Information Notice 2025-04, Use of Quality Assurance Alternatives During Exigent Conditions
| ML25121A128 | |
| Person / Time | |
|---|---|
| Issue date: | 08/06/2025 |
| From: | Philip Mckenna NRC/NRR/DRO/IOEB |
| To: | |
| References | |
| IN-25-004 | |
| Download: ML25121A128 (6) | |
ML25121A128 UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR REACTOR REGULATION
WASHINGTON, DC 20555-0001
August 6, 2025
NRC INFORMATION NOTICE 2025-04:
USE OF APPROVED QUALITY ASSURANCE
ALTERNATIVES DURING EXIGENT CONDITIONS
ADDRESSEES
All holders of, and applicants for, a construction permit for a production or utilization facility, including a medical radioisotope facility, under Title 10 of the Code of Federal Regulations
(10 CFR) Part 50, Domestic Licensing of Production and Utilization Facilities.
All holders of, and applicants for, an operating license for a nuclear power reactor issued under
All holders of, and applicants for, a nuclear power reactor early site permit, combined license, standard design approval, or manufacturing license under 10 CFR Part 52, Licenses, Certifications, and Approvals for Nuclear Power Plants.
All applicants for a standard design certification, including such applicants after initial issuance
of a design certification rule.
All contractors and vendors that supply basic components to U.S. Nuclear Regulatory
Commission (NRC) licensees under 10 CFR Part 50 or 10 CFR Part 52.
Holders of, and applicants for, a fuel cycle facility license under 10 CFR Part 70, Domestic
Licensing of Special Nuclear Material, with an approved Appendix B, Quality Assurance
Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to 10 CFR Part 50 quality
assurance program, or approved management measures program under 10 CFR 70.62(d),
Management measures.
All licensees, certificate holders, and applicants for a certificate of compliance for an
NRC-approved quality assurance (QA) program that must conform to the requirements of
Subpart H, Quality Assurance, to 10 CFR Part 71, Packaging and Transportation of
Radioactive Material. This includes those licensed under another part of Title 10 that have been
issued an NRC QA program approval under 10 CFR Part 71 that limits the scope of their
activities solely to the use of NRC-approved packaging.
All holders of, and applicants for, a license or certificate of compliance with an NRC-approved
QA program that must conform to the requirements of Subpart G, Quality Assurance, to
10 CFR Part 72, Licensing Requirements for the Independent Storage of Spent Nuclear Fuel, High-Level Radioactive Waste, and Reactor-Related Greater than Class C Waste.
PURPOSE
The NRC is issuing this information notice (IN) to inform addressees of the potential for
inappropriate implementation of the QA alternatives approved for use during exigent conditions. This potential includes the use of the QA alternatives to qualify new suppliers, or a licensee, applicant, or vendor incorrectly determining when an exigent condition exists. The NRC expects
that recipients will review the information for applicability to their facilities and consider actions, as appropriate, to avoid similar problems.
INs may not impose new requirements, and nothing in this IN should be interpreted to require
specific action; therefore, no written response is required.
DESCRIPTION OF CIRCUMSTANCES
Criterion VII, Control of Purchased Material, Equipment, and Services, of Appendix B, Quality
Assurance Program Criteria for Nuclear Power Plants and Fuel Reprocessing Plants, to
10 CFR Part 50, states, in part, the following:
Measures shall be established to assure purchased material, equipment, and
services, whether purchased directly or through contractors and subcontractors, conform to the procurement documents. These measures shall include
provisions, as appropriate, for source evaluation and selection, objective
evidence of quality furnished by the contractor or subcontractor, inspection at
the contractor or subcontractor source, and examination of products upon
delivery. [emphasis added]
During the Coronavirus Disease 2019 (COVID-19) public health emergency, first declared on
January 31, 2020, licensees and applicants could meet neither the requirements for inspection
at the source or subcontractor source nor their quality assurance program description (QAPD)
commitments for the frequency of these inspections.1,2 Because of national and international
restrictions and recommendations to protect people during the public health emergency
(e.g., travel restrictions and social distancing), the NRC approved several QA alternatives for
performing fully remote audits, fully remote commercial-grade surveys, and fully remote source
verifications. The NRC also granted a 25 percent grace period extension for the performance of
these activities during exigent conditions (i.e., the COVID-19 pandemic).
The QA alternatives were approved as reductions in commitment due to exigent conditions
under 10 CFR 50.54(a)(4), which sets forth the NRCs regulatory requirements regarding
changes to a QAPD. The NRC considered and granted these QA alternatives and certain
temporary exemptions to allow the operating fleet to continue operating safely during the
unprecedented global crisis caused by the COVID-19 pandemic.3
1 See U.S. Department of Health and Human Services, Determination that a Public Health Emergency
Exists, dated January 31, 2020, https://aspr.hhs.gov/legal/PHE/Pages/2019-nCoV.aspx. The President
declared a national emergency on March 13, 2020. See Declaring a National Emergency Concerning the
Novel Coronavirus Disease (COVID-19) Outbreak, 85 FR 9994 (March 18, 2020).
2 See, for example, U.S. Department of State, COVID-19 Impact on Travel and Consular Operations, dated
March 20, 2020, https://travel.state.gov/content/travel/en/News/Intercountry-Adoption-News/covid-19- impact-on-travel-and-consular-operations.html (noting that the Department of State recommends against
any travel and that [m]any countries have taken or are taking action limiting traveler mobility, including
mandatory quarantines and border restrictions, with little advance notice).
3 See, for example, NRC COVID-19 Update (archived), https://www.nrc.gov/about-nrc/covid-19/security- ep/emergency-preparedness.html. On April 10, 2023, the President of the United States ended the national emergency declared
because of the pandemic.4 The Federal public health emergency for COVID-19 expired on
May 11, 2023.5 Due to the termination of the national emergency and the public health
emergency, the ability to continue performing fully remote audits, fully remote commercial-grade
surveys, and fully remote source verifications, and providing a 25 percent grace period
extension, no longer applies. Licensees, applicants, and vendors that have these
NRC-approved QA alternatives based on COVID-19 exigent conditions in their QAPDs or in an
implementing procedure, or both, may no longer implement these QA alternatives unless a new
exigent condition exists.
BACKGROUND
The safety evaluation report (SER), Safety Evaluation by the Office of Nuclear Reactor
Regulation, Request for Change to the Columbia Operational Quality Assurance Program
Description, Energy Northwest, Columbia Generating Station, Docket No. 50-397, dated
July 22, 2020 (Agencywide Documents Access and Management System Accession
No. ML20203K876), documents the NRC staffs approval for using Electric Power Research
Institute (EPRI) Technical Report No. 3002019436, Remote Source Verification During a
Pandemic or Similar State of Emergency, issued April 2020, for performing fully remote source
verifications during exigent conditions.
The SER, Safety Evaluation by the Office of Nuclear Reactor Regulation, Change to the
Operating Quality Assurance Manual, Revision 34b, Union Electric Company, Callaway Plant, Unit No. 1, Docket Nos. 50-483 and 72-1045, dated August 6, 2020 (ML20216A681),
documents the NRC staffs approval, with conditions, for providing a 25 percent grace period
extension for conducting onsite audits and onsite commercial-grade surveys, during exigent
conditions.
The SER, Safety Evaluation by the Office of Nuclear Reactor Regulation, Request for Change
to the Quality Assurance Topical Report, Edwin I. Hatch Nuclear Plant, Units 1 and 2;
Joseph M. Farley Nuclear Plant, Units 1 and 2; Vogtle Electric Generating Plant, Units 1 and 2;
Southern Nuclear Operating Company, Docket Nos. 50-231, 50-348, 50-424, 50-366, 50-364,
50-425,71-333, 71-521,71-726, 72-036,72-042, and 72-1039, dated June 22, 2021 (ML21161A201), documents the NRC staffs approval for using EPRI Technical Report
No. 300202020796, Remote Assessment Techniques: Planning and Conducting Audits and
Surveys Using Remote Techniques During Exigent Conditions, issued April 2021, for
performing fully remote audits, provisional audits, and fully remote commercial-grade surveys
during exigent conditions.
DISCUSSION
This IN is intended to inform licensees, applicants, and vendors that the requirements of
Criterion VII have not changed and, therefore, that there is potential for inappropriate
implementation of the NRC-approved QA alternatives during exigent conditions now that the
COVID-19 public health emergency is over. The potential for inappropriate implementation
includes (1) using NRC-approved QA alternatives to qualify new suppliers using fully remote
4 Joint Resolution Relating to a National Emergency Declared by the President on March 13, 2020, Pub. L.
No. 118-3, 137 Stat. 6 (2023).
5 See, for example, U.S. Department of Health and Human Services, COVID-19 Public Health Emergency, https://www.hhs.gov/coronavirus/covid-19-public-health-emergency/index.html. audits and (2) a licensee, applicant, or vendor incorrectly determining when an exigent condition
exists.
As documented in Section 6.1.9, Eligibility Requirements for Fully Remote Assessment, and
Section 6.13.1, Eligibility Requirements for Provisional Remote Assessment, of EPRI
Technical Report No. 300202020796, the NRC-approved QA alternatives during exigent
conditions may be used only for suppliers that were previously qualified by an in-person
assessment at the source or subcontractor source, and they may not be used to qualify new
suppliers. The NRC staff also documented this condition in its SER dated June 22, 2021.
With respect to determining when an exigent condition exists, EPRI Technical Report
No. 300202020796 defines exigent conditions as follows:
extreme circumstances where it is not possible to perform on-site verification or
assessment. For example, (1) Conditions that threaten the health and safety of
individuals performing the verification or assessment; (2) local, national, or global
declaration of an emergency; and (3) local, national, or global restrictions on
travel.
The SERs approving EPRI Technical Reports No. 300202020796 and No. 3002019436 state, in
part, that use of this method of verification will only be applicable when a pandemic or similar
state of emergency has been declared restricting access or travel to and/or from those locations
affected by State and National declarations.
The NRC-approved QA alternatives may only be used when an exigent condition exists. For the
United States of America and its territories (Puerto Rico, the U.S. Virgin Islands, Guam, Northern Mariana Islands, and American Samoa), a national exigent condition may be declared
only by the President of the United States or by the Office of the President of the United States, similar to how the COVID-19 national emergency was declared. Likewise, an exigent condition
at the State level may be declared only by a State governor or the mayor for the location where
the exigent condition exists. For international locations, an exigent condition may be declared
only by a duly authorized government official of the country where the exigent condition exists.
Licensees, applicants, and vendors that have these NRC-approved QA alternatives
documented in their QAPDs or in an implementing procedure are not required to change their
documents to remove the NRC-approved alternatives. However, licensees, applicants, and
vendors should be aware that the alternatives may no longer be implemented unless a new
exigent condition exists and is declared consistent with the guidance provided above.
If a licensee, applicant, or vendor has a question about whether the NRC-approved QA
alternatives for an exigent condition in its QAPD or in an implementing procedure can be
exercised in a particular circumstance, please contact the NRC staff.
CONTACT
S
Please direct any questions about this matter to the technical contact listed below.
/RA/
Philip McKenna, Acting Director
Division of Reactor Oversight
Office of Nuclear Reactor Regulation
Technical Contact:
301-415-2228 E-mail: yamir.diaz-castillo@nrc.gov
OFFICE DRO/IQVB QTE
DRO/IQVB
DRO/IOEB
OE/EB
NAME
YDiaz- Castillo
Kazariah- Kribbs
KKavanagh
PClark
JPeralta
DATE
05/01/25
04/28/25
5/5/25
05/01/25
5/14/25 OFFICE OCIO
DRO/IOEB
NRR/DRO
NAME
KBenney
BBenney
PMcKenna
DATE
5/15/25
7/21/25
8/6/25