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Program-Specific Guidance About Possession Licenses for Manufacturing and Distribution - Final Report (NUREG-1556, Vol. 12)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. Table of Contents
Publication Information[ Next | Top of file ] Manuscript Completed: December 2000 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 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. 12, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Possession Licenses for Manufacturing and Distribution," dated December 2000, is the twelfth program-specific guidance developed for the new process and is intended for use by applicants, licensees, and NRC staff, and will also be available to Agreement States. This document combines and updates the guidance found in: (1) 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; (2) NMSS Policy and Guidance Directive FC 84-1, "Review Responsibility - Manufacturing and Distribution of Products to Persons Exempt Pursuant to 10 CFR 32.11 through 32.26," dated April 1984; (3) NMSS Policy and Guidance Directive FC 85-6, "Standard Review Plan for Applications for Licenses and Approvals to Authorize Distribution of Various Items to Group Medical Licensees," dated February 1985; and (4) Draft Regulatory Guide DG-0007, "Guide for the Preparation of Applications for Licenses to Authorize Distribution of Various Items to Commercial Nuclear Pharmacies and Medical Use Licensees," dated March 1997. This report takes a more risk-informed, performance-based approach to licensing possession and reduces the amount of detailed information needed to support an application. If a license of broad scope is being sought (under 10 CFR 33, "Specific Domestic Licenses of Broad Scope for Byproduct Material"), also refer to another document in this series, NUREG-1556, Vol. 11, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope." When published, this final report should be used in preparing manufacturing and distribution license applications. NRC staff will use this final report in reviewing these applications. Figures[ Prev | Next | Top of file ] Figure 8.1 Location of Possession or Possession and Use Figure 8.2 Financial Assurance for Decommissioning Figure 8.3 Records Important to Decommissioning Figure 8.4 Regulation Wheel for Byproduct Material Figure 8.6 RSO Responsibilities Figure 8.7 Facility Diagram for a Radiography Source Manufacturer Figure 8.8 Shielded Protective Enclosure (Hot Cell) With Remote Manipulator Figure 8.9 Examples of Portable Instruments Used in Laboratory Settings Figure 8.10 Material Receipt and Accountability Figure 8.11 Annual Dose Limits for Occupationally Exposed Adults Figure 8.12 Calculating Public Dose Figure 8.13 Use of Appropriate Shielding Figure 8.14 Proper Handling of Incident Figure 8.17 Air and water effluents from manufacturing facility Figure N.1 Storage of Food and Drink Foreword[ Prev | Next | Top of file ] NRC is using Business Process Redesign (BPR) techniques to redesign its materials licensing process. This effort is described in NUREG-1539, "Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated April 1996. A critical element of the new process is the consolidation and updating of numerous guidance documents into a NUREG-series of reports. Below is a list of volumes currently included in the NUREG-1556 series, "Consolidated Guidance About Materials Licenses":
The current document, NUREG-1556, Vol. 12, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Possession Licenses for Manufacturing and Distribution," dated December 2000, is the twelfth 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 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; NMSS Policy and Guidance Directive FC 84-1, "Review Responsibility - Manufacturing and Distribution of Products to Persons Exempt Pursuant to 10 CFR 32.11 through 32.26," dated April 1984; NMSS Policy and Guidance Directive FC 85-6, "Standard Review Plan for Applications for Licenses and Approvals to Authorize Distribution of Various Items to Group Medical Licensees," dated February 1985; and Draft Regulatory Guide DG-0007, "Guide for the Preparation of Applications for Licenses to Authorize Distribution of Various Items to Commercial Nuclear Pharmacies and Medical Use Licensees," dated March 1997. This report also contains pertinent information found in Information Notices and other documents, as listed in Appendix A. This report takes a risk-informed, performance-based approach to licensing possession for manufacturing and distribution. It reduces the amount of information needed from an applicant seeking to possess and use byproduct, source, and/or special nuclear materials for activities associated with possession for manufacturing, and/or distribution to specific licensees and distribution to medical use licensees. A team composed of NRC staff from Headquarters and Regional Offices drafted this document, drawing on their collective experience in radiation safety in general, and as specifically applied to licensing of possession for manufacturing and distribution. A representative of NRC's Office of the General Counsel provided a legal perspective. NUREG-1556, Vol. 12, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Possession Licenses for Manufacturing and Distribution," dated December 2000, 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/NRC/NUREGS/SR1556/V12/index.html>. NUREG-1556, Vol. 12, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Possession Licenses for Manufacturing and Distribution," dated December 2000, is not a substitute for NRC regulations, and compliance is not required. The approaches and methods described in this report are provided for information. Methods and solutions different from those described in this report will be acceptable if they provide a basis for the staff to make the determination needed to issue or continue a license. If a license of broad scope is being sought (under 10 CFR 33, "Specific Domestic Licenses of Broad Scope for Byproduct Material"), also refer to another document in this series, NUREG-1556, Vol. 11, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope." _______________________________________ Donald A. Cool, Director Acknowledgments[ Prev | Next | Top of file ] The writing team thanks the individuals listed below for assisting in the development and review of the report. All participants provided valuable insights, observations, and recommendations. The Participants[ Prev | Next | Top of file ] Cain, Charles L. The team also thanks Nora Azzi, Dianne Geshen, Rolonda Jackson, Tamra King, and Agi Seaton of Computer Sciences Corporation. Abbreviations[ Prev | Next | Top of file ]
1 Purpose of Report[ Prev | Next | Top of file ] This report provides guidance on three types of licenses associated with the manufacturing and distribution of radioactive materials and products containing radioactive materials. It provides guidance to an applicant in preparing a license application for one of these license types: possession for manufacturing and distribution; possession for distribution only and for distribution (only) for medical use, as well as NRC criteria for evaluating the license application. The body of this document contains the standard requirements and guidance for the first two types of licenses: (1) possession and use for manufacturing, including distribution of products to other specific licensees authorized to receive the products; and (2) possession for distribution only (which requires a separate distribution license). Appendix U of this document contains the standard requirements and guidance for the third type of materials licenses for the distribution (only) and transfer of radioactive drugs, sealed sources, and devices directly to medical use licensees. Note that this guidance does not apply to those quantities of special nuclear material exceeding those listed in 10 CFR 70.22 (h)(2)(i)(1). For the purpose of this NUREG, materials manufacturers are those licensees that process raw material and/or sources and distribute those processed materials or manufactured products to users as finished products. Examples are: major radiopharmaceutical processor/manufacturers (not radiopharmacies); sealed source fabricators; device manufacturers; and other manufacturing licensees that possess and use irradiated bulk quantities of raw materials or sources. As noted above, this NUREG also applies to licensing for distribution to specific licensees and to medical use licensees. Guidance for obtaining licenses for distribution to general licensees and for distribution of items to persons exempt from license requirements is supplied in other NUREGs in this series. Distribution-only licensees are not involved in the processing of raw materials or sources, nor in the manufacturing of devices. Distributors also include importers for purposes of distribution. Quality control for finished products is part of the manufacturer licensee's responsibilities. These obligations are described in the regulations of 10 CFR Part 32. Quality control of finished products to be distributed to general licensees or individuals exempt from licenses are listed in NUREG-1556, Vol. 16 and NUREG-1556, Vol. 8, respectively. This report identifies the information needed to complete NRC Form 313 (Appendix B), "Application for Material License," for the possession and use of byproduct, source, and/or special nuclear materials for manufacturing and distribution, and for distribution (only) for medical use. If a license of broad scope is being sought (under 10 CFR 33, "Specific Domestic Licenses of Broad Scope for Byproduct Material"), also refer to another document in this series, NUREG-1556, Vol. 11, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope." The information collection requirements in 10 CFR Part 30, Part 32, Part 40, Part 70, and NRC Form 313 have been approved under the Office of Management and Budget (OMB) Clearance Nos. 3150-0017, 3150-0001, 3150-0020, 3150-0009, and 3150-0120, respectively. The format within this document for each item of technical information is:
Notes and References are self-explanatory and may not be found for each item on NRC Form 313. NRC Form 313 does not have sufficient space for applicants to provide full responses to Items 5 through 11; the answers to those items are to be provided on separate sheets of paper and submitted with the completed NRC Form 313. For convenience and for streamlined handling of possession for manufacturing and distribution applications, applicants may use Appendix C, "Suggested Format For Providing Information Requested In Items 5 through 11 of NRC Form 313," to provide supporting information to NRC. Appendices D through U contain additional information on various radiation safety topics. Appendix D has sample possession for manufacturing and distribution licenses; it contains the conditions most often found on these licenses, although not all licenses will have all conditions. Appendix F provides information on the types of licenses. Appendix U provides guidance in applying for distribution (only) to medical use licensees. In this document, dose or radiation dose means absorbed dose, 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. Roentgen equivalent man (rem), and its SI (Système International) equivalent, sievert (Sv) (0.01 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 rads or roentgens (R). 2 Agreement States[ Prev | Next | Top of file ] Certain states, called Agreement States (see Figure 2.1), have entered into agreements with NRC that give them the authority to license and inspect byproduct, source, or special nuclear materials used or possessed within their borders. Any applicant, other than a Federal agency, 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. These applications should be filed with State officials, not with NRC. 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 from NRC upon request. All Agreement States Letter, SP-96-022, dated February 16, 1996, is available by calling the Office of State and Tribal Programs (STP). Call NRC's toll free number (800) 368-5642, for extension 415-3340, or visit NRC's Office of State and Tribal Programs' (STP's) home page at <http://www.hsrd.ornl.gov/nrc>. Choose "NRC-State Communications," then choose "Other"; scroll down to find "1996" then "SP-96-022." 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 Offices. You can also visit NRC's Office of State and Tribal Programs' (STP's) home page at <http://www.hsrd.ornl.gov/nrc> and choose "Directories," then "State Program Directors." 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 the current versions of "General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, and Inspection Procedure 87110, Appendix A, "Industrial/Academic/ Research Inspection Record." The current version of NUREG-1600 is available electronically at <http://www.nrc.gov/OE>. To obtain hard copies of the current versions of NUREG-1600 and Inspection Procedure 87110, Appendix A, see the Notice of Availability (on the inside front cover of this report). In addition, Inspection Procedure 87110 can 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 have up-to-date copies of applicable regulations, read them, and abide by each applicable regulation. The following Parts of Title 10, Code of Federal Regulations (CFR), contain regulations applicable to possession for manufacturing and distribution:
To obtain copies of the above documents, contact the GPO electronically at <http://www.gpo.gov> or call GPO's order desk in Washington, DC at (202) 512-1800. Applicants should contact the Customer Service desk of the GPO at (202) 512-1803 for inquiries about costs of these documents and methods of payment. To obtain the two-volume bound version of Title 10, Code of Federal Regulations (10 CFR), Parts 0-50 and 51-199, contact the GPO, Superintendent of Documents, Post Office Box 371954, Pittsburgh, Pennsylvania 15250-7954. Single copies of the above documents may also be obtained from NRC's Regional or Field Office (see Figure 2.1 for addresses and telephone numbers). Note that amendments to NRC regulations are published frequently (monthly) in the Federal Register. In addition, the Federal Register is available at <http://www.gpo.gov>. Title 10 is also available 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 On-line Public Document Room. 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 to this document, NRC's new licensing process
will eventually become faster and more efficient, in part, through accepting
and processing electronic applications. In the meantime, NRC will continue
to accept paper applications, which will be scanned and converted to electronic
format. To ensure a smooth conversion, applicants are requested to follow
these suggestions:
5.2 Electronic Application[ Prev | Next | Top of file ] In the future, as the electronic licensing process develops, it is anticipated that NRC will provide mechanisms for filing electronic applications on diskette, compact disc with read-only memory (CD-ROM), or via the Internet. NRC will provide additional filing instructions as these new mechanisms become available. The existing paper process will continue to be used until the electronic process is 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 identifies Agreement States and shows NRC's four Regional Offices and their respective areas for licensing purposes. In general, applicants wishing to possess or use licensed material in Agreement States must file an application with the Agreement State, not NRC. However, if licensed materials will be possessed or used at Federally-controlled sites in Agreement States, applicants must first determine the jurisdictional status of the land in order to determine whether NRC or the Agreement State has regulatory authority. See Section 2, 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. If applying for both a possession and use license and a Medical Distribution license, fees should be included for both licensing actions. Refer to 10 CFR 170.31 to determine the amount of the fee. NRC will not issue the new license prior to fee receipt. Consult 10 CFR 170.11 for information on exemptions from these fees. Once technical review has begun, no fees will be refunded; application fees will be charged regardless of NRC's disposition of an application or should an application be withdrawn. Most NRC licensees are also subject to annual fees; refer to 10 CFR 171.16. Consult 10 CFR 171.11 for additional information on exemptions from annual fees and 10 CFR 171.16(c) on reduced annual fees for licensees that qualify as small entities. Direct all questions about NRC's fees or completion of Item 12 of NRC Form 313 (Appendix B) to the Office of the Chief Financial Officer (OCFO) at NRC Headquarters in Rockville, Maryland, (301) 415-7554. You may also call NRC's toll free number (800) 368-5642, 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 for a new license request. Check box B for an amendment(1) to an existing license, and provide license number. Check box C for renewal1 of an existing license, and provide license number. 8.2 Item 2: Applicant's Name and Mailing Address[ Prev | Next | Top of file ] List the legal name of the applicant's corporation or other legal entity with direct control over possession and use of the radioactive material. A division or department within a legal entity may not be a licensee; however, a subsidiary of a larger entity may be a licensee. An individual may be designated as the applicant only if the individual is acting in a private capacity and the possession and use of the radioactive material is not connected with employment in a corporation or other legal entity. Provide the mailing address where correspondence should be sent. A Post Office box number is an acceptable mailing address. Notify NRC of any changes in the mailing address; these changes do not require a fee. Note: NRC must be notified before control of the license is transferred or when bankruptcy proceedings have been initiated. See below for more details. NUREG-1556, Vol. 15, "Consolidated Guidance About Materials Licenses: Guidance About Changes of Control and About Bankruptcy Involving Byproduct, Source, or Special Nuclear Materials Licenses," discusses the potential for the security and control of licensed material to be compromised during periods of organizational instability. Timely Notification of Transfer of Control Regulations: 10 CFR 30.34(b); 10 CFR 40.41(b); 10 CFR 70.32(a)(3). Criteria: Licensees must provide full information and obtain NRC's prior written consent before transferring control of the license, also commonly referred to as "transferring the license." Discussion: Transferring control may be the result of
mergers, buyouts, or majority stock transfers. Although it is not NRC's
intent to interfere with the business decisions of licensees, it is necessary
for licensees to obtain prior NRC written consent. This ensures that:
Response from Applicant: None required from an applicant for a new license. For additional information, refer to NUREG-1556, Vol. 15, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Changes of Control and About Bankruptcy Involving Byproduct, Source, or Special Nuclear Materials Licenses." Notification of Bankruptcy Proceedings Regulation: 10 CFR 30.34(h); 10 CFR 40.41(f)(1); 10 CFR 70.32(a)(9)(i). Criteria: Immediately following filing of a voluntary or involuntary petition for bankruptcy for or against a licensee, the licensee must notify the appropriate NRC Regional Administrator, in writing, identifying the bankruptcy court in which the petition was filed and the date of filing. Discussion: Even though a licensee may have filed for bankruptcy, the licensee remains responsible for all regulatory requirements. NRC needs to know when licensees are in bankruptcy proceedings in order to determine 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 required at the time of application for a new license. Licensees must immediately (within 24 hours) notify NRC following the filing of a voluntary or involuntary petition for bankruptcy for or against the licensee. References: Information Notices are available in the "Reference Library" on NRC's home page at <http://www.nrc.gov>. See the Notice of Availability (on the inside front cover of this report) to obtain copies of Policy and Guidance Directive PG 8-11, "NMSS Procedures for Reviewing Declarations of Bankruptcy," dated August 8, 1996; and NRC Inspection Manual, Inspection Procedure 87103, "Inspection of Material Licensees Involved in an Incident or Bankruptcy Filing." For additional information, refer to NUREG-1556, Vol. 15, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Changes of Control and About Bankruptcy Involving Byproduct, Source, or Special Nuclear Materials Licenses." 8.3 Item 3: Address(es) Where Licensed Material Will Be Used or Possessed[ Prev | Next | Top of file ] Regulations: 10 CFR 30.34(c); 10 CFR 40.41(c); 10 CFR 70.41(a). Specify each proposed location of possession or possession and use by street address, city, state, and zip code, or other descriptive address (e.g., on Highway 10, 5 miles east of the intersection of Highway 10 and State Route 234, Anytown, State). The descriptive address should be sufficient to allow an NRC inspector to find the facility location. A Post Office box address is not acceptable, as illustrated in Fig. 8.1. If licensed material is to be possessed or possessed and used at more than one location, give the specific address of each location. Applicants for a broad scope license need not identify each facility at a particular address where licensed material will be possessed or possessed and used. For example, broad scope applicants can specify that licensed material will be possessed or possessed and used on the manufacturing campus of ABC Corporation located on Presidential Avenue in Anytown, State. Applicants should identify all facilities designed or established for special uses, e.g., panoramic irradiators, interim or long-term waste storage facilities, high activity laboratories, iodination facilities, alpha laboratories, and incinerators. An NRC-approved license amendment identifying a new location of possession or possession and use, which is not encompassed by a location described on the existing license, is required before receiving, using, and storing licensed material at that location. Figure 8.1 Location of Possession or Possession and Use. An acceptable location of possession or possession and use specifies street address, city, state, and zip code and does not include a Post Office box number.
Note: As discussed later in Section 8.5.2, Financial Assurance and Recordkeeping for Decommissioning, licensees must maintain permanent records of where licensed material was possessed or possessed and used or stored while the license was in force. This is important for making future determinations about the release of these locations for unrestricted use (e.g., before the license is terminated). Acceptable records are sketches, written descriptions of the specific locations, or room numbers where licensed material is possessed and used or stored, and any records of spills or other unusual occurrences involving the spread of contamination in or around the licensee's facilities. 8.4 Item 4: Person to Be Contacted about this Application[ Prev | Next | Top of file ] Identify the individual who can answer questions about the application, and include his or her telephone number. This is typically the proposed RSO, unless the applicant has named a different person as the contact. NRC will contact this individual if there are questions about the application. Notify NRC if the contact person or 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 Items 5: Radioactive Material[ Prev | Next | Top of file ]
Regulations: 10 CFR 30.6; 10 CFR 30.11; 10 CFR 30.32; 10 CFR 30.33; 10 CFR 30.36; 10 CFR 30.37; 10 CFR 30.38; 10 CFR Part 32; 10 CFR Part 40; 10 CFR Part 51; 10 CFR Part 70; 10 CFR 110.9; 10 CFR 110.9a; 10 CFR 110.31; 10 CFR 110.32. Criteria: A specific license is required, describing and authorizing the manufacture or distribution of materials and devices to persons generally licensed, specifically licensed, or specifically licensed to distribute materials and devices to medical use licensees. Licenses authorizing distribution only to specifically licensed or generally licensed persons do not generally allow possession and processing of licensed materials. Licenses authorizing the distribution of materials to persons exempt from licensing are not described in this document. See NUREG-1556, Vol. 8, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Exempt Distribution Licenses."Licenses authorizing the distribution of materials to generally licensed persons are not described in this document. See NUREG-1556, Vol. 16, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses Authorizing Distribution to General Licensees." If a license of broad scope is being sought (under 10 CFR 33, "Specific Domestic Licenses of Broad Scope for Byproduct Material"), also refer to NUREG-1556, Vol. 11, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope." Discussion: Licensees are required to have a specific license authorizing manufacturing or incorporating licensed materials into devices or materials. Licensees or applicants desiring to incorporate a material into a sealed source or incorporate a sealed source into a device shall have the combination approved by NRC according to 10 CFR 32.51 or an Agreement State regulation, and listed in the Sealed Source & Device (SSD) Registry. Licensees who possess and use licensed materials to support the process of manufacturing and/or distribution shall have the appropriate possession and uses described in their licenses. An example may be that a manufacturer of depleted uranium counterweights or shields possesses and uses a cesium-137 level gauge to detect blockage in the raw material hopper feed line. The manufacturer would need authorization not only to possess, use, and distribute the uranium for the counterweights and the shields, but also a line authorization to possess and use the level gauging device. If the licensee wishes to calibrate its own survey meters and perform leakage/contamination tests, then separate line authorizations on the same license are needed for the survey instrument calibration source/device, and the calibration sources for the detection system for leakage/contamination testing. The licensee should have procedures for these uses. Response from Applicant: No response is required. 8.5.1 Sealed Sources and Devices or Unsealed Radioactive MaterialRegulations: 10 CFR 30.6; 10 CFR 30.11; 10 CFR 30.32; 10 CFR 30.33; 10 CFR 30.36; 10 CFR 30.37; 10 CFR 30.38; 10 CFR 32.11; 10 CFR 32.14; 10 CFR 32.17; 10 CFR 32.18; 10 CFR 32.21; 10 CFR 32.22; 10 CFR 32.26; 10 CFR 32.51; 10 CFR 32.53; 10 CFR 32.57; 10 CFR 32.61; 10 CFR 32.71; 10 CFR 32.72; 10 CFR 32.74; 10 CFR 32.210; 10 CFR 40.13; 10 CFR 40.31; 10 CFR 40.32; 10 CFR 40.34; 10 CFR 40.35; 10 CFR 40.36; 10 CFR 40.38; 10 CFR 40.41; 10 CFR 40.44; 10 CFR 51.20; 10 CFR 51.21; 10 CFR 51.22; 10 CFR 70.39; 10 CFR 70.40; 10 CFR 70.41; 10 CFR 110.9; 10 CFR 110.9a; 10 CFR 110.31; 10 CFR 110.32; 10 CFR 150.7. Criteria: An application for a license will be approved if the requirements of 10 CFR 30.33, 10 CFR 40.32, 10 CFR 51.20, 10 CFR 70.39, 10 CFR 110.31 and/or 10 CFR 110.32 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 pursuant to 10 CFR 32.210 or equivalent Agreement State regulations. Discussion: Materials That Must Be Listed in the Application Each authorized radioisotope is listed on the NRC license by its element name, chemical and/or physical form, and the maximum possession limit, as shown in the sample licenses in Appendix D. Table 8.1 shows the type of radioactive material covered by this report. If a license of broad scope is being sought (under 10 CFR 33, "Specific Domestic Licenses of Broad Scope for Byproduct Material"), also refer to NUREG-1556, Vol. 11, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope." 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 possessed 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 volatile material. For example, when requesting authorization to possess and use 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 requested. The applicant must provide evidence (or information) which demonstrates that the material obtained will be non-volatile. NRC may issue the license with separate or combined possession limits depending on the reviewer's analysis of the information provided. Applicants requesting an authorization to possess and use volatile radioactive material must provide appropriate facilities, engineering controls, and radiation safety procedures for handling such material.
The anticipated possession limit in megabecquerels (MBq) (millicuries) or gigabecquerels (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. If materials are expected or requested to be returned from customers, then these materials must be factored into the inventory. Applicants should review the requirements for submitting a certification for financial assurance for decommissioning before specifying possession limits of any radioisotope with a half-life greater than 120 days. These requirements are discussed in Section 8.5.2, Financial Assurance and Decommissioning. 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. The safety evaluation is documented in an SSD registration certificate. Information on SSD registration certificates may be obtained 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 possess and 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, "Consolidated Guidance About Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration." Consult with the proposed supplier, manufacturer, or distributor to ensure that requested sources and devices are compatible with and conform to the SSD 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 possess and 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. It is not acceptable to use multiple exempt quantities in a single device, as set forth in 10 CFR 32.19.
Response from Applicant:
References: See the 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 web site at <http//www.nrc.gov>. 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 Recordkeeping for DecommissioningRegulations: 10 CFR 30.32(h); 10 CFR 30.34(b); 10 CFR 30.35; 10 CFR 30.36(e); 10 CFR 30.36(g)(4)(v); 10 CFR 30.51(d); 10 CFR 30.51(e); 10 CFR 30.51(f); 10 CFR 40.31(i); 10 CFR 40.36; 10 CFR 40.41(b); 10 CFR 40.42(e); 10 CFR 40.42(g)(4)(v); 10 CFR 40.61(d); 10 CFR 40.61(e); 10 CFR 40.61(f); 10 CFR 70.22(a)(9); 10 CFR 70.25; 10 CFR 70.32(a)(3); 10 CFR 70.38(e); 10 CFR 70.38(g)(4)(v); 10 CFR 70.51(b)(6); 10 CFR 70.51(b)(7). Criteria: A licensee authorized to possess licensed material in excess of the limits specified in 10 CFR 30.35, 10 CFR 40.36, and/or 10 CFR 70.25 must submit a decommissioning funding plan (DFP) or provide a certification of financial assurance for decommissioning (F/A). Even if no financial assurance is required, all licensees are required to maintain, in an identified location, decommissioning records important to the decommissioning of a facility. Pursuant to 10 CFR 30.35(g), 10 CFR 40.36(f), and/or 10 CFR 70.25(g), licensees must transfer these records to either of the following:
Discussion: NRC wants to ensure that decommissioning will be carried out with minimum impact on public and occupational health and safety and the environment (53 FR 24018). There are two parts to the rule: financial assurance that applies to SOME licensees, and recordkeeping that applies to ALL licensees. NRC regulations requiring an F/A or a DFP are designed to provide reasonable assurance that the decommissioning of licensed facilities will be accomplished in a safe and timely manner and that licensees will provide adequate funds to cover all costs associated with decommissioning. These requirements, if applicable, specify that a licensee either set aside funds for decommissioning activities or provide a guarantee, through a third party, that funds will be available. Applicants are required to submit an F/A 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 or has an option of submitting either a DFP or an F/A (or neither) are stated in 10 CFR 30.35, 10 CFR 40.36, and /or 10 CFR 70.25. A DFP contains a site-specific cost estimate and a certification of financial assurance. A Certification of Financial Assurance includes a certification that the licensee has provided the required financial assurance and an acceptable financial assurance instrument. Acceptable financial assurance includes prepayment options (trusts, escrow accounts, government funds, certificates of deposit, or deposits of government securities); surety, insurance, or other guarantee methods (letters of credit, surety bonds, lines of credit, parent company guarantees, insurance policies); and statements of intent for Government entities. Criteria for parent company guarantees and self-guarantees can be found in 10 CFR 30, Appendix A, Appendix C, Appendix D, and Appendix E. Refer to 10 CFR 30.35(d) for a table of required amounts of financial assurance for decommissioning by quantity of material. NUREG-1727, "NMSS Decommissioning Standard Review Plan," dated September 2000, provides guidance acceptable to the NRC staff on the information to be provided for establishing financial assurance for decommissioning and a standard format for presenting the information. NUREG-1727, "NMSS Decommissioning Standard Review Plan," dated September 2000, also describes the information required to be submitted for a DFP. Figure 8.2 Financial Assurance for Decommissioning. Most manufacturer licensees do not need to provide financial assurance for decommissioning. Large manufacturers may need one of several approved financial mechanisms. The requirements for maintaining records important to decommissioning, including the type of information required, are stated in 10 CFR 30.35(g), 10 CFR 40.36(f), and/or 10 CFR 70.25(g). All licensees are required to maintain these records in an identified location until the site is released for unrestricted use. 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 must be transferred to NRC. Careful recordkeeping of radionuclides possessed and used, including form, amount, and area used, will facilitate area release and license termination. Figure 8.3 Records Important to Decommissioning. All possession for manufacturing and distribution licensees must maintain records important to decommissioning, regardless of whether they need financial assurance for decommissioning. Response from Applicants: No response is needed from most applicants. If an F/A or a DFP is required, submit the required documents as described in NUREG-1727, "NMSS Decommissioning Standard Review Plan," dated September 2000. References: See the Notice of Availability (on the inside front cover of this report) to obtain copies of NUREG-1727, "NMSS Decommissioning Standard Review Plan," dated September 2000. 8.6 Item 6: Purpose(s) For Which Licensed Material Will Be Possessed And Used[ Prev | Next | Top of file ] Regulations: 10 CFR 30.4; 10 CFR 30.33(a)(1); 10 CFR 32.2; 10 CFR 32.11; 10 CFR 32.14; 10 CFR 32.17; 10 CFR 32.18; 10 CFR 32.21; 10 CFR 32.22; 10 CFR 32.26; 10 CFR 32.51; 10 CFR 32.53; 10 CFR 32.57; 10 CFR 32.61; 10 CFR 32.71; 10 CFR 32.72; 10 CFR 32.74; 10 CFR 32.210; 10 CFR 40.4; 10 CFR 40.32(a); 10 CFR 51.21; 10 CFR 51.22; 10 CFR 70.4; 10 CFR 70.39; 10 CFR 70.42; 10 CFR 110.2; 10 CFR 110.20; 10 CFR 110.42; 10 CFR 110.43; 10 CFR 110.50. Criteria: Requested radioisotopes must be possessed and used for purposes authorized by the Atomic Energy Act of 1954, as amended. Sealed sources and devices containing licensed material must be possessed and used only for the purpose for which they are designed and according to manufacturer's (distributor's) instructions and recommendations for possession and use as specified in the SSD Registration Certificate.
Note: If distributing sealed sources and devices to medical use licenses, also see Appendix U, Medical Distribution. 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. Applicants should pay particular attention to the applicable regulations listed above when applying for a license to manufacture and distribute licensed material (see Figure 8.4). However, this list is not exhaustive, nor does it relieve the applicant from complying with applicable Federal, State, and local requirements. Applicants considering research and development can include the requested licensed materials in this application and should refer to NUREG-1556, Vol. 7, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope." Applicants intending to possess and 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 NUREG-1556, Vol. 9, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses." Applicants intending to become a broad scope licensee should refer to NUREG-1556, Vol. 11, "Consolidated Guidance for Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope," for instructions. Figure 8.4 Regulation Wheel for Byproduct Material. Possession for manufacturing and distribution of radioactive materials is authorized by several distinct regulations. The appropriate regulations to refer to depends on the nature of the material, the purpose(s) for which it will be possessed and used, and to whom it is sent. Applicants may use the format given in Table 8.2 to provide the requested information. Table 8.2 Sample Format for Providing Information About Requested Radioisotopes.
Figure 8.5 Example of a Product Produced Under Possession for Manufacturing and Distribution Authorization. Other designs of technetium generators can contain up to 4 curies of Mo-99/Tc-99m. Applicants should clearly specify if the licensed material will be used in animal studies and/or tracer studies as part of manufacturing. Use of licensed material in animals may be in quality control or research studies. 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). See NUREG-1556, Vol. 7, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Academic, Research and Development, and Other Licenses of Limited Scope." Applicants requesting a license for distribution-only may need to refer to the information in Appendix F, which describes the different types of distribution licenses (i.e., General "G" Distribution License, Medical "MD" Distribution License, and Exempt "E" Distribution License), in order to determine whether this guidance document should be used for their application. Applicants for medical distribution licenses must refer to 10 CFR 32.72 and 32.74, in addition to the guidance specified in Appendices F and U. The applicant should also see the sample "MD" distribution licenses in Appendix D. Some "manufacturers" are importers of materials and devices from abroad and do not require the same extent of information submission and review as a facility that produces an item. However, they are required to have a manufacturer/distributor license as the initial importer and distributor in the United States. The device distributor may be the sponsor of the "Sealed Source and Device Registry" certificate. The manufacturer/distributor license is separate from the "G" or "E" distribution license. The general distribution only license ("G") and the exempt distribution only license ("E") application requirements are not covered in this document. Applicants for these licenses are referred to NUREG-1556, Vol. 16, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses Authorizing Distribution to General Licensees," and NUREG-1556, Vol. 8, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Exempt Distribution Licenses." Response from Applicant: List the specific use or purpose of each radioisotope that will be possessed and used. Use of the suggested table format will facilitate review of the application.
Note: Applicants intending to manufacture sealed sources or devices should refer to Appendix U, Item 10.2 for sealed source and device licensing criteria for evaluation of design and construction. 8.7 Item 7: Individual(s) Responsible for Radiation Safety Program and Their Training and Experience[ Prev | Next | Top of file ] Regulations: 10 CFR 30.33(a)(3); 10 CFR 40.32(b); 10 CFR 70.22(a)(6); 10 CFR 70.23(a)(2). Criteria: Executive management, the Radiation Safety Officer (RSO) (and his/her staff, as necessary), and users work as a team to implement the Radiation Protection Program. Each individual and position plays a critical role within his/her area of responsibility. The roles and responsibilities of executive management, the RSO, the Radiation Safety Office staff, users, and others in restricted areas are discussed in the sections that follow. Refer to the subsequent sections specific to the RSO and Authorized Users described above. Note: NUREG-1516, "Management of Radioactive Material Safety Programs at Medical Facilities," describes the role of executive management and the RSO at medical facilities, but contains information that may be of help to the possession for manufacturing and distribution licensee. Discussion: You must be qualified by training and experience to possess and use the material for the purpose requested in a manner that will protect health and minimize danger to life or property before an application for a license is approved. Each program in which radioactive materials are possessed and used under a Commission license will have someone responsible for radiation safety and compliance with the Commission's regulations. In a small program, the responsibility may be combined with or assigned to (or assumed by) the same individual using radioactive materials, therefore an authorized user may serve as an RSO. In a medium-sized program, the responsibility may be assigned to an individual on a part-time basis, with that person's primary responsibility being in another area of work. In a large program, the many facets of occupational and environmental radiation safety require that responsibility for the Radiation Safety Program be assigned to a qualified individual on a full-time basis. His or her training and experience must be commensurate with his or her duties and responsibilities. Supporting staff should be provided, as appropriate, for the size and scope of the program. A large program may have some or all of the following characteristics:
NRC holds the licensee responsible for the Radiation Protection Program; therefore, it is essential that strong management controls and oversight exist to ensure that licensed activities are conducted safely. Management responsibility and liability are sometimes underemphasized or not addressed in applications and are often poorly understood by licensee employees and managers. As discussed later in this guide, senior management will delegate to the RSO sufficient authority, organizational freedom, and management prerogative to communicate with and direct personnel regarding NRC regulations and license provisions and to terminate unsafe activities involving byproduct material. Other responsibilities will be delegated to other individuals. Such delegations should be clearly communicated to all parties. While these delegations are important to the operation of the program, the licensee senior management maintains the ultimate responsibility for the safety of licensed activities. If a license of broad scope is being sought (under 10 CFR 33, "Specific Domestic Licenses of Broad Scope for Byproduct Material"), also refer to NUREG-1556, Vol. 11, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope." Response from Applicant: Refer to the subsequent sections specific to the individuals described above. Applicants should submit an organizational chart describing the management structure, reporting paths, and the flow of authority between executive management and the RSO. 8.7.1 Radiation Safety OfficerRegulations: 10 CFR 30.33(a)(3); 10 CFR 40.32(b); 10 CFR 70.23(a)(2). 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 (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 possessed and used in a safe manner. Typical RSO duties are illustrated in Figure 8.6 and described in Appendix G. NRC requires the name of the RSO to be listed on the license to ensure that licensee management has identified a responsible, qualified person and that the named individual knows of his or her designation as RSO. Figure 8.6 RSO Responsibilities. Typical duties and responsibilities of RSOs. NRC believes that to demonstrate adequate training and experience, the RSO should have: (1) at a minimum, a college degree at the bachelor level or equivalent training and experience in physical, chemical, biological sciences, or engineering; and (2) training and experience commensurate with the scope of proposed activities. Training should include the following subjects:
The amount of training and experience will depend on the type, form, quantity, and proposed use of the licensed material requested. For instance, in addition to a college degree, RSOs at a manufacturing company where workers handle curie quantities of radioactive material should be specialists in the field of radiation protection and may need 40 hours of radiation safety training specific to their job duties as well as a year of experience with similar types, forms, quantities, and uses of radioactive material before the individual is qualified to be RSO. On the other hand, RSOs at "manufacturers" who are importers of timepieces containing tritium that are received in the U.S. as completed products that will be distributed as exempt quantities may only require a few hours of radiation safety training and no prior experience with timepieces containing tritium to be qualified as an RSO. The proposed RSO's training and experience must be sufficient to identify and control the anticipated radiation hazards. For example, the RSO should have experience planning and conducting evaluations, surveys, and measurements similar to those required by the licensee's Radiation Safety Program. In addition, the RSO designee should have obtained the above training in a formal course designed for RSOs, presented by an academic institution, commercial radiation safety consulting company, or a professional organization of radiation protection experts. Response from Applicant: Provide the following:
Note: It is important to notify NRC, as soon as possible, of changes in the designation of the RSO. The name and qualifications of the replacement RSO must be submitted to NRC as part of an amendment request. 8.7.2 Authorized UsersRegulations: 10 CFR 19.12; 10 CFR 20.1101(b); 10 CFR 30.33(a)(3); 10 CFR 40.32(b); 10 CFR 70.23(a)(2); 10 CFR 71.5; 10 CFR 110.26; 10 CFR 110.27; 10 CFR 110.28; 10 CFR 110.29; 10 CFR 110.30; 10 CFR 110.42; 10 CFR 110.43; 10 CFR 110.44; 49 CFR Parts 170 through 189 (appropriate to the mode of transport). Criteria: Authorized Users (AUs) must have adequate training and experience with the types and quantities of licensed material that they propose to possess and use. Discussion: Applicants must name at least one individual who is qualified to use the requested licensed materials. An AU 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 are used safely and according to regulatory requirements. The AU is also responsible for ensuring 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. For instance, in addition to a college degree, authorized users at a manufacturing company where workers handle curie quantities of radioactive material should have 40 hours of radiation safety training and a minimum of 6 months of experience with similar types, forms, quantities, and uses of radioactive material before the individual is qualified to be an authorized user. On the other hand, authorized users at "manufacturers" who are importers of timepieces containing tritium that are received in the U.S. as completed products that will be distributed as exempt quantities may only require a few hours of radiation safety training and no prior experience with timepieces containing tritium to be qualified as an authorized user. 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. 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. Response from Applicant: Provide the following: Name of each proposed AU with the types and quantities of licensed material to be possessed or possessed and used; Information demonstrating that each proposed AU is qualified by training and experience to possess and use the requested licensed materials.
Note: Applicants for broad scope programs should refer to NUREG-1556, Vol. 11, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope." Broad Scope programs may be permitted to name authorized users without amending the license. 8.8 Item 8: Training for Individuals Working in or Frequenting Restricted Areas[ Prev | Next | Top of file ] Regulations: 10 CFR 19.11; 10 CFR 19.12; 10 CFR 19.13; 10 CFR 20.1801; 10 CFR 20.1802; 10 CFR 30.7; 10 CFR 30.9; 10 CFR 30.10; 10 CFR 30.33(a)(3); 10 CFR 30.34(e); 10 CFR 40.32(b); 10 CFR 40.41(e); 10 CFR 70.23(a)(2); 10 CFR 70.32(b). Criteria: Individuals whose assigned duties involve exposure to radiation and/or radioactive material (from both licensed and unlicensed sources), and in the course of their employment are likely to receive in a year an occupational dose of radiation greater than 1 mSv (100 mrem), whether from all external sources, all internal sources, or any combination, must receive instruction commensurate with their duties and responsibilities, as required by 10 CFR 19.12. Discussion: Before beginning work with licensed material, individuals must receive radiation safety training commensurate with their assigned duties and specific to the licensee's Radiation Safety Program. Each individual should also receive periodic refresher training at no more than 12-month intervals. Training should also be performed whenever there is a significant change in hazards, duties, procedures, regulations, or terms of the license. Licensees should not assume that safety instruction has been adequately covered by prior employment or academic training. Site-specific training should be provided for all individuals. Ancillary personnel (e.g., clerical, housekeeping, security) whose duties may require them to work in the vicinity of radioactive material (whether escorted or not) need to be informed about radiation hazards and the appropriate precautions. The licensee should assess each individual's involvement with licensed material and cover each applicable subject appropriately. Training may be in the form of lecture, demonstrations, videotape, or self-study, and it should emphasize practical subjects important to the safe possession and use of licensed material. If training is not conducted by an instructor, a method should be adopted whereby a trainee can ask questions and discuss topics relating to occupational radiation exposure. The guidance in Appendix H, Radiation Safety Training Topics, may be used to develop a training program. The program should consider all topics pertinent for each group of workers as well as the method and frequency of training. The licensee should determine whether the training succeeded in conveying the desired information and adjust the training program as necessary. This assessment may be performed by a written test or observation of the individual in the performance of assigned duties. Remedial training for missed test questions or other areas of apparent weakness should be conducted or additional formal training planned to cover deficient areas. The person conducting the training should be a qualified individual (e.g., a person who meets the qualifications for RSO or authorized user on the license and is familiar with the licensee's program). Response from Applicant: Submit a description of the radiation safety training program, including topics covered, groups of workers, assessment of training, qualifications of instructors, and the method and frequency of training. 8.9 Item 9: Facilities and Equipment[ Prev | Next | Top of file ] Regulations: 10 CFR 20.1101(b); 10 CFR 20.1406; 10 CFR 30.33(a)(2); 10 CFR 30.35(g); 10 CFR 40.27(b); 10 CFR 40.28(b); 10 CFR 40.31(h); 10 CFR 40.32(c); 10 CFR 40.34(a); 10 CFR 51.20(b); 10 CFR 70.23(a)(3); 10 CFR 70.39(a). 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 Section 8.5.2, Financial Assurance and Recordkeeping for Decommissioning. For additional guidance regarding facilities and equipment, refer to Appendix I, Facilities and Equipment. Response from Applicant: Describe the facilities and equipment to be made available at each location where radioactive material will be possessed or possessed and used (see Appendix I for topics to consider). Include a description of the area(s) assigned for the receipt, shipping, storage, preparation, security, 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 (see Figures 8.7 and 8.8). 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. This information should be from the point of view of performance criteria. For example, state the purpose of your filtration equipment and the associated acceptance criteria to accomplish this purpose (such as the ventilation flow rate you are trying to maintain). If radioactive materials will be used with animals, include a description of the animal handling housing facilities. Appendix G to NUREG-1556, Vol. 7 may also be used as guidance. Figure 8.7 Facility Diagram for a Radiography Source Manufacturer. Figure 8.8 Shielded Protective Enclosure (Hot Cell) With Remote Manipulator. 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. Discussion: It is in the best interest of licensees to have a strong audit program to ensure: Compliance with NRC and DOT regulations and the terms and conditions of the license; Occupational doses and doses to members of the public are ALARA (10 CFR 20.1101) and dose reduction efforts have been considered; and to ensure that Operating procedures are in place for activities which could potentially affect radioactive material or occupational dose (10 CFR 20.1101(a). An audit program that promptly identifies potential violations of regulatory requirements and takes prompt, comprehensive steps to correct them, meets NRC's expectations. Elements of an effective audit program and an example audit form are described below. Audit Objectives. NRC holds the licensee responsible for the Radiation Protection Program. It is essential that strong management controls and oversight exist to ensure that licensed activities are conducted properly. Audits may be used by licensees to self-assess the adequacy of the licensed program, identify program weaknesses, and allow licensees to take early corrective actions (before an NRC inspection). The objectives of the audit should include an evaluation of the licensee's: (1) efforts to maintain doses ALARA; (2) compliance with NRC requirements; (3) ability to identify and correct deficiencies in their Radiation Safety Program; (4) management of their Radiation Safety Program including the role of senior management and the RSO; and (5) implementation of their Radiation Survey Program. Scope of Audit. Audits should cover both the management of the Radiation Safety Program and the details of its implementation in the areas chosen for review. Mechanisms used by senior management to ensure that adequate oversight of the program is exercised should be included in the scope of the audit. Auditor Qualifications. Auditors should have training and experience similar to that of an authorized user (See Section 8.7.2) for the types, forms, uses, and quantities of radioactive material used in the areas audited. Auditors should not be selected from the staff of areas to be audited, nor their management. Ideally, auditors are third parties, from independent organizations. Audit Frequency. Audits should be conducted at least once every 12 months. However, it is recommended that program audits be conducted more frequently than annually if the licensee's activities involve the use of high activity sources or frequent handling of intermediate activity sources. Applicants should consider developing survey and audit schedules based on activity and use (e.g., high use/activity areas may be audited monthly, moderate use/activity areas may be audited quarterly). More frequent audits should be considered if the potential for overexposures exists. Audit Techniques. While documentation should be reviewed during any audit of a Radiation Safety Program, emphasis should be placed on actual observations of work in progress. Applicants should consider performing unannounced audits of radioactive material users to observe work in progress and determine if, for example, operating and emergency procedures are available and are being followed. Radiation safety audits should include activities conducted during all shifts. Some details of typical audit techniques follow: Audit History. Note the date of the last audit, whether any deficiencies were identified, and whether actions were taken to correct the deficiencies. Organization and Scope of Program Area Audited. 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. 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 operating and emergency procedures. Note whether refresher training is conducted in accordance with licensee commitments and that all shift workers are included. By interview and/or observation of selected workers, ensure that each has a copy of the licensee's procedures and can implement them properly. Special attention should be directed to the adequacy of training and observation of new employees performing their radioactive material duties. Facilities. Verify that the facilities are as described in the license documents. Note whether the licensee has permanent field offices and or temporary job sites, and if those sites were visited during the audit. Indicate any findings noted at these additional sites, and if these sites were not visited, give an explanation as to why these sites were not audited. Materials. Verify that the license authorizes the quantities and types of byproduct material that the licensee possesses. 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. Inventories. Verify that inventories are conducted at least once every 6 months to account for all sources; inventory records should be maintained. 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. 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, 40.51, and 70.42. Records of surveys, receipt, and transfer must be maintained in accordance with 10 CFR 20.2103, 30.51, 40.61, 70.51, and 70.54. 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, contain all needed information, and are readily accessible during transport (49 CFR 172.200-204 and 177.718). Personnel Radiation Protection. Evaluate the licensee's determination that unmonitored personnel are not likely to receive more than 10% of the allowable limits. Alternatively, 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. The licensee is also responsible for ensuring that dosimetry results are assigned accurately and should consider that the assigned deep-dose equivalent and shallow-dose equivalent must be for the part of the body receiving the highest exposure. Therefore, if possible, whole body and extremity dosimeters should be placed in the areas that receive the highest exposure. An evaluation must be performed to determine if the maximum dose to a part of the whole body or an extremity may be substantially higher than the dose measured by the dosimeter. If the evaluation indicates that the maximum dose to a part of the whole body or extremity is higher than that measured by the dosimeter, the higher dose will be used as the dose of record (see Section 8.10.4). If any worker declared her pregnancy in writing, evaluate compliance with 10 CFR 20.1208. Check whether records are maintained as required by 10 CFR 20.2101-2104 and 20.2106. 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. Notification and Reports. Check for compliance with the notification and reporting requirements in 10 CFR Parts 19, 20, 21, 30, 40, and 70. Ensure that the licensee is aware of the telephone number for NRC's Emergency Operations Center; (301) 816-5100. Posting and Labeling. Check for compliance with the posting and labeling requirements of 10 CFR 19.11, 10 CFR 20.1902, 20.1904, and 10 CFR 21.6. Recordkeeping for Decommissioning. Check to determine compliance with 10 CFR 30.35(g), 10 CFR 40.36(f), and 10 CFR 70.25(g). Bulletins and Information Notices. Check to determine if bulletins, information notices, NMSS Newsletters, etc., are received from NRC. Check whether appropriate actions were taken in response to NRC mailings. Special License Conditions or Issues. Verify compliance with any special conditions in the license. If there are any unusual aspects of work, review and evaluate compliance with regulatory requirements. Recommendations. List any recommendations to improve the overall efficiency and effectiveness of the audit and Radiation Safety Program. Evaluation of Other Factors. Evaluate management's involvement with the Radiation Safety Program, whether the RSO has sufficient time to perform his/her duties, and whether there is sufficient staff to handle the workload and maintain compliance with regulatory requirements Problems or Deficiencies Noted. The licensee must have a process for correcting violations and deficiencies during and after the audit. The licensee should identify the safety significance of each violation to set priorities and identify resources to correct these violations. Results of the audit program reviews should be reported to senior management to allow for timely and aggressive remedial actions sufficient in scope to ensure compliance with NRC regulations and licensee conditions. Information Notice (IN) 96-28, "Suggested Guidance Relating to Development and Implementation of Corrective Action," provides guidance on this subject. Certain identified problems or potential violations may require notification or a report to NRC. Licensees are encouraged to contact NRC for guidance if they are uncertain about a reporting requirement. All audit findings and corresponding corrective actions, whether from internal, state, or Federal audit findings, should be communicated to the staff for review and added to new and refresher radiation safety training sessions. If the findings represent a significant safety impact to the staff, special training sessions may be appropriate. Records to be Maintained: Licensees must maintain records of audits and other reviews of program content and implementation for 3 years from the date of the record. NRC has found audit records that contain the following information to be acceptable: date of audit, name of person(s) who conducted the audit, persons contacted by the auditor(s), areas audited, audit findings, corrective actions, and follow-up. These records must be maintained for inspection by NRC. Appendix J, Example Audit Form, contains an example audit form for manufacturer licensees. All areas indicated in Appendix J may not apply to every licensee, and all items may not need to be addressed during each audit. For example, licensees need not address areas that do not apply to their activities. Conversely, other licensee specific activities may need to be added to the form. Activities that have not occurred since the last audit need not be reviewed at the next audit. Response from Applicant: The applicant must provide
a description of its audit program that addresses the following:
References: See the Notice of Availability on the inside
front cover of this report to obtain copies of:
8.10.2 Radiation MonitoringRegulations: 10 CFR 20.1501; 10 CFR 20.2103(a); 10 CFR 30.33(a)(2). Criteria: Licensees must possess radiation monitoring instruments to evaluate possible radiation hazards that may be present. Instruments used for quantitative radiation measurements must be calibrated periodically for the radiation measured. Discussion: Licensees must possess calibrated radiation
detection/measurement instruments to perform, as necessary, the following:
For the purposes of this document, radiation monitoring instruments are
defined as any device used to measure the radiological conditions at a
licensed facility. Some of the instruments that may be used to perform
the above functions include:
The choice of instrument should be appropriate for the type of radiation to be measured, and for the type of measurement to be taken (count rate, dose rate, etc.). Figure 8.9 illustrates some common survey instruments used for contamination surveys. Applications should include descriptions of the instrumentation available for use and the instrumentation that applicants intend to purchase prior to starting licensed activities. The description should include type of instrument and probe, and the instrument's intended purpose. Figure 8.9 Examples of Portable Instruments Used in Laboratory Settings. Instruments used for qualitative surveys are only intended to detect contamination in the laboratory. Such instruments should be checked for operational response with an appropriate check source containing radioactive material, and can be calibrated with an electronic pulser instead of a radioactive source. However, these instruments cannot be used for measurement of surface contamination or radiation levels without a calibration with appropriate radioactive sources, as described in Appendix K, Radiation Monitoring Instrument Specifications and Model Survey Instrument and Air Sampler Calibration Program. 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 must submit procedures for review. Appendix K provides information about instrument specifications and model calibration procedures. Applicants should be aware that calibrations often require possession and use of a calibration source or device. Instrumentation for counting smear wipes to detect contamination and/or leakage need calibration sources that may be listed on the manufacturing license. Response from Applicant: Provide one of the following:
OR
OR
AND
Note: Alternative responses will be reviewed using the criteria listed above. 8.10.3 Material Receipt and AccountabilityRegulations: 10 CFR 20.1501(a); 10 CFR 20.1801; 10 CFR 20.1802; 10 CFR 20.1906; 10 CFR 20.2001; 10 CFR 20.2201; 10 CFR 30.34(e); 10 CFR 30.35(g); 10 CFR 30.41; 10 CFR 30.51; 10 CFR 31.11; 10 CFR Part 32; 10 CFR Part 40; 10 CFR 40.13; 10 CFR Part 70. 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 L, Material Receipt and Accountability. 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 8.3. Table 8.3 Package Monitoring Requirements.
* Assumes packages are received during normal working hours. If packages are received outside of normal working hours, the licensee has three hours after the beginning of the next work day to perform the required surveys. Note: Additional information on DOT regulations is contained in this NUREG in Section 8.10.9, Transportation, and Appendix R, Transportation. 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 8.10, 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. Figure 8.10 Material Receipt and Accountability.
Licensees must maintain records of receipt, transfer, and disposal
of licensed material.
Accountability for Materials Not Included in the Manufactured Products 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. The possession limits of 7.4 MBq (200 microcuries) for generally licensed materials specified in 10 CFR 31.11 only apply to any one location of storage or use. The general licensee cannot possess at any one time, at any one location of storage or use (i.e., a location that is physically and administratively separate), a total amount of iodine-125 (I-125), iodine-131 (I-131), selenium-75 (Se-75), and/or iron-59 (Fe-59) in excess of 7.4 MBq (200 microcuries). The licensee may have more than one location of storage or use at its facility, and therefore may possess a total of more than 7.4 MBq (200 microcuries) at any one time, as long as there is not greater than 7.4 MBq (200 microcuries) at any one location. It is recognized that loss, theft, or misplacement of licensed material can occur. However, licensees must have an accountability and control system in place for detecting losses of licensed material. Accountability for Materials Included in the Manufactured and Distributed Products Licensees who use and/or possess sealed sources are required by license condition to perform inventories of sealed sources every 6 months (see Condition Nos. 15 and 16, respectively, in the sample manufacturing licenses, in Appendix D). Some sealed sources may not be in use or are rarely used and are placed in storage. In these cases, licensees should, at least every 6 months, confirm that these sealed sources have not been disturbed. Licensees are also required to conduct leak tests of sealed sources, not in storage, 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 possess or possess and use or supervise the possession or possession and 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 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 L, Material Receipt and Accountability. NRC regulations applicable to transfers are stated in 10 CFR 30.41. Sample policy transfer statements are included in Appendix L. 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, may become contaminated. Surveys of and removal of these items for maintenance, repair, or disposal should also be carefully controlled. Licensees must maintain records of receipt, use, transfer, and disposal (as waste) of all licensed material. Table 8.4 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. Manufacturers/distributors must also make reports to regulatory agencies for exempt and general licensed devices distributed so that these can be accounted for and registered in some cases. Please refer to NUREG-1556, Vol. No. 8, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Exempt Distribution Licenses," and NUREG-1556, Vol. 16, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses Authorizing Distribution to General Licensees." Table 8.4 Record Maintenance.
Receipt, transfer, and disposal records typically contain the following
information:
See Section 8.11, Waste Management, for additional information.
Response from Applicant:
AND
OR
Note:
References: See the Notice of Availability (on the inside front cover of this report)
to obtain a copy of:
Additional References:
8.10.4 Occupational DoseRegulations: 10 CFR 19.13; 10 CFR 20.1003; 10 CFR 20.1201; 10 CFR 20.1202; 10 CFR 20.1203; 10 CFR 20.1204; 10 CFR 20.1207; 10 CFR 20.1208; 10 CFR 20.1501; 10 CFR 20.1502; 10 CFR 20.1703; 10 CFR 20.2104; 10 CFR 20.2105; 10 CFR 20.2106; 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:
Discussion:
According to 10 CFR 20.1502, if an adult (individual) is likely to receive in one year a dose greater than 10% of any applicable limit (See Figure 8.11 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. When working at an NRC-licensed facility, in addition to exposure to material regulated by NRC, a worker may be exposed to radiation and to radioactive material (e.g., radiation emitted by accelerators or accelerator produced radioisotopes such as indium-111 and thallium-201) that is regulated by the State in which the facility is located. With respect to NRC regulation of activities at the facility, State-regulated sources of radiation and radioactive material are considered to be "unlicensed." Occupational dose includes the dose received by individuals in the course of their employment (see 10 CFR 20.1003), including exposure to radiation and to radioactive material from licensed and "unlicensed" sources of radiation, whether in the possession of the licensee or other person. Therefore, in performing an evaluation of likely dose, you should consider these types of radiation exposures. 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. According to 10 CFR 20.1502, if an adult (individual) is likely to receive in one year a dose greater than 10% of any applicable limit (see Figure 8.11 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. Figure 8.11 Annual Dose Limits for Occupationally Exposed Adults. 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 indicated 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). Licensees are required to provide individual radiation exposure data to each worker annually and as otherwise described in 10 CFR 19.13. A common method for dose evaluation is to monitor workers' doses with whole body and extremity dosimetry (TLDs, film, sign badge, etc.) provided by a National Voluntary Laboratory Accreditation Program (NVLAP)-approved dosimetry service. If these devices are used, the licensee is responsible for exchanging and processing them in a timely manner. Also, the licensee is responsible for ensuring that dosimetry results are assigned accurately and should consider that the assigned deep-dose equivalent and shallow-dose equivalent must be for the part of the body receiving the highest exposure. Therefore, if possible, whole body and extremity dosimeters should be placed in the areas that receive the highest exposure. An evaluation must be performed to determine if the maximum dose to a part of the whole body or an extremity may be substantially higher than the dose measured by the dosimeter. If the evaluation indicates that the maximum dose to a part of the whole body or extremity is higher than that measured by the dosimeter, the higher dose will be used as the dose of record. 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. The licensee should also consider a more frequent exchange of dosimeters when employees start a new job function, so that their doses can be closely monitored when they are performing unfamiliar tasks. In addition, see Appendix P, Radiation Safety Survey Topics, Bioassay Monitoring, for information on bioassay monitoring for internal exposure assessment. Table 8.5 Documents That Contain Guidance Relating to Personnel Monitoring and Bioassay That May Be Applicable.
Additional References for Further Reading: U.S. Department of Energy DOE G 441.1-2, "Occupational ALARA Program
Guide," March 17, 1999(3).
Response from Applicant: Provide either of the following:
OR
Note:
8.10.5 Public DoseRegulations: 10 CFR 20.1003; 10 CFR 20.1101(d); 10 CFR 20.1301; 10 CFR 20.1302; 10 CFR 20.1801; 10 CFR 20.1802; 10 CFR 20.2107. Criteria: Licensees must ensure that licensed material will be possessed or possessed and used, transported, stored or disposed of in such a way that members of the public will not receive more than 1 mSv (100 mrem) in one year, and that the dose in any unrestricted area will not exceed 0.02 mSv (2 mrem) in any one hour from licensed operations. In addition, the licensee must ensure that air emissions of radioactive material to the environment will not result in a TEDE in excess of 10 millirem (0.1 mSv) per year to individual members of the public. Discussion: "Public dose" is defined in 10 CFR Part 20 as "the dose received by a member of the public from exposure to radiation and/or radioactive material released by a licensee, or to any other source of radiation under the control of a licensee." Public dose excludes doses received from background radiation, from medical procedures, and from licensees' release of radioactive materials into sanitary sewerage. Whether the dose to an individual is an occupational dose or a public dose depends on the individual's assigned duties. It does not depend on the area (restricted, controlled, or unrestricted) the individual is in when the dose is received. For guidance about accepted methodologies for determining dose to members of the public, please refer to Appendix M, Guidance for Demonstrating That Individual Members of the Public Will Not Receive Doses Exceeding the Allowable Limits. Figure 8.12 shows the steps to calculate the annual dose to an individual member of the public. Figure 8.12 Calculating Public Dose. Steps to calculate the annual dose to an individual member of the public (see Appendix M for more information about occupancy factors). 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: 1. Airborne radioactive material; 2. Waterborne radioactive material; and 3. External radioactive exposure. 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 Section 8.10.7, Radiation Safety Program - Surveys and Leak Tests. 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. Response from Applicant: Initially, the applicant need not provide a response. The application will be evaluated and the license reviewer will determine if enough information is present to assure compliance with the limiting exposure to a member of the public. A response may be required when there is insufficient information to assure that a member of the public will not receive a total exposure exceeding 0.1 mSv (100 millirem). When no response is required, compliance will be examined during inspection. During NRC inspections, licensees must be able to demonstrate, by measurement or calculation, that the 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 M for examples of methods to demonstrate compliance. 8.10.6 Operating and Emergency ProceduresRegulations: 10 CFR 19.11(a)(3); 10 CFR 20.1101; 10 CFR 20.1801; 10 CFR 20.1802; 10 CFR 20.2201-2203; 10 CFR 21.21; 10 CFR 30.34(e); 10 CFR 30.50; 10 CFR Part 32; 10 CFR Part 40; 10 CFR Part 70. Criteria: Operating procedures for activities which can potentially impact radioactive material or occupational dose must be developed, documented, implemented and maintained to comply with 10 CFR 20.1101(a), Radiation Protection Programs. Discussion: Licensees are responsible for the security and safe possession and use of all licensed material from the time it arrives at their facility until it is used, transferred, and/or disposed. Licensees should develop written procedures to ensure safe possession and use of licensed material, and the procedures should also include operational and administrative guidelines. The written procedures should provide reasonable assurance that only appropriately trained personnel will handle and use licensed material without undue hazard to workers or members of the public. General Safety and Manufacturing Process Procedures The written procedures should include the following elements:
These procedures should include policies for:
Applicants should also develop product and radioisotope-specific procedures based on the respective hazards associated with the products and radioisotopes. General safety guidelines are described in Appendix N, General Topics for Safe Possession and Use of Radioactive Materials and Model Emergency Procedures and Appendix P, Radiation Safety Survey Topics. 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. Figure 8.13 Use of Appropriate Shielding. This worker is using high density plastic shielding, which is appropriate for radioisotopes that emit beta radiation. 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 cannot be exposed to or contaminated by the material, and cannot take the material. When any licensed materials are in use in controlled or unrestricted areas, they must be under constant surveillance so that the radiation worker can prevent others from becoming contaminated by or exposed to the material, or to prevent persons from removing the material from the area. Acceptable methods for securing material will vary from one facility to another. Some alternatives used by licensees include: storage and use of licensed materials only in restricted areas; limiting access to an entire facility or building or portion of the building only to radiation workers; providing storage areas that can be locked to prevent access to the material; and implementing procedures that require a radiation worker to be within "line of sight" of the materials whenever licensed materials are in use. Applicants should develop procedures that clearly state acceptable methods to secure licensed material at their facility. Particular attention may need to be paid to security procedures at facilities 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, production processes, transfer, and disposal. Such incidents can result in contamination or release of material to the environment, and unintended radiation exposure to workers and members of the public. In addition, loss or theft of licensed material, sabotage, fires, floods, etc., can jeopardize 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 8.14) 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 limitations in an emergency, along with step-by-step instructions and clear guidelines for whom to contact. Licensees should have a sufficient number of appropriate and calibrated survey instruments readily available. Emergency spill kits should be strategically placed in well-marked locations for use by all users and the radiation safety staff. All equipment should be periodically inspected for proper operation, and replenished as necessary. Appendix N includes model emergency procedures. Applicants may adopt these procedures or develop their own, incorporating the safety features included in these model procedures. Figure 8.14 Proper Handling of Incident. Panels 1 and 2 indicate how contamination can be spread if the incident is not handled properly as in panels 3 and 4. Response from Applicant: The applicant must state that operating and emergency procedures will be developed and documented before receipt of licensed material. In addition, the applicant must state that operating and emergency procedures will be implemented and maintained. The applicant should submit a statement that "Procedures will be revised only if: (1) the changes are reviewed and approved by the licensee management and the RSO in writing; (2) the licensee staff is provided training in the revised procedures prior to implementation; (3) the changes are in compliance with NRC regulations and the license; and (4) the changes do not degrade the effectiveness of the program." If an "Emergency Response Plan" is required for your license pursuant to 10 CFR 30.32(i), submit it as a separate part of the application. 8.10.7 Surveys and Leak TestsRegulations: 10 CFR 20.1501; 10 CFR 20.2103; 10 CFR 30.53; 10 CFR 32.59; 10 CFR 32.102; 10 CFR 40.63; 10 CFR 70.56; 10 CFR 70.57. 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 8.15). These evaluations may be measurements (e.g., radiation levels measured with survey instruments or results of wipe tests for contamination), calculation, or a combination of measurements and calculations. The selection and proper use of appropriate instruments is one of the most important factors in ensuring that surveys accurately assess the radiological conditions. 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 8.15 Types of Surveys. There are many different types of surveys performed by manufacturer and distribution licensees. Radiation surveys are used to detect and evaluate contamination of:
Surveys are also used to plan work in areas where licensed material or radiation exists and to evaluate doses to workers and individual members of the public. Figure 8.16 Personnel Surveys. Users of unsealed licensed material should check themselves for contamination (frisk) before leaving the area of use. 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 P, Radiation Safety Survey Topics). Not all instruments can measure a given type of radiation. The presence of other radiation may interfere with a detector's ability to measure the radiation of interest. Correct use of radiation detection and measurements is an important aspect of any Radiation Safety Program. Table K.1 in Appendix K contains radiation monitoring and survey instruments and calibration programs that are acceptable to NRC. 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. Contamination checks are required before distributing fabricated sources. Table P.5 in Appendix P contains contamination limits that are acceptable to NRC. Sealed Source and Plated Foil Leak Tests 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 microcuries) of radioactivity. Manufacturers, consultants, and other organizations may be authorized by NRC or an Agreement State either to perform the entire leak test sequence for other licensees or provide leak test kits to licensees. In the latter case, the licensee 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 Q, Model Leak Test Program. Service Licenses If a licensee wants to perform leak tests for its customers, it must obtain a service license. This may also be accomplished by amending an existing license. For more information regarding service license applications, see NUREG-1556, Vol. 18, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Service Provider Licenses." Response from Applicant: Do one of the following:
OR
OR
Note:
Reference: See the Notice of Availability (on inside front cover of this report) to obtain a copy of NUREG-1556, Vol. 18, "Program-Specific Guidance About Service Provider Licenses." 8.10.8 MaintenanceRegulations: 10 CFR 20.1101; 10 CFR 30.34(e). Criteria: Maintenance of devices and facilities that use radioactive materials is necessary. Maintenance should be planned and carried out as frequently as needed, using ALARA principles. Individuals performing maintenance should be trained in the procedures they implement. Procedures should be written to account for the skills of the implementing personnel. Ordinarily, individuals handling unshielded materials should have up to forty hours of classroom and on-the-job training in radiation safety. Instructors should be more extensively qualified than the staff they teach. Discussion: Maintenance of equipment and facilities is necessary in order to produce a quality product safely and efficiently and to ensure a safe environment for staff and the public. Manufacturing a product incorporating radioactive materials is an additional hazard, requiring attention to detail when incorporating maintenance information into procedures. Licensee staff should ensure that materials in the process stream are properly shielded/located/protected to minimize the hazard to maintenance staff. Maintenance staff should be aware of the hazards and the procedures to minimize their exposure to radioactive materials that are possessed and used to control the manufacturing process. As examples: (1) a radioisotope hot cell should have its contents moved or shielded before any maintenance requiring entry is begun, and the staff should survey the hot cell working area prior to entry; and (2) a maintenance procedure should direct the shutdown and lockout of applicable process control gauges before beginning work in the area, which may be in the direct beam of the gauge, whether inside the process vessel, or outside the vessel. Maintenance procedures should be prepared with the use of engineering controls first, using ALARA principles and administrative controls, as needed. Response from Applicant: No response is required in the application process. The results of actions taken in the maintenance and repair of facilities and equipment process will be reviewed during inspection. 8.10.9 TransportationRegulations: 10 CFR 20.1101; 10 CFR 30.41; 10 CFR 30.51; 10 CFR 71.5; 10 CFR 71.12; 10 CFR 71.13; 10 CFR 71.14; 10 CFR 71.37; 10 CFR 71.38; 10 CFR 71.47; 10 CFR 71.87; Subpart H of 10 CFR Part 71; 49 CFR Parts 171-178. 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 licensees frequently meet the "Limited Quantity" criteria described in 49 CFR 173.421 and therefore could be exempt from certain DOT requirements. However, they may be subject to other, less restrictive, DOT requirements (e.g., 49 CFR 173.422 and 173.424; also see Appendix R, Transportation, for more information). If they are not exempted, however, licensed material, including radioactive waste, must be packaged and transported in accordance with NRC and 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. (See NUREG-1660/RAMREG-002, "U.S.-Specific Schedules of Requirements for Transport of Specified Types of Radioactive Material Consignments," November 1998.) Licensees should consider the safety of all individuals who may handle
or come into contact with the packages containing licensed material. Therefore,
the primary considerations in packaging licensed material should be to
ensure that package integrity is not compromised during transport and
that radiation levels (including removable contamination levels) at the
package surfaces not only meet the regulatory requirements of 10 CFR 71.47,
but are ALARA.
Licensees shipping radioactive waste for disposal must prepare appropriate documentation. The general license in 10 CFR 71.12 provides the authorization used by
most licensees to transport, or offer for transport, packages of radioactive
material and specifies certain conditions. Transporting licensed materials
originating at some facilities involves quantities of radioactive material
that require a Type B package. The manufacturer (or service licensee)
who is subject to the provisions of 10 CFR 71.12 or 10 CFR 71.14, as appropriate,
is responsible for proper packaging of the radioactive materials and compliance
with NRC and DOT regulations. Licensees who use another manufacturers'
Type B package must ensure that the other manufacturer (or service licensee):
If a licensee plans to make shipments of licensed materials in Type B packages on its own, the licensee must be registered as a user of the package and have an NRC-approved quality assurance (QA) plan, two of the requirements under the 10 CFR 71.12 general license. For information about QA plans, see Revision 1 of Regulatory Guide 7.10, "Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material," dated June 1986. For further information about registering as a user of a package or submitting a QA program for review, contact NRC's Spent Fuel Project Office (SFPO) by calling NRC's toll-free number, 800-368-5642, extension 415-8500. For information about associated fees, contact NRC's Office of the Controller by calling NRC's toll-free number, 800-368-5642, extension 415-7554. During an inspection, NRC uses the provisions of 10 CFR 71.5 and a "Memorandum of Understanding with DOT on the Transportation of Radioactive Material," signed June 6, 1979, to examine and enforce various DOT requirements, listed in Appendix R. Response from Applicant: No response is needed from applicants during the licensing phase. However, before making shipments of licensed materials on its own in Type B packages, a licensee needs to have registered with NRC as a user of the package and obtained NRC's approval of its QA program. Transportation issues will be reviewed during inspection. References: "A Review of Department of Transportation Regulations for Transportation of Radioactive Materials," 1983 revision, can be obtained by calling DOT's Office of Hazardous Material Initiatives and Training, at (202) 366-4425. See the Notice of Availability (on the inside front cover of this report) to obtain a copy of the "Memorandum of Understanding with DOT on the Transportation of Radioactive Material," signed June 6, 1979; and Revision 1 of Regulatory Guide 7.10, "Establishing Quality Assurance Programs for Packaging Used in the Transport of Radioactive Material," dated June 1986. 8.10.10 Minimization of ContaminationRegulations: 10 CFR 20.1406. Criteria: Applicants for new licenses must describe how facility design and procedures for operation will minimize, to the extent practicable, contamination of the facility and the environment, facilitate eventual decommissioning, and minimize, to the fullest extent practicable, the generation of radioactive waste. Discussion: When designing facilities and developing procedures for their safe use, applicants should think ahead and consider how to minimize radioactive contamination/decontamination during operation and during decommissioning efforts, and how to minimize radioactive waste generation during all phases of facility life cycle. Manufacturing activities that produce sealed sources should be aware that a common business option is to accept damaged, unwanted, and replaced sources from their customers or salvagers. Sealed sources that may be returned to the facility present an unknown risk to the receiving department staff and to the persons charged with evaluating the condition of received materials. The manufacturing and distribution applicant may also be requested by customers to provide recovery and shipping services for unwanted, damaged, and replacement sources. As such, the applicant should consider the designs of shipping and recovery containers to meet transportation requirements. Procedures should be developed to enable these activities to be carried out with small impact on the radiological condition of the facility, decommissioning in the future, and employee external and internal radiation exposure. When submitting new applications, applicants should consider the following:
Sealed sources and devices that are approved by NRC or an Agreement State and located and used according to their SSD Registration Certificates usually pose little risk of contamination. Leak tests performed as specified in the SSD Registration Certificate should identify defective sources. Leaking sources must be immediately withdrawn from use and decontaminated, repaired, or disposed of according to NRC requirements. These steps minimize the spread of contamination and reduce radioactive waste associated with decontamination efforts. Other efforts to minimize radioactive waste do not apply to programs using only sealed sources and devices that have not leaked. Response from Applicant: The applicant does not need
to provide a response to this item under the following condition:
8.11 Item 11: Waste ManagementRegulations: 10 CFR 20.1904; 10 CFR 20.1906; 10 CFR 20.2001; 10 CFR 20.2002; 10 CFR 20.2003; 10 CFR 20.2004; 10 CFR 20.2005; 10 CFR 20.2006; 10 CFR 20.2007; 10 CFR 20.2108; 10 CFR 30.51; 10 CFR 61.52; 10 CFR 70.42. Criteria: Radioactive waste generated as part of the manufacturing and distribution process must be disposed of in accordance with regulatory requirements and license conditions. Appropriate records of waste disposal must be maintained. Waste licensed materials (such as glove, rags, tools) may not be received from others. Licensed materials which were distributed (such as decayed sources or devices at end of useful life) may be accepted from others, received, and sent for disposal properly. Discussion: The applicant should discuss the methods for management and disposal of radioactive waste. The program should include procedures for handling of waste, safe and secure storage, waste characterization, waste minimization, and disposal of radioactive waste. Appropriate training should be provided to waste handlers. EPA guidance for developing a comprehensive program to reduce hazardous waste was transmitted to licensees by NRC in IN-94-23, "Guidance to Hazardous, Radioactive, and Mixed Waste Minimization Program," dated March 1994. The application should include, where appropriate for the types of waste involved, provisions for monitoring and segregating waste materials (e.g., radioactive from non-radioactive, short from long half-life, liquid from solid waste). The following methods of waste disposal may be considered and should be addressed in the application as appropriate. Transfer to an Authorized Recipient Waste may be transferred to a recipient (usually a waste disposal service company or the original supplier) who is properly licensed to receive such waste in accordance with 10 CFR 20.2001(a). Each shipment must comply with all applicable NRC and DOT requirements. Licensees should implement procedures to reduce the volume of radioactive waste for final disposal in an authorized low-level radioactive waste (LLW) disposal facility. These procedures include volume reduction by segregating, consolidating, compacting, or allowing certain waste to decay in storage. Waste compaction or other treatments can reduce the volume of radioactive waste, but such processes may pose additional radiological hazards (e.g., airborne radioactivity) to workers, members of the public, and the environment. Safety procedures to address these concerns should be implemented. Decay-in-Storage Storage of radioactive materials with half-lives of greater than 120 days should be characterized regarding volume and anticipated time in residence at the licensee's facility prior to disposal. NRC has concluded that materials with half-lives of less than or equal to 120 days are appropriate for decay-in-storage (DIS). The minimum holding period for DIS is ten half-lives of the longest-lived radioisotope in the waste. Care should be taken that the waste form should not degrade or adversely interact with the waste container. Also, care should be taken to group waste packages by half-life. Waste packages having mixed half-lives must be held for 10 half-lives of the longest lived radionuclide in the package. Therefore, waste with a 65-day half-life (held in storage for 650 days), should not be held in the same container for the 1,200 days as required for material with a 120-day half-life. 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. NRC does not consider storage as a substitute for final disposal of radioactive wastes. Other than storage for radioactive decay, LLW should be stored only when disposal capacity is unavailable, and for no longer than is necessary. NRC Information Notice No. 90-09, "Extended Interim Storage of Low-Level Radioactive Waste For Fuel Cycle and Material Licensees," dated February 1990, provides guidance to licensees for requesting an amendment to authorize extended interim storage of LLW. A model procedure for DIS is contained in Appendix S, Waste Disposal. Release into Air and Water Release of radioactive material into air and water must conform to the requirements described in 10 CFR 20.1302(b)(2) (See Figure 8.17). The applicant should discuss the monitoring and control mechanisms in place to ensure compliance with the requirements. Applicants are reminded of the "constraint" on air emissions of radioactive material required by 10 CFR 20.1101(d) which effectively reduces the limits specified in 10 CFR 20.1302(b)(2) for release of gaseous effluents by a factor of ten. Applicants considering release of radioactive material into air and water should review Regulatory Guide 8.37, "ALARA Levels for Effluents From Materials Facilities," dated July 1993, which deals with the application of ALARA in controlling gaseous and liquid effluents and references documents with acceptable methods of effluent monitoring. Figure 8.17 Air and water effluents from manufacturing facility. Also note the fence, creating a "controlled area." Licensees considering disposal by release to the sanitary sewerage system must comply with the requirements of 10 CFR 20.2003. Licensees are responsible for demonstrating that licensed materials discharged into the sewerage system are readily soluble or biologic readily dispersible in water. NRC IN-94-07, "Solubility Criteria for Liquid Effluent Releases to Sanitary Sewerage Under the Revised 10 CFR 20," dated January 1994, provides the criteria for evaluating solubility of liquid waste. Liquid scintillation media and ash are examples of material that may or may not be readily dispersible. Licensees should carefully consider the possibility of reconcentration of radioisotopes that are released into the sewerage system. NRC alerted licensees to the potentially significant problem of reconcentration of radionuclides released to sanitary sewerage systems in IN-84-94, "Reconcentration of Radionuclides Involving Discharges into Sanitary Sewerage Systems Permitted Under 10 CFR 20.203 (now 10 CFR 20.2003)," dated December 1984. Applicants should provide procedures that will ensure that all releases of radioactive waste into the sanitary sewerage meet the criteria stated in 10 CFR 20.2003 and do not exceed the monthly and annual limits specified in the regulations. Licensees are required to maintain accurate records of all releases of licensed material into the sanitary sewerage. A model procedure for disposal of radioactive waste via sanitary sewer is described in Appendix S. If your facility maintains a private sewerage treatment system, a septic system, or leach fields, the regulations of 10 CFR 20.2003 are not applicable for releases to these systems. You may make releases of liquids to private sewerage systems, septic systems, or leach fields as effluents released to unrestricted areas pursuant to 10 CFR 20.1302(b)(2)(i). If liquid releases are made to a private sewerage treatment system, septic system, or leach field, the sludges or other solids from these systems may become contaminated with radioactive material. Applicants should describe the monitoring planned for these systems in Item 8.10.7 of your application. Contaminated sludges will be required to be disposed of as radioactive waste using one of the methods described in this section. Applicants may obtain approval of alternative disposal methods through application to the Commission as described in 10 CFR 20.2002. Incineration Applicants who wish to treat or dispose of licensed material by incineration must comply with the requirements of 10 CFR 20.2004. Policy and Guidance Directive PG 8-10, "Disposal of Incinerator Ash as Ordinary Waste," dated January 1997, provides guidance relative to the disposal of ash. A model procedure for incineration of waste is described in Appendix S. Applicants who are considering disposal of radioactive material by incineration should review Regulatory Guide 8.37, "ALARA Levels for Effluents From Materials Facilities," dated July 1993. Regulatory Guide 8.37 deals with the application of ALARA in controlling gaseous and liquid effluents and references documents containing acceptable methods of effluent monitoring. Waste Volume Reduction Waste volume reduction operations that could create a radiological hazard to licensee employees or the general public must be described in detail in the application. A model procedure for waste compaction is described in Appendix S. 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. Burial Licensees who were previously authorized to bury radioactive materials pursuant to 10 CFR 20.304 prior to January 28, 1981 should describe the locations, condition, and current status of these former sites in their license application under waste management (i.e., controlled or uncontrolled, active monitoring of the site, and current condition of burial site)[20.2108]. Licenses will not ordinarily be written to allow this option; however, an applicant can submit a request pursuant to 10 CFR 20.2002. Other Methods Specifically Approved by NRC Pursuant to 10 CFR 20.2002 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. Additional Considerations The application should describe the ALARA considerations taken before
disposal of radioactive materials. Discuss the potential for unmonitored
or unanticipated release of radioactive materials to work areas and from
release points (i.e., hoods and incinerator stacks). To be in compliance
with the ALARA philosophy stated in 10 CFR 20.1101, radioactive material
waste stream concentrations should be a fraction (generally 10% to 20%)
of the limits specified in Appendix B, Table II, 10 CFR Part 20. Furthermore,
due to the variability of inventory control programs for monitoring disposal
and releases of licensed material possessed or possessed and in use, a
program for physically measuring releases should be in place whenever
releases exceed the specified ALARA action point.
Response from Applicant: Provide procedures for waste collection, storage, and disposal by any of the authorized methods described in this section. Applicants should contact the appropriate NRC Regional Office for guidance and obtain advance approval of any method(s) of waste disposal other than those discussed in this section. Note: 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. 8.12 Item 12: Fees[ Prev | Next | Top of file ] The next two items on NRC Form 313 are to be completed on the form itself. On NRC Form 313, enter the appropriate fee category from 10 CFR 170.31 and the amount of the fee enclosed with the application. Refer to Section 7, License Fees. 8.13 Item 13: Certification[ Prev | Next | Top of file ] Individuals acting in a private capacity are required to date and sign NRC Form 313. Otherwise, representatives of the corporation or legal entity filing the application should date and sign NRC Form 313. Representatives signing an application must be authorized to make binding commitments and to sign official documents on behalf of the applicant. As discussed previously in Section 3, Management Responsibility, signing the application acknowledges management's commitment and responsibilities for the Radiation 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), 10 CFR 40.43(a), and 10 CFR 70.38(a)). Applicants for license renewal and amendment must do the following:
For renewals, provide a complete and up-to-date application if many outdated
documents are referenced or if there have been significant changes in
regulatory requirements, NRC's guidance, the licensee's organization,
or its Radiation Protection Program. Alternatively, describe clearly the
exact nature of the changes, additions, and deletions.
10 Applications for Exemptions[ Prev | Next | Top of file ] Regulations: 10 CFR 19.31; 10 CFR 20.2301; 10 CFR 30.11(a); 10 CFR 40.14(a); 10 CFR 70.14(a). Criteria: Licensees who request exemptions to regulations must demonstrate that the exemption is authorized by law, will not endanger life or property or the common defense and security, and is otherwise in the public interest. Discussion: Various sections of NRC's regulations address
requests for exemptions (e.g., 10 CFR 19.31, 10 CFR 20.2301, 10 CFR
30.11(a), 10 CFR 40.14(a), and 10 CFR 70.14(a)). These regulations state
that NRC may grant an exemption, either acting on its own initiative or
on an application from an interested person.
Exemptions are not intended to revise regulations, are not intended for
large classes of licenses, and are generally limited to unique situations.
Exemption requests 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 irradiation of materials or objects. See NUREG-1556, Vol. 6, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About 10 CFR Part 36 Irradiator Licenses," 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 Irradiator Licenses." 11 Termination of Activities[ Prev | Next | Top of file ] Regulations: 10 CFR 20.1401; 10 CFR 20.1402; 10 CFR 20.1403; 10 CFR 20.1404; 10 CFR 20.1405; 10 CFR 20.1406; 10 CFR 30.34(b); 10 CFR 30.35(g); 10 CFR 30.36(d); 10 CFR 30.36(g); 10 CFR 30.36(h); 10 CFR 30.36(j); 10 CFR 30.51(f); 10 CFR 40.36; 10 CFR 40.42; 10 CFR 40.51; 10 CFR 40.62(e); 10 CFR 70.38. Criteria: Pursuant to the regulations described above,
the licensee must do the following:
Discussion: As discussed above in "Criteria," before a licensee can decide whether it must notify NRC, the licensee must determine whether residual radioactivity is present and, if so, whether the levels make the building or outdoor area unsuitable for release according to NRC requirements. A licensee's determination that a facility is not contaminated is subject to verification by NRC inspection. NUREG-1727, "NMSS Decommissioning Standard Review Plan," dated September 2000, and NUREG/BR-0241, "NMSS Handbook for Decommissioning Fuel Cycle and Materials Licenses," dated March 1997, contain the current regulatory guidance concerning decommissioning of facilities and termination of licenses. Appendix B of NUREG/BR-0241 contains a comprehensive list of NRC's decommissioning regulations and guidance. NUREG-1727 contains a list of superceded guidance; however, due to ongoing revisions, applicants are encouraged to consult with NRC staff regarding updates of decommissioning guidance. NUREG-1575, "Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM)," dated December 1997, should be reviewed by licensees who have large facilities to decommission. An acceptable computer code for calculating screening values to demonstrate compliance with the unrestricted dose limits is DandD, Version 1.0, which is available for download from NRC's web site at http://www.nrc.gov/RES/rescodes.htm. NUREG-1727 includes a table (Table C2.2) of acceptable license termination screening values of common beta/gamma radionuclides for building surface contamination. NUREG-1727 also contains methods for conducting site-specific dose assessments for facilities with contamination levels above those in the table. Response from Applicant: The applicant is not required to submit a response to NRC during the initial application. The applicant's obligations in this matter begin when the license expires or at the time the licensee ceases operations, whichever is earlier. These obligations are to undertake the necessary decommissioning activities, to submit NRC Form 314 or equivalent information, and to perform any other actions as summarized in the "Criteria." References: Copies of NRC Form 314, "Certificate of Disposition of Materials," are available upon request from NRC's Regional Offices. (See Figure 2.1 for addresses and telephone numbers.) Appendix A: List of Documents Considered in Development of this NUREG[ Prev | Next | Top of file ] This report incorporates and updates the guidance previously found in the NUREG reports, Regulatory Guides (RGs), Policy and Guidance Directives (P&GDs or PGs), and Information Notices (INs). Other NRC documents such as Manual Chapters (MCs), Inspection Procedures (IPs), Memoranda of Understanding (MOU), and Technical Assistance Requests (TARs) were also consulted during the preparation of this report. Table A.1 List of NUREG Reports, Regulatory Guides, and Policy and Guidance Directives.
Table A.2 List of Information Notices.
Table A.3 Miscellaneous NRC Documents.
Appendix B: United States Nuclear Regulatory Commission Form 313[ Prev | Next | Top of file ]
Appendix C: Suggested Format for Providing Information Requested in Items 5 through 11 of NRC Form 313 for a Possession License[ Prev | Next | Top of file ] The table below is designed to help applicants develop their applications. It may also be used as a License Reviewer Checklist for applications for Manufacturing and Distribution licenses. A box in a column (r) indicates that the licensee may agree to use a model procedure, or if not using a model procedure, the licensee is then expected to describe its program or submit its procedures for the particular item. For broad scope usage applications, refer to NUREG-1556, Vol. 11, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses of Broad Scope." Appendix D: Sample Licenses[ Prev | Next | Top of file ] Sample Licenses appear on the following pages. Note: For an example of a distribution license for generally licensed products, see NUREG-1556, Vol. 16, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Licenses Authorizing Distribution to General Licensees." For an example of a distribution license for exempt products, see NUREG-1556, Vol. 8, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Exempt Distribution Licenses."
Appendix E: Information Needed for Transfer of Control Application[ Prev | Next | Top of file ] For information on the transfer of control application, refer to NUREG-1556, Vol. 15, "Consolidated Guidance About Materials Licenses: Guidance About Changes of Control and About Bankruptcy Involving Byproduct, Source, or Special Nuclear Materials Licenses." Appendix F: License Types - Guidance[ Prev | Next | Top of file ] XX (state code)-XXXXX (institution code - a unique identifier for each licensee)-XX (sequential number of license for that licensee). Letters that follow the license number on distribution licenses include: E, G, MD. No letters indicates a possession license.
This specific license is issued to a manufacturer to possess, use, manufacture, etc. licensed material for distribution and for use by the licensee in process controls. It can include distribution to other specific licensees who are also specifically authorized to receive the materials pursuant to their specific license. The manufacturer's possession license contains conditions that prohibit distribution pursuant to 10 CFR 32.72, 32.74, and prohibit distribution to general licensees and to persons exempt from licensing.
This specific license is issued to an importer to possess (only) licensed material for transfer. It only authorizes transfers to other specific licensees authorized by license condition to receive the materials. The importer's possession license contains conditions that prohibit distribution pursuant to 10 CFR 32.72, 32.74, and prohibit distribution to general licensees and to persons exempt from licensing.
This specific license is issued to manufacturers and/or distributors to distribute approved materials to persons who are generally licensed to possess and use the materials. This license does not authorize the possession of byproduct, source, or special nuclear material. The most common products distributed to general licensees are: 10 CFR 32.51/51a/52 Certain measuring, gauging, or controlling devices, including: fixed gauges including density, thickness, etc. and may include multi-curie sources; gas chromatograph ECDs, X-ray fluorescence or other analytical devices; curie-quantity tritium light sources for exit signs; and similar devices. For possession and use by persons authorized by a General License pursuant to 10 CFR 31.5. 10 CFR 32.71 Kits for in vitro clinical or laboratory testing, e.g., microcurie quantities of H-3, C-14, Fe-55, I-125, etc. For possession and use by persons authorized by a General License pursuant to 10 CFR 31.11.
Specific license to distribute approved materials to persons who are not required to have any license in order to possess or use the material. Exempt Distribution is authorized by a Specific License ISSUED BY NRC HEADQUARTERS in Washington, D.C. This license does not authorize the possession of byproduct, source, or special nuclear material.
10 CFR 32.72 and 32.74 Sources/devices for medical use pursuant to 10 CFR 35.57/400/500 for radiopharmaceuticals for medical use pursuant to 10 CFR 35.100/200/300 (since the "new pharmacy rule," which eliminated regulation of cold kits; regulation of distribution of generators is also included). This license does not authorize the possession of byproduct, source, or special nuclear material. Manufacturers of medical devices may wish to plan for return shipments of licensed materials. Manufacturers of sealed source devices such as eye applicators or bone densitometers may wish to provide a return at end of useful life service. Radiopharmaceutical manufacturers may wish to receive spent generator assemblies from their customers and dispose of them by decay-in-storage. The manufacturer should prepare return shipping procedures for customers to use. The shipper is responsible for the proper preparation for shipment. Many licensees request assistance from manufacturers about shipments. These instructions may be included with this license application. Returned materials are possessed pursuant to the manufacturer's possession license. Appendix G: 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 8.5). Typically, these duties and responsibilities
include the following:
Appendix H: Radiation Safety Training[ 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 accomplished by providing a simple hand-out, whereas others may require extensive training, including a written exam to assess retention of the topics presented. The licensee should determine whether the training succeeded in conveying the desired information and adjust the training program as necessary. This assessment may be performed by a written test or observation of the individual in the performance of assigned duties. Remedial training for missed test questions or other areas of apparent weakness should be conducted or additional formal training planned to cover deficient areas. Frequency of Training 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 A. Radiation safety: 1. radiation vs. contamination; 2. internal vs. external exposure; 3. biological effects of radiation; 4. ALARA concept; 5. use of time, distance, and shielding to minimize exposure; 6. contact dose rates and dose rates at a distance from high activity sources; 7. dose reduction responsibilities. B. Regulatory requirements: 1. RSO; 2. material control and accountability; 3. personnel dosimetry; 4. Radiation Safety Program audits; 5. transfer and disposal; 6. recordkeeping; 7. surveys; 8. postings; 9. labeling of containers; 10. handling and reporting of incidents or events; 11. licensing and inspection by NRC; 12. need for complete and accurate information; 13. employee protection; 14. deliberate misconduct. Licensee-Specific Program Elements A. Authorized users and supervised users. B. Worker-specific manufacturing process tasks. C. Shipping. D. Ordering and receiving radioisotopes. E. Applicable regulations and license conditions. F. Areas where radioactive material is used or stored. G. Potential hazards associated with radioactive material in each area where the individuals will work. H. Appropriate radiation safety procedures. I. Licensee's in-house work rules (for instructions on laboratory safety and uses of radioisotopes, see Appendix N). J. Each individual's obligation to report unsafe conditions to the RSO. K. Appropriate response to spills, emergencies, or other unsafe conditions. L. Worker's right to be informed of occupational radiation exposure and bioassay results, if applicable. M. 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. N. Emergency procedures: 1. RSO name and telephone number; 2. immediate steps to prevent or control spread of contamination; 3. clean-up instructions, decontamination. O. Survey program: 1. survey instrument accessibility; 2. who is responsible; 3. types, contamination, and areas; 4. frequency; 5. levels of contamination; 6. personnel, hands, shoes; 7. records. P. Waste: 1. liquid; 2. solids; 3. sanitary sewer; 4. burial (transfer to low-level waste repository); 5. storage; 6. decay-in-storage; 7. waste storage surveys; 8. incineration; 9. records. Q. Dosimetry: 1. whole body; 2. extremities; 3. lost or replacement badges and dose assessment; 4. bioassay procedures; 5. records. R. Instrumentation: 1. survey meters - use, calibration frequency, use of check sources; 2. analytical instruments - gas flow counters, liquid scintillation counters; S. Procedures for receiving packages containing radioactive materials: 1. normal; 2. off-duty; 3. notification of user and RSO; 4. security; 5. exposure levels; 6. possession limit; 7. receipt of damaged packages. T. Procedures for opening and examining packages: 1. leakage and contamination; 2. monitoring packages; 3. monitoring packing materials; 4. gloves; 5. transferring material to users. U. Animal experiments: 1. description of facilities; 2. safety instructions, including handling of animals, waste, carcasses, and cleaning and decontamination of cages; 3. security. V. Sealed sources: 1. leak-test requirements; 2. inventory requirements; 3. exempt quantities; 4. records. W. NRC/State/Licensee audit findings X. Other topics. Y. Question and answer period. For Laboratory Safety and Use of Radioisotopes
Appendix I: Facilities and Equipment[ Prev | Next | Top of file ] Below is a list of topics that should be considered when developing a description of the facilities and equipment that a licensee will use or otherwise have available. Not every applicant will need to address each of these topics in its application.
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 and/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 J: Example Audit Form[ Prev | Next | Top of file ] The following audit form may be used by licensees to self-assess the adequacy of the licensed program, identify program weaknesses, and allow licensees to take early corrective actions (before an NRC inspection). Attachment A may be used by licensees that distribute radioactive drugs. These forms are not intended to be all inclusive. During an audit, the auditor needs to keep in mind not only the requirements of NRC's regulations, but also the licensee's commitments in its applications and other correspondence with NRC. Licensees are encouraged to modify the audit form as needed to include items specific to their licensed program and should ensure that radiation safety audits include activities conducted during all shifts. References are also included. EXAMPLE AUDIT FORM
REFERENCES 1. AMENDMENTS AND PROGRAM CHANGES: Applicable license conditions. 2. MANAGEMENT OVERSIGHT: A. Radiation Safety CommitteeApplicable license conditions. B. Radiation Safety OfficerApplicable license conditions. C. Audits, Reviews, or Inspections10 CFR 20.1101, Radiation Protection Programs. D. ALARA10 CFR 20.1101, Radiation Protection Programs.E. Authorized UsersApplicable license conditions. 3. FACILITIES A. Access Control10 CFR 20.1601, 1602 , Control of access to high/very high radiation areas. B. Engineering Controls10 CFR 20.1101, Radiation Protection Programs. 4. EQUIPMENT AND INSTRUMENTATION: A. Survey Instruments10 CFR 20.1501, General. B. Safety Component Defects10 CFR 21.21, Notification of failure to comply or existence of a defect and its evaluation. 5. MATERIAL USE, CONTROL AND TRANSFER: A. License and applicable license conditions. B. Security and Control10 CFR 20.1003 , Definitions (restricted area and unrestricted area).C. Receipt and Transfer of Licensed Material 6. AREA RADIATION SURVEYS AND CONTAMINATION CONTROL:
7. TRAINING AND INSTRUCTIONS TO WORKERS: 10 CFR 19.12, Instruction to workers. 8. RADIATION PROTECTION: A. Radiation Protection Program 1. Exposure evaluation 10 CFR 20.1501 , General. 2. Programs B. Dosimetry10 CFR 20.1101, Radiation Protection Programs. 1. Dose Limits 10 CFR 20.1201 , Occupational dose limits for adults. 2. External 10 CFR 20.1203 , Determination of external dose from airborne radioactive material.3. Internal C. Records10 CFR 20.2102, Records of Radiation Protection Programs. 9. RADIOACTIVE WASTE MANAGEMENT: A. Disposal10 CFR 20.1904, Labeling containers.B. Effluents 1. GeneralRegulatory Guide 8.37, ALARA Levels for Effluents from Materials Facilities.2. Release to septic tanks10 CFR 20.1003, Definitions (sanitary sewerage). 3. Incineration of waste 10 CFR 20.2004 , Treatment or disposal by incineration.4. Control of air effluents and ashes C. Waste Management10 CFR 20.1201, Occupational dose limits for adults. 1. General10 CFR 20.2001, General requirements.2. Waste compactedApplicable license conditions.3. Waste storage areas 10 CFR 20.1801, Security of stored material.4. Packaging, Control and Tracking 10 CFR Part 20, Requirements for Low-Level Waste Transfer. 5. Transfer10 CFR Part 20, Requirements for Low-Level Waste Transfer. 6. Records10 CFR 20.2103, Records of surveys. 10. DECOMMISSIONING: 10 CFR 30.35 , Financial assurance and recordkeeping for decommissioning. 11. TRANSPORTATION: A. General10 CFR 71.5, Transportation of licensed material.B. Shippers - Requirements for Shipments and Packaging 1. General Requirements49 CFR Part 173, Class 7 (radioactive) materials.2. Transport Quantities 10 CFR 71.4 , Definitions.a. All quantities 10 CFR 71.4 , Definitions.b. Limited quantities 49 CFR 173.421, Excepted packages for limited quantities of Class 7 (radioactive) materials.c. Type A quantities d. Type B quantities10 CFR 71e. LSA material and SCO C. HAZMAT Training3. HAZMAT Communication Requirements49 CFR 173.403, Definitions. 49 CFR 172.702, Applicability and responsibility for training and testing.D. Transportation by Public Highway 49 CFR 171.15, Immediate notice of certain hazardous materials incidents. 12. NOTIFICATIONS AND REPORTS: 10 CFR 19.13 , Notifications and reports to individuals. 13. POSTING AND LABELING: 10 CFR 19.11, Posting of notices to workers. 14. INDEPENDENT AND CONFIRMATORY MEASUREMENTS: No references. 15. AUDIT FINDINGS: No references. 16. SOURCE OR DEVICE REVIEW: 10 CFR 32.210, Registration of product information.
Appendix K: Radiation Monitoring Instrument Specifications and Model Survey Instrument and Air Sampler Calibration Program[ Prev | Next | Top of file ] The specifications in Table K.1 will help applicants and licensees choose the proper radiation detection equipment for monitoring the radiological conditions at their facility(ies). Table K.1 Typical Survey Instruments(7) (Instruments used to measure radiological conditions at licensed facilities).
Model Instrument Calibration Program Training Before allowing an individual to perform survey instrument calibrations, the RSO will ensure that he or she has sufficient training and experience to perform independent survey instrument calibrations. Classroom training may be in the form of lecture, videotape, or self-study
and should cover the following subject areas:
Appropriate on-the-job-training consists of the following:
Facilities and Equipment for Calibration of Dose Rate or Exposure
Rate Instruments
Model Procedure for Calibrating Survey Instruments A radioactive sealed source(s) used for calibrating survey instruments
will:
The three kinds of scales frequently used on dose or dose rate survey
meters are calibrated as follows(8):
Surface Contamination Measurement Instruments2
Model Procedures for Calibrating, Liquid Scintillation Counters,
Gamma Counters, Gas Flow Proportional Counters, and Multichannel Analyzers
Calibration
Calibration Records Calibration records, for all survey instruments, should indicate the
procedure used and the data obtained. The description of the calibration
should include:
The following information should be attached to the instrument as a calibration
sticker or tag:
Air Sampler Calibration In order to assess accurately the air concentration of radioactive materials in a given location, the volume of air sampled and the quantity of contaminant in the sample 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, 7th Edition, American Conference of Governmental Industrial Hygienists, 1989, (available from the American Conference of Governmental Industrial Hygienists, Inc., 1330 Kemper Meadow Drive, Cincinnati, Ohio 45240-1634) provides guidance on total air sample volume calibration methods acceptable to NRC staff, as supplemented below. Air Sampling Instruments, 8th Edition, American Conference of Governmental Industrial Hygienists, 1995 is also available. The 8th Edition has not been reviewed for acceptability by NRC for licensing purposes. NRC license applicants may submit materials based upon the 8th Edition, but be aware that the review will require more time than if using the 7th Edition and the NRC-developed information. Frequency of Calibration
Error Limit For Measurement of Air Sample Volume Most 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 EV, in the determination of total volume, should be less than 20%.3 A sample calculation of the most probable value of the cumulative error in total volume measured is as follows: If accuracies of the scale reading, the calibration factor, and sample time are ± 4, 2 and 1%, respectively, and there are no other significant sources of error, the cumulative error would be:
If there are significant differences in pressure and temperature between the calibration site and the sampling site, appropriate corrections should be made using the ideal gas laws provided below:
Documentation of Calibration of Air Metering Devices The licensee should maintain records of all routine and special calibrations of airflow or volume metering devices, including the primary or secondary standard used, method employed, and estimates of accuracy of the calibrated metering devices. All instruments should be clearly labeled as to the date and results of the most recent calibration and should include the appropriate correction factors to be used. References: See the Notice of Availability (on the inside
front cover of this report) to obtain a copy of:
Additional References:
Appendix L: Material Receipt and Accountability[ Prev | Next | Top of file ] Sample Model Procedure for Ordering and Receiving Radioactive
Material
Sample Memorandum Memorandum 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 another 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 Shipping and Receiving Personnel During normal working hours, immediately upon receipt of any package of licensed material, each package must be visually inspected for any signs of shipping damage such as crushed or punctured containers or signs of dampness. Any obvious damage must be reported to the RSO immediately. Do not touch any package suspected of leaking. Ask the person delivering the package to remain until monitored by the RSO. Outside of normal working hours (e.g., nights, weekends, and holidays), deliveries will usually be handled by security personnel (or other trained individuals) as described in the above procedures. Since certain packages of licensed material will have detectable external radiation, they should be sent immediately to a designated storage area, where they will be checked for contamination and external radiation level as soon as practical. They should not be allowed to remain in the receiving area any longer than necessary, as they may be a source of exposure for receiving personnel. If the instructions are not clear, or if there are questions regarding receiving packages containing radioactive material, please contact: Name:_______________________________________________________________ __________________________ Phone:_______________________________________________________________ __________________________
Sample Model Procedure for Safely Opening Packages Containing Licensed Materials For packages received under the specific license, authorized individuals
shall implement procedures for opening each package, as follows:
Sample Transfer Policy Statements Internal Transfers Licensed 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 Transfers Licensed 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. Gifts On occasion, licensees may be offered or have donated licensed materials by other individuals as gifts (e.g., a retiring medical practitioner donating his cesium needles to the university medical center). All such gifts of radioactive materials must be transferred to the licensee and handled in accordance with NRC requirements and the conditions of the license. In any case, the RSO should approve the gift prior to the transfer. Appendix M: Guidance for Demonstrating That Individual Members of the Public Will Not Receive Doses Exceeding the Allowable Limits[ Prev | Next | Top of file ] This appendix describes methods for determining radiation doses to members of the public. Licensees must ensure that:
The licensee may show compliance with the annual dose limit for individual
members of the public by:
In order to perform a dose assessment, licensees should identify all potential sources of external and internal radiation exposure to members of the public and all locations of use, transport, and storage of radioactive material at their facilities. Licensees must then take radiation measurements or perform calculations to demonstrate compliance. Measurements The licensee may use measurements to demonstrate that the average annual
releases are within regulatory limits, as well as to demonstrate that
the TEDE to the individual likely to receive the highest dose at the boundary
of the unrestricted area does not exceed 1 mSv (100 mrem). These measurements
may include:
The method used to measure dose will depend upon the nature of the radiation source. If the source of radiation is constant, it may be adequate to measure the dose rate and integrate it over time. If the source of radiation differs or changes over time, it may be necessary to perform continuous measurements. Radioactivity releases may be determined by effluent monitoring or by effluent sampling and analysis. Airborne effluents may be discharged when volatile materials are used, such as during iodinations, but the discharge itself is usually not continuous since volatile materials are often used periodically rather than continuously. Liquid effluents may be discharged continuously or may be stored and subsequently discharged on a batch basis. For each type of source and for each route of potential exposure, consider the location of measurement points, whether continuous or periodic monitoring is required, the frequency of sampling and measurement, and any additional information. For discharges of airborne radionuclides, for example, it may be necessary to obtain information on the efficiency of filters and the air flow rate of the discharge system, as well as meteorological data and the distance to the nearest individual member of the public. Calculation Method Using a calculation method, the licensee must determine the highest dose an individual is likely to receive at the boundary of the unrestricted area. The licensee must take into account the individual's exposure from external sources and the concentration of radionuclides in gaseous and liquid releases. In practice, the licensee may wish to make conservative assumptions to simplify the dose calculation. The public dose limit applies to the individual who is likely to receive the highest dose from licensed operations. Therefore, the dose calculations must consider the location with the potential for the highest internal and external exposures. A conservative calculation should assume that the individual was continuously present 24 hours a day, 365 days a year, or an occupancy factor of 1 (see Table M.1). If the result of the calculation using an occupancy factor of 1 demonstrates that the public dose limit is not exceeded, then there is no need for further evaluation. If the calculation demonstrates that the public dose limit is exceeded with an occupancy factor of 1, then more realistic assumptions of the individual's occupancy at the points of highest internal and external exposures may be made. The licensee may use the occupancy factors in Table M.1 or may calculate a specific occupancy factor by determining the likely fraction of time that the individual is present. Table M.1 Standard Occupancy Factors.
Records The licensee must maintain records to demonstrate compliance with the dose limit for individual members of the public until the Commission terminates the license. In general, survey and monitoring records of ambient radiation and effluent radioactivity should be adequate. Records demonstrating the dose to an individual member of the public should identify the instruments used in the survey, the name of the surveyor, the date of the survey, the location of the survey(s), including a description or drawing of the area surveyed, survey results, and if applicable, the occupancy factors used and justification for their use. In addition, records demonstrating the dose to an individual member of the public that involve effluent sampling analysis should include information on concentrations of specific radionuclides, minimum detectable activity of the system, and the estimated uncertainty of measurements. Appendix N: General Topics for Safe Possession and Use of Radioactive Materials and Model Emergency Procedures[ Prev | Next | Top of file ] This appendix describes general topics for safe possession and use of radioactive materials, and procedures for handling and reporting emergencies. General Topics for Safe Possession and Use of Radioactive Materials Each area where radioactive material is used or stored should have general rules, so that workers know what is required. Typical instructions should include:
Figure N.1 Storage of Food and Drink. Food or drink shall not be stored in refrigerators with radioisotopes. Radionuclide-Specific Procedures Licensees should develop written procedures for use of different radionuclides so that users know the types of shielding, protective clothing, survey instruments, surveys, and decontamination activities that are required. Examples of such procedures are included below.
Model Procedures for Handling Emergencies
General Safety Procedures to Handle Spills
Minor Spills of Liquids and Solids
Major Spills of Liquids and Solids
Reminders to RSO
Incidents Involving Radioactive Dusts, Mists, Fumes, Organic
Vapors, and Gases
Minor Fires
Fires, Explosions, or Major Emergencies
Appendix O: Typical Notification and Reporting Requirements[ Prev | Next | Top of file ] This appendix lists some typical notification and reporting requirements found in Title 10 of the Code of Federal Regulations. It is not meant to be all inclusive. Table O.1 Typical NRC Notifications and/or Reports.
Note: Telephone notifications shall be made to the NRC Operations Center at (301) 951-0550, except as noted. Appendix P: 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 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
Ambient Radiation Level Surveys
Contamination Surveys 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 Personnel should survey for contamination in locations where individuals are working with an unsealed form of radioactive material in an amount greater than or equal to 10% of the smallest annual limit on intake (ALI) (either the inhalation or ingestion ALI) listed for that radionuclide in 10 CFR Part 20 Appendix B. These surveys should be done at a frequency appropriate to the types and quantities of radioactive materials in use, but at a minimum quarterly. If amounts are used that are greater than or equal to the smallest ALI listed for that radionuclide in 10 CFR Part 20, detailed, documented surveys should be performed at least monthly. Table P.1 contains suggested contamination survey frequency from Regulatory Guide 8.23. (See Tables P.2, P.3, and P.4 for alternate survey frequencies). Table P.1 Suggested Frequency of Contamination Surveys from Regulatory Guide 8.23.
Alternate Survey Frequency Classification of Laboratories or Areas of Use Table P.2 Survey Frequency Category.
Proportional fractions are to be used for more than one isotope. Table P.3 Survey Frequency Category Modifiers.
The object is to determine how often to survey the laboratory or area of use. To do this, multiply the activity range under LOW, MEDIUM, and HIGH survey frequency in Table P.2 by the appropriate Modifying Factor to construct a new set of FCi ranges for LOW, MEDIUM, and HIGH survey frequency. Survey Frequency:
Table P.4 Isotope Groups.
Contamination in Unrestricted Areas Contamination found in unrestricted areas should be immediately decontaminated to background levels. When it is not possible to get to background levels, the licensee must ensure that the amounts do not exceed the contamination levels listed in Table P.5. Table P.5 Acceptable Surface Contamination Levels.
1 Where surface contamination by both alpha- and beta-gamma-emitting nuclides exists, the limits established for alpha- and beta-gamma-emitting nuclides should apply independently. 2 As used in this table, dpm (disintegration per minute) means the rate of emission by radioactive material as determined by correcting the counts per minute observed by an appropriate detector for background, efficiency, and geometric factors associated with the instrumentation. 3 Measurements of average contaminant should not be averaged over more than 100 square centimeters. For objects of less surface area, the average should be derived for each such object. 4 The maximum contamination level applies to an area of not more than 100 cm2. 5 The amount of removable radioactive material per 100 cm2 of surface area should be determined by wiping that area with filter or soft absorbent paper, applying moderate pressure, and assessing the amount of radioactive material on the wipe with an appropriate instrument of known efficiency. When removable contamination on objects of less surface area is determined, the pertinent levels should be reduced proportionally and the entire surface should be wiped. When equipment or facilities that are potentially contaminated are to be released for unrestricted use, the above table provides the maximum acceptable residual levels. To the extent practicable, it is appropriate to decontaminate to below these levels. Surface contamination surveys should be conducted for both removable and fixed contamination before these facilities or equipment are released from restricted to unrestricted use, to ensure that they meet these limits. A standardized method for smear testing of a relatively uniform area should be used to aid in comparing contamination at different times and places. A smear taken from an area of about 100 cm2 is acceptable to indicate levels of removable contamination. Survey Record Requirements 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 P.1 Area Diagram. This is an example of a laboratory survey map. Air Monitoring in the Workplace
If bioassay measurements are used to determine worker doses of record, air sampling may be used to determine time of intake and to determine which workers should have bioassay measurements. The use of engineering controls and a good air sampling program can eliminate the need for bioassays. Refer to Regulatory Guide 8.25, Revision 1, "Air Sampling in the Workplace," dated June 1992, and NUREG-1400, "Air Sampling in the Workplace," dated September 1993, or the current revision, for further guidance on air sampling. Airborne Effluent Release Monitoring When practicable, airborne radioactive effluents should be released from monitored release points (e.g., monitored stacks, discharges, vents) to provide accurate measurements to estimate public exposure. Licensees should verify the performance of effluent monitoring systems by regular calibration (at least annually) to ensure their reliability. Regulatory Guide 4.20, "Constraints on Release of Airborne Radioactive Materials to the Environment for Licensees Other Than Power Reactors," dated December 1996, provides guidance on methods acceptable (calculation or COMPLY code) to NRC for compliance with the constraint on air emissions to the environment. Regulatory Guide 8.37, "ALARA Levels for Effluents from Materials Facilities," dated July 1993, provides guidance on designing an acceptable program for establishing and maintaining ALARA levels for gaseous and liquid effluents at materials facilities. For release points for which monitoring is not practicable, the licensee should estimate the magnitude of the unmonitored effluents. These unmonitored releases will occur anytime unsealed material is handled outside a fume hood or other device that will control the releases. The licensee should include these estimates when demonstrating compliance with dose limits and ALARA goals. Unmonitored releases may be estimated based on the quantity of material used in these areas or the number of procedures performed or other appropriate methods. The unmonitored effluents should not exceed 30% of the total estimated effluent releases or 10% of the permissible air effluent concentrations found in Column 1 of Table 2 in 10 CFR Part 20, Appendix B, whichever is greater. Effluent monitoring systems should be designed in accordance with ANSI N13.1 (1969), "Document to Sampling Airborne Radioactive Materials in Nuclear Facilities," and ANSI N42.18, "Specification and Performance of On-site Instrumentation for Continuously Monitoring Radioactive Effluents." Liquid Effluent Release Monitoring The licensee should evaluate the concentrations of radioactive material in water that is released to the environment and to the sanitary sewer. The licensee must show that these releases meet the limits in 10 CFR 20.1301 and 20.2003, respectively. The topic of sanitary sewer releases is more fully discussed in Appendix Q. Bioassay Monitoring Frequency of Required Bioassay Measurements Determining the appropriate frequency of routine bioassay measurements
depends upon the exposure potential and the physical and chemical characteristics
of the radioactive material, and the route of entry to the body. Consider
the following elements:
Bioassay measurements used for demonstrating compliance with the occupational dose limits should be conducted often enough to identify and quantify potential exposures and resultant intakes that, during any year, are likely to collectively exceed 0.1 times the ALI. The 10% ALI criterion is consistent with 10 CFR 20.1502(b), which requires licensees to monitor intakes and assess occupational doses for exposed individuals who are likely to exceed 10% of the applicable limit (i.e., intakes likely to exceed 0.1 ALI for adults). Separate categories of bioassay measurements, routine measurements, and special measurements further determine the frequency and scope of measurements. Routine Measurements Routine measurements include baseline measurements, periodic measurements, and termination measurements. These measurements should be conducted to confirm that appropriate controls exist and to assess dose. The method of bioassay selected (for example, whole body counting, urinalysis, etc.) and the samples collected will vary according to the radionuclides and the compound to which it is attached. Sample collection procedures should be developed to ensure that appropriate types, sizes, and numbers of samples are collected that will provide appropriate physiological information for the dose assessment. An individual's baseline measurement of radioactive material within the body should be conducted before beginning work that involves exposure to radiation or radioactive materials for which monitoring is required. In addition to the baseline measurements, periodic bioassay measurements should be performed. The frequency of periodic measurements should be based on the likelihood of significant exposure of the individual. In determining the worker's likely exposure, consider such information as the worker's access, work practices, measured levels of airborne radioactive material, and exposure time. Periodic measurements should be made when the cumulative exposure to airborne radioactivity 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, a termination bioassay measurement should be made, when practicable, to ensure that any unknown intakes are quantified. Collection of Emergency 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 such as sampling urine or
other excreta from the body and calculating the intake from the amount
of material detected in the samples, the time between suspected intake
and sample collection, and knowledge of the rate of excretion of the compound
and/or radionuclide from the body. While there are many ways to perform
the calculations, including using computer models, the method of calculation
is only as good as the quality of the samples and analyses performed.
Because a dose estimate may be required, bioassay procedures for a suspected
intake may differ from those in a routine bioassay screening program,
and 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:
Special Monitoring Because of uncertainty in the time of intakes and the absence of other
data related to the exposure (e.g., physical and chemical forms, exposure
duration), correlating positive results to actual intakes for routine
measurements can sometimes be difficult. Abnormal and inadvertent intakes
from situations such as a failed respiratory protective device, inadequate
engineering controls, inadvertent ingestion, contamination of a wound,
or skin absorption, should be evaluated on a case-by-case basis. When
determining whether potential intakes should be evaluated, consider the
following circumstances:
References:
Appendix Q: Model Leak Test Program[ 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 Leak tests will be conducted at the frequency specified in the respective SSD Registration Certificate. Procedure for Performing Leak Testing and Analysis For each source to be tested, list identifying information such as manufacturer,
model number, serial number, radionuclide, and activity.
Appendix R: Transportation[ Prev | Next | Top of file ] Part 1 - Regulations Transportation The major areas in the DOT regulations that are most relevant for transportation of licensed material shipped as Type A quantities are contained in NUREG-1660/RAMREG-002, "U.S. Specific Schedules of Requirements for Transport of Specified Types of Radioactive Material Consignments," dated November 1998. Appendix R: Transportation - Part 2 Sample Shipping Documents, Placards, and Labels[ Prev | Next | Top of file ]
Appendix S: Waste Disposal[ Prev | Next | Top of file ] General Discussion
Model Procedure for Decay-In-Storage (DIS) Applicants should assure that adequate space and facilities are available for the storage of waste for DIS. Licensees can minimize the need for storage space if the waste is segregated according to physical half-life.
All radiation labels must be defaced or removed from containers and packages prior to disposal as ordinary trash. Syringes/needles placed into sealed waste containers for decay do not need the labels removed provided that the following is done: waste barrels are sealed prior to delivery to the waste disposal firm and delivered directly from the licensee's facility; labels are removed from the waste barrels/containers; the waste is incinerated, not placed in a landfill; and the waste disposal firm is cautioned not to open the container prior to incineration. Model Procedure for Disposal of Liquids Into Sanitary Sewerage
Model Procedure for Incineration These guidelines apply to noncommercial waste disposal (i.e., incineration
of a licensee's own waste). You do not need specific NRC approval in order
to incinerate certain categories of radioactive waste. For example, 10
CFR 20.2005 provides that tritium and carbon-14 in low level concentrations,
in liquid scintillation media and animal tissue, may be disposed of without
regard to radioactivity. After you review your program and confirm that
you have waste which requires specific NRC approval for incineration,
please provide the following information in your license application [20.2108].
NRC Policy and Guidance Directive PG 8-10: Disposal of Incinerator Ash as Ordinary Waste, is excerpted below for your convenience. This policy and guidance directive (P&GD) provides guidance for granting authorizations for disposal of incinerator ash as ordinary waste to municipal landfills. Policy and Guidance Pursuant to 10 CFR 20.2002, licensees may dispose of incinerator ash containing radioactive materials with Atomic Nos. 1-83, except those noted as ordinary waste in a landfill, provided the concentrations of the radionuclides at the time of disposal, when expressed in units of uCi per gram of ash, are numerically no greater than the values in Table II, Column 2, 10 CFR Part 20, Appendix B. The above policy does not apply to the following isotopes, for which the corresponding disposal limits are 10% of the values listed in Table II, Column 2, 10 CFR Part 20, Appendix B: H-3 (hydrogen-3), C-14 (carbon14), Al-26 (aluminum-26), Cl-36 (chlorine-36), Ag-108m (silver-108m), Nb-94 (niobium94), I-129 (iodine-129), Tc-99 (technetium-99), and Tl-204 (thallium-204). In applying the above limits to ash containing more that one radioactive isotope, the sum of fractions approach must be used. To show compliance with the ash release limits specified, appropriate surveys or calculations must be conducted pursuant to 10 CFR 20.1501(a)(2), to determine that the average concentration of licensed material in the ash does not exceed the permissible values. In the case of disposal of H-3, the licensee may assume that all the tritium that was in the incinerator feed is converted to tritiated water and released via the stack as an air effluent, with none remaining in the ash. For disposal of C-14, the licensee may assume that 5% of the C-14 contained in the incinerator feed remains in the ash, the balance being converted to C-14 dioxide and released via the stack as an air effluent. The licensee may be permitted to make similar assumptions for other radionuclides, but these must be approved on a case-by-case basis by the Division of Industrial and Medical Nuclear Safety, NMSS. To obtain such approval, the licensee must provide reliable data supporting the proposed assumptions. Authorizations for disposal of incinerator ash pursuant to this guidance does not excuse the licensee from compliance with other applicable Federal, State, and local regulations. Dilution of incinerator ash produced from incineration of waste containing licensed material with ash from non-radioactive burns prior to determination of compliance with the release limits is not permitted. The concentrations required to show compliance must be determined prior to mixing with other materials for disposal. The reason for this position is that the generic studies on which this policy is based assume a certain total activity being disposed of at a landfill per year. Permitting dilution with clean waste before showing compliance with the release limits could increase the total activity received by the landfill by a substantial margin, thereby invalidating these studies. In addition, in assessing the volume of ash used in the generic studies, ash generated by commercial low-level waste incinerators and waste water treatment plants was not considered. Therefore, this policy is not applicable to either of these two incinerator classes. Requests by such facilities must be handled on a case-by-case basis.As an alternative to the policy, and pursuant to 10 CFR 20.2002, facility-specific release limits for incinerator ash can be submitted based on site-specific dose assessments. The calculations and assumptions used in NRC's "Generic Dose Assessment for Disposal of Incinerator Ash in a Landfill," dated January 1994, may be used for the site-specific assessments, but other methods may also be used. The staff will evaluate these submissions on a case-by-case basis, which should be forwarded to the Division of Industrial and Medical Nuclear Safety, NMSS via technical assistance requests for review. The following license condition should be used for granting authorization to dispose of ash containing licensed material to a landfill: Pursuant to 10 CFR 20.2002, the licensee may dispose of incinerator ash containing radioactive materials with Atomic Nos. 1-83 other than those isotopes listed below, as ordinary waste in a landfill, provided the concentrations of the isotopes, expressed in uCi per gram of ash, at the time of disposal, do not exceed the numerical values listed in Table II, Column 2, 10 CFR 20, Appendix B. Isotopes not included are hydrogen-3, carbon-14, aluminum-26. chlorine-36, silver-108m, niobium-94, iodine-129, technetium-99, and thalium-204, for which the concentrations must not exceed 10% of the values listed in Table II, Column 2, 10 CFR Part 20, Appendix B. Model Procedure for Compaction The following information should be provided by licensees who propose
to compact waste [20.2108]:
Appendix T: Using the Internet to Obtain Copies of NRC Documents and Other Information[ Prev | Next | Top of file ] In an effort to make its documents and information readily available to licensees and the general public, NRC is placing documents and information on its web site. Many of the reference sections of this NUREG refer to the NRC home page <http://www.gpo.gov >. Applicants and licensees who have Internet access may use this address to find more information on a topic, the referenced document, or information on obtaining the referenced document. To access the 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 single-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.gpo.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. Single-click the pointing device button. Next, place the pointer on the blue text, "Title 10 of the Code of Federal Regulations," and single-click the mouse. Place the pointer on the blue text, "20," and single-click. Finally, place the pointer on the blue text "Definitions," and single-click. Appendix U: Medical Distribution[ Prev | Next | Top of file ] 1. INTRODUCTION 1.1 PURPOSE OF APPENDIX The purpose of this appendix is to provide assistance to you, the applicant or licensee, in preparing applications for new licenses, license amendments, and renewals of medical distribution licenses under 10 CFR Part 32, "Specific Domestic Licenses To Manufacture or Transfer Certain Items Containing Byproduct Material" (i.e., licenses that authorize the distribution of radioactive drugs and sealed sources containing byproduct material to the Nuclear Regulatory Commission's (NRC's) and Agreement States' medical use licensees). Medical distribution by applicants registered or licensed with the U.S. Food and Drug Administration or State Agency as a drug or sealed source manufacturer is provided for in 10 CFR 32.72 and 32.74 or equivalent provisions of an Agreement State. The medical distribution license only authorizes distribution; it does not authorize the possession of byproduct material.NUREG-1556, Vol. 13, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Commercial Radiopharmacy Licenses," contains much of the information needed in preparing applications for medical distribution licenses. In order to avoid duplication, many sections in this appendix will refer you to Vol. 13. Some applications for manufacture and distribution of radioactive drugs require a separate application. Nuclear pharmacy applicants should refer to NUREG-1556, Vol. 13 in the preparation of an application for transfer for distribution of radioactive drugs for medical use. Holders of licenses to manufacture and conduct broad scope research and development, who were authorized on January 1, 1995 to distribute radio labeled drugs to medical use licensees by specific license conditions or under the authorized use item of the license, but who did not have a 10 CFR Part 32 medical distribution license, may continue to distribute the radio labeled drugs pursuant to the authorization without obtaining a medical distribution license. However, when the licensee wishes to amend or renew this authorization, a new 10 CFR Part 32 medical distribution license or authorization will be needed. This appendix describes the application procedures for broad scope licenses to manufacture and distribute radio labeled drugs to medical use licensees and conduct research and development. Several words and phrases used in this guide should be explained. The phrase "byproduct material" means any radioisotope produced by a nuclear reactor. The term "distribution" has the same meaning as in 10 CFR Part 32, i.e., the routine transfer of licensed materials to others. For organizations licensed in accordance with 10 CFR 32.72 and 32.74, these transfers of licensed material are to specific licensees in accordance with the requirements of 10 CFR 30.41; these organizations' principal customers are medical use licensees. The phrase "medical use licensee" means a physician, podiatrist, dentist, or medical institution licensed under 10 CFR Part 35 for "medical use," as defined in 10 CFR 35.2. 1.2 FILING AN APPLICATION FOR BROAD SCOPE LICENSES TO MANUFACTURE AND DISTRIBUTE RADIO LABELED DRUGS TO MEDICAL USE LICENSEES FOR RESEARCH A request for an exemption from 10 CFR 32.72(a)(2) should be made from broad scope research and development licensees who are requesting to manufacture and distribute drugs containing byproduct material, pursuant to 10 CFR 32.72, to authorized recipients for human use research. An exemption may be granted if the applicant or licensee specifically requests an exemption from 10 CFR 32.72(a)(2) and provides the following supporting information with regard to the requirements of 10 CFR 32.72(a)(2):
If the exemption is granted, the following authorized use will be added
to the license for Hydrogen-3 and Carbon-14:
In addition, the following license condition will be added to the license:
Since this exemption applies to broad scope research and development licensees, the broad scope licensee will not require an exemption from 33.17(a)(4,) which restricts broad scope licensees from adding byproduct material to drugs designed for human use when applying for 10 CFR 32.72 authorization. The addition of authorization to manufacture, prepare, or transfer radioactive drugs containing byproduct material for medical use (10 CFR 32.72) to a license authorizes Part 32 activities in addition to Part 33 (broad scope) activities. Preparation of radioactive drugs is done under the Part 32 authorization and not the Part 33 authorization. 2. CONTENTS OF AN APPLICATION The following paragraphs are numbered as on NRC Form 313 "Application
for Material License," Appendix B.
Identify the materials you wish to be authorized to distribute to NRC's and the Agreement States' medical use licensees. The regulatory requirements and the subsequent information that is needed are different for radioactive drug and for sealed source licenses. For radioactive drugs, specify the radionuclide and chemical form (for generators, specify the parent and daughter radionuclides and the name and model number, if appropriate, of the generator). For sealed sources, specify the radionuclide, manufacturer's name and model number of each source, the maximum activity in each source, and the anticipated use of the sources. NRC needs to know the anticipated use of the source to perform its safety evaluation. If the sealed sources are usually used in a device (e.g., bone mineral analyzer), specify the manufacturer's name and the model number of the device. The following examples show appropriate responses to Items 5 and 6. Radioactive Drugs: Chromium-51 as Sodium Chromate Sealed Sources: Cesium-137, XYZ Corp., Model 1234 Strontium-90, ABC Corp., Model 567 Iodine-125, FGH Corp., Model 890
According to 10 CFR 32.72 and 32.74, certain radiation safety information
must be submitted regarding licensed material to be distributed to medical
use licensees. The information to be submitted for each type of licensed
material to be distributed to medical use licensees is identified in the
following sections and in NUREG-1556, Vol. 13, "Consolidated Guidance
About Materials Licenses: Program-Specific Guidance About Commercial Radiopharmacy
Licenses."
If you wish to distribute radioactive drugs to medical use licensees
pursuant to 10 CFR 35.100, 35.200, or 35.300, you need to provide the
information identified below or in NUREG-1556, Vol. 13, "Consolidated
Guidance About Materials Licenses: Program-Specific Guidance About Commercial
Radiopharmacy Licenses," for nuclear pharmacy license applicants.
According to 10 CFR 32.72(a)(2), you must provide evidence that you are
registered or licensed with either the U.S. Food and Drug Administration
(FDA) or a State Agency as a drug manufacturer. See NUREG-1556, Vol. 13,
"Consolidated Guidance About Materials Licenses: Program-Specific Guidance
About Commercial Radiopharmacy Licenses," for nuclear pharmacy license
applicants.
According to 10 CFR 32.72(c), you must possess and use instrumentation
to measure the radioactivity in dosages of alpha-, beta-, or photon-emitting
radioactive drugs prior to transfer for commercial distribution. Measurements
may be made by direct measurement or a combination of direct measurement
and calculation (calculation only may be used for alpha and beta radiation).
See NUREG-1556, Vol. 13, "Consolidated Guidance About Materials Licenses:
Program-Specific Guidance About Commercial Radiopharmacy Licenses,." for
nuclear pharmacy license applicants.
See NUREG-1556, Vol. 13, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Commercial Radiopharmacy Licenses."
See NUREG-1556, Vol. 13, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Commercial Radiopharmacy Licenses."
Some licensees offer a generator return program. In this program, customers may return used or spent generators to the licensee. Experience has shown that customers who do not ship radioactive materials frequently may not be familiar with the DOT regulations governing such shipments; the manufacturer's or distributor's instructions to customers have not been sufficiently detailed for these inexperienced shippers. As a result, when some spent generators were shipped back to the manufacturer or distributor, the shipment was not in accordance with applicable regulations.
If you wish to offer a generator return program, the instructions (including instructions on labeling and shipping documents) you have developed and will supply to your customers should be sufficiently detailed to ensure that the shipper can comply with 10 CFR 71.5 and with DOT regulations. As a minimum, these instructions are to:
If you do not plan to offer a generator return program, so state; no
additional information is necessary. However, if you plan to offer a generator
return program, copies or facsimiles of all forms, labels, and instructions
you will provide to customers for shipping the spent generators back to
your facility should be provided. To avoid the problems experienced in
the past by inexperienced shippers, you should ensure that your instructions
achieve the objectives outlined in Items 1 through 3 above. The discussion
of the customer's responsibilities mentioned in Item 3 should include
(but is not limited to):
If you intend to distribute sealed sources to medical use licensees, provide the information identified in NUREG-1556, Vol. 13, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Commercial Radiopharmacy Licenses."
If you are a manufacturer or initial distributor of sealed sources (or devices containing sealed sources), you may need to submit a separate application for authorization to distribute the sealed sources or devices. This separate application will facilitate NRC's review and evaluation of the radiation safety information for the sealed source or device and its certificate of registration. To submit a source or device design for a safety evaluation and registration use NUREG-1556, Vol. 3, "Consolidated Guidance About Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration," dated July 1998. This safety evaluation is required by 10 CFR 32.74 prior to the source or device being approved for distribution and medical use.
Your product labeling must fulfill the requirements of 10 CFR 20.1901, 20.1904, 20.1905 and of 10 CFR 32.74(a)(2)(viii) and 32.74(a)(3). A label, leaflet, or brochure accompanying the sealed source or device must contain appropriate instructions from a radiation safety standpoint for handling and storing the source or device. For example, the instructions may specify the use of extremity monitors, the use of tongs or other devices (rather than bare hands) to pick up sources, storage within auxiliary shielding, and any special procedures needed in the handling and sterilizing of "fragile" sources (e.g., iodine-125 seeds). A label, leaflet, or brochure must also contain the licensing statement required by 10 CFR 32.74(a)(3). For sources, the statement should read, "The (name of source or device) is licensed by the U.S. Nuclear Regulatory Commission for distribution to persons licensed pursuant to [10 CFR 35.57, 35.400, or 35.500] or under equivalent licenses of Agreement States." For each type of sealed source or device you intend to distribute,
you should:
For each type of source or device to be distributed, you should provide a copy of correspondence to and from the FDA that clearly shows that the FDA finds the source or device to be safe and effective or "substantially equivalent" to sources or devices offered for sale in the United States before May 1976. (Note: An NRC registration will not be issued unless the applicant has submitted to NRC a substantially equivalent letter pursuant to Section 510(K) of the Food, Drug, and Cosmetic Act, as amended, or a similar indication of premarketing approval by FDA.) Devices and sources used in conjunction with medical applications involving
computers and patient planning systems are within FDA jurisdiction and
must also have a substantially equivalent letter pursuant to Section 510(k)
of the Food, Drug, and Cosmetic Act, as amended, or a similar indication
of premarketing approval by FDA.
FDA and NRC signed a Memorandum of Understanding on August 26, 1993, to coordinate existing FDA and NRC regulatory programs for medical devices, drugs, and biological products that make use of byproduct, source, or special nuclear materials. The principal statute under which the FDA regulates devices is the Food, Drug, and Cosmetic Act, as amended by the Safe Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Medical Devices Act of 1992. Under the Memorandum of Understanding, the Agencies agree to promptly inform each other whenever they receive a report or otherwise become aware of potential public health problems involving products of mutual regulatory concern. Further, the Agencies will share information to the extent practicable. For NRC's Office of Nuclear Materials Safety and Safeguards (NMSS), this includes information on the design, manufacture, testing, quality | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
A. New License
R-R
C)