ML20128C113

for Comment Issue of Draft Reg Guide Fc 413-4, Guide for Preparation of Applications for Licenses for Use of Radioactive Matls in Calibr Radiation Survey & Monitoring Instruments

ML20128C113
Person / Time
Issue date:	06/30/1985
From:	NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:
References
TASK-FC-413-4, TASK-RE REGGD-10.XXX, NUDOCS 8507030451
Download: ML20128C113 (26)

Text

Far'

[,,,% U.S. NUCLEAR REGULATORY COMMISSION Jun2 1985 p1 da OFFICE OF NUCLEAR REGULATORY RESEARCH Division 10 I

• Task FC 413-4

1. • DRAFT REGULATORY GUIDE AND VALUE/ IMPACT STATEMENT N*****/ *

Contact:

J. Brown (301)427-9008 A.

?

fQ V ex N;

_%g>

fc GUIDE FOR THE PREPARATION OF APPLICATIONS 40R'QCENSES FOR THE USE OF RADI0 ACTIVE MATERIALS IN CAL 18 RATING RADIATION SURVEY AND MONITORING INSTRUMENTS #

e ,. 'q k %,

A p~

gew;)

p N j p }M N .@,,

y. "ip

, . , _ N;,

j b, d

y J

Q hli us J

4

-$=_

t

,,. .e i_ ,  ?

> gg70l 850t.30 10.XXX M py This r:gulatory guide ind the attociated valuerloo.sct Stat **ent tr9 being logued in fr4ft forin to involve the public in the early steget of the develor**nt of 4 requlatory potetten in LN6s tres. They have not receiv 4 complete staf f review end lo not represent an of ficial '48C tt4f f pall'.inet Public comments are being solitited on both drafts, the guide (including any leolseentation Sche 1ulet and the value/lopect statement. Comments on the v41ue/ imp 4ct st atement thoulet be occomp4nted pv turoorting data, Cnwontt en both detits should be tent to the Secretary of the (poettsion. 0.4. Nuclear 1sivittery Coassittlen. Washington. 0.C. 2015%. Attention- Oneteting and service 1raaen. er August 20, 1985.

Requette for 16ngle testes of Jeef t quedet (.nich osy is escreduce1) ir for ol4 cement in in tuta=4 tic distribut196 list f4r tingle cSolet of fy(gre >jegft gyldet in t$eciflC diettlong thould be 94tje la WPilln1 to the d.l. nucle 4r (equl4tney Ccauntitlen. Washington. 0.C. 2055%. 9ttention: Director.

Olvillon if fechnical Information eno .1ocu ent Control.

w-

TABLE OF CONTENTS S*ction Pm

1. INTRODUCTION . ......................... I 1.1 Purpose of Guide ..................... I 1.2 Applicable Regulations .................. 1  !

1.3 As Low As Is Reasonably Achievable (ALARA) Philosophy . . . 2

2. FILING AN APPLICATION ..................... 2

3. CONTENTS OF AN APPLICATION . . . . . . . . . . . . . . . . . . . 4 Item 1 - License Information. . . . . . . . . . . . . . . . . . 4  :

Item 2 - Applicant's Name and Mailing Address . . . . . . . . . 4 Item 3 - Locations of Use . . . . . . . . . . . . . . . . . . . 5 Item 4 - Person To Be Contacted About Application . . . . . . . 5 Item 5 - Material To Be Possessed . . . . . . . . . . . . . . . 5 Item 6 - Purpose for Which Licensed Material Will Be Used . .. 6 Item 7 - Individuals Responsible for Radiation Safety-- -

Their Training and Experience. . . . . . . . . . . . . 7 Item 8 - Training for Individuals Working in or Frequenting Restricted Areas . . . . . . . . . . . . . . . . . . . 8 Item 9 - Facilities and Equipment . . ............. 9 .

Item 10 - Radiation Safety Program . . . . ........... 10 '

I 10.1 Personnel Monitoring Equipment . . . . . . . . . 10 10.2 Radiation Detection Instruments and ^

Instrument Calibration . . . . . . . . . . . . . 10 10.3 Operating and Emergency Procedures . . . . . . . 11 ,

Item 11 - Waste Management . . . . . . . . . . . . . . . . . . . 13 Item 12 - License Fees . . . . . . . . . . . . . . . . . . . . . 14 Item 13 - Certification. . . . . . . . . . . . . . . . . . . . . 14 .

Item 14 - Voluntary Economic Data. . . . . . . . . . . . . . . . 14

4. AMENDMENTS TO A LICENSE .................... 16 f

5. RENEWAL OF A LICENSE . . . . . . . . . . . . . . . . . . . . . . 17  ;

App:ndix A ... .......................... 19 i Draft Value/ Impact Statement .................... 21  !

t l

i e

111 i

1. INTRODUCTION 1.1 PURPOSE OF GUIDE The purpose of this regulatory guide is to provide assistance to applicants and licensees in preparing applications for new licenses, license amendments, and license renewals for the use of radioactive material in commercial calibration services for NRC or Agreement State licensees. The 50rvices covered by this guide are the calibration of radiation survey and conitoring instruments.

This regulatory guide is intended to provide you, the applicant and liccnsee, with information that will enable you to understand specific regula-tory requirements and licensing policies as they apply to your services. The information in this guide is not a substitute for training in radiation safety.

Af ter you are issued a license, you must conduct ycur program in accordance with (1) the statements, representations, and procedures contained in your appilcation, (2) the terms and conditions of the license, and (3) the NRC's regulations. The information you provide in your application should be

) cicer, specific, and accurate.

1.2 APPLICABLE REGULATIONS NRC regulations applicablo to the specified calibration services are in 10 CFR Part 19, " Notices, Instructions and Reports to Workers; Inspections"l 10 CFR Part 20, " Standards for Protection Against Radiation"; 10 CFR Part 21 "R:portin0 of Defects and Noncompliance"; 10 CFR Part 30, " Rules of General Appilcability to Domestic Licensing of Byproduct Material"; 10 CFR Part 71,

" Packaging and Transportation of Radioactive Material"; and 10 CFR Part 170, "Fcos for Facilities and Materials Licenses and Other Regulatory Services Under the Atomic Energy Act of 1954, as Amended." It is your responsibility as an applicant and as a licensee to have copies of, to road, and to abide by each r:gulation As a licensee, you are subject to all applicable provisions of the r gulations that pertain to using licensed material in the specified calibra-tion services.

This guide identifies the information needed to complete NRC form 313 for .

) applications for a Itcense for the use of radioactive material in certain 1

calibration services. The information collection requirements in NRC Form 313 have been cleared under OMB Clearance No. 3150-0120.

1.3 AS LOW AS IS REASONABLY ACHIEVABLE (ALARA) PHILOSOPHY As an applicant, you must not only be prepared to comply with all applicable regulations, but you must also make a commitment to the ALARA philosophy as stated in paragraph 20.1(c) of 10 CFR Part 20: " ... persons engaged in activ-ities under licenses issued by the Nuclear Regulatory Commission pursuant to

, the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974 should, in addition to complying with the requirements set forth in this part, make every reasonable effort to maintain radiation exposures, and releases of radioactive materials in effluents to unrestricted areas, as low as is reasonably achievable." Regulatory Guide 8.10, " Operating Philosophy for Maintaining Occupational Radiation Exposures As Low As Is Reasonably Achievable,"

provides the NRC staff position on this important subject. As an applicant, you should consider the ALARA philosophy as described in Regulatory Guide 8.10 in the development of plans for work with licensed radioactive materials.

2. FILING AN APPLICATION You, as an applicant for a materials license, should complete NRC Form 313 (see Appendix A to this guide). You should complete Items 1 through 4, 12, 13 and 14 on the form itself. For Items 5 through 11, submit the required informa-tion on supplementary pages. Each separate sheet or document submitted with your application should be identified and keyed to the itea number on the application to which it refers. All typed pages, sketches, and, if possible,

! drawings should be on 8-1/2 x 11 inch paper to facilitate handling and review.

If larger drawings are necessary, fold them to 8-1/2 x 11 inches.

You should complete all items in the application in sufficient detall for the NRC to determine that your equipment, facilities, training and experience, and radittion safety program are adequate to protect health and minimize danger to life or property.

Please note that license applications are available for review by the general public in the NRC Public Document Roums. Do not submit proprietary information unless it is absolutely necessary. If submittal of such information (

2

[

L

is necessary, follow the procedure in 6 2.790 of 10 CFR Part 2. Failure to follow this procedure may result in disclosure of the proprietary information to the public or substantial delays in processing your application.

Do not submit personal information about your individual employees unless it is necessary. For example, the training and experience of individuals should b3 submitted to demonstrate their ability to manage radiation safety programs or to work safely with radioactive materials. Home addresses and home telephone numbers should be submitted only if they are part of an emergency response plan.

Datos of birth, Social Security numbers, and radiation dose information should be submitted only if specifically requested by NRC.

You should file your application in duplicate. Retain one copy for yourself, b:cause the license will require that you possess and use licensed material in accordance with the statements and representations in your application and any supplements to it.

If you wish to possess or use licensed material on Federal property or in any State subject to NRC jurisdiction, you should file your application with ths NRC Regional Office for the State in which the material will be possessed or used. (A list of NRC's Regional Offices and the States they cover is provided

) below.) The exceptions to the above are the United States Air Force and Navy and persons wishing to distribute exempt material under 10 CFR Part 32 Subpart A, who should file their applications directly with the U.S. Nuclear Regulatory Commission, Division of Fuel Cycle and Material Safety, Washington, OC 20555.

Tw Wty-seven States have entered into agreements with the NRC that give thra the atsthority to license radioactive materials used or possessed within thstr borders. These States are called Agreement States. A current list of Agreement States (including names, addresses, and telephone numbers of respon-sible officials) may be obtained upon request from the Material Licensing Branch, U.S. Nuclear Regulatory Commission, Washington, DC 20555, or from NRC's Regional Offices, whose addresses are listed below. If you are a non-Fed 2ral organization that wishes to possess or use licensed material in one of thsse Agreement States, your application should be filed with the State's radiation control program and not with the NRC.

If you are located in Connecticut, Dalaware, District of Columbia, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, or Vermont, send your applications to the U.S. Nuclear Regulatory 3

Commission, Region I, Nuclear Material Section B, 631 Park Avenue, King of Prussia, PA 19406.

If you are located in Alabama, Florida, Georgia, Kentucky, Mississippi, North Carolina, Puerto Rico, South Carolina, Tennessee, Virginia, Virgin Islands, or West Virginia, send your applications to the U.S. Nuclear Regulatory Commis-sion, Region II, Material Radiation Protection Section, 101 Marietta Street, Suite 2900, Atlanta, GA 30323.

If you are located in Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, Ohio, or Wisconsin, send your applications to the U.S. Nuclear Regu-latory Commission, Region !!I, Material Licensing Section, 700 Roosevelt Road, Glen Ellyn, IL 60137.

If you are located in Arkansas, Colorado, Idaho, Kansas, Louisiana, Montana, Nebraska, New Mexico, North Dakota, Oklahoma, South Dakota, Texas, Utah, or Wyoming, send your applications to the U.S. Nuclear Regulatory Commission, Region IV, Material Radiation Protection Section, 611 Ryan Plaza Drive, Suite 100, Arlington, TX 76011.

If you are located in Alaska, Arizona, California Hawaii, Nevadzi, Oregon, Washington, or U.S. territories and possessions in the Pacific, send your applica-tions to the U.S. Nuclear Regulatory Commission, Region V, Material Radiation (

Protection Section, 1450 Maria Lane, Suite 210 Walnut Creek, CA 94596.

3. CONTENTS OF AN APPLICATION The following comments apply to the indicated items of NRC form 313.

Item I - LICENSC INFORMATION For a new license, check subitem A. For an amendment to an existing Ilconse, check subitem D. for a renewal of an existing Ilcense, check subitem C.

Item _2 APPLICANT'S NAME AND MAILING ADDRESS If you are an individual, you should be designated as the applicant only if you are acting in a private capacity and the use of byproduct material is not connected with your employment with a corporation ur other Ingal entity.

(

4

r Oth:rwise you, the applicant, should be the corporation or other legal entity applying for the license.

The address specified here should be your malling address for correspondence.

This address may or may not be the same as the address at which the material will be used, as specified in Item 3.

Item 3 - LOCATIONS OF USE You should specify each location of use by the street address, city, and State or other descriptive address (such as 5 miles east on Highway 10, Anytown, Stste) to allow us to easily locate each facility. A Post Office box address is not acceptable. If you wish to maintain and operate more than one location j wh re byproduct material will be used, you must give the specific address of ecch location. In Items 5 through 11 of your application, describe the intended uso and the facilities and equipment at each location. If you wish to perform services at customer facilities, simply state "and at temporary job sites of Ilconsees."

)

It m 4 - PERSON TO DE CONTACTED ABOUT APPLICAi!ON You should name the individual who knows your proposed radioactive materials program and can answer questions about your appilcation. Note his or her tolophone number. This individual wlII serve as the point of contact during the r0 View of your application and during the period of your license. This person is usually the radiation safety officer or a principal user of radioactive mate-l ricIs. Notify the NRC if the person assigned to this function changes.

1 It ms 5 MATIRIAL TO DE P0 HE MED l

You should identify the sealed reference sources to ,bo used in the instru-

! ment calibration services provided to your customers. The following arn

! enamples of listings of Ilconsed materials:

f I

J L_________

a b c Chemical and Physical Form

• Element & Mass (Manufacturer and Model Maximum Activity Number No. of Sources) Per Source

1. Cesium-137 1. Sealed rod source 1. Not to exceed (XYZ Inc. Model 10) 250 microcuries/

source

2. Cesium-137 2. Sealed rod source 2. Not to exceed (Nuclides, Inc. 50 millicuries /

Model 50) source

3. Cesium-137 3. Scaled suurce 3. Not to exceed (Nuclides, Inc. 130 curies / source Model 91)

4. Cobal t-60 4. Scaled source 4. Not to exceed (XYZ, Inc. Model 351) 20 millicures/

source "You should list the manufacturer and model number of the reference sources under subitem b. You need not state under subitem c the number of sources you intend to possess. Simply list the maximum activity per source as in the example.

Item 6 - PURPOSE FOR WHICH t! CENSED MATERIAL WitL__DE USFD Specify the purpose for which each type of source listed in Item $ will be used. if a source la contained in a device, you need to specify the manufac-turer and model number of each device (calibrator). The following is an example of such a listing for the sources specified in Item 5 above.

1. To be used for low range (.01 to 2 mR/hr) calibration of portable survey meters.

2. To be used for medium- (1 to $00 mR/hr) and low range calibration of survey meters.

3. To be used in a Nuclides, Inc. Hodel 100 shielded calibrator for the high range (el R/hr) calibration of radiation measuring meters and devices.

4. To be used fur calibration of medium and low range portable survey meters.

(

6

Item 7 - INDIVIOUALS RESPONSIBLE FOR RADIATION SAFETY--THEIR TRAINING AND EXPERIENCE Paragraph 30.33(a)(3) of 10 CFR Part 30 specifies that, before your appilcation is approved, you must be qualified by training and experience to use the material for the purposes requested in such a manner as to protect health and minimize danger to life or property.

You should provide the following information about the individual or individuals who will be responsible for your radiation safety program

(" responsible individual").

1. The name of each " responsible individual."

l

a. The name of the individual or individuals responsible for both your day-to-day radiation protection program and for ensuring compliance with applicable NRC regulations and the terms and conditions of your license. This individual is normally the Radiation Safety Officer (R50).

b. The names of any other personnel who will actually perform or directly supervise the instrument calibration procedures.

NOTE: The " responsible individuals" you list in a and b will also be listed on your Ilconse as users. The licensed materials specified on your .

license should be used by, or under the supervision of, these designated individuals.

2. The training of each " responsible individual."

You should submit a resum4 of traintny and esperience for each l " responsible individual" listed above. This resumo should cover formal l

academic training and on tha job training in calibrating the speelfled survey and monitoring equipment. Guidelines on training and emportonce are 1  ;

a. Formal training should encompassi (1) The principles and practices of radiation protnctiun, i

i l

L

(2) Radioactivity measurements, monitoring techniques, and the use of instruments.

(3) Mathematics and calculations basic to the use and measurement of radioactivity.

(4) The biological effects of radiation,

b. A minimum of 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> of formal course work should be completed by each " responsible individual" listed in item 7.

c. On-the-job training should encompass hands-on experience in calibrating the types of monitoring and measuring instruments typical of those expected to be calibrated for your customers. On the job training should be for 1 to 2 weeks; the sources or devices used should be similar in activity to those listed in Item 5. The description of on the-job training for each individual should identify where, when, and by whom the training was given,

d. Outline any additional training that will be provided periodi-cally to your " responsible individuals" to keep them up to date on instrument calibration techniques and on any new model survey and monitoring instruments that will be accepted for calibration and maintenance services. Your appitca-tion should indicate that such training will be augmented by using the manu- (

facturers' most recent service manuals and instruction sheets, which would provido new information on the instrument manufacturer's recommended servicing and calibration procedures and methods, JJom 8 TRAININ0 10R !_NDIVIOUALS WORKINC IN OR FREQUENf!NG Rf$iRICE D ARILAj l . ,

l l

$1nce you have named " responsible individuals" and provided resumde of their training and esperience in Item 7, in this item you should provide information on the training (pursuant to !i 19.12 of 10 CFR Part 19) that will o

be provided to any ancillary personnel who may frequent any radiation area or work under the direct supervision of your "respnnsible individuals." Consider secretarial and janitorial personnel and technicians, among others, who might work directly under the supervision of your " responsible individuals" or who might frequent any restricted area in your facility. You should provide the l following information on this training!

(

n

1. An outline of your training program, including the topics that will i b3 covered. Examples of topics to be included in this training are (1) the beste principles and fundamentals of radiation safety and good safety practices [

roicted to your use of radioactive materials, (2) the purpose for which radia- I tion detection instruments will be used, (3) a review of your operating and I cmergency procedures, including safety procedures unique to your uses and fccilities, and (4) specific instruction in precautions and procedures to be l l used to minimize any exposure to radiation and rndloactivo materials. l 1

2. The duration of your training program. The duration should be i commensurate with your radiological health protection problems, but should be j from 2 to 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br />.  ;

3. The name of your training instructor or instructors, if your instructor is not a " responsible individual" specified in item 1 submit his or her qualifications. The minimum qualifications for an instructor should be  !

ths name as those for a " responsible individual" specified in Item 7, i

4. A commitment that records documenting the training of each Individual will be maintained.

Item 9 FACILifl!$ AND (qtJQ E Paragraph 30.33(a)(2) of 10 CFR Part 30 states that an application will j b2 approved if, among other things, the applicant's proposed facilities and equipment are adequate to protect health and minimize danger to life and property. Therefore, you should describe each facility where survey and I monitoring instruments will be calibrated. Annotated alietches are helpful and f should be included when appropriate, if calibrations will be performed at  !

customers' titet, provide information on the types of restricted arent to be j cttabilthed at these titet, include descriptions of the followinyl l

~

' Restricted armat within calibration laboratory areat.

• The location of any beam calibratort and calibration range facilities, including a description of the range facility, j i

e Means of minimising teatter, l l

• The location of an/ tolfacnntained calibration facilities, f l ' Source storage facilities,  !

• Source handling equipment, 9

l 1

l r

(

l

J

• Auxiliary shleiding and description of use.

Means of preventing entry into high radiation areas, and 1

• Means of preventing unauthorized use or removal of licented material.

NOTCt Sketches and descriptions should show the relationship of material use areas to any adjoining unrestricted areas (e 0.. offices, rest rooms, cafeterias, and other areas not under your control).

l

Item 10 RADIATION SAFETY PROGRAM 1

) 10.1 Personnel Monitorina Erluipment Section 20.202 of 10 CFR Part 20 requires that personnel monitoring equipment

, be used by individuals entering restricted areas who receive, or are Ilkely to

{ receive, a dose in excess of 2'A of the done specified in paragraph 20.101(a) of 10 CFR Part 20. The specified doses per calendar quarter are 11/4 rems to the whole body, head and trunk, active blood forming organs, or gonadal 18 3/4 rems to the hands and forearms or feet and ankles; and 7 1/2 rems to the skin of the

) whole body, Individuale under 18 years of age need to use personnel monitoring equipment if they receive, or are likely to receive, a dose in excess of FA of the specified doses in paragraph 20.101(a), in addition, personnel mont'2 ring equipment must be used by any individual who enters a high radiation area, i All your personnel should wear personnel monitoring devices such as film l badges or thermoluminescent dosimeters (TLDs) pursuant to 9 20,202 of 10 CFR Part 20 when performin0 instrument calibration services, If personnel monitor =

ing equipment will be used, specify that the organization furnishing the film badge or TLD service will be a commercial service company and state the enchange intervals for the film badges or TL0s, flim badges should be enchanged at intervals not to emceed 1 month and TL0s at intervals not to escend 3 months, l

10.2 !LellAtin rL0 e iRt!0 rti n u n!*t!.Llu nt im t tume nLC a U ttillna l

{

According to 6 20,201 of 10 CIR Part 20, each Ilconsen must make survey #

as necessary to evaluate the entent of radiation halards that m4y be present  ;

j during the possession and use of Ilconsed material, Thorofore, you should  !

) list the radiation detection (survey or monitoring) Instruments you will have )

10 l i  !

available for your own use in manipulating the requested sealed sources and in performing your calibration services. Your list should specify for each l instrument (1) the type of instrument, (2) the number of instruments available, {

(3) the type of radiation detected, (4) the sensitivity range, and (5) the j sp:cific use. Survey instruments should be calibrated at least annually and l following servicing pursuant to R 30.53 of 10 CFR Part 30. You should state  :

the interval at which your listed instruments will be calibrated. The follow-ing is an example of such a listing:  ;

RADIATION DETECTION INSTRUMENTS l NUMBER RADIATION SENSITIVITY l TYPE AVAllABLC DETECTED RANGE USE l Pcrtable thin window 2 Beta, 0 500 mr/hr Survey an<f l GM survey meter gamma monitoring  !

t I

10.3 pperatinoand[merggnSyproertures  ;

Each individual who will perform calibrations on customers' radiation

[

survey and monttoring instruments should have a set of operating and emergency  ;

procedures. You should state in your application that personnel will be l

provided with operating and emergency procedures. Submit an outline of the l l basic elements of the procedures to be provided to your personnel. The follow = l ing elements should be included in your operating and emergency procedures, if I applicable

1. Step by step instructions for performing callbrations of survey and '

i r

monitoring instruments (including pocket dosimeters, if applicable), i l

The following are considered acceptable criteria for calibrationt* j i

i i

1. for morfiMUTiil information about survey Instrument calibration, see "Hadia- [

tion Protection Instrumentation feet and Calibration," ANSI N)23 1918. Copies are available from the American National $tandards Institute, 1430 Broadway,  !

New York, NY 100111. Additional guidance is beinQ developed on this subjecti f Ordft Negu14 tory Culde Op 012=$. " font and Calibration of Radiation Protectinn  !

instrumentation," has been pubitshed for pubite comment. }

l I

11 j

I l

l

• Calibrations of survey meters should be performed with radio-nuclide sources. (Neither electronic calibrations that do not involve a source of radiation nor the use of small check sources j such as those incorporated into some murvey meters are i acceptable for calibration.)

• The sources should be approximate point sources.

• The activity of the source or exposure rates at given distances should be traceable by documented measurements to a standard  !

source certified within b4 accuracy by the U.S. National Bureau of Standards (N65) or other recognized standards laboratory.

• Instruments should be calibrated at least annually and af ter '

servicing.

tach scale of an instrument should be calibrated at at least [

two points located at approximately 1/3 and 2/3 of full scale. I for logarithmic rate changing instruments, the calibration thould be made near the mid range of each decade, and two points thould be calibrated on at lealt one of the decades.

• The esposure rate measured by the instrument being calibrated  ;

should differ from the true esposure rate by less than 110% at [

the calibration points. (Read the appropriate instrument manual I l todeterminehowtomakethenecetteryadjustmentstobringthe instrument into calibration.) Readings within 120% will be l considered acceptable if a calibration chart, graph, or response factor is prepared and used with the instrument to interpret l meter readings to within 1104 for radiation protection purposet, i 1 2. Step by step procedurst for calibrating customers' pocket dotimeters. '

3. A program for routine area turvey, including the areas to be surveyed, the frequency of turveys, acceptable radiation [

l levels in specific ute areas of the facility, and provitions for l l maintaining recordt of the surveys, f

4. The ube Of thlpldthy and remote handling equipment When handliny  !

hard (high energy) beta = or gamma = emitting materiale. l

6. $ppelal preCautiont to be uted When handling larQo t#aled Calibration j lourtel.  !

i

I f

6. Your program for routine personnel monitoring.

7. Emergency procedures to be followed in the event of fires, equipment malfunction, etc., including notification procedures.

1 l

In addition to describing the basic elements of a radiation safety program. [

you should describe the method you will use for the 6 month leak testing of f scaled sources or devices you possess. If you will use a leak test kit, simply (

provide the name of the manufacturer and the model number of the leak test kit.

(

If you will perform your own inhouse leak testing, including the analysis of i utpe samples, describe the procedures you will use.*

You should also provide a copy or description of the certificate of l instrument calibration you will provide to customers with each calibrated instrument as part of your documentation of the elements of the tadiation protection program and instrument calibration procedure. Be sure that your certificates contain the following Information:

1. The customer's name, address, and person to be contacted, f

2. Identification of the Instrument by manufacturer, type, and model and (

serial number, I

3. Calibration data, such as Instrument readings at a point on a given scale versus esposure rates (me/hr), '

4. Any specific comeents on the calibration or calibration data,

0. Identification of the calibration source or sources used in call-brating nuclide and esposure rates at specified distances (include ,

calibration accuracy),

l

6. Identification of the individual performing the calibration, and  ;

7. The date of the calibration.

ItemJ1 -

WMILMMMW@l i Sections 20.301 and 20,311 of 10 CfR Part 20 specify the general require- '

monts for disposal of licensed material. You should describe the means you will une to dispose of licented materials that are no longer needed such as ,

i

1. a5TifaTcTITI%UiG developed on this subject. Draf t Regulatory Guide FC 412 4, "Gulde for the Preparation of Appilcations for Licenses for the Une of Radio- ,

active Materldla in teakafesting Service 6 " was issued for public comment. '

l 13  :

I w_

i i

contaminated swipes or sealed sources. State which of the following three

options you will exercise.

I

1. Use a waste disposal service or broker licensed by the NRC or Agree-i ment State for the disposal of the Ilcensed material.

2. Return any sealed sources or devices to the manufacturer in accordance

with the manufacturer's specific packaging and shipping instructions, i

3. Describe any other methods you will use and demonstrate their l compilance with the regulations.

4 l.

llam_17 = lICf NM fl0 l An application fee paid in full le required by paragraph 170.12(a) of j 10 CFR Part 170 for most types of licenses, including appilcations for license 1

amendments and renewals. You should refer to 4 170.31. " Schedule of fees for l Materfall Licentes and Other Regulatory Services," to determine the amount of i the fee that must accompany your application. An application received without

a fee or with an inadequate fee may be returned to you. All application fees (

j may be charged irrespective of the NRC't dispolition of the application or j your withdrawal of the application, i

llim_ll".MRIlll(All03 i

! If you are an Individual applicant acting in a private capacity, you are

required to slyn and date the form pursuant to paragraph 30.32(c) of 10 Cf R part 30. Otherwise, your application thould be dated and aloned by your l reptetentative of the corporation or legal entity who it authorlied to sign l official documents and to certify that the application contains Information

that 16 true and currect to the bett of your knowledge and belief. Untigned applicationt will be toturned for proper algnature, I

lilLli "._V010N!A4140N0%DW I

l The Regulatory Ilemlbility Act of 1940 tequires federal agenclet to cona tider the offacts of their rules on small businettet and other small entitlet, f j in order for the h4C to maintain an up to date data base of its licensees, four 1

)

i 14 i

categories of economic information are sought from appilcants. These economic data will be used by the NRC in preparing regulatory analyses that contain, among other things, the anticipated economic burden a proposed rule-making action will have on affected IIcontees. To the extent that it is possible and c:nsistent with public health and safety, the NRC will consider the economic burden in light of the size of the entitles affected by the rule in an attempt  !

to mitigate the potential for a significant economic impact on a substantial f

number of small entitles, i

l 14.a Annual Receiptt_ i Outdance for determining the appropriate bou in 14.a. Annual Recolptst*

l i

1. jjglggfriofOne__NRCLicenna, If your organization (named on the i licente or application) holdt one NRC licente and operates from one addrett, l check the box that most closely approntmates your annual reCelptil in the case f of hospitalt, academic Institutions, or other entitles that do not operate on i the balls of receipts, check the bon that most closely approntmates the annual f' operating budget of your organlaation.

2. flohlers of Ph!1dple NM_1kemet.lgued fotDne_Ahlreit, If your crganization (named on the Itcente or appilcation) holdt multiple NRC Ilcentet,  !

all of which are lieued to the same addrett, check the bon that most closely l approntmates the annual receipts or annual operating budget for your entire crganlaation, regardlett of the number of NRC licentet pottetted at that tingle j addrett,

3. Ll?lil* E l .lf b lt U P l? P L ll O S W J J t d u ld t J & 110 9 3 if your crganlaation (named on the licente or application) huldt multiple NRC IIcontes at multiple addrettet, check the bon that most clotely approntmatet the annual rcceipts or annual operating budget for the operationt conducted at the addrett en this licente or application and not for the entire corporate entity. -

t a 6 a un Vert yW ha each nQ tonpital that nparaL#6 und8r a taparate annual budget and hat been litund multiple licentet, it thould ,

dittinguish the flyutes that pertain tolely to the university from thoop i figuret that portain totely to the teachtny hospital, t I

lb i

14 b Number of Employees The number of employees reported should reflect all employees for the i organization at the address listed on the license or application, excluding outside contractors. The number of employees reported should not be that of a single department or division within the organization.

14.c Number nf Radt (HofpitalsOnly]

l Enter the total number of beds in the hospital excluding bassinets and

) nursing home type unitt, i

i 14.d Would You He Willing To furnish Cost Infornation On the (conomic impard i of Current Regulations or gy future Proposed NRC Re2ulations that May i

Oll'El Y.98 i Indicate if you would be willing to furnish additional economic data to j the NRC that would help the Nfl0 evaluate the economic impact of a rule on affected licentees.

]

4. MINDM[Nf 5.10 A llCLNR

]

i Af ter you are lieued a licente, you must conduct your program in accor=

dance With (1) the statemente, representations, and proCedurel Contained in your j application, (2) the,termt and conditions of the licente, and (3) the Nuclear Negulatory Committfod's regulations.

l It 16 your obligation to keep your licente current. You should anticipate I the need for a licente amendment intofar at pottible, if any of the inforestion pravided In your application ie to be modifled or changed, tubmlL an application for a litante amencent, in the meantime, you must comply with the terms and j conditions of your licente until it ie actually amended 6 NRC regulatione do not l allow ~you to implement changet on the batte of a submittion requesting an 1

amendment to your licente, f An application for a licante amendment may be prepared either on the

) application form (NHC f orm Ill) or in letter form and thould be submitted in l

If, i

l duplicate to the address specified in this guide in Section 2. " Filing An Appli- I cation." Your appilcation should identify your license by number and should i

clearly describe the exact nature of the changes, additions, or deletions. l R2ferences to previously submitted information and documents should be clear end specific and should identify the pertinent information by date, page, and paragraph. For example, if you wish to change the " responsible individual,"

ycur appilcation for a Itcenso amendment should specify the new individual's name, training, and experience. The qualifications of the new individual should i b3 equivalent to those specified in Item 7 of this regulatory guide. l You must send the appropriate fee for a license amendment with your I cpp1(cation. The NRC will not accept an appilcation for filing or processing l b3 fore the proper fee is paid in accordance with 5 170.12 of 10 CFR Part 170, l

5. RfNfWAt OF A t!CEN$1 l l

Licenses are issued for a period of up to 5 years. You must send an  !

cppilcation for renewal in duplicate to the address specified in Section 2 of l this guide. You may submit an entirely new appilcation for renewal as if it  :

core an application for a new license without referrin0 to previously submitted i Information, I i

As an alternative, you mayr  !

I I l 1. Review your current Itcense to determine whether the information t 1

! cccurately represents your current and anticipated program, Identify any n:cessary additions, deletions, or other changes and then prepare information 3

anpropriate for the required additions or changes,  !

2, Noview the documents you have submitted in the past to determine l

j thsther the information in them is up to date and accurately represente your i c:nagement control program, facilities, equipment, personnel, radiation safety  :

procedures, locations of use, and any other Information pertinent to your program, fra tiocuments you consider to represent your current program should l

b3 (dentified by date, Any out of=date or superseded documents should also be  !

I id:ntified, anti changes should be rinde in the documents as necessary to j reflect your current program.  !

1. Neview NNC regulations to be sure that any changes in the regulations 3

are appropriately (,0vered in your program description,  !

! l I  !

i  !? i i

4. Af ter you have completed your review, submit two copies of a letter containing the information specified in Items 1, 2, and 3, as necessary, with the proper fee, requesting renewal of your license. If your current license and supporting documents accurately reflect your current program, state that operations will continue in accordance with these documents, applicable NRC regulations, and license conditions.

5. Include the name and telephone number of the person to be contacted about your renewal application and include your current mailing address if it is not indicated correctly on your license.

If you file your application for license renewal at least 30 days before the expiration date of your license and include the appropriate fee for license renewal, your present Ilconse wl11 automatically remain in effect until the NRC taken final action on your application for renewal. However, if you file an application less than 30 days before the expiration date and the NRC cannot process it before that date, you would be without a valid license when your license empires.

It is important that the appropriate fee accompany your application for license renewal. In accordance with 5 170.12 of 10 CFR Part 170, the NRC will not accept an application for filing or processing before the proper fee is paid.

If you do not with to renew your license, you must dispone of all Ilconsed radioactive material you possess in a manner authorized by $4 20.301 and 20.311 of 10 CFR Part 20. Complete NRC Form 314. " Certificate of Olsposition of Materials," and send it to the NRC before the espiration date of your license with a request that your license be terminated.

If you cannot dispose of all your Itcensed radioactive material befoie the empfration date, you must request a license renewal 'for storage only of the radioactive material. The renewal is necessary to avoid violating NHC's  !

regulations that do not allow you to possess 1(censable material without a valid license.

10

APPENDIX A NRCFORM313 u S. NUCLE A A sitGULATORv COMMISSiOss (1446 to CF R 30,33. 33. 34 APPROVED SV OMS

$1960120 u sas a0 APPLICATION FOR MATERIAL LICENSE E P e S.3in 18e8TRUCTIONS: SEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRUCTIONS FOR COMPLETING APPLICATION. SEND TWO COPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED SELOW.

PSOERAL AGENCtts PILS APPLICATIOest wtTH: IF YOU ARE LOCATED IN-U S. NUCLE AR REGULATORY COMMISSION ILUNOis. INDe AasA, son A. MicMiG AN. MINNESOY A. MISSOURs. OMiO, OR OlvtSiON OF FUEL CYCLE AND MATERIAL SAFETY,NUS$ wtSCONSsN. SEND APPLICATIO8e8 TO WASMINGTO8e,OC 306SS U S NUCLE AR REGULATO81Y COMMISSION. REGION 111 ALL OTMER PERSO8s8 FILE APPUCATIOsse AS FOLLOws.17 YOU ARE W ATERi ALS LICENSING SECTION LOCATEDIN: 799 ROOSEVELT ROAO GLEN ELLyse, #L 80137 L%3tECTICUT, DELAWARE. DISTRICT OP COLuket A, teAINE. MARYLAseO.

anamwe- artyg, ggy agR$g Y, NEW v0RK. PtissetVLVAN64, ResODE ISLAND, A R K ANSAS. COLORADO, 00A MO, K ANSAS. LJutSI AftA. MONT AN A, N E S R ASK A, Oft VERIsONT,SEesO APPUCAflONS 70: 8etn ME RICO. IsORTM OAa07 A. OR LAMOMA. SOUTH DAKOT A,7E RAS. UT AM, Oft wv0eresG SENO APPLICATIO8st TO:

U.S. NUCLE AR REGULATORY COutfisSiON. REGtON I NULLI AR MATE RIAL SECTION e U $ NUCLE AR REGULATORY COMMISSION REGION iv S31 rARK AVEteUE MATERIAL MAOIATION PROTECTION SECTION KING OF PRUSSIA.PA 19408 811 RYAN PLAZA ORevE, $UITE 1000 ARLtNGTON. T A 76011 i # LAGAMA. PLOReOA,0EORGI A. E ENTUCK Y, MIESl484FPI, NORTM CAROLt4 A.

I PutRTO stsCO. 80UTM CAROussa. TEssesaSSE E, viRGefetA. VIRGIN (SLANOS OR ALASK A. A RI2ONA. CAUFOmassa. MAwAlt.15EVADA, OR EGO 8s WASMINGTOes WEST vtRGIN4A,SERIO APPUCAT408ss TO: AssO U S. TERRITORIES AND POSSEStaONS IN THE PACIFIC, SENO APPUCAflONS 70.

i U S 8eUCLE AR REGULA'On v COMMtSS104. REGION il MATERIAL RAOiaTION PROTECTION SECTION U S NUCLE AR REGULATORY COMuttssON REGION V

(' 101 MARIETTA STREET, SulTE 2900 ATLANTA.GA 30323 MATERIAL RAO# ATION PROTECTION SECTION 1430 MARI A LANE. SUITE 210 W ALNUT CRE EK, CA 184596 PERSOsIS LOCATIO IN A04EEMENT STATSS SENO APPUCAfloess TO TME U S. NUCLE AR REGULATORY COMMessions ONLY ep TMEY wiSM TO POSSESS AND USE LICENSEO MATERIAL 18e GTATES SUSJECT TO U.S. NUCLEAR REGULATOR Y COMMISSIO8e JURISOtCTIO88.

TMa518 AN APPUCATIO'e FOR IChere Roeregnes taural 2 NAME ANO MAluNG AOORESS OF APPLtCANT fince w eele Cases A. Ntw UCEPSE 9 AMENOMENT TO UCENSE NUMSER C. RENfwAL OF LICENSE NUMSER

3. ADORES $iESIWMERE LICENSED MATERIAL wiLL 05 USED OR POSSESSED

e. NAME OF PERSON TO SE CONT ACTED A40VT THIS APfuCATION TELEP**ONE NUM8ER SU9Mit ITEMS S THROUGH 11 ON 84 a 11" PAPER THE TvPE AND SCOPE OF INFORMATiON TO Of PROvtOED IS OESCRISEO IN THE LICENSE APPuCATION GulOE B K AOtOACTIVE MATERI AL

& Emment one spees awatier. S. chemeced and/or ohymcal form, one e. niesisawa emowa s which ode he . -se saw one twas.

6 PURPOSEISI FOR WMcCM UCENSED MATERI AL wtLL BE USEO.

T AINissG A I E CE S TR AtNING FOR INOsviouALS wCReUNG IN OR FREQUENTING RESTRICTED AmE AS

9. FACIUTIES AND EQUIPMENT. 10. RAOi ATION SAFETv PsiOGRau

'2 LeCENbEE FEt S nSoo IO Crn 1/Q ene sect on sla lso

11. CASTE MANAGEMENT. sAMOUNT FEE CATEGORY ltNCLOSE D $

13. CERTIFICATION (Mweteesenereme#y epstgeeft TME APPUCANT UNDE RSTANOS TMAT ALL ST ATEMENTS AND REPRESENT ATiONe M ADE *N THIS APfuCATiON ARE SINDING UPON THE APPUCANT TME APPUCANT AssO A8sv OFFICIAL EufCU TING TMis CERTiFIC ATiON ON SEM ALF OF THE AretiCANT, N AMEO iN ITEM 2. CERTIFV TM AY TMis APPUCATiON IS PREPAREO IS TRUE ANO CORRECTIN CONFORMtTV TO THE BESTwiTM OF TITLE 10.CCOE OF TMEIR KNOWLEDGE FEOER ANO 8tutF AL REGULATIONS. PARTS 30. 32. 33.14. 35. ANO e0 ANO TN AT A.L INFORMATION CONTAINED MEREIN F ARNiseG is u 8 C. SECTION 1001 ACT OF JUNE 2S.1948 42 ST AE 743 MAnt$ IT A CRIMfNAL CFFENSE TO Mant a weLLFULLY F ALSE STATEMENT OR REPeESENT AflON TO ANY DEPARTMENT OR AGENCY OF TMS UmstTEO STATES AS TO ANY M ATTER nlTMIN TS JuniSO*CTION 4GNATURE-CERTIFviNG OFPtCER TvPEO,PRINTEO NAME YtTLE ATE

'4 VO L u*e T 4 4 v M*eG uisec 0 4 7 4 m A h as " i Ri da PTE g NUWgER Qe EMPLOY EES (Tees for e WOULO VOU SE wtLUNG IO FURNISM COST INFORMA TION Gamer same enere aaw ss a

< S250K SIM-3 SM 8"#' **#W 'A'##I "' ease readrecterst ON TME ECONOMIC eMPACT OF CURRENT NRC REGULATIONS OR ANY FUTURE PROPOSEOaRC REGULATIONS THAT MAY AFFECT YOUP (NRC segwerrens permet 5250K -600K $3 SM-7M 8 #'8*# "'***#**#"**#8'"'* A##****#

Oeegentp'd Co"rifeQe"ntal'**'"*'

9000K -?S0K $7M40M e NUMSE8e OP SEOS

$790K-1M > $ 10M vfS *iO FOR NRC USE ONLY FYPE OF FEE FEELOG FEE CATEGOR Y COMMENTS APeacvEO s v AMOUNT RECEIVED CMECK NUMgER DAYg t

PRIVACY ACT STATEMisef 08e TME REVERSE 19 +

b .

APPENDIX A (Continued)

PRIVACY ACT STATEMENT Pursuant to 5 U.S.C. 552a(e)(3), enacted into law by section 3 of the Privacy Act of 1974 (Public Law 93-579),the follow-ing statement is furnished to individuals who supply information to the Nuclear Regulatory Commission on NRC Form 313. This information is maintained in a system of records designated as NRC 3 and described at 40 Federal Register 45334 (October 1,1975).

1. AUTHORITY: Sections 81 and 161(b) of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2111 and 2201(b)).

2. PRINCIPAL PURPOSE (S): The information is evaluated by the NRC staff pursuant to the er ieria set forth in 10 CFR Parts 30,32,33,34,35 and 40 to determine whether the application meets the requirements of the Atomic Energy Act of 1954, as amended, and the Commi sion's regulations, for the issuance of a radioactive material license or amendment thereof.

3. ROUTINE USES: The information may be (a) provided to State health departments for their information and use; and (b) provided to Federal, State, and local health officials and other persons in the event of incident or exposure, for their information, investigation, and protection of the public health and safety. The information may also be dis-closed to appropriate Federal, State, and local agencies in the event that the information indicates a vio!ation or potential violation of law and in the course of an administrative or judicial proceeding. In addition, this information may be trans-ferred to an appropriate Federal, State, or local agency to the extent relevant and necessary for an NRC decision or to an appropriate Federal agency to the extent relevant and necessary for that agency's decision about you.

4. WHETHER DISCLOSURE IS MANDATORY OR VOLUNTARY AND EFFECT ON INDIVIDUAL OF NOT PROVID-ING INFORMATION: Disclosure of the requested information is voluntary. If the requested inforrvation is not furn-ished, however, the app!! cation for radioactive material license, or amendment thereof, will not be prc cessed. A request that information be held from public inspection must oe in accordance with the provisions of 10 CFR 2.790. Withhold-ing from public inspection shall not affect the right, if any, of persons properly and directly concerned need to intpect the document.

5. SYSTEM MANAGER (S) AND ADDRESS: U.S. Nuclear Regulatory Commission Director, Division of Fuel Cycle and Material Safety Office of Nuclear Material Safety and Safeguards Washington, D.C. 20555 e

20 NRC FORM 313

DRAFT VALUE/ IMPACT STATEMENT

1. BACKGROUND Among the licenses issued by the NRC are those for possession and use of byproduct material for calibrating radiation survey and monitoring instruments as a commercial service. Until now, the NRC has not provided formal guidance for preparing license applications for this use of byproduct material.

Furthermore, the licente applications were filed on Form NRC-313I, which was superseded in July 1984 by a new application form, NRC Form 313. It was decided that the NRC should issue a new regulatory guide conforming to the new NRC Form 313 and dealing exclusively with this type of commercial service.

2. PROPOSED ACTION 2.1 Description An applicant for a license to use byproduct material for calibrating radiation survey and monitoring instruments must develop a program that complies with NRC regulations and describe this program in the license application. The proposed action is to issue a new regulatory guide that details commercial instrument calibration service requirements and provides guidance for establishing a program for the use of byproduct material in these service operations that would meet NRC regulatory requirements. The proposed action would provide guidance for preparing license applications in con-formance with the new NRC Form 313.

2.2 Need A new regulatory guide is needed to provide guidance that conforms to the new NRC Form 313 to license applicants for the use of byproduct material in commercial calibration services.

21

2.3 Value/ Impact 2.3.1 NRC The review and approval of applications for the use of byproduct material in certain commercial services would be considerably facilitated by the instruction and guidance to be provided in the proposed action. The new guide would clearly list the regulations to be followed and the information required for licensing and implementing an acceptable program for performing these services. Staff review time would be shortened because less correspondence would be needed to compensate for the lack of sufficient detail in license applications.

2.3.2 Other Government Agencies Other government agencies would not be affected.

2.3.3 Industry The proposed action would contribute to a reduction in the time required for preparing license applications. Applicants would spend less time trying to interpret NRC regulations and requirements for information. More importantly, the proposed action would provide information for the design and implementation of a more effective radiation safety program, thereby minimizing the exposure of workers to radiation.

2.3.4 Public No impact on the public is foreseen.

2.3.5 Worker The worker would benefit from the proposed action through reduced exposure to radiation as discussed in Item 2.3.3.

2.4 Decision on Proposed Action A new regulatory guide should be prepared to provide guidance to applicants for preparing license applications for the use of byproduct material in commercial calibration services.

22

3. TECHNICAL APPROACH Not applicable.

4. PROCEDURAL APPROACH 4.1 Alternatives The alternative is to provide no specific guidance to applicants and to write individual letters to applicants.

4.2 Discussion A regulatory guide is the most effective way to transmit information about regulations and licensing requirements. A regulatory guide ensures uniform transmission of information to applicants. Individual letters would be inefficient and, depending on the reviewing official, may not uniformly convey the same information to each applicant. Issuance of a new regulatory guide is the most effective alternative.

5. STATUTORY CONSIDERATIONS 5.1 NRC Authority Authority for the proposed action is derived from the Atomic Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974, as amended, and implemented through the Commission's regulations.

5.2 Need for NEPA Assessment Issuance or amendment of guides for the implementation of regulations in Title 10, Chapter I, of the Code of Federal Regulations is a categorical exclu-sion under paragraph 51.22(c)(16) of 10 CFR Part 51. Thus, an environmental impact statement or assessment is not required for this action.

23

6. RELATIONSHIP TO OTHER EXISTING OR PROPOSED REGULATIONS OR POLICIES No conflicts or overlaps appear to exist.

7.

SUMMARY

AND CONCLUSIONS The regulatory guide, when disseminated, will assist the NRC in its review of applications for the use of byproduct material in commercial calibration services and will provide applicants with guidance on submitting applications that conform to the new NRC Form 313. The proposed regulatory guide should be issued.

\

24

UNITED STATES ,,,,, c ,,,, on, NUCLEAR REGULATORY COMMISSION Postaos e nas Paio C

WASHINGTON, D.C. 20555 of,5*"o c PERMIT No G 47 orriCIAL 80 SIN PENALTY FOR PANA E USE. $300 12C555064215 1 1GF1EO1SA US ARC tDP-DIV 0F TICC ECCLVEAT C42 CCNTRCL CESK-RECEE LASFIAGTCA CC 2C555 k

w e

4 e

O 1

f

, 1 I

/

l