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Program-Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope Including Gas Chromatographs and X-Ray Fluorescence Analyzers - Final Report (NUREG-1556, Vol. 7)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. Section Contents
Publication Information[ Next | Top of file ] Manuscript Completed: December 1999 Prepared by Division of Industrial and Medical Nuclear Safety Abstract[ Prev | Next | Top of file ] As part of its redesign of the materials licensing process, the United States Nuclear Regulatory Commission (NRC) is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539, "Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated April 1996, and draft NUREG-1541, "Process and Design for Consolidating and Updating Materials Licensing Guidance," dated April 1996. NUREG-1556, Vol. 7, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope," dated December 1999, is the seventh 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 for applicants and licensees previously found in (1) Regulatory Guide 10.2, Revision 1, "Guidance to Academic Institutions Applying for Specific Byproduct Material Licenses of Limited Scope," dated December 1976; (2) Regulatory Guide 10.7, "Guide for the preparation of Applications for Licenses for Laboratory and Industrial Use of Small Quantities of Byproduct Material," dated August 1979; and (3) Draft Regulatory Guide FC 405-4, "Guide for the Preparation of Applications for Licenses for the Use of Sealed Sources in Gas Chromatography Devices and X-Ray Fluorescence Analyzers," dated February 1985. This report takes a more risk-informed, performance-based approach to the information needed to support an application for the use of byproduct material. When published this final report should be used in preparing academic, research and development, and other licenses of limited scope (ARDL) license applications. NRC staff will use this final report in reviewing these applications. Figures[ Prev | Next | Top of file ] Figure 8.2 Methods of Certification of Financial Assurance for Decommissioning Figure 8.3 Types of Records That Must Be Maintained for Decommissioning Figure 8.4 RSO Responsibilities Figure 8.6 Examples of Portable Instruments Used in Laboratory Settings Figure 8.7 Material Receipt and Accountability Figure 8.8 Annual Dose Limits for Occupationally Exposed Individuals Figure 8.9 Calculating Public Dose Figure 8.10 Use of Appropriate Shielding Figure 8.11 Proper Handling of Incident Figure P.1 Storage of Food and Drink Foreword[ Prev | Next | Top of file ] The United States Nuclear Regulatory Commission (NRC) is using Business Process Redesign (BPR) techniques to redesign its materials licensing process. This effort is described in NUREG-1539, "Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated April 1996. A critical element of the new process is consolidating and updating numerous guidance documents into a NUREG-series of reports. Below is a list of volumes currently included in the NUREG-1556 series, "Consolidated Guidance About Materials Licenses."
The current document, NUREG-1556, Vol. 7, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope," dated December 1999, is the seventh program-specific guidance developed for the new process. It is intended for use by applicants, licensees, NRC license reviewers, and other NRC personnel. It combines and updates the guidance for applicants and licensees previously found in (1) Regulatory Guide 10.2, Revision 1, "Guidance to Academic Institutions Applying for Specific Byproduct Material Licenses of Limited Scope," dated December 1976, (2) Regulatory Guide 10.7, "Guide for the Preparation of Applications for Licenses for Laboratory and Industrial Use of Small Quantities of Byproduct Material," dated August 1979, and (3) Draft Regulatory Guide FC 405-4, "Guide for the Preparation of Applications for Licenses for the Use of Sealed Sources in Gas Chromatography Devices and X-Ray Fluorescence Analyzers," dated February 1985. In addition, this report also contains pertinent information found in Technical Assistance Requests, Information Notices, Policy and Guidance Directives, and Standard Review Plans, as listed in Appendix A. 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. A team composed of NRC staff from Headquarters and Regional Offices I, II, and III drafted this document, drawing on their collective experience in radiation safety in general and as specifically applied to ARDL users of byproduct material. A representative of NRC's Office of the General Counsel provided a legal perspective. This report represents a step in the transition from the current paper-based process to the new electronic process. This document is available on the Internet at the following address: <http://www.nrc.gov/reading-rm/doc-collections/staff/sr1556/v7/>. NUREG-1556, Vol. 7, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance About Academic, Research and Development and Other Licenses of Limited Scope," dated December 1999, is not a substitute for NRC regulations, and compliance is not required. Josephine M. Piccone, Deputy Director Division of Industrial and Medical Nuclear Safety Acknowledgments[ Prev | Next | Top of file ] The writing team thanks the individuals listed below for assisting in the development and review of the report. All participants provided valuable insights, observations, and recommendations. The team also thanks Kay Avery, Judy Boykin, Randy Glantz, Rolonda Jackson, D.W. Benedict Llewellyn, Steven W. Schawaroch, Agi Seaton, Gina G. Thompson, and Nora Younger of Computer Sciences Corporation. The Participants[ Prev | Next | Top of file ] Cain, Charles L. Abbreviations[ Prev | Next | Top of file ]
1 Purpose of Report[ Prev | Next | Top of file ] This report provides guidance to an applicant in preparing an Academic, Research and Development and Other Licenses of Limited Scope (ARDL) application including gas chromatography devices (GC) and X-RAY fluorescence analyzers (XRF), as well as NRC criteria for evaluating the license application. It is not intended to address licenses of broad scope, licenses for manufacturing and distribution of byproduct material, or licenses for the use of source, or special nuclear material. Within this document, the phrases or terms, "byproduct material," "licensed material," or "radioactive material," are used interchangeably. This document is designed to be used by applicants for a license (not of broad scope) issued by the Commission pursuant to 10 CFR Part 30 that is characterized by a listing of the following specific items:
Byproduct material, as defined in 10 CFR 30.4, is used for a variety of purposes in research, industry, and other fields. The following are typical uses:
NRC's past practice was to issue a separate license to authorize the possession and use of self-shielded irradiators if any of the units exceeded 37 terabecquerels (1,000 curies). NRC may now authorize self-shielded irradiators on the same license as the licensee's other licensed material. NUREG-1556, Vol. 5, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Self-Shielded Irradiator Licenses," provides guidance on licensing self-shielded irradiators. This report identifies the information needed to complete NRC Form 313 (Appendix B), "Application for Material License," for the use of byproduct material for ARDL applicants. The information collection requirements in 10 CFR Part 20, 30, 31, 32 and NRC Form 313 have been approved under the Office of Management and Budget (OMB) Clearance Nos. 3150-0014, 3150-0017, 3150-0016, 3150-0001 and 3150-0120, respectively. The format within this document for each item of technical information is as follows:
Notes and References are self-explanatory and may not be found for each item on NRC Form 313. NRC Form 313 does not have sufficient space for applicants to provide full responses to Items 5 through 11; as indicated on the form, the answers to those items are to be provided on separate sheets of paper and submitted with the completed NRC Form 313. For the convenience of applicants and for streamlined handling of applications for ARDL licenses in the new materials licensing process, use Appendix C to provide supporting information, attach it to NRC Form 313, and submit it to NRC.
In this document, dose or radiation absorbed dose includes: dose equivalent; effective dose equivalent (EDE); committed dose equivalent (CDE); committed effective dose equivalent (CEDE); or total effective dose equivalent (TEDE). These terms are defined in 10 CFR Part 20. Rem, and its SI [Systeme International-(international units)] equivalent, Sievert [0.01 Sievert (Sv) = 1 rem ], 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 (R). 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 the NRC that give them the authority to license and inspect byproduct, source, or special nuclear materials used or possessed within their borders. Any applicant other than a Federal agency who wishes to possess or use 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 State officials, not with the 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 at temporary jobsites in an Agreement State should contact that State's radiation control program office for information about State regulations and questions of jurisdiction on Federal lands or facilities within that Agreement State's boundaries. To ensure compliance with Agreement State reciprocity requirements, licensees should request authorization well in advance of scheduled use. In the special situation of work at Federally-controlled sites in Agreement States, it is necessary to know the jurisdictional status of the land in order to determine whether NRC or the Agreement State has regulatory authority. NRC has regulatory authority over land determined to be "exclusive Federal jurisdiction," while the Agreement State has jurisdiction over non-exclusive Federal jurisdiction land. Licensees are responsible for finding out, in advance, the jurisdictional status of the specific areas where they plan to conduct licensed operations. NRC recommends that licensees ask their local contact for the Federal agency controlling the site (e.g., contract officer, base environmental health officer, district office staff) to help determine the jurisdictional status of the land and to provide the information in writing, so that licensees can comply with NRC or Agreement State regulatory requirements, as appropriate. Additional guidance on determining jurisdictional status is found in 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?
Figure 2.1 U.S. Map. Location of NRC Offices and Agreement States. 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 or Field Offices. You can also visit the NRC Office of State Programs' (OSP's) Home Page <http://www.hsrd.ornl.gov/nrc> and 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 OSP's home page <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 OSP by calling NRC's toll free number (800) 368-5642, extension 415-3340. 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 Notice of Availability (on inside front cover of this report). In addition, NUREG-1600 and Inspection Procedure 87110, Appendix A may be found 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 the use of licensed material by ARDL licensees:
To obtain copies of the above documents, contact the GPO electronically
at <http://www.gpo.gov> 5 How To File[ Prev | Next | Top of file ] 5.1 Paper Application[ Prev | Next | Top of file ] Applicants for a materials license should do the following:
All license applications will be available for review by the general public in NRC's Public Document Rooms. If it is necessary to submit proprietary information, follow the procedure in 10 CFR 2.790. Failure to follow this procedure could result in disclosure of the proprietary information to the public or substantial delays in processing the application. Employee personal information, i.e., home address, home telephone number, social security number, date of birth, and radiation dose information, should not be submitted unless specifically requested by NRC. As explained in the "Foreword," NRC's new licensing process will be faster and more efficient, in part, through acceptance and processing of electronic applications at some future date. NRC will continue to accept paper applications; however, these will be scanned and put through an optical character reader (OCR) to convert them to electronic format. To ensure a smooth transition, applicants are requested to follow these suggestions:
5.2 Electronic Application[ Prev | Next | Top of file ] As the electronic licensing process develops, it is anticipated that NRC may provide mechanisms for filing applications via diskettes or CD-ROM, 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 the section on "Agreement States" for additional information. 7 License Fees[ Prev | Next | Top of file ] Each application for which a fee is specified, must be accompanied by the appropriate fee. Refer to 10 CFR 170.31 to determine the amount of the fee. NRC will not issue the licensing action prior to fee receipt. Consult 10 CFR 170.11 for information on exemptions from these fees. Once technical review has begun, no fees will be refunded; application fees will be charged regardless of the NRC's disposition of an application or the withdrawal of an application. Most NRC licensees are also subject to annual fees; refer to 10 CFR 171.16. Consult 10 CFR 171.11 for 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. Information about fees may also be obtained by calling NRC's toll free number (800) 368-5642, extension 415-7554. The e-mail address is fees@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 renewal1 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 ControlRegulations: 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 D, 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. Reference: See the Notice of Availability on the inside front cover of this report to obtain copies of:
Information Notices are available on NRC's website at <http://www.nrc.gov/NRC/reference.html> Notification of Bankruptcy ProceedingsRegulation: 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. Reference: See the Notice of Availability on the inside front cover of this report to obtain copies of:
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 or stored (e.g., include locations for field studies or other off-site locations; list activities to be conducted at each location). A Post Office Box address is not acceptable, as illustrated in Fig. 8.1. 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.
Note: As discussed later under "Financial Assurance and Record Keeping for Decommissioning," licensees must maintain permanent records describing where licensed material was used or stored while the license was in force. This is important for making future determinations about the release of these locations for unrestricted use (e.g., before the license is terminated). Acceptable records are sketches, written descriptions of the specific locations or room numbers where licensed material is used or stored, and any records of spills or other unusual occurrences involving the spread of contamination in or around the licensee's facilities. 8.4 Item 4: Person To Be Contacted about this Application[ Prev | Next | Top of file ] Identify the individual(s) who can answer questions about the application and include telephone number(s). This is typically the proposed RSO, unless the applicant has named a different person. The NRC will contact this individual if there are questions about the application. Notify NRC if the contact person or his or her 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 or a fee.
8.5 Item 5: Radioactive Material[ Prev | Next | Top of file ] 8.5.1 Unsealed and/or Sealed Byproduct 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(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 of 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 license in Appendix F. Table 8.1 below shows the type of radioactive material covered by this report. Table 8.1 Types of Radioactive Materials
The applicant should list each requested radioisotope by its element name and its mass number [e.g., carbon-14(C-14)] 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. For volatile radioactive material, however, it is necessary to specify whether the requested radioisotope will be acquired in free (volatile) or bound (non-volatile) form, because additional safety precautions are required when handling and using free form volatile material. For example, when requesting authorization to use tritium (H-3) or iodine-125 (I-125), the applicant must specify whether the material will be acquired in free form or bound form. If a radioisotope will be acquired in both free and bound forms, then separate possession limits for each form must be specified. Applicants requesting an authorization to use volatile radioactive material must provide appropriate facilities, engineering controls, and radiation safety procedures for handling of such material.
The anticipated possession limit in MBq (millicuries) or 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 the section on Financial Assurance and Decommissioning. 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. Before proceeding further, applicants should determine if their proposed uses of licensed material are in excess of the quantities specified in 10 CFR 30.71, Schedule B. It is not necessary to submit an application to NRC for quantities of byproduct material that are covered by the exemption in 10 CFR 30.18, provided that they are received from entities that are licensed to distribute them. Similarly, certain prepackaged units (typically called kits) containing byproduct material for conducting in vitro clinical or laboratory tests, are distributed to persons who are generally licensed. Regulations related to possession and use of such prepackaged kits under a general license are stated in 10 CFR 31.11. Persons eligible for this general license are limited to physicians, veterinarians in the practice of veterinary medicine, clinical laboratories, and hospitals; however, these persons are required to register with NRC before acquiring or using these units, unless they have an NRC license under 10 CFR Part 35. Certain devices containing sealed sources of byproduct material, such as ECDs in GCs, are authorized by NRC or Agreement States for distribution to persons who are generally licensed as well as to persons who are specifically licensed. Generally licensed devices can be acquired by the users without obtaining a specific license from NRC. Regulatory requirements for such devices possessed under a general license are stated in 10 CFR 31.5. Distributors of such devices must provide users with appropriate information related to the acquisition, use, and transfer of these generally licensed devices. A safety evaluation of sealed sources and devices is performed by NRC or an Agreement State before authorizing a manufacturer (or distributor) to distribute them to specific licensees. The safety evaluation is documented in a Sealed Source and Device (SSD) Registration Certificate. Information on SSD registration certificates may be obtained by contacting the Registration Assistant by calling NRC's toll-free number (800) 368-5642, extension 415-7231. Before the formalization of the SSD registration process, some older sources or devices may have been specifically approved on a license. Licensees can continue to use those sources and devices specifically listed on their licenses. Applicants must provide the manufacturer's name and model number for each requested sealed source and device so that NRC can verify that they have been evaluated in an SSD Registration Certificate or specifically approved on a license. See also NUREG-1556, Vol. 3. Consult with the proposed supplier, manufacturer, or distributor to ensure that requested sources and devices are compatible with and conform to the sealed source and device designations registered with NRC or an Agreement State. Licensees 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. To ensure that applicants use sources and devices according to the registration certificates, they may want to get a copy of the certificate and review it or discuss it with the manufacturer. Response from Applicant:
References: See Notice of Availability on the inside front cover of this report to obtain copies of Regulatory Guide 3.67, "Standard Format and Content for Emergency Plans for Fuel Cycle and Materials Facilities." Regulatory Guide 3.67 is available on NRC's website at <http//www.nrc.gov>. Additional References: Policy and Guidance Directive 84-14, Revision 1, "Standard Review Plan for Emergency Plans for Fuel Cycle and Materials Licensees." 8.5.2 Financial Assurance and Record Keeping for DecommissioningRegulations: 10 CFR 30.35, 10 CFR 30.34(b). Criteria: A licensee authorized to possess licensed material in excess of the limits specified in 10 CFR 30.35 must submit a decommissioning funding plan (DFP) or provide a certification of financial assurance (F/A) for decommissioning. All licensees are required to maintain records of information important to the decommissioning of the facility in an identified location until the site is released for unrestricted use. Licensees must transfer these records either to the new licensee before licensed activities are transferred or assigned in accordance with 10 CFR 30.34(b) or to the appropriate NRC regional office before the license is terminated. Discussion: NRC wants to ensure that decommissioning will be carried out with minimum impact on the public, occupational health and safety, and the environment. There are two parts to this rule: financial assurance that applies to some licensees, and record keeping that applies to all licensees. NRC regulations requiring an F/A and/or a DFP are designed to provide reasonable assurance that the technical and environmental components of decommissioning are carried out and unrestricted use of the facilities is possible at the conclusion/termination of licensed activities. NRC wants to ensure that decommissioning will be carried out with minimum impact on public and occupational health and safety and on the environment. These requirements, if applicable, specify that a licensee either set aside funds for decommissioning activities or provide a guarantee through a third party that funds will be available (see Figure 8.2). Applicants are required to submit an F/A and/or a DFP when the possession of radioactive material of half life (T1/2) greater than 120 days exceeds certain limits. Criteria for determining whether an applicant is required to submit a DFP and/or an F/A (or neither) are stated in 10 CFR 30.35. Table 8.2 is a partial list of radioisotopes of T1/2 > 120 days with their corresponding limits in excess of which an F/A or a DFP is required; however, it is NRC's experience that most ARDL licensees use only a few of these radioisotopes and that the most frequently used radioisotopes are hydrogen-3 (H-3), C-14, chlorine-36 (Cl-36), and calcium-45 (Ca-45) in unsealed form. The amounts of such radioisotopes required by ARDL licensees rarely exceed the limits that require submitting a DFP or an F/A. See Table 8.2 for possession limits and guidance for submitting either a DFP or an F/A. Radioisotopes of T1/2 > 120 days are listed in column 1. Column 2 lists the corresponding possession limits of radioisotopes in unsealed form requiring an F/A. Column 3 lists the corresponding possession limits of radioisotopes in unsealed form requiring the submittal of a DFP. These limits apply when only one of these radioisotopes is possessed. Figure 8.2 Methods of Certification of Financial Assurance for Decommissioning. Applicants can use the data from Table 8.2 or the method given in Appendix G to determine if an F/A is required and the amount that is required when more than one of these radioisotopes is requested. Most of the ARDL licensees use a small number of these radioisotopes, and in many cases the use is limited to only H-3 and C-14. Such licensees may be able to adjust the amounts of these radioisotopes so that the financial assurance requirement is not applicable. Table 8.2 Commonly Used Unsealed Licensed Materials Requiring Financial Assurance/Decommissioning Funding Plan
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," contains approved wording for each mechanism authorized by the regulation to guarantee or secure funds except for the Statement of Intent for government licensees. Record Keeping The requirements for maintaining records important to decommissioning, including the type of information required, are stated in 10 CFR 30.35(g). All licensees are required to maintain these records in an identified location until the site is released for unrestricted use (see Figure 8.3). In the event that the licensed activities are transferred to another person or entity, these records shall be transferred to the new licensee prior to transfer of the licensed activities. The new licensee is responsible for maintaining these records until the license is terminated. When the license is terminated, these records shall be transferred to NRC. Figure 8.3 Types of Records That Must Be Maintained for Decommissioning
Response from Applicants: No response is needed from most applicants. If F/A or a DFP is required, submit the required documents as described in Regulatory Guide 3.66. Reference: See the Notice of Availability on the inside front cover of this report to obtain copies of these documents:
8.6 Item 6: Purpose(s) for Which Licensed Material Will Be Used[ Prev | Next | Top of file ] Regulations: 10 CFR 30.4, 10 CFR 30.33(a)(1), 10 CFR 51.21, 10 CFR 51.22. Criteria: The applicant must specify the purpose of use for each sealed and/or unsealed radionuclide requested. All sealed sources and devices containing licensed material 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. Discussion: Applicants should clearly specify the purpose for which each radioisotope will be used. The description should be detailed enough to allow NRC to determine the potential for exposure to radiation and radioactive materials, to those working with radioactive materials and members of the public. Research and development, as defined in 10 CFR 30.4, does not include research involving the use of licensed material in or on humans. Applicants intending to use licensed materials for medical research involving humans must be authorized to do so pursuant to a license issued under 10 CFR Part 35, and should refer to Regulatory Guide 10.8, Revision 2, "Guide for the Preparation of Applications for Medical Use Programs," dated August 1987, for instructions. Note: NUREG-1556, Volume 9, "Consolidated Guidance About Material Licenses, Program Specific Guidance about Medical Use Licenses" will supercede Regulatory Guide 10.8, Revision 2 when published as final, and should be used at that time. Applicants may use the format given in Table 8.3 to provide the requested information. Table 8.3 Sample Format for Providing Information About Requested Radioisotopes
Applicants should clearly specify if the licensed material will be used in animal studies and/or tracer studies. Use of licensed material in animals may be in research studies, or by veterinarians for diagnostic and therapeutic purposes. Applicants should also state whether the studies will be limited to small animals (e.g., rats, mice) or may also include larger animals (e.g., pigs, dogs, horses). Similarly, the veterinary use should specify whether the material will be used in pets (cats, dogs) or in farm animals (cattle, horses, pigs). Appendix H provides guidance for developing radiation safety procedures for these studies. If the material will be used in tracer/field studies where licensed material is deliberately released into the environment, or in animal studies that may result in the release of licensed material into the environment, an environmental assessment (EA) may be needed according to 10 CFR 51.21. Revision 1, Supplement to Policy and Guidance Directive FC 84-20, "Impact of Revision of 10 CFR Part 51 on Materials License Actions," dated March 1994, provides criteria for determining when an EA is not needed.
Response from Applicant: List the specific use or purpose of each radioisotope. Reference: Supplement to Policy and Guidance Directive FC 84-20, "Impact of Revision of 10 CFR Part 51 on Materials License Actions," dated March 1994. 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 Officer (RSO)Regulations: 10 CFR 30.33(a)(3). Criteria: RSOs must have training and specific experience, with the types and quantities of licensed material to be authorized on the license. Discussion: The person responsible for implementing the radiation protection program is called the Radiation Safety Officer, or RSO. This individual may also be called the Radiation Protection Officer (RPO). The RSO needs independent authority to stop operations that he or she considers unsafe. He or she must have sufficient time and commitment from management to fulfill certain duties and responsibilities to ensure that radioactive materials are used in a safe manner. Typical RSO duties are illustrated in Figure 8.4 and described in Appendix I. NRC requires the name of the RSO on the license to ensure that licensee management has dentified a responsible, qualified person and that the named individual knows of his or her designation as RSO. Figure 8.4 RSO Responsibilities. Typical duties and responsibilities of RSOs. NRC believes that to demonstrate adequate training and experience, the RSO should have (1) as a minimum, a college degree at the bachelor level, or equivalent training and experience in physical, chemical, biological sciences, or engineering; and (2) training and experience commensurate with the scope of proposed activities. Training should include the following subjects:
The amount of training and experience needed will depend upon the type, form, quantity and proposed use of the licensed material requested. Ultimately, the proposed RSO's training and experience should be sufficient to identify and control the anticipated radiation hazards. In addition, the RSO designee should have obtained the above training in a formal course designed for RSOs presented by an academic institution, commercial radiation safety consulting company, or a professional organization of radiation protection experts. Response from Applicant: Provide the following:
Note: It is important to notify NRC, as soon as possible, of changes in the designation of the RSO. The name and qualifications of the replacement RSO must be submitted to NRC as part of an amendment request. 8.7.2 Authorized UserRegulations: 10 CFR 20.1101 (b), 10 CFR 30.33(a)(3). Criteria: Authorized users (AUs) must have adequate training and experience with the types and quantities of licensed material that they propose to use. Discussion: An AU (also known as "principal investigator") is a person whose training and experience have been reviewed and approved by NRC, who is named on the license, and who uses or directly supervises the use of licensed material. The AU's primary responsibility is to ensure that radioactive materials used in his or her particular lab or area are used safely and according to regulatory requirements (See Figure 8.5). The AU is also responsible to ensure that procedures and engineering controls are used to keep occupational doses and doses to members of the public ALARA. AUs must have adequate and appropriate training to provide reasonable assurance that they will use licensed material safely, including maintaining security of, and access to, licensed material, and respond appropriately to events or accidents involving licensed material to prevent the spread of contamination. NRC believes that to demonstrate adequate training and experience the AU should have (1) a college degree at the bachelor level, or equivalent training and experience in physical, chemical, or biological sciences or in engineering; and (2) training and experience commensurate with the scope of proposed activities. Training should include the following subjects:
The amount of training and experience needed will depend upon the type, form, quantity and proposed use of the licensed material requested, but it should cover the subjects stated. An AU is considered to be supervising the use of radioactive materials when he/she directs personnel in operations involving the licensed material. Although the AU may delegate specific tasks to supervised users (e.g., conducting surveys, keeping records), he/she is responsible for the safe use of radioactive material to assure that areas are not contaminated. Applicants must name at least one individual who is qualified to use the requested licensed materials. In general, AUs must demonstrate training and experience with the type and quantity of material that they propose to use. For example, someone with training and experience only with sealed radioactive sources may not be qualified to use or supervise the use of unsealed licensed material. In addition, someone with experience using only trace quantities may not understand the risks of working with much larger (e.g., 10 or 100 times larger) quantities of the same substance. Applicants should pay particular attention to the type of radiation involved. For example, someone experienced with gamma emitters may not have appropriate experience for high energy beta emitters. Response from Applicant: Provide the following:
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). Criteria: Individuals whose assigned duties involve exposure to radiation and/or radioactive material (from both licensed and unlicensed sources), and in the course of their employment are likely to receive in a year an occupational dose of radiation greater than 1 mSv (100 mrem), must receive instruction commensurate with their duties and responsibilities, as required by 10 CFR 19.12. Discussion: Before beginning work with licensed material, most 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. 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. Particular attention should be given to persons performing work with radioactive materials that may require special procedures, such as hot cell work, waste processing, and animal handling. Also, 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 use of licensed material. The guidance in Appendix J 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: 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(a)(2), 10 CFR 30.35 (g). Criteria: Facilities and equipment must be adequate to protect health and minimize danger to life or property. They must minimize the possibility of contamination and keep exposures to workers and the public ALARA. Discussion: Applicants must demonstrate that their facilities and equipment provide sufficient engineering controls and barriers to protect the health and safety of the public and its employees, keep exposures to radiation and radioactive materials ALARA, and minimize the danger to life and property from the uses of the types and quantities of radioactive materials to be used. Applicants may delay completing facilities and acquiring equipment until after the application review is completed, in case changes are required as a result of the application review. This also ensures the adequacy of the facilities and equipment before the applicant makes a significant financial commitment. In all cases, the applicant may not possess or use licensed material until after the facilities are approved, equipment is procured, and the license is issued. Applicants are reminded that records important to decommissioning include the following:
These records are required to be maintained in an identifiable location. Facilities are required to meet NRC criteria prior to release. Therefore, careful facility design is important to prevent contamination, or facilitate decontamination, reducing the costs needed for decommissioning. For further information, see the section entitled, "Financial Assurance and Record Keeping for Decommissioning." For additional guidance regarding facilities and equipment, refer to Appendix K. If radioactive materials will be used with animals, include a description of the animal handling housing facilities. (See Appendix H.) Response from Applicant: Describe the facilities and equipment to be made available at each location where radioactive material will be used (see Appendix K for topics to consider). Include a description of the area(s) assigned for the receipt, storage, security, preparation and measurement of radioactive materials. A diagram should be submitted showing the locations of shielding, the proximity of radiation sources to unrestricted areas, and other items related to radiation safety. When applicable to facilities where radioactive materials may become airborne, the diagrams should contain schematic descriptions of the ventilation systems, with pertinent airflow rates, pressures, filtration equipment, and monitoring systems. Diagrams should be drawn to a specified scale, or dimensions should be indicated. For facilities where it is anticipated that more than one laboratory or room may be used, a generic laboratory or room diagram may be submitted. 8.10 Item 10: Radiation Safety Program[ Prev | Next | Top of file ] 8.10.1 Audit ProgramRegulations: 10 CFR 20.1101, 10 CFR 20.2102, 10 CFR 21.21(a). Criteria: Licensees must review the content and implementation of their radiation protection programs at least annually to ensure the following:
Discussion: Appendix L contains a suggested audit program that is specific to ARDL licensees and is acceptable to NRC. All areas indicated in Appendix L may not be applicable to every licensee and may not need to be addressed during each audit. For example, licensees do not need to address areas which do not apply to their activities, and activities which have not occurred since the last audit. Generally, audits are conducted at least once every 12 months. Currently, the NRC's emphasis in inspections is to perform actual observations of work in progress. As a part of their audit programs, applicants should consider performing unannounced audits of byproduct material users to determine if, for example, Safe Use and Emergency Procedures are available and are being followed. 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 (IN) 96-28, "Suggested Guidance Relating to Development and Implementation of Corrective Action," dated May 1, 1996, provides guidance on this subject. Certain identified problems or potential violations may require notification or a report to 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 the best interest of the licensee to identify potential violations of regulatory requirements and take necessary steps to correct them. NRC can exercise discretion and may elect not to cite the licensee for these violations if prompt and effective corrective actions are implemented. For information on NRC's use of discretion on issuing a notice of violation, refer to the most recent version of NRC's "General Statement of Policy and Procedures for NRC Enforcement Actions" (NUREG-1600). Licensees must maintain records of these audits and other reviews of program content and implementation for 3 years from the date of the record. Records of these audits 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. These records must be maintained for inspections by NRC. Response From Applicant: The applicant is not required to, and should not, submit its audit program to the NRC for review during the licensing phase. However, this matter may be reviewed during NRC inspections. References: See the Notice of Availability on the inside front cover of this report to obtain copies of:
Inspection Procedure 87110, Appendix A, NUREG-1600, and Information Notice 96-28 are available on the Internet at <http://www.nrc.gov>. 8.10.2 Radiation Monitoring InstrumentsRegulations: 10 CFR 20.1501, 10 CFR 20.2103(a), 10 CFR 30.33(a)(2). Criteria: Licensees must possess, or have access to, 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 shall possess, or have access to, calibrated radiation detection/measurement instruments or licensed services to perform, as necessary the following:
For the purposes of this document, survey instruments are defined as any device used to measure the radiological conditions at a licensed facility. Some of the survey instruments that may be used to perform the above functions include:
Figure 8.6 Examples of Portable Instruments Used in Laboratory Settings. The choice of instrument should be appropriate for the type of radiation to be measured, and for the type of measurement to be taken (count rate, dose rate, etc.). Figure 8.6 illustrates some common survey instruments used for contamination surveys. Applications should include descriptions of the instrumentation available for use and instrumentation applicants intend to purchase prior to starting licensed activities. The description should include type of instrument and probe, and the instrument's intended purpose. Instruments used for qualitative surveys are only intended to detect contamination in the laboratory. Such instruments should be checked for operational response with an appropriate check source containing radioactive material, and can be calibrated with an electronic pulser instead of a radioactive source. However, these instruments cannot be used for measurement of surface contamination or radiation levels without a calibration with appropriate radioactive sources, as described in Appendix M. NRC requires that calibrations be performed by the instrument manufacturer or a person specifically authorized by NRC or an Agreement State, unless the applicant specifically requests this authorization. Applicants seeking authorization to perform survey instrument calibrations shall submit procedures for review. Appendix M provides information about instrument specifications and model calibration procedures. Response from Applicant: Provide one of the following: A description of the instrumentation (as described above) that will be used to perform required surveys and a statement that: "We will use instruments that meet the radiation monitoring instrument specifications published in Appendix M to NUREG-1556, Vol. 7, 'Program-Specific Guidance About Academic, Research and Development, and Other Laboratory Licenses of Limited Scope,' dated December 1999. We reserve the right to upgrade our survey instruments as necessary." OR A description of the instrumentation (as described above) that will be used to perform required surveys and a statement that: "We will use instruments that meet the radiation monitoring instrument specifications published in Appendix M to NUREG-1556, Vol. 7, 'Program-Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope,' dated December 1999. Additionally, we will implement the model survey meter calibration program published in Appendix M to NUREG-1556, Vol. 7, 'Program-Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope,' dated December 1999. We reserve the right to upgrade our survey instruments as necessary." OR A description of alternative equipment and/or procedures for ensuring that appropriate radiation monitoring equipment will be used during licensed activities and that proper calibration and calibration frequency of survey equipment will be performed. Further, the statement "We reserve the right to upgrade our survey instruments as necessary" should be added to the response. Note: Alternative responses will be reviewed using the criteria listed above. 8.10.3 Material Receipt and AccountabilityRegulations: 10 CFR 30.34(e), 10 CFR 30.35(g), 10 CFR 30.41, 10 CFR 30.51, 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 31.11. 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 may require special procedures that take into consideration the type, quantity, or half-life of the nuclide being delivered. Licensees need to make arrangements to receive radioactive packages when they are delivered or to be notified when radioactive packages arrive at the carrier's terminal so that the licensee can pick up the package expeditiously. A model procedure for safely opening packages containing licensed materials is included in Appendix N. In limited scope radiation safety programs, the RSO or his/her staff usually receives the incoming package directly from the carrier, and performs all verification, surveying, opening, and documentation for inventory. The package is then delivered to the AU, or the AU retrieves the package from the RSO. If the package is transported over public roads by the licensee, it must be repackaged and transported in accordance with DOT regulations. If the package of licensed material is delivered to the licensed facility's receiving department (Receiving), individuals working in that department should be trained to do the following:
When notified by Receiving that a package of licensed material has arrived, the RSO or his/her staff should retrieve the package and follow the safe opening 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 8.4, below. Table 8.4 Package Monitoring Requirements
10 CFR 20.1906(d) requires that the licensee immediately notify the final delivery carrier and, by telephone, telegram, mailgram, or facsimile, the Administrator of the appropriate NRC Regional Office listed in Appendix D to 10 CFR Part 20 when removable radioactive surface contamination exceeds the limits of 10 CFR 71.87(i); or external radiation levels exceed the limits of 10 CFR 71.47. As illustrated in Figure 8.7, licensed materials must be tracked from "receipt to disposal" in order to ensure accountability and to ensure that possession limits listed on the license are not exceeded. Licensees frequently possess radioactive material, which is generally licensed or distributed to them as an exempt quantity in addition to that which is specifically listed on their license. 10 CFR Part 31 provides information regarding generally licensed devices. Any person who acquires, receives, possesses, uses, or transfers a generally licensed device must do so in accordance with the provisions of the general license. Generally licensed material possessed by a specific licensee may continue to be possessed under a general license. A specific license does not automatically remove general licensee status nor automatically "move" generally licensed material to the specific license. NRC recognizes that multiple authorizations can create some confusion and, therefore, a specific licensee always has the option of receiving and possessing radioactive materials that "qualify" for a general license, by adding these to its specific license. Similarly, radioactive material received by a specific licensee, that is distributed to them under an exemption from the requirements for a license, is not subject to the terms and conditions of the specific license. Any person may receive byproduct material that is exempt from the requirements of a license pursuant to the regulations in 30.11 through 30.21. Such materials may include "exempt quantities" of byproduct materials that do not exceed the applicable quantity listed in 10 CFR 30.71, as well as items such as smoke detectors and self-luminous watches, that are distributed in accordance with other NRC regulations. Most licensees do not possess or control these type of devices under the provisions of their specific license and NRC does not require or encourage this practice; however, as stated above, the specific licensee always has the option of adding these materials to its license, and controlling them under the conditions of the specific license. In any case, licensees are required to ensure that dose limits are not exceeded, whether or not the dose results from licensed sources or unlicensed sources. Some facilities may have separate laboratories or locations which use material for in-vitro assay that may be possessed under the general license in 10 CFR 31.11. Each location is a separate general license from the other. The multiple locations are not considered to operate under a single general license and are not considered part of the specific license. The possession limit of 7.4 MBq (200 microcuries), only applies to a total amount of I-125, iodine-131 (I-131), selenium-75 (Se-75), and/or iron-59 (Fe-59) used and/or stored in one location. It is recognized that loss, theft, or misplacement of licensed material can occur; however, licensees must have in place an accountability and control system for promptly detecting losses of licensed material. Licensees who use and/or possess sealed sources are required by license condition to perform inventories of sealed sources every six months (see sample license, condition no. 16). Some sealed sources may not be in use or are rarely used and are placed in storage. In these cases, licensees should confirm that these sealed sources have not been disturbed at least every 6 months. Licensees are also required to conduct leak tests of sealed sources at 6-month intervals (or at longer intervals as specified in the SSD Registration Certificate). Since the leak tests require an individual to locate and work with the sealed source, records of leak tests may be used as part of an inventory and accountability program. With regard to unsealed licensed material, licensees use various methods (e.g., computer programs, manual ledgers, log books) to account for receipt, use, transfer, disposal, and radioactive decay. These methods help to ensure that possession limits are not exceeded. To ensure that only trained, experienced, and authorized individuals 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. Control procedures should also be established for the procurement of licensed materials that may be obtained outside the normal channels, e.g., through the loan or other transfer of materials without purchase or through surplus. A model procedure for Ordering and Receiving Radioactive Material is included in Appendix N. NRC regulations applicable to transfers are stated in 10 CFR 30.41. Sample policy transfer statements are included in Appendix N. Transfer of licensed materials within the facility may require special procedures to ensure proper control. In many facilities, pieces of laboratory equipment or components including refrigerators and freezers will become contaminated. Removal of these items for maintenance, repair, or disposal should also be carefully controlled. Licensees must maintain records of receipt, transfer, and disposal (as waste) of all licensed material. Table 8.5 below lists each type of record and how long the record must be maintained. Other records such as transfer records could be linked to radioactive material inventory records. Receipt records should also document cases where excessive radiation levels or radioactive contamination were found on packages or containers of material received and describe the action taken. Table 8.5 Record Maintenance
Receipt, transfer, and disposal records typically contain the following information:
See the section on "Waste Disposal" for additional information.
Response from Applicant:
AND
OR
Note:
Reference: 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 20.1501, 10 CFR 20.1502, 10 CFR 20.1201, 10 CFR 20.1202, 10 CFR 20.1203, 10 CFR 20.1204, 10 CFR 20.1207, 10 CFR 20.1208, 10 CFR 20.1703, 10 CFR 20.2105, 10 CFR 20.2206, 10 CFR 20 Appendix B. Criteria: The use of individual monitoring devices for external dose is required for:
Internal exposure monitoring (not necessarily individual monitoring devices) is required for:
Figure 8.8 Annual Dose Limits for Occupationally Exposed Individuals. Discussion:
According to 10 CFR 20.1502, if an adult (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), monitoring for occupational exposure is required. The licensee should perform an evaluation of the dose the individual is likely to receive prior to allowing the individual to receive the dose. This evaluation need not be made for every individual; evaluations can be made for employees with similar job functions or work areas. Further guidance on evaluating the need to provide monitoring is provided in Regulatory Guide 8.34, "Monitoring Criteria and Methods to Calculate Occupational Doses," dated July 1992. If this prospective evaluation shows that the individual's dose is not likely to exceed 10% of any applicable regulatory limit, there are no recordkeeping or reporting requirements. For individuals who have received doses at other facilities in the current year, the previous dose need not be considered in this prospective evaluation. When determining the need for monitoring, only a dose that could be received at the facilities of the applicant or licensee performing the evaluation needs to be considered, including any recordkeeping and reporting requirements. If an evaluation determined that monitoring was not required and a subsequent evaluation indicates that the 10% regulatory threshold may or will be exceeded, the dose received by an individual when monitoring was not provided should be estimated, recorded, and reported (if required). 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. 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 (TLDs film, ring badge, etc.) provided by a National Voluntary Laboratory Accreditation Program (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. 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 the NRC's web site <http://www.nrc.gov>. Response from Applicant: Provide either of the following:
OR
Note:
Reference: 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 20.1003, 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 20.2107. Criteria: Licensees must ensure that licensed material will be used, transported, stored, and disposed of in such a way that members of the public will not receive more than 1 mSv (100 mrem) in one year, and the dose in any unrestricted area will not exceed 0.02 mSv (2 mrem) in any one hour, from licensed operations. 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. It does not depend on the area (restricted, controlled, or unrestricted) the individual is in when the dose is received. For guidance about accepted methodologies for determining dose to members of public, please refer to Appendix O. 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 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. 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 needs. For additional guidance regarding monitoring of effluents, refer to the section entitled, "Radiation Safety Program - Surveys." 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 O 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 demonstrate, by measurement or calculation, that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed operation does not exceed the annual limit for members of the public. See Appendix O for examples of methods to demonstrate compliance. 8.10.6 Safe Use of Radionuclides and Emergency ProceduresRegulations: 10 CFR 30.34(e), 10 CFR 20.1101, 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 20.1902-1905, 10 CFR 20.2201-2203, 10 CFR 30.32(i), 10 CFR 30.50, 10 CFR 30.72, 10 CFR 21.21, 10 CFR 19.11(a)(3). Criteria: Licensees are required to do all of the following:
Discussion: Licensees are responsible for the security and safe use of all licensed material from the time it arrives at their facility until it is used, transferred, and/or disposed. Licensees should develop and maintain written procedures to ensure safe use of licensed material, and the procedures should also include operational and administrative guidelines. The written procedures should provide reasonable assurance that only appropriately trained personnel will handle and use licensed material without undue hazard to workers or members of the public. General Safety Procedures The written procedures should include the following elements:
These procedures should include policies for:
Applicants should also develop radioisotope-specific procedures based on the respective hazards associated with the radioisotopes. General safety guidelines are described in Appendix P. Applicants should use these guidelines to develop procedures for the safe use of radioisotopes. Licensees should determine if they have areas that require posting in accordance with 10 CFR 20.1902, unless they meet the exemptions listed in 10 CFR 20.1903. Also, containers of licensed material (including radioactive waste) must be labeled in accordance with 10 CFR 20.1904, unless they meet the exemptions in 10 CFR 20.1905. Security Procedures All licensed materials that are stored in controlled or unrestricted areas must be secured from unauthorized access or removal, so that individuals who are not knowledgeable about radioactive materials can not be exposed to or contaminated by the material, and can not take the material. When any licensed materials are in use in controlled or unrestricted areas, they must be under constant surveillance so that the radiation worker can prevent others from becoming contaminated by or exposed to the material, or to prevent persons from removing the material from the area. Acceptable methods for securing material will vary from one facility to another. Some alternatives used by licensees include: storage and use of licensed materials only in restricted areas; limiting access to an entire facility or building or portion of the building only to radiation workers; providing storage areas that can be locked to prevent access to the material; and implementing procedures that require a radiation worker to be with "line of sight" of the materials whenever licensed materials are in use. Applicants should develop procedures that clearly state acceptable methods to secure licensed material at their facility. Particular attention may be required to security procedures at facilities which may have unusual needs due to the activities performed, such as hot cells, animal care facilities, and waste processing facilities. Emergency Procedures Accidents and emergencies can happen during any operation with radioisotopes, including their transportation, use, transfer, and disposal. Such incidents can result in contamination or release of material to the environment, and unintended radiation exposure to workers and members of the public. In addition, loss or theft of licensed material, sabotage, fires, floods, etc., can adversely affect the safety of personnel and members of the public. It is therefore necessary to develop written procedures to minimize, as much as possible, the impact of these incidents on personnel, members of the public, and the environment. Applicants who plan to possess quantities of material in excess of the applicable amounts listed in 10 CFR 30.72 Schedule C may also be required to submit an "Emergency Response Plan for Responding to a Release." Applicants should establish written procedures to handle events ranging from a minor spill (see Figure 8.11) to a major accident that may require intervention by outside emergency response personnel. These procedures should include provisions for immediate response, after-hours notification, handling of each type of emergency, equipment, and the appropriate roles of users and the radiation safety staff. Except for minor spills or releases of radioactivity that can be controlled and cleaned up by the user, the licensee staff should have a clear understanding of their role in an emergency with step-by-step instructions and clear direction of whom to contact. Licensees should have readily available a sufficient number of appropriate and calibrated survey instruments. Emergency spill kits should be strategically placed in well-marked locations for use by all users and the radiation safety staff. All equipment should be periodically inspected for proper operation and replenished as necessary. Appendix P includes model emergency procedures. Applicants may adopt these procedures or develop their own incorporating the safety features included in these model procedures. Collection of Bioassay Samples In the event of an emergency where an individual became contaminated and radioactive material was taken into the body through skin absorption or other means, or is suspected of having ingested or inhaled radioactive material, an estimate of the amount of material taken into the body may be required. Frequently, this estimate is made by performing bioassay of the individual. Bioassays may be performed through direct methods such as whole body counting or thyroid counting, where the radioactive material in the body can be directly measured using appropriate instruments. Bioassays may also be performed through indirect means by sampling urine or other excreta from the body, and calculating the intake from the amount of material detected in the samples, the time between suspected intake and sample collection, and knowledge of the rate of excretion of the compound and/or radionuclide from the body. While there are many ways to perform the calculations, including using computer models, the method of calculation is only as good as the quality of the samples and analyses performed. Because a dose estimate may be required, bioassay procedures for a suspected intake may differ from those in a routine bioassay screening program, and your radiation safety program should include procedures and equipment for appropriate sample collection in an emergency. The following items should be considered in developing your procedures:
Response from Applicant: The applicant must state that procedures for safe use, including security of materials, and emergencies have been developed, or will be developed before receipt of licensed material. If an "Emergency Response Plan" is required for your license pursuant to 10 CFR 30.32(i), submit it as a separate part of the application. If you want the option to make changes in the procedures, submit a statement that "Procedures may be revised only if 1) the changes are reviewed and approved by the licensee management and the RSO in writing; 2) the licensee staff is provided training in the revised procedures prior to implementation; 3) the changes are in compliance with the NRC regulations and the license; and 4) the changes do not degrade the effectiveness of the program." 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. NRC requires testing to determine whether there is any radioactive leakage from sealed sources. Records of surveys and leak tests results must be maintained. Discussion: Surveys are evaluations of radiological conditions and potential hazards (See Figure 8.12). 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. Figure 8.12 Types of Surveys. There are many different types of surveys performed by ARDL licensees. Radiation surveys are used to detect and evaluate contamination of:
Surveys are also used to plan work in areas where licensed material or radiation exists and to evaluate doses to workers and individual members of the public. 10 CFR 20.1501 states that surveys are required when it is reasonable under the circumstances to evaluate a radiological hazard and when necessary for the licensee to comply with the regulations. Many different types of surveys may need to be performed due to the particular use of licensed materials. The most important are as follows:
The frequency of routine surveys depends on the nature, quantity, and use of radioactive materials, as well as the specific protective facilities, equipment, and procedures that are designed to protect the worker from external and internal exposure. Also, the frequency of the survey depends on the type of survey, such as those listed above. (See Appendix Q) 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. 10 CFR Part 20 does not specify limits for surface contamination. Each applicant should propose and justify what removable surface contamination limits will be allowable before decontamination will be performed in each work area. Table Q.5 and Table Q.6 in Appendix Q contain contamination limits that are acceptable to NRC. Sealed Source and Plated Foil Leak Test When issued, a license will require performance of leak tests of sealed and plated foil sources (e.g., GC/XRF) at intervals as approved by NRC or an Agreement State and specified by the SSD Registration Certificate. The measurement of the leak-test sample is a quantitative analysis requiring that instrumentation used to analyze the sample be capable of detecting 185 Bq (0.005 μCi) of the radioisotope contained in the source or foil. 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 sealed source or plated foil manufacturer's (distributor's) and the kit supplier's instructions and return it to the kit supplier for evaluation and reporting results. Leak test samples should be collected at the most accessible area where contamination would accumulate if the sealed source were leaking. Licensees may also be authorized to conduct the entire leak test sequence themselves. Leak tests are not required if:
For more information regarding leak tests, see Appendix R. Response from Applicant: Choose one of the following:
OR
OR
Note:
References: See the Notice of Availability on inside front cover of this report to obtain a copy of Draft Regulatory Guide FC 412-4, "Guide for the Preparation of Applications for the Use of Radioactive Materials in Leak-Testing Services," dated June 1985. 8.10.8 TransportationRegulations: 10 CFR 71.5, 10 CFR 71.12, 10 CFR 71.13, 10 CFR 71.14, 71.47, 71.87, 49 CFR Parts 171-178, 10 CFR 20.1101, 10 CFR 30.41, 10 CFR 30.51. Criteria: Applicants who will transport or ship licensed material, including radioactive waste, must develop, implement, and maintain safety programs for transport of radioactive material to ensure compliance with NRC and U.S. Department of Transportation (DOT) regulations. Discussion: Packages shipped by ARDL licensees frequently meet the "Limited Quantity" criteria as described in 49 CFR 173.421, and therefore could be exempt from certain DOT requirements, but they may be subject to other, less restrictive DOT requirements (e.g., 49 CFR 173.422 and 173.424; also see Appendix S for more information). If they are not exempted, however, licensed material, including radioactive waste, must be packaged and transported in accordance with NRC and the DOT requirements if the transportation involves common carriers or the use of public highways. Licensees should develop and maintain their own radiation safety procedures for transporting licensed material within their own facilities if it does not involve the use of public highways. Licensees should consider the safety of all individuals who may handle or may come into contact with the packages containing licensed material. Therefore, the primary considerations in packaging licensed material should be to ensure that the package integrity is not compromised during transport, and that the radiation levels (including removable contamination levels) at the package surfaces not only meet the regulatory requirements of 10 CFR 71.47, but are ALARA.
Licensees shipping radioactive waste for disposal must prepare appropriate documentation as specified in 10 CFR 20, Appendix G. Response from Applicant: No response is needed from applicants during the licensing phase. Transportation issues are reviewed during inspections. References: "A Review of Department of Transportation Regulations for Transportation of Radioactive Materials (1983 revision)" can be obtained be calling DOT's Office of Hazardous Material Initiatives and Training at (202) 366-4425. 8.10.9 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 SS&D Registration Certificates usually pose little risk of contamination. Leak tests performed as specified in the SS&D 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." 8.11 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, 10 CFR 61.52. Criteria: Radioactive waste must be disposed of in accordance with regulatory requirements and license conditions. Appropriate records of waste disposal must be maintained. Discussion: Radioactive waste is normally generated when conducting licensed activities. Such waste may include used or unused radioactive material, unusable items contaminated with radioactive material, e.g., absorbent paper, gloves, etc. Licensees may not receive radioactive waste from other licensees for processing, storage or disposal, unless specifically authorized to do so by NRC. All radioactive waste must be stored in appropriate containers until its disposal and the integrity of the waste containers must be assured. Radioactive waste containers must be appropriately labeled. All radioactive waste must be secured against unauthorized access or removal. NRC requires ARDL licensees to manage radioactive waste generated at their facilities by one or more of the following methods:
Licensees may chose any one or more of these methods to dispose of their radioactive waste. It has been NRC's experience that most of the ARDL facilities store or dispose of radioactive waste by a combination of the first four methods, because of the types and amounts of licensed materials used by these facilities. Applicants wanting 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 note that compliance with NRC regulations does not relieve them of their responsibility to comply with any other applicable Federal, state, or local regulations. Furthermore, some of the radioactive waste may also include additional hazards, (e.g., biohazard or chemical hazard). Such waste is called "mixed waste," and its storage and disposal must also comply with all other applicable Federal, state, and local regulatory requirements. Applicants should describe their program for management and disposal of radioactive waste. The program should include procedures for handling of waste, safe and secure storage, characterization, minimization, and disposal of radioactive waste. Appropriate training should be provided to waste handlers. Regulations require that licensees maintain all appropriate records of disposal of radioactive waste. The U.S. Environmental Protection Agency (EPA) issued guidance for developing a comprehensive program to reduce hazardous waste that, in many instances, may also include 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 are appropriate for 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. Applicants should assure that adequate space and facilities are available for the storage of such waste. Licensees can minimize the need for storage space, if the waste is segregated according to physical half-life. Waste containing radioisotopes of physical half-lives within a certain range may be stored in one container and allowed to decay for at least ten half-lives of the longest-lived radioisotope in the container. Procedures for management of such waste should include methods of segregation, 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. Additionally, a model procedure for disposal of radioactive waste by DIS, which incorporates the above guidelines, is provided in Appendix T. 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 sludges may be required to be disposed of as radioactive waste, using one of the methods described in Section 8.11 of this document. 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 T. Transfer to an Authorized Recipient Licensees may transfer radioactive waste to an authorized recipient for disposal. It is the licensee's responsibility to verify that the intended recipient is authorized to receive the radioactive waste prior to making any shipment. Almost all radioactive waste generated at ARDL facilities consists of low specific activity (LSA) material. The 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. 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: Provide a statement that: "We will use the model waste procedures published in Appendix T to NUREG-1556, Vol. 7, 'Program-Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope,' dated December 1999." OR If the applicant wishes to use only selected model procedures, provide a statement that "We will use the (specify either (1) Decay-In-Storage, or (2) Disposal of Liquids Into Sanitary Sewerage) model waste procedures that are published in Appendix T to NUREG-1556, Vol. 7, 'Program-Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope,' dated December 1999." OR Provide procedures for waste collection, storage and disposal by any of the authorized methods described in this section. Applicants should contact appropriate Regional Office of the NRC for guidance to obtain approval of any method(s) of waste disposal other than those discussed in this section. OR If access to a radioactive waste burial site is unavailable, the applicant should request authorization for extended interim storage of waste. Applicant should refer to NRC IN 90-09, "Extended Interim Storage of Low-Level Radioactive Waste by Fuel Cycle and Materials Licensees," dated February 1990, for guidance and submit the required information with the application. Note: Applicants do not need to provide information to NRC if they plan to dispose of LLW via transfer to an authorized recipient or to dispose of liquid scintillation media or animals containing low levels of H-3 or C-14 as authorized by 10 CFR 20.2005. 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 at <http://www.nrc.gov>. Additional References:
8.12 Item 12: Fees[ Prev | Next | Top of file ] The next two items on NRC Form 313 are to be completed on the form itself. On NRC Form 313, enter the appropriate fee category from 10 CFR 170.31 and the amount of the fee enclosed with the application. 8.13 Item 13: Certification[ Prev | Next | Top of file ] 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 should do the following:
10 Applications for Exemptions[ Prev | Next | Top of file ] Regulations: 10 CFR 19.31 10 CFR 20.2301, 10 CFR 30.11. Criteria: Licensees who request exemptions to regulations must demonstrate that the exemption is authorized by law, that it will not endanger life or property or the common defense and security, and that it is otherwise in the public interest. Discussion: Various sections of NRC's regulations address requests for exemptions (e.g., 10 CFR 19.31, 10 CFR 20.2301, 10 CFR 30.11(a)). These regulations state that NRC may grant an exemption, acting on its own initiative or on an application from an interested person.
Exemptions are not intended to revise regulations, are not intended for large classes of licenses, and are generally limited to unique situations. Exemption requests must be accompanied by descriptions of the following:
As an example, exemptions to certain regulations are necessary when teletherapy-type units are converted from human use to use for the irradiation of materials or objects. See NUREG-1556, Vol. 6, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance About 10 CFR Part 36 Irradiators," for more information about this special case. Reference: See the Notice of Availability on the inside cover of this report to obtain copies of NUREG-1556, Vol. 6, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about 10 CFR Part 36 Irradiators." 11 Termination of Activities[ Prev | Next | Top of file ] Regulations: 10 CFR 20.1402, 10 CFR 20.1403, 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). Criteria: The licensee must do the following:
Discussion: As noted in several instances discussed 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. For guidance on the disposition of licensed material, see the section on "Waste Management." For guidance on decommissioning records, see the section on "Radioactive Materials - Financial Assurance and Record Keeping for Decommissioning." Response from Applicant: The applicant's obligations in this matter begin when the license expires or at the time the licensee ceases operations, whichever is earlier. These obligations are to undertake the necessary decommissioning activities, to submit NRC Form 314 or equivalent information, and to perform any other actions as summarized in the Criteria. Reference: Copies of NRC Form 314, "Certificate of Disposition of Materials," are available upon request from NRC's Regional or Field 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 ] 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 Regulatory Guides (RG) 10.2 and 10.7. In addition, this report references other RGs, Policy and Guidance Directives (P&GD), Information Notices (IN), Inspection Procedure (IP), and Technical Assistance Requests (TAR) used in its preparation. The guidance incorporated and referenced is listed in Table A.1. Table A.1 List of Documents Considered in the Preparation of this Report
Appendix B: United States Nuclear Regulatory Commission Form 313[ Prev | Next | Top of file ] United States Nuclear Regulatory Commission Form 313 Appendix C: Suggested Format for Providing Information Requested in Items 5 through 11 of NRC Form 313[ Prev | Next | Top of file ] Suggested Format for Providing Information Requested in Items 5 through 11 of NRC Form 313[ Prev | Next | Top of file ] The table below is designed to help applicants develop their applications. In some instances it is acceptable to simply indicate, by checking the box in the third column (Yes), that applicant commits to adopting the model procedures that are referenced. If the third column contains an asterisk (*), the licensee is expected to describe its program or submit its procedures for the particular item. In this instance, the applicant is requested to check the box in the fourth column indicating that the described program and/or procedures are attached to the application (NRC Form 313). If the third column contains an "N/A," the licensee is not required to describe or submit its programs and/or procedures during the licensing phase. However, these program areas may be reviewed during an inspection.
Appendix D: Gas Chromatography Devices and X-ray Fluorescence Analyzer Applications[ Prev | Next | Top of file ] Gas Chromatography Devices and X-ray Fluorescence Analyzer Applications[ Prev | Next | Top of file ] This appendix is designed either to assist the applicant with obtaining a separate license for a gas chromatograph (GC) and/or an X-RAY fluorescence analyzer (XRF) or to be used as part of a license application that may contain other requested radioisotopes and proposed uses. Regulations[ Prev | Next | Top of file ] Licensees are subject to all applicable provisions of the regulations in 10 CFR Parts 20, 21, 30, 71, 170 as they pertain to GC and XRFs. Information for completing Items 1 through 4 of the application have already been provided in this NUREG. Additional information for Item 3 is requested below. Item 3: Address(es) Where Licensed Material Will Be Used or PossessedSpecify 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 or stored. A Post Office Box address is not acceptable. In addition, state whether GC/XRFs will be used at temporary jobsites. Item 5: Material To Be Possessed
Item 6: Purpose for Which Licensed Material Will Be UsedSpecify the purpose for which each GC/XRF will be used.
Item 7: Individual(s) Responsible for Radiation Safety Program and Their Training and Experience - Radiation Safety OfficerProvide the name of the person(s) who will be responsible for the GCs/ XRFs. That person(s) will be specifically named on the license. If no repair or maintenance on the GC/XRFs is proposed by the applicant, then no specific training and experience in the use and handling of radioactive materials is necessary for individuals who will use the device(s) or supervise its use. No special training or experience is needed to perform leak tests using a leak-test kit or to clean detector cells used in GC devices, provided the source or foil is not removed from the detector cell. If the applicant proposes to perform any operations that involve removal of sources containing radioactive material from the device or maintenance and repair of a device that involves the source, then they must ensure a "responsible individual" performs these operations. The responsible individual shall have received instruction and training in the principles and practices of radiation safety, the use of radiation detection instruments, and the performance of these operations. Such training may normally be accomplished in 1 or 2 days. In the application, provide the following information:
Item 8: Training Provided to Other UsersPersons who will only use a GC or XRF under the supervision of the responsible individual named in Item 7 need no special training and their names do not need to be submitted. These supervised individuals should not be permitted to perform any maintenance or repair operations. Only responsible individuals specifically named in Item 7 shall perform such operations. Item 9: Facilities and Equipment10 CFR 30.33(a)(2) states that an application will be approved if the applicant's proposed equipment and facilities are adequate to protect health and to minimize danger to life or property. 10 CFR 20.1801 and 20.1802 also state that licensed material stored in an unrestricted area must be secured from unauthorized removal, and licensed materials in an unrestricted area and not in storage must be under the constant surveillance and immediate control of the licensee. The room, laboratory, or storage area in which the device is located should be (1) accessible only to persons authorized to use the device and (2) locked when an authorized person is not physically present. The application should state that the laboratory or area will be locked or secured when an authorized person is not present. The room, laboratory, or storage area cannot be considered a restricted area if it is accessible to unauthorized persons. Item 10: Radiation Safety Program10.1 Audit Program Licensees must review the content and implementation of their radiation protection programs annually, to ensure compliance with NRC regulations and with the terms and conditions of the license. Appendix J contains a suggested audit program that is acceptable to NRC. All areas indicated in Appendix J may not be applicable to every licensee and may not need to be addressed during each audit. 10.2 Radiation Detection Instruments
If maintenance and repair operations are proposed as described in Item 7, and the operations involve the sealed source, provide information about what surveys will be performed, what type of survey meter will be used for conducting surveys, the range of the survey instrument, and calibration information including frequency of calibration. It is not necessary to specify the manufacturer and model number of the survey meter. For more information on survey meters, see "Radiation Safety Program - Instruments," in the main body of this NUREG. 10.3 Material Receipt and Accountability Licensees are required to maintain records of receipt, transfer, and disposal of licensed material. Loss, theft, or misplacement of licensed material can occur; therefore control and accountability of GC/XRFs must be ensured. Licensees who use and/or possess sealed sources are required by license conditions to perform inventories of sealed sources every six months (see sample license, condition no. 16). Some sealed sources may not be in use or are rarely used and are placed in storage. In these cases, licensees should confirm that these sealed sources have not been disturbed at least every 6 months. 10.4 Personnel Monitoring Equipment Personnel monitoring devices are not required for the following:
If proposed uses of GC/XRFs include the maintenance and repair operations described in Item 7, and these operations involve sealed sources other than in gaseous form or Ni-63, an evaluation for personnel monitoring devices is required for persons performing these operations. The application should indicate that maintenance and/or repair personnel will be provided with either film badges or thermoluminescence dosimeters (TLDs) for use while performing service operations or provide a dose evaluation which indicates that personnel will not be required to wear monitoring devices. 10.5 Leak-Testing NRC requires testing to determine whether there is any radioactive leakage from sealed/plated foil sources. Records of surveys and leak tests results must be maintained. When issued, a license will require performance of leak tests of sealed/plated foil sources at intervals as approved by NRC or an Agreement State and specified by the SSD Registration Certificate. The measurement of the leak-test sample is a quantitative analysis requiring that instrumentation used to analyze the sample be capable of detecting 185 Bq (0.005 μCi) of radioactivity. Manufacturers, consultants, and other organizations may be authorized by NRC or an Agreement State either to perform the entire leak test sequence for other licensees or to provide leak test kits to licensees. In the latter case, the licensee is expected to take the leak test sample according to the sealed source or plated foil manufacturer's (distributor's) and the kit supplier's instructions and return it to the kit supplier for evaluation and reporting results. Leak test samples should be collected at the most accessible area where contamination would accumulate if the sealed source were leaking. Licensees may also be authorized to conduct the entire leak test sequence themselves. For more information about leak testing sealed/plated foil sources, see "Radiation Safety Program - Surveys," in the main body of this NUREG. 10.6 Maintenance and Repair If authorization has been requested to perform maintenance and repair operations as stated in Item 7, then state in the application that the written procedures provided by the device manufacturer will be followed for each such operation requested. If a procedure will be followed other than that provided by the device manufacturer, submit a proposed procedure to use for each operation requested. 10.7 Transportation If authorization has been requested in the application to use GC/XRFs at a temporary jobsite, the applicant must take into consideration DOT regulations, particularly blocking and bracing the device containing licensed material. The applicant is not required to submit transportation information with the application. 10.8 Minimization of contamination New license applicants are required by 10 CFR 20.1406 to describe how facility design and procedures for operation will minimize, to the extent practicable, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the extent practicable, the generation of radioactive waste. Item 11: Waste ManagementBecause of the nature of the licensed material contained in GC/XRF devices, the usual disposal option is to transfer the licensed material to an authorized recipient. State in the application that disposal will be by transfer of the radioactive material to a licensee specifically authorized to possess it, or provide information for an alternate method of disposal for NRC review. Authorized recipients are the original supplier of the device, a commercial firm licensed by NRC or an Agreement State to accept radioactive waste from other persons, or another specific licensee authorized to possess the licensed material. No one else is authorized to receive licensed material. Suggested Format for Providing Information Requested in Items 1 through 4 of NRC Form 313[ Prev | Next | Top of file ] D.1 Item 1: Action Type
D.2 Item 2: Legal Identity
D.3 Items 2 & 3: Address
D.4 Item 4: Person To Be Contacted About this Application
Suggested Format for Providing Information Requested in Items 5 through 11 of NRC Form 313[ Prev | Next | Top of file ] D.5 Items 5 & 6: Materials To Be Possessed and Proposed Uses
D.6 Items 7 through 11: Training and Experience, Facilities and Equipment, Radiation Safety Program, and Waste Disposal
Form 374[ Prev | Next | Top of file ] Appendix E: Information Needed for Transfer of Control Application[ Prev | Next | Top of file ] Information Needed for Transfer of Control Application[ Prev | Next | Top of file ] Licensees must provide full information and obtain NRC's prior written consent before transferring control of the license; some licensees refer to this as "transferring the license." Provide the following information concerning changes of control by the applicant (transferor and/or transferee, as appropriate). If any items are not applicable, so state.
Reference: See the Notice of Availability on the inside front cover of this report to obtain copies. Information Notice 89-25, Revision 1, "Unauthorized Transfer of Ownership or Control of Licensed Activities." Appendix F: Sample License[ Prev | Next | Top of file ] Sample License[ Prev | Next | Top of file ] A sample license appears on the following pages. Form 374 Appendix G: Guidance on Decommissioning Funding Plan and Financial Assurance[ Prev | Next | Top of file ] Table G.1 and the worksheet in Table G.2 are used to determine the need for certification of financial assurance (F/A) for decommissioning or a decommissioning funding plan (DFP), as required by 10 CFR 30.35. Table G.1 is a listing of isotopes with a half-life of greater than or equal to 120 days. If the applicant proposes to use isotopes with a half-life greater than or equal to 120 days, divide the requested possession limit (in µCi)(3) of the isotope by the value for that isotope in Table G.1. If the material requested is in an unsealed form, use the value in the unsealed column. If the material requested is in an sealed form, use the value in the sealed column. Place the fraction in the proper column in worksheet G.2. Add the fractions in the column and place the total in the row labeled total (i.e., "sum of the ratios"). Table G.1 Isotopes with Half-Lives Greater Than or Equal to 120 Days[ Prev | Next | Top of file ]
Table G.2 Sample Worksheet for Determining Need for a Decommissioning Funding Plan or Financial Assurance[ Prev | Next | Top of file ]
If the sum of the fractions is less than or equal to 1, the applicant does not need to submit certification of F/A or a DFP. If the sum of the fractions is greater than 1 but less than or equal to 100, the applicant will need to submit certification of F/A (in the amount shown above) or a DFP. If the sum of the fractions is greater than 100, the applicant must submit a DFP. "Criteria Relating to Use of Financial Tests and Parent Company Guarantees for Providing Reasonable Assurance of Funds for Decommissioning" can be found in 10 CFR 30, Appendix A. "Criteria Relating to Use of Financial Tests and Self Guarantees for Providing Reasonable Assurance of Funds for Decommissioning" can be found in 10 CFR 30, Appendix C. Regulatory Guide 3.66, "Standard Format and Content of Financial Assurance Mechanisms Required for Decommissioning Under 10 CFR Parts 30, 40, 70, and 72," dated June 1990, provides sample documents for financial mechanisms. Reference: See the Notice of Availability (on inside front cover of this report) to obtain copies of Regulatory Guide 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. Appendix H: Considerations for Laboratory Animal and Veterinary Medicine Uses[ Prev | Next | Top of file ] Considerations for Laboratory Animal and Veterinary Medicine Uses[ Prev | Next | Top of file ] This Appendix provides additional information on the use of byproduct materials in laboratory animals, in animals used for research in the environment, and by veterinarians. Laboratory Animals[ Prev | Next | Top of file ] TrainingBefore allowing an individual to care for animals used in studies with or treated with licensed material, the Radiation Safety Officer (RSO), Authorized User (AU), and/or veterinarian must ensure that he or she has sufficient training and experience to maintain doses ALARA, control contamination, handle waste appropriately, etc. Classroom training may be in the form of lecture, videotape, or self-study and should cover the following subject areas:
Appropriate on-the-job-training should consist of:
Contamination Control and Waste Handling[ Prev | Next | Top of file ] In order to minimize the spread of contamination, animals used in studies with or treated with licensed material should be housed in cages or stalls separate from other animals. The facilities, stalls, or cages shall be secured to prevent unauthorized access to the animals. Individuals caring for these animals should reduce the chance of personal contamination by wearing gloves, lab coat, and eye protection, as appropriate. Special care should be observed when cleaning the cage or stall. The cage or stall, the bedding, and waste from the animal may contain radioactive material. Any radioactive material should be properly disposed of as described in Section 8.11, "Waste Management." Disposal of laboratory animals that contain radioactive material require special procedures. Animal carcasses that contain less than 1.85 kBq/gram (0.05 microcuries/gram) of carbon-14 or hydrogen-3 may be disposed of by the same method as non-radioactive animal carcasses. Animal carcasses that contain byproduct material with a half-life of less than 120 days may be allowed to decay-in-storage in a freezer dedicated for radioactive material. Animal carcasses must be held for a minimum of 10 half-lives of the longest lived isotope. After 10 half-lives, the animal carcasses may be disposed as non-radioactive, if radiation surveys (performed in a low background area and without any interposed shielding) of the carcasses at the end of the holding period indicate that radiation levels are indistinguishable from background (See section 8.11, "Waste Management"). Animals Used for Research in the Environment[ Prev | Next | Top of file ] Before a researcher releases an animal that has been injected with a radiopharmaceutical or has had radioactive seeds implanted, the researcher will ensure that the dose that members of the public will receive from the animal is within limits of 10 CFR 20.1301. 10 CFR 20.1301 requires that the total effective dose equivalent to an individual member of the public from the licensed operation does not exceed 1 mSv (0.1 rem) in a year and that the dose in any unrestricted area from external sources does not exceed 0.02 mSv (0.002 rem) in any one hour. Further, the researcher may be required to perform an assessment of the impact the byproduct material will have on the environment (See section "Purpose(s) for Which Licensed Material Will Be Used"). Veterinary UseTraining NRC believes that to demonstrate adequate training and experience, the veterinarian should have training and experience commensurate with the scope of proposed activities. Training should include the following subjects:
The length of the training (usually 40 hours) will depend upon the type, form, quantity and proposed use of the licensed material requested, but training shall cover the subjects stated. Contamination Control and Waste HandlingSee above section, "Laboratory Animals." Release of Animals Before a veterinarian releases an animal that has been injected with a radiopharmaceutical or has had radioactive seeds implanted, the veterinarian must ensure that the dose that members of the public (including the animal's caretaker) will receive from the animal is within limits of 10 CFR 20.1301. 10 CFR 20.1301 requires that the total effective dose equivalent to an individual member of the public from the licensed operation does not exceed 1 mSv (0.1 rem) in a year and the dose in any unrestricted area from external sources does not exceed 0.02 mSv (0.002 rem) in any one hour. Furthermore, licensees should provide instructions to the animal's caretaker to keep doses ALARA. Instructions to Animal Caretaker Upon Release The instructions should be specific to the type of treatment given, such as permanent implants or radioiodine for hyperthyroidism or thyroid carcinoma, and they may include additional information for individual situations. The instructions should not, however, interfere with or contradict the best medical judgment of the veterinarian. The instructions should include the name of a knowledgeable person to contact and that person's telephone number, in case the caretaker has any questions. Additional instructions appropriate for each modality, as shown in examples below, may be provided. Sample Instructions to Caretakers of Animals Administered Radiopharmaceuticals or Other Unsealed Materials Radiopharmaceutical instructions, to the caretaker, should include the following topics:
Example Radiopharmaceutical Instructions The animal has been treated with radioactive material (isotope) and still possesses a low level of radioactivity. The present level of radioactivity is below the regulatory agency level necessary for isolating the animal from humans. Because some radioactivity will be present for the next few days, it is necessary that the following safety precautions be exercised for the next days: 1. The animal should be kept inside or in his cage/stall following hospital discharge. 2. The animal should not be permitted to have prolonged contact with children under the age of 12 for days following hospital discharge. Close contact should be limited to less than minutes per day. 3. Pregnant women should avoid ANY contact with the animal or its urine and/or feces for at least days after discharge. 4. Family members should not be permitted to sleep with the animal for days after discharge. They also should limit close contact with the animal (being within 1 meter or 3 feet of the animal) for the next day(s) to no more than minutes a day. Preferably, contact with the animal should be kept to a distance of more than 1 meter or 3 feet for this period. 5. Use a plastic litter pan liners and a scoopable litter (for cats). 6. Disposable gloves should be worn whenever changing the litter box for the next days after discharge. 7. Wash hands after contact with the animal or the litter. 8. Call to discuss any other radiation safety concerns. Sample Instructions to Caretakers of Animals Implanted with Sealed Sources A small radioactive source has been placed (implanted) inside the animal. The source is actually many small metallic pellets or seeds, which are each about 1/4" to 1/3" long, similar in size and shape to a grain of rice. The following precautions should be taken for days, to minimize exposure to radiation to humans from the source inside the animal:
If a seed or pellet has fallen out, do the following:
Appendix I: Radiation Safety Officer Duties and Responsibilities[ Prev | Next | Top of file ] The RSO's duties and responsibilities include ensuring radiological safety and compliance with NRC and DOT regulations and the conditions of the license; see Figure 8.1. Typically, these duties and responsibilities include the following:
Appendix J: Radiation Safety Training Topics[ Prev | Next | Top of file ] This Appendix is intended only as a guide for developing a training program. Individuals working with radioisotopes may not require training on every topic provided. For example, housekeeping staff may need to know only what symbols to look for, which waste cans to empty, or which areas to enter or avoid. Conversely, laboratory technicians may require detailed information on particular topics. As a result, instruction for some individuals may be provided by providing a simple hand-out, whereas others may require extensive training, including a written exam to assess retention of the topics presented. Frequency of Training[ Prev | Next | Top of file ] A. Before assuming duties with, or in the vicinity of, radioactive materials B. Whenever there is a significant change in duties, regulations, or the terms of the license C. Annually (refresher training). General Information[ Prev | Next | Top of file ] A. Radiation safety
B. Regulatory requirements
Licensee-Specific Program Elements[ Prev | Next | Top of file ] A. Authorized users and supervised users. B. Ordering and receiving radioisotopes. C. Applicable regulations and license conditions. D. Areas where radioactive material is used or stored. E. Potential hazards associated with radioactive material in each area where the individuals will work. F. Appropriate radiation safety procedures. G. Licensee's in-house work rules. (For instructions on laboratory safety and uses of radioisotopes, see Section IV.) H. Each individual's obligation to report unsafe conditions to the RSO. I. Appropriate response to spills, emergencies or other unsafe conditions. J. Worker's right to be informed of occupational radiation exposure and bioassay results, if applicable. K. Locations where the licensee has posted or made available: notices, copies of pertinent regulations, and copies of pertinent licenses and license conditions (including applications and applicable correspondence), as required by 10 CFR Part 19. L. Emergency procedures:
M. Survey program:
N. Waste
O. Dosimetry
P. Instrumentation
Q. Procedures for receiving packages containing radioactive materials.
R. Procedures for opening and examining packages
S. Animal experiments
T. Sealed sources
U. Other topics, as applicable V. Question and answer period. For Laboratory Safety and Use of Radioisotopes[ Prev | Next | Top of file ] A. Control procedures for obtaining permission to use radioactive materials at the facility; give limitations on quantity to be handled per user, allowed per experiment, etc. B. Protective clothing and what laboratory apparel to wear and what equipment to use. C. Limitations and conditions relative to handling unsealed licensed material and what laboratory equipment to use when working with such material. As an example, discuss which licensed materials and what procedures should be confined to radiochemical fume hoods or gloveboxes. Explain what shielding or remote handling equipment is to be used when beta and/or gamma emitting licensed materials are handled. D. Routine survey and monitoring procedures to be followed for contamination control. Include where and how contaminated articles and glassware are to be handled and stored. E. Emergency procedures concerning spills, fires, release of material, and/or accidental contamination of personnel. F. Decontamination procedures to use and whom to contact in case of an emergency. G. Instructions concerning transfer of licensed materials between rooms, halls, or corridors, if applicable. H. Requirements for storage, labeling of containers, and identification of areas where licensed materials are used. I. Personnel monitoring devices to use, where to obtain them, and exchange procedures and exposure results. J. Waste disposal procedures to follow, limitations for disposal of liquid or solid wastes, and procedures to use for waste storage. If program involves experiments with animals, procedures for cleaning animal quarters and handling animal excreta and carcasses for disposal. K. Records to be maintained on use and disposal of licensed materials. L. Prohibition of pipetting by mouth, eating, smoking, and drinking in areas where licensed materials are used. Appendix K: Facilities and Equipment Considerations[ Prev | Next | Top of file ] Below is a list of topics that should be considered when developing a description of the facilities and equipment that an ARDL licensee will use or otherwise have available. Not every ARDL applicant will need to address each topic in its application.
Chemical-type fume hoods provide a working area with controlled inward airflow from the room to the hood exhaust system. Hoods are used for gases, for unsealed volatile licensed materials, and for processes such as evaporation that may release gases and vapors. Fume hoods provide emergency ventilation and exhaust for unplanned releases, such as accidental spills and ruptures, as well as routine exhaust of effluents. Filters may be required in the exhaust stream unless monitoring and/or calculations demonstrate that any planned or likely effluent will be in accordance with the limits found in 10 CFR 20, Appendix B. Glove boxes are sealed boxes with transparent viewing windows, sealable ports or doors for transferring materials and equipment, and gloves sealed to the box through which licensed materials are handled. Glove boxes are used for the containment during storage and use of liquids and solids that can become airborne particulates or aerosols. Glove boxes can be closed or exhausted, with filtration systems if appropriate, to prevent contamination.
Appendix L: Sample Audit Program[ Prev | Next | Top of file ] Sample Audit Program[ Prev | Next | Top of file ] An audit is conducted, in part, to fulfill the requirements of 10 CFR 20.1101 for an annual review of the content and implementation of the licensee's radiation protection program. It should also identify program weaknesses and allow licensees to take early corrective actions (before an NRC inspection). During an audit, the auditor needs to keep in mind not only the requirements of NRC's regulations, but also the licensee's commitments in its applications and other correspondence with NRC. The auditor should also evaluate whether the licensee is maintaining exposures to workers and the general public as low as is reasonably achievable (ALARA) and, if not, make suggestions for improvement. The form in this Appendix can be used to document the annual audit of the radiation protection program. Guidance follows on completing each section of the form. In the "remarks" portions of the form, note any deficiencies that were identified and the corrective actions taken (or to be taken). Section 1, Audit History. Enter the date of the last audit, whether any deficiencies were identified, and whether actions were taken to correct the deficiencies. Section 2, Organization and Scope of Program. Give a brief description of the organizational structure, noting any changes in personnel. Describe the scope of licensed activities at the audited location. Check whether the Radiation Safety Officer (RSO) is the person identified in the license and fulfills the duties specified in the license. Section 3, Training, Retraining, and Instructions to Workers. Ensure that workers have received the training required by 10 CFR 19.12. Be sure that, before being permitted to use byproduct material, the user has received training and has a copy of the licensee's safe use and emergency procedures. Note whether refresher training is conducted in accordance with licensee commitments. Ensure that each worker has a copy of the licensee's procedures, and by interview and/or observation of selected workers that he/she can implement them. Section 4, Audits. Verify that audits fulfill the requirements of 10 CFR 20.1101, are conducted in accordance with licensee commitments, and are properly documented. Section 5, Facilities. Verify that the licensee's facilities are as described in its license documents. Section 6, Materials. Verify that the license authorizes the quantities and types of byproduct material that the licensee possesses. Section 7, Leak Tests. Verify that all sealed/plated foil sources are tested for leakage at the prescribed frequency and in accordance with licensee commitments. Records of results should be maintained. Section 8, Inventories. Verify that inventories are conducted at least once every 6 months to account for all sources; inventory records should be maintained. Section 9, Radiation Surveys. Verify that the licensee has appropriate, operable and calibrated survey instruments available, that the instruments are calibrated (at the required frequency) in accordance with license conditions and in accordance with 10 CFR 20.2103. Calibration records must be retained for 3 years after the record is made. Check that radiation levels in areas adjacent to use are within regulatory limits and in accordance with 10 CFR 20.2103. Verify compliance with 10 CFR 20.1301. Records of surveys must be retained for 3 years after the record is made. Section 10, Receipt and Transfer of Radioactive Material (Includes Waste Disposal). Verify that packages containing byproduct material, received from others, are received, opened, and surveyed in accordance with 10 CFR 20.1906. Ensure that transfers are performed in accordance with 10 CFR 30.41. Records of surveys, receipt, and transfer must be maintained in accordance with 10 CFR 20.2103 and 30.51. Section 11, Transportation. Determine compliance with Department of Transportation (DOT) requirements. Verify that radioactive packages are prepared, marked, and labeled in accordance with 49 CFR Parts 172 and 173 requirements. Verify that shipping papers are prepared, that they contain all needed information, and that they are readily accessible during transport (49 CFR 172.200, 201, 202, 203, 204 and 177.718). Section 12, Personnel Radiation Protection. Evaluate the licensee's determination that unmonitored personnel are not likely to receive more than 10 percent of the allowable limits. Alternately, if personnel dosimetry is provided and required, verify that it complies with 10 CFR 20.1501(c) and licensee commitments. Review personnel monitoring records; compare exposures of individuals doing similar work; determine reasons for significant differences in exposures. If any worker declared her pregnancy in writing, evaluate the licensee's compliance with 10 CFR 20.1208. Check whether records are maintained as required by 10 CFR 20.2101, 2102, 2103, 2104 and 2106. Section 13, Auditor's Independent Measurements (If Made). The auditor should make independent survey measurements and compare the results with those made or used by the licensee. Section 14, Notification and Reports. Check on the licensee's compliance with the notification and reporting requirements in 10 CFR Parts 19, 20, and 30. Ensure that the licensee is aware of the telephone number for NRC's Emergency Operations Center; (301) 816-5100. Section 15, Posting and Labeling. Check for compliance with the posting and labeling requirements of 10 CFR 19.11, 20.1902, 20.1904, and 21.6. Section 16, Recordkeeping for Decommissioning. Check to determine compliance with 10 CFR 30.35(g). Section 17, Bulletins and Information Notices. Check to determine if the licensee is receiving bulletins, information notices, NMSS Newsletters, etc., from NRC. Check whether the licensee took appropriate action in response to NRC mailings. Section 18, Special License Conditions or Issues. Verify compliance with any special conditions on the licensee's license. If the licensee has any unusual aspect of its work, review and evaluate compliance with regulatory requirements. Section 19, Continuation of Report Items. This section is self-explanatory. Section 20, Problems or Deficiencies Noted; Recommendations. This section is self-explanatory. Section 21, Evaluation of Other Factors. Evaluate licensee management's involvement with the radiation safety program, whether the RSO has sufficient time to perform his/her duties, and whether the licensee has sufficient staff to handle the workload and maintain compliance with regulatory requirements. Note: All areas indicated in audit notes may not be applicable to every license and may not need to be addressed during each audit. Sample Checklist[ Prev | Next | Top of file ]
Appendix M: Radiation Monitoring Instrument Specifications and Model Survey Instrument and Air Sampler Calibration Program[ Prev | Next | Top of file ] Radiation Monitoring Instrument Specifications[ Prev | Next | Top of file ] The specifications in Table M.1 will help applicants and licensees choose the proper radiation detection equipment for monitoring the radiological conditions at their facility(ies). Table M.1 Typical Survey Instruments1 (Instruments used to measure radiological conditions at licensed facilities.)
Model Instrument Calibration Program[ Prev | Next | Top of file ] TrainingBefore allowing an individual to perform survey instrument calibrations, the RSO will ensure that he or she has sufficient training and experience to perform independent survey instrument calibrations. Classroom training may be in the form of lecture, videotape, or self-study and will cover the following subject areas:
Appropriate on-the-job-training consists of the following:
Facilities and Equipment for Calibration of Dose Rate or Exposure Rate Instruments[ Prev | Next | Top of file ]
Model Procedure for Calibrating Survey InstrumentsA radioactive sealed source(s) used for calibrating survey instruments will:
The three kinds of scales frequently used on dose or dose rate survey meters are calibrated as follows2:
Surface Contamination Measurement Instruments(5)
Model Procedures for Calibrating Liquid Scintillation Counters, Gamma Counters, Gas Flow Proportional Counters, and Multichannel Analyzers[ Prev | Next | Top of file ] A radioactive sealed source used for calibrating instruments will do the following:
Calibration
Calibration RecordsCalibration records, for all survey instruments, will should indicate the procedure used and the data obtained. The description of the calibration will should include:
The following information should be attached to the instrument as a calibration sticker or tag:
Air Sampler CalibrationIn order to assess accurately the air concentration of radioactive materials in a given location, the volume of air sampled and the quantity of contaminant in the sample must be determined. Accurate determination of the volume of air sampled requires standard, reproducible, and periodic calibration of the air metering devices that are used with air sampling instruments. The publication entitled "Air Sampling Instruments" found in the 7th Edition, American Conference of Governmental Industrial Hygienists, 1989, provides guidance on total air sample volume calibration methods acceptable to NRC staff, as supplemented below. Frequency of Calibration
Error Limit for Measurement of Air Sample VolumeMost methods of calibrating airflow or air volume metering devices require direct comparison to a primary or secondary standard instrument, to determine a calibration curve or a correction factor. An example of a primary standard is a spirometer that measures total air volume directly with high precision by liquid displacement. An example of a secondary standard is a wet-test meter that has been calibrated against a primary standard. Primary standards are usually accurate to within � 1% and secondary standards to within � 2%. The following are significant errors associated with determining the total air volume sampled:
The most probable value of the cumulative error E A sample calculation of the most probable value of the cumulative error in total volume measured is as follows: If accuracies of the scale reading, the calibration factor, and sample time are � 4, 2, and 1 per cent, respectively, and there are no other significant sources of error, the cumulative error would be: E If there are significant differences in pressure and temperature between the calibration site and the sampling site, appropriate corrections should be made using the ideal gas laws provided below: Vs = V1 * (P1/760) * (273/T1)
Documentation of Calibration of Air Metering DevicesThe licensee should maintain records of all routine and special calibrations of airflow or volume metering devices, including the primary or secondary standard used, method employed, and estimates of accuracy of the calibrated metering devices. All instruments should be clearly labeled as to the date and results of the most recent calibration and should include the appropriate correction factors to be used. References: See the Notice of Availability on the inside front cover of this report to obtain a copy of: 1. Regulatory Guide 8.25, Revision 1, "Air Sampling in the Workplace." 2. NUREG-1400, "Air Sampling in the Workplace" Additional References: 3. The Health Physics & Radiological Health Handbook, Revised Edition, Edited by Bernard Shleien, 4. 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> 5. "Air Sampling Instruments," American Conference of Governmental Industrial Hygienists, 1987 Appendix N: Material Receipt and Accountability[ Prev | Next | Top of file ] Material Receipt and Accountability[ Prev | Next | Top of file ] Sample Model Procedure for Ordering and Receiving Radioactive Material
Sample MemorandumMemorandum for Security Personnel From: RSO, President, Vice President, etc. Subject: Procedures for Receipt of Packages Containing Radioactive Material If the package appears to be damaged, immediately contact the RSO. Ask the carrier to remain at the facility until it can be determined that neither the carrier nor the vehicle is contaminated. Any packages containing radioactive material that arrive between (state times, e.g., 4:30 p.m. and 7:00 a.m. or on Saturdays or Sundays) shall be signed for by the security guard (or other designated trained individual) on duty and taken immediately to the designated receiving area. Security personnel (or other designated trained individual) should unlock the door, place the package in the designated secured storage area and re-lock the door. Radiation Safety Officer (RSO): _________________________________________ Office Phone: _______________________________________________________ Home Phone: ________________________________________________________ Sample Instructions to Personnel Involved in Material Receipt[ Prev | Next | Top of file ] Shipping and Receiving PersonnelDuring normal working hours, immediately upon receipt of any package of licensed material, each package must be visually inspected for any signs of shipping damage such as crushed or punctured containers or signs of dampness. Any obvious damage must be reported to the RSO immediately. Do not touch any package suspected of leaking. Request the person delivering the package to remain until monitored by the RSO. Outside of normal working hours (e.g., nights, weekends, and holidays), deliveries will usually be handled by security personnel (or other trained individuals) as described in the above procedures. Since certain packages of licensed material will have detectable external radiation, they should be sent immediately to a designated storage area, where they will be checked for contamination and external radiation level as soon as practical. They should not be allowed to remain in the receiving area any longer than necessary, as they may be a source of exposure for receiving personnel. If the instructions are not clear, or if there are questions regarding receiving packages containing radioactive material, please contact: Name _______________________________________________________ Phone _______________________________________________________
Sample Model Procedure for Safely Opening Packages Containing Licensed Materials[ Prev | Next | Top of file ] For packages received under the specific license, authorized individuals shall implement procedures for opening each package, as follows:
Sample Transfer Policy Statements[ Prev | Next | Top of file ] Internal TransfersLicensed materials that may be transferred from one department or laboratory or AU's control to another should have prior approval from the RSO. A written transfer procedure should be developed by the RSO to ensure that transfers are done in accordance with the conditions of the license. All transfers shall be done in a way that minimizes the probability of spillage or breakage. Double containers should be used, including suitable shielding, for such transfers. External TransfersLicensed material shall not be transferred or shipped from one institution to another without the approval of the RSO. Such transfers/shipments must be packaged and labeled in accordance with DOT, NRC, or U.S. Postal Service Regulations, whichever is applicable. GiftsOn occasion, licensees may be offered or have donated licensed materials by other individuals as gifts (e.g., a retiring medical practitioner donating his cesium needles to the university medical center). All such gifts of radioactive materials must be transferred to the licensee and handled in accordance with NRC requirements and the conditions of the license. In any case, the RSO should approve the gift before the transfer. Appendix O: Public Dose[ Prev | Next | Top of file ] Public Dose[ Prev | Next | Top of file ] This appendix describes methods for determining radiation doses to members of the public. Licensees must ensure that:
The licensee may show compliance with the annual dose limit for individual members of the public by:
In order to perform a dose assessment, licensees should identify all potential sources of external and internal radiation exposure to members of the public and all locations of use, transport, and storage of radioactive material at their facilities. Licensees must then take radiation measurements or perform calculations to demonstrate compliance. Measurements[ Prev | Next | Top of file ] The licensee may use measurements to demonstrate that the average annual releases are within regulatory limits, as well as to demonstrate that the TEDE to the individual likely to receive the highest dose at the boundary of the unrestricted area does not exceed 1 mSv (100 mrem). These measurements may include
The method used to measure dose will depend 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[ Prev | Next | Top of file ] Using a calculation method, the licensee must determine the highest dose an individual is likely to receive at the boundary of the unrestricted area. The licensee must take into account the individual's exposure from external sources and the concentration of radionuclides in gaseous and liquid releases. In practice, the licensee may wish to make conservative assumptions to simplify the dose calculation. The public dose limit applies to the individual who is likely to receive the highest dose from licensed operations. Therefore, the dose calculations must consider the location with the potential for the highest internal and external exposures. 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 K.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 K.1 or may calculate a specific occupancy factor by determining the likely fraction of time that the individual is present. Table O.1 Standard Occupancy Factors
Records[ Prev | Next | Top of file ] The licensee must maintain records to demonstrate compliance with the dose limit for individual members of the public until the Commission terminates the license. In general, survey and monitoring records of ambient radiation and effluent radioactivity should be adequate. Records demonstrating the dose to an individual member of the public should identify the instruments used in the survey, the name of the surveyor, the date of the survey, the location of the survey(s) including a description or drawing of the area surveyed, survey results, and if applicable, the occupancy factors used and justification for their use. In addition, records demonstrating the dose to an individual member of the public that involve effluent sampling analysis should include information on concentrations of specific radionuclides, minimum detectable activity of the system and the estimated uncertainty of measurements. Appendix P: General Topics for Safe Use of Radioisotopes and Model Emergency Procedures[ Prev | Next | Top of file ] General Topics for Safe Use of Radioisotopes and Model Emergency Procedures[ Prev | Next | Top of file ] General Topics for Safe Use of RadioisotopesEach laboratory or area where radioactive material is used or stored should have general rules, so that workers know what is required. Typical instructions should include
Radionuclides-Specific ProceduresLicensees should develop written procedures for use of different radionuclides so that users know the types of shielding, protective clothing, survey instruments, surveys, and decontamination activities that are required. Examples of such procedures are included below. Example 1: If requesting more than 37 MBq (1 µCi) of iodine-125 or iodine-131, special safety instructions should be provided to users, including the following:
Example 2: If requesting more than 37 MBq (1 µCi) of phosphorus-32, special safety instructions should be provided to users, including the following:
Model Procedures for Handling Emergencies[ Prev | Next | Top of file ] Appropriate first aid and other immediate medical needs of injured individuals should not be neglected, delayed, or ignored due to suspected contamination. General Safety Procedures to Handle Spills[ Prev | Next | Top of file ] Name and telephone number of RSO or an alternate person(s) should be posted conspicuously in areas of use, so that it is readily available to workers in case of emergencies. Licensee should have emergency equipment readily available for handling spills. Spill kits should include the following:
Minor Spills of Liquids and Solids
Major Spills of Liquids and Solids
Incidents Involving Radioactive Dusts, Mists, Fumes, Organic Vapors, and Gases
Minor Fires
Fires, Explosions, or Major Emergencies
Appendix Q: Radiation Safety Survey Topics[ Prev | Next | Top of file ] Radiation Safety Survey Topics[ Prev | Next | Top of file ] This Appendix provides applicants and licensees with additional information on surveys, including training requirements, survey frequency, contamination limits, and bioassays. Training[ Prev | Next | Top of file ] Before allowing an individual to perform surveys, the RSO will ensure that he or she has sufficient training and experience to perform surveys independently. Academic training may be in the form of lecture, videotape, or self-study and will cover the following subject areas:
Appropriate on-the-job training consists of the following:
Facilities and Equipment[ Prev | Next | Top of file ]
Ambient Radiation Level Surveys[ Prev | Next | Top of file ]
The frequency of ambient surveys depends 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. While the regulations do not specify a specific survey frequency, the licensee is required to ensure that the dose rate limits are not exceeded. Contamination Surveys[ Prev | Next | Top of file ] Licensees' contamination surveys should be sufficient to identify areas of contamination that might result in doses to workers or to the public. Combined removable and fixed contamination should be surveyed using appropriate radiation detection equipment. Removable contamination can be detected and measured through a wipe test of the surface, which is counted in an appropriate counting instrument, such as a liquid scintillation counter, a sodium iodide or germanium gamma counter, or a proportional alpha/beta counter. Contamination surveys should be performed:
Contamination Survey Frequency[ Prev | Next | Top of file ] Personnel should survey for contamination in locations where individuals are working with an unsealed form of radioactive material. These surveys should be done 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 annual limit on intake (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 Q.1 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 it 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 Q.1 Suggested Contamination Survey Frequency
Contamination in Unrestricted Areas[ Prev | Next | Top of file ] Contamination found in unrestricted areas should be immediately decontaminated to background levels. When it is not possible to get to background levels, the licensee must ensure that the amounts do not exceed the contamination levels listed in Table Q.2. Table Q.2 Acceptable Surface Contamination Levels for Equipment
When equipment or facilities that are potentially contaminated are to be released for unrestricted use, Table Q.2 provides the maximum acceptable residual levels for equipment and Table Q.3 provides screening values for building surface contamination. To the extent practicable, it is appropriate to decontaminate to below these levels. Surface contamination surveys should be conducted for both removable and fixed contamination before these facilities or equipment are released from restricted to unrestricted use to ensure that they meet these limits. A standardized method for smear testing of a relatively uniform area should be used to aid in comparing contamination at different times and places. A smear taken from an area of about 100 cm2 is acceptable to indicate levels of removable contamination. Table Q.3 Screening Values for Building Surface Contamination1
Table Q.3 does not include screening values for radionuclides that emit alpha particles, or for soil contamination. The NRC staff is assessing current screening approaches for sites with alpha emitters and for soil contamination. For such sites, licensees are encouraged to use, in the interim period, site-specific dose assessment based on actual site physical and environmental conditions. Units are disintegrations per minute per 100 square centimeters (dpm/100 cm2). 1 dpm is equivalent to 0.0167 becquerel (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 Guidance DG-4006 for further information on application of the values in this table. Table Q.3 was derived using the DandD screening code, Version 1, and its default input parameters. Table Q.3 provides criteria that permit licensees to demonstrate compliance with the unrestricted release dose criterion in the License Termination Rule. The values correspond to screening "derived concentration guidelines" for each specific radionuclide based on the methodology described in Draft Regulatory Guide DG-4006, "Demonstrating Compliance with the Radiological Criteria for License Termination," dated August 1998. Sites with building surface contamination levels below those listed in Table Q.3 would be deemed acceptable for release for unrestricted use in accordance with the dose criteria in 10 CFR 20.1402, provided that residual radioactivity has been reduced to ALARA levels. The table is intended for use as criteria to facilitate license termination for many simple routine decommissioning cases without a site-specific dose assessment. For facilities with contamination levels above those in Table Q.3, additional site-specific dose assessments may be necessary, and licensees should refer to DG-4006 regarding acceptable methods for conducting the appropriate dose assessment. The DandD code can be installed by downloading the self-extracting program file, setup.exe, accessed through the Web site <http://techconf.llnl.gov/radcri/java.html>. DG-4006, NUREG-1549, "Decision Methods for Dose Assessment to Comply with Radiological Criteria for License Termination," dated July 1998, and NUREG/CR-5512, Vol. 3, "Residual Radioactive Contamination from Decommissioning, Parameter Analysis," dated April 25, 1996, can also be accessed through the above Web site. Survey Record Requirements[ Prev | Next | Top of file ] Each survey record should include the following:
Licensees should record contamination levels observed and procedures followed for incidents involving contamination of individuals. The record should include names of individuals involved, description of work activities, calculated dose, probable causes (including root causes), steps taken to reduce future incidents of contamination, times and dates, and the surveyor's signature. Figure Q.1 Laboratory Layout. This is an example of a laboratory survey map. Air Monitoring in the Workplace[ Prev | Next | Top of file ] Air sampling can be used to do the following:
If bioassay measurements are used to determine worker doses of record, air sampling may be used to determine time of intake and to determine which workers should have bioassay measurements. The use of engineering controls and a good air sampling program may eliminate need for bioassays. Refer to Regulatory Guide 8.25, Revision 1, "Air Sampling in the Workplace," dated June 1992 and NUREG-1400, "Air Sampling in the Workplace," dated September 1993 for further guidance on the air sampling. Airborne Effluent Release Monitoring[ Prev | Next | Top of file ] When practicable, airborne radioactive effluents should be released from monitored release points (e.g., monitored stacks, discharges, vents) to provide accurate measurements to estimate public exposure. Licensees should verify the performance of effluent monitoring systems by regular calibration (at least annually) to ensure their reliability. Regulatory Guide 4.20, "Constraints on Release of Airborne Radioactive Materials to the Environment for Licensees Other Than Power Reactors," dated December 1996, provides guidance on methods acceptable (calculation or COMPLY code) to NRC for compliance with the constraint on air emissions to the environment. Regulatory Guide 8.37, "ALARA Levels for Effluents from Materials Facilities," dated July 1993, provides guidance on designing an acceptable program for establishing and maintaining ALARA levels for gaseous and liquid effluents at materials facilities. For release points for which monitoring is not practicable, the licensee should estimate the magnitude of the unmonitored effluents. These unmonitored releases will occur any time unsealed material is handled outside a fume hood or other device that will control the releases. The licensee should include these estimates when demonstrating compliance with dose limits and ALARA goals. Unmonitored releases may be estimated based on the quantity of material used in these areas or the number of procedures performed or other appropriate methods. The unmonitored effluents should not exceed 30 percent of the total estimated effluent releases or 10 percent 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), "Guide to Sampling Airborne Radioactive Materials in Nuclear Facilities," and ANSI N42.18, "Specification and Performance of On-Site Instrumentation for Continuously Monitoring Radioactive Effluents." Liquid Effluent Release Monitoring[ Prev | Next | Top of file ] The licensee should evaluate the concentrations of radioactive material in water that is released to the environment and to the sanitary sewer. The licensee must show that these releases meet the limits in 10 CFR 20. 1301 and 20.2003, respectively. The topic of sanitary sewerage releases is more fully discussed in Appendix T. Bioassay Monitoring[ Prev | Next | Top of file ] Frequency of Required Bioassay MeasurementsDetermining the appropriate frequency of routine bioassay measurements depends upon the exposure potential and the physical and chemical characteristics of the radioactive material and the route of entry to the body. Consider the following elements:
Bioassay measurements used for demonstrating compliance with the occupational dose limits should be conducted often enough to identify and quantify potential exposures and resultant intakes that, during any year, are likely to collectively exceed 0.1 times the ALI. The 10 percent ALI criterion is consistent with 10 CFR 20.1502(b), which requires licensees to monitor intakes and assess occupational doses for exposed individuals who are likely to exceed 10 percent of the applicable limit (i.e., intakes likely to exceed 0.1 ALI for adults). Separate categories of bioassay measurements, routine measurements, and special measurements further determine the frequency and scope of measurements. Routine MeasurementsRoutine measurements include baseline measurements, periodic measurements, and termination measurements. These measurements should be conducted to confirm that appropriate controls exist and to assess dose. The method of bioassay selected (for example, whole body counting, urinalysis, etc.) and the samples collected will vary according to the radionuclide and the compound to which it is attached. Sample collection procedures should be developed to ensure that appropriate types, sizes, and numbers of samples are collected that will provide appropriate physiological information for the dose assessment. An individual's baseline measurement of radioactive material within the body should be conducted before beginning work that involves exposure to radiation or radioactive materials for which monitoring is required. In addition to the baseline measurements, periodic bioassay measurements should be performed. The frequency of periodic measurements should be based on the likelihood of significant exposure of the individual. In determining the worker's likely exposure, consider such information as the worker's access, work practices, measured levels of airborne radioactive material, and exposure time. Periodic measurements should be made when the cumulative exposure to airborne radioactivity, since the most recent bioassay measurement, is > 0.02 ALI (40 DAC hours). Noble gases and airborne particulates with a radioactive half-life of less than 2 hours should be excluded from the evaluation, since external exposure generally controls these radionuclides. At a minimum, periodic measurements should be conducted annually. Periodic measurements provide additional information on any long-term accumulation and retention of radioactive material in the body, especially for exposures to concentrations of airborne radioactive material below monitoring thresholds. When an individual is no longer subject to the bioassay program, because of change in employment status, termination bioassay measurement should be made, when practicable, to ensure that any unknown intakes are quantified. Special MonitoringBecause of uncertainty in the time of intakes and the absence of other data related to the exposure (e.g., physical and chemical forms, exposure duration), correlating positive results to actual intakes for routine measurements can sometimes be difficult. Abnormal and inadvertent intakes from situations such as a failed respiratory protective device, inadequate engineering controls, inadvertent ingestion, contamination of a wound, or skin absorption, should be evaluated on a case-by-case basis. When determining whether potential intakes should be evaluated, consider the following circumstances:
References: See the Notice of Availability on the inside front cover of this report to obtain a copy of:
Appendix R: Model Leak Test Procedures[ Prev | Next | Top of file ] Model Leak Test Procedures[ Prev | Next | Top of file ] This appendix provides applicants and licensees with model leak test procedures and sample calculations for determining activity on a wipe test sample. Frequency for Conducting Leak Tests of Sealed Sources[ Prev | Next | Top of file ] Leak tests will be conducted at the frequency specified in the respective SSD Registration Certificate. Procedure for Performing Leak Testing and Analysis[ Prev | Next | Top of file ] For each source to be tested, list identifying information such as manufacturer, model number, serial number, radionuclides, and activity.
Appendix S: Transportation[ Prev | Next | Top of file ] Part 1: Major DOT Regulations[ Prev | Next | Top of file ] TransportationThe 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: Sample Shipping Documents, Placards, and Labels[ Prev | Next | Top of file ] Hazard Communications for Class 7 (Radioactive) MaterialsDOT Shipping Papers (49 CFR 172.200-205) Marking Packages (49 CFR 172.300-338) Labeling Packages (49 CFR 172.400-450) Placarding Vehicles (49 CFR 172.500-560) Minimum Required Packaging for Class 7 (Radioactive) Materials Package and Vehicle Contamination Limits (49 CFR 173.443) Example Certificate Enclosed in or on Package, Included with the Packing List, or Otherwise Forwarded with the Package
Appendix T: Model Waste Management Procedures[ Prev | Next | Top of file ] Model Waste Management Procedures[ Prev | Next | Top of file ] General Guidelines
Model Procedure for Disposal by Decay-in-Storage (DIS)
Model Procedure for Disposal of Liquids into Sanitary Sewerage
Appendix U: Using the Internet To Obtain Copies of NRC Documents and Other Information[ Prev | Next | Top of file ] Using the Internet To Obtain Copies of NRC Documents and Other Information[ Prev | Next | Top of file ] In an effort to make NRC documents and information readily available to licensees and the general public, NRC is placing documents and information on its Internet Web site. Many of the reference sections of this NUREG refer to a Web address on the Internet (e.g., <http://www.nrc.gov>). Applicants and licensees who have Internet access may use the referenced address to find more information on a topic, the referenced document, or information on obtaining the referenced document. To access the referenced site, type the address into the location box of the Internet browser software and press the enter key. Sometimes the given address does not go directly to the necessary page; however, the addressed page will have links to the information referenced in this NUREG. Generally, links appear either as blue text or as a picture in the document. To use a link, place the pointer on the blue text or picture. The pointer will change from an arrow to a hand with the index finger extended. By double-clicking the mouse on the blue text or picture, the Internet browser will go to the selected page. For example, if you wanted to review the definitions in 10 CFR Part 20, type <http://www.nrc.gov> in the location box of your browser and press the enter key. After the NRC home page comes up, place the pointer on the reference library icon. The arrow will change to a hand with the index finger extended. Double-click the pointing device button. Next, place the pointer on the blue text, "Title 10 of the Code of Federal Regulations" and double-click the mouse. Place the pointer on the blue text "20" and double-click. Finally, place the pointer on the blue text "Definitions" and double-click. Appendix V: Addendum: Response to Comments on NUREG-1556, Vol. 7[ Prev | Next | Top of file ] Addendum: Response to Comments on NUREG-1556, Vol. 7[ Prev | Top of file ] Comments from: State of Illinois, Department of Nuclear Safety, received on September 22, 1998
[ Top of file ] 1. See "Amendments and Renewals to a License" later in this document. Licensees are required to request and obtain an amendment to the license before making changes in their radiation safety program. Examples of changes that require amendment are change of radiation safety officer (RSO), changes in approved radiation safety procedures, addition 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. 1 curie = 37 gigabecquerels 4. Many solid waste disposal facilities have installed radiation detectors, at the entrance, to prevent the disposal of byproduct material at landfills. If the detectors indicate that there is radioactive material in the waste truck, the waste disposal facility staff or a contractor must search the truck and remove the radioactive material, which is a costly and time-consuming process. Although it is proper to dispose of animal excreta in a landfill, caretakers should consider storing animal excreta in a remote location to allow the radioactive material to decay. If applicable, caretakers should contact the veterinarian for further information about the length of time that animal excreta should be held for decay. 5. ANSI N323A-1997, "Radiation Protection Instrumentation Test and Calibration." 6. The calibration factor should be based on two kinds of determinations. First, correction factors should be determined at several flow rates distributed over the full-scale range. Each flow rate correction factor should be determined while adjusting flow rates upscale and again while adjusting flow rates downscale, and the two sets of data should be compared. Second, subsequent calibrations should compare the new correction factors to those determined during the previous calibration. If observed differences are significant compared to the overall volume error limit of 20 percent, an additional error term should be included in the calculation above. |
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