[Federal Register Volume 87, Number 83 (Friday, April 29, 2022)]
[Notices]
[Pages 25551-25554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09168]


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NUCLEAR REGULATORY COMMISSION

[Docket No. 030-34325; License No. 03-23853-01VA; EA-21-059; NRC-2022-
0101]


In the Matter of Department of Veterans Affairs

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 the Department of Veterans Affairs to memorialize 
the agreement reached during an alternative dispute resolution 
mediation session held on March 2, 2022. The order will resolve all 
issues related to apparent violations that occurred when a nuclear 
medicine technologist willfully failed to conduct a measurement of the 
concentration of strontium-82 and strontium-85 prior to use of a 
strontium-82/rubidium-82 generator and willfully falsified records 
relating to the same failure to conduct the required measurement. The 
Confirmatory Order includes a number of significant commitments 
undertaken by the Department of Veterans Affairs to enhance the safety 
culture among its employees involved in nuclear medicine. The 
Confirmatory Order is effective upon issuance.

DATES: The confirmatory order was issued on April 21, 2022.

ADDRESSES: Please refer to Docket ID NRC-2022-0101 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-2022-0101. 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 the 
Department of Veterans Affairs is available in ADAMS under Accession 
No. ML22062B353.
     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: Shelbie Lewman, Region III, U.S. 
Nuclear Regulatory Commission, telephone: 630-810-4373, email: 
[email protected].

SUPPLEMENTARY INFORMATION: The text of the Order is attached.

    For the Nuclear Regulatory Commission.

    Dated: April 25, 2022.
John B. Giessner,
Regional Administrator, NRC Region III.

United States of America

Nuclear Regulatory Commission

In the Matter of: Department of Veterans Affairs, Greater Los Angeles 
Healthcare System, 030-34325, 03-23853-01VA, EA-21-059

Confirmatory Order Modifying License (Effective Upon Issuance)

I

    The Department of Veterans Affairs (VA) holds Master Materials 
License No. 03-23853-01VA, issued to the U.S. Department of Veterans 
Affairs on March 17, 2003, by the U.S. Nuclear Regulatory Commission 
(NRC or Commission) pursuant to Part 35 of Title 10 of the Code of 
Federal

[[Page 25552]]

Regulations (CFR). The license authorizes the use of any byproduct 
material for purposes authorized by the National Radiation Safety 
Committee and the use of depleted uranium for shielding, as described 
in its application dated September 21, 1998, in accordance with 
conditions specified therein.
    This Confirmatory Order is the result of an agreement reached 
during an Alternative Dispute Resolution (ADR) mediation session 
conducted on March 2, 2022, in Lisle, Illinois.

II

    On April 22, 2021, the NRC completed Investigation Report 03-2020-
010, which documented the identification of apparent violations at the 
facility of VA's permittee, VA Greater Los Angeles Healthcare System. 
The apparent violations were being considered for escalated enforcement 
action in accordance with the NRC Enforcement Policy. The apparent 
violations involved the willful failure of a nuclear medicine 
technologist (NMT) to conduct a measurement of the concentration of 
strontium-82 and strontium-85 prior to use of a strontium-82/rubidium-
82 generator, as required by 10 CFR 35.204(c), and falsification of 
records by the same NMT relating to the same failure to conduct the 
required measurement, in violation of 10 CFR 30.9, 10 CFR 35.204(d) and 
10 CFR 35.2204. VA formally requested a copy of the NRC report on 
December 13, 2021. In accordance with established Commission policy 
(see SRM-SECY-05-0213, ML060060088), NRC denied this request on 
December 14, 2021.
    By letter, dated December 2, 2021, the NRC provided VA with a 
factual summary of the results of the investigation with an opportunity 
to: (1) Provide a response in writing, (2) attend a predecisional 
enforcement conference or (3) participate in an ADR mediation session 
in an effort to resolve these concerns.
    In response to the NRC's offer, VA requested the use of the NRC's 
ADR process to resolve differences it had with the NRC. On March 2, 
2022, the NRC and VA 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. This Confirmatory 
Order is issued pursuant to the agreement reached during the ADR 
process.

III

    During the ADR session, VA and the NRC reached a preliminary 
settlement in an Agreement in Principle.
    The NRC recognizes that VA has already taken corrective actions 
including:
    1. Removing the NMT who committed the willful violations as soon as 
the misconduct was witnessed by the Radiation Safety Officer (RSO); and
    2. Retraining the NMT staff concerning proper quality control 
procedures.
    Therefore, the parties agree to the following terms and conditions:
    1. VA commits to conduct an anonymous safety culture survey of VA 
employees nationwide working in nuclear medicine or related activities 
as identified below:
    a. Individuals handling permitted, unsealed, radioactive material 
in a patient care setting (e.g., nuclear medicine technologists);
    b. Authorized User physicians;
    c. Radiation Safety Officers (RSOs) and their staffs;
    d. National Health Physics Program staff and National Radiation 
Safety Committee (NRSC) members; and,
    e. Other personnel required by 10 CFR part 20 to be monitored due 
to occupational exposure to permitted, unsealed, radioactive material 
in a patient care setting.
    The survey will be conducted by VA's National Center for Patient 
Safety (NCPS), an organization independent of the VHA National Health 
Physics Program, or another independent entity contracted by VA.
    The NRSC will review the results of the survey in consultation with 
the survey designer and the NRSC will determine corrective actions. 
Corrective actions identified and taken or a justification for no 
corrective actions will be available for NRC inspection upon request.
    The survey will be completed and analyzed no later than 18 months 
from the date of the Confirmatory Order and the results will be 
available for NRC inspection upon request.
    2. VA commits to conduct safety culture training. This training 
will consist of two National Health Physics Program (NHPP) webinars 
related to safety culture with announcement to VHA Email Groups for 
RSOs, Nuclear Medicine Supervisors, and Chief/Lead Nuclear Medicine 
Technologists (VA-wide). The NRSC Chair will lead at least one of the 
webinars. The webinars will be recorded for future reference to allow 
RSOs, Nuclear Medicine Supervisors, and Chief/Lead Nuclear Medicine 
Technologists to complete later. Ninety (90) percent of the combined 
group of RSOs and Nuclear Medicine Supervisors, and Chief/Lead Nuclear 
Medicine Technologists must complete one webinar or view one recording.
    Documentation of the webinars and their attendance will be 
available for NRC inspection upon request. The NRC will be invited to 
attend one of the webinars. This commitment will be met no later than 
nine months from the date of the Confirmatory Order.
    3. VA commits to ``re-energize'' its employee concerns program 
related to reporting of radioactive program allegations or adverse 
events. Specifically, VA will:
    a. Add safety culture content to the ``Reporting Radiation Safety 
Concerns'' posters and programs;
    b. Re-emphasize 24/7/365 availability of the hotline in webinars 
discussed above; and,
    c. Issue one or two ``Scatterings'' newsletters discussing its 
employees concerns program, with poster attached.
    This commitment will be met no later than nine months from the date 
of the Confirmatory Order. Documentation of this commitment will be 
available for NRC inspection upon request.
    4. In consideration of the completed actions and commitments 
delineated above and the license modifications described below, the NRC 
agrees to refrain from issuing a Notice of Violation or proposing a 
civil penalty in connection with the NRC's December 2, 2021, letter. 
The NRC agrees that the Confirmatory Order documenting the above items 
will not be considered an escalated enforcement action by the NRC for 
future assessment of violations occurring at VA if VA does not violate 
the terms of this Confirmatory Order.
    The terms and conditions set forth herein shall continue to apply 
for the duration of the Master Material License issued to VA.
    On March 2, 2022, VA consented to issuing this Confirmatory Order 
with the commitments, as described in Section V below. VA 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 VA'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

[[Page 25553]]

the foregoing, I have determined that public health and safety require 
that VA's commitments be confirmed by this Confirmatory Order. Based on 
the above and VA'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, VA is required to notify the NRC in 
writing and summarize its actions.

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 parts 30 and 35, it is hereby 
ordered, effective upon issuance, that license No. 03-23853-01VA is 
modified as follows:
    1. VA will conduct an anonymous safety culture survey of VA 
employees nationwide working in nuclear medicine or related activities 
as identified below:
    a. Individuals handling permitted, unsealed, radioactive material 
in a patient care setting (e.g., nuclear medicine technologists);
    b. Authorized User physicians;
    c. Radiation Safety Officers (RSOs) and their staffs;
    d. National Health Physics Program staff and National Radiation 
Safety Committee (NRSC) members; and,
    e. Other personnel required by 10 CFR part 20 to be monitored due 
to occupational exposure to permitted, unsealed, radioactive material 
in a patient care setting.
    The survey will be conducted by VA's National Center for Patient 
Safety (NCPS), an organization independent of the VHA National Health 
Physics Program, or another independent entity contracted by VA.
    The NRSC will review the results of the survey in consultation with 
the survey designer and the NRSC will determine corrective actions. 
Corrective actions identified and taken or a justification for no 
corrective actions will be available for NRC inspection upon request.
    The survey will be completed and analyzed no later than 18 months 
from the date of the Confirmatory Order and the results will be 
available for NRC inspection upon request.
    2. VA will conduct safety culture training. This training will 
consist of two National Health Physics Program (NHPP) webinars related 
to safety culture with announcement to VHA Email Groups for RSOs, 
Nuclear Medicine Supervisors, and Chief/Lead Nuclear Medicine 
Technologists (VA-wide). The NRSC Chair will lead at least one of the 
webinars. The webinars will be recorded for future reference to allow 
RSOs, Nuclear Medicine Supervisors, and Chief/Lead Nuclear Medicine 
Technologists to complete later. Ninety (90) percent of the combined 
group of RSOs and Nuclear Medicine Supervisors, and Chief/Lead Nuclear 
Medicine Technologists must complete one webinar or view one recording.
    Documentation of the webinars and their attendance will be 
available for NRC inspection upon request. The NRC will be invited to 
attend one of the webinars. VA will complete this safety culture 
training, including the 90% participation requirement, no later than 
nine months from the date of this Confirmatory Order.
    3. VA will ``re-energize'' its employee concerns program related to 
reporting radioactive program allegations or adverse events. 
Specifically, VA will:
    a. Add safety culture content to the ``Reporting Radiation Safety 
Concerns'' posters and programs;
    b. Re-emphasize 24/7/365 availability of the hotline in webinars 
discussed above; and,
    c. Issue at least one ``Scatterings'' newsletters discussing the 
employee concerns program, with poster attached.
    This commitment will be met no later than nine months from the date 
of the Confirmatory Order. Documentation relating to the fulfillment of 
this commitment will be available for NRC inspection upon request.
    The Regional Administrator, Region III may, in writing, relax or 
rescind any of the above conditions upon demonstration of good cause by 
VA 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 VA, 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

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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 
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 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 VA) 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.

    Dated this 21st day of April 2022.

/RA/

John B. Giessner,

Regional Administrator, NRC Region III.

[FR Doc. 2022-09168 Filed 4-28-22; 8:45 am]
BILLING CODE 7590-01-P