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Program-Specific Guidance About Master Materials Licenses - Final Report (NUREG-1556, Vol. 10)On this page: Download complete document The following links on this page are to documents in Adobe Portable Document Format (PDF). See our Plugins, Viewers, and Other Tools page for more information. For successful viewing of PDF documents on our site please be sure to use the latest version of Adobe. Table of Contents
Publication Information[ Next | Top of file ] Manuscript Completed: December 2000 Prepared by Division of Industrial and Medical Nuclear Safety Abstract[ Prev | Next | Top of file ] As part of its redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539, "Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated April 1996, and draft NUREG-1541, "Process and Design for Consolidating and Updating Materials Licensing Guidance," dated April 1996. NUREG-1556, Vol.10, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Master Materials Licenses," dated December 2000, is the tenth program-specific guidance developed for the new process and is intended for use by Federal applicants and licensees, and NRC staff. This document updates the guidance for applicants and licensees previously found in Policy and Guidance Directive PG 6-02, Revision 1: "Standard Review Plan (SRP) for License Application for Master Material License," dated September 25, 1997. Foreword[ Prev | Next | Top of file ] The United States Nuclear Regulatory Commission (NRC) is using Business Process Redesign (BPR) techniques to redesign its materials licensing process. This effort is described in NUREG-1539, "Methodology and Findings of the NRC's Materials Licensing Process Redesign," April 1996. A critical element of the new process is consolidating and updating numerous guidance documents into a NUREG-series of reports. Below is a list of volumes currently included in the NUREG-1556 series.
The current document, NUREG-1556, Vol. 10, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Master Material Licenses," dated December 2000, is the tenth program-specific guidance developed for the new process. It updates the guidance for applicants and licensees previously found in NMSS Policy and Guidance Directive, PG 6-02, Rev. 1, "Standard Review Plan (SRP) for License Applications for Master Material Licenses," dated September 25, 1997. This document provides guidance to Federal organizations preparing a Master Materials License (MML) application and Federal organizations that have MMLs. In addition, it provides the criteria NRC license reviewers and other NRC personnel use in reviewing MML applications and current MMLs. In order for NRC to issue a MML to a Federal organization, NRC must ensure that the organization is capable of performing certain functions and activities as a regulator, in much the same manner that NRC, pursuant to the Atomic Energy Act of 1954, performs these functions and activities. To be granted a MML, a Federal organization must therefore demonstrate that it has a regulatory program that, among other things, can safely issue permits for the possession and use of byproduct, source, and/or special nuclear material at multiple sites; and has an organizational structure capable of providing adequate oversight and inspection of its permittee. NUREG-1556, Vol. 10, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Master Material Licenses," dated December 2000, represents a step in the transition from the current paper-based process to the new electronic process. This document is available on the Internet at the following address: <http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v10/index.html>. NUREG-1556, Vol. 10, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Master Material Licenses," dated December 2000, is not a substitute for NRC regulations, and compliance is not required. ___________________________________________ Acknowledgments[ Prev | Next | Top of file ] The writing team thanks the individuals listed below for assisting in the development and review of the report. All participants provided valuable insights, observations, and recommendations. The team also thanks Dianne Geshen, Rolonda Jackson, Benedict Llewellyn, and Tamra King of Computer Sciences Corporation. The Participants[ Prev | Next | Top of file ] Brown, Carrie Abbreviations[ Prev | Next | Top of file ]
1 Introduction and Purpose of Report[ Prev | Next | Top of file ] This report provides guidance to Federal organizations preparing a Master Materials License (MML) application and Federal organizations that have MMLs; in addition, it provides the criteria NRC license reviewers and other NRC personnel use in reviewing MML applications and current MMLs. In order for NRC to issue a MML to a Federal organization, NRC must ensure that the organization is capable of performing certain functions and activities in a manner that assures compliance with the Atomic Energy Act of 1954, as amended, and other applicable regulations consistent with the public health and safety and the environment. Thus, this document focuses on the information the Federal organization must provide to assure NRC that the applicant has adequate staff, facilities, programs, and procedures necessary to assume the regulatory tasks authorized in the license, and that, with respect to NRC-regulated materials, the MML permittees are subject to the same licensing and inspection requirements and policies as equivalent NRC licensees. As a guidance document, NRC has used the terms "must" and "shall" to designate those programs and commitments it requires an applicant/licensee to meet in its MML in order to comply with either the requirements in 10 CFR 30.33 or the requirements in other NRC regulations. "Should" is used in this document to designate information the Staff believes is necessary to make a licensing decision consistent with the Commission's regulations. "Should" provisions are one way to comply with the Commission's regulations. To the extent an applicant chooses to take a different approach, it will need to justify why the requested information is not necessary in light of the information provided. In the absence of justification, it is NRC's expectation that the applicant/licensee will opt to use the approach in this document in order to maximize the uniformity in the MML licensee's organizational structure, programs and policies with the NRC regulatory process for its licensees and the MML permittees. 1.1 NRC Review Process and Criteria[ Prev | Next | Top of file ] After receipt of a MML application, the appropriate NRC Regional Office will process the application and forward it to NRC Headquarters via a technical assistance request for review and coordination. There a team, the "MML Application Review Team," consisting of Headquarters and Regional staff (including at least one current or former project manager for an existing MML), experienced in licensing and inspection procedures, will review the application. The team leader will typically be from the Region in which the MML is to be based. Because the existing organization's licenses may be located in multiple Regions, when evaluating a new application, regional inspection and licensing staff should make sure to coordinate and communicate information regarding the application. NRC will review the applicant's regulatory philosophy and commitment to follow NRC requirements and criteria as evidenced by the license application, inspection history of the organization's individual licenses, financial status and stability, clerical and professional staffing of the proposed inspection and permitting program, independence of the MML governing body, and commitment to the MML. NRC staff should make one or more pre-licensing visits, and conduct a readiness review prior to issuance of any new MML. During the readiness review process, NRC will visit the applicant and review the applicant's operational and administrative readiness in light of its ability to assume the responsibilities of a MML licensee. NRC staff performing the readiness review may include Headquarters and Regional staff experienced in reviewing the management and coordination of centrally controlled licensing and inspection efforts, MML project management experience, and familiarity with the MML application. 1.2 Definition and Description[ Prev | Next | Top of file ] A MML is a material (byproduct, source, and/or special nuclear material) license issued to a Federal organization, authorizing use of material at multiple sites. The MML authorizes the licensee to issue permits for the possession and use of licensed material under the license, and ties the licensee to a framework for oversight and internal licensee inspection of the MML. A master materials licensee remains an NRC licensee and MML permittees are required to meet NRC regulatory requirements. In the MML, NRC provides a Federal organization with the authority necessary to undertake a limited number of activities as a regulator; therefore, to be granted a MML, the organization must demonstrate that it has a regulatory program that complies with NRC's regulations, e.g., the requirement in 10 CFR 30.33(a)(3) that the MML licensee must be qualified by training and experience to use materials for the purposes requested. Because this includes the issuance of permits for the possession and use of byproduct, source, and/or special nuclear material at multiple sites, the MML licensee must have an organizational structure capable of providing adequate oversight and inspection of the permittee. In order for NRC to issue a MML to a Federal organization, NRC must ensure that the organization can demonstrate it is capable of performing certain functions and activities in a manner that meets the same standards that NRC, pursuant to the Atomic Energy Act of 1954, as amended, applies to itself. In addition, to provide consistency with other NRC programs and licensees, NRC must be able to assure itself that the MML licensee's inspectors and permit reviewers are able to meet the same training requirements (Inspection Manual Chapter (IMC)-1246, "Formal Qualification Programs in the Nuclear Material Safety and Safeguards Program Area," and that in their regulation of a permittee, the MML will use the same licensing and inspection guidance (IMC-2800, and IMC-2600 ("Materials Inspection Program,") as its NRC counterparts. Further, the licensee must have a system for tracking its permitting and inspection actions. MML licensees are inspected annually by NRC to review the management, inspection, permitting, and enforcement activities performed under the license (IMC 2810, "Master Materials License Inspection Program.") 1.3 Issuance Criteria for a Master Materials License[ Prev | Next | Top of file ] A Master Materials License (MML) will be issued only to Federal organizations that successfully meet the criteria in 10 CFR 30.33 (and 10 CFR 40.32 or 10 CFR 70.31, as appropriate), and can demonstrate that it is qualified by training and experience to be granted a MML. This should include at a minimum:
1.4 Master Materials Licensee Authorizations[ Prev | Next | Top of file ] Master materials licensees may permit any byproduct material authorized in the MML or by regulation to be used by components of their organization. The applicant may also request authorization to issue permits for the possession and use of specifically licensed quantities of source and special nuclear material. The MML licensee, through its master radiation safety committee (MRSC), may issue permits for the possession and use of licensed materials in accordance with NRC regulations and licensee permit review and approval procedures and criteria established by the MML licensee's MRSC. To ensure licensing uniformity for MML equivalent NRC licensees and MML permittees, the MRSC-permitting criteria must be consistent with NRC regulations and licensing policies, procedures, and guides. To ensure inspection uniformity for equivalent NRC licensees and MML permittees, the MML must also establish an inspection program consistent with NRC regulations and inspection and enforcement policies, procedures, and guides. The Letter of Understanding (LOU) for a MML will, among other things, identify certain exclusionary activities that unless specifically authorized on the license, the MML cannot conduct. Typically, the exclusions stated in an LOU provide that, unless specifically authorized, persons licensed under MMLs shall not:
Note: Although a MML applicant can request authorization to use source or special nuclear materials requiring a specific license pursuant to 10 CFR Parts 40 or 70, if the applicant does not request this authorization, a specific condition will be added to the LOU that prohibits the MML from conducting these activities. 1.5 Prelicensing Conference and Readiness Review[ Prev | Next | Top of file ] After NRC staff reviews an application for a MML and determines it is generally complete and responsive to NRC Form 313 and this standard review plan, NRC will schedule one or more prelicensing visits at the MML applicants Radiation Control Program central office. The prelicensing visits will include a conference with the applicant's senior management and proposed MRSC members. A prelicensing visit provides NRC staff an opportunity to:
Prior to issuance of a MML, NRC will perform a readiness review to determine the operational and administrative readiness of the centrally-controlled Radiation Safety Program to assume the responsibilities of a MML licensee. In the readiness review, NRC will examine the operational and administrative performance of the centrally-controlled Radiation Safety Program as they pertain to: (1) management oversight, document management, and radiation control procedures; (2) status of the materials inspection program; (3) technical quality of inspections; (4) technical staffing and training; (5) technical quality of licensing actions; and (6) responses to incidents and allegations. 1.6 Programs Not Warranting a Master Materials License[ Prev | Next | Top of file ] If NRC determines that the issuance of a MML is not warranted, the applicant may continue with its existing licensed activities and may submit an application for a MML at a later date without prejudice. 2 Filing a MML Application[ Prev | Next | Top of file ] An applicant for a MML should submit its application, including a draft Letter of Understanding (LOU), a description of the applicant's regulatory performance and centralized experience for the last 5 years, and a completed NRC Form 313 (see Appendix A), to the appropriate NRC Regional Office. Complete all items in the application in enough detail for NRC to determine that the proposed equipment, facilities, training and experience, and Radiation Control Program satisfy regulatory criteria and are adequate to protect health and minimize danger to life, property, and the environment. License applications are available for review by the general public in the NRC Public Document Rooms or electronically from the Publically 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). Therefore, do not submit proprietary information unless absolutely necessary. If submittal of such information is necessary, follow the procedure in 10 CFR 2.790. Failure to follow this procedure may result in disclosure of proprietary information to the public or substantial delays in processing the application. Also, do not submit personal information about individual employees unless necessary. Home addresses and telephone numbers should be submitted only if they are part of an emergency response plan. Dates of birth, Social Security numbers, and radiation dose information should be submitted only if specifically requested by NRC. The applicant should file the application in duplicate and retain a third copy for its licensing files. A Federal agency may apply for a MML for licensed activities at facilities or sites under its control anywhere in U.S. jurisdiction. 2.1 Letter of Understanding[ Prev | Next | Top of file ] Where responsibilities are divided between the MML management and NRC, the division of responsibilities and requirements for coordination will be clearly defined and documented in a LOU between NRC and the applicant. The following are some examples of responsibilities that may be divided:
Response from Applicant: Submit a draft Letter of Understanding that defines and describes the division of responsibilities and the requirements for coordination between the applicant and NRC. (The final letter will be negotiated between NRC and the applicant before issuance of the MML.) 2.2 Licensing and Enforcement History[ Prev | Next | Top of file ] A MML will be issued only to organizations with a good regulatory performance record, based on NRC licensing and inspection of prior activities, and with experience in centralized management, review, and coordination of licensing and inspection efforts. Management, review, and coordination experience will also be assessed during the readiness review. NRC will evaluate the applicant's performance for the last 5 years using, at a minimum, the following indicators:
Response from Applicant: Describe regulatory performance in licensing, inspection and centralized experience in management, review, and coordination of licensing and inspection efforts for the last 5 years. 2.3 Filing NRC Form 313[ Prev | Next | Top of file ] The applicant should complete NRC Form 313 (see Appendix A). Items 1 through 4, 12, and 13 may be completed on the form itself, and items 5 through 11 may be completed on supplementary pages. Identify and key each separate sheet or document submitted with the application to the item number on the application to which it refers. All typed pages, sketches, and, if possible, drawings should be on 8-1/2 x 11 inch paper to facilitate handling and review. If larger drawings are necessary, fold them to 8-1/2 x 11 inches. As with the rest of the application, the applicant must complete all items in NRC Form 313 in enough detail for NRC to determine that the proposed equipment, facilities, training and experience, and Radiation Control Program satisfy regulatory criteria and are adequate to protect health and minimize danger to life, property, and the environment. 3 Contents of NRC Form 313[ Prev | Next | Top of file ] The following comments apply to the indicated items of NRC Form 313: Note: Throughout this document, descriptive items
that will not be incorporated into the license as a requirement are indicated
by a single asterisk (*). Applicants should clearly identify in the MML
application information that constitutes binding commitments (tie down)
as opposed to descriptive information. In some cases, descriptive information
is needed only for the issuance of the license. In other cases, where
changes may affect license conditions and authorizations, the applicant
is instructed to notify NRC of the changes. This is to let NRC determine
the licensing significance of the changes and whether an amendment is
needed. 3.1 NRC Form 313, Item 1: License Information[ Prev | Next | Top of file ] For a new license, check subitem A. For an amendment to an existing license, check subitem B. Since MMLs have an indefinite expiration date, they are not renewed, and subitem C should always be blank. 3.2 NRC Form 313, Item 2: Applicant's Name and Mailing Address[ Prev | Next | Top of file ] Only Federal agencies can apply for a MML. Corporations and private individuals may not apply for a MML. The address specified here should be the mailing address for official correspondence. This may be either the address of the Chairman of the Master Radiation Safety Committee (MRSC) or the Radiation Control Program Director (RPCD). Since a MML has an indefinite license period, if granted a MML, the applicant should inform NRC of any subsequent changes in its mailing address, either during the application process or if granted a MML. 3.3 NRC Form 313, Item 3: Location of Use[ Prev | Next | Top of file ] The Federal Organization's Radiation Control Program and Federally-Controlled Fixed Sites Specify the proposed location of the MML applicant's Radiation Control Program (RCP) Office by the street address, city, and state or other descriptive address (e.g., 5 miles east on Highway 10, Anytown, State). This should be the location of the docketed permittee files for the master materials licensee or where they can be readily retrieved for review. The licensee should maintain a list of locations by program code identical to the one used by NRC and provide an updated list to NRC. Temporary Job Sites If permittees will use radioactive material at temporary job sites, NRC must specifically authorize this activity on the MML. Applicants should indicate if they will authorize permittees to use radioactive material at temporary job sites, so NRC can include this information on the license. Field Studies If permittees will use radioactive material in field studies, NRC must specifically identify and authorize these activities on the MML. Appendix I of NUREG-1556, Vol. 11, "Program-Specific Guidance About Licenses of Broad Scope," contains information required for field use of licensed material. Other Sites If permittees intend to use radioactive material at facilities and sites (other than temporary job sites) that are not located at the MML's Federally-controlled facility, NRC must approve these activities and specifically identify and authorize them on the MML. Response from Applicant:
3.4 NRC Form 313, Item 4: Person to Be Contacted about Application[ Prev | Next | Top of file ] The applicant should specify the individual who will be the RCPD and provide his or her telephone number. Response from Applicant: Identify the individual who will be the RCPD and provide his or her telephone number. 3.5 NRC Form 313, Item 5: Material to Be Possessed[ Prev | Next | Top of file ] While the major authorization in the MML will specify any byproduct material in any form and as needed or limited to some maximum quantity, there may be specific additional line items for some radionuclides; therefore, the applicant should describe, in general, the licensed material the applicant wishes to possess by isotope class (e.g., byproduct, source, or special nuclear material), chemical or physical form, and quantity in curie, millicurie, etc. NRC must describe the authorized uses of these materials on the license and uses broad descriptive terms to do so. Therefore, the applicant should categorize this information into general areas of use, e.g., research and development activities, routine gauging activities, self-contained irradiators, instrument calibrators, and medical applications. If certain nuclides will be needed in much larger quantities than others, they should be listed separately in Items 5a, 5b, and 5c of NRC Form 313, rather than including these under the broad authorization for that class of licensed material (e.g., any byproduct material). Under Item 5b, describe by manufacturer and model number all large activity sealed sources used in devices (e.g., self-contained irradiators, panoramic irradiators, instrument calibrators) that are not registered in accordance with 10 CFR 32.210. The maximum quantity for each individual nuclide and total cumulative possession authorized by the MML licensee for individual permittees should be commensurate with each permittee's needs, facilities, procedures, and personnel and demonstrated experience/capability. The independent amounts of material at each permittee's facility or site and not the aggregate of all materials possessed by the MML licensee is used to determine when a decommissioning funding or emergency plan is necessary. The applicant should describe facilities or permittees that may possess quantities of materials requiring financial assurance, in accordance with the requirements of 10 CFR 30.35, or requiring consideration of the need for an emergency plan for responding to a release, in accordance with 10 CFR 30.32. Response from Applicant:
3.6 NRC Form 313, Item 6: Purpose of Use of Licensed Material[ Prev | Next | Top of file ] The applicant should describe in general terms the purposes for which it will use licensed material and explain why a MML is needed. The uses should be consistent with the applicant's prior licensed activities and categorized in a classification scheme according to NRC's licensing program codes. NRC staff understands that the information provided regarding "Purpose of Use" in this section is a self-imposed limitation contained within the application. If a MML applicant wants to initiate an intended use other than that described in its application and tied down in its license and letter of understanding, it would be necessary to submit an amendment request to the license to modify/expand the "purpose of use." Applicants should include a list of total possession limits for each category of use requested. Note: If the newly added purpose of use includes material use in a unique or specialized activity (e.g., sealed source fabrication), the applicant may be required to submit the criteria used by the Master Radiation Safety Committee (MRSC) in evaluating in-house requests for such use. In this specific example, NUREG-1556, Vol. 3, "Applications for Sealed Source and Device Evaluation and Registration," provides guidance for the evaluation and registration of sealed sources and devices with NRC. State if you intend to use sealed sources other than those that have been registered with NRC's Sealed Source and Device Registry and describe the training and experience of individuals responsible for reviewing applications for use. If the applicant has a permittee that wants to perform field studies, deliberately releasing licensed material to the environment, then the applicant should include the information outlined in Appendix I of NUREG-1556, Vol. 11, "Program-Specific guidance about Licenses of Broad Scope," in the application, so that NRC can approve and specifically authorize the field studies on the MML. Note: 10 CFR 51.22(c)(14)(v) identifies as a "categorical exclusion" (from the requirement to prepare an environmental assessment or impact statement) the issuance, amendment, or renewal of licenses for use of radioactive material for research and development and for educational purposes; however, this "categorical exclusion" does not encompass field studies in which licensed material is deliberately released directly into the environment for purposes of the study (e.g., tagging animals or insects that remain in the wild). Field studies may require applicants to file an environmental report and NRC to perform an environmental assessment pursuant to 10 CFR Part 51. Field studies that do not deliberately release radioactive material into the environment, such as tagging of animals and penning them to prevent escape, may be eligible for a "categorical exclusion" pursuant to 10 CFR 51.22. Response from Applicant:
3.7 NRC Form 313, Item 7: Individuals Responsible for the Radiation Safety Program[ Prev | Next | Top of file ] To assist the applicant in correctly identifying the individuals for the functional positions of senior management, Master Radiation Safety Committee, and Radiation Control Program Director, these sections include descriptive information on some of their duties and responsibilities that will also be discussed in Section 3.10, "Radiation Safety Program." These sections may also request information such as delegations of authorities and establishment of oversight programs under Item 7 of NRC Form 313 and discuss other aspects of program responsibilities under Item 10. The applicant should review the discussions in Items 7 and 10, as well as the checklist Appendix C concurrently, to understand the elements of a MML program. 3.7.1 Senior ManagementThe importance of the senior management's role in the development and functioning of a MML program cannot be overemphasized. NRC issues a MML to accommodate licensees involved in extensive radioactive materials programs where the demand is great for a variety of radionuclides, uses, and locations of use across NRC Regional boundaries; therefore, NRC grants significant authority to MML licensee management to develop and implement an appropriate Radiation Control Program. Consequently, MML licensee management should establish effective administrative controls, oversight, and provisions for organization and management, including management review, necessary to ensure safe operations. When a MML is issued, the Federal Organization's senior executive management (the highest level of licensee management) is responsible for the regulatory activities authorized in the license. Since both the MML licensee and its permittees are governed by NRC requirements, senior management and the Radiation Control Program need to assure the licensing, inspection, event response, and allegation resolution regulatory activities of the MML are performed in the same manner for its permittees as NRC does for its licensees. Consequently, MML licensee management should be knowledgeable of NRC requirements and policies. The applicant should describe senior executive management oversight and processes used by the highest level of management to ensure adequate control over MML-licensed activities (see Section 3.10, "Radiation Safety Program"). To ensure safe operations and compliance with regulatory requirements, NRC expects such oversight to include senior management membership and active participation in regular meetings of the MRSC, as well as oversight of the RCPD and support staff and annual audits of the program. MML licensees are required to establish an MRSC that represents management when reviewing and approving permit applications; therefore, senior executive management (highest level of licensee management) should delegate to the MRSC and the RCPD, in writing, sufficient authority, organizational freedom, and management prerogative, to communicate with and direct MML personnel at all levels regarding NRC regulations, MML license provisions, and permit conditions. (These delegations of authority are also addressed in Sections 3.10.6, "The Master Radiation Safety Committee," and 3.10.7, "The Radiation Control Program Director.") The MML licensee retains the ultimate responsibility for the conduct of licensed activities. It is also essential that the MML licensee devote sufficient financial resources (i.e., funds, equipment, personnel, materials) to support the Radiation Control Program at all levels. The application should include an organizational chart of the applicants management structure depicting reporting paths and flow of authority. Include a statement empowering the MRSC by outlining its authority to oversee the licensed program and its responsibility for control and direction of the Radiation Control Program and the RCPD. Also state the MRSC's authority to suspend or terminate activities based on poor performance or violation of safety standards. These issues are addressed further in Section 3.10. Response from Applicant:
3.7.2 Master Radiation Safety CommitteeThe MRSC not only has the authority to control and direct the centralized Radiation Safety Program, but it also serves as a means by which the highest level of the licensee's senior management gains an overview of the entire MML program, i.e., permittee activities and the respective roles of the RCPD, MRSC, and permittees. MRSC provides guidance and information on the Radiation Control Program to the highest level of senior executive management, ensures that adequate resources are provided by licensee management, and provides oversight to the RCPD in developing, implementing, and maintaining the Radiation Control Program. The MRSC should ensure that the highest level of executive management is periodically given all relevant information regarding the Radiation Control Program, particularly when the highest level of management will make decisions that may affect the program. Membership of the MRSC must include:
Other members can include:
Note: All members of the MRSC should have the education, training, experience, and knowledge to address Radiation Control Program issues adequately. The chairperson of the Committee should be empowered, at a minimum, to do the following:
The following are duties of the Executive Secretary of the MRSC, an assigned duty of the RCPD:
In addition, the Executive Secretary should prepare an annual audit report that summarizes overall program activities, the results of program performance compared to regulatory requirements and license commitments (as determined through licensee and NRC inspections and evaluations), and their permitting actions, inspection reports, allegation responses, and enforcement actions. Response from Applicant:
* The identities of the members of the Radiation Safety Committee are descriptive information. If there are significant changes to actual membership of the MRSC, i.e., functionally significant changes in position titles and job descriptions, you should notify NRC. Notification is not needed for reorganizations that change the position titles without changing the basic radiation safety responsibilities of the position or for the reassignments of new individuals into designated positions.
* The identity of the individual designated the Chairman of the MRSC is descriptive information and is not tied down in the license; however, if the Chairman of the MRSC changes, you should notify NRC. 3.7.3 Radiation Control Program DirectorThe RCPD should ensure that radiation safety activities are being performed according to approved policies and procedures and that the daily operation of the licensed program is in compliance with all regulatory requirements. The RCPD implements the Radiation Control Program with the assistance and support of the MRSC and senior executive management, serving as the Executive Secretary of the MRSC. The RCPDs position as Executive Secretary of the MRSC helps to ensure clear understanding of mission goals and precise communications between the MRSC and the RCP staff. Executive management is obligated to select an RCPD who has sufficient training and experience to address all facets of the applicant's Radiation Control Program. The RCPD's qualifications should include:
Generally, an RCPD at a MML should have:
It is essential for the RCPD to have a thorough knowledge of NRC regulatory requirements. Response from Applicant:
3.7.4 Other Radiation Control Program StaffThe RCP professional staff should have the following qualificaitons:
Written job descriptions, readily identifying professional qualifications needed to fill vacancies, should be prepared. Staff members whose primary duties include reviewing/issuing permits or conducting inspections must meet training qualifications equivalent to NRC license reviewers and inspectors. See NRC Inspection Manual Chapter (IMC-1246) for guidance on such qualifications. Response from Applicant:
*1 The information identifying the individual designated RCPD and his/her qualifications is descriptive information and is not tied down in the license. If the RCPD changes, you should notify NRC. *2 Listing the RPC staff positions is descriptive information and is not tied down in the license. If the number of RPC staff positions change or significant changes are made in job descriptions, you should notify NRC. 3.8 NRC Form 313, Item 8: Training and Experience for Individuals Working in or Frequenting Restricted Areas[ Prev | Next | Top of file ] To meet the requirements of 10 CFR Part 19, applicants with special facilities such as large irradiators, iodination facilities, high dose rate remote brachytherapy (HDR) facilities, etc., must assure that site access training will be provided prior to assigning individuals to work in or frequent restricted areas. Response from Applicant:
3.9 NRC Form 313, Item 9: Facilities and Equipment[ Prev | Next | Top of file ] To meet the requirements of 10 CFR 30.33(a)(2), applicants must describe facilities and equipment used by the RCP staff to facilitate day-to-day operations. Response from Applicant:
* The information on the locations, facilities and laboratory equipment are descriptive information and are not tied down in the license. If the location and facilities used by the RCP staff change, you should notify NRC. Notification is not needed for changes to upgrade equipment, provided the applicant maintains the same level of coverage described in the application. 3.10 NRC Form 313, Item 10, Radiation Safety Program[ Prev | Next | Top of file ] The applicant should refer to Section 3.7 for additional discussion on the role and duties of senior management, the Chairman of the Master Radiation Safety Committee, Radiation Control Program Director, and Master Radiation Safety Committee in the Radiation Safety Program. Information such as delegations of authorities and establishment of oversight programs that are part of the authorities and management of a Radiation Safety Program, may have been requested under Item 7 of NRC Form 313, while discussion of other aspects of program responsibilities are found under Item 10. The applicant should review the discussions in Items 7 and 10, as well as the checklist in Appendix C concurrently to ensure the information on the MML Radiation Safety Program is complete. 3.10.1 Radiation Control Program - an OverviewThe MML program used to establish central control over all elements of the NRC-regulated Radiation Safety Program and centrally manage the permitting/inspection licensed activities is called the Radiation Control Program (RCP). These licensed activities also include, but are not limited to, enforcement, event response, emergency response, and allegation resolution activities. Because the MML licensee and its permittees are governed by NRC requirements, the Radiation Control Program needs to assure that with respect to NRC-licensed materials, all these activities are performed by the MML licensee in the same manner for its permittees as NRC does for its licensees. Thus, the applicant should commit to implementing licensing and inspection programs in accordance with NRC criteria. As discussed in Section 3.10.4, "Regulatory conformance," the applicant may adopt alterative program procedures, provided these procedures are described. In order to meet the requirements in 10 CFR 30.33(a)(3) and ensure safe operations under the license, applicants for MMLs must have established administrative controls and provisions. These should include:
The requirement to develop, document, and implement a radiation protection program commensurate with the scope of the license request is contained in 10 CFR 20.1101; recordkeeping requirements related to the program are in 10 CFR 20.2102. These requirements apply to an RCP. In order for NRC to approve the MML application, it must include a complete description of the applicant's RCP. In this section, that description should take the form of concise commitments and a narrative overview of the detailed program described in greater detail in other sections. Both the narrative overview and the more detailed documents describing the program should, as a minimum, address the following elements: program authorities and responsibilities, communications, quality control surveillance, program audits, procurement, staff selection and qualification, information dissemination, document control and retrieval, and other considerations essential to the successful implementation of the RCP. Note: The applicant should commit to following specific NRC guidance documents in implementing its licensing and inspection program. These NRC guidance documents may in some cases be adopted in their entirety. Other NRC guidance documents may need to be modified to reflect the unique characteristics of the applicant's program. Documents adopted in their entirety can be included in the RCP description by reference and do not have to be inserted in their entirety. If NRC guidance is used, the applicant must provide procedures to ensure that the program is updated as NRC guidance is changed, and that staff is trained in current NRC guidance. Both the concise narrative overview description of written administrative control procedures for the RCP in this section and the procedures themselves need to be sufficient in detail, clarity and specificity to describe how management oversight for program activities will be carried out. Response from Applicant:
Note: While both the description of the written administrative control processes and the licensing and inspection program for the narrative overview of RCP need to be concise, they also need to be sufficient in detail, clarity and specificity to describe how management oversight for program activities will be carried out and how the program functions. All elements in the narrative overview description of the RCP should concisely address the following (a narrative overview description is not needed when NRC guidance documents are included by reference in the RCP because they were adopted in their entirety):
3.10.2 Previous LicensesWhen NRC issues a MML, it terminates all NRC licenses that will become permits issued under the regulatory control of the MML licensee. Because the applicant may elect to have regulatory authority over only some types of materials (e.g., byproduct but not source or special nuclear materials) or some types of licensees. In order for NRC to terminate the correct licenses, NRC must have a list of those licenses that will be incorporated into the MML program. Response from Applicant: List the radioactive materials licenses the applicant wants to include in the MML.* * The list of materials licenses to be included in the MML is descriptive information to assist NRC in accurately terminating licenses and is not tied down in the license. 3.10.3 Material Control and AccountabilityMML applicants should develop and maintain an effective inventory and accountability system, establishing procedures for properly transferring, controlling, and accounting for material throughout the applicant's organization, including its movement among facilities. The inventory and control system should also ensure that licensed possession limits are not exceeded. A successful program requires the dedication of sufficient staff and equipment. See NUREG-1556, Vol. 11, "Program-Specific Guidance About Licenses of Broad Scope," for additional useful information on control and accountability. Response from Applicant: Describe the inventory control and accountability system of licensed material. 3.10.4 Regulatory ConformanceIn order for NRC to approve the license, NRC must have a statement from the applicant's management that the applicant will follow NRC regulations. The applicant may use operational control levels that are more restrictive than NRC regulations; however, at a minimum, the applicant's requirements must be as restrictive as NRC's regulations. The applicant should commit to following specific NRC guidance documents in implementing its licensing and inspection program. These NRC guidance documents may in some cases be adopted in their entirety. Other NRC guidance documents may need to be modified to reflect the unique characteristics of the applicant's program. Documents adopted in their entirety can be included in the RCP description by reference and do not have to be inserted in their entirety. When the applicant commits to use NRC guidance, NRC must have assurances that the applicant's program is updated as NRC guidance is changed and that the applicant's staff has training in the updated guidance. Therefore, the applicant must provide procedures to ensure that the program is updated as NRC guidance is changed, and that staff is trained in current NRC guidance. In order for NRC to approve the MML application, it must contain all policies, procedures, directives, and guides the applicant has developed and will use to manage its RCP pursuant to NRC regulations, policies and guides. (See Section 3.7.4, and the remainder of sections in 3.10 for discussions specific to staff qualification, administrative control, organizational, audit, permitting, inspection, enforcement, incident response, emergency response, and allegation policies, procedures, and guides that must be submitted.) The application must specify those NRC policies, procedures, and guides that the applicant will adopt in their entirety in its RCP. NRC will review the policies, procedures, and guides submitted in the application; however, only those policies and directives describing how the MML will manage its RCP will be incorporated into the MML in a license condition. Note: When submitting documents, the applicant may use the following guidelines for procedures, directives, and guides. If NRC guidance documents are adopted in their entirety, they only need to be referenced. Other NRC guidance documents that need to be modified to reflect the unique characteristics of the applicant's program need to be provided in their entirety. New guidance developed by the applicant also needs to be included its entirety. Response from Applicant:
*1 NRC will review the policies, procedures, and guides submitted in the application; however, only those policies and directives describing how the MML will manage its RCP will be incorporated into the MML in a license condition. *2 Although audit, permitting, inspection, enforcement, incident response, emergency response, and allegation policies, procedures, and guides are discussed in more detail in other sections, the documents associated with the management of these programs needs to be submitted in this section.
3.10.5 Updating of Radiation Control Program DocumentsThe RCP must have established procedures for appropriate and timely updating of MML internal guidelines and requirements to ensure conformance with revisions to NRC regulations, policies, and guidance. The applicant should describe the process for review and approval of changes to procedures and documents. The process should include provisions for submitting updated documents to NRC for review and license amendment, if the document is specifically referenced in the license or causes a material change in the MML licensees policies and procedures. Response from Applicant: Describe the process for review and approval of changes to RCP procedures and documents. 3.10.6 Management Support and Radiation Control Program StructureA MML licensee authorizes the receipt, possession, distribution, use, transportation, transfer, and disposal of NRC-regulated radioactive material (e.g., byproduct (and source and special nuclear material, if requested)) at permittee locations. As discussed in Section 3.7.1, the applicant's senior executive management (the highest level of licensee management) is responsible for the appropriate Radiation Control Program. This includes Senior management's devoting sufficient financial resources (i.e., funds, equipment, personnel, materials) to support the Radiation Control Program at all levels and delegating in writing to the MRSC and the RCPD, sufficient authority, organizational freedom, and management prerogative, to communicate with and direct MML personnel at all levels regarding NRC regulations, MML license provisions, and permit conditions. The MRSC provides administrative control of all NRC-licensed radioactive material used by the licensee and its permittees. For NRC to issue a MML, the applicant must demonstrate that it is financially and technically qualified to conduct a MML program effectively. This includes operating funds to support program needs such as the following:
To meet the requirements of 10 CFR 30.33(a)(2), the RCP must be supported with sufficient staffing and technical expertise and should be located in the MML organization parallel with other comparable health and safety programs. The applicants overall radiation management structure must ensure that the RCPD has access to the highest levels of MML management and some measure of financial and administrative control over permitting and inspection personnel. The RCP should be organized with the view toward achieving an acceptable degree of staff efficiency. The licensee should place appropriate emphasis on major program functions, and provide specific lines of supervision from program management for the execution of program policy. The lines of communication and administrative control between the users and the central office (RCPD) must be clearly drawn to provide authority over the staff and uniformity in inspection policy, procedures, and supervision. The application must include an organizational chart depicting the licensee's management structure, reporting paths, flow of authority, control of finances, and geographical location of all management and staff components of the RCP. Response from Applicant:
3.10.7 Radiation Control Procedures - Administrative Control ProcessesTo meet the requirements in 10 CFR 30.33(a)(2), the applicant for MML must ensure safe operations under the license; therefore, applicants for MMLs must have established administrative controls and provisions. These should include:
The applicant should develop and implement written administrative control processes. These processes should be clear, specific, and detailed enough to demonstrate that the applicant's management will adequately oversee program activities. They should be related to administrative controls and provisions listed above and as a minimum, they should address the following:
Response from Applicant: Submit written administrative control procedures* related to the administrative controls and provisions listed above in sufficient detail, clarity and specificity to describe how management oversight for program activities will be carried out. As a minimum, they should address the following:
* The information provided in the written administrative control procedures is descriptive information and is not tied down in the license. 3.10.8 Master Radiation Safety CommitteeThe authority of the MRSC is contained in the Delegation of Authority for the MRSC signed by the applicant's highest level management. Management's delegation of authority was discussed in Section 3.7.1, "Senior Management." The composition of the MRSC was discussed in Section 3.7.2, "The Master Radiation Safety Committee." The composition and responsibilities of the MRSC are documented in the MRSC's Charter. Both the MRSC delegation of authority and Charter are key documents in the establishment of an effective MML program. Responsibilities of the MRSC include, but are not limited to, the following:
The application should include the organizational and procedural manuals that address each item above; the written delegation of authority for the MRSC; and its charter and quorum requirements (i.e., Chairman, RCPD, and two-thirds of the remaining membership). The applicant should also describe the conditions under which it will obtain assistance from technical boards and other entities and identify and describe any existing boards or entities that it uses to support the MRSC. Response from Applicant:
Note: If you describe how you will meet one of the above responsibilities in an organizational or procedural manual that is more appropriately provided in response to another section of this NUREG, you may simply identify the other section of your application where the information is found.)
Note: The Delegation of Authority and the MRSC Charter must state the MRSC's authority to suspend or terminate activities based on poor performance or violation of safety standards and provide assurance of the chairman's full authority to commit licensee resources to support the conduct of the MML.
3.10.9 the Radiation Control Program DirectorThe authority of the RCPD is contained in the Delegation of Authority for the RCPD signed by the applicant's highest level of management. Responsibilities of the RCPD may also be delegated by the MRSC. In order for NRC to approve the MML application, the application must include a copy of the written delegation of authority from the senior executive manager to the RCPD and a description of his/her responsibilities. Documentation should also show that the RCPD has access to the highest levels of MML management and the measure of administrative and financial control over permitting and inspection personnel. The responsibilities and authorities of the RCPD include, but are not limited to, the following:
Response from Applicant:
3.10.10 Permitting and Inspection StaffThe MML licensees permitting and inspection staff is responsible for the following:
If the RCP staff are not co-located, the applicant should describe in detail how the staff will effectively manage the day-to-day operations of the RCP. The applicant should describe how it will accomplish the following:
Response from Applicant:
3.10.11 Radiation Control Program Internal ProceduresIn order to meet the requirements in 10 CFR 30.33, the RCP must establish written internal procedures* to ensure the following:
* The applicant must confirm it has written internal procedures that as a minimum address the functions addressed above, but it does not need to submit them with the application.
These internal procedures should also ensure a high degree of uniformity and continuity in the applicant's regulatory practices. In addition, these procedures should address internal processing of permit applications, inspection policies and procedures, decommissioning, and other functions required of the program. In order for NRC to issue the license and monitor oversight of the MML, the RCP staff must provide quarterly reports to the MRSC on the status of the program, as well as an annual report on the audit of the program that includes the following:
Response from Applicant: Confirm that you have written internal procedures that, at a minimum, address the functions addressed above; however, these do not need to be submitted with the application. 3.10.12 Management and Master Radiation Committee AuditsThe MRSC should be fully aware of the operations and activities of the RCP Office through frequent and routine meetings. The MRSC should conduct interactive management audits and evaluations of the RCP office's performance, including the RCPDs. Results of the MRSC's audit and program reviews should be reported to senior executive management to allow for timely and aggressive remedial actions sufficient in scope to ensure compliance with NRC regulations and license conditions. A MML licensee should also consider establishing MRSC subcommittees to evaluate and audit those areas of the program within their areas of expertise. Audits of the inspectors and permit reviewers should be conducted on an annual basis. Guidelines should be adopted in advance of the audits, establishing criteria that will be used to determine acceptable versus unacceptable performance. Management policies and guidelines should be in place for reporting audits to senior executive management. In order to meet the requirements of 10 CFR 30.33(a)(3), inspectors must demonstrate competence in evaluating health and safety problems and in determining compliance with NRC regulations. Inspectors must demonstrate to supervisory personnel an understanding of regulations, inspection guides, and policies prior to conducting inspections independently. The MML should establish a system similar to NRC's qualification journal system found in IMC-1246. Because NRC must ensure consistency between NRC and MML inspection programs, the RCPD or the inspection staff supervisor must conduct annual field evaluations of each inspector to assess performance and assure use of appropriate and consistent policies and guides. In order for NRC to approve the MML application, it must contain a description of senior executive management oversight and the mechanisms used by senior executive management to ensure that they are aware of NRC regulations, the provisions of the license, and the compliance status of the institution's RCP. This oversight may include independent audits of the program, frequent meetings with the MRSC, and periodic site visits of selected permittees. In order to meet the requirements in 10 CFR 30.33(a)(3), permit reviewers must demonstrate competence in reviewing applications for permits. In addition, permit reviewers must demonstrate an understanding of regulations, licensing policy and guidance directives, and permitting practices prior to reviewing and issuing permits independently. This should include an audit sampling each permit reviewer's actions to assess performance and assure appropriate and consistent policies and guides. Response from Applicant:
* The process described in the first bullet and the copy of the audit programs are descriptive information and are not tied down in the license. You should notify NRC of significant changes to these programs. 3.10.13 Permitting ProceduresIn order for NRC to approve the MML application, it must include copies of its permitting procedures, policies, and guides. If the applicant commits to using NRC licensing procedures, policies, and guides, it may list those NRC documents used and provide only those licensee documents that differ. The applicant must commit to updating its permitting guidance as it receives updates to NRC licensing guidance. The applicant should provide in its application specific timeliness goals for issuing permits and updating its licensing guidance as updates are received from NRC. In addition, the application must contain a description of the RCP's procedures to assess the essential elements of permittee applications, which meet current regulatory guidance for the following:
To establish the basis for permitting actions, this information should clearly, completely, and accurately document the isotopes, forms, quantities, authorized uses, and permissive and restrictive conditions, and be readily available for audit during pre-permitting visits. Prior to renewal, the RCP should ensure that supporting information in the file reflects the current scope of the permitted program. Internal permitting guides should include checklists and policy memoranda consistent with current NRC licensing guidance. Permit applicants (including applicants for renewals) should be furnished copies of applicable guides and regulatory positions. Compliance history should be considered when issuing new permits or modifications to existing permits. Standard permit conditions identical to current NRC standard license conditions should be used to expedite and provide uniformity in the permitting process. Custom conditions may be developed, provided they are not less restrictive then any applicable NRC requirements and criteria. To ensure consistency with NRC's licensing program, the MML applicant must maintain orderly files to allow efficient, accurate retrieval of information and documentation associated with the permitting program. The applicant should provide a copy of the administrative procedures to accomplish this. Response from Applicant:
3.10.14 Program to Minimize Contamination at Permittee FacilitiesIn order for NRC to approve a MML application after August 20, 1997, the applicant must describe how facility design and procedures for operation will minimize, to the extent practicable, contamination of the permittees facilities and the environment, facilitate eventual decommissioning, and minimize, to the extent practicable, the generation of radioactive waste. All MML applicants for a new license and their permittees need to consider the importance of designing and operating their facilities to minimize the amount of radioactive contamination generated at a site during its operating lifetime and to minimize the generation of radioactive waste during decontamination. Response from Applicant: Describe how facility design and procedures for operation will minimize, to the extent practicable, contamination of the permittees facilities and the environment, facilitate eventual decommissioning, and minimize, to the extent practicable, the generation of radioactive waste. 3.10.15 Permit Termination and Decommissioning of Permit ActivitiesPermit termination and decommissioning were identified in Section 2.1, "Letter of Understanding," as an example of shared responsibilities between NRC and the MML. NRC's requirements for termination of byproduct material licenses are described in 10 CFR Parts 30, 40, and 70. The internal procedures that NRC staff follow to terminate a byproduct materials license are in NRC IMC 2605. The applicant may either provide its permit termination procedures or commit that it will terminate its permits in accordance with NRC regulations, policies, and guides as provided for in the LOU. The NRC decommissioning procedures are contained in NRC IMC 2605 and the Decommissioning Handbook. The applicant must provide its own decommissioning procedures or commit that it will decommission permit facilities as described in NRC IMC 2605 and handbook as provided for in the LOU. Nothing in the following guidance describing the shared responsibility between NRC and the MML precludes the MML from reviewing notifications, decommissioning plans, or other document for their approval before transmitting them to NRC. NRC retains its authority to review and approve decommissioning plans (DPs) on a case-by-case basis and in accordance with the guidance provided below. MML Permit termination and decommissioning procedures are subject to NRC regulations and should use Inspection Manual Chapter IMC 2605 and Nuclear Material Safety and Safeguards (NMSS) Decommissioning Handbook guidance to determine the appropriate decommissioning types. For byproduct materials (Part 30 permittees), the MML must comply with the following notification and reporting directions: Initiation of Decommissioning: Permittees must notify the MML of changes in operating status in accordance with 10 CFR 30.36 (d) and the MML must notify NRC of all changes in operating status pursuant to the notification requirements in 10 CFR 30.36, unless the permittee's principal activities are limited to either; (1) possession of sealed sources with no history of leakage; or (2) possession of only radioactive isotopes with short half lives (less than 120 days). For all other principal activities, the notification must contain sufficient information for NRC to determine if a DP is needed and whether NRC needs to review and approve the permittee's plan. Decommissioning: Permittees must submit a DP in accordance with 10 CFR 30.36 (d), if required by paragraph (g)(1). The MML is required to transmit all DPs to NRC. If NRC determines a DP is required when the MML does not, the MML must either provide the DP or documentation supporting the MML determination. Simple decommissioning will be the responsibility of the MML. Unless notified to the contrary by NRC, the MML may review and approve DPs. NRC will maintain the authority to review and approve DPs on a case-by-case basis. Decommissioning actions that do not qualify for a categorical exclusion in accordance with 10 CFR 51.22 will, in all cases, remain the responsibility of NRC. Request for extensions: Permittees requesting to extend time periods established in 10 CFR 30.36 (d), in accordance with 10 CFR 30.36 (f), must submit such requests to the MML. The MML is required to transmit the request to NRC. Although these requests are not considered to be exemptions to the regulation, NRC will maintain the responsibility for reviewing requests and granting approvals. Completion of Decommissioning and Termination of the Permit: Upon completion of decommissioning, permittees must submit a request for permit termination in accordance with 10 CFR 30.36 (h). Permittees that elect to request an alternative schedule for completion of decommissioning must submit the request to the MML in accordance with 10 CFR 30.36 (h). The MML is required to transmit the request to NRC. Upon completion of decommissioning, permittees must submit a completed Form 314 or equivalent, and a final survey report in accordance with 10 CFR 30.36 (j). NRC will maintain the authority to review and approve final survey reports on a case-by-case basis. The MML is required to submit a copy of the final survey report to NRC for those permittees that filed a DP in accordance with 10 CFR 30.36. NRC's decision to review and approve final survey reports will be based on the complexity of the decommissioning activities. In general, unless notified to the contrary by NRC, the MML may review and approve final survey reports. Decommissioning Records For the MML to meet the requirements of 10 CFR 30.51, permittees must keep records showing the receipt, transfer, and disposal of byproduct materials in accordance with 10 CFR 30.51. Permittees shall forward these records to the MML for storage until the MML is terminated. NRC will review MML records submitted by permittees on an annual basis to verify that permittee records meet the intent of 10 CFR 30.51. The MML application must state that the applicant will provide copies of permit termination requests and permit decommissioning plans to NRC. The application must also state that specific permit decommissioning plans will be submitted, when requested by NRC due to interest in a specific site, to NRC for review and approval prior to approval by the MML RCP. NRC will maintain the authority to review and approve decommissioning plans on a case-by-case basis; however, in general, unless requested by NRC, the MML may review and approve decommissioning plans. Response from Applicant:
3.10.16 Financial AssuranceIn order to meet the requirements in 10 CFR 30.35, the applicant must describe its program for establishing and maintaining adequate funds to decommission all its permitted facilities. In cases involving multiple independent sites under a single license, the financial assurance and, if required, the decommissioning funding plan would have to delineate procedures and cost estimates for each facility or site. The MML may treat each permittee's facility independently and sum the amounts needed for each individual permittee to determine the total amount of financial assurance required to meet the regulations. Co-located permittees must be identified and the applicant's plan for financial assurance provided for each location. NRC uses NUREG-1336, Rev. 1 and Policy and Guidance Directive FC 90-2. Response from Applicant:
3.10.17 Inspection and Enforcement ProceduresIn order the meet the requirements in 10 CFR 30.33, the RCP Office (RCPD and/or staff) must maintain an inspection program adequate to assess permittee compliance with NRC regulations, MML requirements, and permit conditions. To ensure consistency between NRC and the MML applicant's inspection and enforcement programs, the RCPD must maintain statistics adequate to permit program management to assess the status and results of the inspection program on a periodic basis. This statistical information must include the number of inspections conducted, the number overdue, the length of time overdue, and priority categories. This information must be readily available for NRC to review. The RCPD must prepare a semiannual inspection plan that includes the number of inspections to be performed, the level of inspection experience required for the individual permits, identification of special needs, and periodic status reports for completion of the inspections within the plan's schedule. NRC will also use this information in monitoring its oversight of the MML program. The MRSC must either establish an inspection priority system identical to NRC's in Manual Chapter 2800, or the MML management may request authorization from NRC through the MML's licensing Region to alter the inspection frequency to meet the MML's priorities. The specific frequency of inspections should be based upon the potential hazards from permitted operations, e.g., broad scope permits, major processors, and industrial radiographers must be inspected approximately annually, and smaller or less hazardous operations may be inspected less frequently. The MML must have inspection guides consistent with current NRC guidance and provide technical guidance in the inspection of permitted programs. To ensure this consistency, written inspection policies should establish a policy for conducting unannounced inspections, obtaining corrective action, following up and closing out previous violations, conducting interviews with workers and observing operations, assuring exit interviews with management, and issuing appropriate notification of violations or health and safety problems. Independent measurements must be sufficient in number and type to ensure the permittee's control of materials and to validate the permittee's measurements, pursuant to 10 CFR 30.33. In addition, the RCP must have access to laboratory support capability to conduct bioassays, analyze environmental samples, analyze samples collected by inspectors, and other necessary analyses on a priority established by the RCP. Procedures should be established for maintaining permittee compliance histories. Briefing of supervisors or the senior inspector should be performed upon return from inspections. For MML facilities with separate permitting and inspection staffs, procedures should be established for feedback of inspection information to permit reviewers. Although the documentation format may vary depending on the type of inspection or inspection findings (reference NRC IMC 2800 regarding use of inspection records versus formal inspection reports), findings of inspections must be documented for future use by MML inspection staff and permittees. At a minimum, this documentation should include a description of: (1) the scope of inspection; (2) facts and data to substantiate all items of noncompliance, and health and safety issues; (3) the scope of permittee's programs; (4) the substance of discussions with permittee management and the permittee's response; (5) the status of previous items of noncompliance; and (6) the results of any independent measurements made by the inspector. Inspection documents forwarded to the permittee must describe the scope and results of the inspection, including identification of any items of noncompliance, health and safety issues, and areas of permittee's program that should receive special attention by permittee management. Corrective actions planned or taken by the permittee for items of noncompliance must be documented and retained in the permittee file for future evaluation by MML inspectors. The applicant should establish an enforcement program to ensure consistent assessment of the regulatory and safety significance of violations. To ensure uniform enforcement policies between MML permittees and equivalent NRC licensees, the program should commit to following NRC's enforcement policies, consistent with the legal authority of the MML. The program should include a description of the sanctions to be used and its methods used for assessing the severity of violations and taking enforcement actions for the more severe violations. It should also include referral of Severity Level I, II and III violations to NRC for NRC action. MML action against its permittees does not preclude NRC from taking action against the MML, its permittees, or its employees. Response from Applicant:
3.10.18 Incident/Emergency Response ProceduresIn order for NRC to approve the MML application, the application must provide the RCP Office procedures for responding to spills, fires, release or loss of material, overexposures, and contamination of personnel at permittee facilities. The applicant must describe its provisions for immediate response and handling of such incidents, including off-hours notification of appropriate RCP Office staff, state and local authorities, and, when applicable, NRC. The plan must define the oversight responsibilities of the RCP management and staff, including actions to be taken by permittees. The plan must be specific as to persons responsible for initiating response actions, conducting operations, and performing cleanup. Except for minor spills or releases of radioactivity that can be controlled and cleaned up by the permittee, the permittee staff should understand the actions that must be taken to secure the area and respond to immediate hazards, and whom they should contact. Only qualified and experienced individuals should conduct decontamination and recovery operations. Additionally, when permittees request possession of radioactive materials in both unsealed and certain sealed forms in excess of specifically listed quantities, they must prepare an emergency plan. The MML applicant must identify these permittees and submit copies of the approved emergency plans required in 10 CFR 30.32(i)(1). If applicants determine that they need an Emergency Plan, they should submit a detailed plan pursuant to 10 CFR 30.32(i). Guidance for this submittal is contained in Regulatory Guide 3.67, "Standard Format and Content for Emergency Plans for Fuel Cycle and Materials Facilities." The applicants RCP Office emergency response procedures must require that inquiries be promptly made to evaluate the need for onsite review of events. Onsite review of events must be initiated promptly for incidents that are required to be reported to NRC in fewer than 30 days. For those incidents not requiring reporting to NRC in fewer than 30 days, review of events must be made during the next scheduled inspection. Onsite investigations must be made promptly of non-reportable incidents that could be relevant to other permitted operations (e.g., equipment failure, improper operating procedures) and those incidents that may be of significant public interest and concern. Information on incidents involving failure of equipment must be provided to the agency responsible for evaluation of the device, for assessment of possible generic design deficiency (e.g., NRC and Department of Health and Human Services, Food and Drug Administration). This includes compliance with 10 CFR Part 21 and other applicable regulations. Response from Applicant:
3.10.19 Procedures for Handling AllegationsHandling allegations will be a shared responsibility included in the LOU. In order to meet the requirements in 10 CFR 30.7, the MML applicant must establish a program for responding to employee radiation safety concerns which provides for timely investigation and response to these concerns and address prevention of reprisals against employees for expressing their radiation safety concerns to management. The program should include a strong statement encouraging employees to bring forward any perceived radiological safety issues. The program must include training that clearly articulates the right of any employee to raise his or her radiation safety concerns directly to NRC, if he or she so desires.Allegations received by NRC staff from licensed personnel may be investigated by NRC or referred to the MRSC for investigation. The applicantion must specify whether the applicant will follow NRC's procedures for handling allegations (Management Directive 8.8) or include equivalent procedures for handling allegations that are referred to the MRSC. Response from Applicant:
3.11 NRC Form 313, Item 11: Waste Management[ Prev | Next | Top of file ] To assure the applicant will meet the waste disposal requirements in 10 CFR Part 20, the applicant must describe the methods its permittees will use for disposal of radioactive waste. The following disposal methods will be authorized:
Other disposal methods must be specifically addressed in the application. This may include, but is not limited to, treatment or disposal by incineration, land burial, or consolidation of waste from multiple permittee facilities for subsequent disposal. The applicant must describe the locations, conditions, and current status of former burial sites, whether controlled or uncontrolled, any active monitoring of the site, and the current condition of the burial site, for permittees who were NRC licensees authorized prior to January 28, 1981, to bury radioactive materials pursuant to 10 CFR 20.304. Response from Applicant:
3.12 NRC Form 3131, Item 12: License Fees[ Prev | Next | Top of file ] No application fees, license fees, amendment fees, approval fees, or inspection fees are required for a U. S. Government Agency; however, in accordance with 10 CFR 171.16(d), an annual fee will be assessed. There may be an additional annual fee for each Sealed Source Device Registration the MML has. 4 Amendments to a License[ Prev | Next | Top of file ] It is the licensee's obligation to keep the license current. If any of the information provided in the original application that was included in the license tie-down condition is to be modified or changed, the licensee must submit an application for a license amendment before the change takes place. The licensee requires an amendment to change the scope of the program. In addition, the licensee must notify NRC when changing the Radiation Control Program Director or changing the Chairman of the Master Radiation Safety Committee. Applications for license amendment must do the following:
Appendix A: United States Nuclear Regulatory Commission Form 313[ Prev | Next | Top of file ]
Appendix B: Sample Master Material License[ Prev | Next | Top of file ] Sample Master Material License The Master Materials License authorizes the use of byproduct material in any form and as needed or limited to some maximum quantity. It authorizes the licensee to possess and use this material for generic categories of use requested in the application and to issue permits to licensee organizational activities for these authorized uses at licensee facilities. The license must specifically authorize the following items or the licensee is excluded from these uses:
Because of all the possible variations involved in a Master Materials Program, the license conditions are uniquely developed for each master materials license. The following sample licenses provide common authorizations and license conditions that should be applicable to each master materials license, but does not constitute a complete master materials license. Research License Conditions
A sample license appears on the following pages.
Appendix C Checklist for License Application[ Prev | Top of file ]
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