Regulatory Guide 10.7

Guide for the Preparation of Applications for Licenses for Laboratory Use of Small Quantities of Byproduct Material

ML13350A227
Person / Time
Issue date:	02/28/1977
From:	NRC/OSD
To:
References
RG-10.007
Download: ML13350A227 (8)

..:U.S. NUCLEAR REGULATORY

COMMISSION

February SREGULATORY

GUIDE bOFFICE OF STANDARDS

DEVELOPMENT

REGULATORY

GUIDE 10.7 GUIDE FOR THE PREPARATION

OF APPLICATIONS

FOR LICENSES FOR LABORATORY

USE OF SMALL QUANTITIES

OF BYPRODUCT

MATERIAL.1977

1. INTRODUCTION

This..guide describes the type of information needed by the NRC staff t1 evaluate an application

.. fforea specific license for laboratories using millicurie quantities of hbproduct material (reactor-produced radionuclides).

This type of license is provided for..under Title 10. CodeofrFederalRegulations.

Part 30.-Rules of General Applicability to Licensing of Byproduct Material.-

S.Paragraph

20.1(c)-of

10 CFR Part 20. "Standards for Protection Against Radiation." states that"..persons engaaed in activities under licenses issued hy the Nuclear Regulatory Commission pursuant to the Atomic Energy Act of 1954. as amended, and the* .Energy. Reorganization Act of 1974 should. in addi-,ton tocomplying with the requirements set forth in this part, make everv-reasonuhle effort to maintain..diation exposures.

and rleases of radioactve

.materials:

n einlucLnts to unrestricted arcas.as-low as i is reasonabhl ahtcvahich" (A LAR_). Rcgu titatol3'SGude-8.10. " )Operating.

Philosophv IrI Maintaining" Occupational Radiation Exposures AssLow As Is Reasonabhh Achiev.,, provides thc*RC staff position on thi. iamirta l1_subject.

License applicants should g-, 0on;'. 60tion to the A LA RA philos inWRegulatory Guide 8.10. in I v Fln tif 01ans for work with licensed ra ct b~6uial'° 2. LICENSE FEES An application

'fee. is required for most types of licenses.

The applicant should refer -to §170.31."Schedule of Fees.for Materials Licenses." of 10* "CFR Part 170 to determine the amountof fee that must accompany the application.

Review of the ap-plication will not Iwgin ut, il the proper fee is received by the NRC.3. FILING AN APPLICATION

A licenew application for by product nmuterial should he suhmitted tfi Form NRC 313* ",'Applica- lion for Byproduct Miaterial l.iLcnsC (%L ibe appeu-di\ to this guide). All items on the zpplicuaiib6 form should he completed in sutTicicnt dotuil for thc NRC it) determine thatil fi t uppikil ntls:"t'qUipllellt.

facilities.

and rai~oio~to reanare ade-qultte it) protect,ý, iL~lth Andrii~tsn~imi datnger to life and proprt'. " hc.h spce' provided on Form NRC-313 is irhmited1. applctant should append additional to provide complete information.

F:ach se .paratc sheet or document subLtllted with the ap-plicalion should he identified by a heading indicating the appropriate item number (on Form NRC-313)and its purpose (e.g.. radiation safety instructions).

The applica.tion should lie completed in triplicaite.

The original and one copy should he mailed to: Radioisotope:, Licensing Branch. Division of Fuel Cvyec aod MIatertal Safety. Office of Nuclear Material Safety and Safeltuards.

U.S. Nuclear Regulatory Commission.

Washington.

D.C. 20555.One copy of the application.

with all attachments.

should he retained by the applicant, since the license will require. as :t condition.

that the institution follo-w the stLtcmenits and representations set forth in the ap-plication and any stIpplememt to it.* Form N R C-13 Was foirmerly designated Form ALEC-313.Exisling copies or F:osrm AIEC.-313 m:A, still hb use

d. USNRC REGULATORY

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4. CONTENTS OF AN APPLICATION

Most items of Form NRC-313 are sclf-explanator: (se instructions with the form). The following corn ments apply to the indicated numbered items of th.form.hIem 1(a). Specify the applicant corporation o other legal entity by name and address of principa office. Individuals should be designated as the appli cant only if the use of the byproduct material is no connected with the individual's employment with corporation or other entity. If the applicant is an in dividual, the individual should be specified by ful name and address, including state and zip code.hem 1(h). Specify the street address of the locatior of use if the address differs from the one given in itcrr I(a). If use is to be at more than one location.

thi specific address of each should be given. Describe thi extent of use and the facilities and equipment at eaca location.

A post office box address is not acceptable Item 4. Specify the names of the persons who wil directly supervise the use of radioactive material oi who will use radioactive material without supervi.sion.hem 5. Specify the name of the person who will ht designated as the radiation protection officer.*

This person should be responsible for implementing th(radiation safety program and therefore readily available to the users in case of difficulty and should be trained and experienced in radiation protectior and in the use and handling of radioactive materials.

Ite't 6(a i amdl 1b. Describe the byproduct rnatcria by isotope, chemical and/or physical form. and ac.tivity. in millicuries or microcurics.

A separate pos.session limit for each nuclide should be specified Possession limits requested should cover the total an.ticipated inventory, including stored materials and waste. and should be commensurate with the appli-cant's needs and facilities for safe handling.If the use of sealed or plated sources is con-templated, the isotope. manufacturer, and model number of each sealed or plated source should be If a source will be used in a gas chromatograph, gauge, or other device. the manufac-turer and model number of the device should be specified.

Item 7. The use to be made of the radioactive materials should be clearly described.

Sufficient detail should be given to allow a determination of the potential for exposure to radiation and radioactive materials of both those working with the materials and the public,*The terms "radiation protection officer" and-radiological safety officer" are synonymous.

items 8 and 9. A resume of the training and ex-perience of each person who will directly supervise y the use of material, who will use material without-supervision, or who will have responsibilities for c radiological safety should be submitted.

The resume should include the type (on-the-job or formal course work), location, and duration of the training.

Train-r ing should cover(1) principles and practices ofradia-I tion protection:

(2) radioactivity measurements," standardization, and monitoring techniques and in-t struments, (3) mathematics and calculations basic to the use and measurement of radioactivity, and (4)-biological effects of radiation.

The description of the I use of radioactive materials should include the specific isotopes handled, the maximum quantities of materials handled, where the experience was gained, n the duration of experience, and the type of use. The qualifications, training, and experience of each person should be commensurate with the material e and its use as proposed in the application.

The amount and type of training and experience with radiation and radioactive materials required to sup-port a determination of adequacy by the Commission i will vary markedly with certain factors.The use of microcurie quantities of a few non-volatile radioactive materials by a person with a e minimum of training and expcrience under precisely specified and carefully controlled conditions subject to the surveillance of a competent and adequately y trained radiation protection officer may be justified.

I Such minimum training and experience may consist of a few hours of training and experience in the use of one or more radioactive materials similar to the use proposed in the application under the supervision I and tutorship of a licensed user.Persons using miillicurie quantities of a number of radionuclides for general laboratory tracer work un-der unspecified condition should have more exten-sive training and experier.ce and, depending on the exact nature of the proposed program or use of radionuclides, may need to have completed formal-course work at the college or university level covering the areas listed under Item 8 of Form NRC-313.The use of larger quantities of material (ap-proaching a curie) under conditions where a potential exists for significant loss and ingestion, inhalation, or absorption of the radioactive material by those work.ing with the material is normally done under carefully controlled conditions using specialized equipment.

A person who is to use radioactive materials inde.pendently under these conditions should not only have a background of formal training in all areas of Item 8 of Form NRC-313 but should also have exten.sive experience working with radioactive material and a thorough working knowledge of the equipment required to handle the material safely.10.7-2 I

l Items 10 and II. Specify for each radiation detec-tion instrument the manufacturer's name and model number, the number of each type of instrument available, the type of radiation detected (alpha. beta.or gamma), the sensitivity range (milliroentgens per hour or counts per minute), the window thickness in mg/cm 2.and the type of use. The type of use would normally be monitoring, surveying, assaying, or measuring.

Describe the instrument calibration procedure.

State the frequency.

and describe the methods and procedures for the calibration of survey and monitor-ing instruments, as well as any other instruments and systems used in the radiation protection program.such as measuring instruments used to assay scaled-source leak-test samples (see Item 14). contamination samples (e.g., air samples, surface "wipe' samples).and bioassay samples (see Item 12).An adequate calibration of survey instruments usually cannot be performed with built-in check sources. Electronic calibrations that do not involve a source of radiation arc also not adequate to deter-mine the proper functioning and response of all com-ponents of an instrument.

Daily or other frequent checks of survey instru-ments should be supplemented every 6 months with a two.point calibration on each scale of each instru-ment with the two points separated by at least 50% of the scale. Survey instruments should also be calibrated following repair. A survey instrument may be considered properly calibrated when the instru-ment readings are within +/-10 percent of the calculated or known values for each point checked.Readings within- +/-20 percent are considered accep-table if a calibration chart or graph is prepared and attached to the instrument.

If the applicant proposes to calibrate his survey in-struments, a detailed description of planned calibra-tion procedures should be submitted.

The description of calibration procedures should include, 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 the source(s).

The traceability of the source to a primary standard should be provided.d. The step-by-step procedures, including as-sociated radiation safety procedures, and e. The name and pertinent experience of each person who will perform the calibrations.

If the applicant intends to contract out the calibra-tion of instruments, the name, address, and license numher of the Firm should be specified together %% ith the frequency of calibration.

The applicant should contact the firm that "rill perform the calibration.

to determine if information concerning calibration procedures has been filed with the Commission.

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

Quantitative measuring instruments used to monitor the adequacy of containment and con-tamination control such as those used for measuring leak test. air. effluent.

bioassay, suork area. and cquipnient contamination samples should usually he calibrated prior to each use. The procedures and fre-quency for calibration of such instruments should he submitted and should include: a. The name of the manufacturer and model number of each of the standards to he used.h. The nuclide and quanity of radioactiVc material contained in each of the standard sources.c. A statement orthe accuracy of each of the stan-dard sources. The source accuracy should be. as a minimum. +/- 5 percent of the stated value and traceable to a primary standard, such as that main-tained by the National Bureau of Standards.

d. Step-by-step calibration procedures and. if ap-propriate.

associated radiation safety procedures.

and e. The name and pertinent experience of each person who will perform the instrument calibrations.

hem 12. Personnel monitoring is required if a person is likely to receive in a calendar quarter 313 millirems to the body. 4.69 rems to the estremities.

or 1.88 reins to the skin (lowcr limits apply to those un-der 18 years of age: see ,20.101 and 20.202 of 10 CFR Part 20). Personnel monitoring is also required if a person enters a high radiation area (greater than 100 millirems per hour). If personnel monitoring equipment will be used. the name of the organization furnishing film badge or thermoluminescent dosimeter (TLD) service and the frequency for changing badges, dosimeters.

etc.. should be specified.

If pQcket chambers or pocket dosimeters will be used, the useful range of the device, in mil-liroentgens.

the frequency of reading, and the procedures for maintaining and calibrating the devices should be specified.

If personnel monitoring will not be used, the appli-cant should submit calculations or documentation from radiation surveys that demonstrate that it is un-likely that any individual will receive a dose equal to or greater than that indicated in the preceding paragraph.

The applicant should show that the need for bioas-says has been thoroughly considered and should es-tablish the adequacy of the proposed hioassay S 0 10.7-3 I program in relation to the proposed program of use of radioactive material.

Bioassays are normally re-quired when individuals work with millicurie

4 uun-tities of hydrogen-3.

iodine-125.

or iodinc-131 depending on the type of work, equipment, and piocedures followed.

Other materials man also be used in physical or chemical forms and under condi-tions that present an opportunity for uptake by the body through ingestion.

inhalation, or absorption.

A bioassay program to determine and control the up-take of radioactive material should be considered and discussed in relation to cach such material.procedure.

etc. Regulatory Guide 8.9. "Acceptable Concepts.

Models. Equations.

and Assumptions for a Bioassay Program."'

may be consulted.

The criteria to he used in determining the need for bioassays, the type and frequency of bioassays that will he performed, and the bioassay procedures should be specified and described in detail. If a com-mercial bioassav service is to be used, the name and address of the firm should be provided.ilioassaf.s may not he substituted for other cle-ments of a safety program such as air monitoring and dispersion control (hoods. glove boxes. etc.) and for%tell-thought-out and ssell-cxecuted handling procedures.

liem 13. The equipment and facilities for each site of use should be described in detail. The proposed equipment and facilities for each operation to be con-ducted should he adequate to protect health and minimize danger to life and property.

In describing available equipment and facilities, the following types ot information should be included, as appropriate:

a. Physical plant. laboratory, or working area facilities.

Fume hoods, glove boxes, waste recep.taces, special sinks, ventilation and containment systems, effluent filter systems, and all processing, work. and protective clothing change areas should be described.

b. Containers.

devices. protective clothing, aux-iliary shielding, general laboratory equipment, air sampling equipment, etc., actually employed in the daily use of material.

Special provisions for shielding and containment to minimize personnel exposure should be described.

c. Storage containers and facilities.

These should provide both shielding and security for materials.

d. The number, type. and length of remote handl-ing devices.* A copy of this guide may he obtained by a written request to the U.S. Nuclear Rcgulatory Commission.

Washington.

D).C. 20555., Attention:

Director.

Office of Standards Development.

lIent 14.a. Survey Program. Commission regulations re-quire that surveys be made to determine if radiation hazards exist in a facility in which radioactive materials are used or stored (see §20.201. 10 CFR Part 20). A survey should include the evaluation of external exposure to personnel, concentrations of air-borne radioactive material in the facility, and radioactive effluents from the facility.

Although a theoretical calculation is often used to demonstrate compliance with regulations regarding airborne or external radiation, it cannot always be used in lieu of a physical survey.Except for those cases where sources of radiation and radioactive material are well known and ac-curately and precisely controlled.

it will usually be necessary that a physical survey be made with ap-propriate detection and measurement instruments to determine the nature and extent of radiation and radioactis material or, as a minimum, confirm the results of a theoretical determination.

A radiation protection program should include the following surveys for radioactive contamination and radiation: (I) In laboratory areas (e.g., checking for con-tamnination on bench tops, handling and storage equipment, clothing, hands, etc.).(2) Whilc work is being done with radiation or radioactivc materials (e.g.. breathing zone air sur-veys: general air surveys; personnel exposure measurements, including eyes and extremities:

check-ing shutters and containment.

etc.).(3) In areas associated with disposal or release of radioactive materials (e.g., checking disposal con-tainers and disposal sites: liquid, gas, and solid ef-fluents: filters and filter-duct systems: etc.).The frequency of surveys will depend on the nature of the radioactive materials and their use. However.surveys should be performed prior to the use of radioactive materials in order to establish a baseline.The surveys should be repeated when radioactive materials arc present, when the quantity of material present changes, or when changes occur in their con-tainment systems or methods of use. Repetitive sur-veys may also be necessary to control the location of radioactive materials in the handling system and in tic case of the use of sealed sources outside a shielded container.

For operations involving materials in gas, liquid, or finely divided forms, the survey program should be designed to monitor the adequacy of containment and control of the materials involved.

The program should include air sampling, monitoring of effluents, 0 10.7-4 and surveys to evaluate contamination of personnel, facilities, and equipment.

The description of an air sampling program should include the area where samples will be taken, the fre-quency of sampling, and the location of the sampler with respect to workers' breathing zones. Assays per-formed to evaluate air samples and the methods used to relate results to actual personnel exposures should also be described.

The effluent monitoring program for releases to unrestricted areas should encompass all airborne and liquid radioactive material releases.

Theoretical evaluations should be suppLmcnted by stack monitoring, water sampling, and nther environmen- tal monitoring appropriate for thc planned and potential releases.For operations involving only sealed sources, a survey program should include evaluation and/or measurement of radiation levels for storage and use configurations.

When sources are used in devices having "on" and "ofr' positions.

both positions should be evaluated at the time of installation.

Sup-plemental surveys should be performed following any changes in operation, shielding, or use.The types. methods. and frequency of surveys should be specified.

Guidance may be obtained from the National Council on Radiation Protection Report No. 10. "Radiological Monitoring Methods and Instruments,*'

and the International Atomic Energy Agency's Technical Rcport Series No. 120."Monitoring of Radioactive Contamination on Sur-faces."*b. Records Management Program. Provision for keeping and revicwing records of surveys: materials inventories:

per'sonnel exposures;

receipt. use. and disposal of materials.

etc.. should be described.

Persons responsible for keeping and reviewing records should be identified.

c. Emergency Procedures.

The applicant should submit written emergency procedures for-employees in case of spills. fires, release or loss of material, or accidental contamination of personnel, including decontamination procedures and the names of persons who arc to be notified in an emergency.

d. Sealed-Source Leak-Test Procedures.

Sealed sources containing more than 100 microcuries of a beta or gamma emitter or more than 10 microcuries of an alpha emitter must be leak tested at 6-month in-tervals. Leak testing of alpha-particle-emitting sources containing more than 10 microcuries of an*Copies may be obtained from NCRP Publications, P.O.Box 4867. Washington.

D.C. 20008.69Copies may be obtained from UNIPUB. Inc.. P.O. Box 433. New York. N.Y. 10016.alpha emitter is rcqliired at 3-month intervals.

If a commercial firm is to perform the Irak tests, the name. address. and license number of the firm should he submitted, If the tests arc to be performed using a commercial "kit." the name of the kit manufacturer or distributor and the kit model designation should be given. If the applicant intends to p.rform his ou n leak tests without the use of a commercial kit, the fol.lowing information should be submitted:

I) Qualifications of personnel who will perform the leak test.(2) Procedures and materials to be used in tak-ing test samples.(3) The type manufacturer's name. model number, and r;4iajiin detection and measurement characteristics o the'nstrument to be used for assay of test samples.(4) lnstruwment calibration procedures., including calibration source characteristics.

make. and model number, and (5) The method, including a sample calculation.

to be used to convert instrument readings to units of activity.

e.g.. microcurics.

hctm 15. The procedures for disposing of byproduct material waste should be described.

Under NRC regulations, a licensee may dispose of waste in the following ways: a. Transfer to a person properly licensed to receive such waste in conformance with paragraph

20.301(a)of 10 CFR Part 20. The name of the firm (which should be contacted in advance to determine an%limitations that the firm may have on acceptance of waste) should be given.b. Release into a sanitary sewer in conformance with §20.303 of 10 CFR P:trt 20. Depending on water usage. releases of up to I curie per year are permitted.

c. Burial in soil in conformance with §20.304 of 10 CFR Part 20. Up to 12 burials per year are permissi-ble. The allowable quantity depends upon the radionuclide.

d. Release into air or water in concentrations in conformance with §20.106 of 10 CFR Part 20. Possi-ble exposure to persons offsite limits the amount that may he released.e. Treatment or disposal by incineration in confor-mance with §20.305 of 10 CFR Part 20. This must be specifically approved by the Commission.

f. Other methods specifically approved by the Commission pursuant to §20.302 of 10 CFR Part 20.E 0 10.7-5

5. AMENDMENTS

TO LICENSES S. RENEWAL OF A LICENSE Licensees are required to conduct their programs in accordance with statements, representations, and procedures contained in the license application and supportive documents.

The license must therefore be amended if the licensee plans to make any changes in facilities, equipment (including monitoring and sur-vey instruments), procedures, personnel, or byproduct material to be used.Applications for license amendments may be filed eith.r w. the application form or in letter form. The application should identify the license by number and should clearly describe the exact nature of the changes, additions, or deletions.

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

An application for renewal of a license should be filed at least 30 days prior to the expiration date. This will ensure that the license does not expire until final action on the application has been taken by the NRC as provided for in paragraph

30.37(b) of 10 CFR Part 30.Renewal applications should be filed on Form NRC-313, appropriately supplemented, and should contain complete and up-to-date information about the applicant's current program.In order to facilitate the review process, the ap-plication for renewal should be submitted without reference to previously submitted documents and in-formation.

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

S 0 0I 10.7-6 O APPENDIX Form AIC-313 UNITED STATES ATOMC eNerGY COCMISSION

10 CIA 30 APPLICATION

FOR BYPRODUCT

MATERIAL LICENSE 'e"" " o USSTRUCT"OF4S.-Complate Horns 1 through 16 if this Is an iritiil applic4alon of an application for henewal of a license. Informiaton contaled an r.vius applicatlOnls (dd with the CommItf4ah n with respect to Items 0 through 15 mey be incoporlteo by reflerence promded rterences at# ci.so andi spiochc. Use supplemental shoets whire nTcussaty.

Item 15 must be completed on all Maii two copies Wo U S Atomic Energy Comms-ioa. Washington.

D.C.. 20545, Attention:

Matiials Branch. Direclorate of ULcensing.

upon approval of this application.

the applicaml win an AEC Byproduct Material Lcn"s. An AEC Byproduct Material Uclnts Is Issued In accordance with the general requirements contained in Tnl 10. Code of Fed-ratl Flegulation.

Pail 30, and the Is subject to Title 10, Code of Federal Rgplatioti4.

Pan 20. and the ft ptovisions ot Tifle 10. Code of Federal Regulations, PaiR 170. The license fee cateqory should be staled in Haem 16 and the appropriate lee enclosed. (See Nloe in Instrueloen sheoel1. (a) kAME AND STRET AlOMlSS OF APPIUCANT. (htitutftbi.

Iran. tiloagH per. 11.1 StWall ADD* SSIISI AT WHiiCa 57P500UCI .AIIIIAt WJLl U LJ*IO sif Soo. 0rC baciw* D Code mod blofphof.

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40 11`11 APPLICANT1 AND ANY OFFICIAL.

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61.15.11-P100

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