ML19259B819

Draft Guide for Preparation of Applications for the Use of Gamma Irradiators. Issued for Comment

ML19259B819
Person / Time
Issue date:	02/28/1979
From:	NRC OFFICE OF STANDARDS DEVELOPMENT
To:
References
RTR-REGGD-10.009, TASK-OH-706-4, TASK-OS REGGD-10.XXX, NUDOCS 7903230226
Download: ML19259B819 (43)

Text

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U.S. NUCLEAR REGULATORY COMMISSION February 1979 a

0FFICE ur ST.ANDARDS DEVELOPMENT Division 10 o[

DRAFT REGULATORY GUIDE AND VALUE/ IMPACT STATEMENT Task OH 706-4 s.e.../

b GUIDE FOR PREPARATION OF APPLICATIONS

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FOR THE USE OF GAMMA IRRADIATORS

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1.

INTRODUCTION h

f This guide describes the type of information that,is needed to evaluate

%su 3 an application for a license to use sealed radioa,ctive'N d'soisrces for the gamma N

pj irradiation of materials.

Section 4.a outlines-itIms ihat should be con-s ~ - q tained in applications for self-contained / dry soyrce-storage irradiators un (an irradiator so constructed that thepealed so'urce(s) and the material s.g sf being irradiated are contained in a gjyielded volume, which in the designed f:

~3 configuration of the device is always physically inaccessible by any part 1J e

of the human body).

Section 4D,utli;ies the items that should be contained

.d in applications for other types o Cirradiators.

n 1.1 Applicable Regulations 3 y

ReCulations pertaining to this type of license are found in 10 CFR Part 2, " Rule fLPract) ice;" 10 CFw Part 19, " Notices Instructions and p

W ReportstoWo(kers; Inspections;"10CFRPart20,"StandardsforProtection AgainstRadiationI"10CFRPart30,"RulesofGeneralApplicabilityto Licensing Byproduct Material;" 10 CFR Pa.'t 71, " Packaging of Radioactive This. regulatory guide and the associated value/ impact statement are being issued in draft fona to involve the public in the early stages of the development of a regulatory position in this area. They have not received complete staff review and do not represent an official NRC staff position.

Public coments are being solfeited on both drafts, the guide (including any implementation schedule) and the value/ impact statement. Coments on the value/frtpact statement should be accompanied by supporting data. Coments on both drafts should be sent to the Secretary of the Comission. U.S..huclear Regulatory Comission. Washington. 0.C. 20555. Attention: Docketing and Service Granch, by APR 3 01979 Requests for single copies of issued guides and draf t cuides (wnich eay be reproduced) or for placement on an autcmatic distribution list for single copics of future guides and draft geldes in specific divisions should be made in writing to the U.S. Nuclear Regulatory Comission. Washington, pgggtg3-M:

tfon Of rector. Division of Technical Ir.."snnation and Document Central.

Materials for Transport and Transportation of Radioactive Material Under Certain Conditions;" 10 CFR Part 170, " Fees for Facilities and Haterials Licenses Under the Atomic Energy Act of 1954, as amended;" and 10 CFR Part 150, " Exemptions and Continued Regulatory Authority in Agreement States Under Section 274."

The applicant should study carefully the regulations and this guide and submit all information requested.

1. 2 Items Requiring Separate Applications Uses of byproduct materials other than for the gamma irradiation of materials are not within the scope of this guide.

1. 3 As Low As Is Reasonably Achievable (ALARA)

Paragraph 20.l(c) of 10 CFR Part 20 states that "... person engaged in activities under licenses issued by the Nuclear Regulatory Commission pursuant to the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974 should, in addition to complying with the requirements set forth in this part, make every reasonable effo' t to maintain radiation exposures, and releases of radioactive materials in effluents to unrestricted areas, as low as is reast.aably achievable."

Regulatory Guide 8.10, " Operating Philosoph'r for Maintaining Occupational Rrdiation Exposures As Low As Is Reasonably Achievable," provides the NRC staff position on this importanc subject.

License applicants should give consideration to the ALARA philosophy, as described in Regulatory Guide 8.10, in the development of plans for work with licensed radioactive materials.

O 2

2.

LICENSE FEES An application fee is required for most types of licenses.

The appli-cant shouid refer to S170.31, " Schedule of Fees for Material Licenses," of 10 CFR Part 170 to determine the amount of the fee that must accompany the application.

Review of the application will not begin until the proper fee is received by the NRC.

3.

FILING AN APPLICAfl0N 3.1 App.ication Form NRC-313(I)

An application for a license to possess and use byproduct material for the gamma irradiation of materials should be filed on Form NRC-313(I), "

Application for Byproduct Material License." All items on the application form should be completed in sufficient detail for the NRC to determine that the applicant's equipment, facilities, and radiation protection program are adequate to protect health and minimize danger to life and property.

Since the space provided on the application form is limited, the appli-cant should append additional sheets to provide complete information.

Each separate sheet or document submitted with the application should be identified as to its purpose, e.g., response to an item of the application form, radia-tion safety instructions.

Three copies of the application should be completed.

The original and one copy should be mailed to:

Division of Fuel Cycle and Material Safety, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C.

20555.

One copy should be retair.ed by the 3

applicant since the license will re. quire that the institution adhere to the statements and representations made in the application and ary supplement to it.

3.2 Proprietary Information The applicant should not submit proprietary information unless it cannot be avoided in giving a complete description of the applicant's equipment, facilities, and radiation protection program.

If the use of proprietary information cannot be avoided, the proprietary information should be separated from the rest of the application and an application for withholding from public inspection should be submitted in conformance with the requirements of S2.790 of 10 CFR Part 2, " Rules of Practice."

3.3 Environmental Information j

A formal environmental, report is not specifically required for the type of activities included in the scope of this document.

3.4 Safeguards No safeguard information is required in an application for licenses covered by this guide.

4.

CONTENTS OF AN APPLICATION 4.a General Requirements:

Self-Contained Irradiators, Dry Source-Storage Many items of the NRC Form 313(I) are self-explanatory (see instructions with the form, Appendix A).

The following comments apply to the items of the form as indicated.

4

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.

If no street is available, the applicant should provide a specific description that designates the location accurately.

Items 8A-D. Quantity and Form of Byproduct Material The applicant should specify the isotope, number of curies per sou.,

name of manufacturer and model number of each source, and total number of sources that will be contained in the irradiator.

If the sources have been evaluated previously by the NRC or an Agreement State,* specification of the manufacturer and model number of the sources will be a sufficient description.

If the sources have not been evaluated previously, the applicant should provide the information requested in " Guide-Information to be Submitted fur Evaluation of Sealed Sources Utilizing Radioactive Materials." This guide is available from the Division of Fuel Cycle and Material Safety, Office of Nuclear Material Safety and Safeguards, U.S.

Nuclear Regulatory Commission, Washington, D.C. 20555.

Item 8E. Purpose for Which Byproduct Material Will Be Used The applicant should specify that the sources will be used in an irradiator (including name of manufacturer and model number) for the irradiation of materials.

AAn Agreement State is a State that has assumed authority for regulating the use of byproduct, source, and special nuclear material (in quantities less than critical mas.) within the boundaries of the State.

5

Item 9. Storage of Sealed Sources List as indicated on form and refer to detailed descriptions under Item 13, as appropriate.

Items 10. and 11. Radiation Detection Instruments Radiation survey instruments that are used in support of irradiator operations should be capable of accurately measuring normally expected radia-tion levels in the vicinity of the irradiator and should have sufficient range to detect unusual radiation levels that might be indicative of shielding failure, source disconnection, or major contamination.

Portable survey instruments that are used to measure radiation levels near the irradiator need not be placed on a rigorous 6-month calibration schedule as are most other survey instruments.

However, users should test the radiation detection instruments with a check source of radiation before each use.

The check ik y source should expose the detector to radiation levels of the same order of magnitude as those that are encountered during normal operations.

These instrument check tests should be supplemented by at least an annual calibration that meets the performance specifications identified in Section 4.b, Items 10 and 11 of this guide.

Soon after its annual cali-bration an instrument should be used to measure radiation levels at various distances from the check source; and a record of the instrument's readings should be kept and used for reference in subsequent instrument J;9cks until the next calibration.

6

Those instruments that are used to detect radioactive contamination or the leakage of radioactive materials should have the same characteristics and be calibrated in the same way as described for the same kinds of instru-ments in Section 4.b, Items 10 and 11 in this guide.

Item 12. Personnel Dose Monitoring Devices The applicant should (1) specify the type of personnel dose monitoring devices to be used (film badge, TLD, pocket chambers), (2) provide the name of the commercial supplier of the film badge or TLD, dosimetry service, and (3) specify the frequency at which film badges or TLD's will be evaluated.

For pocket chambers, the applicant should provide the name of the manufacturer, type, model number, and the range (mR) and frequency of reading and specify provisions for the maintenance and calibration.

Item 13. Facilities and Equipment A number of self-contained, dry source-storage irradiators have been evaluated oy the Nuclear Regulatory Commission (NRC) or Agreement States.

Since the manufacturers of these irradiators have submitted detailed descrip-ticas of these irradiators to the NRC or Agreement States for generic evalua-tion, a detailed description of the engineering design of such an irradiator need not be repeated by each person making application for a license to use this equipment.

The applicant should provide only the name of the manufacturer and model number of the irradiator if it has been so evaluated.

'nformation on whether or not a particular irradiater has been so evaluated should be available from the manufacturer.

7

If the device has not been previously evaluated, the applicant should provide a complete description of the irradiator.

This description should include the following:

a.

Engineering drawings of the device.

All drawings should have a drawing number, revision number, company number, title, date of revision, bill of materials or reference to same, dimensional scale and dimensional tolerances.

Additional sketches may be used if they provide necessary information concerning the main function or safety features of the device Assembly views of engineering drawings and the use of photographs are help-ful in providing a description of the irradiator.

All engineering drawings and photographs should be of good quality and legible.

The description should specify the dimensions and materials of construction.

b.

A complete description of all mechanical and electrical systems, including the shutter or source positioning mechanism, interlocks, source position indicators, warning lights, and alarm.

Interlocks and warning iights should be designed so that failure of the system or loss of elec-trical power will result in an adequately shielded, safe condition (i.e.,

access to the source or high radiation levels is prevented).

c.

A copy of the radiation profile (in mR/hr) for a prototype model of the irradiator.

Radiation levels should be measured with the irradiator containing the maximum quantity, in curies, of radioactive material to be contained and in the " store," " transit," " load and unload," and " operate" O

8

positions.

The radiation survey of the prototype irradiator should provide a complete three-dimensional profile of the irradiator at 5 cm and 1 meter from the exterior surface.

The applicant should specify the name of the manufacturer, the model number and the date of calibration of the radiation survey instrument used, and the method of instrument calibration.

If the irradictor will be used in an area where the applicant will not restrict access for radiation protection purposes, the radiation levels from the irra-diator's source anywhere outside the irradiator should not exceed 2 mR/hr, and the irradiator should be able to be secured against unauthorized use.

d.

A description of the tests performed on the irradiator.

These tests should establish the integrity of the irradiator shielding and the operability of the control system (such as source positioning mechanism, shutters, on-off indicators) under ordinary conditions or in storage, use, and handling, and under accident conditions.

e.

A facsimile of the labels to be attached to the device and a description of how and where the labels vill be attached.

The le5els must, as a minimum, meet the requirements of 99 20.203(f)(1) and (2) of 10 CFR Part 20.

The applicart should describe the space where the irradiator will be located, including an annotated sketch of the floor pla;. of the building in which the irradiat^- will be located.

This sketch should note the location of the irradiator and should identify the types of activities that will be 9

conducted in adjoining areas.

The room where the irradiator will be located should be equipped with an automatically operated fire detection and control system (sprinkler, chemical, or gas) adequate to ensure the integrity of the irradiator and source in a fire if the irradiator has not passed prototype tests for a standard industrial fire.

Item 14.

Waste Disposal The applicant should describe plans for the disposal of the sealed sources and the contaminated smears (if any) from leak tests.

Item 15.

Radiation Protection Program a.

Organization and Administrative Procedures The applicant should provide an organizational chart that specifies the radiation safety officer, the operators, and their respective supcrvisors.

The applicant should provide a copy of the written administrative procedures that govern the responsibility for the safe use of the irradiater.

These procedures should crearly identify the functions, duties, and responsibili-ties of each operator and of the radiation safety officer.

The applicant should describe the methods of ensuring that only authorized persons will use the irradiator or have access to the space whe*a it is located.

These methods can include ccntrol of keys to the door of the room containing the irradiator ccntrol console, controi of operating console keys, or other positive methods of excluding access.

10

b.

Operating and Emergency Procedures The applicant should provide a copy of the step-by-step proce-dures that will be followed by operators while using the irradiator.

Pro-cedures for ensuring safety and the security of the device during extended irradiations should be described in detail.

The applicant should provide a copy of concise, easily followed emergency procedures.

These procedures should describe the conditions that will be indicative of an emergency situation and should state the emergency action to be taken.

Instructions should specify the immediate action to be taken to minimize radiation exposure to persons in the vicinity of the irra-diator, and should include the names and telephone numbers of persons who are to be contacted to direct remedial actions.

Aci, ions that are prohibited or to be avoided in the event of abnormal conditions should also be described.

The applicant should provide a copy of the procedures that will be used to determine possible leakage of radioactive material from the source capsule.

Test methods must be sufficiently sensitive to detect 0.05 micro-curie of activity.

Leak testing of the source every 6 aionths will be required.

The test sample should be taken from appropriate accessible surfaces of the device in which the sources are permanently stored.

Procedures for the installation, relocation, removal, or mainte-nance of the irradiator should be described.

If these tasks are to be per-formed by persons who are specifically licensed by the NRC or Agreen;ent 11

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to use and measurement of radioactivity, and (4) biological effects of radia-tion. The description of actual use of radioactive materials should specify the isotopes handled, the maximum quantities of materials handled, where the experience was gaiced, the duration of experience, and the type of use.

Additional information on specific training for operators of the facility si.ould be submitted under Item 15 of the application as indicated above in this guide.

4.b Gener'.1 Pequirements:

Other Irradiat9rs Many items of the NR; Form 313(I) are self-explanatory (See instruc-tions with the form, Appendix A).

The following comments apply to the items of the form as indicated.

Item 5.

Location of Use of Byproduct Material See Section 4.a, Item 5.

Items 8A-D.

Quantity and Form of Byproduct Material See Section 4.a, Items 8A-D.

Note additionally that radioactive sources for water-shielded irradiators must be doubly encapsulated.

Item 9.

Storage of Sealed Sources List as indicated on form and refer to detailed descriptions under Item 13, as appropriate.

13

Items 10. and 11.

Radiation Detection Instruments The applicant should provide for each type of instrument available the manufacturer's name and model numbers, how many of each type are available, the type of radiation detected (beta or gamma), the sensitivity range (milli-2 roentgens per hour, or counts per minute), and the window thickness in mg/cm,

The type of use for each instrument should be specified.

The type of use would normally be monitoring, surveying, assaying, or measuring.

The applicant should have available am ng the detection instruments at least one ionization-chamber type of radiation measuring instrument of a design that does not " blank-out," i.e., tend to read.ero in a very intense radiation field, and that is capable of measuring accurately radiation levels from 2 mR/hr to at least 1 R/hr.

If source leak tests are to be evaluated by the applicant, a radiation counting instrument should be used (such as a M tube with a scaler) that is capable of measuring accurately 0.05 microcurie of activity on smear-test samples or, with the sample preparation tecnnique

-5

employed, 5 x 10 Ci/ml of activity in a water sample.

Instrument calibration provir, ions should be described.

State the fre-quency, and describe the methods and procedures for calibration of survey and monitoring instruments as well as any other instruments and systems used in the radiation protection program such as measuring instruments used to assay sealed-source leak-test samples, contamination scmples (e.g., air samples, surface smear-test samples), and bioassay samples.

An adequate calibration of survey instruments usually cannot be per',ormed with built-in check sources.

Electronic calibrations that do not 14

involve a source of radiation are also not adequate to determine the proper functioning and response of all components of an instrument.

Daily or other frequent checks of survey instruments should be supple-mented every 6 months with a two point calibration on each scale of each instrument with the two points separated by at least 50% of the scale.

Survey instruments should also be calibratcd following repair.

A survey C..scrument may be considerau properly calibrated when the instrument readings are within 110% of the calculated or known values of each point checked.

Readings within l

120% are considered acceptable if a calibration chart or graph is prepared and attached to the instrument.

If the applicant proposes to calibrate its survey instruments, a detailed description of planned calibration procedures should be submitted.

The description of calibration procedures should include the following as a minimum:

a.

The manufacturer and model number of each radiation source to be

used, b.

The nuclide and quantity of radioactive material contained in each source, c.

The accuracy of each source (the traceability of the source to a primary standard should be provided),

15

d.

The step-by-step procedures, including associated radiation safety procedures, and The,ame and pertinent experience of each person who will perform e.

thc calibrations.

If the applicant intends to contract out ti.: calibration of survey instruments, the name, address, and license number of the calibration firm should be specified together with the frequency of calibration.

The applicant should contact the firm that will perfonn the calibrations to determine if information concerning calibrations procediires has been filed with the Commission.

If information concerning calibration procedures has not been filed, it should be obtained and submitted.

l Quantitative measuring instruments used to monitor the adequacy of containment and contamination control such as those used for measuring leak-test, air effluent, bioassay, work area, and equipment contamination samples should usually be calibrated prior to each use.

The procedures and frequency for calibration of such instruments should be submitted and should include the following:

The name, the manufacturer, and model number of each of the a.

standards to be used, 16

b.

The nuclide and quantity of radioactive material contained in each of the standard sources, c.

A statement of the accuracy of each of the standard sources.

The source accuracy should be, as a minimum, +5% of the stated value and traceable to a primary standard such as that maintained by the National Bureau of Standards.

d.

Step-by-step calibration procedures and, if app.opriate, associated radiation safety procedures, and The name and pertinent experience of each person who will perform e.

the instrument calibrations.

Item 12.

Personnel Dose Monitoring Devices See Section 4.a, Item 12.

Item 13.

Facilities and Equipment The applicant should provide a complete description of the irradiator construction and function, including annotated plans and elevation drawings showing dimensions and materials of construction.

The application should:

Identify the location of the building (s) and other structures of a.

the irradiator facility on a map or drawing (to scale) showing their loca-tion in the local commun'ty or local area.

The boundary that encompasses 17

the area owned or leased by the applicant should be shown.

The restricted area (s), as defined in 10 CFR Part 20, 6 20.3, should be shown or described.

b.

Show the layout of the building (s) and structures using engineer-ing type drawings.

Plans and elevations should be provided in sufficient detail to identify all features, including operational and control areas, to be discussed.

Spatial and equipment identification data should be included directly on layouts or (with suitable designations) in tabular listings.

The applicant should discuss the components and systems in the area under

onsidemiion, including dimensions and materials of construction.

c.

Describe pertinent physical features of the irradiator, its sys-tems, and the surrounding areas, including rooms, walls, roofs, and floor radiation shielding characteristics.

The locations of the source (s) in the stored and in the exposed positions should be indicated.

These descriptions should include details of fire-resistant characteristics of the source room and building and of the automatically-operated fire detection and control system to be used.

The shielding description should include notatiun of all v Ids such as those used for ventilation ducts, control cables, elec-trical conduits, and viewing windows.

d.

Describe mechanical ana electrical systems used in the operation of the irradiator, including the source holders and the source handling mechanisms.

O 18

e.

Describe all of the design features that protect the source from damage during operation of the facility such as from conveyor malfunctions, falling objects or packages, and faulty source movement mechanisms.

f.

Describe the shutter or source positioning mechanisms that are used for exposing the source.

g.

Describe the systems, procedures, and physical barriers that will serve to prevent exposure of personnel to the irradiation source (s).

Pro-vide a complete description of physical barriers, interlocks, source posi-tion indicators, warning lights, alarms, and warning signs, including the manner in which compliance witie pertinent requirements of 10 CFR Part 20, SS 20.203(c)(6) and (7) will be achieved.

All these safety provisions and systems must ensure compliance with SE 20.203(c) and 20.101 of 10 CFR Part 20.

h.

If the facility includes a water storage pool, describe the pool constraction and the water circulation, treatment, monitoring, and makeup systems.

Storage pools should be built either in impervious soils or with a secondary water-containment envelore.

The leak rate of such a containment envelope should be low enough that, in the event of a gross pooi leak, makeup water could be supplied to the pool at a rate sufficient to keep the sources adequately covered.

The design of the pool should include considerations for ultimate decommissioning of the facility, including considerations for 19

disposing of potentially contaminated soil or other fill materials exterior to the pool walls.

i.

If the facility includes in-air irradiation, describe the ventila-tion system (equipment, operating specifications, ventilation rate, location of intake and exhaust) and include an analysis of ozone production and the measures taken to protect personnel and safety-related equipment against exposure to ozone.

j.

Provide an analysis and calculations of radiation levels in all areas surrounding source room with the source in both the shielded and the exposed positions.

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

O k.

Describe the system that provides a readily visible indication of the source position (stored, intermediate, exposed).

1.

For a large irradiation facility that is not self-contained, that falls within the purview of 6 20.203(c)(6) or (7), and that is in a seismic area, provide an analysis that demonstrates the shielding (pool or cell and complementary structures) is constructed so that it will be able to with-stand lateral or vertical displacements that might occur from ground move-ments. The applicant should submit an ana~iysis of the previous earthquake activity in the tectonic province of the irradiator and in adjacent tectonic provinces if the site is near a tactonic border.

An explanation should be 20

submitted that substantiates that the facility is designed and constructed to withstand the movement.

For such irradiators in seismic areas, specify how the irradiator will be equipped with a seismic switch that will ignal the radiation source to return to the safe storage position should the switch be actuated.

Specify whether the switch will be an omnidirectional horizontai er a vertical uniaxial type and that it will be set to signal at 0.05g (gravitational acceleration) or less.

For tua purposes of applications for irradiator licenses, a " seismic ares may be considered to be any area where horizontal acceleration in rock of 0.03 (30% of the acceleration due to gravity) or greater may occur with a 90% probability of not being exceeded in 50 years (i.e., where there is only a 10% probability that a greater horizontal acceleration would occur ir. 50 years), as determined by the U.S. Geological Survey and as set out in U.S. Department of Lhe Interior, Geological Survey Open File Report 76-416, 1976 "A Probabilis' ic Estimate of Maximu.n Acceleration in Rock in the Con-tiguous United States."

Item 14.

Waste Disposal The applicant should name the organization that will dispose of the sealed sources and the contaminated smears (if any) from leak tests.

21

Item 15.

Radiation Protection Program a.

Ensuring that Occupational Radiation Exrosures Are As Low As Is Reasonably Achievable (ALARA)

Describe the management policy and organizational structure related to ensuring that occupational radiation exposures are ALARA.

Describe the applicable responsibilities and tl.e related activities to be conducted by the individuals having responsibility for radiation protection.

Indicate whether, aad if so how, the guidance given in Regulatory Guide 8.10,

" Operating Philcsophy for Maintaining Occupational Radiation Exposures As Low As Is Reasonably Achievable," will be followed; if it will not be fol-lowed, describe the specific alternativa approaches to be used.

The application should contain a commitment by the applicant that all safety-related operations will be conducted in conformaace with detailed written procedures.

A detailed description of the procedures should be provided.

b.

Organization The applicant should provide a programmatic organizational chsrt that-specif'es all of those persons who will act in a manage:nent or supervisory capacity or who will have radiation safety responsibilities.

The applicant should provide a copy of the written administrative procedures that govern the responsibility for the safe use of the irradiator.

The procedures should clearly specify the functions, duties and responsibilities, and authority 22

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F of each supervisor and of the radiation safety officer.

Reference Items 1-1 and 17, as appropriate.

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c.

Adminstrative Procedures The administrative procedures should contain the internal inspection

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The applicant s

should specify the minimum frequency of on-the-job audits and should pro-k vide the names and positions of the individual or individuals who will per-5 J.

form the audits.

Reference items 12 2 ~i 17, as appropriate.

The applicant should describe the methods of ensuring that only author-ized persons will use the irradiator or have access to the space where it is locat?d.

These methods can include control of keys to the door of the room containing the irradiator control console, control of operating con-4 sole keys, or other positive methods of excluding access.

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i A description should be provided of the process for review, change, and approval of all administrative, operating, maintenenace, testing, and n

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other procedures.

The identity should be provided of the persons (by posi-

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tion) who have the responsibility for writing procedures snd of the persons i:?

1m who must approve them before they are implemented.

Reference Items 16 and a

17, as appropriate.

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The following categories should be considered but need not necessarily form the basis for classifying administrative procedures:

(1) Standing orders to licensed users and to shift supervisors and shift crews, including authorities and responsibilities.

(2) Special orders of a transient or self-cancelling character.

(3) Irradiator and equipment control procedures.

(4) Control of maintenance and modifications.

(5) Master surveillance testing schedule (s).

(6) Procedures for logbook use and control.

(7) Temporary procedures (authority to issue and approve).

(8) Procedural system (writing, review, approval, implementation).

(9) Internal inspection (audit) system.

O d.

Operating and Emergency Procedures The applicant should provide a copy of the step-by-step procedures that sill be kept at the irradiator control console and that will be fol-lowed by operators while using the irradiator.

These " cook-book" procedures should include instructions concerning interlocks to be checked, surveys to be taken, frequency of reading of pocket dosimeters, and instruc-tions for dealing with equipment malfunctions (such as the loss of electrical power, the loss of air pressure to control equipment, or the failure of the radiation monitoring, interlock, or safety systems).

24

The applicant should provide a copy of concise, easily followed emer-gency procedures.

These procedures should describe the conditions that will be indicative of a malfunction or of an emergency situation and should state the emergency action to be taken.

Instructions should specify the immediate action to be taken to place the irradiator in a safe condition and to minimize radiation exposure to persons in the vicinity of the irra-diator and should include the names and telephone numbers of persons who are to be contacted to direct remedial actions.

Immediate action proce-dures that the applicant will require " operators" to memorize should be identified.

The applicant should describe the procedures for operations that are performed primarily by licensed users ("irradiator operators") ir! :le con-trol area (s) of the facility and the procedures for those operations that are performed by shift crews in operating the irradiator facility.

The applicant should provide a detailed description of the source-loading and irradiator installation procedures.

This description should include all tools and equipment to be used.

The step-by-step procedures for all steps of the operation should be provided.

The applicant should provide a copy of the procedures that are to be used to determine possible leakage of radioactive material from the source capsule.

Test methods must be sufficently sensitive to detect 0.05 micro-curie of activity.

A commitment to leak test the source at least every 25

6 months is necessary.

A description should be provided of the method and frequency for and procedures used in inspecting and testing the source capsules to ensure mechanical integrity, including inspecting and testing for physical deformation such as bending or bowing and for evidence of cor-rosion of source encapsulation.

The applicant should provide a copy of the procedures that will be fol-lowed during inspection and preventive maintenance of the irradiator.

The frequency of this inspection should be specified.

Examples of components that should be included are interlocks, radiation monitoring instruments, water level indicators, and water treatment systems.

Components directly related to radiation safety (such as interlocks, radiation level monitors, or warning lights) should be checked prior to operation each day that the irradiator is in use in accordance with 920.203(c)(6)(vii).

Other compo-nents that are related to radiation safety (such as water level indicator and water treatreent sytems) should be checked at least weekly.

Still other components (such as source hoist mechanisms and product positioning sys-tems) should be checked at least semiannually.

A schedule of more complete checks of the entry control and warning systems should be submitted in accordance with $20.203(c)(6)(vii).

The applicant should provide the criteria for selection of portable and laboratory technical equipment and instrumentation for performing radiation and contamination surveys and for other radioactivity monitoring and sampling, for area radiation monitoring, and for personnel monitoring.

26

.v The applicant should describe the type of detectors and monitors and the quantity, sensitivity, range, and frequency and methods of calibtation for a.1 of the technical equipment and instrumentation mentioned.

The applicant should describe the instrument storage, calibration, and maintenance facilities.

Describe and identify the location of the radia-tion protection facilities (including locker rooms, shower rooms, and access control stations), laboratory facilities for radioactivity analyses, protec-tive clothing, decontamination control equipment, or other control areas or equipment that will be available.

Reference Items 10 and 11, as appropriate.

The applicant should describe the methods, frequencies, and procedures for conducting radiation surveys.

Describe the procedures and methods of operation that have been developed for ensuring that occupational radiation exposures will be ALARA. Also describe the procedures that are to be used in (a) the receipt, handling, and loading of radiation sources into the irradiator; (b) the storage, exchange, packaging, anti shipment of sources; (c) ti',e inservice inspections of irradiatm t.quipment and sourcas; and (d) the normal operations and routine maintenance of equipment and facilities.

The applicant should describe the physical and administrative measures for controlling access, egress, and stay time for radiation areas and con-tamination zones, and should describe the methods and procedures for person-nel monitoring, including methods of recording, reporting, and analyzing

- G 27 l

e-a

z results.

Reference Item 12, as appropriate.

Include the criteria for selecting personnel who will be required to wear personnel-monitoring devices and the criteria for selection of the routine monitoring period, i.e., badge or TLD exchange frequency.

Each operating and emergency action procedure should be identified by title and included in a described classification system.

The following categories should be considered but need not necessarily form the basis for classifying these procedures:

(1) Irradiator and system operating procedisres.

(2) General facility procedures.

(3) Off-normal operating procedures.

(4) Emergency action (to correct malfunction) procedures.

(5) Alarm response procedures.

(6) Temporary procedures.

e.

Other Procedures The applicant should provide an explanation of how other operating ar.o maintenance procedures are classified, what group or groups within the opera-ting organization have the responsibility for following each class of proce-dures, and the general objectives and character of each class or subclass of procedures.

Reference Items 16 and 17, as appropriate.

O 28

The applicant should describe the proce'fures for o m rgency prepared-ness in dealing with various types of accidents that affect or threaten the health and safety of the public, employees of the licensee, or other persons assigned temporarily or permanently to work at the fccility.

The description of procedures should include the identity of and arrangements with facilities or persons having a capability to furnish necessary advice or assistance in dealing with facility emergencies (such as, medical facilities or medical treatment for individuals affected by radiological emergencies).

The categories of procedures listed below should also be considered.

If their general objectives and character are described elsewhere in the applict.oion, they may be described by specific reference to the section where they are covered.

(1) Facility radiation protection procedures.

(2) Emergency preparedness procedures.

(3)

Instrument calibration and test procedures.

(4) Water quality control procedures.

(5) Radioactive waste management procedures.

(6) Maintenance and modi 1 % tion procedures.

f.

Instructions to Workers The applicant should provide a complete description of the training program to be conducted pursuant to 10 CFR 19, S 19.12, " Instructions to Workers." The description should specify the form of training (lectures 29

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or on-the-job) an outline of the subject matter that is covered, the time devoted to each subject, the equipment used, and the methods and criteria used to determine tFe competency of each individual to work about or operate the irradiator.

Provisions for initial training and for retraining should be specified.

The description of the on-the-job training should specify the minimum time.iriod that an individual will work under the direct supervision of a qualified instructor prior to being certified as an operator.

Classifica-tions of personnel who will receive different levels of instruction should be identified.

The applicant should identify the personnel in the organiza-tion who are responsible for the training programs, including the mainte-nance of records on the status of trained personnel, the training of new employees, and the refresher or upgrade training of people.

Reference Items 16 and 17, as appropriate.

Items 16. and 17.

Technical Qualifications of Personnel a.

Personnel Positions Describe the organization, functions, and responsibilities of the posi-tions that are established to operate and maintain the irradiator facility; provide an organization chart showing the title of each position, the num-ber of operating shift crews, and the positions for which licensed users are required.

The functions, responsibilities, and authorities of posi-tions corresponding to the following should be described:

overall irra-diator facility management, operations supervision, shi#t cie,t supervision, O

30

"irradiator operators," technical supervision, radiation protection super-vision, instrumentation and controls engineering supervision, instrumenta-tion and controls maintenance supervision, and internal inspection and audit supervision.

Describe the line of succession of authority and responsibility for overall facility operation both for normal operations and for emergencies.

Specify the delegat. ion of authority to operating shift crew supervisors, including the authority to issue standing or special orders or procedures.

b.

Qualifications Describe the requiremer.ts established for education, training, and experience for each management, operating, technical, and maintenance posi-tion category in the operating organization.

The application should contain a commitment that the qualification requirements will be met by all incumbents of the identified positions.

The qualifications of the initial incumbents of organizational positions should be presented in rdsumd format for key facility managerial and super-visory personnel through the supervisory level of shift crews (i.e., each person who will directly supervise the operations or who will have radio-logical safety responsibilities).

The rdsumds should describe the training and experience in the use of radioisotopes and radiation.

The description of training should include both on-the-job training and formal course work, location where the training was received, and the duration of the training.

Training information should also cover knowledge of (1) principles and prac-tices of radiation protectir1, (2) radiometric measurements and techniques 31

and instruments for standardization and monitoring, (3) mathematics and calculations basic to use and measurement of radiation and radioattivity, (4) biological effects of radiation, (5) design and construction of the irradiator and its associated safety systems, (6) the applicant's radiation safety program, (7) the applicant's operating and emargency procedures, and (8) pertinent requirements of the NRC and other cognizant regulatory agencies. The description of experience and actual use of radioactive materials should specify the isotopes handled, the maximum quantities of materials handled, where the experience was gained, the duration of experience, and the type of use(s).

c.

Training Program The application should include a complete description of the training program for irradiator operators. The description should include the proposed subject matter of each course, including a syllabus or equivalent description of the course, the duration of the course (approximate number of hours or days in full-time attendance), the type of training (lectures, on-the-job),

and the identity of the organization or person (s) teaching the course or supervising the instru: tion.

The description of the on-the-job training should specify the minimum time period that an individual will work under the direct supervision of a qualified instructor or operator prior to being certified as an irradiator operator.

The application should also describe the methods and criteria used both to determine the competency of each indi-vidual to operate the irradiator and to evaluate the effectiveness of the training program.

32

The application t person-nel and to provide refresher or requalification training for persons who are " certified" as irradiator operators.

A description of the type and fre-Refer-quency of refresher or requalification training should be provided.

ence Item 15, as appropriate.

5.

AMEN 0MENTS TO LICENSES Licensees are required to conduct their programs in accordance with statements, representations, and procedures contained in the license applica-tion and supportive documents.

The license must therefore be amended if the licensee plans to make any changes in facilities, equipment (including monitoring and survey instruments), procedures, personnel, or byproduct mate-rial to be used.

Applications for license amendments may be filed either on the applica-tion form or in letter form.

The application should identify the license by number, should clearly describe the exact nature of the changes, additions, or deleticos, and should include all additional supporting information.

References to previously submitted information and documents should be clear and specific and should identify the pertinent information by date, page, and paragraph.

If a section of a manual or instruction is to be amended, dated substitute pages should be provided, and the changed sections should be noted in the margin.

33

6.

RENEWAL OF A LICENSE Byproduct material licenses are normally issued for a period not in excess of 5 years.

An application for renewal of a license should be filed at least 30 days prior to the expiration date.

This filing will ensure that the li;ense does not expire until final action or, the application has been taken by the NRC staff as provided for in 9 30.37(b) of 10 CFR 'Part 30.

Renewal applications should be filed on Form NRC-313(I), appropriately stpplemented, and should contain complete and up-to-date information about the applicant's current program.

In order to facilitate the review process, the application for renewal should be submitted without reference to previously submitted documents and information.

If such references cannot be avoided, they should be clear and specific and should identify the pertinent information by date, page, and paragraph.

34

Ferm NRC-313 (1)

M/78)

U.S. NUCLEAR REGULATORY COMMIS310N 10 CFR 30 INSTRUCTIONS FOR PREPARATION OF APPLICATION FOR BYPRODUCT MATERIAL LICENSE FORM NRC-313 (I)

GENER AL IN FORMATION An apphcant for a " Byproduct Matenal(Radioisotopes) License,"

3. Broad License (research and develo? ment) "Licensms Guide should complete Form NRC-313 (D in detail and submit in duphcate for Type-A Licenses of Broad Scope for Researdiand Develop-to the U.S. Nuclear Regulatory Commission. The apphcant should ment;"

endeavor to cover his entire radiotstope program with one application, if possible. However, separate appbcations should be submitted for

4. Licensms Gundes for the performance of wer logging operations.

gamma irradiators. Appbcatens for medical uses should be submarted

$. Licensmg guide for the use of sealed sources in portable and semi-on Form NRL 313 (M) and appbcations for use of sealed sources in radiography shoub be submitted on Form NRC-313R. Supplemental portable gaugmg devices.

sheets may be appened when necessary to provide complete infor-The Commisuon charges fees for filing of applications for Lcenses as Irem 18 must be completed on allapphcarsons. Submission of an incomplere apphcstaan will often result in a delar be issuenceof specified in Section 170.12. Title 10 Code of Federal Regulations.

mation.

Part 170. The apphcant should refer to Sectson 170.31. Scheduit of the hcense because of the correspondence necessary to obrave urfor.

fees for materials hcenser, to deternme what fee should accompany maison reginested on the apphcaron.

the appbcation. No action can be taken on appbcations until fees are NOTE ~When the apphcaten mcludes one of the specut uses hsted paid. Checks or money orders should be made payable to the U.S.

Nuclear Regulatory Commusaan.

below,.he appbcant should request the approprute pamphlet which provides additional mstructens:

Two cepics of the completed Form NRC-313 (D and two copies of each attachment thereto, should be sent to the Divuion nf Fuel Cycle 1 Industrial Radmgraphy "Licensmg Requirements for Industnal and Materal Safety, Omce of Nuclear Material Safety and Safeguards.

Radography" (use appbcaton Form NRC-313R for Radi-U.S. Nuclear Regulatory Commission. Washmgton, D.C. 20555. One ography);

copy should be retamed for the appbcant's file. Appbcations may 2 Laboratory and Industrul Uses of Smau Quantities 'tunde for also be filed in person at the Commisuon's omce at 1717 H Street.

Preparataon of Apphcations for Laboratory and Industnal N.W., Washington. D.C. or at 7915 Eastern Avenue, Silver Spnng.

Uses of Smau Quantities of Byproduct Materni."

Maryland.

EXPLANATION OF FORM NRC-313 (I)

Form NRC-313 (D is designed for use in supplyms information S.

The actual sites of use should be bsted as indicated. Per-manent fac1hties such as field offices for portable gauges 0-on programs of varymg o)mplexity. The appucant should provide devices should be identified m item 5 by Street. Addrest complete information on has proposed program for the possession and use of hcerised material. For those stems that do not apply,andscate City and State. Temporary field locations of use should be specified as " temporary job sates of the appb. ant" and as N.A. (not applicable).

hst the States throughout which the temporary job utes will be located. Attach additional properly keyed sheet if mor, item No.

space is needed.

1.

Self-explanatory 2.

The "appbcant" is the organization or persons legally res-ponsible for possession and use of the hcensed materals 7.

The "Radiaton Protecten Officer"is the samed andmdual specsfied in the appbcation.

who is espected to coordmate the safe use or the beensed mateful specified in the appbution and who will ensure 3.

Self-explanatory complunce with the apphoble parts of Title 10. Coo. oi Federal Regulations.

4.

Self-e xplanatory 35

APPENDIX A 8.

List by name each radioisotcpe to be possessed used Attach additional property keyed sheets tf more space is under the bcense. Example:

needed.

8.E State the use of each ucensed material hsted m 8.A. B. C, A

B and D.

(1) lodine-131 (1) lodide (2) Iodme-131 (2) Iodmated Humaa 9.

Description of containers and/or devices in which sealed Serum Albumin sources hsted in item 8 wt!! be stored or used. Example:

(3) Krypton-45 (3) Gas (4# Cesium-137 (4) Scaled Source A

B (1) =4 - Source houstes Iso. Corp C

D (1) Not Applicable (1) 10 milhcunes C

(2)

N. A.

(2) I milheurie Model Z-278 (3) N. A.

(3) 1 millicurte (4) Iso. Corp (4) 2 source of 150 10-18 Self-explanatory. (For those items that do not apply, Model Z-78 milhcunes each indicate as N.A. (not applicable).

9 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 fouowing statement is furrushed to indivtduals who supply information to the Nuclear Regulatory Commission on Forms NRC-313M, NRC-313a, NRC-3131, or NRC-313R. Thas tr. formation is tnaintamed in a system of records designated as NRC-3 and described at 40 Federal Register 45334 (October 1,1975).

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

2. PRINCIPAL 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 appucation meets the requirements of the At.mic Energy Act of 1954, as amended, and the Commission's regulations,for the tssuance of a byproduct materiallicense or amendment thereof.

3. ROUTINE USES The information may be used. (a) to provide records to State health departments for theirinformation and use;and (b)to provide information to Federal, State, and local health officials and other persons in the event of incident of esposure, for their information, mvestigatson, 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 judictal proceeding. In addition, this information may be transferred to an appropriate Federal, State, or local agency to the eatent relevant and necessary for a NRC dsciaton or to an appropriate Federal agency to the extent relevant and neesinary for that agency's decimon about you. A copy of the license issued willroutinely be placed in the NRC's Public Document Room,1717 H Street, N. W., Washington, D.C.

4. WHETHER DISCLOSURE !$ 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 appucation for byproduct matenal license, or amendment thereof, wt3 not ; e processed.

5. SYSTEM MANAGER (S) AND ADDRESS Director, Division of FuelCycle and Materialsafety,0fnce of Nucisar Material Safety and Safeguards, U.S. Nuclear Regulatory Commtsinon, Washington, D.C. 20535.

36

APPENDIX A FomM NRC 313 l U.S. NU;LE AR REGULATORY COMMISSION

1. APPLICATION FOR:

(6 78)

IChace and/or compete as approprsate) 10 CF R 30 APPLICATION FOR BYPRODUCT MATERIAL LICENSE

a. NEW LICENSE INDUSTRIAL D. AMENDMENT TO See attached onstructuons for detents.

LeCENSE NUMBER Completed applications are filed on dualcare wrth the Do>*sion of Fuel Cycle and Material Safety.

OH ce of Nuclear Material Safety, and Safeguards. v.s. wc> ear Regulatory Commussion.

i c',E N,w,L O, _

aasnington. OC 20555 or applications may be fried on pe-son at the Commiss:on's office at L,g g n,,,u y 1717 H Street. NW. Washrngton. D C. or 1915 Eastem kenue. Saver Sonng. Marvtand.

2. APPLICANT'S NAME (Inst,tution, ferm, person, arc.)

3. NAME OF PERSON TO BE CONTACTED REGARDING THIS APPLICATION TELEPHONE NUMBER: ARE A CODE - NUMBER E XTENSiON TELEPHONE NUMBE R-ARE A CODE - NUMBER EXTENSION

4. APPLICANT'S MAILING ADDRESS (include lip Code /

5. STREET ADDRESS WHERE LICENSED MATERIAL WILL BE USED (include Zip Codel ilF 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 ISee items 16 and ti for reau, red traons g and esoeroence of each undivdual named beMwl FULL N AVE TITLE a.

c.

1 c.

1. R ADIATION PROTECTlON OFFICER

' A rtach a resume of person's trarning and emoer ence as curtoned on items o

I16 and 17 and describe has resoons brist es under item 15 i

I

8. LICENSED MATERIAL L

ELEMENT CHEMICAL NAME OF MANUFACTURER MAxlMUM NUMBER OF i

AND ANDiOR AND MILLICURIES AND/OH SEALED N

MASS NUMBE R PHYSICAL FORM MOOEL NUMBER SOURCES AND MAXIMUM ACTI.

III Seared Source)

VITY PER SOURCE WHICH WILL E

SE POSSESSED AT ANY ONE TIME j

N O-A B

l C

D (1) m (3) 141 DESCRIBE USE OF LICENSED MATERI AL E

I11 121 131 (4)

FORM NRC 313 46 78) 37

AFPENDIX A

9. STORAGE OF SEALED SOURCES I

CONTAINER AND/CR DEVICE IN MCM EACM SEALED N AME OF MAhuFACTURER MCO2L NUMSER

=

SOURCE WILL SE STCRED CR USED.

no.

A.

8-C.

til l

m G

44)

I

10. RADIATION DETECTION INSTRUVENTS TYPE M A.PsUF ACTURE R1 MODEL seUw8E R RAOiATION SEhSITIVITY

{

OF NAME NUMBE R AVAILABLE DETECTED RANCE

=

INSTRUM ENT

/*o^*. bers, im h e

• owe

,8,,

awa. ee rmal or coverpauvrel A

B C

D E

F el I

I I

i i

l I

I l

e

-l l

l l

l I

i

11. CAllBR ATION OF INSTRUMENTS LISTED IN ITEM 10 C a CALIBRATED BY SERVICE COMPANY CE Call 8 RATED BY APPLICANT N ave. A::RESS. A.so FRECufNCY A rise *

• sco*'*<* m a*sc'en ~~~oe. rme, av nexam used for cbbrart*g 9tstWtA

12. PERSONNEL MONITORING DEVICES TYPE SUPP LIE R i

l EXCH ANGE FREQUENCY (Chect M 'or comcare as accroonare)

(Se v e Co":*"re C

A B

C til Fttu BADGE C VCSTwLv C m TwEaVCiUv NESCENCE C CLAS*ERLY CCS.METEle (TLC)

C Q OT-ER (Soee4s:

C CTwEa co,e,;;

4 i

13. FACILITIES AND ECUIPYF.NT (Checm we e a:=rceriate aM a a

• vnetated sket&01 r! cec:tets).

Ot LABCR ATORY F ACILITIES PLANT F ACILtTIES. FUVE MOCOS tIeewe F 7 erea. <f ea l. ETC.

r C O. STCR AGE F1CIL itES. CCNTAiNE RS. S*ECI AL SwiE L0tNG (f sea aw er re-soro<>. ETC C c. REMOTE N ANOLING TOOLS CR EQUIPMENT. ETC.

C e RESA R ATCRY *RCTECTivE Equi' VENT. ETC.

14. W ASTE DISPOSAL l

a. NAME CF CCVVE RCI AL W ASTE CISPCSAL SERvlCE EMPLCYEC

t. IF CCWWERCI AL W ASTE OtS*CSA SE8tviCE 15 NOT EuPLOYEC.SUBU4T A CETAILED CESCA.PTIC% CF MET =COS Wa:CM WILL l SE ("SEO FCR OtSPCS4NG CF R AOrC ACT!vE WASTES AND ES'ruATES CF THE *YPE AND AuCw%T CF AC*:vITY :svCL% ED-(*

THE APPLICATICN 65 FCR SEALEO SCURCES AND CEViCES ANO TMEY wiLL SE R ETURNEC TC TaE M ANvF AC*UR ER.SC S*ATEj i

I l

Pcau Nm0-313 4 6781 38

APPENDIX A INFORMATION REQUIRED FOR ITEMS 15,16 AND 17 Describe in detail the information reau ad for items 15,16 and 17. Begin each item on a separate page and key to the appliestine as follows:

15.

RADIATION PROTECTION PROGRAM. Describe the radiation protection program as appropriate for the material to be used including the duties and respondbilities of the Radiation Protection Officer, control measures, bioassay procedures fit needad), day today 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 perfo6med 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 the following areas where applicable. Include tM name of person or institution providing the training, duration of training, when training was received, etc.

s. Principles and practices of radiation protection.

b. Radioactivity measurement standardization and monitoring techniques and instruments.

c. Mathematics and calculations basic to the use and measuremot of radioactivity.

d. Biological effects of radiation.

17.

EXPERIENCE. Attach a resume for each individual named in iteens 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 t i each used.

18. CERTIFICATE (Thd item must be completed by apolomet)

The applicent and any official esecutong this certificate on behalf of the applicant named in item 2, certa!y that tt'os applicetoon is prepared on conformity wrth Turw 10, Code of Federal Regulatoons, Part 30, ano Lsat ak informstron contarned herran, including any suppkments artached hereto, is true and correct to the best of our knowkdge and belief, WARNING.-18 USE.. Sect on 1001; Act of June 25,1948: 62 Stat. 749; makas it a criminal offense to make a willf ully false statement or tapresentanon to any department or esency of the Uruted States as to any matter within ns jurisdiction,

s. LK.ENSE FEE REQUIRED

b. CERTIFYING OblCIAL IStraturel (See Sectron 170.31,10 CFR 170)

c. NAME (Type or pront)

11) LICENSE FEE CATEGORY:

12) LICENSE FEE ENCLOSED: $

FORM NRC413 i {648) 39

DRAFT VALUE/ IMPACT STATEMENT PREPARED FOR GUIDES FOR PREPARATION OF LICENSE APPLICATIONS The Division of Material-and Fuel Cycle Facility Licensing has forwarded a draft of the subject guide to the Office of Standards Development, Occu-pational Health Standards Branch (0HSB), for publication as a regulatory guide.

One important consideration is whether a guide would be beneficial to licensees and the NRC staff or if the licensing program can function equally well without the issuance of guidanca to licensees.

Another important consideration is the importance of this task compared to the importance of other OHSB tasks.

1.

Rationale for Schedule l

The schedule for completion of this task was determined taking into con-sideration past scheduling experience within the Occupational Health Standards Branch for other 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 license reviewers in Nuclear Material Safety and Safeguards (NMSS).

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

40

2.

Analysis of Need In CY 1975, the radioisotopes license reviewers wrote letters of deficiency to license applicants containing approximately 200 questions related to bioassays, 370 questions related to calibration of survey meters, 400 questions related to area surveys, and 270 related to training of individ-uals (other than physicians).

In CY 1975, there were 730 new or renewal applications.

The number of new or renewal applications contirues to increase.

NMSS personnel believe that the licensing guides will result in applications that are more complete, thus eliminating the need for some deficiency letters.

Guides of this type were recommended by the Office of the Inspector and Auditor following an audit of what was then the Radio-isotopes Licensing Branch (currently the License Management Branch).

3.

Alternative Solutions Alternative 1:

Publish a guide for the preparation of applications.

Alternative 2:

Publish a guide for the review of license applications describing what should be reviewed and the detail to which the various items of the application should be reviewed.

This type of guidance to the NRC staff could also be used by license applicants as a guide for the preparation of their applications.

41

4.

Recommended Solutions It is recommended that Alternative 1 be implemented as the better solution.

Potential for accomplishment of Alternative 2, given current staff and work-load of NMSS, is nil.

Alternative 1 is in concert with recorimendation of OIA and concurred in by EDO.

5.

Value/ Impact a.

Value Issuance of a regulatory guide for preparation of license applications will:

9 (1) be beneficial to license applicants by providing them with information that will simplify their preparation and submittal of license applications, (2) reduce the inquiries by applicants for information, and (3) reduce the numer of questions and letters of inquiry that must be sent to applicants, thereby saving time and effort for both license applicants and the NRC staff.

42

b.

Imaact There is no impact, other than the allocation of staff resources to the Jevelopment and production of the guide.

G 43

UNITED STATES NUCLE AR REGULATORY COM MISSION

{

]

W ASHINGTON, D. C. 20555 post AGE AND FEES P AID U.S. NUC LE A R R E G U L ATo R Y OFFICI AL BUSINESS couusssioN PEN ALTY FOR PRIV ATE USE, $300 t

J 120555003927 1 SG US NRC SECY PUBLIC DOCUMENT R30M ERANCH CHIEF HST LGBBY WASHINGTON DC 20555 O