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 1977 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.

1. INTRODUCTION plication will not Iwgin ut, il the proper fee is received by the NRC.

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 3. FILING AN APPLICATION

radionuclides). This type of license is provided for

.. under Title 10. CodeofrFederalRegulations. Part 30. A licenew application for by product nmuterial

-Rules of General Applicability to Licensing of should he suhmitted tfi Form NRC 313* ",'Applica- Byproduct Material.- 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

S.Paragraph 20.1(c)-of 10 CFR Part 20. "Standards for Protection Against Radiation." states that".. it) determine thatil fit uppikil ntls:"t'qUipllellt.

persons engaaed in activities under licenses issued hy facilities. and rai~oio~to reanare ade- the Nuclear Regulatory Commission pursuant to the qultte it) protect,ý, iL~lth Andrii~tsn~imi datnger to life Atomic Energy Act of 1954. as amended, and the and proprt'. "

• . Energy. Reorganization Act of 1974 should. in addi-

,ton tocomplying with the requirements set forth in hc.hspce' provided on Form NRC-313 is this part, make everv-reasonuhle effort to maintain. irhmited1. *,Ih applctant should append additional

. diation exposures. and rleases of radioactve to provide complete information. F:ach

.materials: n einlucLnts to unrestricted arcas.as-low as i .paratc sheet or document subLtllted with the ap- se is reasonabhl ahtcvahich" (A LAR_). Rcgutitatol3' *' plicalion should he identified by a heading indicating SGude-8.10.)Operating. " Philosophv IrI Maintaining" the appropriate item number (on Form NRC-313)

Occupational Radiation Exposures AssLow As Is and its purpose (e.g.. radiation safety instructions).

Reasonabhh Achiev.,, provides thc*RC staff position on thi. iamirta l1_subject. License applicants The applica.tion should lie completed in triplicaite.

should g-, 0on;'. 60tion to the A LA RA The original and one copy should he mailed to:

philos *ph.s *rib" inWRegulatory Guide 8.10. in Radioisotope:, Licensing Branch. Division of Fuel I v Fln tif 01ans for work with licensed Cvyec aod MIatertal Safety. Office of Nuclear ra ct b~6uial Material Safety and Safeltuards. U.S. Nuclear Regulatory Commission. Washington. D.C. 20555.

'° 2. LICENSE FEES One copy of the application. with all attachments.

should he retained by the applicant, since the license An application 'fee. is required for most types of will require. as :t condition. that the institution follo-w licenses. The applicant should refer -to §170.31. the stLtcmenits and representations set forth in the ap-

"Schedule of Fees.for Materials Licenses." of 10 plication and any stIpplememt to it.

• "CFRPart 170 to determine the amountof fee that

• Form N R C-13 Was foirmerly designated Form ALEC-313.

must accompany the application. Review of the ap- Exisling copies or F:osrm AIEC.-313 m:A, still hb used.

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4. CONTENTS OF AN APPLICATION items 8 and 9. A resume of the training and ex- perience of each person who will directly supervise Most items of Form NRC-313 are sclf-explanator: y the use of material, who will use material without (se instructions with the form). The following corn- supervision, or who will have responsibilities for ments apply to the indicated numbered items of th.c radiological safety should be submitted. The resume form. should include the type (on-the-job or formal course work), location, and duration of the training. Train- hIem 1(a). Specify the applicant corporation o r ing should cover(1) principles and practices ofradia- other legal entity by name and address of principa I tion protection: (2) radioactivity measurements, office. Individuals should be designated as the appli " standardization, and monitoring techniques and in- cant only if the use of the byproduct material is no t struments, (3) mathematics and calculations basic to I

connected with the individual's employment with the use and measurement of radioactivity, and (4)

corporation or other entity. If the applicant is an in - biological effects of radiation. The description of the dividual, the individual should be specified by ful I use of radioactive materials should include the name and address, including state and zip code. specific isotopes handled, the maximum quantities of materials handled, where the experience was gained, hem 1(h). Specify the street address of the locatiorn the duration of experience, and the type of use. The of use if the address differs from the one given in itcrr qualifications, training, and experience of each I(a). If use is to be at more than one location. thi person should be commensurate with the material specific address of each should be given. Describe thi e and its use as proposed in the application. The extent of use and the facilities and equipment at eaca amount and type of training and experience with location. A post office box address is not acceptable radiation and radioactive materials required to sup- port a determination of adequacy by the Commission Item 4. Specify the names of the persons who wil i will vary markedly with certain factors.

directly supervise the use of radioactive material oi who will use radioactive material without supervi.

sion. The use of microcurie quantities of a few non- volatile radioactive materials by a person with a hem 5. Specify the name of the person who will hte minimum of training and expcrience under precisely designated as the radiation protection officer.* This specified and carefully controlled conditions subject person should be responsible for implementing th( to the surveillance of a competent and adequately radiation safety program and therefore readily y trained radiation protection officer may be justified.

available to the users in case of difficulty and should I Such minimum training and experience may consist be trained and experienced in radiation protectior of a few hours of training and experience in the use of and in the use and handling of radioactive materials. one or more radioactive materials similar to the use proposed in the application under the supervision Ite't 6(a i amdl 1b. Describe the byproduct rnatcria I and tutorship of a licensed user.

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 Persons using miillicurie quantities of a number of Possession limits requested should cover the total an. radionuclides for general laboratory tracer work un- ticipated inventory, including stored materials and der unspecified condition should have more exten- waste. and should be commensurate with the appli- sive training and experier.ce and, depending on the cant's needs and facilities for safe handling. exact nature of the proposed program or use of radionuclides, may need to have completed formal If the use of sealed or plated sources is con- - course work at the college or university level covering templated, the isotope. manufacturer, and model the areas listed under Item 8 of Form NRC-313.

number of each sealed or plated source should be s*,ecificd. If a source will be used in a gas chromatograph, gauge, or other device. the manufac- The use of larger quantities of material (ap- turer and model number of the device should be proaching a curie) under conditions where a potential specified. exists for significant loss and ingestion, inhalation, or absorption of the radioactive material by those work.

Item 7. The use to be made of the radioactive ing with the material is normally done under carefully materials should be clearly described. Sufficient controlled conditions using specialized equipment. A

detail should be given to allow a determination of the person who is to use radioactive materials inde.

potential for exposure to radiation and radioactive pendently under these conditions should not only materials of both those working with the materials have a background of formal training in all areas of and the public, Item 8 of Form NRC-313 but should also have exten.

sive experience working with radioactive material

• The terms "radiation protection officer" and and a thorough working knowledge of the equipment

-radiological safety officer" are synonymous. required to handle the material safely.

10.7-2

l Items 10 and II. Specify for each radiation detec- numher of the Firm should be specified together %% ith tion instrument the manufacturer's name and model the frequency of calibration. The applicant should number, the number of each type of instrument contact the firm that "rill perform the calibration. to available, the type of radiation detected (alpha. beta. determine if information concerning calibration or gamma), the sensitivity range (milliroentgens per procedures has been filed with the Commission. If hour or counts per minute), the window thickness in information concerning calibration procedures has mg/cm2 . and the type of use. The type of use would not been filed, it should be obtained and submitted.

normally be monitoring, surveying, assaying, or measuring. Quantitative measuring instruments used to monitor the adequacy of containment and con- Describe the instrument calibration procedure. tamination control such as those used for measuring State the frequency. and describe the methods and leak test. air. effluent. bioassay, suork area. and procedures for the calibration of survey and monitor- cquipnient contamination samples should usually he ing instruments, as well as any other instruments and calibrated prior to each use. The procedures and fre- systems used in the radiation protection program. quency for calibration of such instruments should he such as measuring instruments used to assay scaled- submitted and should include:

source leak-test samples (see Item 14). contamination a. The name of the manufacturer and model samples (e.g., air samples, surface "wipe' samples).

number of each of the standards to he used.

and bioassay samples (see Item 12).

h. The nuclide and quanity of radioactiVc An adequate calibration of survey instruments material contained in each of the standard sources.

usually cannot be performed with built-in check c. A statement orthe accuracy of each of the stan- sources. Electronic calibrations that do not involve a dard sources. The source accuracy should be. as a source of radiation arc also not adequate to deter- mine the proper functioning and response of all com- minimum. +/- 5 percent of the stated value and ponents of an instrument. traceable to a primary standard, such as that main- tained by the National Bureau of Standards.

Daily or other frequent checks of survey instru- d. Step-by-step calibration procedures and. if ap- ments should be supplemented every 6 months with a propriate. associated radiation safety procedures.

two.point calibration on each scale of each instru- and ment with the two points separated by at least 50% of e. The name and pertinent experience of each S the scale. Survey instruments should also be calibrated following repair. A survey instrument may be considered properly calibrated when the instru- person who will perform the instrument calibrations.

hem 12. Personnel monitoring is required if a ment readings are within +/-10 percent of the calculated or known values for each point checked. person is likely to receive in a calendar quarter 313 Readings within- +/-20 percent are considered accep- millirems to the body. 4.69 rems to the estremities. or table if a calibration chart or graph is prepared and 1.88 reins to the skin (lowcr limits apply to those un- attached to the instrument. der 18 years of age: see ,20.101 and 20.202 of 10

CFR Part 20). Personnel monitoring is also required If the applicant proposes to calibrate his survey in- if a person enters a high radiation area (greater than struments, a detailed description of planned calibra- 100 millirems per hour). If personnel monitoring tion procedures should be submitted. The description equipment will be used. the name of the organization of calibration procedures should include, as a furnishing film badge or thermoluminescent minimum: dosimeter (TLD) service and the frequency for a. The manufacturer and model number of each changing badges, dosimeters. etc.. should be radiation source to be used. specified. If pQcket chambers or pocket dosimeters will be used, the useful range of the device, in mil- b. The nuclide and quantity of radioactive liroentgens. the frequency of reading, and the material contained in each source, procedures for maintaining and calibrating the devices should be specified.

c. The accuracy of the source(s). The traceability of the source to a primary standard should be If personnel monitoring will not be used, the appli- provided. cant should submit calculations or documentation from radiation surveys that demonstrate that it is un- d. The step-by-step procedures, including as- likely that any individual will receive a dose equal to sociated radiation safety procedures, and or greater than that indicated in the preceding e. The name and pertinent experience of each paragraph.

person who will perform the calibrations. The applicant should show that the need for bioas- If the applicant intends to contract out the calibra- says has been thoroughly considered and should es-

0 tion of instruments, the name, address, and license tablish the adequacy of the proposed hioassay

10.7-3

I

program in relation to the proposed program of use lIent 14.

of radioactive material. Bioassays are normally re- quired when individuals work with millicurie 4 uun- a. Survey Program. Commission regulations re- tities of hydrogen-3. iodine-125. or iodinc-131 quire that surveys be made to determine if radiation depending on the type of work, equipment, and hazards exist in a facility in which radioactive piocedures followed. Other materials man also be materials are used or stored (see §20.201. 10 CFR

used in physical or chemical forms and under condi- Part 20). A survey should include the evaluation of tions that present an opportunity for uptake by the external exposure to personnel, concentrations of air- body through ingestion. inhalation, or absorption. A borne radioactive material in the facility, and bioassay program to determine and control the up- radioactive effluents from the facility. Although a take of radioactive material should be considered and theoretical calculation is often used to demonstrate discussed in relation to cach such material. compliance with regulations regarding airborne or procedure. etc. Regulatory Guide 8.9. "Acceptable external radiation, it cannot always be used in lieu of Concepts. Models. Equations. and Assumptions for a a physical survey.

Bioassay Program."' may be consulted.

The criteria to he used in determining the need for Except for those cases where sources of radiation and radioactive material are well known and ac- bioassays, the type and frequency of bioassays that curately and precisely controlled. it will usually be will he performed, and the bioassay procedures should be specified and described in detail. If a com- necessary that a physical survey be made with ap- mercial bioassav service is to be used, the name and propriate detection and measurement instruments to address of the firm should be provided. determine the nature and extent of radiation and radioactis material or, as a minimum, confirm the ilioassaf.s may not he substituted for other cle- results of a theoretical determination.

ments of a safety program such as air monitoring and dispersion control (hoods. glove boxes. etc.) and for A radiation protection program should include the

%tell-thought-out and ssell-cxecuted handling following surveys for radioactive contamination and radiation:

procedures.

(I) In laboratory areas (e.g., checking for con- liem 13. The equipment and facilities for each site tamnination on bench tops, handling and storage of use should be described in detail. The proposed equipment, clothing, hands, etc.).

equipment and facilities for each operation to be con- ducted should he adequate to protect health and (2) Whilc work is being done with radiation or minimize danger to life and property. In describing radioactivc materials (e.g.. breathing zone air sur- available equipment and facilities, the following types veys: general air surveys; personnel exposure ot information should be included, as appropriate: measurements, including eyes and extremities: check- ing shutters and containment. etc.).

a. Physical plant. laboratory, or working area facilities. Fume hoods, glove boxes, waste recep. (3) In areas associated with disposal or release taces, special sinks, ventilation and containment of radioactive materials (e.g., checking disposal con- systems, effluent filter systems, and all processing, tainers and disposal sites: liquid, gas, and solid ef- work. and protective clothing change areas should be fluents: filters and filter-duct systems: etc.).

described.

The frequency of surveys will depend on the nature b. Containers. devices. protective clothing, aux- of the radioactive materials and their use. However.

iliary shielding, general laboratory equipment, air surveys should be performed prior to the use of sampling equipment, etc., actually employed in the radioactive materials in order to establish a baseline.

daily use of material. Special provisions for shielding The surveys should be repeated when radioactive and containment to minimize personnel exposure materials arc present, when the quantity of material should be described. present changes, or when changes occur in their con- tainment systems or methods of use. Repetitive sur- c. Storage containers and facilities. These should veys may also be necessary to control the location of provide both shielding and security for materials. radioactive materials in the handling system and in tic case of the use of sealed sources outside a shielded d. The number, type. and length of remote handl- container.

ing devices.

For operations involving materials in gas, liquid,

• A copy of this guide may he obtained by a written request or finely divided forms, the survey program should be to the U.S. Nuclear Rcgulatory Commission. Washington. designed to monitor the adequacy of containment D).C. 20555., Attention: Director. Office of Standards and control of the materials involved. The program Development. should include air sampling, monitoring of effluents,

0

10.7-4

and surveys to evaluate contamination of personnel, alpha emitter is rcqliired at 3-month intervals. If a facilities, and equipment. commercial firm is to perform the Irak tests, the name. address. and license number of the firm should The description of an air sampling program should he submitted, If the tests arc to be performed using a include the area where samples will be taken, the fre- commercial "kit." the name of the kit manufacturer quency of sampling, and the location of the sampler or distributor and the kit model designation should with respect to workers' breathing zones. Assays per- be given. If the applicant intends to p.rform his ou n formed to evaluate air samples and the methods used leak tests without the use of a commercial kit, the fol.

to relate results to actual personnel exposures should lowing information should be submitted:

also be described.

I) Qualifications of personnel who will perform The effluent monitoring program for releases to the leak test.

unrestricted areas should encompass all airborne and liquid radioactive material releases. Theoretical (2) Procedures and materials to be used in tak- evaluations should be suppLmcnted by stack ing test samples.

monitoring, water sampling, and nther environmen- tal monitoring appropriate for thc planned and (3) The type manufacturer's name. model potential releases. number, and r;4iajiin detection and measurement characteristics o the'nstrument to be used for assay For operations involving only sealed sources, a of test samples.

survey program should include evaluation and/or measurement of radiation levels for storage and use (4) lnstruwment calibration procedures., including configurations. When sources are used in devices calibration source characteristics. make. and model having "on" and "ofr' positions. both positions number, and should be evaluated at the time of installation. Sup- plemental surveys should be performed following any (5) The method, including a sample calculation.

changes in operation, shielding, or use. to be used to convert instrument readings to units of activity. e.g.. microcurics.

The types. methods. and frequency of surveys should be specified. Guidance may be obtained from the National Council on Radiation Protection hctm 15. The procedures for disposing of Report No. 10. "Radiological Monitoring Methods byproduct material waste should be described. Under E and Instruments,*' and the International Atomic Energy Agency's Technical Rcport Series No. 120.

"Monitoring of Radioactive Contamination on Sur- NRC regulations, a licensee may dispose of waste in the following ways:

faces."* a. Transfer to a person properly licensed to receive such waste in conformance with paragraph 20.301(a)

b. Records Management Program. Provision for of 10 CFR Part 20. The name of the firm (which keeping and revicwing records of surveys: materials should be contacted in advance to determine an%

inventories: per'sonnel exposures; receipt. use. and limitations that the firm may have on acceptance of disposal of materials. etc.. should be described. waste) should be given.

Persons responsible for keeping and reviewing records should be identified. b. Release into a sanitary sewer in conformance with §20.303 of 10 CFR P:trt 20. Depending on water c. Emergency Procedures. The applicant should usage. releases of up to I curie per year are permitted.

submit written emergency procedures for-employees in case of spills. fires, release or loss of material, or c. Burial in soil in conformance with §20.304 of 10

accidental contamination of personnel, including CFR Part 20. Up to 12 burials per year are permissi- decontamination procedures and the names of ble. The allowable quantity depends upon the persons who arc to be notified in an emergency. radionuclide.

d. Sealed-Source Leak-Test Procedures. Sealed d. Release into air or water in concentrations in sources containing more than 100 microcuries of a conformance with §20.106 of 10 CFR Part 20. Possi- beta or gamma emitter or more than 10 microcuries ble exposure to persons offsite limits the amount that of an alpha emitter must be leak tested at 6-month in- may he released.

tervals. Leak testing of alpha-particle-emitting sources containing more than 10 microcuries of an e. Treatment or disposal by incineration in confor- mance with §20.305 of 10 CFR Part 2

0. This must be

• Copies may be obtained from NCRP Publications, P.O. specifically approved by the Commission.

Box 4867. Washington. D.C. 20008.

69Copies may be obtained from UNIPUB. Inc.. P.O. Box f. Other methods specifically approved by the

0 433. New York. N.Y. 10016. Commission pursuant to §20.302 of 10 CFR Part 20.

10.7-5

5. AMENDMENTS TO LICENSES S. RENEWAL OF A LICENSE

An application for renewal of a license should be Licensees are required to conduct their programs in accordance with statements, representations, and procedures contained in the license application and filed at least 30 days prior to the expiration date. This will ensure that the license does not expire until final S

supportive documents. The license must therefore be action on the application has been taken by the NRC

amended if the licensee plans to make any changes in as provided for in paragraph 30.37(b) of 10 CFR Part facilities, equipment (including monitoring and sur- 30.

vey instruments), procedures, personnel, or byproduct material to be used. Renewal applications should be filed on Form NRC-313, appropriately supplemented, and should contain complete and up-to-date information about Applications for license amendments may be filed the applicant's current program.

eith.r w. the application form or in letter form. The application should identify the license by number and In order to facilitate the review process, the ap- should clearly describe the exact nature of the plication for renewal should be submitted without changes, additions, or deletions. References to reference to previously submitted documents and in- previously submitted information and documents formation. If such references cannot be avoided. they should be clear and specific and should identify the should be clear and specific and should identify the pertinent information by date, page. and paragraph. pertinent information by date, page, and paragraph.

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10.7-6

APPENDIX

Form AIC-313 UNITED STATES ATOMC eNerGY COCMISSION

O 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 *plpiCtfon. Maii two copies WoU S Atomic Energy Comms- ioa. Washington. D.C.. 20545, Attention: Matiials Branch. Direclorate of ULcensing. upon approval of this application. the applicaml win rec*i-v 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- ratlFlegulation. Pail 30, and the Lc*nsea Is subject to Title 10, Code of Federal Rgplatioti4. Pan 20. and the lIce*nse 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 sheoel

1. (a) kAME ANDSTRET AlOMlSS OF APPIUCANT. (htitutftbi. Iran. tiloagH per. 11.1StWall ADD* SSIISI AT WHiiCa57P500UCI .AIIIIAt WJLl U LJ*IO sif Soo.0rC baciw*D Code mod blofphof. nvmber1 I &Wsitk... 11. &via.%ZFCO. I

2. DIPAX1XINI TOUISEitSOUOV kAUTINIAt 3. PRIVIOtJI SIINIL MUMMIES[$) fit ika'a m. pM Vo P..af ~~

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10.7-7

1RAINING AND EXPERIENCI: OF EACH INDIVIDUAL NAMED IN ItEM 4 evi..I.nnO

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• TYPE OF TRAINING

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13 FACIIIII AND EQUIPMENT Desc-b. Iebaoatwy let1,hmeo end m-Moh he-dllsg stlyp~ei. stwage cemo'a j. 1%...Id--, P..-O Noojs, sto: 1.010,4a'.. iA.NI

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and~~t II WASTE DolSPO141I agcommudsng. erete d-iflesal get-te sI eeilaygod. gpoilPy oeos of tolosopon. 01onso.$S~. febll,t de'a.1*4 dec.pI 4 -sA ..4.4 k .jI

be .sod #a, dopooo-o of sod-oath*. -01111 and ash-Wet., I%#0 hPe and .... otl of O(.socino.o1 Inelod, CERTIFICATE (This Item must be completed by applicant)

40 11`11APPLICANT1AND ANY OFFICIAL. EXECUTING 18441C1IITIPICAll ON SItHA Of T111APPIICAMT NAMED IN ITEMA1. CERTIFYTHAT1THISAMIIC.A1TON IS

PIEP4210 IN CONIFOMITY WT1H?MEs10. Cool Of FDERAL IIGULAT)Ok$. PAl? 30. AID tHAI Att4INPOIM.ATION CONTAINED '415148

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61.15.11-P100 1973-043.126/21

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