[Federal Register Volume 89, Number 123 (Wednesday, June 26, 2024)]
[Notices]
[Pages 53455-53461]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13977]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-00001; License No. 24-04206-01; EA-21-055; NRC-2024-
0109]
In the Matter of Curium US LLC; Confirmatory Order Modifying
License
AGENCY: Nuclear Regulatory Commission.
ACTION: Notice; issuance.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing a
Confirmatory Order to Curium US LLC to memorialize the agreement
reached during an alternative dispute resolution mediation session held
on March 5-6, 2024. The Confirmatory Order contains commitments made to
resolve 10 apparent violations of NRC requirements relating to an
August 2019 contamination incident involving molybdenum-99 and
technetium-99m. The commitments include actions by Curium US LLC to
enhance its operating procedures, corrective action program, employee
training, and safety culture. The Confirmatory Order is effective upon
issuance.
DATES: The Confirmatory Order was issued on June 13, 2024.
ADDRESSES: Please refer to Docket ID NRC-2024-0109 when contacting the
NRC about the availability of information regarding this document. You
may obtain publicly available information related to this document
using any of the following methods:
Federal Rulemaking website: Go to https://www.regulations.gov and search for Docket ID NRC-2024-0109. Address
questions about Docket IDs in Regulations.gov to Stacy Schumann;
telephone: 301-415-0624; email: [email protected]. For technical
questions, contact the individual listed in the ``FOR FURTHER
INFORMATION CONTACT'' section of this document.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly available documents online in the
ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``Begin Web-based ADAMS
Search.'' For problems with ADAMS, please contact the NRC's Public
Document Room (PDR) reference staff at 1-800-397-4209, at 301-415-4737,
or by email to [email protected]. The NRC Reactive Inspection Report
No. 03000001/2019003(DRSS)--Curium US LLC. is available in ADAMS under
Accession No. ML24005A060.
NRC's PDR: The PDR, where you may examine and order copies
of publicly available documents, is open by appointment. To make an
appointment to visit the PDR, please send an email to
[email protected] or call 1-800-397-4209 or 301-415-4737, between 8
a.m. and 4 p.m. eastern time (ET), Monday through Friday, except
Federal holidays.
FOR FURTHER INFORMATION CONTACT: Diana Betancourt-Roldan, Region III,
U.S. Nuclear Regulatory Commission, telephone: 630-810-4373; email:
[email protected].
SUPPLEMENTARY INFORMATION: The text of the order is attached.
Dated: June 20, 2024.
For the Nuclear Regulatory Commission.
John B. Giessner,
Regional Administrator, Region III.
Attachment--Confirmatory Order
UNITED STATES OF AMERICA
NUCLEAR REGULATORY COMMISSION
In the Matter of: Curium US LLC, Docket No. 030-00001, License No. 24-
04206-01, EA-21-055
Confirmatory Order Modifying License (Effective Upon Issuance)
I
Curium US LLC holds Materials License No. 24-04206-01 issued on May
18, 2023 (Amendment No. 105), by the U.S. Nuclear Regulatory Commission
(NRC or Commission) pursuant to Part 30 of Title 10 of the Code of
Federal Regulations (10 CFR). At the time of the events that led to the
NRC's October 2019 reactive inspection, Curium conducted operations
under Amendment 99 of License No. 24-04206-01, which was issued on July
2, 2019. The license authorizes the use of byproduct material, as
described in the application dated December 22, 2011, in accordance
with conditions specified in the license.
This Confirmatory Order is the result of an agreement reached
during an Alternative Dispute Resolution (ADR) mediation session
conducted on March 5-6, 2024, in Lisle, Illinois.
II
On October 29-30, 2019, the NRC conducted a reactive inspection
with continued in-office review through December 21, 2023. On January
11, 2024, the NRC issued Inspection Report 03000001/2019003 to Curium
US LLC which documented the identification of 10 apparent violations
that occurred at the Maryland Heights, Missouri facility as the result
of a contamination event on August 19, 2019. The apparent violations
were being considered for escalated enforcement action in accordance
with the NRC Enforcement Policy. The apparent violations involved the
failure to: (1) report, within 24 hours of discovery, an event that
involved loss of control of licensed material that caused the release
of radioactive material, so that, had an individual been present for 24
hours in the area, the individual could have received an intake in
excess of one occupational annual limit on intake, as required by 10
CFR 20.2202(b)(2); (2) notify the NRC within 24 hours after the
discovery of an unplanned contamination event as required by 10 CFR
30.50(b)(1); (3) assess dose to determine the compliance with
occupational dose equivalent limits by taking suitable and timely
measurements of concentrations of radioactive materials in air in the
work area, quantities of radionuclides in the body, or quantities of
radionuclides
[[Page 53456]]
excreted from the body as required by 10 CFR 20.1204(a); (4) conduct an
adequate survey to ensure compliance with limits on licensed material
released into sanitary sewerage, as required by 10 CFR 20.1501 and 10
CFR 20.2003(a)(2); (5) furnish dose information to an individual as
required by 10 CFR 19.13(b)(1); (6) maintain records of surveys as
required by 10 CFR 20.2103(a); (7) provide information to the
Commission that is complete and accurate in all material respects as
required by 10 CFR 30.9; (8) maintain Curium's Corrective Action
Program as required by License Condition 18; (9) comply with the terms
and conditions of the Certificate of Compliance (CoC) No. 9320 as
required by 10 CFR 71.71(c)(2); and (10) implement Curium's standard
operating procedure (SOP) for performing personal contamination surveys
as required by License Condition 21.
By letter dated January 11, 2024, the NRC provided Curium with a
reactive inspection report with the opportunity to: (1) request a
Predecisional Enforcement Conference (PEC); or (2) request ADR.
In response to the NRC's offer, Curium requested the use of the
NRC's ADR process to resolve differences it had with the NRC. On March
5-6, 2024, the NRC and Curium met in an ADR session mediated by a
professional mediator, arranged through Cornell University's Institute
on Conflict Resolution. The ADR process is one in which a neutral
mediator, with no decision-making authority, assists the parties in
reaching an agreement on resolving any differences regarding the
dispute. The Confirmatory Order is issued pursuant to the agreement
reached during the ADR process.
III
During the ADR session, Curium and the NRC reached a preliminary
settlement in an Agreement in Principle, which is reproduced in full
below:
Pursuant to the Nuclear Regulatory Commission Office of
Enforcement's Enforcement Alternative Dispute Resolution (ADR) Program,
the following are the terms and conditions agreed upon in principle by
Curium US LLC (Curium) and the Nuclear Regulatory Commission (NRC)
relating to the apparent violations identified in the inspection report
No. 03000001/2019003 (DRSS) issued by the NRC to Curium on January 11,
2024.
The NRC seeks lasting and effective corrective actions to preclude
any additional contamination incidents similar to the incident that
occurred at Curium's Maryland Heights, Missouri, manufacturing facility
on August 19, 2019.
Therefore, the parties agree to the following terms and conditions:
I. Hot Cell Procedures
Curium will revise its relevant Standard Operating Procedures
(SOPs), including the SOP for hot cell operations, to ensure that
payload internals, including the secondary container (R2 sleeve), are
removed from shipping casks before the casks are removed from the hot
cell except as provided in paragraph 3 of this section of the
Agreement.
1. Curium will use a tool that Curium has developed to remove
detached R2 sleeves from casks while they are in the hot cell.
2. In the event that a R2 sleeve becomes detached, Curium will
include in the revised SOP for hot cell operations a requirement that a
second person be present to observe and assist in removal of the R2
sleeve in the hot cell.
3. If Curium is unable to remove a detached R2 sleeve from a cask:
a. Curium will reseal the cask in the hot cell and place the cask
in storage in Building 650;
b. The cask containing the R2 sleeve will be labeled with prominent
identification that the cask contains an R2 sleeve prior to removing
the cask from Building 650;
c. Once an external reading on contact of the cask is below 5 mR
per hour, the cask may be removed from Building 650 and moved to
Building 500;
d. Once an external reading on contact of the cask is below 3 mR
per hour, the R2 sleeve may be removed provided that:
i. A Health Physics support employee is present; and
ii. Air sampling for airborne radioactivity is performed for the
duration of the cleaning of the cask;
e. Each occurrence shall be documented in the Radiation Safety
Corrective Action Program.
4. Within 120 days of the effective date of the Confirmatory Order
(CO), Curium will submit the revised procedures to the NRC for review
and comment to verify that the revised procedures meet the requirements
of Section I of this Agreement.
5. Within 120 days after receiving the results of the NRC's review,
Curium will implement the revised SOPs and provide initial training to
all V4 technicians and their supervisors.
6. Curium will add to their procedures a requirement to provide
training to all new V4 technicians and all new V4 technician
supervisors on these revised SOPs.
7. For a period of 5 years after the effective date of the CO,
prior implementing any subsequent revisions to these SOPs with respect
to the requirements of Section I of this Agreement, Curium will submit
the proposed revisions to the NRC for review to verify that the revised
procedures meet Section I requirements.
II. Safety Culture
The NRC acknowledges that Curium has taken the following actions
with respect to safety culture: (a) 2022 Safety Culture Assessment; (b)
Curium's CEO provided a site wide safety culture statement to all
employees in North America; (c) conducted initial Safety Leadership
Training; and (d) developed a safety culture plan (Project VPP-Safety
Culture).
1. Within 270 days of the effective date of the CO, Curium will
contract with the same vendor that conducted the 2022 Safety Culture
Assessment to perform a follow-up fleet wide safety culture assessment.
a. Curium will evaluate the results of the assessment, including
any recommendations, and take appropriate actions.
b. Curium will make the assessment available to the NRC upon
request.
2. Between 12 and 18 months after the completion of the follow-up
fleet wide safety culture assessment, Curium will conduct a subsequent
assessment of the fleet-wide safety culture using the same vendor.
a. Curium will evaluate the results of the assessment, including
any recommendations, and take appropriate actions.
b. Curium will make the assessment available to the NRC upon
request.
3. Within 180 days of the effective date of the CO, Curium will
conduct Safety Leadership Training for their Executive Leadership Team
(ELT) and the People Leaders in Operations, R&D, and Quality groups
(hereinafter referred to as ``SLT'') with at least 90 percent
participation for each of the ELT and of the SLT.
III. Corrective Action Program for Radiation Safety
Curium will contract with an independent external reviewer to
conduct an independent assessment of the Corrective Action Program for
radiation safety (CAP) governed by SOP 33-201 and prepare a report of
the findings.
1. Prior to entering into a contract with the independent reviewer,
Curium will provide the reviewer's name and qualifications to the NRC
for review to verify independence and qualification.
[[Page 53457]]
2. The assessment will look backwards at least 4 years from the
effective date of the CO and will evaluate, at a minimum, the following
items: (a) Curium's ability to identify and enter items into the CAP;
(b) Curium's ability to evaluate and prioritize issues in the CAP; and
(c) Curium's ability to track and implement timely corrective actions.
3. If issues are identified in the assessment that indicate the CAP
is not functioning properly, the independent reviewer will make
specific recommendations in the report on how to address and correct
those issues. Curium will evaluate the results of the assessment,
including any recommendations, and take appropriate actions if
necessary.
4. The CAP assessment and final report will be completed within one
year of the effective date of the CO. Curium will make the final CAP
assessment report available to the NRC upon request.
IV. Event Reporting
Within 180 days of the effective date of the CO, Curium will
develop and implement a procedure for reporting events to the NRC.
1. The procedure will include instructions for evaluating an event
to determine whether it meets NRC reportability requirements in 10 CFR
part 20 and 10 CFR part 30 and for documenting the results of the
evaluation. This procedure will ensure that at least two qualified
individuals are involved in the evaluation. The instructions will
specifically address how to evaluate whether each criterion in 10 CFR
20.2202 and 30.50 has been met.
2. Within 120 days of implementing the procedure, Curium will train
all health physics personnel and any other personnel involved in making
reportability determinations on the procedure.
3. Curium will train all new health physics personnel and any other
new personnel involved in making reportability determinations on the
procedure.
4. Curium will make the procedure available to the NRC upon
request.
V. Training
Curium will develop and implement live training as specified below:
1. Within 180 days of the effective date of CO, Curium will insert
a brief case study about the 2019 contamination event and lessons
learned into the annual radiation safety training provided to all
radiation workers.
2. Within 180 days of the effective date of the CO, Curium will
develop an in-depth case study (e.g. 45-60 minutes) about the 2019
contamination event and lessons learned and provide that training to
the Curium SLT.
3. Within 180 days of the effective date of the CO, Curium will
develop an in-depth case study (e.g. 45-60 minutes) about the 2019
contamination event and lessons learned and provide that training to
the Curium ELT.
4. Within 180 days of the effective date of the CO, all health
physics personnel will receive training on managing contamination
events and contaminated personnel. Topics for this training will
include, at a minimum, the following: conducting surveys and air
sampling for contamination events; maintain records of surveys;
estimating of extent of contamination; internal dosimetry and dose
assessment, including bioassays; decontamination/treatment of
contaminated persons and items; relevant licensee procedures; and
relevant NRC regulations and guidance. This training will be provided
on a recurring basis. All new health physics personnel will receive the
training during qualification.
5. Curium will ensure that the annual radiation safety training for
radiation workers will include training on what to do if the worker
becomes contaminated.
6. The Health Physics department will send out periodic safety
messages, at least quarterly, to the facility regarding current
radiation safety topics for two years from effective date of the CO.
VI. Internal Dose Assessment and Updated Dose Records
Within 180 days of the effective date of the CO, Curium will
contract with an independent consultant to complete an internal dose
assessment for the individual who was involved in the August 19, 2019,
contamination event (the ``affected individual'').
1. Prior to entering into a contract with an independent
consultant, Curium will provide the consultant's qualifications to the
NRC for review to verify independence and qualifications.
2. Curium will provide the consultant with a complete copy of
Investigation Report 19-0088, including attachments, for use in
conducting the assessment.
3. The independent consultant will provide Curium with a written
report that includes the estimated internal dose to the affected
individual and a description of the methods and assumptions used to
perform the dose calculations. Curium will make the written report
available to the NRC upon request.
4. Upon completion of the internal dose assessment, Curium's
Radiation Safety Officer (RSO) will review the written report and
decide whether the estimated dose is reasonable. The RSO will then
present the results of the assessment to the Maryland Heights
facility's Radiation Safety Committee (RSC).
5. The decision and endorsement will be documented in the minutes
of the RSC. If the RSC or the RSO disagree with the independent dose
assessment, the basis for the disagreement will be explained in the
minutes of the RSC. Curium will make the minutes of the RSC available
to the NRC upon request.
6. Curium will provide an updated NRC Form 5 for the affected
individual as appropriate.
VII. Sharing Operating Experience
Within one year of the effective date of the CO, Curium will offer
to make a presentation on the 2019 contamination event and management
of the response to one national organization, including local chapters,
whose membership comprises health physics and radiation professionals
(e.g., the Health Physics Society, Society of Nuclear Medicine, or the
American Nuclear Society).
1. If the presentation is accepted, Curium will inform the NRC at
least a month in advance of the date and location.
2. Curium will provide the slides for the presentation to the NRC
upon request.
VIII. Building 500 Evaluation
Within 180 days of the effective date of the CO, Curium will
evaluate the Building 500 facilities at Maryland Heights, Missouri,
based on the assessment that the facilities in Building 500 are not
appropriate for cask cleaning activities other than wipe downs, as
stated on pages 16 and 17 of Curium's Investigation of Incident No. 19-
0088.
1. Curium will document the assessment and develop and implement
appropriate corrective actions, if necessary, to provide sufficient
radiation protection measures for the cask cleaning activities
conducted in Building 500.
IX. Sanitary Sewage
Within 180 days of the effective date of the CO, Curium will revise
the SOP for responding to a contamination event (33-141) to establish a
process for assessing any discharge of radioactive material into the
public sanitary sewer system to ensure compliance with regulatory
requirements. The revised procedure will require that the results of
[[Page 53458]]
this assessment will be documented. Curium will make the revised
procedure available to the NRC upon request.
X. Administrative
1. In exchange for the commitments and corrective actions agreed to
by Curium;
a. The NRC agrees not to pursue any further enforcement action in
connection with the August 19, 2019, contamination event as described
in NRC's January 11, 2024, reactive inspection report to Curium US LLC.
b. The NRC agrees to exercise discretion to refrain from issuing a
Notice of Violation or proposed civil penalty for any violations
arising from the results of the independent internal dose evaluation
that Curium has agreed to perform.
c. The NRC agrees not to issue a civil penalty for apparent
violations identified in the NRC's January 11, 2024, reactive
inspection report to Curium US LLC.
2. This agreement is binding upon all successors and assigns of
Curium.
The NRC acknowledges that Curium has completed the following
corrective actions: (1) conducting a fleet-wide safety culture
assessment in 2022, (2) providing a site-wide safety culture statement
from Curium's CEO to all employees in North America, (3) conducting
initial ``Safety Leadership Training,'' (4) developing a safety culture
plan (Project VPP-Safety Culture), (5) updating the shallow dose
assessment for the contaminated individual, and (6) informing the
individual of the updated dose assessment results. Based on these
completed actions, and the commitments described in Section V below,
the NRC agrees not to pursue any further enforcement action in
connection with the August 19, 2019, contamination event; not to issue
a civil penalty for the apparent violations identified in NRC
Inspection Report 03000001/2019003; and to exercise discretion to
refrain from issuing a Notice of Violation or civil penalty for any
violations arising from the results of the independent internal dose
evaluation that Curium will perform.
On May 31, 2024, Curium consented to issuing the Confirmatory Order
with the commitments as described in Section V below. Curium further
agreed that this Confirmatory Order is to be effective upon issuance,
that the agreement memorialized in this Confirmatory Order settles the
matter between the parties, and that it has waived its right to a
hearing.
IV
I find that Curium's completed actions, as described in Section III
above, combined with the commitments as set forth in Section V are
acceptable and necessary, and conclude that with these commitments the
public health and safety are reasonably assured. In view of the
foregoing, I have determined that public health and safety require that
Curium's commitments be confirmed by this Confirmatory Order. Based on
the above and Curium's consent, this Confirmatory Order is effective
upon issuance.
By no later than thirty (30) days after the completion of the
commitments specified in Section V, Curium is required to notify the
NRC in writing and summarize its actions.
V
Accordingly, pursuant to Sections 81, 161b, 161i, 161o, 182, and
187 of the Atomic Energy Act of 1954, as amended, and the Commission's
regulations in 10 CFR 2.202 and 10 CFR parts 30 and 35, it is hereby
ordered, effective upon issuance, that license No. 24-04206-01 is
modified as follows:
A. Hot Cell Procedures
1. Curium will revise its relevant Standard Operating Procedures
(SOPs), including the SOP for hot cell operations, to ensure that
payload internals, including the secondary container (R2 sleeve), are
removed from shipping casks before the casks are removed from the hot
cell, except as provided in paragraph V.A.1.c below. The revisions will
address the following items:
a. A tool developed by Curium will be used to remove detached R2
sleeves from casks while they are in the hot cell.
b. In the event that a R2 sleeve becomes detached, a second person
will be present to observe and assist in removal of the R2 sleeve in
the hot cell.
c. If Curium is unable to remove a detached R2 sleeve from a cask
in the hot cell:
i. Curium will reseal the cask in the hot cell and place the cask
in storage in Building 650;
ii. The cask containing the R2 sleeve will be labeled with
prominent identification that the cask contains an R2 sleeve prior to
removing the cask from Building 650;
iii. Once an external reading on contact of the cask is below 5 mR
per hour, the cask may be removed from Building 650 and moved to
Building 500;
iv. Once an external reading on contact of the cask is below 3 mR
per hour, the R2 sleeve may be removed in Building 500 provided that a
Health Physics support employee is present and air sampling for
airborne radioactivity is performed for the duration of cask cleaning.
v. Each occurrence shall be documented in the Radiation Safety
Corrective Action Program.
2. Within 120 days of the effective date of the Confirmatory Order
(CO), Curium will submit the revised SOPs to the NRC for review and
comment to verify that the revised SOPs meet the requirements of
paragraph V.A.1.
3. Within 120 days after receiving the results of the NRC's review,
Curium will implement the revised SOPs and provide initial training to
all manufacturing technicians assigned to work V4 hot cells and their
supervisors.
4. Curium will add to their procedures a requirement to provide
training to all new manufacturing technicians assigned to work V4 hot
cells and supervisors of these manufacturing technicians on these
revised SOPs.
5. For a period of 5 years after the effective date of the CO,
prior to implementing any subsequent revisions to these SOPs with
respect to the requirements of paragraph V.A.1, Curium will submit the
proposed revisions to the NRC for review to verify that the revisions
meet the requirements of paragraph V.A.1.
B. Safety Culture
1. Within 270 days of the effective date of the CO, Curium will
contract with the same vendor that conducted the 2022 Safety Culture
Assessment, or a vendor with similar qualifications, to perform a
follow-up fleet-wide safety culture assessment.
a. Curium will evaluate the results of the assessment, including
any recommendations, take appropriate actions, and document any actions
taken.
b. Curium will make the assessment available to the NRC upon
request.
2. Between 12 and 18 months after the completion of the follow-up
fleet wide safety culture assessment, Curium will conduct a subsequent
assessment of the fleet-wide safety culture using the same vendor or a
vendor with similar qualifications.
a. Curium will evaluate the results of the assessment, including
any recommendations, take appropriate actions, and document any actions
taken.
b. Curium will make the assessment available to the NRC upon
request.
3. Within 180 days of the effective date of the CO, Curium will
conduct the
[[Page 53459]]
Aubrey Daniels International ``Safety Leadership Training'' for their
Executive Leadership Team (ELT) and the People Leaders in Operations,
R&D, and Quality groups (hereinafter referred to as ``SLT'') with at
least 90 percent participation for each of the ELT and of the SLT.
C. Corrective Action Program for Radiation Safety
1. Curium will contract with an independent external reviewer to
conduct an independent assessment of the Corrective Action Program
(CAP) for radiation safety governed by SOP 33-201 and prepare a written
report of the findings. Prior to entering into a contract with the
independent reviewer, Curium will provide the reviewer's name and
qualifications to the NRC for review to verify the reviewer's
independence and qualifications.
2. The assessment will look backwards at least 4 years from the
effective date of the CO and will evaluate, at a minimum, the following
items: (a) Curium's ability to identify and enter items into the CAP;
(b) Curium's ability to evaluate and prioritize issues in the CAP; and
(c) Curium's ability to track and implement timely corrective actions.
3. If issues are identified in the assessment that indicate the CAP
is not functioning properly, the independent reviewer will make
specific recommendations in the report on how to address and correct
those issues. Curium will evaluate the results of the assessment,
including any recommendations, take appropriate actions if necessary,
and document any actions taken.
4. The CAP assessment and final written report will be completed
within one year of the effective date of the CO. Curium will make the
final written report available to the NRC upon request.
D. Event Reporting
1. Within 180 days of the effective date of the CO, Curium will
develop and implement a procedure for reporting events to the NRC. The
procedure will include instructions for evaluating an event to
determine whether it meets NRC reportability requirements in 10 CFR
part 20 and 10 CFR part 30 and for documenting the results of the
evaluation. This procedure will ensure that at least two qualified
individuals are involved in the evaluation. The instructions will
specifically address how to evaluate whether each criterion in 10 CFR
20.2202 and 30.50 has been met.
2. Within 120 days of implementing the procedure, Curium will
provide training on the procedure to all health physics personnel and
any other personnel involved in making reportability determinations.
3. Curium will provide training on the procedure to all new health
physics personnel and any other new personnel involved in making
reportability determinations.
4. Curium will make the procedure available to the NRC upon
request.
E. Training
1. Curium will develop and implement live training as specified
below:
a. Within 180 days of the effective date of CO, Curium will insert
a brief case study about the 2019 contamination event and lessons
learned into the annual radiation safety training provided to all
radiation workers.
b. Within 180 days of the effective date of the CO, Curium will
develop an in-depth case study (e.g. 45-60 minutes) about the 2019
contamination event and lessons learned and provide that training to
the Curium SLT.
c. Within 180 days of the effective date of the CO, Curium will
develop an in-depth case study (e.g. 45-60 minutes) about the 2019
contamination event and lessons learned and provide that training to
the Curium ELT.
d. Within 180 days of the effective date of the CO, all health
physics personnel will receive training on managing contamination
events and contaminated personnel. Topics for this training will
include, at a minimum, the following: conducting surveys and air
sampling for contamination events; maintain records of surveys;
estimating of extent of contamination; internal dosimetry and dose
assessment, including bioassays; decontamination/treatment of
contaminated persons and items; relevant licensee procedures; and
relevant NRC regulations and guidance. This training will be provided
on a recurring basis (not less frequently than every three years). All
new health physics personnel will receive the training during
qualification.
2. Curium will ensure that the annual radiation safety training for
radiation workers will include training on what to do if a worker
becomes contaminated.
3. The Health Physics department will send out periodic safety
messages, at least quarterly, to the facility regarding current
radiation safety topics for two years starting on the effective date of
the CO.
F. Internal Dose Assessment and Updated Dose Records
1. Within 180 days of the effective date of the CO, Curium will
contract with an independent consultant to complete an internal dose
assessment for the individual who was involved in the August 19, 2019,
contamination event (the ``affected individual'').
a. Prior to entering into a contract with an independent
consultant, Curium will provide the consultant's qualifications to the
NRC for review to verify the consultant's independence and
qualifications.
b. Curium will provide the consultant with a complete copy of
Investigation of Incident Report 19-0088, including attachments, for
use in conducting the assessment.
c. The independent consultant will provide Curium with a written
report that includes the estimated internal dose to the affected
individual and a description of the methods and assumptions used to
perform the dose calculations. Curium will make the written report
available to the NRC upon request.
2. Within 90 days of completion of the internal dose assessment,
Curium's Radiation Safety Officer (RSO) will (a) review the written
report and decide whether the estimated dose is reasonable, and (b)
present the results of the assessment to the Maryland Heights
facility's Radiation Safety Committee (RSC).
3. The RSO's decision and RSC's views will be documented in the
minutes of the RSC. If the RSC or the RSO disagree with the independent
dose assessment, the basis for the disagreement will be explained in
the minutes of the RSC. Curium will make the minutes of the RSC
available to the NRC upon request.
4. Curium will provide an updated NRC Form 5 for the affected
individual as appropriate.
G. Sharing Operating Experience
1. Within one year of the effective date of the CO, Curium will
offer to make a presentation on the 2019 contamination event and
management of the response to one national organization, including
local chapters, whose membership comprises health physics and radiation
professionals (e.g., the Health Physics Society, Society of Nuclear
Medicine, or the American Nuclear Society). If the presentation is
accepted, Curium will designate an appropriate person to make the
presentation. Curium will inform the NRC at least a month in advance of
the date and location.
[[Page 53460]]
2. Curium will provide the slides for the presentation to the NRC
upon request.
H. Building 500 Evaluation
1. Within 180 days of the effective date of the CO, Curium will
evaluate the Building 500 facilities at its Maryland Heights, Missouri,
location based on Curium's assessment that the facilities in Building
500 are not appropriate for cask cleaning activities other than wipe
downs, as stated on pages 16 and 17 of Curium's Investigation of
Incident Report No. 19-0088.
2. Curium will document the evaluation and develop and implement
appropriate corrective actions, if necessary, to provide sufficient
radiation protection measures for the cask cleaning activities
conducted in Building 500.
I. Sanitary Sewage
1. Within 180 days of the effective date of the CO, Curium will
revise SOP 33-141 (the procedure for responding to a contamination
event) to establish a process for assessing any discharge of
radioactive material into the public sanitary sewer system to ensure
compliance with regulatory requirements. The revised procedure will
require that the results of this assessment will be documented.
2. Curium will make the revised procedure available to the NRC upon
request.
This agreement is binding upon successors and assigns of Curium US
LLC. The Regional Administrator, Region III may, in writing, relax or
rescind any of the above conditions upon demonstration of good cause by
Curium or its successors.
VI
In accordance with 10 CFR 2.202 and 10 CFR 2.309, any person
adversely affected by this Confirmatory Order, other than Curium, may
request a hearing within thirty (30) calendar days of the date of
issuance of this Confirmatory Order. Where good cause is shown,
consideration will be given to extending the time to request a hearing.
A request for extension of time must be made in writing to the
Director, Office of Enforcement, U.S. Nuclear Regulatory Commission,
Washington, DC 20555, and include a statement of good cause for the
extension.
All documents filed in NRC adjudicatory proceedings, including a
request for hearing, a petition for leave to intervene, any motion or
other document filed in the proceeding prior to the submission of a
request for hearing or petition to intervene (hereinafter
``petition''), and documents filed by interested governmental entities
participating under 10 CFR 2.315(c), must be filed in accordance with
the NRC's E-Filing rule (72 FR 49139; August 28, 2007, as amended at 77
FR 46562, August 3, 2012). The E-Filing process requires participants
to submit and serve all adjudicatory documents over the internet, or in
some cases to mail copies on electronic storage media. Participants may
not submit paper copies of their filings unless they seek an exemption
in accordance with the procedures described below.
To comply with the procedural requirements of E-Filing, at least 10
days prior to the filing deadline, the participant should contact the
Office of the Secretary by email at [email protected], or by
telephone at 301-415-1677, to (1) request a digital identification (ID)
certificate, which allows the participant (or its counsel or
representative) to digitally sign submissions and access the E-Filing
system for any proceeding in which it is participating; and (2) advise
the Secretary that the participant will be submitting a petition or
other adjudicatory document (even in instances in which the
participant, or its counsel or representative, already holds an NRC-
issued digital ID certificate). Based upon this information, the
Secretary will establish an electronic docket for the hearing in this
proceeding if the Secretary has not already established an electronic
docket.
Information about applying for a digital ID certificate is
available on the NRC's public website at http://www.nrc.gov/site-help/e-submittals/getting-started.html. Once a participant has obtained a
digital ID certificate and a docket has been created, the participant
can then submit adjudicatory documents. Submissions must be in Portable
Document Format (PDF). Additional guidance on PDF submissions is
available on the NRC's public website at http://www.nrc.gov/site-help/electronic-sub-ref-mat.html. A filing is considered complete at the
time the document is submitted through the NRC's E-Filing system. To be
timely, an electronic filing must be submitted to the E-Filing system
no later than 11:59 p.m. Eastern Time on the due date. Upon receipt of
a transmission, the E-Filing system time-stamps the document and sends
the submitter an email notice confirming receipt of the document. The
E-Filing system also distributes an email notice that provides access
to the document to the NRC's Office of the General Counsel and any
others who have advised the Office of the Secretary that they wish to
participate in the proceeding, so that the filer need not serve the
document on those participants separately. Therefore, applicants and
other participants (or their counsel or representative) must apply for
and receive a digital ID certificate before adjudicatory documents are
filed so that they can obtain access to the documents via the E-Filing
system.
A person filing electronically using the NRC's adjudicatory E-
Filing system may seek assistance by contacting the NRC's Electronic
Filing Help Desk through the ``Contact Us'' link located on the NRC's
public website at http://www.nrc.gov/site-help/e-submittals.html, by
email to [email protected], or by a toll-free call at 1-866-672-
7640. The NRC Electronic Filing Help Desk is available between 9 a.m.
and 6 p.m., Eastern Time, Monday through Friday, excluding government
holidays.
Participants who believe that they have a good cause for not
submitting documents electronically must file an exemption request, in
accordance with 10 CFR 2.302(g), with their initial paper filing
requesting authorization to continue to submit documents in paper
format. Such filings must be submitted by: (1) first class mail
addressed to the Office of the Secretary of the Commission, U.S.
Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention:
Rulemaking and Adjudications Staff; or (2) courier, express mail, or
expedited delivery service to the Office of the Secretary, Sixteenth
Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland
20852, Attention: Rulemaking and Adjudications Staff. Participants
filing a document in this manner are responsible for serving the
document on all other participants. Filing is considered complete by
first-class mail as of the time of deposit in the mail, or by courier,
express mail, or expedited delivery service upon depositing the
document with the provider of the service. A presiding officer, having
granted an exemption request from using E-Filing, may require a
participant or party to use E-Filing if the presiding officer
subsequently determines that the reason for granting the exemption from
use of E-Filing no longer exists.
Documents submitted in adjudicatory proceedings will appear in
NRC's electronic hearing docket, which is available to the public at
http://adams.nrc.gov/ehd, unless excluded pursuant to an order of the
Commission or the presiding officer. Participants are requested not to
include personal privacy information, such as social security numbers,
home addresses, or
[[Page 53461]]
home phone numbers in their filings, unless an NRC regulation or other
law requires submission of such information. With respect to
copyrighted works, except for limited excerpts that serve the purpose
of the adjudicatory filings and would constitute a Fair Use
application, participants are requested not to include copyrighted
materials in their submission.
The Commission will issue a notice or order granting or denying a
hearing request or intervention petition, designating the issues for
any hearing that will be held and designating the Presiding Officer. A
notice granting a hearing will be published in the Federal Register and
served on the parties to the hearing.
If a person (other than Curium) requests a hearing, that person
shall set forth with particularity the manner in which his interest is
adversely affected by this Confirmatory Order and shall address the
criteria set forth in 10 CFR 2.309(d) and (f).
If a hearing is requested by a person whose interest is adversely
affected, the Commission will issue an order designating the time and
place of any hearings. If a hearing is held, the issue to be considered
at such hearing shall be whether this Confirmatory Order should be
sustained.
In the absence of any request for hearing, or written approval of
an extension of time in which to request a hearing, the provisions
specified in Section V above shall be final 30 days from the date of
this Confirmatory Order without further order or proceedings. If an
extension of time for requesting a hearing has been approved, the
provisions specified in Section V shall be final when the extension
expires if a hearing request has not been received.
For the Nuclear Regulatory Commission.
/RA/
John B. Giessner,
Regional Administrator, NRC Region III.
Dated this 13th day of June 2024.
[FR Doc. 2024-13977 Filed 6-25-24; 8:45 am]
BILLING CODE 7590-01-P