ML20203A068
| ML20203A068 | |
| Person / Time | |
|---|---|
| Issue date: | 10/31/1998 |
| From: | Henson J, Donna-Beth Howe, Jackie Jones, Thompson T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| References | |
| NUREG-1556, NUREG-1556-DRFT, NUREG-1556-V10-DR-FC, NUDOCS 9902090277 | |
| Download: ML20203A068 (50) | |
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NUREG-1556 Vol.10 Consolidated Guidance. About
- Materials Licenses Program-Specific Guidance About Master Materials Licenses Draft Report for Comment Manuscript Completed: October 1998 Date Published: October 1998 Prepared by J.D. Jcnes, J. Henson, D.B. Howe, T. Thompson Division ofIndustrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission Wcshington, DC -20555-0001
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t i COMMENTS ON DRAFT REPORT t Any interested party may submit comments on this repon for consideration by the NRC staff. Comments may be accompanied by additional relevant information or supporting data. Please specify the report number draft NUREG-1556, Vol.10, in your comments, and send them by a February 20,1999 to-t Chief, Rules Review and Directives Branch U.S. Nuclear Regulatory Commission Mail Stop T6-D59 Washington, DC 20555-0001 You may also provide comments at the NRC Web site, http://www.nrc. gov. See tIie link under " Technical Reports in the NUREG Series" on the ' Reference Library" page. Instructions for-I sending comments electronically are included with the document, NUREG-1556, Vol.10, Draft, at the web site. For any questions about the material in this report, please contact: ' Sally S. Merchant Mail Stop: TWFN 9-F31 U.S. Nuclear Regulatory Commission Washington, DC 20555-0001 - Phone: 301-415-7874 E-mail: SLM2 ? t t s I t
1 i ABSTRACT As part of its redesign of the materials licensing process, NRC is consolidating and upddng numerous guidance documents into a single comprehensive repository as described in NUREG - 1539, " Methodology and Findings of the NRC's Materials Licensing P:ocess Redesign," dated April 1996, and draft NUREG-1541, " Process and Design for Consolidating and Updating Materials Licensing Guidance," dated April 1996. Draft NUREG-1556, Vol.10, " Consolidated Guidance about Materials Licenses: Program-Specific Guidaace about Master Materials Licenses," dated October 1998, is the tenth program-specific guic'ance developed for the new process and is intended for use by Federal applicants and licensees, and NRC staff. This document combines and 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 October 25,1997. No*.e that this document is strictly for public comment and is not for use in preparing or reviewing applications for Master Materials licenses until it is published in final form. i i iii Draft NUREG - 1556, Vol.10
i CONTENTS ABSTRACT...............................................................................W FO RE WO R D............................................................................. vii A C KNO WLEDG M ENTS.................................................................... ix A B B REVI ATI ON S......................................................................... xi 1 PURPOSE OF DRAFT REPORT....................................................... 1 1 1.1 DEFINITION AND DESCRIIYrlON.................. ........... 1-1 1.2 ISSUANCE CRITERIA FOR A MASTER MATERIALS LICENSE...... .,....... 1-1 1.3 MASTER MATERIALS LICENSEE AUTHORIZATIONS........ ............... 1-2 1.4 PRE-LICENSING CONFERENCE.......................... .............13 ( l.5 PROGRAMS NOT WARRANTING A MASTER MATERIALS LICENSE 1-3 \\ 2 REVIEW OF A MASTER MATERIALS LICENSE APPLICATION......................... 2 1 2.1 LETTER OF UNDERSTANDING......... .......... 2-1 2.2 UCENSING AND ENFORCEMENT HISTORY.. ........ 2-2 3 FI LING A N A PPLICATION........................................................... 3 1 4 CONTENTS OF AN APPLICATION.................................................... 4 1 i 4.1 NRC FORM 313, ITEM 1: LICENSE INFORMATION......................... 4-1 4.2 NRC FORM 313, ITEM 2: APPLICANTS NAME AND MAILING ADDRESS 4-1 4.3 NRC FORM 313, ITEM 3: LOCATION OF USE............. . 4-1 4.4 NRC FORM 313, ITEM 4: PERSON TO BE CONTACTED ABOUT APPUCATION..... .4-2 4.5 NRC FORM 313, ITEM 5: MA'HiRIAL TO BE POSSESSED.......... .............4-2 4.6 NRC FORM 313, ITEM 6: PURPOSE OF USE OF UCENSED MATERIAL......... . 4-3 4.7 - NRC FORM 313, ITEM 7: INDIVIDUALS RESPONSIBLE FOR THE RADIATION SAFETY PR OG RAM.................................... ............... 4-4 4.7.1 SENIOR MANAGEMENT...... ............ 4-4 4.7.2 MASTER RADIATION SAFETY COMMFITEE........................ 4-5 4.7.3 RADIATION CONTROL PROGRAM DIRECTOR ........... 4-6 4.7.4 OTHER RCP STAFF.. ......... 4-8 4.8 NRC FORM 313, ITEM 8: TRAINING AND EXPERIENCE FOR INDIVIDUAIS WORKING IN OR FREQUENTING RESTRICTED AREAS...... 4-8 4.9 NRC FORM 313. ITEM 9: FACILITIES AND EQUIPMENT........ ...........49 4.10 NRC FORM 313. ITEM 10. RADIATION SAFETY PROGRAM........ . 4-9 4.10.1 PREVIOUS LICENSES 4-10 4.10.2 REGULATORY CONFORMANCE..... . 4 10 4.10.3 UPDATING OF RCP PROGRAM DOCUMENTS.... ..... 4-10 4.10.4 MANAGEMENT OVERSIGHT AND RADIATION CONTROL PROGRAM PROCEDURES.............. 4-10 4.10.5 MASTER RADIATION SAFETY COMMITTEE.... 4 12 4.10.6 THE RADIATION CONTROL PROGRAM DIRECTOR.. .4-13 4.10.7 PERMITTING AND INSPECTION STAFF. .............4-14 4.10.8 RCP PROCEDURES. 4-15 4.10.9-MANAGEMENT AND MASTER RADIATION COMMITTEE AUDITS........ 4-15 4.10.10 PERMITTING PROCEDURES 4-16 v Draft NUREG - 1556, Vol.10
i l CONTENTS J 4.10.11 PERMITEE MINIMIZATION OF CONTAMINATION PROGRAM........... 4-17 4.10.12 PERMIT TERMINATION AND DECOMMISSIONING OF PERMIT ACTIVITIES. 4-17 4.10.13 FINANCIAL ASS URANCE........................................... 4-18 4.10.14' INSPECTION AND ENFORCEMENT PROCEDURES...................... 4-18 '4.10.15 INCIDENT / EMERGENCY RESPONSE PROCEDURES...................... 4-19 4.10.16 PROCEDURES FOR HANDLING ALLEGATIONS...................... 4-21 4.11 NRC FORM 313, ITEM l l: WASTE MANAGEMENT.......................... 4-21 4.12 NRC FORM 313, ITEM 12: LICENSE FEES....... ..............................4-22 5 - AMENDMENTS TO A LICENSE...................................................... 4-23. APPENDICES A. United States Nuclear Regulatory Commission Form 313 ....................................A-1 B. Sample Master Material License.................... ... B-1 e i l l Draft NUREG - 1556, Vol.10 vi l
9 FOREWORD 4 j The United States Nuclear Regulatory Commission (NRC) is using Business Process Redesign 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. Below is a list of volumes currently included in the NUREG-1556 series. Vol Volume Title Status
- No.
1 Program-Specific Guidance About Portable Gauge Licenses Final Report _2-Program-Specific Guidance About Radiography Licenses - Final Report 3 Applications for Sealed Source and Device Evaluation and Final Report Registration 4 Program-Specific Guidance About Fixed Gauges Final Report 5 Program-Specific Guidance About Self-Shielded Irradiators Draft for Comment '6 Program-Specific Guidance about 10 CFR Part 36 Irradiators Draft for Comment 7 Program-Specific Guidance About Academic, Research and Draft for Comment Development, and Other Licenses of Limited Scope (8-Program-Specific Guidance About Exempt Distribution Licenses Final Report 1 '9 Program-Specific Guidance About Medical Uses of Byproduct Draft for Comment Material The current document, draft NUREG-1556, Vol.10, " Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Master Material Licenses," dated October 1998, is the tenth program-specific guidance developed for the new process. It is intended for use by - applicants representing Federal organizations, licensees, NRC license reviewers, and other NRC personnel. It combines and 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 October 25,1997. This draft report was prepared by a team composed of NRC staff from regional offices and headquarters, drawing on their collective experience in managing licensing and inspection programs specific to radiation safety. A representative of NRC's Office of the General Counsel provided a legal perspective. Draft NUREG-1556, Vol.10, " Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Master Material Licenses," dated October 1998, represents a vii Draft NUREG - 1556, Vol.10
FOREWORD step in the transition from the current paper-based process to the new electronic process. This draft document is available on the Internet at the following address: <http://www.nrc. gov /N RC/NUREG S/S R 1556/V 10/index.html>. i This draft report is strictly for public comment and is not for use in preparing or reviewing applications for master material licenses until it is published in final form.- It is being distributed for comment to encourage public participation in its development.lPlease submit comments within 90 days of the draft report's publication. Comments received after that time will be considered if practicable. Address comments to: Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration, U. S. Nuclear Regulatory Commission, Washington, DC 20555-0001. l Hand deliver comments to 11545 Rockville Pike, Rockville, Maryland, between 8:15 a.m. and l 4:30 p.m. on Federal workdays. Comments may also be submitted through the Internet by addressing electronic mail to dlm1 @nrc. gov. Draft NUREG-1556, Vol.10," Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Master Material Licenses," dated October 1998, is not a substitute for NRC regulations, and compliance is not required. The approaches and methods described in this draft report are provided for information and comment only. ,e f, / / 5 l \\ l y ~. Frederick C. Combs, Acting Director Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards i l I Draft NUREG - 1556, Vol.10 viii
ACKNOWLEDGMENTS The writing team thanks the individuals listed below for assisting in the development and review of the draft report. All participants provided valuable insights, observations, and recommendations. The team also thanks Kay Avery, Judy Boykin, Grace S. Lee, Steven W. Schawaroch, and Gina G. Thompson of Computer Sciences Corporation. The Participants Camper, Larry W. Collins, Douglas M. Cool, Donald A. Combs, Frederick C. Henson, Jay L. Howe, Donna-Beth Howell, Linda L. Jones, John D. Madera, John R. Merchant, Sally L. Piccone, Josephine M. Roe, Mary Louise Schwartz, Maria E. Shanbaky, Mohamed M. Thompson, Thomas, K. Treby, Stuart A. ix Draft NUREG - 1556, Vol.10 1
c ABBREVIATIONS CFR . Code of Federal Regulations IMC Inspection Manual Chapter LOU Letter of Understanding MML Master Materials License MRSC Master Radiation Safety Committee - NMSS Office of Nuclear Material Safety and Safeguards NRC Nuclear Regulatory Conunission RCP Radiation Control Program RCPD Radiation Control Program Director RSO ~ Radiation Safety Officer SRP Standard Review Plan l xi Draft NUREG - 1556, Vol.10 t
1 PURPOSE OF DRAFT REPORT l This document is strictly for public comment and is not for use in preparing or reviewing applications for Master Materials Licenses until this document is published in final form. This draft report provides guidance to applicants preparing Master Materials License (MML) applications and provides the criteria used by NRC in reviewing MML applications. After submittal, NRC regional license reviewers initially review the application to ensure it is complete before submitting for final review by neadquarters. Because the existing organization's licenses may be located in multiple regions, there should be close regional inspection and licensing staff communication when evaluating new applications. The 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 i of the proposed inspection and pemiitting program, independence of the MML governing body, and commitment to the MML. One or more pre-licensing visits should be conducted prior to issuance of any new MML. 1.1 DEFINITION AND DESCRIPTION An MML is a multisite material (byproduct, source, and/or special nuclear material) license. The MML authorizes the licensee to issue permits for the possession and use oflicensed material under the license, and ties the licensee to a framework for oversight and internal licensee inspection of the MML. The MML licensee issues permits and conducts inspections of its permittees. The licensee must have a system for tracking permitting and inspection actions. The MML licensee's inspectors and permit reviewers must meet the same training requirements (Inspection Manual Chapter (IMC)-1246," Formal Qualification Programs in the Nuclear Material Safety and Safeguards Program Area," and use the same licensing and inspection guhlance (IMC-2800, and IMC-2600 " Materials Inspection Program") as their NRC counterparts. MML licensees are inspected annually by the NRC to review the management, inspection, permitting, and enforcement activities performed under the license (IMC 2810, " Master Materials License Inspection Program.") 1.2 ISSUANCE CRITERIA FOR A MASTER MATERIALS LICENSE l A Master Materials License (MML) will be issued only to federal organizations which have: i l
- Engaged in a centralized control of activities involving the use of byproduct materials under j
specific licenses of broad and limited scope. Normally an applicant should have had a 1-1 Draft NUREG - 1556, Vol.10
PURPOSE OF DRAFT REPORT centrally coordinated program for at least 5 years. (While recognizing the applicant does not have a master materials program at the time of application, the NRC will evaluate the applicant's past centralized program for elements fundamental to a master materials program.) An acceptable regulatory performance record, based on NRC licensing and inspection of activities for the last 5 years. (NRC will compare the applicant's existing licensees' performance record with that of other similar licensees for the same time period.) . A radioactive materials use program for the last 5 years requiring a variety oflicenses and radionuclides and the operational flexibility to cover numerous uses, users, and locations typically in multiple NRC regions. Either proposed or existing centralized radiation control program, centralized administrative structure and organization, staff, facilities, equipment, and procedures adequate to protect the health and safety of workers and the public against radiation hazards from the materials and uses over which the licensee proposes to assume responsibility for permitting and inspecting. (NRC will compare these elements with similar elements for existing MML licensees.) . Successfully met the criteria in 10 CFR 30.33. 1.3 MASTER MATERIALS LICENSEE AUTHORIZATIONS 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. The MRSC-permitting criteria must be consistent with NRC regulations and licensing policies, procedures, and guides. The MML must also establish an inspection program which is consistent with NRC regulations and inspection and enforcement policies, procedures, and guides. The letter of Understanding (LOU) for an MML may contain exclusions that provide that unless specifically authorized, a MML may not conduct certain activities. Typically, the exclusions stated in an LOU provide that, unless specifically authorized, persons licensed under MMLs shall not: . Grant exemptions to NRC regulations . Conduct tracer studies in the environment involving the direct release of radioactive material (field uses) Conduct activities authorized under 10 CFR Part 32 (manufacture or distribution ofitems to persons exempt from licensing, items to general licensees and radioactive drugs for medical Draft NUREG - 1556, Vol.10 1-2
PURPOSE OF DRAFT REPORT distribution, sealed sources, and medical devices containing sealed sources for medical distribution),10 CFR Part 34 (radiography),10 CFR Part 35 (medical use),10 CFR Part 36 (irradiators),10 CFR Part 39 (well logging);
- Conduct activities requiring a specific license pursuant to 10 CFR Parts 40 and 70
- Add or cause the addition of byproduct material to any food or other product designated for ingestion or inhalation by, or application to, a human being unless specifically authorized (i.e.,
medical use). 1.4 PRE-LICENSING CONFERENCE 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 pre-licensing visits at the MML applicant's radiation control program central office. The pre-licensing visits will include a conference with the applicant's senior management and proposed MRSC members. A pre-licensing visit provides NRC staff an opportunity to:
- Better evaluate applicant's proposed program, and necessity for an MML
- Meet with applicant's senior management, proposed MRSC members, and other responsible staff Convey the importance of applicant's responsibilities a
Discuss and agree on additional information and commitments . Review implementation details. 1.5 PROGRAMS NOT WARRANTING A MASTER MATERIALS LICENSE If the 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. 1-3 Draft NUREG 1556, Vol.10
2 REVIEW OF A MASTER MATERIALS LICENSE APPLICATION Initially, Regions review MML applications (i.e., NRC form 313 and attachments) for i completeness, and then forward them, with comments, to NRC Headquarters via a technical assistance request for review and coordination. There, a team of headquarters and regional staff (including at least one project manager for an existing MML), experienced in licensing and inspection procedures, will review the applications. The team leader will typically be from the region in which the MML is to be based 2.1 LETTER OF UNDERSTANDING - Where responsibilities are divided between the MML management and NRC, division of responsibilities and requirements for coordination must be clearly defined and documented in a LOU between the NRC and the applicant. The following are some examples of responsibilities that may be divided: . Investigations of allegations . Enforcement activities . Permit termination and decommissioning
- Use of byproduct material without specific regulations, policies, or guidance published by NRC
= Waste incineration in accordance with 10 CFR 20.2002. In the following examples of responsibilities which will not be shared, the licensee must continue to: . Report to and notify NRC in accordance with regulatory requirements
- Request authorization for exemptions to the regulations
. Submit environmental assessment repon pursuant to 10 CFR Part 51 Submit decommissioning financial assurance in accordance with 10 CFR 30.35 . Submit an emergency contingency plan for possession oflicensed materials pursuant to 10 CFR 30.32(i)(1). 2-1 Draft NUREG - 1556, Vol.10
REVIEW OF A MASTER MATERIALS LICENSE APPUCATION 2.2 LICENSING AND ENFORCEMENT HISTORY A MML will be issued only to organizations with a good regulatory performance record, based on NRC licensing and inspection of prior activities. The NRC will evaluate the applicant's performance for the last 5 years using, at a minimum, the following indicators: . Demonstrated proficiency at completing license applications . Timely and effective communications within the organization at all levels regarding radiation safety program issues Selfidentification and correction of generic safety issues and regulatory compliance Existence of cases brought to NRC's attention in which employee radiation safety concerns were not adequately addressed by the applicant Number ofinspections that resulted in: - no cited violations l - violations cited in a notice of violation - violations considered for escalated enforcement l NRC findings with significant programmatic implications Number of escalated enforcement cases that involved management oversight issues Number and nature of recurrent violations Number of escalated enforcement cases that involved repeat violations a Timely, comprehensive, and effective response to violations. l l l l Draft NUREG - 1556, Vol.10 22
\\ 3 FILING AN APPLICATION The applicant must apply for a MML by completing 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 on j 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. Complete allitems 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. l License applications are available for review by the general public in the NRC Public Document Rooms: 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 the NRC. The applicant must file the application in duplicate and retain a third copy for its licensing files. Federal agencies may apply for a MML for use of licensed activities anywhere in U.S. jurisdiction. 3-1 Draft NUREG - 1556, Vol.10
~ 4 CONTENTS OF AN APPLICATION The following conunents 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 will be legally required (tie down) as opposed to descriptive information not legally required. NRC will retum any application not signed by the certifying official (Item 13). 4.1 NRC FORM 313, ITEM 1: LICENSE INFORMATION For a new license, check subitem A. For an amendment to an existing license, check subitem B. Since MML's have an indefinite expiration date, they are not renewed and subitem C should always be blank. 1 4.2 NRC FORM 313, ITEM 2: APPLICANT'S NAME AND MAILING ADDRESS ? Applicants should be Federal entities. Therefore, 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 (RCPD). Since a MML has an indefinite license period, the applicant should inform NRC of any subsequent changes in its mailing address. 4.3 NRC FORM 313, ITEM 3: LOCATION OF USE 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, Any town, 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 oflocations by program code identical to the one used by the NRC and provide an updated list to the NRC. Applicants must indicate if they will authorize permittees to use radioactive material at temporaryjob sites. 4-1 Draft NUREG - 1556, Vol.10 1
CONTENTS OF AN APPLICATION If permittees will use radioactive material in field studies, these activities must be specifically identified and authorized on the MML. Appendix B contains information required for field use oflicensed material, i.e., Policy and Guidance Directive E t-20. NRC will follow the guidance provided in Appendix C and Policy and Guidance Directive 84-20 when evaluating such requests. 4.4 NRC FORM 313, ITEM 4: PERSON TO BE CONTACTED ABOUT APPLICATION t The applicant must specify the individual who will be the RCPD and provide his or her telephone number. 4.5 NRC FORM 313, ITEM 5: MATERIAL TO BE POSSESSED. 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. Catagorize this possession request 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 Sa,5b, and 5c of NRC Form 313, rather than including these under the broad authorization for that class oflicensed material (e.g., any byproduct material). Under Item 5b, describe by manufacturer and model number all large activity scaled 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 applicant should describe facilities or permittees which may possess quantities of materials requiring finanew 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. MML applicants should develop and maintain a strong 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 must also ensure that licensed possession limits are not exceeded. A Draft NUREG - 1556, Vol.10 4-2
CONTENTS OF AN APPLICATION successful program requires the dedication of sufficient staff and equipment. See NUREG 1551 for additional useful inforrnation on control and accountability.
- The applicant must describe its procedures for inventory control and accountability oflicensed material.
4.6 NRC FORM 313, ITEM 6: PURPOSE OF USE OF LICENSED MATERIAL 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 the 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 an 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 unique or specialized activity (e.g., scaled source fabrication), the applicant may be required to submit the criteria used by the MRSC in evaluating in-house requests for such use. Regulatory Guide 10.10, " Guide for the Preparation of Applications For Radiation Safety Evaluation and Registration of Devices Containing Byproduct Material," and 10.11, " Guide for the Preparation of Applications for Radiation Safety Evaluation and Registration of Sealed Sources Containing Byproduct Material," provide guidance for the evaluation and registration of sealed sources and devices with the NRC. Policy and Guidance Directive 84-22, Rev.1, "What Source and Device Designs require an Evaluation" may also be helpful. State if you intend to use sealed sources other than those that have been registered with the 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 he or she must include with the application the information outlined in Appendix E of Regulatory Guide 10.5, Second Proposed Rev. 2 (DG-0005) " Applications for Licenses of Broad Scope." and such field studies must be specifically authorized in the MML. 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 4-3 Draft NUREG - 1556, Vol.10
CONTENTS OF AN APPLICATION purposes. However, this " categorical exclusion" does not encompass, performing 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. Provide sufficient information about these studies for NRC to determine whether a categorical exclusion is appropriate. 4.7 NRC FORM 313, ITEM 7: INDIVIDUALS RESPONSIBLE FOR THE RADIATION SAFETY PROGRAM 4.7.1 SENIOR MANAGEMENT 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, the NRC grants significant authority to MML licensee management to develop and implement an appropriate radiation control program. Consequently, MML licensee management must establish strong administrative controls, oversight, and provisions for organization and management, including management review, necessary to ensure safe operations. Management responsibility is often under emphasized in applications and poorly understood by licensee employees and managers. MML licensees are required to establish a MRSC that represents management when reviewing and approving permit applications. Therefore, senior executive management (highest level oflicensee 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. The MML licensee retains the ultimate responsibility for the conduct oflicensed 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 applicant should describe senior executive management oversight and processes used by senior executive management to ensure adequate control over MML licensed activities. 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. The application should include an organizational chart of the applicant's management structure depicting reporting paths and flow of authority. Include a statement empowering the MRSC by Draft NUREG - 1556, Vol.10 4-4 e
CONTENTS OF AN APPLICATION 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 4.10. i 1 4.7.2 MASTER RADIATION SAFETY COMMITTEE J The MRSC serves as a window to the licensed program through which management gains an overall picture of MML activities and the respective roles of the RCPD, MRSC, and other responsible individuals, including permittee activities. The MRSC provides guidance and information on the radiation control program to 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 executive managen ent is periodically given all relevant information regarding the radiation control program, particularly when management will make decisions that may affect the program. The chairperson of the Committee should be empowered at a minimum to do the following:
- Set the agenda
. Direct committee meetings . Determine the existence of a quorum . Verify the minutes
- Summarize the committee's position regarding decisions
. Sign all official documents of the committee . Appoint a temporary replacement chairperson (not the executive secretary) in the event af his/her required absence . Vote. The following are duties of the Executive Secretary of the MRSC, an assigned duty of the RCPD:
- Serves as a liaison between the MRSC and the RCP staff
. Informs the Chairperson of staff commitments and resources
- Assists the Chairperson in preparing the agenda 4-5 Draft NUREG - 1556, Vol.10
CONTENTS OF AN APPLICATION
- Advises the committee of current regulations and proposed changes in NRC regulations and policies
. Provides the committee with quarterly reports on the status of the program. s In addition, the Executive Secretary should prepare an annual audit report including overall conduct, result of the program performance compared to regulatory requirements and commitments, review of permitting actions, inspection reports, and enforcement actions. Membership of the MRSC must include: 'A senior manager from the applicants executive management organization to serve as the Chairman . Managers capable of establishing RCP policies. These managers should be drawn from major division, department, or organizational elements that represent the permittee community . RCPD who serves as the Executive Secretary of the MRSC Manager from the applicant's finance organization. Other members include: Managers responsible for establishing and implementing major program activities under MML Managers who represent permitting and inspecting organization = Representatives of occupationally exposed workers The applicant must do the following: Identify the Chairman of the MRSC and provide assurance of the chairman's full authority to commit licensee resources to support the conduct of the MML Identify other individual members of the MRSC by position title and job description = Describe how the applicant ensures that each MRSC member has adequate education, training, experience, and knowledge to adequately address radiation control program issues 4.7.3 RADIATION CONTROL PROGRAM DIRECTOR The 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 Draft NUREG - 1556, Vol.10 4-6
A CONTENTS OF AN APPLICATION program with the assistance and support of the MRSC and senior executive management, and serves as the Executive Secretary of the MRSC. The RCPD's 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 applicants radiation' control program.- The RCPD's qualifications should include:
- An academic degree in a physical or biological science or engineering
- Specific training in radiation health sciences
- Considerable professional experience (generally a minimum of 5 years) with a broad spectrum e
of radioactive materials. Generally, a RCPD at a MML should have:
- Experience managing a radiation safety program where a broad spectrum of isotopes were used and licensed activities were conducted.
- Management abilities such as developing and administering a budget, supervising a staff, familiarity with human resource matters o' Good writing and oral communication skills.
1 In addition, it is essential for the RCPD to have a thorough knowledge of NRC regulatory . requirements. ' The applicant must provide generically the minimum qualifications of the RCPD. ]
- The specific individual designated RCPD and his/her qualifications should be included as f
. demonstration information. L.
- Identify the individual designated as the RCPD
= Provide documentation on education, training, and experience demonstrating the individual is L - qualified to manage the RCP l l i i_ 4-7 Draft NUREG - 1556, Vol.10
l l CONTENTS OF AN APPLICATION f 4.7.4 OTHER RCP STAFF The RCP professional staff must have the following qualifications:
- Sufficient education, training, and experience in the physical and/or life sciences
=. Bachelor's degree, or equivalent training and experience, = At least 40 hours training in the safe handling of radioactive materials, and in the l-characteristics ofionizing radiation, units of radiation dose and quantities, radiation detection instrumentation, and biological hazards of exposure to radiation appropriate to the type and forms of byproduct to be used. Additioual training commensurate with the types of hazards and technology to be permitted. l Written job descriptions, readily identifying professional qualifications needed to fill vacancies, l should be prepared. Staff members whose primary duties include reviewing / issuing permits or conducting inspections are to be appropriately qualified. See NRC Inspection Manual Chapter (IMC-1246) for guidance on such qualifications.
- The applicant should:
l = Provide a list of the RCP office staff positions byjob title, description, and number of individuals for each position
- Describe its procedures and criteria for ensuring that members of the RCP office staff are adequately qualified.
4.8 NRC FORM 313, ITEM 8: TRAINING AND EXPERIENCE FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS If applicants have special facilities such as large irradiators,iodination facilities, high dose rate afterloading brachytherapy facilities, etc., assure that site access training will be provided prior to assigning individuals to work in or frequent restricted areas in accordance with requirements of 10 CFR Part 19. The response should include: . Identifying any special facilities requiring site access training = Describing training and experience required of individuals who will be required to work in, inspect, or frequent any restricted areas included under the MML. Draft NUREG - 1556, Vol.10 4-8
CONTENTS OF AN APPLICATION 4.9 NRC FORM 313, ITEM 9: FACILITIES AND EQUIPMENT Applicants must describe facilities and equipment used by the RCP staff to facilitate day-to-day operations. Applicants must include the following: = Description and location of all facilities used by the RCP staff to carry out its activities . State in the application where the master or central pennittee files and all other docketed and required files and records will be maintained . List and describe the uses oflaboratory equipment such as counting systems, portable survey equipment, air monitoring or other devices necessary for conducting the inspection of permittees. 4.10 NRC FORM 313, ITEM 10, RADIATION SAFETY PROGRAM i The MML program used to manage the permitting and inspcction oflicensed activities is called the radiation control program (RCP). To ensure safe operations under the license, applicants for MMLs must have established administrative controls and provisions for: = Organization and management Procedures Recordkeeping Material control and accounting Management review. The licensee should commit to implementing licensing and inspection programs in accordance with NRC criteria or submit any alterr ative procedures. 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. If alternative procedures are adopted, The RCP description should be in narrative form and include the elements identified below. 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; record keeping requirements related to the program are in 10 CFR 20.2102. These requirements apply to a RCP and at a minimum, should address program authorities and responsibilities, communications, quality control surveillance, program audits, procurement, staff selection and qualification, information dissemination, document control and retrieval, etc. In addition, written administrative control procedures should be submitted. 49 Draft NUREG - 1556, Vol.10
CONTENTS OF AN APPLICATION
- These procedures should be sufficient in detail, clarity and specificity to describe how management oversight for program activities will be carried out.
4.10.1 PREVIOUS LICENSES
- List the radioactive materials licenses the applicant wants to include in the MML.
4.10.2 REGULATORY CONFORMANCE The MML applicants' management must clearly indicate that the applicant will follow NRC regulations. The Applicant may use operational controllevels that are more restrictive than NRC regulations; however, at a minimum the applicants' requirements must be as restrictive as NRC's regulations. The MML applicant must submit all policies, procedures, directives, and guides the applicant has developed and will use to manage its RCP pursuant to NRC regulations, policies and guides. The applicant must specifically identify those NRC policies, procedures, and guides which the applicant will adopt in their entirety in its RCP. These documents will be incorporated into the MML in a license condition. 4.10.3 UPDATING OF RCP PROGRAM DOCUMENTS The 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 confirm that any updates of these documents which involve a material change in the MML licensee's policies and procedures from the original commitments which were submitted in lieu of NRC criteria will be submitted to the NRC as part of a license amendment request. 4.10.4 MANAGEMENT OVERSIGHT AND RADIATION CONTROL PROGRAM PROCEDURES A MML licensee authorizes the receipt, possession, distribution, use, transportation, transfer, and disposal of NRC regulated radioactive material (e.g., byproduct, source and special nuclear material) at permittee locations. The MRSC provides administrative control of all NRC licensed radioactive material used by the licenree and its permittees. The applicant must demonstrate that it is financially and technically qualified to effectively conduct a MML program. Draft NUREG - 1556, Vol.10 4-10 l l
CONTENTS OF AN APPLICATION Applicants must have sufficient operating funds to support program needs such as the following:
- Finaxial assurance for decommissioning
- Staff travel necessary to conduct an effective permitting compliance program (including pre-
. permitting site visits, routine inspections, follow-up or special inspections, and responses to incidents and'other emergencies)
- : Instrumentation and other equipment to support the RCP -
- L Administrative costs -
- Laboratory costs
- Laboratory service a ' Computer and/or word processing support U
- - Preparation of correspondence
. Office equipment. The RCP must be supported with sufficient staffing and technical expertise and be located in the MML organization parallel with other comparable health and safety programs. The applicant's overall radiation management structure must ensure that the RCPD has access to the highest L levels of MML management and some measure of financial and administrative control over i permitting and inspection personnel. The RCP must 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 cler.rly drawn to provide authority over the staff and uniformity in inspection policy, procedures, and supervision.
- The applicant should develop and implement written administrative control processes. These i
processes should be clear, specific, and detailed enough to demonstrate that the applicant's
- management will adequately oversee program activities. As a minimum, they should address the following:
. Program authorities and responsibilities '. Communications = : Quality control surveillance . Program audits
- - Procurement -
4-11 Draft NUREG - 1556, Vol.10 k m r v-
i CONTENTS OF AN APPLICATION Staff selection and qualification . - Information dissemination . Document control and retrieval
- Other program elements essential to the successful implementation of the RCP.
l The application must include an organizational chart depicting the licensee's management structure, reporting paths, flow of authority and control of finances, and geographical location of all management and staff components of the RCP. 4.10.5 MASTER RADIATION SAFETY COMMITTEE Responsibilities of the MRSC include, but are not limited to, the following: . Establishing procedures for the control, use, acquisition, and accountability of byproduct, source, and special nuclear material Managing and overseeing the MML i Monitoring the performance of the RCP Office and the RCPD, and audit the implementation a of the RCP Advising senior executive management of the results of the MRSC audits and program reviews Ensuring adequate resources are provided to implement the RCP, including implementation of permittee radiation safety programs Ensuring adequate resources are provided for the training of MRSC, RCP, and permittee staff Ensuring that permitting and inspection staff are appropriately qualified as described in NRC Inspection Manual Chapter 1246 (IMC-1246) Maintaining records under the MML = l ' Reviewing permit applications and recommend action to be taken by the Chairman or his l' = designated representative Meeting at least quarterly with the required quorum to review the activities of the RCPD Maintaining a current list of quantities, uses, and locations where radioactive material is received, possessed, used, or stored Establishing procedures to control the procurement and acquisition of radioactive material to ensure compliance with the MML Draft NUREG - 1556, Vol.10 4-12
CONTENTS OF AN APPLICATION Ensuring inspections are conducted to assess permittee compliance with the provisions of the = l NRC license, NRC regulations, and of the specific permits. Establishing enforcement policies and procedures Advising senior executive management and NRC of all non-compliance items potentially a categorized at severity levels I, II, or III as identified in the NRC enforcement policy l Providing copies of permits and inspection reports to the appropriate NRC regional office Requesting assistance from appropriate individuals and licensee organizations when necessary to assist the MRSC in the execution ofits responsibilities l Establishing technical committees to extend staff capabilities for unique or technically complex problems. The applicant must provide its organizational and procedural manuals that address each item above. The applicant must include 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. J 4.10.6 THE RADIATION CONTROL PROGRAM DIRECTOR The responsibilities and authorities of the RCPD include, but are not limited to, the following:
- Managing and controlling the RCP
- Serving as the Executive Secretary of the MRSC Conducting day-to-day operations of the RCP and issuing permits in accordance with procedures approved by the Chairman of the MRSC
- Serving as the routine point of contact between the MML licensee and the NRC for matters concerning the MML
= Informing the MRSC and senior executive managemer! regarding the status of the RCP Implementing the MRSC's enforcement sanctions a Stopping work activities that may pose undue risk or hazard, or may violate conditions of the license or the NRC regulations j
- Reviewing all radiological incidents and recommending corrective actions to the MRSC.
1 4-13 Draft NUREG 1556, Vol.10
CONTENTS OF AN APPLICATION The applicant must provide a copy of the written delegation of authority from the senior executive manager to the RCPD and a description of his/her responsibilities. The applican; must provide documentation to show that the RCPD has access to the highest levels of MML management and the measure of administrative and fm' ancial control over permitting and inspection personnel. 4.10.7 PERMITTING AND INSPECTION STAFF The MML licensee's permitting and inspection staff shall: provide guidance to licensee organizations in the preparation of requests for permits a be responsible to provide content of NRC generic communications to appropriate permittees in a timely manner review permit applications for completeness and compliance with current regulations, policies a and guides prepare permits and forward to the MRSC (oi delegate) for review and signature a perform inspections to assess compliance with current licensee and NRC regulations, policies, and guides and provisions of the MML and specific permits prepare reports ofinspection results, and forward reports of non-compliance to the MRSC a conduct technical assistance visits as necessary = conduct pre-licensing visits respond to incidents 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: l Respond to events at permittee facilities l Maintain uniformity of program implementation l- ~ Maintain daily communications Ensure consistency of guidance provided to permittees Provide training to RCP staff Monitor and evaluate RCP staff performance. a Draft NUREG - 1556, Vol.10 4-14
CONTENTS OF AN APPLICATION 4.10.8 RCP PROCEDURES
- The RCP must establish written internal procedures to ensure the following:
- MML satisfies NRC requirements and criteria
- Staff performs its duties as required
- A high degree of uniformity and continuity in regulatory practices.
These procedures should address internal processing of permit applications, inspection policies and procedures, decommissioning, and other functions required of the program. The MRSC must receive quarterly reports from the RCP staff on the status of the program. In addition, the MRSC will receive a report annually on the audit of the program including the following:
- Overall conduct of the program
. Result of the program performance compared to regulatory requirements and commitments
- Review of permitting actions, inspection reports, and enforcement actions.
4.10.9 MANAGEMENT AND MASTER RADIATION COMMITTEE AUDITS
- The applicant must provide its process describing 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. The 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 RCPD's. 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 area of expertise. 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 independently 4-15 Draft NUREG - 1556, Vol.10
CONTENTS OF AN APPLICATION. j l conducting inspections. The MML should establish a system similar to the NRC's qualification journal system found in IMC-1246. - 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. The RCPD or the inspection staff supervisor must conduct annual field evaluations of each inspector to assess performance and assure appropriate and consistent policies and guides. Permit reviewers must demonstrate competence in reviewing applications for permits. In - . addition, such reviewers must demonstrate an understanding of regulations, licensing policy and guidance directives, and permitting practices prior to independently reviewing and issuing permits. The MML should establish a system similar to the NRC's qualification journal system found in IMC-1246. The RCPD must audit a sample of each permit reviewer's actions to assess performance and assure appropriate and consistent policies and guides.
- The applicant must provide a copy of the process that is used to audit its inspection and permitting staff audit program.
4 4.10.10 PERMITTING PROCEDURES The applicant must provide copies ofits 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. i The applicant should provide in its application specific timeliness goals for the issuing permits and updating its licensing guidance as updates are received from the NRC. The RCP must establish procedures to assess the essential elements of permittee applications. These elements must meet current regulatory guidance for the following: Descriptions ofisotopes and quantities to be used
- Qualifications of persons who will use material
- Facilities and equipment Operating and emergency procedures
. Minimization of contamination. i I' Draft NUREG 1556, Vol.10 4-16 h i m
-. = - CONTENTS OF AN APPLICA'IlON This information must be sufficient to establish the basis for permitting actions. Clear, complete, and accurate documentation ofisotopes, forms, quantities, authorized uses, and permissive anc' restrictive conditions must be readily available for audit during pre-permitting visits. The RCP must have procedures for reviewing permits prior to renewal to ensure that supporting information in the file reflects the current scope of the permitted program. The RCP must have internal permitting guides, 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 stanid hcense 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. Orderly files must be maintained to allow fast, accurate retrieval of information and documentation associated with the permitting program. The applicant should provide a copy of the administrative procedures to accomplish this. 4.10.11 PERMITEE MINIMIZATION OF CONTAMINATION PROGRAM Applicants for an MML after August 20,1997 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. 4.10.12 PERMIT TERMINATION AND DECOMMISSIONING OF PERMIT ACTIVITIES The NRC's requirements for termination of byproduct material licenses are described in 10 CFR Parts 30,40, and 70. The internal procedures that the NRC staff follow to terminate a byproduct materials license are in NRC IMC 2605. The applicant may either provide its permit termination procedules or commit that it will tenninate 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 the NRC IMC 2605 and handbook as provided for in the LOU. 4-17 Draft NUREG - 1556, Vol.10
r-CONTENTS OF AN APPLICATION The MML application must contain statements that the applicant agrees to provide copies of permit termination requests and permit decommissioning plans. The applicant must further agree, when requested by NRC due to interest in a specific site, to submit specific permit decommissioning plans to the 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 the NRC, the MML may review and approve decommissioning plans. 4.10.13 FINANCIAL ASSURANCE Decommissioning financial assurance requirements for NRC specific licensees are described in 10 CFR 30.35. The applicant must describe its program for establishing and maintaining adequate funds to decommission its permitted facilities. NRC uses NUREG-1336, Rev. I and Policy and Guidance Directive FC 90-2. 4.10.14 INSPECTION AND ENFORCEMENT PROCEDURES 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. The RCPD must maintain statistics which are 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 ofinspections conducted, the number overdue, the length of time overdue, and priority categories. This infonnation must be readily available. The RCPD must prepare a semiannual inspection plan that includes the number ofinspections 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. The MRSC must either establish an inspection priority system identical to the NRC's in Manual Chapter 2800 or the MML management may request authorization from the NRC through the MML's licensing region to alter the inspection frequency to meet the MML's priorities. The specific frequency of inspections must 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. Inspection guides consistent with current NRC guidance, must be used by inspectors to assure unifonn and complete inspection practices and provide technical guidance in the inspection of permitted programs. Written inspection policies must be issued to establish a policy for conducting unannounced inspections, obtaining corrective action, following up and closing out I previous violations, conducting interviews with workers and observing operations, assuring exit interviews with management and issuing appropriate notification of violations of health and Draft NUREG - 1556. Vol.10 4-18
( CONTENTS OF AN APPLICATION i l safety problems. Independent measurements must be sufficient in number and type to ensure the l permittee's control of materials and to validate the permittee's measurements. l The RCP must provide for in-house laboratory support capability, or readily available through established procedures, to conduct bioassays, analyze environmental samples, analyze samples collected by inspectors, and other necessary analyses on a priority established by the RCP. l l Procedures must be established for maintaining permittee compliance histories. Oral briefing of supervisors or the senior inspector should be performed upon return from non-routine inspections. For MML facilities with separate permitting and inspection staffs, procedures must be l established for feedback ofinspection information to permit reviewers. Findings of inspections must be documented in a report describing the scope of inspections, substantiating all items of noncompliance, and health and safety matters, describing the scope of permittees programs and indicating the substance of discussions with the permittee management and the permittee's response. Repons must uniformly and adequately document the results of inspections and identify areas of permittee's program which must receive special attention at the next inspection. Reports must show the status of previous noncompliance and the results of any independent physical measurement made by the inspector. The applicant must provide its permit inspection procedures as described above and its procedures for documenting inspection findings and enforcement actions. 4.10.15 INCIDENT / EMERGENCY RESPONSE PROCEDURES MML representatives must submit a written plan for responding to incidents such as spills, over exposures, transportation accidents, fire, explosion, theft, or any other emergency situation that may result from the specific nature of the licensee's activities. The plan must define the oversight responsibilities of the RCP management and staff; and actions to be taken by permittees. The plan must be specific as to persons responsible for initiating response actions, conducting operations, and cleanup. l Additionally, applicants who request possession of radioactive materials in both unsealed and certain sealed forms in excess of specifically listed quantities must address the need for an Emergency Plan, according to 10 CFR 30.32(i)(1). If applicants determine that they need an l 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." l 4-19 Draft NUREG - 1556, Vol.10 1
CONTENTS OF AN APPLICATION The applicant must provide its RCP Office procedures for responding to spills, fires, release or loss of material, over exposures, 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, the NRC. Except for minor spills or releases of radioactivity that can be controlled and cleaned up by the permittee, the permittee staff should understand what actions must be taken to secure th.e area, respond to immediate hazards, and whom they should contact. Only qualified and experienced individuals should conduct decontamination and recovery operations. The applicant's 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 which are required to be reported to NRC within less than 30 days. For those incidents not requiring reporting to NRC in less than 30 days, review of events raust be made during the next scheduled inspection. Onsite investigations must be made promptly of non-reportable incidents which could be relevant to other permitted operations (e.g., equipment failure, imp-oper operating procedures) and those incidents which may be of significant public inte :t and concern. Information on incida..s involving failure of equipment must be provided to the agency responsible for evalut on of the device for assessment of possible generic design deficiency (NRC and Department of Health and Human Services, Food and Drug Administration). This includes compliance with 10 CFR Part 21, and other applicable regulations. The applicant should establish an Emergency Response Team composed of individuals experienced in vaiious emergency response functions (e.g., radiological, medical, emergency management, security, and fire protection). The applicant must provide its incident / emergency response procedures as described above, including, but not limited to, the following: Initial response actions and responsibilities, including immediate safety . Precautions for people and property at permittee facilities Area and permittee facility access control and security Mechanisms and responsibilities for notifying RCP Office staff and external authorities I Provisions for medical and offsite agency assistance Description of emergency response equipment available for use by the RCP Office staff f 1 Dmfi NUREG - 1556. Vol.10 4-20
CONTENTS OF AN APPLICATION i 4.10.16 PROCEDURES FOR HANDLING ALLEGATIONS The applicant must confirm that it will follow the NRC's procedures for handling allegations or provide equivalent procedures for handling allegations that are referred to the MRSC. MML applicants must establish a program for responding to employee radiation safety concerns. This program must provide for timely investigation and response to these concerns and address prevention of reprisals against employee's concerns for expressing their radiation safety concerns to management. 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 licensee personnel may be investigated by the NRC or referred to the MRSC for investigation. Those allegations referred to the MRSC must be handled in the same' manner as the NRC would and as described in Management Directive 8.8. The applicant must provide its procedures for handling and documenting employee concerns, and must specify what training will be provided to all employees to ensure they understand their right to contact NRC directly about radiation safety or regulatory issues. The program should include l a strong statement encouraging employees to bring forward any perceived radiological safety issues. 4.11 NRC FORM 313, ITEM 11: WASTE MANAGEMENT The applicant must describe the methods its permittees will use for disposal of radioactive waste. The following disposal methods will be authorized:
- Transfers to a recipient (usually a waste disposal service company or the original supplier) who is properly licensed to receive such waste in accordance with 10 CFR 20.2001(a)
Decay-in-storage Disposal of materials that contain radioactivity from hydrogen-3 and carbon-14 in scintillation counting media and in animal tissue in concentration of 0.05 microcurie or less per gram, subject to certain restrictions stated in 10 CFR 20.2005 Release of radioactive materials into air and water in conformance with 10 CFR 20.1302 and 20.2003. 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. 4-21 Draft NUREG - 1556, Vol.10
CONTENTS OF AN APPLICATION The applicant must describe the locations, conditions, and current status of former burial sites, i.e., 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. 4.12 NRC FORM 313, ITEM 12: LICENSE FEES 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. l i i 1 Draft NUREG - 1556, Vol.10 4-22
5 AMENDMENTS TO A LICENSE It is the licensee's obligation to keep the license current. If any of the information provided in the original application which 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. A licensee must receive a license amendment before changing the scope of the program, changing the Radiation Control Program Director, or changing the Chairman of the Master radiation Safety Committee. l Applications for license amendment must do the following: Be sure to use the most recent guidance in preparing an amendment l . Submit in duplicate, either an NRC Form 313 or a letter requesting amendment l Provide the license number i Provide a complete and up-to-date application if many outdated documents are referenced or there have been significant changes in regulatory requirements, the licensee's organization, or radiation control program. Alternatively, describe clearly the exact nature of the changes, additions, and deletions. l l l 4 4-23 Draft NUREG - 1556, Vol.10
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- l.
- a i
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4 1 4 Appendix A United States Nuclear Regulatory Commission Form 313 l
~ NRC FORM 313 U. 8, NUCLEAR REGULATORY COMINSSION APPROwEn eV OMS: NO, aseteias EXPIRES: Tr31riese (6 1907) ' 10 CF7,30,32,33 Estnoted immen par roepense is comply weh Ihie Hannaton cotecten 34,36,30,30 and 40 esipost T hows. Semanni of Ihe e is noosenery la ilotermee tiet tie appkurt le couped and lhet adequate proceeses east to proted tie ketc heesh and sof.ty Fonserd cornmente regeren0 Insilon estenste to tio Harmenon and Reconse hennegamere erench (T4 F33), U.S. Nudeer APPLICATION FOR MATERIAL LICENSE Wl";;*g';gac,2*",,*;,0,,;',",,@ %,i.t re,,s. DC, esp.0, NRC - noi.onot c, ,,s. end.e.,e. 20 to on e en us,m.m.ncoe.a.on. ee e curency vend Osas carent nummer. INSTRUCTIONS: SEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPLICATION. SEND TWO COPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW. APPUCATIOfe FOR DISTIUSUTION OF EXEAIPT PRODUCTS PILE APPUCATIOpeS WITH: IF YOU ARE LOCATED IN: DM63ON OF INDUSTRIAL AND MEDICAL NUCLEAR SAFETY gLussces,IMOGANA. IOWA, RICHIGAN, tilteNESOTA,001000UR8. OHIO, OR mammam OFFCE OF MUCLEAR MATERnALS SAFETY ANO SAFEQUARD8 SEBeO APPUCATIO088 70: U.S. NUCLEAR REGULATORY COMB 48810N WASHINGTON, DC 2006H001 MATERIALS LEENSING SECTION ALL OTHER PEftSONS PILE APPUCATIOpeS AS POLLOWS: so Cs YOU ARE LJCATEg me: USLE, IL 806324361 ColeNECTICUT, DELAWARE, DISTRICT OF COLutoGIA, BRAl8eE, R$ARYLAND, ALASMA, ARIZONA Apmaae CAUPORMLA, COLORADO,HAWAN,IDANO KANSAS, IAASSACHUSETTS, leEW HAGIPSHIRE, NEW JEftSEY, NEW YORK, PENNSYLVANIA, LOUISlANA MONTANA,leESRASMA,leEVADA,NEWIIEJGCO, NORTH DAKOTA, i RHODE ISLAND, OR VERGIONT,3E000 APPUCATIO988 TO: OKLAMOtlA, OREGON, PACIPtC TRUST TEftfuTORIES, SOUTH DAKOTA, TEXAS, UTAH, WASHipeGTON, OR WYORNHG, SSNO APPUCATIONS TO: UCENSING ASSISTANT SECTION NUCLEAR MATERLALS SAFEfY BRANCH NUCLEAR MATERIALS UCENSING SECTION U.S. NUCLEAR REGULATORY COMANSCION, REGION i U 8. NUCLEAR REQUI ATORY COMMISSION, REGION N i 475 AL1ENDALE ROAD 011 RYAN PLAZA DRNE, SUfTE 400 lGNO OF PRUS84A, PA 194061415 ARUNOTON, TX 70011-8064 ALASAA8A, PLORIDA,00004064, NENTUCHY, IIISSISSIPPI, NORTH CAftOUNA, PUERTO IWCCL SOUTH CAftOUNA, TENNESSEE, VIRGINIA, VIRGIN
- me OR WEST VlftGINIA, SEND APPuCAftONS TO:
ATLANTA FEDERAL CENTER U. S. NUCLEAR REGULATORY COMMISSION, REGION N St FORSYTH STREET,8 W., SUITE 23T06 ATLANTA, GEOROIA 30300 3415 PERSOese LOCATED IN A4ftEE10ENT STATES BEND APPUCATIONS TO THE U.S. NUCLEAR REOULATORY COtteIISSION ONLY IF THEY WISH TO POSSESS AND USE UCENSED isATEluAL IN STATES SUSJECT TO U.S. NUCLEAR REOULATOftY COIstIISSION JUIWSCICTIONS. 1. _TH66 80 AN APPUCATION FOR (Choc4 appropresse som)
- 2. NAME AND MAILMG ADORE 88 OF APPUCANT (incfusfe 25 ceste)
A NEW LEENSE B. - AMENDMENT TO LCENSE NUMBER 1 C. RENEWAL OF LEEN8E NUMBER I & ADDRESS (ES)WHERE UCENSED MATERIAL WILL SE USED OR PO88E88ED
- 4. NAME OF PERSON TO BE CONTACTED ABOUT THIS APPUCATION TELEPHONE NUh4BER SUOMff ffEMS 6 THROUGH 11 ON 0-1/2 X 11" PAPER. THE TYPE AND SCOPE OF INFORMATION TO BE PROVIDED IS DESCRl8EQ M THE LCENSE APPUCATION GUIDE.
6, RADtOA."TNE MATER 4AL. & Element and mese nwneer, tt chemical andkr phyescal form; and a manurnum amowit 8. PURPOSE (S) FOR WHICH UCENSED MATERIAL WILL DE USED. whuri weillie posee.ted et any one eme. 7. NDivlOUAL(8) RESPONSISLE FOR RADIATION SAFETY FROGRAM AND THEIR 8 TRAMING FOR HDMOUALS WORMMG H OR FREOUENTWO RESTRICTED AREAS TRAP #NO EXPERENCE 8. FActLfTIES AND EOUIPMENT.
- 10. RADLATION SAFETY PROGRAM.
) l
- 12. UCEN8EE FEES (See 10 CFR 170 and Secnon 170.31)
- 11. WA8TE MANAGEMENT.
sAMOUNT FEE CATEGORY lENCLOSEO 8
- 13. CEJflFICATIOst (afust be comfpefod by especent) THE APPUCANT UDoDERSTANDS THAT ALL STATEMENTS AND REPRESENTATIONS MADE M THIS APPLEATION ARE BINDING UPON THE APPUCANT THE APPUCANT AND ANY OFFICIAL EXECUTNG TH88 CERTIFCATION ON BEHALF OF THE APPUCANT, NAMED M ITEM 2. CERTIFY THAT THIS APPUCATION 88 PREPARED M CONFORhelTY WITH TITLE 10. CODE OF FEDERAL REGULATION $, PARTS 30,32,33,34,36,36,30 AND 40, AND THAT ALL INFORMATION CONTAINED HEREN 18 TRUE AND l
COfutECT TL THE BEST OF theft MNOWLEDGE AND BEUEF. IMWtNING it U.S C. SECTION 1001 ACT OFJUNE 25,1940 62 STAT. 740 MAME8 fT A CRibelNAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURSSDCTION. CERTIFYING OFFICER -TYPED 4'RINTED NAME AND TITLE SiONATV'tE DATE FOR NRC USE ONLY TYPE OFIE FEE LOO FEE CATEOORY AMOUNT RECENED CHECK NUMBER COMMENT 5 APPROv.D sY DATE MRC FORD 313 (5-1907) PRINTED ON RECYCLED PAPER A-1 Draft NUREG - 1556, Vol,10
b e Appendix B Sample Master Material License
l l i APPENDIX B 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: . Conducting tracer studies in the environment involving direct release of byproduct material. . Receive, acquire, own, possess, use, transfer, or import devices containing 100,000 curies or more of byproduct material in scaled sources used for irradiation of materials. . Conduct activities that require a specific license issued by the Commission under Part 32,34, 35,36, or 39 of Title 10 of the Code of Federal Regulations. . Possess and use source material. Possess and use special nuclear materials. Conduct research on human subjects using source, special nuclear material, or the radiation from an NRC licensed utilization facility. 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 license provides common authorizations and license conditions that should be applicable to a master materials license, but does not constitute a complete master materials license. Research License Conditions . The Master Radiation Safety Committee shall assure that all uses of byproduct material on human research subjects are authorized and performed in accordance with the requirements in 10 CFR 35.6. . This license does not authorize the use of source material, special nuclear material, or radiation from an NRC licensed utilization facility on human subjects. A sample license appears on the following pages. B-1 Draft NUREG - 1556, Vol.10
APPENDIX B Nhc FORM 374 u.s. NUCLEAR REGUL% TORY Commission MATERIALS LICENSE Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganistion Act of 1974 (Public Law 93-438), and Title 10, Code of Federal Regulations, Chapter 1, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to deliver or transfer such inaterial to persons authorited to receive it in accordance with the regulations of the applicable Part(s). This license chill be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations, and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified
- below, ucensee in accordance with application dated January 1,1998
- 1. Department of the Federal Government
- 3. Ucense nu 99 2345-01 pRF E o,, ( uf,
Federal Radiation Safety Committee
- 2. Washington, D.C. 23455 h
- 4. ExpirItio'o dadl6dels)lth J@go. 030
- 5. o 1111 ere m, W j N
$@M
- 8. f[aximum amount that licensee may
- 6. Byproduct, source, and/or special 7, Chemicaland/or [
al p' podess at any one time under this nuclear material 4/ N. d._ e,' hfjh "*U b A. Any byproduct mated @ M' \\M1 A. (ps needed V G p Ef., Ar)y % 3 J B. Sfs needed B. Any source materialg I? f C.$As needed; however, E([k R Special nuclear matebal i C. 3 ~d # I N quantities for any site or b permit authorized by the l D Federal Radiation Safety s f h jS' (( mmittee shall not exceed 1 O '-) g g the critical mass quantities as determined by the g "g Tqd g,, _.g/ rs procedures specified in /* 10 CFR, Part 150.11(a) 9. Authorized Use: A., B., and C. For uses authorized by the Master Radiation Safety Committee as described in its application dated January 1,1998, including, but not limited to the following: l (1) Medical use defined in 10 CFR Part 35. (2) Research and development as defined in 10 CFR Part 30. (3) Radiography as defined in 10 CFR Part 34. CONDITIONS
- 10. Licensed materials may be used at Department of the Federal Government facilities by Department of the Federal Government personnel as authorized by permits issued by the Master Radiation Safety Committee.
Draft NUREG - 1556, Vol.10 B-2
. _ - - ~ _ - - _.... APPENDIX B ' NRC PoRM 374A ~ u.s. NUCLEAR REQuLAToRY Commission PAGE '2 of 3 PAGES Ucense Number 99-12345-01 I MATERIALS LICENSE DxW w Mwence Number SUPPLEMENTARY SHEET 030-11111
- 11. Licensed' materials may only be used by, or under the supervision of, individuals designated by the Master
.. Ridiation Safety Committee.
- 12. This license does not authorize the' use of source material, special nuclear material, or radiation from an NRC licensed utilization facility on human subjects.
- 13. D:paitment of the Federal Governmeng.rhmkrM"N
= v oveming the use of licensed radioactive materials m 'tpeYonsistent with the ommission's regulations. 14.2 Tbs Master Radiation Safe mittee shall assure that s 'roduct material on human rzsearch subiects are authoMzed and performed in uirements in 10 CFR 35.6. D royalto the Nuclear Regulatory
- 15. Th3 Master Radiation $ty shall s
Commission for exemptions fror i 3 The licensee shahuire pe nventory e@y six months to account for l 16 A. all sources and/o% vices r (f) ir respecg permits. i ~ B. The licensee shall quire ysicahentories for five years from the date of each I to and s of teensed material, manufacturer's na V@ rces a r devices, and the date of the p inventory. r -17. Except as specifically pr se in th , the en all conduct its program in accordance with the stateme opr ntations, and pr res tained in the documents, including cny enclosures, listed below. The N rQg sion's regulations shall govem unless the i statements, representations and pr ref n application and correspondence are more .. restrictive than the regulations. A. Application dated January 1,1998 B. Letters dated: '(1) January 28,1998 _(2) February 22,1998 i. B-3 Draft NUREG-1556, Vol.10 ,( + --,.,n --e.,,
APPENDIX B NRC FORM 374A U.S. NUCLEAR REGULATORY CoMMISSloN PAGE 3 of 3 PAGES Ucense Number 99-12345-01 MATERIALS LICENSE Docket or Reference Number 030-11111 SUPPLEMENTARY SHEET
- 16. continued '
C. Letter of Understanding dated: February 22,1998 between the Department of the Federal G ent and the Nuclear Regulatory i icens Commission (as amended effectiv is atgf + e 9 4 m
- .s.
+ ]. i-p G ]k"'W f ss o H
- 1 -
IGtt . / u e ~ Yg,g h N l FOR THE U.S. NUCLEAR REGULATORY COMMISSION M. M. L. Reviewer i DATE BY Region X, Division of Nuclear Materials Safety 111 Nuclear Way Atomic City, ST 33333 - Draft NUREG - 1556, Vol.10 B-4
NRC FORM 33s U.s. NUCLEAR REouLAToRY ColdtaSSloN
- 1. REPORT NUMBER
- Yob1102, and n
320s, a2o2 BIBLIOGRAPHIC DATA SHRET '8*****"***"**' NUREG-1556
- 2. TITLE ANO sV5 TITLE Vol.10 1
Consolidated Guidance About Materials Licenses Program Specific Guidance About Master Materiais Licenses 3. DATE REPORT PUBUS (. Draft Report for Comment October 1998 l
- 4. FIN OR GRANT NUMBER
- 5. AUTHOR (S).-
- 6. TYPE OF REPORT j
~ John D Jones, Jay Henson, Donna Beth Howe, Thomas Thompson Draft
- 7. PERIOD COWRED (faciumve Defes)
- 8. PERFORMING ORGANIZATION NAME AND ADDRESS (vNRC,powde Dwoon, Omos or % uS NucfeerHegufefory comnosman, and modas ar**ees;#corurecsor proude nome end me6ng e& tees)
Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards U.S, Nuclear Regulatory Commission Washington, DC 20555-0001
- 9. SPONSORING ORGANIZATIOh'. NAME AND ADoRESS (r NRc, type "Some as ecove" #contrecfor, prowde NRC Dwoort, osce or nogeon, us. Nucieer Repufocary comansaart, and madne adeses)
J . Same as above i
- 10. SUPPLEMENTARY NOTES
- 11. ABSTRACT (200 words oress) g
- As part of its redesign of the materials licensing process, NRC is consolidating and updating nurnerous guidance documents into a single comprehensive reposito as described in NUREG-1539, " Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated ril 1996, and draft NUREG-1541," Process and Design for Consolidating and Updating Materials Licensing Guidance," dated ril 1996. Draft NUREG-1556, Vol.10," Consolidated Guidance about Materials Licenses: Program-Specific Guidance a ut Master Materials Licenses," dated Octobert 1998, 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 oocument combines and 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, Note that this document is strictly for public comment and is not for use in preparing or reviewing applications for Master Materials licenses until it is published in final form.
- 12. KEY WOROS/DESCRIPToRS (Isst words or phrases met uns asest masomers a foceeng me report) 13 AVAILAstLrry STATEMENT Master Material: License.
unlimited Letter of Undersunding 14 SECURnYCMS$FICATION Radiation Control Program Director (n u rees). Master Radiation Safety Committee unclassified (nes assoro unclassified
- 15. NUMBER OF PAGE5
- 16. price NRc FORM 335(24%
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