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Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Service Provider Licenses (NUREG-1556, Volume 18)On this page: Download complete document The following links on this page are to documents in Adobe Portable Document Format (PDF). See our Plugins, Viewers, and Other Tools page for more information. For successful viewing of PDF documents on our site please be sure to use the latest version of Adobe. Publication InformationManuscript Completed: November 2000 Prepared by: Division of Industrial and Medical Nuclear Safety Table of Contents
Abstract[ Prev | Next | Top of file ] As part of its redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539, "Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated April 1996, and draft NUREG-1541, "Process and Design for Consolidating and Updating Materials Licensing Guidance," also dated April 1996. NUREG-1556, Vol. 18, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Service Provider Licenses," dated November 2000, is the eighteenth program-specific guidance developed for the new process, and is intended for use by applicants, licensees, and NRC staff, and will also be available to Agreement States. This document combines and updates the guidance found in the following draft regulatory guides: "Guide for the Application for a License for the Use of Radioactive Materials for Calibrating Radiation Survey and Monitoring Instruments," dated June 1985; "Guide for the Application for the Use of Radioactive Materials in Leak-Testing Services," dated June 1985; and "Guide for the Applications for the Use of Radioactive Materials in Servicing Preregistered Gauges, Measuring Devices, and Sealed Sources Used in Such Devices," dated June 1985. Additionally, NRC staff included information contained in the corresponding Standard Review Plans for these three draft regulatory guides. This report takes a more risk-informed, performance-based approach to licensing service providers, and reduces the information (both the amount and the level of detail) needed to support an application for these activities. Figures[ Prev | Next | Top of file ] 8.2 Examples of Sealed Sources and/or Devices Possessed, Used, or Serviced 8.3 Methods of Certification of Financial Assurance for Decommissioning 8.4 Types of Records That Must Be Maintained for Decommissioning 8.6 Examples of Portable Instruments 8.7 Material Receipt and Accountability 8.8 Annual Dose Limits for Occupationally Exposed Individuals. 8.12 Routine Maintenance and Lubrication M.1 Bird's Eye View of Office With Stored Calibration Source M.2 Down-Hole Storage Array in Waste Broker Facility Q.1 Sample Shipping Documents, Placards, and Labels Foreword[ Prev | Next | Top of file ] The United States Nuclear Regulatory Commission (NRC) is using business process redesign techniques to redesign its materials licensing process. This effort is described in NUREG-1539, "Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated April 1996. A critical element of the new process is consolidating and updating numerous guidance documents into a NUREG series of reports. Below is a listing of volumes currently included in the NUREG-1556 series: "Consolidated Guidance About Materials Licenses":
The current document, NUREG-1556, Vol. 18, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Service Provider Licenses," dated November 2000, is the eighteenth program-specific guidance developed for the new process. It 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 drafted this document, drawing on their collective experience in radiation safety in general and as specifically applied to service provider licenses. A representative of NRC's Office of the General Counsel provided a legal perspective. Since this report takes a risk-informed, performance-based approach to licensing, it specifies the amount of information needed from an applicant seeking to use sealed and unsealed byproduct material. NRC's considerable experience with these licensees indicates that radiation exposures to workers are generally low, if the workers follow basic safety procedures.This NRC report represents a step in the transition from the current paper-based process to the new electronic process. This document is available on NRC's web site at the following address: (http://www.nrc.gov/NRC/NUREGS/SR1556/v18/index.html). NUREG-1556, Vol. 18, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Service Provider Licenses," dated November 2000, 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. _________________________________________ 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 thanks Dianne Geshen, Rolonda Jackson, Tamra King, and Agi Seaton of Computer Sciences Corporation. The Participants[ Prev | Next | Top of file ] Bermúdez, Héctor Abbreviations[ Prev | Next | Top of file ]
1 Purpose of Report[ Prev | Next | Top of file ] This report provides guidance to an applicant in preparing a service provider license application, as well as providing NRC with the appropriate criteria for evaluating such applications. Service providers provide commercial services to both specific and general licensees, and in some instances, recover both licensed and unlicensed material from the public domain. Customers who possess such radioactive material may require commercial services to manage materials at concentrations and activities they are not authorized to handle. In these unique situations, a service provider licensee is authorized to possess these radioactive materials under its license incident to performing specific services required by its customers. Optionally, licensees may elect to transfer licensed material such as radioactive waste and contaminated materials to service providers (e.g., radioactive waste brokers, decontamination and decommissioning service providers or nuclear laundry operators). Licensees who in the course of doing business, receive physical samples and possess equipment containing licensed materials related to the performance of service activities such as leak test and environmental sample analyses, survey instrument and dosimetry calibration services are also included in the service provider category. Service providers addressed in this NUREG are limited to licensed entities providing the following types of commercial services:
- Commercial incineration - Compaction, Super Compaction - Solidification or vitrification - Packaging and repackaging of radioactive waste for transportation.
This report identifies the information needed to complete NRC Form 313 (Appendix B), "Application for Material License." The information collection requirements in 10 CFR Part 20 and Part 30 and NRC Form 313 have been approved under the Office of Management and Budget (OMB) Clearance Nos. 3150-0014, 3150-0017, and 3150-0120, respectively. The format within this document for each item of technical information is as follows:
Notes and References are self-explanatory. NRC Form 313 does not provide sufficient space for applicants to include full responses to Items 5 through 11; as indicated on the form, the answers to those items are to be provided on separate sheets of paper and submitted with the completed NRC Form 313. For the convenience of applicants and for streamlined handling of applications for service provider licenses, use Appendix C to provide supporting information, attach it to NRC Form 313, and submit it to NRC. Appendix D is a checklist that NRC staff uses to review applications and applicants can use to check for completeness. Appendix E contains samples of the different types of licenses for service providers, each license contains the conditions most often found on these type of license, although not all licenses issued to service providers will have all conditions. 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. These terms are defined in 10 CFR Part 20. Rem, and its International System of Units (abbreviated SI from the French Systemè International d'Unités) equivalent Sievert (1 rem = 0.01 Sievert (Sv), is used to describe units of radiation exposure or dose. This is because 10 CFR Part 20 sets dose limits in terms of rem, not rad or roentgen, and the sealed sources that emit beta and gamma rays, which means that 1 roentgen = 1 rad = 1 rem. 2 Agreement States[ Prev | Next | Top of file ] Certain states, called Agreement States (see Figure 2.1), have entered into agreements {Section 274b, Atomic Energy Act, 1954, as amended} 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 who wishes to possess or use licensed material in one of these Agreement States needs to contact the responsible officials in that state for guidance on preparing an application. File these applications with Agreement State officials, not with NRC. Refer to the reference paragraph below for information for submitting an application to a particular state. NRC's materials licensees who wish to conduct operations under reciprocity at temporary job sites in an Agreement State should contact that state's Radiation Control Program Office for information about state regulations. To ensure compliance with Agreement State reciprocity requirements, licensees should request authorization well in advance of scheduled use. Under the provisions of 10 CFR 150.20, NRC can recognize and grant a general license to Agreement State licensees. This general license authorization allows Agreement State licensees to conduct licensed operations identified on the Agreement State license in non-Agreement States, areas of exclusive Federal jurisdiction within Agreement States, and offshore waters provided:
Activities, other than those in offshore waters, including storage of materials, are limited to a total of 180 days in any calendar year. Offshore activities, as specified in 10 CFR 150.20(b)(4), are authorized for an unlimited period of time. NRC must be notified in accordance with the provision of 10 CFR 150.20(b)(1).
In the special situation of work at Federally-controlled sites in Agreement States, it is necessary to know the jurisdictional status of the land in order to determine whether NRC or the Agreement State has regulatory authority. NRC has regulatory authority over land determined to be "exclusive Federal jurisdiction," while the Agreement State has jurisdiction over non-exclusive Federal jurisdiction land. Licensees are responsible for finding out, in advance, the jurisdictional status of the specific areas where they plan to conduct licensed operations. NRC recommends that licensees ask their local contact for the Federal agency controlling the site (e.g., contract officer, base environmental health officer, district office staff) to help determine the jurisdictional status of the land and to provide the information in writing, so that licensees can comply with NRC or Agreement State regulatory requirements, as appropriate. Additional guidance on determining jurisdictional status is found in All Agreement States Letter, SP-96-022, dated February 16, 1996, which is available as indicated below. Table 2.1 provides a quick way to check on which agency has regulatory authority. Table 2.1 Who Regulates the Activity?
Reference: A current list of Agreement States (including names, addresses, and telephone numbers of responsible officials) may be obtained upon request from NRC's Regional Offices. You can also visit the NRC Office of State and Tribal Programs' (STP's) web site at (http://www.hsrd.ornl.gov/nrc); choose "Directories then "State Program Directors." All Agreement States Letter, SP-96-022, on determining jurisdictional status at a Federal facility, dated February 16, 1996, is available on STP's web site at (http://www.hsrd.ornl.gov/nrc/home.html); choose "NRC-State Letters," then scroll down to "Other Information - 1996" for SP-96-022. You can also request the letter from STP by calling NRC's toll free number (800) 368-5642, extension 415-3340. Figure 2.1 U.S. Map. Location of NRC Offices and Agreement States. 3 Management Responsibility[ Prev | Next | Top of file ] NRC recognizes that effective radiation safety program management is vital to achieving safe and compliant operations. NRC believes that consistent compliance with its regulations provides reasonable assurance that licensed activities will be conducted safely. NRC also believes that effective management will result in increased safety and compliance.
To ensure adequate management involvement, a 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 "General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, and Inspection Procedure 87110, Appendix A, "Industrial/Academic/Research Inspection Field Notes"; see the Notice of Availability (on inside front cover of this report). In addition, NUREG-1600 and Inspection Procedure 87110, Appendix A may be found on NRC's web site at (http://www.nrc.gov ). 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 service provider licensees:
To request copies of the above documents, call GPO's order desk in Washington, DC at (202) 512-1800. Order the two-volume bound version of Title 10, Code of Federal Regulations, Parts 0-50 and 51-199 from the GPO, Superintendent of Documents, Post Office Box 371954, Pittsburgh, Pennsylvania 15250-7954. You may also contact the GPO electronically at (http://www.gpo.gov). Additionally, Title 10, Code of Federal Regulations, Parts 0-50 and 51-199, is available electronically on NRC's Reference Library page on NRC's web site at (http://www.nrc.gov). Individuals may request single hard copies of the above documents from NRC's Regional Offices (see Figure 2.1 for addresses and telephone numbers).
5 How to File[ Prev | Next | Top of file ] 5.1 Paper Application[ Prev | Next | Top of file ] Applicants for a materials license should do the following:
All license applications will be available for review by the general public in NRC's Public Document or Electronic Reading Rooms. If it is necessary to submit proprietary information, follow the procedure in 10 CFR 2.790. Failure to follow this procedure could result in disclosure of the proprietary information to the public or substantial delays in processing the application. Employee personal information, i.e., home address, home telephone number, social security number, date of birth, and radiation dose information, should not be submitted unless specifically requested by NRC.
As explained in the "Foreword," NRC's new licensing process will be faster and more efficient, in part, through acceptance and processing of electronic applications at some future date. NRC will continue to accept paper applications; however, these will be scanned and put through an optical character reader (OCR) to convert them to electronic format. To ensure a smooth transition, applicants are requested to follow these suggestions:
5.2 Electronic Application[ Prev | Next | Top of file ] As the electronic licensing process develops, it is anticipated that NRC may provide mechanisms for filing applications via diskettes or CD-ROM, and through the Internet. Additional filing instructions will be provided as these new mechanisms become available. 6 Where to File[ Prev | Next | Top of file ] Applicants wishing to possess or use licensed material in any State or U.S. territory or possession subject to NRC jurisdiction must file an application with the NRC Regional Office for the locale in which the material will be possessed and/or used. Figure 2.1 shows NRC's four Regional Offices and their respective areas for licensing purposes, and identifies Agreement States. In general, applicants wishing to possess or use licensed material in Agreement States must file an application with the Agreement State, not NRC. If work will be conducted at Federally controlled sites in Agreement States, however, applicants must first determine the jurisdictional status of the land in order to determine whether NRC or the Agreement State has regulatory authority. See Section 2, "Agreement States," for additional information. 7 License Fees[ Prev | Next | Top of file ] Each application for which a fee is specified, including applications for new licenses and license amendments, must be accompanied by the appropriate fee. Refer to 10 CFR 170.31 to determine the amount of the fee. NRC will not issue the new license prior to fee receipt. An application for a new license or an amendment to an existing license requesting authorization to conduct field flood studies requires that an environmental assessment be performed. Fees for a licensing action that requires an environmental assessment are charged at an hourly rate. Full cost fee recovery is assessed by the professional staff time expended, as described in footnote e.3. to 10 CFR 170.31. Once technical review begins, 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 additional information on exemptions from annual fees and 10 CFR 171.16 (c) on reduced annual fees for licensees that qualify as "small entities." Direct all questions about NRC's fees or completion of Item 12 of NRC Form 313 (Appendix B) to the Office of the Chief Financial Officer (OCFO) at NRC Headquarters in Rockville, Maryland, (301) 415-7554. You may also call NRC toll-free at (800) 368-5642, extension 415-7554. The e-mail address is fees@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). 8.1 Item 1: License Action Type[ Prev | Next | Top of file ] THIS IS AN APPLICATION FOR (Check appropriate item)
Check box A if the application is for a new license. Check box B if the application is for an amendment(1) to an existing license, and provide the license number. Check box C if the application is for the renewal(1) of an existing license, and provide the license number. 8.2 Item 2: Applicant's Name and Mailing Address[ Prev | Next | Top of file ] List the legal name of the applicant's corporation or other legal entity with direct control over use of the radioactive material; a division or department within a legal entity may not be a licensee. An individual may be designated as the applicant only if the individual is acting in a private capacity and the 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 changes in mailing address; these changes do not require a fee. Note: NRC must be notified before control of the license is transferred or when bankruptcy proceedings have been initiated. See below for more details. NRC Information Notice (IN) 97-30, "Control of Licensed Material during Reorganizations, Employee-Management Disagreements, and Financial Crises," dated June 3, 1997, discusses the potential for the security and control of licensed material to be compromised during periods of organizational instability. Timely Notification of Transfer of Control Regulations: 10 CFR 30.34(b). Criteria: Licensees must provide full information and obtain NRC's prior written consent before transferring control of the license, or, as some licensees call it, "transferring the license." Discussion: Transfer of control may be the result of mergers, buyouts, or majority stock transfers. Although it is not NRC's intent to interfere with the business decisions of licensees, it is necessary for licensees to obtain NRC's written consent before the transaction is finalized. This is to ensure the following:
Response from Applicant: None from an applicant for a new license; Appendix F, excerpted from IN 89-25 (Revision 1), "Unauthorized Transfer of Ownership or Control of Licensed Activities," dated December 7, 1994, identifies the information to be provided about transferring control. References: See the Notice of Availability on the inside front cover of this report to obtain hard copies of INs. Electronic copies are available in the "Reference Library" on NRC's web site at (http://www.nrc.gov ).
Notification of Bankruptcy Proceedings Regulation: 10 CFR 30.34(h). Criteria: Immediately following filing of voluntary or involuntary petition for bankruptcy for or against a licensee, the licensee must notify the appropriate NRC Regional Administrator, in writing, identifying the bankruptcy court in which the petition was filed and the date of filing. Discussion: Even though a licensee may have filed for bankruptcy, the licensee remains responsible for all regulatory requirements. NRC needs to know when licensees are in bankruptcy proceedings in order to determine whether all licensed material is accounted for and adequately controlled, and whether there are any public health and safety concerns (e.g., contaminated facility). NRC shares the results of its determinations with other involved entities (e.g., trustee), so that health and safety issues can be resolved before bankruptcy actions are completed. Response from Applicant: None at time of application for a new license. Generally, licensees should notify NRC within 24 hours of filing a bankruptcy petition. References: See the Notice of Availability on the inside front cover of this report to obtain copies of:
INs are available in the "Reference Library" on NRC's web site at (http://www.nrc.gov). For hard copies, see the Notice of Availability (on the inside front cover of this report). 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 at which licensed material will be used, stored, or dispatched, and list the specific activities to be conducted at each location. As illustrated in Fig. 8.1, a post office box or drawer address is not acceptable. Figure 8.1 Location of Use. An acceptable location of use specifies street address, city, state, and zip code and does not include a post office box number. An NRC-approved license amendment is required before receiving, using and storing licensed material at an address or location not included with the application or already listed on the license.
8.4 Item 4: Person to Be Contacted about this Application[ Prev | Next | Top of file ] Identify the name of the individual who can answer specific administrative or technical questions about the application and include his or her telephone number. This is typically the proposed RSO, unless the applicant has named a different person as the contact. NRC will contact this individual if there are questions about the application. Notify NRC if the contact person or the contact person's telephone number changes so that NRC can contact the applicant or licensee in the future with questions, concerns, or information. This notice is for "information only" and does not require a license amendment unless the notification involves a change in the contact person who is also the RSO.
8.5 Item 5: Radioactive Material[ Prev | Next | Top of file ] Regulations: 10 CFR 30.14; 10 CFR 30.15; 10 CFR 30.18; 10 CFR 30.19; 10 CFR 30.21; 10 CFR 30.32(g); 10 CFR 30.32(i); 10 CFR 30.33; 10 CFR 31.5; 10 CFR 31.8; 10 CFR 31.11; 10 CFR 32.210. Criteria: An application for a license will be approved if the requirements in 10 CFR 30.33 are met. In addition, licensees will be authorized to possess and use only those sealed sources and devices that are specifically approved or registered by NRC or an Agreement State. Discussion: Each authorized radioisotope is listed on the NRC license by its element name, chemical and/or physical form, and the maximum possession limit, as shown in the sample licenses in Appendix E. Table 8.1 below lists the type of radioactive material covered by this report. Note: Additional safety equipment and precautions are required when handling and using unsealed free-form volatile radioactive materials. Volatile means that a liquid, and in rare cases a solid, becomes a gas at a relatively low temperature when exposed to the environment. Table 8.1 Types of Radioactive Materials.
* Accelerator or Reactor Produced The applicant should list each requested radioisotope by its element name and its mass number [e.g., cobalt-60 (Co-60)] in Item 5. 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 radioisotope is not required. Service providers requesting authorization to possess and use volatile radioactive material must provide appropriate facilities, engineering controls, and radiation safety procedures necessary to handle such materials. The anticipated possession limit in megabecquerel (MBq)/millicuries or gigabecquerel (GBq)/ curies for each radioisotope should also be specified. Possession limits must cover 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 radioisotope with a half life greater than 120 days. These requirements are discussed in Section 8.5.3, "Financial Assurance and Recordkeeping for Decommissioning." When requesting authorization for possession limits in excess of the quantities listed in Schedule C of 10 CFR 30.72, you must provide in conjunction with the license application either: (1) an evaluation showing that the maximum off-site dose due to a release of radioactive materials would not exceed 0.01 Sv (1 rem) effective dose equivalent or 0.05 Sv (5 rem) to the thyroid; or (2) an emergency response plan for responding to the release in accordance with the criteria listed in 10 CFR 30.32(i)(3). For additional information regarding emergency plans, refer to Regulatory Guide 3.67 and Policy and Guidance Directive 84-14. Requests to license naturally-occurring radioactive material (NORM) and accelerator-produced radioactive material should be made to the appropriate State regulatory agency. NRC does not regulate NORM or accelerator-produced radioactive material. Response from Applicant: No response required, unless an emergency plan is required. For NRC to grant authorization to possess quantities equal to the activities specified in Schedule C of 10 CFR 30.72, it is necessary to provide the information outlined in 10 CFR 30.32(i) sufficient to evaluate the need for an emergency plan. References:
8.5.1 Unsealed And/or Sealed Byproduct MaterialRegulations: 10 CFR 30.32(g); 10 CFR 30.33(a)(2); 10 CFR 32.210. Criteria: Applicants for a service provider license must provide the manufacturer's or distributor's name and model number for each requested sealed source and device that it will possess, use, and service. Service provider licensees in most circumstances will possess, use, or service only those sealed sources and devices specifically approved or registered by NRC or an Agreement State. However, some sealed sources and/or devices not registered by NRC or an Agreement State may be possessed or used by service providers or individual clients needing services. Possession and use of these unique types of sealed sources result from, either of the following:
OR
- Contain beta and/or gamma emitting material in amounts not exceeding either 3.7 MB (100 microcuries) or ten times the quantity specified in 10 CFR 30.71, Schedule B, whichever is greater. - Contain alpha emitting material in amounts not exceeding 0.37 MB (10 microcuries). OR
When requesting authorization to possess or provide services involving these unique sealed sources see Section 8.5.2, "Unsealed Radioactive Material." Discussion: NRC or an Agreement State performs a safety evaluation of sealed sources and/or devices before authorizing distribution to general or specific licensees. This safety evaluation is documented in a certificate in NRC's Sealed Source and Device (SSD) Registry. Before the SSD registration process was formalized by NRC, some older sealed sources and/or devices may have been evaluated, but not formalized in a separate document. However, these sealed sources and/or devices were specifically approved on a license. Service licensees, in possession of these devices, can continue to use these devices provided they are specifically listed on their licenses, or optionally, if they are authorized to possess equivalent amounts of unsealed material. Examples of the types of devices that are possessed, used, or serviced by service provider licensees are shown in Figure 8.2. Figure 8.2 Examples of Sealed Sources and/or Devices Possessed, Used, or Serviced. Service providers, when possessing, using, or servicing sealed sources and/or devices, should consult with the manufacturer or distributor to ensure that requested sources and devices are compatible and conform to the sealed source and device designations registered with NRC or an Agreement State. Licensees, unless approved by NRC or an Agreement State, may not make any changes to the sealed source, device, or source/device combination that would alter the description or specifications from those indicated in the respective registration certificates, without obtaining NRC's prior permission in a license amendment. Sealed Source and Device registration certificates may be obtained by contacting the SSD Registration Assistant by calling NRC's toll-free number (800) 368-5642, extension 415-8140, or visiting NRC's web site at (http://www.nrc.gov). To ensure that service providers possess and use sealed sources and/or devices according to the registration certificates, they may want to get a copy of the SSD certificate and review it or discuss use and service with the manufacturer. "Conditions of Normal Use" and "Limitation and Other Considerations of Use" are described in most SSD Registration Certificates. These certificates generally include limitations derived from conditions imposed by the manufacturer or distributor, including particular conditions of use that would reduce radiation safety of the device, or circumstances unique to the sealed source and/or device. Information may include environmental conditions such as working life of the device, temperature, vibrations, corrosive atmospheres, etc. Except as specifically approved by NRC or Agreement States, licensees are required to use devices according to their respective SSD Registration Certificates. For additional information about the SSD registration process, see the current version of NUREG-1556, Vol. 3, "Consolidated Guidance About Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration." See Appendix G for a copy of the standard NRC SSD registration certificate format.
Response from Applicant:
Note: For more information about the SSD registration process, see the current version of NUREG-1556, Vol. 3, "Consolidated Guidance About Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration." It is available electronically in the "Reference Library" on NRC's web site at (http://www.nrc.gov); for a hard copy, see the Notice of Availability on the inside front cover of this report. 8.5.2 Unsealed Radioactive MaterialRegulations: 10 CFR 30.14; 10 CFR 30.15; 10 CFR 30.18; 10 CFR 30.19; 10 CFR 30.21; 10 CFR 30.32(i); 10 CFR 30.33; 10 CFR 31.11. Criteria: An application for a license will be approved if the requirements of 10 CFR 30.32, 10 CFR 30.33, 10 CFR 33.11,10 CFR 33.13, 10 CFR 33.14, 10 CFR 33.15, and 10 CFR 33.17 are met. Discussion: Applicants who request unsealed licensed material typically:
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.
Response from Applicant: Possession requests by service provider applicants should be categorized into general areas of use, e.g., survey instrument and personnel dosimeter calibrations, leak test sample analysis, equipment maintenance, environmental sample analysis, decommissioning, waste management, nuclear laundry services, commercial incineration, etc.
8.5.3 Financial Assurance and Recordkeeping for DecommissioningRegulations: 10 CFR 30.34(b); 10 CFR 30.35; 10 CFR 40.36; 10 CFR 70.25. Criteria: Financial assurance is not required for many service providers; however, each licensee is obligated to maintain, in an identified location, decommissioning records related to facilities where licensed material is used, stored, or dispatched. Pursuant to NRC regulations when terminating the license, licensees must transfer records important to decommissioning to either of the following:
Discussion: NRC regulations, when applicable, require the applicant, when not operating at temporary job sites, to provide certification of financial assurance (F/A) or a decommissioning funding plan (DFP). This is to provide reasonable assurance that after the technical and environmental components of decommissioning are carried out, that unrestricted use of the facilities specifically identified in the license is possible at the termination of licensed activities. NRC's primary objective is to ensure that decommissioning will be carried out with minimum impact on the health and safety of the public and occupationally exposed individuals, and the environment (53 FR 24018). These requirements specify that a licensee either set aside funds for decommissioning activities or provide a guarantee through a third party that funds will be available (see Figure 8.3). Before a license is issued, applicants are required to submit an F/A or a DFP when requesting authorization to possess any sealed or unsealed radioactive material with half life (T1/2 ) greater than 120 days exceeding certain the limits. Criteria for determining whether an applicant must submit a DFP or has an option of submitting either a DFP or an F/A are described in 10 CFR 30.35, 10 CFR 40.36, or 10 CFR 70.25. Figure 8.3 Methods of Certification of Financial Assurance for Decommissioning.
Regulatory Guide (RG) 3.66, "Standard Format and Content of Financial Assurance Mechanisms Required for Decommissioning Under 10 CFR Parts 30, 40, 70, and 72," dated June 1990, contains approved wording for each mechanism authorized by the regulation to guarantee or secure funds except for the Statement of Intent for government licensees. Recordkeeping The requirements for maintaining records important to decommissioning, including the type of information required, are stated in 10 CFR Parts 30, 40 and 70. All licensees are required to maintain these records in an identified location until the site is released for unrestricted use (see Figure 8.4). In the event that the licensed activities are transferred to another person or entity, these records shall be transferred to the new licensee before transferring the licensed activities. The new licensee is responsible for maintaining these records until the license is terminated. When the license is terminated, these records shall be transferred to NRC.
Response from Applicants: Financial assurance is not required for most service provider applicants. Applicants need only indicate that they will maintain and transfer decommissioning records as specified in 10 CFR 30.35(g). NRC may require financial assurance for waste brokers who provide services or store radioactive waste prior to disposal at locations specifically identified on the license. If an F/A or a DFP is required, submit the required documents as described in Regulatory Guide 3.66. Figure 8.4 Types of Records That Must Be Maintained for Decommissioning. Note: With the exception of temporary job site locations, licensees must maintain permanent records on locations where licensed materials are used or stored while the license is in force. These permanent records are important for making future determinations about the release of these locations for unrestricted use (e.g., before the license is terminated). Acceptable permanent records include sketches, written descriptions of specific locations where radioactive material is used or stored, and records of any leaking sealed sources, radioactive material spills, contaminated waste storage areas, or other unusual occurrences involving the spread of contamination in or around the licensee's facilities. References: See the Notice of Availability (on the inside front cover of this report) to obtain copies of RG 3.66 and Policy and Guidance Directive FC 90-2 (Rev. 1), "Standard Review Plan for Evaluating Compliance with Decommissioning Requirements," dated April 30, 1991. 8.6 Items 6: Purpose(s) for Which Licensed Material Will Be Used[ Prev | Next | Top of file ] Regulations: 10 CFR 30.33(a)(1). Criteria: Radioisotopes and sealed sources requested in the application must be used for purposes authorized by the Atomic Energy Act of 1954, as amended. Discussion: The licensee must specify the purpose for which each radioisotope or sealed source listed in Item 5 is to be used or possessed incident to providing a specific service. Sealed sources and devices containing licensed materials shall be used only for the purpose for which they are designed, and according to manufacturer's (distributor's) instructions and recommendations for use as specified in the SSD Registration Certificate. Use of sealed sources and devices other than those listed in the SSD Registration Certificate require review and approval by NRC or an Agreement State. Only a person specifically licensed by NRC or an Agreement State shall install, maintain, adjust or repair a device that involves work on the sealed source(s) shielding, the source(s) driving unit, or other electrical or mechanical component that could expose the source, reduce the shielding around the source(s), or compromise the radiation safety of the device or the source(s). Response from Applicant:
- State that possession will be for use in performing commercial leak test services.
- State that the material will be used for performing commercial laboratory analysis of environmental samples.
- State that possession of sealed sources will be used for commercial calibration of radiation survey instruments and/or personnel dosimetry.
- State that possession "incident to performing services" on sealed sources and/or devices will be used for purpose of performing commercial:
- State that use, possession, and "possession incident to performing commercial services" on unsealed materials will be used for the purpose of performing:
- Decontamination and decommissioning services. - Site characterization services. - Radiation protection or health physics training and instruction. - Other service providers not identified above excluding activities involving critical mass quantities of SNM. 8.7 Item 7: Individual(s) Responsible for Radiation Safety Program and Their Training and Experience[ Prev | Next | Top of file ] 8.7.1 Radiation Safety Office (RSO)Regulations: 10 CFR 30.33(a)(3). Criteria: Service provider licensees must have an RSO who is qualified by training and experience in radiation protection, and who is available for advice and assistance on radiological safety matters. The RSO's training and experience must include the uses of licensed material identified on the license so that the RSO is able to oversee the radiation safety program during normal and emergency conditions. Discussion: Service provider licensees must appoint an RSO who is responsible for radiation safety and compliance with the regulations for the use of radioactive material, that may include byproduct, source, and special nuclear material. The RSO must ensure that radiation safety activities are being performed safely according to approved policies and procedures, and that all regulatory requirements are met. The RSO should have full access to all activities involving the use of licensed material and the authority to terminate any activity in which health and safety appear to be compromised without consulting with executive management. The RSO's duties and responsibilities include ensuring radiological safety and compliance with NRC and DOT regulations and the conditions of the license (see Figure 8.5). Figure 8.5 RSO Responsibilities. Typical duties and responsibilities of RSOs. Typically, these duties and responsibilities include ensuring the following:
The responsibilities of the RSO may not be transferred to other individuals. Many tasks and duties associated with managing the program may be assigned or delegated to other qualified individuals; however, the responsibility for these tasks and duties remains with the RSO. NRC recognizes that a qualified individual will on occasion fill in for the RSO when the RSO is away for short periods of time, e.g. professional conferences, vacation, illness, etc. Absences that have a major impact on licensed activities should not occur for extended or indefinite periods of time. Consideration should be given to how individuals temporarily delegated the duties and tasks of the absent RSO could contact the RSO in the event of an emergency. When management selects an RSO, they should keep in mind the duties and responsibilities of the position, and select an individual who is qualified to serve as the RSO. The RSO will need a basic technical knowledge sufficient to understand, in general, the majority of the work being done with licensed materials under his or her responsibility. The individual selected as RSO should have sufficient training and experience to perform the duties required by his or her position. Executive management should ensure that the RSO has sufficient time is allocated to carry out the responsibilities of the position. Response from Applicant: Provide the following:
AND
AND EITHER
OR
Note: It is important to notify NRC, as soon as possible, typically within 30 days, of changes in the designation of the RSO. The name and qualifications of the replacement RSO must be submitted to NRC as part of an amendment request. Applicants should review the regulations for program areas which have specific requirements regarding changes in the RSO. 8.7.2 Authorized UsersRegulations: 10 CFR 19.11; 10 CFR 19.12; 10 CFR 19.13; 10 CFR 30.33(a)(3); 10 CFR 30.34(e); 10 CFR 40.32; 10 CFR 70.22. Criteria: Authorized users (AUs) must have adequate training and experience to use, possess, or provide services involving licensed materials. Duration of training and experience should be commensurate with the expected hazards service provider personnel may encounter during routine and emergency conditions. Successful completion of training as described in Appendix H is evidence of adequate training and experience. Experience requirements could consist of on-the-job training done under the supervision of a qualified individual (AU, RSO, or manufacturer's representative that is authorized by NRC or an Agreement State for the purpose(s) or activities that will be authorized in the license, when issued.). Frequency of Training Discussion: An AU is a person whose training and experience meet NRC criteria specified in Appendix H, who is named either explicitly or implicitly on the license, and who uses or directly supervises the use of licensed materials. An AU must ensure the proper use of licensed materials possessed under the license. AUs must have training to provide reasonable assurance that they will use, possess, or provide services involving licensed materials in a safe manner, maintain security, prevent unauthorized access, and respond appropriately to emergencies. The classroom part of the training for AUs could range from a few hours to several days or more. An AU is considered to be supervising the use of licensed material when he or she directs personnel in operations involving licensed material. Although the AU may delegate specific tasks to supervised users (e.g., maintaining records, conducting routine maintenance), the AU remains responsible for safe use of licensed material. An individual's supervised hands-on experience should be adequate to address routine licensed activities and include a discussion or drill on emergency procedures. Response from Applicant: Provide either of the following:
OR
Note: Alternative response will be evaluated using the criteria listed above. 8.7.3 Ancillary PersonnelRegulations: 10 CFR 19.11; 10 CFR 19.12; 10 CFR 19.13; 10 CFR 30.7; 10 CFR 30.9; 10 CFR 30.10; 10 CFR 30.33. Criteria: Ancillary personnel may include individuals whose assigned duties involve exposure to radiation and/or radioactive material, and individuals who in the course of their employment are likely to receive in a year an occupational dose of radiation greater than 1 millisievert (mSv) = (100 mrem). These individuals must receive instruction commensurate with their duties and responsibilities, as required by 10 CFR 19.12. Ancillary personnel may include clerical, housekeeping, security, any customers' personnel or staff member working under the supervision and direction of the service provider's RSO or AU at the time licensed materials are possessed (incident to providing services) under the service provider's license, and other similar types of personnel whose duties may require them to work in the vicinity of radioactive material, whether they are escorted or not by authorized users. These individuals should be informed about radiation hazards and the appropriate precautions they should take when working in the vicinity of licensed material. The licensee should assess each individual's involvement with licensed material and provide appropriate training. Discussion: Before beginning work with licensed material, most individuals must receive radiation safety training commensurate with their assigned duties. Each individual should also receive periodic refresher training. Licensees should not assume that safety instruction has been adequately covered by previous radiation safety training. Particular attention should be given to individuals performing work or in the immediate vicinity or work being performed with radioactive materials that may require special procedures, e.g., sealed source exchange, service operations that create high radiation areas, etc. Training may be in the form of lecture, demonstrations, videotape, or self-study, and should emphasize practical subjects important to the safe use of licensed material. The guidance in Appendix H may be used to develop a training program. The program should consider both the topics pertinent for each group of workers and the method and frequency of training. 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: Provide either of the following:
OR
8.8 Item 8: Training for Individuals Working in or Frequenting Restricted Areas (Occupationally Exposed Individuals and Ancillary Personnel)[ Prev | Next | Top of file ] Regulations: 10 CFR 19.11; 10 CFR 19.12; 10 CFR 19.13; 10 CFR 20.1801; 10 CFR 20.1802; 10 CFR 30.7; 10 CFR 30.9; 10 CFR 30.10; 10 CFR 30.33(a)(3); 10 CFR 30.34(e); 10 CFR 40.32(b); 10 CFR 40.41(e); 10 CFR 70.23(a)(2); 10 CFR 70.32(b). 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 millirem (mrem)], whether from all external sources, all internal sources, or any combination, must receive instruction commensurate with their duties and responsibilities, as required by 10 CFR 19.12. If a licensee's prospective analysis determines that the potential exposure is greater than 5 mSv (500 mrem), then more extensive training commensurate with the potential radiological health protection problems is appropriate. Discussion: Before beginning work with licensed material, individuals must receive radiation safety training commensurate with their assigned duties and specific to the licensee's radiation safety program. Each individual should also receive periodic refresher training at no more than 12 month intervals. 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 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 H may be used to develop a training program. The program should consider all topics pertinent for each group of workers and also the method and frequency of training. The program should evaluate whether or not the audience understands the materials presented. 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: 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 30.33; 10 CFR 30.33(a)(2); 10 CFR 30.35(g); 10 CFR 40.32(c); 10 CFR 70.23(a)(3). Criteria: Facilities and equipment must be adequate to protect health, minimize danger to life or property, minimize the possibility of contamination, and keep exposure to occupationally exposed workers and the public ALARA. Discussion: Applicants must demonstrate that proposed facilities and equipment provide adequate storage capabilities, appropriate shielding, maintain radiation exposures ALARA, and minimize the possibility of contamination or release of licensed materials as a result of normal and emergency conditions including fire, floods, and wind damage. Licensed materials located in an unrestricted area and not in storage must be under the constant surveillance and immediate control of the licensee. Licensed materials should be accessible only by authorized persons and secured or locked when an authorized person is not physically present. If accessible by unescorted, unauthorized persons, use or storage areas cannot be considered restricted areas for purposes of radiation safety. Applicants may elect to delay completing permanent facilities that will be specifically listed on its license and acquiring equipment described in the application until the technical review of the application is completed by the licensing staff. Delaying the acquisition allows for changes identified as a result of the technical review of the application.
Response from Applicant: For permanent facilities specifically identified on the license: Applicants requesting the use of sealed radioactive material in the following commercial applications:
- Submit a drawing or sketch of the proposed permanent facility identifying areas where radioactive materials, including radioactive wastes, will be used or stored. - Show in the drawings the relationship and distance between restricted areas and adjacent unrestricted areas. - Specify in the drawings shielding materials (concrete, lead, etc.) and means for securing radioactive materials from unauthorized removal. - Drawings, sketches, diagrams, etc. should indicate the scale, or include dimensions on each drawing or sketch. - Describe engineered safety systems e.g. area monitors, interlocks, alarms, etc. Applicants requesting the use of unsealed radioactive material in the following applications:
- Describe the permanent facilities and equipment to be made available at each location where unsealed radioactive material will be used or handled. - Include a description of the area(s) assigned for the receipt, storage, security, preparation, handling, waste storage and measurement of radioactive materials. - Submit a facility diagram showing the proximity of licensed materials to unrestricted areas. - Drawings, sketches, diagrams, etc. should indicate the scale, or include dimensions on each drawing or sketch. - Submit a diagram, sketch, or drawing, when applicable, that identifies areas where radioactive materials may become airborne. The diagram should contain descriptions of the ventilation systems, with pertinent airflow rates, filtration equipment, sample collection points, and monitoring systems. - Submit a diagram of radioactive waste handling equipment that includes incinerators, compactors, solidification equipment, hold-up tanks, sample collection points, etc. - Describe proposed laundry facilities, if applicable, used for contaminated protective equipment and clothing. Specify how the contaminated waste water from the laundry machines or sinks is disposed. Operating and emergency procedures should address decontamination of the laundry area and equipment. - Describe protective clothing (such as rubber gloves, coveralls, respirators, and face shields), auxiliary shielding, absorbent materials, secondary containers for waste water storage for decontamination purposes, plastic bags for storing contaminated items, etc., that will be available. - Identify specialized handling tools, facility safety interlocks designed to prevent operation of radiological safety systems in the event that operation of a system could result in accidental exposure or release of material (e.g., high efficiency particulate air (HEPA) filters, ventilation system, safety door interlocks, etc.) or equipment. For temporary job sites:
- For applicants requesting the use of licensed sealed radioactive sources that do not require the use of specialized handling tools.
- For applicants requesting the use of licensed sealed radioactive material that requires the use of specialized handling tools.
For applicants requesting the use of unsealed radioactive material:
8.10 Item 10: Radiation Safety Program[ Prev | Next | Top of file ] Regulations: 10 CFR 20.1101; 10 CFR 20.2102; 10 CFR 30.32. A radiation safety program must be established and submitted to NRC as part of the application. The program must be commensurate with the scope and extent of activities for the use of licensed materials in service operations. Each applicant must develop, document, and implement a radiation protection program-specific to its types of operations. Radiation safety programs should address the following elements:
Discussion: Individual components of a radiation safety program are addressed in the topics found in this NUREG. Some topics will not require the applicant to submit information as part of an application, but simply provide the applicant with guidance to comply with a specific NRC requirement. Applicants who plan to provide services using sealed or unsealed materials should submit their operating and emergency procedures for NRC approval or, optionally, provide an outline or summary of each procedure that includes the important radiation safety aspects of each individual procedure. Additionally, radiation safety programs that include authorization for handling unsealed or uncontained licensed materials should include in its operating and emergency procedures radiation safety practices that addresses the specific concerns listed below:
Response from Applicant: The applicant must establish and submit its radiation protection program. Each item listed above should be addressed in the corresponding sections of this guide. 8.10.1 Audit ProgramRegulations: 10 CFR 20.1101; 10 CFR 20.2102; 10 CFR 71.5. Criteria: Licensees must review the content and implementation of their radiation protection programs at least annually to ensure the following elements are satisfied:
Discussion: A review of the content and implementation of the radiation protection program by the licensee or its consultant is required at least annually. Appendix I contains a suggested audit checklist that is specific to Service Provider licensees who perform activities within the scope of this document. All areas indicated in Appendix I may not be applicable to every licensee. For example, licensees do not need to address areas which do not apply to their activities. If an audit identifies violations of NRC requirements, the licensee should first evaluate the safety significance of each violation to set priorities and identify resources to correct these violations. Information Notice 96-28, "Suggested Guidance Relating to Development and Implementation of Corrective Action," dated May 1, 1996, provides guidance on this subject. Certain identified problems or potential violations may require notification or a report to NRC. Licensees are encouraged to contact NRC for guidance if there is any uncertainty regarding a reporting requirement. NRC routinely reviews licensee's records to verify if appropriate corrective actions were implemented in a timely manner to prevent recurrence. It is in a licensee best interest to identify potential violations of regulatory requirements and take necessary steps to correct them. NRC can exercise discretion and elect not to cite the licensee for these violations if prompt and effective corrective actions are implemented. Additionally, NRC policy allows licensees with a good regulatory performance, as shown by a licensee's inspection history, to be inspected less frequently than licensees where NRC staff identify significant violation(s) during an inspection. For information on NRC's use of discretion on issuing a notice of violation, refer to NUREG-1600, "General Statement of Policy and Procedures for NRC Enforcement Actions." Currently, NRC's emphasis in inspections is to perform actual observations of work in progress. As a part of the audit programs, licensee are encouraged to perform unannounced audits of authorized users to determine if, for example, operating and emergency procedures are available and followed. When conducting inspections, NRC routinely reviews corrective actions to ensure they were implemented in a timely manner following a self-identified violation and in such a manner prevent recurrence. Licensees must maintain records of these audits and other reviews of program content and implementation for at least 3 years from the date of the record. Audit records should include the following information: date of audit, name of person(s) who conducted audit, persons contacted by the auditor(s), areas audited, audit findings, corrective actions, and follow-up. Response from Applicant: The applicant's program for reviewing the content and implementation of its radiation protection program will be examined during inspections, but should not be submitted in the license application. References: The current version of NUREG-1600 is available electronically on NRC's web site at (http://www.nrc.gov/OE ). INs are available in the "Reference Library" on NRC's web site at (http://www.nrc.gov). For hard copies of NUREG-1600, IN 96-28, and Manual Chapter (MC) 87110, Appendix A, "Industrial/Academic/Research Inspection Field Notes," see the Notice of Availability (on the inside front cover of this report). 8.10.2 Radiation Monitoring InstrumentsRegulations: 10 CFR 20.1501; 10 CFR 20.2103(a); 10 CFR 30.33(a)(2). Criteria: Licensees must possess and periodically calibrate radiation monitoring instruments that are necessary to protect health and minimize danger to life or property. Instruments used for quantitative radiation measurements must be calibrated periodically for the radiation measured. Discussion: Licensees must ensure that an adequate number of calibrated radiation detection and measurement instruments are available to make radiation measurements. Instruments should be calibrated periodically for the types of radiation being measured. In this document, survey instruments are defined as any device used to measure radiological conditions. Figure 8.6 illustrates some common survey instruments used for making contamination surveys and to taking direct radiation measurements. Figure 8.6 Examples of Portable Instruments. Service provider applications should include:
- Ion-chambers; - Geiger-Muellers (G-Ms); - Liquid scintillation counters; - Pocket ion chambers; - Alarming ratemeters; - Area monitors. NRC requires that radiation monitoring devices used to determine compliance with regulatory requirements be calibrated periodically by the instrument manufacturer or persons specifically authorized by NRC or an Agreement State. Radiation monitoring devices and personnel dosimetry devices (PIC, alarming ratemeters, etc.) should be calibrated at least annually (every 12 months) unless otherwise specified by regulation or license condition. Licensees seeking authorization to perform radiation monitoring instrument calibrations will need to submit procedures for review or commit to implementing the procedure in Appendix J. The licensee may wish to review available industry standards for calibration of instruments such as American National Standards Institute (ANSI) N323A-1997, "Radiation Protection Instrumentation Test and Calibration, Portable Survey Instruments." Response from Applicant: Provide one of the following:
OR
OR
Note: Alternative responses will be reviewed using the criteria listed above. 8.10.3 Material Receipt and AccountabilityRegulations: 10 CFR 20.1501(a); 10 CFR 20.1801; 10 CFR 20.1802; 10 CFR 20.1906; 10 CFR 20.2001; 10 CFR 20.2201; 10 CFR 30.34(e); 10 CFR 30.35(g); 10 CFR 30.41; 10 CFR 30.51. Criteria: Licensees must do the following:
Discussion: Licensees are required to develop, implement, and maintain written procedures for safely opening packages in accordance with 10 CFR 20.1906. Some packages containing licensed material may require special opening procedures based on the types, quantities, or half-lives of the nuclide being delivered. Arrangements should be made to receive radioactive packages expeditiously when they are delivered to your permanent facility or at temporary job sites at a customer's facility that will receive packages. Alternatively, arrangements may be made for you to be notified when radioactive packages arrive at the carrier's terminal. A model procedure for safely opening packages containing licensed materials is included in Appendix K. Individuals that will receive packages containing licensed material should be trained to do the following:
When notified that a package of licensed material has arrived, the RSO or AUs should retrieve the package and follow radioactive material receipt procedures. NRC regulations in 10 CFR 20.1906(b) and (c) state the requirements for monitoring packages containing licensed material. These requirements are described in Table 8.2 below. Table 8.2 Package Monitoring Requirements.
* Assumes packages are received during normal working hours. If packages are received outside of normal working hours, the licensee has three hours after the beginning of the next work day to perform the required surveys. If removable radioactive surface contamination on the package exceeds the limits of 10 CFR 71.87(i); or external radiation levels exceed the limits of 10 CFR 71.47, 10 CFR 20.1906(d) requires that the licensee immediately notify the final delivery carrier. Additionally, the administrator of the appropriate NRC Regional Office listed in Appendix D to 10 CFR Part 20 must be notified immediately (within 24 hours). As illustrated in Figure 8.7, licensed materials must be tracked from receipt to disposal in order to ensure accountability and to confirm that possession limits are not exceeded. Figure 8.7 Material Receipt and Accountability. Licensees must maintain records of receipt, transfer, and disposal of licensed material. Licensed material possessed at customers' facilities may be received by the customer in advance of the service provider licensee performing services. In certain circumstances, this material is received and possessed by the customer under the auspices of the customer's license until a licensed service provider can take possession incident to performing services. Licensees must have in place an accountability and control system for promptly detecting missing licensed material at permanent facilities, customer's facilities, temporary job sites, or any other locations where loss, theft, or misplacement of licensed material can occur. Operating and emergency procedures should address how you will maintain control and accountability of licensed material possessed incident to performing commercial services at customer's facilities. Licensees who use and/or possess sealed sources are required by license condition to perform inventories of sealed sources every six months. Service provider licensees must account for all sealed sources, including those that have been taken out of service and await disposal, sources placed in storage prior to use or installation, and sources in the control of the licensee. At six month frequency, licensees should confirm that the sealed sources and devices that have been placed in storage or removed from service have not been lost, misplaced, and that radiological conditions have not deteriorated. Because licensees are required to conduct periodic leak tests of sealed sources, records of leak tests may serve as an inventory record provided the leak test records include necessary information to identify the source and location. If leak tests are performed at intervals of greater than six months, additional inventories aside from those associated with leak tests must be performed. Licensees may use various methods (e.g., computer programs, manual ledgers, log books) to account for receipt, use, transfer, disposal, and decay of licensed material. To ensure that only the RSO or AUs use or supervise the use of licensed material, the RSO should know who has requested an order of licensed material and the types and amounts of licensed materials requested. A model procedure for ordering and receiving radioactive material is included in Appendix K. Licensees must maintain records of receipt, use, transfer, and disposal (as waste) as indicated in Table 8.3. Table 8.3 Record Maintenance.
Response from Applicant:
OR
AND
Note:
References: See the Notice of Availability on the inside front cover of this report to obtain a copy of:
Additional References:
8.10.4 Occupational DoseRegulations: 10 CFR 20.1201; 10 CFR 20.1202; 10 CFR 20.1203; 10 CFR 20.1204; 10 CFR 20.1207; 10 CFR 20.1208; 10 CFR 20.1501; 10 CFR 20.1502; 10 CFR 20.1703; 10 CFR 20.2106; 10 CFR 20 Appendix B. Criteria: The use of individual monitoring devices for external dose is required for service personnel with the potential of receiving 10% of the annual dose identified in Figure 8.8. Discussion: The licensee should perform an evaluation of the dose 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. 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; - 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; - 5 mSv (0.5 rem) shallow-dose equivalent to any extremity.
Internal exposure monitoring is required for:
If an individual is likely to receive in 1 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. Figure 8.8 Annual Dose Limits for Occupationally Exposed Individuals. If monitoring is not required to demonstrate compliance with all limits, but is required relative to one or more specific limits, the licensee should enter "NR" for "not required" in the blocks on NRC Forms 4 and 5 to indicate the areas for which monitoring was not required (e.g., extremity or skin doses). Where monitoring was provided but not measurable, the licensee should enter "ND" for "not detectable." If the prospective dose evaluation shows that the individual is likely to exceed 10% of an applicable limit, monitoring is required (10 CFR 20.1502). Recordkeeping of the results of monitoring performed regardless of the actual dose received, is required by 10 CFR 20.2106 (a). A common method for dose evaluation is to monitor workers' dose with whole body and extremity dosimetry (thermoluminescent dosimeters (TLD), optically stimulated luminescence dosimeters (OSLs), film badges, ring badge, etc.) provided by an NVLAP-approved dosimetry service. Workers are typically monitored for a year or more to determine 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, isotopes used, etc.
Internal Radiation Dose: Bioassays are required when individuals work with airborne radioactive material in the quantities, chemical and physical forms, and activities that make it likely that the radionuclide will be ingested, inhaled, or absorbed resulting in an intake in excess of 10% of the applicable annual limit on intakes (ALIs) in Table 1, Columns 1 and 2, of Appendix B to 10 CFR Part 20. One ALI results in a committed effective dose equivalent (CEDE).
Bioassay services are available and provided by local hospitals, universities, or other vendors specifically approved to provide such services. Response from Applicant: Provide the following:
OR
AND/ADDITIONALLY FOR UNSEALED OR UNCONTAINED MATERIALS
OR
For guidance about methodologies for determination of internal occupational dose and summation of occupational dose, refer to Regulatory Guide 8.34, "Monitoring Criteria and Methods to Calculate Occupational Doses," dated July 1992, and Regulatory Guide 8.9, "Acceptable Concepts, Models, Equations, and Assumptions for a Bioassay Program," dated July 1993. NRC also has additional Regulatory Guides that have been developed for specific isotopes such as H-3 and iodine. For copies of these guidance documents contact the appropriate NRC Regional Office or contact NRC's web site at (http://www.nrc.gov). Response from Applicant: Provide either of the following:
OR
Note:
References: See the Notice of Availability on the inside front cover of this report to obtain copies of:
8.10.5 Public DoseRegulations: 10 CFR 20.1301; 10 CFR 20.1302; 10 CFR 20.1801; 10 CFR 20.1802; 10 CFR 20.2107. Criteria: Licensees must do the following:
Discussion: "Public dose" is defined in 10 CFR Part 20 as "the dose received by a member of the public from exposure to radiation and/or radioactive material released by a licensee, or to any other source of radiation under the control of a licensee." Public dose excludes doses received from background radiation and from medical procedures. Whether the dose to an individual is an occupational dose or a public dose depends on the individual's assigned duties and not 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 public, please refer to Appendix M. Members of the public include persons who work in or may occupy locations where licensed material is used or stored. Employees whose assigned duties do not include the use of licensed material and work in the vicinity where it is used or stored are also included as members of the public. Public dose is controlled, in part, by ensuring that licensed material is secured (e.g., located in a locked area) to prevent unauthorized access or use. Sealed and unsealed materials are usually restricted by controlling access to the keys needed to gain access to storage locations, including storage bunkers. Only the RSO or authorized user should have access to keys. Public dose is also affected by the choice of storage and use locations at temporary job sites. Licensed material must be located so that the resulting public dose in an unrestricted area (e.g., an office or the exterior surface of an outside wall) does not exceed 1 mSv (100 mrem) in a year or 0.02 mSv (2 mrem) in any one hour. Applicants should use the concepts of controlling time, distance, and shielding when choosing storage and use locations. Decreasing the time that an individual is exposed, increasing the distance from the radioactive material, and adding shielding that is appropriate for the specific type of radiation (e.g., brick, concrete, lead, hydrogenous materials, etc.) will reduce the radiation exposure. Information provided on anticipated radiation levels of sealed sources and unsealed materials both inside their respective transport containers and outside the transport container at given distances is the type of information needed to make public dose calculations. Licensees may assess radiation levels located in adjacent areas to radioactive material either by making calculations or by using a combination of direct measurements and calculations. After obtaining anticipated radiation levels or by making direct radiation measurements using an appropriate survey instrument an applicant can use the "inverse square" law to evaluate the effect on the public, and use this information to determine operating and emergency procedures for using radioactive materials. See Appendix M for an example demonstrating that individual members of the public will not receive doses exceeding the allowable public limits. Figure 8.9 shows the steps to calculate the annual dose to an individual member of the public. There are many possible internal dose pathways that contribute to the total effective dose equivalent (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. If, after making an initial public dose evaluation, a licensee changes the conditions used for the evaluation (e.g., relocates radioactive material within a designated storage area, increases the amount of radioactive materials in storage, changes the frequency radioactive material is in use, or changes the occupancy of adjacent areas) the licensee must perform a new evaluation to ensure that the public dose limits are not exceeded and take corrective action, if required. Licensees should design a monitoring program to ensure compliance with 10 CFR 20.1302(b). The extent and frequency of monitoring will depend upon each licensee's specific needs. Figure 8.9 Calculating Public Dose. Steps to calculate the annual dose to an individual member of the public (see Appendix M for more information about occupancy factors). 10 CFR 20.2107 requires that licensees maintain records sufficient to demonstrate compliance with the dose limits for members of the public until the Commission terminates the license. Refer to Appendix M for additional guidance regarding compliance with the recordkeeping requirements. Response from Applicant: No response is required from the applicant in a license application, but compliance will be examined during inspection. During NRC inspections, licensees must be able to provide documentation demonstrating, either by measurement, calculation, or a combination of both, that the total effective dose equivalent to any individual member of the public that is likely to receive the highest dose from licensed operations is less than 1 mSv (100 mrem) in one year, and any unrestricted area does not exceed 0.02 mSv (2 mrem) in any one hour. See Appendix M for examples of methods to demonstrate compliance. 8.10.6 Safe Use of Radionuclides And Emergency ProceduresRegulations: 10 CFR 19.11(a)(3); 10 CFR 20.1101; 10 CFR 20.1801; 10 CFR 20.1802; 10 CFR 20.1902-1905; 10 CFR 20.2201-2203; 10 CFR 21.21; 10 CFR 30.32(i); 10 CFR 30.34(e); 10 CFR 30.50; 10 CFR 30.72. Criteria: As part of the application package, the licensee must develop, implement, and maintain operating and emergency procedures and submit a summary of the procedures to NRC. This summary should addresses the important radiation safety aspects of each procedure. Discussion: The purpose of operating and emergency procedures is to provide personnel specific guidance for all operations they will perform. The operating and emergency procedures should include each topic important to safe operation and use considered applicable to the materials and uses proposed in the application. Each licensee must develop, implement, and maintain operating and emergency procedures, which should include the items outlined below:
- Minimization of distance to areas, to the extent practicable, where licensed materials are used and stored; - Maximization of survey frequency, within reason, to enhance detection of contamination; - Segregation of radioactive material in waste storage areas; - Segregation of sealed sources and tracer materials to prevent cross-contamination; - Separation of radioactive material from explosives; - Separation of potentially contaminated areas from clean areas by barriers or other controls. Note: Service providers who perform specific operations involving sealed sources such as inspection and maintenance of devices, and removal and replacement of sealed sources, should include appropriate procedures and instructions for these operations in the applicant's operating and emergency procedures; OR The licensee should provide a commitment to follow the manufacturer's procedures for inspection, maintenance, source exchange, and operations that involve access to the sealed source(s) and safety systems, if applicable. Table 8.4 Typical NRC Incident Notifications Required for Service Provider Licensees.
Note: Telephone notifications shall be made to the NRC Operations Center at (301) 816-5100 or (301) 951-0550. Response from Applicant: Applicants should either submit their operating and emergency procedures or an outline or summary in responding to subsequent sections. 8.10.7 SurveysRegulations: 10 CFR 30.53; 10 CFR 20.1501; 10 CFR 20.2103. Criteria: Licensees are required by 10 CFR 20.1501 to make surveys of potential radiological hazards in their workplace. Records of surveys and leak tests results must be maintained. Discussion: Surveys are evaluations of radiological conditions and potential hazards (See Figure 8.10). These evaluations may be measurements (e.g., radiation levels measured with survey instrument 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. 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. 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 8.11 Personnel Surveys. Users of unsealed licensed material should check themselves for contamination (frisk) before leaving the laboratory or any area with potential contamination. 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:
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. Refer to Appendix J for a listing of the types of radiation survey instruments available. Ambient survey and routine contamination survey frequencies depend on the quantity and use of radioactive materials, as well as the specific protective facilities, equipment, and procedures that are designed to protect the worker and members of the public from external exposure to radiation. NRC regulations do not provide specific limits for surface contamination in restricted areas, only that ALARA considerations must prevail. Each applicant should propose and justify fixed and removable surface contamination limits allowable in a work area before decontamination is required. Contamination Survey Frequency Personnel working with, in, or around unsealed forms of radioactive material should survey for contamination. Contamination surveys should be conducted at a frequency appropriate to the types and quantities of radioactive materials in use. If the activity used is greater than or equal to the smallest ALI (for either inhalation or ingestion) as identified in 10 CFR Part 20, Appendix B, then documented surveys should be performed at least daily in accordance with 10 CFR 20.2103. Table 8.5 contains suggested contamination survey frequencies based on ALIs. The suggested frequency of surveys is based upon the amount of licensed material "in use" at any one time at any particular location. If licensed material has not been used for a period of time greater than the required survey frequency, then it is considered to be "not in use." Table 8.5 Suggested Contamination Survey Frequency.
Contamination in Unrestricted Areas Contamination found in unrestricted areas should be immediately decontaminated to background levels. When it is not possible to get to background levels, the licensee must ensure that the amounts do not exceed the contamination levels listed in Table 8.6. Table 8.6 Acceptable Surface Contamination Levels for Equipment.
(a) Where surface contamination by both alpha- and beta-gamma-emitting nuclides exists, the limits established for alpha- and beta-gamma-emitting nuclides should apply independently. (b) As 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. (c) Measurements of average contaminant should not be averaged over more than 1 square meter. For objects of less surface area, the average should be derived for each such object. (d) The maximum contamination level applies to an area of not more than 100 cm2 . (e) The 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. * 1 Bq = 1 Disintegration per second When equipment or facilities that are potentially contaminated are to be released for unrestricted use, Table 8.6 provides the maximum acceptable residual levels for equipment. 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 equipment and facilities are released from restricted to unrestricted use, to ensure that they meet these limits. A standardized method for smear testing of a relatively uniform area should be used to aid in comparing contamination at different times and places. A smear taken from an area of about 100 cm2 is acceptable to indicate levels of removable contamination. Survey Record Requirements Each survey record should include the following:
Licensees should record contamination levels observed and procedures followed for incidents involving contamination of individuals. The record should include names of individuals involved, description of work activities, calculated dose, probable causes (including root causes), steps taken to reduce future incidents of contamination, times and dates, and the surveyor's signature. Air Monitoring in the Workplace Air sampling can be used to do the following:
Refer to Regulatory Guide 8.25, Revision 1, "Air Sampling in the Workplace," dated June 1992 and NUREG-1400, "Air Sampling in the Workplace," dated September 1993 for further guidance on the air sampling. Airborne Effluent Release Monitoring When practicable, airborne radioactive effluents should be released from monitored release points (e.g., monitored stacks, discharges, vents) to provide accurate measurements to estimate public exposure. Licensees should verify the performance of effluent monitoring systems by regular calibration (at least annually) to ensure their reliability. Regulatory Guide 4.20, "Constraints on Release of Airborne Radioactive Materials to the Environment for Licensees Other Than Power Reactors," dated December 1996, provides guidance on methods acceptable (calculation or COMPLY code) to NRC for compliance with the constraint on air emissions to the environment. Regulatory Guide 8.37, "ALARA Levels for Effluents from Materials Facilities," dated July 1993, provides guidance on designing an acceptable program for establishing and maintaining ALARA levels for gaseous and liquid effluents at materials facilities. For release points for which monitoring is not practicable, the licensee should estimate the magnitude of the unmonitored effluents. These unmonitored releases will occur anytime unsealed material is handled outside a fume hood or other device that will control the releases. The licensee should include these estimates when demonstrating compliance with dose limits and ALARA goals. Unmonitored releases may be estimated based on the quantity of material used in these areas 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 on column 1 of Table 2 in 10 CFR Part 20, Appendix B, whichever is greater. Effluent monitoring systems should be designed in accordance with ANSI N13.1 (1969), "Document to Sampling Airborne Radioactive Materials in Nuclear Facilities," and ANSI N42.18, "Specification and Performance of On-site Instrumentation for Continuously Monitoring Radioactive Effluents." Liquid Effluent Release Monitoring The licensee should evaluate the concentrations of radioactive material in water that is released to the environment and to the sanitary sewer. The licensee must show that these releases meet the limits in 10 CFR 20. 1301 and 20.2003, respectively. The topic of sanitary sewerage releases is more fully discussed in Appendix N. Response from Applicant: Choose one of the following:
OR
Note: Alternative responses will be reviewed using the criteria listed above. References:
8.10.8 Leak TestsRegulations: 10 CFR 20.2103(a)(4); 10 CFR 30.53. Criteria: NRC requires testing of sealed sources containing greater than 3.7 MBq (100 microcuries) of beta/gamma or 0.37 MBq (10 microcuries) of alpha radioactive material in order to determine whether there is any radioactive leakage from sealed sources. Requirements for leak tests are based on the type of radiation escaping from the inner capsule. Records of test results must be maintained. Discussion: Sealed sources and devices that are approved by NRC or an Agreement State and used according to the respective SSD Registration Certificate usually pose little risk of contamination. Leak tests performed at the frequency specified in the SSD Registration Certificate should identify leaking sources. Leaking sources must be immediately withdrawn from use and decontaminated, repaired, or disposed of according to NRC requirements. Other efforts to minimize radioactive waste do not apply to programs using only sealed sources and devices that have not leaked. NRC licenses will require the performance of leak tests on sealed sources at intervals approved by NRC or an Agreement State and specified in the SSD Registration Sheet. The measurement of the leak-test sample is a quantitative analysis requiring that instrumentation used to analyze the sample be capable of detecting 185 Becquerel (0.005 microcurie) of radioactivity. Manufacturers, consultants, and other organizations may be authorized by NRC or an Agreement State to either perform the entire leak test sequence for other licensees or provide leak test kits to licensees. In the latter case, the licensee is expected to take the leak test sample according to the gauge manufacturer's and the kit supplier's instructions and return it to the kit supplier for evaluation and reporting results. Licensees may also be authorized to conduct the entire leak test sequence themselves. If you will be providing leak tests as a service to others, you may wish to distribute commercial leak test kits. Leak test kits should contain:
- Customer's name; - License number; - Source or device (by manufacturer, model number, nuclide and activity) wiped; and - The name of the individual who made the wipes. Response from Applicant: Do one of the following:
OR
OR
In addition, if you will distribute leak test kits to customers, either:
OR
Note: Requests for authorization to perform leak testing and sample analysis will be reviewed on a case-by-case basis and, if approved, NRC staff will authorize via a license condition. Alternative procedures submitted by the applicant will be evaluated against Appendix O criteria. References: Draft Regulatory Guide FC 412-4, "Guide for the Preparation of Applications for the Use of Radioactive Materials in Leak-Testing Services," is available from NRC upon request. 8.10.9 MaintenanceRegulations: 10 CFR 20.1101; 10 CFR 30.34(e). Criteria: This section applies to individuals who perform maintenance on their own licensed devices. Service providers who perform maintenance as a commercial service to other licensees should refer to Section 8.10.8, "Leak Tests." Licensees must maintain devices (e.g., survey instrument calibrators, self-shielded irradiators, etc.) according to the manufacturer's written recommendations and instructions; see Figure 8.12. "Routine maintenance" of the device includes, but is not limited to, cleaning, lubrication, changing batteries, relays or fuses. "Non-routine maintenance" is the repair, removal, replacement, or alteration involving activities during which personnel could receive radiation doses exceeding NRC limits. These activities could include maintenance on electrical and mechanical systems that directly control source or shielding movement, the device's shielding or sealed source, safety interlocks, any component that may affect safe operation of the device, or any other Non-routine maintenance must be performed by the device manufacturer (or distributor) or a person specifically licensed by NRC or an Agreement State; see Figure 8.12. Discussion: Before any maintenance or repair work is done on your licensed devices, you need to ensure that you:
The NRC license will require that non-routine maintenance be performed only by the manufacturer (or distributor) or other persons specifically licensed by NRC or an Agreement State to perform such services. Applicants seeking authorization to perform non-routine maintenance must submit specific procedures for review. See Appendix P for more information. Figure 8.12 Routine Maintenance and Lubrication. To ensure proper operation of the unit, licensees need to perform routine maintenance according to the manufacturer's (or distributor's) written instructions and recommendations. Response from Applicant: For performance of routine maintenance, submit either of the following:
OR
For performance of non-routine maintenance, submit either of the following:
OR
Note: Alternative procedures submitted by the applicant for performing routine maintenance will be reviewed using the criteria in Appendix P. Information requested in Appendix P will be reviewed on a case-by-case basis; if approved, the license will contain a specific condition authorizing the licensee to perform non-routine maintenance. References: INs are available in the "Reference Library" on NRC's web site at (http://www.nrc.gov). For hard copies, see the Notice of Availability (on the inside front cover of this report). 8.10.10 Minimization of ContaminationRegulations: 10 CFR 20.1406. Criteria: Applicants 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 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 during operation, decontamination and decommissioning efforts, and radioactive waste generation. When submitting new applications, applicants should consider the following:
Sealed sources and devices that are approved by NRC or an Agreement State and located and used according to their SSD Registration Certificates usually pose little risk of contamination. Leak tests performed as specified in the SSD Registration Certificate should identify defective sources. Leaking sources must 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: "Radioactive Material - Unsealed and/or Sealed Sources," "Facilities and Equipment," "Radiation Safety Program - Safe Use of Radioisotopes and Emergency Procedures," "Radiation Safety Program - Surveys," and "Radiation Safety Program - Waste Management." 8.10.11 TransportationRegulations: 10 CFR 20.1101; 10 CFR 30.41; 10 CFR 30.51; 10 CFR 71.5; 10 CFR 71.12; 10 CFR 71.13; 10 CFR 71.14; 10 CFR 71.37; 10 CFR 71.38; 10 CFR 71.47; Subpart H of 10 CFR Part 71; 49 CFR Parts 171-178. Criteria: Applicants must develop, implement, and maintain safety programs for transport of radioactive material to ensure compliance with NRC and DOT regulations. Discussion: The general license in 10 CFR 71.12 provides the authorization used by most licensees to transport, or offer for transport, packages of radioactive material and specifies certain conditions. Licensees should consider the safety of all individuals who may handle or may come into contact with the transport containers or packages containing licensed material. The primary consideration in packaging licensed material should be to ensure that the package integrity is not compromised during transport, and that the radiation levels or removable contamination levels at the package surfaces meet the regulatory requirements of 10 CFR 71.47. In all cases, ALARA concerns are addressed prior to, during, and after transporting any radioactive material. Service provider personnel are authorized to prepare packages for shipment at customer facilities. Regardless of who prepares the package for shipment the shipper (i.e., the individual signing the Shipper's Certification on the shipping papers) is responsible for proper package preparation. If a service provider licensee becomes the shipper, the material will be transferred to the service provider's license. HAZMAT training (49 CFR 172, Subpart H-Training) is required for individuals that prepare packages for shipment. Transporting licensed materials originating at certain facilities (e.g., irradiators) may involve quantities of radioactive material that require a Type B package that involve special requirements. In many cases, this material will be transferred to your license and you will act as the shipper. In these cases, you must ensure that you:
For information about QA plans, see Revision 1 of Regulatory Guide 7.10, "Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material," dated June 1986. For further information about registering as a user of a package or submitting a QA program for review, contact NRC's Spent Fuel Project Office (SFPO) by calling NRC toll-free at (800) 368-5642, extension 415-8500. For information about associated fees, contact NRC's Office of the Controller by calling NRC toll-free at (800) 368-5642, extension 415-7554. Note: Licensees shipping radioactive waste for disposal must prepare the shipment and its shipping manifest as required by 10 CFR Part 20, Appendix F. During an inspection, NRC uses the provisions of 10 CFR 71.5 and a "Memorandum of Understanding with DOT on the Transportation of Radioactive Material" (signed June 6, 1979) to examine and enforce various DOT requirements. See Appendix Q for a Schedule Summary of the Principal Requirements for Transport of Specified Types of Radioactive Material Consignments. Response from Applicant: No response is needed from applicants during the licensing phase. However, before making shipments of licensed materials in Type B packages, a licensee must have registered with NRC as a user of the package and obtained NRC's approval of its QA program. Transportation issues will be reviewed during inspection. References: "Radioactive Materials Regulations Review" can be obtained be calling DOT's Office of Hazardous Material Initiatives and Training at (202) 366-2301. See the Notice of Availability (on the inside front cover of this report) to obtain a copy of the "Memorandum of Understanding with DOT on the Transportation of Radioactive Material," the current version of Regulatory Guide 7.10, "Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material," and NUREG-1660/RAMREG-002, "U.S.-Specific Schedules of Requirements for Transport of Specified Types of Radioactive Material Consignments." 8.11 Item 11: Waste Management[ Prev | Next | Top of file ] Regulations: 10 CFR 20.1904; 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 30.51. Criteria: Radioactive waste must be managed and disposed of in accordance with regulatory requirements and license conditions. Appropriate records of waste disposal must be maintained. Discussion: This section applies to service providers who generate radioactive waste as a result of services operations, but does not include licensees providing waste management services to customers. Waste management service may include, but is not limited to, commercial incineration, compaction, solidification/vitrification, and packaging, repackaging, and transportation of radioactive waste. Service providers who perform these activities as a service to other licensees should refer to Section 8.9.6, "Operating and Emergency Procedures." Radioactive waste generated or handled when conducting licensed activities may include contaminated samples, sealed sources, and unusable items contaminated with radioactive material, e.g., absorbent paper, gloves, filters, tools, etc. You may also be called upon to package radioactive waste at customer facilities for disposal by the customer. Service providers may not receive radioactive waste from other licensees for processing, storage or disposal, unless specifically authorized to do so by NRC. If customers wish to dispose of radioactive waste including sealed sources, service provider licensees may assist them only by transferring licensed material to any person authorized to possess these materials. Individuals authorized to possess materials include:
All radioactive waste must be stored in appropriately labeled containers until it is disposed. During the period between storage and disposal container integrity must be assured. All radioactive waste must be secured against access or removal by unauthorized personnel. NRC regulations require that all licensees must dispose of radioactive waste as follows:
Additionally, radioactive waste management programs can include compaction, solidification/vitrification, and packaging, repackaging of radioactive waste. With service provider licensees, NRC's experience is that most dispose of radioactive waste by transfer to an authorized recipients. Applicants requesting authorization to dispose of radioactive waste by incineration should refer to Policy and Guidance Directive PG 8-10, "Disposal of Incinerator Ash as Ordinary Waste," dated January 1997.
Applicants should describe their radioactive waste management program. This program should include procedures for handling and storing, characterization and minimization, and disposal of radioactive waste. The U.S. Environmental Protection Agency (EPA) issued guidance for development of a comprehensive program to reduce hazardous waste, including radioactive waste. NRC transmitted these guidelines to licensees in IN-94-23, "Guidance to Hazardous, Radioactive, and Mixed Waste Minimization Program," dated March 1994. Disposal By Decay-in-storage (DIS) NRC has concluded that materials with half-lives of less than or equal to 120 days may be disposed of by DIS. The minimum holding period for decay is ten half-lives of the longest-lived radioisotope in the waste. Such waste may be disposed of as ordinary trash if radiation surveys (performed in a low background area and without any interposed shielding) of the waste at the end of the holding period indicate that radiation levels are indistinguishable from background. All radiation labels must be defaced or removed from containers and packages prior to disposal as ordinary trash. If the decayed waste is compacted, all labels that are visible in the compacted mass must also be defaced or removed. Procedures for management of waste being held for DIS should include methods of segregation according to half life, surveys prior to disposal, and maintenance of records of disposal. Records should include the date when the waste was put in storage for decay, date when ten half-lives of the longest-lived radioisotope have transpired, date of disposal, and results of final survey before disposal as ordinary trash. Appendix N provides a model procedure for disposal of radioactive waste by DIS that incorporates the above guidelines. Release Into Sanitary Sewerage 10 CFR 20.2003 authorizes disposal of radioactive waste by release into a public sanitary sewerage system if each of the following conditions is met:
Licensees are responsible to demonstrate that licensed materials discharged into the public sewerage system are indeed readily soluble 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 acceptable criteria for evaluating solubility of liquid waste. Liquid scintillation media and ash are examples of material that may or may not be "readily dispersible." Careful consideration should be given to the possibility of reconcentration of radioisotopes that are released into the sewer. 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. The regulations in 10 CFR 20.2003 are not applicable for releases to a private sewerage treatment system, a septic system, or leach fields. Licensees may make releases to these systems as effluents released to unrestricted areas pursuant to 10 CFR 20.1301. However, if licensed material is released to a private sewage treatment system, septic system, or leach field, the sludge or other solids from these systems may become contaminated with radioactive material. Such sludge may be required to be disposed of as radioactive waste, using one of the methods described in this section. Applicants should provide procedures that will ensure that all releases of radioactive waste into the sanitary sewerage meet the criteria stated in 10 CFR 20.2003 and do not exceed the monthly and annual limits specified in regulations. Licensees are required to maintain accurate records of all releases of licensed material into the sanitary sewerage. A model program for disposal of radioactive waste via sanitary sewer is described in Appendix N. Incineration These guidelines apply to noncommercial waste disposal, i.e., incineration of a licensee's own waste. You do not need specific NRC approval in order to incinerate certain categories of radioactive waste. For example, 10 CFR 20.2005 provides that tritium and carbon-14 in low level concentrations in liquid scintillation media and animal tissue may be disposed of without regard to radioactivity. After you review your program and confirm that you have waste that requires specific NRC approval for incineration, a description of the following should be provided.
Model Procedure for Compaction The following information should be provided from licensees who propose to compact waste. These guidelines apply to noncommercial compaction, i.e., compaction of a licensee's own waste. A description of the following should be provided.
Transfer to an Authorized Recipient When transferring radioactive waste, it is the licensee's responsibility to verify that the intended recipient is authorized to receive the radioactive waste prior to making any shipment. The radioactive waste must be packaged in approved containers for shipment, and each container must identify the radioisotopes and the amounts contained in the waste. Additionally, packages must comply with the requirements of the particular burial site's license and state requirements. Each shipment must comply with all applicable NRC and DOT requirements. In some cases, the waste handling contractor may provide guidance to the licensee for packaging and transportation requirements; however, the licensee is ultimately responsible for ensuring compliance with all applicable regulatory requirements. The shipper must provide all information required in NRC s Uniform Low-Level Radioactive Waste Manifest, and transfer this recorded manifest information to the intended recipient in accordance with 10 CFR Part 20, Appendix G. Each shipment manifest must include a certification by the waste generator, as specified in Section II of the appendix. Each person involved in the transfer for disposal and disposal of waste, including waste generator, waste collector, waste processor, and disposal facility operator, must comply with requirements specified in Section III of Appendix G. 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 and members of the public. The program should include adequate safety procedures to protect workers, members of the public, and the environment.
Disposal of Specific Waste As If It Were Not Radioactive The following radioactive wastes may be disposed of as non-radioactive waste:
Applicants should have procedures that will ensure that the above limits are not exceeded and that the disposal of animal tissue or carcasses containing licensed material is in a manner that will not permit their use either as food for humans or animals. Applicants must maintain accurate records of these disposals. Alternate Methods Applicants 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. Extended Interim Storage Some licensees do not have an LLW disposal facility available to them and therefore must 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. The 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. Other than DIS, LLW should be stored only when disposal capacity is unavailable and for no longer than is necessary. NRC 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. Response from Applicant:
OR
OR
OR
Alternative responses will be reviewed using the criteria listed above. References: See the Notice of Availability on the inside front cover of this report to obtain copies of:
Information Notices are available on NRC's web site at (http://www.nrc.gov). 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. Note: Applicants who wish to perform service operations (e.g., licensees that will repackage radioactive wastes) that require an environmental assessment should review 10 CFR Part 51 (particularly 10 CFR 51.30, 51.60, and 51.66) for further information concerning the environmental information needed by NRC to prepare an environmental assessment. Environmental assessments are full-cost recovery items under 10 CFR Part 170. Full cost will be determined based on the professional staff time and appropriate staff time expended as described in footnote e.3. to 10 CFR 170.31.
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 must be authorized to make binding commitments and to sign official documents on behalf of the applicant. As discussed previously in "Management Responsibility," signing the application acknowledges management's commitment and responsibilities for the radiation protection program. NRC will return all unsigned applications for proper signature. Note:
9 Amendments and Renewals to a License[ Prev | Next | Top of file ] It is the licensee's obligation to keep the license current. If any of the information provided in the original application is to be modified or changed, the licensee must submit an application for a license amendment before the change takes place. Also, to continue the license after its expiration date, the licensee must submit an application for a license renewal at least 30 days before the expiration date (10 CFR 2.109, 10 CFR 30.36(a)). Applications for license amendment, in addition to the following, must provide the appropriate fee. For renewal and amendment requests applicants must do the following:
Note: Using the suggested wording of responses and committing to using the model procedures in this report will expedite NRC's review. 10 Applications for Exemptions[ Prev | Next | Top of file ] Regulations: 10 CFR 19.31; 10 CFR 20.2301; 10 CFR 30.11. The regulations state that NRC may grant an exemption, acting on its own initiative or on an application from and interested person. Key considerations are whether the exemption is authorized by law, will endanger life or property or the common defense and security, and is otherwise in the public interest.
Exemptions are not intended for large classes of licenses, and are generally limited to unique situation. Exemption requests must 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); 10 CFR 30.51(f); 10 CFR 40.42; 10 CFR 70.38. Criteria: Pursuant to the regulations described above, the licensee must do the following: Notify NRC within 60 days, in writing, of the following:
- A decision to permanently cease licensed activities at the entire site (regardless of contamination levels); - A decision to permanently cease licensed activities in any separate building or outdoor area, if they contain residual radioactivity making them unsuitable for release according to NRC requirements; - No principal activities having been conducted at the entire site under the license for a period of 24 months; - No principal activities having not been conducted for a period of 24 months in any separate building or outdoor area, if they contain residual radioactivity making them unsuitable for release according to NRC requirements.
Discussion: As discussed above in "Criteria," before a licensee can decide whether it must notify NRC, the licensee must determine whether residual radioactivity is present and, if so, whether the levels make the building or outdoor area unsuitable for release according to NRC requirements. A licensee's determination that a facility is not contaminated is subject to verification by NRC inspection. The permanent cessation of principal activities in an individual room or laboratory may require the licensee to notify NRC if no other licensed activities are being performed in the building. This also applies to buildings that were approved by the broad scope licensee as locations of use but not specifically named on the broad scope license. Draft Regulatory Guide DG-4006, "Demonstrating Radiological Criteria For License Termination," issued July 8, 1998 and NUREG/BR-0241, "NMSS Handbook for Decommissioning Fuel Cycle and Materials Licenses," dated March 1997, contain the current regulatory guidance concerning decommissioning of facilities and termination of licenses. Appendix B of the Handbook contains a comprehensive list of NRC's decommissioning regulations and guidance. NUREG-1575, "Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM)," dated December 1997, should be reviewed by licensees who have large facilities to decommission. An acceptable screening computer code for calculating screening values to demonstrate compliance with the unrestricted dose limits is Decontamination and Decommissioning computer code (DandD), Version 1, issued on August 20, 1998. Supplemental information on the implementation of the final rule on radiological criteria for license termination was published in the Federal Register (Volume 63, Number 222, Page 64132-64134) on November 18, 1998. This includes the following acceptable license termination screening values of common radionuclides for building surface contamination. Table 11.1 Acceptable License Termination Screening Values of Common Radionuclides for Building Surface Contamination.
* Screening levels are based on the assumption that the fraction of removable surface contamination is equal to 0.1. For cases when the fraction of removable contamination is undetermined or higher than 0.1, users may assume, for screening purposes, that 100% of surface contamination is removable; and therefore the screening levels should be decreased by a factor of 10. Alternatively, users having site-specific data on the fraction of removable contamination (e.g., within 10% to 100% range) may calculate site-specific screening levels using DandD, Version 1, based on site-specific resuspension factor. For Unrestricted Release (dpm/100 cm2) Units are disintegrations per minute per 100 square centimeters (dpm/100 cm2). 1 dpm is equivalent to 0.0167 Bq. The screening values represent surface concentrations of individual radionuclides that would be deemed in compliance with the 0.25 mSv/yr (25 mrem/yr) unrestricted release dose limit in 10 CFR 20.1402. For radionuclides in a mixture, the "sum of fractions" rule applies; see 10 CFR Part 20, Appendix B, Note 4. Refer to NRC Draft Regulatory Guide DG-4006 for further information on application of the values in this table. Response from Applicant: The applicant is not required to submit a response to NRC during the initial application. However, when the license expires or at the time the licensee ceases operations, then any necessary decommissioning activities must be undertaken, NRC Form 314 or equivalent information must be submitted, and other actions must be taken as summarized in the Criteria. Reference: Copies of NRC Form 314, "Certificate of Disposition of Materials," are available upon request from NRC's Regional Offices. (See Figure 2.1 for addresses and telephone numbers). Appendix A : List of Documents Considered in Development of this NUREG[ Prev | Next | Top of file ] This report incorporates and updates the guidance previously found in the NUREG reports, Regulatory Guides (RGs), Policy and Guidance Directives (P&GDs), and Information Notices (INs), listed below. 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. The documents marked with an asterisk (*) have been superseded and should not be used. Table A.1 List of NUREG Reports, Regulatory Guides, and Policy and Guidance Directives.
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[ Prev | Next | Top of file ]
Appendix D : Checklist for License Application[ Prev | Next | Top of file ]
Appendix E: Sample Licenses[ Prev | Next | Top of file ]
Appendix F: Information Needed for Transfer of Control[ Prev | Next | Top of file ] Information Needed for Transfer of Control Licensees must provide full information and obtain NRC's prior written consent before transferring control of the license; some licensees refer to this as "transferring the license." Provide the following information concerning changes of control by the applicant (transferor and/or transferee, as appropriate). If any items are not applicable, so state. 1. The new name of the licensed organization. If there is no change, the licensee should so state. 2. The new licensee contact and telephone number(s) to facilitate communications. 3. Any changes in personnel having control over licensed activities (e.g., officers of a corporation) and any changes in personnel named in the license such as radiation safety officer, authorized users, or any other persons identified in previous license applications as responsible for radiation safety or use of licensed material. The licensee should include information concerning the qualifications, training, and responsibilities of new individuals. 4. An indication of whether the transferor will remain in non-licensed business without the license. 5. A complete, clear description of the transaction, including any transfer of stocks or assets, mergers, etc., so that legal counsel is able, when necessary, to differentiate between name changes and transferring control. 6. A complete description of any planned changes in organization, location, facility, equipment, or procedures (i.e., changes in operating or emergency procedures). 7. A detailed description of any changes in the use, possession, location, or storage of the licensed materials. 8. Any changes in organization, location, facilities, equipment, procedures, or personnel that would require a license amendment even without transferring control. 9. An indication of whether all surveillance items and records (e.g., calibrations, leak tests, surveys, inventories, and accountability requirements) will be current at the time of transfer. Provide a description of the status of all surveillance requirements and records. 10. Confirmation that all records concerning the safe and effective decommissioning of the facility, pursuant to 10 CFR 30.35(g), 40.36(f), 70.25(g), and 72.30(d); public dose; and waste disposal by release to sewers, incineration, radioactive material spills, and on-site burials, have been transferred to the new licensee, if licensed activities will continue at the same location, or to NRC for license termination. 11. A description of the status of the facility. Specifically, the presence or absence of contamination should be documented. If contamination is present, will decontamination occur before transfer? If not, does the successor company agree to assume full liability for the decontamination of the facility or site? 12. A description of any decontamination plans, including financial assurance arrangements of the transferee, as specified in 10 CFR 30.35, 40.36, and 70.25. Include information about how the transferee and transferor propose to divide the transferor's assets, and responsibility for any cleanup needed at the time of transfer. 13. Confirmation that the transferee agrees to abide by all commitments and representations previously made to NRC by the transferor. These include, but are not limited to: maintaining decommissioning records required by 10 CFR 30.35(g); implementing decontamination activities and decommissioning of the site; and completing corrective actions for open inspection items and enforcement actions. With regard to contamination of facilities and equipment, the transferee should confirm, in writing, that it accepts full liability for the site, and should provide evidence of adequate resources to fund decommissioning; or the transferor should provide a commitment to decontaminate the facility before transferring control. With regard to open inspection items, etc., the transferee should confirm, in writing, that it accepts full responsibility for open inspection items and/or any resulting enforcement actions; or the transferee proposes alternative measures for meeting the requirements; or the transferor provides a commitment to close out all such actions with NRC before license transfer. 14. Documentation that the transferor and transferee agree to transferring control of the licensed material and activity, and the conditions of transfer; and the transferee is made aware of all open inspection items and its responsibility for possible resulting enforcement actions. 15. A commitment by the transferee to abide by all constraints, conditions, requirements, representations, and commitments identified in the existing license. If not, the transferee must provide a description of its program, to ensure compliance with the license and regulations. Appendix G: Standard Sealed Source and Device Registration Certificate Format[ Prev | Next | Top of file ]
Appendix H: Criteria for Acceptable Training and Experience for Authorized Users[ Prev | Next | Top of file ] Criteria for Acceptable Training and Experience for Authorized Users Classroom Training Classroom training may be in the form of lecture, videotape, or self-study that emphasize practical subject matter important to the safe handling of licensed materials. Duration and technical level of training should be commensurate with the expected hazards encountered during routine and emergency conditions. Frequency of Training
Suggested Radiation Safety Topics
- Characteristics of radiation; - Units of radiation dose and quantity of radioactivity; - Hazards of exposure to radiation; - Levels of radiation from licensed material; - Methods of controlling radiation dose (time, distance, and shielding); - ALARA concept.
- Operation; - Calibration; - Limitations of radiation survey instruments; - Radiation survey techniques for measuring radiation field; - Radiation survey techniques for measuring removable/fixed contamination; - Handling and proper use of personnel monitoring equipment.
- Proper use of protective equipment; - Decontamination of contaminated protection equipment.
- Successful completion of closed-book written/oral examination depending on the complexity and hazards of authorized activities; - Review of incorrect answers with student.
- On-the-job training done under the supervision of a qualified individual (AU, RSO, or manufacturer's representative authorized by NRC or an Agreement State) that includes supervised hands-on experience performing the task authorized on the license that are commensurate with the expected hazards during routine and emergency conditions; - Practical examination consisting of an assessment by the RSO to ensure that each proposed AU is qualified to work independently and that each individual is knowledgeable of the radiation safety aspects of licensed activities. This may be demonstrated by observing the proposed AU perform licensed activities.
Classroom Course Instructor Qualifications 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). Instructors who provide classroom training to individuals in the principles of radiation and radiation safety should have knowledge and understanding of these principles beyond those obtainable in a course similar to the one given to prospective authorized users. Individuals who provide instruction in the hands-on use of licensed materials should have training and experience that would qualify them to be authorized users, or should possess a thorough understanding of the licensee operations. Appendix I: Suggested [Specific Program] Audit Checklist[ Prev | Next | Top of file ]
Appendix J: Radiation Monitoring Instrument Specifications and Model Survey Instrument Calibration Program[ Prev | Next | Top of file ] Radiation Monitoring Instrument Specifications and Model Survey Instrument Calibration Program The specifications in Table J.1(3) will help applicants and licensees choose the proper radiation detection equipment for monitoring the radiological conditions at their facilities or job sites. Table J.1 Typical Survey Instruments(4).
Model Instrument Calibration Program Training Before allowing an individual to perform survey instrument calibrations, the RSO will ensure that he or she has sufficient training and experience to perform independent survey instrument calibrations. Classroom training may be in the form of lecture, videotape, or self-study and will cover the following subject areas:
Appropriate on-the-job training consists of the following:
Facilities and Equipment for Calibration of Dose Rate or Exposure Rate Instruments
Model Procedure for Calibrating Survey Instruments A radioactive sealed source(s) used for calibrating survey instruments will:
The three kinds of scales frequently used on dose or dose rate survey meters are calibrated as follows:
Surface Contamination Measurement Instruments(5)
Model Procedures for Calibrating, Liquid Scintillation Counters, Gamma Counters, Gas Flow Proportional Counters, and Multichannel Analyzers A radioactive sealed source used for calibrating instruments will do the following:
Calibration
Calibration Records Calibration records, for all survey instruments, should indicate the procedure used and the data obtained. The description of the calibration should include:
The following information should be attached to the instrument as a calibration sticker or tag:
References: See the Notice of Availability on the inside front cover of this report to obtain a copy of: 1. Draft Regulatory Guide FC 413-4, "Guide for the Preparation of Applications for Licenses for the Use of Radioactive Materials in Calibrating Radiation Survey and Monitoring Instruments," dated June 1985. Additional References: 2. "The Health Physics & Radiological Health Handbook, Revised Edition," edited by Bernard Shleien, dated 1992. 3. ANSI N323A-1997, "Radiation Protection Instrumentation Test and Calibration." Copies may be obtained from the American National Standards Institute, 1430 Broadway, New York, NY 10018 or ordered electronically at the following address: (http://www.ansi.org). Appendix K: Material Ordering and Package Receipt and Opening[ Prev | Next | Top of file ] Material Ordering and Package Receipt and Opening The RSO should approve or place all orders for radioactive material and should ensure that the requested material, quantities, manufacturer, and model are authorized by the license and that the possession limits are not exceeded. During normal working hours, carriers should be instructed to deliver radioactive packages directly to the Radiation Safety Office (or designated receiving area). During off-duty hours, security or other designated trained personnel should accept delivery of radioactive packages in accordance with the procedure outlined in the sample memorandum below: Sample Memorandum Memorandum for Security Personnel From: RSO, Management Representative, etc. Subject: Procedures for Receipt of Packages Containing Radioactive Material If the package appears to be damaged, immediately contact the RSO. Ask the carrier to remain at the facility until it can be determined that neither the carrier nor the vehicle is contaminated. Any packages containing radioactive material that arrive between (state times, e.g., 4:30 p.m. and 7:00 a.m. or on Saturdays or Sundays) shall be signed for by the security guard (or other designated trained individual) on duty and taken immediately to the designated receiving area. Security personnel (or other designated trained individual) should unlock the door, place the package in the designated secured storage area and re-lock the door. Radiation Safety Officer (RSO): Office Phone: Home Phone: Sample Instructions to Personnel Involved in Material Receipt During normal working hours, immediately upon receipt of any package of licensed material, each package must be visually inspected for any signs of shipping damage such as crushed or punctured containers or signs of dampness. Any obvious damage must be reported to the RSO immediately. Do not touch any package suspected of leaking. Request the person delivering the package to remain until monitored by the RSO. Outside of normal working hours (e.g., nights, weekends, and holidays), deliveries will usually be handled by security personnel (or other trained individuals) as described in the above procedures. Since certain packages of licensed material will have detectable external radiation, they should be sent immediately to a designated storage area, where they will be checked for contamination and external radiation level as soon as practical. They should not be allowed to remain in the receiving area any longer than necessary, as they may be a source of exposure for receiving personnel. If the instructions are not clear, or if there are questions regarding receiving packages containing radioactive material, please contact: Name: Phone:
Sample Model Procedure for Safely Opening Packages Containing Licensed Materials For packages received under the specific license, authorized individuals shall implement procedures for opening each package, as follows:
Sample Transfer Policy Statement Licensed material shall not be transferred or shipped from one licensee to another without the approval of the RSO. Such transfers/shipments must be packaged and labeled in accordance with DOT, NRC, or U.S. Postal Service Regulations, whichever is applicable. If licensed material is possessed at a customer's facility incident to performing services, this material will not be transferred to us unless we will be preparing it to be shipped AND will be the shipper of record (i.e., signing the Shipper's Certification on the shipping paper. Appendix L: Guidance for Demonstrating That Unmonitored Individuals Are Not Likely to Exceed 10 Percent of the Allowable Limits[ Prev | Next | Top of file ] Guidance for Demonstrating That Unmonitored Individuals Are Not Likely to Exceed 10 Percent of the Allowable Limits Dosimetry is required for individual adults who are likely to receive in 1 year an occupational dose from sources external to the body in excess of 10% of the applicable regulatory limits in 10 CFR 20.1201. In instances where pocket chambers are used instead of film badges or TLDs to assess radiation dosage of personnel, a check of the response of the dosimeters to radiation should be made every 12 months. Acceptable pocket dosimeters should read within plus or minus 20% of the true radiation dose. To demonstrate to NRC that dosimetry is not required for ancillary personnel, a licensee needs to have available an evaluation demonstrating that these nonmonitored workers are not likely to exceed 10% of the applicable annua limits specified in 10 CFR 20.1201. A licensee will need to conduct an evaluation of doses occupationally exposed workers could receive in performing tasks involving the handling of radioactive materials to assess the need for dosimetry. Example: A radiation measurement of the work area indicates a dose rate of 0.015 mSv/hr (1.5 mrem/hr). Service personnel are not expected to spend more than a total of 3 hours per week at the location of the measurement. Based on this measured dose rate, the annual dose is expected to be less than 2.34 mSv (234 mrem). Specifically, 3 hr/wk x 1.5 mrem/hr x 52 wk/yr = 234 mrem. Based on the above, if any service personnel work in the area less than 6.4 hours per week, no dosimetry is required. Note: 6.4 hours is the total number of hours it would take for an individual to meet the 5 mSv (500 millirems) per year limit. Appendix M: Guidance for Demonstrating That Individual Members of the Public Will Not Receive Doses Exceeding the Allowable Limits[ Prev | Next | Top of file ] Guidance for Demonstrating That Individual Members of the Public Will Not Receive Doses Exceeding the Allowable Limits This appendix describes methods for determining radiation dose 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. 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 when volatile materials are used, such as during iodinations, but the discharge itself is usually not continuous since volatile materials are often used periodically rather than continuously. Liquid effluents may be discharged continuously or may be stored and subsequently discharged on a batch basis. For each type of source and for each route of potential exposure, consider the location of measurement points, whether continuous or periodic monitoring is required, the frequency of sampling and measurement, and any additional information. For discharges of airborne radionuclides, for example, it may be necessary to obtain information on the efficiency of filters and the air flow rate of the discharge system, as well as meteorological data and the distance to the nearest individual member of the public. Calculation Method Using a calculation method, the licensee must determine the highest dose an individual is likely to receive at the boundary of the unrestricted area. The licensee must take into account the individual's exposure from external sources and the concentration of radionuclides in gaseous and liquid releases. In practice, the licensee may wish to make conservative assumptions to simplify the dose calculation. The public dose limit applies to the individual who is likely to receive the highest dose from licensed operations. Therefore, the dose calculations must consider the location with the potential for the highest internal and external exposures. 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 M.1). If the result of the calculation using an occupancy factor of 1 demonstrates that the public dose limit is not exceeded, then there is no need for further evaluation. If 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 M.1 or may calculate a specific occupancy factor by determining the likely fraction of time that the individual is present. Table M.1 Standard Occupancy Factors.
Records The licensee must maintain records to demonstrate compliance with the dose limit for individual members of the public until the Commission terminates the license. In general, survey and monitoring records of ambient radiation and effluent radioactivity should be adequate. 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. The following is a simple example to demonstrate the above concepts for calculating, direct measurement with sensitive instrumentation, and combination of calculating and measurement. Calculation Method(6) These measurements must be made with calibrated survey meters sufficiently sensitive to measure background levels of radiation. However, licensees must exercise caution when making these measurements, and they must use currently calibrated radiation survey instruments. A maximum dose of 1 mSv (100 mrem) received by an individual over a period of 2080 hours (i.e., a "work year" of 40 hr/wk for 52 wk/yr) is equal to less than 0.5 microsievert (0.05 mrem) per hour.
Figure M.1 Bird's Eye View of Office With Stored Calibration Source. Instruments used to make measurements for calculations must be sufficiently sensitive. An instrument equipped with a scintillation-type detector (e.g., NaI(Tl)) or a micro-R meter used in making very low gamma radiation measurements should be adequate. Licensees may also choose to use environmental TLDs in unrestricted areas next to the down-hole source storage area for monitoring. This direct measurement method would provide a definitive measurement of actual radiation levels in unrestricted areas without any restrictive assumptions. Records of these measurements can then be evaluated to ensure that rates in unrestricted areas do not exceed the 1 mSv/yr (100 mrem/yr) limit.
The combined measurement-calculation method may be used to estimate the maximum dose to a member of the public. The combined measurement-calculation method takes a tiered approach, going through a two-part process, starting with a worst case situation and moving toward more realistic situations. It makes the following simplifications: (1) each cesium-137 source is considered a point source; (2) typical radiation levels are encountered when the source is in the unshielded position; and (3) no credit is taken for any shielding found between the source storage area and the unrestricted areas. The method is only valid for the source activity at the time of measurement and must be repeated if the source strength or shielding is changed. Part 1 of the combined measurement-calculation method is simple but conservative. It assumes that an affected member of the public is present 24 hours a day and uses only the inverse square law to determine if the distance between the down-hole storage area and the affected member of the public is sufficient to show compliance with the public dose limits. Part 2 considers not only distance, but also the time that the affected member of the public is actually in the area under consideration. Using this approach, licensees make only those calculations that are needed to demonstrate compliance. The results of these calculations typically result in higher radiation levels than would exist at typical facilities, but they provide a method for estimating conservative doses that could be received. Example To better understand the combined measurement-calculation method, we will examine DISPOZ, Inc., a waste management broker. Yesterday, the company's president noted that the top shield of the down-hole storage area is close to an area used by workers whose assigned duties do not include the use of licensed materials, and he asked Clem, the Radiation Safety Officer (RSO), to determine if the company is complying with NRC's regulations. The area in question is near the floor under the workers' desks, which constitutes the primary shield of the down-hole storage area. Clem measures the distance from the shield to the center of the area in question and, using a calibrated survey instrument, measures the highest dose rate at one foot from the shield to be 2 mrem per hour. Figure M.2 Down-Hole Storage Array in Waste Broker Facility. Table M.2 summarizes the information Clem has on the down-hole storage area. Table M.2 Information Known about Dose at the Shield of the Cs-137 Source.
Example: Part 1 Clem's first thought is that the distance between the down-hole storage area shield and the area in question may be sufficient to show compliance with the regulation in 10 CFR 20.1301. So, taking a worst case approach, he assumes: 1) the cesium-137 is constantly located in down-hole storage area (i.e., 24 hr/day); and 2) the workers are constantly in the unrestricted work area (i.e., 24 hr/d). Clem proceeds to calculate the dose the workers might receive hourly and yearly from the source, as shown in Table M-3 below. Table M.3 Calculation Method, Part 1: Hourly and Annual Doses Received from a Source Stored in Above Ground.
Note: The result in Step 3 demonstrates compliance with the 2 mrem in any one hour limit. Re-evaluate if assumptions change. If the result in Step 4 exceeds 100 mrem/yr, proceed to Part 2 of the calculation method. At this point, Clem is pleased to see that the total dose that an individual could receive in any one hour is only 0.125 mrem in an hour, less than the 2 mrem in any one hour limit but notes that an individual could receive a dose of 260 mrem in a year, higher than the 100 mrem limit. Example: Part 2 Clem reviews the assumptions and recognizes that the workers are not in area all of the time. A realistic estimate of the number of hours the workers spends in the area is made, keeping the other assumptions constant (i.e., the source is constantly in the down-hole storage area (i.e., 24 hr/day). The annual dose received is then recalculated. Table M.4 Calculation Method, Part 2: Annual Dose Received from a Source Stored Above Ground.
Clem is pleased to note that the calculated annual dose received is significantly lower, and does not exceed the 100 mrem in a year limit. Clem is glad to see that the results in Step 9 show compliance with the 100 mrem in a year limit. Had the result in Step 9 been higher than 100 mrem in a year, then Clem could have done one or more of the following:
Note that in the example, Clem evaluated the unrestricted area outside only one wall of the down-hole storage area. Licensees also need to make similar evaluations for other unrestricted areas and to keep in mind the ALARA principle, taking reasonable steps to keep radiation dose received below regulatory requirements. In addition, licensees need to be alert to changes in situations (e.g., adding sources to the storage area, changing the work habits of the workers, or otherwise changing the estimate of the portion of time spent in the area in question) and to perform additional evaluations, as needed.
Appendix N: Model Waste Disposal Program[ Prev | Next | Top of file ] Model Waste Disposal Program General Guidelines
Model Procedure for Disposal by Decay-in-storage (DIS) Applicants should assure that adequate space and facilities are available for the storage of waste for DIS. Licensees can minimize the need for storage space if the waste is segregated according to physical half life. 1. Only short-lived waste (physical half-life of less than or equal to 120 days) may be disposed of by DIS. 2. Short-lived waste should be segregated from long-lived waste. 3. Waste should be stored in suitable well marked containers and the containers should provide adequate shielding. 4. Liquid and solid wastes must be stored separately. 5. When the container is full, it should be sealed. The sealed container should be identified with a label affixed or attached to it. 6. The identification label should include the date when the container was sealed, the longest-lived radioisotope in the container, total activity, date when ten half-lives of the longest-lived radioisotope will have transpired, and the initials of the individual who sealed the container. The container may be transferred to the DIS area. When large quantities are held for DIS, sufficient quantities may be present even after 10 half-lives that persons performing surveys should be aware of the potential for measurable radiation. 7. The contents of the container should be allowed to decay for at least ten half-lives of the longest-lived radioisotope in the container. 8. Prior to disposal as ordinary trash, each container should be monitored as follows: a. Check the radiation detection survey meter for proper operation. b. Survey the contents of each container in a low background area. c. Remove any shielding from around the container. d. Monitor all surfaces of the container. e. Discard the contents as ordinary trash only if the surveys of the contents indicate no residual radioactivity, i.e. surface readings are indistinguishable from background. f. If the surveys indicate residual radioactivity, return the container to DIS area and contact the RSO for further instructions. 9. If the surveys indicate no residual radioactivity, record the date when the container was sealed, the disposal date, type of waste (used or unused material, gloves, etc.), survey instrument used, and the initials of the individual performing surveys and disposing of the waste.All radiation labels must be defaced or removed from containers and packages prior to disposal as ordinary trash. Syringes/needles placed into sealed waste containers for decay do not need the labels removed provided that the following is done: waste barrels are sealed prior to delivery to the waste disposal firm and delivered directly from the licensee's facility; labels are removed from the waste barrels/containers; and that the waste is incinerated, not placed in a landfill, and the waste disposal firm is cautioned not to open the container prior to incineration. Model Procedure for Disposal of Liquids Into Sanitary Sewerage 1. Confirm that the sewer system is a public system, not a private sanitary sewer, septic system or leach field. 2. Confirm that the liquid waste being discharged is soluble (or is biological material that is readily dispersible) in water. 3. Calculate the amount of each radioisotope that can be discharged by using the information from prior, similar discharges and the information in 10 CFR 20, Appendix B. 4. Make sure that the amount of each radioisotope does not exceed the monthly and annual discharge limits specified in 10 CFR 20.2003(a)(4) and 10 CFR 20, Appendix B, Table 3 (records for individual users/laboratories). 5. If more than one radioisotope is released, the sum of the ratios of the average monthly discharge of a radioisotope to the corresponding limit in 10 CFR Part 20, Appendix B, Table 3 must not exceed unity. 6. Total quantity of licensed material released into the sanitary sewerage system in a year does not exceed 185 GBq (5 Ci) of H-3 (tritium), 37 GBq (1 Ci) of C-14, and 37 GBq (1 Ci) of all other radioisotopes combined. 7. Record the date, radioisotope(s), estimated activity of each radioisotope, location where the material is discharged, and the initials of the individual discharging the waste. 8. Liquid waste should be discharged only via designated sinks or toilets. 9. Discharge liquid waste slowly to minimize splashing with water running to be sure that the material moves out of the sink into the sewer system. 10. Survey the sink and surrounding work surfaces to confirm that no residual material or contamination remained in the sink or on work surfaces. Decontaminate as appropriate. 11. Decontaminate all areas or surfaces if found to be contaminated. 12. For all releases to the sanitary sewer from the licensed facility, maintain records of each radioisotope and its quantity and concentration that is released into the sewer system that demonstrate compliance with the regulatory limits for total quantity released and concentrations released by the licensed facility. Appendix O: Model Leak Test Program[ Prev | Next | Top of file ] Model Leak Test Program Training Before allowing an individual to perform leak test analysis independently, the RSO will ensure that this individual has sufficient classroom and on-the-job training to show competency in performing leak test analysis. Classroom training in the performance of leak test analysis may be provided in the form of lecture, videotape, or self-study. This classroom training and should cover the following subject areas:
Appropriate on-the-job training consists of:
Facilities and Equipment To ensure the required sensitivity of measurements, leak tests will be analyzed in a low-background area. Before leak test swipes are analyzed, individuals conducting leak tests will use a calibrated and operable survey instrument to check leak test samples for gross contamination. If the sensitivity of the counting system is unknown, the minimum detectable activity (MDA) needs to be determined. The MDA may be determined using the following formula:
For example:
An NaI(Tl) well counter system with a single or multi-channel analyzer will be used to count samples from sealed sources containing gamma-emitters (e.g., cesium-137, cobalt-60). A liquid scintillation, gas-flow proportional, or solid state counting system will be used to count samples containing alpha-emitters (e.g., americium-241). Procedure for Performing Leak Testing and Analysis
Appendix P: Information Needed to Support Applicant's Request to Perform Non-Routine Maintenance Checklist[ Prev | Next | Top of file ] Information Needed to Support Applicant's Request to Perform Non-Routine Maintenance Checklist Applicants should review the section in this document on "Maintenance," which discusses, in general, licensee responsibilities before any maintenance or repair is performed. Non-routine operations include installation of the sealed source/device, initial radiation survey, repair or maintenance involving or potentially affecting components, including electronics, related to the radiological safety (e.g., the source, source holder, source drive mechanism, shutter, shutter control, or shielding), relocation, replacement, and disposal of sealed sources, alignment, removal of a sealed source/device from service, and any other activities during which personnel could receive radiation doses exceeding NRC limits. Any non-manufacturer/non-distributor supplied replacement components or parts, or the use of materials (e.g., lubricants) other than those specified or recommended by the manufacturer or distributor need to be evaluated to ensure that they do not degrade the engineering safety analysis performed and accepted as part of the device registration. Licensees also need to ensure that, after maintenance or repair is completed, the sealed source/device is tested and functions as designed, before the unit is returned to routine use. If non-routine operations are not performed properly with attention to good radiation safety principles, the sealed source/device may not operate as designed and personnel performing these tasks could receive radiation doses exceeding NRC limits. Thus, applicants wishing to perform non-routine operations must use personnel with special training and follow appropriate procedures consistent with the manufacturer's or distributor's instructions and recommendations that address radiation safety concerns (e.g., use of radiation survey meter, shielded container for the source, and personnel dosimetry (if required)). Accordingly, provide the following information. Describe the types of work, maintenance, cleaning, or repair that involve:
The principal reason for obtaining this information is to assist in the evaluation of the qualifications of individuals who will conduct the work and the radiation safety procedures they will follow.
- Doses to personnel and members of the public are within regulatory limits and ALARA (e.g., use of shielded containers or shielding); - The source is secured against unauthorized removal or access or under constant surveillance; - Appropriate labels and signs are used; - Manufacturer's or distributor's instructions and recommendations are followed; - Any non-manufacturer/non-distributor supplied replacement components or parts, or the use of materials (e.g., lubricants) other than those specified or recommended by the manufacturer or distributor are evaluated to ensure that they do not degrade the engineering safety analysis performed and accepted as part of the device registration; and - Before being returned to routine use, the sealed source/device is tested to verify that it functions as designed and source integrity is not compromised.
- Commit to performing surveys with a survey instrument (as described above); - Specify where and when surveys will be conducted during non-routine operations; and - Commit to maintaining, for 3 years from the date of the survey, records of the survey (e.g., who performed the survey, date of the survey, instrument used, measured radiation levels correlated to location of those measurements), as required by 10 CFR 20.2103. Appendix Q: Transportation[ Prev | Next | Top of file ] Transportation Part 1: Major DOT Regulations The major areas in the DOT regulations that are most relevant for transportation of licensed material shipped as Type A quantities are as follows:
Part 2: Schedule Summary of the Principal Requirements for Transport of Specified Types of Radioactive Material Consignments Technical guidance to shippers on compliance with U.S. Nuclear Regulatory Commission (NRC) and U.S. Department of Transportation (DOT) regulations for packaging and transporting radioactive materials in the United States is provided in NUREG-1660, RAM REG-002, "U.S.- Specific Schedules of Requirements for Transport of Specified Types of Radioactive Material Consignments," available on NRC's web site at (http:/www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1600/). The guidance is in the form of Schedules (guides). These Schedules reflect the U.S. regulations in effect on April 1, 1997, and are intended to be the domestic counterpart to the schedules issued by the International Atomic Energy Agency (IAEA) for international transportation safety regulations. These Schedules are a consolidation of the requirements of the Regulations for each of 12 categories of radioactive material. Once the shipper has properly categorized the radioactive material shipment, these Schedules can be used to define the specific requirements for shipment of that category of radioactive material. They were developed by collecting the requirements applicable to each type of shipment from the regulations, then paraphrasing the regulation for simplicity and conciseness. A regulatory reference is provided so that the regulation can be readily consulted when desired. These Schedules do not specifically address all possible shipments involving radioactive materials; in particular, they do not fully address shipments of mixed wastes or other radioactive materials that also satisfy the DOT definition for another hazard class. A sample Schedule is provided as Table Q.1. Table Q.1 Schedule Summary of the Principal Requirements for Transport of Specified Types of Radioactive Material Consignments (Principal requirements only - consult regulations for detailed provisions) Figure Q.1 Sample Shipping Documents, Placards, and Labels. Appendix R: Addendum: Response to Comments on Draft NUREG-1556, Vol. 18[ Prev | Top of file ] Addendum: Response to Comments on Draft NUREG-1556, Vol. 18 Table R.1 Comments from: State of Illinois, Department of Nuclear Safety, received on September 5, 2000.
1. See "Amendments and Renewals to a License" later in this document. Licensees are required to request and obtain an amendment to the license before making changes in their radiation safety program. Examples of changes that require amendment are: change of RSO, changes in approved radiation safety procedures, addition or removal of authorized user(s), changes in areas of use, and changes in licensed material, including increases in possession limit of byproduct material. 2. Copies may be obtained from the National Council on Radiation Protection and Measurements, 7910 Woodmont Ave., Suite 800, Bethesda, MD 20814-3095 or ordered electronically at (http://www.nrpc.com). 3. Table from The Health Physics & Radiological Health Handbook, Revised Edition, Edited by Bernard Shleien, 1992 (except for * items). 4. Instruments used to measure radiological conditions at licensed facilities. 5. 2ANSI N323A-1997, "Radiation Protection Instrumentation Test and Calibration." 6. For ease of use, the examples in this Appendix use conventional units. The conversions to SI units are as follows: 1 foot (ft) = 0.305 meter; 1 mrem = 0.01 mSv. |
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Ci/ml).
