Nuclear Regulatory Commission: Efforts Intended to Improve Procedures for Requesting Additional Information for Licensing Actions Are Under Way
Published: 2017-04-25T00:00:00

Fast Facts:
The Nuclear Regulatory Commission reviews more than 2,500 applications per year from applicants seeking, for example, licenses to construct reactors or dispose of nuclear waste.
To help NRC decide whether to approve such applications, staff may request additional information from applicants. This process has been criticized for the amount of time and resources it takes.
Applicants we interviewed were generally satisfied with the process, but identified concerns, such as NRC staff sometimes departing from guidance. NRC is taking steps to improve the process, including increasing communication with the applicants and updating guidance.

Highlights:
section_title: Why GAO Did This Study
paragraphs: NRC issues RAIs to obtain information in licensing requests to ensure that officials can make a fully informed, technically correct, and legally defensible regulatory decision. RAIs are necessary when the information was not included in an applicant's initial submission, is not contained in any other docketed correspondence, or cannot reasonably be inferred from the information available to agency staff. NRC's use of RAIs has come under scrutiny in the past. For example, NRC's Inspector General, in a 2015 report, cited concerns about RAIs, including the amount of time it took to complete the RAI process and the resources required to do so.
GAO was asked to review how NRC uses RAIs. This report examines (1) NRC's guidance for developing and issuing RAIs and how it differs across offices; (2) how many RAIs NRC has issued over the past 5 years and the kinds of activities that elicit RAIs; and (3) strengths and weaknesses of NRC's processes to develop RAIs identified by NRC and licensees and the actions NRC is taking to address concerns. GAO examined agency guidance documents and selected licensing actions containing RAIs. GAO interviewed NRC officials and selected licensees. GAO randomly selected licensing actions and licensees from a sample of recent licensing actions that included cases from each of NRC's RAI-issuing offices.
section_title: What GAO Found
paragraphs: At the Nuclear Regulatory Commission (NRC), individual offices that issue requests for additional information (RAI) each have their own guidance that is generally the same across the offices. NRC offices have some efforts underway to update their guidance. These efforts are intended to improve oversight of RAIs and include an increased focus on oversight of RAIs and on staff compliance through managerial review. For example, one of the offices that issues RAIs calls for management to discuss the need to send a licensee additional questions on the same topic before doing so.
NRC offices that issue RAIs do not specifically track the number of RAIs that they have issued and do not have a comprehensive accounting for the last 5 years, although one office has a system capable of tracking the number of RAIs. Information from NRC officials and licensees GAO interviewed suggests that certain activities and circumstances often elicit RAIs. There is no legal requirement for the agency to track the number of RAIs; however, offices are updating their internal tracking systems in order to improve information on their licensing activities. Receiving RAIs is not unusual, particularly for certain activities such as complex licensing actions and activities for which regulations are unclear, according to officials. In such cases, increased coordination between NRC and the licensee may be required to resolve certain issues.
Licensees GAO interviewed were generally satisfied with the RAI process, identifying strengths and two common weaknesses, and NRC has made recent efforts intended to address these weaknesses. Some licensees noted that they see RAIs as a natural part of interacting with a regulator and identified NRC's openness to communication and engagement as a strength of the RAI process. Two common weaknesses that licensees cited are a gap between NRC's expectations and licensees' understanding of what to include in their applications, and staff departure from guidance. NRC offices have made recent efforts to address these issues. For example, to address inconsistencies between NRC's expectations and licensees' understanding, NRC offices are emphasizing greater communication between review staff and licensees.
section_title: What GAO Recommends
paragraphs: GAO is not making any recommendations. NRC generally agreed with GAO's findings.

section_title: Letter
paragraphs: The Nuclear Regulatory Commission (NRC), the independent nuclear  regulatory agency of the United States, reviews about 2,500 licensing  actions per year in its regulation of commercial nuclear power plants and  other uses of nuclear materials, such as in nuclear medicine, through  licensing, inspection, and enforcement of NRC’s requirements. Through  the licensing process, NRC may authorize an applicant to conduct the  following activities: (1) construct, operate, and decommission commercial  reactors and fuel cycle facilities; (2) possess, use, process, export and  import nuclear materials and waste, and handle certain aspects of their  transportation; and (3) site, design, construct, operate, and close waste  disposal facilities. To become licensed for the aforementioned activities  (or to amend, renew, or transfer an existing license), an entity must  submit an application to NRC and, if applicable, respond to any requests  for additional information (RAI) from NRC staff. According to NRC  documents, RAIs are intended to help agency staff obtain information  needed to make a regulatory decision that is fully informed, technically  correct, and legally defensible. NRC documents also state that RAIs are  necessary when information is not included in an applicant’s initial  submission, is not contained in any other docketed correspondence, or  cannot reasonably be inferred from the information available to agency  staff. For example, agency staff may use RAIs during an environmental  review to look for new or updated information on the issues they are  reviewing as part of a license renewal. In other cases, agency staff may  use RAIs to obtain information missing from an initial application, such as  qualifications of applicants using nuclear materials for medical purposes.
Three NRC offices are responsible for reviewing and approving licensing  actions and associated RAIs:  the Office of New Reactors, which is responsible for licensing and  processing license amendment requests for new reactors;  the Office of Nuclear Reactor Regulation, which is responsible for  licensing for operating nuclear power reactors; and the Office of Nuclear Material Safety and Safeguards, which is  responsible for the safe and secure production of nuclear fuel; the  safe storage, transportation, and disposal of high level radioactive  waste and spent nuclear fuel; and the transportation of certain  radioactive material.
These offices operate under the Executive Director for Operations, the  arm of NRC that carries out the policies and decisions of the five-member  Nuclear Regulatory Commission.
NRC’s use of RAIs has come under scrutiny in the past. During the late  1990s, the Senate Environment and Public Works Committee identified  concerns regarding excessive use of RAIs that resulted in unnecessary  increased costs and schedule delays. More recently, in 2015, NRC’s  Inspector General cited concerns about RAIs in a report on oversight of  spent fuel pools, including the amount of time it took to complete the RAI  process and the resources required to conduct and review complex  research and analyses requested through RAIs.
You asked us to review NRC’s use of RAIs in the licensing process. This  report examines: (1) NRC’s guidance for developing and issuing RAIs and how it differs across offices; (2) how many RAIs NRC has issued  over the past 5 years and the kinds of activities that elicit RAIs; and (3)  strengths and weaknesses of NRC’s processes to develop RAIs identified  by NRC and licensees, and the actions NRC is taking to address  concerns.
For all three objectives, we interviewed a nongeneralizable sample of 12  industry licensees. We selected interviewees from a set of licensing  actions submitted within the randomly selected month of March 2015.  From the set of licensing actions submitted to NRC in March 2015, we  randomly selected two licensees that submitted a licensing action to the  Office of New Reactors, four licensees that submitted to the Office of  Nuclear Reactor Regulation, and six licensees that submitted to the Office  of Nuclear Material Safety and Safeguards, in keeping with the general  proportion of licensing actions processed annually by each office. Our  approach ensured that selected licensees had recent experience working  with NRC and that we obtained at least two licensees’ perspectives for  each of the three RAI-issuing offices. We interviewed licensees by using  a standard set of questions that included questions about: (1) the  licensees’ experience with RAIs, (2) the effect of RAIs on site operations,  (3) NRC guidance pertaining to RAIs, (4) past and current challenges with  RAIs, and (5) strengths and weaknesses of the RAI process. We  analyzed the licensees’ responses and grouped them into categories  developed through team consensus. When referring to the findings from  this analysis, we use “some” to refer to responses from 2 or 3 licensees,  “several” to refer to responses from 4 or 5 licensees, “half” to refer to  responses from 6 licensees, “many” to refer to responses from 7 to 9  licensees, and “most” to refer to responses from 10 licensees.
To examine NRC’s guidance for the development and issuance of RAIs,  we reviewed applicable sections of title 10 of the Code of Federal  Regulations. We also reviewed guidance documents specific to each of  NRC’s RAI-issuing offices. These documents included, among others,  office instruction for the Office of New Reactors, the Office of Nuclear  Reactor Regulation’s License Amendment Review Procedures, and  guidance documents for the four RAI-issuing divisions of the Office of  Nuclear Material Safety and Safeguards. To ensure the completeness  and relevancy of the information, we interviewed knowledgeable NRC  officials from the offices that issue RAIs and use these documents. We  asked NRC officials about efforts underway to maintain the focus on  improving the RAI process and staff compliance with guidance. We also  asked the nongeneralizable sample of 12 industry licensees about their  experiences using NRC guidance documents when addressing RAIs.
In an effort to determine the number of RAIs issued by NRC in the past 5  years, we asked NRC officials to estimate how many RAIs they issued, to  describe internal and external tracking systems they use, and to describe  the ability of these systems to provide information on the number of  additional, follow-up questions issued to licensees. We also reviewed  NRC’s guidance for tracking RAIs, issuing follow-up questions, and  managing the licensee response to RAIs. To identify the type of  information contained in RAIs, we asked NRC officials to describe  common reasons for RAI issuance and reviewed a nongeneralizable  sample of three licensing actions with RAIs. The sample contained one randomly selected licensing action from each of the three RAI-issuing  offices submitted within the randomly selected month of March 2015. The  examples also reflected different types of licensing actions, as one was  for a license renewal, another was for a license amendment request, and  the third was for a relief request. We also asked the nongeneralizable  sample of 12 industry licensees about the type of information requested in  RAIs they received.
To assess the strengths and weaknesses of NRC’s processes for  developing and issuing RAIs, we asked for the perspective of NRC  officials and conducted interviews with the 12 industry licensees or  applicants, as noted above. To obtain additional perspective, we also  interviewed an industry interest group representative who interacts with  both industry and NRC on regulatory issues. To identify NRC efforts to  address concerns raised, we reviewed updates made to guidance  documents and asked NRC officials and licensees about actions taken to  mitigate challenges.
We conducted this performance audit from June 2016 to April 2017 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.
subsections: section_title: Background
paragraphs: The process for developing and issuing RAIs begins with either pre- application activities or the submission of an application (see fig. 1), and  is generally consistent across the NRC offices that use RAIs.
Pre-application activities occur before NRC receives an application; these  activities may include a meeting between the licensee and NRC staff, or  communication between parties via phone or e-mail. NRC offices assign  each licensee a project manager or license reviewer who is responsible  for overseeing the licensing process and coordinating with review staff.  Pre-application activities provide an opportunity for licensees to ask  clarifying questions of NRC staff and for NRC staff to prepare for the  review of an incoming application. Not all license applications or NRC  offices include this step, as pre-application activities vary based on the  complexity of the application. All licensing actions across NRC offices,  however, include the submission of an application. After NRC receives an  application, officials may conduct an acceptance review to ensure there is  enough information contained in the application to perform a technical  review. NRC considers submitted applications “tendered” until the  acceptance review is complete. If it is found during acceptance review  that the application does not contain sufficient information, the application  may remain tendered while the applicant submits supplemental  information, or may be denied.
The process of developing and issuing RAIs begins after either the  submission of the application or acceptance review and culminates in a  licensing decision. NRC reviewers have to make a conclusion that what  the licensee is proposing provides a reasonable assurance of safety; this  allows reviewers to complete a safety evaluation report and conduct both  a technical review and a regulatory review. If NRC’s reviewers are able to  arrive at a conclusion with the information that the licensee provided in  the application, then there is no need for NRC to issue an RAI. However,  if there are areas where the information the licensee has submitted  appears incomplete, then NRC staff will address these areas by  developing and preparing RAIs for management review. After  management review, NRC issues RAIs to licensees. Prior to issuance,  NRC staff may also send draft RAIs to the licensee and reach out to the  licensee via telephone to ensure that the information that NRC needs is  understood and that the RAI language is clear. In such cases, NRC would  issue the formal RAIs after this outreach. The licensee is then expected to  submit responses to the RAIs within a specified period of time, typically  within 30 or up to 60 days. The NRC review team may develop and issue  additional, follow-up questions to the original RAIs—also known as  “additional rounds”—if the review staff requires more information than the  licensee’s initial response contained. When the NRC review team has the  information needed to ensure a fully informed, technically correct, and  legally defensible decision, it will either approve or deny the license  application.
section_title: Individual NRC Offices Have Their Own Guidance to Issue RAIs and Are Updating It in an Effort to Improve the RAI Process
paragraphs: Each NRC office that issues RAIs has its own guidance, and the Office of  Nuclear Reactor Regulation, the Office of New Reactors, and some  divisions in the Office of Nuclear Material Safety and Safeguards have  efforts underway to update guidance intended to improve oversight of  RAIs. Guidance for developing and issuing RAIs is generally the same  across individual offices that issue them but also reflects each office’s  own specific responsibilities and procedures.
subsections: section_title: NRC Offices Have Their Own Guidance to Issue RAIs, and Offices Have Efforts Under Way to Update Guidance Intended to Improve RAI Oversight
paragraphs: NRC offices that issue RAIs each have their own guidance, and some  offices have been updating their guidance over the past year in an effort  to improve the RAI process. This updated guidance includes an increased  focus on ensuring staff compliance with the process through managerial  review. The Office of Nuclear Reactor Regulation’s guidance on RAIs is  contained in an office instruction document for license amendment-review  procedures called LIC-101. In April 2016, the Office of Nuclear Reactor  Regulation issued an expectations memorandum to staff intended to  provide additional guidance and clarity to expectations addressed in  existing office guidance and practice. For example, the expectations  memorandum elevates the issuance of additional questions on the same  topic to divisional management to discuss the need for an additional  round of RAIs before submitting them to a licensee. The memorandum  also calls for the branch chief to review the draft safety evaluation report  and confirm that the holes in the draft report align with RAIs. This is a  change from the version of LIC-101 that officials had been using. NRC  incorporated changes contained in the April 2016 expectations  memorandum into a new edition—version five—of LIC-101 in January  2017. The Office of Nuclear Reactor Regulation’s management also  issued a memorandum in August 2016 to all operating reactor licensees  that stated, among other things, that staff will actively seek opportunities  to conduct an on-site audit or a public meeting in order to reduce the  number of rounds of RAIs.
In the Office of New Reactors, office instruction document NRO-REG-101  provides information to guide staff in the processing of RAIs. In 2008, the  office also produced a detailed pamphlet on the RAI process—called a  job aid—intended to help standardize office practices, ensure proper  focus in the reviews, and enhance efficiency. In October 2016,  management in the Office of New Reactors issued a memorandum to  staff on the effective use of RAIs in new reactor licensing reviews.  According to the memorandum, all RAIs in the Office of New Reactors will  be reviewed up through division management, and the office director will  review samples of RAIs in an effort to keep informed of issues deemed  high priority identified in reviews. This memorandum accompanied an  updated RAI job aid to replace the earlier version, as well as two other job aids focused on carrying out audits and confirmatory analysis, in which  NRC staff conduct an independent assessment of a licensee’s  calculation. The updated RAI job aid contains some modifications to the  text from the 2008 version that include, for example, instruction to division  management to audit draft RAIs to assure conformance with office  expectations for quality.
RAI guidance for the Office of Nuclear Material Safety and Safeguards’  Division of Spent Fuel Management is contained in an instruction  document referred to as SFM-3. The division issued a new instruction  document in August 2016—referred to as Office Instruction 26—that is  intended to provide management expectations and guidance to  employees. The document calls for staff to follow the existing division  guidance for RAIs and outlines new guidance that staff are required to  follow as well. This new guidance includes preparing, for supervisory  review, a draft safety evaluation report showing the regulatory holes that  call for RAIs. The new guidance also calls for notifying management of  additional rounds of RAIs and receiving management concurrence before  issuance. The office’s Division of Material Safety, State, Tribal and  Rulemaking Programs relies on guidance contained in Volume 20 of a  multi-volume series of guidance documents on materials licenses called  NUREG-1556. Volume 20 provides guidance on administrative licensing  procedures and, according to officials, is currently being updated along  with the other volumes in the series. Officials told us that Volume 20 is  expected to be published as a draft report for comment in spring 2017  and published as a final report sometime that year.
According to officials, procedures to process RAIs in the Division of  Decommissioning, Uranium Recovery, and Waste Programs were first  issued in 2000. These procedures include the requirement that a draft  safety evaluation report be used to support RAIs, calls for RAIs to refer to  specific portions of regulation, guidance, or both when issued to  licensees, and encourages staff to conduct telephone conferences to  discuss technical issues and possible resolution. The instruction  document covers licensing as it applies to all project managers, technical  reviewers, and staff within the Division of Decommissioning, Uranium  Recovery, and Waste Programs. According to officials, the most recent  revision to the procedures in 2009 did not include changes to specific  procedures guiding the development of RAIs.
In addition to guidance, NRC’s offices have practices in place intended to  ensure management and staff continue to focus on improving RAIs.  Officials from each of the NRC offices that issue RAIs said that their  management is continually focused on improving RAIs. For example,  officials from the Office of New Reactors told us there are plans to assess  the revised process for developing and issuing RAIs throughout upcoming  license reviews to look for additional opportunities for improvement. In the  Office of Nuclear Material Safety and Safeguards, officials told us that  RAIs receive attention from the management of all divisions and that  office leadership is working with licensee representatives to identify ways  to improve the RAI process. Officials also told us that because most of  the staff are involved in the process to develop and issue RAIs, it is an  essential component of their work. As a result, their work on RAIs will  factor into their performance review. According to officials, NRC’s  standards for employee assessments are written at a general level for  almost all staff at NRC. Technical staff are evaluated against four  standards: planning and implementation, problem solving and analysis,  communication, and professional development and organizational  effectiveness.
section_title: NRC Offices’ Guidance Reflects Their Specific Responsibilities and Procedures, but Processes Are Similar across Offices
paragraphs: According to NRC officials, the individual guidance developed by each  office reflects the office’s own responsibilities and procedures. Guidance  may differ across offices when a license application requires review by  multiple technical branches; one office may issue RAIs to the licensee as  they are completed by a technical branch, while another may wait to issue  RAIs until all relevant technical branches have completed the initial  review. For example, the Fuel Cycle Licensing Review Handbook used by  the Division of Fuel Cycle Safety, Safeguards and Environmental Review  in the Office of Nuclear Material Safety and Safeguards notes that if the  same regulatory issue occurs in more than one technical section, the  issue should be addressed in a general section rather than multiple times  in each section. The handbook also encourages reviewers to issue one  set of RAIs, as opposed to multiple sets.
Guidance on the response times given to licensees also differs among  NRC offices. Consequently, the Office of Nuclear Reactor Regulation’s  guidance document, LIC-101, calls for licensees to respond to RAIs in 30  days or within a timeframe specified by the review team. Updates  intended to align LIC-101 with the office’s expectations memorandum  include guidance for a default response period of 30 days, an extended  response period of 60 days, and approval for a longer response period if  the review schedule allows. However, the Office of Nuclear Material  Safety and Safeguards’ Fuel Cycle Licensing Review Handbook calls for  the project manager to set a response date of 30 to 60 days. The Office  of New Reactors’ guidance for RAIs references NRC regulations calling  for responses within 30 days of the date of the request, and states that  applicants will be encouraged to respond to questions once they have  prepared their responses, rather than respond to packages of multiple  questions on a set date. The Office of New Reactors’ guidance also  requires that officials use email to transmit RAIs.
In addition, guidance on the level of management’s review given to RAIs  varies by NRC office. RAIs issued for combined license applications and  early site permits in the Office of New Reactors are automatically sent to  branch managers and are reviewed by both division management and the  Office of General Counsel. Guidance for the Office of Nuclear Reactor  Regulation states that RAIs should be reviewed by branch managers. It  also calls for branch managers and staff to discuss the need for a second  round of RAIs and whether alternative methods to obtain information— such as a public meeting or an audit—may be more effective and  efficient. In the Office of Nuclear Material Safety and Safeguards, the  level of management review is determined by the guidance of each  division. For example, in the Division of Spent Fuel Management, RAIs  must be submitted to branch management for review, and divisional  management must be notified of additional rounds of RAIs.
Nevertheless, based on our review of the guidance, the guidance is  generally the same across the offices. Specifically, guidance for the  different offices describes similar processes for issuing RAIs, including  the reason for issuing an RAI, the procedures undertaken to develop  RAIs, and time frames during the process. Guidance for all offices states  that RAIs should be used to gain the information needed for making a  licensing decision, and due to recent updates, most office guidance also  states that RAIs be used to fill gaps in a safety evaluation report. The  process for developing and issuing an RAI is also similar across all  offices, and includes: (1) the development of RAIs by technical reviewers  based on information contained in an application, (2) the review of  proposed RAIs by management, (3) the issuance of RAIs to licensees for  response, and (4) the incorporation of information received through RAIs  into the safety evaluation report and final licensing decision. Additionally,  guidance across all offices includes direction on setting time frames for  issuing RAIs and receiving responses from licensees.
section_title: NRC Offices Do Not Track the Number of RAIs They Issue, and Certain Activities Often Elicit RAIs
paragraphs: NRC offices do not track the number of RAIs and do not know how many  they have issued over the past 5 years, and there is no legal requirement  for NRC to track the number of RAIs it issues. According to NRC officials  and some licensees we interviewed, certain activities and circumstances  often elicit RAIs, such as complex licensing actions and activities for  which regulations are unclear.
subsections: section_title: Offices Do Not Track the Number of RAIs That NRC Issues, and There Is No Legal Requirement to Do So
paragraphs: NRC offices that issue RAIs do not specifically track the number of RAIs  that they issue, and there is no legal requirement for the agency to track  the number of RAIs. An official from the Office of New Reactors estimated  that a combined license application could have 1,000 RAIs, while a  license amendment request could have few, if any, RAIs. Officials added  that the number of RAIs issued in a given review varies depending on the  complexity and size of the requested licensing action. Officials also said  the number of RAIs per year depends on how many license applications  the office receives; it can take 5 years or more to review and make a  decision on a combined license application. In contrast, for plants that are  licensed, officials said that NRC typically reviews 20 to 25 license  amendments per year. According to officials, the Office of Nuclear  Reactor Regulation reviews about 700 licensing actions per year, and  officials also estimated that on average, each licensing action has 5 to 10  RAIs. Officials added that the Office of Nuclear Material Safety and  Safeguards reviews about 1,800 license applications or amendments per  year, with varying numbers of RAIs per action.
NRC officials cannot say with certainty how many RAIs they have issued  over the past 5 years, in part because the current internal tracking  systems used by the Office of Nuclear Reactor Regulation and the Office  of Nuclear Material Safety and Safeguards do not track the number of  RAIs. Officials in the Office of Nuclear Reactor Regulation told us that  they do not track the number of RAIs because RAIs are only one  component in the broader licensing process. Instead, officials said, they  focus more on whether the office is carrying out licensing activities in an  efficient, effective manner. The Office of New Reactors has an internal  tracking system, called eRAI, which is specifically configured to manage  RAIs and is capable of tracking the number of RAIs per year. However,  according to an official, the office does not use eRAI to track the number  of RAIs. Instead, the Office of New Reactors uses eRAI to monitor RAIs  associated with applications that can be up to 12,000 pages long, identify  related questions, and track RAIs by regulatory issue area.
Some NRC offices have been working to update their internal tracking  systems for licensing actions. These updates are intended to, among  other things, allow officials to better track milestone dates in the licensing  action process, such as the date that an RAI response is due. For  example, the Office of Nuclear Reactor Regulation is changing to a new  system called the Replacement Reactor Program System, which tracks  major milestones within each of the licensing reviews. Unlike the previous  system, the new system can track multiple rounds of RAIs. In addition,  according to NRC officials, the Division of Spent Fuel Management in the  Office of Nuclear Material Safety and Safeguards is moving to a web- based tracking system from a system that only tracked milestone dates.  The new system is intended to track RAIs and to help identify issues early  in the process that may influence the timeliness of the review. Elsewhere  in the Office of Nuclear Material Safety and Safeguards, officials in the  Division of Fuel Cycle Safety, Safeguards and Environmental Review told  us that they are upgrading their tracking system and will use the same  one as the Division of Spent Fuel Management. Further, the office’s  Division of Material Safety, State, Tribal, and Rulemaking Programs is  also in the process of enhancing its tracking system by streamlining the  process to allow the staff to issue licensing actions directly from the  system.
NRC officials told us that tracking the number of RAIs is challenging and  may not reflect the role that RAIs play in the licensing process. According  to officials, counting the number of RAIs may be challenging because  different reviewers can refer to an RAI as a single question, or as a letter  to a licensee containing several questions. Officials also told us that the  number of RAIs does not capture the variance in size and complexity of  RAIs; for example, NRC may request simple editorial changes that  require little effort and time on the part of the licensee, or RAIs may  request additional technical analyses that require more effort and time to  address.
section_title: RAIs Are Not Unusual, and Certain Activities Often Elicit RAIs
paragraphs: NRC officials told us that receiving RAIs as part of a licensing action is  not unusual, and officials and licensees we interviewed said that RAIs are  often issued for the following activities and circumstances: complex  licensing actions, activities for which regulations are unclear, new  activities, and when the initial application does not contain adequate  information or detail.
Complex licensing actions: NRC officials told us that licensing actions  and the associated RAIs vary greatly in complexity, and the number of  RAIs issued may vary depending on the complexity of the review. Some  actions are simple and may take 40 to 80 hours to review, while others  are more complex and may take more than 5,000 hours for review. Many  licensees we interviewed stated that they would expect to receive more  RAIs for more complex licensing actions. For example, a licensee we  interviewed told us that most of the RAIs the company receives are  related to technical specifications, which are NRC’s standardized  requirements for its approved reactor types. Officials from this licensee  said they may receive additional questions for technical specifications and  issues that are plant-specific, such as differences in equipment when  compared to other plants with the same reactor type, and more detailed  drawings and information about the plant’s equipment. Conversely,  another licensee told us that a simple license amendment request for a  name change on a license did not elicit any RAIs.
Unclear regulatory guidance: Some licensees we interviewed also said  that they would expect to receive more RAIs for activities for which  regulations are unclear and may require increased coordination between  NRC and the licensee. One licensee described an instance where  guidelines pertaining to the licensing action were not clear, and it took  several years and additional RAIs to try to reach agreement with NRC.  NRC officials told us that licensees are most likely to receive RAIs in  cases where they request an exception to regulatory guidance. NRC  officials and licensees said that a request for an exception can occur, for  example, when a licensee asks NRC for a license to use a construction  material that is not referenced in regulatory guidance. Further, NRC  officials said that applications for new reactors typically elicit RAIs,  particularly when technology proposed by licensees does not align with  regulations, such as the shift from analog instrumentation and controls  used in most operating reactors to digital instrumentation and controls  proposed for new reactors.
First-of-its-kind activities: NRC officials told us that a new type of  licensing action may require more RAIs. Half of the licensees we  interviewed told us that they received RAIs when requesting a license for  an activity that is the first of its kind or is setting a precedent. For  example, a licensee stated that the company received RAIs for a license  amendment that was one of the first submitted to NRC for a particular  activity.
Quality of the application: Officials told us that the number of RAIs  associated with each license application often depends on the quality of  the application. For example, a license application or response to an RAI  that does not contain adequate information can result in more than one  round of RAIs. Conversely, an application that is comprehensive and  addresses all of the requirements outlined in NRC guidance is less likely  to receive RAIs, and if RAIs are issued, they are less likely to receive  more than one round of RAIs. Some licensees told us that they may  receive RAIs for issues that may have been addressed in another  application or, as one licensee stated, were otherwise obvious; licensees  noted that this was likely because NRC wanted that information included  as part of the docket.
The nongeneralizable sample of licensing actions that we reviewed  reflected several different types of licensing actions and contained RAIs  that varied in format. We reviewed three licensing actions that contained  RAIs—each one representing one of the three offices that issue RAIs.  One action was for a license renewal, another was for a license  amendment request, and the third was for a relief request. One of the  licensing actions received four RAIs sent in two separate e-mails several  weeks apart. NRC officials described these as “official” RAIs, which they  followed with an email identifying apparent editorial errors in the  application. In another example, NRC sent a licensee two draft RAIs in  advance of the formal RAI submission. With regard to the types of  information that NRC asked in its RAIs, one RAI asked for clarification on  technical specifications the licensee used to support its request. Another  asked for specific information about the equipment used, including name  and model number, as well as details concerning maintenance. In the  third example, NRC asked for clarification about testing completed for a  particular piece of equipment in order to approve a license renewal.  Because this was a nongeneralizable sample, our results are not  generalizable to all licensing actions but provide illustrative examples of  the types of information included in RAIs.
section_title: Licensees Were Generally Satisfied with the RAI Process but Also Identified Weaknesses, Which NRC Has Made Recent Efforts to Address
paragraphs: Many of the licensees we interviewed were generally satisfied with the  current process to develop and issue RAIs and identified certain  strengths. NRC officials and licensees also identified two common  weaknesses in the process to develop and issue RAIs, weaknesses that  NRC has made recent efforts to address.
subsections: section_title: Licensees We Interviewed Were Generally Satisfied with the RAI Process and Identified Certain Strengths
paragraphs: Many of the licensees we interviewed expressed satisfaction with NRC’s  current process to develop and issue RAIs and acknowledged the role of  RAIs in the licensing process. Some said that they viewed them as a  natural part of interacting with a regulator. For example, one licensee said  that RAIs are needed to allow for formal communication between NRC  and licensees on issues that may arise again in future licensing actions.  Some licensees said that the experience with NRC had been positive,  and another stated that the RAI process worked well for completing  licensing actions.
Licensees identified NRC guidance as a strength of the RAI process.  Most licensees we interviewed told us that they found NRC guidance to  be helpful; such guidance includes regulatory documents, procedural  documents, and memorandums. For example, the majority of the  licensees we interviewed that worked with the Office of Nuclear Reactor  Regulation said that the office’s April 2016 expectations memorandum  was a positive step by the agency and an improvement in the RAI  process. Specifically, one licensee told us that the policy of ensuring that  RAIs ask for information needed to fill a gap in the safety evaluation  report—as outlined in the memorandum—was an appropriate procedure.  Some licensees also said that they found it particularly useful when NRC  reviewers identified for them specific passages of a guidance document  relevant to the licensing action or RAI.
Licensees we interviewed also identified NRC’s openness to  communication and engagement as a strength of the RAI process. Most  licensees we interviewed said that communication with NRC staff during  the process to develop and issue RAIs was helpful, including pre- application meetings, informal interactions via phone or e-mail, and  coordination with project managers. As mentioned above, pre-application  meetings provide an opportunity for the licensee and NRC to clarify  potential issues or questions before the initial license application is  submitted and RAIs are issued. Of those licensees we interviewed who  participated in a pre-application meeting, the majority said that the  meeting helped to either resolve or clarify issues before the acceptance  review. Some licensees said that pre-application meetings were  particularly helpful when NRC staff assigned to the review participated,  with one licensee stating that it was critical for the staff member who  develops RAIs to be present. A licensee also stated that participating in a  pre-application meeting significantly reduced the number of RAIs issued  later in the process. Additionally, some licensees told us that informal  interactions via phone or e-mail with NRC staff also helped to resolve  issues quickly, as opposed to clarifying or resolving issues through formal  correspondence. Similarly, several licensees noted that the active  engagement of project managers in the review process improved the  efficiency of the review and the quality of RAI questions. For example,  officials from one licensee said that in recent years NRC’s project  manager e-mailed draft RAIs to them, which allows the licensee to review  them in advance, ask clarifying questions, and propose response times.  In another case, a licensee told us that a project manager included  divisional management in a conference call to discuss RAIs, which  resulted in NRC withdrawing some RAIs.
In addition, several licensees we interviewed noted NRC’s  responsiveness to industry operational issues and time constraints in the  review process as a strength. Several licensees described instances in  which operational issues or time constraints required flexibility from NRC,  and they told us that NRC worked with them to ensure uninterrupted  operation or service. Some licensees told us that NRC extended the  response time required for RAIs when licensees asked for additional time.  In another instance, a licensee described a case where NRC expedited  the review process to prevent a disruption in patient medical care that  relies on radiological material. An industry interest group representative  we interviewed told us that both industry and NRC should take steps to  ensure that the recent improvements to the process to develop and issue  RAIs are maintained going forward.
section_title: Licensees Identified Two Common Weaknesses in the RAI Process, Which NRC Has Made Recent Efforts to Address
paragraphs: Licensees and NRC officials that we interviewed identified weaknesses in  the RAI process, including two commonly mentioned ones: (1) a gap  between NRC’s expectations and licensees’ understanding of what  should be included in a license application and (2) staff departure from  guidance that leads to RAI questions that appear to be redundant or  beyond the scope of the review.
Gap in expectations and understanding: NRC officials and licensees  whom we interviewed told us that a gap between NRC’s expectations and  licensees’ understanding of license application content can be a  weakness of the RAI process. Both NRC officials and licensees stated  that inconsistencies may exist between NRC’s expectations and  licensees’ understanding of what should be included in a licensing  application, especially in cases of complex or new activities. According to  NRC officials, such inconsistencies can lead to reviewers’ using RAIs to  gather the information needed to make a licensing decision. NRC officials  said that varying levels of understanding regarding expectations may  result in confusion for licensees and may incentivize them to exert fewer  resources when developing an initial application. According to one NRC  official, licensees may submit an application containing enough technical  information to pass the acceptance review with the understanding that  NRC will develop RAIs to address unresolved issues in the application.  Officials added that the standard and level of detail required for issuing a  licensing action is more stringent than that for an acceptance review. For  half of the licensees, expectations have become clearer in the last several  years as a result of increased communication with NRC. However,  several licensees we interviewed identified unclear or inconsistent  expectations as a current concern. For example, one licensee described  a case where a license amendment received RAIs on a new activity for  which NRC did not have permanent guidance in place. The licensee  rescinded the license amendment request rather than expend the  resources needed to answer RAIs according to NRC’s interim guidance.
The Office of New Reactors, the Office of Nuclear Reactor Regulation,  and the Division of Spent Fuel Management in the Office of Nuclear  Material Safety and Safeguards have made recent efforts to address  inconsistencies between NRC’s expectations and licensees’  understanding by emphasizing greater communication between review  staff and licensees. The Office of New Reactors placed more emphasis  on the pre-application period in which the NRC review team works with  licensees to resolve questions and potential issues that otherwise may  necessitate formal RAIs. In addition, through its April 2016 expectations  memorandum, the Office of Nuclear Reactor Regulation’s management is  encouraging project managers and review staff to engage in increased  communication with licensees to resolve questions, in addition to placing  increasing emphasis on acceptance review. Division of Spent Fuel  Management leadership has also made recent efforts to encourage more  frequent conversations through updated guidance. Some licensees we  interviewed recognized NRC’s efforts, and one licensee told us that NRC  officials have recently been more receptive to discussing RAIs over e- mail, a practice which has helped to make the process more efficient. It is  too soon to tell whether these initiatives will address the gap in  expectations between NRC and licensees in the long term.
Staff departure from guidance: NRC officials and licensees both told us  that some staff may depart from guidance by issuing redundant or  unrelated RAIs, which may require additional time and resources for the  licensee to address. According to officials and licensees, an RAI is  redundant if the information requested is contained in or could be inferred  from information contained in the original license application, other  correspondence, or a response to a previous RAI. Likewise, an RAI is  unrelated to the application if the information requested is not necessary  for making a regulatory decision or filling a gap in the safety evaluation  report. NRC officials said that ensuring staff adherence to internal  guidance regarding appropriate RAIs can be challenging, and many of the  licensees we interviewed identified the influence of individual staff  reviewers as a weakness of the process to develop and issue RAIs. Half  of the licensees we interviewed said that they noticed questions that were  either redundant or seemed to appear unrelated to a regulatory  requirement, but which may have been intended to satisfy the individual  reviewer’s curiosity. Some licensees also said that inexperienced  reviewers may ask redundant questions or revisit issues that have  already been resolved and codified in the licensing document through  prior communication with NRC. According to licensees, redundant or out- of-scope RAIs create additional work for them, and most of the licensees  interviewed identified the impact of RAIs on resources as a related  weakness of the RAI process. For example, one licensee reported  receiving questions outside of the scope of the license application that  required additional analyses and work—nearly doubling the length of the  review and costing the licensee almost double the amount in fees  budgeted for the review.
In an effort to mitigate concern over the influence of individual staff  reviewers, the Office of New Reactors, Office of Nuclear Reactor  Regulation, and the Division of Spent Fuel Management in the Office of  Nuclear Material Safety and Safeguards recently updated guidance and  introduced more management review of RAIs. As mentioned above,  updated NRC guidance includes an increased focus on ensuring staff  compliance with the RAI process. For example, the offices and division  cited above have recently updated internal guidance to clarify the  expectation that staff reviewers use RAIs to fill holes in a draft safety  evaluation report. Guidance updated by all three offices also includes  calls for elevating questions at least to divisional management: in the  Office of Nuclear Reactor Regulation and the Division of Spent Fuel  Management, all second-round RAIs require division management  approval; and in the Office of New Reactors, all RAIs require divisional  management approval and the office director reviews samples of RAIs on  high priority issues. Half of the licensees we interviewed expressed that  these efforts represent an improvement in the RAI process. Several  licensees specifically described the expectations memorandum issued by  the Office of Nuclear Reactor Regulation as an improvement, and officials  from one licensee noted that they have seen progress with NRC’s  management intervening when potential unnecessary questions are  identified. Because these efforts were made recently, it is too early to  assess the effectiveness of such approaches to mitigating the influence of  individual staff reviewers.
section_title: Agency Comments and Our Evaluation
paragraphs: We provided a draft of this product to NRC for comment. NRC generally  agreed with our findings and provided technical comments, which we  incorporated as appropriate. NRC’s comments are reprinted in Appendix  I.
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If you or your staff have any questions about this report, please contact  me at (202) 512-3841 or ruscof@gao.gov. Contact points for our Offices  of Congressional Relations and Public Affairs may be found on the last  page of this report. GAO staff who made key contributions to this report  are listed in appendix II.
section_title: Appendix I: Comments from the Nuclear Regulatory Commission
section_title: Appendix II: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the individual named above, Hilary Benedict (Assistant  Director), Bridget Grimes, and Rachel Rhodes made key contributions to  this report. Tim Bober, Kevin Bray, Antoinette Capaccio, Cindy Gilbert,  Timothy M. Persons, and Dan Royer also made important contributions.