ML22241A109

IMC 0616 Fuel Cycle Safety and Safeguards Inspection Reports

ML22241A109
Person / Time
Issue date:	10/04/2022
From:	Dylanne Duvigneaud NRC/NMSS/DFM/IOB
To:
DyLanne Duvigneaud NMSS/DFM/IOB 415-4010
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ML22276A152, ML22241A107	List:
References
CN 22-020
Download: ML22241A109 (39)

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NRC INSPECTION MANUAL NMSS/DFM INSPECTION MANUAL CHAPTER 0616 FUEL CYCLE SAFETY AND SAFEGUARDS INSPECTION REPORTS Effective Date: 10/04/2022

Issue Date: 10/04/22 i

0616 TABLE OF CONTENTS 0616-01 PURPOSE................................................................................................................... 1 0616-02 OBJECTIVES.............................................................................................................. 1 0616-03 DEFINITIONS.............................................................................................................. 1 0616-04 RESPONSIBILITIES................................................................................................... 4 04.01 General Responsibilities........................................................................................ 4 04.02 Inspectors.............................................................................................................. 4 04.03 Branch Chiefs........................................................................................................ 4 04.04 Division of Fuel Management (DFM) - Inspection and Oversight Branch (IOB)... 5 0616-05 THRESHOLDS OF SIGNIFICANCE - SCREENING INSPECTION RESULTS.......... 5 0616-06 DOCUMENTING NONCOMPLIANCES...................................................................... 6 06.01 Types of Noncompliances..................................................................................... 6 06.02 Supporting Details and Discussions of Safety or Safeguards Significance........... 7 06.03 Violations Involving Willfulness............................................................................. 8 0616-07 DOCUMENTING VIOLATIONS USING THE FOUR-PART FORMAT........................ 8 07.01 Introduction............................................................................................................ 9 07.02 Description.......................................................................................................... 10 07.03 Analysis............................................................................................................... 10 07.04 Enforcement........................................................................................................ 11 07.05 Unresolved Item Closure..................................................................................... 11 0616-08 UNRESOLVED ITEMS (URIs................................................................................... 11 08.01 Opening............................................................................................................... 11 08.02 Follow-up and Closure........................................................................................ 12 0616-09 DISCUSSED OPEN ITEMS...................................................................................... 13 0616-10 CLOSURE OF WRITTEN EVENT REPORTS.......................................................... 13 0616-11 CLOSURE OF CITED VIOLATIONS......................................................................... 14 0616-12 VIOLATIONS WARRANTING ENFORCEMENT DISCRETION............................... 14 12.01 Enforcement Action............................................................................................. 15 12.02 Discretion............................................................................................................ 15 12.03 Unresolved Item Closure..................................................................................... 15 0616-13 LICENSEE-IDENTIFIED VIOLATIONS..................................................................... 15 13.01 Licensee-identified Violations.............................................................................. 15 13.02 Violations Identified During an Extent of Condition Review as Part of a Licensee Self-Assessment or Corrective Action Program Review..................................... 16 0616-14 MINOR VIOLATIONS, OBSERVATIONS, ASSESSMENTS, AND POTENTIAL ISSUES INVOLVING LACK OF CLARITY IN THE LICENSING BASIS................... 17 14.01 Minor Violations................................................................................................... 17 14.02 Observations/Assessments................................................................................. 18 14.03 Potential Issues Involving Lack of Clarity in the Licensing Basis........................ 18 0616-15 OTHER GUIDANCE.................................................................................................. 19 15.01 Treatment of Third-Party Reviews....................................................................... 19

Issue Date: 10/04/22 ii 0616 15.02 Treatment of Sensitive Unclassified Non-Safeguards Information (SUNSI) in Non-Security Related Reports............................................................................. 20 15.03 Amending Inspection Reports............................................................................. 20 15.04 Plain Language................................................................................................... 21 15.05 Graphics/Visual Aids........................................................................................... 21 15.06 Caution Regarding the Creation of Staff Positions.............................................. 21 0616-16 GUIDANCE FOR INSPECTION REPORT CONTENT............................................. 21 16.01 Cover Letter......................................................................................................... 22 16.02 Cover Page......................................................................................................... 25 16.03 Summary............................................................................................................. 25 16.04 Table of Contents (if applicable).......................................................................... 25 16.05 Plant Status......................................................................................................... 25 16.06 Inspection Scope................................................................................................. 26 16.07 Inspection Results............................................................................................... 27 16.08 Exit Meetings and Debriefs................................................................................. 27 16.09 Third Party Reviews (if applicable)...................................................................... 28 16.10 Documents Reviewed......................................................................................... 28 16.11 Report Attachments (if applicable)...................................................................... 28 16.12 List of Acronyms (if applicable)............................................................................ 28 16.13 Cover Letter Enclosures (if applicable)................................................................ 28 0616-17 RELEASE AND DISCLOSURE OF INSPECTION REPORTS AND ASSOCIATED DOCUMENTS........................................................................................................... 29 17.01 General Public Disclosure and Exemptions........................................................ 29 17.02 Release of Investigation-Related Information...................................................... 29 Appendix A: List Of Acronyms And Abbreviations Used in this IMC................................... AppA-1 Exhibit 1: Standard Fuel Cycle Facilities Inspection Report Outline..................................... Ex1-1 : Revision History for IMC 0616....................................................................... Att1-1

Issue Date: 10/04/22 1

0616 0616-01 PURPOSE 01.01 Provide guidance on inspection report content, format, and style for preparing fuel cycle inspection reports.

01.02 Provide screening criteria to determine the minor and more-than-minor threshold for violations.

01.03 Ensure that all violations of U.S. Nuclear Regulatory Commission (NRC) requirements by fuel cycle facility licensees are appropriately dispositioned in accordance with the "NRC Enforcement Policy."

0616-02 OBJECTIVES 02.01 Clearly communicate significant inspection results in a consistent manner to licensees, NRC staff, and the public.

02.02 Provide conclusions about the effectiveness of the programs or activities inspected. The depth and scope of the conclusions should be commensurate with the depth and scope of the inspection.

02.03 Document the basis for the determination of significance for any enforcement action (EA), as appropriate.

02.04 Assess licensee performance in a periodic, short-term context, and present information in a manner that will be useful to NRC management in developing longer-term, broad assessments of licensee performance such as Licensee Performance Reviews (LPRs).

0616-03 DEFINITIONS Agency Record. A record in the possession and control of the NRC that is associated with Government business.

Apparent Violation. A situation or circumstance that does not appear to meet NRC requirements and for which the NRC staff has not made a final enforcement determination. This definition is typically used to characterize potential Severity Level (SL) III or higher violations being considered for escalated EA or violations being considered for enforcement discretion.

Certificate Holder. An entity responsible for meeting certain NRC requirements defined in an NRC-issued Certificate of Compliance (CoC) (e.g., Title 10 of the Code of Federal Regulations (10 CFR) Parts 71 or 72). Note that for the purposes of this Inspection Manual Chapter (IMC),

the use of the term licensee includes certificate holder.

Closed Item. A matter previously reported as a violation, a written event report, or an unresolved item (URI), that the inspector concludes has been satisfactorily addressed based on information obtained during the current inspection.

Conclusion. An assessment that relates inspection results to the broader context of a licensee program.

Issue Date: 10/04/22 2

0616 Controlled Unclassified Information Program (CUI). Information that requires safeguarding or dissemination controls pursuant to and consistent with applicable law, regulations, and governmentwide policies.

Deviation. A licensees failure to satisfy a written commitment, such as a commitment to conform to the provisions of applicable codes, standards, guides, or accepted industry practices when the commitment, code, standard, guide, or practice involved has not been made a requirement by the Commission.

NOTE: For 10 CFR Part 21 and vendor inspections, the term deviation generally refers to the definition given in Part 21 (i.e., a departure from the technical requirements included in a procurement document).

Escalated Enforcement Action. A Notice of Violation (NOV) for any SL-I, II, or III violation (or problem); a civil penalty; or order based on a violation.

Inspection. The examination and assessment of any licensee activity regulated by the NRC to determine its effectiveness, to ensure safety, and/or to determine compliance. A single inspection report may encompass resident inspection, in-office document review, and/or one or more visits by Regional or Headquarters inspectors; however, a single report is normally limited to a specific period of inspection.

Inspection Document. Any material obtained or developed during an inspection that is considered to be an agency record (see above).

Integrated Inspection Reports. A fuel facility inspection report that typically combines inputs from all inspections (resident, regional, etc.) conducted within a specific period prescribed by management. Reactive inspections or other inspection activities may be reported separately from integrated reports. Typically, integrated reports are issued for all operating fuel facility sites, with and without resident inspectors, and are issued each quarter to communicate our continued oversight and assessment of the facility to the public.

Licensee. The holder of an NRC license, construction permit, or combined license. The provisions listed as applicable to licensees in this IMC are also applicable to vendors, facility clearance, and certificate holders.

Licensee-Identified. Licensee-identified violations are identified as a result of deliberate observation by licensee personnel. Examples of deliberate observations that result in licensee-identified violations include (1) those identified during activities such as post maintenance testing, operator rounds, engineering walkdowns, or audits; and (2) degraded conditions identified during testing which do not result in test failure.

Minor Violation. A violation that is less significant than a Severity Level IV. Minor violations do not warrant enforcement action and are not normally documented in inspection reports.

However, minor violations must be corrected (See NRC Enforcement Policy section 2.2.2.e).

Appendix B to this IMC provides the minor screening criteria and examples of violations that can be considered minor.

Non-Cited Violation. A method for dispositioning a Severity Level IV violation that meets the criteria in section 2.3.2 of the "NRC Enforcement Policy."

Issue Date: 10/04/22 3

0616 Noncompliance. A violation (regardless of whether it is cited or not), nonconformance, or deviation.

Nonconformance. A vendors or CoC holders failure to meet a contract requirement related to NRC activities, where the NRC has not placed the requirement directly on the vendor or CoC holder.

Notice of Violation. A written notice setting forth one or more violations of a legally binding requirement (see 10 CFR 2.201, Notice of Violation).

NRC-Identified. See NRC Enforcement Policy section 2.3.4.b.1 and 2.3.4.b.2.

Observation. A factual detail noted during an inspection which is documented in an inspection report when the governing inspection procedure allows.

Potential Violation. A potential noncompliance with a regulatory requirement, regardless of possible significance or severity level, that has not yet been formally dispositioned by the NRC.

Regulatory Commitment. An explicit statement to take a specific action, agreed to or volunteered by a licensee, where the statement has been submitted in writing on the docket to the NRC. This may include a response to an NOV, a commitment as part of a performance improvement program, etc.

Regulatory Requirement. A legally binding obligation such as a statute, regulation, license condition, or Order that is enforceable by the NRC.

Self-Revealed. Self-revealed violations are those identified as a result of a condition that (1) become apparent through a readily detectable degradation in material condition, capability, or functionality of equipment or plant operations; and (2) does not meet the definition of licensee-identified or NRC-identified. Includes violations identified through an event. See NRC Enforcement Policy sections 2.3.4.b.1 and 2.3.4.b.2.

Sensitive Unclassified Non-Safeguards Information (SUNSI). Any information of which the loss, misuse, modification, or unauthorized access can reasonably be foreseen to harm the public interest, the commercial or financial interests of the entity or individual to whom the information pertains, the conduct of NRC and Federal programs, or the personal privacy of individuals.

Stand-alone Inspection Reports. A fuel facility inspection report that is typically issued for a specific inspection activity that is not documented in an integrated inspection report. Typically, stand-alone reports are issued for INFOSEC, MC&A, Physical Security, reactive, and supplemental inspections.

Unresolved Item. An issue associated with an inspection activity that requires more information to determine if it constitutes a noncompliance.

Vendor. A supplier of products or services to be used in an NRC-licensed facility or activity. In some cases, the vendor may be an NRC or Agreement State licensee (e.g., nuclear fuel fabricator, radioactive waste broker) or the vendors product may be required to have an NRC CoC (e.g., certain transport packages such as spent fuel casks).

Violation. The failure to comply with a requirement.

Willfulness. See NRC Enforcement Policy section 2.2.1.d

Issue Date: 10/04/22 4

0616 0616-04 RESPONSIBILITIES All NRC inspectors assessing fuel cycle licensed activities should prepare inspection reports in accordance with the guidance provided in this IMC. General and specific responsibilities are listed below.

04.01 General Responsibilities Each inspection of a licensee, vendor, and certificate holder shall be documented in a report consisting of a cover letter, inspection report enclosure, and attachments.

04.02 Inspectors

a. Inspectors should prepare inspection reports in accordance with the guidance provided in this IMC.

b. Inspectors have the primary responsibility for ensuring that observations and noncompliances are accurately reported, that referenced material is correctly characterized, and that the scope and depth of conclusions are adequately supported by documented observations and noncompliances.

c. Inspectors are responsible for ensuring that the content of the report does not conflict with the information presented at the exit meeting. If the report will differ significantly from the information provided at the exit meeting, the inspector (or the report reviewer) should discuss those differences with the licensee before the report is issued.

d. Report writers and reviewers should ensure that inspection reports follow the general format given in this IMC, where appropriate.

e. For inspections conducted by regional and resident inspectors, the report numbers should be issued per Regional Instructions and should be consistent with Agencywide Documents Access and Management System (ADAMS) templates.

f.

The report number sequence is as follows: Docket No./Year (four digits) followed by the sequential number of the report in that year. The inspection reports number sequence for the Division of Fuel Cycle Inspection (DFFI) inspections are 0700XXXX/20YY00X or 04000XXXX/20YY00X. Safeguards and Security inspection report numbers would be 0700XXXX/20YY40X.

g. For all sites that possess classified matter, the lead inspector should ensure a screening of inspection reports is performed to verify that no classified matter is contained within public reports.

h. Inspectors should align the level of detail and scope of the inspection report with the risk of the activity.

04.03 Branch Chiefs A branch chief, or designee, familiar with NRC requirements in the inspected area shall review each inspection report, prior to issuance, to ensure that the report follows the guidance given in this IMC.

Issue Date: 10/04/22 5

0616

a. The management reviewer shall ensure that inspection noncompliances are consistent with NRC policies and technical requirements, that enforcement-related violations are addressed in accordance with the NRC Enforcement Policy and the NRC Enforcement Manual, and conclusions are logically drawn and sufficiently supported by observations and noncompliances.

b. Management should ensure that a record of inspectors and reviewers concurrences are maintained on record. Management should ensure continued inspector concurrence when substantive changes are made to the report as originally submitted, and mediate disagreements that occur during the review process. As a minimum, substantial changes should be discussed with the inspector or inspectors involved to ensure continued concurrence, and disagreements that cannot be adequately resolved should be documented using the process described in Management Directive 10.158, NRC Non-Concurrence Process.

c. The applicable branch chief is responsible for the report content, conclusions, and overall regulatory focus, and timeliness of inspection reports. Typically, stand-alone reports are issued no later than 30 calendar days after inspection completion. Inspection completion is normally defined as the day of the onsite exit meeting, or the day of the last re-exit meeting, whichever is later.

d. The branch chief is responsible for issuing integrated reports for fuel cycle facilities typically on a quarterly basis. Typically, integrated reports are issued no later than 45 calendar days after the last day of the quarter.

04.04 Division of Fuel Management (DFM) - Inspection and Oversight Branch (IOB)

a. IOB is responsible for providing interpretations and support for information contained in this IMC.

b. IOB is responsible for answering questions related to program guidance.

c. IOB is responsible for facilitating resolution of identified gaps in IMC directions and guidance.

d. IOB is responsible for updating program guidance to address identified gaps 0616-05 THRESHOLDS OF SIGNIFICANCE - SCREENING INSPECTION RESULTS When conducting inspections, the NRC inspector reviews an appropriate sample of selected procedures, events, and operations; the inspector is not expected to monitor all the activities in progress, or to document every minor discrepancy that occurs. As part of maintaining a focus on safety, inspectors continually use NRC requirements, inspection procedures, industry standards, regional and headquarters guidance, and their own training and insight to make judgments about which issues are worth pursuing and which are not.

To communicate effectively, inspection reports must reflect judgment and prioritization:

significant safety issues should be discussed in appropriate detail, and less significant issues should be discussed succinctly. To maintain some consistency in how minor issues are treated, report writers must recognize certain thresholds of significance; that is, they must use similar

Issue Date: 10/04/22 6

0616 criteria in deciding whether an issue is important enough to document, important enough to track or follow up, etc.

The NRC Enforcement Policy and NRC Enforcement Manual acknowledge that some violations of minor safety, safeguards, environmental, and regulatory concern are below the level of significance of SL-IV violations. Because of their minor nature, these minor violations are not the subject of formal enforcement action and are not usually documented in inspection reports.

Appendix B, Examples of Minor Violations, contains examples of minor issues which are violations of requirements but have insignificant safety, safeguards, or regulatory impact or have no more than minimal risk. The appendix explains how to determine whether or not the issue is minor.

0616-06 DOCUMENTING NONCOMPLIANCES The primary guidance for all matters related to enforcement, including documentation, is given in the NRC Enforcement Policy and the NRC Enforcement Manual. The following discussion summarizes certain aspects of that guidance related to inspection reports.

06.01 Types of Noncompliances The manner of documenting a noncompliance in the inspection report depends on how that noncompliance will be dispositioned. A noncompliance may be addressed as a minor violation, a non-escalated enforcement action (i.e., a cited SL-IV violation or non-cited violation (NCV), a deviation, or a nonconformance), an apparent violation (AV), or as an escalated enforcement action (i.e., a SL-I, II, or III violation).

Note that if an issue is described in an inspection report in sufficient detail to conclude that a noncompliance has occurred, then that issue must be dispositioned as a violation, an apparent violation, or an NCV (for violations); or a Notice of Deviation or Nonconformance may be issued (for deviations and nonconformances). To simply document a noncompliance as a weakness, licensee failure, observed discrepancy, or similar characterization without dispositioning it, is inappropriate. If a violation has not occurred, to avoid any confusion, it may be appropriate in certain situations to include a statement such as, this issue does not constitute a violation of NRC requirements. If it cannot be determined if a noncompliance exists due to insufficient information from either the licensee or NRC, it may be treated as a URI. Note that minor violations are not normally documented in inspection reports (See 0616-12, Minor Violations).

a. Non-Escalated Enforcement Actions. Most violations of low significance (i.e., more than minor concerns) fall into the SL-IV category. If at the time of issuing the inspection report a violation has been categorized at SL-IV, then an NOV is generally sent out with the inspection report, as a non-escalated EA. The cover letter for reports that include non-escalated EAs should follow the appropriate NRC Enforcement Manual guidance.

Whether an NOV accompanies the report or is issued later, the designation of SL is made in the NOV itself. However, to substantiate the significance of the violation, the four-part format (section 0616-07) should contain the logic for determining the significance with possible reference to a specific NRC Enforcement Policy violation example, if applicable.

Issue Date: 10/04/22 7

0616 Deviations and nonconformances are also considered non-escalated enforcement actions. When a licensee fails to meet a regulatory commitment or to conform to the provisions of an applicable code or industry standard, the failure may result in a Notice of Deviation. When a vendor or certificate holder fails to meet a contract requirement related to NRC activities, the failure may result in a Notice of Nonconformance. For specific guidance on documenting deviations and nonconformances, see NRC Enforcement Manual sections 4.4 and 4.5, respectively.

b. Non-Cited Violations. The criteria for dispositioning a violation as an NCV is laid out in the NRC Enforcement Policy, section 2.3.2. SL-IV violations that are self-revealing or NRC-identified at facilities with an NRC-approved CAP should be dispositioned as NCVs using the four-part write-up as described in section 0616-07, Documenting Violations Using the Four-Part Format. Licensee-identified SL-IV violations at facilities without an NRC-approved CAP should also be documented using section 0616-07. Licensee-identified SL-IV violations at facilities with an NRC-approved CAP that meet the NCV criteria should be dispositioned with minimal documentation, as described in section 0616-13, Licensee-Identified Violations.

c. Potential Escalated Enforcement Actions. When an issue is being considered for escalated EA, the inspection report should refer to the potential violation as an apparent violation. The report should not include any speculation on the SL of such violations nor on expected NRC enforcement sanctions. Potential EAs, by their nature, require further Agency deliberation (and, usually, additional licensee input) to determine the appropriate SL and NRC action.

Similarly, reports that discuss apparent violations should be carefully constructed to avoid making explicit conclusions (i.e., final judgments) about the safety or safeguards significance of the issue. The report should include any available details that demonstrate safety or safeguards significance, or that would help in making such a decision and should also describe any corrective actions taken or planned by the licensee. However, because a potential escalated enforcement action automatically entails further evaluative steps, neither the inspection report details nor the accompanying cover letter should present a final judgment on the issue.

06.02 Supporting Details and Discussions of Safety or Safeguards Significance The discussion of violations must be sufficiently detailed to substantiate any NRC safety, safeguards, and regulatory concerns and to support any enforcement action (EA) the NRC may choose to issue. The degree of detail necessary to support an EA is a function of the significance and complexity of the violation. At a minimum, for a violation, the report should state:

a. What requirement was violated;

b. How the violation occurred;

c. When the violation occurred and how long it existed;

d. Who identified it, and when;

e. Any actual or potential safety consequence;

Issue Date: 10/04/22 8

0616

f.

The root cause (if identified); Whether the violation appears isolated or programmatic;

g. What corrective actions have been taken or planned; and

h. Who was involved with the violation (i.e., management, operators, technicians)?

Although supporting details clearly assist in determining the safety or safeguards significance of violations, inspectors should be cautious in making direct statements regarding safety or safeguards significance in the inspection report details. Violation SLs, as described in the NRC Enforcement Policy," are based on the degree of safety or safeguards significance involved. In assessing the significance of a violation, the NRC considers four specific issues: (1) actual safety or safeguards consequences; (2) potential safety or safeguards consequences, including the consideration of risk information; (3) potential for impacting the NRCs ability to perform its regulatory function; and (4) any willful aspects of the violation. As a result, if an inspection report refers to a violation as being of low safety or safeguards significance (the meaning of which could be interpreted as implying that the violation did not result in any actual adverse impact on equipment or personnel), the writer may have inadvertently made it difficult for the NRC to subsequently decide that the potential for an adverse impact or the regulatory significance of the violation warrants issuance of a SL-III violation.

Therefore, when characterizing the safety or safeguards significance of a violation, the inspector should address both the actual and potential safety or safeguards and regulatory consequences.

06.03 Violations Involving Willfulness Inspection reports should neither speculate nor reach conclusions about the intent behind a violation, such as whether it was deliberate, willful, or due to careless disregard. As with any observation, the report discussion should include relevant details on the circumstances of the violation without making a conclusion about the intent of the violator.

EXAMPLE: The technician failed to follow established sampling procedures, although he had informed the inspectors earlier that he had been properly trained on the use of the proper tools and technique; not, The technician deliberately failed to take quality assurance (QA) samples using established procedures.

Conclusions about the willfulness of a violation are agency decisions and are normally not made until after the Office of Investigation (OI) has completed an investigation. A premature or inaccurate discussion of the willfulness of an apparent violation in the inspection report could result in later conflicts based on additional input and review.

Inspection reports that include potentially willful violations are to be coordinated with OI and the Office of Enforcement (OE).

0616-07 DOCUMENTING VIOLATIONS USING THE FOUR-PART FORMAT The four-part format should be used for documenting more-than-minor violations and is organized as follows:

Introduction Description

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0616 Analysis Enforcement The following table should be used to document traditional enforcement violations, including severity level I through IV NOVs, severity level IV NCVs, and apparent violations. Note: the table for licensee identified NCVs is covered in section 0616.13, Licensee-Identified Violations.

Table 1: Traditional Enforcement Violation

[Violation Title]

Severity Report Section Severity Level [X]

NCV/NOV [Tracking Number]

Open/Closed EA-YY-XXX

[IP Number]

[07.01 - Introduction]

==

Description:==

[07.02 - Description]

Corrective Actions: [07.02a - Corrective Actions]

Corrective Action

References:

[07.02b - Corrective Action Reference]

Analysis: [07.03 - Analysis]

Enforcement:

Severity: [07.04a - Severity Level]

Violation: [07.04b - Violation]

Enforcement Action: [07.04c - Enforcement Action]

[07.05 - Unresolved Item Closure]

07.01 Introduction The introduction should be one or two sentences that provide a brief discussion of the violation. This section does not need to stand alone because the description that follows will provide the supporting details. The introduction should include:

a. The SL (or identification as an AV)

b. The identification credit (self-revealing, NRC-identified, or licensee-identified). Note that this is not appropriate for AVs.

c. The violation and whether it is an NCV, NOV, or AV.

Issue Date: 10/04/22 10 0616 Typically, an NCV is a non-willful violation. The NRC Enforcement Policy provides criteria that may allow a noncompliance to be characterized as an NCV despite evidence of willfulness. The criteria, as outlined in NRC Enforcement Policy section 2.3.2, must be met to consider this designation. The inspection report should include additional discussion to address these criteria before providing the standard conclusive language.

For example: Although this violation is willful, it was brought to the NRCs attention by the licensee, it involved isolated acts of a low-level individual without management involvement, the violation was not caused by a lack of management oversight, and it was addressed by appropriate remedial action. Therefore, this non-repetitive, licensee-identified and corrected violation is being treated as a Non-Cited Violation, consistent with section 2.3.2 of the NRC Enforcement Policy.

07.02 Description The description must describe the circumstances associated with the violation and include the supporting factual information that will be used to support the justifications used in the analysis and enforcement section determinations. Additionally, if the violation was determined to be NRC-identified because the inspector identified a previously unknown weakness in the licensees classification, evaluation, or corrective actions, the description should provide evidence that the licensee had identified the issue and had failed to properly classify, evaluate, and/or correct the problem. The description must include sufficient detail commensurate with the significance for the reader to understand the issue, evaluation of significance, and enforcement conclusions. Where applicable, the write-up should include a description of any positive licensee performance that mitigated a potential problem and influenced the significance. Most violations are based on relatively simple circumstances, can be described in less than one page and should rarely exceed two pages. Violations based on more-complex circumstances may merit more discussion.

a. Short and (if applicable) long term corrective actions taken to restore compliance or ensure adequate safety. If the planned corrective action is still being evaluated, a sentence stating why continued noncompliance does not present an immediate safety or security concern.

b. A reference to any licensees corrective action document number(s).

07.03 Analysis The level of detail must allow a knowledgeable reader to reconstruct the decision logic used to arrive at the final conclusion. The analysis must include the following as applicable:

Applicable More-than-Minor screening questions found in IMC 0616 Appendix B and the reason why that question was answered yes for the violation.

Applicable Minor/More-than-Minor example (e.g.., Operations/Chemical Safety example 1a).

Examples in NRC Enforcement Policy section 6.0, Violation Examples, aligning with SL-I through SL-IV violations, if applicable.

Issue Date: 10/04/22 11 0616 Actual and potential safety or security significance, including a discussion of the safety margin and duration of the violation, as well as the regulatory consequences.

07.04 Enforcement Violations are documented in accordance with the NRC Enforcement Policy. The enforcement section must include the following for violations which do not receive enforcement discretion (except as noted below):

a. Logic used to determine the SL of the violation including a specific reference to the NRC Enforcement Policy examples as applicable. If an NOV is being used to disposition a violation normally dispositioned as an NCV, additionally describe the circumstances in accordance with section 2.3.2 of the NRC Enforcement Policy.

Because the SL of an AV has not yet been determined, the logic should describe why the violation is being considered for escalated enforcement.

b. What requirement was violated and how it was violated (this requires a contrary to statement consistent with guidance in the NRC Enforcement Manual, using language that is parallel to that of the requirement).

c. When the violation occurred and how long it existed.

d. Specific enforcement actions, including documenting any enforcement discretion granted in accordance with an existing Enforcement Guidance Memorandum, should be documented.

e. Tracking number and title resulting from the violation (e.g., NCV, NOV, or AV [Tracking Number], Title).

f.

A statement similar to one of the following:

1. For NCVs: This violation is being treated as an NCV, consistent with section 2.3.2 of the NRC Enforcement Policy.

2. For NOVs: This violation is being cited because [reason], consistent with section 2.3.2 of the Enforcement Policy.

07.05 Unresolved Item Closure If the violation results in a URI closure, include a reference to URI [Docket Number(s)]/[Report Number]-[Unique Sequential Integer] being closed. (e.g., This closes URI 07001234/2020001-01.).

0616-08 UNRESOLVED ITEMS (URIS 08.01 Opening An inspector should open a URI when an observation is identified but more information is required to determine if the observation is a noncompliance.

A URI cannot be used to determine the significance of a violation (except when more information is needed to determine if a violation is minor or more than minor), to track

Issue Date: 10/04/22 12 0616 completion of licensees actions associated with a violation or an inspection question, or to determine if enforcement discretion should be granted for a violation. The action of documenting URIs is a commitment of future resources.

The URI should be documented using the format shown in the table below.

Table 2: Open Unresolved Item Unresolved Item (Open)

[URI Title]

[URI Tracking Number]

[IP Number]

==

Description:==

[08.01a - Description]

Planned Closure Actions: [08.01b - Planned Closure Actions]

Licensee Actions: [08.01c - Licensee Actions]

Corrective Action

References:

[08.01d - Corrective Action References]

a. The description section should describe the issue with sufficient detail to allow another inspector to complete the inspection and document the effort. The description should clearly state that a URI was identified and indicate what additional information is needed to make the enforcement determination.

b. The planned closure action section should identify the specific licensee or NRC actions needed to determine whether the issue of concern is a violation or if a violation is minor or more than minor.

c. The licensee action section should describe any corrective actions taken to eliminate any perceived immediate safety or security concerns.

d. The corrective action reference section should identify the licensees corrective action records.

URIs should not be documented in the inspection report cover letter. URIs appear under the List of Additional Tracking Items section of the report. URIs should be opened in the section for the inspection module in which they were found (e.g., Operational Safety).

08.02 Follow-up and Closure The level of detail devoted to closing URIs depends on the nature and significance of the additional information identified. Documentation of the closure of a URI must include a summary of the topic and the inspector's follow-up actions, evaluation of the adequacy of any licensee actions, and determination of whether a noncompliance has occurred.

Sufficient detail must be provided to justify closing the URI. If resolution to a URI was based on discussions between inspector(s) and DFM technical staff, concisely document the details of these discussions as the basis for the regulatory decision.

After the information needed to close a URI is obtained, document the closure as follows:

Issue Date: 10/04/22 13 0616 For a URI being closed to no violation, document the closure of the URI under the inspection procedure used to review and close the URI. The closed URI should be listed under the Additional Tracking Items section of the report and be documented in the Inspection Results.

For a URI being closed to a noncompliance, document the closure of the URI and the opening of the resultant noncompliance under the inspection procedure used to review and close the URI. The closed URI should be listed under the Additional Tracking Items section of the report and the resultant noncompliance should be listed under the List of Violations section of the report and be documented in the Inspection Results. Note:

Minor violations should not be listed under the List of Violations section of the report.

0616-09 DISCUSSED OPEN ITEMS Use the following table to document open items being discussed.

Table 3: Discussed Item

[09a - Item Type]

(Discussed)

[09b - Title and Tracking]

[IP Number]

Discussion: [09c - Discussion]

Open Items such as unresolved items, apparent violations, and notices of violation requiring a response were assigned an open tracking status in a previously issued inspection report.

Document discussed open items in the results section of the report under the inspection procedure associated with the sample or inspection activity that resulted in the opening of the item.

a. Item Type. Describe the item type (e.g., Unresolved Item).

b. Title and Tracking. Enter the previously used title and tracking number assigned when the item was opened in a prior report.

c. Discussion. Capture follow up actions, pertinent facts gathered, and observations which may support a future disposition of the item.

0616-10 CLOSURE OF WRITTEN EVENT REPORTS Fuel facilities are required to submit written reports to the NRC for certain previously reported event notifications in accordance with Parts 20, 30, 40, 70, 71, 73, and 95 requirements.

Inspectors review these written event reports and document their review and closure, including revisions to written event reports, under the inspection procedure used to review and close the WER.

In general, written event report reviews should have a brief description of the event and reference the docketed written report. If a written event report review is already documented in a separate NRC correspondence, then close the written event report with a brief statement in an

Issue Date: 10/04/22 14 0616 inspection report referencing the separate correspondence. In addition, document closure of the written event report as follows:

a. No Violations. No NRC-Identified or Licensee-Identified Violations, and no Self-revealing Violations. Include a statement similar to The Written Event Report was reviewed. No violations of NRC requirements were identified."

b. Minor Violations. Use guidance in section 0616 Appendix B, Examples of Minor Violations. Document as specified in section 0616-14, Minor Violations, Observations, Assessments, and Very Low Safety Significance Issues.

c. Licensee-identified Violations. The safety significance and enforcement should be discussed per section 0616-13, Licensee-Identified Violations.

d. NRC-Identified or Self-revealing Violations. NRC-Identified or Identified Through an Event Violations should use section 0616-07, Documenting Violations Using the Four-Part Format, if not previously documented.

0616-11 CLOSURE OF CITED VIOLATIONS After receipt of the licensees response to an NOV and completion of any necessary inspections, document the closure of cited violations under the inspection procedure used to review and close the NOV. The level of detail required to document closure of cited violations depends on the extent of corrective actions conducted by the licensee. In general, the write-up must summarize the inspector's follow-up actions to evaluate the adequacy of any licensee actions and provide enough detail to justify closing the violation.

0616-12 VIOLATIONS WARRANTING ENFORCEMENT DISCRETION Bring violations that may warrant enforcement discretion to the attention of the Regional Enforcement Coordinator. Default to any overriding directions found in an Interim Enforcement Policy, an Enforcement Guidance Memorandum, or the Enforcement Manual. Unless otherwise directed, document violations receiving enforcement discretion in the results section of the report under the applicable inspectable area. Use the following table to document violations receiving enforcement discretion.

Table 4: Enforcement Discretion Enforcement Discretion

[12.01 - Enforcement Action]

[IP Number]

==

Description:==

[07.02 - Description]

Corrective Actions: [07.02a - Corrective Actions]

Corrective Action

References:

[07.02b - Corrective Action References]

Enforcement:

Significance/Severity: [07.04a - Severity Level]

Issue Date: 10/04/22 15 0616 Violation: [07.04b - Violation]

Basis for Discretion: [12.02 - Discretion]

[12.03 - Unresolved Item Closure]

12.01 Enforcement Action Identify the Enforcement Action Number and provide a title with a reference to any applicable Enforcement Guidance Memorandum (EGM).

12.02 Discretion State why enforcement discretion is being granted. Include an appropriate statement such as:

The NRC exercised enforcement discretion in accordance with section [#.#] of the Enforcement Policy because [reason].

Note: Violations must be assigned an enforcement action (EA) number, which can be obtained through the Regional Enforcement Coordinator. The cover letter must contain the required language for exercising enforcement discretion.

12.03 Unresolved Item Closure If the granting of enforcement discretion results in a URI closure, include a reference to URI [Docket Number(s)]/[Report Number]-[Unique Sequential Integer] being closed.

(e.g., This closes URI 07001234/2020001-01.).

0616-13 LICENSEE-IDENTIFIED VIOLATIONS NRC policy requires that all identified violations be dispositioned in accordance with the NRC Enforcement Policy, regardless of who identified them. Particular attention should be given to screening all documented violations captured in docketed communications such as those associated with required reporting (10 CFR 40.60, 70.50, 70.52, 71.95, 73.71, 74.11, 74.43, 74.57, 74.59, 20.2201, 20.2202, 20.2203, and 95.57) and voluntary reports submitted at the licensee's discretion.

13.01 Licensee-identified Violations Licensee-identified violations which meet the requirements for an NCV in accordance with NRC Enforcement Policy section 2.3.2 and are associated with a facility with an NRC-approved CAP, should receive minimal documentation, using the Traditional Enforcement Violation table with abbreviated writeups, shown below.

Issue Date: 10/04/22 16 0616 Table 1a: Licensee-Identified NCV Licensee Identified NCV Severity Report Section Severity Level IV NCV [Tracking Number]

Closed

[IP Number]

[13.01a - Introduction]

==

Description:==

[13.01b - Description]

Corrective Action

References:

[13.01c - Corrective Action References]

Analysis: [13.01d - Analysis]

Enforcement:

Severity: [13.01e - Basis for Severity Level Determination]

Enforcement Action: This violation is being treated as a non-cited violation, consistent with section 2.3.2 of the Enforcement Policy.

[13.01f - Unresolved Item Closure]

For licensee-identified NCVs, document the following:

a. Introduction. Insert a sentence stating that a licensee-identified, Severity Level IV non-cited violation is documented below.

b. Description. Briefly describe (a few sentences) what requirement was violated and how it was violated (this requires a contrary to statement consistent with the guidance in the Enforcement Manual).

c. Corrective Action References. Provide a reference to the licensees corrective action document number.

d. Analysis. This section should be marked N/A.

e. Severity. Briefly describe the SL-IV categorization in accordance with the NRC Enforcement Policy examples.

f.

Unresolved Item Closure. If the violation results in a URI closure, include a reference to URI [Docket Number(s)]/[Report Number]-[Unique Sequential Integer] being closed.

(e.g., This closes URI 07001234/2020001-01.).

13.02 Violations Identified During an Extent of Condition Review as Part of a Licensee Self-Assessment or Corrective Action Program Review Under certain circumstances, a violation that can be classified as a non-cited violation (NCV) does not require documentation. This is generally justified when the licensee identifies a violation (or violations) via an extent of condition effort initiated by a self-assessment or corrective action program further examples of the violations exist. The inspector is not expected to cite the four violations nor report the details of those

Issue Date: 10/04/22 17 0616 violations in the inspection report. Instead, the NRC report should assess the adequacy of the licensees extent of condition effort, including a clear reference to the name, dates, and general subject matter of the self-assessment or corrective action program initiative.

NOTE: This expectation only applies to SL-IV and non-willful violations. All violations that could be categorized at SL-III or above must be documented in the inspection report using the four-part write-up and given appropriate follow-up.

0616-14 MINOR VIOLATIONS, OBSERVATIONS, ASSESSMENTS, AND POTENTIAL ISSUES INVOLVING LACK OF CLARITY IN THE LICENSING BASIS Minor violations and observations are not routinely documented in inspection reports. However, observations may be documented when specifically allowed by an inspection procedure or temporary instruction.

14.01 Minor Violations Minor violations should only be documented when it becomes necessary to capture a required inspection activity or conclusion for the record such as closing out a written event report or URI. When a minor violation is documented, sufficient detail must be provided to allow an informed, independent reader to understand the basis for the minor determination (See the NRC Enforcement Manual section 2.1.1 for more information).

Minor violations should not be included in the List of Violations section or Additional Tracking Items section of the report. Document minor violations in the results section of the report under the applicable inspectable area, when necessary. For minor violations, document using the following table:

Table 5: Minor Violation Minor Violation

[IP Number]

Minor Violation: [14.01a - Minor Issue Description]

Screening: [14.01b - Minor/More than Minor Screening Text]

Enforcement: [14.01c - Enforcement]

[14.01d - Unresolved Item Closure]

a. Minor Issue Description. Briefly describe the minor violation.

b. Minor/More than Minor Screening. State the reason why the violation is minor in accordance with IMC 0616, Appendix B, More-than-Minor screening questions or the NRC Enforcement Policy as applicable.

c. Enforcement. State that the licensee has taken actions to restore compliance and include a statement similar to the following: This failure to comply with [requirement]

constitutes a minor violation that is not subject to enforcement action in accordance with the NRC Enforcement Policy.

Issue Date: 10/04/22 18 0616

d. Unresolved Item Closure. If the minor violation results in a URI closure, include a reference to URI [Docket Number(s)]/[Report Number]-[Unique Sequential Integer] being closed. (e.g., This closes URI 07001234/2020001-01.).

14.02 Observations/Assessments.

When specifically allowed by the IP, document observations in the results section of the report under the applicable inspectable area. Use the following table to document observations:

Table 6: Observation Observation: [Observation Title]

[IP Number]

[Observation Description]

Document the corrective action program and other supplemental (e.g., assessment conclusion regarding holding open or closing a cited violation) or infrequent abnormal assessments in the results section of the report using the following table. Note assessments are different than observations because observations only communicate factual details and do not draw conclusions.

Table 7: Assessment Assessment

[IP Number]

[Assessment Description]

14.03 Potential Issues Involving Lack of Clarity in the Licensing Basis.

Use the following table to document issues in accordance with the Potential Issues Involving Lack of Clarity in the Licensing Basis process defined in IMC 2600. Do not use this table to document an issue that is a more than minor violation.

Issue Date: 10/04/22 19 0616 Table 8: Potential Issue Involving Lack of Clarity in Licensing Basis Potential Issue Involving Lack of Clarity in Licensing Basis: [14.03a - Title]

[IP Number]

This issue is a current licensing basis question and inspection effort is being discontinued in accordance with the Potential Issue Involving Lack of Clarity process. No further evaluation is required.

==

Description:==

[14.03b - Description]

Licensing Basis: [14.03c - Licensing Basis]

Significance/Severity: [14.03d - Significance]

Corrective Action

Reference:

[14.03e - Corrective Action Reference #]

[14.03f - Unresolved Item Closure]

a. Title. Include a title which describes the issue

b. Description. Describe the circumstances associated with the issue.

c. Licensing Basis. Describe the licensees supporting basis on why the issue of concern is not in their licensing basis and any relevant information on the licensing basis developed during the inspection.

d. Significance/Severity. Describe the logic used to determine that the issue of concern would not have screened as more than Severity Level IV per the NRC Enforcement Policy and per IMC 0616 Appendix B.

e. Corrective Action Reference #. If documented by the licensee, provide a reference to any corrective action program document the licensee generated as a result of discussions regarding the issue.

f.

Unresolved Item Closure. If a potential issue involving lack of clarity in the licensing basis results in the closure of a pre-existing URI, include a reference to the URI [Docket Number/Report Number-sequential integer] being closed to this issue. (e.g., This issue closes URI 070XXXXX/2020001-01).

0616-15 OTHER GUIDANCE 15.01 Treatment of Third-Party Reviews Detailed NRC reviews of Institute of Nuclear Power Operations (INPO) evaluations, findings, recommendations, and corrective actions, or other third party reviews with similar information are not referenced in NRC inspection reports, tracking tools, or other agency documents unless the issue is of such safety significance that no other reasonable alternative is acceptable. INPO findings, recommendations and associated licensee corrective actions are not normally tracked by the NRC. If a finding is of such

Issue Date: 10/04/22 20 0616 safety significance that it warrants tracking, it should be independently evaluated, inspected, documented, and tracked as a URI.

INPO findings, recommendations, corrective actions, and operating experience which are placed in the licensees corrective action program, can be considered appropriate for inspection. Additionally, when documenting review of these issues, inspection reports should not refer to any proprietary INPO reports or documents, INPO reference numbers, or identify specific sites when referencing operating experience. If it is necessary to document review of an INPO document (i.e., an evaluation referring to the INPO document was an inspection sample), then state the reference number of the reviewed item and provide general words for the title, if applicable (e.g., Condition Report 235235 concerning industry information on pumps.)

If documenting review of an INPO evaluation, in accordance with Executive Director of Operations Policy 220, include a short statement that the review was completed. Do not include a recounting or listing of INPO findings or reference a final INPO rating when documenting an INPO evaluation. Discuss the specifics of any significant differences between NRC and INPO perceptions with regional management.

15.02 Treatment of Sensitive Unclassified Non-Safeguards Information (SUNSI) in Non-Security Related Reports SUNSI must not be made publicly available and must be segregated from other portions of the report which are to be made publicly available. This can typically be accomplished by creating and referencing a separate report enclosure which can be profiled in ADAMS as Non-Publicly Available. The documents containing SUNSI must be marked in accordance with Management Directive 12.6, NRC Sensitive Unclassified Information Security Program. The NRC policy for handling, marking, and protecting SUNSI is publicly available on the NRC Public Web site at https://www.nrc.gov/docs/ML0417/ML041700603.pdf.. Additional staff guidance for handling of SUNSI is published on the NRC internal Web site at https://drupal.nrc.gov/sunsi.

The CUI program will replace the NRCs current SUNSI program on November 1, 2023.

CUI will include Safeguards Information and other categories of unclassified information that were not included in SUNSI but that nonetheless require protection, or are permitted to be protected, under law, regulation, or governmentcywide policy.

15.03 Amending Inspection Reports When it becomes necessary to correct an issued report, the previously issued report should generally be revised and reissued in its entirety under the same inspection report number. The revised report would receive a new and unique ADAMS accession number and should include an appropriate cover letter explaining why the report is being reissued. Note that a revised inspection report must not be used to document new violations or inspection activities which occurred after the initial report was issued. Also, note that depending on the nature of the correction, it may be more appropriate to discuss the change in a future report, rather than to go back and reissue a complete report.

Issue Date: 10/04/22 21 0616 15.04 Plain Language Inspectors will use plain language in reports. For additional guidance, inspectors should refer to NUREG-1379, NRC Editorial Style Guide.

15.05 Graphics/Visual Aids Use graphics (drawings, diagrams, photographs, or photocopies) if their inclusion will simplify describing a complex condition that would otherwise require substantially more text. Photographs of plant areas or equipment or photocopies of technical or vendor manual pages must be handled in accordance with IMC 0620, Inspection Documents and Records. When including graphics, the following should be considered:

a. Format as a jpeg and adjust size (height, width, and resolution) so as not to significantly increase overall file size.

b. Locate on less than 1/2 page or put in an attachment.

c. Center on page and left/right indented from the text.

d. Include a unique identifier (Figure/Diagram/Photograph X) with a descriptive title (e.g.,

Breaker Trip Latch Alignment).

15.06 Caution Regarding the Creation of Staff Positions The statement No violations of more than minor significance were identified does not create a staff position. This language acknowledges the possibility that noncompliances existed but were not documented in the report (e.g., because the inspectors did not discover them or because any identified noncompliances were found to be minor).

However, if the inspection report states, The licensee complied with [Requirement X],

as related to an issue of concern, that language would constitute a staff position. If the NRC subsequently determined there is a noncompliance with Requirement X related to the issue of concern, then the NRC may need to consider that discovery a change in staff position subject to the backfitting provision.

As such, the staff must exercise caution and avoid creating staff positions by not documenting statements about the adequacy of the licensing basis or statements about licensee compliance (some exceptions may apply depending on the type of inspection).

0616-16 GUIDANCE FOR INSPECTION REPORT CONTENT Inspection results shall be reported to the licensee by issuance of an inspection report consisting of a cover letter signed by the cognizant Branch Chief, Division Director, Regional Administrator, or other designee, depending on the significance of any violations, an NOV if applicable, an inspection cover sheet, and report details.

The NRC Inspection Report is the document that states the official Agency position on the inspection scope, any observations, assessments, noncompliances, and/or URIs noted by the inspectors, and any conclusions that were reached relating to the inspection. All enforcement, routine and escalated, and all other Agency actions that may result from an inspection (such as

Issue Date: 10/04/22 22 0616 Orders), will be based upon the associated inspection report. Inspection reports must be clear, accurate, consistent, and complete.

This section provides guidance on the contents of inspection reports for fuel facility inspections.

Region II DFFI or DFM may prepare additional instructions or guidance on inspection reports based on the specific needs of the programs they manage. Flexibility is provided in this area because of the many disciplines covered by fuel cycle inspections. Because fuel cycle inspections cover a variety of inspections, the inspector is advised to use the template for the particular discipline as a starting point. Some disciplines call for a more detailed description than others. In general, provide enough detail that the report will be understandable and useful in the subsequent inspection(s).

16.01 Cover Letter The purpose of the cover letter is to transmit the inspection report results. Inspection reports are transmitted using a cover letter from the applicable NRC official as delegated by NRC headquarters or the regions to the designated licensee executive.

a. Cover Letter Content. Cover letter content varies somewhat depending on whether the inspection identified violations. In general, however, every cover letter is based on a standard letter from the NRC Enforcement Manual Appendix B (https://www.nrc.gov/reading-rm/basic-ref/enf-man/app-b.html) and has the same basic structure, as follows:

Addresses, Date, and Salutation. At the top of the first page, the cover letter begins with the NRC seal and address, followed by the date on which the report cover letter is signed and the report issued.

For cover letters transmitting report details with violations assigned an EA number, the EA number should be placed in the upper left-hand corner above the principal addressees name. The EA number should be placed into the ADAMS profile of the document for the case/reference number. Additionally, on event-related documents, the Nuclear Materials Events Database (NMED) number or Fuel Cycle Nuclear Materials Events Database (FCNMED) number should also be included on the document below the EA number.

b. The name and title of the principal addressee is placed at least four lines below the letterhead, followed by the licensees name and address. Note that the salutation is placed after the subject line.

c. Subject Line. The subject line of the letter should state the facility name (if it is not apparent from the Addressee line), the docket or license number, and inspection subject.

The words NOTICE OF VIOLATION (or NOTICE OF DEVIATION, etc.) should be included if such a notice accompanies the inspection report. The entire subject line shall be capitalized.

d. Introductory Paragraphs. The first two paragraphs of the cover letter should give a brief introduction, including the type of inspection report, except for security and safeguards reports.

e. Body. The body of the letter should discuss the most important topics first.

Issue Date: 10/04/22 23 0616 The cover letter is written to transmit the inspection report to the licensees management, and to deliver the big picture message regarding the inspection.

Because it is the highest-level document, it does not need to (and normally will not) detail all the items inspected and the inspection procedures used. It will note the areas covered by the inspection. The cover letter must never contain any significant information which is not also contained in the summary and supported in the report details.

The tone of the cover letter must have a correct balance. The NRC focuses on performance issues. If a licensee performed some activity 100 times, and succeeded 99 times, we will be most interested in the single failure. But that does not mean that the cover letter will make it appear that the licensee rarely did succeed. The safety and regulatory significance of any licensee failure will be a primary consideration, above and beyond the numerical frequency of failure compared to success.

The cover letter must always be consistent with the inspection report. In addition, it must be consistent with the information which the inspector conveyed to licensee managers at the exit meeting. If the inspectors understanding of the facts or the significance of the violations changes after the exit meeting, the NRC shall call the licensee and re-exit. The re-exit should be documented in the cover letter. There should never be any surprises in a cover letter to anyone who was present at the exit meeting.

Lastly, the cover letter usually should not contain recommendations. There should not be any statements to the effect, The licensee needs to... or, The licensee should.... If the licensee is not meeting safety or regulatory requirements, the statements should clearly show those facts. If the NRC believes that a licensee cannot ensure the safety of its activities, then an Order or some similar official action may be appropriate. Guiding licensee decision-making using a cover letter to an inspection report is not the appropriate method for accomplishing this type of action.

The content of a publicly-available cover letter to a non-public inspection report and NOV should be limited. The cover letter should closely follow the template provided in the Enforcement Manual. The number and SL of the violations identified should be stated, if the violations are NCVs or SL-IV violations. The number of violations pertaining to escalated enforcement should also be stated; however, the specific severity level should not be given. In all cases, the content of the violations shall be withheld, and the NOV shall not be included on the public docket. The specific regulation that the licensee was in violation of should not be specified. The type of inspection (Material Control and Accounting (MC&A), physical security, information security, etc.) should not be specified in the publicly-available cover letter.

A publicly-available cover letter should accompany all security and safeguards -related inspection reports that include enforcement information, including but not limited to:

choice letters, conference letters, predecisional enforcement letters, and final determination letters. In the instance that a security or safeguards-related inspection report does not contain a NOV, the publicly-available cover letter should clearly state this.

However, in rare and exceptional instances, the NRC may choose not to release a cover letter or enforcement document with security-related violations when the information could potentially increase the security risk of a licensee or when another Federal agency requests the NRC not to issue any public notifications regarding a specific event. On a

Issue Date: 10/04/22 24 0616 case-by-case basis, NRC senior management from the office issuing the cover letter of an enforcement document, the Office of Nuclear Security and Incident Response (NSIR), the Office of Enforcement (OE), the Office of the General Counsel (OGC) and the Office of Investigations (OI) (for cases involving OI reports) will determine when withholding a cover letter of an enforcement document is appropriate after reviewing specific circumstances of the case.

f.

Closing. The final paragraph consists of standard legal language that varies depending on whether enforcement action is involved.

The signature of the appropriate NRC official is followed by the docket number(s),

license number(s), enclosures, and cc: list. The distribution list is then on the concurrence page. The LISTSERV cc is meant for external recipients and the distribution list is for internal recipients. An example is below.

Docket No. 70-XXXX License No. SNM-XXXX

Enclosure:

As stated cc w/ encl: Distribution via LISTSERV DISTRIBUTION:

X. XXXX, RII (Director)

X. XXXX, RII (BC)

X. XXXX, RII (SRI)

X. XXXX, RII (SPI)

X. XXXX, RII (PI)

X. XXXX, NMSS (PM)

PUBLIC Add additional NRC staff to the distribution list if needed.

g. NOV (If Applicable). Licensees are officially notified that they have failed to meet regulatory requirements when NRC issues an NOV. An NOV may be sent to licensees as part of a package of documents which also includes a cover letter and associated inspection report. An NOV may be sent with a cover letter which refers to an inspection report that was distributed previously. An NOV should not be sent to the licensee in advance of the inspection report.

Every NOV must be clear, so that there is little doubt that the licensee (or other interested reader) can understand the basis for the violation. The licensee may not agree with the NRC basis, but they must understand the NRC position.

Every NOV must clearly state what requirement was not met. That may mean that the date and revision number of the applicable document will need to be provided. Then, a clear statement of what happened (including when and for how long, if the timing is important) will be provided. The intention is that any interested reader will be able to clearly see and understand what the requirement was and how it was not met. For additional guidance on documenting violations, refer to the NRC Enforcement Manual.

Issue Date: 10/04/22 25 0616 The NOV should be an enclosure to the cover letter. Additional guidance on EAs is found in section 0616-06 of this document.

16.02 Cover Page The report cover page gives a brief summary of information about the inspection. It contains the docket/certificate number, report number, Enterprise Identifier, licensee, facility name, location, dates of inspection, names and titles of participating inspectors, and name and title of the approving NRC manager.

16.03 Summary Include a paragraph similar to the following and modify it to accurately describe the content of the report regarding violations, and licensee identified violations.

The U.S. Nuclear Regulatory Commission (NRC) continued monitoring the licensees performance by conducting a(n) [integrated] inspection at [Site Name], in accordance with the fuel cycle facility inspection program. This is the NRCs program for overseeing the safe operation of licensed fuel cycle facilities. Refer to https://www.nrc.gov/materials/fuel-cycle-fac.html for more information.

a. List of Violations. Copy the violation headers from the write-ups done for section 0616-07, Documenting Violations using the Four Part Writeup, and section 0616-13, Licensee Identified Violations. Organize the violation headers by the order they appear in the report. If no violations were identified, include a statement similar to No violations of more than minor significance were identified., as appropriate under the List of Violations section.

b. Additional Tracking Items. Include a list of items opened, closed, and discussed which are not directly covered in the list of violations above. For each listed item, include the item type, tracking number, title, status, (i.e., Open, Closed, or Discussed), and a reference to the appropriate report section.

16.04 Table of Contents (if applicable)

For reports that are considered complicated or are of significant length (e.g., the Report Summary section to the Exit Meetings and Debriefs section is more than 20 pages long),

the writer should include a table of contents as an aid to clarity. This requirement does not apply to routine integrated and stand-alone inspection reports.

16.05 Plant Status Include a Plant Status section, if appropriate. Briefly describe the overall operations at the facility and plant status for the report period. An example of plant status would be that normal production activities were ongoing or list degraded conditions which significantly affected operations. This summary is not needed for some inspections since plant operating status may not be relevant. Example plant status statements are as follows:

During the inspection period, routine fuel manufacturing operations and maintenance activities were conducted in the fuel processing areas, Uranium Recovery (UR) facility, and in the Research and Test Reactors and Targets (RTRT) facility.

Issue Date: 10/04/22 26 0616 The Framatome facility converts uranium hexafluoride (UF6) into uranium dioxide (UO2) for the fabrication of low-enriched fuel assemblies used in commercial light water reactors. During the inspection period, normal operations were ongoing.

16.06 Inspection Scope This section details the specific items such as equipment or programs that were inspected and the regulatory standards that were used to determine if the licensee was in compliance. In most cases, the approach that should be used in writing the scope should be consistent with the Inspection Procedure (IP) used in performing the inspection. When describing the Scope, it is acceptable to state either what the inspector(s) did, or what the inspection accomplished. That is, a Scope section could be phrased, This inspection included a review (or observation, or evaluation, etc.) of.... or it could be written as, The inspectors reviewed (observed, evaluated) the.... The Scope statements should also describe why certain items were inspected. For example,...to determine compliance with....

There should always be a readily identifiable connection between the stated Scope and the items that the inspector reviewed. Thus, if the Scope was to review personnel dosimetry records, the inspector should not include issues associated with packaging and shipping problems. The scope may, when germane to the inspection, include (1) how the inspection was conducted (i.e., the methods of inspection), (2) what was inspected, (3) approximately when each activity was performed, (4) where the inspection took place (i.e., what room(s) or buildings) and (5) the inspection objectives and/or criteria for determining whether the licensee is in compliance.

a. Scope Paragraph. Include a paragraph similar to the following one at the beginning of the scope sections:

Inspections were conducted using the appropriate portions of the inspection procedures (IPs) in effect at the beginning of the inspection unless otherwise noted. Currently approved IPs with their attached revision histories are located on the public website at http://www.nrc.gov/reading-rm/doc-collections/insp-manual/inspection-procedure/index.html. Inspections were declared complete when the IP requirements most appropriate to the inspection activity were met consistent with Inspection Manual Chapter (IMC) 2600, Fuel Cycle Facility Operational Safety and Safeguards Inspection Program. The inspectors reviewed selected procedures and records, observed activities, and interviewed personnel to assess licensee performance and compliance with Commission rules and regulations, license conditions, site procedures, and standards.

b. Individual Inspection Scopes. Following the general scope paragraph, subsequent sections include, when appropriate, the Functional Areas that are used in the Licensee Performance Review Process (IMC 2604). These Functional Areas are Safety Operations, Safeguards, Radiological Controls, Facility Support and Other Areas. These Functional Areas are further divided into sections defined by the inspection procedures, as listed in IMC 2600, Appendix B, NRC Core Inspection Requirements. For inspection activities performed, identify the report section by the IP number and title. Then include a scope section about the specific inspection activity. An example is shown below.

Issue Date: 10/04/22 27 0616 88020 - Operational Safety This is the scope text for IP 88020.

Identification of Safety Controls and Related Programs (IP section 02.01)

This is the scope text for section 02.01. The inspectors reviewed the following safety controls:

Safety Control XX and attributes Y and Z Safety Control XX and attributes Y and Z All inspection scopes shall be listed under the IP that was used to conduct the review.

The scope should focus on the activities conducted to follow-up on the issue, but it should not mention any opinions about the adequacy of licensee actions. For follow-up on previously identified issues, inspectors should typically use the IP and Functional Area under which the item was originally opened. For event follow-up, the inspectors should use the IP and Functional Area most closely related to the event, or use IP 88075, Event Follow-Up.

16.07 Inspection Results Organize the inspection results (e.g., tabled information documented using sections 0616-07 through 0616-14) in accordance with IMC 0616 Exhibit 1, grouped by IP, applicable IP section, and finally by the order of the table used in this IMC to document the results (except Table 7, Assessment, which should be listed first when used).

When there are no inspection results in the report, include a statement similar to, No violations of more than minor significance were identified.

For safeguards reports that contain Official Use Only, Safeguards Information, or Classified Information, care must be taken to ensure the proper screening review for classified matter is performed. If all the information required by the Four-Part write-up will not be included to maintain the report at a lower classification, the Office of Enforcement should be consulted prior to issuance of the report. If it is determined that information cannot be removed, then the report must be classified at the appropriate level.

The inspector should note that the determination of willfulness associated with a violation is an agency decision and is normally made after the Office of Investigations has completed an investigation. A premature or inaccurate discussion of the willfulness of a violation in an inspection report could result in later conflict based on additional input and review. Do not speculate or draw conclusions about the intent behind a violation.

Inspection reports that include potentially willful violations or that contain material that may be related to an ongoing investigation must be reviewed by the Office of Investigations and the Office of Enforcement prior to issuance.

16.08 Exit Meetings and Debriefs This section appears following the Inspection Results section of the inspection report and briefly summarizes the exit meeting(s), which is/are also described in the first paragraph of the cover letter and identifies the most senior licensee manager who attended the meeting(s).

Issue Date: 10/04/22 28 0616 At the exit meeting, the inspectors should verify that the information the inspector reviewed during the inspection, if intended to be included in the report, is not proprietary or classified. If the licensee does not identify any material as proprietary, the Exit Meetings and Debriefs section should include a sentence to that effect. For fuel cycle facilities, most operations and information reviewed will be at least proprietary.

If the NRCs position on a noncompliance changes significantly after the exit meeting, that change should be discussed with the licensee before the report is issued.

Licensee responses should not be included in the summary.

16.09 Third Party Reviews (if applicable)

In rare circumstances, it may be necessary to document the completion of third-party reviews in this section of a report. For example, state The inspectors reviewed Institute on Nuclear Power Operations reports that were issued during the inspection period.

Omit this report section when there are no reviews.

16.10 Documents Reviewed A list of the documents and records reviewed during an inspection must be included in the inspection report. The list need not include those reviewed documents and records already identified in the body of the report nor those which, upon review, were determined not to support the inspection scope and determinations. The level of detail for listed documents must be sufficient to allow the NRC to retrieve the document from the licensee in the foreseeable future. Therefore, a unique identifier, which may include the tracking number, title, revision and/or date, must be provided for each document referenced.

16.11 Report Attachments (if applicable)

If desired, attachments (e.g., escalated enforcement supporting details) may be referenced and added to the end of the inspection report. The attachments may be combined into a single attachment entitled "Supplemental Information" if desired.

16.12 List of Acronyms (if applicable)

Acronyms should be spelled out when first used in inspection report text (e.g., Licensee Performance Review (LPR)). A list of acronyms should be included in the inspection report or referenced, when the report section is 20 pages or longer. When referenced, the list of acronyms should be made publicly available for publicly available reports.

16.13 Cover Letter Enclosures (if applicable)

The inspection report, starting with the cover page, is typically cover letter Enclosure 1.

An additional cover letter enclosure may be necessary to communicate an NOV.

Issue Date: 10/04/22 29 0616 0616-17 RELEASE AND DISCLOSURE OF INSPECTION REPORTS AND ASSOCIATED DOCUMENTS 17.01 General Public Disclosure and Exemptions Except for report enclosures containing exempt information, all final inspection reports will be routinely disclosed to the public. Information that should not appear in an inspection report is described in 10 CFR 2.390 and 9.17. MD 8.8, Management of Allegations, addresses the manner in which an inspection report may be used to document allegation follow up activities. Minor violations revealed during allegation follow up shall not be included in the inspection report as a minor violation. IMC 0620, Inspection Documents and Records, provides guidance on acquisition and control of NRC records, including inspection-related documents.

Inspection reports containing Official Use Only-Security Related Information will not be disclosed to the public. The number and severity of violations contained within these reports, however, will be stated in a publicly-available cover letter. If the severity level of the violation is an NCV or Severity Level IV violation, then the specific level should be listed. If the severity level of the violation is Severity Level I - III, then the publicly-available cover letter should only state that the violation is escalated enforcement. The content behind these violations shall not be discussed on the public docket or in public meetings.

17.02 Release of Investigation-Related Information When an inspector accompanies an investigator on an investigation, the inspector must not release either the investigation report or his or her individual input to the investigation report. This information is exempt from disclosure by 10 CFR 9.17, Agency Records Exempt from Public Disclosure, and must not be circulated outside the NRC without specific approval of the Chairman (refer to OI Policy Statement 23).

List of Appendices:

Appendix A: List of Acronyms and Abbreviations Used in this Inspection Manual Chapter Appendix B: Examples of Minor Issues List of Exhibits:

Exhibit 1: Standard Fuel Cycle Facilities Inspection Report Outline END

Issue Date: 10/04/22 AppA-1 0616 Appendix A: List Of Acronyms And Abbreviations Used in this Inspection Manual Chapter ADAMS Agency Document and Management System AIT Augmented Inspection Team AV Apparent Violation BC Branch Chief CFR Code of Federal Regulations CoC Certificate of Compliance DD Division Director EA Enforcement Action FCNMED Fuel Cycle Nuclear Materials Event Database FCSS Fuel Cycle Safety and Safeguards FOIA Freedom of Information Act GPO Government Printing Office IIT incident Investigation Team IMC Inspection Manual Chapter IROFS Items Relied On For Safety LPR Licensee Performance Review MD Management Directive NCV Non-Cited Violation NMED Nuclear Materials Event Database NMSS Office of Nuclear Material Safety and Safeguards NOV Notice of Violation NRC Nuclear Regulatory Commission OD Office Director OE Office of Enforcement OI Office of Investigations PDR Public Document Room PI&R Problem Identification and Resolution QA Quality Assurance RA Regional Administrator SI International System of Units SL Severity Level TI Temporary Instruction URI Unresolved Item VIO Violation END

Issue Date: 10/04/22 E1-1 0616 Exhibit 1: Standard Fuel Cycle Facilities Inspection Report Outline Cover Letter (IMC 0616 section 16.01)

Cover Page (IMC 0616 section 16.02)

Summary (IMC 0616 section 16.03)

Table of Contents (IMC 0616 section 16.04)

Plant Status (IMC 0616 section 16.05)

Inspection Scopes (IMC 0616 section 16.06) - Outline provided below Inspection Results (IMC 0616 section 16.07) - Outline provided below Exit Meetings and Debriefs (IMC 0616 section 16.08)

Third Party Reviews (IMC 0616 section 16.09)

Documents Reviewed (IMC 0616 section 16.10)

Report Attachments (IMC 0616 section 16.11)

List of Acronyms (IMC 0616 section 16.12)

Cover Letter Enclosures (IMC 0616 section 16.13)

Report Section Inspection Procedure Title SAFETY OPERATIONS 88015 Nuclear Criticality Safety 88020 Operational Safety 88055 Fire Protection 88135.02 Resident Inspection Program Plant Status Activities 88135.04 Resident Inspection Program ISA Implementation 88135.05 Resident Inspection Program Fire Protection (Annual and Quarterly) 88135.17 Resident Inspection Program Permanent Plant Modifications 88135.19 Resident Inspection Program Post-Maintenance Testing 88135.22 Resident Inspection Program Surveillance Testing SAFEGUARDS 81335 Physical Protection of Shipment of SNM-MSS (non-public) 81340 Physical Protection of Shipment of SNM-LSS (non-public) 81431 Fixed Site Physical Protection of SNM-LSS (non-public) 81700.01 Category I FLE Cycle Facility Strategic Special Nuclear Material Security Controls (non-public) 81700.02 Category I FLE Cycle Facility Access Control Measures (non-public) 81700.04 Category I FLE Cycle Facility Equipment Performance, Testing and Maintenance (non-public) 81700.05 Category I FLE Cycle Facility Physical Protection Program and Protective Strategy (non-public)

Issue Date: 10/04/22 E1-2 0616 81700.06 Licensee Conducted Force-on-Force Exercises at Category I FLE Cycle Facilities (non-public) 81700.07 Category I FLE Cycle Facility Security Training (non-public) 81700.08 Category I FLE Cycle Facility Fitness for Duty Programs (non-public) 81700.10 Protection of Safeguards Information at Category I FLE Cycle Facilities (non-public) 81700.11 Annual Observation of Licensee Conducted Force-on-Force Exercises at Category I FLE Cycle Facilities (non-public) 81810 Protection of Safeguards Information (non-public) 81815 Authorization for Access to National Security Information (NSI) & Restricted Data (RD) (non-public) 81820 Physical Protection Facility Approval and Safeguarding of National Security Information (NSI) & Restricted Data (RD) (non-public) 96001 Contingency Response-Annual Force-on-Force Testing Category I FLE Cycle Facilities (non-public)

IMC 2683 IPs As Listed (non-public)

RADIOLOGICAL CONTROLS 86740 Inspection of Transportation Activities 88030 Radiation Protection 88045 Effluent Control and Environmental Protection FACILITY SUPPORT 88050 Emergency Preparedness 88051 Evaluation of Exercises and Drills 88070 Plant Modifications (Annual) 88072 Plant Modifications (Triennial) 88161 Corrective Action Program (CAP) Implementation at Fuel Cycle Facilities OTHER AREAS 40100 Independent Safety Culture Assessment Follow-up 71152 Problem Identification and Resolution 71153 Follow-up of Events and Notices of Enforcement Discretion 84850 Radioactive Waste Management - Inspection of Waste Generator Requirements of 10 CFR Part 20 and 10 CFR Part 61

Issue Date: 10/04/22 E1-3 0616 88003 Reactive Inspection for Events at Fuel Cycle Facilities 88005 Management Organization and Controls 88010 Training 88071 Configuration Management Programmatic Review 88075 Event Follow-Up 88161 Corrective Action Program (CAP) Implementation at Fuel Cycle Facilities 92701 Follow-Up 92702 Follow-Up on Traditional Enforcement Actions Including Violations, Deviations, Confirmatory Action Letters, and Orders 92709 Contingency Plans for Licensee Strikes or Lockouts 92711 Implementation of Licensee Contingency Plans During a Strike/Lockout 92712 Resumption of Normal Operations After a Strike 93001 OSHA Interface Activities 93100 Safety-Conscious Work Environment Issue of Concern Follow up 93800 Augmented Inspection Team 93812 Special Inspection 95003.02 Guidance for Conducting an Independent NRC Safety Culture Assessment

Issue Date: 10/04/22 Att1-1 0616 : Revision History for IMC 0616 Commitment Tracking Number Accession Number Issue Date Change Notice Description of Change Description of Training /

Knowledge Management Required and Completion Date Comment Resolution and Closed Feedback Form Accession Number (Pre-Decisional Non-Public Information)

N/A 07/29/08 CN 08-021 This new IMC is for the use of FCSS and Region II inspectors. These Offices will no longer use IMC 0610.

No ML081640248 N/A ML11314A098 12/21/11 CN 11-042 Revision to include discussion of the significance of the violation No N/A ML14071A139 07/28/14 CN 14-017 Major rewrite.

Updated NRC Enforcement Policy section numbers, added requirement to use four-part violation format, deleted Appendices B and C.

and added new Appendix B, Examples of Minor Issues.

Yes ML14142A309 N/A ML15112A050 06/15/15 CN 15-011 Removed documentation requirement to include minor violations identified during allegation follow up.

Inspection reports containing OUO-Security Related Information will not be disclosed to the public. The associated cover letters will be disclosed to the public and will include the number and severity levels of violations.

Addition per SRM-SECY-14-0034.

No ML15112A055

Issue Date: 10/04/22 Att1-2 0616 Commitment Tracking Number Accession Number Issue Date Change Notice Description of Change Description of Training /

Knowledge Management Required and Completion Date Comment Resolution and Closed Feedback Form Accession Number (Pre-Decisional Non-Public Information)

N/A ML16098A162 06/27/16 CN 16-014 Corrected an inaccurate statement in minor/more-than-minor example 7.e of Appendix B. Specifically, the language referring to crediting IROFS from other accident sequences to ensure the accident remains highly unlikely was removed from the not a violation if section and the phrase an inadequate management measure was added to the not minor if section.

No Comments vetted through meetings with Region II N/A ML16160A380 08/15/17 CN 17-014 Deleted the definitions Inspector Follow-up Item (IFI) and Finding. Revised Section 8 to improve the four-part-write up process by removing redundancies and providing more guidance on documenting AVs. Clarified Sections 11.01 and 11.02. In Section 14 moved the four-part write-up guidance from the Inspection Scope sub-section to the Conclusions sub-section. Clarified the high-level guidance in the beginning of Appendix B and deleted the 4th General screening question that referred to a violation only associated with paperwork and no clear nexus to safety. Added two more-than-minor examples to Appendix B (1.j and 2.k).

No Comments vetted through meetings with Region II

Issue Date: 10/04/22 Att1-3 0616 Commitment Tracking Number Accession Number Issue Date Change Notice Description of Change Description of Training /

Knowledge Management Required and Completion Date Comment Resolution and Closed Feedback Form Accession Number (Pre-Decisional Non-Public Information)

N/A ML21082A281 04/01/21 CN 21-017 Revised to update organization changes, include additional definitions, and to reflect new method of documenting inspection reports using the RRPS/ISTAR auto report generator. Removed not a violation if statements to maintain focus on the intent of the guidance - screening criteria to support the minor/more-than-minor threshold determination for issues that have been determined to be violations.

Complete by February 2021 N/A N/A ML22241A109 10/04/22 CN 22-020 Editorial changes. Appendix B made into a separate document. Also added information about CUI program.

N/A N/A