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Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator (NUREG-1556, Vol. 21)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 InformationDate Completed: October 2007 Prepared by Office of Federal and State Materials and Environmental Management Programs Table of Contents
Abstract[ Prev | Next | Top of file ] On August 8, 2005, the Energy Policy Act of 2005 (EPAct) gave NRC new regulatory authority over additional byproduct material. This new byproduct material now also includes naturally occurring materials, such as discrete sources of radium-226 (Ra-226), and accelerator-produced radioactive materials (NARM). This guidance document provides assistance to applicants in preparing a license application for a specific possession license for the production of radioactive material using an accelerator. This guidance document should be used for activities that take place once radioactive materials are produced by the accelerator, which include material in the target and associated activation products, to the transfer or distribution of material to another license for preparation of the final product (e.g., radioactive drugs). This document does not include information for the operation of the accelerator, as NRC does not regulate the accelerator or its operation. Also, neutron accelerators and other types of accelerators (e.g., linear accelerators) that are used to produce particle beams and not radioactive materials will not be covered in this document. This report also provides guidance to applicants in applying for authorization for the production and noncommercial distribution of Positron Emission Tomography (PET) radioactive drugs to medical use licensees in a consortium. This document describes both the methods acceptable to NRC license reviewers in implementing the regulations and the techniques used by the reviewers in evaluating the application to determine if the proposed activities are acceptable for licensing purposes. Paperwork Reduction Act Statement This NUREG contains information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These information collections were approved by the Office of Management and Budget (OMB), approval numbers 3150-0044; 3150-0014; 3150-0035; 3150-0017; 3150-0016; 3150-0001; 3150-0015; 3150-0010; 3150-0021; 3150-0135; 3150-0008; 3150-0120; and 3150-0028. Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number. Figures[ Prev | Next | Top of file ] 2.1 U.S. Map Location of NRC Offices and Agreement States 8.1 Location of Possession and/or Use 8.2 Financial Assurance for Decommissioning 8.3 Records Important to Decommissioning 8.5 Facility Diagram for a Radioactive Materials Production Facility 8.6 Shielded Protective Enclosure (Hot Cell) With Remote Manipulators 8.7 Examples of Portable Instruments Used in Laboratory Settings 8.8 Annual Dose Limits for Occupationally Exposed Adults 8.10 Proper Handling of Incident 8.13 Air and Water Effluents from a Production Facility Foreword[ Prev | Next | Top of file ] The United States Nuclear Regulatory Commission (NRC) is using Business Process Redesign (BPR) techniques to redesign its materials licensing process. This effort is described in NUREG-1539, "Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated April 1996. A critical element of the new process is the consolidation and updating of numerous guidance documents into a NUREG-series of reports. Below is a list of volumes currently included in the NUREG-1556 series, "Consolidated Guidance About Materials Licenses."
The current document, NUREG-1556, Vol. 21, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator," dated May 2007, is intended for use by applicants, licensees, NRC license reviewers, and other NRC personnel. A team composed of NRC staff from headquarters and regional offices prepared this document, drawing on their collective experience in radiation safety in general and as specifically applied to accelerator-produced radioactive materials. This report represents a step in the transition from the current paper-based process to the new electronic process. This document is available on the Internet at the following address: http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v21/. NUREG-1556, Vol. 21 is not a substitute for NRC regulations, and compliance 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. _________________________________________ Acknowledgments[ Prev | Next | Top of file ] The writing team thanks the individuals listed below for assisting in the development and review of the report. All participants provided valuable insights, observations, and recommendations. The team would like to thank NRC regional offices, and all of the States that provided comments and technical information that assisted in the development of this report. The team also thanks Justine Cowan, Loleta Dixon, Agi Seaton, and Roxanne Summers of Computer Sciences Corporation (CSC). The Participants Bailey, Edgar D.Bakhsh, Sarah R. Beardsley, Michelle R. Blanton, Richard L. Carrico, J. Bruce Howe, Donna-Beth Katanic, Janine F. Taylor, Torre M. Tobin, Jennifer C. Ullrich, Elizabeth X. White, Duane E. Williamson, Michael K. ABBREVIATIONS[ Prev | Next | Top of file ]
1 PURPOSE OF REPORT[ Prev | Next | Top of file ] This report provides guidance to applicants that produce radioactive materials using an accelerator(s). It provides guidance to an applicant in preparing a license application as well as NRC criteria for evaluating the license application. The body of this document contains the standard requirements and guidance for the possession and distribution of radioactive material (e.g., radiochemicals) that is produced by an accelerator(s), which is located at the applicant's facility. This report also provides guidance to applicants in applying for authorization for the production and noncommercial distribution of Positron Emission Tomography (PET) radioactive drugs to medical use licensees in a consortium. This report was developed in accordance with the Energy policy Act of 2005 (EPAct), which expanded the definition of byproduct material as defined in Section 11(e) of the Atomic Energy Act of 1954 (AEA), placing additional material under NRC regulatory authority to include accelerator-produced radioactive materials and naturally occurring radioactive material such as discrete sources of radium-226 (Ra-226). This report does not provide guidance on the operation of an accelerator because NRC does not regulate the operation of the accelerator. Also, this report is not to be used by materials manufacturers that process raw material and/or sources without the use of an accelerator and distribute the processed materials to users as finished products. For manufacturing and distribution of byproduct material, see NUREG-1556, Vol. 12, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Possession Licenses for Manufacturing and Distribution," dated December 2000. This report identifies the information needed to complete NRC Form 313, "Application for Material License," (Appendix B) for the possession and use of byproduct material. If the applicant requires another type of license(s) for its activities such as a commercial radiopharmacy license or a broad-scope license, also refer to the other guidance documents in this NUREG-1556 series, which are available at http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/. The information collection requirements in Title 10 of the Code of Federal Regulations (CFR), Part 30, and NRC Form 313 have been approved under the Office of Management and Budget (OMB) Clearance Numbers 3150-0017, 3150-0001, 3150-0020, 3150-0009, and 3150-0120, respectively. As a guidance document intended to assist a wide variety of applicants, this report contains a considerable amount of information about how licensees may choose to implement their programs to meet NRC regulatory requirements. The information in this document is not intended to impose any conditions beyond those required by the regulations in 10 CFR. This report provides specific guidance on what information should be submitted in an application to satisfy NRC requirements. Guidance and model procedures provided in this NUREG that are not required to be submitted are for illustrative purposes to guide licensees in developing their programs. Use of the word "should" implies "may" and is not intended to mean "must" or "shall"; the procedures provided in this guidance are intended to serve only as examples. Sections 1 through 7 of this document provide background information. Section 8 describes, item-by-item, the information that should be provided in Items 1 through 11 of NRC Form 313, in completing a license application. The format within this document for each item of technical information is:
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; the answers to those items are to be provided on separate sheets of paper and submitted with the completed NRC Form 313. For convenience and for streamlined handling of possession for production and distribution applications, applicants may use the format in Appendix C, "Suggested Format For Providing Information Requested in Items 5 through 11 of NRC Form 313 for a Possession License," to provide supporting information to NRC. Appendices E through P contain additional information on various radiation safety topics. Appendix D contains a sample possession license for production and distribution activities; it contains the conditions most often found on this type of license, although not all licenses will have all conditions. Appendix Q provides guidance on preparing information for an authorization to produce and noncommercially distribute PET radioactive drugs to medical use licensees in a consortium. In this document, dose or radiation dose means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, or total effective dose equivalent (TEDE). These terms are defined in 10 CFR Part 20. Rem, and its International System of Units (SI) equivalent sievert (1 rem = 0.01 sievert (Sv)), is used to describe units of radiation exposure or dose. This is done because 10 CFR Part 20 sets dose limits in terms of rem, not rad or roentgen (R). When the radioactive material emits beta and gamma rays, for practical reasons, we assume that 1 R = 1 rad = 1 rem. For alpha-emitting radioactive material, 1 rad is not equal to 1 rem. Determination of dose equivalent (rem) from an absorbed dose (rad) from alpha particles requires the use of an appropriate quality factor (Q) value. Q values are used to convert absorbed doses (rad) to dose equivalent (rem). Q values for alpha particles are addressed in Tables 1004(b)(1) and (2) in 10 CFR 20.1004. 2 AGREEMENT STATES[ Prev | Next | Top of file ] Certain states, called Agreement States (see Figure 2.1), have entered into agreements with 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 or Federally recognized Indian tribe, who wishes to possess or use licensed material in one of these Agreement States should contact the responsible officials in that State for guidance on preparing an application. These applications should be filed with State officials, not with NRC. Figure 2.1 U.S. Map Location of NRC Offices and Agreement States. 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. The NRC has regulatory authority over land
determined to be "exclusive Federal jurisdiction," while the Agreement State has jurisdiction
over nonexclusive Federal jurisdiction land. Applicants are responsible for finding out, in
advance, the jurisdictional status of the specific areas where they plan to conduct licensed
operations. The NRC recommends that applicants 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,
in order to comply with NRC or Agreement State regulatory requirements, as appropriate.
Additional guidance on determining jurisdictional status is found in All Agreement States
Letter, SP-96-022, dated February 16, 1996, which is available at
http://nrc-stp.ornl.gov/asletters/other/sp96022.pdf Table 2.1 provides a quick way to check on which agency has regulatory authority. Table 2.1 Who Regulates the Activity?
1NRC exercises jurisdiction as the regulatory authority on land where a Federally recognized Indian tribe has tribal jurisdiction. Section 274b Agreements do not give States authority to regulate nuclear material in these areas. Companies owned or operated by native American Indians or non-Indians wishing to possess or use licensed material in these areas would contact the appropriate NRC Regional Office to request a license application. Reference: A current list of Agreement States is available at the Office of Federal and State Materials and Environmental Management Programs' (FSME) public website, which is located at http://nrc-stp.ornl.gov. As an alternative, request the list from an NRC Regional Office. 3 MANAGEMENT RESPONSIBILITY[ Prev | Next | Top of file ] The NRC recognizes that effective Radiation Safety Program management is vital to achieving safe operations that are in compliance with the regulations.
To ensure adequate management involvement, a management representative must sign the submitted application, acknowledging management's commitments and responsibility for the following:
For information on NRC inspection, investigation, enforcement, and other compliance programs, see the current version of NRC's Enforcement Policy, which is included on NRC's Web site at http://www.nrc.gov/about-nrc/regulatory/enforcement.html. 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, read and understand the requirements of each of these regulations, and comply with each applicable regulation. The following Parts of 10 CFR Chapter I contain regulations applicable to possession for production of radioactive materials using an accelerator:
Copies of the above documents may be obtained by calling the Government Printing Office
(GPO) order desk in Washington, DC at (202) 512-1800, or online at
http://www.bookstore.gpo.gov 5 HOW TO FILE5.1 PAPER APPLICATION[ Prev | Next | Top of file ] Applicants for a materials license should do the following:
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 in the future. The NRC will continue to accept paper applications. However, these will be scanned through an optical character reader to convert them to electronic format. To ensure a smooth transition to electronic applications, applicants should: Submit printed or typewritten - not handwritten - text on smooth, crisp paper that will feed easily into the scanner;
5.2 IDENTIFYING AND PROTECTING SENSITIVE INFORMATION[ Prev | Next | Top of file ] All licensing applications, except for portions containing sensitive information, will be made available for review in NRC's Public Document Room and electronically at the Public Electronic Reading Room. For more information on the Public Electronic Reading Room, visit www.nrc.gov/reading-rm.html. There are several types of sensitive information which must be identified, marked, and protected against unauthorized disclosure to the public. Key examples are as follows:
5.3 PAPER FORMAT AND ELECTRONIC FORMAT[ Prev | Next | Top of file ] As the electronic licensing process develops, it is anticipated that NRC may provide mechanisms for filing applications via CD-ROM 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. Federally recognized Indian tribes also must file applications with the appropriate NRC Regional Office. Figure 2.1 shows NRC's four Regional Offices and their respective areas for licensing purposes and identifies Agreement States. Note that all materials license applications are submitted to Regions I, III, or IV. All materials license applicants located in Region II's geographical area should send their applications to Region I. 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 must be accompanied by the appropriate fee. Refer to 10 CFR 170.31 to determine the amount of the fee. The NRC will not issue the licensing action prior to fee receipt. Consult 10 CFR 170.11 for information on exemptions from these fees. Once technical review has begun, no fees will be refunded; application fees will be charged regardless of 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 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 to the Office of the Chief Financial Officer at NRC Headquarters in Rockville, Maryland, (301) 415-7554. Information about fees may also be obtained by calling NRC's toll free number (800) 368-5642, extension 415-7554. The e-mail address is FEES.Resource@nrc.gov. 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 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 will be given, when developing the application, to the concepts of keeping exposure as low as is reasonably achievable (ALARA) and the minimization of contamination. Regarding ALARA, 10 CFR 20.1101(b) states: "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." Applicants for production licenses must address ALARA considerations in all aspects of their programs; e.g., monitoring and controlling external and internal personnel exposure and monitoring and controlling air and liquid effluents. ALARA considerations, including establishing administrative action levels and monitoring programs, need to be documented in the application. Under 10 CFR 20.1406, license applicants are required to 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 its programs. All information related to activities under NRC jurisdiction submitted during the licensing process will be incorporated as part of the license, unless otherwise specified, and may 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 A for a new license request. Check B for an amendment (1) to an existing license, and provide license number. Check C for renewal (1) of an existing license, and provide 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 possession and use of the radioactive material. A division or department within a legal entity may not be a licensee; however, a subsidiary of a larger entity may be a licensee. An individual may be designated as the applicant only if the individual is acting in a private capacity and the possession and use of the radioactive material is not connected with employment in a corporation or other legal entity. Provide the mailing address where correspondence should be sent. A Post Office box number is an acceptable mailing address. Notify NRC of any changes in the mailing address; these changes do not require a fee. Note: The NRC must be notified before control of the license is transferred or when bankruptcy proceedings have been initiated. See below for more details. NUREG-1556, Vol. 15, "Consolidated Guidance About Materials Licenses: Guidance About Changes of Control and About Bankruptcy Involving Byproduct, Source, or Special Nuclear Materials Licenses," discusses the potential for the security and control of licensed material to be compromised during periods of organizational instability. Timely Notification of Transfer of ControlRegulation: 10 CFR 30.34(b). Criteria: Licensees must provide full information and obtain NRC's prior written consent before transferring control of the license, also commonly referred to as "transferring the license." Discussion: Transferring 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 prior NRC written consent. This ensures that:
Response from Applicant: None required from an applicant for a new license. For additional information, refer to NUREG-1556, Vol. 15, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Changes of Control and About Bankruptcy Involving Byproduct, Source, or Special Nuclear Materials Licenses," dated November 2000. Notification of Bankruptcy Proceedings Regulation: 10 CFR 30.34(h). Criteria: Immediately following 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. The NRC must know when licensees are in bankruptcy proceedings in order to determine whether there are any public health and safety concerns (e.g., contaminated facility). The 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 required at the 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 NUREG-1556, Vol. 15, "Guidance About Changes of Control and About Bankruptcy Involving Byproduct, Source, or Special Nuclear Materials Licenses," dated November 2000. 8.3 ITEM 3: ADDRESS(ES) WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED[ Prev | Next | Top of file ] Specify 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) for each facility. The descriptive address should be sufficient to allow an NRC inspector to find the facility location. Sketches or street maps indicating the nearest intersection and the location of the proposed facility would be helpful but are not required. A Post Office Box address is not acceptable, as illustrated in Figure 8.1. Documents that give exact location of use should be marked "Security-Related Information - Withhold Under 10 CFR 2.390". If licensed material is to be possessed or possessed and 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 licensed material will be possessed or possessed and used. For example, broad-scope applicants can specify that licensed material will be possessed or possessed and used on the manufacturing campus of ABC Corporation located on Presidential Avenue in Anytown, State. Applicants should identify all facilities designed or established for special uses; e.g., interim or long-term waste storage facilities, high-activity laboratories and iodination facilities. An NRC-approved license amendment identifying a new location of possession or possession and 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. Figure 8.1 Location of Possession and/or Use. An acceptable location of possession and/or use specifies street address, city, state, and zip code and does not include a Post Office box number.
Note: As discussed later under "Financial Assurance and Recordkeeping for Decommissioning," licensees must maintain permanent records of where licensed material was possessed or possessed and 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 possessed and 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 RSO, 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 his or her telephone number changes. Notification of a contact change is for information only and would not be considered an application for license amendment, unless the notification involves a change in the contact person who is also the RSO. 8.5 ITEM 5: RADIOACTIVE MATERIAL8.5.1 UNSEALED AND/OR SEALED BYPRODUCT MATERIAL[ Prev | Next | Top of file ] Regulations: 10 CFR 30.4, 10 CFR 30.6, 10 CFR 30.11, 10 CFR 30.32, 10 CFR 30.33, 10 CFR 30.34, 10 CFR 30.36, 10 CFR 30.37, 10 CFR 30.38, 10 CFR 32.19, 10 CFR 32.210, 10 CFR Part 51. Criteria: A specific license is required, describing and authorizing the production and distribution of radioactive materials to persons specifically licensed. Applicants must submit information specifying each radionuclide that will be produced, the form of the radionuclide, and the maximum activity to be possessed at any one time. The list of radionuclides should also include incidentally activated radionuclides that are produced during production of the primary radionuclide(s). Discussion: For incidentally activated radionuclides, the applicant could request authorization to possess and use byproduct material with atomic numbers from 1 through 83. The applicant should indicate the total cumulative quantity for all radionuclides to be possessed at any one time, and the total cumulative possession should be commensurate with the applicant's needs, facilities, procedures, and demonstrated experience. If certain incidentally activated radionuclides will be produced in much larger quantities than described in the atomic number 1-83 request and the radionuclides have a half-life great than 120 days, the applicant should list these separately rather than increase the possession limit for all radionuclides. Similarly, if it is known that certain relatively more hazardous incidentally activated radionuclides are produced in smaller quantities, they should also be listed separately. Note that it is important to carefully select the type of material used in the equipment (e.g., accelerator), shielding, and facility of an accelerator facility in order to minimize the amount and type of incidentally activated radionuclides that are produced during the production of radioactive material using an accelerator. If needed, an applicant 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. Each authorized radionuclide is listed on an NRC license by its element name, form, and the maximum amount the licensee may possess at any one time (maximum possession limit), as shown in items 6, 7, and 8 of the sample licenses in Appendix D. On August 8, 2005, the EPAct gave NRC regulatory authority over additional byproduct material. This new byproduct material includes naturally occurring radionuclides, such as radium-226, and accelerator-produced radionuclides (see 10 CFR 30.4 for a complete definition of byproduct material under the EPAct). Applicants and licensees should also determine whether they possess or will possess sealed sources or devices, which would include check, calibration, transmission, and reference sources, or unsealed radioactive materials containing this new byproduct material. Applicants must request authorization for possession of these sealed source(s) or device(s). Note that naturally occurring and accelerator-produced sealed sources and devices that were produced prior to August 8, 2005, may not have received radiation safety evaluations and/or have been registered by the NRC or Agreement State. If the applicant possesses these types of sources and/or devices, the applicant must submit the information required in 10 CFR 30.32(g).
The applicant should list each requested radionuclide by its element name and its mass number in Item 5 on NRC Form 313. It is necessary to specify whether the material will be acquired and used in unsealed or sealed form. The name of the specific chemical compound that contains the radionuclide is not generally required. For unsealed radioactive material, applicants should specify whether radionuclides that are produced will be in volatile or nonvolatile form, since additional safety precautions are required when handling material in a volatile form. Also, if the facility possesses discrete sources of radium-226, the discrete source should be described, since additional precautions may need to be taken if the source is compromised. Applicants requesting discrete sources of radium-226 and authorization to manipulate volatile radioactive material must describe appropriate facilities and engineering controls as described in Section 8.9, �Facilities and Equipment,� and radiation safety procedures for handling of such material in specific responses to Section 8.10.4, �Occupational Dose�; Section 8.10.5, �Public Dose�; Section 8.10.6, �Safe Handling of Radionuclides and Emergency Procedures�; and Section 8.10.7, �Surveys and Leak Tests.� The anticipated possession limit in becquerel (Bq) or curie (Ci) for each radionuclide should also be specified. Possession limits must include the total anticipated inventory, including licensed material in storage and waste, and should be commensurate with the applicant's needs and facilities for safe handling. Applicants should review the requirements for submitting a certification for financial assurance for decommissioning before specifying possession limits of any radionuclide with a half-life greater than 120 days. These requirements are discussed in Section 8.5.2, Financial Assurance and Recordkeeping for Decommissioning. Response from Applicant: For unsealed materials:
Note: For incidentally activated radionuclides, the applicant may request authorization to possess and use any form of byproduct material with atomic numbers 1 through 83. However, the applicant should indicate the total cumulative quantity for all radionuclides to be possessed at any one time. For potentially volatile materials (e.g., I-123):
For sealed radioactive materials and discrete sources of radium-226:
Notes:
8.5.2 FINANCIAL ASSURANCE AND RECORDKEEPING FOR DECOMMISSIONING[ Prev | Next | Top of file ] Regulations: 10 CFR 30.35, 10 CFR 30.34(b). Criteria: A licensee authorized to possess radioactive material in excess of the limits specified in 10 CFR 30.35 must submit a decommissioning funding plan (DFP) or provide a certification of financial assurance (FA) for decommissioning. Even if a DFP or FA is not required, licensees are required to maintain, in an identified location, decommissioning records related to structures and equipment where radioactive materials are used or stored and related to leaking sources. Pursuant to 10 CFR 30.35(g), licensees must transfer records important to decommissioning to either of the following:
Discussion: The NRC wants to ensure that decommissioning will be carried out with minimum impact on public and occupational health and safety and the environment (53 FR 24018). Most accelerator production facilities will be required to comply with the financial assurance requirements because of the activation materials that are produced during operation. NRC regulations requiring a DFP or FA 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, through a third party, that funds will be available. Applicants are required to submit a DFP or FA 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 DFP or has an option of submitting either a DFP or FA (or neither) are stated in 10 CFR 30.35. 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. NUREG-1757, Vol. 3, "Consolidated NMSS Decommissioning Guidance: Financial Assurance, Recordkeeping, and Timeliness," dated September 2003, provides guidance acceptable to NRC staff on the information (see Figure 8.2) to be provided for establishing financial assurance for decommissioning and a standard format for presenting the information. Figure 8.2 Financial Assurance for Decommissioning. Most licensees that possess and operate an accelerator will need to provide financial assurance for decommissioning. Large manufacturers may need one of several approved financial mechanisms. The requirements for maintaining records important to decommissioning, including the type of information required, (see Figure 8.3) are stated in 10 CFR 30.35(g). All licensees are required to maintain these records in an identified location until the site is released for unrestricted use. In the event that the licensed activities are transferred to another person or entity, these records shall be transferred to the new licensee prior to transfer of the licensed activities. The new licensee is responsible for maintaining these records until the license is terminated. Careful recordkeeping of radionuclides possessed and used, including form, amount, and area used, will facilitate area release and license termination. Figure 8.3 Records Important to Decommissioning. Licensees must maintain records important to decommissioning, regardless of whether they need financial assurance for decommissioning. Response from Applicants: If a DFP or FA is required, submit the required documents as described in NUREG-1757, Vol. 3, "Consolidated NMSS Decommissioning Guidance: Financial Assurance, Recordkeeping, and Timeliness," dated September 2003. 8.6 ITEM 6: PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED[ Prev | Next | Top of file ] Regulations: 10 CFR 30.33(a)(1), 10 CFR 30.4. Criteria: For this license, the materials will be produced by an accelerator and transferred or distributed to another license for use. The radioactive material produced will be possessed and possibly stored. Also, the activated products will be handled during maintenance, repair and disposal activities. Discussion: Applicants should specify that the radioactive material requested in Item 5 will be possessed and/or stored incident to production by an accelerator in accordance with the regulations. Applicants may use the format given in Table 8.1 to provide the requested information. Once material is produced, it will be transferred internally to another license or it will be distributed to another licensee that will use the material to create the final product. The produced radioactive material can be transferred or distributed to the following types of licenses:
For more information on applying for these types of licenses, refer to the following NUREG-1556 guidance reports:
If the applicant is a member of a consortium, and plans to produce and noncommercially distribute PET radioactive drugs to medical use licensees within the consortium, the applicant will need to request an authorization to perform these activities as part of its license application. As defined in 10 CFR 30.4, a consortium is an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own and share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distribution among its associated members for medical use. Furthermore, the PET radionuclide production facility within the consortium must be located at an educational institution, Federal facility, or medical facility. Specific guidance for applicants requesting authorization for the production and noncommercial distribution of PET radioactive drugs to medical use licensees in a consortium can be found in Appendix Q of this document. Table 8.1 Sample Format for Providing Information About Requested Radioisotopes.
Response from Applicant: For accelerator-produced radionuclides, applicants should state that radioactive materials will be possessed and stored incident to their production by an accelerator in accordance with the regulations. For sealed sources that are not produced, specify their proposed use (e.g., calibration of instruments). Use of the format in Table 8.1 will facilitate the review of the application. 8.7 ITEM 7: INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR TRAINING AND EXPERIENCE[ Prev | Next | Top of file ] Regulation: 10 CFR 30.33(a)(3). Criteria: Executive management, the RSO (and his/her staff, as necessary), and users work as a team to implement the Radiation Safety Program. Each individual plays a critical role within his or her area of responsibility. The roles and responsibilities of executive management, the RSO, the RSO�s staff, users, and others in restricted areas are discussed in the Sections that follow. Refer to the subsequent Sections specific to the RSO and individuals authorized to handle licensed material. Discussion: Individuals must be qualified by training and experience to possess and use the material for the purpose(s) requested in a manner that will protect health and minimize danger to life or property before an application for a license is approved. Each program in which radioactive materials are possessed and used under a Commission license will have someone responsible for radiation safety and compliance with the Commission's regulations. The individual's training and experience must be commensurate with his or her duties and responsibilities. Supporting staff should be provided, as appropriate, for the size and scope of the program. A Radiation Safety Program for a production facility may consist of some or all of the following characteristics:
NRC holds the licensee responsible for the Radiation Safety Program; therefore, it is essential that strong management controls and oversight exist to ensure that licensed activities are conducted safely. Management responsibility and liability are sometimes under-emphasized or not addressed in applications and are often poorly understood by licensee employees and managers. As discussed later in this guide, senior management will delegate to the RSO sufficient authority, organizational freedom, and management prerogative to communicate with and direct personnel regarding NRC regulations and license provisions and to terminate unsafe activities involving byproduct material. Other responsibilities will be delegated to other individuals. Such delegations should be clearly communicated to all parties. While these delegations are important to the operation of the program, the licensee senior management maintains the ultimate responsibility for the safety of licensed activities. Response from Applicant: Refer to the subsequent sections specific to the individuals described above. Applicants should submit an organizational chart describing the management structure, reporting paths, and the flow of authority between executive management and the RSO. 8.7.1 RADIATION SAFETY OFFICER[ Prev | Next | Top of file ] Regulation: 10 CFR 30.33(a)(3). Criteria: RSOs must have training and specific experience with the types and quantities of licensed material to be authorized on the license. Discussion: The person responsible for implementing the Radiation Safety Program is the RSO. This individual may also be called the Radiation Protection Officer. The RSO needs independent authority to stop operations that he or she considers unsafe. He or she must have sufficient time and commitment from management to fulfill certain duties and responsibilities to ensure that radioactive materials are possessed and used in a safe manner. Typical RSO duties are illustrated in Figure 8.4 and described in Appendix E. NRC requires the name of the RSO to be listed on the license to ensure that licensee management has identified a responsible, qualified person and that the named individual knows of his or her designation as RSO. To demonstrate adequate training and experience at a production facility, it is recommended that the RSO have: (1) at a minimum, a college degree at the bachelor level or equivalent training and experience in physical, chemical, biological sciences, or engineering; and (2) training and experience commensurate with the scope of proposed activities. Training should include the following subjects:
Figure 8.4 RSO Responsibilities. Typical duties and responsibilities of RSOs. The amount of training and experience will depend on the type, form, quantity, and proposed use of the licensed material requested. For instance, in addition to a college degree, RSOs at accelerator facilities where workers may handle curie quantities of radioactive material should be specialists in the field of radiation protection and may need at least 40 hours of radiation safety training specific to their job duties as well as a year of experience with similar types, forms, quantities, and uses of radioactive material before the individual is qualified to be RSO. The proposed RSO's training and experience must be sufficient to identify and control the anticipated radiation hazards. For example, the RSO should have experience planning and conducting evaluations, surveys, and measurements similar to those required by the licensee's Radiation Safety Program. In addition, the RSO designee should have obtained the above training in a formal course designed for RSOs, presented by an academic institution, commercial radiation safety consulting company, or a professional organization of radiation protection experts. Response from Applicant: Provide the following:
Note: It is important to notify NRC, as soon as possible, of changes in the designation of the RSO. The name and qualifications of the replacement RSO should be submitted to NRC as part of an amendment request. 8.7.2 INDIVIDUALS AUTHORIZED TO HANDLE LICENSED MATERIAL[ Prev | Next | Top of file ] Regulations:10 CFR 19.12, 10 CFR 20.1101(b), 10 CFR 30.33(a)(3). Criteria: Individuals authorized to handle licensed material must have adequate training and experience with the types and quantities of licensed material that they propose to possess and handle. Discussion: Applicants must name at least one individual who is qualified to handle the requested licensed materials. For a production license, handling of licensed materials includes, for example, the processing of radiochemicals and the handling or manipulation of activated targets and/or components. An individual who is authorized to handle licensed material is a person whose training and experience have been reviewed and approved by NRC, who is named on the license, and who uses or directly supervises the use of licensed material. This individual's primary responsibility is to ensure that radioactive materials are handled safely and according to regulatory requirements. The individual is also responsible for ensuring that procedures and engineering controls are used to keep occupational doses and doses to members of the public ALARA. Individuals authorized to handle licensed material must have adequate and appropriate training to provide reasonable assurance that they will handle licensed material safely, including maintaining security of, and access to, licensed material, and respond appropriately to events or accidents involving licensed material to prevent the spread of contamination. To demonstrate adequate training and experience at an accelerator facility, the authorized individual should have: (1) a college degree at the bachelor level, or equivalent training and experience in physical, chemical, or biological sciences or in engineering; and (2) training and experience commensurate with the scope of proposed activities such as handling of activated targets and activated products associated with accelerator activities. Training should include the following subjects:
The amount of training and experience will depend on the type, form, quantity, and proposed use of the licensed material requested. For instance, in addition to a college degree or equivalent experience, an authorized individual at a radioactive materials production facility who may use Curie quantities of radioactive material should have at least 40 hours of radiation safety training specific to his or her job duties as well as a minimum of 6 months of experience with similar types, forms, quantities, and uses of radioactive material before the individual is qualified to be authorized to handle licensed material. In general, authorized individuals should demonstrate training and experience with the type and quantity of material they propose to handle. For example, an individual with training and experience only with sealed radioactive sources might not be qualified to use or supervise the use of unsealed licensed material. In addition, someone with experience using only trace quantities of radioactive materials may not understand the risks of working with much larger (e.g., 10 or 100 times larger) quantities of the same substance. Applicants should pay particular attention to the type of radiation involved. For example, someone experienced with low-energy beta emitters may not have appropriate experience for high-energy gamma emitters. Individuals that are named on an Agreement State license for authorization to produce and/or handle licensed material may provide the Agreement State license to demonstrate appropriate training and experience for the uses requested. An individual who is authorized to handle licensed material is considered to be supervising the handling of radioactive materials when he or she directs personnel in activities involving licensed material. Although the authorized individual may delegate specific tasks to supervised users (e.g., conducting surveys, keeping records), the authorized individual is responsible for the safe handling of radioactive material. Note that accelerator manufacturers or companies that provide repair and/or maintenance service to licensed accelerator facilities may need to possess an NRC service provider license or equivalent Agreement State license. In particular, this would be required when individuals (e.g., service engineers) perform certain maintenance and repair activities that involve the handling of radioactive materials (e.g., activated targets or components) during the accelerator maintenance and repair activities. For guidance on how to apply for an NRC service provider license see NUREG-1556, Vol. 18, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Service Provider Licenses." For guidance on how to work under an Agreement State license while in NRC jurisdiction, refer to NUREG-1556, Vol. 19, "Guidance for Agreement State Licensees About NRC Form 241 'Report of Proposed Activities in Non-Agreement States, Areas of Exclusive Federal Jurisdiction, or Offshore Waters' and Guidance for NRC Licensees Proposing to Work in Agreement State Jurisdiction (Reciprocity)." Response from Applicant: Provide the following:
Note: Applicants for broad-scope programs should refer to NUREG-1556, Vol. 11, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope." Broad-scope programs may be permitted to name authorized individuals without amending the license. 8.8 ITEM 8: TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS[ Prev | Next | Top of file ] Regulations: 10 CFR19.12, 10 CFR 30.33(a)(3). Criteria: Individuals whose assigned duties involve exposure to radiation and/or radioactive material (from both licensed and unlicensed sources), and in the course of their employment are likely to receive in a year an occupational dose of radiation greater than 1 mSv (100 mrem), whether from all external sources, all internal sources, or any combination, must receive instruction commensurate with potential radiological health protection problems present in the work place, as required by 10 CFR19.12. Discussion: Before beginning work with licensed material, individuals should 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 at no more than 12-month intervals. Training should also be performed whenever there is a significant change in hazards, duties, procedures, regulations, or terms of the license. Licensees should not assume that safety instruction has been adequately covered by prior employment or academic training. Site-specific training should be provided for all individuals. Ancillary personnel (e.g., clerical, housekeeping, security) whose duties may require them to work in the vicinity of radioactive material (whether escorted or not) need to be informed about radiation hazards and the appropriate precautions. The licensee should assess each individual's involvement with licensed material and cover each applicable subject appropriately. Training may be in the form of lecture, demonstrations, videotape, or self-study, and it should emphasize practical subjects important to the safe possession and use of licensed material. If training is not conducted by an instructor, a method should be adopted whereby a trainee can ask questions and discuss topics relating to occupational radiation exposure. The guidance in Appendix F, "Radiation Safety Training Topics," may be used to develop a training program. The program should consider all topics pertinent for each group of workers as well as the method and frequency of training. The licensee should determine whether the training succeeded in conveying the desired information and adjust the training program as necessary. This assessment may be performed by a written test or observation of the individual in the performance of assigned duties. Remedial training for missed test questions or other areas of apparent weakness should be conducted or additional formal training planned to cover deficientareas. The person conducting the training should be a qualified individual (e.g., a person who meets the qualifications for RSO or authorized user on the license and is familiar with the licensee's program). Response from Applicant: Submit a description of the radiation safety training program, including topics covered, groups of workers, assessment of training, qualifications of instructors, and the method and frequency of training. 8.9 ITEM 9: FACILITIES AND EQUIPMENT[ Prev | Next | Top of file ] Regulations: 10 CFR 20.1101(b), 10 CFR 20.1406, 10 CFR 30.3, 10 CFR 30.33(a)(2), 10 CFR 30.35(g). Criteria: Facilities and equipment must be adequate to protect health and minimize danger to life or property. Licensee must minimize the possibility of contamination and keep exposures to workers and the public ALARA. Discussion: Applicants must demonstrate that their facilities and equipment provide sufficient engineering controls and barriers to protect the health and safety of the public and their employees, keep exposures to radiation and radioactive materials ALARA, and minimize the danger to life and property from the uses of the types and quantities of radioactive materials to be used. Applicants may delay completing facilities and acquiring equipment until after the application review is completed, in case changes are required as a result of the application review. This also ensures the adequacy of the facilities and equipment before the applicant makes a significant financial commitment. In all cases, the applicant may not possess or use licensed material until after the facilities are approved, equipment is procured, and the license is issued. Applicants are reminded that records important to decommissioning include the following:
These records are required to be maintained in an identifiable location. Facilities are required to meet NRC criteria prior to release. Therefore, careful facility design is important to prevent contamination, or facilitate decontamination, reducing the costs needed for decommissioning. For further information, see Section 8.5.2, "Financial Assurance and Recordkeeping for Decommissioning." For additional guidance regarding facilities and equipment, refer to Appendix G, Facilities and Equipment. Response from Applicant: Describe the facilities and equipment to be made available at each location where radioactive material will be produced, possessed, and/or used (see Appendix G for topics to consider). Include the following information:
Note: Mark drawings and diagrams that provide the exact location of materials or depict the specific location of safety or security equipment as: �Security-Related Information - Withhold Under 10 CFR 2.390." SECURITY-RELATED INFORMATION - WITHHOLD UNDER 10 CFR 2.390* SECURITY-RELATED INFORMATION - WITHHOLD UNDER 10 CFR 2.390* * For the purposes of this NUREG, this diagram is marked appropriately for an application. This particular diagram does not contain real security-related information. Figure 8.5 Facility Diagram for a Radioactive Materials Production Facility. Note: When responding to this section, applicants should follow the guidance in Section 5.2 to determine if their response includes sensitive security-related information and needs to be marked accordingly. Figure 8.6 Shielded Protective Enclosure (Hot Cell) With Remote Manipulators. 8.10 ITEM 10: RADIATION SAFETY PROGRAM8.10.1 AUDIT PROGRAM[ Prev | Next | Top of file ] Regulations: 10 CFR19.11, 10 CFR19.12, 10 CFR 20.1101, 10 CFR 20.1301, 10 CFR 20.1501(c), 10 CFR 20.1902, 10 CFR 20.1904, 10 CFR 20.1906, 10 CFR 20.2102, 10 CFR 20.2103, 10 CFR 20.2108, 10 CFR 20.2101-2104, 10 CFR 20.2106, 10 CFR 21.6, 10 CFR 21.21(a), 10 CFR 30.35(g), 10 CFR 30.41, 10 CFR 30.51. Criteria: Licensees must review the content and implementation of their Radiation Safety Programs at least annually. Discussion: It is in the best interest of licensees to have a strong audit program to ensure:
An audit program that promptly identifies potential violations of regulatory requirements and takes prompt, comprehensive steps to correct them, meets NRC's expectations. Elements of an effective audit program are described below. Audit Objectives. NRC holds the licensee responsible for the Radiation Safety Program. It is essential that strong management controls and oversight exist to ensure that licensed activities are conducted properly. Audits 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). The objectives of the audit should include an evaluation of the licensees': (1) efforts to maintain doses ALARA; (2) compliance with NRC requirements; (3)ability to identify and correct deficiencies in their Radiation Safety Program; (4) management of the Radiation Safety Program including the role of senior management and the RSO; and (5)implementation of the Radiation Survey Program. Scope of Audit. Audits should cover both the management of the Radiation Safety Program and the details of its implementation in the areas chosen for review. Mechanisms used by senior management to ensure that adequate oversight of the program is exercised should be included in the scope of the audit. Auditor Qualifications. Auditors should have training and experience similar to that of an individual authorized for the types, forms, uses, and quantities of radioactive material used in the areas audited. Auditors should not be selected from the staff of areas to be audited, nor their management. Ideally, auditors are third parties, from independent organizations. Audit Frequency. Audits should be conducted at least once every 12 months. However, it is recommended that program audits be conducted more frequently than annually if the licensee's activities involve the use of high-activity materials or frequent handling of intermediate activity materials. Applicants should consider developing survey and audit schedules based on activity and use (e.g., high-use/activity areas may be audited monthly, moderate-use/activity areas may be audited quarterly). More frequent audits should be considered if the potential for overexposures exists. Audit Techniques. While documentation should be reviewed during any audit of a Radiation Safety Program, emphasis should be placed on actual observations of work in progress. Applicants should consider performing unannounced audits of radioactive material users to observe work in progress and determine if, for example, operating and emergency procedures are available and are being followed. Radiation safety audits should include activities conducted during all shifts. Some details of typical audit techniques follow:
Problems or Deficiencies Noted. The licensee should have a process for correcting violations and deficiencies during and after the audit. The licensee should identify the safety significance of each violation to set priorities and identify resources to correct these violations. Results of the audit program reviews should be reported to senior management to allow for timely and aggressive remedial actions sufficient in scope to ensure compliance with NRC regulations and licensee conditions. Information Notice (IN) 96-28, �Suggested Guidance Relating to Development and Implementation of Corrective Action,� provides guidance on this subject. Certain identified problems or potential violations may require notification or a report to NRC. Licensees are encouraged to contact NRC for guidance if they are uncertain about a reporting requirement. All audit findings and corresponding corrective actions, whether from internal, State, or Federal audit findings, should be communicated to the staff for review and added to new and refresher radiation safety training sessions. If the findings represent a significant safety impact on the staff, special training sessions may be appropriate. Records to be Maintained: Licensees must maintain records of audits and other reviews of program content and implementation for 3 years from the date of the record. Audit records should contain the following information: 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 NRC. Appendix H contains an example of an audit form that can be used to document the annual audit of the radiation protection program. Response from Applicant: No response is required. The licensee's program for auditing its Radiation Safety Program will be reviewed during inspection. 8.10.2 RADIATION MONITORING[ Prev | Next | Top of file ] Regulations: 10 CFR 20.1501, 10 CFR 20.2103(a), 10 CFR 30.33(a)(2). Criteria: Licensees must possess radiation monitoring instruments to evaluate possible radiation hazards that may be present. Instruments used for quantitative radiation measurements must be calibrated periodically for the radiation measured. Discussion: Licensees must possess calibrated radiation detection/measurement instruments to perform, as necessary, the following:
For the purposes of this document, radiation monitoring instruments are defined as any device used to measure the radiological conditions, which include licensed and non-licensed (e.g., accelerator operation) activities, at a licensed facility. Some of the instruments that may be used to perform the above functions include:
The choice of instrument should be appropriate for the type of radiation to be measured, and for the type of measurement to be taken (count rate, dose rate, etc.). Figure 8.7 illustrates some common survey instruments used for contamination surveys. Applications should include descriptions of the instrumentation available for use and the instrumentation that applicants intend to purchase prior to starting licensed activities. The description should include type of instrument and probe, and the instrument's intended purpose. Figure 8.7 Examples of Portable Instruments Used in Laboratory Settings. Instruments used for qualitative surveys are only intended to detect contamination in the laboratory. Such instruments should be checked for operational response with an appropriate check source containing radioactive material and can be calibrated with an electronic pulser instead of a radioactive source. However, these instruments cannot be used for measurement of surface contamination or radiation levels without performing a calibration with appropriate radioactive sources, as described in Appendix I, �Radiation Monitoring Instrument Specifications and Model Survey Instrument and Air Sampler Calibration Program.� Instrument calibrations should be performed by the instrument manufacturer or a person specifically authorized by NRC or an Agreement State, unless the applicant specifically requests this authorization. Applicants seeking authorization to perform survey instrument calibrations should submit procedures for review. Appendix I provides information about instrument specifications and model calibration procedures. Applicants should be aware that calibrations often require possession and use of a calibration source or device. Instruments for counting smear wipes to detect contamination and/or leakage need calibration sources that may be listed on the production license. Response from Applicant: Provide one of the following: A description of the instrumentation (as described above) that will be used to perform required surveys and a statement that: �We will use instruments that meet the radiation monitoring instrument specifications published in Appendix I to NUREG-1556, Vol. 21, �Program-Specific Guidance About Possession License for Production of Radioactive Materials Using an Accelerator�.� OR A description of alternative equipment and/or procedures for ensuring that appropriate radiation monitoring equipment will be used during licensed activities and that proper calibration and calibration frequency of survey equipment will be performed. Calibrations may be performed by licensees specifically authorized to provide this service. It is not necessary to have a copy of the instrument manufacturer's license, but calibration vendors other than the instrument manufacturer should be verified to ensure they have authorization to calibrate instruments for others. AND A description of the instruments used to quantitatively measure the radioactivity in the products and process, and the procedures followed to ensure accuracy of those measurements. Note: Alternative responses will be reviewed using the criteria listed above. 8.10.3 MATERIAL ACCOUNTABILITY[ Prev | Next | Top of file ] Regulations: 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 20.1906, 10 CFR 20.2001, 10 CFR 20.2102, 10 CFR 20.2201, 10 CFR 30.41, 10 CFR 30.51. Criteria: Licensees must ensure the security and accountability of licensed material. Discussion: Licensed material must be tracked from production to disposal in order to ensure accountability; identify when licensed material could be lost, stolen, or misplaced; and ensure that possession limits listed on the license are not exceeded. Licensees may exercise control and accountability over licensed material by including the following items:
Licensees must secure and control licensed material and should have a means of promptly detecting losses of licensed material. 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. Licenses will normally contain specific conditions requiring the licensee to perform inventories and leak tests of sealed sources every six months (see sample license in Appendix D). Since the leak tests require an individual to locate and work with the sealed source, records of leak tests may be used as part of an inventory and accountability program. Sources in storage that are used infrequently may not require leak testing; however, the inventory must still be performed at the specified interval. With regard to unsealed licensed material, licensees use various methods (e.g., computer programs, manual ledgers, log books) to account for production, use, transfer, disposal, and radioactive decay. These methods help to ensure that possession limits are not exceeded. Table 8.2 list the types and retention times for the records the applicant must maintain of production, use, transfer, and disposal (as waste) of all licensed material. Other records such as transfer records could be linked to radioactive material inventory records.
Material accountability records typically contain the following information:
See the section on "Waste Disposal" for additional information.
Response from Applicant: Provide the following statements: "We have developed, and will implement and maintain written procedures for licensed material accountability and control to ensure that:
AND "We will conduct physical inventories of sealed sources of licensed material at intervals not to exceed 6 months." 8.10.4 OCCUPATIONAL DOSE[ Prev | Next | Top of file ] Regulations: 10 CFR 20.1501, 10 CFR 20.1502, 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 20.2106, 10 CFR Part 20 Appendix B. Criteria: Each licensee shall evaluate the potential occupational exposures of all workers and monitor occupational exposure to radiation when required. Discussion: The licensee should perform an evaluation of the dose, which may be received from licensed and non-licensed (e.g., accelerator operation) activities, the individual is likely to receive prior to allowing the individual to receive the dose (prospective evaluation). When performing the prospective evaluation, only a dose that could be received at the facilities of the applicant or licensee performing the evaluation needs to be considered. These estimates can be based on any combination of work location, radiation monitoring, survey results, monitoring results of individuals in similar work situations, or other estimates to produce a "best estimate" of the actual dose received. For individuals who have received doses at other facilities in the current year, the previous dose need not be considered in the prospective evaluation if monitoring was not required at the other facilities. This evaluation need not be made for every individual; evaluations can be made for employees with similar job functions or work areas. Further guidance on evaluating the need to provide monitoring is provided in Regulatory Guide 8.34, "Monitoring Criteria and Methods to Calculate Occupational Doses, dated July 1992." If the prospective evaluation shows that an individual's dose is not likely to exceed 10% of any applicable regulatory limit, the individual is not required to be monitored for radiation exposure and there are no recordkeeping or reporting requirements for doses received by that individual. If the prospective dose evaluation shows that the individual is likely to exceed 10% of an applicable limit, monitoring is required. Licensees shall monitor worker exposures for:
—5 mSv (0.5 rem) deep-dose equivalent; —15 mSv (1.5 rems) eye dose equivalent; —50 mSv (5 rems) shallow-dose equivalent to the skin; and —50 mSv (5 rems) shallow-dose equivalent to any extremity. —1.0 mSv (0.1 rem) deep-dose equivalent; —1.5 mSv (0.15 rem) eye dose equivalent; —5 mSv (0.5 rem) shallow-dose equivalent to the skin; and —5 mSv (0.5 rem) shallow-dose equivalent to any extremity. —Adults likely to receive in one year an intake in excess of 10% of the applicable annual limit on intake (ALI) for ingestion and inhalation; and —Minors and declared pregnant women likely to receive in one year a committed effective dose equivalent in excess of 1.0 mSv (0.1 rem). If an individual is likely to receive in one year a dose greater than 10% of any applicable limit (see Figure 8.8 for annual dose limits for adults), monitoring for occupational exposure is required. When working at an NRC-licensed facility, in addition to exposure to material regulated by NRC, a worker may be exposed to radiation (e.g., radiation emitted by accelerators) that is regulated by the State in which the facility is located. With respect to NRC regulation of activities at the facility, State-regulated sources of radiation and radioactive material are considered to be "unlicensed." An occupational dose includes the dose received by individuals in the course of their employment (see 10 CFR 20.1003), including exposure to radiation and to radioactive material from licensed and "unlicensed" sources of radiation, whether in the possession of the licensee or other person. Therefore, authorized individuals and other radiation workers at a production facility are generally likely to receive 10% of the limits for an occupational dose. Figure 8.8 Annual Dose Limits for Occupationally Exposed Adults.
Most licensees use either film badges, thermoluminescent dosimeters (TLDs), or Optically-Stimulated Luminescence (OSL) dosimeters that are supplied by a processor approved by the National Voluntary Laboratory Accreditation Program (NVLAP) to monitor for external exposure. Applicants should verify that the processor is NVLAP-approved. Consult the NVLAP-approved processor for its recommendations for exchange frequency and proper use. If monitoring is required, then the licensee must maintain records of the monitoring regardless of the actual dose received. For individuals that handle licensed material at production facilities, extremity and whole body dosimeters should be worn. It is recommended that extremity and whole body dosimeters be exchanged at least monthly. Also, for individuals that will handle PET radionuclides or other radionuclides that emit high energy gammas/photons, it is recommended that extremity dosimeters be exchanged at least bi-weekly and a pocket or alarming dosimeter, which provides a real-time dose estimate, be used in addition to the individual's personal whole body dosimeter. Workers are typically monitored for a year or more to determine an actual annual dose. The monitoring results are then used to determine the need to continue monitoring workers. The dose to workers may need to be reevaluated if there are changes to the licensee's program, such as procedures, frequency of use, quantity of licensed material used, or isotopes used. The licensee should also consider a more frequent exchange of dosimeters when employees start a new job function, so that their doses can be closely monitored when they are performing unfamiliar tasks. In addition, see Appendix L, "Radiation Safety Survey Topics" for information on bioassay monitoring for internal exposure assessment. Routine bioassays should be performed when volatile radioactive material (e.g., I-123) is produced and/or handled. Note that Table8.3 below provides a list of other guidance documents that provide information on personnel monitoring and bioassay procedures. Table 8.3 Documents That Contain Guidance Relating to Personnel Monitoring and Bioassay That May Be Applicable.
Response from Applicant: Provide the following statement: "We have developed and will implement and maintain written procedures for monitoring occupational doses that meet the requirements in 10 CFR 20.1501, 10 CFR 20.1502, 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 20.2106, as applicable." Note:
8.10.5 PUBLIC DOSE[ Prev | Next | Top of file ] Regulations: 10 CFR 20.1003, 10 CFR 20.1101(d), 10 CFR 20.1301, 10 CFR 20.1302, 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 20.2107, 10 CFR 20.2203. Criteria: Licensees must do the following:
Discussion: "Member of the public" is defined in 10 CFR Part 20 as "any individual except when that individual is receiving an occupational dose." "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, sanitary sewerage discharges from licensees, and medical procedures. 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 the area (restricted, controlled, or unrestricted) the individual is in when the dose is received. For guidance about accepted methodologies for determining dose to members of the public, refer to Appendix I, "Guidance for Demonstrating That Individual Members of the Public Will Not Receive Doses Exceeding the Allowable Limits." Figure 8.9 shows the steps to calculate the annual dose to an individual member of the public.
Figure 8.9 Calculating Public Dose. Steps to calculate the annual dose to an individual member of the public (see Appendix I for more information about occupancy factors). There are many possible internal dose pathways that contribute to the TEDE. The TEDE can, however, be broken down into three major dose pathway groups:
The licensee should review these major pathways and decide which are applicable to its operations. The licensee must ensure that the TEDE from all exposure pathways arising from licensed activities does not exceed 1.0 mSv (100 mrem) to the maximally exposed member of the public. In addition, the licensee must control air emissions, such that the individual member of the public likely to receive the highest TEDE does not exceed the constraint level of 0.1 mSv (10mrem) per year from those emissions. If exceeded, the licensee must report this, in accordance with 10 CFR 20.2203, and take prompt actions to ensure against recurrence. Licensees should design a monitoring program to ensure compliance with 10 CFR 20.1101(d) and 20.1302(b). The extent and frequency of monitoring will depend upon each licensee's needs. For additional guidance regarding monitoring of effluents, refer to the section entitled, "Radiation Safety Program - Surveys." During NRC inspections, licensees must be able to provide documentation demonstrating, by measurement or calculation, that the TEDE to the individual member of the public likely to receive the highest dose from the licensed operation does not exceed the annual limit and the dose constraint. Response from Applicant: Initially, the applicant need not provide a response. The application will be evaluated and the license reviewer will determine if enough information is present to assure compliance with the limiting exposure to a member of the public. A response may be required when there is insufficient information to assure that a member of the public will not receive a total exposure exceeding 0.1 mSv (100 mrem). When no response is required, compliance will be examined during inspection. During NRC inspections, licensees must be able to demonstrate, by measurement or calculation, that the TEDE to the individual likely to receive the highest dose from the licensed operation does not exceed the annual limit for members of the public. See Appendix I for examples of methods to demonstrate compliance. 8.10.6 SAFE HANDLING OF RADIONUCLIDES AND EMERGENCY PROCEDURES[ Prev | Next | Top of file ] Regulations: 10 CFR 19.11(a)(3), 10 CFR 20.1101, 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 20.1902, 10 CFR 20.1903, 10 CFR 20.1904, 10 CFR 20.1905, 10 CFR 20.2201-2203, 10 CFR 21.21, 10 CFR 30.32(I), 10 CFR 30.50. Criteria: Operating procedures for activities that can potentially impact radioactive material or occupational dose must be developed, documented, implemented and maintained to comply with 10 CFR 20.1101(a), Radiation Safety Programs. Discussion: Licensees are responsible for the security and safe possession and use of all licensed material from the time it is produced at the facility until it is used, transferred/delivered, and/or disposed of. Licensees must develop written procedures to ensure safe possession and use of licensed material, and the procedures should also include operational and administrative guidelines. The written procedures should provide reasonable assurance that only appropriately trained personnel will handle and use licensed material without undue hazard to workers or members of the public. General Safety ProceduresThe written procedures should include the following elements:
These procedures should include policies for:
Applicants should also develop product- and radionuclide-specific procedures based on the respective hazards associated with the products and radionuclides. General safety guidelines are described in Appendix K, “General Topics for Safe Possession and Use of Radioactive Materials and Model Emergency Procedures,” and Appendix M, “Radiation Safety Survey Topics.” Applicants should use these guidelines to develop procedures for the safe use of radionuclides. Licensees should determine if they have 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. Security ProceduresAll licensed materials that are stored in controlled or unrestricted areas must be secured from unauthorized access or removal, so that individuals who are not knowledgeable about radioactive materials cannot be exposed to or contaminated by the material and cannot take the material. When any licensed material is handled in controlled or unrestricted areas, it must be under constant surveillance to prevent others from becoming contaminated by or exposed to the material, or to 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: storage and use of licensed materials only in restricted areas; limiting access to an entire facility or building or portion of the building only to radiation workers; providing storage areas that can be locked to prevent access to the material; and implementing procedures that require a radiation worker to be within "line of sight" of the materials whenever licensed materials are in use. Applicants should develop procedures that clearly state acceptable methods to secure licensed material at their facility. Particular attention may need to be paid to security procedures at facilities that may have unusual needs due to the activities performed, such as hot cells, animal care facilities, and waste processing facilities. Emergency ProceduresAccidents and emergencies can happen during any operation with radionuclides, including their transportation, use, production processes, transfer, and disposal. Such incidents can result in contamination or release of material to the environment, and unintended radiation exposure to workers and members of the public. In addition, such incidents as loss or theft of licensed material, sabotage, fires, and floods can jeopardize the safety of personnel and members of the public. It may therefore be necessary to develop written procedures to minimize, as much as possible, the impact of these incidents on personnel, members of the public, and the environment. Applicants who plan to possess quantities of material in excess of the applicable amounts listed in 10 CFR 30.72, Schedule C, may also be required to submit an “Emergency Response Plan for Responding to a Release.” Applicants should establish written procedures to handle events ranging from a minor spill (see Figure 8.10) to a major accident that may require intervention by outside emergency response personnel. For accelerator facilities, written procedures should be included for specific accident scenarios such as target failures, spills or releases outside a containment enclosure, delivery line failures, malfunction of air supply or exhaust systems, and high radiation levels in exhaust monitors or systems. 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, the licensee staff should have a clear understanding of their limitations in an emergency, along with step-by-step instructions and clear guidelines for whom to contact. Licensees should have a sufficient number of appropriate and calibrated survey instruments readily available. 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. Appendix K includes model emergency procedures. Applicants may adopt these procedures or develop their own, incorporating the safety features included in these model procedures. Figure 8.10 Proper Handling of Incident. Panels 1 and 2 indicate how contamination can be spread if the incident is not handled properly as in panels 3 and 4. Response from Applicant: The applicant should state that procedures for safe handling of radionuclides and emergencies will be developed and documented before production of licensed material. In addition, the applicant should state that operating and emergency procedures will be implemented and maintained. The applicant should submit a statement that "Procedures will be revised only if: (1) the changes are reviewed and approved by the licensee management and the RSO in writing; (2) the licensee staff is provided training in the revised procedures prior to implementation; (3) the changes are in compliance with NRC regulations and the license; and (4) the changes do not degrade the effectiveness of the program." If an "Emergency Response Plan" is required for a license pursuant to 10 CFR 30.32(I), the applicant should submit it as a separate part of the application. 8.10.7 SURVEYS AND LEAK TESTS[ Prev | Next | Top of file ] Regulations: 10 CFR 20.1501, 10 CFR 20.2103, 10 CFR 30.53, 10 CFR 32.59, 10 CFR 32.102. Criteria: Licensees are required by 10 CFR 20.1501 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 tests results must be maintained. Discussion: Surveys are evaluations of radiological conditions and potential hazards (see Figure 8.11). These evaluations may be measurements (e.g., radiation levels measured with survey instruments or results of wipe tests for contamination), calculation, or a combination of measurements and calculations. The selection and proper use of appropriate instruments is one of the most important factors in ensuring that surveys accurately assess the radiological conditions for both licensed and non-licensed (e.g., accelerator operation) activities and the licensed facility. In order to meet regulatory requirements for surveying, measurements of radiological quantities should be understood in terms of their properties (i.e., alpha, beta, gamma) and compared to the appropriate limits. Figure 8.11 Types of Surveys. There are many different types of surveys performed by manufacturer and distribution licensees. Radiation surveys are used to detect and evaluate contamination of:
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. Figure 8.12 Personnel Surveys. Users of unsealed licensed material should check themselves for contamination (frisk) before leaving the restricted area(s) of the facility. 10 CFR 20.1501 states that surveys are required when it is reasonable under the circumstances to evaluate a radiological hazard, and when necessary for the licensee to comply with the regulations. 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 (see Appendix M, �Radiation Safety Survey Topics�). Not all instruments can measure a given type of radiation. The presence of other radiation may interfere with a detector’s ability to measure the radiation of interest. Correct use of radiation detection and measurements is an important aspect of any Radiation Safety Program. Table I.1 in Appendix I contains radiation monitoring and survey instruments and calibration programs that are acceptable to NRC. No limits for surface contamination are specified in 10 CFR Part 20. Each applicant should propose and justify what removable surface contamination limits will be allowable before decontamination will be performed in each work area. Contamination checks are required before distributing licensed material. Table M.5 in Appendix M contains contamination limits that are acceptable to NRC. Sealed Source and Plated Foil Leak TestsWhen 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 SSDR 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 Bq (0.005 microcuries) of radioactivity. Manufacturers, consultants, and other organizations may be authorized by NRC or an Agreement State either to perform the entire leak test sequence for other licensees or provide leak test kits to licensees. In the latter case, the licensee should take the leak test sample according to the sealed source or plated foil manufacturer's (distributor's) and the kit supplier's instructions and return it to the kit supplier for evaluation and reporting results. Leak test samples should be collected at the most accessible area where contamination would accumulate if the sealed source were leaking. Licensees may also be authorized to conduct the entire leak test sequence themselves. Leak tests are not required if:
For more information regarding leak tests, see Appendix M, Model Leak Test Program. Response from Applicant: Do one of the following:
OR
Note:
8.10.8 MAINTENANCE[ Prev | Next | Top of file ] Regulations: 10 CFR 20.1101. Criteria: Maintenance of equipment and facilities for the production and use of radioactive materials (e.g., accelerators and chemistry synthesis units) is necessary. Maintenance should be planned and carried out as frequently as needed, using ALARA principles. Individuals performing maintenance should be trained in the procedures they implement. Procedures should be written to account for the skills of the implementing personnel. Ordinarily, individuals handling unshielded materials should have up to forty hours of classroom and on-the-job training in radiation safety. Instructors should be more extensively qualified than the staff they teach. Discussion: Maintenance of equipment and facilities is necessary in order to produce a quality product safely and efficiently and to ensure a safe environment for staff and the public. Producing radioactive materials is an additional hazard, requiring attention to detail when incorporating maintenance information into procedures. Licensee staff should ensure that materials in the process stream are properly shielded/located/protected to minimize the hazard to maintenance staff. Maintenance staff should be aware of the hazards and the procedures to minimize their exposure to radioactive materials that are possessed and used to control the production process. As examples: (1) the staff should survey the accelerator working area prior to entry into the accelerator vault or opening of accelerator self-shields; and (2) a maintenance procedure should direct the shutdown and lockout of the accelerator before beginning work in the area. Maintenance procedures should be prepared with the use of engineering controls first, using ALARA principles and administrative controls, as needed. Response from Applicant: No response is required in the application process. The results of actions taken in the maintenance and repair of facilities and equipment process will be reviewed during inspection. 8.10.9 TRANSPORTATION[ Prev | Next | Top of file ] Regulations: 10 CFR 30.41, 10 CFR 30.51, 10 CFR 71.5, 10 CFR 71.14, 10 CFR 71.17, 10 CFR 71.19, 10 CFR 71.20, 10 CFR 71.47, 10 CFR 71.87, 49 CFR 107, 49 CFR 171-180, 49 CFR 390-397. Criteria: A licensee who transports licensed material outside the site of usage, as specified in the NRC license, or where transport is on public highways, or who delivers licensed material to a carrier for transport, shall comply with the applicable requirements of DOT regulations in 49 CFR Parts 107, 171 through 180, and 390 through 397, appropriate to the mode of transport. Therefore, applicants who will package, 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 DOT regulations. Discussion: In accordance with a Memorandum of Understanding between the DOT and NRC, NRC inspects and enforces DOT's regulations governing the transport of radioactive materials by NRC's licensees. Licensees should consider the safety of all individuals who may handle or come into 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 radiation levels (including removable contamination levels) at the package surfaces not only meet the regulatory requirements of 10 CFR 71.47, but are ALARA. DOT regulations require that individuals who perform functions related to the packaging and shipment of radioactive material packages receive training specific to those functions. The training must include a general awareness of DOT requirements, function-specific training for the individuals' duties, safety training, and security awareness training. DOT also specifies the frequency of the training and a record retention requirement for training. The types and quantities of radioactive materials shipped by production licensees generally meet the criteria for shipment in a "Type A" package, as defined by DOT. The requirements for these packages include the provisions for shipping papers, packaging design standards, package marking and labeling, and radiation and contamination level limits. For licensees who transport their own packages, the packages must be blocked and braced, and shipping papers must be stored in the driver's compartment as described in 49 CFR 177.817.
The general license in 10 CFR 71.17 provides the authorization used by most licensees to transport, or offer for transport, packages of radioactive material and specifies certain conditions. Transporting licensed materials originating at some facilities involves quantities of radioactive material that require a Type B package. The manufacturer (or service licensee) who is subject to the provisions of 10 CFR 71.17 or 10 CFR 71.19, as appropriate, is responsible for proper packaging of the radioactive materials and compliance with NRC and DOT regulations. If a licensee plans to make shipments of licensed materials in Type B packages on its own, the licensee must be registered as a user of the package and have an NRC-approved quality assurance (QA) plan, two of the requirements under the 10 CFR 71.17 general license. For information about QA plans, see Revision 2 of Regulatory Guide 7.10, "Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material," dated March 2005. Licensees should also develop and maintain their own radiation safety procedures for transporting licensed material within their own facilities if it does not involve the use of public highways. Response from Applicant: No response is needed from applicants during the licensing phase. However, before making shipments of licensed materials on its own using Type B packages, a licensee needs to have registered with NRC as a user of the package and obtained NRC's approval of its QA program. Transportation activities will be reviewed during inspection. 8.10.10 MINIMIZATION OF CONTAMINATION[ Prev | Next | Top of file ] Regulations: 10 CFR 20.1406. Criteria: Applicants for new licenses must 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 fullest extent practicable, the generation of radioactive waste. Discussion: When designing facilities and developing procedures for their safe use, applicants should think ahead and consider how to minimize radioactive contamination/decontamination during operation and during decommissioning efforts, and how to minimize radioactive waste generation during all phases of facility life cycle. For accelerator production facilities, it is important to consider the types of materials used for the construction of the facility and for the shielding of the accelerator. Due to the neutron activation that generally takes place during the operation of the accelerator, it is important to carefully characterize all of the materials used in the accelerator (e.g., target material), the shielding of the accelerator, and the accelerator facility to minimize the amount of activated products that are produced. Customers may also request the licensee of the production facility to provide recovery and shipping services for unwanted, damaged, and replacement materials/sources. As such, the licensee should consider the designs of shipping and recovery containers to meet transportation requirements. Procedures should be developed to enable these activities to be carried out with small impact on the radiological condition of the facility, decommissioning in the future, and employee external and internal radiation exposure. When submitting new applications, applicants should also consider the following:
Sealed sources and devices that are approved by NRC or an Agreement State and located and used according to their SSDR certificates usually pose little risk of contamination. Leak tests performed as specified in the SSDR certificate should identify defective sources. Leaking sources should be immediately withdrawn from use and decontaminated, repaired, or disposed of according to NRC requirements. These steps minimize the spread of contamination and reduce radioactive waste associated with decontamination efforts. Other efforts to minimize radioactive waste do not apply to programs using only sealed sources and devices that have not leaked. Response from Applicant: The applicant does not need to provide a response to this item under the following condition: NRC will consider that the above criteria have been met if the applicant's responses meet the criteria in the following sections: Section 8.5.1, "Radioactive Material – Unsealed and/or Sealed Byproduct Material," Section 8.9, "Facilities and Equipment," Section 8.10.6, "Radiation Safety Program – Safe Handling of Radionuclides and Emergency Procedures," Section 8.10.7, "Radiation Safety Program – Surveys and Leak Tests," and Section 8.11, "Waste Management." 8.11 ITEM 11: WASTE MANAGEMENT[ Prev | Next | Top of file ] Regulations: 10 CFR 20.1101, 10 CFR 20.1302, 10 CFR 20.1904, 10 CFR 20.1906, 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, 10 CFR 20.1101, 10 CFR 20.1302, 10 CFR 30.51, 10 CFR 61.52. Criteria: Radioactive waste generated as part of the production and distribution process must be disposed of in accordance with regulatory requirements and license conditions. Appropriate records of waste disposal must be maintained. Waste materials (such as glove, rags, tools) may not be received from others unless recipients are specifically licensed to receive such waste. Licensed materials which were distributed (such as decayed sources or devices at end of useful life) may be received from others and sent for proper disposal. 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. Environmental Protection Agency (EPA) guidance for developing a comprehensive program to reduce hazardous waste was transmitted to licensees by 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 (e.g., radioactive from nonradioactive, short from long half-life, liquid from solid waste). 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-StorageStorage of radioactive materials with half-lives of greater than 120 days should be characterized regarding volume and anticipated time in residence at the licensee's facility prior to disposal. NRC permits licensed materials with half-lives of less than or equal to 120 days to be disposed of by decay-in-storage (DIS). Waste should be held in storage until the radiation exposure rate cannot be distinguished from background radiation levels. Applicants should assure that adequate space and facilities are available for the storage of such waste and care should be taken to ensure that the waste form does not degrade or adversely interact with the waste container. Procedures for management of waste by DIS should include methods of segregation, surveys prior to disposal, and maintenance of records of disposal. Licensees can minimize the need for storage space, if radioactive waste is segregated according to physical half-life. Segregation of waste is accomplished by depositing radioisotopes of shorter physical half-lives in containers separate from those used to store radioactive waste with longer physical half-lives. Radioactive waste with shorter half-lives will take less time to decay and thus may be disposed in shorter periods of time, freeing storage space. 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 by Fuel Cycle and Material Licensees," dated February1990, provides guidance to licensees for requesting an amendment to authorize extended interim storage of LLW. A model procedure for DIS is contained in Appendix P, "Waste Disposal." 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) (See Figure 8.13). 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 by a factor of ten. Applicants 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, which deals with the application of ALARA in controlling gaseous and liquid effluents and references documents with acceptable methods of effluent monitoring. Figure 8.13 Air and Water Effluents from a Production Facility. Also note the fence, creating a "controlled area." Licensees considering disposal by release to the sanitary sewerage system must comply with the requirements of 10 CFR 20.2003. Licensees are responsible for demonstrating that licensed materials discharged into the sewerage system are readily soluble or biologically 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 liquid waste. Liquid scintillation media and ash are examples of material that may or may not be readily dispersible. Licensees should carefully consider the possibility of reconcentration of radioisotopes that are released into the sewerage system. 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 system meet the criteria stated in 10 CFR 20.2003 and do not exceed the monthly and annual limits specified in the regulations. Licensees are required to maintain accurate records of all releases of licensed material into the sanitary sewerage system. A model procedure for disposal of radioactive waste via a sanitary sewer is described in Appendix P. 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 the application. Contaminated sludges should 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 NRC 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. A model procedure for incineration of waste is described in Appendix P. Applicants who are considering disposal of radioactive material by incineration should review Regulatory Guide 8.37, "ALARA Levels for Effluents from Materials Facilities," dated July1993. 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 (e.g., compaction) that could create a radiological hazard to licensee employees or the general public should be described in detail in the application. A model procedure for waste compaction is described in Appendix P. Other Methods Specifically Approved by 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. Some licensees do not have an LLW disposal facility available to them and therefore may wish to use on-site interim storage until such time that a facility becomes available. Licensees should exhaust all possible alternatives for disposal of radioactive waste and rely upon on-site extended interim storage of radioactive waste only as a last resort, since protection of workers and the public is enhanced by disposal rather than storage of waste. Licensees may also find it more economical to dispose of radioactive waste than to store it on-site because as the available capacity decreases, the cost of disposal of radioactive waste may continue to increase. LLW should be stored only when disposal capacity is unavailable and for no longer than is necessary. NRC Information Notice (IN) 90-09, "Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees," dated February 1990, provides guidance to licensees for requesting an amendment to authorize extended interim storage of LLW. Additional ConsiderationsThe 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 10 CFR Part 20, Appendix B, Table II. Furthermore, due to the variability of inventory control programs for monitoring disposal and releases of licensed material possessed or possessed and 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 disposal by any of the authorized methods described in this section. Applicants should contact the appropriate NRC Regional Office for guidance and obtain advance approval of any method(s) of waste disposal other than those discussed in this section. Note: Alternative responses will be reviewed using the criteria listed above. 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. Refer to Section 7, License Fees. 8.13 ITEM 13: CERTIFICATION[ Prev | Next | Top of file ] Individuals acting in a private capacity are required to date and sign NRC Form 313. Otherwise, representatives of the corporation or legal entity filing the application should date and sign NRC Form 313. Representatives signing an application should be authorized to make binding commitments and to sign official documents on behalf of the applicant. As discussed previously in Section 3, Management Responsibility, signing the application acknowledges management's commitment and responsibilities for the Radiation Safety Program. NRC will return all unsigned applications for proper signature. Note:
9 AMENDMENTS AND RENEWALS TO A LICENSE[ Prev | Next | Top of file ] Regulations: 10 CFR 2.109, 10 CFR 30.36(a), 10 CFR 30.37, 10 CFR 30.38. 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 should 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 (10 CFR 2.109 and 10 CFR 30.36(a)). Applicants for license renewal and amendment should 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(a). Criteria: Licensees who request exemptions to regulations 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 and 10 CFR 30.11(a)). These regulations state that NRC may grant an exemption, either 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 should be accompanied by descriptions of the following:
11 TERMINATION OF ACTIVITIES[ Prev | Next | Top of file ] Regulations: 10 CFR 20.1401, 10 CFR 20.1402, 10 CFR 20.1403, 10 CFR 20.1404, 10 CFR 20.1405, 10 CFR 20.1406, 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). Criteria: 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. NUREG-1727, "NMSS Decommissioning Standard Review Plan," dated September 2000, and NUREG/BR-0241, "NMSS Handbook for Decommissioning Fuel Cycle and Materials Licenses," dated March 1997, contain the current regulatory guidance concerning decommissioning of facilities and termination of licenses. Appendix B of NUREG/BR-0241 contains a comprehensive list of NRC's decommissioning regulations and guidance. NUREG-1727 contains a list of superceded guidance; however, due to ongoing revisions, applicants are encouraged to consult with NRC staff regarding updates of decommissioning guidance. NUREG-1575, "Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM)," dated December1997, should be reviewed by licensees who have large facilities to decommission. An acceptable computer code for calculating screening values to demonstrate compliance with the unrestricted dose limits is DandD. NUREG-1727 includes a table (Table C2.2) of acceptable license termination screening values of common beta/gamma radionuclides for building surface contamination. NUREG-1727 also contains methods for conducting site-specific dose assessments for facilities with contamination levels above those in the table. Response from Applicant: The applicant is not required to submit a response to NRC during the initial application. The applicant's obligations in this matter begin when the license expires or at the time the licensee ceases operations, whichever is earlier. These obligations are to undertake the necessary decommissioning activities, to submit NRC Form 314 or equivalent information, and to perform any other actions as summarized in the "Criteria." References: 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 ] This report incorporates and updates the guidance previously found in the NUREG reports, Regulatory Guides (RGs), Policy and Guidance Directives (P&GDs or PGs), and Information Notices (INs). Other NRC documents such as Manual Chapters (MCs), Inspection Procedures (IPs), Memoranda of Understanding (MOU), and Technical Assistance Requests (TARs) were also consulted during the preparation of this report. See Tables A.1 and A.2 for a list of the documents considered in the development of this NUREG.
APPENDIX B: United States Nuclear Regulatory Commission Form 313[ Prev | Next | Top of file ] APPENDIX C: Suggested Format for Providing Information Requested in Items 5 through 11 of NRC Form 313 for a Possession License[ Prev | Next | Top of file ] The table below is designed to help applicants develop their applications. It may also be used as a License Reviewer Checklist for applications for a production and distribution license. A box (in a column ❒) indicates that the licensee may agree to use a model procedure, or if not using a model procedure, the licensee should describe its program or submit its procedures for the particular item.
APPENDIX D: Sample License[ Prev | Next | Top of file ] Sample License
A. through F. (1) For production, possession, or handling of radiochemicals and sealed sources for transfer to persons authorized to receive the licensed material pursuant to the terms and conditions of a specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement State. (2) Research and development as defined in 10 CFR 30.4. (3) For packaging and distribution of produced radiochemicals and sealed sources to persons authorized to receive licensed materials pursuant to the terms and conditions of specific licenses issued by the Nuclear Regulatory Commission or Agreement States. This should not be distributed as a radiopharmaceutical or radioactive drug. * Note: Certain information about quantities and locations of radioactive material are no longer released to the public. See Section 5.2. G. and H. Calibration and checking of the licensee's instruments. I. through L. For possession and storage of byproduct materials incidental to radionuclide production. CONDITIONS
Date: [insert license issue date] By: [Signature] APPENDIX E: Radiation Safety Officer Duties and Responsibilities[ Prev | Next | Top of file ] The RSO's duties and responsibilities include ensuring radiological safety and compliance with NRC and DOT regulations and the conditions of the license. Typically, these duties and responsibilities include the following:
APPENDIX F: Radiation Safety Training[ Prev | Next | Top of file ] This Appendix is intended only as a guide for developing a training program. Individuals working with radionuclides may not require training on every topic provided. For example, housekeeping staff may need to know only what symbols to look for, which waste cans to empty, or which areas to enter or avoid. Conversely, laboratory technicians may require detailed information on particular topics. As a result, instruction for some individuals may be accomplished by providing a simple hand-out, whereas others may require extensive training, including a written exam to assess retention of the topics presented. The licensee should determine whether the training succeeded in conveying the desired information and adjust the training program as necessary. This assessment may be performed by a written test or observation of the individual in the performance of assigned duties. Remedial training for missed test questions or other areas of apparent weakness should be conducted or additional formal training planned to cover deficient areas. Frequency of Training
General Information
Licensee-Specific Program Elements
For Laboratory Safety and Use of Radionuclides
APPENDIX G: Facilities and Equipment[ 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 of these topics in its application. Restricted areas are defined as areas to which access is limited by the licensee to protect individuals against undue risks from exposure to radiation and radioactive materials. Restricted areas do not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area. Refer to 10 CFR Part 20 for more information regarding restricted area controls. The application should contain detailed descriptions and diagrams of the facilities, including information about the shielding properties of the construction materials used. Scaled drawings and sketches should be submitted showing the relationship between restricted areas and unrestricted areas and the location of all pertinent safety-related equipment. Drawings should show the uses of adjacent areas, including those beside, above, and below, and a recitation of the various shielding materials in the separating surfaces.
Appendix H: Example of an Audit Form[ 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 any commitments in the licensee's applications and other correspondence with NRC that have been incorporated as license conditions. Licensees are encouraged to modify the audit form as needed to include items specific to their licensed program and should ensure that radiation safety audits include activities conducted during all shifts. References are also included. EXAMPLE OF AN AUDIT FORM
REFERENCES
APPENDIX I: Radiation Monitoring Instrument Specifications and Model Survey Instrument and Air Sampler Calibration Program[ Prev | Next | Top of file ] The specifications in Table I.1 will help applicants and licensees choose the proper radiation detection equipment for monitoring the radiological conditions at their facility(ies). Table I.1 Typical Survey Instruments1 (Instruments used to measure radiological conditions at licensed facilities).
Model Instrument Calibration ProgramTraining Before allowing an individual to perform survey instrument calibrations, the RSO should 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 should cover the following subject areas:
Appropriate on-the-job-training should consist of the following:
Facilities and Equipment for Calibration of Dose Rate or Exposure Rate Instruments
Model Procedure for Calibrating Survey InstrumentsA radioactive sealed source(s) used for calibrating survey instruments should:
Refer to the American National Standards Institute (ANSI) document N323A-1997, "Radiation Protection Instrumentation Test and Calibration," for the following:
Notes:
Surface Contamination Measurement Instruments(2)
Model Procedures for Calibrating Liquid Scintillation Counters, Gamma Counters, Gas-Flow Proportional Counters, and Multichannel AnalyzersA radioactive sealed source used for calibrating instruments should do the following:
Calibration
Calibration Records Calibration reports, for all survey instruments, should indicate the procedure used and the data obtained. The description of the calibration will include:
The following information should be attached to the instrument as a calibration sticker or tag:
Air Sampler Calibration In 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 should 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 9th Edition, American Conference of Governmental Industrial Hygienists, 2001, 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 Volume Most methods for 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 or gas displacement. An example of a secondary standard is a wet-test meter that has been calibrated against a primary standard. Primary standards are usually accurate to within ± 1% and secondary standards to within ± 2%. The following are significant errors associated with determining the total air volume sampled: EC: The error in determining the calibration factor. (An acceptable estimate is the percentage error associated with the standard instrument used in the calibration).(3) ES: Intrinsic error in reading the meter scale. (An acceptable estimate is the percentage equivalent of one-half of the smallest scale division, compared to the scale reading). Et: The percentage error in measurement of sampling time that should be kept within 1%. EV: The most probable value of the cumulative percentage error in the determination of the total air volume sampled. EV: can be calculated from the following equation, provided there are no additional significant sources of errors: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:
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: where: Vs = volume at standard conditions (760 mm & 0C) Documentation of Calibration of Air Metering Devices The 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:
Additional References:
APPENDIX J: Guidance for Demonstrating that Individual Members of the Public Will Not Receive Doses Exceeding the Allowable Limits[ Prev | Next | Top of file ] This Appendix describes methods for determining radiation doses to members of the public. Licensees must ensure that:
The licensee may show compliance with the annual dose limit for individual members of the public by:
In order to perform a dose assessment, licensees 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 their facilities. Licensees must then take radiation measurements or perform calculations to demonstrate compliance with public dose limits. Measurements 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 upon 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 during accelerator operation. Due to the uncertainty of this type of discharge, it may be important to perform effluent monitoring continuously or at least during the operation of the accelerator. 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 Using a calculation method, the licensee should 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. A conservative calculation should assume that the individual was continuously present 24 hours a day, 365 days a year, or an occupancy factor of 1 (see Table J.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. Figure J.1 provides the steps on how to calculate the annual dose to an individual member of the public. Also, see Regulatory Guide 4.20, "Constraint on Releases of Airborne Radioactive Materials to the Environment for Licensees other than Power Reactors," for more information on calculating public dose. Figure J.1 Calculating Public Dose. Steps to calculate the annual dose to an individual member of the public. If the calculation demonstrates that the public dose limit is exceeded with an occupancy factor of 1, then more realistic assumptions of the individual's occupancy at the points of highest internal and external exposures may be made. The licensee may use the occupancy factors in Table J.1 or may calculate a specific occupancy factor by determining the likely fraction of time that the individual is present. Table J.1 Standard Occupancy Factors.
RecordsThe 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. Records demonstrating the dose to an individual member of the public should identify the instruments used in the survey; the name of the surveyor; the date of the survey; the location of the survey(s), including a description or drawing of the area surveyed; survey results; and if applicable, the occupancy factors used and justification for their use. In addition, records demonstrating the dose to an individual member of the public that involve effluent sampling analysis should include information on concentrations of specific radionuclides, minimum detectable activity of the system, and the estimated uncertainty of measurements. APPENDIX K: General Topics for Safe Possession and Use of Radioactive Materials and Model Emergency Procedures[ Prev | Next | Top of file ] This Appendix describes general topics for safe possession and use of radioactive materials, and procedures for handling and reporting emergencies. General Topics for Safe Possession and Use of Radioactive MaterialsEach area where radioactive material is produced, handled, or stored should have general rules, so that workers know what is required. Typical instructions should include:
Figure K.1 Storage of Food and Drink. Food or drink shall not be stored in refrigerators with radioisotopes. Radionuclide-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 EmergenciesThe following are acceptable procedures for responding to emergencies:
General Safety Procedures to Handle Spills
Minor Spills of Liquids and Solids
Major Spills of Liquids and Solids
Note: For major spills, the criteria are generally determined based on the reporting requirements of 10 CFR 30.50(b). Incidents Involving Radioactive Dusts, Mists, Fumes, Organic Vapors, and Gases
Minor Fires
Fires, Explosions, or Major Emergencies
APPENDIX L:Typical Notification and Reporting Requirements[ Prev | Next | Top of file ] This Appendix lists some typical notification and reporting requirements found in 10 CFR. It is not meant to be all inclusive. Table L.1 Typical NRC Notifications and/or Reports.
Note: Telephone notifications shall be made to the NRC Operations Center at 301-816-5100 or (301) 951-0550, except as noted. APPENDIX M: Model Leak Test Program[ 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. Note that the NRC does not regulate the operation of the accelerator and therefore does not regulate radiation surveys performed on the accelerator during its operation. This Appendix refers to radiation surveys performed because of the use, handling, and/or storage of the radioactive materials that have been produced by an accelerator. TrainingBefore allowing an individual to perform surveys, the RSO should 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
Ambient Radiation Level Surveys
Contamination SurveysLicensees' 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 FrequencyPersonnel 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 ALI (either the inhalation or ingestion ALI) listed for that radionuclide in 10 CFR Part 20 Appendix B. 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 radionuclide in 10 CFR Part20, detailed, documented surveys should be performed at least monthly. Table M.1 contains the suggested contamination survey frequency from Regulatory Guide 8.23. (See Tables M.2, M.3, and M.4 for alternate survey frequencies.) Table M.1 Suggested Frequency of Contamination Surveys from Regulatory Guide 8.23.
Alternate Survey FrequencyClassification of Laboratories or Areas of Use Table M.2 Survey Frequency Category.
Proportional fractions should be used for more than one isotope. Table M.3 Survey Frequency Category Modifiers.
The object is to determine how often to survey the laboratory or area of use. To do this, multiply the activity range under the LOW, MEDIUM, and HIGH survey frequency in Table M.2 by the appropriate Modifying Factor to construct a new set of activity ranges for LOW, MEDIUM, and HIGH survey frequency. Survey Frequency:
Contamination in Unrestricted AreasContamination found in unrestricted areas should be immediately decontaminated to background levels. When it is not possible to get to background levels, the licensee should ensure that the amounts do not exceed the contamination levels listed in Table M.5. Table M.5 Acceptable Surface Contamination Levels.
1Where surface contamination by both alpha- and beta-gamma-emitting nuclides exists, the limits established for alpha- and beta-gamma-emitting nuclides should apply independently. 2As used in this table, dpm (disintegration per minute) means the rate of emission by radioactive material as determined by correcting the counts per minute observed by an appropriate detector for background, efficiency, and geometric factors associated with the instrumentation. 3Measurements of average contaminant should not be averaged over more than 100 square centimeters. For objects of less surface area, the average should be derived for each such object. 4The maximum contamination level applies to an area of not more than 100 cm2. 5The amount of removable radioactive material per 100 cm2 of surface area should be determined by wiping that area with filter or soft absorbent paper, applying moderate pressure, and assessing the amount of radioactive material on the wipe with an appropriate instrument of known efficiency. When removable contamination on objects of less surface area is determined, the pertinent levels should be reduced proportionally and the entire surface should be wiped. 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 RequirementsEach survey record should include the following:
Figure M.1 Area Diagram. This is an example of a laboratory survey map. 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 WorkplaceAir 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, or the current revision, for further guidance on air sampling. Airborne Effluent Release MonitoringWhen 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 any time 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 or 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 in 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 MonitoringThe 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 sewer releases is more fully discussed in Appendix P. Bioassay MonitoringFrequency of Required Bioassay Measurements Determining 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 that 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 MeasurementsRoutine 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 and urinalysis) 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 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 a change in employment status, a termination bioassay measurement should be made, when practicable, to ensure that any unknown intakes are quantified. Collection of Emergency Bioassay SamplesIn the event of an emergency where an individual becomes contaminated and radioactive material has been 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 should be performed. Frequently, this estimate is made by performing a bioassay of the individual. Bioassays may be performed through direct methods such as whole body counting or thyroid counting, where the radioactive material in the body can be directly measured using appropriate instruments. Bioassays may also be performed through indirect means such as sampling urine or other excreta from the body and calculating the intake from the amount of material detected in the samples, the time between suspected intake and sample collection, and knowledge of the rate of excretion of the compound and/or radionuclide from the body. While there are many ways to perform the calculations, including using computer models, the method of calculation is only as good as the quality of the samples and analyses performed. Because a dose estimate may be required, bioassay procedures for a suspected intake may differ from those in a routine bioassay screening program, and the licensee’s Radiation Safety Program should include procedures and equipment for appropriate sample collection in an emergency. The following items should be considered in developing your procedures:
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:
APPENDIX N: Summary of DOT Requirements for Transportation of Type A or Type B Quantities of Licensed Material[ Prev | Next | Top of file ] Model Leak Test ProgramTrainingBefore allowing an individual to perform leak testing, the licensee should ensure that he or she has sufficient classroom and on-the-job training to show competency in performing leak tests independently. Classroom training may be in the form of lecture, videotape, or self-study and should cover the following subject areas:
Appropriate on-the-job-training consists of:
Facilities and Equipment
Frequency for Conducting Leak Tests of Sealed SourcesLeak tests must be conducted at the frequency specified in the respective SSDR certificate. Procedure for Performing Leak Testing and Analysis
Reference: See NUREG-1556 Vol. 18, "Program-Specific Guidance About Service Provider Licenses," dated November 2000. APPENDIX O: Summary of DOT Requirements for Transportation of Type A or Type B Quantities of Licensed Material[ Prev | Next | Top of file ] The major areas in the DOT regulations that are most relevant for transportation of Type A or Type B quantities of licensed material are:
For additional transportation information, licensees may consult DOT’s “A Review of the Department of Transportation Regulations for Transportation of Radioactive Materials” or contact DOT at http://www.dot.gov APPENDIX P: Waste Disposal[ Prev | Next | Top of file ] General Discussion
Model Procedure for Decay-In-Storage (DIS)Licensees can minimize the need for storage space if the waste is segregated according to physical half-life.
Note: All radiation labels should be defaced or removed from containers and packages prior to disposal as ordinary trash. Model Procedure for Disposal of Liquids Into Sanitary Sewerage
Model Procedure for IncinerationThese guidelines apply to noncommercial waste disposal (e.g., incineration of a licensee’s own waste). Specific NRC approval is not necessary 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 reviewing the disposal program and confirming the existence of waste that requires specific NRC approval for incineration, provide the following information in the license application [20.2108]:
Model Procedure for CompactionThe following information should be provided by licensees who propose to compact waste [20.2108]:
APPENDIX Q: Production and Noncommercial Distribution of PET Radioactive Drugs to Consortium Members[ Prev | Next | Top of file ] PURPOSE OF APPENDIXThe purpose of this Appendix is to provide guidance to the educational institution, medical facility, or Federal facility applicant with a Positron Emission Tomography (PET) radionuclide production facility that is a member of a “consortium” as defined in 10 CFR 30.4 and that is requesting authorization under 10 CFR 30.32(j) for the production and noncommercial distribution of PET radioactive drugs to medical use licensees within the consortium. The information required in this Appendix is specific to this authorization and supplements information required for other uses of byproduct material covered under the applicant’s byproduct materials license application. In 10 CFR 30.4: “consortium means an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility within the consortium must be located at an educational institution or a Federal facility or a medical facility.” Note that medical-use applicants/licensees may also refer to Appendix AA of NUREG 1556, Vol. 9, Rev. 2 “Program-Specific Guidance About Medical Use Licenses” for similar guidance on the production and commercial distribution of PET radioactive drugs to consortium members. The regulatory requirements for educational institutions, Federal facilities, and medical facilities to receive authorization for producing PET radioactive drugs for noncommercial distribution to licensees in a consortium may be found in 10 CFR 30.32(j). Regulatory requirements for licensees with this specific authorization are found in 10 CFR 30.34(j). The noncommercial distribution of PET radioactive drugs can be requested as an additional authorization on a current byproduct material possession license (e.g., educational institution, medical facility, or Federal facility broad-scope or limited specific license). The information associated with the Radiation Safety Program specifically needed for producing PET radioactive drugs can be found in the current version of NUREG-1556, Vol. 13, “ Program-Specific Guidance About Commercial Radiopharmacy Licenses.” To avoid duplication, many sections in this Appendix refer the applicant to the appropriate sections in NUREG 1556 Vol. 13. It should be noted that, as stated in 10 CFR 30.34(j)(1), the authorization under 10 CFR 30.32(j) to produce PET radioactive drugs for noncommercial distribution to medical use licensees in a consortium does not relieve the applicant or licensee from complying with applicable U. S. Food and Drug Administration (FDA), other Federal, and State requirements governing radioactive drugs. CONSORTIUM CRITERIAIn accordance with 10 CFR 30.32(j), only an applicant from a medical facility, educational institution, or Federal facility can produce PET radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under 10 CFR Part 35 or equivalent Agreement State requirements. Therefore, the NRC must have sufficient information to make the necessary determination that the licensee is a member of a consortium that meets the definition in 10 CFR 30.4, and that the applicant will distribute the PET radioactive drugs only to medical use licensees in its consortium. To assist the NRC in making this determination, the applicant should describe this consortium. Since the medical use consortium members are authorized by 10 CFR 35.100(a), 35.200(a), or 35.300(a) to receive the PET radioactive drugs, the applicant does not have to specifically identify the medical use members of the consortium if the description of the criteria for consortium membership is provided. This description should focus on the regulatory requirements. This includes a description of the geographical area in which the members are located. Even if the individual members of the consortium are provided, the applicant should provide documentation of the terms of the association demonstrating the joint ownership or sharing of the operation and maintenance cost of the PET radionuclide production facility. This documentation may include, but may not be limited to, signed agreements or contracts indicating roles and responsibilities of all of the individuals/entities involved. The applicant for authorization under 10 CFR 30.32(j) for the production of PET radioactive drugs is required to be a consortium member but is not required to be the consortium member that has the PET radionuclide production facility. The applicant is required by 10 CFR 30.32(j)(1) to either request authorization for the production of PET radionuclides, if the applicant has the PET radionuclide production facility and does not have a license for it, or provide evidence of an existing license issued under 10 CFR Part 30 or the Agreement State requirements for a PET radionuclide production facility within its consortium from which it receives PET radionuclides. Response from the Applicant:
QUALIFIED TO PRODUCE PET RADIOACTIVE DRUGS10 CFR 30.32(j)(2) requires that the applicant be qualified to produce PET radioactive drugs for medical use by meeting one of the following criteria:
Response from the Applicant:
RADIOACTIVE MATERIALS AND USESUnder 10 CFR 30.32(j)(4), the applicant is required to identify the PET radioactive drugs authorized under 10 CFR 30.32(j) for production and noncommercial distribution and requires the applicant to submit information on the radionuclide in the PET radioactive drug; the chemical and physical form; and the maximum activity per vial, syringe, generator, or other container of the radioactive drug. Because applicants are only authorized for production and noncommercial distribution of these PET radioactive drugs, the applicant should request authorization to receive potentially contaminated “empty” radiation transport shields back from consortium members. It is the responsibility of the medical use consortium licensees under 10 CFR 20.2001 to properly dispose of licensed materials such as unused dosages and residual radioactivity remaining in syringes, and vials that were received from the licensee authorized to produce and transfer PET radioactive drugs to consortium members. Response from the Applicant:
INDIVIDUALS RESPONSIBLE FOR RADIOACTIVE SAFETY PROGRAMS AND THEIR TRAINING AND EXPERIENCEIndividuals responsible for the Radiation Safety Program for the production of PET radioactive drugs and their transfer are the applicant’s (or licensee’s) Radiation Safety Officer (RSO) and the authorized individual(s) responsible during the production processing of the PET radionuclides into radioactive drugs. The applicant’s RSO and authorized individuals must meet the requirements in 10 CFR 30.33(a)(3). If these individuals are already identified for other materials and uses, they may already be authorized for the quantities, materials, and radiation safety considerations associated with the PET radioactive drug production process. In order to demonstrate that these individuals are qualified by their training and experience to use these materials for the purpose requested, as required by 10 CFR 30.33(a)(3), applicants should describe their additional training and experience for the quantities, materials, and radiation safety considerations that differ substantially from the current authorization(s). If the applicant is producing the PET radioactive drugs in a pharmacy, the applicant must have an Authorized Nuclear Pharmacist (ANP). The applicant should refer to the current version of NUREG-1556, Vol. 13, “Commercial Radiopharmacy Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Commercial Radiopharmacy Licenses,” for guidance on the minimum training and experience requirements for an ANP and optional use of NRC Form 313A (ANP) to document the individuals’ training and experience. A licensee that produces PET radioactive drugs under a 10 CFR 30.32(j) authorization in a pharmacy is permitted to allow an individual to begin work as an ANP if the individual meets the board certification requirements in 10 CFR 35.55(a), and is listed on an NRC or Agreement State license as an ANP or listed as an ANP on a permit issued by a master materials licensee. Note that the licensee is required to notify the NRC within 30 days from the date the individual began work and must provide the specified information in accordance with 10 CFR 35.14. Response from the Applicant:
TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREASIndividuals working with licensed material must receive radiation safety training commensurate with their assigned duties and specific to the licensee’s Radiation Safety Program. In addition, those individuals who, in the course of employment, are likely to receive in a year a dose in excess of 100 mrem (1 mSv) must be instructed according to 10 CFR 19.12. Applicants should have already provided the training information for individuals working in or frequenting restricted areas as part of their radionuclide possession license application. In addition to this training information, applicants must ensure that individuals that will be involved in the preparation and transportation of hazardous materials, such as PET radioactive drugs, meet the training requirement in 49 CFR 172.704. Section 8.8.2 and Section 8.8.3 of the current version of NUREG-1556, Vol. 13, “Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Commercial Radiopharmacy Licenses,” provide guidance on training requirements for individuals involved in the preparation and transport of hazardous materials packages and for supervised individuals who will prepare radioactive drugs. Response from the Applicant:
FACILITIES AND EQUIPMENTApplicants should have already provided information regarding the facilities and equipment used for the radionuclide facility. In addition to this information, in order to demonstrate that the facilities and equipment are adequate to protect public health and safety, as required by 10 CFR 30.33(a)(2), the applicant must provide a description of the facilities and equipment used for the production of PET radioactive drugs and the noncommercial distribution to consortium members. Section 8.9.2 (Facilities and Equipment for PET Radiopharmacies) of the current version of NUREG-1556, Vol. 13, “Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Commercial Radiopharmacy Licenses,” provides guidance on the information that should be provided regarding the PET radioactive drug production and distribution facility/area. Response from the Applicant:
Include the following information:
RADIATION SAFETY PROGRAMThe majority of information regarding the Radiation Safety Program may have already been provided to NRC as part of a radionuclide production/possession license application. The applicant should review its authorization to determine whether supplementary information should be submitted about its Radiation Safety Program. Section 8.10 (Item 10: Radiation Safety Program) of this guidance document provides guidance regarding an acceptable Radiation Safety Program for a radionuclide production facility. This guidance also applies to the production of PET radioactive drugs. However, in addition to the radiation safety guidance mentioned in this document, applicants that will produce and noncommercially distribute PET radioactive drugs to their consortium members pursuant to 10 CFR 30.32 (j) must adhere to the following: Dosage Measurement System Among other things, 10 CFR 30.33(a)(2) requires that the applicant’s proposed equipment be adequate to protect public health. In 10 CFR 30.34(j)(2)(ii), a licensee is required to possess and use instrumentation to measure the radioactivity of the PET radioactive drugs intended for noncommercial distribution to members of its consortium and have procedures for use of the instrumentation. In addition, 10 CFR 30.34(j)(2)(ii) requires licensees to measure, by direct measurement or by a combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting radioactive drugs prior to transfer for commercial distribution. The licensee must also perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; make adjustments when necessary; and check each instrument for constancy and proper operation at the beginning of each day of use. Therefore, the licensee shall have procedures for the use of instrumentation. In addition, the licensee shall measure, by direct measurement or a combination of direct measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting radioactive drugs prior to noncommercial distribution. The licensee must also ensure that the dose calibrator, or other dose measurement systems, function properly. This is accomplished by performing periodic checks and tests prior to first use, followed by checks at specified intervals, and following repairs that could affect system performance. Equipment used to measure dosages that emit gamma, alpha, or beta radiation must be calibrated for the applicable radionuclide being measured. For photon-emitters such as PET radionuclides, activity measurement is a fairly straightforward determination. Generally, PET radionuclides can be measured using direct measurement only and do not require calculations to be performed, which is often required for beta-emitting radionuclides. For each dose measurement system, specific periodic tests must be performed, as appropriate to the system, to ensure correct operation. Typically, all systems must be checked each day of use for constancy to ensure continued proper operation of the system. In addition, other appropriate tests may include accuracy (for the range of energies to be measured), linearity (for the range of activities to be measured), and geometry dependence (for the range of volumes and product containers). Licensees should assay patient dosages in the same type of vial or syringe and geometry as used to determine the correct dose calibrator settings. The use of vials or syringes other than those used for geometry dependence may result in measurement errors. Also, the applicant should ensure that it possesses a sufficient number of such instruments to allow for periods when instruments are out of service for repair and calibration. Response from the Applicant:
Radioactive Drug Labeling for Distribution Section 30.34(j)(2)(i) of 10 CFR Part 30 requires the licensee for the noncommercial transfer of PET radioactive drugs to label each transport radiation shield to show the radiation symbol (as described in 10 CFR 20.1901). The label must also include the words “CAUTION, RADIOACTIVE MATERIAL,” or “DANGER, RADIOACTIVE MATERIAL,” the name of the radioactive drug or its abbreviation, and the quantity of radioactivity at a specified date and time. The term “transport radiation shield” refers to the primary shield for the radioactive drug, which may include the syringe, vial, or syringe or vial shield. In order to comply with 10 CFR 30.32(j)(4), the transport radiation shield should be constructed of material appropriate for the isotope to be transferred for noncommercial distribution. The licensee must also label each syringe, vial, or other container (e.g., generator) used to hold PET radioactive drugs for noncommercial transfer to consortium members to show the radiation symbol, as described in 10 CFR 20.1901. The label must include the words “CAUTION, RADIOACTIVE MATERIAL” OR “DANGER, RADIOACTIVE MATERIAL.” The label must also include an identifier that ensures the syringe, vial, or other container can be correlated with the information on the transport radiation shield label. Identifiers may include the prescription number, the name of the radioactive drug or its abbreviation, the name of the patient, or the clinical procedure. Response from the Applicant:
Radioactive Drug Shielding for Noncommercial Transfer Among other things, 10 CFR 30.33(a)(2) requires that the applicant’s proposed equipment be adequate to protect public health. Under 10 CFR 30.34(j)(4) the shielding provided for each radioactive drug to be noncommercially distributed is required to be appropriate for safe handling and storage by the consortium members. The applicant must provide appropriate transport radiation shields for the primary container of each PET radioactive drug that it intends to distribute. The shielding must be adequate for the types and quantities of radioactive materials that the applicant intends to transfer. Typically, transport radiation shields used to carry radioactive drugs include two-piece, shielded syringe and vial containers (or “pigs”). Facilities have used lead and tungsten shields for gamma-/photon-emitting materials. The applicant should select appropriate shielding materials and dimensions to ensure not only that occupational doses are ALARA, but also that the transport radiation shield can be easily handled. Response from the Applicant: For each PET radioactive drug to be noncommercially distributed:
Note: With respect to the transport radiation shield, it is not acceptable to state that the applicant will comply with DOT regulations. The dose rate limits that DOT imposes apply to the surface of the package, not the surface of the transport radiation shield. Transportation For the transportation of PET radioactive drugs to consortium members, refer to Section 8.10.9 (Transportation) of this document for guidance. The required transportation information should be consistent with the information provided for the production and distribution of accelerator-produced radionuclides.
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General Comment | PET Radiopharmaceu-tical Manufacturing | Many of the commercial PET radiopharmacies currently operate as a hybrid of a radiopharmaceutical manufacturing and as a radiopharmacy due to the unique rules governing PET radiopharmaceuticals. We urge consideration of this in the development of guidance that will apply to licensing of these facilities. |
NRC Staff Response: During the development of this guidance document, where applicable, we have taken these unique features into account. |
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General Comment | Engineering Controls | One should consider the fundamental conflict between engineering controls used to insure compliance with Good Manufacturing Practices for drug manufacturing, and those commonly employed for control of contamination from radioactive materials. Resolving this conflict may require a novel approach and recognition that perhaps a radionuclide with a low volatility hazard can be safely handled in a positive pressure space in order to guarantee sterility of the final product. |
NRC Staff Response: This guidance document does not address drug manufacturing, but with regard to engineering controls, NRC requires the licensee to perform its operations in accordance with regulatory dose limits found in 10 CFR Part 20 and maintain radiation doses as low as reasonably achievable (ALARA). |
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General Comment | Grandfathering of Individuals | There is no discussion of grandfathering in the draft of Volume 21, and this could be critical to ensuring the continued supply of accelerator produced radiopharmaceuticals during and after implementation of the final rules. We request that discussion be included in section 8-7 and in the suggested response for Item 7 of NRC Form 313 on page C-3. |
NRC Staff Response: Unlike 10 CFR Part 35 medical use licensees that are required to meet specific training and experience requirements, 10 CFR Part 30 licensees that use accelerators to produce byproduct material are required to meet general performance criteria in 10 CFR 30.33(a)(3). The training and experience of individuals proposed to be involved in licensed activities to produce byproduct material are reviewed during the licensing process to ensure that they are qualified to perform those activities. Because the NRC does not have specific requirements for these individuals, there is no need to provide a “grandfather provision” for them. Applicants with accelerators used to produce byproduct material will be required to describe the radiation safety training and work experience of those individuals using materials that they are seeking authorization to use. Individuals that use these byproduct materials should document that their radiation safety training and work experience from using these materials are sufficient to meet the general performance criteria such that they may be recognized as authorized individuals. |
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General Comment | Training Requirements for Authorized Individuals | There was discussion earlier in the rulemaking process regarding classification of service personnel for accelerators. These individuals are critical to ensuring the reliability of accelerators used to produce radiopharmaceuticals on a timely basis, but may not possess the academic background suggested in section 8.7.2 of the draft. In the interest of ALARA as much time as possible is usually allowed from the last production cycle of the accelerator until the beginning of maintenance on the unit. Under a Nuclear Pharmacy type of license, it could be required that an ANP is present whenever this work is taking place, when it is often on a shift opposite of the normal Pharmacist's production schedule. We suggest that a combination of training, outside of academia, and experience be more broadly defined. For example, many accelerator service personnel come from a military background and may not have had formal coursework in the physical sciences or engineering fields, but nevertheless have been provided extensive radiation safety training from either the employer/licensee or from the accelerator manufacturer. |
NRC Staff Response: Section 8.7.2 indicates that the authorized individual should have a college degree at the Bachelor level or “equivalent training” and experience in physical, chemical, or biological sciences or in engineering. The use of the term “equivalent training” allows flexibility, as it is understood that these individuals will have varying educational/training backgrounds. Adding specific criteria to these education/training requirements might limit individuals from being authorized under the license. |
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Abstract (Page iii - first paragraph) |
Purpose for Guidance Document | This guidance document should be used for activities that take place once radioactive materials are produced by the accelerator, which include material in the target and associated activation products, to the transfer or distribution of material to another license for preparation of the final product (e.g., radioactive drugs). Suggested rewording of this sentence is as follows:
We are requesting emphasis on the scope of the newly defined by-product to include activation products in the cyclotron itself as well as in the surrounding shielding, whether self-shielded or in a bunker. Production of the final product often takes place at the same facility. Volume 13 covers radiopharmacy licensees but not necessarily radiopharmaceutical manufacturing. |
NRC Staff Response: The abstract has been revised as suggested by the commenter to include the activated products within the accelerator along with its associated shielding. |
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Section 5.3 (page 5-2) | Electronic Application | There is discussion in this section about NRC's intent to move to a "faster and more efficient" processing of electronic applications "in the future." It seems pointless to include "Electronic Format" in the title of this section when there really isn't an electronic application option. In addition, we strongly urge NRC to move to provide the option of electronic submission of applications as soon as possible. |
NRC Staff Response: This Section has been revised to more closely match the wording used in other NUREG 1556 guidance documents. The NRC is still planning to have an electronic application process. |
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Section 8 (Page 8-1, paragraphs 3 and 4) | Incidentally-Activated Radionuclides | Include mention of material selection and its impact on creation of activation products in the discussion on ALARA in paragraphs three and four in order to highlight this issue for licensees. |
NRC Staff Response: Material selection and its impact on the creation of incidentally activated products are discussed in the Unsealed and /or Sealed Byproduct Material section (Section 8.5.1) of this guidance document. |
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Section 8.2 (Page 8-2) | Timely Notification of Transfer of Control | It is often difficult or impossible for licensees to meet this requirement as often the RSO is not at a level to be made aware of such a change in the business prior to its execution. The best that can be expected is for immediate notification when the RSO is made aware of the change. |
NRC Staff Response: As discussed in this Section, it is the licensee’s responsibility, not the Radiation Safety Officer’s responsibility, to provide notification and obtain NRC’s written consent prior to transferring control of the license. No change was made to this Section. |
Location | Subject | Comment |
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Figure 8.1 (Page 8-4) | Acceptable Location of Possession and Use | The sentence under this figure is essentially a repeat of the last sentence on Page 8-3. |
NRC Staff Response: The sentence under Figure 8.1 has been removed. |
Location | Subject | Comment |
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Figure 8.1 (Page 8-4) | Acceptable Location of Possession and Use | The sentence under this figure is essentially a repeat of the last sentence on Page 8-3. |
NRC Staff Response: The sentence under Figure 8.1 has been removed. |
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Section 8.5.1 (Page 8-5) | Incidentally-Activated Radionuclides | Some reasonable and practical guidance is needed here on how to determine the radionuclides and quantity of activity that is expected in various locations (e.g. cyclotron components, targets and target systems, vault shielding, etc) in addition to the discussion provided on sealed sources. The added guidance should be based on established licensing practices used by the Agreement States. |
NRC Staff Response: The statement that the location of activated products should be indicated has been removed. The applicant should provide a list of all byproduct material, which includes activated products with half-lives greater than 120 days, and their maximum activities. If the applicant is not able to determine the activated products and their maximum activities, the manufacturer of the accelerator should be contacted for guidance on how to obtain this information. |
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Section 8.5.1 (Page 8-7) | Incidentally-Activated Radionuclides | The first bullet under “For unsealed materials:” is impractical guidance. It is unreasonable to assume that licensees would be able to identify and list on the license each and every distinct location where radioactive materials may exist as a result of activation from accelerator operation. Licensees should be allowed to follow the practice endorsed by the Agreement States where an estimate of activity is determined (with a maximum for any radionuclide stated) for atomic numbers 1 - 83, in any chemical/physical form, with a general authorized use provided (e.g. target loading and irradiation, transfer of target materials, storage of induced radioactivity in cyclotron components and related equipment and facilities). |
NRC Staff Response: The statement that the location of incidentally activated radionuclides should be indicated has been removed. |
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Section 8.5.2 (Page 8-8) | Financial Assurance for Decommissioning | There is no guidance in this section related to financial assurance for decommissioning of accelerator facilities with the exception of the statement, "most accelerator facilities will be required to comply.. . because of activation materials.. . produced by operation." Considering this document is intended for accelerator operators, it would be very useful for some detailed guidance to be provided here to enable licensees to determine how and to what extent they may be subject to the financial surety requirements. This guidance should include a provision for some PET cyclotron operators to establish a threshold of operational parameters below which it has been demonstrated that activation of ancillary facilities would not result in accumulated activities subject to decommissioning plans, cost estimates and financial assurance. |
NRC Staff Response: As stated in Section 8.5.2, NUREG-1757, Volume 3, “Consolidated NMSS Decommissioning Guidance - Financial Assurance, Recordkeeping, and Timeliness” provides specific guidance on what is required for financial assurance for decommissioning for all radioactive material facilities, which includes accelerator facilities. Also, 10 CFR 30.35 provides the criteria for determining when licensees are subject to financial assurance requirements. |
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Section 8.7.1 (Page 8-14) | Radiation Safety Officer | The first sentence differs from other guidance where the RSO is responsible for oversight on implementation, and not directly for the program's implementation. |
NRC Staff Response: As provided in other volumes of NUREG-1556, the RSO as named on the NRC Part 30 license is responsible for implementing the radiation safety program. Although the performance of certain radiation safety tasks may be delegated by the RSO to other individuals, the responsibility for the overall effectiveness of the radiation safety program and for compliance with NRC rules and regulations and conditions of the license resides with the RSO. No changes were made to this Section of the guidance document. |
Location | Subject | Comment |
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Section 8.7.1 (Page 8-15) | Radiation Safety Officer | The requirement for a "specialist in the field of radiation protection" directly implies that a Health Physicist would be the minimum qualification for RSO at accelerator facilities with curie quantities of radioactivity and differs substantially from RSO requirements at Nuclear Pharmacy licensees. Curie quantities of radioactive materials, with much longer half-lives or that present internal dose concerns, are also handled safely at Nuclear Pharmacy licensees by M s[sic]. This appears to come from guidance developed for Manufacturing and Distribution licensees and should not be applied to all accelerator facilities. In many cases, the facility will also be operating as a Nuclear Pharmacy licensee and this would appear to require that a single licensee would need a Health Physicist as RSO on one license and an Authorized Nuclear Pharmacist (ANP) on the Nuclear Pharmacy license. CORAR recognizes the NRC's concern with respect to the higher potential for radiation exposure from PET radionuclides but urges the NRC to consider the extensive operating experience at the many such PET radiopharmacies currently licensed by Agreement States where ANPs have served well as RSO on the license. The inclusion of an accelerator into the facility should not by itself require such a high threshold for the position of RSO. In addition, CORAR requests that guidance be included here and elsewhere as appropriate to address the issue of "grandfathering" as discussed extensively in the proposed rulemaking documentation. |
NRC Staff Response: The term “specialist in the field of radiation protection” is not meant to imply that the RSO must be a Health Physicist. Any individual with the appropriate training and experience in the field of radiation protection as it relates to an accelerator facility may be the RSO of the accelerator facility. Therefore, an ANP that has adequate training and experience in radiation protection in the production of radioactive materials using an accelerator may be qualified to become an RSO. The NRC does not believe the language in Section 8.7.1 needs to be revised. As stated earlier, the NRC does not have specific requirements for the RSO or individuals that handle/use radioactive materials under a production license. Therefore, there is no need to provide a “grandfather provision” for them. |
Location | Subject | Comment |
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Section 8.7.2 (Page 8-17) | Individuals Authorized to Handle Licensed Material | In the last paragraph it states, "accelerator manufacturers or companies that provide repair and/or maintenance service to licensed accelerator facilities may need to possess an NRC service provider license or equivalent Agreement State license." While a service provider may be subject to registration requirements for servicing an accelerator as a radiation-producing machine, this should be retained within the jurisdiction of the relevant state agencies. Regarding the "handling of radioactive materials" produced by accelerator operation in the course of providing repair or maintenance services; this should be allowed without an NRC or Agreement State service provider license if the accelerator operator licensee has a provision that allows for this work to be done by a contracted service provider. Since this is a licensing guide for accelerator operators, this provision should be included in the discussion on authorized users. Some States do not list individual names on the service license. |
NRC Staff Response: The NRC staff does not agree with the method proposed. Under 10 CFR 30.3, the applicant is required to be qualified by training and experience to use radioactive materials for the purposes requested in such a manner as to protect health and minimize danger to life or property. Therefore, any individual who will be using/handling radioactive material must do so under the supervision of an authorized individual on the production license, be listed as an authorized individual on the production license, or be authorized under an NRC service provider license or an equivalent Agreement State license. This paragraph will be revised to ensure that these conditions are properly addressed. |
Location | Subject | Comment |
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Section 8.9 (Page 8-20) | Facilities and Equipment | The first bullet under “Response from Applicant” needs further explanation because much information in a license application is considered binding i.e. is treated by inspectors or licensing as a license condition. |
NRC Staff Response: It was not the NRC’s intent to make the information describing the accelerator to be binding on the licensee. However, to avoid any confusion this bullet has been removed from this Section. |
Location | Subject | Comment |
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Section 8.10.1 (Page 8-23) | Audit Program | Observation of Emergency Procedure implementation is not normally observed during an audit. |
NRC Staff Response: It is not required that the auditor observe emergency procedure implementation. This was provided as an example only, and therefore no changes are warranted to this text. |
Location | Subject | Comment |
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Section 8.10.4 (Page 8-31) | Occupational Dose | The assertion of the last sentence does not necessarily follow from the preceding sentence. Some accelerator facilities will fall into the greater than 10% rule and require monitoring. Most radiation exposure to staff at an accelerator facility comes from activated material or the target material and not from prompt radiation fields around the accelerator during operation. |
NRC Staff Response: The NRC did not mean to imply that radiation exposure to staff at an accelerator facility comes from prompt radiation fields. This paragraph has been revised accordingly. |
Location | Subject | Comment |
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Section 8.10.5 (Page 8-34) | Public Dose | Clarify that the first bullet under "Criteria" is for radioactive material outside of the DOT cycle. Properly marked and labeled packages awaiting transport are in the DOT cycle and not subject to the public dose limits in 10 CFR 20. |
NRC Staff Response: Properly marked and labeled packages within the licensee’s facility awaiting transport are not considered part of the transportation cycle. Under 10 CFR 71.5, transportation of licensed material (DOT cycle) occurs when licensed material is transported outside the site of usage, or where transport is on a public highway, or when licensed material is delivered to a carrier for transport. Therefore, this licensed material must be controlled in accordance with the public dose limit in 10 CFR Part 20 and this bullet does not need to be revised. |
Location | Subject | Comment |
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Section 8.10.6 (Page 8-37) | Safe Handling of Radionuclides | The picture in Figure 8.10 is intended to show the use of appropriate shielding (apparently in a nuclear pharmacy operation), out of context, but suggests a situation that does not employ best practices with regard to ALARA and dosimeters are not apparent as they are in other illustrations. For example, there are multiple unshielded containers in proximity to the extremities and no evidence of any remote or extended handling devices within reach. The handling is also done on a bench top which would generally be unacceptable for dispensing of radiopharmaceuticals. This picture should be left out of the guidance or replaced with a more acceptable example. |
NRC Staff Response: This figure has been removed. |
Location | Subject | Comment |
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Section 8.10.6 (Page 8-38) | Security Procedures | It is not clear why the presence of "hot cells" qualifies as an unusual need for greater security. The other two examples are fairly well understood. Please clarify or remove the reference to hot cells. |
NRC Staff Response: The reference to hot cells has been removed from this sentence. |
Location | Subject | Comment |
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Section 8.10.6 (Page 8-39) | Emergency Procedures | Figure 8.11 shows several poor practices. No safety glasses or extremity dosimeter, and kneeling on a potentially contaminated floor in order to clean up a spill. |
NRC Staff Response: This figure is not intended to be precise. This figure is part of a set of panels that generally illustrates proper handling of a contamination incident. No change was made to this figure. |
Location | Subject | Comment |
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Section 8.10.7 (Page 8-41) | Personnel Surveys | In Figure 8.13, the detector needs to be closer to surveyed object. Generally a distance of one to two inches is specified for personal contamination surveys. |
NRC Staff Response: This figure is meant only to illustrate that there are many different types of surveys performed by production licensees. Therefore, no change was made to this figure. |
Location | Subject | Comment |
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Appendix D (Page D-1) | Sample Production Materials License | This is an impractical approach. It is unreasonable to assume that licensees would be able to identify and list on the license each and every distinct location where radioactive materials may exist as a result of activation from accelerator operation. This approach fails to take into consideration the fact that there are likely more radionuclides (due to target material impurities) present in the target foils than just the radionuclides provided (Co-60 and Zn-65) on the sample license. This is one example of why licensees should be allowed to follow the practice endorsed by the Agreement States where an estimate of activity is determined (with a maximum for any radionuclide stated) for atomic numbers 1 - 83, in any chemical/physica1 form, with a general authorized use provided (e.g. target loading and irradiation, transfer of target materials, storage of induced radioactivity in cyclotron components and related equipment and facilities). This document should also provide some guidance on how the activity is to be determined for the various radionuclides that are expected to be produced in activated components and associated equipment and facilities. |
NRC Staff Response: As indicated earlier, the location of incidentally activated radionuclides no longer needs to be provided. Also, note that this license is just a sample license and is not meant to show all of the possible radionuclides and/or license conditions a specific possession license may list. |
Location | Subject | Comment |
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Appendix G (Page G-1) | Facilities and Equipment | The guidance in this section is lacking discussion on critical topics including, but not limited to, target handling systems, shielding of activated machine components and control of access to areas such as vaults where there are very high levels of radiation due to prompt interaction of primary beam with targets and surrounding materials. |
NRC Staff Response: Guidance has been added to this Appendix, which includes shielding of activated machine components and access to areas with high radiation levels. |
Location | Subject | Comment |
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Appendix G (Page G-1) | Facilities and Equipment | Glove boxes and hot cells are very rarely sealed- too expensive and not necessary for gamma-beta emitters. |
NRC Staff Response: The word “sealed” will be removed from the text when referring to glove boxes and hot cells. |
Location | Subject | Comment |
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Appendix G (Page G-1) | Facilities and Equipment | Glove boxes and hot cells are very rarely sealed- too expensive and not necessary for gamma-beta emitters. |
NRC Staff Response: The word “sealed” will be removed from the text when referring to glove boxes and hot cells. |
Location | Subject | Comment |
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Appendix G (Page G-2) | Facilities and Equipment | The last bullet is overly simplistic and does not take into account the variety of accelerator facilities with different design and operational requirements. This statement is not accurate for a number of situations and should be removed or replaced with more appropriate guidance to consider in the engineering of ventilation systems on a case-by-case basis. For instance, one wouldn't want a high air flow in a vault where there is loose surface contamination since this could create an unnecessary airborne hazard. |
NRC Staff Response: This bullet has been revised to take into account the variety of accelerator facilities with different design and operational requirements. |
Location | Subject | Comment |
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Appendix G (Page G-3) | Facilities and Equipment | Fourth Bullet. One must recognize the potential for radiation damage to electronics and possible need for replacement in areas with potentially high radiation fields or contamination levels. |
NRC Staff Response: This bullet has been revised to include a note about possible electronic damage from potentially high radiation fields or contamination levels. |
Location | Subject | Comment |
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Appendix H (Page H-5) | Air Sampling | Some types of spirometers also use gas displacement i.e. bubble spirometers. |
NRC Staff Response: This Section has been revised to include spirometers that use gas displacement. |
Location | Subject | Comment |
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Appendix I (Page I-1) | Public Dose | The table on “Doses to Members of the Public” should include another mention of radiation from licensed and "unlicensed" sources being considered in total by the NRC for purposes of demonstrating compliance with the limits. |
NRC Staff Response: This table has been revised to indicate that doses from NRC licensed and “unlicensed” sources of radiation should be included when demonstrating compliance with public dose limits. |
Location | Subject | Comment |
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Appendix I (Page I-2) | Effluent Monitoring | For the sentence “Due to the uncertainty of this type of discharge, it is important to perform......”, replace the word “is” with “may be” in order to be more general. |
NRC Staff Response: The text in this paragraph has been revised as suggested. |
Location | Subject | Comment |
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Appendix I (Page I-2) | Public Dose Calculation Method | Should make reference to the guidance included in NRC Regulatory Guide 4.20, "Constraints on Release of Airborne Radioactive Materials to the Environment for Licensees Other Than Power Reactors." |
NRC Staff Response: A reference to NRC Regulatory Guide 4.20, “Constraints on Release of Airborne Radioactive Materials to the Environment for Licensees Other Than Power Reactors." has been added to the “Calculation Method” section of this Appendix. |
Location | Subject | Comment |
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Appendix I (Page I-4) | Occupancy Factors | CORAR requests reference to the guidance from the NCRP in Report 147 (page 31) on the use of occupancy factors in planning and assessing public doses. We suggest that these newer occupancy factors be incorporated into Table I. 1 on page I-4. |
NRC Staff Response: Changing the occupancy factors is not in the scope of the revision to this document. This question will be evaluated during future changes to the NUREG-1556 series guidance documents. |
Location | Subject | Comment |
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Appendix J (Page J-2, Example 2) |
Safe Use of Radionuclides | It is not clear why high density materials would need to be layered properly in order to be effective shielding for F-18. It is no longer considered standard practice to have low density materials first to shield beta or positron radiation followed by higher density materials to deal with bremsstrahlung and gammas. Any bremsstrahlung generated by positrons will be adequately shielded by consideration of the two 511 keV photons also associated with each decay. |
NRC Staff Response: This bullet has been revised by removing the text “layered properly”. The commenter is correct in that shielding for beta emitters using low density materials is not required for Fluorine-18 (F-18). High density materials should be the only materials used for shielding of F-18. |
Location | Subject | Comment |
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Appendix J (Page J-2, Example 2) |
Safe Use of Radionuclides | What would be considered "each use"? Generally accepted practice is for surveys to be completed as soon as practical at the end of work involving radioactive materials. Personnel contamination surveys are more frequent depending on use. |
NRC Staff Response: The bullet in this example has been revised to clarify how often radiation surveys and wipe tests should be performed. |
Location | Subject | Comment |
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Appendix J (Page J-5) | Emergency Procedures | The criteria provided for minor and major radioactive spills need to include the distance from the source at which the 50 mR/h criteria apply. |
NRC Staff Response: This Section has been revised to reflect the requirements for reporting in 10 CFR 30.50(b)(1)(ii). Under the regulation, a major spill would be the quantity of radioactive material greater than five times the lowest annual limit on intake specified in Appendix B of 10 CFR 20.1001-2401 for the material. |
Location | Subject | Comment |
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Appendix L (Page L-1) | Radiation Safety Surveys | This section needs to discuss the distinction between radiation produced by the accelerator (not regulated by NRC) and radiation emitted from radioactive material produced by the accelerator (regulated by NRC), and then provide guidance on how this distinction is taken into account when radiation level surveys are performed. |
NRC Staff Response: New text was added to the introduction to this Appendix to highlight the distinction between surveys on radioactive material produced by the accelerator, which is regulated by the NRC, and radiation produced by the operation of the accelerator, which is not regulated by the NRC. |
Location | Subject | Comment |
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Appendix L (Page L-3) | Radiation Safety Surveys | A strange arrow character is located immediately in front of "Ci". It appears this should be the Greek symbol for "micro" and was perhaps a result of translation between different programs. |
NRC Staff Response: The symbol should have been “µ” and has been corrected. |
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Appendix L(Page L-4, Table L.4) | Radiation Safety Surveys | Several commonly produced radionuclides are not included. We recommend adding I-123 to Group 2, In-111, Ga-67, and Pb-201 to Group 3, and C-11 and N-13 to Group 4. |
NRC Staff Response: After reviewing the characteristics of these radionuclides, the NRC agrees that the radionuclides should be added to the table as recommended, and they have been added. |
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Appendix L (Page L-5, Table L.5) | Radiation Safety Surveys | I- 129 and I- 133 are a lesser hazards due to the very low-specific activity of one and the short halflife of the other. All radioiodines should be listed with the gamma-beta emitters as those levels of contamination would not pose an internal contamination hazard. |
NRC Staff Response: Due to the radiological characteristics of these isotopes, we believe the placement of these isotopes within table M.5 is correct. Therefore, no change will be made to this table. |
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Appendix L (Page L-8) | Airborne Effluent Monitoring | A revised report, ANSIIHPS N13.1-1999 was issued in 1999 to supersede the 1969 report. We suggest you reference the new version. This should also be updated in the References to Appendix M. The US EPA has updated their regulatory references to the newer standard. |
NRC Staff Response: This ANSI reference has been updated to ANSI N13.1,"Sampling and Monitoring Releases of Airborne Radioactive Substances From the Stacks and Ducts of Nuclear Facilities,” which was published in 1999. |
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Appendix P (Page P-9) | Return Waste to Consortium Members | Additional discussion in this section would be helpful to clarify that residual material contained in returned syringes and vials has a very short half-life and that this material can readily decay to background, enabling used syringes and vials to be returned to the PET producer without being categorized as "radioactive waste." |
NRC Staff Response: NRC staff does not agree that this additional guidance is needed for this Section. The NRC believes that the consortium member who receives and uses the radioactive materials generally knows the characteristics of the radioactive materials and when the material decays to where it cannot be distinguished from background radiation levels. |
Location | Subject | Comment |
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Entire Document | General Comment | In at least two locations the article, "a", is used in front of the abbreviation NRC. This seems to occur when "A" is the first letter of a sentence (see for example last paragraph of page 8-3 and first paragraph on page 8-4). The proper article for a word that begins with a vowel sound is "an". "An" is used throughout the text in other places. |
NRC Staff Response: Changes have been made where applicable. |
Location | Subject | Comment |
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Entire Document | General Comment | Throughout the document the term "radioisotope(s)" is used to refer to generic radionuclides. It is more proper when referring to many radioisotopes of many elements to refer to them as radionuclides. The term radioisotopes is more properly used when referring to a single element, not several or all elements. |
NRC Staff Response: The change from the term “radioisotope” to “radionuclide” has been made, when applicable. |
Table R.2 Comments from Washington University in St. Louis, Dated July 3, 2007
Location | Subject | Comment |
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Entire Document | General Comment | We recommend NRC allow a Medical license to include possession for production of radioactive materials using an accelerator. |
NRC Staff Response: The NRC has determined that a separate possession license will be required for the production of radioactive materials using an accelerator. However, this license could be provided in conjunction with other licenses the licensee may have such as a Medical-use License. |
Location | Subject | Comment |
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Appendix P | Consortium | Does the "Note" listed in Appendix P referring the reader to Appendix AA of the current version of NUREG-1556. Vol. 9 indicate that the new draft Vol. 9 Appendix AA will be similar to Vol. 21 Appendix P indicating that NRC will allow inclusion of this "production" license as part of another license type? |
NRC Staff Response: The “Note” has been removed. |
Location | Subject | Comment |
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Appendix P | Consortium | Does the "Note" listed in Appendix P referring the reader to Appendix AA of the current version of NUREG-1556. Vol. 9 indicate that the new draft Vol. 9 Appendix AA will be similar to Vol. 21 Appendix P indicating that NRC will allow inclusion of this "production" license as part of another license type? |
NRC Staff Response: The “Note” has been removed. |
Location | Subject | Comment |
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Section 8.6 (Page 8-12) | Purpose for which Material Will be Used | Instead of listing Co-60, Mg-54 and Cd-109 separately, as indicated in Table 8.1, should not the radioisotope request be any byproduct material with atomic numbers 1 through 83, target foil or body, not to exceed 20 millicuries per radionuclide and 1 curie total, except as noted - Co-60 not to exceed 50 millicuries; Mg-54 not to exceed 100 millicuries; and Cd-109 not to exceed 100 millicuries? |
NRC Staff Response: Section 8.5.1 of Volume 21 provides an option to list activated products separately or to group the activated products under atomic numbers 1-83. Table 8.1 provides an example of how radioactive material may be formatted on a license, which could include listing Co-60, Mn-54, and Cd-109 separately. |
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Section 8.5.1 (Page 8-5) | Unsealed and/or Sealed Byproduct Material | How will NRC deal with very short-lived radioactive materials (e.g., half-life less than 2 minutes) that may be activated to activities exceeding the requested limits? Should the license application state that possession limits apply to incidentally activated radioactive materials with half-lives greater than or equal to 2 minutes? |
NRC Staff Response: Generally, NRC is concerned with those radionuclides that have a half-life greater than 120 days because these radionuclides would determine the amount of financial assurance that would be needed for decommissioning the facility. |
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Chapter 3 (Page 3-1) | Management Responsibility | The definition of "Management" should be identical to the definition in Vol. 9 by adding ". . . ensure safety and to.. ." between "to" and "achieve". |
NRC Staff Response: The definition for “Management” found on page 3-1 of Volume 21 is consistent with other 10 CFR Part 30 license guidance documents (e.g., NUREG-1556, Volume 12). The definition for “Management” found in NUREG-1556, Volume 9, Rev.1, “Program-Specific Guidance About Medical Use Licenses” is specific for 10 CFR Part 35 licensees. |
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Section 8.3 (Page 8-3) | Address Where Licensed Material Will be Used or Possessed | For the Second paragraph under Section 8.3, is this paragraph needed here, because it is covered in 8.9 describing what information is required for "Item 9: Facilities and Equipment"? |
NRC Staff Response: This paragraph is needed here because it reminds the applicant that addresses for all radioactive material facilities, which would include special use facilities, should be listed on the license application. |
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Section 8.6 (Page 8-10) | Purpose For Which Licensed Material Will Be Used | Does the statement. "Once material is produced, it will be transferred internally to another license..," mean that the NRC recognizes that an accelerator production license can be combined with any of the License types listed in this section? |
NRC Staff Response: The production license will be a separate license with the understanding that the licensee may have another materials license(s) (e.g., commercial radiopharmacy license) that will be used in conjunction with the production license. |
Location | Subject | Comment |
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Section 8.7 (Page 8-14) | Individual’s Responsible for the Radiation Safety Program | The first complete sentence starts. "As discussed later in this guide senior management will delegate to the RSO sufficient authority.. . ." Does NRC consider "senior management" to be the same as “executive management”? Where is the discussion in this guide of senior management's responsibilities? |
NRC Staff Response: While general guidance is provided on page 3-1 as to interpretation of the term “management” which is consistent with other NUREG guidance documents, neither the regulations nor other guidance documents specifically define “senior management” or “executive management.” These terms should be defined by the applicant. |
Location | Subject | Comment |
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Section 8.9 (Page 8-21) | Facilities and Equipment | Figure 8.5 is labeled as -“Security-Related Information”, but a disclaimer statement is also listed. Should applicants only use this labeling for byproduct materials subject to Increased Controls? Will applicants be able to consider information on their facilities and procedures as privileged and confidential under 10 CFR 2.390(a)(4)? We believe that NRC needs to have information on the facilities involved in the production and use of accelerator-produced radioactive materials, but we would prefer not to provide this detailed information in a public forum. |
NRC Staff Response: The labeling of this Figure is an example of how security-related information should be submitted to NRC in accordance with 10 CFR 2.390. Section 5.2 of this guidance document provides information on identifying and protecting sensitive information. |
Location | Subject | Comment |
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Section 8.10.3 (Page 8-29) | Material Accountability | First bullet after Table 8.2. Not all activities produced in an accelerator will be measured, but instead may be estimated by calculation or by dose rate measurements. We recommend the statement end with ". . . and activity date of the byproduct material". |
NRC Staff Response: This sentence was revised to provide instead that licensees should indicate the date when the byproduct material’s activity was measured and/or calculated. |
Table R.3 Comments from Michigan Department of Environmental Quality, Dated July 11, 2007
Location | Subject | Comment |
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General Comment | Public Dose - Air Emissions | Accelerators that produce radionuclides used for positron emission tomography (PET) and the associated radiochemical synthesis units release radioactive material to the air during their normal processes. The integrity of the accelerator target can catastrophically fail. We strongly urge the Nuclear Regulatory Commission (NRC) to require PET accelerator facilities to submit an assessment of the potential doses to members of the public during routine use and during a catastrophic target failure. We do not believe that the average NRC or state agreement inspector can adequately evaluate the ventilation system design and the computer modeling of public doses during a routine inspection. The complexity of the ventilation systems, the inherent limitations of the different computer codes, and the breadth of input data for the computer codes would be difficult for an inspector to evaluate during an on-site inspection. With the dose assessment submitted during licensing of the facility, NRC staff can adequately evaluate the premises and conclusions of the dose assessment. Then the inspector knows before the inspection that an annual release to the atmosphere of "x" curies of a radionuclide means a dose of "y" millirems to a member of the public. The inspector would need to verify during the inspection that the other input parameters in the dose assessment had not changed. |
NRC Staff Response: The applicant must provide enough information to demonstrate that its operations will be in compliance with all regulations. During the license application review process, an NRC license reviewer will determine if enough information has been provided to assure compliance with the limiting exposure, which includes air emissions, to a member of the public. If the information provided by the applicant is insufficient, more information will be requested by the license reviewer. Subsequently, during an NRC inspection, the licensee must be able to demonstrate, by measurement or calculation, that the annual dose limits for members of the public have not been exceeded. |
Location | Subject | Comment |
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General Comment | Activated Material | All material made radioactive during operation of an accelerator is an activation product including the intended radioactive product and the other accelerator and shielding components incidentally made radioactive. To eliminate confusion, we recommend that the terms activation products, activation radionuclides, activation radioisotopes, activation materials, activated material, activated products, activated components, and activated targets be replaced by incidental activation products, incidentally-activated material, etc. when referring to the incidentally-radioactive products. |
NRC Staff Response: When referring to the activated materials that are produced incidental to the production of the intended radioactive product, the term “incidental” or “incidentally” has been added. |
Location | Subject | Comment |
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General Comment | Public Dose - Air Emissions | The ANSI standards referenced in Regulatory Guide 8.37, "ALARA Levels for Effluents from Materials Facilities" and Regulatory Guide 4.20, "Constraints on Release of Airborne Radioactive Materials to the Environment for Licensees Other Than Power Reactors," have been revised. These Regulatory Guides should be reviewed and revised.
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NRC Staff Response: The revised ANSI standards N42.18 and N13.1 have been reviewed and the reference in Appendix M of this guidance document has been updated to reflect the revised standards. Revision of Regulatory Guides 8.37 and 4.20 is beyond the scope of this guidance document revision. |
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Abbreviations (Page xiii) | General Comment |
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NRC Staff Response: The current abbreviations section is consistent with NRC policy and the guidance documents in the NUREG-1556 series. Therefore, NRC staff does not believe the changes are warranted. |
Location | Subject | Comment |
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Section 8.6 (Page 8-12) | Purpose for which Licensed Material Will Be Used | Table 8.1 "Sample Format for Providing Information About Requested Radioisotopes" should have an entry such as: Radioisotope: Any byproduct material with atomic numbers 1 through 83. Chemical/Physical Form: Any Maximum Possession Limit: 1 millicurie Proposed Use: Basic Research |
NRC Staff Response: The changes have not been incorporated because Table 8.1 provides a sample format for providing information about requested radionuclides and is not all inclusive. |
Location | Subject | Comment |
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Section 8.9 (Page 8-20) | Facilities and Equipment | "Response from Applicant" regarding "Facilities and Equipment." This section states, "Verification that ventilation systems ensure that effluents are ALARA, are within the dose limits of 10 CFR 20.1301, and are within the ALARA constraints for air emissions established under 10 CFR 20.1 101 (d)." What would be considered sufficient verification? Does a facility need to submit a computer model calculating the projected doses to members of the public at various nearby locations or will an unsupported statement that public doses are ALARA be considered sufficient? |
NRC Staff Response: The applicant should provide sufficient information, which could include calculations or measurements, that would verify that effluents from the facility will be ALARA. A single statement that public doses are ALARA would not be sufficient. As stated in Appendix M of this guidance document, Regulatory Guide 4.20 provides guidance on methods that are acceptable to NRC staff for compliance with the constraint on air emissions to the environment. |
Location | Subject | Comment |
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Section 8.10.1 (Page 8-24) | Audit Program | The Radiation Protection Program Audit program should include: Air Emissions. Verify that the annual average concentrations of radioactive material released to the air at the boundary of the unrestricted area did not exceed the values specified in table 2 of appendix B to part 20 and, if a catastrophic release occurred, that an individual in an unrestricted area would not have received a dose in excess of 0.002 rem (0.02 mSv) in an hour. |
NRC Staff Response: This Section discusses some of the elements of an effective audit program and is not all inclusive. The licensee should include all aspects of the radiation safety program as part of its audit program, which should include air emissions. |
Location | Subject | Comment |
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Section 8.10.1 (Page 8-24) | Audit Program | Under Radiation Surveys, add a section verifying that the radiation exhaust monitors have been calibrated with a known bolus of activity and/or periodically checked with a check source. |
NRC Staff Response: This Section discusses some of the elements of an effective audit program and is not all inclusive. Calibration of radiation monitors may be added as part of the audit program. |
Location | Subject | Comment |
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Section 8.10.8 (Page 8-43) | Maintenance | This section should specifically mention that a radiation survey and wipe tests should be conducted when the accelerator is opened for servicing. |
NRC Staff Response: This Section states that a radiation survey should be performed prior to entering an accelerator vault or after opening the accelerator shielding. A wipe test is not generally performed when the accelerator is opened for servicing because it is generally assumed that removable radioactive contamination will be present inside of the accelerator. Therefore, performing a wipe test was not added to this Section. |
Location | Subject | Comment |
---|---|---|
Section 8.11 (Page 8-47) | Waste Management - Decay in Storage | It is a reality of accelerator operation that a mixture of radionuclides is produced within the same metal part. Some of these radionuclides have short half-lives and some have longer half-lives. This section on decay in storage should discuss whether the licensee can store activated components having both short and long half-lives. In Michigan, we had an incident where an activated component was partially vaporized during operation of a 50-MeV accelerator. When the accelerator was opened for servicing, contamination spread throughout the therapy suite. Laboratory analysis of a wipe of the contaminated area identified Sb-124 (14 d), Cr-51 (28 d), Fe-59 (45 d), Co-58 (71 d), Sn-113 (115 d), Zn-65 (244 d), Co-57 (271 d), Mn-54 (313 d), Sb-125 (1,023 d), and Co-60 (1,936 d). If adequate storage space is available, we support storing radioactive components to reduce ambient radiation levels. |
NRC Staff Response: As discussed in this Section, radioactive material with half-lives greater than 120 days should be characterized regarding volume and anticipated time in residence at the licensee’s facility prior to disposal, and radionuclides with half-lives less than 120 days may be disposed of by decay-in-storage. For activated components that have multiple radionuclides with different half-lives, the component should be disposed of according to the radionuclide with the longest half-life. Activated components may be stored at the facility if adequate storage space is available and the activated components are within the licensee’s possession limits. |
Location | Subject | Comment |
---|---|---|
Section 8.11 (Page 8-48) | Release into Air and Water | This section should have an extensive discussion on computer modeling and the input parameters needed for dose assessment due to atmospheric releases. |
NRC Staff Response: The NRC policy or regulations do not specify any specific method for determining dose due to atmospheric releases. The licensee must demonstrate to the NRC that atmospheric releases are within regulatory limits. The licensee may demonstrate this by using various methods described in Regulatory Guide 4.20 that include computer modeling. |
Location | Subject | Comment |
---|---|---|
Appendix C (Page C-2) | Incidentally-Activated Radionuclides | The note states: "For activation radionuclides, the applicant could request authorization to possess and use any form of byproduct material with atomic numbers 1 through 83. However, the applicant should indicate the maximum quantity of each radionuclide to be possessed at any one time and the total cumulative quantity for all radionuclides." The purpose of having an "activation products" designation is to allow the activated parts of the accelerator to be licensed without the licensee needing to determine exactly what will be the incidentally-activated radionuclides and their individual activities. The second sentence should be amended to read "However, the applicant should indicate the maximum total activity for all these activation products to be possessed at any one time." If a specific activity limit is stipulated for a radionuclide, how will the licensee or an NRC inspector verify that the sum of that radionuclide's activity in all activated components is less than the stipulated quantity? |
NRC Staff Response: This text has been revised as suggested. |
Location | Subject | Comment |
---|---|---|
Appendix C (Page C-4) | Facilities and Equipment | "Provide verification that ventilation systems ensure that effluents are within the dose limits of 10 CFR 20.1 301, and the ALARA constraints for air emissions established under 10 CFR 20.1101(d) are ALARA." What would be considered sufficient verification? Does a facility need to submit a computer model calculating the projected doses to members of the public at various nearby locations or will a statement that public doses are ALARA be considered sufficient? |
NRC Staff Response: As stated earlier, the applicant should provide sufficient information, which could include calculations or measurements, that would verify that effluents from the facility will be ALARA. A single statement that public doses are ALARA would not be sufficient. As stated in Appendix M of this document, Regulatory Guide 4.20 provides guidance on verification methods that are acceptable to NRC. Note that the table in Appendix C is a checklist that duplicates the response to applicant text found in the main body (Chapter 8) of this document. |
Location | Subject | Comment |
---|---|---|
Appendix H | Radiation Monitoring | “Radiation Monitoring Instrument Specifications and Model Survey Instrument and Air Sampler Calibration Program" should include a discussion on the calibration of radiation detection equipment installed to monitor and quantify the activity released to the atmosphere. For PET accelerators, stack exhaust monitors are typically sodium iodide detectors mounted adjacent to the exhaust system. They are calibrated by releasing a known millicurie quantity of radioactive material at installation. The number of counts above background can then be correlated with a known activity. This guidance document should state if the NRC will require subsequent periodic releases to annually (quarterly, monthly) "calibrate" these monitor or will the NRC accept a procedure using check sources to confirm that the response to the check source has not changed since the initial calibration. |
NRC Staff Response: 10 CFR Part 30 does not provide prescriptive requirements for how and when radiation monitoring instruments are calibrated. Instruments should be calibrated in accordance with the instrument manufacturer’s recommendations. Therefore, specific guidance on the calibration of air monitoring instruments is not provided in this Appendix. |
Location | Subject | Comment |
---|---|---|
Appendix I | Public Dose | “Guidance for Demonstrating That Individual Members of the Public Will Not Receive Doses Exceeding the Allowable Limits" should mention that air intakes for the accelerator building and for adjacent buildings need to be considered in the evaluation of doses to members of the public. |
NRC Staff Response: This Appendix provides general guidance for demonstrating that public dose limits have not been exceeded. The guidance in this Appendix is not all inclusive. |
Location | Subject | Comment |
---|---|---|
Appendix L (Page L-1) | Radiation Surveys | For self-shielded cyclotrons, an ambient radiation survey should be performed whenever the cyclotron is opened for repair or other modifications. |
NRC Staff Response: As stated earlier, the NRC believes radiation surveys should be performed whenever the accelerator is opened for repair or other modifications. However, this Appendix provides general guidance about radiation surveys and the staff does not believe that this specific text needs to be added to this Appendix. A discussion about performing this type of survey may be found in Section 8.10.8 of this guidance document. |
Location | Subject | Comment |
---|---|---|
Appendix L (Page L-2) | Contamination Surveys | For self-shielded cyclotrons, a contamination survey including wipe tests should be performed whenever the cyclotron is opened for repair or other modifications. |
NRC Staff Response: As stated earlier, a wipe test is not generally performed when the accelerator is opened for servicing because it is generally assumed that removable radioactive contamination will be present inside of the accelerator. Therefore, performing a wipe test was not added to this guidance document. |
Location | Subject | Comment |
---|---|---|
Appendix L (Page L-4) | Radiation Surveys | The term "FCi" should be clarified in the following paragraph: "The object is to determine how often to survey the laboratory or area of use. To do this, multiply the activity range under the LOW, MEDIUM, and HIGH survey frequency in Table M.2 by the appropriate Modifying Factor to construct a new set of FCi ranges for LOW, MEDIUM, and HIGH survey frequency." |
NRC Staff Response: The term “FCi” was replaced with the word “activity”. |
Location | Subject | Comment |
---|---|---|
Appendix L (Page L-8) | Airborne Effluent Release Monitoring | ANSI N13.1 "Guide to Sampling Airborne Radioactive Materials in Nuclear Facilities" was revised in 1999 and renamed "Sampling and Monitoring Releases of Airborne Radioactive Substances From the Stacks and Ducts of Nuclear Facilities." |
NRC Staff Response: The current reference has been updated to the revised 1999 ANSI N13.1 standard. |
Location | Subject | Comment |
---|---|---|
Appendix L (Page L-10) | Airborne Effluent Release Monitoring | "References."
|
NRC Staff Response: These references have been updated to the revised ANSI standards. |
Location | Subject | Comment |
---|---|---|
Entire Document | General Comment | Several spelling errors were noted. |
NRC Staff Response: Spelling errors have been corrected. |
Table R.4 Wisconsin Radioactive Materials Program, Dated July 11, 2007
Location | Subject | Comment |
---|---|---|
Section 8.6 (Page 8-10) | Purpose for which Licensed Material Will be Used | This guidance document pertains to possession licenses for Production of Radioactive Material Using an Accelerator. It would be impossible to only use this specific guidance document. The recommendation is: Clarify in the text under Discussion in Item 6 what additional guidance should be used for the 3-4 different uses following the production of radioisotopes. |
NRC Staff Response: This Section indicates where to find additional guidance for the different possession licenses that could use the produced radionuclides. Therefore, the NRC staff does not believe further clarification is necessary. |
Location | Subject | Comment |
---|---|---|
Section 8.6 (Page 8-11) | Purpose for which Licensed Material Will be Used | There are currently licensees who are stand-alone facilities and who are funded via a consortium that are not educational institutions or federal facilities. |
NRC Staff Response: As defined in 10 CFR 30.4, a consortium is an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own and share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distribution among its associated members for medical use. Furthermore, the PET radionuclide production facility within the consortium must be located at an educational institution, Federal facility, or medical facility. Therefore, entities located in other types of facilities could not be members of a consortium that operates under an NRC license. A change to the consortium definition would require a revision to the regulations and is beyond the scope of this guidance document. Note that NRC’s definition of consortium only applies to the production of PET radioactive drugs for noncommercial distribution. |
Location | Subject | Comment |
---|---|---|
Section 8.6 (Page 8-10) | Purpose for which Licensed Material Will be Used | On page 8-10 under Discussion for “Purposes for Which Licensed Material Will Be Used”, there is a bullet for “medical use license (e.g. noncommercial radiopharmacy)” that appears to include the consortium type of licensee. If this is an additional term that is being used to cover the same type of activity, then further explanation should be provided. |
NRC Staff Response: The term “noncommercial radiopharmacy” has been removed from this Section. |
Location | Subject | Comment |
---|---|---|
Section 8.5.1 (Page 8-6) | Unsealed and/or Sealed Byproduct Material | Delete paragraph concerning authorization to possess depleted uranium. |
NRC Staff Response: The paragraph about depleted uranium has been deleted from this Section as the use of depleted uranium for shielding is unlikely for production of radioactive material using an accelerator. |
Location | Subject | Comment |
---|---|---|
Section 8.7.2 (Page 8-16) | Individuals Authorized to Handle Licensed Material | Discussion should clearly differentiate between the authorized user who can work on the accelerator and the individual who will prepare the radiopharmaceutical doses. In most facilities the pharmacy prep area will be in the immediate vicinity of and under the same organization and radiation safety program. Qualifications and duties should be clearly identified. |
NRC Staff Response: This guidance document does not cover the activities pertaining to the preparation of radiopharmaceuticals. NUREG-1556, Volume 13, Rev. 1, “Program-Specific Guidance About Commercial Radiopharmacy Licenses,” provides guidance on the preparation of radiopharmaceuticals at a commercial radiopharmacy. This Section refer to those individuals who will handle the radioactive material (not radiopharmaceuticals) produced by the accelerator. |
Location | Subject | Comment |
---|---|---|
Section 8.9 (Page 8-20) | Facilities and Equipment | Since the accelerator will produce a radiation field, information regarding shielding sufficient to do an independent assessment of the adequacy of the shielding should be submitted and included as a license condition (contrary to the text). |
NRC Staff Response: The NRC was not given jurisdiction over the actual accelerator operation by the EPAct. Therefore, shielding used for the operation of the accelerator will not be regulated by the NRC and is not discussed in this guidance document. |
Location | Subject | Comment |
---|---|---|
Section 8.10.2 (Page 8-26) | Radiation Monitoring | Discussion is lacking concerning type of surveys. Specifically, area monitoring is a term that is not defined. In addition, under response from applicant, there is no recommendation to add the statement “We reserve the right to upgrade our survey instrumentation” as is found in other guidance documents. |
NRC Staff Response:Section 8.10.2 discusses the types of instruments used to monitor radiation. The discussion on types of surveys is in Section 8.10.7 (page 8-40) of this document. The term area monitoring in Section 8.10.2 is interpreted to be a specific type of dose rate or exposure rate survey for a specific area (e.g., accelerator room) within the facility. Since area monitoring is a type of dose rate survey, which is already defined in this Section, the terms area monitoring and area monitors have been removed from this Section. Also, the “Response from Applicant” Section of Section 8.10.2 does not require the applicant to list a specific type of instrument, but rather requires the applicant to ensure that the instruments used meet the specified radiation monitoring requirements. The current wording does not prohibit the applicant from upgrading its survey instrumentation. Therefore, it is not necessary to add the statement “We reserve the right to upgrade our survey instrumentation”. |
Location | Subject | Comment |
---|---|---|
Section 8.10.3 (Page 8-28) | Material Accountability | Discussion section references Figure 8.6. There is no Figure 8-6. |
NRC Staff Response: The reference to Figure 8.6 has been removed. |
Location | Subject | Comment |
---|---|---|
Section 8.10.6 (Page 8-36) | Safe Handling of Radionuclides | There should be a specific requirement for safety procedures for opening up the accelerator and handling the activation targets. This would typically include “wait times” based on how long the accelerator was in operation and could also specify a radiation level that must be achieved before handling or approaching the targets. |
NRC Staff Response: The NRC does not set specific requirements for the procedures the licensee uses for opening up the accelerator and handling the activation targets. |
Location | Subject | Comment |
---|---|---|
General Comment | Transfer of Control | Where is “Information Needed for Transfer of Control?” |
NRC Staff Response: Information regarding transfer of control may be found under Section 8.2. |
Location | Subject | Comment |
---|---|---|
General Comment | Audit Form | Where is a Sample/Example Audit Form? |
NRC Staff Response: A new appendix (Appendix H) was added to this guidance document, which contains an example of an audit form. |
Table R.5 Comments from Kansas Department of Health and Environment, Dated July 12, 2007
Location | Subject | Comment |
---|---|---|
Appendix P (Page P-1) | Noncommercial Distribution to Consortium Members | The note in Appendix Q of NUREG 1556 volume 21 stating it only applies to educational and federal institutions should be stricken. There are existing consortiums which meet the criteria in the guidance for consortiums but are neither educational nor federal institutions. Appendix Q should apply to these private non-commercial consortiums also. |
NRC Staff Response: As stated above, a consortium is defined in 10 CFR 30.4 as an association of medical use licensees and a PET radionuclide production facility in the same geographical area that jointly own and share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distribution among its associated members for medical use. Furthermore, the PET radionuclide production facility within the consortium must be located at an educational institution, Federal facility, or medical facility. Therefore, entities located in other types of facilities could not be members of a consortium that operates under an NRC license. A change to the consortium definition would require a revision to the regulations and is beyond the scope of this guidance document. Note that NRC’s definition of consortium applies to the production of PET radioactive drugs for non-commercial distribution. |
Location | Subject | Comment |
---|---|---|
Appendix D (Page D-1) | Sample License | The example license in Appendix D of Nureg 1556 volume 21 includes an authorization for the possession of activation products incident to the production of the primary isotopes produced. See line L of items 6, 7, 8 and 9 of the example license. This line item should be stricken from the example license. The Energy Policy Act of 2005 specifically excludes accelerator produced activation products from the revised definition of byproduct material. The following excerpt from Section 170H(e) of the EPAct illustrates: "(i) has been made radioactive by use of a particle accelerator; and (ii) is produced, extracted, or converted after extraction, before, on, or after the date of enactment of this paragraph for use for a commercial, medical, or research activity;" It is clear there are two tests that accelerator produced radioactive material must meet before they can be considered "byproduct material" under the new definition. First, the material must be made radioactive by use of a particle accelerator, and second the material must be "produced............. for a commercial, medical, or research activity." The first test is clearly met, however, since activation products referenced in line L of the example license are not specifically produced for a commercial, medical or research activity they do not meet the second test and therefore cannot be considered "byproduct material" and do not fall under the authority of the Nuclear Regulatory Commission as granted by the EPAct. If this is not stricken from the example license then NRC should seek an OGC opinion clarifying the intent of the EPAct and justifying the inclusion of these activation products in their regulatory authority. |
NRC Staff Response: As explained in the supplementary information accompanying the final rule establishing requirements for the expanded definition of byproduct material, the NRC regulates radioactive material both intentionally and incidentally produced by all accelerators that are intentionally operated to produce a radioactive material for its radioactive properties for use for a commercial, medical, or research activity (71 FR 42952). This authority includes the intentionally and incidentally produced radioactive material produced by an accelerator which is used to produce both radioactive materials and particle beams for use for a commercial, medical, or research activity. |
Table R.6 Comments from Illinois Emergency Management Agency, Dated July 10, 2007
Location | Subject | Comment |
---|---|---|
Section 8.5.1 (Page 8-5) | Unsealed and/or Sealed Byproduct Material | This section references a request for use of radionuclides with atomic number 1-83. Yet the guidance also references use of radium, which has an atomic number of 88, which is higher than 83. It appears the range of atomic numbers 1-83 should be increased as there are a number of radionuclides with atomic numbers > 83 that are accelerator produced. This would be more efficient than listing other radionuclides that are outside of this range as line items on the license. |
NRC Staff Response: This Section has been revised to include a discussion about receiving authorization for radionuclides with atomic numbers greater than 83. |
Location | Subject | Comment |
---|---|---|
Section 8.7 | Training of Individuals | The training section should reference the DOT hazardous materials training required every 3 years if the licensee is shipping radioactive materials. |
NRC Staff Response: The DOT hazardous materials training is discussed in the “Transportation” Section of this guidance document under Section 8.10.9. The DOT training is not discussed in Section 8.7 because it is not required to produce, use, and/or store radioactive materials. |
Location | Subject | Comment |
---|---|---|
Section 8.9 (Page 8-20) |
Facilities and Equipment | The licensee should be required to submit shielding calculations of the accelerator room as this will also have radioactive material in it coming from the targets. NRC did not require the submittal of such details e.g., construction materials, densities, distances, etc. for the reviewer to be able to perform their own calculations. The application does request submittal of a design and description of shielded areas, but the Appendix G describes shielding used for bench tops, containers, glove boxes, etc. and does not mention shielding in the production areas. Shielding may also be necessary around duct work and any type of remote delivery systems employed. The licensee should specify where on the diagram that intake/exhausts and the nearest intake to the exhaust so the reviewer can evaluate airborne hazards to adjacent facilities. |
NRC Staff Response: The shielding used for the accelerator room is generally calculated based on the operation of the accelerator. The NRC does not have authority over the accelerator or its operation. Therefore, NRC does not regulate the shielding used for the accelerator. Appendix G provides general guidance on the facility and equipment that may be used at a facility that handles and/or uses radioactive material. The information provided in these sections of the guidance document is not all inclusive. |
Location | Subject | Comment |
---|---|---|
Section 8.10.3 (Page 8-29) | Section 8.10.3 (Page 8-29) | States, "Sources in storage that are used infrequently may not require leak testing." This implies that just because they are infrequently used that they do not have to be tested. I recommend that a clarification statement be added that if they have not been tested in the last 6 months (3 for alpha) and they are removed from storage for use, that they must be leak tested prior to use. |
NRC Staff Response: Section 8.10.7 discusses the criteria for performing leak tests. In Section 8.10.7, the discussion does state that sources that are stored and are not being used do not require leak testing, but leak testing must be done before use or transfer of the source. The NRC staff believes Section 8.10.3 does not require additional discussion about performing a leak test, as the main focus of Section 8.10.3 is on material accountability. |
Location | Subject | Comment |
---|---|---|
Section 8.10.6 (Page 8-39) | Safe Handling of Radionuclides | States the procedures that "should" be developed. It also states the applicant "should" make a statement regarding making changes to the procedures and not a commitment that they'll develop and implement the procedures that "should" be developed. Technically, they do not have to develop the proposed NRC procedural topics nor address the changes since the directive is "should." |
NRC Staff Response: There is no specific NRC regulation that requires the applicant to state that such procedures have been developed. Therefore, the text has not been changed. |
Location | Subject | Comment |
---|---|---|
General Comment | Servicing the Accelerator | There is no mention of servicing the accelerator or training and procedures for employees conducting service. |
NRC Staff Response: Section 8.10.8 provides guidance on maintenance and/or repair of the facilities and equipment (e.g., accelerator) used for the production of radioactive materials. This Section also provides information regarding individual training and radiation safety procedures. |
Location | Subject | Comment |
---|---|---|
General Comment | Distribution of Radioactive Materials | The only mention of distribution is that of a consortium for noncommercial use and is limited to PET. There is no mention of commercial distribution, procedures or packaging of product prior to distribution. Additionally, there is no mention of product return or procedures for receipt of returned product whether it is waste or unused product. |
NRC Staff Response: Distribution of radioactive material may be found in NUREG-1556, Vol. 12, ”Program-Specific Guidance About Possession Licenses for Manufacturing and Distribution.” Return of product would be handled like the return of any other radioactive material and therefore is not specifically discussed in this guidance. |
Location | Subject | Comment |
---|---|---|
General Comment | Recall of Product | There is no mention of recall of product produced by the licensee or tracking trends in production problems. |
NRC Staff Response: Information on the recall of the product and/or tracking trends are beyond the scope of this guidance document revision. |
[ Top of file ]
1. Table from The Health Physics & Radiological Health Handbook, Revised Edition, Edited by Bernard Shleien, 1992 (except for * items).
2. ANSI N323A-1997, �Radiation Protection Instrumentation Test and Calibration.�
3. 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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