[Federal Register Volume 87, Number 104 (Tuesday, May 31, 2022)]
[Notices]
[Pages 32470-32475]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11528]
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NUCLEAR REGULATORY COMMISSION
[Docket Nos. 030-11252 and 030-39216; License Nos. 40-16571-01 and -02;
EA-21-027; NRC-2022-0122]
In the Matter of Avera McKennan Hospital
AGENCY: Nuclear Regulatory Commission.
ACTION: Confirmatory order; issuance.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing a
Confirmatory Order to Avera McKennan and Avera McKennan/Nuclear
Medicine (collectively known as Avera McKennan) to document commitments
made as part of a settlement agreement made between the NRC and Avera
McKennan following an alternative dispute resolution mediation session
held on April 20, 2022. The mediation addressed two apparent violations
involving Avera McKennan's willful failure to accurately determine and
record the activity of each dosage before medical use and the failure
to maintain required information that was complete and accurate. Avera
McKennan has committed to various measures intended to restore its
ability to accurately measure dose activity, monitor the performance of
its nuclear medicine technologists, and to train its employees and
contractors on the NRC enforcement actions that may result from
deliberate misconduct. The Confirmatory Order is effective upon
issuance.
DATES: The Confirmatory Order was issued on May 19, 2022.
ADDRESSES: Please refer to Docket ID NRC-2022-0122 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-2022-0122. 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, 301-415-4737, or
by email to [email protected]. The Confirmatory Order to Avera
McKennan is available in ADAMS under Accession No. ML22130A588.
NRC's PDR: You may examine and purchase copies of public
documents, by appointment, at the NRC's PDR, Room P1 B35, One White
Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. 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
8:00 a.m. and 4:00 p.m. (ET), Monday through Friday, except Federal
holidays
FOR FURTHER INFORMATION CONTACT: Jeremy Groom, Region IV, U.S. Nuclear
Regulatory Commission, telephone: 817-200-1182, email:
[email protected].
SUPPLEMENTARY INFORMATION: The text of the Order is attached.
Dated: May 24, 2022.
For the Nuclear Regulatory Commission.
Scott A. Morris,
Regional Administrator, NRC Region IV.
Attached--Confirmatory Order
United States of America
Nuclear Regulatory Commission
In the Matter of: AVERA MCKENNAN, AVERA MCKENNAN/NUCLEAR
MEDICINE
Docket No. 030-11252, License No. 40-16571-01
Docket No. 030-39216, License No. 40-16571-02
EA-21-027
Confirmatory Order Modifying License
(Effective Upon Issuance)
I
Avera McKennan and Avera McKennan/Nuclear Medicine (collectively
known as Avera McKennan or the licensee) are the holders of Materials
License Nos. 40-16571-01 and 40-16571-02 respectively, issued 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). The
licenses authorize the operation of facilities in accordance with
conditions specified therein. The facilities are located on the
licensee's sites in South Dakota.
This Confirmatory Order (CO) is the result of an agreement reached
during an Alternative Dispute Resolution (ADR) mediation session
conducted on April 20, 2022.
II
On February 13, 2019, the NRC's Office of Investigations (OI)
opened an investigation (OI case No. 4-2019-007) at Avera McKennan.
Based on the evidence developed during its investigation, the NRC
identified two apparent violations involving the failure to determine,
by direct measurement, the activity of dosages before medical use as
required by 10 CFR 35.63(a); and the failure to maintain information
that was complete and accurate in all material respects as required by
10 CFR 30.9. It is Avera McKennan's view that no violation of
requirements occurred.\1\ The parties agree to disagree on whether
violations occurred. By letter dated December 21, 2021 (Agencywide
Documents Access and Management System (ADAMS) Accession No.
ML21355A366), the NRC notified Avera McKennan of the results of the
investigation and provided Avera McKennan with an opportunity to: (1)
[[Page 32471]]
Attend a predecisional enforcement conference or (2) participate in an
ADR mediation session in an effort to resolve these concerns.
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\1\ Avera McKennan's view on the apparent violations is
available at ML22117A183.
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In response to the NRC's offer, Avera McKennan requested the use of
the NRC ADR process. On April 20, 2022, the NRC and Avera McKennan 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 to resolve any differences
regarding the dispute. This Confirmatory Order is issued pursuant to
the agreement reached during the April 20, 2022 ADR session.
III
During the ADR session, Avera McKennan and the NRC reached a
preliminary settlement agreement.
``Avera McKennan'' refers to the licensees of Avera McKennan
(License 40-16571-01) and Avera McKennan/Nuclear Medicine (License 40-
16571-02). ``Contractors'' refers to individuals performing NRC
licensed activities under either the Avera McKennan license (License
40-16571-01) or the Avera McKennan/Nuclear Medicine license (License
40-16571-02).
The NRC recognizes the corrective actions that Avera McKennan has
already implemented associated with the apparent violations:
A. Avera McKennan ordered new dippers for use in all dose
calibrators and replaced the modified dippers for all dose calibrators.
B. Avera McKennan communicated that the new dippers were ordered
and that modified dippers should not be used after new dippers arrived.
C. Avera McKennan transitioned from the use of molybdenum
generators to create individual dosages to the use of unit doses
supplied by a third-party radiopharmacy.
D. Avera McKennan implemented a field observation program that
includes an annual one-on-one observation of each nuclear medicine
technologist focused on ensuring radiation safety. Each annual
observation includes formal documentation of any improvement, if
needed.
E. Avera McKennan has retained the use of an outside entity to
provide an independent assessment of Avera McKennan performance.
Additional commitments made in the preliminary settlement
agreement, as signed by both parties, consist of the following:
Communications
A. Avera McKennan will develop a communication that will: Include a
summary of the events that resulted in the Confirmatory Order, stress
the importance of complying with NRC regulations and the conditions of
the license, and emphasize the importance of ensuring documents are
complete and accurate, and the consequences for engaging in willful
violations. Avera McKennan will submit the communication to the NRC for
review and approval within 2 months of the issuance date of the
Confirmatory Order.
B. Within 2 months of NRC approval of the communication, Avera
McKennan will issue the Condition A communication as a stand-alone
communication from a senior hospital official to all authorized users,
nuclear medicine technologists, all other employees performing in NRC
licensed activities and Contractors. Avera McKennan will retain a copy
of the communication presented and a record of the personnel receiving
the communication.
C. Beginning on the date Avera McKennan has issued the Condition A
communication and until December 31, 2026, Avera McKennan will provide
the Condition A communication to all new employees performing NRC
licensed activities or Contractors prior to those individuals
performing NRC licensed activities. Avera McKennan will also provide
the Condition A communication to current employees or Contractors with
new duties performing NRC licensed activities prior to those
individuals performing the new duties. Avera McKennan will retain a
record of the personnel receiving the communication.
D. Within 6 months of the date Avera McKennan has issued the
Condition A communication, Avera McKennan will issue an additional
communication to all authorized users, nuclear medicine technologists,
all other employees involved in NRC licensed activities, and
Contractors reemphasizing its intolerance of willful misconduct and
update such workforce on the status of compliance with this
Confirmatory Order. Avera McKennan will continue to issue this
communication at intervals not to exceed 12 months until December 31,
2026. Avera McKennan will retain a copy of the communication presented
and a record of the personnel receiving the communication. Avera
McKennan will document the reason for any person not obtaining the
communication and the additional efforts used to provide the
communication.
Training
E. Avera McKennan will develop a training program to provide to all
authorized users, nuclear medicine technologists, all other employees
involved in NRC licensed activities, and Contractors. The training will
address what is meant by willfulness and the potential enforcement
actions that the NRC may take against employees who engage in
deliberate misconduct and the associated NRC enforcement actions that
may be taken against a licensee. The training will request that the
recipients provide feedback on the training. Avera McKennan will submit
this training program to the NRC for review and approval within 6
months of the issuance date of the Confirmatory Order.
F. Within 6 months of NRC approval of the training program, Avera
McKennan will provide this training to all authorized users, nuclear
medicine technologists, all other employees involved in NRC licensed
activities, and Contractors. Avera McKennan will continue to provide
this training at least once every calendar year until December 31,
2026. Avera McKennan will maintain a record of the individuals
receiving the training, a summary of the feedback on the training, the
instructor providing the training (if applicable), and the date of the
training.
G. Beginning on the date Avera McKennan has first provided the
Condition E training and until December 31, 2026, Avera McKennan will
provide the Condition E training to all new employees or Contractors
within 3 months of starting work in NRC licensed activities. Avera
McKennan will also provide the Condition E training to current
employees or Contractors with new duties performing NRC licensed
activities. Avera McKennan will retain a record of the individuals
receiving the training, a summary of the feedback on the training, the
instructor providing the training (if applicable), and the date of the
training.
H. Until December 31, 2024, while Ms. Shannon Gray remains employed
by Avera McKennan, Avera McKennan will support and allow Ms. Gray to
provide a total of eight live training sessions to personnel involved
in NRC licensed activities at Avera McKennan, Avera St. Mary's Hospital
(40-07328-03), Avera St. Luke's (40-18000-01), and Avera Sacred Heart
Hospital (40-01683-01). Until December 31, 2024, while Ms. Traci
Hollingshead remains employed by Avera McKennan, Avera McKennan will
support and allow Ms. Hollingshead to provide a total of eight
[[Page 32472]]
live training sessions to personnel involved in NRC licensed activities
at Avera McKennan, Avera St. Mary's Hospital (40-07328-03), Avera St.
Luke's (40-18000-01), and Avera Sacred Heart Hospital (40-01683-01).
These eight live training sessions may be co-presented by Ms. Gray and
Ms. Hollingshead.
Field Observation Program, Applicable to License 40-16571-02 Only
I. Avera McKennan will develop or maintain a field observation
program for Avera McKennan/Nuclear Medicine license (License 40-16571-
02). Avera McKennan will observe NRC licensed activities performed by
each nuclear medicine technologist. The observations shall include, at
a minimum, mobile medical operations, dosage measurements, and
dosimetry practices. Avera McKennan will submit the field observation
program to the NRC for review and approval within 2 months of the
issuance date of the Confirmatory Order.
J. Within 2 months of NRC approval of the field observation
program, Avera McKennan will conduct a field observation developed in
Condition I and will document the results of the field observation.
Avera McKennan will then perform an annual field observation for each
nuclear medicine technologist until December 31, 2026, and will
document the results of each field observation.
Assessment, Applicable to License 40-16571-02 Only
K. Avera McKennan will engage an outside entity to perform a
comprehensive assessment of Avera McKennan/Nuclear Medicine's radiation
safety program. The outside entity should have familiarity and
experience with 10 CFR 35.80 mobile nuclear medicine authorizations.
The assessment will include an evaluation of the corrective actions
associated with NRC Inspection Report 030-39216/2021-002 and
Investigation Report 4-2019-007 dated December 21, 2021, and the
corrective actions associated with the Notice of Violation, NRC
Inspection Report 030-11252/2017-001 and Investigation Report 4-2016-
021 dated December 21, 2017. This will include the following actions:
1. Within 3 months of the issuance date of the Confirmatory Order,
Avera McKennan will submit the qualifications of the outside entity to
the NRC for review and approval.
2. Within 6 months of the NRC approval of the outside entity, Avera
McKennan will submit a copy of the assessment report and Avera
McKennan's written response to the assessment report to the NRC. Avera
McKennan's written response will either address how it will implement
the recommendations and corrective actions of the assessment report,
including a proposed timeline; or provide an explanation and
justification for why the recommendation(s) and corrective action(s)
will not be implemented.
Organizational Health Survey
L. Avera McKennan will engage an outside entity to develop and
conduct an organizational health survey to identify safety culture
concerns that could contribute to willful misconduct. The outside
entity will also develop recommendations and corrective actions based
on the results of the survey.
1. Within 6 months of the issuance date of the Confirmatory Order,
Avera McKennan will submit the qualifications of the outside entity to
the NRC for review and approval.
2. Within 6 months of the NRC approval of the outside entity, the
outside entity will conduct the organizational health survey and will
develop recommendations and corrective actions based on the results
organizational health survey.
3. Within 6 months of the conducting the Condition L.2 organization
health survey, Avera McKennan will submit the survey results and a
written response to the NRC. Avera McKennan's written response will
either address how it will implement the recommendations and corrective
actions of the survey, including a proposed timeline, or provide an
explanation and justification for why the recommendation(s) and
corrective action(s) will not be implemented.
M. Between 24 to 36 months after the completion of the survey in
Condition L, the outside entity will conduct a second organizational
health survey and will develop recommendations and corrective actions
based on the results of the survey.
Effectiveness Reviews
N. By December 31 of calendar years 2022, 2024, and 2026 or 6
months after the last organizational health survey is conducted,
whichever is later, Avera McKennan will perform an effectiveness review
of the corrective actions implemented as a result of this Confirmatory
Order. The effectiveness review will include: The lessons learned from
feedback from the communications and training, if any is received; and
the results of the radiation safety program assessment, field
observations, and the organizational health surveys. Avera McKennan
will modify its corrective actions, as needed and consistent with this
Confirmatory Order, based on the results of the effectiveness review.
Avera McKennan will send a copy of the effectiveness review and
provide, as applicable, a copy of any additional corrective actions and
modifications made to previously developed corrective actions as a
result of the effectiveness review to the NRC.
Administrative Items
O. By March 31 of each calendar year 2023 through 2028, Avera
McKennan will provide in writing to the NRC a summary of the actions
implemented the previous calendar year as a result of the Confirmatory
Order.
P. Until December 31, 2028, Avera McKennan will retain a copy of
all documentation created to demonstrate compliance with the conditions
of the Confirmatory Order.
Q. Documents that are required to be sent to the NRC as a result of
the Confirmatory Order conditions will be sent the Director, Division
of Radiological Safety and Security, U.S. Nuclear Regulatory
Commission, Region IV, by email to [email protected].
Based on the completed actions described above, and the commitments
described in Section V below, the NRC agrees not to issue a Notice of
Violation and not impose a civil penalty for the apparent violations
discussed in NRC Inspection Report 030-39216/2021-002 and Investigation
Report 4-2019-007 (EA-21-027) to Avera McKennan dated December 21,
2021.
On May 17, 2022, Avera McKennan consented to issuing this
Confirmatory Order with the commitments, as described in Section V
below. Avera McKennan further agreed that this Confirmatory Order is to
be effective upon issuance, 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 the corrective actions that Avera McKennan has already
implemented, as described in Section III above, combined with the
commitments as set forth in Section V below are acceptable and
necessary, and I 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 Avera McKennan's
commitments be confirmed by this Confirmatory Order. Based on the above
and Avera McKennan's
[[Page 32473]]
consent, this Confirmatory Order is effective upon issuance.
V
Accordingly, pursuant to Sections 81, 161b, 161i, 161o, 182, and
186 of the Atomic Energy Act of 1954, as amended, and the Commission's
regulations in 10 CFR 2.202 and 10 CFR part 30, IT IS HEREBY ORDERED,
EFFECTIVE UPON ISSUANCE, THAT LICENSE NOS. 40-16571-01 AND 40-16571-02
ARE MODIFIED AS FOLLOWS:
For the purposes of this Confirmatory Order, ``Avera McKennan''
refers to the licensees of Avera McKennan (License 40-16571-01) and
Avera McKennan/Nuclear Medicine (License 40-16571-02). ``Contractors''
refers to individuals performing NRC licensed activities under either
the Avera McKennan license (License 4016571-01) or the Avera McKennan/
Nuclear Medicine license (License 401657102).
Communications
A. Avera McKennan will develop a communication that will: Include a
summary of the events that resulted in the Confirmatory Order, stress
the importance of complying with NRC regulations and the conditions of
the license, emphasize the importance of ensuring documents are
complete and accurate, and discuss the consequences for engaging in
willful violations. Avera McKennan will submit the communication to the
NRC for review and approval within 2 months of the issuance date of the
Confirmatory Order.
B. Within 2 months of NRC approval of the communication, Avera
McKennan will issue the Condition A communication as a stand-alone
communication from a senior hospital official to all authorized users,
nuclear medicine technologists, all other employees and Contractors
performing in NRC licensed activities. Avera McKennan will retain a
copy of the communication presented and a record of the personnel
receiving the communication.
C. Beginning on the date Avera McKennan has issued the Condition A
communication and until December 31, 2026, Avera McKennan will provide
the Condition A communication to all new employees and Contractors
performing NRC licensed activities prior to those individuals
performing NRC licensed activities. Avera McKennan will also provide
the Condition A communication to current employees and Contractors with
new duties performing NRC licensed activities prior to those
individuals performing the new duties. Avera McKennan will retain a
record of the personnel receiving the communication.
D. Within 6 months of the date Avera McKennan has issued the
Condition A communication, Avera McKennan will issue an additional
communication to all authorized users, nuclear medicine technologists,
all other employees and Contractors involved in NRC licensed activities
reemphasizing its intolerance of willful misconduct and update such
workforce on the status of compliance with this Confirmatory Order.
Avera McKennan will continue to issue this communication at intervals
not to exceed 12 months until December 31, 2026. Avera McKennan will
retain a copy of the communication presented and a record of the
personnel receiving the communication. Avera McKennan will document the
reason for any person not obtaining the communication and the
additional efforts used to provide the communication.
Training
E. Avera McKennan will develop a training program to provide to all
authorized users, nuclear medicine technologists, all other employees
and Contractors involved in NRC licensed activities. The training will
address what is meant by willfulness and the potential enforcement
actions that the NRC may take against employees who engage in
deliberate misconduct and the associated NRC enforcement actions that
may be taken against a licensee. The training will request that the
recipients provide feedback on the training. Avera McKennan will submit
this training program to the NRC for review and approval within 6
months of the issuance date of the Confirmatory Order.
F. Within 6 months of NRC approval of the training program, Avera
McKennan will provide this training to all authorized users, nuclear
medicine technologists, all other employees and Contractors involved in
NRC licensed activities. Avera McKennan will continue to provide this
training at least once every calendar year until December 31, 2026.
Avera McKennan will maintain a record of the individuals receiving the
training, a summary of the feedback on the training, the instructor
providing the training (if applicable), and the date of the training.
G. Beginning on the date Avera McKennan has first provided the
Condition E training and until December 31, 2026, Avera McKennan will
provide the Condition E training to all new employees and Contractors
within 3 months of starting work in NRC licensed activities. Avera
McKennan will also provide the Condition E training to current
employees and Contractors with new duties performing NRC licensed
activities. Avera McKennan will retain a record of the individuals
receiving the training, a summary of the feedback on the training, the
instructor providing the training (if applicable), and the date of the
training.
H. Until December 31, 2024, while Ms. Shannon Gray remains employed
by Avera McKennan, Avera McKennan will support and allow Ms. Gray to
provide a total of eight live (e.g., in person or virtual) training
sessions to personnel involved in NRC licensed activities at Avera
McKennan, Avera St. Mary's Hospital (License 40-07328-03), Avera St.
Luke's (License 40-18000-01), and Avera Sacred Heart Hospital (License
40-01683-01). Until December 31, 2024, while Ms. Traci Hollingshead
remains employed by Avera McKennan, Avera McKennan will support and
allow Ms. Hollingshead to provide a total of eight live training
sessions to personnel involved in NRC licensed activities at Avera
McKennan, Avera St. Mary's Hospital (License 40-07328-03), Avera St.
Luke's (License 40-18000-01), and Avera Sacred Heart Hospital (License
40-01683-01). These eight live training sessions may be co-presented by
Ms. Gray and Ms. Hollingshead.
Field Observation Program, Applicable to License 40-16571-02 Only
I. Avera McKennan will develop or maintain a field observation
program for Avera McKennan/Nuclear Medicine license (License 40-16571-
02). Avera McKennan will observe NRC licensed activities performed by
each nuclear medicine technologist. The observations shall include, at
a minimum, mobile medical operations, dosage measurements, and
dosimetry practices. Avera McKennan will submit the field observation
program to the NRC for review and approval within 2 months of the
issuance date of the Confirmatory Order.
J. Beginning December 31, 2022, or within 2 months of NRC approval,
whichever date is later, Avera McKennan will implement the field
observation program developed under Condition I. Upon the program's
implementation, and until December 31, 2026, Avera McKennan will
perform annual field observations of each nuclear medicine technologist
and will maintain documentation of the observations.
Assessment, Applicable to License 40-16571-02 Only
K. Avera McKennan will engage an outside entity to perform a
[[Page 32474]]
comprehensive assessment of Avera McKennan/Nuclear Medicine's radiation
safety program. The outside entity should have familiarity and
experience with 10 CFR 35.80 mobile nuclear medicine authorizations.
The assessment will include an evaluation of the corrective actions
associated with NRC Inspection Report 030-39216/2021-002 and
Investigation Report 4-2019-007 dated December 21, 2021, and the
corrective actions associated with the Notice of Violation, NRC
Inspection Report 030-11252/2017-001 and Investigation Report 4-2016-
021 dated December 21, 2017. This will include the following actions:
1. Within 3 months of the issuance date of the Confirmatory Order,
Avera McKennan will submit the qualifications of the outside entity to
the NRC for review and approval.
2. Within 6 months of the NRC approval of the outside entity, Avera
McKennan will submit a copy of the assessment report and Avera
McKennan's written response to the assessment report to the NRC. Avera
McKennan's written response will either address how it will implement
the recommendations and corrective actions of the assessment report,
including a proposed timeline; or provide an explanation and
justification for why the recommendation(s) and corrective action(s)
will not be implemented.
Organizational Health Survey
L. Avera McKennan will engage an outside entity to develop and
conduct an organizational health survey to identify safety culture
concerns that could contribute to willful misconduct. The outside
entity will also develop recommendations and corrective actions based
on the results of the survey.
1. Within 6 months of the issuance date of the Confirmatory Order,
Avera McKennan will submit the qualifications of the outside entity to
the NRC for review and approval.
2. Within 6 months of the NRC approval of the outside entity, the
outside entity will conduct the organizational health survey and will
develop recommendations and corrective actions based on the results
organizational health survey.
3. Within 6 months of the conducting the Condition L.2 organization
health survey, Avera McKennan will submit the survey results and a
written response to the NRC. Avera McKennan's written response will
either address how it will implement the recommendations and corrective
actions of the survey, including a proposed timeline, or provide an
explanation and justification for why the recommendation(s) and
corrective action(s) will not be implemented.
M. Between 24 to 36 months after the completion of the survey in
Condition L, the outside entity will conduct a second organizational
health survey and will develop recommendations and corrective actions
based on the results of the survey.
Effectiveness Reviews
N. By December 31, 2022; December 31, 2024; and December 31, 2026
or 6 months after the second organizational health survey described in
Condition M is conducted, whichever is later, Avera McKennan will
perform an effectiveness review of the corrective actions implemented
as a result of this Confirmatory Order. The effectiveness review will
include: The lessons learned from feedback from the communications and
training, if any is received; and the results of the radiation safety
program assessment, field observations, and the organizational health
surveys. Avera McKennan will modify its corrective actions, as needed
and consistent with this Confirmatory Order, based on the results of
the effectiveness review. Avera McKennan will send a copy of the
effectiveness review and provide, as applicable, a copy of any
additional corrective actions and modifications made to previously
developed corrective actions as a result of the effectiveness review to
the NRC.
Administrative Items
O. By March 31 of each calendar year 2023 through 2028, Avera
McKennan will provide in writing to the NRC a summary of the actions
implemented the previous calendar year as a result of the Confirmatory
Order.
P. Until December 31, 2028, Avera McKennan will retain a copy of
all documentation created to demonstrate compliance with the conditions
of the Confirmatory Order.
Q. Documents that are required to be sent to the NRC as a result of
the Confirmatory Order conditions will be sent the Director, Division
of Radiological Safety and Security, U.S. Nuclear Regulatory
Commission, Region IV, by email to [email protected].
In the event of the transfer of the license(s) of Avera McKennan to
another entity, the terms and conditions set forth hereunder shall
continue to apply to the new entity and accordingly survive any
transfer of ownership or license. The Regional Administrator, Region
IV, may, in writing, relax, rescind, or withdraw any of the above
conditions upon demonstration by Avera McKennan or its successors of
good cause.
VI
In accordance with 10 CFR 2.202 and 10 CFR 2.309, any person
adversely affected by this Confirmatory Order, other than Avera
McKennan, 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 and petition for leave to intervene (petition), any
motion or other document filed in the proceeding prior to the
submission of a request for hearing or petition to intervene, and
documents filed by interested governmental entities that request to
participate 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. Detailed
guidance on making electronic submissions may be found in the Guidance
for Electronic Submissions to the NRC and on the NRC website at https://www.nrc.gov/site-help/e-submittals.html. 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
[[Page 32475]]
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
stating why there is good cause for not filing electronically and
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, 11555
Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and
Adjudications Staff. Participants filing adjudicatory documents 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 the
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. If you do not have an NRC-issued
digital ID certificate as described above, click ``cancel'' when the
link requests certificates and you will be automatically directed to
the NRC's electronic hearing dockets where you will be able to access
any publicly available documents in a particular hearing docket.
Participants are requested not to include personal privacy information,
such as social security numbers, home addresses, or personal phone
numbers in their filings, unless an NRC regulation or other law
requires submission of such information. For example, in some
instances, individuals provide home addresses in order to demonstrate
proximity to a facility or site. 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 Avera McKennan) 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,
Scott A. Morris,
Regional Administrator, NRC Region IV.
Dated this 23rd day of May 2022.
[FR Doc. 2022-11528 Filed 5-27-22; 8:45 am]
BILLING CODE 7590-01-P