Role

Responsibility

Laboratory Director or Designee

• Appoints Berkeley Lab Enforcement Coordinators.
• Communicates and reinforces the importance of proactively identifying, reporting and managing issues and noncompliance.
• Participates in and supports DOE Enforcement activities.

Berkeley Lab General Counsel

• Advises the University of California National Laboratories (UCNL), Laboratory Director, Laboratory Deputy Directors for Research and Operations, OIAI, Enforcement Coordinators, and other senior management during preparation for and/or in response to a DOE Office of Enterprise Assessments (EA-10) program review, investigation, and/or enforcement actions.
• Advises the Enforcement Coordinator and other stakeholders regarding interpretation and applicability of requirements, as necessary.
• Reviews Preliminary Notices of Violation (PNOVs), advises on draft responses, makes recommendations relative to any considerations to deny a PNOV, to appeal a PNOV, or to request that a Compliance Order be rescinded or modified and prepares appeals to Final Notices of Violation (FNOVs) and Compliance Orders, as appropriate.
• Represents Berkeley Lab during an Enforcement Action.

Office of Institutional Assurance and Integrity (OIAI) Manager

• Provides shared oversight and administration of the Enforcement Program with EHS.
• Provides management support to, and oversight of, the Enforcement Coordinators.
• Interfaces with the Enforcement Coordinators and laboratory leadership on the status of the Enforcement Program and externally-reported noncompliances, as necessary.
• Upon notification from the EA-10 of intent to perform a program review or enforce a Rule, along with EHS, ensures coordination of the Lab’s preparation efforts for program reviews, investigations, on-site visits and enforcement conferences.

EHS Division Director

• Provides shared oversight and administration of the Enforcement Program with OIAI.
• Provides management support to, and oversight of, the Enforcement Coordinators.
• Interfaces with the Enforcement Coordinators and laboratory leadership on the status of the Enforcement Program and externally-reported noncompliances.
• Upon notification from the EA-10 of intent to perform a program review or enforce a Rule, along with OIAI, ensures coordination of the Lab’s preparation efforts for program review investigations, on-site visits and enforcement conferences.

Enforcement Coordinators

• Oversee LBNL’s compliance with PAAA 10 CFR 708, 10 CFR 820, 10 CFR 824, 10 CFR 830, 10 CFR 835, 10 CFR 850 and 10 CFR 851.
• Independently reviews and determines if sources of potential noncompliances are reportable, including reviewing documents/ records, interviewing Lab or subcontractor staff, and/or observing work processes.
• Interfaces with EA-10 and the DOE Site Office on the status of the Enforcement Program and noncompliances.
• Serves as the principal or co-lead for EA-10 visits, program reviews and enforcement actions.
• Coordinates DOE EA requests for information, onsite and offsite visits, investigations and enforcement conferences.
• Consults with Laboratory Counsel regarding requirements interpretation and applicability for actual or potential noncompliances, as necessary.
• Interfaces with Laboratory leadership, Laboratory Counsel, cognizant managers and staff regarding the Enforcement Program and potential and actual noncompliances.
• Notifies UCNL, DOE Site Office, Lab leadership, Laboratory Counsel, responsible organizations and other stakeholders, as appropriate, of Noncompliance Tracking System (NTS) reportable noncompliances.
• Distributes compliance-related communications to affected LBNL organizations and stakeholders.
• Maintains NTS documentation files.
• Verifies that NTS-reportable noncompliances are managed in accordance with the Institutional Issues Management Program.

Line Management (LBNL and Subcontractors)

• Notifies the Division Safety Coordinator (DSC), Radiological Contro Manager (RCM) and Enforcement Coordinator of potential and actual environmental, health, safety, radiological and/or quality assurance issues and actual and near miss events.
• Assures that staff performs work consistent with work authorizations, procedures and requirements.
• Assures that noncompliances and issues are identified, analyzed and mitigated in accordance with this manual and the Issues ManagementProgram (LBNL/PUB-5519).
• Ensures that staff, suppliers and subcontractors are aware of 10 CFR 708, 10 CFR 820, 10 CFR 830, 10 CFR 835, 10 CFR 850 and 10 CFR 851requirements and their responsibility to adhere to them.
• Provides support, as necessary, to respond to Enforcement inquiries, Enforcement Investigations, Enforcement Conferences and Enforcement Actions.
• Provides unfettered access to all information, documentation and personnel, as requested, to the Enforcement Coordinator for potential and actual noncompliances.
• Provides support, as necessary, and performs causal analyses, CAPs/develop corrective actions, and perform effectiveness reviews of corrective actions taken in response to a noncompliance in accordance with the Issues Management Program (LBNL/PUB-5519).
• Provides assessment reports, causal analyses reports, effectiveness review reports, issues and other pertinent data to the Enforcement Coordinator for review for potential noncompliances.
• Ensures that corrective actions are entered in the Corrective Action Tracking System (CATS) database, and are tracked for timely completion and resolution of the issues.
• Ensures adequate preparation and verification of corrective action closure documentation ensures objective evidence of corrective action completion is uploaded into the CATS database and is provided to the Enforcement Coordinator.
• Communicates potential lessons learned via the Laboratory Lessons Learned/Best Practices Database.

Subcontractors, including subtier subcontractors 

• Notify cognizant Lab management of potential issues or events.
• Provide information, as requested, to Enforcement Coordinators for potentially reportable noncompliances including source documentation (e.g., assessment reports, Occurrence Reporting and Processing System [ORPS] reports, issues, and other pertinent data); training records, equipment records; procedures; names of personnel, dates of incidents/issues; causal analysis reports, effectiveness review reports; corrective action plans, etc.
• Provide support, as necessary, to perform causal analyses, develop corrective actions, and to ensure effectiveness of corrective actions for noncompliances.

Lab Employees 

• Conscientiously and proactively identify issues, noncompliances and needed improvements.
• Implement corrective actions to address issues and prevent recurring noncompliances and problems.
• Share lessons learned and best practices.

Terms

Definitions

Compliance Order

An order issued by the Secretary of Energy to a contractor that mandates a remedy, work stoppage, or other action to address a situation that violates, potentially violates, or is inconsistent with a requirement of a PAAA rule.

Consent Order

Any written document, signed by the DOE Director of Enforcement and a contractor, containing stipulations or conclusions of fact or law and a remedy acceptable to both DOE and the contractor.

Enforcement Action

The issuance of an Enforcement Letter, Consent Order, or a Preliminary Notice of Violation (PNOV) or Final Notice of Violation (FNOV) with or without a civil penalty.

Exemptions

The final order that sets forth the relief, waiver, or release, either temporary or permanent, from a DOE nuclear safety requirement, as granted by the appropriate Secretarial Officer pursuant to the provisions of Subpart E of 10 CFR 820.

Final Notice of Violation (FNOV)

A document that determines a contractor has violated or is continuing to violate a requirement of the PAAA Rules. The FNOV includes a statement specifying the requirement to which the violation relates; a concise statement of the basis for the determination; any remedy, including the amount of any civil penalty; and a statement explaining the reasoning behind any remedy.

Final Order

An order of the Secretary of Energy that represents final agency action and, where appropriate, imposes a remedy with which the recipient of the order must comply.

Noncompliance

Failure to comply with an applicable DOE nuclear safety, worker safety and health, or security requirement, the Berkeley Lab Contractor Assurance System Description (CASD), Quality Assurance Program Description (QAPD), Worker Safety and Health Program (WSHP), or Radiation Protection Program (RPP).

Noncompliance Tracking System (NTS)

A centralized database maintained by DOE for reporting and tracking externally-reportable noncompliances of nuclear safety, security, and worker safety and health requirements, allowing DOE contractors to take advantage of mitigation provisions in the enforcement policy.

Preliminary Notice of Violation (PNOV)

A document that sets forth the preliminary conclusions that a contractor has violated or is continuing to violate a requirement nuclear safety, worker safety and health, or security rules. The PNOV specifies the requirement to which the violation relates; concisely states the basis for alleging the violation; describes any remedy, including the amount of any proposed civil penalty; and explains the reasoning behind any proposed remedy.

Price-Anderson Amendments Act (PAAA)

The federal law that authorizes DOE to establish an enforcement program subjecting DOE contractors, subcontractors, and suppliers to potential civil and criminal penalties for violation of DOE nuclear safety, worker safety and health, and security rules, regulations, and compliance orders.