Enforcement Manual - Revision 4 - Summary of Changes

Revision 4 was issued on September 30, 2002, and addressed the following issues in the order that they appear in the Enforcement Manual.

Applicable sections throughout the Manual were revised to reflect the creation of the Office of Nuclear Security and Incident Response (NSIR) and its role in the enforcement program.

2.3.4 Enforcement Staff: Added the following items to indicate that OE staff (j) prepares Regulatory Notifications (RNs) for significant regulatory actions, such as a Final Significance Determination for a white, yellow, or red finding (that does not include an NOV) or an order that requires additional safety measures beyond the regulatory framework (versus an order based on compliance issues); (k) coordinates press releases and State notification for actions issued by the program offices; (l) coordinates and reviews press releases for significant enforcement issues, such as revisions to the Enforcement Policy; (t) prepares an annual report for the enforcement program; (u) develops and provides training on the enforcement program.

2.4.4 Regional Enforcement Coordinators: Added item (l) that reiterates responsibility for ensuring that any minor violation, Severity Level IV violation, or violation associated with a green SDP finding (regardless of whether it was dispositioned as an NCV or in an NOV) that is disputed by the licensee be coordinated with OE.

2.6.1 Delegation of Authority to the Director, NRR: Modified existing guidance to be more consistent with NMSS and the regional offices and added new requirement (2.6.1.b.7) to ensure that disputed non-escalated enforcement actions (NCVs and NOVs) involving vendors or non-power reactors are coordinated with OE.

2.6.4 NRR Enforcement Coordinator: Added new requirement (2.6.4.g) to ensure that disputed non-escalated enforcement actions (NCVs and NOVs) involving vendors or non-power reactors are coordinated with OE.

2.7.2 Redelegation of Authority by the Director, NMSS: Revised to reflect November 8, 2001, delegation of authority that provides that the Director, NMSS may redelegate authority to sign and issue NRC Form 591 to qualified inspectors.

2.7.4 NMSS Staff: Modified guidance to reflect staff responsibilities when the office has direct inspection responsibilities and when the office assumes a supporting function and added a new requirement (2.7.4.a.5) to reflect November 8, 2001 delegation of authority that provides that the Director, NMSS may redelegate authority to sign and issue NRC Form 591 to qualified inspectors.

2.8 Office of Nuclear Security Incident Response (NSIR): Added new section to address office functions and responsibilities and those of the Division Director of Nuclear Security and the NSIR Enforcement Coordinator.

2.12 Commission Notification and Consultation: Revised to include that escalated NOVs associated with white, yellow, or red SDP findings require a three-day EN. Revised to require that ENs should include a detailed discussion of the basis for assessing a civil penalty for any violation that is characterized through the SDP in accordance with the ROP. Revised to include that OE takes responsibility for issuing Regulatory Notifications (RNs) for significant regulatory actions, such as Final Significance Determination letters with white, yellow, or red SDP findings (without NOVs) and orders that are not based on compliance issues (e.g., 2002 security orders).

3.4.c Impacting the Regulatory Process: Added failures associated with 10 CFR 50.54(a) (involving quality assurance programs), 10 CFR 50.54(p) (involving safeguards plans), 10 CFR 50.54(q) (involving emergency plans) as examples of violations that can impact the regulatory process.

3.9 Minor Violations: Modified the section to include certain portions of guidance previously included in 1999 memo from Director, OE that was included in Appendix A.

3.10.1 Enforcement Action (EA) Numbers: Modified 3.10.1.j to clarify that enforcement actions related to NOEDs should be assigned EA numbers, not the NOEDs. Modified 3.10.1.r to clarify that any minor violation, Severity Level IV violation, or violation associated with a green SDP finding (regardless of whether it was dispositioned as an NCV or in an NOV) that is disputed by the licensee should get an EA number. Disputed escalated actions should be tracked using the existing EA number. Appropriate keywords should be used to identify the violation as disputed in EATS. Added new 3.10.1.s to address orders issued by the program offices that impose additional requirements beyond the existing regulatory requirements (e.g., 2002 security orders). One EA number may be used in the event the same order is issued to multiple licensees.

3.11 Enforcement and SDP Panels: Separated previous guidance in paragraphs (c) into new paragraphs (c) and (d). Paragraph (c) makes it clear that panels are required for potential escalated cases where the staff proposes to exercise discretion in accordance with Sections VII.B.2-6. Reiterated that OE should be consulted by telephone for Severity Level IV issues. Paragraph (d) makes it clear that panels are required for potential escalated cases where the staff proposes to issue non-escalated action.

3.12.1 Documenting Minor Violations: Added guidance that provides that if a licensee disputes that a minor violation is a violation, the region should respond by following the procedures in Section 4.2.6 Licensee Denial of NCV.

3.12.2 Documenting NCVs: Added that cover letters should include a Nuclear Materials Events Database (NMED) number, if applicable.

3.12.8 Documenting Related Violations (Violation Grouping): Added more guidance and included examples.

4.2.1 NCVs for Power Reactor Licensees: Added note to indicate that violations at a decommissioned facility that still has a Part 50 corrective action program and Part 72 violations that occur at a facility with a Part 50 corrective action program should be evaluated under this NCV policy.

4.2.5 NCV Signature Authority: Updated to reflect that (1) the Regional Administrator may redelegate the authority to issue NCVs on NRC Form 591s to qualified inspectors, (2) program office Section Chiefs normally sign and issue inspection reports that include NCVs, and (3) the Director, NMSS may redelegate the authority to issue NCVs on NRC Form 591s to qualified inspectors.

4.2.6 Licensee Denial of NCV: Revised guidance to include new timeliness goals and alternative approaches based on whether the licensee disputes the violation or whether they dispute the significance.

Formal responses will only be sent to licensees that can point to specific NRC guidance that supports minor violation classification. OE will review all disputed violations.

4.3.2 Preparing a Non-Escalated NOV: Added that cover letters should include a Nuclear Materials Events Database (NMED) number, if applicable.

4.3.4 Non-Escalated NOV Signature Authority: Corrected to indicate that Director, NMSS may redelegate authority to sign and issue non-escalated NOVs to Section Chiefs and above.

4.3.6 Licensee Response to a Non-Escalated NOV: Revised to make guidance consistent with process for responding to disputed NCVs. Revised guidance to include new timeliness goals and alternative approaches based on whether the licensee disputes the violation or whether they dispute the significance.

Formal responses will only be sent to licensees that can point to specific NRC guidance that supports minor violation classification. OE will review all disputed violations.

4.4.1 Preparing a Form 591: Added that Form 591 should include a Nuclear Materials Events Database (NMED) number, if applicable.

4.4.3 Form 591 Signature Authority: Corrected to include that the Director, NMSS may redelegate his or her authority to sign and issue Form 591s to qualified inspectors.

5.2 Predecisional Enforcement Conferences and Regulatory Conferences: Added reference to current Public Meeting Policy and included link to internal Communications and Public Meetings Web page.

5.2.2 Scheduling and Announcing Predecisional Enforcement Conferences: Clarified existing guidance on preparing meeting notices and included link to Public Meeting Checklist.

5.4.2.1 Initial Escalated Action: Modified guidance to address how past enforcement history should be considered when a licensee moves and gets a new license.

5.5 Escalated Notice of Violation (NOV) (Without Civil Penalty): Added agency output measures and new timeliness goals.

5.5.1 Preparing an Escalated NOV (Without Civil Penalty) Action: Added that in addition to an EA number that, cover letter should include an NMED number, if applicable.

5.5.3 Escalated NOV (Associated with White, Yellow, or Red SDP Findings) Enforcement Notification: Added new section to require that ENs be issued for NOVs associated with white, yellow, or red SDP findings.

5.5.4 Escalated NOV (Without Civil Penalty) Signature Authority: Added that the Director, NRR, may redelegate to the Deputy Director, the authority to sign and issue NOVs for Severity Level I and II violations involving non-power reactors, after appropriate coordination with OE (and the DEDO, if applicable) and may redelegate to the Division Director and above, the authority to sign and issue NOVs with Severity Level III violations involving non-power reactors after appropriate coordination with OE (and the DEDO, if applicable). (Consistent with 1998 delegation of authority memo.)

5.5.5 Licensee Notification, Mailing, & Distribution of Escalated NOVs (Without Civil Penalties): Added Notes to reiterate that escalated NOVs should NOT be made publically available in ADAMS until confirmation that the licensee has received a copy of the enforcement action (i.e., e-mail, facsimile, courier), and requirement that e-mail transmitting the action include a statement such as, "The licensee has received a copy of the enforcement action."

5.5.6 Press Releases for Escalated NOVs (Without Civil Penalties): Added that press releases are normally issued for NOVs associated with white, yellow, or red SDP findings.

5.6 Notice of Violation and Proposed Imposition of Civil Penalty (Civil Penalty): Added agency output measures and new timeliness goals.

5.6.1 Preparing a Civil Penalty Action: Added that in addition to an EA number that, cover letter should include an NMED number, if applicable.

5.6.4 Civil Penalty Signature Authority: Added that the Director, NRR may redelegate to the Deputy Director, the authority to issue civil penalty actions for violations involving non-power reactors, after review and approval by the Director, OE (and the DEDO and the Commission, if applicable).(Consistent with 1998 delegation of authority memo.)

5.6.5 Licensee Notification, Mailing, & Distribution of Civil Penalties: Added the region's State Liaison Officer will normally handle sending a copy of program office civil penalty actions to the appropriate State. The OE Enforcement Specialist should notify the Regional Enforcement Coordinator. Added Notes to reiterate that escalated NOVs should NOT be made publically available in ADAMS until confirmation that the licensee has received a copy of the enforcement action (i.e., e-mail, facsimile, courier), and requirement that e-mail transmitting the action include a statement such as, "The licensee has received a copy of the enforcement action."

5.6.6 Press Releases for Civil Penalties: Added that press releases for program office civil penalty actions may be coordinated through the applicable RPAO or headquarters OPA staff. Because of the infrequency of these program office actions, the OE Enforcement Specialist should make sure that a press release is drafted.

5.8 Order Modifying, Suspending, or Revoking License: Added a note to clarify that the procedures included in the Manual are primarily intended to address compliance orders, not program office orders that impose additional regulatory requirements. In addition to program office guidance for these safety orders, the staff should follow the guidance included in Section 5.8.4 on the issuance of Regulatory Notifications (RNs), Sections 5.8.6 and 5.8.9 on Web site posting, and 3.10.1 on the issuance of EA numbers.

5.8.4 Enforcement Notification and Regulatory Notification for Orders: Added guidance to address issuance of RNs for program office safety orders.

5.8.9 Relaxation of Orders: Added requirement that if the Director of NRR or NMSS relax a program office security order, a copy of the correspondence to the licensee should be sent to "OEWEB" to ensure prompt posting in the security order document collection.

6.4 Notice of Enforcement Discretion (NOED): Added a note highlighting that NOEDS should be e-mailed to "OEWEB" to ensure prompt posting to the NOED document collection.

7.3.3 Action Against the Individual: Added a note to paragraph (b) that highlights that with the exception of violations against the deliberate misconduct rule, NOV "contrary to" paragraphs should not include the word "willful" or "deliberate misconduct." In these cases, the discussion of willfulness should be included in the cover letter as part of the significance discussion. Including "deliberate misconduct" in "contrary to" paragraphs is required when violations are based on the deliberate misconduct requirements.

7.3.4 Action Against the Facility Licensee: Added a note to paragraph (c) that highlights that with the exception of violations against the deliberate misconduct rule, NOV "contrary to" paragraphs should not include the word "willful" or "deliberate misconduct." In these cases, the discussion of willfulness should be included in the cover letter as part of the significance discussion. Including "deliberate misconduct" in "contrary to" paragraphs is required when violations are based on the deliberate misconduct requirements. Paragraph (d) was modified to include that DFIs to licensees should include individuals' titles instead of their names and that licensees should not get copies of DFIs to individuals if the DFIs are subject to a 45-day hold.

7.3.8 Orders Restricting NRC-Licensed Activities and Requiring Notice of New Employment: Renamed section for clarification and updated guidance to direct the staff to the Enforcement Web site to find prohibition/restriction orders to individuals vs. using the restricted individuals list, which was eliminated. Included direct link to Escalated Enforcement Actions Issued to Individuals Web page.

7.4 Enforcement Actions Involving Fitness-For-Duty (FFD): Modified guidance in this entire section to reflect that, in addition to power reactors, FFD also applies to licenses authorized to possess or use formula quantities of SSNM, or to transport formula quantities of SSNM.

7.4.2.2 Coordination and Review for FFD Actions: Added NSIR.

7.5.4.3 Enforcement Panel for OI Report: Modified guidance to be more explicit in the ability of a panel to request additional information to be reviewed, particularly in DOL cases.

7.5.4.4 Enforcement Action for Willful Violations: Added a note that highlights that with the exception of violations against the deliberate misconduct rule, NOV "contrary to" paragraphs should not include the word "willful" or "deliberate misconduct." In these cases, the discussion of willfulness should be included in the cover letter as part of the significance discussion. Including "deliberate misconduct" in "contrary to" paragraphs is required when violations are based on the deliberate misconduct requirements.

7.9 Enforcement Action Against Non-Licensees: Modified to reflect 1999 Policy revision that states that NOVs can be issued to Certificate of Compliance holders subject to the provisions of 10 CFR Part 72. Added link to FRN.

7.12 Meetings With Licensees on NRC Enforcement Action: Modified to clarify that if the NRC holds a meeting with a licensee after enforcement action has been issued (but before process has been completed) that the meeting would normally be transcribed and the transcript would subsequently be made public. The guidance notes that there may be occasions when the meeting will need to be closed because the new information the licensee plans on disclosing involves privacy, safeguards, or proprietary information.

7.15 Enforcement Actions Involving Non-Power Reactor Licensees: Deleted section (which included processing/coordinating guidance) based on delegation to NRR for these cases.

8.1.11 Actions Involving the Maintenance Rule: This section was modified based on stakeholder input. Draft Maintenance Rule enforcement guidance was posted on the Enforcement Web site and comments were solicited from the public. Two commentors responded, both from power reactor licensees.

Comments

The commentors recommended various clarifications and changes to the guidance. The most prevalent comment involved the guidance regarding the consideration of both reliability and availability when evaluating the performance of structures, systems or components (SSCs). Both commentors stated that availability need only be considered for high safety significant SSCs.

Discussion

Although the rule language is non-specific, when considering whether an SSC is capable of performing its intended function, it is reasonable to conclude that this determination should include whether the SSC would reliably function when called upon to work and whether it is available to work when called upon. The terminology used to describe these two conditions is "reliability" and "availability." In the Statements of Consideration (SOC) for the rule, the Commission said:

Reliability and Availability of SSCs Subject to Either Paragraphs (a)(1) or (a)(2)

SSCs which are treated under paragraph (a)(1) may have formally established reliability and availability goals against which they are explicitly monitored, where goals of this nature are appropriate. In addition, and regardless of the nature of the monitoring and goals established to satisfy paragraph (a)(1), reliability and availability over the longer term must be assessed periodically pursuant to the requirements of paragraph (a)(3), as part of the evaluation of goals, monitoring requirements, and preventive maintenance requirements.

SSCs which are treated under paragraph (a)(2) are not subject to monitoring against established goals of any nature. Therefore, reliability and availability are not required to be assessed under paragraph (a)(2). The reliability and availability of such SSCs is still required to be considered, however, over the longer term under the requirements of paragraph (a)(3), as part of the periodic assessment of preventive maintenance requirements.

Throughout the SOC, both reliability and availability are mentioned together consistently with equal treatment. The Commission made no distinction for the differing safety significance of the various SSCs regarding the establishment of reliability and availability goals under paragraph (a)(1), quoted above. The specific SOC statement regarding reliability and availability assessment under paragraph (a)(3) makes it clear that both are to be considered for the periodic assessment. Further, the specific "balancing" requirement of paragraph (a)(3) cannot possibly be met without consideration of both availability and reliability.

Section 50.65(b) of the rule describing the required scope has no scoping criteria for safety or risk significance other than the general "safety related" criteria. The Commission stated in the SOC:

Scope of Monitoring

It is not the intent of the Commission to require a monitoring program so extensive that it detracts from licensees' ability to otherwise maintain equipment. The extent of monitoring may vary from system to system depending upon system importance to plant risk. Some monitoring at the component level may be necessary; however, it is envisioned that much of the monitoring could be done at the system or train functional level. For example, for less risk-significant systems, indicators of system reliability (where sufficient performance data exists) and availability may be all that is necessary. For more risk-significant systems, some parameter trending, beyond that already required by NRC requirements to provide early warning of degradation, may also be necessary for critical components whose unavailability causes a system train to be unavailable or whose failure is otherwise unacceptable. (Emphasis added)

Here it is clear that for less risk-significant SSCs, both reliability and availability were intended to be considered.

In contrast, 50.65(a)(4) includes a specific provision for limiting the scope of required risk assessment prior to maintenance "to structures, systems, and components that a risk-informed evaluation process has shown to be significant to public health and safety." In that this provision applies only to 50.65(a)(4) and no scope limiting provision exists in sections a(1) - a(3), the staff concluded that no scope reduction was intended by the Commission for those sections based on risk or safety significance.

Finally, in dispositioning this comment, the staff considered the SOC statement, "...formally established reliability and availability goals against which they are explicitly monitored, where goals of this nature are appropriate." Considering all the relevant SOC statements and specific rule language, the staff concluded the appropriateness of reliability and availability goals depended on the type of SSC being considered. For example, a structure or other inherently reliable SSC could be considered to be always reliable and may also be always available in that it may never be out of service. Setting reliability and/or availability goals for SSCs of this sort may not be meaningful. Thus, the staff concluded that the "appropriate" clause refers to the type of SSC and not to any differences in the safety significance of SSCs.

Conclusion

The staff concluded that the draft enforcement guidance was consistent with the rule language and Commission intent in stating that both reliability and availability should be considered when evaluating SSC performance. Nonetheless, a clarification was added to emphasize the point that only Section (a)(4) of the rule authorizes a scope reduction based on safety/risk significance.

8.4.2 Enforcement Policy Regarding Occupational Doses From "Hot Particles": Eliminated guidance based on revision to Part 20.

8.4.4 Loss, Abandonment, or Improper Transfer or Disposal of Licensed Material: Modified guidance to include examples of cases dispositioned at Severity Level III and Severity Level IV and included additional guidance on the adjustment of civil penalty amounts based on experience and current practices. Discussion also identifies optional paragraphs that should be used in conference and choice letters and civil penalty cover letters.

Appendix B: All applicable forms were modified to include the new Web site addresses for the Enforcement Policy and ADAMS and NMED No. reference. Escalated action forms were all modified to include a statement that significant actions are posted on the NRC's Web site. Orders were modified to include new mailing instructions and a footnote regarding CFR correction and inclusion of "104b" in the authority section for all licensees that were issued under 104b.

Modified Form 1-I (conference letter) to include optional paragraph to address cases involving the loss, abandonment, or improper transfer or disposal of a sealed source or device.

Modified Form 1-II (choice letter) to include optional paragraph to address cases involving the loss, abandonment, or improper transfer or disposal of a sealed source or device. Removed statement that response be under oath or affirmation.

Modified Form 3-I (Cover letter for Escalated NOVs Without Civil Penalty (without SDP)) to include the footnote that identifies the previous escalated action that was previously omitted.

Added new Form 3-III (Cover Letter for NOV to an Individual).

Modified Form 4-I (NOV to reactor) to include that the licensee's reply should include the EA number.

Modified Form 4-II (NOV to materials licensee) to include that the licensee's reply should include the EA number (if applicable).

Modified Form 4-III (NOV to non-licensee) to include that the company's reply should include an EA number (if applicable).

Modified Form 4-IV (NOV to individual) to include that the individual's reply should include the IA number.

Modified Form 5 (NOV/CP letter) to include two optional paragraphs to address cases involving the loss, abandonment, or improper transfer or disposal of a sealed source or device.

Modified Form 13 (Cover Letter for Order Imposing Civil Monetary Penalty) to clarify that licensee can either (1) pay the civil penalty in accordance with Section IV of the Order, or (2) request a hearing in accordance with Section V of the Order.

Added new Form 26-III to include EN for NOV associated with white, yellow, or red SDP finding.

Added new Form 26-IV to include multiple examples for ENs, exercise of discretion, Order Suspending License, and Confirmatory Order Relaxing Order.

Added new Forms 27-I, 27-II to address Regulatory Notifications (RNs) for SDP cases with no NOVs and orders imposing additional safety requirements.

Modified Forms 38 and 39 (Letter of Reprimand to Unlicensed and Licensed Individual) to make both letters consistent by including standard language about public availability of letter in ADAMS and optional language to use when letter should be held for 45 days.

Deleted the Hot Particle Enforcement Policy as Appendix D.

Appendix D: Added Predecisional Enforcement & Regulatory Conference Meeting Notice Checklist.

Appendix D: Modified Public Availability of Individual Actions matrix by eliminating the reference to the restricted individual's list.

Appendix D: Updated Distribution Lists for Reactor and Material Escalated Enforcement Actions to include NSIR.