Regulatory Guide 10.2
| ML13350A217 | |
| Person / Time | |
|---|---|
| Issue date: | 03/31/1976 |
| From: | NRC/OSD |
| To: | |
| References | |
| RG-10.002 | |
| Download: ML13350A217 (5) | |
U.S. NUCLEAR REGULATORY COMMISSION March 1976 REGULATORY GUIDE
OFFICE OF STANDARDS DEVELOPMENT
REGULATORY GUIDE 10.2 GUIDANCE TO ACADEMIC INSTITUTIONS
APPLYING FOR SPECIFIC BYPRODUCT MATERIAL LICENSES
I. INTRODUCTION
Separate license applications should be submitted for special nuclear mateiial (see LO: CIR Part 70). source This guide describes the type of information that material (see 10 CFR Part 40) ori*'kilucurie sources used should be submitted in applications for specific licenses in gamma ihradiation failities. Tafurnitatioii ont the for lhe possession and use by academic institutions of preparation of license ,applications 'ror special nuclear byproduct malcrial (rcactor-produic.d radionuclides). It material and for gammi'Irradiittbs may also be obtained also includes the general principles that will be con. from the NRC Radioisotopes Licnsing Branch.
sidered in evaluating an applicant's proposed radiation safety measures. This type of license is provided for Before proce6ag lurlher. ati applicant should deler- under Title 10, Code of Federal Regulations, Part 30, mine if tl4:tinstifiltor needs are in excess of the
"Rules of General Applicability to Licensing of By. quantitics I
,,d Iiit'§ 30.71, Schedule 13.10 CFR Part product Material" (10 CFR Part 30). Other regulations 30.ary to submit ant application t) lte pertaining to this type of license are found in 10 CFR NRCr'*I'q*.an'tties of byproduct materi:il that may be Part 19, "Notice. Instructions, and Reports to Workers: po*meinc:ýursuant to the excinption in § 30.18.
Inspections," and 10 CFR Part 20, "Standards for Protection Against Radiation." The applicant should.') : cf. iobgeneral principles will be considered in evaluat- carefully study the regulations awid this guide and subn ilt t*',$roposed radiation safety measures. Recognition by all information requested. ,,lJ2£ N
e institution of:
The Nuclear Regulatory Commission (N wil I. The management's* responsibility for tlhe safety of normally issue a single license to cover4, aI employees and the public;
institution's entire radioisotope pr, am. S pa' e licenses are not normally issued to diffTt dep ments 2. Its responsibility for maintaining offsite releases as of an academic institution, nor ar 4.. ed to low as is reasonably achievable ý.ALARA);
individuals associated with the institution.
3. Its responsibility for minimnizing exposures to em- If the institution has extensive radioisotope ployees, students, and visitors' and program with a need f gr riety ol radionuclides for many uses, it may wi ap for a specific license 4. Its responsibility for avoiding significant increases in of broad scope. 1censc is described in 10 environmental radioactivity.
CFR Part 33, " ecifi ice ses of Broad Scope for Byproduct N e Inf ation on the preparation of This guide is intended only for general guidance in applicatio or censes of broad scope may be preparation of the license application and should not be obtained adioisotopcs Licensing Branch, Divi- sion of Fuel - and Material Safety, Office of Nuclear "Management is defined as those persons authurized by lhe Material Safety d Safeguards, U.S. Nuclear Regulatory charter of the academic institution to make its policies and Commission, Washington, D.C. 20555. diiect its activities.
USNRC REGULATORY GUIDES Comments should be sent to the Secfetat~y of Ph*Commi~stio.. U S. Nucear, Aagwleto,v Gudas 0,0 .%sued to desco~beand makeavaelable to th public RAgulatory Commimssion.Wathnmgtoe. OtC. 20%56. Attention Doctiateemg and methods acecotable to the NRC %tallof nimplementing specific panst the seric Secio Comnmission'& regulations. to det-aeto lechneqseaausead by the Satlef, 4 avald the guihdes a.. tts,~ed in the followiig Isn broad 4-1-eons aminespecific problems of postlethted accidents. ot to provide guidenc to aspI'
CantsI Regulatory Guide% are not substitutes tot tetrulat~ons- and con'ptance I Power fleetiots 1, Products withmthemnise not ailit.fed Methods end soluetions idfiefent learn ths fist o in 2 Reeac and Test Reactors P Teaneponettrrt the guidirt wdl be seceptvable 41they ) 0-ovdda hat., tIn,the findings requ'iste, to I fuel&and Meteec16 atsPcit-ies a Occupateonel Health the~~~~~~~~~~~~~~~
emt( l~nOb01ri~~ne~ h om~~na v,tan,onfeteand Siting
1suar 9 Ant~trust fleview, Comme.nts and %wgyesi.0ns foe mli'ovemen.*ts in these guide$ aid, enCouwged S Meteriets end Plant Protect-on ?0 OGn..eta
- I Ai times,. and gd.do weillbe if-tsed, at Appeopt-Ala. to accormmodate amen.
monte and Io reflect new, informatiron of waspeeoncit However. comments on Copies of pubisihed guides may be obtained by wrtenftf sequest indicatintg f#,.
this u.,da.f0 eceived within about two O noflh, After Ift Issuance. Wit1be 0ee divisions desiead to tha VS Nieclaae Regulatory Commnission, Wathtngtomn, 0 C
Ieculadfv useful ontanalauctnq the need fo- an tparty Attenttimn Diactoe. Office of Standard$ Oaaetopmenc
70Wson16.
considered a substitute for the applicant's careful safety IV. INFORMATION TO BE SUBMITTED
evaluation of the proposed use of byproduct material.
The applicant imust ensure that the application correctly Since time space on the Form NRC-313 is usually not and adequately describes the radiation safety measures sufficient to contain all the required information, and procedures to be followed in order to pruvide additional sheets should be appended. Each separate adequate protection and satisfy ite four general princi- sheet or document submitted with time application pies listed above. should be identified by a hcadbig indicating the appro.
Paragraph 20.1(c) of 10 CFR Part 20 states that priate item number (Forti NRC-313) and its purpose,
".personsengaged in activities under licenses issued by e.g., radiation safety instructions, survey procedures, or the Nuclear Regulatory Commission pursuant to the instructions for opening packages.
Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974 should. in addition htemn 1(a) Enter the natte and corporate address of to complying with the requirements set forth in this the academic institution.
part, make every reasonable effort to maintain radiation exposures, and releases of radioactive inaterials in Itetm 1(b) List all addresses and locations where effluents to unrestricted areas, as low as is reasonably byproduct material will be used or stored if other than achievable" (ALARA). Regulatory Guide 8.t0. that inl Iter0 1(a), e.g., tniversity-ownled farm, secOltd
"Operating Philosophy for Maintaining Occupational campus. research statiott. A post office box number Radiation Exposures As Low As Is Reasonably should not be stated as the address for a place of use.
Achievable." provides the NRC stafr position on this important subject. License applicants should give Iten: 2 List all departments or sinilar subdivisions of consideration to the ALARA philosophy, as described in the institution where byproduct material will be used, Regulatory Guide 8.10. in tite developmnent of plans for e.g.. biology. physics. chemistry, department of reseat ch.
work with licensed radioactive materials.
Item 3 State previous byproduct license number if II. LICENSE FEES this is all application for renewal or amendment (see Sections V and VI of this guide).
An application fee is required for most types of licenses. The applicant should refer to § 170.31. hem 4 List all individuals who will use or directly
"Schedule of Fees for Materials Licenses." of 10 CFR supervise the use of byproduct material. Give the title or Part 170 to determine tile atnount of fee that mrust position and describe the training and experience of each accompany the application. Review of the application individual as outlined in Itenms 8 and 9.
will not begin until the proper fee is received by tite NRC.
lIemn 5 State name(s) and title(s) of person(s) desig- III. FILING AN APPLICATION nated by. and responsible to, the institution's manage- mtent for the coordination of the institution's radiation protection program (somtetimes designated the "Radia- A license application for byproduct material should tion Safety Officer").
be submitted on Form NRC.313.* "Application for
13)product Material License." All items on tihe applica- tion form should be completed in sufficient detail for Item 6(a) Ust each radionuclide to be used and the NRC to determine that the applicant's equipment, specify the particular nuclides to be licensed for use by facilities, and radiation protection program are adequate each Individual named in Item 4.
to protect health and minimize danger to life and property. Item 6(b) List the chemical and physical form and The application should be completed in triplicate. maximum quantity (in millicurles) of cach radionucllde The original and one copy should be mailed to: to be possessed at any one time. State separate posses- Radioisotopes Licensing Branch, Division of Fuel Cycle sion limits for eachi chemical and physical form re- and Material Safety, Office of Nuclear Material Safety quested, e.g., Iodine-131 as Iodide and as labeled and Safeguards. U.S. Nuclear Regulatory Commission, proteins. List the manufacturer, model number, and Washington. D.C. 20555. One copy of the application, quantity for all sealed sources. The possession limit for with all attachments, should be retained by tile appli- each radionuclide should include material held as radio.
cant. since the license will require, as a condition, that active wastes.
the institution follow the statements and representations set forth in the application and any supplement to it. Item 7 Describe the intended use for each radio.
nuclidc and form listed in lterm 6(a) and 6(b). Any use
'Form NRC-313 was formcrly dcsibnatcd Form AEC.313. of radioactive material in animals should be indicated.
Existing copies of Form AEC.313 may still be uscd. (Human use applications should be fided separately.)
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Note': For items 8 thrnugh 15, the applicant will find 1ten 13 Describe the facilities and equipminr (e.g.,
it necessarn to append additional sh/ets to prmoide remote handling equipment. storage containers. shield- (l'otnlclt injbronnalion. ing. fume hoods) it be made available at each location where radioactive matcrial will be used. Include a Itemns 8.9 Items 8 and 9 should be completed for description of tie area(s) assigned for the receipt.
eadi individual narmed in Items 4 and 5 of the storage, preparation, and measurement of radioactivc appli,.mation form. Use scparate appended sheets for each materials. A diagram should be suhmitted showing the individual. Describe the training and experience of the locations of shielding, the proximity of radiation sources radiation protection officer listed in Item 5. including to unrestricted areas, and other itemas related to radia- his experience in using radiation and radioactive mate- tion safety. Wherl applicabl Ieto facihlies where
' radio*
rials and his training in radiation protection. The active material may become airborne, itie diacrani, radiation protection officcr should be responsible to srould also include schemia tic descr iptions ot tire ventila- management for the overall radiation program within the lion system, with periinrlnl airl ow tates. pressumies.
institution. A statement describing this individual's filtratirn equipment, and monitoring instruments.
responsibilities and authority for carrying out the Diagramrs should be drawn to a specified scale. or radiation safety progrant should be provided. dimensions should be indicated.
item 10 List all radiation monitoring or measuring Item 14 Written radiation safety procedures it)be instruments that will be available for the use of followed by users should be pyovid ._ as part of the byproduct material. List the manufacturer's name and application and should include the following items:
model number of cach instrument, the number of instruments available, t[ie type of radiation detected (e.g.. beta, gamma). the range (e.g., mr/li,. cpm). a. Procedures for ordering radioactive materials. for window thickness, if applicable, and how used (e.g.. receipt of materials during off-duoy *hours, and for measuring, surveying). notification of responsible persons upon receipt of radioactive nmterials. These procedures should he ade.
Item 11 Describe the method. frequency. and the quate to ensure that possession limits are not exceeded.
standard(s) used for the maintenance arid calibration of that radioactive materials are secured against unautho.
radiation detection and survey instruments. Tests with rized removal at all times, and that radiation levels in small check sources (usually to determine that the unrestricted areas do not exceed the limits specified mi battery is good and the instrument is operating) are § 20.105 of 10 CFR Part 20.
important but should be supplemented with periodic calibrations on all ranges of the instruments to be used b. Procedures for examining incomning packages for for surveys. leakage. contamination. or danrage and for safely open.
ing packages in accordance with § 20.205 of 10 CFR
Itent 12 State tie name of tie organization furnish- Part 20. The monituring should be performed as soon as ing film badge or thernmoluminescent dosimeter (TLD) practicable after receipt of the package of radioactive service and specify the frequency with which the badges material. The procedures may vary depending upon the are changed and evaluated. If pocket chambers or pocket quantity of radioactive material received, but should, at dosimeters are used, state the useful range. frequency of a minimum, include instructions for surveying packages, reading, and the procedures for maintaining and calibrat- wearing gloves while opening packages, and checking ing tre devices. packing material for contaminatio
n. Even though
§ 20.205 exempts certain packages fotom insmediaic Describe the criteria, procedures, and equipment used monitoring, all packages should be monitored before for performing bioassays. If a commercial bioassay they are opened.
service is to be used, provide the name and address of the finr. Bioassays may be required when individuals c. A description of training required for laboratory work with millicurie quantities of hydrogen-3. iodine- personnel or students who are involved in or associated
125, or iodine-131 (depending on the chemical and with tie use of radioactive materials. The description physical form, the procedures followed, and the equip- should include the form of training (e.g., formal course ment used). Bioassays may also be required for other work, lectures), the duration of training, tie subject radionuclides if the chemical or physical form or matter included, and the means of determining the procedures and equipment used make it likely that proficiency of each person handling radioactive mate- radioactive material will be ingested, inhaled, or ab- rials. The training program should be of sufficient scope sorbed into the body. The Institution should show In its to ensure that all personnel using radioactive materials application that the need for bioassays has been thor- receive proper instruction in accordance with § 19.12 of oughly considered and that the proposed bioassay 10 CFR Part 19 and are knowledgeable in radiation program is appropriate for the institution's intended use safety procedures and techniques pertinent to their of radioactive material. respective duties.
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d. A copy of general instructions to be followed by e. A copy of emergency instructions to be posted in laboratory personnel or students while working with all laboratory areas where radioactive materials are used.
radioactive materials. These instructions should: These instructions should (I) describe immediate action to be taken in order to prevent contamination of personnel and work areas, e.g., turning off the ventila.
(i) Outline control procedures for obtaining per- tion, evacuation of the areas, containment of the spill, mission to use radioactive materials at the institution; (2) state the telephone numbers of the responsible give limitations on quntity to be handlcd per student or persons to be notified in case of an emergency, and (3)
allowed per experiment. instruct personnel on appropriate methods for recnter.
ing, decontaminating, arnd recovering facilities that may
(2) Explain what laboratory apparel to wear and have been accidentally contaminated.
what safety equipment to use (e.g., use of laboratory coats, gloves, and remote pipetting devices).
f. Procedures to be followed if radioisotopes will he used in animals, including (I) a description of the animal
(3) Prcscribc limitations and conditions on han- housing facilities, (2) a copy of instructions provided to dling liquid or loose (unencapsulated or dispersible) animal caretakers for handling animals, animal wastes, radioactive materials and what laboratory equipment to and carcasses, (3) instructions for cleaning and decon.
use in working with them. For example. explain when taminating animal cages, and (4) procedures for ensuring materials and operations should be confined to radio- that animal rooms will be locked or otherwise secured chemical fume hoods or gloveboxes and explain what unless attended by authorized users of radioactive shielding or remote handling equipment is to be used material.
when hard beta- or gamma-cmitting materials are handled. g. A description of the routine survey program, including the areas to be surveyed, the types and levels
(4) Instruct the user about routine survey and of radiation and contamination considered to be accept.
monitoring procedures for each contamination control able. and provisions for mainlaining records of surveys.
zone. The individual user should supplement the surveys performed by the radiation safety staf
f. Regularly used
(5) Instruct the user about movement of materials laboratories should be surveyed for contamination at the between rooms, halls, or in corridors, if applicable. cnd of each workday, and the user should maintain records of such surveys in units required by 10 CFR Part
(6) Explain requirements for storage of materials 20.
and labeling of containers and how areas will be identified where radioactive mnterials are used. Explain where and how contaminated articles and glassware are ltenm 15 Provide a complete description of specific to be handled and stored. methods used by the licensee for waste disposal of byproduct material. A licensee may dispose of waste by:
(7) Specify personnel monitoring devices to be used, where to obtain them, and instructions given on a. Transfer to a person properly licensed to receive recording exposure results or properly turning in person. such waste, e.g., commercial waste disposal firm (see nel monitoring devices ror processing at appropriate Section 20.301 of 10 CFR Part 20).
intervals.
b. Release into a sanitary sewer in conformance with
(8) Instruct the user in waste disposal procedures Section 20.303 of 10 CFR Part 20.
to follow in the laboratory, including limitations for disposal of liquid or solid wastes by the user and c. Burial in soil in conformance with Section 20304 procedures to use for waste storage within each labora- of 10 CFR Part 20.
tory.
d. Release into the air in conformance with Section
(9) Explain what records are to be kept for the 20.106 of 16 CFR Part 20.
use and disposal of materials.
e. Other methods specifically approved by the NRC
(10) Describe sealed source leak test procedures. pursuant to Section 20.302 of 10 CFR Part 20.
(II) Describe contamination control procedures, Note: No licensee may dispose of byproduct mate- including restrictions against smoking and consumption ral waste by incinerationunless specifically authorized of food and beverages. by the NRC (see Section 20.305 of 1O CFR Part20).
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Iemn 16 The application must be signed by a person ted informaliun and documents should be clear and authorized to sign onl behalf of the academic institution. specific and should identify the pertinent inforniatiutn This will usually be an executive officcr of tihc institu. by date, page, and paragraph.
lion, the dean of the particular school, the business manager. or some otl,:r designated official. VI. RENEWAL OF A LICENSE
V. AMENDMENTS TO LICENSES An application fur renewal of a license should be filed at least 30 days prior to the expiration date. This will Licensees are required to conduct their programs in ensure that the license does not expire until final action on the application has been taken by the NRC as accordance with statements, representations, and pro.
provided for in paragraph 30.37(b) of 10 cFR Part 30.
cedures contained in thie license application and suppor- tive documents. The license must therefore bc amended Renewal applications should he filed on Form if' the licensee plans to make any changes in facilities.
NRC-313. appiopriatcly supplemented. and should eon- equipment (including monitoring ard survey instiu.
tain complete and up-to-date infurmation about the ments), procedures, personnel, or byproluct material to apphcant's current proc'r*ii;i.
be used.
In order to facilitate the it-view process. tihe applica- Applications for license amcndntents may be filed tion for renewal shout' .iibmitlcd without rcference either on the application form or in letter formn. The to previously submitted documents and information. If application should identify the license by number and such references cannot he avoided. they should be clear should clearly describe the exact nature of the changes. and specific and shotild identify the pertinent infornia.
additions, or deletions. References to previously subiiit- tion by date, page, and paragraph.
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