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Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope (NUREG-1556, Volume 11)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. Publication InformationManuscript Completed: April 1999 Prepared by: Division of Industrial and Medical Nuclear Safety Table of Contents
Abstract[ Prev | Next | Top of file ] As part of its redesign of the materials licensing process, the United States Nuclear Regulatory Commission (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. 11, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Licenses of Broad Scope," dated April 1999, is the eleventh program-specific guidance document developed for the new process and is intended for use by applicants, licensees, and NRC staff and will also be available to Agreement States. This document combines, updates and supersedes the guidance for applicants and licensees previously found in Draft Regulatory Guide DG-0005 dated October 1994. Included in this guidance document is a new option for Type A licensees of broad scope to have increased flexibility to make changes in some program areas and revise some procedures previously approved by the NRC without amendment of the license. This option is discussed in detail in Chapter 1 of this document. NUREG-1556, Volume 11, is not intended to be used alone. Because broad scope licensees may be involved in many different program areas (e.g., medicine, research and development, manufacturing and distribution, etc.), this document frequently refers the user to other more program-specific guidance documents in the NUREG-1556 series. A single document containing all of the guidance that might be required by a broad scope licensee or an applicant for a broad scope license would be unwieldy and would quickly become obsolete as guidance in the individual program areas is revised. This document takes a more risk-informed, performance-based approach to the information needed to support an application for a license of broad scope. This final report should be used in preparing broad scope license applications. NRC staff will use this final report in reviewing these applications. Figures[ Prev | Next | Top of file ] Figure 8.1 Types of Records that Must be Maintained for Decommissioning Foreword[ Prev | Next | Top of file ] The 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," dated 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. Additional volumes are planned.
The current document, NUREG-1556, Vol. 11, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope," dated April 1999, is the eleventh program-specific guidance developed for the new process. It is intended for use by applicants, licensees, NRC license reviewers, and other NRC personnel. It combines, updates and supersedes the guidance for applicants and licensees previously found in Draft Regulatory Guide DG-0005, "Applications for Licenses of Broad Scope," dated October 1994. In addition, this document also contains pertinent information found in Regulatory Guides, Technical Assistance Requests, Information Notices, Policy and Guidance Directives, and Standard Review Plans, as listed in Appendix A. This report takes a risk-informed, performance-based approach to licensing. It identifies the information needed from an applicant seeking to use sealed and unsealed byproduct material under a broad scope license. NRC's considerable experience with materials licensees indicates that radiation exposures to workers are generally low if the workers follow basic safety procedures. A team composed of NRC staff from Headquarters and Regional offices drafted this document, drawing on their collective experience in radiation safety in general and as specifically applied to users of byproduct material under a broad scope license. A representative of NRC's Office of the General Counsel provided a legal perspective. NUREG-1556, Vol. 11, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope," dated April 1999, 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 uniform resource locator (URL) <http:www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v11/index.html>. This document, dated April 1999, is not a substitute for NRC regulations, and compliance with this guidance is not required. The approaches and methods described in this report are provided for information only. Methods and solutions different from those described in this report will be acceptable if they provide a basis for the staff to make the determination needed to issue or continue a license. Donald A. Cool, Director Division of Industrial and Medical Nuclear Safety 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 Participants[ Prev | Next | Top of file ] Camper, Larry W. The team especially wants to thank the authors of Volumes 1 through 10 of NUREG-1556, who developed much of the guidance incorporated or referenced in this document. The team also thanks Kay Avery, D. W. Benedict Llewellyn, Steven W. Schawaroch, Gina G. Thompson, and Nora Younger of Computer Sciences Corporation. Abbreviations[ Prev | Next | Top of file ]
1 Purpose of Report[ Prev | Next | Top of file ] This document provides guidance to an applicant in preparing a broad scope license application and describes the criteria used by NRC staff when evaluating the application. Whereas the applicant for a limited scope license generally must submit to the NRC, for review and approval, the specific training and experience of each proposed user and the facilities and equipment available to support each proposed use, the applicant for a broad scope license normally must submit to the NRC, for review and approval, a description of the internal review process and criteria that will be used to approve users and uses. As opposed to limited scope licenses, which typically identify specific isotopes that may be possessed, the broad scope license generally authorizes the possession and use of a wide range of byproduct radioactive materials. Because NRC grants significant decision making authority to broad scope licensees through the license, a broad scope license is not normally issued to a new licensee. An applicant for a broad scope license typically has several years of experience operating under a limited scope license and a good regulatory performance history. This document is intended to provide the additional guidance required by the experienced limited scope licensee to prepare an application for a broad scope license. Guidance related to specific program areas, which may not apply to all broad scope licensees, is not included in this document but can be found in other volumes of NUREG-1556, often referred to in this document as "the base NUREGs" or "the base documents," or in guidance documents that have not yet undergone the consolidation process. Applicants are expected to have first established limited scope licensed programs in accordance with the guidance described in the appropriate base NUREG(s) and then use this document to complete the application for broad scope license. For example, applicants for a broad scope license who use byproduct material for research and development should review NUREG-1556, Volume 7, "Program-Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope," for guidance. Similarly, applicants for broad scope license who use byproduct material for medical purposes should review NUREG-1556, Volume 9, "Program-Specific Guidance About Medical Use Licenses." A list of the currently available base NUREGs is included in the "Forward" to this document. 10 CFR Part 33, "Specific Domestic Licenses of Broad Scope for Byproduct Material," provides for three distinct categories of broad scope license, i.e., Type A, Type B, and Type C, which are defined in 10 CFR 33.11. Type A licenses of broad scope are typically the largest licensed programs and encompass a broad range of uses. Type A broad scope licensees use a Radiation Safety Committee (RSC), Radiation Safety Officer (RSO), and criteria developed and submitted by the licensee and approved by NRC during the licensing process, to review and approve all uses and users under the license. The requirements for issuance of a Type A broad scope license are described in 10 CFR 33.13. An applicant for a Type A broad scope license must establish administrative controls and provisions relating to organization and management, procedures, recordkeeping, material control, and accounting and management review that are necessary to assure safe operations, including:
Type B broad scope licensed programs are normally smaller and less diverse than Type A broad scope programs. Type B broad scope licensees use an RSO and criteria developed and submitted by the licensee and approved by NRC during the licensing process, to review and approve all uses and users under the license. Because the RSO reviews and approves all uses and users under the license, and not a full RSC as established for Type A broad scope programs, the types and quantities of byproduct material authorized by the Type B broad scope license are limited to those described in 10 CFR 33.11(b) and Section 33.100, Schedule A, Column I. While the quantities of individual radionuclides described in Section 33.100, Schedule A, Column I may be large, total license possession limits are further restricted by the Unity Rule (see Section 8.5.1 for additional information on license possession limits and the Unity Rule). Generally, the scope of authorization for Type B licenses is limited to the experience and knowledge of the RSO. The requirements for issuance of a Type B broad scope license are described in 10 CFR 33.14. An applicant for a Type B broad scope license must also establish administrative controls and provisions relating to organization and management, procedures, recordkeeping, material control, and accounting and management review that are necessary to assure safe operations, including:
Type C broad scope licensed programs are typically issued to institutions that do not require significant quantities of radioactive material but need the flexibility to possess a variety of different radioactive materials. Users of licensed material under these programs are approved by the licensee based on training and experience criteria described in 10 CFR 33.15(b). The types and quantities of byproduct material authorized by the Type C broad scope license are limited to those described in 10 CFR 33.11(c) and Section 33.100, Schedule A, Column II, again, considering the Unity Rule. The requirements for issuance of a Type C broad scope license are described in 10 CFR 33.15. While 10 CFR 33.15 does not require Type C broad scope licensees to appoint an RSO, the licensee must establish administrative controls and provisions relating to procurement of byproduct material, procedures, recordkeeping, material control and accounting, and management review to assure safe operations. This should include the appointment of someone responsible for the day-to-day operation of the Radiation Safety Program, such as an RSO. Except for activities specifically excluded from broad scope licenses by 10 CFR 33.17(a), a Type A broad scope license can include any licensed material the applicant needs and for which it qualifies. An application for a Type A broad scope license can include uses of source material and special nuclear material under the same program (e.g., laboratory-scale research and development or the use of uranium as shielding) as the byproduct material to be possessed under the provisions of 10 CFR 30.32(d). However, applicants should submit separate applications for the use of source and special nuclear materials for purposes not directly related to the use of byproduct material under the Type A broad scope license (e.g., use of source material in subcritical assemblies and special nuclear material in cardiac pacemakers). Types B and C broad scope licenses are restricted in their possession of byproduct material by 10 CFR 33.11(b), 33.11(c), and 33.100 Schedule A. Type B and Type C licensees who require materials not specified in Schedule A will need to: (1) develop Type A broad scope programs, which would require a license amendment; or (2) carry these additional materials under a separate specific license of limited scope. The latter option would require that the licensee review the base NUREG related to the specific use of this material and submit the information required by the license reviewer as described in that document. For example, applicants who require materials not specified in Schedule A for purposes of research and development should review NUREG-1556, Volume 7, "Program-Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope" and submit the information described therein. Licensees are reminded that changes to the specific license of limited scope require amendment of the license. Type B licensees who require quantities of material specified in Schedule A, but in excess of that prescribed by 10 CFR 33.11(b), will need to: (1) develop a Type A broad scope program; or (2) carry these additional materials under a separate specific license of limited scope, as described in the previous paragraph. Type C licensees who require quantities of material specified in Schedule A, but in excess of that prescribed by 10 CFR 33.11(c), will need to: (1) develop, as appropriate, a Type A or Type B broad scope program; or (2) carry these additional materials under a specific license of limited scope. Once again, changes to the specific license of limited scope require amendment of the license. In practice, Part 33 reduces the administrative burden for both licensees and the Commission without reducing the safety standards or lessening the licensing requirements for training, experience, facilities, and equipment. Both the NRC and the licensee benefit from the reduction in license amendments that might otherwise be needed to change authorized radionuclides, quantities, or names of individuals who may use, or supervise the use of, byproduct material. Part 33 does not specifically permit a broad scope licensee to make other types of changes to the radiation program as described in the application, such as changing the dosimetry provider, without amendment of the license. However, NRC has permitted broad scope licensees, on a case by case basis, to build in limited program flexibility during the licensing process. For example, rather than requiring that the applicant identify the company that would provide personnel dosimetry, the broad scope licensee could specify that dosimetry would be provided by an organization holding current personnel dosimetry accreditation from the National Voluntary Laboratory Accreditation Program (NVLAP) of the National Institute of Standards and Technology. NRC will continue to allow licensees to build in this type of program flexibility. Through license condition, NRC will provide even greater flexibility to Type A broad scope licensees who have developed an adequate radiation safety program oversight structure. Type A broad scope licensees and applicants for Type A broad scope license who specify the duties and responsibilities of management, the RSC, and the RSO, including: (1) review and approval of program and procedural changes by the RSC; (2) implementation of program and procedural changes; (3) audit of licensed operations to determine compliance; and (4) taking appropriate actions when noncompliance is identified, including analysis of the cause, corrective actions, and actions to prevent recurrence, will be authorized, through use of the license condition listed below, to make some program changes and to revise some procedures previously approved by NRC without amendment of the license as long as the program change or revised procedure:
For Type A broad scope applicants or licensees requesting this additional flexibility, a clear description of the process for procedure and program review and approval must be provided. Applicants must describe how specific changes will be documented. At a minimum, documentation shall state the reason for the change and summarize the radiation safety matters that were considered prior to the approval of each change. Type A Broad Scope License Condition Used to Grant Additional Flexibility:
The guidance that follows in this Volume specifies that Type A broad scope licensees who have developed an adequate radiation safety program oversight structure may be granted the flexibility to make program changes and revise procedures in the areas of:
This report identifies the information needed to complete NRC Form 313 (Appendix B), "Application for Material License," for the use of byproduct material for licenses of broad scope. The information collection requirements in 10 CFR Part 30 and NRC Form 313 have been approved under the Office of Management and Budget (OMB) Clearance Nos. 3150-0017, and 3150-0120, respectively. The format within this document for each item of technical information is as follows:
Notes and References are self-explanatory and may not be found for each item on NRC Form 313. NRC Form 313 does not have sufficient space for applicants to provide full responses to Items 5 through 11; as indicated on the form, the answers to those items are to be provided on separate sheets of paper and submitted with the completed NRC Form 313. For the convenience of applicants and for streamlined handling of applications in the new materials licensing process, use Appendix C to provide supporting information, attach it to NRC Form 313, and submit them to NRC. Appendix C may also be used by applicants to check applications for completeness. Appendices D, E, F and G are sample broad scope licenses for licensees involved in research and development. Appendix D is a Type A license of broad scope, Appendix E is a Type A license of broad scope that contains the license condition authorizing additional program flexibility, and Appendix F and G are Type B and Type C licenses of broad scope, respectively. These sample licenses contain the conditions most often found on these licenses, although not all licenses will have all conditions. Applicants are encouraged to review sample licenses published in the base NUREG (i.e., that volume of NUREG-1556) that most closely applies to their type of program. Appendices H through V contain additional information on various radiation safety topics. Within this document, the phrases or terms, "byproduct material," "licensed material," and "radioactive material," are used interchangeably. 2 Agreement States[ Prev | Next | Top of file ] Certain states, called Agreement States (see Figure 2.1), have entered into agreements with the NRC that give them the authority to license and inspect byproduct, source, or special nuclear materials used or possessed within their borders. Any applicant, other than a Federal Agency, who wishes to possess or use byproduct, source, or special nuclear material in one of these Agreement States needs to contact the responsible officials in that State for guidance on preparing an application. Applications should be filed with State officials, not with NRC. A current list of Agreement States, including the names, addresses, and telephone numbers of responsible officials, may be obtained upon request from NRC's Regional Offices. This information can also be found on the NRC Office of State Programs' web site at <http://www.hsrd.ornl.gov/nrc/asframe.htm>. Figure 2.1 U.S Map. Location of NRC Offices. NRC's materials licensees who wish to conduct operations at temporary jobsites in an Agreement State, and who are specifically authorized on the license to conduct such activities, should contact that State's radiation control program office for information about State regulations and questions of jurisdiction on Federal lands or facilities within that Agreement State's boundaries. To ensure compliance with Agreement State reciprocity requirements, licensees should request authorization well in advance of scheduled use. In the special situation of work at Federally-controlled sites in Agreement
States, it is necessary to know the jurisdictional status of the land in order
to determine whether NRC or the Agreement State has regulatory authority. NRC
has regulatory authority over land determined to be "exclusive Federal jurisdiction,"
while the Agreement State has jurisdiction over non-exclusive Federal jurisdiction
land. Licensees are responsible for finding out, in advance, the jurisdictional
status of the specific areas where they plan to conduct licensed operations.
NRC recommends that licensees ask their local contact for the Federal Agency
controlling the site (e.g., contract officer, base environmental health officer,
district office staff) to help determine the jurisdictional status of the land
and to provide the information in writing, so that licensees can comply with
NRC or Agreement State regulatory requirements, as appropriate. Additional guidance
on determining jurisdictional status is found in the All Agreement States Letter,
SP-96-022, dated February 16, 1996. A copy of SP-96-022 can be obtained by calling
NRC toll free at (800) 368-5642 and asking for the Office of State Programs
(extension 415-3340). This letter can also be found on the Office of State Programs'
web site at <http://www.hsrd.ornl.gov/nrc/agstates/other/sp96022.pdf Table 2.1 provides a quick way to determine which agency has regulatory authority over the possession and use of byproduct, source, or special nuclear material. Table 2.1 Who Regulates the Activity?
3 Management Responsibility[ Prev | Next | Top of file ] The NRC recognizes that effective radiation safety program management is vital to achieving safe and compliant operations. NRC believes that consistent compliance with its regulations provides reasonable assurance that licensed activities will be conducted safely. NRC also believes that effective management will result in increased safety and compliance.
To ensure adequate management involvement, a duly authorized management representative must sign the submitted application acknowledging management's commitments and responsibility for the following:
For further discussion of management responsibilities, see Section 8.7. For information on NRC inspection, investigation, enforcement, and other compliance programs, see NRC Inspection Manual, Inspection Procedure 87100 "Licensed Materials Programs," and the current version of "General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600. These documents are available electronically at <http://www.nrc.gov>. For hard copies of the Inspection Procedures and NUREG 1600, see Notice of Availability on the inside front cover of this report. 4 Applicable Regulations[ Prev | Next | Top of file ] It is the applicant's or licensee's responsibility to obtain up-to-date copies of applicable regulations, to read and understand the requirements of each of these regulations, and to comply with each applicable regulation. The following Parts of 10 CFR Chapter I contain regulations applicable to the use of licensed material by broad scope licensees:
The following Parts of 10 CFR Chapter I contain regulations which, depending on the type or types of activities authorized by the license, may be applicable to the use of licensed material by broad scope licensees:
To obtain copies of the above documents, contact the GPO on their website at <www.gpo.gov> or call GPO's Order Desk in Washington, DC at (202) 512-1800. Applicants should contact the GPO's Customer Service Desk at (202) 512-1803 for inquiries about the costs of these documents and methods of payment. Single copies of the above documents may also be obtained from the NRC's Regional Offices (See Figure 2.1 for addresses and telephone numbers). To obtain the two-volume bound version of Title 10, Code of Federal Regulations (10 CFR), Parts 0-50 and 51-199, contact the GPO, Superintendent of Documents, Post Office Box 371954, Pittsburgh, Pennsylvania 15250-7954. Note that amendments to NRC regulations are published frequently in the Federal Register. 10 CFR Parts 0-50 and 51-199 can also be found on the NRC's website at <www.nrc.gov/reading-rm/doc-collections/cfr/>. 5 How to File[ Prev | Next | Top of file ] 5.1 Paper Application[ Prev | Next | Top of file ] Applicants for a materials license should do the following:
All license applications will be available for review by the general public in NRC's Public Document Rooms. If it is necessary to submit proprietary information, follow the procedure in 10 CFR 2.790. Failure to follow this procedure could result in disclosure of the proprietary information to the public or substantial delays in processing the application. Employee personal information, i.e., home address, home telephone number, Social Security Number, date of birth, and radiation dose information, should not be submitted unless specifically requested by NRC. As explained in the "Foreword," NRC's new licensing process will be faster and more efficient, in part, through acceptance and processing of electronic applications at some future date. NRC will continue to accept paper applications. However, these will be scanned and put through an optical character reader (OCR) to convert them to electronic format. To ensure a smooth transition, applicants are requested to follow these suggestions:
5.2 Electronic Application[ Prev | Next | Top of file ] As the electronic licensing process develops, it is anticipated that NRC may provide mechanisms for filing applications via diskettes or CD-ROM (compact disc-read only memory), and through the Internet. Additional filing instructions will be provided as these new mechanisms become available. 6 Where to File[ Prev | Next | Top of file ] Applicants wishing to possess or use licensed material in any State or U. S. territory or possession subject to NRC jurisdiction must file an application with the NRC Regional Office for the locale in which the material will be possessed and/or used. Figure 2.1 shows NRC's four Regional Offices and their respective areas for licensing purposes and identifies Agreement States. In general, applicants wishing to possess or use licensed material in Agreement States must file an application with the Agreement State, not NRC. However, if work will be conducted at Federally controlled sites in Agreement States, applicants must first determine the jurisdictional status of the land in order to determine whether NRC or the Agreement State has regulatory authority. See the section on "Agreement States" for additional information. 7 License Fees[ Prev | Next | Top of file ] Each application for which a fee is specified, including applications for new licenses and license amendments, must be accompanied by the appropriate fee. Refer to 10 CFR 170.31 to determine the amount of the fee. NRC will not issue the new or amended license prior to fee receipt. Once technical review has begun, no fees will be refunded; application fees will be charged regardless of the NRC's disposition of an application or the withdrawal of an application. Most NRC licensees are also subject to annual fees; refer to 10 CFR 171.16. Consult 10 CFR 171.11 for additional information on exemptions from annual fees and 10 CFR 171.16(c) on reduced annual fees for licensees that qualify as "small entities." Direct all questions about NRC's fees or completion of Item 12 of NRC Form 313 (Appendix B) to the Office of the Chief Financial Officer (OCFO) at NRC Headquarters in Rockville, Maryland, (301) 415-7554. You may also call NRC's toll-free number, (800) 368-5642 and then ask for extension 415-7554. 8 Contents of an Application[ Prev | Next | Top of file ] The following comments apply to the indicated items on NRC Form 313 (Appendix B). All items in the application should be completed in enough detail for the NRC to determine that the proposed equipment, facilities, training and experience, and radiation safety program satisfy regulatory requirements and are adequate to protect health and minimize danger to life and property. Consideration shall be given, when developing your application, to the concepts of ALARA and the minimization of contamination. Regarding ALARA, 10 CFR 20.1101(b) states that "The licensee shall use, to the extent practicable, procedures and engineering controls based upon sound radiation protection principles to achieve occupational doses and doses to members of the public that are as low as is reasonably achievable (ALARA)." ALARA concepts and philosophy are discussed in Regulatory Guide 8.10, "Operating Philosophy for Maintaining Occupational Radiation Exposures As Low As Is Reasonably Achievable." Applications for broad scope licenses must address ALARA considerations in all aspects of their programs (e.g., monitoring and controlling external and internal personnel exposure, monitoring and controlling air and liquid effluents). ALARA considerations, including establishing administrative action levels and monitoring programs, need to be documented in the application. 10 CFR 20.1406 requires that license applicants describe how facility design and procedures for operation will minimize, to the extent practicable, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the extent practicable, the generation of radioactive waste. Like ALARA, the applicant must address these concerns in all aspects of their programs. After an application for broad scope authority has been reviewed by the NRC staff and found to be generally complete and responsive to NRC Form 313 (Appendix B) and this guidance, a prelicensing visit may be scheduled by NRC at the licensee's facility. A visit or conference may also be scheduled as part of the license renewal process. A prelicensing visit provides the NRC staff with an opportunity to better evaluate the proposed program and the necessity for a broad scope license. It also provides the NRC staff an opportunity to meet with licensee management and others responsible for the radiation protection program and stress the importance of their responsibilities under a broad license and to discuss and agree on additional information and commitments that may be needed. If a broad license is not warranted, continuation of the program with an appropriate specific license can be discussed. All information submitted to NRC during the licensing process will be incorporated as part of the license and will be subject to review during inspection. 8.1 Item 1: License Action Type[ Prev | Next | Top of file ] THIS IS AN APPLICATION FOR (Check appropriate item)
Check box A if the application is for a new broad scope license. As stated in the chapter entitled "Purpose of this Report," NRC will not normally issue a broad scope license to a new licensee. Check box B if the application is for an amendment(1) to an existing broad scope license or if the application is to upgrade a limited scope license into a broad scope license. Provide the license number. Check box C if the application is for the renewal(2) of an existing broad scope license and provide the license number. 8.2 Item 2: Applicant's Name and Mailing Address[ Prev | Next | Top of file ] List the legal name of the applicant's corporation or other legal entity with direct control over use of the radioactive material; a division or department within a legal entity may not be a licensee. Because of the significant authority given a broad scope licensee to oversee licensed activities, it is not appropriate for an individual to apply for a broad scope license. No individual other than the duly authorized applicant may, for any licensing matter, act on behalf of the applicant or provide information without written authorization of the applicant. Provide the mailing address where correspondence should be sent. A Post Office box number is an acceptable mailing address. NRC should be notified of changes in mailing address so that the license can be amended. These license amendments do not require a fee. Note: The NRC must be notified before control of the license is changed, and the licensee must receive written consent from the NRC prior to the change. The NRC must also be notified when bankruptcy proceedings have been initiated. NUREG-1556, Volume 15, "Consolidated Guidance About Materials Licenses; Guidance About Changes of Control and Bankruptcy Involving Byproduct, Source, or Special Nuclear Materials Licenses," provides additional information about NRC requirements related to changes of control and bankruptcy considerations. NRC Information Notice (IN) 97-30, "Control of Licensed Material during Reorganizations, Employee-Management Disagreements, and Financial Crises," dated June 3, 1997, discusses the potential for the security and control of licensed material to be compromised during periods of organizational instability. See below for more information. Timely Notification of Change of Control Regulations: 10 CFR 30.34(b); 10 CFR 40.46; and 10 CFR 70.36. Criteria: The regulations require that "No license issued or granted pursuant to the regulations, nor any right under a license, shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person, unless the Commission shall, after securing full information, find that the transfer is in accordance with the provisions of the Act and shall give its consent in writing." Therefore, control of licenses cannot be transferred without the prior written consent of the Commission. Discussion: Change of control may be the result of mergers, buyouts, or majority stock transfers. Although it is not NRC's intent to interfere with the business decisions of licensees, it is necessary for licensees to obtain NRC's written consent before the transaction is finalized. This is to ensure the following:
Response from Applicant: None from an applicant for a new license; Appendix H, excerpted from IN 89-25 (Rev. 1), "Unauthorized Transfer of Ownership or Control of Licensed Activities," dated December 7, 1994, identifies the information to be provided about transferring control. Reference: See the Notice of Availability (on the inside front cover of this report) to obtain copies of IN 89-25 (Rev. 1), "Unauthorized Transfer of Ownership or Control of Licensed Activities," dated December 7, 1994, and IN 97-30, "Control of Licensed Material during Reorganizations, Employee-Management Disagreements, and Financial Crises," dated June 3, 1997. Information Notices are available on NRC's website at <www.nrc.gov/NRC/reference.html> Notification of Bankruptcy Proceedings Regulation: 10 CFR 30.34(h). Criteria: Immediately following the filing of a voluntary or involuntary petition for bankruptcy for or against a licensee, the licensee must notify the appropriate NRC Regional Administrator, in writing, identifying the bankruptcy court in which the petition was filed and the date of filing. Discussion: Even though a licensee may have filed for bankruptcy, the licensee remains responsible for all regulatory requirements. NRC needs to know when licensees are in bankruptcy proceedings in order to determine whether all licensed material is accounted for and adequately controlled and whether there are any public health and safety concerns (e.g., contaminated facility). NRC shares the results of its determinations with other involved entities (e.g., trustee) so that health and safety issues can be resolved before bankruptcy actions are completed. Response from Applicant: None at time of application for a new license. Licensees must immediately (within 24 hours) notify NRC following the filing of a voluntary or involuntary petition for bankruptcy for or against the licensee. Reference: See the Notice of Availability (on the inside front cover of this report) to obtain copies of Policy and Guidance Directive PG 8-11, "NMSS Procedures for Reviewing Declarations of Bankruptcy," dated August 8, 1996, and NRC Inspection Manual, Inspection Procedure 87103, "Inspection of Material Licensees Involved in an Incident or Bankruptcy Filing. 8.3 Item 3: Address(es) Where Licensed Material Will Be Used or Possessed
[ Prev | Next | Top of file ] Specify each proposed location of use by the street address, city, and state or other descriptive address (e.g., on Highway 10, 5 miles east of the intersection of Highway 10 and State Route 234, Anytown, State). The descriptive address should be sufficient to allow an NRC inspector to find the facility location. A Post Office box address is not acceptable. If byproduct material is to be used at more than one location, give the specific address of each location. Applicants for a broad scope license need not identify each facility at a particular address where byproduct material will be used. For example, applicants can specify that byproduct material will be used on the Main Campus of ABC University located in Anytown, State. Applicants should identify the location of all facilities designed or established for special uses, e.g., panoramic irradiators, interim or long-term waste storage facilities, high activity laboratories, iodination facilities, alpha laboratories, incinerators, and animal facilities. If byproduct material (e.g., portable gauging devices) will be used at temporary job sites, so indicate, and describe the scope of these activities. If byproduct material is to be used in field studies, the activities must be specifically identified and authorized on the license. Appendix I contains information required of applicants prior to granting authorization for field use of licensed material. An NRC-approved license amendment identifying a new location of use, which is not encompassed by a location described on the existing license, is required before receiving, using and storing licensed material at that location.
Note: As discussed later under "Financial Assurance and Recordkeeping for Decommissioning," licensees must maintain permanent records on where licensed material was used or stored while the license was in force. This is important for making future determinations about the release of these locations for unrestricted use (e.g., before the license is terminated). Acceptable records are sketches, written descriptions of the specific locations, or room numbers where licensed material is used or stored and any records of spills or other unusual occurrences involving the spread of contamination in or around the licensee's facilities. 8.4 Item 4: Person to Be Contacted About This Application[ Prev | Next | Top of file ] Identify the individual who can answer questions about the application and include his or her telephone number. This individual, usually the Radiation Safety Officer, will serve as the point of contact during the review of the application and during the period of the license. If this individual is not a full-time employee of the licensed entity, his or her position and relationship should be specified. No individual other than the duly authorized applicant may, for any licensing matter, act on behalf of the applicant or provide information without the applicant's written authorization. The NRC should be notified if the person assigned to this function changes or if their telephone number changes. Notification of a contact change is for information only and would not be considered an application for license amendment (or require a fee), unless the notification involves a change in the contact person who is also the Radiation Safety Officer.
8.5 Item 5: Radioactive Material[ Prev | Next | Top of file ] 8.5.1 Unsealed And/Or Sealed Byproduct MaterialRegulation: 10 CFR 30.18; 10 CFR 30.32(d); 10 CFR 30.32(g); 10 CFR 30.32(i); 10 CFR 30.33(a)(2); 10 CFR 32.210; 10 CFR 33.11; 10 CFR 33.13; 10 CFR 33.14; 10 CFR 33.15; and 10 CFR 33.17. Criteria: An application for a license will be approved if the requirements of 10 CFR 30.32; 10 CFR 30.33; 10 CFR 33.11; 10 CFR 33.13; 10 CFR 33.14; 10 CFR 33.15; and 10 CFR 33.17 are met. Discussion: Applicants for a Type A broad scope license typically request any form of byproduct material with atomic numbers from 1 through 83. The applicant should state the maximum quantity of each radionuclide to be possessed at any one time and the total cumulative quantity for all radionuclides. When establishing individual radionuclide and total cumulative quantities, all materials possessed under the license should be included (i.e., materials received awaiting use, materials in use/process, and those categorized as waste awaiting disposal). The maximum quantity for each individual radionuclide and total cumulative possession should be commensurate with the applicant's needs, facilities, procedures, and demonstrated experience/capability. If certain individual radionuclides will be needed in much larger quantities than described in the atomic number 1-83 request, they should be listed separately rather than increasing the possession limit for all radionuclides. Similarly, if it is known that certain relatively more hazardous radionuclides (e.g., strontium-90) are needed only in smaller quantities, they should be listed separately. If needed, an applicant for a Type A broad scope license may request authorization to possess byproduct materials with atomic numbers greater than 83 (e.g., atomic numbers 84 to 96). For this request, the applicant should state the maximum quantity of each radionuclide to be possessed at any one time and the total cumulative quantity for all radionuclides. Note that authorization to possess byproduct materials with atomic numbers 84 through 96 does not authorize the possession of uranium, thorium, or plutonium because, even though these elements have atomic numbers within the range of 84 through 96, these materials are either source material or special nuclear material and not byproduct material. Licensees may request source material and special nuclear material when use of these materials is directly related to the use of byproduct material under the broad scope license (e.g. laboratory-scale research and development or the use of depleted uranium as shielding). Applicants should submit separate applications for the use of source and special nuclear materials for purposes not directly related to the use of byproduct material under the broad scope license (e.g., sub-critical assemblies and nuclear pacemakers). A separate listing should also be submitted for sealed sources needed in quantities larger than that described in the atomic number 1-83 request (e.g., self-contained irradiators, instrument calibrators, sealed sources used for medical therapy, portable and non-portable gauging devices, etc.). Applicants must provide the manufacturer's name and model number for each requested sealed source and device so that NRC can verify that they have been evaluated in a Sealed Source and Device (SSD) Registration Certificate or specifically approved on a license. Before the formalization of the SSD registration process, some older sources or devices may have been specifically approved on a license. Licensees can continue to use those sources and devices specifically listed on their licenses. Sealed sources or devices containing sealed sources that are intended for use solely under broad scope licenses and are not transferred to another licensee need not be evaluated by the NRC prior to use if: (1) the licensee is authorized to possess the requested quantity of radioactive material in unsealed form; and (2) the licensee performs its own safety evaluation in accordance with the administrative procedures required by 10 CFR 33.13(c)(3)(ii), 33.14(b)(2)(ii) or 33.15(c), as appropriate. For example, a broad scope licensee who is authorized to possess and use any form of iridium-192 or cobalt-60 in the fabrication of sources and devices for industrial radiography may use the fabricated sources and devices to conduct its own licensed activities without first submitting the sources and devices to NRC (or the Agreement State) for evaluation and registration.
Possession requests should be categorized into general areas of use, e.g., research and development activities, routine gauging activities, self-shielded irradiators, instrument calibrators, and medical applications. Applicants for Type A broad scope license should review the requirements for financial assurance and decommissioning before specifying possession limits for radioisotopes with a half life greater than 120 days. These requirements are discussed in Section 8.5.2 of this document. Licensees who possess radioactive materials in excess of the quantities listed in 10 CFR 30.72 must provide with the application either of the following:
If you are required to establish an emergency plan, guidance is provided in Regulatory Guide 3.67, "Standard Format and Content for Emergency Plans for Fuel Cycle and Materials Facilities," dated January 1992, and Policy and Guidance Directive 84-14, Revision 1, "Standard Review Plan for Emergency Plans for Fuel Cycle and Materials Licenses." NUREG 1140, "A Regulatory Analysis on Emergency Preparedness for Fuel Cycle and Other Radioactive Material Licensees, Final Report," dated January 1988, also contains valuable information.(3) Applicants for a Type B or Type C broad scope license should request any chemical or physical form of byproduct material specified in 10 CFR 33.100, Schedule A. The possession limit for a Type B broad scope license, if only one radionuclide is possessed, is the quantity specified for that radionuclide in 33.100, Schedule A, Column I. If two or more radionuclides are possessed, the possession limit is determined as follows. For each radionuclide, determine the ratio of the quantity possessed to the applicable quantity specified in 33.100, Schedule A, Column I, for that radionuclide. The sum of the ratios for all radionuclides possessed under the license shall not exceed unity. The possession limit for a Type C broad scope license, if only one radionuclide is possessed, is the quantity specified for that radionuclide in 33.100, Schedule A, Column II. If two or more radionuclides are possessed, the sum of the ratios, determined in the same manner as discussed above, for all radionuclides possessed under the license shall not exceed unity. Type B and Type C broad scope licensees who require materials not specified in Schedule A will need to: (1) develop Type A broad scope programs; or (2) carry these additional materials under a separate specific license of limited scope. The latter option would require that the licensee review the base NUREG related to the specific use of this material and submit the information required by the license reviewer as described in that document. For example, applicants who require materials not specified in Schedule A for purposes of research and development should review NUREG-1556, Volume 7, "Program-Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope," and submit the information described therein. Type B licensees who require quantities of material in excess of that permitted by 10 CFR 33.11(b), will need to: (1) develop a Type A broad scope program; or (2) carry these additional quantities under a separate specific license of limited scope, as described in the previous paragraph. Type C licensees who require quantities of material in excess of that permitted by 10 CFR 33.11(c), will need to: (1) develop, as appropriate, a Type A or Type B broad scope program; or (2) carry these additional materials under a separate specific license of limited scope. Applicants for Type B or Type C broad scope license may consider limiting their possession of isotopes described in Schedule A with half lives greater than 120 days below that amount permitted by 10 CFR 33.11(b) or 33.11(c) respectively, to avoid being required to submit certification of financial assurance or a decommissioning funding plan. See Section 8.5.2 of this document for a discussion of Financial Assurance and Recordkeeping for Decommissioning. Response from Applicant: Applicants for a Type A broad scope license should request any form of byproduct material with atomic numbers from 1 through 83. The applicant should state the maximum quantity of each radionuclide to be possessed at any one time and the total cumulative quantity for all radionuclides. The applicant should separately list individual radionuclides needed in much larger quantities or in much smaller quantities than that described in the atomic number 1-83 request. The maximum quantities of nuclides with atomic numbers above 83 also should be listed separately. A separate listing should also be submitted for sealed sources needed in larger quantities than that described in the atomic number 1-83 request. Applicants must provide the manufacturer's name and model number for each requested sealed source and device so that NRC can verify that they have been evaluated in a Sealed Source and Device (SSD) Registration Certificate or specifically approved on a license. This information need not be submitted if the licensee is authorized to possess the requested quantity of radioactive material in unsealed form and the licensee performs the required safety evaluation of the source and device. Possession requests should be categorized into general areas of use, e.g., research and development activities, routine gauging activities, self-shielded irradiators, instrument calibrators, and medical applications. Licensees who possess radioactive materials in excess of the quantities listed in 10 CFR 30.72 must provide with the application either of the following:
Applicants for a Type B or Type C broad scope license should request any chemical or physical form of byproduct material specified in 10 CFR 33.100, Schedule A. Type B licensees should request the quantity of material specified in 10 CFR 33.11(b). Type C licensees should request the quantity of material specified in 10 CFR 33.11(c). 8.5.2 Financial Assurance And Recordkeeping For DecommissioningRegulations: 10 CFR 30.32(h); 10 CFR 30.34(b); 10 CFR 30.35; 10 CFR 30.36(e); 10 CFR 30.36(g)(4)(v); 10 CFR 30.51(d); 10 CFR 30.51(e); 10 CFR 30.51(f); 10 CFR 40.31(i); 10 CFR 40.36; 10 CFR 40.42(e); 10 CFR 40.42(g)(4)(v); 10 CFR 40.61(d); 10 CFR 40.61(e); 10 CFR 40.61(f); 10 CFR 70.22(a)(9); 10 CFR 70.25; 10 CFR 70.38(e); 10 CFR 70.38(g)(4)(v); 10 CFR 70.51(b)(6); and 10 CFR 70.51(b)(7). Criteria: A licensee authorized to possess licensed material in excess of the limits specified in 10 CFR 30.35, 10 CFR 40.36, and 10 CFR 70.25 must meet the requirements for decommissioning financial assurance. All licensees are required to maintain records of information important to the decommissioning of the facility in an identified location until the site, or any area, is released for unrestricted use. Licensees must transfer these records either to the new licensee, when licensed activities are transferred or assigned, or to the appropriate Nuclear Regulatory Commission (NRC) Regional office when the license is terminated. Discussion: NRC wants to ensure that decommissioning will be carried out with minimum impact on public and occupational health and safety and the environment. There are two parts to the rule: financial assurance that applies to some licensees and recordkeeping that applies to all licensees. NRC decommissioning financial assurance regulations are designed to provide reasonable assurance that the decommissioning of licensed facilities will be accomplished in a safe and timely manner and that licensees will provide adequate funds to cover all costs associated with decommissioning. These requirements, if applicable, specify that a licensee either set aside funds for decommissioning activities or provide a guarantee that funds will be available. Applicants are required to provide financial assurance when the possession of radioactive material of half life (T1/2) greater than 120 days exceeds certain limits. Criteria for determining whether an applicant is required to submit a decommissioning funding plan (DFP) or has an option of submitting either a DFP or a Certification of Financial Assurance are stated in 10 CFR 30.35, 10 CFR 40.36, and 10 CFR 70.25. A DFP contains a site-specific cost estimate and a certification of financial assurance. A Certification of Financial Assurance includes a certification that the licensee has provided the required financial assurance and an acceptable financial assurance instrument. Acceptable financial assurance includes prepayment options (trusts, escrow accounts, government funds, certificates of deposit or deposits of government securities); surety, insurance, or other guarantee methods (letters of credit, surety bonds, lines of credit, parent company guarantees, insurance policies), and statements of intent for Government entities. Criteria for parent company guarantees and self-guarantees can be found in 10 CFR 30, Appendix A, Appendix C, Appendix D, and Appendix E. Regulatory Guide (RG) 3.66, "Standard Format and Content of Financial Assurance Mechanisms Required for Decommissioning Under 10 CFR Parts 30, 40, 70, and 72," dated June 1990, provides guidance acceptable to the NRC staff on the information to be provided for establishing financial assurance for decommissioning and a standard format for presenting the information. A revision to RG 3.66 will incorporate new guidance related to self-guarantees. RG 3.66 also describes the information required to be submitted for a DFP. NUREG-1337, Revision 1, "Standard Review Plan for the Review of Financial Assurance Mechanisms for Decommissioning Under 10 CFR Parts 30, 40, 70, and 72," dated August 1989, also provides guidance for decommissioning financial assurance reviews. The requirements for maintaining records important to decommissioning, including the type of information required, are stated in 10 CFR 30.35(g), 10 CFR 40.36(f), and 10 CFR 70.25(g). All licensees are required to maintain these records in an identified location until the site is released for unrestricted use. Careful recordkeeping of radionuclides used, including form, amount, and area used, will facilitate area release and license termination. In the event that the licensed activities are transferred to another person or entity, these records shall be transferred to the new licensee when the transfer of the licensed activities takes place. The new licensee is responsible for maintaining these records until the license is terminated. When the license is terminated, these records must be transferred to NRC. Figure 8.1 Types of Records that Must be Maintained for Decommissioning.
Response from Applicant: If a DFP or certification of financial assurance is required, submit the required documents as recommended in RG 3.66. 8.6 Item 6: Purpose(s) For Which Licensed Material Will Be Used[ Prev | Next | Top of file ] Regulations: 10 CFR 30.4; 10 CFR 30.32(d); 10 CFR 30.33(a)(1); 10 CFR 33.11; and 10 CFR 33.17. Criteria: Requested radioisotopes must be used for purposes authorized by the Atomic Energy Act of 1954, as amended. Sealed sources and devices containing licensed material must be used only for the purpose for which they are designed and according to the manufacturer's (distributor's) instructions and recommendations for use as specified in the SSD Registration Certificate. Sealed sources or devices containing sealed sources that are intended for use solely under broad scope licenses, and that will not be transferred to another licensee, need not be evaluated by the NRC prior to use if the licensee is authorized to possess the requested quantity of radioactive material in unsealed form and the licensee performs its own safety evaluation. Applicants desiring activities disallowed by 10 CFR 33.17(a) should apply for specific authorization. Discussion: The applicant should describe in general terms the purposes for which the licensed material will be used. New applicants should describe why a broad scope license is needed rather than amendments to an existing limited scope license. The uses should be consistent with prior licensed activities. Sufficient information should be provided to enable the reviewer to have a clear understanding of each use and to determine the potential for exposure of workers and members of the public to radiation and radioactive materials. The information provided regarding "Purpose of Use" is understood by the NRC staff as a self-imposed limitation contained within the application. If a broad scope licensee desires to initiate a use other than those described in its application and committed to in its license, the licensee must submit an amendment to the license to modify or expand the "purpose." The exclusions stated in 10 CFR 33.17(a) provide that, unless specifically authorized by other parts of the regulations, persons licensed under broad licenses will not do any of the following:
Applicants desiring these activities should review the appropriate base NUREG (i.e., that volume of NUREG-1556 that most closely applies) and request specific authorization in accordance with the guidance contained therein. For example, broad scope licensees who wish to perform industrial radiography should review NUREG-1556, Volume 2, "Program-Specific Guidance About Radiography Licenses," and provide necessary information, as specified. Response from Applicant: Describe in general terms the purposes for which the licensed material will be used. 8.7 Item 7: Individual(s) Responsible For Radiation Safety Program[ Prev | Next | Top of file ] Executive management, the Radiation Safety Committee (RSC), if required, and the Radiation Safety Officer (RSO) and his or her staff, as necessary, work as a team to oversee the broad scope program. Each plays a critical role within its area of responsibility. The roles and responsibilities of executive management, the RSC, the RSO, and the radiation safety office staff are discussed in the sections that follow. Note: NUREG-1516, "Management of Radioactive Material Safety Programs at Medical Facilities," describes the role of executive management, the RSC, and the RSO at medical facilities but contains information pertinent to all broad scope programs. 8.7.1 Executive ManagementRegulations: 10 CFR 20.1101(c); 10 CFR 33.13(c); 10 CFR 33.14(b); and 10 CFR 33.15(c). Criteria: The applicant must have administrative controls and provisions relating to organization and management and management review necessary to assure safe operations. Discussion: Executive management is the individual at the senior management level who is responsible for oversight of the facility's radiation safety program and has the ultimate responsibility for the license and the activities associated with the license. Executive management has an important role in implementing and managing the radiation safety program. NRC expects executive management to be knowledgeable of the program. Due to the various structures of different organizations, NRC recognizes that executive management may need to delegate certain responsibilities to other managers for the day-to-day oversight of the program. For example, a large company may have several licenses issued to it for different facilities or for different activities. In this case, a company may choose to establish a senior level manager with responsibility for all of the licenses issued to that company, with the day-to-day responsibility for each license designated to the facility senior manager or program area senior manager. There are numerous ways in which an applicant may wish to structure its management oversight to meet the needs of the organization. However, there must still be one level of management, as the licensee's representative, with ultimate responsibility for the radiation safety program. In a Type A broad scope program, executive management or her/his delegate is a vital member of the RSC and should attend Committee meetings. In all licensed programs, executive management should be knowledgeable of the results of periodic audits and the annual review of the licensed program, to ensure all activities are in compliance with regulatory requirements and the conditions of the license, and that activities are being conducted in a safe manner. Annual reviews and audits are discussed in more detail in Section 8.10.1 of this guidance document. The licensee should consider several factors when selecting executive management for the radiation safety program. This individual represents the highest level of facility management and has the authority to delegate resources for the program and appropriate funds in a timely manner. This individual must be available to facilitate effective and immediate action on behalf of management, the RSC (for Type A broad scope programs), and the RSO, particularly in the event of an emergency. Executive management must have the authority to make prompt decisions without having to consult with higher management officials, including the authority to take whatever action is necessary to ensure that all radiation safety practices are in accordance with the regulations and conditions of the license. Executive management is involved in selecting the chairperson and members of the RSC (for Type A broad scope) and the RSO (for Type A and Type B broad scope), and defines the role, duties and responsibilities of each. Executive management should support the RSC and the RSO, creating an atmosphere of cooperation and professionalism such that individuals feel comfortable raising radiation safety concerns. Authority will be enhanced if authorized users clearly understand that there is strong management support for, and participation in, the licensed program. Many problems can be avoided if management takes proactive steps before radiation safety problems escalate. Individuals should understand management's expectations regarding internal enforcement of program requirements and the consequences for non-compliance. NUREG-1516, "Management of Radioactive Material Safety Programs at Medical Facilities," Chapter 1, describes the role of executive management at medical facilities, but it also contains information pertinent to all broad scope programs. Response from Applicant: The applicant must describe administrative controls and provisions relating to organization and management and management review necessary to assure safe operations. It is recommended that the applicant submit an organizational chart describing the management structure, reporting paths, and the flow of authority between executive management, the RSC (for Type A broad scope), and the RSO (For Type A and Type B broad scope). 8.7.2 Radiation Safety CommitteeRegulations: 10 CFR 33.13(c)(1) and 33.13(c)(3)(iii). Criteria: Type A broad scope licensees must establish a Radiation Safety Committee (RSC), which works with executive management and the Radiation Safety Officer (RSO) in implementing the radiation safety program. Type B and Type C broad scope licensees are not required to establish an RSC. Discussion: An applicant for a Type A broad scope license must establish a RSC pursuant to 10 CFR 33.13(c)(1). The RSC works with executive management and the RSO in implementing the radiation safety program, and will be involved in establishing policies and procedures for managing the radiation safety program. The RSC, through the executive management, must have the authority and flexibility necessary so that it may effectively fulfill its role in managing the radiation safety program. The RSC for a Type A broad scope program is composed of such persons as the RSO, executive management, and persons trained and experienced in the safe use of byproduct materials. Each area of use under the license should be represented on the RSC. A chairperson for the committee should be selected. There are several factors to consider when selecting a chairperson for the RSC. An individual with a knowledge of radiation safety issues, good leadership abilities, the authority and credibility by virtue of their position within the facility, and a desire to serve as chairperson will facilitate the effectiveness of the RSC. Additionally, the individual chosen as the chairperson must have the time to devote to the position in addition to other responsibilities he or she might have within the facility. Executive management should delegate a level of authority to the position so that the chairperson is effective. In general, the RSO should not be appointed as the chairperson of the Committee, since the RSO is responsible for the day-to-day operation of the radiation safety program and may be too closely involved with the licensed activities to be objective. The RSC should establish a quorum for RSC meetings. A quorum consisting of the chairperson of the committee (or his/her designee), the RSO, the executive management (or his/her alternate), a representative from each area of use from which specific issues will be discussed, and any other member whose field of expertise is necessary for the discussion is considered acceptable. The meeting frequency for RSC meetings for broad scope programs is not specified in 10 CFR Part 33. The RSC should meet as often as needed to ensure the radiation safety program is operating in compliance with the license, established procedures and the regulations. For most programs, quarterly RSC meetings are needed to adequately oversee the program. The RSC should maintain minutes of its meetings. The minutes should include the date of the meeting, the members present and absent to demonstrate a quorum was present, a summary of the discussions, recommendations and the results of votes. The RSC should also document its review of new users, uses, and program changes. The minutes should also include information related to the ALARA program reviews and the annual audit review. Duties and ResponsibilitiesThe committee is responsible for reviewing personnel dosimetry data, discussing the results of required radiation surveys, and any significant incidents, including spills, contamination, misadministrations, etc. The RSC is also required to review the program for maintaining doses ALARA and providing any necessary recommendations to ensure doses are ALARA. The overall compliance status for authorized users should be thoroughly reviewed. The RSC, working with the executive management, shares responsibility with the RSO for conducting periodic audits of the radiation safety program. Additionally, the Committee reviews any consultant's audit findings and acts upon those findings. The RSC also reviews the results of the annual audit of the radiation safety program. Possible trends should be analyzed, and suggestions for timely and corrective action should be made. Problems should be clearly defined and reviewed in the future as open items. An assessment of the effectiveness of corrective actions is also helpful in deterring or eliminating future problems and violations. One of the primary responsibilities of the RSC for a broad scope program is to evaluate new users and new uses of byproduct material. The RSC needs to consider all available information in making decisions. This includes evaluating the training and experience of applicants who request authorization to use radioactive material at the facility, using criteria developed by the RSC. The RSC members should be aware of the regulatory training and experience criteria that apply to each type of use at their institution. For example, 10 CFR Part 35 contains the training and experience required for authorized users in medical programs. The criteria developed by the committee should include such things as the requester's training and experience, the proposed facilities, the protocol for using radioactive material to ensure that all procedures are in accordance with good radiation safety practices, and waste disposal. For Type A broad scope licensees or applicants for a Type A broad scope license who desire the flexibility to make certain program changes and changes to certain procedures as discussed in Section 1 of this document, the RSC, along with executive management and the RSO, will review and approve program and procedural changes in accordance with criteria developed and approved by the RSC. The criteria for reviewing and approving such changes should include provisions for training staff before implementing new procedures and ensure that the proposed changes will not degrade the effectiveness of the currently approved program. Additionally, the audit program should include an evaluation process that will assure that changes have been properly implemented by the staff and will determine the effectiveness of changes made in achieving program goals. NUREG-1516, "Management of Radioactive Material Safety Programs at Medical Facilities," Chapter 2, describes the role of the radiation safety committee at medical facilities, but contains information pertinent to all broad scope programs. For medical broad scope programs, the requirements of 10 CFR Part 35 must be met. Broad scope licensees should review other base NUREGs that may apply to their licensed program, such as NUREG-1556,Volume 9, "Program Specific Guidance About Medical Use Licenses," for licensees who possess radioactive material for medical use. Response from Applicant: Applicants for a Type A broad scope license should submit the following:
In addition, applicants for a Type A broad scope license who are requesting the flexibility to make some program changes and revise some procedures previously approved by the NRC without amendment of the license should submit the following:
8.7.3 Radiation Safety OfficerRegulations: 10 CFR 30.33(a)(3); 10 CFR 33.13(c)(2); 10 CFR 33.14(b)(1); 10 CFR 34.42; 10 CFR 35.21; and 10 CFR 36.13(d). Criteria: Type A and Type B broad scope licensees must have a Radiation Safety Officer (RSO) who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiological safety matters. The RSO's training and experience must include the types and quantities of licensed material to be authorized on the license. While regulation does not require Type C broad scope licensees to have an RSO, 10 CFR 33.15 requires that the licensee establish administrative controls and provisions relating to procurement of byproduct material, procedures, recordkeeping, material control and accounting, and management review to assure safe operations. Type C broad scope licensee management should appoint someone responsible for the day-to-day operation of the radiation safety program, such as an RSO. Discussion: Each Type A and Type B program in which byproduct materials are used must appoint an RSO who is responsible for radiation safety and compliance with the regulations for the use of byproduct material. Each Type C broad scope program should appoint an individual who is responsible for the day-to-day operation of the radiation safety program. In a Type A broad scope license the RSO is a member of the RSC and works closely with the RSC and executive management in implementing the radiation safety program. The RSO must ensure that radiation safety activities are being performed safely according to approved policies and procedures, and that all regulatory requirements are met. The RSO should have full access to all activities involving the use of byproduct material and the authority to terminate any activity in which health and safety appear to be compromised without consulting with executive management or the RSC, if required. The applicant should submit a "Radiation Safety Officer Delegation of Authority" signed by executive management. Appendix J contains a model "Delegation of Authority" that is acceptable to NRC. In a Type A broad scope licensed program, the RSO typically performs a preliminary review of proposed new uses and users, prior to formally discussing the proposal with the RSC. The RSC grants the formal approval of new users and uses in a Type A broad scope license. The task of reviewing and approving proposed uses and users in a Type B broad scope licensed program is the responsibility of the RSO. In a Type C broad scope program, individuals are qualified as users if they meet the training and experience criteria described in 10 CFR 33.15(b). While no licensee Committee or individual is required by regulation to make the determination that an individual is qualified to use the material possessed under the Type C broad scope license, or that a particular use of byproduct material is safe, licensee management is ultimately responsible for assuring safe operations. The RSO performs audits of all areas of use and individuals who are authorized to use byproduct material to ensure work is done in accordance with the license, regulations, and user permit conditions. Specific duties and responsibilities of the RSO include:
The responsibilities of the RSO may not be transferred to other individuals. Many tasks and duties associated with managing the program may be assigned or delegated to other qualified individuals; however, the responsibility for these tasks and duties is with the RSO. NRC does recognize that a qualified individual will have to fill in for the RSO when the RSO will be away for short periods of time for professional conferences, vacation, or illness. However, this should not occur for extended or indefinite periods of time. Consideration should also be given to how this individual would be contacted in the event of an emergency. When selecting an RSO, the applicant should keep in mind the duties and responsibilities of the position, select an individual who is qualified to serve as the RSO. The RSO will need a basic technical knowledge sufficient to understand, in general, the majority of the work being done with byproduct materials under his or her responsibility. NRC recognizes that an RSO cannot be an expert in all areas that might be involved in a broad scope program. The RSO should be qualified by training and experience to perform the duties required for the position. Executive management should ensure that enough time is allocated to the individual selected as the RSO to carry out the responsibilities of the position. The applicant should review the Radiation Safety Officer guidance provided in the base NUREG corresponding to the particular type of licensed program. For example, NUREG-1556, Volume 7, "Program Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope," contains guidance that is appropriate for broad scope licensees who are involved in research and development. The applicant should also be aware of specific regulatory requirements for the RSO which may apply to their licensed program. For example, 10 CFR Part 35 contains specific requirements for an RSO in a medical program. However, an individual who qualifies as a medical RSO is not necessarily qualified to be RSO in a broad scope program. Chapters 3 and 4 of NUREG-1516, "Management of Radioactive Material Safety Programs at Medical Facilities," describes the role of the RSO and selection of the RSO at medical facilities but it also contains information pertinent to all broad scope programs. Response from Applicant: For Type A and Type B Applicants:
For Type B Applicants, submit the criteria used by the RSO to approve of new users and uses of byproduct material. For Type C Applicants, submit the name of the person who will serve as the individual responsible for the day-to-day operation of the radiation safety program, e.g., the RSO, who will be contacted if there are further questions about this application, and who is duly authorized to act for the applicant or licensee, as required by 10 CFR 30.32(c).
Note: It is important to notify NRC, as soon as possible, typically within 30 days, of changes in the designation of the RSO. The name and qualifications of the replacement RSO must be submitted to NRC as part of an amendment request. Applicants should review the regulations for specific program areas, such as medical uses, that have specific requirements regarding changes in the RSO. 8.7.4 Radiation Safety Office StaffCriteria: Licensees should provide sufficient staff to assist the Radiation Safety Officer in implementing the radiation safety program. Discussion: The licensee should provide the RSO with a sufficient staff of professional and administrative support personnel. The number of staff and their qualifications will vary depending on the scope of the program. For small programs, the RSO may not require any assistance. Licensees should evaluate the licensed program and ensure that the RSO has adequate resources to effectively manage the program. Chapters 6 and 7 of NUREG-1516, "Management of Radioactive Material Safety Programs at Medical Facilities," discusses the subjects of radiation safety program resources and the use of consultants and service companies at medical facilities, but contains information pertinent to all broad scope programs. Response from Applicant: No response is required. 8.8 Item 8: Training For Individuals Working in or Frequenting Restricted Areas (Instructions to Occupational Workers and Ancillary Personnel)[ Prev | Next | Top of file ] Regulations: 10 CFR 19.11; 10 CFR 19.12; 10 CFR 19.13; 10 CFR 30.33(a)(3); and 10 CFR 30.34(e). Criteria: Before beginning work with or in the vicinity of licensed material, all individuals who are likely to receive an occupational dose in excess of 1 mSv (100 mrem) in a year must receive radiation safety training commensurate with their assigned duties and specific to the licensee's radiation safety program. Each individual should also receive periodic refresher training. Discussion: 10 CFR 19.12(a) describes the training that licensees are required to provide individuals who, in the course of their employment, are likely to receive in a year an occupational dose in excess of 1 mSv (100 mrem). 10 CFR 19.12(b) requires that the licensee, in determining which individuals are subject to the training requirements of 19.12(a), consider assigned activities during both normal and abnormal situations involving exposure to radiation and/or radioactive material that can reasonably be expected to occur during the life of a licensed facility. While many licensees can demonstrate that it is not likely during a normal situation for a laboratory worker, manufacturing technician, hospital technologist, or environmental services worker at their facility to receive in a year an occupational dose in excess of 1 mSv (100 mrem), these individuals and others could reasonably be expected to receive this level of exposure during abnormal situations (e.g., radioactive material left unsecured, a contamination event, or improper disposal of radioactive material in the regular trash) or, by their actions, cause others to receive this level of exposure. Untrained workers represent a potential hazard to themselves, other individuals, and property. Licensees should not assume that safety instruction has been adequately covered by prior employment or academic training. Practical, site-specific training should be provided for all individuals prior to beginning work with or in the vicinity of licensed material. Periodic refresher training should also be provided. Topics covered should, at a minimum, include those described in 10 CFR 19.12(a). The training may take any form. Many licensees utilize video tapes or interactive on line or off line computer programs to provide training. The licensee should determine whether the training succeeded in conveying the desired information and adjust the training program as necessary. The person conducting the training should be a qualified individual who is familiar with the licensee's program. Retraining should be performed whenever there is a change in duties or the work environment and at a frequency sufficient to ensure that all staff are adequately trained. Applicants should review the model training program described in the appropriate base NUREG corresponding to the particular type of licensed program. For example, NUREG-1556, Volume 7 describes a training program that is acceptable to NRC for licensees who are involved in research and development, and Volume 9 describes a training program that is acceptable to NRC for licensees who possess radioactive material for medical use. The applicant should also be aware of additional specific training requirements that may apply to their licensed program. For example, 10 CFR Part 35 contains specific requirements for the training of individuals who will work under the supervision of medical authorized users. Response from Applicant:
In addition, if you are a Type A broad scope licensee or applicant, and you want the flexibility to revise your radiation safety training program without amendment of the license as discussed in Sections 1 and 8.7.2 of this document, describe the process that will be used to revise and implement your submitted training program. 8.9 Item 9: Facilities And Equipment[ Prev | Next | Top of file ] Regulations: 10 CFR 20.1101(b); 10 CFR 20.1101(d); 10 CFR 20.1406; 10 CFR 30.33(a)(2); 10 CFR 30.34(e); 10 CFR 30.35(g); 10 CFR 33.13; 10 CFR 33.14; and 10 CFR 33.15. Criteria: Facilities and equipment must be adequate to protect health and minimize danger to life or property. They must minimize the possibility of contamination and keep exposures to workers and the public ALARA. Discussion: Applicants for all broad scope licenses need to demonstrate that their facilities and equipment provide sufficient engineering controls and barriers to protect the health and safety of the public and its employees, keep exposures to radiation and radioactive materials ALARA, and minimize the danger to life and property from the types and quantities of radioactive materials to be used. Facilities and equipment designed to control exposure can range from a vial that contains licensed material, to buildings, fences, or exclusion areas that are between the source and the maximally exposed member of the public. These facilities not only reduce the exposure from the source but may also limit access to the source. The licensee should list and describe these facilities for the following purposes:
Licensees should consider controlling exposures through available engineering options, as well as through limiting the releases of effluents to the environment. The licensee should describe all facilities and equipment essential to achieving these goals. The licensee will also need to describe the criteria that will be used by the RSC and/or RSO, as appropriate, to review and approve of proposed facilities. Facilities and equipment used for special applications where the impact upon workers or the public could be significant if radioactive material were released accidentally, need to be specifically described. These would include, for example, room irradiators, specialized iodination/tritiation facilities, alpha laboratories, radioactive waste processing facilities (including incinerators, compactors, liquid reclamation processors, etc.), radioactive waste storage facilities (including decay-in-storage locations), individual laboratories processing 3.7 gigabecquerels (GBq) (100 millicuries) or more of radioactive materials per experiment or process, nuclear pharmacies, specially designed therapy rooms, and sealed source storage areas. Significant modifications affecting facilities and equipment should have prior RSO review and RSC approval before commencement of such modifications. Also note that if radioactive materials will be used in or on animals, a description of the animal handling and housing facilities will need to be discussed. Appendix H of NUREG-1556, Volume 7, "Program-Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope," provides guidance on the information that should be addressed concerning the use of radioactive materials in animals. In your discussion of the criteria used to evaluate your facilities and equipment, you should include a discussion on how a laboratory or facility classification scheme relates to toxicity and quantity of radioactive material and your facility and equipment requirements. For example, the International Atomic Energy Agency (IAEA), as well as other health physics and industrial hygiene professional organizations, has developed classification schemes used in assessing minimum needs (e.g., equipment and facilities, user training, personnel monitoring, surveys) that consider the hazard and quantity of byproduct materials to be used (IAEA Safety Standard, Safety Series No. 1, "Safe Handling of Radionuclides, 1973 Edition.") Applicants may consider the development of such a classification scheme since it can be correlated with all aspects of the radiation safety program. Each applicant's scheme should be based upon the types and quantities of radioactive material anticipated to be used. The criteria used to develop the classification scheme should be provided to each RSC member for use when evaluating requests to use licensed materials. Appendix K provides the radionuclide toxicity and laboratory classification information excerpted from IAEA, which is acceptable to the NRC staff. This table is not all inclusive and is meant to be used as an example only. Based on chemical/physical form, need and quantities, your classification scheme may differ from that of the IAEA excerpt. Your application will need to describe the minimum facilities and equipment requirements for each laboratory classification. Appendix L provides additional guidance regarding facilities and equipment used to handle radioactive materials in a laboratory setting. Response from Applicant: Describe the criteria your RSC and/or RSO, as appropriate, will use to review and approve facilities and equipment (research laboratories, iodination facilities, waste storage facilities, survey and counting equipment, etc.). Your description will need to include your method of classifying laboratories based on type, toxicity and quantity of byproduct material being requested. Sample diagrams should be provided for each classification scheme that take into consideration shielding, the proximity of radiation sources to unrestricted areas and other items related to radiation safety. When reviewing facilities where radioactive materials may become airborne, sample diagrams should take into consideration descriptions of the ventilation systems including pertinent airflow rates, pressures, filtration equipment and monitoring systems. For special application facilities, such as those facilities described above, you will need to specify their locations (i.e. buildings and room numbers) and special considerations that your RSC and/or RSO will use in authorizing byproduct material use. Also describe your procedures for control, review, and approval of significant facilities or equipment modifications. 8.10 Item 10: Radiation Safety Program[ Prev | Next | Top of file ] 8.10.1 Audit ProgramRegulations: 10 CFR 33.13(c); 10 CFR 33.14(b); 10 CFR 33.15(c); 10 CFR 20.1101; and 10 CFR 20.2102. Criteria: Applicants for Type A, Type B, and Type C broad scope licenses are required by 10 CFR 33.13(c), 33.14(b), and 33.15(c) respectively, to establish administrative controls and provisions relating to management review necessary to ensure safe operations. 10 CFR 20.1101(c) requires the licensee to review the radiation program content and implementation, periodically (at least annually). Licensees are required by 10 CFR 20.2102 to maintain records of the radiation protection program, including: (1) the provisions of the program; and (2) audits and other reviews of the program contents and implementation. Discussion: Management and Radiation Safety Committee AuditsThe application for a Type A, B, or C broad scope license should discuss executive management oversight of the licensed program and the mechanisms they will use to ensure that they are aware of NRC regulations, the provisions of the license, and the compliance status of the institution's licensed program. This oversight may include independent audits of the program, frequent meetings with the RSC and/or RSO as appropriate, and periodic tours of selected facility areas. In a Type A broad scope program, the RSC assists executive management in performing this oversight function. Detailed written procedures should be developed and implemented for the operation of the RSC to ensure that appropriate oversight is provided. The RSC should be fully aware of the operations and activities of the Radiation Safety Office. The RSC should conduct periodic interactive management audits and evaluations of the Radiation Safety Program's performance, including: non-conformance reports; corrective action; status reports and audits; incident investigation reports; ALARA program development and implementation; effluent releases; qualification and radiological safety training; and performance of the RSO. Results of the RSC's audit and program reviews should be reported to executive management to allow for timely and aggressive remedial actions sufficient in scope to ensure compliance with NRC regulations and license conditions. Appendix M contains a model audit program that is acceptable to NRC for use in the review of most non-medical broad scope programs. 10 CFR 20.1101(c) requires the licensee to review the radiation program content and implementation periodically (at least annually). Generally, these audits are conducted at least once every 12 months. Internal AuditsThe application should describe the audit mechanism implemented by the RSO and her or his staff, or other individual who is responsible for the day-to-day operation of the licensed program, to determine user compliance with NRC regulations, the terms and conditions of the NRC license, the requirements of the RSC or RSO-approved permits (as appropriate), and good health physics practices. The audit program should include routine unannounced inspections of each user's facility and practices to supplement and audit the routine monitoring performed by the user. Facility inspections should include:
The types and frequencies of monitoring performed by the RSO should be indicated. The intervals of surveys and audits should be frequent enough to ensure close communications and proper surveillance of individual radioactive material users. Applicants should consider developing survey and audit schedules based on activity and use (e.g., high use facilities and users of volatile radioactive materials may be audited weekly or biweekly, intermediate use facilities may be audited monthly, and low-level facilities may be audited quarterly). If an audit identifies violations of NRC requirements, the licensee should evaluate the safety significance of each violation to set priorities and identify resources to correct these violations. Information Notice (IN) 96-28, "Suggested Guidance Relating to Development and Implementation of Corrective Action," dated May 1, 1996, provides guidance on this subject. Certain identified problems or potential violations may require notification or a report to the NRC. For information on NRC's reporting requirements, refer to "Guide to NRC Reporting and Recordkeeping Requirements," NUREG-1460, Revision 1, dated July 1994. NUREG-1460, Revision 1, was compiled from requirements in Title 10 of the U.S. Code of Federal Regulations as codified on December 31, 1993. Appendix N of this document describes the more common NRC reporting requirements. Licensees are encouraged to contact NRC for guidance if there is any uncertainty regarding a reporting requirement. NRC routinely reviews licensees' records to verify if appropriate corrective actions were implemented in a timely manner to prevent recurrence. It is in the best interest of the licensee to identify potential violations of regulatory requirements and take necessary steps to correct them. NRC can exercise discretion and may elect not to cite the licensee for these violations if prompt and effective corrective actions are implemented. For information on NRC's use of discretion in issuing a notice of violation, refer to the current version of NUREG-1600, "General Statement of Policy and Procedures for NRC Enforcement Actions." The NRC's emphasis in inspections is for applicants to perform actual observations of work in progress. As a part of their audit programs, applicants should consider performing unannounced audits of byproduct material users to determine if, for example, safe use of radionuclide procedures and emergency procedures are available and are being followed. Recordkeeping 10 CFR 20.2102 requires that licensees maintain records of audits and other reviews of program content and implementation for 3 years from the date of the record. Records of audits should include: date of audit, name of person(s) who conducted the audit, persons contacted by the auditor(s), areas audited, audit findings, corrective actions, and follow-up. These records must be maintained for inspection by the NRC. Response From Applicant:
In addition, if you are a Type A broad scope licensee or applicant, and you want the flexibility to revise the audit mechanism implemented by the RSO without amendment of the license as discussed in Sections 1 and 8.7.2 of this document, describe the process you will use to revise and implement your audit program. References: See the Notice of Availability on the inside cover of this report to obtain copies of NUREG-1460, Revision 1, "Guide to NRC Reporting and Recordkeeping Requirements," dated July 1994; NUREG-1600, "General Statement of Policy and Procedures for NRC Enforcement Actions;" and IN 96-28, "Suggested Guidance Relating to Development and Implementation of Corrective Action." The current version of NUREG-1600, "General Statement of Policy and Procedures for NRC Enforcement Actions," is available electronically at <http://www.nrc.gov/OE>. INs are available in the "Reference Library" on NRC's Home Page at <http://www.nrc.gov>. 8.10.2 Radiation Monitoring InstrumentsRegulations: 10 CFR 20.1501; 10 CFR 20.2103(a); 10 CFR 30.33(a)(2); 10 CFR 33.13; 10 CFR 33.14; 10 CFR 33.15; 10 CFR 34.25; and 10 CFR 35.51. Criteria: Licensees must, pursuant to 10 CFR 20.1501, possess and periodically calibrate radiation monitoring instruments that are necessary to protect health and minimize danger to life or property. Discussion: Licensees must possess an adequate number of radiation detection and measurement instruments as necessary and ensure they are calibrated periodically for the radiation being measured. For purposes of this document, survey instruments are defined as any device used to measure the radiological conditions at a licensed facility. The choice of instrument needs to be appropriate for the type of radiation to be measured and for the type of measurement to be taken (count rate, dose rate, etc.). The applicant should submit the criteria used in determining what radiation detection and monitoring equipment will be required for each type of use by authorized users and the availability of a sufficient quantity of these instruments to both the radiation safety office and authorized users (e.g., ion-chambers, G-Ms, air samplers, liquid scintillation counters). NRC requires that survey instruments used to determine compliance with regulatory requirements be calibrated periodically by the instrument manufacturer or persons specifically authorized by NRC or an Agreement State. Survey instruments should be calibrated at least annually (every 12 months), unless otherwise specified by regulation or license condition. Licensees seeking authorization to perform their own survey instrument calibrations will need to submit calibration procedures for review. The licensee may wish to review available industry standards for calibration of instruments such as ANSI N323A-1997, "Radiation Protection Instrumentation Test and Calibration, Portable Survey Instruments." Appendix O of this document provides useful information about instrument specifications and model calibration procedures that are acceptable to NRC. Some instruments may only need to be checked periodically for operability and response to radiation rather than receive full calibration. For example, Geiger-Mueller (G-M) type survey instruments used to identify contamination in laboratories may only need to be checked for ability to detect low level contamination. Applicants will need to submit their method for assuring that instruments are checked and/or calibrated at proper frequencies. Response from Applicant:
In addition, if you are a Type A broad scope licensee or applicant, and you want the flexibility to revise your instrument specifications and procedure for calibration of instruments without amendment of the license as discussed in Sections 1 and 8.7.2 of this document, describe the process that will be used to revise and implement these submitted procedures. Note: If you wish to perform instrument calibration as a commercial service, you will need to either amend your existing broad scope license or apply for a new NRC license authorizing commercial calibration service. 8.10.3 Material Receipt And AccountabilityRegulations: 10 CFR 20.1501(a); 10 CFR 20.1801; 10 CFR 20.1802; 10 CFR 20.1906; 10 CFR 20.2001; 10 CFR 20.2108(b); 10 CFR 20.2201; 10 CFR 30.34(e); 10 CFR 30.35(g); 10 CFR 30.41; 10 CFR 30.51; 10 CFR 33.13; 10 CFR 33.14; and 10 CFR 33.15. Criteria: Licensees must, pursuant to 10 CFR Parts 20, 30, and 33, develop, implement, and maintain written procedures for all of the following:
The licensee must also maintain records of receipt, utilization, transfer, and disposal of licensed material. Discussion: Applicants for a broad scope license are required to establish appropriate administrative controls and provisions that are necessary to assure safe operations including procedures to assure the control of procurement and use of byproduct material. Administrative procedures must assure that only authorized individuals receive radioactive materials and that individuals receive only the types and quantities of radioactive material that they are authorized to receive. Applicants for a broad scope license are strongly encouraged to develop an administrative procedure to control procurement and use of radioactive material that emphasizes centralized purchasing and receipt. NRC has found centralized purchasing and receipt to be effective in controlling licensed materials entering the licensed institution through normal commercial channels, particularly for larger institutions. Procedures must also be established to control licensed materials obtained outside of the normal channels, e.g., through the loan or transfer of materials without purchase or through surplus. Appendix P of this document describes a model procedure for controlling procurement and use of radioactive material that is acceptable to NRC. Licensees are required to develop, implement, and maintain written procedures for safely receiving and opening packages in accordance with 10 CFR 20.1906. Appendix P of this document describes a model procedure for safely receiving and opening packages containing licensed materials that is acceptable to NRC. Applicants for a broad scope license are required to establish appropriate administrative controls and provisions relating to material control and accounting that are necessary to assure safe operations. Licensees use various methods to account for receipt, use, transfer, disposal, and radioactive decay of unsealed licensed material (e.g., computer programs, manual ledgers, log books, etc.). These methods help to assure that licensee and individual authorized user possession limits are not exceeded. Licensees who possess sealed sources are required to perform periodic inventories. The frequency of these inventories is normally established by license condition as every 6 months; however, regulation may specify a different inventory frequency (e.g., sealed sources used for medical therapy are required to be inventoried every 3 months). Licensed material is considered to become part of the licensee's inventory at the time that it is received by the licensee, be it during normal working hours or after hours when delivered by the carrier in accordance with procedures established by the licensee. If through some error, the licensee receives material it is unauthorized to possess or receives quantities of material that would result in the total inventory being in excess of license possession limits, the licensee should place the package in secure storage and arrange for the return of these materials in a timely manner. If return of the materials is not possible, the licensee should contact the NRC Regional Office and request issuance of an expedited license amendment. The materials must not be used until the amendment is granted. 10 CFR 20.1801 and 20.1802 require licensees to secure radioactive materials from unauthorized removal or access while in storage and to control and maintain constant surveillance over licensed material that is not in storage. Applicants for broad scope licenses must establish policies and procedures to ensure compliance with security requirements. Licensees must maintain records of receipt, use, transfer, and disposal of all licensed material. Table 8.1 below lists each type of record and how long the record must be maintained. Table 8.1 Record Maintenance
Response from Applicant: Describe your administrative procedures to assure control of procurement and use of byproduct material. While the applicant is required to develop and implement safe opening procedures for packages containing radioactive material, the applicant need not submit the procedures during the licensing process. These procedures will be reviewed during inspection. Describe your administrative controls and provisions relating to materials control, accounting and security. In addition, if you are a Type A broad scope licensee or applicant, and you want the flexibility to revise your administrative procedures to assure control of procurement and use of byproduct material and your administrative controls and provisions relating to material control, accounting and security, without amendment of your license as discussed in Sections 1 and 8.7.2 of this document, describe the process that will be utilized by your Radiation Safety Committee to revise these administrative procedures, controls, and provisions. 8.10.4 Occupational DoseRegulations: 10 CFR 20.1201; 10 CFR 20.1202; 10 CFR 20.1203; 10 CFR 20.1204; 10 CFR 20.1207; 10 CFR 20.1208; 10 CFR 20.1501; 10 CFR 20.1502; 10 CFR 20.1703; 10 CFR 20.2106; and 10 CFR 20 Appendix B. Criteria: The use of individual monitoring devices for external dose is required, pursuant to 10 CFR 20.1502(a), for:
Internal exposure monitoring is required, pursuant to 10 CFR 20.1502(b), for:
Discussion: If an adult is likely to receive in 1 year a dose greater than 10% of any applicable limit, monitoring is required. The licensee should perform an evaluation of the dose the individual is likely to receive prior to allowing the individual to receive the dose. This evaluation need not be made for every individual; evaluations can be made for employees with similar job functions or work areas. If this prospective evaluation shows that the individual is not likely to exceed 10% of any applicable limit, there are no recordkeeping or reporting requirements in regard to the individual's exposure. For individuals who received exposure at other facilities in the current year, the previous dose need not be considered in this prospective evaluation. Only dose that could be received at the facility performing the evaluation need be considered when determining the need for monitoring, and therefore, recordkeeping and reporting requirements. If it is determined that monitoring is not required and a subsequent evaluation shows that the 10% threshold has or will be exceeded, the dose received when monitoring was not provided should be estimated, recorded, and reported. These estimates can be based on any combination of work location radiation monitoring or survey results, monitoring results of individuals in similar work situations or other estimates to produce a "best estimate" of the actual dose received. If monitoring is not required to demonstrate compliance with all limits but is required relative to one or more specific limits, the licensee should enter "NR" for "Not Required" in the blocks on NRC Forms 4 and 5 to indicate the areas for which monitoring was not required (e.g., extremity or skin doses). Where monitoring was provided but not measurable, the licensee should enter "ND" for "Not Detectable." If the prospective evaluation shows that the individual is likely to exceed 10% of an applicable limit, then monitoring, and reporting of the results of monitoring performed regardless of the actual dose received, is required. If air sampling or bioassay is required, discussion of air sampling or bioassay should provide enough detail that the NRC staff is assured that appropriate steps will be taken to manage and monitor such exposure. Table 8.2 Documents that Contain Guidance Relating to Personnel Monitoring and Bioassay that may be Applicable
Additional References for Further Reading:
Response from Applicant: Submit a description of the method used to demonstrate compliance with the referenced regulations or submit a statement that an evaluation disclosed that individuals do not require monitoring. In addition, if you are a Type A broad scope licensee or applicant and you want the flexibility to revise your personnel dosimetry program without amendment of the license, as discussed in Sections 1 and 8.7.2 of this document, describe the process that will be used to revise and implement your submitted personnel dosimetry program. 8.10.5 Public DoseRegulations: 10 CFR 20.1003; 10 CFR 20.1301; 10 CFR 20.1302; 10 CFR 20.1801; 10 CFR 20.1802; and 10 CFR 20.2107. Criteria: Licensees must ensure that licensed material will be used, transported, stored, and disposed in such a way that the total effective dose equivalent (TEDE) to members of the public will not exceed more than 1 mSv (100 mrem) in one year, and the dose in any unrestricted area will not exceed 0.02 mSv (2 mrem) in any one hour. Discussion: Public dose is defined in 10 CFR Part 20 as "the dose received by a member of the public from exposure to radiation and/or radioactive material released by a licensee, or to any other source of radiation under the control of a licensee." Public dose excludes doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with 10 CFR 35.75, from voluntary participation in medical research programs, and from the licensee's disposal of radioactive material into sanitary sewerage in accordance with 10 CFR 20.2003. Whether the dose to an individual is an occupational dose or a public dose depends on the individual's assigned duties. It does not depend on whether the individual is in a restricted area, a controlled area, or an unrestricted area when the dose is received. There are both external exposure components and internal exposure components of public dose. The licensee should review all possible internal and external exposure pathways and decide which are applicable to its operations. Licensees should design a monitoring program to ensure compliance with 10 CFR 20.1302(b). The extent and frequency of monitoring will depend upon the nature of the licensee's operations, potential releases, exposures and pathways to cause public dose or environmental contamination. For additional guidance regarding monitoring of effluents, refer to section entitled "Radiation Safety Program - Surveys." 10 CFR 20.2107 requires that licensees maintain survey and monitoring records that demonstrate compliance with the dose limits for members of the public until the Commission terminates the license. Response from Applicant: No response is required from the applicant, but records and written materials documenting compliance will be examined during inspection. During NRC inspections, licensees must be able to provide documentation demonstrating, by measurement or calculation, that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed operation does not exceed the annual limit for members of the public. For guidance about accepted methodologies for determining doses to members of the public, see Appendix Q of this document. 8.10.6 Safe Use of Radionuclides And Emergency ProceduresRegulations: 10 CFR 19.11(a)(3); 10 CFR 20.1101; 10 CFR 20.1801; 10 CFR 20.1802; 10 CFR 20.2201-2203; 10 CFR 21.21; 10 CFR 30.32(i); 10 CFR 30.34(e); 10 CFR 30.50; 10 CFR 30.72; 10 CFR 33.13; 10 CFR 33.14; and 10 CFR 33.15. Criteria: Licensees are required, pursuant to the regulations stated above, to:
Discussion: Licensees are responsible for developing and implementing procedures to ensure the security and safe use of all licensed material from the time it arrives at their facility until it is used, transferred, and/or disposed. The written procedures should provide reasonable assurance that only appropriately trained personnel will handle and use licensed material without undue hazard to themselves, other workers, or members of the public. All licensed materials that are stored in controlled or unrestricted areas must be secured from unauthorized access or removal, so that individuals who may not be knowledgeable about radioactive materials cannot be exposed to or contaminated by the material, and individuals cannot take the material. When any licensed materials are in use in controlled or unrestricted areas, they must be under constant surveillance so that the radiation worker can prevent others from becoming contaminated by or exposed to the material, or prevent persons from removing the material from the area. Acceptable methods for securing material will vary from one facility to another. Some alternatives used by licensees include:
You should develop procedures that clearly state acceptable methods to secure licensed material at your facility. Particular attention may be required at facilities that may have unusual needs due to the activities performed, such as hot cells, animal care facilities, and waste processing facilities. Your security procedures may be in a separate document or included in the "General Safety Procedures." Applicants should develop radioisotope-specific procedures based on the respective hazards associated with the radioisotopes. General safety guidelines are described in Appendix R of this document. Licensees are encouraged to use these guidelines in developing procedures for the safe use of radioisotopes. Licensees need to identify all areas that require posting in accordance with 10 CFR 20.1902, unless they meet the exemptions listed in 10 CFR 20.1903. Also, containers of licensed material (including radioactive waste) must be labeled in accordance with 10 CFR 20.1904, unless they meet the exemptions in 10 CFR 20.1905. Applicants need to establish written procedures to handle emergencies ranging from a minor spill to a major accident that may require intervention by outside emergency response personnel. These procedures should include provisions for immediate response, after-hours notification, handling of each type of emergency, equipment, and the appropriate roles of users and the radiation safety staff. Except for minor spills or releases of radioactivity that can be controlled and cleaned up by the user, individual users should have a clear understanding of their limitations in an emergency, with step-by-step instructions and clear direction of whom to contact. Model Emergency Procedures that are acceptable to NRC are described in Appendix R of this document. Emergency spill kits should be strategically placed in well marked locations for use by all users and the radiation safety staff. All equipment should be periodically inspected for proper operation and replenished, as necessary. The licensee should also consider establishing an Emergency Response Team composed of individuals experienced in various emergency response functions (e.g., radiological, medical, emergency management, security, and fire protection). 10 CFR 20.2201-20.2203, 10 CFR 21.21 and 10 CFR 30.50 require certain incidents and emergencies be reported to NRC. Appendix N of this document provides examples of some events that require notification and/or reports. Note that Appendix N is not all inclusive, as there are other notification and/or reporting requirements that may apply to your specific program (i.e. 10 CFR Parts 34, 35, 36, 39 etc.). NUREG-1460, Revision 1, "Guide to NRC Reporting and Recordkeeping Requirements," is a compilation of requirements based on regulations codified as of December 31, 1993. If you plan to possess quantities of material in excess of the applicable amounts listed in 10 CFR 30.72, Schedule C, then you may also be required to submit an "Emergency Response Plan for Responding to a Release." See Section 8.5.1 for specific information related to this requirement. Response from Applicant: Submit your procedures for safe use of radionuclides and emergencies. Your submission should include procedures for maintaining security of licensed radioactive materials. As an alternative, you may state "We will adopt the procedures for the safe use of radionuclides and emergencies as published in Appendix R of NUREG-1556, Volume 11, "Program-Specific Guidance About Licenses of Broad Scope." In addition, if you are a Type A broad scope licensee or you are applying for a Type A broad scope license, and you want the flexibility to revise your safe use and emergency procedures without amendment of the license as described in Sections 1 and 8.7.2 of this document, discuss the process that will be used to revise and implement your submitted safe use and emergency procedures. 8.10.7 SurveysRegulations: 10 CFR 20.1501; 10 CFR 20.2103; 10 CFR 30.53; 10 CFR 33.13; 10 CFR 33.14; 10 CFR 33.15; 10 CFR 34.27(c)(2); 10 CFR 34.67; 10 CFR 35.59(d); 10 CFR 36.81(h); and 10 CFR 39.35(a). Criteria: Licensees are required, pursuant to the regulations listed above, to make surveys of potential radiological hazards in their workplace. NRC requires testing to determine whether there is any radioactive leakage from sealed sources. Records of surveys and leak test results must be maintained. Discussion: Survey is defined as an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of radioactive material or other sources of radiation. These evaluations may be measurements (e.g., radiation levels measured with a survey instrument or results of wipe tests for contamination), calculation, or a combination of measurements and calculations. The licensees must interpret and evaluate such measurements and calculations to take appropriate action. The selection and proper use of appropriate instruments is one of the most important factors in ensuring that surveys accurately assess the radiological conditions. Surveys are also used to plan work in areas where licensed material or radiation exists and to evaluate doses to workers and individual members of the public. In certain cases, environmental monitoring may be required to demonstrate compliance with 10 CFR Part 20. Surveys are required when it is necessary for the licensee to comply with the regulations or to evaluate a radiological hazard. Many different types of surveys may need to be performed due to the particular use of licensed materials. The most important are as follows:
The frequency of routine surveys depends on the nature, quantity, and use of radioactive materials, as well as the specific protective facilities, equipment, and procedures that are designed to protect the worker from external and internal exposure. Also, the frequency of the survey depends on the type of survey, such as those listed above. 10 CFR Part 20 does not specify limits for surface contamination. Each applicant should propose and justify what removable surface contamination limits will be allowable before decontamination will be performed in each work area. Appendix S of this document describes survey procedures that are acceptable to NRC. NUREG/BR-0241, "NMSS Handbook for Decommissioning Fuel Cycle and Materials Licenses," dated March 1997, contains the current regulatory guidance concerning decommissioning of facilities and termination of licenses. Appendix B of the Handbook contains a comprehensive list of NRC's decommissioning regulations and guidance. Also, NUREG-1575, "Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM)," dated December 1997, should be reviewed by licensees who have large facilities to decommission. Leak Test When issued, a license will require performance of leak tests of sealed/plated foil sources at intervals as approved by NRC or an Agreement State and specified by the Sealed Source and Device (SSD) Registration Certificate. The measurement of the leak-test sample is a quantitative analysis requiring that instrumentation used to analyze the sample be capable of detecting 185 becquerels (Bq) (0.005 microcuries) of radioactivity. Leak tests are not required if:
For more information regarding leak tests, see Appendix T of this document. Response from Applicant:
In addition, if you are a Type A broad scope licensee or you are applying for a Type A broad scope license, and you want the flexibility to revise your survey or leak test program without amendment of the license, as described in Sections 1 and 8.7.2 of this document, discuss the process that will be used to revise and implement your submitted survey and leak test program. References: See the Notice of Availability on the inside front cover of this report to obtain a copy of Draft Regulatory Guide FC 412-4, "Guide for the Preparation of Applications for the Use of Radioactive Materials in Leak-Testing Services," dated June 1985. 8.10.8 TransportationRegulations: 10 CFR 20.1101; 10 CFR 30.41; 10 CFR 30.51; 10 CFR 33.13; 10 CFR 33.14; 10 CFR 33.15; 10 CFR 34.35; 10 CFR 71.5; 10 CFR 71.12; 10 CFR 71.13; 10 CFR 71.14; 10 CFR 71.47; 10 CFR 71.87; and 49 CFR Parts 171-178. Criteria: Broad Scope licensees who will transport or ship licensed material, including radioactive waste, must develop, implement, and maintain safety programs for transport of radioactive material to ensure compliance with NRC and U.S. Department of Transportation (DOT) regulations. Discussion: Department of Transportation regulations (49 CFR) were written to help assure that transportation of hazardous materials in commerce were transported uniformly and safely. NRC licensees who transport byproduct material (hazardous material) in commerce would, therefore, be required to comply with all applicable regulations found in DOT. However, many NRC licensees routinely transport byproduct material that is not in commerce. In 1979, 10 CFR 71.5 was codified to ensure that all NRC licensees who transport byproduct material, in commerce or not, transport byproduct material in a uniformly safe manner. Some broad scope licensees have applied for certain exemptions to 10 CFR 71.5; however, those exemption requests to 10 CFR 71.5 were not granted. NRC's position regarding the transportation regulations in 49 CFR is that they already allow for flexibility and are thus considered to be performance-based requirements rather than prescriptive requirements. For example, packages shipped by broad scope licensees frequently meet the "Limited Quantity" criteria as described in 49 CFR 173.421 and are therefore excepted from certain DOT requirements provided certain other less restrictive requirements are met. Appendix U of this document provides an overview of the transportation requirements commonly affecting NRC licensees. Licensees may also wish to review NUREG-1660, "U.S.-Specific Schedules of Requirements for Transport of Specified Types of Radioactive Material Consignments," published jointly by NRC and DOT in November 1998. Knowing how 10 CFR 71.5 and 49 CFR interrelate is very important to broad scope programs. Therefore, it is imperative that your radiation safety staff be thoroughly familiar with 10 CFR 71.5 and 49 CFR in order to comply and to take full advantage of the flexibility inherent in DOT requirements. Licensed material, including radioactive waste, must be packaged and transported in accordance with NRC and DOT requirements if the transportation involves the use of public highways. In addition, broad scope licensees need to develop and maintain their own radiation safety procedures for transporting licensed material within their own facilities if such transportation does not involve the use of public highways. Licensees also need to consider the safety of all individuals who may handle or may come in contact with the packages containing licensed material. Therefore, the primary considerations in packaging licensed material should be to ensure that package integrity is not compromised during transport and that the radiation levels (including removable contamination levels) at the package surfaces not only meet the regulatory requirements of 10 CFR 71.47, but are ALARA. Licensees shipping radioactive waste for disposal must prepare appropriate documentation as specified in 10 CFR 20, Appendix G. Response from Applicant: No response is needed from applicants during the licensing phase. Compliance with transportation requirements will be reviewed during NRC inspections. Reference: "A Review of Department of Transportation Regulations for Transportation of Radioactive Materials (1983 revision)" can be obtained by calling DOT's Office of Hazardous Material Initiatives and Training, at (202) 366-4900. The Memorandum of Understanding with DOT on the Transportation of Radioactive Material (signed June 6, 1979) is available from NRC upon request. 8.11 Item 11: Waste Management[ Prev | Next | Top of file ] Regulations: 10 CFR 20.1501; 10 CFR 20.2001; 10 CFR 20.2002; 10 CFR 20.2003; 10 CFR 20.2004; 10 CFR 20.2005; 10 CFR 20.2006; 10 CFR 20.2007; 10 CFR 20.2108; and 10 CFR 30.51. Criteria: Radioactive waste must be disposed of in accordance with regulatory requirements, and appropriate records of waste disposal must be maintained. Discussion: The applicant should discuss the methods for management and disposal of radioactive waste. The program should include procedures for handling of waste, safe and secure storage, waste characterization, waste minimization, and disposal of radioactive waste. Appropriate training should be provided to waste handlers. Licensees may not receive radioactive waste from other licensees for processing, storage, or disposal unless specifically authorized by NRC. The U.S. Environmental Protection Agency (EPA) issued guidance for developing a comprehensive program to reduce hazardous waste. This guidance was transmitted to licensees by the NRC in IN-94-23, "Guidance to Hazardous, Radioactive, and Mixed Waste Minimization Program," dated March 1994. The application should include, where appropriate for the types of waste involved, provisions for monitoring and segregating waste materials (radioactive from nonradioactive, short from long half-life, liquid from solid waste, etc.). The following methods of waste disposal may be considered and should be addressed in the application as appropriate. Transfer to an Authorized RecipientWaste may be transferred 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). Each shipment must comply with all applicable NRC and DOT requirements. Licensees should implement procedures to reduce the volume of radioactive waste for final disposal in an authorized low-level radioactive waste (LLW) disposal facility. These procedures include volume reduction by segregating, consolidating, compacting, or allowing certain waste to decay in storage. Waste compaction or other treatments can reduce the volume of radioactive waste, but such processes may pose additional radiological hazards (e.g., airborne radioactivity) to workers, members of the public, and the environment. Safety procedures to address these concerns should be implemented. Decay-In-Storage (DIS) and Extended Interim StorageThe NRC has concluded that materials with half-lives of less then or equal to 120 days are appropriate for DIS and interim storage. The minimum holding period for decay is ten half-lives of the longest lived radioisotope in the waste. Such waste may be disposed of as ordinary trash if radiation surveys (performed in a low background area and without any interposed shielding) of the waste at the end of the holding period indicate that radiation levels are indistinguishable from background. All radiation labels must be defaced or removed from containers and packages prior to disposal as ordinary trash. If the decayed waste is compacted, all labels that are visible in the compacted mass must also be defaced or removed. The NRC does not consider storage as a substitute for final disposal of radioactive wastes. Other than storage for radioactive decay, LLW should be stored only when disposal capacity is unavailable, and for no longer than is necessary. NRC Information Notice No. 90-09, "Extended Interim Storage of Low-Level Radioactive Waste For Fuel Cycle and Material Licensees," dated February 1990, provides guidance to licensees for requesting an amendment to authorize extended interim storage of LLW. A model procedure for DIS is contained in Appendix V of this guidance document. Release into Air and WaterRelease of radioactive material into air and water must conform to the requirements described in 10 CFR 20.1302(b)(2). The applicant should discuss the monitoring and control mechanisms in place to ensure compliance with the requirements. Applicants are reminded of the "constraint" on air emissions of radioactive material required by 10 CFR 20.1101(d), which effectively reduces the limits specified in 10 CFR 20.1302(b)(2) for release of gaseous effluents. Applicants who are considering release of radioactive material into air and water should review Regulatory Guide 8.37, "ALARA Levels for Effluents From Materials Facilities," dated July 1993. Regulatory Guide 8.37 deals with the application of ALARA in controlling gaseous and liquid effluents, and references documents containing acceptable methods of effluent monitoring. Licensees considering disposal by release to the sanitary sewerage system must comply with the requirements of 10 CFR 20.2003. 10 CFR 20.2003 authorizes disposal of licensed material by release into a public sanitary sewerage system if certain conditions are met. Licensees are responsible for demonstrating that licensed materials discharged into the public sewerage system are readily soluble in water or are biological materials that are readily dispersible in water. NRC IN 94-07, "Solubility Criteria for Liquid Effluent Releases to Sanitary Sewerage Under the Revised 10 CFR 20," dated January 1994, provides the criteria for evaluating solubility of waste. Licensees should carefully consider the possibility of reconcentration of radioisotopes that are released into the sewer. The NRC alerted licensees to the potentially significant problem of reconcentration of radionuclides released to sanitary sewerage systems in IN 84-94, "Reconcentration of Radionuclides Involving Discharges into Sanitary Sewerage Systems Permitted Under 10 CFR 20.203 (now 10 CFR 20.2003)," dated December 1984. Applicants should provide procedures that will ensure that all releases of radioactive waste into the sanitary sewerage meet the criteria stated in 10 CFR 20.2003 and do not exceed the monthly and annual limits specified in regulations. Licensees are required to maintain accurate records of all releases of licensed material into the sanitary sewerage. A model procedure for disposal of radioactive waste via sanitary sewer and maintenance of records is described in Appendix V of this guidance document. If your facility maintains a private sewerage treatment system, a septic system, or leach fields, the regulations of 10 CFR 20.2003 are not applicable for releases to these systems (see 10 CFR 20.1003, definition of "sanitary sewerage"). You may make releases of liquids to private sewerage systems, septic systems, or leach fields as effluents released to unrestricted areas pursuant to 10 CFR 20.1302(b)(2)(i). If liquid releases are made to a private sewerage treatment system, septic system, or leach field, the sludges or other solids from these systems may become contaminated with radioactive material. Applicants should describe the monitoring planned for these systems in Item 8.10.7 of your application. Contaminated sludges will be required to be disposed of as radioactive waste using one of the methods described in this Section. Applicants may obtain approval of alternative disposal methods through application to the Commission, as described in 10 CFR 20.2002. IncinerationApplicants who wish to treat or dispose of licensed material by incineration must comply with the requirements of 10 CFR 20.2004. Applicants proposing incineration should be aware that a notice in the Federal Register may be required before disposal of ash as ordinary waste can be approved. However, approval of incineration pursuant to 10 CFR 20.2004 does not require notice in the Federal Register if the ash is disposed as radioactive waste or transferred to a specific licensee. Policy and Guidance Directive PG 8-10, "Disposal of Incinerator Ash as Ordinary Waste," dated January 1997, provides guidance relative to the disposal of ash. A model procedure for incineration of waste is described in Appendix V of this guidance document. Applicants who are considering disposal of radioactive material by incineration should review Regulatory Guide 8.37, "ALARA Levels for Effluents From Materials Facilities," dated July 1993. Regulatory Guide 8.37 deals with the application of ALARA in controlling gaseous and liquid effluents and references documents containing acceptable methods of effluent monitoring. Waste Volume ReductionWaste volume reduction operations that could create a radiological hazard to licensee employees or the general public must be described in detail in the application. A model procedure for waste compaction is described in Appendix V of this guidance document. Disposal of Specific Waste as If it Were Not RadioactiveThe following radioactive wastes may be disposed of as non-radioactive waste:
Applicants should have procedures that will ensure that the above limits are not exceeded and that the disposal of animal tissue or carcasses containing licensed material is in a manner that will not permit their use either as food for humans or animals. Applicants must maintain accurate records of these disposals. BurialLicensees who were previously authorized to bury radioactive materials pursuant to 10 CFR 20.304 prior to January 28, 1981, should describe the locations, condition and current status of these former sites, i.e., controlled or uncontrolled, active monitoring of the site, and current condition of burial site. Other Methods Specifically Approved by the NRC Pursuant to 10 CFR 20.2002Applicants may also request alternate methods for the disposal of radioactive waste generated at their facilities. Such requests must describe the waste containing licensed material, including the physical and chemical properties that may be important to assess risks associated with the waste, and the proposed manner and conditions of waste disposal. Additionally, the applicant must submit its analysis and evaluation of pertinent information on the nature of the environment, nature and location of other affected facilities, and procedures to ensure that radiation doses are maintained ALARA and within regulatory limits. The application should describe the ALARA considerations taken before disposal of radioactive materials. Discuss the potential for unmonitored or unanticipated release of radioactive materials to work areas and from release points, i.e., hoods and incinerator stacks. To be in compliance with the ALARA philosophy stated in 10 CFR 20.1101, radioactive material waste stream concentrations should be a fraction (generally 10% to 20%) of the limits specified in Appendix B, Table II, 10 CFR Part 20. Furthermore, due to the variability of inventory control programs for monitoring disposal and releases of byproduct material in use, a program for physically measuring releases should be in place whenever releases exceed the specified ALARA action point.
Response from Applicant: Provide procedures for waste collection, storage, and the disposal by any of the authorized methods described in this section. Applicants should contact appropriate Regional Office of the NRC for guidance to obtain approval of any method(s) of waste disposal other than those discussed in this section. Note: Applicants do not need to provide information to NRC if they plan to dispose of LLW via transfer to an authorized recipient or to dispose of liquid scintillation media or animals containing low levels of H-3 or C-14, as authorized by 10 CFR 20.2005. 8.12 Item 12: Fees[ Prev | Next | Top of file ] The next two items on NRC Form 313 are to be completed on the form itself. On NRC Form 313, enter the appropriate fee category from 10 CFR 170.31 and the amount of the fee enclosed with the application. 8.13 Item 13: Certification[ Prev | Next | Top of file ] Representatives of the corporation or legal entity filing the application should date and sign NRC Form 313. Representatives signing an application must be authorized to make binding commitments and to sign official documents on behalf of the applicant. As discussed previously in "Management Responsibility," signing the application acknowledges management's commitment and responsibilities for the radiation protection program. NRC will return all unsigned applications for proper signature. Note:
9 Amendments and Renewals 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 is to be modified or changed, the licensee must submit an application for a license amendment before the change takes place. Also, to continue the license after its expiration date, the licensee must submit an application for a license renewal at least 30 days before the expiration date. Applications for license amendment, in addition to the following, must provide the appropriate fee. For renewal and amendment requests, applicants must do the following:
10 Applications For Exemptions[ Prev | Next | Top of file ] Regulations: 10 CFR 19.31; 10 CFR 20.2301, 10 CFR 30.11; 10 CFR 34.111; 10 CFR 35.19; 10 CFR 36.17; and 10 CFR 39.91. Criteria: Licensees may request exemptions to regulations. The licensee must demonstrate that the exemption is authorized by law, will not endanger life or property or the common defense and security, and is otherwise in the public interest. Discussion: Various sections of NRC's regulations address requests for exemptions (e.g., 10 CFR 19.31, 10 CFR 20.2301, 10 CFR 30.11(a)). These regulations state that NRC may grant an exemption, acting on its own initiative or on an application from an interested person. Exemptions are not intended to revise regulations, are not intended for large classes of licenses, and are generally limited to unique situations. Exemption requests must be accompanied by descriptions of the following:
11 Termination of Activities[ Prev | Next | Top of file ] Regulations: 10 CFR 30.34(b); 10 CFR 30.35(g); 10 CFR 30.36(d); 10 CFR 30.36(g); 10 CFR 30.36(h); 10 CFR 30.36(j); 10 CFR 30.51(f); 10 CFR 20.1401; 10 CFR 20.1402; 10 CFR 20.1403; 10 CFR 20.1404; 10 CFR 20.1405; and 10 CFR 20.1406. Criteria: Pursuant to the regulations described above, the licensee must do the following:
Discussion: As discussed above in "Criteria," before a licensee can decide whether it must notify NRC, the licensee must determine whether residual radioactivity is present and, if so, whether the levels make the building or outdoor area unsuitable for release according to NRC requirements. A licensee's determination that a facility is not contaminated is subject to verification by NRC inspection. The permanent cessation of principal activities in an individual room or laboratory may require the licensee to notify NRC if no other licensed activities are being performed in the building. This also applies to buildings that were approved by the broad scope licensee as locations of use but not specifically named on the broad scope license. Draft Regulatory Guide DG-4006, "Demonstrating Radiological Criteria For License Termination," issued July 8, 1998 and NUREG/BR-0241, "NMSS Handbook for Decommissioning Fuel Cycle and Materials Licenses," dated March 1997, contains the current regulatory guidance concerning decommissioning of facilities and termination of licenses. Appendix B of the Handbook contains a comprehensive list of NRC's decommissioning regulations and guidance. NUREG-1575, "Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM)," dated December 1997, should be reviewed by licensees who have large facilities to decommission. An acceptable screening computer code for calculating screening values to demonstrate compliance with the unrestricted dose limits is D and D, Version 1; this was issued on August 20, 1998. Supplemental information on the implementation of the final rule on radiological criteria for license termination was published in the Federal Register (Volume 63, Number 222, Page 64132-64134) on November 18, 1998. This includes the following acceptable license termination screening values of common radionuclides for building surface contamination. Table 11.1 Acceptable License Termination Screening Values of Common Radionuclides for Building Surface Contamination
Response from Applicant: The applicant is not required to submit a response to the NRC during the initial application. However, when the license expires or at the time the licensee ceases operations, then any necessary decommissioning activities must be undertaken, NRC Form 314 or equivalent information must be submitted, and other actions must be taken as summarized in the Criteria. Reference: Copies of NRC Form 314, "Certificate of Disposition of Materials," are available upon request from NRC's Regional Offices. (See Figure 2.1 for addresses and telephone numbers). Appendix A : List of Documents Considered in Development of this NUREG[ Prev | Next | Top of file ] Table A.1 List of Documents Considered in Development of this NUREG
Appendix B : United States Nuclear Regulatory Commission Form 313[ Prev | Next | Top of file ] Form 313 (gif) Appendix C : Suggested Format for Providing Information Requested in Items 5 Through 11 of NRC Form 313[ Prev | Next | Top of file ]
Appendix D : Sample License - Type A[ Prev | Next | Top of file ] A Type A Sample License appears on the following pages. Materials License - Page 1 of 4 Materials License - Page 2 of 4 Materials License - Page 3 of 4 Materials License - Page 4 of 4 Appendix E : Sample License - Type A with Increased Flexibility[ Prev | Next | Top of file ] A Type A with Increased Flexibility Sample License appears on the following pages. Materials License - Page 1 of 5 Materials License - Page 2 of 5 Materials License - Page 3 of 5 Materials License - Page 4 of 5 Materials License - Page 5 of 5 Appendix F : Sample License - Type B[ Prev | Next | Top of file ] A Type B Sample License appears on the following pages. Materials License - Page 1 of 4 Materials License - Page 2 of 4 Materials License - Page 3 of 4 Materials License - Page 4 of 4 Appendix G : Sample License - Type C[ Prev | Next | Top of file ] A Type C Sample License appears on the following pages. Materials License - Page 1 of 4 Materials License - Page 2 of 4 Materials License - Page 3 of 4 Materials License - Page 4 of 4 Appendix H : Information Needed for Transfer of Control Application[ Prev | Next | Top of file ] Licensees must provide full information and obtain NRC's prior written consent before transferring control of the license; some licensees refer to this as "transferring the license." Provide the following information concerning changes of control by the applicant (transferor and/or transferee, as appropriate). If any items are not applicable, so state. 1. The new name of the licensed organization. If there is no change, the licensee should so state. 2. The new licensee contact and telephone number(s) to facilitate communications. 3. Any changes in personnel having control over licensed activities (e.g., officers of a corporation) and any changes in personnel named in the license such as radiation safety officer, authorized users, or any other persons identified in previous license applications as responsible for radiation safety or use of licensed material. The licensee should include information concerning the qualifications, training, and responsibilities of new individuals. 4. An indication of whether the transferor will remain in non-licensed business without the license. 5. A complete, clear description of the transaction, including any transfer of stocks or assets, mergers, etc., so that legal counsel is able, when necessary, to differentiate between name changes and transferring control. 6. A complete description of any planned changes in organization, location, facility, equipment, or procedures (i.e., changes in operating or emergency procedures). 7. A detailed description of any changes in the use, possession, location, or storage of the licensed materials. 8. Any changes in organization, location, facilities, equipment, procedures, or personnel that would require a license amendment even without transferring control. 9. An indication of whether all surveillance items and records (e.g., calibrations, leak tests, surveys, inventories, and accountability requirements) will be current at the time of transfer. Provide a description of the status of all surveillance requirements and records. 10. Confirmation that all records concerning the safe and effective decommissioning of the facility, pursuant to 10 CFR 30.35(g), 40.36(f), 70.25(g), and 72.30(d); public dose; and waste disposal by release to sewers, incineration, radioactive material spills, and on-site burials, have been transferred to the new licensee, if licensed activities will continue at the same location, or to the NRC for license terminations. 11. A description of the status of the facility. Specifically, the presence or absence of contamination should be documented. If contamination is present, will decontamination occur before transfer? If not, does the successor company agree to assume full liability for the decontamination of the facility or site? 12. A description of any decontamination plans, including financial assurance arrangements of the transferee, as specified in 10 CFR 30.35, 40.36, and 70.25. Include information about how the transferee and transferor propose to divide the transferor's assets and responsibility for any cleanup needed at the time of transfer. 13. Confirmation that the transferee agrees to abide by all commitments and representations previously made to NRC by the transferor. These include, but are not limited to: maintaining decommissioning records required by 10 CFR 30.35(g); implementing decontamination activities and decommissioning of the site; and completing corrective actions for open inspection items and enforcement actions. With regard to contamination of facilities and equipment, the transferee should confirm, in writing, that it accepts full liability for the site, and should provide evidence of adequate resources to fund decommissioning; or the transferor should provide a commitment to decontaminate the facility before transferring control. With regard to open inspection items, etc., the transferee should confirm, in writing, that it accepts full responsibility for open inspection items and/or any resulting enforcement actions; or the transferee proposes alternative measures for meeting the requirements; or the transferor provides a commitment to close out all such actions with NRC before license transfer. 14. Documentation that the transferor and transferee agree to transferring control of the licensed material and activity, and the conditions of transfer; and the transferee is made aware of all open inspection items and its responsibility for possible resulting enforcement actions. 15. A commitment by the transferee to abide by all constraints, conditions, requirements, representations, and commitments identified in the existing license. If not, the transferee must provide a description of its program to ensure compliance with the license and regulations. References: The information above is contained in IN 89-25, Revision 1, "Unauthorized Transfer of Ownership or Control of Licensed Activities." See the Notice of Availability (on the inside front cover of this report) to obtain copies. Appendix I : Information Needed for Field Use of Byproduct Material[ Prev | Next | Top of file ] 10 CFR 51.22(c)(14)(v) identifies as a categorical exclusion (from the requirement to prepare an environmental assessment or impact statement) the use of radioactive material for research and development and for educational purposes. However, this categorical exclusion does not encompass, among other things, performance of field studies in which licensed material is deliberately released directly into the environment for purposes of the study (e.g., tagging of animals or insects that remain in the wild). These types of requests may require an environmental report filed by the applicant and an environmental assessment by NRC, 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 (c)(14)(xvi). If you desire to perform field studies in which licensed material is deliberately released to the environment for the purposes of studies, please provide the following information:
Appendix J : Model Delegation of Authority for Radiation Safety Officer[ Prev | Next | Top of file ] MODEL DELEGATION OF AUTHORITY RADIATION SAFETY OFFICER
___________________________ has been appointed Radiation Safety Officer and is responsible for ensuring the safe use of byproduct material. The Radiation Safety Officer is responsible for managing the radiation safety program; identifying radiation safety problems; initiating, recommending, or providing corrective actions; verifying implementation of corrective actions; and ensuring compliance with regulations for the use of byproduct material. The Radiation Safety Officer is hereby delegated the authority necessary to meet these responsibilities. The Radiation Safety Officer has the authority to immediately stop any operations involving the use of byproduct material in which health and safety may be compromised or may result in non-compliance with NRC requirements. Appendix K : Radionuclides Classified According to Relative Toxicity (Excerpted from (IAEA Safety Standard, Safety Series No. 1, "Safe Handling of Radionuclides, 1973 Edition")[ Prev | Next | Top of file ] Radionuclides Classified According to Relative Toxicity (Excerpted from (IAEA Safety Standard, Safety Series No. 1, "Safe Handling of Radionuclides, 1973 Edition") This table is not all inclusive and is meant to be used as an example only. Based on chemical/physical form, need and quantities, your classification scheme may differ from that of the IAEA excerpt. Table K.1: Radionuclides Classified According to Relative Radiotoxicity (Excerpted from IAEA Safety Standard, Safety Series No. 1, "Safe Handling of Radionuclides, 1973 Edition") Group 1: Very High Radiotoxicity
Group 2: High Radiotoxicity
Group 3: Moderate Radiotoxicity
Group 4: Low Radiotoxicity
Table K.2: Limitations on Activities in Various Types of Working Place or Laboratory(4)
Appendix L : Facilities and Equipment Considerations[ Prev | Next | Top of file ] Below is a list of topics that should be considered when developing a description of the facilities and equipment that a licensee will use or otherwise have available. Not every applicant will need to address each topic in its application.
Appendix M : Sample Audit Program - Non-Medical[ Prev | Next | Top of file ] The following audit form may be used by licensees to self-assess the adequacy of the licensed program, identify program weaknesses, and allow licensees to take early corrective actions (before an NRC inspection). This form is not intended to be all inclusive. During an audit, the auditor needs to keep in mind not only the requirements of NRC's regulations, but also the licensee's commitments in its applications and other correspondence with NRC. Licensees are encouraged to modify the audit form as needed to include items specific to their licensed program. The auditor should also evaluate whether the licensee is maintaining exposures to workers and the general public as low as is reasonably achievable (ALARA) and, if not, make suggestions for improvement. References are included at the end of this audit form. 1. MANAGEMENT OVERSIGHT: 2. AMENDMENTS AND PROGRAM CHANGES: 3. FACILITIES: 4. EQUIPMENT AND INSTRUMENTATION: 5. MATERIAL USE, CONTROL, AND TRANSFER: 6. AREA RADIATION SURVEYS AND CONTAMINATION CONTROL: 7. TRAINING AND INSTRUCTIONS TO WORKERS: 8. RADIATION PROTECTION: 9. RADIOACTIVE WASTE MANAGEMENT: 10. DECOMMISSIONING: 11. TRANSPORTATION: 12. NOTIFICATIONS AND REPORTS: 13. POSTING AND LABELING: 14. INDEPENDENT AND CONFIRMATORY MEASUREMENTS: 15. AUDIT FINDINGS: REFERENCES
Appendix N : Reporting Requirements[ Prev | Next | Top of file ] Typical NRC Notifications And/Or Reports
Note:Telephone notifications shall be made to the NRC Operations Center at 301-951-0550, except as noted. Appendix O : Instrument Specifications and Model Survey Instrument and Air Sampler Calibration Program[ Prev | Next | Top of file ] Radiation Monitoring Instrument Specifications[ Prev | Next | Top of file ] The specifications in Table O.1 will help applicants and licensees choose the proper radiation detection equipment for monitoring the radiological conditions at their facility(ies). Table O.1 Typical Survey Instruments1 (instruments used to measure radiological conditions at licensed facilities).
Model Instrument Calibration Program[ Prev | Next | Top of file ] TrainingBefore allowing an individual to perform survey instrument calibrations, the RSO will ensure that he or she has sufficient training and experience to perform independent survey instrument calibrations. Classroom training may be in the form of lecture, videotape, or self-study and will cover the following subject areas:
Appropriate on-the-job-training consists of the following:
Facilities and Equipment for Calibration of Dose Rate or Exposure Rate Instruments[ Prev | Next | Top of file ]
Model Procedure for Calibrating Survey InstrumentsA radioactive sealed source(s) used for calibrating survey instruments will:
The three kinds of scales frequently used on dose or dose rate survey meters are calibrated as follows:
Surface Contamination Measurement Instruments(5)
Model Procedures for Calibrating, Liquid Scintillation Counters, Gamma Counters, Gas Flow Proportional Counters, and Multichannel Analyzers[ Prev | Next | Top of file ] A radioactive sealed source used for calibrating instruments will do the following:
Calibration
Calibration RecordsCalibration records, for all survey instruments, should indicate the procedure used and the data obtained. The description of the calibration should include:
The following information will be attached to the instrument as a calibration sticker or tag:
Air Sampler CalibrationIn order to assess accurately the air concentration of radioactive materials in a given location, the volume of air sampled and the quantity of contaminant in the sample must be determined. Accurate determination of the volume of air sampled requires standard, reproducible, and periodic calibration of the air metering devices that are used with air sampling instruments. The publication entitled "Air Sampling Instruments" found in the 7th Edition, American Conference of Governmental Industrial Hygienists, 1989, provides guidance on total air sample volume calibration methods acceptable to NRC staff, as supplemented below. Frequency of Calibration
Error Limit For Measurement of Air Sample VolumeMost methods of calibrating airflow or air volume metering devices require direct comparison to a primary or secondary standard instrument, to determine a calibration curve or a correction factor. An example of a primary standard is a spirometer that measures total air volume directly with high precision by liquid displacement. An example of a secondary standard is a wet-test meter that has been calibrated against a primary standard. The following are significant errors associated with determining the total air volume sampled:
EV = [ES2 + EC2 + Et2]1/2 The most probable value of the cumulative error EV, in the determination of total volume, should be less than 20%. A sample calculation of the most probable value of the cumulative error in total volume measured is as follows: If accuracies of the scale reading, the calibration factor, and sample time are ± 4, 2, and 1%, respectively, and there are no other significant sources of error, the cumulative error would be: EV = [42 + 22 + 12]1/2 = 4.58% or approx. 5% If there are significant differences in pressure and temperature between the calibration site and the sampling site, appropriate corrections should be made using the ideal gas laws provided below: Vs = V1 * (P1/760) * (273/T1) where Vs = volume at standard pressure and temperature (760 mm Hg and 273K V1 = volume measured at conditions P1 and T1 T1 = temperature of V1 in K P1 = pressure of V1 in mm Hg Documentation of Calibration of Air Metering DevicesThe licensee should maintain records of all routine and special calibrations of airflow or volume metering devices, including the primary or secondary standard used, method employed, and estimates of accuracy of the calibrated metering devices. All instruments should be clearly labeled as to the date and results of the most recent calibration and should include the appropriate correction factors to be used. References: See the Notice of Availability on the inside front cover of this report to obtain a copy of: 1. Draft Regulatory Guide FC 413-4, "Guide for the Preparation of Applications for Licenses for the Use of Radioactive Materials in Calibrating Radiation Survey and Monitoring Instruments," June 1985. 2. Regulatory Guide 8.25, Revision 1, "Air Sampling in the Workplace," June 1992. 3. NUREG-1400, "Air Sampling in the Workplace," September 1993. Additional References: 4. The Health Physics & Radiological Health Handbook, 3rd Ed. Edited by Bernard Shleien, Lester A. Slaback, Jr., and Brian Kent Birky, 1998. 5. ANSI N323A-1997, "Radiation Protection Instrumentation Test and Calibration, Portable Survey Instruments." Copies may be obtained from the American National Standards Institute, 1430 Broadway, New York, NY 10018 or ordered electronically at the following address: <http://www.ansi.org>. 6. "Air Sampling Instruments," American Conference of Governmental Industrial Hygienists, 7th Edition, 1989. 7. DOE G 441.1-7, "Portable Monitoring Instrument Calibration Guide," U.S. Department of Energy, March 1999. 8. DOE G 441.1-8, "Air Monitoring Guide," U.S. Department of Energy," March 1999. Appendix P : Material Receipt and Accountability[ Prev | Next | Top of file ] Material Receipt and Accountability[ Prev | Next | Top of file ] Sample Model Procedure for Ordering and Receiving Radioactive Material
Sample MemorandumMemorandum for Security Personnel From: RSO, President, Vice President, etc. Subject: Procedures for Receipt of Packages Containing Radioactive Material If the package appears to be damaged, immediately contact the RSO. Ask the carrier to remain at the facility until it can be determined that neither the carrier nor the vehicle is contaminated. Any packages containing radioactive material that arrive between (state times, e.g., 4:30 p.m. and 7:00 a.m. or on Saturdays or Sundays) shall be signed for by the security guard (or other designated trained individual) on duty and taken immediately to the designated receiving area. Security personnel (or other designated trained individual) should unlock the door, place the package in the designated secured storage area, and re-lock the door. Radiation Safety Officer (RSO): _______________________________________________ Office Phone: _______________________________________________ Home Phone: _______________________________________________ Sample Instructions to Personnel Involved in Material Receipt[ Prev | Next | Top of file ] Shipping and Receiving PersonnelDuring normal working hours, immediately upon receipt of any package of licensed material, each package must be visually inspected for any signs of shipping damage, such as crushed or punctured containers or signs of dampness. Any obvious damage must be reported to the RSO immediately. Do not touch any package suspected of leaking. Request the person delivering the package to remain until monitored by the RSO. Outside of normal working hours (e.g., nights, weekends, and holidays), deliveries will usually be handled by security personnel (or other trained individuals), as described in the above procedures. Since certain packages of licensed material will have detectable external radiation, they should be sent immediately to a designated storage area, where they will be checked for contamination and external radiation level as soon as practical. They should not be allowed to remain in the receiving area any longer than necessary, as they may be a source of exposure for receiving personnel. If the instructions are not clear, or if there are questions regarding receiving packages containing radioactive material, please contact: Name _______________________________________________ Phone _______________________________________________
Materials Possessed Under a General License, or Received from a General Licensee[ Prev | Next | Top of file ] Individuals at your facility may receive and use material pursuant to a general license as authorized in 10 CFR Part 31. Generally licensed materials are distributed by manufacturers authorized by the NRC to distribute materials directly to the persons who will use them under a general license. Some common items include nickel-63 sources in electron capture detectors in certain gas chromatographs, tritium gas contained in self-luminous EXIT signs, calibration sources in liquid scintillation counters, and uranyl acetate used for staining electron microscope samples. You should develop a policy for how your institution will require responsible use and tracking of this material. Generally licensed material may also be received when a general licensee transfers a generally licensed item to a specific license that is authorized to possess the material. However, when received by the specific licensee (your facility), the item must now be considered as specifically licensed and should be tracked with other specifically licensed material. Sample Model Procedure for Safely Opening Packages Containing Licensed Materials[ Prev | Next | Top of file ] For packages received under the specific license, authorized individuals shall implement procedures for opening each package, as follows:
Sample Transfer Policy Statements[ Prev | Next | Top of file ] Internal TransfersLicensed materials that may be transferred from one department or laboratory or AU's control to another should have prior approval from the RSO. A written transfer procedure should be developed by the RSO to ensure that transfers are done in accordance with the conditions of the license. All transfers shall be done in a way that minimizes the probability of spillage or breakage. Double containers should be used, including suitable shielding, for such transfers. External TransfersLicensed material shall not be transferred or shipped from one institution to another without the approval of the RSO. Such transfers/shipments must be packaged and labeled in accordance with DOT, NRC, or U.S. Postal Service Regulations, whichever is applicable. GiftsOn occasion, licensees may be offered or have donated licensed materials by other individuals as gifts (e.g., a retiring medical practitioner donating his cesium needles to the university medical center). All such gifts of radioactive materials must be transferred to the licensee and handled in accordance with NRC requirements and the conditions of the license. In any case, the RSO should approve the gift prior to the transfer. Additional References: 1. DOE G 441.13-1, "Sealed Radioactive Source Accountability and Control," U.S. Department of Energy," April 1998. Appendix Q : Methodology for Determining Public Dose[ Prev | Next | Top of file ] Methodology for Determining Public Dose[ Prev | Next | Top of file ] This appendix describes methods for determining radiation doses to members of the public. Licensees must ensure that:
he licensee may show compliance with the annual dose limit for individual members of the public by:
In order to perform a dose assessment, the licensee should identify all potential sources of external and internal radiation exposure to members of the public and all locations of use, transport, and storage of radioactive material at the facility. The licensee must then take radiation measurements or perform calculations to demonstrate compliance. Measurements[ Prev | Next | Top of file ] The licensee may use measurements to demonstrate that the average annual releases are within regulatory limits, as well as to demonstrate that the TEDE to the individual likely to receive the highest dose at the boundary of the unrestricted area does not exceed 1 mSv (100 mrem). These measurements may include:
The method used to measure dose will depend on the nature of the radiation source. If the source of radiation is constant, it may be adequate to measure the dose rate and integrate it over time. If the source of radiation differs or changes over time, it may be necessary to perform continuous measurements. Radioactivity releases may be determined by effluent monitoring or by effluent sampling and analysis. Airborne effluents may be discharged when volatile materials are used, such as during iodinations, but the discharge itself is usually not continuous since volatile materials are often used periodically rather than continuously. Liquid effluents may be discharged continuously or may be stored and subsequently discharged on a batch basis. For each type of source and for each route of potential exposure, consider the location of measurement points, whether continuous or periodic monitoring is required, the frequency of sampling and measurement, and any additional information. For discharges of airborne radionuclides, for example, it may be necessary to obtain information on the efficiency of filters and the air flow rate of the discharge system, as well as meteorological data and the distance to the nearest individual member of the public. Calculation Method[ Prev | Next | Top of file ] Using a calculation method, the licensee must determine the highest dose an individual is likely to receive at the boundary of the unrestricted area. The licensee must take into account the individual's exposure from external sources and the concentration of radionuclides in gaseous and liquid releases. In practice, the licensee may wish to make conservative assumptions to simplify the dose calculation. The public dose limit applies to the individual who is likely to receive the highest dose from licensed operations. Therefore, the dose calculations must consider the location with the potential for the highest internal and external exposures. An extremely conservative calculation would assume that the individual was continuously present 24 hours a day, 365 days a year, or an occupancy factor of 1 (see Table Q.1). If the result of the calculation using an occupancy factor of 1 demonstrates that the public dose limit is not exceeded, then there is no need for further evaluation. If, however, the licensee would rather choose a more realistic assumption of the individual's occupancy at the points of highest internal and external exposures, then the licensee may use the occupancy factors in Table Q.1 or may calculate a specific occupancy factor by determining the likely fraction of time that the individual is present. Table Q.1 Standard Occupancy Factors
Records[ Prev | Next | Top of file ] The licensee must maintain records to demonstrate compliance with the dose limit for individual members of the public, until the Commission terminates the license. In general, survey and monitoring records of ambient radiation and effluent radioactivity should be adequate. Appendix R : General Topics for Safe Use of Radioisotopes and Model Emergency Procedures[ Prev | Next | Top of file ] General Topics for Safe Use of Radioisotopes[ Prev | Next | Top of file ] Each laboratory or area where radioactive material is used or stored should have general rules, so that workers know what is required. Typical instructions should include:
Radionuclides-specific ProceduresLicensees should develop written procedures for use of different radionuclides so that users know the types of shielding, protective clothing, survey instruments, surveys, and decontamination activities that are required. Examples of such procedures are included below.
Model Procedures for Handling Emergencies[ Prev | Next | Top of file ] General Safety Procedures to Handle Spills
The decision to implement a major spill procedure instead of a minor spill procedure depends on many incident specific variables, such as the number of individuals affected; other hazards present; the likelihood of spread of contamination; and types of surfaces contaminated as well as the radiotoxicity of the spilled material. For some spills of short-lived radionuclides, the best spill procedure may be restricted access pending complete decay. The applicant should establish criteria for determining when the major spill procedure and minor spill procedure should be utilized. Minor Spills of Liquids and Solids
Major Spills of Liquids and Solids
Incidents Involving Radioactive Dusts, Mists, Fumes, Organic Vapors, and Gases
Minor Fires
Fires, Explosions, or Major Emergencies
Procedures for Collecting Bioassay Samples[ Prev | Next | Top of file ] In the event of an emergency where an individual may become contaminated and radioactive material was taken into the body through skin absorption or other means, or is suspected of having ingested or inhaled radioactive material, an estimate of the amount of material taken into the body may be required. The following items should be considered in developing your procedures:
Appendix S : Radiation Safety Survey Topics[ Prev | Next | Top of file ] Radiation Safety Survey Topics[ Prev | Next | Top of file ] This Appendix provides applicants and licensees with additional information on surveys, including training requirements, survey frequency, contamination limits, and bioassays. Training[ Prev | Next | Top of file ] Before allowing an individual to perform surveys, the RSO (or for Type C broad scopes, the individual designated as responsible for the day-to-day operation of the radiation safety program) will ensure that he or she has sufficient training and experience to perform surveys independently. Academic training may be in the form of lecture, videotape, or self-study and will cover the following subject areas:
Appropriate on-the-job-training consists of the following:
Facilities and Equipment[ Prev | Next | Top of file ]
Ambient Radiation Level Surveys[ Prev | Next | Top of file ]
Contamination Surveys[ Prev | Next | Top of file ] Licensees' contamination surveys should be sufficient to identify areas of contamination that might result in doses to workers or to the public. Combined removable and fixed contamination should be surveyed using appropriate radiation detection equipment. Removable contamination can be detected and measured through a wipe test of the surface, which is counted in an appropriate counting instrument, such as a liquid scintillation counter, a sodium iodide or germanium gamma counter, or a proportional alpha/beta counter. Contamination surveys should be performed:
Contamination Survey Frequency[ Prev | Next | Top of file ] Personnel should survey for contamination in locations where individuals are working with an unsealed form of radioactive material in an amount greater than or equal to 10% of the smallest annual limit on intake (ALI) (either the inhalation or ingestion ALI) listed for that Radionuclides in 10 CFR Part 20. These surveys should be done at a frequency appropriate to the types and quantities of radioactive materials in use, but at a minimum quarterly. If amounts are used that are greater than or equal to the smallest ALI listed for that Radionuclides in 10 CFR Part 20, detailed, documented surveys should be performed at least monthly. Table S.1 contains suggested contamination survey frequency from Regulatory Guide 8.23 (See Tables S.2, S.3, and S.4 for alternate survey frequencies). Table S.1 Suggested Frequency of Contamination Surveys from Regulatory Guide 8.23
Alternate Survey Frequency[ Prev | Next | Top of file ] Classification of LaboratoriesTable S.2 Survey Frequency Category
Proportional fractions are to be used for more than one isotope. Table S.3 Survey Frequency Category Modifiers
The object is to determine how often to survey the laboratory. To do this, multiply the activity range under LOW, MEDIUM, and HIGH survey frequency by the appropriate Modifying Factor to construct a new set of mCi ranges for LOW, MEDIUM, and HIGH survey frequency. Survey Frequency:
Table S.4 Isotope Groups
Contamination in Unrestricted Areas[ Prev | Next | Top of file ] Contamination found in unrestricted areas should be immediately decontaminated to background levels. When it is not possible to get to background levels, the licensee must ensure that the amounts do not exceed the contamination levels listed in Table S.5. Table S.5 Acceptable Surface Contamination Levels
When equipment or facilities that are potentially contaminated are to be released for unrestricted use, the above table provides the maximum acceptable residual levels. To the extent practicable, it is appropriate to decontaminate to below these levels. Surface contamination surveys should be conducted for both removable and fixed contamination before these facilities or equipment are released from restricted to unrestricted use, to ensure that they meet these limits. A standardized method for smear testing of a relatively uniform area should be used to aid in comparing contamination at different times and places. A smear taken from an area of about 100 cm2 is acceptable to indicate levels of removable contamination. Survey Record Requirements[ Prev | Next | Top of file ] Each survey record should include the following:
Licensees should record contamination levels observed and procedures followed for incidents involving contamination of individuals. The record should include names of individuals involved, description of work activities, calculated dose, probable causes (including root causes), steps taken to reduce future incidents of contamination, times and dates, and the surveyor's signature. Air Monitoring in the Workplace[ Prev | Next | Top of file ] Air monitoring can be used to do the following:
If bioassay measurements are used to determine worker doses of record, air sampling may be used to determine time of intake and to determine which workers should have bioassay measurements. The use of engineering controls and a good air sampling program can eliminate the need for bioassays. Refer to Regulatory Guide 8.25, Revision 1, "Air Sampling in the Workplace," dated June 1992, and NUREG-1400, "Air Sampling in the Workplace," dated September 1993, for further guidance on the air sampling. Airborne Effluent Release Monitoring[ Prev | Next | Top of file ] When practicable, airborne radioactive effluents should be released from monitored release points (e.g., monitored stacks, discharges, vents) to provide accurate measurements to estimate public exposure. Licensees should verify the performance of effluent monitoring systems by regular calibration (at least annually) to ensure their reliability. Regulatory Guide 4.20, "Constraints on Release of Airborne Radioactive Materials to the Environment for Licensees Other Than Power Reactors," dated December 1996, provides guidance on methods acceptable (calculation or COMPLY code) to NRC for compliance with the constraint on air emissions to the environment. Regulatory Guide 8.37, "ALARA Levels for Effluents from Materials Facilities," dated July 1993, provides guidance on designing an acceptable program for establishing and maintaining ALARA levels for gaseous and liquid effluents at materials facilities. For release points for which monitoring is not practicable, the licensee should estimate the magnitude of the unmonitored effluents. These unmonitored releases will occur anytime unsealed material is handled outside a fume hood or other device that will control the releases. The licensee should include these estimates when demonstrating compliance with dose limits and ALARA goals. Unmonitored releases may be estimated based on the quantity of material used in these areas, the number of procedures performed, or other appropriate methods. The unmonitored effluents should not exceed 30% of the total estimated effluent releases or 10% of the permissible air effluent concentrations found on column 1 of Table 2 in 10 CFR Part 20, Appendix B, whichever is greater. Effluent monitoring systems should be designed in accordance with ANSI N13.1 (1969), "Document to Sampling Airborne Radioactive Materials in Nuclear Facilities," and ANSI N42.18, "Specification and Performance of On-site Instrumentation for Continuously Monitoring Radioactive Effluents." Liquid Effluent Release Monitoring[ Prev | Next | Top of file ] The licensee should evaluate the concentrations of radioactive material in water that is released to the environment and to the sanitary sewer. The licensee must show that these releases meet the limits in 10 CFR 20.1301 and 20.2003, respectively. The topic of sanitary sewerage releases is more fully discussed in Appendix X. Bioassay Monitoring[ Prev | Next | Top of file ] Frequency of Required Bioassay MeasurementsDetermining the appropriate frequency of routine bioassay measurements depends upon the exposure potential and the physical and chemical characteristics of the radioactive material and the route of entry to the body. Consider the following elements:
Bioassay measurements used for demonstrating compliance with the occupational dose limits should be conducted often enough to identify and quantify potential exposures and resultant intakes that, during any year, are likely to collectively exceed 0.1 times the ALI. The 10% ALI criterion is consistent with 10 CFR 20.1502(b), which requires licensees to monitor intakes and assess occupational doses for exposed individuals who are likely to exceed 10% of the applicable limit (i.e., intakes likely to exceed 0.1 ALI for adults). Separate categories of bioassay measurements, routine measurements and special measurements further determine the frequency and scope of measurements. Routine Measurements[ Prev | Next | Top of file ] Routine measurements include baseline measurements, periodic measurements, and termination measurements. These measurements should be conducted to confirm that appropriate controls exist and to assess dose. The method of bioassay selected (for example, whole body counting, urinalysis, etc.) and the samples collected will vary according to the radionuclides and the compound to which it is attached. Sample collection procedures should be developed to ensure that appropriate types, sizes, and numbers of samples are collected that will provide appropriate physiological information for the dose assessment. An individual's baseline measurement of radioactive material within the body should be conducted before beginning work that involves exposure to radiation or radioactive materials for which monitoring is required. In addition to the baseline measurements, periodic bioassay measurements should be performed. The frequency of periodic measurements should be based on the likelihood of significant exposure of the individual. In determining the worker's likely exposure, consider such information as the worker's access, work practices, measured levels of airborne radioactive material, and exposure time. Periodic measurements should be made when the cumulative exposure to airborne radioactivity since the most recent bioassay measurement is > 0.02 ALI (40 DAC hours). Noble gases and airborne particulates with a radioactive half-life of less than 2 hours should be excluded from the evaluation, since external exposure generally controls these radionuclides. At a minimum, periodic measurements should be conducted annually. Periodic measurements provide additional information on any long-term accumulation and retention of radioactive material in the body, especially for exposures to concentrations of airborne radioactive material below monitoring thresholds. When an individual is no longer subject to the bioassay program because of change in employment status, termination bioassay measurement should be made, when practicable, to ensure that any unknown intakes are quantified. Special Monitoring[ Prev | Next | Top of file ] Because of uncertainty in the time of intakes and the absence of other data related to the exposure (e.g., physical and chemical forms, exposure duration), correlating positive results to actual intakes for routine measurements can sometimes be difficult. Abnormal and inadvertent intakes from situations such as a failed respiratory protective device, inadequate engineering controls, inadvertent ingestion, contamination of a wound, or skin absorption, should be evaluated on a case-by-case basis. When determining whether potential intakes should be evaluated, consider the following circumstances:
References:
Appendix T : Model Leak Test Procedures[ Prev | Next | Top of file ] This appendix provides applicants and licensees with model leak test procedures and sample calculations for determining activity on a wipe test sample. Frequency for Conducting Leak Tests of Sealed Sources[ Prev | Next | Top of file ] Leak tests will be conducted at the frequency specified in the respective SSD Registration Certificate. Procedure for Performing Leak Testing and Analysis[ Prev | Next | Top of file ] For each source to be tested, list identifying information such as manufacturer, model number, serial number, radionuclide, and activity.
where: cpm = counts per minute std = standard bkg = background Bq = becquerels
Appendix U : Transportation Requirements[ Prev | Next | Top of file ] The major areas in the DOT regulations that are most relevant for transportation of licensed material shipped as Type A quantities are as follows:
DOT shipping papers (49 CFR 172.200-205) Marking Packages (49 CFR 172.300-338) Labeling Packages (49 CFR 172.400-450) Placarding Vehicles (49 CFR 172.500-560) Minimum required packaging for Class 7 (Radioactive) Materials Package and vehicle contamination limits (49 CFR 173.443) Example Certificate Enclosed In/or on Package, Included with the Packing List or Otherwise Forwarded with the Package
Appendix V : Model Waste Management Procedures[ Prev | Next | Top of file ] General Guidelines[ Prev | Next | Top of file ]
Model Procedure for Disposal by Decay-in-Storage (DIS)[ Prev | Next | Top of file ] Applicants should assure that adequate space and facilities are available for the storage of waste for DIS. Licensees can minimize the need for storage space if the waste is segregated according to physical half-life.
All radiation labels must be defaced or removed from containers and packages prior to disposal as ordinary trash. Syringes/needles placed into sealed waste containers for decay do not need the labels removed, provided that the following is done: waste barrels are sealed prior to delivery to the waste disposal firm and delivered directly from the licensee's facility; labels are removed from the waste barrels/containers; and that the waste is incinerated, not placed in a landfill; and the waste disposal firm is cautioned not to open the container prior to incineration. Model Procedure for Disposal of Liquids Into Sanitary Sewerage[ Prev | Next | Top of file ]
Model Procedure for Incineration[ Prev | Next | Top of file ] These guidelines apply to noncommercial waste disposal, i.e., incineration of a licensee's own waste. You do not need specific NRC approval in order to incinerate certain categories of radioactive waste. For example, 10 CFR 20.2005 provides that tritium and carbon-14 in low level concentrations in liquid scintillation media and animal tissue may be disposed of without regard to radioactivity. After you review your program and confirm that you have waste that requires specific NRC approval for incineration, please provide the following information.
Model Procedure for Compaction[ Prev | Next | Top of file ] The following information should be provided from licensees who propose to compact waste.
Appendix W : Addendum: Summary of Comments Received on Draft NUREG-1556, Vol. 11, and Other Changes[ Prev | Next | Top of file ] Comments Provided by the California Chapter of the American College of Nuclear Physicians (ACNP-CA), Dated December 2, 1998[ Prev | Next | Top of file ]
Comments Provided by Mallinckrodt, Inc. (St. Louis, MO), Dated December 7, 1998[ Prev | Next | Top of file ]
Comments Provided by UCLA School of Medicine, Harbor - UCLA Medical Center, Department of Radiology (Torrence, CA), Dated December 21, 1998[ Prev | Next | Top of file ]
Comments Provided by Michigan State University, Dated December 21, 1998[ Prev | Next | Top of file ]
Comments Received from the Council on Radionuclides and Radiopharmaceuticals, Inc. (CORAR) on December 3, 1998[ Prev | Next | Top of file ]
In their December 3, 1998 letter, CORAR also recommended that NRC review comments they submitted to NRC on February 4, 1997, in response to the proposed revision of 10 CFR Part 33, "Specific Domestic Licenses of Broad Scope for Byproduct Material" and NRC Draft Regulatory Guide DG-0005, "Applications for Licenses of Broad Scope." In that document, CORAR stated that their main concern was that NRC was proposing to prescribe how licensees were to structure their organization and how to design duties and responsibilities within the organization. CORAR maintained that such suggestions should be presented in a Regulatory Guide, as examples of how to organize a radiation protection program, rather than in a regulation. In addition, CORAR provided the following comments:
NRC agreed with the comments expressed by CORAR in their February 4, 1997 submission. Comments from CORAR and similar comments provided by others resulted in the withdrawal of the proposed revision of 10 CFR Part 33. NRC believes that NUREG-1556 Volume 11 addresses all of the concerns addressed by CORAR in their February 4, 1997 submission. Comments Provided by Illinois Department of Nuclear Safety, Dated December 11, 1998[ Prev | Top of file ]
[ Top of file ] 1. See "Amendments and Renewals to a License" later in this document. Licensees are required to request and obtain an amendment to the license before making changes in their radiation safety program. Examples of changes that require amendment are change of Radiation Safety Officer (RSO) and increases in the license possession limit. 2. See "Amendments and Renewals to a License" later in this document. Licensees are required to request and obtain an amendment to the license before making changes in their radiation safety program. Examples of changes that require amendment are change of Radiation Safety Officer (RSO) and increases in the license possession limit. 3. NUREG-0767, "Criteria for Selection of Fuel Cycle and Major Materials Licenses Needing Radiological Contingency Plans," dated July 1981, was superseded by 10 CFR 30.32(i) and 30.72; NUREG-0762, "Standard Format and Content for Radiological Contingency Plans for Fuel Cycle and Materials Facilities," dated November 1987, was superseded by Regulatory Guide 3.67; and NUREG-0810, "Standard Review Plan for the Review of Radiological Contingency Plans for Fuel Cycle and Materials Facilities," dated April 1987, was superseded by Policy and Guidance Directive 84-14, Revision 1, "Standard Review Plan for Emergency Plans for Fuel Cycle and Materials Licensees." 4. Laboratory Types correspond to the laboratory classification criteria of IAEA Safety Standard, Safety Series No. 1. Type C is a good quality chemical laboratory. Type B is a specially designed radioisotope laboratory. Type A is a specially designed laboratory for handling large activities of highly radioactive materials. In the case of a conventional modern chemical laboratory with adequate ventilation and non-porous work surfaces, it may be possible to increase the upper limits of activity for Type C laboratories toward the limits for Type B for toxicity groups 3 and 4. 5. ANSI N323A-1997, "Radiation Protection Instrumentation Test and Calibration." 6. The calibration factor should be based on two kinds of determinations. First, correction factors should be determined at several flow rates distributed over the full-scale range. Each flow rate correction factor should be determined while adjusting flow rates upscale and again while adjusting flow rates downscale, and the two sets of data should be compared. Second, subsequent calibrations should compare the new correction factors to those determined during the previous calibration. If observed differences are significant compared to the overall volume error limit of 20%, an additional error term should be included in the calculation above. |
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