Regulatory Guide 10.9

Guide for the Preparation of Application for Licenses for the Use of Gamma Irradiators

ML12181A392
Person / Time
Issue date:	04/30/1980
From:	Office of Nuclear Regulatory Research
To:
References
OH 706-4 RG-10.009
Download: ML12181A392 (16)

April 1980

U.S. NUCLEAR REGULATORY COMMISSION

REGULATORY GUIDE

OFFICE OF STANDARDS DEVELOPMENT

REGULATORY GUIDE 10.9 (Task OH 706-4)

GUIDE FOR THE PREPARATION OF APPLICATIONS FOR LICENSES

FOR THE USE OF GAMMA IRRADIATORS

1. INTRODUCTION license required); nor does it, generally, include explosive materials or food for human consumption (special authori- This guide describes the type of information that the zation under the terms of a specific license required).

NRC staff needs to evaluate an application for a license to use sealed radioactive sources for the gamma irradiation of 1.3 As Low As Is Reasonably Achievable (ALARA)

materials (see Item 1.2 following). Section 4.a outlines items that should be contained in applications for self-contained, Paragraph 20. 1 (c) of 10 CFR Part 20 states that "...persons dry source-storage irradiators (an irradiator so constructed engaged in activities under licenses issued by the Nuclear that the sealed source(s) and the material being irradiated Regulatory Commission pursuant to the Atomic Energy are contained in a shielded volume, which in the designed Act of 1954, as amended, and the Energy Reorganization configuration of the device is always physically inaccessible Act of-]974 should, in addition to complying with the by any part of the human body). Section 4.b outlines the requirements set forth in this part, make every reasonable items that should be contained in applications for other effort to maintain radiation exposures, and releases of types of irradiators. radioactive materials in effluents to unrestricted areas, as low as is reasonably achievable." Regulatory Guide 8.10,

1.1 Applicable Regulations "Operating Philosophy for Maintaining Occupational Radiation Exposures As Low As Is Reasonably Achievable,"

Regulations pertaining to this type of license are found provides the NRC staff position on this important subject.

in 10 CFR Part 2, "Rules of Practice for Domestic Licensing License applicants should give consideration to the ALARA

Proceedings"; 10 CFR Part 19, "Notices Instructions and philosophy in the design of the irradiator facility and in the Reports to Workers; Inspections"; 10 CFR Part 20, "Stand- development of jlans for work with licensed radioactive ards for Protection Against Radiation"; 10 CFR Part 30, materials (see Regulatory Guide 8.10).

"Rules of General Applicability to Domestic Licensing of Byproduct Material"; 10 CFR Part 71, "Packaging of

2. LICENSE FEES

Radioactive Materials for Transport and Transportation of Radioactive Material Under Certain Conditions"; 10 CFR An application fee is required for most types of licenses.

Part 170, "Fees for Facilities and Materials Licenses and The applicant should refer to § 170.31, "Schedule of Fees Other Regulatory Services Under the Atomic Energy Act of for Material Licenses and Other Regulatory Services," of

1954, as amended"; and 10 CFR Part 150, "Exemptions 10 CFR Part 170 to determine the amount of the fee that and Continued Regulatory Authority in Agreement States must accompany the application. Review of the application Under Section 274." The applicant should study carefully will not begin until the proper fee is received by the NRC.

the regulations and this guide and submit all information requested. 3. FILING AN APPLICATION

1.2 Items Requiring Separate Applications 3.1 Application Form NRC-313(I)

Uses of byproduct materials other than for the gamma An application for a license to possess and use byproduct irradiation of materials are not within the scope of this guide. material for the gamma irradiation of materials should be

"Materials" does not include human beings (teletherapy filed on Form NRC-313(l), "Application for Byproduct USNRC REGULATORY GUIDES Comments should be sent to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, Regulatory Guides are Issued to describe and make available to the Attention: Docketing and Service Branch.

public methods acceptable to the NRC staff of implementing specific parts of the Commission's regulations, to delineate tech- The guides are issued in the following ten broad divil4ons:

niques used by the staff in evaluating specific problems or postu- lated accidents or to provide guidance to applicants. Regulatory 1. Power Reactors 6. Products Guides are not substitutes for regulations, and compliance with 2. Research and Test Reactors 7. Transportation them is not required. Methods and solutions different from those set 3. Fuels and Materials Facilities 8. Occupational Health out in the guides will be acceptable if they provide a basis for the 4. Environmental and Siting 9. Antitrust and Financial Review findings requisite to the issuance or continuance of a permit or 5. Materials and Plant Protection 10. General license by the Commission.

Copies of issued guides may be purchased at the current Government Comments and suggestions for improvements in these guides are Printing Office price. A subscription service for future guides in spe- encouraged at all times, and guides will be revised, as appropriate, cific divisions is available through the Government Printing Office.

to accommodate comments and to reflect new information or Information on the subscription service and current GPO prices may experience. This guide was revised as a result of substantive com- be obtained by writing the U.S. Nuclear Regulatory Commission, ments received from the public and additional staff review. Washington, D.C. 20555, Attention: Publications Sales Manager.

Material License." All items on tne application form should Items 8A-D. Quantity and Form of Byproduct Material be completed in sufficient detail for the NRC to determine that the applicant's equipment, facilities, and radiation The applicant should specify the isotope, number of protection program are adequate to protect health and curies per source, name of manufacturer and model number minimize danger to life and property. of each source, and total number of sources that will be Since the space provided on the application contained in the irradiator. If the sources have been evaluated form is previously by the NRC or an Agreement State,* specification limited, the applicant should append additional sheets to of the manufacturer and model number of the sources will be provide complete information. Each separate sheet or a sufficient description. If the sources have not been evaluated document submitted with the application should be identi- previously, the applicant should provide the information fied as to its purpose, e.g., response to an item of the requested in "Guide-Information to be Submitted for Eval- application form, radiation safety instructions. uation of Sealed Sources Utilizing Radioactive Materials."

This document is available from the Division of Fuel Cycle Three copies of the application should be completed. and Material Safety, Office of Nuclear Material Safety and The original and one copy should be nmailed to: Division of Safeguards, U.S. Nuclear Regulatory Commission, Washing- Fuel Cycle and Material Safety, Office of Nuclear Material ton, D.C. 20555.

Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555. One copy should be retained Item 8E. Purpose for Which Byproduct Material Will Be by the applicant since the license will require that the Used institution adhere to the statements and representations made in the application and any supplement to it. The applicant should specify that the sources will be used in an irradiator (including name of manufacturer and model

3.2 Proprietary Information number) for the irradiation of materials (see Item 1.2).

The applicant should not submit proprietary information Item 9. Storage of Sealed Sources unless it cannot be avoided in giving a complete description of the applicant's equipment, facilities, and radiation List as indicated on form and refer to detailed descrip- protection program. If the use of proprietary information tions under Item 13, as appropriate.

cannot be avoided, the proprietary information should be separated from the rest of the application and an applica- Items 10. and 11. Radiation Detection Instruments tion for withholding from public inspection should be submitted in conformance with the requirements of § 2.790, Describe the capability of the radiation survey instruments

"Public Inspections, Exemptions, Requests for Withholding," that are used in support of irradiator operations for accurately of 10 CFR Part 2, "Rules of Practice for Domestic Licensing measuring normally expected radiation levels in the vicinity Proceedings." of the irradiator. Show that these instruments have suffi- cient range to detect unusual radiation levels that might be

3.3 Environmental Information indicative of shielding failure, source disconnection, or major contamination. Describe how the radiation detection An environmental report is not specifically required for instruments will be tested by use of a check source of radia- the type of activities included in the scope of this document. tion before each use. Indicate the capability of the check source for exposing the detector to radiation levels of the

3.4 Safeguards same order of magnitude as those that are encountered during normal operations.

No safeguard information is required in an application for licenses covered by this guide. The applicant should specify that these instrument check tests will be supplemented by at least an annual

4. CONTENTS OF AN APPLICATION calibration that meets the performance specifications identified in Section 4.b, Items 10 and 11 of this guide.

4.a General Requirements: Self-Contained, Dry Also specify that survey instruments will be calibrated Source-Storage Irradiators before use following repair. Indicate that instruments will be used to measure radiation levels at various distances Many items of the NRC Form 313(I) are self-explanatory from the check source soon after their annual calibrations.

(see instructions with the form, Appendix A). The follow- Describe what record of the instrument's readings will be ing comments apply to the items of the form as indicated. kept for use and reference in subsequent instrument checks between calibrations.

Item 5. Location of Use of Byproduct Material The street address, building number (if any), and room number where the irradiator will be used should be provided. *An Agreement State is a State to which the Commission has If no street address is available, the applicant should provide relinquished authority for regulating the use of byproduct, source, and special nuclear material (in quantities less than critical mass)

a specific description that designates the location accurately. within the boundaries of the State.

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Specify that those instruments used to detect radioactive and in the "store," "transit," "load and unload," and "oper- contamination or the leakage of radioactive materials will ate" positions. The radiation survey of the prototype have the same characteristics and be calibrated in the same irradiator should provide a comolete three-dimensional way as described for the same kinds of instruments in Sec- profile of the irradiator at 5 cm and 1 meter from the tion 4.b, Items 10 and 11 in this guide. exterior surface. The applicant should specify the name of the manufacturer, the model number and the date of Item 12. Personnel Dose Monitoring Devices calibration of the radiation survey instrument used, and the method of instrument calibration. If the irradiator will be The applicant should (1) specify the type of personnel used in an area where the applicant will not restrict access dose monitoring devices to be used (film badge, TLD, for radiation protection purposes, specify that the radiation pocket chambers), (2) provide the name of the commercial levels from the irradiator's source anywhere outside the supplier of the film badge or TLD, dosimetry service, and irradiator will not exceed 2 mR/hih, and indicate how the

(3) specify the frequency at which film badges or TLDs irradiator will be secured against unauthorized use.

will be evaluated. For pocket chambers, the applicant should provide the name of the manufacturer, type, model d. A description of the tests performed on the irradia- number, and the range (mR) and frequency of reading and tor. These tests should establish t6e integrity of the irra- specify provisions for the maintenance and calibration. diator shielding and the operability of the control system (such as source-positioning mechanism, shutters, on-off Item 13. Facilities and Equipment indicators) under ordinary conditions or in storage, use, and handling, and under accident conditions.

A number of self-contained, dry source-storage irradiators have been evaluated by the Nuclear Regulatory Commission e. A facsimile of the labels to be attached to the device (NRC) or Agreement States. Since the manufacturers of and a description of how and where the labels will be these irradiators have submitted detailed descriptions of attached. The labels must, as a minimum, meet the require- these irradiators to the NRC or Agreement States for ments of § §20.203(f)(1) and (2) of 10 CFR Part 20.

generic evaluation, a detailed description of the engineering design of such an irradiator need not be repeated by each The applicant should describe the space where the person making application for a license to use this equipment. irradiator will be located, including an annotated sketch of The applicant need provide only the name of the manu- the floor plan of the building in which the irradiator will be facturer and model number of the irradiator if it has located. This sketch should note the location of the irra- been so evaluated. Information on whether or not a particuilar diator and should identify the types of activities that will irradiator has been so evaluated should be available from be conducted in adjoining areas. If the irradiator has not the manufacturer. passed prototype tests for a standard industrial fire, note that the room where the irradiator will be located will be If the device has not been previously evaluated, the equipped with an automatically operated fire detection and applicant should provide a complete description of the control system (sprinkler, chemical, or gas) that is adequate irradiator. This description should include the following: to ensure the integrity of the irradiator and source in a fire.

a. Engineering drawings of the device. All drawings should have a drawing number, revision number, company Item 14. Waste Disposal number, title, date of revision, bill of materials or reference thereto, dimensional scale and dimensional tolerances. The applicant should describe plans for the disposal of Additional sketches may be used if they provide necessary the sealed sources and the contaminated smears (if any)

information concerning the main function or safety features from leak tests.

of the device. Assenrbly views of engineering drawings and the use of photographs are helpful in providing a description Item 15. Radiation Protection Program of the irradiator. All engineering drawings and photographs should be of good quality and be legible. The description a. Organizationand Administrative Procedures should specify the dimensions and materials of construction.

The applicant should provide an organizational chart b. A complete description of all mechanical and electrical that specifies the radiation safety officer, the operators, and systems, including the shutter or source positioning mechan- their respective supervisors. The applicant should provide a ism, interlocks, source position indicators, warning lights, copy of the written administrative procedures that govern and alarm. Show how interlocks and warning lights are the responsibility for the safe use of the irradiator. These designed so that failure of the system or loss of electrical procedures should clearly identify the functions, duties, power will result in an adequately shielded, safe condition and responsibilities of each operator and of the radiation (i.e., access to the source or high radiation levels is prevented). safety officer.

cý A copy of the radiation profile (in mR/hr) for a The applicant should describe the methods of ensuring prototype model of the irradiator. Radiation levels should that only authorized persons will use the irradiator or have be measured with the irradiator containing the maximum access to the space where it is located. These methods can quantity, in curies, of radioactive material to he contained include control of keys to the door of the room containing

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the irradiator control console, control of operating console of the training. Training information should also cover keys, or other positive methods of excluding access. knowledge of (1) principles and practices of radiation protection, (2) radioactivity measurements, standardization b. Operatingand Emergency Procedures and monitoring techniques, and instruments, (3) mathematics and calculations basic to use and measurement of radioactivi- The applicant should provide a copy of the step-by-step ty, and (4) biological effects of radiation. The description procedures that Will be followed by operators while using of actual use of radioactive materials should specify the the irradiator. Procedures for ensuring safety and the isotopes handled, the maximum quantities of materials security 'of the device during extended irradiations should handled, where the experience was gained, the duration of be described in detail. experience, and the type of use. Additional information on specific training for operators of the facility should be The applicant should provide a copy of concise, easily submitted under Item 15 of the application as indicated followed emergency procedures. These procedures should above in this guide.

describe the conditions that will be indicative of an emer- gency situation and should state the emergency action to be 4.b General Requirements: Other Irradiators taken. These procedures should include instructions for the immediate action to be taken to minimize radiation exposure Many items of the NRC Form 313(I)are self-explanatory to persons in the vicinity of the irradiator and should (see instructions with the form, Appendix A). The following include the names and telephone numbers of persons who comments apply to the items of the form as indicated.

are to be contacted to direct remedial actions. Actions that are prohibited or to be avoided in the event of abnormal Item 5. Location of Use of Byproduct Material conditions should also be described.

See Section 4.a, Item 5.

The applicant should provide a copy of the procedures that will be used to determine possible leakage of radioactive Items 8A-D. Quantity and Form of Byproduct Material material from the source capsule. Show that the test methods are sufficiently sensitive to detect 0.05 microcurie See Section 4.a, Items 8A-D. Note additionally that of activity, Describe the procedures that ensure the leak radioactive sources for water-shielded irradiators must be testing of the source every 6 months. Indicate that the test doubly encapsulated.

sample will be taken from appropriate accessible surfaces of the device in which the sources are permanently stored. Item 9. Storage of Sealed Sources Procedures for the installation, relocation, removal, or List as indicated on form and refer to detailed descriptions maintenance of the irradiator should be described. If these under Item 13, as appropriate.

tasks are to be performed by persons who are specifically licensed by the NRC or Agreement States for such work, Items 10. and 11. Radiation Detection Instruments the applicant should provide the names and license numbers of such persons. The applicant should provide for each type of instrument available the manufacturer's name and model numbers, how c. Training Program many of each type are available, the type of radiation detected (beta or gamma), the sensitivity range (milliroent- The applicant should provide a complete description of gens per hour, or counts per minute), and the window the training program for the operators. The description thickness in mg/cm2. The type of use for each instrument should specify the form of training (e.g., lectures, on-the-job should be specified. The type of use would normally be training), an outline of the subject matter that is covered monitoring, surveying, assaying, or measuring.

and the time devoted to each subject, and provisions for retraining. The names and qualifications of the instructors The applicant should specify that among the detection should be provided; and procedures for documenting instruments available there is at least one ionization-chamber training should be included. The application should also type of radiation measuring instrument of a design that describe the methods and criteria used both to determuine does not "blank-out," i.e., tend to read zero in a very the competency of each individual to operate the irradiator intense radiation field, and that is capable of measuring and to evaluate the effectiveness of the training program. accurately radiation levels from 2 mR/hr to at least I R/hr.

If source leak tests are to be evaluated by the applicant, Items 16. and 17. Technical Qualifications of Personnel indicate that a radiation counting instrument will be used (such as a GM tube with a scaler) that is capable of The applicant should provide a resume of the training measuring accurately 0.05 microcurie of activity on smear- and experience in the use of radioisotopes and radiation for test samples or, with the sample preparation technique each person in the applicant's organization who will directly employed, 5 x 10-5 /Ci/ml of activity in a water sample.

supervise the operations or who will have radiological safety responsibilities. The resume should include a description of Instrument calibration provisions should be described.

training (both on-the-job training and formal course work), State the frequency, and describe the methods and proce- location where the training was received, and the duration dures for calibration of survey and monitoring instruments

10.9-4

as well as any other instruments and systems used in the a. The name, the manufacturer, and model number of radiation protection program such as measuring instruments each of the standards to be used, used to assay sealed-source leak-test samples, contamination samples (e.g., air samples, surface smear-test samples), and b. The nuclide and quantity of radioactive material bioassay samples. contained in each of the standard sources, (Note: An adequate calibration of survey instruments c. A statement of the accuracy of each of the standard usually cannot be performed with built-in check sources. sources, i.e., accuracy, as a minimum, +5% of the Electronic calibrations that do not involve a source of stated value and traceable to a primary standard radiation are also not adequate to determine the proper such -as that maintained by the National Bureau of functioning and response of all components of an instru- Standards, ment.)

d. Step-by-step calibration procedures and, if appropriate, Show that daily or other frequent checks of survey assodiated radiation safety procedures, and instruments are supplemented at least every 6 months with a two-point calibration on each scale of each instrument e. The 'name and pertinent experience of each person with the two points separated by at least 50% of the scale. whomwill perform the instrument calibrations.

Also, show that survey instruments will be calibrated before use following repair. Indicate that survey instruments Item 12. Personnel Dose Monitoring Devices will be properly calibrated, i.e., instrument readings are within +10% of the calculated or known values of each See Section 4.a, Item 1 2.

point checked or readings are within +20% if a calibration chart or graph is prepared and attached to the instrument. Item 13. Facilities and Equipment If the applicant proposes to calibrate its survey instru- The applicant should provide a complete description of mients, a detailed description of planned calibration proce- the irradiator construction and function, including annotated dures should be submitted. The description of calibration plans and elevation drawings showing dimensions and procedures should include the following; as a minimum: materials of construction. The application should:

a. The manufacturer and model number of each radia- a. Identify the location of the building(s) and other tion source to be used, structures of the irradiator facility on a map or drawing (to scale) sh6wing their location in the local community or b. The nuclide and quantity of radioactive material local area. The boundary that encompasses the area owned contained in each source, or leased by the applicant should be shown. The restricted area(s), as defined in 10 CFR Part 20, § 20.3, should be c. The accuracy of each source (the traceability of the shown or. described.

source to a primary standard should be provided),

b. Show the layout of the building(s) and structures d. The step-by-step procedures, including associated using engineering drawings. Plans and elevations should be radiation safety procedures, and provided in sufficient detail to identify all features to be discussed, including operational and control areas. Spatial e. The name and pertinent experience of each person and equipment identification data should be included who will perform the calibrations. directly on layouts or (with suitable designations) in tabular listings. The applicant should discuss the components and If the applicant intends to contract out the calibration systems in the area under consideration, including dimen- of survey instruments, the name, address, and license sions and materials of construction.

number of the calibration firm should be specified together with the frequency of calibration. The applicant should c. Describe pertinent physical features of the irradiator, contact the firm that will perform the calibrations to its systems, and the surrounding areas, including rooms, determine if information concerning calibrations procedures walls, roofs, and floor radiation shielding characteristics.

has been filed with the Commission. If information concern- The locations of the source(s) in the stored and in the ing calibiation procedures has not been filed, it should be exposed positions should be indicated. These descriptions obtained and submitted. should include details of fire-resistant characteristics of the source room and building and of the automatically The applicant should indicate that, when appropriate, operated fire detection and control system to be used. The quantitative measuring instruments used to monitor the shielding description should include notation of all voids adequacy of containment and contamination control (such such as those used for ventilation ducts, control cables, as those used for measuring leak-test, air effluent, bioassay, electrical conduits, and viewing windows.

work area, and equipment contamination samples) will be calibrated prior to each use. The procedures and frequency d. Describe mechanical and electrical systems used in for calibration of such instruments should be submitted and the operation of the irradiator, including the source holders should include the following: and the source-handling mechanisms.

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e. Describe all of the design features that protect the For such irradiators in seismic areas, specify how the source from damage during operation of the facility from, irradiator will be equipped with a seismic switch that will for example, conveyor malfunctions, falling objects or signal the radiation source to return to the safe storage packages, and faulty source movement mechanisms. position should the switch be actuated. Specify whether the switch will be an omnidirectional horizontal or a f. Describe the shutter or source positioning mechanisms vertical uniaxial type and that it will be set to signal at that are used for exposing the source. 0.05g (gravitational acceleration) or less. For the purposes of applications for irradiator licenses, a "seismic area" may g. Describe the systems, procedures, and physical be considered to be any area where horizontal acceleration barriers that will serve to prevent exposure of personnel to in rock of 0.3g (30% of the acceleration due to gravity) or the irradiation source(s). Provide a complete description of more may occur with a 90% probability of not being physical barriers, interlocks, source position indicators, exceeded in 50 years (i.e., where there is only a 10%

warning lights, alarms, and warning signs, including the probability that a greater horizontal acceleration would manner in which compliance with pertinent requirements occur in 50 years), as determined by the U.S. Geological of 10 CFR Part 20, §§20.203(c)(6) and (7) will be achieved. Survey and as set out in U.S. Department of the Interior, Show how these safety provisions and systems ensure com- Geological Survey Open File Report 76-416, 1976, "A

pliance with §§20.203(c) and 20.101 of 1OCFR Part 20. Probabilistic Estimate of Maximum Acceleration in Rock in the Contiguous United States."

h. If the facility includes a water storage pool, describe the pool construction and the water circulation, treatment, Item 14. Waste Disposal monitoring, and makeup systems. If the storage pools are not built in impervious soils, show that the leak rate of the The applicant should name the organization that will secondary water-containment envelope is low enough to dispose of the sealed sources and the contaminated smears ensure that, in the event of a gross pool leak, makeup water (if any) from leak tests.

could be supplied to the pool at a rate sufficient to keep the sources adequately covered. Describe the features Item 15. Radiation Protection Program incorporated in the design of the pool for ultimate decom- missioning of the facility, including the considerations for a. Ensuring that Occupational Radiation Exposures Are disposing of potentially contaminated soil or other fill As Low As Is Reasonably Achievable (ALARA)

materials exterior to the pool walls.

Describe the management policy and organizational i. If the facility includes in-air irradiation, describe the structure related to ensuring that occupational radiation ventilation system (equipment, operating specifications, exposures are ALARA. Describe the applicable responsibi- 0

ventilation rate, location of intake and exhaust) and include lities and the related activities to be conducted by the an analysis of ozone production and the measures taken to individuals having responsibility for radiation protection.

protect personnel and safety-related equipment against Indicate whether, and if so how, the guidance given in exposure to ozone. Regulatory Guide 8.10, "Operating Philosophy for Main- taining Occupational Radiation Exposures As Low As Is j. Provide an analysis and calculations of radiation levels Reasonably Achievable," will be followed; if it will not be in all areas surrounding the source room with the source in followed, describe the specific alternative approaches to be both the shielded and the exposed positions. Include an used.

estimate of the degree and type of occupancy for each area.

The application should contain a commitment by the k. Describe the system that provides a readily visible applicant that all safety-related operations will be conducted indication of the source position (stored, intermediate, in conformance with detailed written procedures. A detailed exposed). description of the procedures should be provided.

1. For a large irradiation facility that is not self-contained, b. Organization that falls within the purview of §20.203(c)(6) or (7), and that is in a seismic area, provide an analysis that demonstrates The applicant should provide a programmatic organiza- the shielding (pool or cell and complementary structures) is tional chart that specifies all of those persons who will act constructed so that it will be able to withstand lateral or in a management or supervisory capacity or who will have vertical displacements that might occur from ground radiation safety responsibilities. The applicant should movements. The applicant should submit an analysis of the provide a copy of the written administrative procedures previous earthquake activity in the tectonic province of the that govern the responsibility for the safe use of the irradia- irradiator and in adjacent tectonic provinces if the site is tor. The procedures should clearly specify the functions, near a tectonic border. An explanation should be submitted duties and responsibilities, and authority of each supervisor tliat substantiates that the facility is designed and construc- and of the radiation safety officer. Reference Items 16 and ted to withstand the movement. 17, as appropriate.

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c. Administrative Procedures safe condition and to minimize radiation exposure to persons in the vicinity of the irradiator and should include The administrative procedures should contain the the names and telephone numbers of persons who are to be internal inspection system that will be used by the applicant contacted to direct remedial actions. Immediate action to ensure that operations will be performed safely and in procedures that the applicant will require "operators" to accordance with NRC requirements. The applicant should memorize should be identified.

specify the minimum frequency of on-the-job audits and should provide the names and positions of the individual or The applicant should describe the procedures for opera- individuals who will perform the audits. Reference Items 16 tions that are performed primarily by licensed users ("irra- and 17, as appropriate. diator operators") in the control area(s) of the facility and the procedures for those operations that are performed by The applicant should describe the methods of ensuring shift crews in operating the irradiator facility.

that only authorized persons will use the irradiator or have access to the space where it is located. These methods can The applicant should provide a detailed description of include control of keys to the door of the room containing the source-loading and irradiator-installation procedures.

the irradiator control console, control of operating console This description should include all tools and equipment to keys, or other positive methods of excluding access. be used. The step-by-step procedures for all steps of the operation should be provided.

A description should be provided of the process for review, change, and approval of all administrative, operating, The applicant should provide a copy of the procedures maintenance, testing, and other procedures. The identity that are to be used to determine possible leakage of radio- should be provided of the persons (by position) who have active material from the source capsule. Show that the test the responsibility for writing procedures and of the persons methods are sufficiently sensitive to detect 0.05 microcurie who must approve them before they are implemented. of activity. Describe the procedures that ensure the leak Reference Items 16 and 17, as appropriate. testing of the source at least every 6 months. A description should be provided of the frequency for and procedures The following categories should be considered but need used in inspecting and testing the source capsules to ensure not necessarily form the basis for classifying administrative mechanical integrity, including inspecting and testing procedures: for physical deformation such as bending or bowing and for evidence of corrosion of source encapsulation. The applicant I. Standing orders to licensed users and to shift supervi- should also specify the actions that are to be taken if such sors and shift crews, including authorities and respon- in situ visual or simple mechanical inspection and testing sibilities. reveals any significant change in the sources.

2. Special orders of a transient or self-canceling character.

3. Irradiator and equipment control procedures. The applicant should provide a copy of the procedures

4. Control of maintenance and modifications. that will be followed during inspection and preventive

5. Master surveillance testing schedule(s). maintenance of the irradiator. The identities and qualifica-

6. Procedures for logbook use and control. tions of the persons or contractors performing this work

7. Temporary procedures (authority to issue and approve). should be specified. The frequency of this inspection

8. Procedural system (writing, review, approval, imple- should be specified. Examples of components that should mentation). be included are interlocks, radiation monitoring instruments,

9. Internal inspection (audit) system. water level indicators, and water treatment systems. Indicate that components directly related to radiation safety (such d. Operating and Emergency Procedures as interlocks, radiation level monitors, or warning lights)

will be checked prior to operation each day that the irradia- The applicant should provide a copy of the step-by-step tor is in use in accordance with §20.203(c)(6)(vii). In procedures that will be kept at the irradiator control addition, indicate that other components that are related to console and that will be followed by operators while using radiation safety (such as water level indicator and water the irradiator. These "cookbook" procedures should treatment sytems) will be checked at least weekly and that include instructions concerning interlocks to be checked, still other components (such as source hoist mechanisms surveys to be taken, frequency of reading of pocket dosim- and product positioning systems) will be checked at least eters, and instructions for dealing with equipment malfunc- semiannually. A schedule of more complete checks of the tions (such as the loss of electrical power, the loss of air entry control and warning systems should be submitted in pressure to control equipment, or the failure of the radiation accordance with § 20.203(c)(6)(vii).

monitoring, interlock, or safety systems).

The applicant should provide the criteria for selection of The applicant should provide a copy of concise, easily portable and laboratory technical equipment and instrumen- followed emergency procedures. These procedures should tation for performing radiation and contamination surveys describe the conditions that will be indicative of a malfunc- and for other radioactivity monitoring and sampling, tion or of an emergency situation and should state the for area radiation monitoring, and for personnel monitoring.

emergency action to be taken. Instructions should specify The applicant should describe the type of detectors and the immediate action to be taken to place the irradiator in a monitors and the quantity, sensitivity, range, and frequency

10.9-7

and methods of calibration for all of the technical equip- rarily or permanently to work at the facility. The description ment and instrumentation mentioned. of procedures should include the identity of and arrange- ments with facilities or persons having a capability to The applicant should describe the instrument storage, furnish necessary advice or assistance in dealing with calibration, and maintenance facilities. Describe and identify facility emergencies (such as, medical facilities or medical the location of the radiation protection facilities (including treatment for individuals affected by radiological emergen- locker rooms, shower rooms, and access control stations), cies).

laboratory facilities for radioactivity analyses, protective clothing, decontamination control equipment, or other The categories of procedures listed below should also be control areas or equipment that will be available. Reference considered. If their general objectives and character are Items 10 and It, as appropriate. described elsewhere in the application, they may be described by specific reference to the section where they are covered.

The applicant should describe the methods, frequencies, and procedures for conducting radiation surveys. Describe 1. Facility radiation protection procedures.

the procedures and methods of operation that have been 2. Emergency preparedness procedures.

developed for ensuring that occupational radiation exposures 3. Instrument calibration and test procedures.

will be ALARA. Also describe the procedures that are 4. Water quality control procedures.

to be used in (a) the receipt, handling, and loading of 5. Radioactive waste management procedures.

radiation sources into the irradiator; (b) thestorage, exchange, 6. Maintenance and modification procedures.

packaging, and shipment of sources; (c) the inservice inspections of irradiator equipment and sources; and (d) the f. Instructions to Workers normal operations and routine maintenance of equipment and facilities. The applicant should provide a complete description of the training program to be conducted pursuant to § 19.1 2, The applicant should describe the physical and adminis- "Instructions to Workers," of 10 CFR Part 19. The descrip- trative measures for controlling access, egress, and stay time tion should specify the form of training (lectures or on-the- for radiation areas and contamination zones, and should job) an outline of the subject matter that is covered, describe the methods and procedures for personnel monitor- the time devoted to each subject, the equipment used, and ing, including methods of recording, reporting, and analyzing the methods and criteria used to determine the competency results. Reference Item 12, as appropriate. Include the of each individual to work about or operate the irradiatoi ,.

criteria for selecting personnel who will be required to wear Provisions for initial training and for retraining should be personnel-monitoring devices and the criteria for selection specified.

of the routine monitoring period, i.e., badge or TLD

exchange frequency. The description of the on-the-job training should specify the minimum time period that an individual will work Each operating and emergency action procedure should under the direct supervision of a qualified instructor prior be identified by title and included in a described classifica- to being certified as an operator. Classifications of personnel tion system. The following categories should be considered who will receive different levels of instruction should be but need not necessarily form the basis for classifying these identified. The applicant should identify the personnel in procedures: the organization who are responsible for the training programs, including the maintenance of records on the I. Irradiator and system operating procedures. status of trained personnel, the training of new employees,

2. General facility procedures. and the refresher or upgrade training of peopl

e. Reference

3. Off-normal operating procedures. Items 16 and 17, as appropriate.

4. Emergency action (to correct malfunction) procedures.

5. Alarm response procedures. Items 16. and 17. Technical Qualifications of Personnel

6. Temporary procedures.

a. PersonnelPositions e. Other Procedures Describe the organization, functions, and responsibilities The applicant should provide an explanation of how of the positions that are established to operate and maintain other operating and maintenance procedures are classified, the irradiator facility; provide an prganization chart showing what group or groups within the operating organization the title of each position, the number of operating shift have the responsibility for following each class of procedures, crews, and the positions for which licensed users are required.

and the general objectives and character of each class or The functions, responsibilities, and authorities of positions subclass of procedures. Reference Items 16 and 17, as corresponding to the following should be described: overall appropriate. irradiator facility management, operations supervision, shift crew supervision, "irradiator operators," technical supervi- The applicant should describe the procedures for emer- sion, radiation protection supervision, instrumentation and gency preparedness in dealing with various types of accidents controls engineering supervision, instrumentation and con- that affect or threaten the health and safety of the public, trots maintenance supervision, and internal inspection and employees of the licensee, or other persons assigned tempo- audit supervision.

10.9-8

Describe the line of succession of authority and respon- individual to operate the irradiator and to evaluate the sibility for overall facility operation both for normal effectiveness of the training program.

operations and for emergencies. Specify the delegation of authority to operating shift crew supervisors, including the The application should contain commitments to train authority to issue standing or special orders or procedures. replacement personnel and to provide refresher or requalifi- cation training for persons who are "certified" as irradiator b. Qualifications operators. A description of the type and frequency of refresher or requalification training should be provided.

Describe the requirements established for education, Reference Item 15, as appropriate.

training, and experience for each management, operating, technical, and maintenance position category in the operat- 5. AMENDMENTS TO LICENSES

ing organization. The application should contain a commit- ment that the qualification requirements will be met by all Licensees are required to conduct their programs in incumbents of the identified positions. accordance with statements, representations, and procedures contained in the license application and supportive docu- The qualifications of the initial incumbents of organiza- ments. The license must therefore be amended if the tional positions should be presented as resumes for key licensee plans to make any changes or modifications in facility managerial and supervisory personnel through the facilities, equipment (including monitoring and survey supervisory level of shift crews (i.e., each person who will instruments), procedures, personnel, or byproduct m'aterial directly supervise the operations or who will have radiolo- to be used.

gical safety responsibilities). The resumes should describe the training and experience in the use of radioisotopes and Applications for license amendments may be filed either radiation. The descriptions of the training should include on the application form or in letter form. The application both on-the-job training and. formal course work, location should identify the license by number, should clearly where the training was received, and the duration of the describe the exact nature of the changes, modifications, training. The descriptions should also cover the incumbent's additions, or deletions, and should include all additional knowledge of (1) principles and practices of radiation supporting information including the identities and qualifi- protection, (2) radiometric measurements and techniques cations of the persons or contractors who will perform the and instruments for standardization and monitoring, (3) work. References to previously submitted information and mathematics and calculations basic to use and measurement documents should be clear and specific and should identify of radiation and radioactivity, (4) biological effects of the pertinent information by date, page, and paragraph. If a radiation, (5) design and construction of the irradiator and section of a manual or instruction is to be amended, dated its associated safety systems, (6) the applicant's radiation substitute pages should be provided, and the changed safety program, (7) the applicant's operating and emergency sections should be noted in the margin.

procedures, and (8) pertinent requirements of the NRC and other cognizant regulatory agencies. The description of

6. RENEWAL OF A LICENSE

experience and actual use of radioactive materials should specify the isotopes handled, the maximum quantities of Byproduct material licenses are normally issued for a materials handled, where the experience was gained, the period not in excess of 5 years.

duration of experience, and the type(s) of use(s).

An application for renewal of a license should be filed at c. TrainingProgram least 30 days prior to the expiration date. This filing will ensure that the license does not expire until final action The application should include a complete description of on the application has been taken by the NRC staff as the training program for irradiator operators. The description provided for in §30.37(b) of 10 CFR Part 30.

should include the proposed subject matter of each course, including a syllabus or equivalent description of the course, Renewal applications should be filed on Form NRC-313(1),

the duration of the course (approximate number of hours appropriately supplemented, and should contain complete or days in full-time attendance), the type of training and up-to-date information about the applicant's current (lectures, on-the-job), and the identity of the organization program.

or person(s) teaching the course or supervising the instruc- tion. The description of the on-the-job training should In order to facilitate the review process, the application specify the minimum time period that an individual will for renewal should be submitted without using references work under the direct supervision of a qualified instructor to previously submitted documents and information. If or operator prior to being certified as an irradiator operator. such references cannot be avoided, they should be clear and The application should also describe the methods and specific and should identify the pertinent information criteria used both to determine the competency of each by date, page, and paragraph.

10.9-9

APPENDIX A

Form NRC-313 (I)

(6/78)

U.S. NUCLEAR REGULATORY COMMISSION

10 CFR 30

INSTRUCTIONS FOR PREPARATION OF

APPLICATION FOR BYPRODUCT MATERIAL LICENSE

FORM NRC-313 (I)

GENERAL INFORMATION

An applicant for a "Byproduct Material (Radioisotopes) License," 3. Broad License (research and development)-"Licensing Guide should complete Form NRC-313 (I) in detail and submit in duplicate for Type-A Licenses of Broad Scope for Research and Develop- to the U.S. Nuclear Regulatory Commission. The applicant should ment;"

endeavor to cover his entire radioistope program with one application, if possible. However, separate applications should be submitted for 4. Licensing Guides for the performance of well logging operations.

gamma irradiators. Applications for medical uses should be submitted on Form NRC-313 (M) and-applications for use of sealed sources in 5. Licensing guide for the use of sealed sources in portable and semi- radiography should be submitted on Form NRC-313R. Supplemental portable gauging devices.

sheets may be appened when necessary to provide complete infor- mation, Item 18 must be completed on all applications. Submission The Commission charges fees for filing of applications for licenses as of an incomplete application will often result in a delay in issuance of specified in Section 170.12, Title 10, Code of Federal Regulations.

the license because of the correspondence necessary to obtain infor. Part 170. The applicant should refer to Section 170.31, Schedule of mation requested on the application. fees for materials licenses, to determine what fee should accompany the application, No action can be taken on applications until fees are NOTE. -When the application includes one of the special uses listed paid. Checks or money orders should be made payable to the U.S.

below, the applicant should request the appropriate pamphlet which Nuclear Regulatory Commission.

provides additional instructions:

Two copies of the completed Form NRC-313 (1) and two copies of I Industrial Radiography-"Licensing Requirements for Industrial each attachment thereto, should be sent to the Division of Fuel Cycle Radiography" (use application Form NRC-313R for Radi- and Material Safety, Office of Nuclear Material Safety and Safeguards.

ography); U.S. Nuclear Regulatory. Commission, Washington, D.C. 20555. One copy should be retained for the applicant's fil

e. Applications may

_2_ Laboratory and Industrial Uses of Small Quantities-"Guide for also be filed in person at the Commission's office at 1717 H Street.

Preparation of Applications for Laboratory and Industrial N.W., Washington, D.C. or at 7915 Eastern Avenue, Silver Spring.

Uses of Small Quantities of Byproduct Material." Maryland.

EXPLANATION OF FORM NRC-313 (1)

Form NRC-313 (1) is designed for use in supplying information 5. The actual sites of use should be listed as indicated. Per- on programs of varying complexity. The applicant should provide manent facilities such as field offices for portable gauges o complete information on his proposed program for the possession devices should be identified in Item 5 by Street, Address.

and use of licensed material. For those items that do not apply, indicate City and State. Temporary field locations of use should as N.A. (not applicable). be specified as "temporary job sites of the applicant" anG

list the States throughout which the temporary job sites will Item No. be located. Attach additional properly keyed sheet if mor, space is needed.

1. Self-explanatory

6. Self-explanatory

2. The "applicant" is the organization or persons legally res- ponsible for possession and use of the licensed materials

3.

specified in the application.

Self-explanatory

7. The "Radiation Protection Officer" is the named individual who is expected to coordinate the safe use of the licensed material specified in the application and who will ensure compliance with the applicable parts of Title 10, Code oi

0

4. Self-explanatory Federal Regulations.

10.9-10

APPENDIX A

8. List by name each radioisotope to be possessed and used Attach additional properly keyed sheets if more space is under the license. Example: needed.

0 A

(1) Iodine-l31 (1) Iodide B

8.E State the use of each Licensed material listed in 8A, B, C,

and D.

(2) lodine-131 (2) lodinated Human 9. Description of containers and/or devices in which sealed Serum Albumin sources listed in Item 8 will be stored or used. Example:

(3) Krypton-85 (3) Gas

(4) Cesium-137 (4) Sealed Source A B

(1) * - Source housing iso. Corp C D

(1) Not Applicable (1) 10 millicuries C

(2) N.A. (.2) I micurie Model Z-278

(3) N.A. (3) 1 millicurie

(4) Iso. Corp (4) 2 source of 150 10-18 Self-explanatory. (For those items that do not apply, Model Z-78 milicuuies each indicate as N.A. (not applicable).

PRIVACY ACT STATEMENT

Pursuant to 5 U.S.C. 552a(e)(3), enacted into law by section 3 of the Privacy Act of 1974 (Public Law 93-579), the following statement is furniahed tQ individuals who supply information to the Nuclear Regulatory Commission on Forms NRC-313M, NRC-313a, NRC-3131, or NRC-313R. This information is maintained in a system of records designated as NRC-3 and described at 40 Federal Register 45334 (October 1, 1975).

1, AUTHORITY Sections 81 and 161(b) of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2111 and 2201(b)).

2, PRINCIPA

L. PURPOSE

(S) The information is evaluated by the NRC staff pursuant to the criteria set forth in 10 CFR Parts 30-36 to determine whether the application meets the requirements of the Atomic Energy Act of 1954, as amended, and the Commission's regulations, for the issuance of a byproduct material license or amendment thereof.

3. ROUTINE USES The information may be used: (a) to provide records to State health departments for their information and use; and (b) to provide information to Federal, State, and local health officials and other persons in the event of incident of exposure, for their information, investigation, and protection of the public health and safety. The information may also be disclosed to appropriate Federal, State and local agencies in the event that the information indicates a violation or potential violation of law and in the course of an administrative or judicial proceeding. In addition, this information may be transferred to an appropriate Federal, State, or local agency to the extent relevant and necessary for a NRC

decision or to an appropriate Federal agency to the extent relevant and necessary for that agency's decision about you. A copy of the license issued will routinely be placed in the NRC's Public Document Room, 1717 H Street, N. W., Washington, D.C.

4. WHETHER DISCLOSURE IS MANDATORY OR VOLUNTARY AND EFFECT ON INDIVIDUAL OF NOT PROVIDING INFORMATION

Disclosure of the requested information is voluntary. If the request information is not furnished, however, the application for byproduct material license, or amendment thereof, will not be processed.

5. SYSTEM MANAGER(S) AND ADDRESS Director, Division of Fuel Cycle and Material Safety, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.

10.9-11

APPENDIX A

FORM NRC-313 I U.S. NUCLEAR REGULATORY COMMISSION 1. APPLICATION FOR:

(6-78) (Check and/or compAete as appropriate)

10 CFR 30

APPLICATION FOR BYPRODUCT MATERIAL LICENSE

INDUSTRIAL

a. NEW LICENSE

See attached instructions for details. b. AMENDMENT TO:

LICENSE NUMBER

Completed applicationsare filed in duplicate with the Division of Fuel Cycle and Material Safety, Office of Nuclear Material Safety, and Safeguards, U.S. Nuciear Regulatory Commission, cc. RENEWAL OF:

Washington, DC NW,

20555 or applications Washington, D. C. may be filed or 7915 in person Eastern at Silver Avenue, the Commission's office at Spring, Marylan

d. LICENSE NUMBER

1717 Hi Street,

2. APPLICANT'S NAME (Institution, firm, person, etc.)

E. CONTACT

ED REGARDING THIS

APPLICATION

TELEPHONE NUMBER: AREA CODE - NUMBER EXTENSION TELEPHONE NUMBER: AREA CODE - NUMBER EXTENSION

4. APPLICANT'S MAILING ADDRESS (Include Zip Code) 5. STREET ADDRESS WHERE LICENSED MATERIAL WILL BE USED

(Include Zip Code)

(IF MORE SPACE IS NEEDED FOR ANY ITEM, USE ADDITIONAL PROPERLY KEYED PAGES.)

6. INDIVIDUAL(S) WHO WILL USE OR DIRECTLY SUPERVISE THE USE OF LICENSED MATERIAL

(See Items 16 and 17 for required trainingand experience of each individualnamed below)

FULL NAME TITLE

a.

b.

-l C.

7. RADIATION PROTECTION OFFICER Attach a resume of person's trainingand experience as outlined in Items

16 and 17 and describe his responsibilitiesunder Item 15.

8. LICENSED MATERIAL

L ELEMENT CHEMICAL NAME OF MANUFACTURER MAXIMUM NUMBER OF

I AND AND/OR AND MILLICURIES AND/OR SEALED

N MASS NUMBER PHYSICAL FORM MODEL NUMBER SOURCES AND MAXIMUM ACTI-

E (If Sealed Source) VITY PER SOURCE WHICH WILL

BE POSSESSED AT ANY ONE TIME

NO. A B C 0

(1)

(2)

(3)

(4)

DESCRIBE USE OF LICENSED MATERIAL

E

(2)

(3)

- i 1 FORM NRC-313 116.78)

10.9-12

APPENDIX A

B ~TORA~F OF SEA LED SOURCES

CONTAINER AND/OR DEVICE IN WHICH EACH SEALED NAME OF MANUFACTURER MODEL NUMBER

N SOURCE WILL BE STORED OR USED.

NO. A. c.

C.

II)

12)

(3)

141

10. RADIATION DETECTION INSTRUMENTS

TYPE MANUFACTURER'S, MODEL NUMBER RADIATION SENSITIVITY

L OF NAME NUMBER AVAILABLE DETECTED RANGE

N INSTRUMENT (alpha, beta, (mi//iroantgens/hour gamma, neutron) or counts/minure)

NO. A B C D E F

(1) ___________

(2)

(3)

(4)

11. CALIBRATION OF INSTRUMENTS LISTED IN ITEM 10

Ca. CALIBRATED BY SERVICE COMPANY Ob. CALIBRATED BY APPLICANT

NAME, ADDRESS, AND FREQUENCY Attach a separate sheer describing method, frequency and standards used for calibratinginstruments.

12. PERSONNEL MONITORING DEVICES

TYPE SUPPLIER EXCHANGE FREQUENCY

(Check and/or complete as appropriate.d (Service Company) C

A B C

0(1) FILM BADGE C MONTHLY

0021 THERMOLUMINESCENCE C QUARTERLY

DOSIMETER (TLD)

-(3) OTHER (Specify): C3 OTHER (Specify):

13. FACILITIES AND EQUIPMENT (Check were appropriate and attach annotated sketch(es) and description(s).

C a. LABORATORY FACILITIES, PLANT FACILITIES, FUME HOODS (Include filtration, if any), ETC.

C b. STORAGE FACILITIES, CONTAINERS, SPECIAL SHIELDING (fixed and/or temporary), ETC.

C c. REMOTE HANDLING TOOLS OR EQUIPMENT, ETC.

C d. RESPIRATORY PROTECTIVE EQUIPMENT, ETC.

1

4. WASTE DISPOSAL

a. NAME OF COMMERCIAL WASTE DISPOSAL SERVICE EMPLOYED

b. IF COMMERCIAL WASTE DISPOSAL SERVICE IS NOT EMPLOYED, SUBMIT A DETAILED DESCRIPTION OF METHODS WHICH WILL

BE USED FOR DISPOSING OF RADIOACTIVE WASTES AND ESTIMATES OF THE TYPE AND AMOUNT OF ACTIVITY INVOLVED. IF

THE APPLICATION IS FOR SEALED SOURCES AND DEVICES AND THEY WILL BE RETURNED TO THE MANUFACTURER, SO STATE.

FORM NRC-313 1(6-781

10.9-13

APPENDIX A

I- l INFORMATION REQUIRED FOR ITEMS 15, 16 AND 17 I ý

w Describe in detail the information required for Items 15, 16 and 17. Begin each item on a separate page and key to the application as follows:

15. RADIATION PROTECTION PROGRAM. Describe the radiation protection program as appropriate for the material to be used including the duties and responsibilities of the Radiation Protection Officer, control measures, bioassay procedures (if needed), day-to-day general safety instruction to be followed, etc. If the application is for sealed source's also submit leak testing procedures, or if leak testing will be performed using a leak test kit, specify manufacturer and model number of the leak test kit.

16. FORMAL TRAINING IN RADIATION SAFETY. Attach a resume for each individual named in Items 6 and 7. Describe individual's formal training in thd following areas where applicable. Include the name of person or institution providing the training, duration of training, when training was received, etc.

a. Principles and practices of radiation protection.

b. Radioactivity measurement standardization. and monitoring techniques and instruments.

c. Mathematics and calculations basic to the use 'and measurement of radioactivity.

d. Biological effects of radiation.

17. EXPERIENCE. Attach a resume for each individual named in Items 6 and 7. Describe individual's work experience with radiation, including where experience was obtained. Work experience or on- the-job training should be commensurate with the proposed use. Include list of radioisotopes and maximum activity of each used.

1

8. CERTIFICATE

(This item must be completed by applicant)

The applicant and any official execurino this certificate on behalf of the applicant named in Item 2, certify that this application is prepared in conformity with Title 10, Code of Federal Regulations, Part 30, and that all information contained herein, including any supplements attached hereto, is true and correct to the best of our knowledge and belief.

WARNING-1l8 U.S.C., Section 1001; Act of June 25, 1948; 62 Stat. 749; makes it a criminal offense to make a willfully false statement or representation to any department or agency of the United States as to any matter within its juriadiction.

a. LICENSE FEE REQUIRED b. CERTIFYING OFFICIAL (Signature)

(See Section 170.31, 10 CFR 770)

c. NAME (Type or print)

(1) LICENSE FEE CATEGORY:

d. TITLE

(2) LICENSE FEE ENCLOSED: S 7 . DATE

P

FORM NRC.-313 I lo-I78)

10.9-14

VALUE/IMPACT STATEMENT

PREPARED FOR GUIDES FOR PREPARATION OF LICENSE

APPLICATIONS

The Division of Material and Fuel Cycle Facility Licens- Alternative 2: Publish a guide for the review of license ing has forwarded a draft of the subject guide to the Office applications describing what should be reviewed and the of Standards Development, Occupational Health Standards detail to which the various items of the application Branch (OHSB), for publication as a regulatory guide. Oneim- should be reviewed. This type of guidance to the NRC

portant consideration is whether a guide would be beneficial staff could also be used by license applicants as a guide to licensees and the NRC staff or if the licensing program can for the preparation of their applications.

function equally w;ell without the issuance of guidance to licensees. Another important consideration is the importance of this task compared to the importance of other OHSB tasks. 4. Recommended Solutions I. Rationale for Schedule It is recommended that Alternative I be implemented as the better solution. Potential for accomplishment of The schedule for completion of this task was determined Alternative 2, given current staff and workload of NMSS, is taking into consideration past scheduling experience within nil. Alternative I is in concert with recommendation.

the Occupational Health Standards Branch for other of OIA and concurred in by EDO.

licensing guides. We have found with this series of guides that circulation for comments is necessary only once, primarily because the drafts are developed by the actual 5. Value/Impact license reviewers in Nuclear Material Safety and Safeguards

.(NMSS). Work on the task was performed in conformance a. Value with a previously arranged schedule for the task leader.

Issuance of a regulatory guide for preparation of license

2. Analysis of Need applications will:

In CY 1975, the radioisotopes license reviewers wrote '(1) be beneficial to license applicants by providing them letters of deficiency to license applicants containing approx- with information that will simplify their preparation imately 200 questions related to bioassays, 370 questions and submittal of license applications, related to calibration of survey meters, 400 questions related to area surveys, and 270 related to training of individuals (2) reduce the inquiries by applicants for information, (other than physicians). In CY 1975, there were 730 new or and renewal applications. The number of new or renewal appli- cations continues to increase. NMSS personnel believe that (3) reduce the number of questions and letters of inquiry the licensing guides will result in applications that are more that must be sent to applicants, thereby saving time complete, thus eliminating the need for some deficiency and effort for both license applicants and the NRC

letters. Guides of this type were recommended by the staff.

Office of the Inspector and Auditor following an audit of what was then the Radioisotopes Licensing Branch (currently b. Impact the License Management Branch).

There is no impact, other than the allocation of staff re-

3. Alternative Solutions sources to the development and production of the guide.

The guide presents information on current licensing require- Alternative 1: Publish a guide for the preparation of ments and reflects consideration of public comments received applications. on the draft guide.

10.9-15

UNITED STATES

NUCLEAR REGULATORY COMMISSION

WASHINGTON, D. C. 20555 POSTAGE AND FEES PAID

OFFICIAL BUSINESS U.S. NUCLEAR REGULATORY

PENALTY FOR PRIVATE USE, $300 COMMISSION

US NRC REGION I

OFFICE OF INSPECTION & ENFORCE

R J BORES

631 PARK AVENUE

REGION I

KING OF PRUSSIA PA 19406