, Device B and Device C, so
that this is their inventory of devices and sealed
sources. So, you know, with this scenario there'd
be assigned fee for A, assigned fee for B and assigned
fee for C whereas another example might show that it
would be more cost-effective to do a full blow
decommissioning funding plan as opposed to the line-
itemdevice costs. Does that make sense?
MS. SHOBER: Okay.
CHAIRMAN JADVAR: Okay. Thank you. So,
I see Dr. Einstein has his hand up.
DR. EINSTEIN: Yeah. Thank you, Mr.
Green for a really comprehensive overview of the
different alternatives and a pretty clear explanation
of the general approaches.
My understanding is that with a 7 percent
NPV the costs associated with Alternative 6b would be
$44 million. I can't say that I completely
understand where those costs are incurred and what
they effectively gain in comparison to other
approaches. Could you or someone else better or in
more detail explain the economics of this and the $44
million in particular?
VICE CHAIRMAN GREEN: I would have to
state that that's going beyond my depth. Do we have 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 32
any member of the NRC staff that can assist us here?
MR. SHAW: Hey, good afternoon. This is
Mr. Shaw with the NRC. I also cannot speak to the
total cost of 44 million. But we can speak to the
cost per device as outlined through the alternative
of 6b, and that would be the cost per device that
they have listed in the table there.
So, the reg basis, again, to summarize
for option 6b or Alternative 6b, provides a
decommissioning funding assurance cost per device.
And that device is theoretically per activity as
well.
So, there is that associated cost. We
could speak to that. But the total cap of 44 million,
I'm not able to speak to that.
DR. EINSTEIN: And not to be difficult,
but I think it sort of -- since we're making a
judgment, that goes on the -- I don't know, the
regulatory basis but also on the economics of this,
I think it would be helpful to better understand the
economic decision which we're voting on.
VICE CHAIRMAN GREEN: Dr. Einstein, I
think there are two things we need to clearly
distinguish. There will be a regulatory burden for
a licensee to fill out paperwork, for the NRC 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 33
review the paperwork and accept the paperwork. That
is a transactional cost. That's new if this
regulatory basis goes forward and the rulemaking goes
forward.
What is not changing is that licensees
need to get rid of sources they are no longer going
to use. And they are bearing those costs today. And
that's part of that $44 million that you're
describing is you still need to get rid of the source.
And so, this process facilitates their
being cognizant of the need to decommission,
cognizant of the need to dispose and plan for that
disposition costing as they begin to acquire the
device, not leaving it at the last -minute saying, oh,
my gosh. What do we do now?
So that big value, much of that, if not
most of that, is costs currently borne by licensees
to get rid of sealed sources today.
DR. TAPP: And that is helpful. I pulled
the regulatory analysis, and it does break it down.
It is a very long document, regulatory analysis, with
the total cost. You would have to go through to see
each line item andhave to read the whole report.
But there is a statement on Page 48 of
the regulatory analysis that says that three main 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
cost contributors to the 6b option are the industry
self-shift, which is what Mr. Green just identified.
It's 52.1 million. And this is industry as a whole,
not just medical, but everything the NRC regulates
and Agreement States.
Industry implementation, which is about
30 million, again and then industry observation about
5.6 million.
This is offset by some gains. You really
have to read the entire draft report to understand
how it all rolls together in a regulatory analysis
because there are gains and losses. But those are
the three main drivers.
Again, this is just not medical industry.
This is all industry. And I'm Dr. Tapp from the
medical team. We also -- I don't know if Ryan Whited,
who is the PM, I saw you come off mute for a second.
But you had something to add here as well.
MR. WHITED: Yes. Thank you so much.
So, my name is Ryan Whited. I am the NRC project
manager. I think you captured though the summary of
the components of cost really well.
I was looking at the document myself.
And there is a table, it's Table 8, in the document
that starts on Page 36 that breaks down the costs of 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
each of the alternatives that the staff evaluated.
And, again, you know, the main components
of those costs really are the costs for the
regulators, both NRC and the Agreement States to
promulgate the rule, build up the infrastructure and
then in the field, you know, as the rule's
implemented, do inspections and whatever field
implementation is needed for that.
So, you have those costs for the
regulators, both the NRC and Agreement States. And
then the industry costs. And the industry costs are
things like doing the initial analysis, taking
inventory of what they have and using the table or
developing a DFP to come up with the financial
assurance amount. Then they have to go out to a bank
or other financial institution to get an instrument.
And there is an initiation fee for that. And there
is also an annual cost associated with that.
And then there is a periodic re-looking
at the financial assurance. For example, if they
have a DFP, they've got to reassess that every three
years. So,there will be recurring costs associated
with that across industry.
So, you know, those are the major
components. That Table 8 in the document does break 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
them down on a pretty granular basis. And you can
see, you know, for example, for 6b, that 44 million
figure is the bottom line in Table 8.
DR. EINSTEIN: Yeah. That's where I got
that from.
MR. WHITED: Yes. Now I believe we also
have Greg Trussell on the call. And Greg is a cost
analyst by trade. So, if there are more detailed
questions, Greg might be able to help with that. But
at a high level, I think we kind of covered the major
components of that $44 million cost.
DR. EINSTEIN: So, the NRC effectively
would be paying $1.8 million for the selection of
Option 6b, and the Agreement States would be paying
$6.7 million, and industry would bear the brunt of
the costs?
MR. WHITED: I'm looking at the table.
Yeah, so the reason for B
DR. EINSTEIN: And then the DOE would
benefit a lot, if I'm understanding correctly.
MR. WHITED: So, a couple things. So,
you know, the reason the Agreement States total is
higher is because the Agreement States have a lot
more of the licensees now that there are so many more
Agreement States compared to the NRC licensees.
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The reason DOE benefits, and that's for
all the alternatives, is, you know, they have been
operating a couple programs designed to recover and
disposition sealed sources.
One is their offsite source recovery
program, which handles the high, kind of Cat 1 and 2
high activity sources. And they also have what's
called the SCATR program, which they operate through
CRCPD to handle the lower activity sources.
You know, there is a discussion in the
paper about if we implement these new requirements
and we have licensees who are now providing financial
assurance and considering the full life cycle costs
of these sources, they should rely less on those DOE
programs and that would give DOE the opportunity to
reduce the scope of those programs. And so that's
where you see that benefit to DOE from implementing
this rulemaking.
DR. EINSTEIN: Okay.
CHAIRMAN JADVAR: Thank you all for this
very nice discussion. I think Melissa Martin has her
hand up if Im,correct?
MS. MARTIN: Thank you, Dr. Jadvar. The
question that has come forward, we have been talking
about very high-level costs, and high-level 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
discussions. Is there a presentation or a possible
breakdown as an example for -- I'll bring it down
very simply, a medical facility that is looking to
obtain an HDR unit. They've never had one.
Is there a proposal somewhere that says
what it would actually cost them in these new fees
compared to what it would cost them what would they
be paying currently under the current set up, what it
would cost under the new fees because this will all
factor in to medical facilities that are making
decisions as to whether to add these brachytherapy
sources to their facilities or not.
And I realize this is a granular
question, but I think somewhere we need that actual
breakdown to real life examples because this is what
the hospitals need to know.
VICE CHAIRMAN GREEN: Melissa, I think
that's why we, as a subcommittee, suggested that
there be some examples, such as you are describing,
provided.
It would be hard to say what the costs
are going to be currently borne by the licensee.
They are going to acquire that device and may not be
looking forward to 15 years from now when it needs to
get retired.
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And this whole process will require them
to focus, not just on the new thing under the
Christmas tree, but 15 years from now when it's lived
its life, how to get rid of it and what the cost to
be borne.
So, I think most of the costs are going
to be borne already, but this just focuses their
attention on the end-of-life cycle and not the new
sparkly thing.
MS. MARTIN: Thank you.
CHAIRMAN JADVAR: Thank you. And I
think Ms.Shober has another question.
MS. SHOBER: Yes. Thank you. Megan
Shober. I have just a comment on Melissa's question.
To speak to the HDR situation specifically, they
would not be subject to this regulatory change
because iridium-192, the half-life is less than 120
days. And that's outside the scope of financial
assurance the way the regulations are currently and
with the proposed changes. So, it would not impact
HDR facilities.
MS. MARTIN: You just made my day. Thank
you very much.
CHAIRMAN JADVAR: Okay. Thank you,
Megan. Okay. Any other comments or questions by 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
the ACMUI members? Okay. Moving on to any
additional comments or questions by the NRC staff?
Hearing None, so I guess at this time I'm going to
ask the help of Ms. Sarah Lopas to navigate us through
the potential questions from the remote attendees.
MS. LOPAS: Sure. So, at this point in
time, I would ask people that are joining us via Teams
to use the raise hand function. So, you just need
to click once on the little raise hand function and
that will bring you to the top of the list so I can
see that, you know, you will be able to unmute your
microphone.
And if you have joined us on a cell phone,
all you need to do is press star 5 on your cell phone
and that will raise your hand, that will show me. I
see Dr. Wallner has his hand raised. Go ahead, Dr.
Wallner, you can unmute yourself and start by
introducing yourself, please.
And you will have to unmute yourself.
So, click on the microphone, Dr. Wallner. And I hope
that will work for you. All right. Dr. Wallner, I
see you that you should have access to your
microphone. So, try it one more time. I am assuming
there is some sort of issue going on here. But you
do have to click once on the microphone icon to unmute 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 41
yourself. I cannot unmute you.
Let me try one more thing for you, Dr.
Wallner. I am going to try to switch your status.
I am going to send you back as an attendee and then
re-promote you, and we'll see if that works. Okay.
Now I'm going to scroll down and find you.
Hopefully, I canfind you.
Hang on a second. Okay. Now try to go
ahead and enable your microphone or unmute yourself.
See if that works. Dr. Wallner? Because I am seeing
you there, and I am seeing that your mic is enabled.
Let me try this one more time.
All right. I just disabled and then
enabled your microphone again. So, see if you're
able to unmute yourself Dr. Wallner.
Okay. I apologize that this is not
working. Dr. Wallner, the last thing I will ask you
to do is to maybe exit out of the Teams meeting and
then rejoin if you want to give that a try and then
we'll try you again if that's okay. But we have time
to wait for you.
All right. For other folks, anybody else
want to give it a whirl and see if their microphones
work? Just use the raise hand. Press once on the
raise hand button. If you're on the phone, you press 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
star 5.
And I'm not seeing any other raised
hands, but we will wait for Dr. Wallner to rejoin us.
Okay. Josh, go ahead, please.
MR. MAILMAN: Yeah, it's less of a
comment, but more of a fill time while we're waiting.
So, first of all, thank you for this presentation,
Richard. It's a pretty complex topic, and I really
enjoyed the overview.
I am especially thinking forward to not
just find the bright shiny equipment now but also
figuring out how we properly dispose of them or safely
dispose of them 15, 16 years from now because it's
just too easy to buy things now and not think of what
we're going to do with it later.
So, I really appreciate -- I know this
was a really complex topic. And thank you for the
overview that you provided.
MS. LOPAS: All right. And I am not
seeing that Dr. Wallner has rejoined us yet so.
Let's see.
CHAIRMAN JADVAR: Maybe another time
filler while we wait for Dr. Wallner.
MS. LOPAS: Yeah.
CHAIRMAN JADVAR: Richard, can you 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 43
very briefly mention the major differences between
6a, 6b and 6c. Because in the presentation, 6b was
presented very nicely with advantages and
disadvantages, but 6a and 6c were not -- I don't think
they had any slides.
VICE CHAIRMAN GREEN: Let me see if I can
get to that.
CHAIRMAN JADVAR: By the way, this was
Hossein Jadvar asking.
VICE CHAIRMAN GREEN: Let's see if I can
find that first. Okay. That's going to be on Page
20 of the document. Let's slide down to 20 really
quick.
DR. FOLKERT: And this is Mike Folkert.
It looks like in the meantime, Dr. Wallner is on the
list now. I see him -- Paul Wallner under five
further down.
MS. MARTIN: That's not Dr. Wolkov.
VICE CHAIRMAN GREEN: So, Dr. Jadvar, the
alternatives 6a and 6b and 6c are hybrid approaches
that combines 2, 3 and 5. So there's a fixed DFA
amount that are provided for many common sources
while other instances that will force the licensee to
prepare a DFP. So 6a applies to all licenses
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radioactive sealed sources.
6b applies to only Category 1-3 licenses
thatare subject to physical protection requirements
of 10 CFR Part 35. And 6c applies to licenses
possessing only Category 1 or 2 byproduct material
radioactive sealed sources that are subject to the
physical protection requirements. So,there are the
nuances between the a, b and c.
CHAIRMAN JADVAR: Perfect. Thank you so
much.
MS. LOPAS: Okay. Dr. Wallner, let's
try your microphone again. My fingers are crossed.
All right. Let's see. Let me try one more time.
Let me trythat trick of switching your status. And
Dr. Wallner, if you don't mind raising your hand for
me again so that I can easily identify you. There
you go. Great. I like that you can at least hear
me.
All right. So, I do see that your
microphone is enabled, but I'm just not sure why you
are unable to unmute yourself.
So let me pull up the meeting information
quickly. Dr. Wallner worst case scenario, would you
be amenable to calling in on the cell phone if you're
-- if you'd like to do that. If you have a pen 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
available, I can give you the phone number right now.
It's also available on the meeting notice. But the
phone number is 1-301-576-2978. That's 301-576-2978
and then you'll have to enter a conference ID, which
is 901692104#, 901692104#.
And so, I suggest maybe trying to call in
on your cell phone potentially. And we will see if
that works. Lillian, maybe it would be helpful just
to flash to the very first slide, the beginning slide,
where it does list the phone number just in case
anybody elseis having any issues with microphones.
And in the meantime, if anybody else
would like to make a comment, just try to raise your
hand, hand raise icon, hit that once.
All right. I think I may --Dr. Wallner
did you just pop on? Are you 23 B
DR. WALLNER: I did. Thank you all for
your patience.
MS. LOPAS: Finally. Yeah.
DR. WALLNER: I must apologize. There
is something wrong at one of our ends, either mine or
yours.
MS. LOPAS: Yeah.
DR. WALLNER: I just have a very brief
comment. It's Paul Wallner, W-A-L-L-N-E-R, 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
representing the American College of Radiology. I
want to commend the staff and the subcommittee for
the work. I think it's a Herculean effort.
If there is final rulemaking that does
relate to Alternative 6b, which I think is okay, I
think there should be built into the rulemaking
though a fixed interval for review of the tables, the
financial data on the tables. And I commend the fact
that perhaps 90 percent of licensees could use those
tables.
But there should be a fixed period for
review. And there should be some method by which an
interim analysis or interim appeal could be initiated
if there is some significant change in cost of
disposal.
VICE CHAIRMAN GREEN: I think those were
all very good points. Thank you for bringing them
forward. I think those are things that I think the
public should formally comment on.
I don't think we'll revise the ACMUI
subcommittee report, but I think those are very valid
points and should be brought out and clarified.
Thank you.
DR. WALLNER: Thank you.
MS. LOPAS: Okay. I'm going to do a last 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 47
call for any public comments with the hand raise icon
or if you're on the phone, you press star 5 to raise
your hand.
And I'm not seeing any, so ACMUI, I will
hand it back to you all.
CHAIRMAN JADVAR: Thank you, Sarah, very
much. So, I think at this time, the last piece is
to finalize the subcommittee's report. And I want
to ask for a motion for acceptance of the
subcommittee's report.
DR. HARVEY: This is Dr. Richard Harvey.
I would be happy to make that motion.
CHAIRMAN JADVAR: Thank you, Richard.
Go ahead.
MS. MARTIN: This is Melissa Martin. I
second that motion.
CHAIRMAN JADVAR: Okay. Wonderful. All
in favor say aye.
(Chorus of ayes.)
CHAIRMAN JADVAR: Thank you. Is there
any opposed?
(No audible response.)
CHAIRMAN JADVAR: Any abstention or
recusals?
And finally, is there any dissenting or 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
deferring views or comments? Hearing None, the
subcommittee report is finalized and approved by the
I want to again thank Richard Green and
all the other subcommittee members and the NRC staff
and finally also Mr. Einberg for today's meeting.
And unless there is anything that Mr.
Einberg or anybody else wants to say, we can go ahead
and adjourn the meeting.
MR. EINBERG: Yeah, you know, thank you,
Dr. Jadvar. Yeah, no, I would also like to echo your
sentiments and thank the subcommittee, the ACMUI
staff members, the NRC staff and then also Sarah Lopas
for facilitating this and so excellent discussion,
and the members of the public and Dr. Wallner for
your comments.
So, thank you so much. And I think we
can go ahead and adjourn the meeting.
CHAIRMAN JADVAR: Thank you so much.
Meeting is adjourned. Bye-bye.
(Whereupon the above-entitled matter
went off the record at 3:10 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 49
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