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Program-Specific Guidance About Licenses Authorizing Distribution to General Licensees - Final Report (NUREG-1556, Vol. 16)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 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 ] This guide has been developed in parallel with the rulemaking on 10 CFR Parts 30, 31, and 32, "Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct Material." This guidance document is consistent with the final rule. As part of its redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539, "Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated April 1996, and draft NUREG-1541, "Process and Design for Consolidating and Updating Materials Licensing Guidance," dated April 1996. NUREG-1556, Vol. 16, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Licenses Authorizing Distribution to General Licensees," dated December 2000, is the sixteenth program-specific guidance document developed for the new process and is intended for use by applicants, specific and general licensees, and NRC staff. It also will be available to Agreement States. The requirements for an NRC general license for persons who receive, possess, use, transfer, own, or acquire byproduct material in generally licensed products are provided in 10 CFR Part 31, "General Domestic Licenses for Byproduct Material." The requirements to obtain an NRC general distribution license for persons who distribute or initially transfer byproduct material in generally licensed products are provided in 10 CFR Part 32, "Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material." Generally licensed products include static elimination devices, gauging devices, gas chromatograph detector cells, tritium signs, in vitro clinical or laboratory kits, and check sources. These devices/products are distributed to general licensees by companies who have a specific license from NRC or an Agreement State authorizing such distribution. This document combines and supersedes the guidance previously found in Information Notices and Policy and Guidance documents listed in Table A.1 of this NUREG. This document provides assistance to applicants in preparing license applications for a specific license to distribute generally licensed devices. It also describes both the methods acceptable to NRC license reviewers in implementing the regulations and the techniques used by the reviewers in evaluating the applications to determine if the proposed general distribution activity is acceptable for licensing purposes. This document was not intended for providing guidance to applicants requesting a specific license for possession and use of radioactive materials. Appendices K and L are intended to assist specific licensees in providing their customers (general licensees) with information. They provide the general licensee with a concise listing of the regulatory requirements that apply to generally licensed devices. Appendix L does so specifically for users of self-luminous exit signs. Specific licensees may forward Appendices K or L to their customers. It is not intended, however, to take the place of the information requirements in 10 CFR 32.51a (a), (b), and (c). Figures[ Prev | Next | Top of file ] Figure 5.1 Gas Chromatograph Units Figure 5.2 Fixed Gauging Devices Figure 5.6 Calibration Standards Figure K.2 Gas Chromatograph Unit Figure K.3 Self-Luminous Exit Sign Figure L.1 Self-Luminous Exit Sign Figure L.6 Locations of NRC Offices and Agreement States Foreword[ Prev | Next | Top of file ] The United States Nuclear Regulatory Commission (NRC) is using Business Process Redesign (BPR) techniques to redesign its materials licensing process. This effort is described in NUREG-1539, "Methodology and Findings of the NRC's Materials Licensing Process Redesign," dated April 1996. A critical element of the new process is consolidating and updating numerous guidance documents into a NUREG series of reports. Below is a list of volumes currently included in the NUREG-1556 series.
The current document, NUREG-1556, Vol. 16, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Licenses Authorizing Distribution to General Licensees," dated December 2000, is the sixteenth program-specific guidance developed for the new process. It is intended for use by applicants, licensees, NRC license reviewers, and other NRC personnel. A team composed of NRC staff from Headquarters and Regional Offices drafted this document, drawing on their collective experience in radiation safety in general and knowledge of general distribution of radioactive products. A representative of NRC's Office of the General Counsel provided a legal perspective. This document represents a step in the transition from the current paper-based process to the new electronic process. It is available on the Internet at the following address: <http://www.nrc.gov/NRC/NUREGS/SR1556/V16/index.html> This document is not a substitute for NRC regulations, and compliance is not required. The approaches and methods described in this report are provided for information only. _______________________________________ 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 final report. All participants provided valuable insights, observations, and recommendations. The team also thanks Dianne Geshen, Rolonda Jackson, Tamra King, D.W. Benedict Llewellyn, Agi Seaton, and Nora Younger of Computer Sciences Corporation. The Participants[ Prev | Next | Top of file ] Baggett, Steven L. Abbreviations[ Prev | Next | Top of file ]
1 Purpose of Report[ Prev | Next | Top of file ] This report provides both guidance to an applicant in preparing an application to distribute generally licensed products or devices and NRC criteria for evaluating a general distribution license application. It also provides guidance to general licensees covered in 10 CFR 31.5 on the use, possession, and registration requirements for general licensees. General distribution licenses authorize the distribution (initial transfer) of byproduct material to persons generally licensed by 10 CFR 31.3, 31.5, 31.7, 31.8, 31.10 and 31.11. This report identifies the information needed to complete NRC Form 313 (Appendix B), "Application for Material License," for the use of byproduct material contained in devices or products distributed to general licensees. The information collection requirements in 10 CFR Parts 30, 31, and 32, NRC Form 313, and NRC Form 483 have been approved under the Office of Management and Budget (OMB) Clearance Nos. 3150-0017, 3150-0016, 3150-0001, 3150-0120, and 3150-0038 respectively. NRC Form 653 is also included under OMB Clearance No. 3150-0001. The format within this document for each item of technical information is as follows:
Notes and references are self-explanatory and may not be found for each item on NRC Form 313. 2 NRC Regions And 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 byproduct, source, or special nuclear material in one of these Agreement States needs to contact the responsible officials in that State for guidance on preparing an application. A current list of Agreement States, including the names, addresses, and telephone numbers of responsible officials, may be obtained upon request from NRC's Regional Offices. This information can also be found on the NRC Office of State and Tribal Programs' web site at <http://www.hsrd.ornl.gov/nrc/asframe.htm>. Figure 2.1 U.S. Map. Location of NRC Offices and Agreement States. Table 2.1 provides a quick way to determine which Agency has regulatory authority over the possession and use of byproduct, source, or special nuclear material. Table 2.1 Who Regulates the Activity?
3 Management Responsibility[ Prev | Next | Top of file ] 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 version of "General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600. NUREG-1600 is available electronically at <http://www.nrc.gov/OE>. For hard copies of NUREG-1600, see the Availability Notice (on the inside front cover of this report). 4 Applicable Regulations[ Prev | Next | Top of file ] The primary regulations applicable to persons who possess byproduct material in generally licensed products are located in 10 CFR Part 31, "General Domestic Licenses for Byproduct Material." Part 32, "Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material," outlines, in part, the information required to initially transfer for sale or distribute products containing byproduct material. The following is a list of the regulations for general licensees in Part 31 and the corresponding requirements for distributors of generally licensed products in Part 32.
Additional regulations applicable to holders of a general license and distributors of generally licensed products are found in the following 10 CFR Parts:
To request copies of the above documents, call GPO's order desk in Washington, DC at (202) 512-1800. Order the two-volume bound version of Title 10, Code of Federal Regulations, Parts 0-50 and 51-199 from the GPO, Superintendent of Documents, Post Office Box 371954, Pittsburgh, Pennsylvania 15250-7954. You may also contact the GPO electronically at <http://www.gpo.gov>. Request single copies of the above documents from NRC's Regional Offices (see Figure 2.1 for addresses and telephone numbers). Note that NRC publishes amendments to its regulations in the Federal Register. 5 General License Distribution[ Prev | Next | Top of file ] 5.1 General[ Prev | Next | Top of file ] On February 12, 1959 (24 FR 1089) (Federal Register, Volume 24, page 1089), the Atomic Energy Commission (AEC) amended its regulations to provide a general license for the use of byproduct material contained in certain measuring, gauging, or controlling devices. Under current regulations (10 CFR 31.5), certain persons may receive and use a device containing byproduct material under this general license if the device has been manufactured and distributed according to the specifications contained in a specific license issued by NRC or by an Agreement State. A specific license authorizing distribution of generally licensed devices is issued if a regulatory authority determines that the safety features of the device and the instructions for safe operation of that device are adequate and meet regulatory requirements. The general licensee must comply with the requirements for labeling, instructions for use, and proper storage or disposition of the device. A generally licensed device usually consists of radioactive material, contained in a sealed source, within a shielded device. The device is designed with inherent radiation safety features so that it can be used by persons with no radiation training or experience; thus, the general license is meant to simplify the licensing process so that a case-by-case determination of the adequacy of the radiation training or experience of each user is not necessary. The distributor of the generally licensed product/device is required to assure NRC or the Agreement State that all products are distributed in accordance with the specifications provided in its license application. These specific licenses are issued by NRC or the Agreement State and are referred to as "general distribution" licenses. See Appendix N for an example of a general distribution license. General distribution licenses only authorize the distribution of products and device(s) to general licensees and do not authorize possession or use of radioactive material; therefore, applicants for general distribution licenses will need to file a separate application for a specific license authorizing possession and use of byproduct material, with the NRC Regional Office or the Agreement State for the State in which the material will be possessed and/or used. However, the determination of where to file the general distribution license application should be made based on the location from which the applicant wishes to distribute, not necessarily where the applicant possesses and/or uses the byproduct material (i.e., where the product is manufactured). The four Regions and the Regional Office addresses are provided on NRC Form 3, in 10 CFR Part 20, Appendices K and L, and in Section 2 of this document (Figure 2.1). A license authorizing distribution to general licensees cannot be issued until the applicant (1) obtains a registration certificate (see Section 5.2) for the device (if applicable); and (2) obtains a possession and use license. To expedite the licensing process, the applicant should apply for the possession license and registration certificate concurrently, then apply for authorization to distribute once the registration certificate has been issued. 5.2 Licensing And Sealed Source/Device Registration[ Prev | Next | Top of file ] Applicants of a general distribution license are required to provide specific information about the sources and products, as outlined in 10 CFR 32.51, 32.53, 32.57, 32.61, and 32.71, concerning the radionuclides and activities, containment and construction, labeling, quality control and assurance programs, etc. NRC will evaluate the information submitted in the application to ensure it meets all applicable standards and regulations and will contact the applicant, if necessary, to obtain additional clarification or information. A sealed source and device (SSD) safety evaluation will be performed on the sealed sources and devices the applicant proposes to distribute to general licensees. Information about the review and approval process for SSDs is contained in NUREG-1556, Vol. 3. Upon completion of the SSD evaluation, a registration certificate will be issued. The registration certificate must be complete and available before the licensing reviewer may issue the license. An SSD evaluation and registration certificate is required for all devices authorized in 10 CFR 31.3, 31.5, 31.7, and 31.10. An SSD evaluation is not required for devices/products authorized in 10 CFR 31.8 and 31.11. An example of a registration certificate is provided in Appendix C of this document.
After the issuance of a license, licensees must conduct their programs for the distribution of generally licensed products/devices in accordance with the following:
Section 30.9 of 10 CFR Part 30, "Rules of General Applicability to Domestic Licensing of Byproduct Material," requires that the information provided in the application be complete and accurate in all material respects. Information is considered to be material if it is likely to change or affect an Agency decision on issuing the license; therefore, information should be clear, specific, and accurate. Section 30.10, 10 CFR Part 30, "Deliberate misconduct," states that those providing information concerning a licensee's activities may not deliberately engage in misconduct or provide incomplete or inaccurate information to NRC. It is important that applicants and licensees understand that the information provided in an application and approved in the license is considered a limitation by NRC on the licensee to engage only in those activities and products as described in the application or license. NRC should be notified of any changes or additions to the information submitted in the application. While some changes may not result in an amendment to the license, licensees should not assume that an amendment is not needed or that an amendment request has been granted until they receive a written confirmation in the form of a letter or license amendment. 5.3 Types of Generally Licensed Devices[ Prev | Next | Top of file ] General distribution licenses are based on the types of products/device(s) to be distributed according to the six categories of products/device(s) found in 10 CFR Part 31. The following provides the applicable regulation and some examples of products/device(s) that may be distributed under a general distribution license and possessed by a general licensee:
Figure 5.1 Gas Chromatograph Units. Certain gas chromatograph units (detector cells) used for analysis of chemical composition can be possessed under a general license (10 CFR 31.5). Figure 5.2 Fixed Gauging Devices. Certain nuclear gauges can be possessed under a general license (10 CFR 31.5). Figure 5.3 Static Eliminators. Certain static elimination devices can be possessed under 10 CFR 31.5. Figure 5.4 Tritium Exit Signs. Certain tritium exit signs can be possessed under 10 CFR 31.5 (typical devices contain 25 Ci of tritium per sign).
Figure 5.5 Luminous Exit Sign. Safety devices, such as luminous exit signs, containing tritium or promethium-147 that are used in aircraft may be used under the 10 CFR 31.7 general license.
Figure 5.6 Calibration Standards. Certain calibration and reference sources containing americium-241 can be possessed under a general license authorized in 10 CFR 31.8.
Figure 5.7 In Vitro Kit. Certain in vitro kits used in medicine, veterinary medicine, hospitals, and clinical laboratories are authorized in 10 CFR 31.11. 5.4 Proprietary and Private Information[ Prev | Next | Top of file ] License applications are generally made available for review by the public. Private information, including 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. Also, proprietary information as described in 10 CFR 2.790 (i.e., information not to be disclosed to the public) should not be included in an application unless necessary. Any proprietary or financial information submitted should be clearly marked by the applicant as "Proprietary Information." In addition, the applicant must support the request to withhold by submitting an affidavit following the procedure in 10 CFR 2.790, "Public inspection, exemption, requests for withholding." Failure to follow this procedure may result in disclosure of the proprietary information to the public or substantial delays in processing the application. Applications containing information marked as "Proprietary Information," will be reviewed to determine if this information is necessary to issue the license. If the information is determined unnecessary, it will be returned to the applicant. If the information is deemed necessary to issue the license, it will be reviewed by NRC to determine if it is indeed proprietary or confidential and should be withheld from public disclosure. If NRC determines that the affidavit is deficient, i.e., does not contain the required information as outlined in 10 CFR 2.790(b)(4), the applicant will be notified that additional information is needed and that the review will continue when the required information is received. Applicants will be informed that NRC must review the information before determining whether to withhold it from public disclosure and that the review of their request for licensing may continue. If NRC determines that the information is not proprietary, but the applicant does not want the information released to the public, the information will be returned to the applicant. A license cannot be issued until the request to withhold information is resolved. Once NRC has reviewed the application and affidavit and determined whether or not to withhold the information from public disclosure, NRC will notify the licensee by letter of its decision and the appropriateness of the 10 CFR 2.790 affidavit (see Appendix D). Appendix D also includes a checklist for requests for withholding the information.
Note: Additional procedures for the handling of proprietary information can be found in Directive 12.6 (formerly MC 2101), "NRC Sensitive Unclassified Information Security Program." 5.5 Foreign Vendors[ Prev | Next | Top of file ] Foreign vendors are unique in that NRC has no jurisdiction over the foreign entities. Pursuant to 10 CFR 110.53, "United States address, records, and inspections," foreign vendors or licensees involved in importing and exporting nuclear material and equipment are required to establish an address in the United States where papers may be served, where records can be maintained, and where NRC can inspect the applicant's activities and records as necessary to accomplish its mission. A general distribution license will, therefore, not be issued to a foreign vendor unless the requirements set forth in 10 CFR 110.53 have been satisfied. 6 How To File[ Prev | Next | Top of file ] 6.1 Paper Application[ Prev | Next | Top of file ] Applicants wishing to distribute or initially transfer products containing byproduct material to persons generally licensed under 10 CFR Part 31 should complete NRC Form 313, "Application for Material License" (Appendix B). An application for a distribution license should contain information concerning the distribution of radioactive material only (not possession and use). Applicants for a materials license should do the following:
Please note that if it is necessary when filing for a license to reference information contained in other licensees' file(s) or registration certificate(s), whether current, retired or inactive, the information should be submitted, in its entirety, as part of the application. All license applications will be available for review by the public. 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. See Section 5.4, Proprietary and Private Information, for guidance. As explained in the Foreword, NRC's new licensing process will be faster and more efficient, in part, through acceptance and processing of electronic applications at some future date. NRC will continue to accept paper applications. However, these will be scanned and put through an optical character reader (OCR) to convert them to electronic format. To ensure a smooth transition, applicants are asked to follow these suggestions:
6.2 Electronic Application[ Prev | Next | Top of file ] As the electronic licensing process develops, it is anticipated that NRC may provide mechanisms for filing applications via diskettes, CD-ROM, and through the Internet for those applicants/licensees who choose to file electronically. Additional filing instructions will be provided as these new mechanisms become available. The existing paper process will be solely used until the electronic process is available. 6.3 Where to File[ Prev | Next | Top of file ] Applicants wishing to distribute or initially transfer products (containing byproduct material to persons generally licensed under 10 CFR Part 31 or equivalent Agreement State regulations) from any State or U.S. territory or possession subject to NRC jurisdiction, must file an application with the NRC Regional Office in the locale from which the material will be distributed or initially transferred. Figure 2.1 in Section 2 shows NRC's four Regional Offices and their respective areas for licensing purposes and identifies Agreement States. In general, applicants wishing to distribute or initially transfer such products from a location in an Agreement State must file an application with the Agreement State, not NRC. See Section 2, NRC Regions and Agreement States, for additional information. Requests for safety evaluations of sealed sources or devices are submitted directly by applicants to the Division of Industrial and Medical Nuclear Safety, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 (address is also found at the top of NRC Form 313). 7 Application and Annual Fees[ Prev | Next | Top of file ] Each application for which a fee is specified must be accompanied by the appropriate fee. Refer to 10 CFR 170.31, "Schedule of fees for materials licenses and other regulatory services, including inspections, and import and export licenses," to determine the amount of the fee that must accompany your application. NRC will not issue the new license before receiving the fee. Once technical review has begun, no fees will be refunded; application fees will be charged regardless of NRC's disposition of an application or the withdrawal of an application. For applicants wishing to distribute items containing byproduct material pursuant to 10 CFR 31.3, 31.5, 31.7, and 31.10 that require a source or device evaluation, the fee categories are 3B for possession and use license, 3J for distribution license, and 9A for the device evaluation or 9C for source evaluation. For applicants wishing to distribute items pursuant to 10 CFR 31.8 and 31.11 that do not require a source or device evaluation, the fee categories are 3B for possession and use and 3K for distribution. Most NRC specific licensees are also subject to annual fees; refer to 10 CFR 171.16. The same fee categories that applied to the application, renewal, and registration fees also apply to the annual fees. 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. Or call NRC toll free at (800) 368-5643, extension 415-7554. NRC conducts rulemaking each year to establish the Part 171 annual fees and to make any necessary changes to the Part 170 licensing and inspection fees. The proposed changes to the fees are published in the Federal Register for public comment, and a copy of the proposed rule is mailed to all specific licensees. After consideration of the comments received, a final rule is published in the Federal Register and a copy is mailed to all licensees. At that time, invoices are issued for the annual fees. Although the invoices are issued for the full amount of the annual fee, the amount due may be reduced, as provided in 10 CFR 171.16(c), if the licensee qualifies as a small entity under NRC's size standards and so certifies by completing and returning NRC Form 526, "Small Entity Certification," which is enclosed with each annual fee invoice. A new certification must be submitted with the annual fee payment each year. 8 Contents of an Application[ Prev | Next | Top of file ] The following comments apply to the indicated items of NRC Form 313 (see 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 a 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 the distribution of the radioactive material (product). A division or department within a legal entity may not be a licensee. An individual may be designated as the applicant only if the individual is acting in a private capacity and the distribution of the radioactive material (product) 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. Note: While a U.S. address is required in order to issue a license, it is acceptable for the licensee's mailing address and the state code in the license number to be based on an address located in Puerto Rico, Canada, or the U.S. Virgin Islands. Notify NRC of changes in mailing address; these changes do not require a fee.
NRC Information Notice (IN) 97-30, "Control of Licensed Material during Reorganizations, Employee-Management Disagreements, and Financial Crises," dated June 3, 1997, discusses the potential for the security and control of licensed material to be compromised during periods of organizational instability. NUREG-1556, Volume 15, "Consolidated Guidance About Materials Licenses: Guidance About Changes of Control and Bankruptcy Involving Byproduct, Source, or Special Nuclear Material Licenses," provides additional information about NRC requirements related to both changes of control and bankruptcy. 8.2.1 Timely Notification of Transfer ControlRegulations: 10 CFR 30.34(b). Criteria: Licensees must provide full information and obtain NRC's prior written consent before transferring control of the license. Discussion: Control over licensed activities can be construed as the authority to decide when and how that license (licensed material and/or activities) will be used. A change of ownership may be an example of a change of control, depending on whether the authority over the license has been transferred from one person to another. For example, a change may result from a merger or buyout. The transfer of stock or other assets is not a change of control, unless there is a change of authority over the license. It is not NRC's intent to interfere with the business decisions of licensees. NRC will require licensees to submit only such business information as is necessary to determine whether a change of control will take place. This information is required to ensure that all NRC requirements are followed. Response from the Applicant:
Reference: See the Availability Notice on the inside front cover of this report to obtain copies of:
Information Notices are available on NRC's web site at </reading-rm/basic-ref.htmll>. 8.2.2 Notification of Bankruptcy ProceedingsRegulations: 10 CFR 30.34(h). Criteria: Immediately following filing of a voluntary or involuntary petition for bankruptcy, specific licensees (as well as general licensee registrants) must notify the appropriate NRC Regional Administrator, in writing, identifying the bankruptcy court in which the petition was filed and the date of filing. Discussion: Even though a licensee may have filed for bankruptcy, the licensee remains responsible for all regulatory requirements. NRC needs to know when licensees are in bankruptcy proceedings in order to determine whether all NRC requirements are followed prior to the completion of the bankruptcy actions. 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:
References:
8.3 Item 3: Address(es) from Which Licensed Material Will Be Distributed[ Prev | Next | Top of file ] An applicant for a general distribution license must be an organization with an address in the United States from which it will distribute the items. The applicant must specify the street address, city, and state or other descriptive address (e.g., on Highway 10, 5 miles east of the intersection of Highway 10 and State Route 234, Anytown, State) for each and every facility used as a location from which distribution will occur. A Post Office Box address is not acceptable. Each point of distribution will be listed on the general distribution license.
8.4 Item 4: Person to Be Contacted About This Application[ Prev | Next | Top of file ] Identify the individual who can provide information and answer questions about the application and the product(s) to be distributed, and include his or her telephone number. This is typically the RSO for the license for possession and use of the material, 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 regarding questions, concerns, or information. Notification of a contact change is for information only and would not be considered an application for license amendment. The individual named in Item 4 of the application may or may not be the same individual who signs the application as the "certifying official" on behalf of the licensee and has the authority to make commitments to NRC (see Item 13 on Form 313, Appendix B). Any commitments made by the applicant should be signed by the individual named in Item 13, since only that individual is considered by NRC to have the authority to make commitments on behalf of the applicant. NRC will not, therefore, accept license amendments or renewals signed by the individual identified in Item 4, if this person differs from the one named in Item 13. NRC recognizes that licensees may use a consultant or consultant group to help prepare the license application and provide support to the radiation protection program. Licensees are reminded that regardless of the role of the consultant in radiation protection program management, the licensee remains ultimately responsible for all aspects of the licensed program, including the services performed by the consultant. When selecting the person to be contacted, be aware that further important NRC communications will be directed to this person. 8.5 Items 5 and 6: Radioactive Material And Purpose(s) For Which Licensed Material Will Be Used[ Prev | Next | Top of file ] Regulations: 10 CFR 30.33; 10 CFR 32.51; 10 CFR 32.53; 10 CFR 32.57; 10 CFR 32.61; 10 CFR 32.71. Criteria: An application for a general distribution license will be approved if the requirements of 10 CFR 30.33, and the applicable requirements of 10 CFR 32.51, 10 CFR 32.53, 10 CFR 32.57, 10 CFR 32.61, and/or 10 CFR 32.71 are met. Discussion: Applicants should determine what devices or products are to be distributed and provide information about each type of product. Describe in general terms the purpose of each product. Activity should be specified in terms of "XX becquerels (YY curies)." For example, "the maximum activity per sealed source is 370 MBq (10 mCi) of cesium-137." A safety evaluation of sealed sources and devices is required on certain generally licensed devices. An SSD evaluation is required for all devices authorized in 10 CFR 31.3, 31.5, 31.7, and 31.10. An SSD evaluation is not required for devices/products authorized in 10 CFR 31.8 and 31.11. This evaluation is performed by NRC or an Agreement State before authorizing a manufacturer (or distributor) to distribute the device to general licensees. The safety evaluation is documented in an SSD Registration Certificate. Information on SSD registration certificates is available on NRC's web site at <http://www.hsrd.ornl.gov/nrc/ssdrform.htm>. Information may also be obtained by contacting the Registration Assistant at NRC's toll free number, (800) 368-5642, extension 415-7231. For additional guidance relating to sealed sources and devices, also see NUREG-1556, Vol. 3, "Applications for Sealed Source and Device Evaluation and Registration." You may not apply for a distribution license for devices that require an SSD evaluation and have not yet been through the above procedure. First obtain an SSD Registration Certificate, and then apply for a distribution license. Response from Applicant: The applicant should provide the following information for each device to be distributed:
References: See the Availability Notice (on the inside front cover of this report) to obtain a copy of NUREG-1556, Vol. 3, "Consolidated Guidance about Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration." Also, see the Sample Registration Certificates for Generally Licensed Products, in Appendix C of this document. 8.6 Items 7, 8, 9 and 11: Not Applicable[ Prev | Next | Top of file ] These items on Form 313 are not applicable for general distribution licenses. 8.7 Item 10: Radiation Safety Program (Requirements For a General Distribution License)[ Prev | Next | Top of file ] 8.7.1 10 CFR 32.51: Requirements For Initial Transfer of Devices For Use Under 10 cfr 31.5 (Certain Measuring, Gauging, or Controlling Devices)Regulations: 10 CFR 31.5; 10 CFR 32.51; 10 CFR 32.51a; 10 CFR 32.52. Criteria: Applicants for a specific license to distribute generally licensed devices, as specified in 10 CFR 31.5, should provide information relative to the material transfer reports and records. Applicants should also provide a copy of the information packet to be sent to customers before transfer. An SSD review is required (See Section 5.2). All other requirements of 10 CFR 32.51 are handled in the SSD review. Discussion: The following information must be submitted or addressed as part of the license application. Quarterly Material Transfer Reports Licensees are required to file a report with NRC within 30 days of the end of each calendar quarter in accordance with 10 CFR 32.52. Appendix Q contains NRC Form 653 entitled "Transfers of Industrial Devices Report." This form may be used to submit these quarterly reports. Alternatively, the licensee may use another report format as long as the report includes the following information:
Important Notes on Transfer Reports:
Recordkeeping Information on all 10 CFR 31.5 transfers and receipts that supports the above reports, are required to be maintained for 3 years after the recorded event. Licensees are required to make available, upon request, to the various regulatory agencies, records of final disposition of devices in the event the licensee files for bankruptcy or requests termination of the license. Information to be Supplied to Customers Licensees are required to provide information to their generally licensed customers before transfer of devices in accordance with 10 CFR 32.51a (a) and (b). The intent is for the customer to be aware of this information prior to making a commitment to purchase (e.g., so they can consider the requirements associated with the general license and the costs of disposal of the device in making a decision to purchase). The following information must be provided:
If the customer is planning to use the device in an Agreement State, a copy of applicable state regulations and the name, address, and phone number of the contact at the Agreement State Regulatory Agency should be provided. A copy of the NRC regulations listed in Item 1 above can be substituted for the Agreement State regulations, with a note that the device is regulated by the Agreement State regulations. Item 4 is not applicable in this case. Note that Appendices K and L can be supplied to customers for information as well. In the easy-to-read question and answer format, these Appendices contain useful information regarding generally licensed devices. Appendix K may be helpful to a wide range of generally licensees, and Appendix L may be helpful to general licensees who use Self-Luminous Exit signs. Response from Applicant: Submit the following: A statement that: "We will provide quarterly transfer reports in accordance with 10 CFR 32.52(a) and (b) and will maintain records in accordance with 10 CFR 32.52(c). We will provide information to customers prior to purchase in accordance with 10 CFR 32.51a (a) and (b)." References: Appendix F contains a checklist for use in reviewing general distribution license applications for 10 CFR 31.5 devices. Appendix K contains guidance for General Licensees in the form of questions and answers. Appendix L contains guidance specific to Self-Luminous Exit Signs (tritium exit signs) in the form of questions and answers. Appendix Q contains a form for use in submitting quarterly material transfer reports. 8.7.2 10 CFR 32.53: Requirements For Initial Transfer of Luminous Safety Devices For Use in AircraftRegulations: 10 CFR 31.7; 10 CFR 32.53; 10 CFR 32.56. Criteria: Applicants for a specific license to initially transfer luminous safety devices for use in aircraft containing tritium or promethium-147, for distribution to general licensees under 10 CFR 31.7, must provide sufficient information relative to annual material transfer reports. All devices distributed under 10 CFR 31.7 require an SSD review. All other requirements of 10 CFR 32.53 are handled in the SSD review (See Section 5.2). For products distributed to general licensees pursuant to 10 CFR 31.7, the specific licensed distributor is required under 10 CFR 32.56 to file an annual report with NRC before July 30 of each year, covering the year ending June 30. The report must include the following information:
The report should also identify the specific licensee submitting the report (the distributor) and the specific license number. Response from Applicant: Submit the following: A statement that: "We will provide annual material transfer reports in accordance with 10 CFR 32.56." References: Appendix G contains a checklist for use in reviewing a general distribution license application for luminous safety devices for aircraft. 8.7.3 10 CFR 32.57: Requirements For Initial Transfer of Calibration or Reference Sources Containing Americium-241Regulations: 10 CFR 31.8; 10 CFR 32.57; 10 CFR 32.58; 10 CFR 32.59. Criteria: Applicants for a specific license to initially transfer calibration or reference sources containing americium-241, for distribution to persons generally licensed under 10 CFR 31.8, must provide sufficient information relative to 10 CFR 32.58. Note that an SSD registration certificate is not required for americium-241 calibration sources that contain no more than 185 kBq (5.0 microcuries), and thus, the application process for a manufacturing license of such sources should include a review of 10 CFR 32.57 and 32.59. For information regarding applications for manufacturing, see NUREG-1556, Vol.12. Discussion: This section outlines the requirements to obtain a license for an applicant wishing to distribute americium-241 reference and calibration sources. The byproduct material must be prepared for distribution in calibration or reference sources consisting of americium-241 not exceeding 185 kBq (5.0 microcuries). Each source or storage container for the source must bear a label that contains sufficient information relative to safe use and storage of the source and the following statement (or a substantially similar statement): Response from Applicant: Submit an actual label for each americium-241 check or reference source to be distributed. These labels must contain the information described in the Discussion section above. Reference: Appendix H contains a checklist for use in reviewing a general distribution license application for americium-241 calibration or reference sources under 10 CFR 31.8. 8.7.4 10 CFR 32.61: Requirements For Initial Transfer of Ice Detection Devices Containing Strontium-90Regulations: 10 CFR 31.10, 10 CFR 32.61. Criteria: Applicants for a specific license to initially transfer ice detection devices containing strontium-90 for distribution to persons generally licensed under 10 CFR 31.10, must only provide sufficient information relative to Items 1 through 6 of NRC Form 313. An SSD review is required (See Section 5.2). All other requirements of 10 CFR 32.61 are handled in the SSD review. Response from Applicant: No specific response required. References: Appendix I contains a checklist for use in reviewing general distribution license applications for ice detection devices. 8.7.5 10 CFR 32.71: Requirements For Initial Transfer in Vitro Kits Under 10 CFR 31.11Regulations: 10 CFR 20.1901(a); 10 CFR 20.2001; 10 CFR 30.42(d); 10 CFR 31.11; 10 CFR 32.71. Criteria: Applicants for a specific license to initially transfer byproduct material for certain in vitro clinical or laboratory testing for distribution to persons generally licensed under 10 CFR 31.11, must provide sufficient information to satisfy 10 CFR 32.71(b)-(e). Discussion: This section outlines the requirements to obtain a license for an applicant requesting authorization to distribute in vitro kits to persons who use them for a variety of clinical tests such as Schillings tests, red cell survival tests, hormone evaluations, and thyroid stimulating hormone tests (TSH). An SSD review is not required. The byproduct material must be prepared for distribution in prepackaged units consisting of any of the following:
Each prepackaged unit must bear a durable, clearly visible label including the following information:
Each package must also have a statement, or a substantially similar statement, that contains the following information on a label affixed to the prepackaged unit or in a leaflet or brochure accompanying the package. This label or leaflet/brochure must contain adequate information about the precautions to be observed in handling and storing such byproduct material. Regarding Mock Iodine-125 reference/calibration sources, the information must also contain directions on disposing of waste in accordance with 10 CFR 20.2001. Usually, compliance with this requirement is achieved by transfer to an authorized recipient. In accordance with 10 CFR 31.11(f), except for mock iodine-125 sources, these licensees are exempt from the requirements in 10 CFR Parts 19, 20, and 21, including the requirements on disposal of licensed material. The distribution licensees may wish to inform their customers of this exemption.
Response from Applicant: Submit an actual package label and/or leaflet/brochure for each type of prepackaged kit. These labels and/or leaflet/brochures must contain the information described in the Discussion section above. References: Appendix J contains a checklist for reviewing general distribution license applications for certain in vitro kits under 10 CFR 31.11. 8.8 Item 12: Fees[ Prev | Next | Top of file ] On NRC Form 313, enter the appropriate fee category from 10 CFR 170.31 and the amount of the fee enclosed with the application. Applicants should be aware that they may be responsible for fees in each category applicable to their application or license. Refer to Section 7 for more information. NRC may begin reviewing licensing requests without the proper fees; however, NRC will not issue a new license, amendment, renewal, or registration certificate before receiving the appropriate fee. 8.9 Item 13: Certification of Application[ 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 the form. Representatives signing an application must be authorized to make binding commitments and to sign official documents on behalf of the applicant. As discussed previously in "Management Responsibility," signing the application acknowledges management's commitment and responsibilities for the radiation protection program. NRC will return all unsigned applications for proper signature. Note:
9 Deficiency in the Application[ Prev | Next | Top of file ] If, in the process of evaluating an application, it is determined that insufficient information has been submitted, the license reviewer will contact the applicant to obtain the necessary information. Depending on the type and complexity of the information needed, the reviewer may request the additional information through a formal written request or, especially for simple answers and clarifications, via telephone or electronic mail. Submittal of an inadequate or deficient application may delay the issuance of the license. The application could be rejected by NRC for failure to provide a prompt or timely response to a deficiency in the application. Applicants may request an extension of time in order to respond to any correspondence or request for additional information about its application, provided NRC determines there is good cause and the additional time is reasonable. The request may be in writing or via telephone. Typically, the reviewer notifies the applicant by telephone that an extension has been granted and gives the applicant the new proposed date. 10 Issuance of a License[ Prev | Next | Top of file ] Licenses authorizing distribution of generally licensed products or devices under 10 CFR 32.51, 32.53, 32.57, 32.61, and/or 32.71 are prepared using NRC Form 374 (see Appendix M for a typical example). This is a separate license from the possession and use license, and it is commonly referred to as a "General Distribution" license. All general distribution licenses include the following information:
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