10 CFR 830 (Appendix A to Subpart B to Part 830) - General Statement of Safety Basis Policy

Question 1

What does Part 830 Appendix A describe? (Section A)

Answer 1

This appendix describes DOE’s expectations for the safety basis requirements of 10 CFR part 830, acceptable methods for implementing these requirements, and criteria DOE will use to evaluate compliance with these requirements. This appendix does not create any new requirements and should be used consistently with DOE’s policy that work be conducted safely and efficiently and in a manner that ensures protection of workers, the public, and the environment.

Question 2

Appendix A to Subpart B to Part 830 - General Statement of Safety Basis Policy (Section B)

What is the Purpose (requirements), 2 parts.

Answer 2

1. The safety basis requirements of Part 830 require the contractor responsible for a DOE nuclear facility to analyze the facility, the work to be performed, and the associated hazards and to identify the conditions, safe boundaries, and hazard controls necessary to protect workers, the public and the environment from adverse consequences. These analyses and hazard controls constitute the safety basis upon which the contractor and DOE rely to conclude that the facility can be operated safely. Performing work consistent with the safety basis provides reasonable assurance of adequate protection of workers, the public, and the environment.
2. The safety basis requirements are intended to further the objective of making safety an integral part of how work is performed throughout the DOE complex. Developing a thorough understanding of a nuclear facility, the work to be performed, the associated hazards and the needed hazard controls is essential to integrating safety into management and work at all levels. Performing work in accordance with the safety basis for a nuclear facility is the realization of that objective.

Question 3

Appendix A to Subpart B to Part 830 - General Statement of Safety Basis Policy (Section C)

What is the Scope, 2 parts.

Answer 3

1. A contractor must establish and maintain a safety basis for a Hazard Category 1, 2, or 3 DOE nuclear facility because these facilities have the potential for significant radiological consequences. DOE-STD-1027 sets forth the methodology for categorizing a DOE nuclear facility based on the inventory of radioactive materials.
2. Unlike the quality assurance requirements of Part 830 that apply to all DOE nuclear facilities, the safety basis requirements only apply to Hazard Category 1, 2, and 3 DOE nuclear facilities and do not apply to nuclear facilities below Hazard Category 3.

Question 4

Appendix A to Subpart B to Part 830 - General Statement of Safety Basis Policy (Section D)

What are the three components of Integrated Safety Management?

Answer 4

1. The safety basis requirements are consistent with integrated safety management. DOE expects that, if a contractor complies with the Department of Energy Acquisition Regulation (DEAR) clause on integration of environment, safety, and health into work planning and execution (48 CFR 970.5223-1, Integration of Environment, Safety and Health into Work Planning and Execution) and the DEAR clause on laws, regulations, and DOE directives (48 CFR 970.5204-2, Laws, Regulations and DOE Directives), the contractor will have established the foundation to meet the safety basis requirements.
2. The processes embedded in a safety management system should lead to a contractor establishing adequate safety bases and safety management programs that will meet the safety basis requirements of this Subpart. Consequently, the DOE expects if a contractor has adequately implemented integrated safety management, few additional requirements will stem from this Subpart and, in such cases, the existing safety basis prepared in accordance with integrated safety management provisions, including existing DOE safety requirements in contracts, should meet the requirements of this Subpart.
3. DOE does not expect there to be any conflict between contractual requirements and regulatory requirements. In fact, DOE expects that contract provisions will be used to provide more detail on implementation of safety basis requirements such as preparing a documented safety analysis, developing technical safety requirements, and implementing a USQ process.

Question 5

Appendix A to Subpart B to Part 830 - General Statement of Safety Basis Policy (Section E)

Enforcement will be orientated towards? What will DOE focus its enforcement efforts on?

Answer 5

1. Enforcement of the safety basis requirements will be performance oriented. That is, DOE will focus its enforcement efforts on whether a contractor operates a nuclear facility consistent with the safety basis for the facility and, in particular, whether work is performed in accordance with the safety basis.

Question 6

Appendix A to Subpart B to Part 830 - General Statement of Safety Basis Policy (Section E)

What will DOE review the safety basis documentation for?

Answer 6

DOE will review the content and quality of the safety basis documentation. DOE intends to use the approval process to assess the adequacy of a safety basis developed by a contractor to ensure that workers, the public, and the environment are provided reasonable assurance of adequate protection from identified hazards.

Question 7

Appendix A to Subpart B to Part 830 - General Statement of Safety Basis Policy (Section E)

Will safety basis documentation be subject to regulatory enforcement actions?

Answer 7

Once approved by DOE, the safety basis documentation will not be subject to regulatory enforcement actions unless DOE determines that the information which supports the documentation is not complete and accurate in all material respects, as required by 10 CFR 820.11. This is consistent with the DOE enforcement provisions and policy in 10 CFR part 820.

Question 8

Appendix A to Subpart B to Part 830 - General Statement of Safety Basis Policy (Section E)

Does DOE not intend the adoption of the safety basis requirements to affect the existing quality assurance requirements or the existing obligation of contractors to comply with the quality assurance requirements?

Answer 8

DOE does not intend the adoption of the safety basis requirements to affect the existing quality assurance requirements or the existing obligation of contractors to comply with the quality assurance requirements. In particular, in conjunction with the adoption of the safety basis requirements, DOE revised the language in 10 CFR 830.122(e)(1) to make clear that hazard controls are part of the work processes to which a contractor and other persons must adhere when performing work. This obligation to perform work consistent with hazard controls adopted to meet regulatory or contract requirements existed prior to the adoption of the safety basis requirements and is both consistent with and independent of the safety basis requirements.

Question 9

Appendix A to Subpart B to Part 830 - General Statement of Safety Basis Policy (Section E)

Does a DSA address all the hazards or just some?

Answer 9

A documented safety analysis must address all hazards (that is, both radiological and nonradiological hazards) and the controls necessary to provide adequate protection to the public, workers, and the environment from these hazards. Section 234A of the Atomic Energy Act only authorizes DOE to issue civil penalties for violations of requirements related to nuclear safety. Therefore, DOE will impose civil penalties for violations of the safety basis requirements (including hazard controls) only if they are related to nuclear safety.

Question 10

Appendix A to Subpart B to Part 830 - General Statement of Safety Basis Policy (Section F)

What must a DSA demonstrate?

Answer 10

A documented safety analysis must demonstrate the extent to which a nuclear facility can be operated safely with respect to workers, the public, and the environment.

Question 11

Appendix A to Subpart B to Part 830 - General Statement of Safety Basis Policy (Section F)

Can the contractor use a graded approach to develop a DSA?

Answer 11

DOE expects a contractor to use a graded approach to develop a documented safety analysis and describe how the graded approach was applied. The level of detail, analysis, and documentation will reflect the complexity and hazards associated with a particular facility. Thus, the documented safety analysis for a simple, low hazard facility may be relatively short and qualitative in nature, while the documented safety analysis for a complex, high hazard facility may be quite elaborate and more quantitative. DOE will work with its contractors to ensure a documented safety analysis is appropriate for the facility for which it is being developed.

Question 12

Appendix A to Subpart B to Part 830 - General Statement of Safety Basis Policy (Section F)

When will DOE review the DSA?

Answer 12

Because DOE has ultimate responsibility for the safety of its facilities, DOE will review each documented safety analysis:

(i) As part of the initial submittal;
(ii) When revisions are submitted as part of a positive USQ determination or major modification;
(iii) If DOE has reason to believe a portion of the safety basis to be inadequate, or;
(iv) If DOE has reason to believe a portion of the safety basis has substantially changed.

Question 13

Appendix A to Subpart B to Part 830 - General Statement of Safety Basis Policy (Section F)

If DOE has reason to believe a portion of the safety basis has substantially changed, what will DOE review the DSA for?

Answer 13

DOE will review the documented safety analysis to determine whether the rigor and detail of the documented safety analysis are appropriate for the complexity and hazards expected at the nuclear facility.

Question 14

Appendix A to Subpart B to Part 830 - General Statement of Safety Basis Policy (Section F)

What specifically with DOE evaluate for the evaluation of the extend of the DSA changes?

Answer 14

(A) Satisfies the provisions of the methodology used to prepare the documented safety analysis and

(B) Adequately addresses the criteria set forth in 10 CFR 830.204(b). DOE will prepare a Safety Evaluation Report to document the results of its review of the documented safety analysis. A documented safety analysis must contain any conditions or changes required by DOE in the Safety Evaluation Report. Generally, DOE’s review of the annual submittal may be limited to ensuring that the results of USQs have been adequately incorporated into the documented safety analysis. If additional changes are proposed by the contractor and included in the annual update that have not been previously approved by DOE or have not been evaluated as a part of the USQ process, DOE must review and approve these changes. DOE has the authority to review the safety basis at any time.

Question 15

Appendix A to Subpart B to Part 830 - General Statement of Safety Basis Policy (Section F)

Will the contract specify methodology for developing a DSA?

Answer 15

In most cases, the contract will provide the framework for specifying the methodology and schedule for developing a documented safety analysis. Table 1 sets forth acceptable methodologies for preparing a documented safety analysis.