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Program-Specific Guidance About Self-Shielded Irradiator Licenses - Final Report (NUREG-1556, Vol. 5)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: October 1998 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 Nuclear
Regulatory Commission (NRC) is consolidating and updating numerous guidance
documents into a single comprehensive repository as described in NUREG-1539,
"Methodology and Findings of the NRC's Materials Licensing Process Redesign,"
dated April 1996, and draft NUREG-1541, "Process and Design for Consolidating
and Updating Materials Licensing Guidance," dated April 1996. Figures
[ Prev | Next | Top of file ] Figure 1.1 Types of Irradiators Figure 8.1 RSO Responsibilities Figure 8.2 Material Receipt and Accountability Figure 8.3 Annual Dose Limits for Occupationally Exposed Individuals Figure 8.4 Proper Location of Irradiator Figure 8.5. Proper Handling of Incident Figure 8.6 Routine Maintenance and Lubrication Figure 8.7 Non-Routine Maintenance Figure M.1 Diagram of Office and Irradiator Area 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 consolidating and updating numerous guidance documents into a NUREG-series of reports. Below is a list of volumes currently included in the NUREG-1556 series, "Consolidated Guidance About Materials Licenses":
The current document (NUREG-1556, Vol. 5, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Self-Shielded Irradiators," dated October 1998, is the fifth program-specific guidance developed for the new process. It is intended for use by applicants, licensees, NRC license reviewers, and other NRC personnel. It supersedes the guidance for applicants and licensees previously found in RG 10.9, Rev. 1, "Guide for the Preparation of Applications for Licenses for the Use of Self-Contained Dry Source-Storage Gamma Irradiators," dated December 1988, the guidance for licensing staff previously found in P&GD FC 84-16, Rev. 1, "Standard Review Plan for Applications for Use of Self-Contained Dry Source-Storage Gamma Irradiators," dated January 26, 1989, and the documents marked with an asterisk (*) in Appendix A. NUREG-1556, Vol. 5, incorporates the comments received during the comment period on draft NUREG-1556, Vol. 5. See the Addendum for summaries of comments, staff responses, and other changes. This report takes a risk-informed, performance-based approach to licensing self-shielded irradiators, i.e., it reduces the amount of information needed from an applicant seeking to possess and use a relatively safe device. These self-shielded irradiators containing sealed sources of radioactive material incorporate features engineered to enhance their safety. NRC's considerable experience with these licensees indicates that radiation exposures to workers are generally low, if the irradiators operate as designed and workers follow basic safety procedures. 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 self-shielded irradiators. A representative of NRC's Office of the General Counsel provided a legal perspective. NUREG-1556, Vol. 5, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Self-Shielded Irradiator Licenses," dated October 1998, 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 uniform resource locator (URL): <http://www.nrc.gov/NRC/NUREGS/SR1556/V5/index.html> The performance-based approach in NUREG-1556, Vol. 5, gives licensees greater flexibility than previously permitted under licenses based on applications prepared according to RG 10.9, Rev. 1. This guidance document permits licensees to make more changes in their radiation safety program without amending their licenses, thus reducing the regulatory burden on licensees and the NRC staff. Accordingly, existing self-shielded irradiator licensees have the option of submitting a complete application using NUREG-1556, Vol. 5, at the time that they file an amendment request. Licensees choosing this option should incorporate the requested change into the complete application, submit it with the appropriate amendment fee, and indicate that the complete revision is an amendment request to take advantage of the new guidance. When the staff has reviewed the request and resolved any outstanding issues, they will amend the license without changing the expiration date. Licensees wishing to renew their licenses should submit a complete application according to NUREG-1556, Vol. 5. The staff's action will be similar to that described for amendments, but will include an extension of the license's expiration date. By following this procedure, the staff expects all existing self-shielded irradiator licenses to be converted to the more performance-based format within a few years. This report describes and makes available to the public information on: methods acceptable to the NRC staff for implementing specific parts of the Commission's regulations; techniques the staff uses in evaluating applications, including specific problems or postulated accidents; and data the NRC staff needs to review applications for licenses. NUREG-1556, Vol. 5, "Consolidated Guidance about Materials Licenses: Program-Specific Guidance about Self-Shielded Irradiator Licenses," dated October 1998, is not a substitute for NRC regulations, and compliance is not required. The approaches and methods described in this report are provided for information only. Methods and solutions different from those described in this report will be acceptable if they provide a basis for the staff to make the determinations needed to issue or continue a license. Frederick C. Combs, Acting Director Acknowledgments
[ Prev | Next | Top of file ] The writing team thanks the individuals listed below for assisting in the development and review of both the draft and final reports. All participants provided valuable insights, observations, and recommendations. The team also thanks Kay Avery, Eric Bazerghi, Veronica Bellone, Judy Boykin, Elaine Gerdine, C. Harris Huckabee, Tina Jordan, Kathryn M. LaViolette, Grace S. Lee, D. W. Benedict Llewellyn, Alyce J. Martin, Steven W. Schawaroch, Gina G. Thompson, and Tim Woods of Computer Sciences Corporation; Angela S. Case of Total Systems Solutions, Inc.; Paul M. Tyree of CIS-US, Inc.; Mary F. Shepherd of J. L. Shepherd and Associates; and Tham Tran of MDS Nordion. The Participants Baggett, Steven L. Abbreviations
[ Prev | Next | Top of file ]
1 Purpose of Report
[ Prev | Next | Top of file ] This report provides guidance to an applicant in preparing a self-shielded irradiator(1) license application as well as NRC criteria for evaluating a self-shielded irradiator license application. It is not intended to address the research and development or the commercial aspects of manufacturing, distribution, and service of self-shielded irradiators and their associated sources. Within this document, the phrases or terms, "self-shielded irradiator," "self-contained irradiators," or "irradiators" are used interchangeably.
The American National Standards Institute (ANSI) has developed and published safety standards for gamma irradiators. In determining basic safety requirements, ANSI divided all gamma irradiators into four general categories. This report deals with the type of irradiator discussed in ANSI Standard N433.1, "Safe Design and Use of Self-Contained, Dry Source Storage Gamma Irradiators (Category I)."(2) This report also uses the same definition of a self-shielded irradiator as the ANSI definition for a Category I irradiator: "[a]n irradiator in which the sealed source(s) is completely contained in a dry container constructed of solid materials, the sealed source(s) is shielded at all times, and human access to the sealed source(s) and the volume(s) undergoing irradiation is not physically possible in its designed configuration." Depending on the design, the radiation source within the irradiator may be in a fixed position or may be movable. In the latter case, interlocks are used to ensure that the source does not move into a position that, during normal use of the irradiators, may cause a radiation hazard to any individual. Bypassing or failure of an interlock could cause persons to be exposed to high levels of radiation. Self-shielded irradiators typically contain several hundred to several thousand terabecquerels (TBq) (or curies (Ci)) of cesium-137 (Cs-137) or cobalt-60 (Co-60) and range in weight from several hundred to several thousand kilograms (kg) (or pounds). Other irradiators contain megabecquerel (MBq) (or millicurie (mCi)) quantities of strontium-90 (Sr-90), a beta emitter, and are used primarily for thermoluminescent dosimeter (TLD) calibration. The NRC's past practice was to issue a separate license to authorize the possession and use of self-shielded irradiators if any of the units exceeded 37 TBq (1,000 Ci). NRC will now authorize self-shielded irradiators on the same license as the licensee's other licensed material. This report identifies the information needed to complete NRC Form 313 (Appendix B), "Application for Material License," for the use of sealed sources in self-shielded irradiators. The information collection requirements in Title 10, Code of Federal Regulations, Part 30 (10 CFR Part 30) and NRC Form 313 have been approved under the Office of Management and Budget (OMB) Clearance Nos. 3150-0017, and 3150-0120, respectively. The format within this document for each item of technical information is as follows:
Notes and References are self-explanatory and may not be found for each item on NRC Form 313. NRC Form 313 does not have sufficient space for applicants to provide full responses to Items 5 through 11; as indicated on the form, the answers to those items are to be provided on separate sheets of paper and submitted with the completed NRC Form 313. For the convenience of applicants and for streamlined handling of self-shielded irradiator applications in the new materials licensing process, use Appendix C to provide supporting information, attach it to NRC Form 313, and submit them to NRC. Appendices D through Q contain additional information on various radiation safety topics. Appendix R is a sample self-shielded irradiator license; it contains the conditions most often found on these licenses, although not all licenses will have all conditions. Appendix S is a checklist that NRC staff uses to review applications and applicants can use to check for completeness. The Addendum contains the comments received on draft NUREG 1556, Vol. 5, and NRC staff's response to each comment. 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. Rem, and its SI equivalent Sievert (1 rem = 0.01 Sievert (Sv)), is used to describe units of radiation exposure or dose. This is because 10 CFR Part 20 sets dose limits in terms of rem, not rad or roentgen (R), and the sealed sources used in irradiators emit beta and gamma rays, which means that 1 R = 1 rad = 1 rem. 2 Agreement States
[ Prev | Next | Top of file ] Certain states, called Agreement States (see Figure 2.1), have entered into agreements with the NRC that give them the authority to license and inspect byproduct, source, or special nuclear materials used or possessed within their borders. Any applicant other than a Federal agency who wishes to possess or use licensed material in one of these Agreement States needs to contact the responsible officials in that State for guidance on preparing an application; file these applications with State officials, not with the NRC. In the special situation of work at Federally-controlled sites in Agreement States, it is necessary to know the jurisdictional status of the land in order to determine whether NRC or the Agreement State has regulatory authority. NRC has regulatory authority over land determined to be "exclusive Federal jurisdiction," while the Agreement State has jurisdiction over non-exclusive Federal jurisdiction land. Licensees are responsible for finding out, in advance, the jurisdictional status of the specific areas where they plan to conduct licensed operations. NRC recommends that licensees ask their local contact for the Federal agency controlling the site (e.g., contract officer, base environmental health officer, district office staff) to help determine the jurisdictional status of the land and to provide the information in writing, so that licensees can comply with NRC or Agreement State regulatory requirements, as appropriate. Additional guidance on determining jurisdictional status is found in All Agreement States Letter, SP-96-022, dated February 16, 1996, which is available as indicated below. Table 2.1 provides a quick way to check on which agency has regulatory authority. Table 2.1 Who Regulates the Activity?
Figure 2.1 U.S. Map. Location of NRC Offices and Agreement States. References: A current list of Agreement States (including
names, addresses, and telephone numbers of responsible officials) is available
by choosing "Directories" on the NRC Office of State Programs' (OSP's)
Home Page at <http://www.hsrd.ornl.gov/nrc/home.htm All Agreement States Letter, SP-96-022, dated February 16, 1996, is available
on OSP's Home Page at <http://www.hsrd.ornl.gov/nrc/home.htm 3 Management Responsibility
[ Prev | Next | Top of file ] The 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 duly authorized 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, and Inspection Procedure (IP) 87110, Appendix A, "Industrial/Academic/Research Inspection Field Notes." These documents are available electronically at <http://www.nrc.gov>. For hard copies of NUREG-1600 and IP 87110, see the Notice of Availability (on the inside front cover of this report). 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 10 CFR Chapter I contain regulations applicable to self-shielded irradiators:
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 How to File
[ Prev | Next | Top of file ] 5.1 Paper Application
[ Prev | Next | Top of file ] Applicants for a materials license should do the following:
All license applications will be available for review by the general public in NRC's Public Document Rooms. If it is necessary to submit proprietary information, follow the procedure in 10 CFR 2.790. Failure to follow this procedure could result in disclosure of the proprietary information to the public or substantial delays in processing the application. Employee personal information, i.e., home address, home telephone number, social security number, date of birth, radiation dose information, should not be submitted unless specifically requested by NRC. As explained in the "Foreword," NRC's new licensing process will be faster and more efficient, in part, through acceptance and processing of electronic applications at some future date. NRC will continue to accept paper applications. However, these will be scanned and put through an optical character reader (OCR) to convert them to electronic format. To ensure a smooth transition, applicants are requested to follow these suggestions:
5.2 Electronic Application
[ Prev | Next | Top of file ] As the electronic licensing process develops, it is anticipated that NRC may provide mechanisms for filing applications via diskettes or compact disk with read-only memory (CD-ROM), and through the Internet. Additional filing instructions will be provided as these new mechanisms become available. The existing paper process will 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 shows NRC's four Regional Offices and their respective areas for licensing purposes and identifies Agreement States. In general, applicants wishing to possess or use licensed material in Agreement States must file an application with the Agreement State, not NRC. However, if work will be conducted at Federally controlled sites in Agreement States, applicants must first determine the jurisdictional status of the land in order to determine whether NRC or the Agreement State has regulatory authority. See the section on "Agreement States" for additional information. 7 License Fees
[ Prev | Next | Top of file ] Each application for which a fee is specified, including applications for new licenses and license amendments, must be accompanied by the appropriate fee. Refer to 10 CFR 170.31 to determine the amount of the fee. NRC will not issue the new license prior to fee receipt. Once technical review has begun, no fees will be refunded; application fees will be charged regardless of the NRC's disposition of an application or the withdrawal of an application. Most NRC licensees are also subject to annual fees; refer to 10 CFR 171.16. Consult 10 CFR 171.11 for 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 and then ask for extension 415-7554. 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(3) to an existing license, and provide license number. Check box C for a renewal3 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 use of the radioactive material; a division or department within a legal entity may not be a licensee. An individual may be designated as the applicant only if the individual is acting in a private capacity and the use of the radioactive material is not connected with employment in a corporation or other legal entity. Provide the mailing address where correspondence should be sent. A Post Office box number is an acceptable mailing address. Notify NRC of changes in mailing address; these changes do not require a fee. Note: NRC must be notified before control of the license is transferred or when bankruptcy proceedings have been initiated. See below for more details. NRC Information Notice (IN) 97-30, "Control of Licensed Material during Reorganizations, Employee-Management Disagreements, and Financial Crises," dated June 3, 1997, discusses the potential for the security and control of licensed material to be compromised during periods of organizational instability. Timely Notification of Transfer of Control Regulations: 10 CFR 30.34(b). Criteria: Licensees must provide full information and obtain NRC's prior written consent before transferring control of the license, or, as some licensees call it, "transferring the license." Discussion: 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 before the transaction is finalized. This is to ensure the following:
Response from Applicant: None from an applicant for a new license; Appendix D, excerpted from IN 89-25 (Rev. 1), "Unauthorized Transfer of Ownership or Control of Licensed Activities," dated December 7, 1994, identifies the information to be provided about transferring control. Notification of Bankruptcy ProceedingsRegulations: 10 CFR 30.34(h). Criteria: Immediately following filing of voluntary or involuntary petition for bankruptcy for or against a licensee, the licensee must notify the appropriate NRC Regional Administrator, in writing, identifying the bankruptcy court in which the petition was filed and the date of filing. Discussion: Even though a licensee may have filed for bankruptcy, the licensee remains responsible for all regulatory requirements. NRC needs to know when licensees are in bankruptcy proceedings in order to determine whether all licensed material is accounted for and adequately controlled and whether there are any public health and safety concerns (e.g., contaminated facility). NRC shares the results of its determinations with other involved entities (e.g., trustee) so that health and safety issues can be resolved before bankruptcy actions are completed. Response from Applicant: None at time of application for a new license. Generally, licensees should notify NRC within 24 hours of filing a bankruptcy petition. References: INs are available in the "Reference Library" on NRC's Home Page at <http://www.nrc.gov>. For hard copies, see the Notice of Availability (on the inside front cover of this report). 8.3 Item 3: Address(es) Where Licensed Material Will Be Used or Possessed
[ Prev | Next | Top of file ] Specify the street address, city, and state or other descriptive address (e.g., on Highway 10, 5 miles east of the intersection of Highway 10 and State Route 234, Anytown, State) for each facility. The descriptive address should be sufficient to allow an NRC inspector to find the facility location. A Post Office Box address is not acceptable. To allow licensees greater flexibility, the applicant should not identify the self-shielded irradiator location by room number and should not submit drawings of the location within the facility. The acceptability of the irradiator's location will be reviewed during the inspection process; see section on "Facilities and Equipment" for additional information. When a new self-shielded irradiator is acquired and will be used at the facility address listed in the license, the license need not be amended. An NRC-approved license amendment is required before locating an irradiator at an address not already listed on the license, whether that irradiator is an additional unit or a relocation of an existing unit.
Note: As discussed later under "Financial Assurance and Record Keeping for Decommissioning," licensees do need to maintain permanent records on where licensed material was used or stored while the license was in force. This is important for making future determinations about the release of these locations for unrestricted use (e.g., before the license is terminated). For self-shielded irradiator licensees, acceptable records are sketches or written descriptions of the specific locations where each irradiator is used or stored and any information relevant to damaged devices or leaking radioactive sources. 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. The NRC will contact this individual if there are questions about the application. Notify NRC if the contact person or his or her telephone number changes so that NRC can contact the applicant or licensee in the future with questions, concerns, or information. This notice is for "information only" and does not require a license amendment or a fee.
8.5 Item 5: Radioactive Material
[ Prev | Next | Top of file ] 8.5.1 Unsealed and/or Sealed Byproduct MaterialRegulations: 10 CFR 30.32(g), 10 CFR 30.33(a)(2), 10 CFR 32.210. Criteria: Applicants must provide the manufacturer's (or distributor's) name and model number for each requested sealed source and device. Licensees will be authorized to possess and use only those sealed sources and devices specifically approved or registered by NRC or an Agreement State. Discussion: NRC or an Agreement State performs a safety evaluation of self-shielded irradiators before authorizing a manufacturer (or distributor) to distribute the irradiators to specific licensees. The safety evaluation is documented in a Sealed Source and Device (SSD) Registration Certificate. Before the formalization of the SSD registration process, some older irradiators may have been specifically approved on a license. Licensees can continue to use those units specifically listed on their licenses. Applicants must provide the manufacturer's (or distributor'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. As explained in an "Urgent Notice" with an enclosed Order, both dated July 3, 1984 (see Appendix E), an NRC licensee identified a malfunction that could have resulted in a radiation overexposure. The malfunction involved an interlock mechanism which would have failed to prevent a shielded door from being opened after the source had moved out of the shielded position. The Order, which remains in effect, modifies licenses that authorize J. L. Shepherd Mark I or Model 81-22 irradiators. Applicants wishing to use either of these models must comply with the Order's requirements. Consult with the proposed manufacturer (or distributor) to ensure that requested sources and devices are compatible and conform to the sealed source and device designations registered with NRC or an Agreement State. Licensees 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. Such changes may necessitate a custom registration review, increasing the time needed to process a licensing action. SSD Registration Certificates contain sections on "Conditions of Normal Use" and "Limitation and Other Considerations of Use." These sections may include limitations derived from conditions imposed by the manufacturer (or distributor), by particular conditions of use that would reduce radiation safety of the device, or by circumstances unique to the sealed source or device. For example, working life of the device or appropriate temperature and other environmental conditions may be specified. Except as specifically approved by NRC, licensees are required to use irradiators according to their respective SSD Registration Certificates. Accordingly, applicants may want to get a copy of the certificate and review it or discuss it with the manufacturer (or distributor). Response from Applicant:
Note: For information on SSD registration certificates,
contact the Registration Assistant by calling NRC's toll free number (800)
368-5642 and then asking for extension 415-7217. For more information
about the SSD registration process, see the current version of 8.5.2 Financial Assurance and Recordkeeping for DecommissioningRegulations: 10 CFR 30.34(b), 10 CFR 30.35. Criteria: Self-shielded irradiator licensees authorized to possess sealed sources containing radioactive material in excess of the limits specified in 10 CFR 30.35 must provide evidence of financial assurance for decommissioning. Even if no financial assurance is required, licensees are required to maintain, in an identified location, decommissioning records related to structures and equipment where irradiators are used or stored and to leaking sources. Pursuant to 10 CFR 30.35(g), licensees must transfer these records important to decommissioning to either of the following:
Discussion: The requirements for financial assurance are specific to the types and quantities of byproduct material authorized on a license. Most self-shielded irradiator applicants and licensees do not need to take any action to comply with the financial assurance requirements because their total inventory of licensed material does not exceed the limits in 10 CFR 30.35. The limits for typical self-shielded irradiator sealed sources are shown in Table 8.1. Applicants requesting more than one radionuclide need to use the sum of the ratios method to determine whether financial assurance is needed. See Appendix F for additional information. Table 8.1 Minimum Inventory Quantity Requiring Financial Assurance
In most cases, a licensee would need to possess several irradiators before the financial assurance requirements would apply. Since the standard self-shielded irradiator license does not specify the maximum number of irradiators that a licensee may possess (allowing flexibility in obtaining additional irradiators specifically authorized by the license without amending its license), it contains a condition requiring the licensee to limit its possession of self-shielded irradiators to quantities not requiring financial assurance for decommissioning. Applicants and licensees wanting to possess self-shielded irradiators or irradiators and other licensed materials exceeding the limits in 10 CFR 30.35 must submit evidence of financial assurance or a decommissioning funding plan (10 CFR 30.35 (b)). RG 3.66, "Standard Format and Content of Financial Assurance Mechanisms Required for Decommissioning Under 10 CFR Parts 30, 40, 70, and 72," dated June 1990, contains approved wording for each mechanism authorized by the regulation to guarantee or secure funds except for the Statement of Intent for government licensees. See Appendix F for the recommended wording for a Statement of Intent. NRC will authorize possession exceeding the limits shown in Table 8.1 without requiring decommissioning financial assurance, for the purpose of normal source exchange for no more than 30 days. The same regulation also requires that licensees maintain records important to decommissioning in an identified location. All self-shielded irradiator licensees need to maintain records of structures and equipment where each irradiator was used or stored. As-built drawings with modifications of structures and equipment shown as appropriate fulfill this requirement. If drawings are not available, licensees shall substitute appropriate records (e.g., a sketch of the room or building, or a description of the area) concerning the specific areas and locations. If no records exist regarding structure and equipment where self-shielded irradiators were used or stored, licensees shall make all reasonable efforts to create such records based upon historical information (e.g., employee recollections). In addition, if self-shielded irradiator licensees have experienced unusual occurrences (e.g., leaking sources, other incidents that involve spread of contamination), they also need to maintain records about contamination that remains after cleanup or that may have spread to inaccessible areas.
Response from Applicant: No response is needed from most applicants. If financial assurance is required, submit evidence as described in RG 3.66.
References: See the Notice of Availability (on the inside front cover of this report) to obtain copies of RG 3.66 and P&GD FC 90-2 (Rev. 1), "Standard Review Plan for Evaluating Compliance with Decommissioning Requirements," dated April 30, 1991. 8.6 Item 6: Purpose(s) for Which Licensed Material Will Be Used
[ Prev | Next | Top of file ] Regulations: 10 CFR 30.33(a)(1). Criteria: Proposed activity is authorized by the Atomic Energy Act of 1954, as amended, and irradiators will be used only for the purposes for which they were designed and according to the manufacturer's (or distributor's) recommendations and instructions for use as specified in an approved SSD Registration Certificate. Uses other than those already listed must not compromise the integrity of the source or source shielding or other components of the device critical to radiation safety. Discussion: Allowed uses normally include irradiation of blood, insects, animals, biological samples, and inanimate objects. Usually prohibited are irradiation of flammable and explosive materials which may harm the shielding or the sealed source containment, or other materials (e.g., unsealed containers of acids or corrosive liquids) which may interfere with the safe operation of the device. Irradiation of food for commercial distribution to the public is subject to regulations of the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) and will not be discussed in this document. Requests to irradiate items not listed or prohibited in the SSD Registration Certificate will be reviewed on a case-by-case basis. Applicants need to submit enough information to demonstrate that irradiation of the proposed items will not compromise the integrity of the source or source shielding, or other components critical to radiation safety of the device. Contact the appropriate NRC Regional Office (see Figure 2.1) for additional case-specific guidance. Being granted an NRC license does not relieve a licensee from complying with other applicable Federal, State, or local regulations (e.g., FDA and USDA regulations about irradiation of food for commercial distribution). Response from Applicant: If the self-shielded irradiator will be used for the purposes listed on the SSD Registration Certificate, state the following: "The self-shielded irradiator(s) will be used for the purposes described in their respective SSD Registration Certificates." If the self-shielded irradiator will be used for purposes other than those listed on the SSD Registration Certificate, specify these purposes and submit safety analyses (and procedures, if needed) to support safe use. 8.7 Item 7: Individual(s) Responsible for Radiation Safety Program and Their Training Experience
[ Prev | Next | Top of file ] 8.7.1 Radiation Safety Officer (RSO)Regulations: 10 CFR 30.33(a)(3). Criteria: RSOs must have adequate training and experience. Successful completion of training as described in Appendix G is evidence of adequate training and experience. Discussion: The person responsible for the radiation protection program is called the Radiation Safety Officer, or RSO. The RSO needs independent authority to stop operations that he or she considers unsafe. He or she must have sufficient time and commitment from management to fulfill certain duties and responsibilities to ensure that radioactive materials are used in a safe manner. Typical RSO duties are illustrated in Figure 8.1 and described in Appendix H. NRC requires the name of the RSO on the license to ensure that licensee management has always identified a responsible, qualified person and that the named individual knows of his or her designation as RSO. Figure 8.1 RSO Responsibilities. Typical duties and responsibilities of RSOs. Response from Applicant: Provide the following:
AND EITHER
AND
OR
Note:
8.7.2 Authorized Users (AUs)Regulations: 10 CFR 30.33(a)(3). Criteria: Authorized users (AUs) must have adequate training and experience. Successful completion of training as described in Appendix G is evidence of adequate training and experience. Discussion: An AU is a person whose training and experience meet NRC criteria, who is named either explicitly or implicitly on the license, and who uses or directly supervises the use of licensed material. AUs must ensure the proper use, security, and routine maintenance of self-shielded irradiators containing licensed material. They must have appropriate training to provide reasonable assurance that they will use the irradiator safely, maintain security of and access to the irradiator, and respond appropriately to accidents and malfunctions. An AU is considered to be supervising the use of licensed material when he or she directs personnel in operations involving the material. Although the AU may delegate specific tasks to supervised users (e.g., maintaining records), he or she is still responsible for safe use of licensed material. Response from Applicant: Provide either of the following:
OR
Note: Alternative responses will be evaluated using the criteria listed above. 8.8 Item 8: Training for Individuals Working in or Frequenting Restricted Areas (Instructions to Occupationally Exposed Workers and Ancillary Personnel)
[ Prev | Next | Top of file ] Regulations: 10 CFR 19.11, 10 CFR 19.12, 10 CFR 19.13, 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 30.7, 10 CFR 30.9, 10 CFR 30.10, 10 CFR 30.33. Criteria: Individuals working with, as well as in the vicinity of, a self-shielded irradiator must have adequate training and experience. For those individuals who are not AUs yet work in the vicinity of a self-shielded irradiator and, in the course of employment, are likely to receive in a year an occupational dose of radiation over 1 millisievert (mSv) (100 millirem (mrem)), the licensee must provide training as required by 10 CFR 19.12. The extent of this training must be commensurate with potential radiological health protection problems present in the work place. Discussion: Licensees need to perform a prospective evaluation to determine radiation doses likely to be received by different individuals or groups. AUs, individuals performing routine maintenance, and individuals performing installations, relocations, non-routine maintenance, or repairs would be most likely to receive doses in excess of 1 mSv (100 mrem) in a year. See the previous section for a discussion of training and experience for AUs. Individuals, other than AUs (e.g., biomedical engineers), may perform routine maintenance on irradiators. However, they must be trained in radiation safety and in the irradiator manufacturers' operating procedures, or they must work under the supervision and in the direct physical presence of someone who has this training. Some licensees may have specific individuals trained to perform installations, relocations, non-routine maintenance, or repairs. Authorizations for these functions are separate from those for an AU or an individual who performs routine maintenance and will be specifically stated in a license condition. Appendix I contains suggested training for individuals who will conduct non-routine maintenance. While performing prospective evaluations, a licensee may recognize that some individuals (e.g., housekeeping staff), although not likely to receive doses over 1 mSv (100 mrem), should receive training to ensure adequate security and control of licensed material. Licensees may provide these individuals with training commensurate with their involvement with licensed material. For example, housekeeping staff may receive training on the nature and location of the irradiator and the meaning of the radiation symbol, and instructions not to touch the irradiator and to remain out of the room if the irradiator door is open. Response from Applicant: The applicant's training program will be examined during inspections, but should not be submitted in the license application. 8.9 Item 9: Facilities and Equipment
[ Prev | Next | Top of file ] Regulations: 10 CFR 30.33(a)(2). Criteria: Facilities and equipment must be adequate to protect health and minimize danger to life or property. Discussion: Self-shielded irradiators incorporate many engineering features to protect individuals from unnecessary radiation exposure. These devices are usually designed for use in a laboratory environment, i.e., inside a building, protected from the weather, and without wide variations of temperature and humidity. For information to help applicants determine the location of irradiators, see the sections on the SSD Registration Certificate entitled, "Conditions of Normal Use" and "Limitations and/or Other Considerations of Use." For example, if a proposed location for a self-shielded irradiator is not within the conditions of normal use or the limitations of use, the applicant will need to provide adequate justification. In addition, the applicant will need to take compensatory measures (e.g., increased surveillance and maintenance) to ensure that the irradiator operates as designed and provides the intended level of protection. IN 96-35, "Failure of Safety Systems on Self-Shielded Irradiators Because of Inadequate Maintenance and Training," dated June 11, 1996, discusses an incident resulting from irradiator failure in which the lack of a climate-controlled environment (i.e., loading dock) may have accelerated the degradation of internal components leading to a failed interlock and excessive dose received by an irradiator operator. Self-shielded irradiators vary in weight from several hundred to several thousand kilograms (pounds). Before installing an irradiator, licensees need to evaluate whether the floor in the proposed location can support the irradiator. Often licensees locate self-shielded irradiators on a ground floor. Some smaller and lighter irradiators require additional security measures to prevent unauthorized removal (e.g., locked in a room, bolted to the floor). For more information see "Radiation Safety Program - Operating and Emergency Procedures" and "Radiation Safety Program - Public Dose." The fire-resistant properties of most irradiators should provide adequate radioactive material containment and shielding integrity in most situations; however, additional protection is desirable for some situations. For example, the room housing the irradiator should be equipped with an automatically-operated fire detection and control system (sprinkler, chemical, or gas). As an alternative, the self-shielded irradiator should be located under conditions (e.g., ground floor location in fire-resistant building with little combustible material) and other controls (e.g., coordination with and training of firefighting personnel) that ensure a low level of radiation risk attributable to fires. Response from Applicant: Provide either of the following:
OR
Note: Alternative information will be reviewed using the criteria listed above. References: INs are available in the "Reference Library" on NRC's Home Page at <http://www.nrc.gov>. For hard copies, see the Notice of Availability (on the inside front cover of this report). 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. Criteria: Licensees must review the content and implementation of their radiation protection programs annually to ensure the following:
Discussion: Appendix J contains a suggested audit program that is specific to the use of self-shielded irradiators and is acceptable to NRC. All areas indicated in Appendix J may not be applicable to every licensee and may not need to be addressed during each audit. For example, licensees do not need to address areas which do not apply to their activities, and activities which have not occurred since the last audit need not be reviewed at the next audit. Generally, audits are conducted at least once every 12 months. Currently the NRC's emphasis in inspections is to perform actual observations of work in progress. As a part of their audit programs, applicants should consider performing unannounced audits of irradiator users to determine if, for example, Operating and Emergency Procedures are available and are being followed. It is essential that once identified, problems be corrected comprehensively and in a timely manner; IN 96-28, "Suggested Guidance Relating to Development and Implementation of Corrective Action," dated May 1, 1996, provides guidance on this subject. The NRC will review the licensee's audit results and determine if corrective actions are thorough, timely, and sufficient to prevent recurrence. If violations are identified by the licensee and these steps are taken, the NRC can exercise discretion and may elect not to cite a violation. The NRC's goal is to encourage prompt identification and prompt, comprehensive correction of violations and deficiencies. For additional information on NRC's use of discretion on issuing a notice of violation, refer to the current version of NUREG-1600, "General Statement of Policy and Procedures for NRC Enforcement Actions." 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 audit, persons contacted by the auditor(s), areas audited, audit findings, corrective actions, and follow-up. Response From Applicant: The applicant's program for reviewing the content and implementation of its radiation protection program will be examined during inspections, but should not be submitted in the license application. References: The documents referenced above are available electronically at <http://www.nrc.gov>. For hard copies of NUREG-1600, IN 96-28, and IP 87110, Appendix A, "Industrial/Academic/Research Inspection Field Notes," see the Notice of Availability (on the inside front cover of this report). 8.10.2 Radiation Monitoring InstrumentsRegulations: 10 CFR 20.1501, 10 CFR 20.2103(a), 10 CFR 30.33(a)(2). Criteria: Licensees must possess, or have access to, radiation monitoring instruments which are necessary to protect health and minimize danger to life or property. Instruments used for quantitative radiation measurements must be calibrated periodically for the radiation measured. Discussion: All licensees possessing self-shielded irradiators should have, or have access to, calibrated radiation detection instruments to determine radiation levels in areas adjacent to the irradiator. Usually, it is not necessary for a licensee to have a survey meter solely for use during irradiator operations, since it is not expected that a survey be performed each time a sample is irradiated. In these cases it is acceptable for the meter to be available on short notice in the event of an accident or malfunction that could reduce the shielding of the sealed source(s). Surveys may be required to verify source integrity and to ensure that dose rates in unrestricted areas and public and occupational doses are within regulatory limits. As explained in an "Urgent Notice" with an enclosed Order, both dated July 3, 1984 (see Appendix E), an NRC licensee identified a malfunction that could have resulted in a radiation overexposure. The malfunction involved an interlock mechanism which would have failed to prevent a shielded door from being opened after the source had moved out of the shielded position. The Order, which remains in effect, modifies licenses which authorize J. L. Shepherd Mark I or Model 81-22 irradiators and requires licensee to provide either a calibrated and operable radiation survey meter or room monitor for use with either of these irradiators. Although not required for all licensees possessing moving-source irradiators, it would be prudent for these licensees to use either a calibrated survey meter or room monitor to ensure that the sources are in the shielded position whenever a sample is not undergoing irradiation. The NRC requires that survey meter calibrations be performed by the instrument manufacturer or a person specifically authorized by the NRC or an Agreement State, unless the applicant specifically requests this authorization. Applicants seeking authorization to perform survey meter calibrations must submit additional information for review. See Appendix K for more information. Response from Applicant: Provide one of the following:
OR
OR
Note:
8.10.3 Material Receipt and AccountabilityRegulations: 10 CFR 30.34(e), 10 CFR 30.41, 10 CFR 30.51, 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 20.2201, 10 CFR 30.35(g)(2). Criteria: Licensees must do the following:
Discussion: While loss, theft, or misplacement of most self-shielded irradiators is unlikely because of their size and weight, accountability for licensed materials must be ensured; see Figure 8.2. Many licensees record use of self-shielded irradiators in a log book. Licensees are also required to conduct leak tests of irradiator sealed source(s) at the frequency specified in the SSD Registration Certificate. Since both of these activities require that an individual approach the irradiator, records of use and leak tests may be used as part of an accountability program. For more information, see "Radiation Safety Program - Operating and Emergency Procedures" and "Radiation Safety Program - Leak Tests" in this report. However, since some irradiators may not be in use or are used rarely, NRC expects licensees to physically approach and account for all sealed sources at least every 6 months.
Information on locations where irradiators are used or stored are records important to decommissioning and required by 10 CFR 30.35(g)(2). Table 8.2 Record Maintenance
* See the section entitled, "Financial Assurance and Recordkeeping for decommissioning." Response from Applicant: Provide either of the following:
OR
Note: Alternative responses will be evaluated using the criteria listed above. 8.10.04 Occupational DoseRegulations: 10 CFR 20.1502, 10 CFR 20.1201, 10 CFR 20.1207, 10 CFR 20.1208, 10 CFR 20.2106. Criteria: Applicants must do either of the following:
OR
Figure 8.3 Annual Dose Limits for Occupationally Exposed Individuals. Discussion: Under conditions of routine use and maintenance, the typical self-shielded irradiator user does not require a personnel monitoring device (dosimetry). However, individuals who perform non-routine maintenance do require personnel monitoring devices. Appendix L provides guidance on performing a prospective evaluation demonstrating that self-shielded irradiator users are not likely to exceed 10% of the applicable limits and thus, are not required to have personnel dosimetry. When personnel monitoring is needed, most licensees use either film badges or TLDs that are supplied by a NVLAP-approved processor. The exchange frequency for film badges is usually monthly due to technical concerns about film fading. The exchange frequency for TLDs is usually quarterly. Applicants should verify that the processor is NVLAP-approved. Consult the NVLAP-approved processor for its recommendations for exchange frequency and proper use. Some licensees use self-reading dosimeters in lieu of processed dosimetry. This is acceptable if the criteria above are met. See ANSI N322, "Inspection and Test Specifications for Direct and Indirect Reading Quartz Fiber Pocket Dosimeters," for more information. Response from Applicant: Provide either of the following:
OR
Note:
References: National Institute of Standards and Technology
(NIST) Publication 810, "National Voluntary Laboratory Accreditation Program
Directory," is published annually and is available electronically at <http://ts.nist.gov/nvlap > 8.10.5 Public DoseRegulations: 10 CFR 20.1301, 10 CFR 20.1302, 10 CFR 20.1003, 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 20.2107. Criteria: Licensees must do the following:
Discussion: Public dose is defined in 10 CFR Part 20 as "the dose received by a member of the public from exposure to radiation and/or radioactive material released by a licensee, or to any other source of radiation under the control of a licensee." Public dose excludes doses received from background radiation and from medical procedures. Whether the dose to an individual is an occupational dose or a public dose depends on the individual's assigned duties. It does not depend on the area (restricted, controlled, or unrestricted) the individual is in when the dose is received. In the case of self-shielded irradiators, members of the public include persons who work or may be near locations where self-shielded irradiators are used or stored and employees whose assigned duties do not include the use of licensed materials and who work in the vicinity where irradiators are used or stored. Security procedures described in "Facilities and Equipment" and "Radiation Safety Program - Operating and Emergency Procedures" should be effective in limiting the exposure to the public during use or storage. See Figure 8.4. Public dose is controlled, in part, by ensuring that irradiators are secure (e.g., located in a locked area) to prevent unauthorized access or use. As shown in Figure 1.1, most self-shielded irradiators are massive [i.e., hundreds of kilograms (pounds) and the size of file cabinets], not likely to be easily removed from their intended location, and may not need to be in a locked area to prevent loss, theft, or unauthorized relocation. Smaller units, however, such as those used to calibrate TLDs, are more easily moved and should be located in a locked area or bolted in place. Irradiator use is usually restricted by controlling access to the keys needed to operate the irradiator and/or to keys to the locked irradiator area. Only authorized users should have access to these keys. Public dose is also affected by the choice of storage and use locations and conditions. Since a self-shielded irradiator presents a radiation field, it must be located so that the radiation level in an unrestricted area (e.g., an office or the exterior surface of an outside wall) does not exceed 1 mSv (100 mrem) in a year or 0.02 mSv (2 mrem) in any one hour. Use the concepts of time, distance, and shielding when choosing storage and use locations. Decreasing the time spent near an irradiator, increasing the distance from the irradiator, and using shielding (i.e., brick, concrete, lead, or other solid walls) will reduce the radiation exposure. Licensees can determine the radiation levels adjacent to the irradiator location either by calculations or a combination of direct measurements and calculations using some or all of the following: typical known radiation levels provided by the irradiator manufacturer (or distributor), the inverse square law to evaluate the effect of distance on radiation levels, occupancy factor to account for the actual presence of the member of the public, and limits on the use of self-shielded irradiator(s). See Appendix M for an example. If, after making an initial evaluation, a licensee changes the conditions used for the evaluation (e.g., changes the location of irradiators, changes the type or frequency of irradiator use, adds self-shielded irradiators, changes the occupancy of adjacent areas), then the licensee must perform a new evaluation to ensure that the public dose limits are not exceeded and take corrective action, as needed. During NRC inspections, licensees must be able to provide documentation demonstrating, by measurement or calculation, that the TEDE to the individual likely to receive the highest dose from the licensed operation does not exceed the annual limit for members of the public. See Appendix M for examples of methods to demonstrate compliance. Response from Applicant: No response is required from the applicant in a license application, but documentation demonstrating compliance will be examined during inspection. 8.10.6 Operating and Emergency ProceduresRegulations: 10 CFR 30.34(e), 10 CFR 20.1101, 10 CFR 20.1801, 10 CFR 20.1802, 10 CFR 20.2202, 20.2203, 10 CFR 30.50, 10 CFR 21.21, 10 CFR 19.11(a)(3). Criteria: Before using an irradiator, licensees must do the following:
AND
Discussion: When used as designed, properly functioning self-shielded irradiators pose little radiation safety risk. However, improper maintenance, irradiating material incompatible with an irradiator's design, or operating an irradiator in an environment other than that recommended by the manufacturer (or distributor), could lead to damage or malfunction of an irradiator and elevated exposure rates in the irradiator's immediate vicinity. Operating and emergency procedures should be developed to minimize these risks, while keeping radiation exposures ALARA. These procedures must be model-specific to account for potentially significant differences in irradiator design and construction that lead to manufacturers (or distributors) providing different instructions and recommendations for operating and maintaining irradiators. Sources contained in many self-shielded irradiators are designed to deliver significant doses in short periods of time. Although self-shielded irradiators are safe when used correctly, unauthorized access to the irradiator or the irradiator's sources by untrained individuals could lead to a life-threatening situation. Therefore, operating procedures will also need to address access control and accountability. Many licensees achieve access control by permitting only AUs or the RSO to have access to the keys for the irradiator and/or the irradiator area. Accountability of an operating irradiator may be ensured by using a log book to record irradiator use, maintenance, service calls, and sealed source leak tests. Each activity requires an individual to interact in some way with the irradiator and thereby verify its presence. For sources contained in irradiators that are not actively used, licensees would need to find other methods to maintain accountability, such as conducting inventories. Licensees must post current copies of the operating procedures applicable to licensed activities (e.g., at the irradiator control panel). If posting of a document is not practicable, the licensee may post a notice which describes the document and states where it may be examined.
Appendix O provides information for applicants to consider when developing their procedures for self-shielded irradiators. Licensees may change their operating and emergency procedures without amending their licenses if:
Response from Applicant: Do the following:
AND EITHER
OR
Note:
8.10.7 Leak TestsRegulations: 10 CFR 30.53, 10 CFR 20.1501, 10 CFR 20.2103. Criteria: NRC requires testing to determine whether there is any radioactive leakage from the source in the self-shielded irradiator. Records of test results must be maintained. Discussion: When issued, a license will require performance of leak tests at intervals approved by the NRC or an Agreement State and specified in 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 microcurie) of radioactivity. Manufacturers, consultants, and other organizations may be authorized by NRC or an Agreement State to either perform the entire leak test sequence for other licensees or provide leak test kits to licensees. In the latter case, the licensee is expected to take the leak test sample according to the self-shielded irradiator manufacturer's (or 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. Response from Applicant: Do one of the following:
OR
OR
Note:
References: See the Notice of Availability (on the inside front cover of this report) to obtain a copy of Draft RG FC 412-4, "Guide for the Preparation of Applications for the Use of Radioactive Materials in Leak-Testing Services," dated June 1985. 8.10.8 MaintenanceRegulations: 10 CFR 20.1101, 10 CFR 30.34(e). Criteria: Licensees must routinely maintain self-shielded irradiators according to the manufacturer's (or distributor's) written recommendations and instructions; see Figure 8.6. For self-shielded irradiators, radiation safety procedures for routine maintenance must consider ALARA and ensure that the irradiator functions as designed and source integrity is not compromised.
Non-routine maintenance must be performed by the self-shielded irradiator manufacturer (or distributor) or a person specifically authorized by NRC or an Agreement State; see Figure 8.7. Requests for specific authorization to perform non-routine maintenance (see Appendix I) must demonstrate that personnel performing the work do the following:
Discussion: NRC IN 96-35, "Failure of Safety Systems on Self-Shielded Irradiators because of Inadequate Maintenance and Training," dated June 11, 1996, emphasizes the importance of proper maintenance and describes two incidents in which safety interlocks on self-shielded irradiators failed to prevent inadvertent exposure. Generally, before any maintenance or repair work is done, licensees need to determine (and assure themselves of the adequacy of) the following:
NRC permits self-shielded irradiator licensees to perform routine maintenance of the irradiator provided they follow the self-shielded irradiator manufacturer's (or distributor's) written recommendations and instructions. Although manufacturers (or distributors) may use different terms, "routine maintenance" includes, but is not limited to, cleaning, lubrication, changing batteries, relays or fuses. Routine maintenance does not include any activities that involve the source, source drive mechanism, or removing the shielding or source and any other activities during which personnel could receive radiation doses exceeding NRC limits. The NRC license will require that non-routine maintenance (as defined above) be performed only by the manufacturer (or distributor) or other persons specifically licensed by the Commission or an Agreement State to perform such services. Most licensees do not perform non-routine maintenance because they must have specialized equipment and technical expertise to perform these activities. Applicants seeking authorization to perform non-routine maintenance must submit specific procedures for review. See Appendix I for more information. Response from Applicant: Routine Maintenance: Submit either of the following:
OR
Non-Routine Maintenance: Submit either of the following:
OR
Note:
References: INs are available in the "Reference Library" on NRC's Home Page at <http://www.nrc.gov>. For hard copies, see the Notice of Availability (on the inside front cover of this report). 8.10.9 TransportationRegulations: 10 CFR 71.5, 10 CFR 71.12, 10 CFR 71.13, 10 CFR 71.14, 10 CFR 71.37, 10 CFR 71.38, Subpart H of 10 CFR Part 71, 49 CFR Parts 171, 172, 173, 174, 175, 176, 177, 178, 10 CFR 20.1101, 10 CFR 30.41, 10 CFR 30.51. Criteria: Applicants must develop, implement, and maintain safety programs for transport of radioactive material to ensure compliance with NRC and DOT regulations. Discussion: The general license in 10 CFR 71.12 provides the authorization used by most licensees to transport, or offer for transport, packages of radioactive material and specifies certain conditions. Most self-shielded irradiators contain quantities of radioactive material that require using a Type B package. Before offering a Type B package for shipment, the licensee needs to 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 Rev. 1 of RG 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 and asking for extension 415-8500. For information about associated fees, contact NRC's OCFO by calling NRC's toll-free number 800-368-5642 and asking for extension 415-7554. Some irradiator licensees who rarely ship radioactive material have chosen to transfer possession of radioactive materials to an irradiator manufacturer (or distributor) (or service licensee) with an NRC or Agreement State license who then acts as the shipper. The manufacturer (or distributor) (or service licensee), who is subject to the provisions of 10 CFR 71.12 or 10 CFR 71.14, as appropriate, then becomes responsible for proper packaging of the radioactive materials and compliance with NRC and DOT regulations. Licensees who do this must ensure that the manufacturer (or distributor) (or service licensee):
During an inspection, NRC uses the provisions of 10 CFR 71.5 and a Memorandum of Understanding (MOU) with DOT on the Transportation of Radioactive Material (signed June 6, 1979) to examine and enforce various DOT requirements applicable to irradiator licensees. Part 1 of Appendix Q lists major DOT regulations and Part 2 contains a sample bill of lading.
Response from Applicant: No response is needed from applicants during the licensing phase. However, before offering a Type B package for shipment, 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 be 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 copies of the MOU or RG. 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 extent practicable, the generation of radioactive waste. Discussion: All applicants for new licenses need to consider the importance of designing and operating their facilities to minimize the amount of radioactive contamination generated at the site during its operating lifetime and to minimize the generation of radioactive waste during decontamination. Irradiator applicants usually do not need to address these issues as a separate item since they are included in responses to other items of the application. Sealed sources and devices that are approved by NRC or an Agreement State and located and used according to their SSD Registration Certificates usually pose little risk of contamination. Leak tests performed as specified in the SSD Registration Certificate should identify defective sources. Leaking sources must be immediately withdrawn from use and decontaminated, repaired, or disposed of according to NRC requirements. These steps minimize the spread of contamination and reduce radioactive waste associated with decontamination efforts. Other efforts to minimize radioactive waste do not apply to programs using only sealed sources and devices that have not leaked. Response from Applicant: The applicant does not need to provide a response to this item under the following condition. NRC will consider that the above criteria have been met if the applicant's responses meet the criteria in the following sections: "Radioactive Material - Sealed Sources and Devices," "Facilities and Equipment," "Radiation Safety Program - Operating and Emergency Procedures," "Radiation Safety Program - Leak Tests," and "Waste Management - Self-Shielded Irradiator Transfer and Disposal." 8.11 Item 11: Waste Management
[ Prev | Next | Top of file ] 8.11.1 Self-Shielded Irradiator Disposal And TransferRegulations: 10 CFR 20.2001, 10 CFR 30.41, 10 CFR 30.51. Criteria: Licensed materials must be disposed of according to NRC requirements by transfer to an authorized recipient. Appropriate records must be maintained. Discussion: When disposing of self-shielded irradiators, licensees must transfer them to an authorized recipient. Authorized recipients are the original manufacturer (or distributor) of the irradiator, a commercial firm licensed by the NRC or an Agreement State to accept radioactive waste from other persons, or another specific licensee authorized to possess the licensed material (i.e., its license specifically authorizes the same radionuclide, form, and use). Before transferring radioactive material, a licensee must verify that the recipient is properly authorized to receive it using one of the methods described in 10 CFR 30.41. In addition, all packages containing radioactive sources must be prepared and shipped according to NRC and DOT regulations. Records of the transfer must be maintained as required by 10 CFR 30.51.
Response from Applicant: The applicant does not need to provide a response to this item during the licensing phase. However, the licensee should develop, implement, and maintain self-shielded irradiator transfer and waste disposal procedures in its radiation safety program.
The next two items on NRC Form 313 are to be completed on the form itself. 8.12 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. 8.13 Item 13: Certification
[ Prev | Next | Top of file ] Individuals acting in a private capacity are required to date and sign NRC Form 313. Otherwise, representatives of the corporation or legal entity filing the application should date and sign NRC Form 313. Representatives signing an application must be authorized to make binding commitments and to sign official documents on behalf of the applicant. As discussed previously in "Management Responsibility," signing the application acknowledges management's commitment and responsibilities for the radiation protection program. NRC will return all unsigned applications for proper signature. Note:
9 Amendments and Renewals to a License
[ Prev | Next | Top of file ] It is the licensee's obligation to keep the license current. If any of the information provided in the original application is to be modified or changed (except as may be permitted for operating and emergency procedures), the licensee must submit an application for a license amendment before the change takes place. Also, to continue the license after its expiration date, the licensee must submit an application for a license renewal at least 30 days before the expiration date (10 CFR 2.109, 10 CFR 30.36(a)). Applications for license amendment, in addition to the following, must provide the appropriate fee. For renewal and amendment requests applicants must do the following:
The performance-based approach in NUREG-1556, Vol. 5, gives licensees greater flexibility than previously permitted under licenses based on applications prepared according to RG 10.9, Rev. 1. This permits licensees to make more changes in their radiation safety program without amending their licenses, thus reducing the regulatory burden on licensees and the NRC staff. Accordingly, existing self-shielded irradiator licensees have the option of submitting a complete application using NUREG-1556, Vol. 5, at the time that they file an amendment request. Licensees choosing this option should incorporate the requested change into the complete application, submit it with the appropriate amendment fee, and indicate that the complete revision is an amendment request to take advantage of the new guidance. When the staff has reviewed the request and resolved any outstanding issues, the staff will amend the license without changing the expiration date. Licensees wishing to renew their licenses should submit a complete application according to NUREG-1556, Vol. 5. The staff's action will be similar to that described for amendments, but will include an extension of the license's expiration date. By following this procedure, the staff expects all existing self-shielded irradiator licenses to be converted to the more performance-based format within a few years.
10 Applications for Exemptions
[ Prev | Next | Top of file ] 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 71.8). These regulations state that NRC may grant an exemption, acting on its own initiative or on an application from an interested person. Key considerations are whether the exemption is authorized by law, will endanger life or property or the common defense and security, and is otherwise in the public interest.
Exemptions are not intended 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:
Some licensees with self-shielded irradiators built before 1966 may need an exemption from the requirements in 10 CFR Part 71 in order to transport these irradiators. Part 3 of Appendix Q provides more detailed information about this special situation. 11 Termination of Activities
[ Prev | Next | Top of file ] Regulations: 10 CFR 20.1402, 10 CFR 20.1403, 10 CFR 30.34(b), 10 CFR 30.35(g), 10 CFR 30.36(d), 10 CFR 30.36(g), 10 CFR 30.36(h), 10 CFR 30.36(j), 10 CFR 30.51(f). Criteria: The licensee must do the following:
Discussion: As noted in several instances discussed in "Criteria," before a licensee can decide whether it must notify NRC, the licensee must determine whether residual radioactivity is present and if so, whether the levels make the building or outdoor area unsuitable for release according to NRC requirements. A licensee's determination that a facility is not contaminated is subject to verification by NRC inspection. For guidance on the disposition of licensed material, see the section on "Waste Management - Self-Shielded Irradiator Disposal or Transfer." For guidance on decommissioning records, see the section on "Radioactive Materials - Financial Assurance and Record Keeping for Decommissioning." Response from Applicant: The applicant is not required to submit a response to the NRC during the initial application. However, when the license expires or at the time the licensee ceases operations, then any necessary decommissioning activities must be undertaken, NRC Form 314 or equivalent information must be submitted, and other actions must be taken as summarized in the Criteria. Reference: Copies of NRC Form 314, "Certificate of Disposition of Materials," are available upon request from NRC's Regional Offices. (See Figure 2.1 for addresses and telephone numbers). Appendix A : List of NRC Documents Considered in The Preparation of This NUREG Report
[ Prev | Next | Top of file ] This report incorporates and updates the guidance previously found in the RGs, P&GDs, INs, and TARs listed below. Other NRC documents such as IPs and MOUs were also consulted during the preparation of this report. The documents marked with an asterisk (*) are superseded by this report and should not be used. Table A.1 List of Regulatory Guides and Policy and Guidance Directives
Table A.2 List of Information Notices
Table A.3 List of Technical Assistance Requests
Table A.4 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 or NRC Form 313
[ Prev | Next | Top of file ] Table C.1 Items 5 & 6: Materials to Be Possessed and Proposed Uses
Table C.2 Items 7 Through 11: Training and Experience, Facilities and Equipment, Radiation Safety Program, and Waste Disposal
Appendix D : Information Needed for Transfer of Control Application
[ Prev | Next | Top of file ] Licensees must provide full information and obtain NRC's prior written consent before transferring control of the license; some licensees refer to this as "transferring the license." Provide the following information concerning changes of control by the applicant (transferor and/or transferee, as appropriate). If any items are not applicable, so state. 1. The new name of the licensed organization. If there is no change, the licensee should so state. 2. The new licensee contact and telephone number(s) to facilitate communications. 3. Any changes in personnel having control over licensed activities (e.g., officers of a corporation) and any changes in personnel named in the license such as radiation safety officer, authorized users, or any other persons identified in previous license applications as responsible for radiation safety or use of licensed material. The licensee should include information concerning the qualifications, training, and responsibilities of new individuals. 4. An indication of whether the transferor will remain in non-licensed business without the license. 5. A complete, clear description of the transaction, including any transfer of stocks or assets, mergers, etc., so that legal counsel is able, when necessary, to differentiate between name changes and transferring control. 6. A complete description of any planned changes in organization, location, facility, equipment, or procedures (i.e., changes in operating or emergency procedures). 7. A detailed description of any changes in the use, possession, location, or storage of the licensed materials. 8. Any changes in organization, location, facilities, equipment, procedures, or personnel that would require a license amendment even without transferring control. 9. An indication of whether all surveillance items and records (e.g., calibrations, leak tests, surveys, inventories, and accountability requirements) will be current at the time of transfer. Provide a description of the status of all surveillance requirements and records. 10. Confirmation that all records concerning the safe and effective decommissioning of the facility, pursuant to 10 CFR 30.35(g), 40.36(f), 70.25(g), and 72.30(d); public dose; and waste disposal by release to sewers, incineration, radioactive material spills, and on-site burials, have been transferred to the new licensee, if licensed activities will continue at the same location, or to the NRC for license terminations. 11. A description of the status of the facility. Specifically, the presence or absence of contamination should be documented. If contamination is present, will decontamination occur before transfer? If not, does the successor company agree to assume full liability for the decontamination of the facility or site? 12. A description of any decontamination plans, including financial assurance arrangements of the transferee, as specified in 10 CFR 30.35, 40.36, and 70.25. Include information about how the transferee and transferor propose to divide the transferor's assets, and responsibility for any cleanup needed at the time of transfer. 13. Confirmation that the transferee agrees to abide by all commitments and representations previously made to NRC by the transferor. These include, but are not limited to: maintaining decommissioning records required by 10 CFR 30.35(g); implementing decontamination activities and decommissioning of the site; and completing corrective actions for open inspection items and enforcement actions. With regard to contamination of facilities and equipment, the transferee should confirm, in writing, that it accepts full liability for the site, and should provide evidence of adequate resources to fund decommissioning; or the transferor should provide a commitment to decontaminate the facility before transferring control. With regard to open inspection items, etc., the transferee should confirm, in writing, that it accepts full responsibility for open inspection items and/or any resulting enforcement actions; or the transferee proposes alternative measures for meeting the requirements; or the transferor provides a commitment to close out all such actions with NRC before license transfer. 14. Documentation that the transferor and transferee agree to transferring control of the licensed material and activity, and the conditions of transfer; and the transferee is made aware of all open inspection items and its responsibility for possible resulting enforcement actions. 15. A commitment by the transferee to abide by all constraints, conditions, requirements, representations, and commitments identified in the existing license. If not, the transferee must provide a description of its program, to ensure compliance with the license and regulations. Appendix E : J. L. Shepherd Order
[ Prev | Next | Top of file ] JULY 3, 1984 TO ALL LICENSEES WHO POSSESS J. L. SHEPHERD IRRADIATORS An NRC licensee recently identified a malfunction in the lock mechanism of its J. L. Shepherd self-shielded irradiator which could have resulted in a radiation overexposure. Although no overexposure appears to have occurred, the potential hazard warrants immediate preventive action. Therefore, we have prepared the enclosed Order which requires the use of radiation survey equipment when the irradiators are being used. If you possess a J. L. Shepherd Mark I or Model 81-22 self-shielded irradiator, do not use it unless you provide appropriate radiation monitoring as specified in the Order. If you do not currently possess the appropriate equipment, you must obtain it before you resume use of your irradiator. Also, you should report any problems to your nearest NRC regional office immediately. Do not attempt to repair an irradiator, or allow anyone else to attempt repairs, unless specific authorization for repair of the irradiator which you possess is provided in an NRC license. We suggest that you review who has access to your irradiator, and establish strict controls to assure that no untrained personnel have access. Trained persons who continue to use the irradiator should conduct careful radiation surveys as specified in the Order. Irradiator doors should be opened slowly, to minimize any accidental exposure and to avoid "blanking out" of instruments due to high exposure rates. Any unusual meter reading should be taken as evidence of a problem. We are including in this mailing certain licensees about which we are uncertain whether they possess J. L. Shepherd irradiators. If you do not possess a J. L. Shepherd irradiator, please disregard this notice. Because this Order is effective immediately, it is important that you notify your radiation safety personnel immediately, and retain this Order with your license records. Questions and comments may be directed to your nearest NRC regional office. Sincerely, Richard E. Cunningham, Director Enclosure: Order Modifying License UNITED STATES OF AMERICA ORDER MODIFYING CERTAIN LICENSES (EFFECTIVE IMMEDIATELY) I Recently, the Nuclear Regulatory Commission (NRC) staff was notified by a licensee of the failure of a locking mechanism on a self-shielded irradiator which could have resulted in a radiation overexposure. ("Self-shielded" irradiators are designed so that the radioactive source remains in a shielded position at all times, both during storage and during irradiations. Therefore, the irradiators need not be placed in a shielded room.) The irradiator is a J. L. Shepherd Mark I, containing about 6,000 curies of cesium 137. The unit is operated as follows: (1) With the source in its shielded storage position, the shielded door is opened, (2) materials to be irradiated are placed inside the irradiator chamber, (3) the shielded door is closed, (4) the radioactive source is raised into the irradiation chamber, (5) after irradiation is complete, the source is lowered, and (6) the door is opened for removal of irradiated materials. The shielded door is interlocked so that it should not open when the radioactive source is in the irradiation chamber. However, in the case reported to NRC, the lock mechanism failed. In such a situation, an operator who opens the shielded door with the source raised could be subjected to substantial radiation exposure. The J. L. Shepherd Model 81-22 irradiator employs an interlock similar to the Mark I. The NRC staff has examined the irradiator in question and confirmed the defect. Furthermore, a New York City inspector checking a J. L. Shepherd Mark I irradiator in New York reported a malfunctioning interlock system. NRC and the Agreement States are studying the problem further to assess its generic implications. Based on the foregoing, I have concluded that the possibility of failure of locking mechanisms and/or mechanical timers on J. L. Shepherd Mark I and Model 81-22 irradiators represents a potential radiation hazard warranting immediate preventive action pending further investigation. I have determined, therefore, that the public health, safety, and interest require that the restrictions on the use of such irradiators as prescribed in Section II of this Order should be made immediately effective. II Accordingly, pursuant to Sections 81, 116 I, 162 o, and 182 of the Atomic Energy Act of 1954, as amended, and 10 CFR Parts 2 and 30 of the Commission's regulations, IT IS HEREBY ORDERED, EFFECTIVE IMMEDIATELY, THAT: Each license that authorizes possession of byproduct material in a J. L. Shepherd Mark I or Model 81-22 self-shielded irradiator is hereby amended to add the following conditions: 1. The J. L. Shepherd irradiator shall not be used unless the licensee provides a calibrated and operable radiation survey meter or room monitor for use with the irradiator. 2. The irradiator door shall not be opened until the operator has checked visual indicators to verify that the source has returned to its safe storage position. 3. Each room monitor (a) shall be operable at all times when the irradiator is in use, (b) shall activate a visible and audible alarm when radiation levels exceed 2 millirems per hour, (c) shall be located to detect any radiation escaping from the irradiator door, and (d) shall be located so that it is visible to the irradiator user when he is next to the irradiator. 4. If a room monitor is not installed, a survey meter shall be used (a) to determine the radiation level at the irradiator door when the door is closed, and (b) to check for any increase in radiation levels each time the irradiator door is opened. In conducting such checks, operators shall position themselves so as to minimize exposure to any radiation escaping from the open door. 5. If abnormal radiation levels or any malfunction of the irradiator are detected at any time, the licensee shall stop use of the irradiator and immediately notify the appropriate NRC regional office by telephone. 6. The licensee shall not attempt repair or authorize others to attempt repair of the irradiator except as specifically authorized in a license issued by NRC. III Any affected licensee may request a hearing on this Order. A request for a hearing shall be submitted within twenty (20) days of the date of this Order to Mr. R. E. Cunningham, Director, Division of Fuel Cycle and Material Safety, U. S. Nuclear Regulatory Commission, Washington, D. C. 20555, with a copy to the Executive Legal Director, U. S. Nuclear Regulatory Commission, Washington, D. C. 20555. ANY REQUEST FOR A HEARING SHALL NOT STAY THE IMMEDIATE EFFECTIVENESS OF THIS ORDER. IV If a hearing is requested, the Commission will issue an Order designating the time and place of any such hearing. If a hearing is held the issue to be considered at such a hearing will be: Whether, on the basis of the matters set forth in Section 1 and II of this Order, this Order should be sustained. FOR THE NUCLEAR REGULATORY COMMISSION Richard E. Cunningham, Director Office of Nuclear Material Safety and Safeguards Dated at Bethesda, Maryland this 3rd day of July, 1984 Appendix F : Guidance on Financial Assurance
[ Prev | Next | Top of file ] Determining Need for Financial Assurance If the only radioactive materials possessed are sealed sources in self-shielded irradiators, use Table F.1 to determine if financial assurance is required. Table F.1 Worksheet for Determining Need for Financial Assurance for Self-Shielded Irradiators
* For ease of use by most irradiator licensees, this table uses only conventional units. The conversion to SI units is: 1 Ci = 37 GBq. If the sum of the fractions is greater than or equal to 1, the applicant will need to submit certification of financial assurance or a decommissioning funding plan (10 CFR 30.35(e)). RG 3.66,(4) "Standard Format and Content of Financial Assurance Mechanisms Required for Decommissioning Under 10 CFR Parts 30, 40, 70, and 72," dated June 1990, provides sample documents for financial mechanisms. The recommended wording for a Statement of Intent for government licensees is shown below. Suggested Wording for a Statement of Intent for a Government Licensee [DATE] STATEMENT OF INTENT As [Title] of [Licensee Name] I exercise express authority and responsibility to approve funding for decommissioning activities associated with operations authorized by U.S. Nuclear Regulatory Commission Material License No. [License Number]. This authority is established by [Name of Document(s) Governing Control of Funds]. Within this authority, I intend to have funds made available when necessary in an amount up to [Dollar Amount] to decommission [Description of Facilities]. I intend to request and obtain these funds sufficiently in advance of decommissioning to prevent delay of required activities. A copy of [Name of Documents] is attached as evidence that I am authorized to represent [Licensee Name] in this transaction. [SIGNATURE] Attachment: As stated Appendix G : Model Training Program
[ Prev | Next | Top of file ] Course Content Training may be in the form of lecture, videotape, hands-on, or self-study, and emphasizes practical subjects important to the safe use of the self-shielded irradiator:
Instructor's Qualifications The individual preparing and conducting training is qualified as RSO or AU on a self-shielded irradiator license before giving training. Training Assessment Management will ensure that potential RSOs and authorized users are qualified to work independently with each type of the licensee's irradiators. This may be demonstrated by written or oral examination or by observation. Appendix H : Typical Duties and Responsibilities of the Radiation Safety Officer
[ Prev | Next | Top of file ] The RSO's duties and responsibilities include ensuring radiological safety and compliance with NRC and DOT regulations and the conditions of the license; see Figure 8.1. Typically, these duties and responsibilities include ensuring the following:
Appendix I : Information Needed to Support Applicant's Request to Perform Non-routine Maintenance
[ Prev | Next | Top of file ] Review the section on "Maintenance" which discusses, in general, licensee responsibilities before any maintenance or repair is performed. Non-routine maintenance includes repairs, removal, replacement, or alterations involving:
See Figure 8.7. If this maintenance or repair is not performed properly with attention to radiation safety principles, the self-shielded irradiator may not operate as designed and personnel performing these tasks could receive radiation doses exceeding NRC limits. Non-routine maintenance should be performed only by qualified and specifically authorized individuals. Self-shielded irradiator licensees should conduct these operations only after their procedures have been evaluated and specifically approved by license condition. Also, any non-manufacturer- (non-distributor-) supplied replacement components or the use of materials (e.g., lubricants) other than those specified or recommended by the manufacturer (or distributor) need to be evaluated to ensure that they do not degrade the engineering safety analysis performed and accepted as part of the device registration. Licensees also need to ensure that, after maintenance or repair is completed, the irradiator is tested and functions as designed, before the unit is returned to routine use. Accordingly, applicants wishing to perform non-routine maintenance must provide the following information, as appropriate:
Appendix J : Suggested Self-Shielded Irradiator Audit Checklist
[ Prev | Next | Top of file ] Note: All areas indicated in audit notes may not be applicable to every license and may not need to be addressed during each audit. For example, licensees do not need to address areas which do not apply to the licensee's activities and activities which have not occurred since the last audit need not be reviewed at the next audit.
Audit History
[ Prev | Next | Top of file ] A. Were previous audits conducted annually? [10 CFR 20.1101] B. Were records of previous audits maintained? [10 CFR 20.2102] C. Were any deficiencies identified during last two audits or two years, whichever is longer? D. Were corrective actions taken? (Look for repeated deficiencies). Organization and Scope of Program
[ Prev | Next | Top of file ] A. Radiation Safety Officer 1. If the RSO was changed, was license amended? 2. Does new RSO meet NRC training requirements? 3. Is RSO fulfilling his/her duties? 4. To whom does RSO report? B. Licensed Material 1. Does the license authorize all of the NRC-regulated radioactive material contained in self-shielded irradiators? 2. Does the total amount of radioactive material possessed require financial assurance? [10 CFR 30.35(a)] C. Are the self-shielded irradiators as described in the Sealed Source and Device (SSD) Registration Certificate? Have copies of (or access to) SSD Certificates? Have manufacturer's (or distributor's) manuals for operation and maintenance? [10 CFR 32.210] D. Are the actual uses of self-shielded irradiators consistent with the authorized uses listed on the license? E. If the mailing address or places of use changed, was the license amended? F. If control of license transferred or bankruptcy filed, was NRC prior consent obtained or notification made, respectively? Training and Instructions to Workers
[ Prev | Next | Top of file ] A. Were all workers who are likely to exceed 1 mSv (100 mrem) in a year instructed per [10 CFR 19.12]? Was refresher training provided, as needed [10 CFR 19.12]? B. Did each authorized user and person independently performing routine or non-routine maintenance attend license-required training before working with self-shielded irradiators? C. Are training records maintained for each individual? D. Did interviews with workers reveal that they know the emergency procedures and repair, maintenance, and relocation limitations? E. Did this audit include observations of operators using the self-shielded irradiators? Performing routine or other authorized maintenance? F. Did the audit identify any operator error in reporting maintenance and repair or operation issues to the RSO for review before starting work? Radiation Survey Instruments
[ Prev | Next | Top of file ] A. Describe the survey instruments possessed: 1. Do they meet the NRC's criteria? 2. Are they appropriate for the source type(s)? 3. Are they checked for function before use? 4. If they are used with moving-source irradiators or during non-routine maintenance, are they calibrated as required? [10 CFR 20.1501] B. If the licensee does not possess a survey meter, are specific plans made to have one available? Location: ___________ Location/Operation verified: ________________ C. Are calibration records, if required, maintained? [10 CFR 20.2103(a)] D. For J. L. Shepherd Mark I or Model 81-22 irradiator, check for compliance with license condition Self-shielded Irradiator Inventory and Location
[ Prev | Next | Top of file ] A. Is a record kept showing the receipt of each self-shielded irradiator? [10 CFR 30.51(a)(1)] B. Has the location(s) changed since the last audit? Personnel Radiation Protection
[ Prev | Next | Top of file ] A. Are ALARA considerations incorporated into the radiation protection program? [10 CFR 20.1101(b)] B. Were prospective evaluations performed showing that unmonitored users receive 10% of limit? [10 CFR 20.1502(a)] C. Did unmonitored users' activities change during the year which could put them over 10% of limit? D. If yes to 3. above, was a new evaluation performed? E. Is external dosimetry required (user receiving >10% of limit)? Is dosimetry provided to users? 1. If processed dosimetry: a. Is the dosimetry supplier NVLAP-approved? [10 CFR 20.1501(c)] b. Are dosimetry reports reviewed by the RSO when they are received? 2. If self-reading dosimeters: a. Have a range of zero to at least 2 mSv (200 mrem)? b. Are checked at periods not to exceed one year for correct response to radiation? c. Are read within �20% of the true radiation exposure? d. Are used under a program that prescribes action to evaluate the individual's dose? F. Are the dosimeters exchanged or read at the license required frequency? G. Are the records NRC Forms or equivalent? [10 CFR 20.2104(d), 10 CFR 20.2106(c)] 1. NRC-4 "Cumulative Occupational Exposure History" completed? 2. NRC-5 "Occupational Exposure Record for a Monitoring Period" completed? H. Declared pregnant worker/embryo/fetus 1. If a worker declared her pregnancy, did licensee comply with 10 CFR 20.1208? 2. Were records kept of embryo/fetus dose per 10 CFR 20.2106(e)? I. Are records of exposures, surveys, monitoring, and evaluations maintained [10 CFR 20.2102, 10 CFR 20. 2103, 10 CFR 20. 2106] Public Dose
[ Prev | Next | Top of file ] A. Are self-shielded irradiators located and used in a manner to keep doses below 1 mSv (100 mrem) in a year? [10 CFR 20.1301(a)(1)] B. Has a survey or evaluation been performed per 10 CFR 20.1501(a)? C. Have there been any additions or changes to the storage, security, or use of surrounding areas that would necessitate a new survey or evaluation? D. Do unrestricted area radiation levels exceed 0.02 mSv (2 mrem) in any one hour? [10 CFR 20.1301(a)(2)] E. Are self-shielded irradiators being used or stored in a manner that would prevent unauthorized access or removal? [10 CFR 20.1801] F. Records maintained? [10 CFR 20.2103, 10 CFR 20.2107] Operating and Emergency Procedures
[ Prev | Next | Top of file ] A. Have operating and emergency procedures been developed? B. Do they contain the required elements? C. Does each operator have a current copy of the operating and emergency procedures? Maintain copy at each irradiator's control panel or post notice indicating where to obtain copy? D. Did any emergencies occur? 1. If so, were they handled properly by operator? 2. Were appropriate corrective actions taken? 3. Was NRC notification or reporting required? (10 CFR 20.2201, 10 CFR 20.2202, 10 CFR 20.2203) E. For J. L. Shepherd Mark I or Model 81-22 irradiator, check for compliance with license condition F. Were operating or emergency procedures changed since last audit? If so, before new procedures were implemented: 1. Did licensee management and the RSO approve? 2. Did affected staff receive training? 3. Are the changes consistent with license conditions? licensee commitments? 4. Do the changes degrade safety? Leak Tests
[ Prev | Next | Top of file ] A. Was each sealed source leak tested every 6 months (or at other license prescribed intervals)? B. Was the leak test performed as described in correspondence with NRC and according to the license? C. Are records of results retained with the appropriate information included? D. Were any sources found leaking and if yes, was NRC notified? Maintenance of Self-shielded Irradiators
[ Prev | Next | Top of file ] A. Are manufacturer's (or distributor's) written procedures followed for routine (not safety critical) cleaning and lubrication and mechanical/electrical maintenance and repair of self-shielded irradiators? B. Was non-routine maintenance performed? C. If yes, was it performed according to license requirements (e.g., extent of work, individuals performing the work, procedures, dosimetry, survey instrument, compliance with dose limits)? D. Since the last audit, did operator(s) report a need for non-routine maintenance and repair to the RSO before requesting or conducting the work? Transportation
[ Prev | Next | Top of file ] A. Were self-shielded irradiator(s) or sources shipped since the last audit? B. If so, were 10 CFR Part 71 requirements followed? 1. DOT-Type A or Type B packages used? [10 CFR Part 71, 49 CFR 173.415, 49 CFR 173.416(b)] If Type B, NRC Certificate of Compliance granted before shipment or shipper is registered as a user of the Type B package? NRC-approved QA program? 2. Package performance test records on file? [49 CFR 173.415(a)] 3. Special form sources documentation? [49 CFR 173.476(a)] 4. Package has 2 labels (ex. Yellow-II) with TI, Nuclide, Activity, and Hazard Class? [49 CFR 172.403, 49 CFR 173.441] 5. Package properly marked? [49 CFR 172.301, 49 CFR 172.304, 49 CFR 172.310, 49 CFR 172.324] 6. Package closed and sealed during transport? [49 CFR 173.475(f)] 7. Shipping papers prepared, used, and maintained? [49 CFR 172.200(a)] 8. Shipping papers contain proper entries? {Shipping name, Hazard Class, Identification Number (UN Number), Total Quantity, Package Type, Nuclide, RQ, Radioactive Material, Physical and Chemical Form, Activity (SI units required), Category of Label, TI, Shipper's Name, Certification and Signature, Emergency Response Phone Number, Cargo Aircraft Only (if applicable)} [49 CFR 172.200, 49 CFR 172.201, 49 CFR 172.202, 49 CFR 172.203, 49 CFR 172.204, 49 CFR 172.604] 9. Secured against movement? [49 CFR 177. 834 ] 10. Placarded on vehicle, if needed? [49 CFR 172.504] 11. Proper overpacks, if used? [49 CFR 173.25] 12. Any incidents reported to DOT? [49 CFR 171.15, 49 CFR 171.16] 13. Irradiators manufactured before 1966 a. Were any shipped? b. Were NRC and DOT exemptions, if needed, received in advance? Auditor's Independent Survey Measurements (If Made)
[ Prev | Next | Top of file ] A. Describe the type, location, and results of measurements. B. Do any radiation levels exceed regulatory limits? Notifications and Reports
[ Prev | Next | Top of file ] A. Was any radioactive material lost or stolen? Were reports made? [10 CFR 20.2201, 10 CFR 30.50] B. Did any reportable incidents occur? Were reports made? [10 CFR 20.2202, 10 CFR 30.50] C. Did any overexposures and high radiation levels occur? Reported? [10 CFR 20.2203, 10 CFR 30.50] D. If any events (as described in items 1 through 3 above) did occur, what was root cause? Were corrective actions appropriate? E. Is the licensee aware of telephone number for NRC Emergency Operations Center? [(301) 816-5100] Posting and Labeling
[ Prev | Next | Top of file ] A. NRC-3 "Notice to Workers" posted? [10 CFR 19.11] B. NRC regulations, license documents posted or a notice posted? [10 CFR 19.11, 10 CFR 21.6] C. Other posting and labeling? [10 CFR 20.1902, 10 CFR 20.1904, 10 CFR Part 21] Record Keeping for Decommissioning
[ Prev | Next | Top of file ] A. Records kept of information important to decommissioning? [10 CFR 30.35(g)] B. Records include all information outlined in [10 CFR 30.35(g)]? Bulletins and Information Notices
[ Prev | Next | Top of file ] A. NRC Bulletins, NRC Information Notices, NMSS Newsletters, received? B. Appropriate training and action taken in response? Special License Conditions or Issues
[ Prev | Next | Top of file ] A. Did auditor review any special license conditions? B. Did auditor review any other issues (e.g., non-routine maintenance)? Deficiencies Identified in Audit; Corrective Actions
[ Prev | Next | Top of file ] A. Summarize problems/deficiencies identified during audit. B. If problems/deficiencies identified in this audit, describe corrective actions planned or taken. Include date(s) when corrective actions are implemented. C. Provide any other recommendations for improvement. Evaluation of Other Factors
[ Prev | Next | Top of file ] A. Senior licensee management is appropriately involved with the radiation protection program and/or Radiation Safety Officer (RSO) oversight? B. RSO has sufficient time to perform his/her radiation safety duties? C. Licensee has sufficient staff to support the radiation protection program? Appendix K : Radiation Monitoring Instrument Specifications and Model Survey Instrument Calibration Program
[ Prev | Next | Top of file ] Instrument(s) used with moving-source gamma irradiators must meet the following criteria:
Instrument(s) used with fixed-source gamma irradiators (or beta irradiators) are:
Model Survey Instrument Calibration Program
[ Prev | Next | Top of file ] TrainingBefore allowing an individual to perform survey instrument calibrations, the RSO will ensure that the individual has sufficient classroom and on-the-job training to show competency in performing independent survey instrument calibrations. Classroom training may be in the form of lecture, videotape, or self-study and will cover the following subject areas:
Appropriate on-the-job-training consists of:
Facilities and Equipment
Model Procedure for Calibrating Survey Instruments for Gamma Detection
References: Detailed information about survey instrument calibration may be obtained by referring to ANSI N323A-1996, "American National Standard Radiation Protection Instrumentation Test and Calibration - Portable Survey Instruments." Copies may be ordered electronically at <http://www.ansi.org> or by writing to ANSI, 1430 Broadway, New York, NY 10018. See the Notice of Availability (on the inside front cover of this report) to obtain a copy of Draft RG FC 413-4, "Guide for the Preparation of Applications for Licenses for the Use of Radioactive Materials in Calibrating Radiation Survey and Monitoring Instruments," dated June 1985.
[ Prev | Next | Top of file ] Appendix L : Guidance for Demonstrating That Unmonitored Individuals Are Not Likely to Exceed 10 Percent of the Allowable Limits Dosimetry is required for individuals likely to receive, in 1 year from sources external to the body, a dose in excess of 10% of the applicable regulatory limits in 10 CFR 20.1201. To demonstrate that dosimetry is not required, a licensee needs to perform a prospective evaluation to demonstrate that its workers are not likely to exceed 10% of the applicable annual limits. The most common way that individuals might exceed 10% of the applicable limits is by performing frequent routine maintenance on the irradiator. However, for most new irradiators even these activities result in the individual's receiving minimal doses. Before allowing workers to perform these tasks, a licensee will need to evaluate the doses which its workers might receive to assess whether dosimetry is required; this is a prospective evaluation. Example The following is an example of an estimate of the dose received by the extremities and whole body of a person performing routine maintenance (cleaning and lubrication) on a self-shielded irradiator rotating drawer drive chain. The estimate is based on observations of individuals performing the recommended procedure according to good radiation safety practices. The manufacturer can provide the following types of information:
From this information, an estimate of the doses that the individual performing this procedure could receive is as follows:
The applicable TEDE (whole body) limit is 50 mSv (5 rems) per year and 10% of that value is 5 mSv (500 mrems) per year. If one of these procedures delivers 0.0033 mSv (0.33 mrem), then an individual could perform 1,515 of these procedures each year and remain within 10% of the applicable limit. The applicable shallow-dose equivalent (SDE) (extremities) is 500 mSv (50 rems) per year and 10% of that value is 50 mSv (5 rems or 5000 mrems) per year. If one of these procedures delivers 0.001 mSv (0.1 mrem), then an individual could perform 50,000 of these procedures each year and remain within 10% of the applicable limit. Based on the above specific situation, no dosimetry is required if a worker performs fewer than 1,515 routine maintenance procedures per year. Guidance to Licensees
[ Prev | Next | Top of file ] Licensees who wish to demonstrate that they are not required to provide dosimetry to their workers need to perform prospective evaluations similar to that shown in the example above. The expected dose rates, times, and distances used in the above example may not be appropriate to individual licensee situations. In their evaluations, licensees need to use information appropriate to the type(s) of self-shielded irradiator(s) they intend to use; this information is generally available from the irradiator manufacturer (or distributor) or the SSD Registration Certificate maintained by the NRC and Agreement States. Table L.1 may be helpful in performing a prospective evaluation.(5) Licensees should review evaluations periodically and revise them as needed. Licensees need to check assumptions used in their evaluations to ensure that they continue to be up-to-date and accurate. For example, if workers become lax in following good radiation safety practices, perform the task more slowly than estimated, work with new irradiators containing sources of different activities or radionuclides, or use modified procedures, the licensee would need to conduct a new evaluation. Table L.1 Dosimetry Evaluation
* Expected Whole Body Doses less than 500 mrem requires no dosimetry ** Expected Extremity Doses less than 5000 mrem requires no dosimetry Appendix M : Guidance for Demonstrating That Individual Members of the Public Will Not Receive Doses Exceeding the Allowable Limits
[ Prev | Next | Top of file ] Licensees must ensure that:
Licensees must show compliance with both portions of the regulation. For areas around self-shielded irradiator facilities, calculations or a combination of calculations and measurements (e.g., using an environmental TLD) are often used to prove compliance. Calculational Method(6)
[ Prev | Next | Top of file ] The calculational method takes a tiered approach, going through a three-part process starting with a worst case situation and moving toward more realistic situations. It makes the following simplifications: (1) each irradiator is a point source; (2) typical radiation levels encountered when the source is in the shielded position are taken from either the SSD Registration Certificate, ANSI N433.1,(7) "Safe Design and Use of Self-Contained, Dry Source Storage Gamma Irradiator (Category I)," or the manufacturer's (or distributor's) literature; and (3) no credit is taken for any shielding found between the irradiator and the unrestricted areas. Part 1 of the calculational method is simple but conservative. It assumes that an affected member of the public is present 24 hours a day and uses only the inverse square law to determine if the distance between the irradiator and the affected member of the public is sufficient to show compliance with the public dose limits. Part 2 considers not only distance, but also the time that the affected member of the public is actually in the area under consideration. Part 3 considers the distance, the portion of time and dose rate while the sample is in transit, the portion of time and dose rate while the sample is not in transit, and the portion of time that the affected member of the public is present. Using this approach, licensees make only those calculations that are needed to demonstrate compliance. In many cases licensees will need to use the calculational method through Part 1 or Part 2. The results of these calculations typically result in higher radiation levels than would exist at typical facilities, but provide a conservative method for estimating doses which could be received. Example 1To better understand the calculational method, we will examine Bugs-Away, Inc., a self-shielded irradiator licensee. Yesterday, the company's president noted that the new irradiator area is close to his secretary's desk and he asked Joe, the Radiation Safety Officer (RSO), to determine if the company is complying with NRC's regulations. The secretary's desk is near the wall separating the reception area from the designated, locked self-shielded irradiator room where the company has located its irradiator. Joe measures the distance from the self-shielded irradiator to the wall and assumes that the irradiator would have the maximum dose rate allowed under ANSI N433.1: 10 mrem per hour at one meter. This is the maximum dose rate permitted while the sample is in transit (i.e., moving into or out of the irradiation position). Figure M.1 is Joe's sketch of the areas in question, and Table M.1 summarizes the information Joe has on the irradiator. Table M.1 Information Known about the Self-Shielded Irradiator
Example 1: Part 1 Joe's first thought is that the distance between the irradiator and the secretary's chair may be sufficient to show compliance with the regulation in 10 CFR 20.1301. So, taking a worst case approach, he assumes: 1) the self-shielded irradiator is constantly present (i.e., 24 hr/d) with the samples constantly in transit, and 2) the secretary is constantly sitting in the desk chair (i.e., 24 hr/d). Joe proceeds to calculate the dose she might receive hourly and yearly from the self-shielded irradiator as shown in Table M.2 below. Table M.2 Calculational Method, Part 1: Hourly and Annual Dose Received from Self-Shielded Irradiator
At this point, Joe is pleased to see that the total dose that an individual could receive in any one hour is only 0.48 mrem, but notes that an individual could receive a dose of 4,200 mrem in a year, much higher than the 100 mrem limit. Example 1: Part 2 Joe reviews his assumptions and recognizes that the secretary is not at the desk 24 hr/d. He decides to make a realistic estimate of the number of hours the secretary sits in the chair at the desk, keeping his other assumptions constant (i.e., the self-shielded irradiator is constantly present (i.e., 24 hr/d) with the samples constantly in transit). He then recalculates the annual dose received. Table M.3 Calculational Method, Part 2: Annual Dose Received from Self-Shielded Irradiator
Although Joe is pleased to note that the calculated annual dose received is significantly lower, he realizes it still exceeds the 100 mrem in a year limit. Example 1: Part 3 Again Joe reviews his assumptions and recognizes that the irradiator is not constantly in use nor is the sample continuously in transit during an irradiation cycle when the secretary is seated at the desk. As he examines the situation, he realizes he must take these factors into account. Table M.4 Calculational Method, Part 3: Summary of Information
Table M.5 Calculational Method, Part 3: Annual Dose Received from Irradiator
Joe is glad to see that the results in Step 23 show compliance with the 100 mrem in a year limit. Had the result in Step 23 been higher than 100 mrem in a year, then Joe could have done one or more of the following:
Note that in the example, Joe evaluated the unrestricted area outside only one wall of the irradiator area. Licensees also need to make similar evaluations for other unrestricted areas and to keep in mind the ALARA principle, taking reasonable steps to keep radiation dose received below regulatory requirements. In addition, licensees need to be alert to changes in situations (e.g., moving the self-shielded irradiator closer to the secretarial workstation, adding a second irradiator, changing the secretary to a full-time worker, or changing the estimate of the portion of time spent at the desk) and to perform additional evaluations, as needed.
Combination Measurement-Calculational Method
[ Prev | Next | Top of file ] This method, which allows the licensee to take credit for shielding between the irradiator and the area in question, begins by measuring radiation levels in the areas, as opposed to using ANSI-N433.1 or manufacturer- (or distributor-) supplied rates at a specified distance from each irradiator. These measurements must be made with calibrated survey meters sufficiently sensitive to measure background levels of radiation. However, licensees must exercise caution when making these measurements, and they must use currently calibrated radiation survey instruments. A maximum dose of 1 mSv (100 mrem) received by an individual over a period of 2080 hours (i.e., a "work year" of 40 hr/wk for 52 wk/yr) is equal to less than 0.5 microsievert (0.05 mrem) per hour.
Instruments used to make measurements for calculations must be sufficiently sensitive. An instrument equipped with a scintillation-type detector (e.g., NaI(Tl)) or a micro-R meter used in making very low gamma radiation measurements should be adequate. Licensees may also choose to use environmental TLDs(9) in unrestricted areas next to the irradiator area for monitoring. This direct measurement method would provide a definitive measurement of actual radiation levels in unrestricted areas without any restrictive assumptions. Records of these measurements can then be evaluated to ensure that rates in unrestricted areas do not exceed the 1 mSv/yr (100 mrem/yr) limit. Example 2As in Example 1, Joe is the RSO for Bugs-Away, Inc., a self-shielded irradiator licensee. The company has one irradiator in a designated, locked area that adjoins an unrestricted area where a secretarial work station is located. See Figure M.1 and Table M.2 for information. Joe wants to see if the company complies with the public dose limits at the secretarial station. Joe placed an environmental TLD badge in the secretarial work space for 30 days. The TLD processor sent Joe a report indicating the TLD received 100 mrem. Table M.6 Combination Measurement-Calculational Method
Appendix N : Typical NRC Incident Notifications Required for Self-Shielded Irradiator Licensees
[ Prev | Next | Top of file ] Table N.1 Typical NRC Incident Notifications Required for Self-Shielded Irradiator Licensees
Note: Telephone notifications shall be made to the NRC Operations Center at 301-816-5100 or 301-951-0550. Appendix O : Information for Applicants to Consider When Developing Operating and Emergency Procedures for Self-Shielded Irradiators
[ Prev | Next | Top of file ] Elements of Operating Procedures Applicable to All Types of Self-Shielded Irradiators
[ Prev | Next | Top of file ]
Specific Operating Procedures Applicable to Moving-Source Irradiators(10)
[ Prev | Next | Top of file ]
- be operable at all times when the irradiator is in use - activate a visible and audible alarm when radiation levels exceed 0.02 mSv (2 mem) per hour - be located to detect any radiation escaping from the irradiator door - be located so that it is visible to the irradiator user when next to the irradiator.
- determine the radiation level at the irradiator door when the door is closed - check for any increase in radiation levels each time the irradiator door is opened. In conducting such checks, operators should position themselves to minimize exposure to any radiation escaping from the open door. - If abnormal radiation levels or any malfunction of the irradiator are detected at any time, the licensee should stop using the irradiator, restrict access to the area housing the irradiator, immediately notify the RSO, and determine if a report to NRC is required. - The licensee should not attempt to repair or authorize others to attempt to repair the irradiator except as specifically authorized in a license issued by NRC. Elements of Emergency Procedures Applicable to All Types of Self-Shielded Irradiators
[ Prev | Next | Top of file ]
Changes to Operating and Emergency Procedures Without a License Amendment
[ Prev | Next | Top of file ]
Appendix P : Model Leak Test Program
[ Prev | Next | Top of file ] Training
[ Prev | Next | Top of file ] Before allowing an individual to perform leak testing, the RSO will ensure that he or she has sufficient classroom and on-the-job training to show competency in performing leak tests independently. Classroom training may be in the form of lecture, videotape, hands-on, or self-study and will cover the following subject areas:
Appropriate on-the-job-training consists of:
Facilities and Equipment
Frequency for Conducting Leak Tests of Sealed Sources
[ Prev | Next | Top of file ]
Procedure for Performing Leak Testing and Analysis
[ Prev | Next | Top of file ]
Reference: See the Notice of Availability (on the inside front cover of this report) to obtain a copy of Draft RG FC 412-4, "Guide for the Preparation of Applications for Licenses for the Use of Radioactive Materials in Leak-Testing Services," dated June 1985. Appendix Q : Transportation
[ Prev | Next | Top of file ] Part 1 Major DOT Regulations
[ Prev | Next | Top of file ] The major areas in the DOT regulations that are most relevant for transportation of typical self-shielded irradiators that are shipped as Type A or Type B quantities are as follows:
Part 2 Sample Bill of Lading
[ Prev | Next | Top of file ] Part 3 Irradiators Built Before 10 CFR Part 71 Regulation Implementation
[ Prev | Next | Top of file ] Before the adoption of the requirements of 10 CFR Part 71 in 1966, irradiators could be transported without being evaluated under the hypothetical accident conditions now incorporated in 10 CFR Part 71. Unlike most post-1966 irradiators, pre-1966 irradiators are not certified shipping packages. Transport of pre-1966 units may require transferring the sealed source from the irradiator to a Type B package or the use of a certified package for the irradiator containing the sealed sources.
An exemption may be granted if the request is authorized by law and will not endanger life or property or the common defense and security. In this case, an exemption request should demonstrate the need for the exemption, describe why alternatives considered are not viable, specify from what requirement(s) an exemption is requested and the period for which the exemption is requested, and describe steps taken to ensure that the shipment will not endanger life or property or the common defense and security (e.g., steps to minimize accident risk and to respond to a transportation accident). Typically, approved requests are for a limited period (e.g., 30 days). Circumstances vary, but additional information supporting an exemption request may include the following:
- DOT's hazardous material routing requirements - Transport during time of low road usage - Use of good roads and avoidance of residential areas to maximum extent possible - Accompaniment of shipment by escort knowledgeable in the use of radiation survey instruments - Provision of escort with appropriate survey instruments and supplies to permit the establishment of a radiation exclusion area - Written procedures to be followed by the escort in an emergency situation. - Use of exclusive-use vehicle and shoring to limit movement of package during transport - Notification of State radiological health officials and local fire department of time and route of shipment.
Before applying to the NRC for its approval, the licensee should contact the radiological health organization within each State (as indicated below) through which the shipment will be made to confirm the points of contact and to discuss the proposed controls for the shipment. In several previous cases, short distance shipment of irradiators have been successfully made with the cooperation of State officials. NRC Headquarters staff must review these requests, which are typically requests to amend materials (10 CFR Part 30) licenses. Licensees should address their requests, accompanied by the amendment fee specified in 10 CFR 170.31, to the appropriate Regional Office. The Regional Office will refer the request to NRC Headquarters staff for review by the Package Certification Section, SFPO. If the exemption is approved, SFPO staff will provide the language for the license condition.
Response from Applicant: Demonstrate that the request is authorized by law and will not endanger life or property or the common defense and security. AND The following:
Reference: The names, addresses, and telephone numbers
for officials in Agreement and non-Agreement States are available by choosing
"Directories" on the NRC's OSP Home Page at <http://www.hsrd.ornl.gov/nrc/home.htm>
Appendix R : Sample Self-Shielded Irradiator License
[ Prev | Next | Top of file ] Form 374-1.gif 32 Kb Form 374-2.gif 39 Kb Form 374-3.gif 46 Kb Form 374-4.gif 38 Kb Form 374-5.gif 35 Kb Form 374-6.gif 18 Kb Appendix S : Checklist for Self-Shielded Irradiator License Application
[ Prev | Next | Top of file ] Checklist for Self-shielded Irradiator License Application Item 1: Action Type
Item 2: Legal Identity
Items 2 & 3: Address
Item 4: Person to Be Contacted About This Application
Table S.1 Items 5 and 6: Material to Be Possessed and Uses
Table S.2 Items 7 Through 11: Training and Experience, Facilities and Equipment, Radiation Safety Program, and Waste Management
Appendix T : Addendum: Summary of Comments Received on Draft NUREG - 1556, Vol. 5, and Other Changes
[ Prev | Next | Top of file ] On December 23, 1997, NRC announced in the Federal Register (62 FR 67100) that draft NUREG-1556, Vol. 5 was available for comment. NRC requested that comments be submitted by March 23, 1998. NRC also mailed copies of the document to its self-shielded irradiator licensees. NRC received two comments, both from licensees. The comments, a letter and an e-mail message, are available for inspection in NRC's Public Document Room. Letter
[ Prev | Next | Top of file ] Issue 1: The writer is with a medical institution that holds an NRC license issued pursuant to 10 CFR Parts 30 and 35. The institution requested an amendment to its license to add a self-shielded irradiator to irradiate blood in accordance with procedures specified by the American Association of Blood Banks and FDA regarding blood transfusions. The writer believes that, given the proposed use of the irradiator, the institution's license should have retained its assigned Fee Category 7.C. and should not have been assigned an additional separate fee category. [The writer has raised this issue in previous correspondence with OCFO and regional staff, who have responded to him.] Response to Issue 1: Although fee-related issues are outside the scope of NUREG-1556, Vol. 5, the NRC staff wishes to provide the following information in addition to the separate correspondence. 10 CFR 170.3 defines human use as "the internal or external administration of byproduct, source, or special nuclear material, or the radiation therefrom, to human beings." 10 CFR 170.31 states, in pertinent part, that Fee Category 7.C. is for "[o]ther licenses issued pursuant to Parts 30, 35� for human use of byproduct� material, except licenses for byproduct material� in sealed sources contained in teletherapy devices." Self-shielded irradiators contain byproduct material and are not included in Fee Category 7.C. because their use is not within the definition of "human use." Rather, blood that has been irradiated in the self-shielded irradiator is administered to patients; that blood does not contain NRC-licensed material and the patient is not administered any radiation from the sources in the self-shielded irradiator. Fee Categories 3.F. and 3.G. cover self-shielded irradiators. Issue 2: NUREG-1556, Vol. 5 does not address using self-shielded irradiators for "human use as a blood irradiator." Response to Issue 2: Use of a self-shielded irradiator to irradiate blood is not within the 10 CFR Part 170 definition of "human use"or the 10 CFR Part 35 definition of "medical use." However, as indicated in the Discussion on page 8.8 of this document, the NRC staff recognizes that irradiation of blood is normally an "allowed use" of a self-shielded irradiator. The list of "typical uses" on page 1-1 has been revised; the new text is shown in bold italics: "irradiating blood and blood products." Issue 3: The writer refers to the statement on page 1-2 of draft NUREG-1556, Vol. 5: "NRC will now authorize self-shielded irradiators on the same license as the licensee's other licensed material." The writer asks if "there could still be separate categories under one license, or could it be covered under one category as I have requested?" Response to Issue 3: Under the current regulations in 10 CFR Part 170, self-shielded irradiators are a separate fee category. The radioactive materials and authorized uses listed on an NRC license can include more than one fee category. E-Mail Message
[ Prev | Next | Top of file ] Issue 1: The writer points out that, in the second to last bullet on page H-1, the word "individual" is vague and could mean radiation worker or member of the public. Response to Issue 1: Page H-1 contains a bulleted list of typical duties and responsibilities of an RSO. The item in question has been revised to read as follows (with bold italics showing new wording): "Documentation is maintained to demonstrate, by measurement or calculation, that the TEDE to the individual member of the public likely to receive the highest dose from the licensed operation does not exceed the annual limit in 10 CFR 20.1301." Issue 2: Addressing Appendix K, the writer disagrees with checking a survey meter or room monitor "at the beginning of each day with a check source." The writer's room monitor is checked semiannually by the irradiator manufacturer. The writer believes semiannual checks are sufficient and points out the following problems: many licensees would need to obtain a check source (with possible need to amend their licenses); his irradiator is not used every day so that daily checks of the room monitor with a radioactive source would not be in desirable from an ALARA standpoint since a worker performing these checks would "double his usual dose of radiation." The writer believes that there must be a "better way to address the safety issue" described in Appendix E. Response to Issue 2: The writer is referring to the portion of Appendix K that provides specifications for radiation monitoring instruments for moving-source irradiators. These specifications are based on the requirements of the July 3, 1984, Order shown in Appendix E. Neither the Order nor Appendix K specifies daily (emphasis added) checks of the room monitor, the writer's principal concern. Rather, the Order and Appendix K specify checks "at the beginning of each day of use (emphasis added)." As further described in Appendix E, the Order was issued because a lock mechanism on a moving-source irradiator failed and could have caused a substantial exposure to a worker. The use of a calibrated and operable survey instrument or room monitor warns workers if similar malfunctions occur. In comparison, 10 CFR 35.51 and 10 CFR 35.615(d)(3) also require, respectively, checks of survey instruments on each day of use and checks of teletherapy room monitors each day before patient treatment. Workers should not receive significant additional dose if they check the room monitor on each day of use with a low-activity check source (e.g., exempt quantity) and follow appropriate radiation safety procedures. Summary of Other Changes
[ Prev | Top of file ] The NRC staff made other changes to the text in addition to those discussed above. These changes encompass the following:
[ Top of file ] 1. Irradiators subject to the requirements of 10 CFR Part 36 are discussed in draft NUREG-1556, Vol. 6, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About 10 CFR Part 36 Irradiators." 2. Copies may be ordered electronically at the following
URL: <http://www.ansi.org> 3. See "Amendments and Renewals to a License" later in this document. Licensees may request an amendment to an existing license to add authorization for a self-shielded irradiator. 4. See the Notice of Availability (on the inside front cover of this report) to obtain copies of RG 3.66. 5. For ease of use by most irradiator licensees, this table uses conventional units. The conversion to SI units is: 1 mrem = 0.01 mSv 6. For ease of use by most self-shielded irradiator licensees, the examples in this Appendix use conventional units. The conversions to SI units are as follows: 1 ft = 0.305 m; 1 mrem = 0.01 mSv. 7. Copies may be ordered electronically at <http://www.ansi.org.> 8. National Council on Radiation Protection and Measurements (NCRP) Report No. 49, "Structural Shielding Design and Evaluation for Medical Use of X Rays and Gamma Rays of Energies Up to 10 MeV," contains helpful information. It is available from NCRP, 7910 Woodmont Avenue, Suite 800, Bethesda, Maryland 20814. NCRP's telephone numbers are: (301) 657-2652 or 1-800-229-2652. 9. TLDs used for personnel monitoring (e.g., LiF)
may not have sufficient sensitivity for this purpose. Generally, the minimum
reportable dose received is 0.1 mSv (10 mrem). Suppose a TLD monitors
dose received and is changed once a month. If the measurements are at
the minimum reportable level, the annual dose received could have been
about 1.2 mSv (120 mrem), a value in excess of the 1 mSv/yr (100 mrem/yr)
limit. If licensees use TLDs to evaluate compliance with the public dose
limits, they should consult with their TLD supplier and choose more sensitive
TLDs, such as those containing CaF 10. These procedures are required for licensees authorized for J. L. Shepherd Mark I or Model 81-22 irradiator. |
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