25 August 2003 Source: http://www.access.gpo.gov/su_docs/aces/fr-cont.html ----------------------------------------------------------------------- [Federal Register: August 25, 2003 (Volume 68, Number 164)] [Notices] [Page 51034-51040] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr25au03-61] ----------------------------------------------------------------------- NUCLEAR REGULATORY COMMISSION Notice of Availability of a Standard Review Plan (NUREG-1569) for Staff Reviews for in Situ Leach Uranium Extraction License Applications AGENCY: Nuclear Regulatory Commission. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has developed a [[Page 51035]] Standard Review Plan (NUREG-1569) which provides guidance for staff reviews of applications to develop and operate uranium in situ leach facilities. Under the provisions of Title 10 of the Code of Federal Regulations, part 40 (10 CFR part 40), Domestic Licensing of Source Material, an NRC Materials License is required to conduct uranium recovery by in situ leach extraction techniques. Applicants for a new license and operators seeking an amendment or renewal of an existing license are required to provide detailed information on the facilities, equipment, and procedures used in the proposed activities. In addition, the applicant for a new license also provides an Environmental Report that discusses the effects of proposed operations on the health and safety of the public and assesses impacts to the environment. For amendment or renewal of an existing license, the original Environmental Report is supplemented, as necessary. This information is used by the NRC staff to determine whether the proposed activities will be protective of public health and safety and the environment and to fulfill NRC responsibilities under the National Environmental Policy Act (NEPA). The purpose of the Standard Review Plan (NUREG-1569) is to provide the NRC staff with guidance on performing reviews of information provided by the applicant and to ensure a consistent quality and uniformity of staff reviews. Each section in the review plan provides guidance on what is to be reviewed, the basis for the review, how the staff review is to be accomplished, what the staff will find acceptable in a demonstration of compliance with the regulations, and the conclusions that are sought regarding the applicable sections in 10 CFR part 40, Appendix A. NUREG-1569 is also intended to improve the understanding of the staff review process by interested members of the public and the uranium recovery industry. The review plan provides general guidance on acceptable methods for compliance with the existing regulatory framework. As described in an NRC white paper on risk- informed, performance-based regulation (SECY-98-144), however, the applicant has the flexibility to propose other methods as long as it demonstrates how it will meet regulatory requirements. A draft of NUREG-1569 was issued in October 1997 and subsequently revised to reflect responses to public comments and the results of Commission policy decisions affecting uranium recovery issues described in NRC Regulatory Issue Summary (RIS) 2000-23, dated November 30, 2000. RIS 2000-23 addressed two issues related to in situ leach facilities. In the first, the NRC took the position that all waste water generated during or after the uranium extraction phase of operations at an in situ leach facility, and all evaporation pond sludges derived from such waste waters, are 11e.(2) byproduct material. In the second, the NRC reaffirmed its authority to regulate ground water at in situ leach facilities, but expressed its intent to continue discussions with the U.S. Environmental Protection Agency (EPA) and appropriate States to try to minimize duplicative ground-water reviews. On February 5, 2002 (FR 5347), the NRC made the revised second draft of NUREG-1569 available for a 75-day public comment. In preparing the final version of NUREG-1569, the NRC staff reviewed and considered more than 750 written comments received by the close of the public comment period on April 22, 2002. To simplify the analysis, the NRC staff grouped all comments into the following major topic areas: (1) Editorial and Organizational Comments (322 comments); (2) Policy Issues (including administrative, quality assurance, and surety/financial issues) (103 comments); (3) Ground water (123 comments); (4) Operational (47 comments); (5) Health Physics (78 comments); (6) Monitoring (55 comments); and (7) Environmental aspects related to NRC responsibilities under NEPA (40 comments). ADDRESSES: Electronic copies of this document are available for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html (The Public Electronic Reading Room). NUREG-1569 is under Adams Accession Number ML032250177. The document is also available for inspection or copying for a fee at the NRC's Public Document Room, 11555 Rockville Pike, Room O1-F21, Rockville, Maryland 20852. This guidance document is not copyrighted, and Commission approval is not required to reproduce it. FOR FURTHER INFORMATION CONTACT: John Lusher, Office of Nuclear Material Safety and Safeguards, Division of Fuel Cycle Safety and Safeguards, Mail Stop T-8 A33, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Telephone (301) 415-7694, or e-mail jhl@nrc.gov. SUPPLEMENTARY INFORMATION: The following provides a more detailed discussion of the NRC evaluation of the major topic areas and the NRC responses to comments. 1. Editorial and Organizational Comments Issue: The standard review plan has a number of redundancies and editorial errors. Comment: Several commenters identified editorial concerns, text omissions, or areas where the organization of the standard review plan could be improved. Most of the organizational comments addressed perceived redundancies in the standard review plan or opportunities to streamline the style. Most editorial comments addressed inconsistent terminology, identified typographical and grammatical mistakes, or questioned the accuracy of reference documents. Response: NUREG-1569 is structured consistent with NRC practice for standard review plan style and format. While this style and format may be considered complex or redundant by some commenters, no substantive changes have been made. This will preserve consistency with other NRC standard review plans. The commenters have provided numerous suggestions for improving the readability and clarity of the review plan. Editorial comments on inconsistent terminology, typographical and grammatical mistakes, or the accuracy of reference documents were accepted and incorporated in preparing the final standard review plan, as appropriate. The individual editorial comments are not addressed in this comment summary document. An appendix (Effluent Disposal at Licensed In Situ Leach Uranium Extraction Facilities) was deleted since the guidance therein was superseded by the Staff Requirements Memorandum for SECY-99-013 which provided staff with direction on classification of liquid wastes at these facilities. Issue: There is sometimes a lack of agreement between the topics to be reviewed and the corresponding acceptance criteria. Comment: Commenters stated that in several review plan sections, the areas of review identified at the beginning of the section did not correspond well to the acceptance criteria that would be used to make the evaluation findings. Response: The staff concurs with this comment. NUREG-1569 was edited to provide correspondence among areas of review, review methods, acceptance criteria, and evaluation findings in each section. [[Page 51036]] Issue: Chapter 5 (Operations) of the standard review plan has many editorial and technical discrepancies. Comment: Several commenters identified editorial and technical concerns with Chapter 5 of the draft standard review plan. In some cases, the editorial problems may have made the regulatory guidance difficult to implement. Resolution: The staff concurs with the commenters. Chapter 5 was rewritten to incorporate editorial and regulatory guidance improvements. The separate section on recordkeeping and reporting was combined with the section on the management control program to more closely match Regulatory Guide 3.46.1 (Standard Format and Content of License Applications, Including Environmental Reports, for In Situ Uranium Solution Mining). Editorial comments are not addressed individually in this comment summary document except where they have particular impact on the standard review plan. Issue: Additional clarifying or background information should be included in NUREG-1569. Comment: Several commenters suggested that specific additional information related to proceedings for a given site or that would provide general background information on in situ uranium extraction techniques and hazards be included. Resolution: The NRC has elected not to include the suggested information in NUREG-1569 because the standard review plan is not written for application to a specific site, and general information is available in other references on in situ uranium extraction operations. 2. Policy Issues (Including Administrative, Quality Assurance, and Surety/Financial Issues) Issue: NUREG-1569 attempts to apply a risk-informed, performance- based regulatory philosophy without a regulatory basis for doing so. Comment: Commenters, while noting that risk-informed, performance- based regulatory philosophies could be applied to in situ leach uranium extraction facilities, argued that no regulatory basis exists for implementing such philosophies. The commenters stated that 10 CFR part 40 should be modified to incorporate risk-informed, performance-based regulatory concepts before the associated standard review plan is modified in that way, because standard review plans are not to be used to promulgate regulatory policy. Commenters also stated that the NRC should not expect license applicants to conduct the accident analyses, consequence evaluations, and probability determinations associated with risk-informed, performance-based regulation. Finally, the commenters argued that the risk-informed, performance-based approach presented in NUREG-1569 was too cursory, contained undefined terms, assumed the existence of a facility change mechanism, and that the review plan contained highly prescriptive acceptance criteria. Response: The NRC agrees that standard review plans cannot be used to promulgate regulatory requirements, and has no intent to do so using NUREG-1569. In related action, the Commission considered promulgating a new regulation (10 CFR part 41) that would specifically address regulatory requirements for in situ leach uranium extraction facilities and that would formally incorporate risk-informed, performance-based regulatory philosophies. However, considering feedback from the uranium extraction industry and other stakeholders, and taking into account the economic status of the uranium extraction industry which would have to bear the cost of the rulemaking, the Commission determined that rulemaking was not an appropriate action at this time. Instead, in making this decision, the Commission directed the staff to update its regulatory guidance related to in situ leach uranium extraction facilities. NUREG--1569 incorporates this direction from the Commission. It outlines risk-informed, performance-based approaches that staff reviewers may apply to in situ leach uranium extraction facilities that are also consistent with existing NRC regulations at 10 CFR part 40. In NUREG/CR-6733 (A Baseline Risk-Informed, Performance-Based Approach for In Situ Leach Uranium Extraction Licensees) staff analyses of in situ leach uranium extraction facility operations and accidents that consider both likelihood of occurrence and consequence (and therefore, risk) are presented. The analyses in NUREG-6733 are conservative and demonstrate that in situ leach uranium extraction facilities operated with properly trained workers and effective emergency response procedures generally pose low levels of radiologic risk. The staff considers analyses similar to, or based on, those in NUREG-6733 to be an appropriate basis for licensee safety analyses. NUREG-1569 is not intended to require applicants to prepare complex accident analyses, consequence evaluations, and probability determinations. However, site-specific conditions and circumstances must be addressed in any application. For several years, the NRC staff has been approving in situ leach uranium extraction facility license renewals that incorporate a performance-based license condition that provides a facility change mechanism using a Safety and Environmental Review Panel. This accepted practice is continued in NUREG-1569. Finally, the staff has not attempted to implement overly prescriptive acceptance criteria in NUREG-1569. Rather, standard practices that have been found acceptable in demonstrating compliance at in situ leach uranium extraction facilities have been placed in the standard review plan as one approach that the staff may use in determining compliance. Other approaches may be found acceptable as long as the staff can determine that such approaches comply with applicable regulations. In addition, the introduction to 10 CFR part 40, Appendix A, allows applicants to propose alternative standards to the specific requirements in the Appendix A to demonstrate compliance, and the staff will review any such alternative standards that are submitted. NUREG-1569 has been edited to remove inconsistent use of terms or undefined terms. Where useful, acceptance criteria have been modified to be less prescriptive. However, risk-informed, performance-based approaches to determining compliance have been incorporated in the standard review plan to the extent consistent with existing regulations. Issue: Standard review plan guidance with respect to overlapping jurisdiction is not adequate. Comment: Commenters were concerned that NUREG-1569 did not provide sufficiently clear guidance on coordinating license application reviews with federal and state agencies. Commenters also stated that the NRC should accept state guidelines in conducting reviews. Response: NUREG-1569 implements Commission direction in SECY-99-013 regarding ground-water issues at in situ leach uranium extraction facilities. While this direction requires the staff to determine the extent to which it can rely on the U.S. Environmental Protection Agency's (EPA) Underground Injection Control program and to work to implement agreements with appropriate states on these issues, it does not suggest that the NRC broadly accept state guidelines. As appropriate, minimizing dual regulation and implementing agreements with affected states remains an objective of the NRC, [[Page 51037]] and interactions with the EPA and the states continue on these issues. The review plan has been revised to clarify this intent. Issue: The standard review plan directs the staff to inappropriately seek disclosure of an applicant's primary corporate internal costs. Comment: Commenters argued that corporate internal costs such as capital costs of land acquisition and improvement, capital costs of facility construction, and other operating and maintenance costs addressed in the draft standard review plan were not appropriate for staff review. The commenters suggested that only the forecast costs for plant decommissioning and site reclamation should be examined by the staff. Resolution: The staff agrees with the commenters. The standard review plan has been revised to remove guidance that the staff examine costs outside of those associated with plant decommissioning and site reclamation. Issue: The NRC is exceeding its legal authority by requiring that a determination be made that a proposed licensing action is appropriate prior to allowing construction to proceed. Comment: The Executive Summary to NUREG-1569 states that ``beginning construction of process facilities, well fields, or other substantial actions that would adversely affect the environment of the site, before the staff has concluded that the appropriate action is to issue the proposed license, is grounds for denial of the application.'' The commenter disagrees with the ``sweeping nature'' of this statement and asserts that the NRC has no jurisdiction over wells in an exempted aquifer until lixiviant injection begins. Response: The NRC considers this statement to be consistent with the requirements of 10 CFR 40.32(e) and believes it to be appropriate for the agency's responsibilities to protect public health and safety and the environment. The license applicant shall not commence construction activities with a potential for adverse impacts prior to the NRC completing its environmental assessment in accordance with 10 CFR part 51. 3. Ground Water Issue: Some acceptance criteria for ground-water protection seem overly prescriptive or inconsistent with current practices at specific in situ leach uranium extraction facilities. Comment: Several comments pertained to the use of examples of acceptable methods and approaches cited in the various acceptance criteria for ground-water protection. These comments expressed concern that the examples cited were not consistent with current practices at some in situ leach uranium extraction facilities. For example, several comments stated that the examples of acceptable methods for conducting mechanical integrity tests on injection wells are not consistent with methods currently employed or with state-approved practices. Response: Examples of acceptable practices cited in the review plan acceptance criteria for ground-water protection were obtained from operations plans of currently operating in situ leach uranium extraction facilities. These examples refer to methods used to implement ground-water protection requirements that have been considered acceptable in past NRC licensing reviews. The NRC recognizes that an optimal approach to ground-water protection at one facility is not necessarily applicable or appropriate at all in situ leach uranium extraction facilities. As stated in the introduction to NUREG-1569, applicants may take approaches to demonstrating compliance that are different from the acceptance criteria in the standard review plan so long as the staff can make the requisite decisions concerning environmental acceptability and compliance with applicable regulations. Where appropriate, these comments were addressed by modifying text to clarify that the given examples are not prescriptive requirements. Comment: Several comments recommended deletion of constituents from the list of typical baseline water quality indicators in Table 2.7.3-1 of NUREG-1569. In a specific example, a rationale was provided for eliminating radium-228 from the list of baseline water quality indicators to be sampled in each new well field. Response: The rationales provided by the commenters for elimination of certain chemical constituents from the list of typical baseline water quality indicators are not necessarily applicable for all in situ leach uranium extraction facilities. A licensee may provide the rationale for the exclusion of water quality indicators in a license application or amendment request if operational experience or site- specific data demonstrate that concentrations of constituents such as radium-228 are not significantly affected by in situ leach operations. NRC reviewers will determine whether proposed exclusions are justified by the information provided. No changes to Table 2.7.3-1 were made for the final standard review plan. Comment: Two commenters pointed out an apparently new policy that an excursion of lixiviant solutions will be deemed to have occurred if any single excursion indicator exceeds its upper control limit by 20 percent, where previous guidance considered an excursion to have occurred only when two or more excursion indicators exceed their upper control limits by any amount. Response: Acceptance criterion (5) in Section 5.7.8.3 in the draft NUREG-1569 was revised by deleting the statement regarding a single excursion indicator exceeding its upper control limit by 20 percent for determination of when an excursion has occurred. However, the same acceptance criterion retains the requirement that corrective action for an excursion is deemed complete when all excursion indicators are below their respective upper control limits, or when no single indicator exceeds its control limit by more than 20 percent. Ideally, corrective action for an excursion would be to restore all indicators to below their upper control limits. However, in the past, corrective action has been considered acceptable when a monitor well no longer meets the criteria for being on excursion status. Excursion status criteria allow one indicator to be above the respective upper control limit. However, once an excursion has occurred, the reduction in concentrations of indicator constituents by corrective action may not occur at the same rate. Therefore, corrective action may be terminated prematurely if one of two indicators are brought below upper control limits while another remains substantially above its control limit. Issue: The NRC is unduly concerned with protection of ground water in aquifers where exemptions have been obtained from the requirements of the Safe Drinking Water Act. Comment: Several commenters took exception to Acceptance Criterion (4) in Section 6.1.3 of the draft standard review plan, which states that the primary goal for restoration of well fields, following uranium extraction, is to return each well field to its pre-operational baseline water quality conditions. The commenters correctly pointed out that EPA requirements for the Underground Injection Control program result in the uranium production zones being classified as ``Exempted Aquifers.'' This means they are not considered a potential source of drinking water and, therefore, are not subject to requirements of the Safe Drinking Water Act. Response: Acceptance Criterion (4) of Section 6.1.3 in the draft standard review plan was revised to clarify that the goal of ground- water restoration at [[Page 51038]] in situ leach uranium extraction facilities is to protect present or potential future sources of drinking water outside of the exempted production zone. Generally, if water quality within the production zone is restored to the pre-operational baseline water quality, then protection of water resources outside the exempted zone is assured. Hence, restoration of water quality within the production zone to pre- operational conditions is considered a primary goal whenever degradation of water outside of the exempted zone is a possibility. It is recognized, however, that restoration to pre-operational baseline conditions may not be practicable or feasible, owing to geochemical changes in the production zone during operations. Hence, applicants may propose secondary standards for monitored constituents that are protective of water resources outside of the exempted zone. This has also been clarified in the final standard review plan. 4. Operations Issue: It is unclear which hazardous chemicals have the potential to impact safety at in situ leach uranium extraction facilities. Comment: Some commenters expressed concern that the standard review plan addressed hazardous chemicals that were not realistic concerns at in situ leach uranium extraction facilities. Response: In 10 CFR part 40, Appendix A, regulations implement EPA Standards at 40 CFR part 192, as required by law. Specifically, 10 CFR part 40, Appendix A, Criterion 13 identifies those hazardous constituents for which standards must be set and complied with if the specific constituent is reasonably expected to be in, or derived from, the byproduct material, and has been detected in ground water. At the same time, the introduction to 10 CFR part 40, Appendix A, allows applicants to submit alternative proposals for meeting the requirements that take into account local or regional conditions. 10 CFR part 40, Appendix A, Criterion 13 also notes that the Commission does not consider the subsequent list of hazardous constituents to be exhaustive. In summary, NUREG-1569 reflects the regulatory requirements but also allows the reviewer to consider any demonstration presented by an applicant that addresses the potential hazardous constituents at a specific site. Issue: The responsibilities of the Safety and Environmental Review Panel are not well defined. Comment: Various commenters stated that the responsibilities of the Safety and Environmental Review Panel, and their authority to authorize changes without a license amendment were either not clear or had no regulatory basis. Resolution: The staff agrees that clarification of Safety and Environmental Review Panel responsibilities and authorities would facilitate use of the standard review plan. These portions of the draft plan were rewritten for clarity. However, consistent with a risk- informed, performance-based licensing approach, use of Safety and Environmental Review Panels has been accepted by NRC staff, and an evaluation of their use was left in NUREG-1569. Issue: The NRC is placing inappropriate restrictions on use of potentially hazardous process chemicals at in situ leach uranium extraction facilities. Comment: The commenter refers to NUREG/CR-6733 (A Baseline Risk- Informed, Performance-Based Approach for In Situ Leach Uranium Extraction Licensees) and states that the analyses in this document were conservative. The commenter concludes that chemical safety must be based on a realistic analysis of the hazards. Resolution: The NRC staff interpreted the conclusions from the analyses presented in NUREG/CR-6733 differently from the commenter. NUREG/CR-6733 conducted deliberately conservative analyses for the purpose of evaluating whether risks at in situ leach uranium extraction facilities were significant. The conclusion presented in NUREG/CR-6733 for chemical hazards was that licensees should follow design and operating practices published in accepted codes and standards that govern hazardous chemical systems. This recommendation leaves licensees flexibility to establish chemical safety measures appropriate for a specific facility and consistent with good engineering and safety practice. NUREG-1569 places no specific strictures on chemical safety practices at in situ leach uranium extraction facilities. 5. Health Physics Issue: The NRC is requesting information on radiation safety programs that is unnecessary, based on the operational record at in situ leach uranium extraction facilities, or is outside NRC licensing authority. Comment: Some commenters expressed a concern that the NRC was requesting information that is not necessary to fulfill the agency mission of protecting the public health and safety and the environment from the effects of radiation. An example cited was information on radiation safety programs, such as the qualifications of those people proposed for the health physics staff. Response: While the NRC agreed with many of these commenters that some of the information requested was not needed, information on qualifications is necessary. However, much of this information is identified in Regulatory Guide 8.30, ``Health Physics Surveys in Uranium Recovery Facilities'' (May 2002), and Regulatory Guide 8.31, ``Information Relevant to Ensuring That Occupational Radiation Exposures at Uranium Recovery Facilities will be As Low As is Reasonably Achievable'' (May 2002). Chapter 5 of NUREG-1569 was revised to ensure that it is consistent with NRC regulations and regulatory guidance applicable to in situ leach uranium extraction facilities by referring to those regulatory guides, rather than repeat the information in the SRP. In addition, the licensees are required by license condition to follow the guidance set forth in Regulatory Guide 8.30, and Regulatory Guide 8.31. This is to ensure protection of the worker, the public health and safety, and the environment. Issue: NUREG-1569 references regulatory guides that are outdated. Comment: A number of commenters noted that the standard review plan referenced regulatory guides that have been revised or that are in the process of revision. Response: The commenters correctly noted that some of the references in the draft standard review plan had been superseded or were in the process of revision. The standard review plan has been edited to reference current guidance. However, NRC has a number of regulatory guides that are being updated, and revised versions may only be referenced when they have been formally approved. This has necessitated retaining reference to some draft regulatory guides. Issue: NUREG-1569 introduces a new and undefined concept in discussing ``control systems relevant to safety.'' Comment: Several commenters objected to inconsistent use of terms and a lack of definition for terms related to control systems that may affect safety. Response: NUREG-1569 was edited to incorporate consistent use of terms, and the term ``controls'' was defined consistent with other NRC regulatory guidance. [[Page 51039]] 6. Monitoring Issue: In situ leach uranium extraction facility licensees are not subject to long-term surveillance costs. Comment: A commenter stated that including long-term surveillance costs in financial surety requirements, as addressed in the draft standard review plan, is inappropriate. Response: NRC staff agrees with the commenter. Reference to long- term surveillance costs has been removed from NUREG-1569. 7. Comments Related to NRC Responsibilities Under the National Environmental Policy Act Issue: The NRC is requesting non-radiological information that is outside its area of regulatory authority. Comment: Many commenters expressed concern that the NRC was requesting information that is not necessary to fulfill the agency mission of protecting the public health and safety and the environment from the effects of radiation. The areas of concern included information on water quality, air quality, and historical and cultural information. Response: As a federal agency, the NRC is subject to the NEPA. NEPA requires the NRC to consider impacts to the human environment as a part of its decision making process for licensing actions. The regulations governing NRC implementation of NEPA requirements are in 10 CFR part 51, Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions. Guidance to the NRC staff on conducting environmental reviews is also provided in NUREG-1748 ``Environmental Review Guidance for Licensing Actions Associated with NMSS Programs.'' In fulfilling its requirements under NEPA, the NRC routinely prepares an environmental impact assessment when evaluating applications for new materials licenses or amendments to such licenses. Areas of potential environmental impact that are investigated include water availability and quality, air quality, historical and cultural resources, ecology, aesthetic resources, and socioeconomic effects. In preparing its environmental impact assessment under NEPA, it is necessary for the NRC to establish background conditions for the affected area. This may require collection of data over a larger geographic area than the licensed area, as well as collection of data in technical and sociological areas that are beyond the traditional scope of radiation safety assessments. The commenters noted that detailed environmental impact assessments may not be necessary for all licensing actions, such as license amendment requests that may be minor in scope or short in duration. The text of the review plan has been modified to clarify those situations where NRC has traditionally performed a detailed environmental impact assessment, but the NRC necessarily reserves the right to determine the nature of the assessment on a site-specific basis in accordance with the requirements of 10 CFR part 51. Issue: The standard review plan inappropriately examines corporate financial information in evaluating the socioeconomic effects in cost- benefit analyses. Comment: A number of commenters noted that the standard review plan examines detailed internal corporate financial data as part of the review of cost-benefit analyses for a licensing action. The commenters expressed concern that this information was proprietary and beyond the scope of information necessary for an evaluation of the socioeconomic impact of a facility. Response: The commenters correctly noted that some of the information identified in the draft standard review plan was beyond the scope of information typically required for cost-benefit analyses. The text of the standard review plan has been revised to eliminate requests for proprietary corporate financial information and to clarify the purpose and use of the financial information that is addressed in the standard review plan. Issue: Commenters questioned whether the standard review plan applies to facilities planned for private land as well as those on public land. Comment: Several commenters expressed uncertainty as to whether the review methods and acceptance criteria developed in the standard review plan were also applicable to in situ leach facilities wholly located on private lands. Response: The NRC must consider the environmental impacts of activities on both private and public lands to meet its responsibilities under NEPA, particularly with regard to assessment of direct, indirect, and cumulative impacts of proposed actions. The specific information to be provided by a licensee, and the level of the NRC staff review, will be determined on a site-specific basis considering the nature of the proposed action. The standard review plan is general guidance to the staff on the type of information that is commonly acceptable for evaluating the environmental impact of a proposed licensing action. Consistent with the NRC risk-informed, performance-based licensing philosophy, licensees may use compliance demonstration methods different from those presented in the standard review plan so long as the staff can determine whether public health and safety and the environment are protected. The standard review plan text has been revised for clarity, but it has not been changed to reflect different approaches for facilities operating on private and public lands. Issue: Licensees should not be required to choose the alternative that has the least impact on the environment. Comment: Several commenters expressed concern that the standard review plan requires a licensee or applicant to select the alternative that has the least impact on the environment, or requires that the NRC use license conditions to mitigate adverse environmental impacts that are deemed outside the scope of NRC responsibilities. Response: The NRC agrees that while NEPA requires the agency to identify a preferred alternative, it does not require that the alternative with the least impact on the environment be selected. However, if an environmental impact statement (EIS) is necessary for a proposed action, NEPA requires that all reasonable alternatives be evaluated and that the environmentally preferable alternative be identified in the final EIS. NUREG-1569 does not require the applicant or licensee to select the most environmentally benign alternative. As guidance to the NRC staff, the standard review plan asks the reviewers to determine whether the choice of a particular uranium recovery method has been adequately justified and whether different techniques and processes were evaluated as part of this justification. The standard review plan also directs the staff to evaluate the bases and rationales used by an applicant in evaluating and ranking alternatives. As stated in Council on Environmental Quality regulations (40 CFR 1502.16), in preparing an EIS, federal agencies are to identify all reasonable mitigation measures that can offset the environmental impacts of a proposed action, even if they are outside the jurisdiction of the lead agency. These mitigation measures are intended to avoid, minimize, rectify, reduce, or compensate for significant impacts of a proposed action. If an environmental assessment identifies potentially significant impacts that can be reduced to less-than-significant levels by mitigation, an agency may issue a mitigated finding of no significant impact (FONSI). In the case of a [[Page 51040]] mitigated FONSI, the mitigation measures should be specific and tangible, such as may be stated as license conditions. The standard review plan states that the NRC has responsibilities under NEPA to identify and implement measures to mitigate adverse environmental impacts of the proposed action. Dated at Rockville, Maryland this 15th day of August, 2003. For the Nuclear Regulatory Commission. Robert C. Pierson, Director, Division of Fuel Cycle Safety and Safeguards, Office of Nuclear Material Safety and Safeguards. [FR Doc. 03-21656 Filed 8-22-03; 8:45 am] BILLING CODE 7590-01-P ----------------------------------------------------------------------- [Federal Register: August 25, 2003 (Volume 68, Number 164)] [Notices] [Page 51040-51043] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr25au03-62] ----------------------------------------------------------------------- NUCLEAR REGULATORY COMMISSION Notice of Availability of a Standard Review Plan (NUREG-1620) Revision 1 for Staff Reviews of Reclamation Plans for Mill Tailings Sites Under Title II of the Uranium Mill Tailings Radiation Control Act AGENCY: Nuclear Regulatory Commission. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has revised the Standard Review Plan (NUREG-1620) that was developed to provide guidance for staff reviews of reclamation plans for uranium mill tailings sites covered by Title II of the Uranium Mill Tailings Radiation Control Act. Revision 1 also incorporates information to address new Commission policy on several issues related to uranium recovery, including administrative, quality assurance, surety/financial issues, geotechnical stability, ground-water, and exclusive jurisdication. Under the provisions of Title 10 of the Code of Federal Regulations, part 40 (10 CFR part 40), Domestic Licensing of Source Material, an NRC Materials License is required in conjunction with uranium or thorium milling, or with byproduct material at sites formerly associated with such milling. The licensee's site Reclamation Plan documents how the proposed activities demonstrate compliance with the criteria in Appendix A of 10 CFR part 40. This information, combined with the licensee's Environmental Report, is used by the NRC staff to determine whether the proposed activities will be protective of public health and safety and the environment. The purpose of the Standard Review Plan (NUREG-1620) is to provide the NRC staff with guidance on performing reviews of information provided by licensees. The use of the Standard Review Plan is also intended to ensure a consistent quality and uniformity of staff reviews. Each section in the review plan provides guidance on what is to be reviewed, the basis for the review, how the staff review is to be accomplished, what the staff will find acceptable in a demonstration of compliance with the regulations, and the conclusions that are sought regarding the applicable sections in 10 CFR part 40, appendix A. NUREG-1620 will also assist in improving the understanding of the staff review process by interested members of the public and the uranium recovery industry. The review plan provides general guidance on acceptable methods for compliance with the existing regulatory framework. As described in an NRC white paper on risk-informed, performance-based regulation (SECY- 98-144), however, the licensee has the flexibility to propose other methods as long as it demonstrates how it will meet regulatory requirements. A draft of NUREG-1620 was issued in January 1999 for public comment. A final NUREG-1620, which incorporated NRC staff responses to the comments received on the draft, was issued in June 2000. On February 5, 2002 (FR5348), the NRC made the draft of NUREG-1620, Revision 1, available for a 75-day public comment period. In preparing the final version of NUREG-1620, Revision 1, the NRC staff carefully reviewed and considered about 120 written comments received by the close of the public comment period on April 22, 2002. To simplify the analysis, the NRC staff grouped all comments into the following major topic areas: (1) Editorial and Organizational Comments (31 comments); (2) Policy Issues (including administrative, quality assurance, and surety/financial issues) (51 comments); (3) Geotechnical Stability (17 comments); (4) Ground water (15 comments); and (5) Environmental aspects related to NRC responsibilities under NEPA (4 comments). ADDRESSES: Electronic copies of this document are available for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html (The Public Electronic Reading Room). NUREG 1620 is under ADAMS Accession Number ML032250190. The document is also available for inspection or copying for a fee at the NRC's Public Document Room, 11555 Rockville Pike, Room O1-F21, Rockville, Maryland 20852. This guidance document is not copyrighted, and Commission approval is not required to reproduce it. FOR FURTHER INFORMATION CONTACT: John Lusher, Office of Nuclear Material Safety and Safeguards, Division of Fuel Cycle Safety and Safeguards, Mail Stop T-8 A33, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Telephone (301) 415-7694, or e-mail jhl@nrc.gov. The following provides a more detailed discussion of the NRC evaluation of the major topic areas and the NRC responses to comments. 1. Editorial and Organizational Comments Issue: The draft standard review plan has a number of redundancies and editorial errors. Comment: Several commenters identified editorial concerns, text omissions, or areas where the organization of the draft standard review plan could be improved. Most of the organizational comments addressed perceived redundancies in the standard review plan or opportunities to streamline the style. Most editorial comments addressed inconsistent terminology, identified typographical and grammatical mistakes, or questioned the accuracy of reference documents. Response: NUREG-1620, Revision 1, is structured consistent with the NRC practice for standard review plan style and format. While the style and format may be considered complex or redundant by some commenters, no substantive changes have been made. This will preserve consistency with other NRC standard review plans. The commenters have provided numerous suggestions for improving the readability and clarity of the review plan. Most editorial comments that addressed inconsistent terminology, typographical and grammatical mistakes, or the accuracy of reference documents were accepted and incorporated in preparing the final standard review plan. The individual editorial comments are not addressed in this comment summary document. 2. Policy Issues (Including Administrative, Quality Assurance, and Surety/Financial Issues) Issue: The NRC is inappropriately examining economic assessments that are the prerogative of the applicant. Comment: The draft standard review plan asked the reviewer to examine the [[Page 51041]] economic benefits when slopes steeper than 5 horizontal: 1 vertical (5h:1v) are proposed by an applicant. The NRC staff should be concerned only with whether the slope design will be stable enough to protect the tailings. Resolution: The NRC agrees with the commenter. The final standard review plan has been edited to remove consideration of economic factors in slope design. Issue: Guidance provided on alternate feed materials and non- 11e.(2) byproduct material is not informative. Comment: Commenters stated that information presented in Appendix I [Guidance on Disposal of Alternate Feed Materials and Non-11e.(2) Byproduct Materials in Uranium Mill Tailings Impoundments] of the draft standard review plan was not useful. The commenter suggested that additional guidance was not needed and recommended that the appendix be deleted from the review plan. Resolution: The NRC staff agrees with the commenters to some extent. Appendix I did not contain sufficient information to assist the reviewers in examining requests for disposal of these materials in mill tailings impoundments. However, recent guidance from the Commission on these subjects is relevant to such reviews. Accordingly, Regulatory Issue Summary 2000-23, which presents Commission guidance on these matters has been included in the appendix to facilitate staff reviews. Issue: NUREG-1620 should present guidance on examining multi-site problems. Comment: One commenter noted that guidance on review of multi-site problems should be included in the final standard review plan. The reviewer stated that if a group of licensees raise a common issue, it would be cost effective to address it generically. Response: The NRC staff agrees that addressing multi-site problems in an integrated manner could be cost effective and potentially beneficial to public health and safety and the environment. Omitting this information from NUREG-1620 is not meant to reflect a lack of staff interest in multi-site problems. Rather, the standard review plan is meant to address licensing reviews that can be completed using well- accepted techniques. The staff believes that the technical and regulatory aspects of multi-site problems are such that it is best to examine them on a case-by-case basis. Issue: The long-term custodian must accept transfer of property at termination of the specific license. Comment: One commenter expressed concern regarding language in NUREG-1620 that there must be assurance that the long-term custodian will accept the property necessary to protect public health and safety. The commenter was concerned that the language in the standard review plan implied that the long-term custodian has the option to refuse transfer of the property. Response: The language in the standard review plan is included to ensure that the reviewer verifies that the long-term custodian is aware of the full extent of required land transfer prior to termination of the specific license. The intent is to avoid delays in license termination because the licensee and the long-term custodian may not have a mutual understanding on the extent of land transfer. The text on this issue has been clarified to avoid any potential misunderstanding. Issue: NUREG-1620 guidance on consideration of reasonably attainable corrective actions and economic constraints is unclear. Comment: One commenter was concerned that standard review plan guidance to not eliminate potential corrective actions because of economic constraints is inconsistent with guidance to assess three reasonably attainable, practicable corrective actions. The commenter notes that in some cases there may not be three reasonably attainable, practicable corrective actions to assess. Resolution: While the NRC understands the commenter's concern, the language in the standard review plan on this matter is appropriate to the intent of the guidance and needs no further detail. The guidance to evaluate three reasonably attainable, practicable corrective actions is not a regulatory requirement. The NRC expects that an applicant will present corrective action alternatives that are reasonable and practicable for a specific site and a specific set of circumstances. Issue: Guidance that equipment owned by the licensee not be considered in reducing surety cost evaluations is inappropriate. Comment: One commenter expressed concern that in estimating costs to complete reclamation by a third-party independent contractor, direction that the equipment owned by the licensee and the availability of licensee staff should not be considered in reducing costs was inappropriate. The commenter added that extreme interpretations of this approach could lead to extravagantly expensive or even unattainable surety requirements. Resolution: It is appropriate not to consider equipment owned by the licensee and the availability of licensee staff in calculating costs for surety. The purpose of the surety is to ensure that there will be adequate funds available to complete site reclamation in the event that the licensee is unable to do so. The most likely circumstance that would result in the licensee being unable to complete reclamation is bankruptcy by the licensee. Unless the licensee can show that the equipment and staff would be available during and after a bankruptcy, credit for such can not be taken. The text has been clarified to address this issue. Issue: NUREG-1620 should be used as a tool for public education. Comment: Several commenters suggested that discussions could be expanded in various sections of the standard review plan to improve public understanding of regulatory issues at Title II uranium mill tailings sites. Response: Discussions in several sections of the standard review plan were revised to improve clarity and to correct editorial errors. Although it is made available to the public, the primary intent of the Standard Review Plan is to provide guidance to the NRC staff, not to serve as a tool for public education. The staff believes that the standard review plan contains the appropriate level of detail for its intended purpose as a guide for staff reviews of reclamation plans for Title II mill tailings sites. 3. Geotechnical Stability Issue: NUREG-1620 requires additional flexibility in criteria for selection of rock erosion protection materials. Comment: One commenter suggested that criteria in the standard review plan should provide more flexibility in selecting a less durable rock for erosion protection when obtaining more durable rock is not practical. Response: Flexibility in selecting rock types for erosion protection is implicitly provided in several locations in NUREG-1620, Revision 1 (e.g., Section 3.5.3), as long as the applicant can demonstrate with reasonable assurance that the radon barrier will be effective for 1,000 years, to the extent reasonably achievable, and, in any case, for at least 200 years. Clarifying text has been added to indicate explicitly that this option is available. Issue: Terminology for erosion protection covers needs to be clarified. Comment: One commenter requested clarification in use of the terms ``unprotected soil cover'' and ``vegetative soil cover.'' Response: The staff agrees with the commenter. Section 3.5 of the standard [[Page 51042]] review plan has been retitled ``Design of Erosion Protection,'' and the review guidance in that section has been clarified to avoid confusion in the use of terms. Issue: The NRC is requiring detailed seismic hazard analysis, even in zero seismic risk areas identified in the Uniform Building Code. Comment: One commenter noted that for cases where a given site is located in a ``zero'' seismic risk area, as identified in the Uniform Building Code, no further seismic characterization, explanation, or description should be needed for the licensee or applicant. Response: Maps for the maximum considered earthquake ground motion for the United States in the most recent version of the building code (2000 International Building Code) are based on probabilistic seismic hazard maps with additional modifications incorporating deterministic ground motions in selected areas and the application of engineering judgement. These maps were prepared for the National Earthquake Hazards Reduction Program by the United States Geological Survey. Because it is based on probabilistic methods, within the new update, the ``zero'' seismic risk areas no longer exist. The NRC is currently establishing risk-informed and performance- based regulations. One example of this philosophy is the application of a risk-graded approach in developing seismic design requirements for nuclear facilities. Under this approach, for example, nuclear power plants have to meet the most stringent design requirements because they pose the greatest radiological risk to public health and safety. Other nuclear facilities like dry cask and canister storage facilities or uranium mining operations could be designed to less stringent design criteria because they pose substantially less radiological risk to public health and safety. This type of graded approach to radiological hazard is described in U.S. Department of Energy (DOE) Standard 1020- 2002, ``Natural Phenomena Hazards Design and Evaluation Criteria for Department of Energy Facilities.'' In that guidance, the DOE developed five performance categories according to the relative risks posed by the potential failure of a structure, system, or components (SSCs) to perform its intended safety function. Performance Category (PC)-2 is intended for occupational safety and the design requirements for this category match those in the IBC-2000. PC-3 SSCs are for hazard confinement and the design requirements go beyond those within IBC- 2000. Given the potential radiological hazards posed by Mill Tailing sites, evaluations of seismic hazards should therefore exceed those prescribed in the IBC-2000 for buildings. In addition, the National Earthquake Hazards Reduction Program maps do not take site effects into account. Local site effects, such as soil amplification, can greatly increase the level, spectral frequency content, and duration of vibratory ground motions at a site that is produced during an earthquake. Therefore, these effects need to be understood in order to accurately predict the seismic hazard at any site. Based on these two considerations (graded risk approach and possible site amplification effects), staff conclude that site-specific seismic evaluations are necessary for all sites. Issue: The NRC has not provided an adequate definition of the intent of using probabilistic seismic hazard analysis to satisfy the consideration of the maximum credible earthquake. Comment: One commenter noted that the draft standard review plan indicates that licensees can use an alternative to the maximum credible earthquake, such as probabilistic seismic hazard analysis, but does not indicate whether the intent is to allow probabilistic analyses to satisfy 10 CFR part 40, appendix A, criterion 4(e) or it is being considered as an alternative requirement. Response: The application of a probabilistic seismic hazard analysis in place of a deterministic approach is not intended to be an alternative requirement to, as defined in the question, but another way of satisfying the existing move toward risk-informed and performance- based regulations. In addition, other NRC regulations clearly recommend the use of a probabilistic approach as an acceptable way to account for uncertainties [e.g., 10 CFR 100.23(d)(1)]. Issue: The NRC has provided only general guidance to seismic hazard analysis, rather than guidance specific to certain geographic provinces. Comment: One commenter noted that references cited in the standard review plan did not provide useful guidance with regard to site- specific seismicity issues, and suggested other references specific to Wyoming and the intermountain region of the western United States. Response: The standard review plan is intended to provide general guidance to the NRC staff on reviewing license applications, license renewals, and amendment requests. The standard review plan does not preclude licensees from providing additional site-specific information as necessary in their license application or amendment requests, and identifying how this information supports a specific licensing action. 4. Ground Water Issue: NUREG-1620 should be consistent in use of terminology related to ground water. Comment: The term ``constituent of concern'' seems to be used interchangeably with the term ``hazardous constituent.'' Constituents of concern are not necessarily hazardous constituents unless they have migrated into ``non-exempted'' aquifers. Response: Section 4.2.1 of the standard review plan was revised to delete a sentence equating constituents of concern with hazardous constituents. The term ``hazardous constituent'' is now used consistent with the definition in 10 CFR part 40, appendix A, criterion 5B(2). Issue: The difference in an As Low As Reasonably Achievable (ALARA) analysis for radiological and nonradiological parameters needs to be more clearly presented. Comment: An ALARA analysis for a nonradiological parameter differs from that for a radiological parameter in that once the concentration of a nonradiological parameter falls below the maximum concentration limit, the licensee has no obligation to further reduce the parameter's concentration. The NRC should distinguish between the two types of ALARA studies. Response: The NRC concurs with the commenter. A sentence was added to Section 4.3.3.3 of the standard review plan to indicate that, when a nonradiological hazardous constituent concentration is below its regulatory maximum concentration level, the licensee has no further obligation to reduce the constituent concentrations. Issue: The benefits of ground-water corrective action requirements at remote sites are questionable. Comment: Two commenters noted that the NRC should provide further guidance on addressing instances where the benefits of ground-water correction action may not justify the cost. One comment referred to circumstances where restrictions on site access or site-specific physical characteristics may make it infeasible for members of the public to access ground water. Another comment suggested that the future value of the ground water removed and evaporated during corrective actions may exceed any risk posed by the contaminant. Response: No changes to the standard review plan were made to address these comments. In such site-specific circumstances as described by the [[Page 51043]] commenters, the burden is on the licensee to demonstrate that termination of ground-water corrective actions would pose no significant threat to human health and the environment. Licensees may propose alternate concentration limits that meet the requirements of 10 CFR part 40, appendix A, criterion 5B(6). Consideration of the remoteness of a site, potential future water uses, and future value may be included in a licensee's basis for determining that alternate concentration limits are protective of human health and the environment, and that limits are as low as reasonably achievable. These and other factors for consideration by the Commission are specifically mentioned in 10 CFR, part 40, appendix A, criterion 5B(6), which is appropriately cited in the standard review plan. 5. Comments Related to NRC Responsibilities Under the National Environmental Policy Act Issue: The NRC is reviewing information that is outside its areas of regulatory authority. Comment: Several commenters noted that the NRC is asking for information that appears to be beyond its regulatory authority. This includes information on nonradiological hazardous constituents and review of restoration plans for borrow areas. Response: As a federal agency, the NRC is subject to the National Environmental Policy Act (NEPA). This requires the NRC to consider impacts to the human environment as a part of its decision making process. The regulations governing the NRC implementation of NEPA are described in 10 CFR part 51. Guidance to the NRC staff on conducting environmental reviews is also provided in NUREG-1748 ``Environmental Review Guidance for Licensing Actions Associated with NMSS Programs.'' With regard to NEPA, the NRC must consider the environmental impacts of both radiological and nonradiological aspects of a proposed action, particularly with regard to assessment of direct, indirect, and cumulative impacts of the proposed action. The exact nature of the information to be provided by a licensee and the level of NRC staff review will be determined on a site-specific basis. The standard review plan is intended as general guidance to the staff on the type of information that is commonly acceptable for evaluating the environmental impact of a proposed licensing action. Under the risk- informed, performance-based licensing philosophy used by the NRC, the licensee is free to present alternative approaches for NRC consideration. With regard to restoration plans for borrow areas, the intent of the section of the standard review plan identified by the commenter is to have staff review restoration plans for borrow areas as part of characterizing the stratigraphy and materials at a given site, and fulfilling NRC requirements under NEPA. The NRC also needs to consider the cumulative impacts of both radiological and nonradiological hazardous constituents to meet its obligations under NEPA. General guidance to the NRC staff for the evaluation of cumulative impacts is provided in Section 4.2.5 of NUREG-1748 ``Environmental Review Guidance for Licensing Actions Associated with NMSS Programs.'' Dated at Rockville, Maryland this 15th day of August, 2003. For the Nuclear Regulatory Commission. Robert C. Pierson, Director, Division of Fuel Cycle Safety and Safeguards, Office of Nuclear Material Safety and Safeguards. [FR Doc. 03-21655 Filed 8-22-03; 8:45 am] BILLING CODE 7590-01-P