ML19220C531
| ML19220C531 | |
| Person / Time | |
|---|---|
| Site: | Crane  |
| Issue date: | 12/31/1975 |
| From: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| Shared Package | |
| ML19220C530 | List: |
| References | |
| RPG-751231, NUDOCS 7905110162 | |
| Download: ML19220C531 (21) | |
Text
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DRAFT GUIDE FOR PREPARATICS CF APPLICATICNS FOR LA30RATORY USE OF SMALL QUANT ~ TIES OF BYPRODUCT MATERIAL NUCLEAR REGULATORY CCM'!ISSION DIVISION OF MATERIALS AND FUEL CYCLE FACILITY LICENSING MATERIALS BRANCH
'a'ASHINGTON, D. C.
20555 1975 DRAFT w
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? AGE I. INTRODUCTION.
1 II. FILING AN APPLICATION.
1 A.
License Fees 2
B.
Completing :ne Application.
2 Specification of Applicant 2
Specification of Location of Use 3
Specification of Users 3
Specification of Radiation Protection Officer.
3 Specification of 3yproduct Material 4
Specification of Use.
5 Technical Qualifications of Perscenel.
5 Description of Radiation Detecticn Instru:ents and Calibration 7
Description of Personnel Menitoring and Bioassays 9
Description of Ecuipment and Facilities 11 Description of Radiation Protection Program.
12 Survey Program.
12 Records Management Progr.is.
16 Energency Procedures 16 Sealed Source Leak Test Procedures 16 Description of 'a'aste Disposal Procedures.
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I.
INTF.CDUCTICN This guide outlines the type of infor=ation that is needed to evaluate an application for a specific license for laboratories using =illicurie quantities of byproduct =aterial (reactor produced rad ionuclides). This type license is provided for under Title 10, Code of Federal Regulations, Part 30, " Rules of General Applicability to licensing of Byproduct Material."
II. FILING AN APPLICATICN All items on the application for NRC-313*, " Application for Syproduct Material License," should be co=pleted in full so that a =eaningful reiiew =ay be made of the applicant's instru=entation, facilities, provisions for personnel monitoring, radiation safety pro;ra=,
v:ste disposal procedures, and other pertinent information as indicated.
The space provided on For: NRC-313 is li=ited.
Therefore, the applicant should append additional sheets so that cc=plete informa-tion =ay be presented.
Each separate sheet or docu=ent submitted with the application should be identified as to its purpose (e.g.
radiation safety instructions) and keyed to respond to an iten of the application for=.
The original and one copy of the cc=plete application should be sub=itted.
The Lafor=ation contained in an application should be sub=itted in sufficient detail to allow the Co==ission to deter =ine that the
- Existing copies of the For= AEC-313 will be used.
96 13 applicant's proposed equipment, facilities, procedures, and control over the use of radionuclides are adequate to protect health and
=inimize danger to life and property. The a=ount of detail vill depend pri=arily on the scope of the proposed radioactive =aterials program.
A.
License Fees License fees are required for issuing =ost types of licenses.
The applicant should refer to Section 170.31, 10 CFR 170, " Schedule of fees for caterials licenses," to determine the fee, if any, that should acco=pany the application. No action will be taken upon applications filed without the proper fees.
B.
Cc=cleting the Application Most ite=s of the Form NRC-313 are self-explanatory.
The following co==ents apply to the indicated nu=bered ite=s of the form.
1(a).
Specification of Aoplicant Specify the applicant corporation or other legal entity by na=e and address of principal office.
Individuals should be designated as the applicant only if the use of 96 214
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the byproduct =aterial is not connected with e= ploy =ent with a corporation or other entity.
If the applicant is an individual, the individual should be specified by full na=e and address including state and zip code.
1(b).
Soecification of Location of Use Specify the street address of each location of use.
If use is to be at = ore than one location, the specific addresses should be specified and a description of the extent of use at each location and a description of the facilities and equip =ent at each location should be sub=itted. A post office box is not an appropriate place of use.
4
_Snecification of Users Specify the na=es of the persons who will supervise the use of radioactive =sterial or who will use radioactive
=aterial without supervision.
5.
Soecification of Radiation protection Of ficer Specify the name of the person who will be designated as the radiation protection officer.
This person should be responsible for i=plementing the radiation safety progra=
f 9b 7aI3
. 7.
Specification of Use The use to be =ade of the radioactive caterials should be clearly described.
Sufficie..t detail should be given to allow a determination of the potential for exposure to radiation and radioactive materials of both those working with the caterials and the public.
8 and 9.
Technical Oualificaticas of Persennel A resu=e of the training and experience of each person who will directly supervise the use of =aterial or who will have responsibilities for radiological safety should be sub=1tted.
The resu=e should include the type (on-the-job or for=al course work), location and the duration of the training. Training should cover (a) principles and practices of radiation protection, (b) radioactivity ceasure=ents, standardization, and conitoring techniques and instr.=ents, (c) =athecatics and calculations basic to the use and ceasure=ent of radioactivity, and (d) biological effects of radiation.
The description of the use of radioactive caterials should include the specific isotopes handled, the =axi=u= quantities of
=aterials handled, where the experience was gained, the duration of experience, and the type of use.
The qualifications, training, and experience of each person should be cc==ensurate with the caterial and its use as proposed in tne application.
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The a=ount and type of training and experience with radiation and radioactive =aterial required to support a determination of adequacy by the Co==1ssion will vary
=arkedly with certain factors.
The use of =icrocurie quantities of a few nonvolatile radioactive =aterials under precisely specified and carefully controlled conditions subject to the surveillance of a co=petent and adequately trained radiation protecticn of ficer by a person with a =ini=u= of training and experience
=ay be justified.
Such training and experience =ay consist of a few hours of training and experience in the use of one or more radioactive caterials si=ilar to the use pro-pared in the application under the supervision and te:orship of a licensed user.
The use of millicurie quantities of a nu=ber of radio-nuclides for general laboratory tracer work under unspecified conditions requires core extensive training and experience cad, depending on the exact nature of the proposed progra=
of use of radionuclides, =ay require the co=pletion of formal course work at the college or university IcVel covering the areas listed under Ite= 8 of the Form NRC-313.
9 6 'l h 7
. The use of larger quantities of caterial (approaching a curie) under conditions where a potential exists for significant loss and ingestion, inhalation or absorption of the radioactive material by those working with the material is normally done under carefully controlled conditions using specialized equipment. An individual who is to independ.'ntly use radio-active materials under these conditions should not only have a background of for=al training in all areas of Item 8 of the Form NRC-313, but should also have extensive experience in work with radioactive =aterial and a thorough working knowledge of the equip =ent required to safely handle the caterial.
Also, it =ay be possible to justify the use of relatively large quantities of radioactive caterials in potentially hazardous chemical and physical for=s by li=iting the potential hazards through the use of enclosed, shielded, f unctionally ef f ective and carefully =aintained special handling equipment operated in accordance with detailed written operating procedures.
10 and 11. Descriotion of Radiation Detection Instru=ents and Calibraticn Specify the manufacturer's name and codel number, the nu=ber available, the type of radiation detected (alpha, beta or ga==a), the sensitivity range (=1111 roentgens 90 2'b
per hour or counts per cinute) the window thickness in n
=tiligra=s/ centimeter' and type of use for each radiation detection instru=ent.
The type of use would nor= ally be conitoring, surveying, assaying or =casuring.
Describe your instru=ent calibration procedure.
State the frequency and describe the methods and procedures for calibration of survey and =onitoring instru=ents as well as any other instru=ents and systess used in your radiation protection program, such as measuring instruments used to assay sealed source leak test sa=ples (see Sec. II. 3.
- 14. d), contamination samples (air sa=ples, surface
" wipe" sa=ples, etc.), and bicassay sa=ples (see Sec. II.
B. 12).
An adequate calibration of survey instru=ents usually cannot be perfor ed with built-in " check sources."
Electronic "culibrations" that do not involve a source of radiation are also not cdequate to determine the proper functioning and response of all components of an instrunent.
Daily or other frequeat checks of survey instruments should be supple =ented every three =caths with a two point calibration on each scale of each instru=ent with the two points separated _y at least 50; of the scale.
Survey instrc=ents should also be calibrated following renait.
A survey instru=ent =ay be considered properly calibrated at 1 point when it reads within 10% of the air
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. Jose (or particle fluence) calculated for the position occupied by the detector.
If survey instruments will not be returned to the manufacturer for calibration, a detailed description of planned calibration procedures should be submitted.
The description should include:
a)
Reference standard sources to be used, b)
A copy of written calibration procedures and associated radiation safety instructions, and c)
Pertinent experience of each individual who will perf orm the calibrations.
12.
Descriotion of Personnel Monitorine and Bioassays Personnel monitoring is required if a person is likely to receive in a calendar quarter 313 millirem to the body, 4.69 res to the extremities, or 1.88 rem to the skin (lower li=its apply to those under 18 years of age, see Sections 20.101 and 20.202, 10 CFR 20).
Personnel tenitoring is also required if a person enters a high radiation area (greater than 100 cillire= per hour).
If personnel conitoring equip =ent will be used, the name of the organization furnishing the service (film badge, TLD badge or dost=eters) and the frequency for changing personnel conitors should xse specified rc pocket cha: berg
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96 220 or pocket dosimeters are used, the range of the device in milliroentgens, frequency of reading, and the procedures for maintaining and dete minir; the accuracy of che devices should be specified.
If personnel conitoring is not used, a calculation or documentation from radiation surveys which deconstrates that it is unlikely that any individual will receive a dose as indicated above, should be submitted.
Bioassays are nor= ally r: quired when individuals work with cultimillicurie quantities of hydrogen-3, idine-125 or iodine-131, depending on the chemical and physical for=, the procedures followed and the equipment used.
Acceptable bicassay =ethods for iodine and tritium consist of the ceasurement of activity in the thyroid and urine (urinalysis), respectively.
Bioassays =ay also be required for other radionuclides if the che=1 cal or physical form or procedures and equipment umed.ake it' possible for radioactive caterials to be ingested, inhaled, or absorbed into the body. Tha applicant should show in his application that the need for bicassays has been 96 22'-
. thoroughly considered and should describe his proposed bicassay program in relation to his proposed program for use of radioactive =aterials. Regulatory Guide 8.9= =ay be consulted for " Acceptable Concepts, Models, Equaticns, and Assu=ptions for a Bicassay Program." If a co==crcial biocssay service is to be used, the name and address of the firm should be provided.
13.
Description of Ecuip=ent and Facilities Describe the equip ent and facilities for each site of use in detail. The propcsed equipment and facilities for each operation to be conducted should be adequate to protect health and cini=1:e danger to life and property.
In describing available equip =ent and facilities, the following types of information should be included, as appropriate:
a.
Physical plant, laboratcry, or working area facilities.
Tume hocds, glove boxes, waste receptacles, special sinks, ventilation and containment systc=s, effluent filter systems, and all processing, work, and protective clothing change areas should be described.
- Copies of these guides may be obtained by a written request to the U.S. Nuclear Regulatory Cc= ission, 'a*ashington, D. C.
- 20555, Attention: Director, Of fice of Standards Development.
96 2nq4 b.
Containers, devices, protective clothing, auxiliary shielding, general laboratory equip =ent, air sampling equip =ent, etc. actually c= ployed in the daily use of =aterial.
Special consideration for shielding and containment and provisions to minimize personnel exposure should be described.
c.
Storage containers and facilities.
Indicate both shielding and security of caterials.
d.
The nu=ber, type, and length of remote handling devices.
14.
Descriotion of Radiation Protection Progra=
a.
Survey Program Co= mission regulations require that surveys be =ade of external exposure to
- sonnel, air concentrations in the breathing cues of personnel, and effluents from a facility in which radioactive caterials are used (Section 20. 2 01, 10 CFR 20). A survey cay be a physical ceasure=ent or a theoretical calculation.
Although a theoretical calculation is usually used to de=onstrate the lack of a hazard from either airborne or external radiation, it c anno t always be used in lieu of a physical survey.
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. Except for those casas where sources of radiation and radioactive caterial are very well known and accurately and precisely controlled, it will usually be necessary that a physical survey be =ade with appropriate detection and =easure=ent instru=ents to determine the nature and extent of radiation and radioactive material or, as a =ini=u=, confirm the results of a theoretical determination.
A radiation protection progra= shculd include surveys for radioactive =aterial (contamination) and radiation:
(i) in laboratory areas (ccatamination on bench tops, handling and storage equipment, clothing, hands, etc.).
(ii) During work with radiation or rad. ac e
=aterials (b reathing zone air surveys; general air surveys; personnel exposure =easure=ents, including eyes and extre=ities; checking shutters and tain=ent; etc.).
(iii) Assetiated with disposal or release of radio-active =aterials (disposal containers, disposal sites; liquid, gas and solid effluents; filters and filter-duct syste=s, etc.).
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The frequency of surveys will depend on the nature of the radioactive =aterials and their use; however, surveys should be perfor ed prict to the use of radioactive caterials in order to establish a baseline and repeated when changes occur in radio-active caterials, their containment syste=s, =ethod of use, etc.
Repetitive surveys =ay also be necessary for the purpose of controlling the location of radioactive =aterials in the handling syste= or in the case of the use of sealed sources outside a shielded container.
For operations involving =aterials in gas, liquid or finely divided forms the survey progra= should be designed to =onitor the adequacy of contain=ent and control of the =aterials involved.
The program should include air sa=pling, =onitoring of ef fluents and surveys to evaluate conta=ination of personnel, facilities, and equip =ent.
The description of an air sampling progra= should include the area where samples will be taken, the frequency of sa=pling, and location of the sa=pler with respect to workers' breathing zones. The type gh
4
. of assays that will be performed to evaluate the samples and the methods to relate results to actual personnel exposures should be described.
The effluent moni er'ng program for releases to unrestricted areas shoula encompass all airborne and liquid releases.
_heot t v 'l evmluations should be supplemente:! b3 s t...
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- at in water sa=pling, or other envircreent al caalt'rir g appropriate for the planned anu po, al rcleases.
For operations involving only sealed sources, a
survey program should include evaluation and/ur
=casure=ent of radiation levels for storage and use configurations.
b' hen sources are used in devices having "on" and "off" positions, both positions should be evaluated at the time of installation.
Supplemental surveys should be perforced following any changes in operation, shielding, or us_.
You should specify the types, methods, and frequency of your surveys.
Guidance concerning " Radiological Monitoring Methods and Instru=ents" say t e obtained from the National Cocaission on Radiation Protection Report No. 10 and the International Atomic Energy 96 226 Agency's Technical Report Series No. 120 covering
" Monitoring of Radioactive Contamination on Surfaces."
b.
Records Manacement Procram Provisiona for keeping and reviewing records of surveys; materials inventories; personnel exposures; receipt, use, and disposal of =aterials, etc. should be described. Persons responsible for keeping and reviewing records should be identified, c.
E=ercency Procedures Submit written e=ergency procedures for employees concerning spills, fires, release or loss of caterial, and/or accidental conta=1 nation of personnel, including decontamination procedures and the names of those persons who are to be notified in an e=ergency.
d.
Sealed Source Leak Test Procedures Sealed sources containing core than 100 cicrocuries of a beta or gn--a e=itter must be leak tested at six-conth intervals. Leak testing of alpha particle emitting sources containing = ore than 10 microcuries of an alpha emitter is required at three-conth int e rvals.
If a cc =ercial firm will perfor= the n7 C)()
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. leak tests, the name, address, and license nu=ber of the fir = should be sub=itted.
If the tests are to be performed utilizing a co==ercial " kit," the na=e of the kit =anufacturer or distributor and the kit codel designation should be given.
If the applicant intends to perfor= his own leak tests (without the use of a co==ercial " kit") the following information should be sub=itted:
(1) Qualifications of personnel who vill perfor=
the leak test, (ii) Procedures and =aterials to be used in taking test samples, (iii) The type, =anuf acturer's na=e, =odel nu=ber and radiation detection and =easure=ent characteristics of the instru=ent to be used for assay of test sa=ples, (iv) Instru=ent calibration procedures including calibration source characteristics, =ake and model nu=ber.
% 23
. (v)
The method (including a sample calculation) to be used to convert instrument readings to microcuries of activity.
15.
Description of Waste Disposal Procedures The procedures for disposing of byproduct caterial waste should be described. Under NRC regulations, a licensee may dispose of waste in the follcwing ways:
a.
Transfer to a person properly licensed to receive such waste.
The name of the firs should be given.
(The firm should be contacted in advance to deter-
=ine any limitations which they may have on acceptance of waste.)
b.
Decay and/or release into a sanitary sewer in con-formance with Section 20.303, 10 CFR 20.
Depending upon water usage, releases of up to 1 curie per year are per=itted.
c.
Burial in soil in conformance with Section 20.304, 10 CFR 20.
Up to 12 burials per year are permissible.
The allowable quantity depends upon the radionuclide.
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d.
Release into air or water in concentrations conforming with Section 20.106, 10 CFR 20.
Possible exposure to persons off-site limits the amount that =ay be released.
e.
Other =ethods specifically approved by the Co= mission pursuant to Section 20.302, 10 CFR 20.
III. A'.'ENDMENT OF LICENSES Applications for amendment of existing licenses should be filed in the sane canner as initial applications.
The application should clearly identify the number of the license to be a= ended.
The exact nature of the requested changes should be specified and additional supporting information, as necessary, should be provided.
IV.
RENEWAL OF LICENSE A complete application (For, NRC
appropriately supplenented) should be submitted at least 30 days arior to the expiration date of the license. The license will then renain in effect until final action is taken on the ap,,lication (Refer to Section 30.37(b),
hb
. Title 10, Code of Federal Regulations, Part 30). A renewal applica-tion should include up-to-date information on the licensee's program. References to previously submitted infor=ation 4: permissible provided the references clearly and specifically identify by docu=ent, page number and date the information to be considered. General references such as "See previous applications" are not adequate.
Attach =cnts:
1.
NRC 313(I) 2.
10 CFR 19 3.
10 CFR 20 4.
10 CFR 30 5.
10 CFR 170 g6 D'
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NRC FORu 218 v.s. NUCLE AR RE GU LATO R Y COMMISSION DATE 2(/ [?f (4 76)
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