Regulatory Guide 10.4: Difference between revisions
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{{#Wiki_filter:r!U.S. NUCLEAR REGULATORY | |||
COMMISSION | |||
REGULATORY | |||
GUIDEOFFICE OF STANDARDS | |||
DEVELOPMENT | |||
REGULATORY | |||
GUIDE 10.4GUIDE FOR THE PREPARATION | |||
OF APPLICATIONS | |||
FORLICENSES | |||
TO PROCESS SOURCE MATERIALJuly 1976 | |||
===1. INTRODUCTION=== | |||
1.1 Purpose of GuideThis ouide describes the information needed tohexafluoride production, are not within the scope of thisguide.1.4 As Low As Is Reasonably Achievable (ALARA)evaluate an application for a specific license to process Paragraph | |||
20.1(c) of 10 CFR Part.20 states thatsource materials. | |||
Examples of such processing activities | |||
"... persons cngak,:d in activities under licenses issuedare manufacture of depleted uranium and thorium, by the Nuclear Regulatory Commssion pursuant to themagnesium alloy products; | |||
shaping, grinding, and Atomic Energy Act of l954."as:amn nded, and thepolishing of lenses containing thorium: | |||
and the manurac- Energy Reorganization'Act of 1974 should, in additionture and distribution of other products containing to complying with the i'equirenicnts set foiti in thissource material. | |||
part,make every reasoriable effort to maintain radiation exposures,. | |||
and.,,. elescs-0f radioactive materials in1.2 Applicable Regulations effluents to' unretricted areas, as low as is reasonably | |||
'.Regulatory Guide 8.10, "Operating Philo-The Commission's rules and regulations concerning sophy for Maintaining Occupational Radiation Ex-licensing of source material are contained in Title 10, ..posuraisAs LOW; As Is Reasonably Achievable," | |||
providesCode of Federal Regulations, Part 40, "Licensing of 'ih, NRC :staff position on this important subject.Source Material." | |||
Source material means (1) uranium or 'ALacineniapplicants should give consideration to thethorium, or any Combination thereof, in any physical ,1Ai. philosophy, as described in Regulatory Guidechemical form or (2) ores that contain by weight 1/20 of "'-8. 10, in thie development of plans for work with licensedone percent (0.05%) or more of uranium, tltoriutný.or | |||
,ý'radioactive inaterials. | |||
any combination thereof. | |||
Source materit:dbes not'include special nuclear material. | |||
OthetI, regulations | |||
1.5 General Licens.e-. | |||
pertaining to source material licenses are':found.li | |||
10CFR Part 19, "Notices, Instructions and'Rep&rts to Although this guide pertains to the filing of applica.Workers, Inspections;" | |||
10 CFR Part 20, "Standards for tions for specific licenses, the applicant should be awareProtection Against Radiation, | |||
10 CFR Part 71, of the existence of general licenses. | |||
General licenses are"Packaging of Radioacti | |||
'' airi for Transport and effective without the filing of an application or theTransportation of Radioac' | |||
Under Certain issuance of specific documents. | |||
(Specific licenses requireConditions;" | |||
and 10- & rPaRt4,70, | |||
"Fees for Facilities filing of an application and the Issuance of licensing and Materials Licetes Un'Zr th; Atomic Energy Act of documents to specific persons.) | |||
1954, as Amoddedi".=The | |||
,4plicant should study care-fully the rsgula&d' | |||
{{RG-Nav}} | {{RG-Nav}} | ||
Revision as of 10:21, 3 July 2018
| ML13350A215 | |
| Person / Time | |
|---|---|
| Issue date: | 07/30/1976 |
| From: | NRC/OSD |
| To: | |
| References | |
| RG-10.004 | |
| Download: ML13350A215 (10) | |
r!U.S. NUCLEAR REGULATORY
COMMISSION
REGULATORY
GUIDEOFFICE OF STANDARDS
DEVELOPMENT
REGULATORY
GUIDE 10.4GUIDE FOR THE PREPARATION
OF APPLICATIONS
FORLICENSES
TO PROCESS SOURCE MATERIALJuly 1976
1. INTRODUCTION
1.1 Purpose of GuideThis ouide describes the information needed tohexafluoride production, are not within the scope of thisguide.1.4 As Low As Is Reasonably Achievable (ALARA)evaluate an application for a specific license to process Paragraph
20.1(c) of 10 CFR Part.20 states thatsource materials.
Examples of such processing activities
"... persons cngak,:d in activities under licenses issuedare manufacture of depleted uranium and thorium, by the Nuclear Regulatory Commssion pursuant to themagnesium alloy products;
shaping, grinding, and Atomic Energy Act of l954."as:amn nded, and thepolishing of lenses containing thorium:
and the manurac- Energy Reorganization'Act of 1974 should, in additionture and distribution of other products containing to complying with the i'equirenicnts set foiti in thissource material.
part,make every reasoriable effort to maintain radiation exposures,.
and.,,. elescs-0f radioactive materials in1.2 Applicable Regulations effluents to' unretricted areas, as low as is reasonably
'.Regulatory Guide 8.10, "Operating Philo-The Commission's rules and regulations concerning sophy for Maintaining Occupational Radiation Ex-licensing of source material are contained in Title 10, ..posuraisAs LOW; As Is Reasonably Achievable,"
providesCode of Federal Regulations, Part 40, "Licensing of 'ih, NRC :staff position on this important subject.Source Material."
Source material means (1) uranium or 'ALacineniapplicants should give consideration to thethorium, or any Combination thereof, in any physical ,1Ai. philosophy, as described in Regulatory Guidechemical form or (2) ores that contain by weight 1/20 of "'-8. 10, in thie development of plans for work with licensedone percent (0.05%) or more of uranium, tltoriutný.or
,ý'radioactive inaterials.
any combination thereof.
Source materit:dbes not'include special nuclear material.
OthetI, regulations
1.5 General Licens.e-.
pertaining to source material licenses are':found.li
10CFR Part 19, "Notices, Instructions and'Rep&rts to Although this guide pertains to the filing of applica.Workers, Inspections;"
10 CFR Part 20, "Standards for tions for specific licenses, the applicant should be awareProtection Against Radiation,
10 CFR Part 71, of the existence of general licenses.
General licenses are"Packaging of Radioacti
airi for Transport and effective without the filing of an application or theTransportation of Radioac'
Under Certain issuance of specific documents.
(Specific licenses requireConditions;"
and 10- & rPaRt4,70,
"Fees for Facilities filing of an application and the Issuance of licensing and Materials Licetes Un'Zr th; Atomic Energy Act of documents to specific persons.)
1954, as Amoddedi".=The
,4plicant should study care-fully the rsgula&d'o id this guide and submit allinformation tiu sted. 1.5.1 General License to Receive Tide to Source'" Material1.3 Items Requirinrg Separate Applications Activities that are related to the reactor fuel cycle,such as uranium and thorium milling and uraniumA general license to receive title, only, to sourcematerial is provided by §40.2 1. 10 CFR Part 40. Underthis general license, materials may be owned withoutUSNRC REGULATORY
GUIDES Comments thould be $*en to the Sacetety at She Comm'rissin.
U5 Nu.clearRegulatory Conimiton.m Washington.
OC ',SW. Aglontion Docket~ing en~dRegulatory Guides Old $Stued to describe and make available go the Public 5,,,ics, Sectiou.melthods acceptable I* She PdRC staff Of im~~meniling
- Pacific Petit at theCorymrossiones tegulat.ono.
to delineate techniques used be the $left on tvli The gwidots#reissued in I%& following ton broaddie'.oons
- lang specific problems a or S'tulated accidenits, ofto provide guidance to appl.drift Regulaetory Ouid*% are not subtiluest tot togulationt.
and comnplianice I Pows# Reactors
6 Productswvivh theme i not le4,.red Methods end soltuions different from those set out.in patriarch end Test Rsterlts
7 T.raep@tio
t. iof the guiotdoe
- ,t be ACCeptable if they provide a basis tor the findings req.,isaol to Fueus and Material&
Facilities
4 OeCUPSIAMIHal Ietththe issuance Ot ort-wntei*
ofta oeitnit or license by She Commnission
4 (uosil~nmontet end $,long 0 Antotoust ReviewCommiventsf arnd suiggeettlonsl ot ,improvements
,1n thet guidds ate, encouraged
5 MeAer,.41 slid Plant protection
10 General'teitnos,,
and guides -.lt be to-sted, as appropriate.
to accomimodate coinmonglo nd to ;calle" neRw Informatlion Of ..Poioancoo However.
comnments on Copies of published qurid*& may be obta~ined by writtent request &inidcatin~g thethis gude. .1 0ec..eed Ailh.,, about two months &flat its issuance, will be psi divsieonsl dolited to the U.S Nucleet Regulatory Commission.
Washinuton.
D Ctitularly utetutf in avlele~uai St.. need For en ejsiS, revition
2
6. AttentionS
Director, Office of Standards Developmeft regard to quantity but may not be physically possessed or used in any manner.1.S.2 General License for Possession of Small Quan-titiesSection 40.22. 10 CFR Par, 40, provides a generallicense for the use and transfer by certain persons forcertain uses of up to 15 pounds of source material itany one time provided that no more than 150 pounds ofsource material arc received in any caletndar year. Notethat the 15 pounds and 150 pounds of source materialrefer to contained source material.
For exdmple.
375pounds of thorium-magnesium alloy containing
4%thorium could be transferred and used at any one timeunder the general license.1.5.3 General Licenses to ExportThe export of source material in certain forms andquantities is authorized by a number of general licenseprovisions in §40.23. 10 CFR Part 40. If it is desired toexport forms or quantities of source material that arenot provided for in the general licenses of §40.23, it willbe necessary to file an application for a specific licensepursuant to § §40.31 and 40.33.above do not meet the applicant's needs, an application should be filed on Form NRC-2. All items of the applica-tion form should be completed In sufficient detail forthe NRC to determine that the applicant's equipment, facilities, and radiation protection program are adequateto protect health and ninimize danger to life andproperty.
Since the space provided un the application form islimited, the applicant should append additional sheets toprovide complete information.
Each separate sheet ordocument submitted with the application should beidentified as to its purpose, e.g., response to an item ofthe application form, radtation safety instructions, etc.Five copies of the application should be completed.
The original and three copies should be mailedto: Radioisotopes Licensing Branch, Division of FuelCycle and Material Safety, Office of Nuclear MaterialSafety and Safeguards, U.S. Nuclear Regulatory Corn.mission, Washington, D.C. 20555. One copy should beretained by the applicant since the license will require, asa condition, that the institution follow the statements and representations set forth i. the application and anysupplement to it.1.6 Exemptions
3.2 Proprietary Information Paragraphs
40.13(a)
and (b) provide certain exemp-tions from Commisson rules and regulations andrequirements for licensing.
If the concentration byweight of source material in the materials beingprocessed does not exceed 1/20th of one percent(0.05%) at any time during processing and use, suchprocessing and use are cexempt from licensing.
Thereceipt, possession, use, and transfer and the import of"unrefined and unprocessed"
ore a:. also exempt fromlicensing.
2. LICENSE FEESAn application fee is required for most types oflicenses.
The applicant should refer to §170.31,"Schedule of Fees for Materials Licenses,"
of 10 CFRPart 170 to determine the amount of the fee that mustaccompany the application.
Review of the application will not begin until the proper fee is received by theNRC.3. FILING AN APPLICATION
3.1 Application Form NRC-2*When the exemptions or general licenses described
"Form NRC-2 was fotmefly designated Form AEC.2. Existingcopies of Form AEC-2 may still be used. See Appendix to thisguide.The applicant should not submit proprietary inform-ation unless it cannot be avoided in giving a completedescription of the applicant's equipment, facilities, andradiation protection program.
If the use of proprietary information cannot be avoided, the proprietary informa-tion should be separated from the rest of theapplication, and an application for withholding frompublic inspection should be submitted in conformance with the requirements of § 2.790 of 10 CFR Part 2.3.3 Environmental Information A formal environmental report is not specifically required for the type of activities included in the scopeof this document.
However, the Commission has aresponsibility to determine if the "conduct of any otheractivity"
will significantly affect the quality of theenvironment when issuing new licenses or amendments and renewals of existing licenses.
Certain large-scale processing operations and associated waste storage anddisposal activities may require evaluation pursuant to 10CFR Part 51, "Licensing and Regulatory Policy andProcedures for Environmental Protection,"
unless theinformation submitted clearly shows no significant impact on the environment from the proposed opera-tions. The information concerning effluents submitted to show lack of impact should cover all aspects of theoperation and include the technical basis and rationale that support the evaluation of potential environmental effects.10.4.2
3.4 Safeguards No safeguard information is required in an initialapplication for licenses covered by this guide.The Commission uses an electronic data processing procedure to record certain types of information concerning source material.
Tiis sytem uses a three-letter Reporting Identification Symbol (RIS) to identifylicensees who must submit material transfer reports andperiodic material status reports in accordance with§40.64. 10 CFR Part 40. Applicants will be assigned aReporting Identification Symbol and will be informedhow it is to be used following issuance of the license.This information will be forwarded under separate coverfullinwing issuance of a license or license amendment authorizing greater than 1,000 kilograms of sourcematerial,
4. CONTENTS
OF AN APPLICATION
Many itenis on Form NRC-2 are self-explanatory.
Thefollowing comments apply to the indicated items onForm NRC.2.Item 4. Each site of use or storage should be given.Each site should be identified by street address.
city, andstate.Item 7. A brief narrative description of services orproducts in which the source material will be usedshould be submitted.
Item 8. The physical form specification (Item 8(c))should include percent by weight of source material.
This is necessary to determine the amount of sourcematerial to be covered by the license.
For example,2.000 pounds of monazite ore containing
5% naturalthorium would contain 0.05 x 2,000 = 100 pounds ofsource material.
In this case, "5%- should be entered inItem 8(c) and "100 pounds" in 8(d). Percent specifica.
tions may be given as a range. but the "MaximumAmount" (Item 8(d)) should be based on the upperlimit. The maximum total quantity to be on hand (item8(e)) should include all source materials, i.e., rawmaterials, materials in process and storage, scrap materi-als, and wastes. The possession limit requested should becommensurate with the applicant's needs and facilities for safe handling and disposal.
Item 9. An evaluation of the potential external andInternal radiation and uranium chemical*
hazards toworkers and the public should be submitted.
Applicants are expected to utilize all practicable means for reducingradiation levels and concentrations of radioactive
- For soluble mixtures of U 238, U.234. and U-235 in air,chemical toxicity may be the limiting facto
r. See Footnote
3 toAppendix B. 10 CFR Part 20.materials in ambient air and water and in effluents byemploying modern process.
containment, and ventilation engineering to avoid unnecessary exposures.
The limitsin 10 CFR Part 20 are not to be considered as designlimits. The analysis should include a narrative d',-:rip- tion of the proposed possession and tise of sour:ematerials from the time of receipt of raw materials toultimate disposition of products and wastes. Thechemical and physical form. percent by weight. and totalbatch size for each step in a processing operation shouldbe estimated.
A sampling program may be required forraw materials and when changing or initiating
!,ewprocedures to determine concentrations and quantities of source materials at each stage of a process.
Each staczeof a process should be con.i~dered in evaluating potential hazards.
For example.
the processing of uranium mayproduce dust in the processing rea., release radondaughter products.
result in loose contamination iroinspills during transfers, and result in releases of dusts tothe environment from ventilatii
' system exhausts.
Written radiation safety procedures and instructions covering all operations should be submitted.
Theseshould cover potential external radiation exposures topersonnel;
the possible production of gas. vapor. dust. orother airborne radioactivity:
generation of liquidscontaining suspended or dissolved materials:
and thegeneration of solids as fines, scrap, slav. etc.. according to the process involved.
Item 10. A description of the training and experience of each person who will directly supervise the use ofimaterial or who will have responsibilities for radiological or uranium chemical safety should be submitted.
The description should include the type (on-the.job or formal course work). location, duration, and nature(subject.
depth, scope. etc.) of the training.
Trainingshould cover (a) principles and practices of radiation protection.
(b) radioactivity measurements, stanu'ardiza- tion. and monitoring techniques and instruments.
(c)mathematics and calculations basic to the use andmeasurement of radioactivity, (d) biological effects ofradiation, and (c) principles and practices of protection against the chemical toxicity of source materials.
The description of the personal use of radioactive materials or equivalent experience should include thespecific isotopes handled, the quantities of materials handled, the chemical and physical form of materials handled, where rthe experience was gained, the durationof experience, and the type of use. Personnel qualifica- tions should be commensurate with the use of thematerials as proposed in the application.
Item 11. The equipment, facilities, and instrument:a- tion for each site of use soiould be described in detail.The proposed equipment and facilities for each opera-tion must be adequate to protect health and minimize10.4-3
3.4 Safeguards No safeguard information is required in an initialapplication for licenses covered by this guide.The Comnmission uses an electronic data processing procedure to record certain types of information concerning source material.
This sytem uses a three.letter Reporting Identification Symbol (RIS) to identifylicensees who must submit material transfer reports andperiodic material status reports in accordance with§40.64, 10 CFR Part 40. Applicants will be assigned aReporting Identification Symbol and will be informedhow it is to be used followving issuance of the license.This information will be forwardc-d under separate coverfollowing issuance of a license or license amendment authorizing greater than 1 ,000 kilograms of sourcematerial.
4. CONTENTS
OF AN APPLICATION
Many items on Form NRC.2 are self.explanatory.
Thefollowing comments apply to the indicated items onForm NRC.2.Item 4. Each site of use or storage should be given.Each site should be identified by street address, city, andstate.Itcn 7. A brief narrative description of services orproducts in which the source material will be usedshould be submitted.
Item 8. The physical form specification (Item 8(c))should include percent by weight of source material.
This is necessary to determine the amount of sourcematerial to be covered by the license.
For example,2.000 pounds of monazite ore containing
57e naturalthorium would contain 0.05 x 2,000 = 100 pounds ofsource material.
In this case, "5%" should be entered inItem 8(c) and "100 pounds" in 8(d). Percent specifica.
tions may be given as a range. but the "MaximumAmount" (Item 8(d)) should be based on the upperlimit. The maximum total quantity to be on hand (Item8(e)) should include all source materials, i.e., rawmaterials, materials in process and storage, scrap materi-als, and wastes. The possession limit requested should becommensurate with the applicant's needs and facilities for safe handling and disposal.
Item 9. An evaluation of the potential external andintemal radiation and uranium chemical$
hazards toworkers and the public should be submitted.
Applicants are expected to utilize all practicable means for reducingradiation levels and concentrations of radioactive
- For sluble mixtures of U 238, U-234, and U-235 in airchemical toxicity may be the limriting facto
r. See Footnote
3 toAppendix B. 10 CFR Part 20.materials in arbient air and water and in effluents byemploying modern process.
containment, and ventilatton engineering to avoid unnecessary exposures.
Tihe limitsin 10 CFR Part 20 arc not to be considered as desipilimits. The analysis should include a narrative d'.,crip- tion of the proposed possession and use of sourxematerials from the time of receipt of raw mnateriab, toultimate disposition of products and waste-. Thechemical arid physical form. percent by weight. arid totalbatch size for each step in a processing operation shouldbe estimated.
A sampling program may be required forraw materials and when changing or initiating newprocedures to determine concentrations and quantitics of source materials at each stage of a process.
Each stageof a process should be con.idered in evaluating potential hazards.
For example.
the processing of uranium mayproduce dust in the processing area, release radondaughter products, result in loose contamination trotmspills during transfers, and result in releases of dusts tothe environment from ventilatiL
i system exhausts.
Written radiation safety procedures and instructions covering all operations should be submitted.
Theseshould cover potential external radiation exposures topersonnel;
the possible production of gas. vapor. dust. orother airborne radioactivity:
generation of liquidscontaining suspended or dissolved materials:
and th'>generation of solids as fines. scrap. slag. etc.. according to the process involved.
Item 10. A description of the training and experience of each person who will directly supervise the use ofntaterial or who will have responsibilities for radiological or uranium chenical safety should be submitted.
The description should include the type (on-the-job or formal course work), location, duration.
and nature(subject, depth, scope. etc.) of the training.
Trainingshould cover (a) principles and practices of radiation protection, (b) radioactivity niasurencents.
standardiza- tion, and monitoring techniques and instruments.
(c)mathematics and calculations basic to the use andmeasurement of radioactivity.
(d) biological effects ofradiation, and (e) principles and practices of protection against the chemical toxicity of source materials.
The description of the personal use of radioactive materials or equivalent experience should include thespecific isotopes handled, the quantities of materials handled, the chemical and physical form of materials handled, where the experience was gained, the durationof experience, and the type of use. Personnel qualifica- tions should be commensurate with the use of thematerials as proposed in the application.
Item 11. The equipment.
facilities, and instrumenta- tion for each site of use should be described in detail.The proposed equipment and facilities for each opera-tion must be adequate to protect health and minimime10.4-3 danger to life and property.
In describing equipment andfacilities, the following information should be included:
a. Description of site. A description of the areasurrounding each facility should be submitted estab.lishing distances to, and the use of, neighboring buildings and facilities.
A general site description should includestorage, processing, and waste holding areas. Restricted areas and methods for controlling access to such areasshould be described.
Diagrams of the plant layoutdepicting process areas, storage areas, laboratories, clothing change areas, offices, etc.. should be submitted.
Explanatory sketches, drawings, and process flowdiagrams should be appended to the application, asappropriate.
b. Description of storage facilities.
Consideration ofshielding, containment, and security of material shouldbe included.
c. Description of general safety equipment.
Adescription of protective clothing, general and personalair sampling equipment, fume hoods, waste receptacles, auxiliary shielding,
"veste holding tanks, firefighting andfire prevention equipment, vacuum systems, safetyshowers, and any other equipment that would contrib.ute to safe- use of materials should be described asappropriate.
d. Description of ventilation and containment systems, filters, dust collection devices, scrubbers.
anddischarge stacks and vents. Ventilation and containment equipment should be described as it relates to the phaseor type, of processing of source material involved.
Criteria and procedures for evaluating the performance of the equipment should be specified.
e. Description of respiratory protection program.Applicants are expected to consider means for reducingconcentrations of airborne radioactive materials byemploying modern process, containment, and ventilation engineering controls whenever possible.
The use ofrespiratory equipment will not be considered anadequate substitute for a well.planned safety programfor reduction of potential airborne contamination.
Section 20.103, 10 CFR Part 20, currently requiresapplicants to obtain specific approval before makingallowance for the protection afforded by use of respira.tory protective devices.
However, Commission require-ments concerning respirators and associated protection factors are not meant to discourage their use as anadditional precaution in routine operations, Inemergency situations, or in cases where protection fromrespiratory hazards other than airborne radioactive material is needed.A formal respiratory protection program may beestablished and approved pursuant to Section 20.103(c)
of 10 CFR Part 20.0 Specification of a respiratory protection program should include the following information:
(I) A written management policy statement.
Subjects to be covered by the policy statement includethe ;tse of practicable engineering controls instead ofrespirt.'ors;
the use of respirators in routine, nonroutine, and emergency situations:
and limits on periods ofrespirator use and relief from respirator use.(2) Specification of respiratory equipment andrationale for selection.
Equipment approved underappropriate approval schedules in 30 CFR Part I I of theU.S. Bureau of Mines -National Institute for Occupa.tional Safety and Health (NIOSH) should be used.(3) Written operating procedures to cover trainingof personnel and fitting, use, testing, cleaning, dczontamination, inspection, repair, and storage ofrespiratory protection equipment.
(4) A description of the air sampling program.(5) A description, of the bioassay program tomonitor effectiveness of the respiratory protection program.(6) A descriptiori of the medical evaluation program.
Workers should be evaluated by competent medical personnel to ensure that they are physically andmentally able to wear respirators.
These evaluations should be part of the employee's periodic physicalexamination.
f. Description of the radiation detection instruments to be used.(1) The manufacturer's name, Instrument modelnumber, the number available, the type of radiation detected (alpha, beta, or gamma), the range (milliroent.
gens/hour, or counts/minute),
the window thickness inmg/cm2, and type of use should be specified for eachinstrument.
The type of use would normally bemonitoring, surveying, assaying, or measuring.
(2) The frequency and methods of calibration ofinstruments should be described, Daily or more frequentoperational checks of survey instruments should be*A notice of proposed amendments to §20.103,
10 CFR Part20, was published for public comment on August 21. 1974 (39FR 30164). Guidance as to acceptable methods of implement.
4% the proposed rule changes, such as protection factors andreferences to acceptable equipment, would be set out in aregulatory guide, and related technical Information would beprovided in an associated manual. The regulatory guide and themanual will be issued following the adoption of the proposedamendments to § 20.103.!i10.4-4
0supplemented periodically by a complete calibration ofall ranges of each instrument.
If survey instruments willnot be returned to the manufacti-'-
Fr calibration, adetailed de;cription of planned calibr-tion procedures should be submitted.
The description should includestandard sources to be used, facilities to be used,pertinent experience of each individual who will performthe calibrations, and procedures to ensure safe andaccurate calibrations.
g. Description of personnel monitoring equipment.
The type of equipment (film badges, TLD. pocketdosimeters)
to be used, the f-equency of evaluation, andwhether the devices are used to evaluate whole body orextremity exposure should be specified.
A description ofmethods of calibrating and processing monitoring equip-ment or specification of the type of services to beobtained from a commercial supplier should besubmitted.
Item 12 Radiological and uranium chremicall safetyprocedures should be developed regarding all aspects ofthe radiation and uranium chemical safety program.These procedures should be established to ensurecompliance with the provisions of 10 CFR i.'t, 19."Notices, Instructions and Reports to Workers;Inspections,"
and 10 CFR Part 20, "Standards forProtection Against Radiation."
The procedures shouldbe specific to the activities for which a license is sough:and should cover all external and internal radiation hazards associated with these activities at all locations ofuse.Item 12[a). Safet, features and procedures.
Safetyand fire prevention aipects of the program such asstorage of flammable or caustic reagents apart fromsource materials, temperature controls on dryers, or useof inert atmospheres in thorium-magnesium machining should be described.
Item 12(b). Emergency and decontamination procedures.
A copy of emergency procedures to beposted in all laboratory or work areas where radioactive materials are used should be submitted.
These instruc-tions should describe immediate action to be taken incase of an emergency in order to prevent release ofradioactive material or further contamination of workareas and personnel.
Examples of emergency procedures are turning off the ventilation systems, evacuation of thearea, re-entry, procedures for containment of spills, etc.The instructions should specifically state the names andtelephone numbers of responsible persons to be notified.
- For gluble mixtures of U.238. U-234, and U-235 in air,chemical toxicity may be the limiting facto
r. See Footnote
3 toAppendix B, IOCFR Put 20.Item 12(c).a. Radiation Survey Program.
A survey means anevaluation of the radiation hazards incident to produc-tion, use. release, disposal, or presence of radioactive materials under a specific set of conditions.
Whenappropriate, such evaluation in:ludes a physical sarveyof 'he location of materials and equipment and measure-ments of levels cf radiation or concentrations ofmaterials present.A more extensive survey program may be needed forevaluation and verification of potential hazardsassociated with pilot studies and initial phases of a full-scale produat',n
,.peration than is needed for day.to-day operations within an established program.
Provisions forevaluation
,,f all changes in operations should be mad
e. The proposeJ
survey program should he designed tomonitor t!he adequacy of containment and control provi-sions for radiological safety purposes.
The areas ofprimary concern for source material operations are airsampling, monitoring releases to unrestricted areas.surveying for personnel contamination, and surveying toevaluate surface contamination.
Gamma surveys ofprocessing and storage areas may be required for opera-tions involving concentrated or pure source materials.
The types, methods, and frequency of surveys should bedescribed in detail as they relate to the type of progr:rminvolved.
(1) The survey program for evaluation of alphacontamination of personnel and plant surfaces shouldinclude provisions for monitoring protective clothing, hands, and feet of workers leaving restricted areas beforebreaks and at the end of shifts. Surveys of gloves andother protective clothing, equipment, or toots requiredduring processing should be described.
The survey program associated with cleanupefforts where dust or loose materials may be involvedshould be described.
Reasonable efforts should be madeto remove all residual contamination.
Surface contamination evaluation should includeunrestricted areas such as lunch rooms, offices.
etc.Acceptable limits of fixed and removable contamination for facilities and equipment should be established andsubmitted.
(2) Acceptable limits of fixed and removable contamination for fa:iities and equipment to bereleased for unrestricted use should also be established and submitted.
For example, if, after reasonable effortsto remove all residual contamination, maximum alphareadings are 3,000 dpm/100 cm2 or less and the averageis 1,000 dpm/100 cm2, unrestricted use is permissible provided that removable alpha contamination does notexceed 200 dpm/100 cm2.These guidelines apply to10.4-5 natural thorium.
For natural and depleted uranium, thelevels may be a factor of 5 higher.(3) A description of an air sampling programshould define the areas where samples will be taken, thefrequency of sampling, and appropriate spatial relation- ship between sampling locations and workers'
breathing Lones. The type (gross alpha, fluorimetric, etc.), justifi-cation for, and sensitivity of assays that will beperformed to evaluate air samples should be described.
The methods used to relate sample results to actualpersonnel exposure should be described.
If air samplinginstruments
%%ill not be returned to the manufacturer forcalibration, the methods, frequency, and standards usedfor calibration should be specified.
(4) The effluent monitoring program for releasesto unrestricted areas should encompass all airborne andliquid releases.
Calculational evaluations should besupplemented by stack monitoring, waste streammonitoring, water sampling, or other environmental m-,nitoring as appropriat, for the planned and potential releases of radioactive materials.
b. Specification of radiation safety responsibilities and duties. The responsibilities and duties of manage-ment, any radiation safety committees, radiation safetyofficers, and use of consultants should be established and clearly described.
Individuals having radiation safetyresponsibilities should be identified by name and eachindividual's pertinent training and experience described.
Assignment of duties should cover all aspects of theradiation safety program.c. Bioassay program.
Regulatory Guide 8.11,"Applications of Bioassay for Uranium."
outlines theinformation to be submitted concerning a bioassayprogram.
Regulatory Guide 8.11 specifically deals withdepleted, natural, and enriched uranium;
however, someof the methods and concepts are applicable to thorium.d. Records management.
Provisions for keeping andreviewing records of surveys, material inventories, personnel exposures, and receipt, use, and disposal ofmaterials should be described.
e. Materials control provisions.
Procedures forordering materials, for notification of responsible persons upon receipt, and for safely opening packagesshould be submitted.
Section 20.205, 10 CFR Part 20,requires monitoring of certain packages upon receiptdepending on the quantity of contained material and Itsform. Monitoring of external package surfaces forcontamination is required upon receipt of packagescontaining more than I millicurie of source materials (greater than 3.3 pounds of natural uranium).
Ifremovable contamination in excess of 0.01microcuries/l00
cm2is found on the external surfacesof the package, notification of the shipper and theCommission is required by §20.205,
10 CFR Part 20.f. Procedures for training personnel.
A description ofthe training programs for all personnel who arc involvedin or associated with the use of materials should besubmitted.
The description should include the form oftraining (formal course work, lectures, on-the-job instruction, written instruction, or manuals),
duration oftraining, retraining provisions, and the subject matter tobe included.
Copies of training procedures and manualsshould be submitted.
Itent 13. The description of the waste disposalprogram should specify the quantities and types ofradioactive waste products generated by all phases ofoperation.
Consideration should be given to the disposalof contaminated equipment such as filters, tools, processequipment.
scrap, fines, and any wastes generated frommolding, grinding, or machining operations.
Airbornewastes released from processing facilities, ventilation systems, or dust collection systems, and liquids andsolids from chemical processing and melting should beconsidered where such processes are involved.
Wastes generated ps a result of operations involving source materials should be disposed of in a safe manne
r. Sections
20.301 through 20.305, 10 CFR Part 20, dealwith waste disposal.
The applicant should specifically describe waste disposal methods and procedures.
Wastes which are soluble or readily dispersible inwater may be disposed of in the sanitary sewer systemsubject to the concentration and the daily, monthly, andannual limits specified in § 20.303, 10 CFR Part 20. Forexample, up to one millicurie of natural uranium may bedisposed of daily provided the concentration in sewagedoes not exceed 1 x 10-3 microcuries/ml when dilutedby the licensee's average daily quantity of sewage. Sewerdisposal of radioactive materials by a licensee Is limitedto a total of one curie/year and average monthlyconcentrations not exceeding restricted area waterconcentrations.
Wastes may be buried in soil. Such burials aresubject to the four-foot depth. six-foot separation, and12-per-year limitations of §20.304,
10 CFR Part 20.The quantity per burial is limited to 100 rnmllicuries forsource materials
(330 pounds of natural uranium).
The most commonly used method of disposal istransfer to a commercial firm licensed to accept suchwastes. Lists of such firms are available from theCommission upon request.
In dealing with such firms,prior contact is recommended to determine specificservices provided.
If other methods of disposal are requested, theinformation specified in §20.302.
10 CFR Part 20,10.4-6 should be submittcd.
The information should includethe quantities and kind of materials, levels of radio-activity, a description of the manner and conditions ofdisposal, and evaluation of environmental effects, andcontrol procedures.
Any long-range disposal plans for large volumes oflow concentration source material waste should bedescribed.
Applications for processing operations, suchas rare earth extraction, that generate large volumes ofwastes should include detailed specific plans for ultimatedisposal of such materials.
When such wastes are to be held for significant periods of time on site in basins, etc., adequate provi-sions for containment, security, and long-term controlshould be made. Plans for any interim type of storageshould be described in detail.Ihem 14. If distribution of products containing source material is planned, the detailed description ofthe products outlined in Item 14 of the application Form NRC-2 should be supplemented, as appropriate, with the following:
a. A description of the quality assurance program,including process control measures, sampling plans,product examination and testing, acceptance criteria.
and testing and examination of prototype or production products, which establishes that the products willconsistently have the radiation safety characteristics described to the Commission and that these charac-teristics will not be significantly degraded over theexpected lifetime of each product.b. If appropriate, a description of labeling, including label materials, content, location on the product, andmethod of attachment.
c. Estimates of radiation doses to users of theproducts and others who 'may be exposed to radiation orradioactive materials from the products and the basis forthese estimates.
5. AMENDMENTS
TO LICENSESLicensees are required to conduct their programs inaccordance with statements, rcprescntationis, andprocedures contained in the licenso application andsupportive documents.
The license must therefore b.aniended if the licensee plans to make any changes infacilities, equipment (including monitoring and surveyinstruments),
procedures, personnel, or source materialto be used.Applications for license amendments may be filedeither on the application form or in letter form. Theapplication should identify the license by number andshould clearly describe the exact nature of the changes.additions, or deletions.
References to previously submitted information and documents should be clearand specific and should identify the pertinent informa-tion by date, page, and paragraph.
6. RENEWAL OF A LICENSEAn application for renewal of a license should be filedat least 30 days prior to the expiration date. This willensure that the license does not expire until final actionon the application has been taken by the NRC asprovided for in paragraph
40.43(b)
of 10 CFR Part 40.Renewal applications should be filed on the FormNRC-2, appropriately supplemented, and should containcomplete and up-to-date information about theapplicant's current program.In order to facilitate the review process, the applica-tion for renewal should be submitted without reference to previously submitted documents and information.
Ifsuch references cannot be avoided, they should be clearand specific and should identify the pertinent informa-tion by date, page. and paragraph.
10.4-7 APPENDIXfORM CC-2 FORM APPROVED(- OUREAU OF BUDOET NO 3-Ao002UNITED STATES ATOMIC ENERGY COMMISSION
APPLICATION
FOR SOURCE MATERIAL
LICENSEPursuant to the regulations in Title 10, Code ot Federal Regulations, Chapter 1, Part 40, application is herebymade for a license to receive, possess, use, transfer, deliver or import into the United States, source materialfor the activity or activities described.
1. tCAch 2. N1AME OF APPLICANT
0 (a) New licenseC (b) Amendment to License No.
3. PRINCIPAL
auSINES.S
ADODESIS3 (c) Renewal of License No.O (d) Previous License No.4 STATE THE ADDRESSIES)
AT WHICH SOURCE MATERIAL
WILL oB POSSESSED
OR USED5 BUSINESS
OR OCCUPATION
&. (1 IF APP.ICANT
IS AN INDIVIDUAL.
STATE (b) AGECITIsrs I7 DESCRIBE
FOR WHICH SOURCE MATERIAL
WILL BEr USED0 %TATE THE TYPE OR TYPES. CHEMICAL
FORM OR FORMS. AND QUANTITIES
OF SOURCE MATERIAL
YOU PROPOSE TO 1RE1CCIVE.
POSSESS.
USC. OR TRANSFER
UNDER THE LICENSE(a) TYPE (b) CHEMICAL
FORM (c) PHYSICAL
FORM (Includin (cd) MAXIMUM AMOUNT AT% U or Th.) ANY ONE TIME (in pounds)NATUHAL URANIUMURANIUM DEPLETID
INTHE U-235 ISOTOPETHORIUM tIsOrOPLi (a) MAXIMUM TOTAL QUANTITY
OFr 6OUV4CE MATERIAL
YOU WILL. HAVE ON HAND AT ANY TIME (.inpou~d.1
9 DESCRIBE
THE CHEMICAL.
PHYSICAL.
METALLURGICAL.
OR NUCLEAR PROCESS OR PROCCISES
IN WHICH THE SOURCE MATIERIAL.WILL
BE USED. I NOICATING
THE MAXIMUM AMOUNT OF SOURCE MATERIAL
INVOLVED
IN EACH PROCESS AT ANY ONE TIME. AND PROVIDING
A THOROUGH
EVALUATION
Or THE POTENTIAL
RADIATION
HAZARDS ASSOCIATED
WITH EACH STEP OF THOSE PROCESSES.
10 OISCRcIIUE
THE MINIMUM TECHNICAL
OUALIFICATIONS
INCLUDING
TRAINING
AND 1EXPERIENCE
THAT WILL BE RECUIRO OC" AP-PLICANT'S
SUPERVISORY
PERSONNEL
INCLUDING
PERSON RESPONSIBLE
FOR RADIATION
SAFcTy PROGRAM (OR OF APPLICANT
IFAPPLICANT
IS AN INDIVIDUAL).
1l OfSCRIBE
THE LOUIPMENT
AND FACILITIES
WHICH WILL 0E USED TO PROTECT HEALTH AND MINIMIZe OANGEIR TO LIFE OR PROPERTYAND RDELAfE 1 HE kjU.E OF THEN LOUIPM ENT ANOFACILITIES
TOTHE OPERATIONS
LISTEo IN ITEJM gINCLUODE(a)RAOIATtONPDETECTION
AND RELA T ED INTF1UMENTS
including badgln. dosdmctIn counters, lit sampling.
and other survey equtpmrriwt soappeovelate.
The d,.etiptlon o1rtadltl-fi ICIftI~tPI
If~c t IA)lI Icilu*.lt the Inttrumnet characteristic*
ouch as type of radiation detectd.
window Ihicbnfst, and the rgnsr(e)
of each in.stUwme4flt).
(6) METHOD.
AND STANDARDS
USED IN CALIBRATING
INSTRUMENTS
LISTED IN (W) ABOVE. INCLUDING
AIR SAMPLINGI
EQUIPMENT
(for fim badges. sprtrfy method of casltahl and processing or amem
10.4.8 APPENDIX-Continued Page 21I(c). VENTILATION
ECQUIPMENT
WHICH WILL BE U!;rD IN OPERATIONS
WHICH PRoDUCc DUo?. rumes. OR GA5C:E. INCLUDING
PLAN VIEW SHOWIN4G
TYPE AND LOCATIONOF
HOOD0 ANDr ILTCES.MINIMUM
VELOCITIES
MAINTAINCOAT
H10 OPLSNI.G
AND PRO.CEOURES FO)l TESTING SUCH EQUIPMENT
I
t. DESCRIBE
PROPOSED
PROCEDURES
TO PROTECT HECALTH AND MINIMIZC
DANGER TO LI4E A^NO PROPERTY
AND RELATE PRO.CEDURES TO THE OPERATIONS
LISTED IN ITEM 9ý INCLUDE (e) SAFrTY FEATURES
AND P4OCCDURnEs TU AVOID NONNUCLLA"
AC"I.CENTS, SUCH AS FIRE. EXPLOSION.
ETC , IN sOURCC MATERIAL
STORAGE AND PsG'oCcSsaG
AMFAI,4b) EMERGENCY
tb) ~ n ;;--, -MREC -V"N r~5.l*CLLL
JML- HHLLV NTO ACCIDENTý!""'C"
MIGHT INVOLVE SOURCE MATERIAL(*) DETAILED
DESCRIPTION
OF RAOIAl ION SURVrEY PROGRAM AND PROCEDURES.
1I. WASTE PRODUCTS:
If none will be gellerelted.
state "'None" opposite (a). below. It waste products will be dener.ated. check here 0 and esplain on a supplemental sheet:(a) Quantity and type or radioactive waste that will be generated.
(b) Detailed procedures for waste disposal.
I&. IF PRODUCTS
FOR DISTRIBUTION
TO THE GENERAL PUBLIC UNDER AN EXEMPTION
CONTAINED
IN10 CFR 40 ARE TO BE MANUFACTURED,
USE A SUPPLEMENTAL
SHEET TO FURNISH A DETAILEDDESCRIPTION
OF THE PRODUCT.
INCLUDING:
(a) PERCENT SOURCE MATERIAL
IN THE PRODUCT AND ITS LOCATION
IN THE PRODUCT.(b) PHYSICAL
DESCRIPTION
OF THE PRODUCT INCLUDING
CHARACTERISTICS.
IF ANY. THAT WILLPREVENT INHALATION
OR INGESTION
OF SOURCE MATERIAL
THAT MIGHT BE SEPARATED
FROM THE PRODUCT.(c) BETA AND BETA PLUS GAMMA RADIATION
LEVELS (Specify instrument used. date of calibration andcalibration technique used) AT THI SURFACE OF THE PRODUCT AND AT 12 INCHES.(d) METHOD OF ASSURING
THAT SOURCE MATERIAL
CANNOT BE DISASSOCIATED
FROM THE MAN.UFACTURED
PRODUCT.CERTIFICATE
(This item must be completed by applicant)
is. The applicant, and any official executing this certificate on behalf of the applicant named in Item 2,certify that this application is prepared in conformity with Title 10, Code of Federal Regulations, Part 40, and that all information contained herein, including any supplements attached hereto, istrue and correct to the beat of our knowledge and belief.DatedlApph~eant na~med In haem 3)BY:APrent of type name under u'ans lueir),Tart ut ..-II'Iwng 0MCe', .) ther,,ed'
ato anE behalf of Ahc applwatsC
WAItNlN.%(:
1.11 II.S.I. Sreclioti
1001. Art iruni Jue'*V. 1918;t "1 Six(. 749; makmh ts haefrnmineal Ouinje to MakP a Will(Ully UNA' S ,IaCmeni or rt'plrr~t~snticin lo an) departmenl t orallene of the' Unlied Slhiell 9410 anY Muller within Its JurisdIction.
it u's ovwma4l mIft pU Inoaal@10.4.9