Provisions and Implementation of 10 CFR Part 21

1. Provisions and Implementation of 10 CFR Part 21 Presented to: National Spent Nuclear Fuel Program Strategy Meeting Presented by: Timothy C. Gunter Supervisor, Regulatory Compliance Branch Regulatory Affairs Division Office of Civilian Radioactive Waste Management April 15, 2009

2. Introduction • 10 CFR Part 21 implements the requirements of Section 206 of the Energy Reorganization Act of 1974. • Among the pertinent requirements of 10 CFR Part 21 are Reporting, Communication, Notification and Posting requirements for facilities holding licenses from the U.S. Nuclear Regulatory Commission (Commission). • Today’s presentation will discuss these requirements as well as the manner in which the DOE Office of Civilian Radioactive Waste Management (OCRWM) has implemented 10 CFR Part 21.

3. Reporting Requirements • The reporting requirements of 10 CFR PART 21 apply to “basic Components” • 10 CFR Part 21 definition of basic component: 21.3(3) When applied to other facilities and other activities licensed under 10 CFR parts 30, 40, 50 (other than nuclear power plants), 60, 61, 63, 70, 71, or 72 of this chapter, basic component means a structure, system, or component, or part thereof, that affects their safety function, that is directly procured by the licensee of a facility or activity subject to the regulations in this part and in which a defect or failure to comply with any applicable regulation in this chapter, order, or license issued by the Commission could create a substantial safety hazard. 21.3(4) In all cases, basic component includes safety-related design, analysis, inspection, testing, fabrication, replacement of parts, or consulting services that are associated with the component hardware, design certification, design approval, whether these services are performed by the component supplier or others. • OCRWM definition of basic component includes structures, systems and components that are: • Important to safety; or • Important to waste isolation

4. Reporting Requirements (cont’d) • Reporting requirements of 10 CFR Part 21 are triggered if: A basic component fails to comply with the Atomic Energy Act of 1954 or any applicable rule, regulation, order, or license condition of the Commission relating to substantial safety hazards, or A basic component contains defects which could create a substantial safety hazard. • Upon discovery of a failure to comply, or a deviation, an evaluation to determine whether or not a substantial safety hazard exists is performed within 60 days (or an interim report submitted to the NRC within 60 days of discovery). • The director or responsible officer shall be informed within 5 working days of completion of the evaluation.

5. Reporting Requirements (cont’d) • The purchaser/licensee may perform the evaluation of the safety hazard significance of the non-compliance or deviation for the supplier if the supplier determines it does not have the capability to perform the evaluation. In this case the supplier must notify the purchaser/licensee within 5 working days of their determination. • Procedures shall be adopted to evaluate deviations and failures to comply and ensure that required notifications are made.

6. Communications/Notifications • Written communications and reports concerning the requirements in 10 CFR PART 21 shall be provided to the NRC as prescribed in 10 CFR 21.5. • Initial notification by fax shall be made to the NRC Operations Center within two days of receipt of information on the identification of defect or failure to comply. • Written notification to the NRC shall be made with 30 days of receipt of information on the identification of defect or failure to comply, and shall include the information required by 10 CFR 21.21.

7. Posting Requirements • Each entity/licensee subject to the requirements of 10 CFR Part 21 is required to post current copies of: • 10 CFR Part 21 regulations • Section 206 of the Energy Reorganization Act of 1974 • Procedures adopted pursuant to 10 CFR Part 21 • Documents must be posted in a conspicuous position where subject activities are conducted. • If such posting is not practicable, licensees or firms may post notice describing regulations, and procedures.

8. Enforcement • Failure to provide notifications required by 10 CFR 21.21 can result in civil penalties. • Criminal sanctions are provided for willful violation, attempted violation of, or conspiracy to violate certain regulations of 10 CFR Part 21.

9. OCRWM Implementation of 10 CFR Part 21 • In June 2008 Department of Energy, OCRWM, implemented 10 CFR Part 21 with the submittal of its License Application. • Postings were made throughout the site and supporting complex. • Implementing procedures were developed and issued. • Appropriate clauses were included in all applicable vendor contracts. • The Corrective Action Process was designated as the tool for tracking and correcting identified non-compliance or defect issues.

10. EM Implementation of 10 CFR Part 21 • Implementation of 10 CFR Part 21 agreed to in the Memorandum of Agreement for Acceptance of Spent Nuclear Fuel and High-Level Radioactive Waste between EM and RW (Rev 2, February 2007). • Ensure existing procedures are adequate or implement new procedures to identify deficiencies and non-compliances and notify RW. • RW can evaluate deficiencies and non-compliances for substantial safety hazards, and report to the NRC per existing RW procedures. • Appropriate posting of EM facilities should be determined by EM