In the Matter of Curium US LLC; Confirmatory Order Modifying License, 53455-53461 [2024-13977]

Agencies

• NUCLEAR REGULATORY COMMISSION

[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 https://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 https://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 https://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 
https://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