DEPARTMENT OF ENERGY (DOE) RESPONSES TO SPECIFIC QUESTIONS FOR PUBLIC COMMENT
ON PROPOSED 10 CFR PART 63

The DOE responses to the NRC's five specific questions for public comment are as follows:

1.  Approach to Defining the Critical Group

NRC Question:
The Commission solicits comments on the appropriateness of its proposed approach to defining the critical group and reference biosphere for Yucca Mountain.  In particular, the Commission solicits comments on any other candidate population groups, biosphere assumptions and potential exposure pathways that should be considered in the establishment of a "critical group" for Yucca Mountain.

DOE Response:
Overall, the DOE believes the critical group chosen is appropriately conservative, consistent with the recommendations of the National Academy of Sciences, and protective of public health and safety.

2.  Human Intrusion Scenario

NRC Question:
The Commission solicits comments on the appropriateness of its proposed human intrusion scenario, and the assumed timing of its occurrence, as a reasonable measure for evaluating the consequences of intrusion at a repository at Yucca Mountain.

DOE Response:
While the DOE agrees with the concept of a stylized human intrusion scenario, we believe that application of a quantitative dose limit to such a scenario is inappropriate, for reasons detailed in our specific comments (see comment #1).

3.  Quality Assurance Program

NRC Question:
The Commission solicits comment on the merits of requiring the DOE to implement a quality assurance program for the geologic repository based on the criteria of Appendix B of 10 CFR Part 50.

DOE Response:
The DOE believes the proposed wording invoking Appendix B to 10 CFR Part 50 is appropriate.  The DOE has developed its NRC-approved quality assurance program based on Appendix B and believes that Appendix B is protective of public health and safety.

4.  Changes, Tests, and Experiments

NRC Question:
The Commission solicits comments on the suitability of alternative criteria for proposed § 63.44.  These alternative criteria are included in the statement of considerations discussion of proposed § 63.44 and are substantially equivalent to that proposed last year for nuclear reactors and spent fuel storage facilities. 

DOE Response:
The DOE believes that the proposed alternative criteria for § 63.44, Changes, Tests, and Experiments (found in the supplementary Information Section XVI pages 8653 and 8654) provide a reasonable approach to addressing facility modifications and are preferable to the proposed § 63.44 presented in the body of the proposed rule.  The DOE supports the NRC's intent to clarify what activities would require a license or construction authorization amendment.  The DOE also supports the intent of the proposed alternative criteria in Section XVI of the Supplementary Information to more clearly define when an unreviewed safety question exists.  Finally, we recommend that lessons learned from similar issues regarding 10 CFR 50.59 be applied to the repository regulations.  In addition, Attachment 2 contains specific DOE recommendations for changes to the language of the proposed alternative criteria. 

5.   Applicability of § 63.44

NRC Question:
The Commission solicits comments on whether the approach and criteria for changes, tests, and experiments at § 63.44 should apply solely to the Safety Analysis Report or to the contents of the entire license application, irrespective of whether § 63.44 or the alternative criteria presented in the statement of consideration are selected.

DOE Response:
The DOE recommends that the NRC state that § 63.44 applies to activities described in the Safety Analysis Report and not to the general information.  Consistent with practice the NRC applies to its licensees who operate nuclear reactors, the Safety Analysis Report is a living document, changes to which are appropriately controlled through § 63.44.  The physical protection, material control and accounting, and safeguards plans are controlled by separate requirements in 10 CFR Parts 72 and 73 invoked by the proposed 10 CFR Part 63.  Changes to these plans are appropriately addressed in the governing regulations.  The remaining parts of the general information required by § 63.21(b) are summaries and general descriptions.  Where the descriptions are related to safety, they are provided in detail in the Safety Analysis Report and merely summarized in the general information.  Invoking § 63.44 for changes to the descriptions in the general information is not appropriate.  Should the NRC believe it necessary to invoke the controls of § 63.44 for any of these descriptions, the DOE recommends the requirements for the descriptions be moved to § 63.21(c) such that they will be provided in the Safety Analysis Report.