ML20215A253

Reg Guide 10.11, Guide for Preparation of Applications for Radiation Safety Evaluation & Registration of Sealed Sources Containing Byproduct Matl

ML20215A253
Person / Time
Issue date:	06/30/1987
From:	NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:
References
TASK-FC-603-4, TASK-RE REGGD-10.011, NUDOCS 8706160579
Download: ML20215A253 (30)

Text

. . Pb, g#"% U.S. NUCLEAR RECULATORY COMMISSl2N Jun.1ss7

(%***.*) REGULATORY OFFICE OF NUCLEAR REGULATORY RESEARCH GUIDE REGULATORY GUIDE 10.11 (Task FC 6034)

GUIDE FOR THE PREPARATION OF APPLICATIONS FOR RADIATION SAFETY EVALUATION AND REGISTRATION OF SEALED SOURCES CONTAINING BYPRODUCT MATERI AL 8706160579 070630 PDR REGOD 10.011 R PDR USNRC REGULATORY GUIDES The guides are issued in the following ten broad divisions:

Regulatory Guides are issued to describe and make available to the public methods acceptable to the NRC staff of implementing 1. Power Reactors 6. Products specific parts of the Commission's regulations, to delineate tech. . Research and Test Reactnes 7. Transportation niques used by the staff in evaluating specific problems or postua . Fuels and Materials Facilities 8. Occupational Health lated accidents or to provide guidance to appl 6 cants. Regulatory . Environmental and Elling 9. Antitrust and Financial Review Guides are noI substitutes for regulations, and compilance with S. Materials end Plant Protection 10 General them is not reQulted. Methods and solutions different from those set out in the guides will be acceptable if they provide a balls for the findings requisite to the issuance or conttr'uance of a permit of CoDies of issued guides may be purchased from the Government license by the Commission. Printing Office at the current GPO pr6ce, information on current GPO prices may be obtained by contacting the Superintendent of This guide was issued after consideration of comments received from Documents. U.S. Government Printing of fice. Post of fece som the publ6c. Comments and suggestions for improvements in these 3 7082, Wash 6ngton, DC 20013 1082, telephone (202)275 2060 or guides are encouraged at all times, and guides will be revised, as (202)276 2171 appropriate, to accommodate comments and to reflect new informe-tion or espertence.

Issued guides may also be purchased from the Nateonal Technical Written comments may be submitted to the Rules end Procedures information Serv 6ce on a standing order basis. Details on this Branch. ORR ADM U.S. Nuclear Regulatory Commission, serv 6ce may be obtained by writing Nil 5, $285 Port Royal Road, Washington, D 20SSS, Springfield. V A 22161.

TABLE OF CONTENTS '

Section Pag

1. INTRODUCTION ......................... 10.11-1 1.1 Purpose of Guide . . . . . . . . . . . . . . . . . . . . . 10.11-1

1. 2 Applicable Regulations . . . . . . . . . . . . . . . . . . 10.11-1 1.3 Radiation Safety Evaluation Fees . . . . . . . . . . . . . 10.11-2 1.4 As Low As Is Reasonably Achievable (ALARA) Philosophy. . . 10.11-2 1

2. FILING AN APPLICATION . . . . . . . . . . . . . . . . . . . . . 10.11-3 2.1 Style .......................... 10.11-3 2.2 Composition ....................... 10.11-3 1 2.3 Proprietary Information ................. 10.11-4 2.4 Certification ...................... 10.11-4 2.5 Where to File ...................... 10.11-5 2.6 Medical Sealed Sources . . . . . . . . . . . . . . . . . . 10.11-5 2.7 Registration of a Foreign-Manufactured Sealed Source . . . 10.11-5 i

2.8 Manufacturers / Distributors Located in Agreement States . . 10.11-6 2.9 Naturally Occurring and Accelerator-Produced Radioactive Materials ............... ........ 10.11-6

2.10 Transportation . . . . . . . . . . . . . . . . . . . . . . 10.11-6

3. CONTENTS OF AN APPLICATION .................. 10.11-7 I

3.1 Summary Data . . . . . . . . . . . . . . . . . . . . . . . 10.11-8 3.2 Summary Description ................... 10.11-9 3.3 Details on Construction and Use ............. 10.11-10 1 4. CERTIFICATE OF REGISTRATION . . . . . . . . . . . . . . . . . . 10.11-14

5. AMEN 0MENTS TO REGISTRATION CERTIFICATES FOR SEALED SOURCES. . . 10.11-14

6. RESPONSIBILITY OF REGISTRANT ................. 10.11-15

7. IMPLEMENTATION ........................ 10.11-15 APPENDIX A Agreement States .................. A-1 APPENDIX B Proprietary Information, Availability of Official Records B-1

APPEflDIX C Principal Use Codes and Definitions for Sealed Sources and Devices .......... C-1 l APPENDIX D Check List for Sealed Source Radiation Safety Evaluation . . . . . . . . . . . . . . . . . D-1

VALUE/ IMPACT STATEMENT . . . . . . . . . . . . . . . . . . . . . . . V/I-1 i,

10.11-111

1. INTRODUCTION 1.1 PURPOSE OF GUIDE The purpose of this regulatory guide is to provide assistance to sealed source manufacturers and distributors on submitting requests for the U.S.

Nuclear Regulatory Commission's (NRC's) radiation safety evaluation and regis-tration of sealed sources containing byproduct material.

For many uses of byproduct materia 12 that are licensed by the NRC, the radioactive material is contained in a sealed source. As used in this guide, a sealed source is radioactive material that is sealed in a protective envelope (capsule), contained in a foil, or plated on an inactive surface. The term

" sealed source" or " source" includes the radioactive material and its confining barrier, i.e., the capsule, foil, or plated surface. The confining barrier is relied on to prevent dispersion of the radioactive material under normal condi-tions for use of the source and most accident conditions.

Before authorizing the distribution and use of byproduct material in a sealed source, the NRC determines the adequacy of the radiation safety proper-ties of the source. This determination is reached by reviewing the information submitted by the manufacturer or distributor of the source.

The NRC maintains a registry of radiation safety information on sealed sources containing byproduct material that are intended for transfer by their manufacturers and distributors. Agreement States 2 also provide information on their radiation safety evaluations to the NRC for the registry. Both the NRC and the States use the information in the registry. Thus a manufacturer /

distributor need provide detailed information about its sealed source only to a single agency, and the results of the radiation safety evaluation will be available for use in granting licensing approval to users of the sealed source throughout the United States.

1.2 APPLICABLE REGULATIONS NRC regulations applicable to sealed sources containing byproduct material and to NRC radiation safety evaluations are found in 10 CFR Part 2, " Rules of Practice for Domestic Licensing Proceedings"; 10 CFR Part 19, " Notices, Instruc-tions, and Reports to Workers; Inspections"; 10 CFR Part 20, " Standards for Protection Against Radiation"; 10 CFR Part 30, " Rules of General Applicability to Domestic Licensing of Byproduct Material"; 10 CFR Part 31, " General Domestic Licenses for Byproduct Material"* 10 CFR Part 32, " Specific Domestic Licenses

~

ToManufactureorTransferCertaInItemsContainingByproductMaterial";10CFR Part 34, " Licenses for Radiography and Radiation Safety Requirements for Radio-graphic Operations"; 10 CFR Part 35, " Human Uses of Byproduct Material";

1" Byproduct material" is defined in paragraph 30.4(d) of 10 CFR Part 30 and in paragraph 40.4(a-1) of 10 CFR Part 40. For the purposes of this guide, "by-product material" means radioactive material that is produced in a nuclear reactor.

2" Agreement State" is defined in paragraph 30.4(c) of 10 CFR Part 30. Generally speaking, in an Agreement State, the State instead of the NRC regulates the use of byproduct material. A list of Agreement States is provided in Appendix A of this guide.

10.11-1

10 CFR Part 71, " Packaging and Transportation of Radioactive Material;" and 10 CFR Part 170, " Fees for Facilities and Materials Licenses and Other Regula-tory Services Under the Atomic Energy Act of 1954, as Amended."a Before preparing your application you should be acquainted with the

! applicable regulations. Single copies of a specific NRC regulation may be l

obtained without cost from the Division of Rules and Records, Office of Administration and Resources Management, U.S. Nuclear Regulatory Commission, Washington, DC 20555. A bound vo'une of NRC regulations may be purchased from the Superintendent of Documents, U.S. Government Printing Office, Post Office Box 37082, Washington, DC 20013-7082.

Detailed requirements for certain sources are set out in the regulations (for example, calibration or reference sources distributed under the provisions of 5 32.57 of 10 CFR Part 32 for use under a general license). For many other sources, the regulatory requirements are less detailed and NRC's radiation safety evaluation of the source is based principally on the comprehensive requirement in paragraph 30.33(a)(2) of 10 CFR Part 30 that the user's equipment and facili-ties must be adequate to protect health and minimize danger to life or property.

Any information collection activities mentioned in this regulatory guide are contained as requirements in 10 CFR Parts 19, 20, 30, 31, 32, 34, 35, and 71, which provide the regulatory basis for this guide. The-information collec-tion requirements in these parts have been cleared under OMB Clearance Nos.

3150-0044, 3150-0014, 3150-0017, 3150-0016, 3150-0001, 3150-0007, 3150-0010, and 3150-0008, respectively.

1.3 RADIATION SAFETY EVALUATION FEES A radiation safety evaluation fee is required by paragraph 170.12(a) of 10 CFR Part 170. Refer to 5170.31, " Schedule of Fees for Materials Licenses and Other Regulatory Services," to determine the amount of the fee that must accompany your application. An application received without the required fee or with an inadequate fee may be returned to you. All application fees may be charged regardless of the NRC's disposition of the application or your with-drawal of it.

1.4 AS LOW AS IS REASONABLY ACHIEVA8LE (ALARA) PHILOSOPHY l

Paragraph 20.1(c) of 10 CFR Part 20 states "... persons engaged in activi-ties 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 reason-ably achievable." Regulatory Guide 8.10 " Operating Philosophy for Maintaining OccupationalRadiationExposuresAsLowdsIsReasonablyAchievable,"provides the NRC staff position on this important subject. You should consider the ALARA philosophy as described in Regulatory Guide 8.10 when designing and construct-ing sources in order to avoid unnecessary exposures during the use of the source.

aihe NRC has issued a proposed 10 CFR Part 39, " Licenses and Radiation Safety Requirements for Well-Logging Operations" (50 FR 13797).- When Part 39 becomes I an effective regulation, its provisions will also be considered in the radia-tion safety evaluation of certain sources.

10.11-2 i

l I

2. FILING AN APPLICATION When applying for a radiation safety evaluation and registration of a sealed source, you should submit an application containing the information out-lined in Section 3. No special form is required, although applicants are encour-aged to follow the format of Section 3. The application should indicate whether the sealed source is intended for use under (1) an exemption from the regulations, e.g., sources contained in ionization radiation measuring instruments for pur-poses of internal calibration or standardization to be used under the provisions of 5 30.15, (2) a general license, e.g., an americium-241 calibration or refer-ence source to be used under the provisions of S 31.8, (3) a specific license, e.g. , a sealed source in a radiographic exposure device to be used under the provisions of 10 CFR Part 34, or (4) either a general license or a specific license, e.g., a sealed source in an industrial density-measuring gauge that may be used by some persons under the general license in S 31.5 and by other persons who elect not to comply with all the provisions of 6 31.5 under a specific license issued under S 30.33.

Do not submit personal information about your employees unless it is neces-sary. For example, you should submit the title and work telephone number of the individual to be contacted for additional information or clarification of your application. An employee's home telephone number should be submitted only if it is the only means of contact about your application.

NRC's review of your application will be facilitated if you follow the guidelines in the following sections.

2.1 STYLE All pages in an application should be numbered consecutively. If revisions are necessary after an application has been submitted, revised pages should be submitted; your revision should include clear and specific reference to those portions of the submission that are being revised. If revised pages are sub-mitted, each revised page should show the date of revision. If supplemental pages are submitted for insertion, they should be indicated alphanumerically (e.g.,2a,2b,etc.).

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 neces-sary, fold them to 8-1/2 x 11 inches. All drawings should have a drawing number, revision number, c d any name, title, scale, and date. If drawings have been reduced or enlarged, this should be clearly indicated so that the scale may be applied properly.

When drawings, descriptiv? sales literature, or similar documents are sub-mitted as part of 7.he application, they should be identified clearly as being part of the application. This might be done by marking the materials individu-ally and listing them on a cover sheet for the application or listing them as enclosures to the letter that transmits the application.

I 2.2 COMPOSITION l You should strive for clear, concise presentation of the information pro- 1 vided in the application, avoiding ambiguous statements ard wordy descriptions that do not contribute to a technical review. The radiation safety adequacy 10.11-3 1

} . .

l  ;

f of designs should be supported by technical data, i.e., by an appropriate engi- ,

i neering evaluation and descriptions of tests on sealed sources and the test  ;

j results. Documented field experience with comparable sources may be included. l t

j Terms should be used as they are defined in NRC regulations and national j

consensus standards. Abbreviations not in general use should be defined. Refer-  ;

j ences to tests, regulations, or standards in a foreign language should be r supported by submitting an English translation of the cited document. The appli- l i

cation, including notations on engineering drawings, must be in English. To  !

i facilitate preparing an application for a sealed source manufactured outside '

i the United States, the applicant may elect to write or othenvise affix the i English translation directly on the engineering drawing. l Appendices may be used to include infonsstion not appropriate to the main f

{

text. Appendices may include, for example, photographs of physical tests.  ;

i In a feet instances, it may be advantageous to submit a dummy sealed source  !

(i.e., without radioactive material) with an application. Sources containing  ;

i j

1 radioactive material should not be submitted.

i i

} 2.3 PROPRIETARY INFORMATION I

jl . Proprietary (i.e., not to be disclosed to the public) data should not be

submitted unless it is the only means to adequately describe the radiation ,

safety properties of the source. If the application contains data you con-sider to be proprietary, the data should be clearly marked for appropriate l handling by NRC. In addition, the letter transmitting the application should i J

contain a request for withholding from pubile disclosure as discussed in para-1 graph 2.790(b) of NRC's regulations in 10 CFR Part 2, "Aules of Practice for (

l Domestic Licensing Proceedings." Pertinent portions of 9 2.790 and a related

> 5 9.5 of 10 CFR Part 9, "Public Records," are contained in Appendix 8 of this

} guide. It is essential that these procedures be followed so that NRC can ,

recognize that a request for withholding is being made and then consider the  :

request on its merits. l i

j Standard blueprint blocks stating that drawings, sketches, etc., are ,

i " confidential," " restricted," or "are to be the express property of Company X" l

l and similar notes in manuals and other documents should be removed from all i l submittals, or a statement should be made that the notes are to be disregarded, unless a formal request for withholding has been filed and properly supported  !

! with information required under 5 2.790. l 1 i t

! 2.4 CERTIFICATION I

l If you are an individual applicant acting in a private capacity, you should  !

sign the application for radiation safety eva uation. Otherwise, your applica- l tion should be dated and signed by a representative of the corporation or other t i legal entity who is authorized to sign official documents and to certify that j l the application contains information that is true and correct to the best of your knowledge and belief. An unsigned application will be returned for proper l j '

l signature.

f l f

i 10.11-4 j

_ _ _ . _ . _ _ _. - ___a

i i l 2.5 WERE TO FILE You should prepare your application in triplicate. Retain one copy for .

yourself because you will be obligated to construct and distribute the sealed i i source in accordance with the statements and representations in your application.

1 1

The original signed copy and one additional copy of your application for  ;

1 radiation safety evaluation and registration of your sealed source, together i

! with the fee payment (see Section 1.3 above), should be sent to:  ;

) U.S. Nuclear Regulatory commission l 4

Division of Fuel Cycle, Medical, Academic,  ;

! and Commercial use Safety 1 Medical, Academic, and Commercial Use Safety Branch j Washington, DC 20535

! Please note that the above address is different from that of the appropriate  !

NRC Regional Office or Washington, OC Office (identified in 5 30.6 of 10 CFR j i Part 30) to which you would apply for authority to possess and use radioactive i j material under a manufacturing and distribution license, i

! When the NRC completes its radiation safety evaluation of your sealed source, I you will be sent a certificate of registration that acknowledges the registration l

! of information about the source and the availability of that < nformation for use j j in the issuance of specific licenses.

. 2.6 MEDICAL SEALED SOURCES

(

l Please note that if a sealed source is to be used for medical purposes and j is subject to regulation by the Food and Drug Administration (FDA), an NRC l j registration certificate will not be issued unless the applicant has submitted l to the NRC an FDA 510k Certificate or similar indication of marketing approval by FDA. Infonnation on FDA requirements may be obtained by contacting:  !

t Food and Drug Administration Center for Devices and Radiological Health i HFZ-401 ,

j 8757 Georgia Avenue i

' Silver Spring, MD 20910 l 2.7 REGISTRATION 0F A FOREIGN-MANUFACTURED SEALED SOURCE l j A sealed source manufactured outside the United States may be registered  :

by the NRC if appropriate information is supplied and if NRC's administrative l requirements are satisfied. The registrant must establish an address or repre-I sentative in the United States where papers may be served, where records ,

required by the NRC will be maintained, and where the NRC can inspect the  ;

registrant's activities as necessary to fulfill the requirements of NRC's i regulations, j A person in the U.S. may elect to import a source that will be manufactured

in a foreign country in accordance with specifications determined by that person.

Under these tion safety conditions, infomation the NRC with the person or with (user) theshould register Agreement Statethe seeapp Sec- (ropriate radia-tion 2.8 of this guide) if located in an Agreement State.

10.11-5

~. ____ _ _. _ _ _ _ _ _ . _ _ _ _

l l 2.8 MANUFACTURERS / DISTRIBUTORS LOCATED IN AGREEMENT STATES s

! A sealed source manufacturer or distributor located in an Agreement State ,

! (see Appendix A) should contact that State's regulatory authority for guidance on preparing requests for evaluation of sources and applications for licenses  !

to possess and use radioactive material.

2.9 NATURALLY OCCURRING AND ACCELERATOR-PRODUCEO RADI0 ACTIVE MATERIALS  !

I Radioactive material includes " byproduct material" that is subject to regu-j lation by the NRC and the Agreement States. Another class of radioactive mate-t rial, called "NARM" (natura' ly occurring and accelerator-produced radioactive materials), is not subject to regulation by the NRC but is regulated by all l 50 States, i

The Food and Drug Administration (FDA) assists the States in their review  !

and regulatory approval for distribution of sealed sources containing radium and other NARM. In their evaluations, they frequently apply the NARM guide *  ;

published by the Department of Health and Human Services. Guidance provided in this regulatory guide for sealed sources containing byproduct material is l j

comparable to guidance provided in the NARM guide for sources containing NARM. j j Asaponeralrule,theNRCdoesnotacceptapplicationsforradiation  !

i safety eva untion and registration of sealed sources that will contain NARM. J i There are two exceptions to this general rule. One exception is if the radio- l nuclide used in the source is available from either a reactor (defined as l byproduct material) or from an accelerator (defined as NAIDl). Cadmium-109 is t an example of such a radionuclide. The NRC will accept applications concerning i Cd-109, assuming for purposes of source evaluation and registration that the  !

Cd-109 will be produced in a reactor. The other exception is if the NARM is i commingled with byproduct material. I t

2.10 TRANSPORTATION This regulatory guide does not cover detailed requirements for the trans- l portation of sources. The NRC's transportation requirements are contained in  !

10 CFR Part 71, " Packaging and Transportation of Radioactive Material." Part 71  !

i establishes (1) requirements for quality assurance, packaging, preparation.for

} shipment, and transportation of licensed material and (2) procedures and stand- '

j ards for NRC approval of packaging and shipping procedures for fissile material

and for a quantity of licensed material in excess of a " A quantity" (i.e., i

{ exceeding At and As as defined in S 71.4 of 10 CFR Part 71 . [

Although the application for radiation safety evaluation of a source is i not expected to include a detailed description of packaging and transportation  !

j procedures to demonstrate full compliance with 10 CFR Part 71, the applicant is  !

i expected to be familiar with the way those requirements apply to the source and .

j the action needed to ensure that transportation of the source is performed in l accordance with applicable requirements.

j 9;opfes of the NARM guide (HMS Publication FDA 81-9025) may be purchased at l current rates from the U.S. Government Printing Office, Washington, DC j

20013-7042, er the National Technical Infonnet' on Service, 5285 Port Royal bl ;

Road, Springfield, VA 22161.

10.11-6

Two requirements for transportation of sources are particularly important with respect to sources that are frequently transported by the user (shipper),

such as gamma radiography sources and well-logging sources. The manufacturer or distributor should be prepared to advise and supply the shipper (user) with the following:

1. A copy of the safety analysis, including documentation of the tests, demonstrating that the sealed source meets the "special form" require-ments of NRC/ DOT transport regulations (SS 71.75 and 71.77 of 10 CFR Part 71; SS 173.469 and 173.476 of 49 CFR Part 173). This is not required, however, in cases where At equals A2 and the source is not described on t1e shipping documents as "special form."

2. If an A3 or A2 quantity of radioactive material is involved, a copy of the documentation on the tests and engineering evaluation or com-parative data showing that the package design meets the requirements of a DOT Specification 7A package (see paragraph 173.415(a) of 49 CFR Part173).

Shippers of radioactive material are required to maintain the above docu-f ments on file for at least 1 year after any shipment. It is therefore important that the manufacturer or distributor supply the shipper (user) with this infor-mation.

Any manufacturer or distributor who has questions about the requirements for transportation may contact the appropriate NRC Regional Office (listed in S 30.6 of 10 CFR Part 30) to obtain assistance.

3. CONTENTS OF AN APPLICATION An application for radiation safety evaluation and registration of a sealed source is reviewed most readily by the NRC if the application is organized into three sections. The first section of the application should contain the infor-nation discussed here in Section 3.1, " Summary Data." This information is used principally by the NRC to prepare the first page of the registration certificate.

The first page of the certificate identifies the sealed source (model number),

radioactive material (nuclides and quantity of each), leak-test requirement, 4 and manufacturers and distributors who are involved.

The second section of the application should contain the information dis-cussed in Section 3.2, " Summary Description." This information is used by the NRC for the descriptive portion of the registration certificate. This portion explains for interested persons, such as NRC field personnel and Agreement State regulatory personnel, what the sealed source looks like and how it is used.

The third section of the application should contain the information dis-cussed in Section 3.3, " Details on Construction and Use." This information is important to NRC's radiation safety evaluation of the sealed source and deter-mination of the conditions under which the sealed source will be authorized for distribution and use.

10.11-7

Note that the format in this Section 3 is recommended, not required. How-ever, applicants are encouraged to use this format to expedite the review proc-ess and minimize the number of follow-up letters and telephone calls.

3.1 SumARY DATA This section should be presented on one page and should contain key infor-sation under the following headings.

3.1.1 Date Give the date of the application.

3.1.2 Applicant Give the name and complete mailing address of the organization submitting the application; indicate whether the applicant is the manufacturer, distributor, or both. Also give the name, title, and telephone number of the individual to be contacted if additional information or clarification is needed by the NRC.

3.1. 3 Sealed Source Type State the name used by the industry to identify the sealed source (e.g.,

radiography source, gamma irradiator source, teletherapy source, calibration source).

3.1.4 Model State the model number, series number, or drawing number used by the manu-i facturer or distributor to uniquely identify the sealed source. This number will be used by regulatory groups to rapidly identify a registered sealed source and to locate information about the sealed source. All sealed sources should have a model number or other specific identifier.

3.1. 5 Other Companies Involved Give the name and address of any other companies directly involved in the manufacture or distribution of this sealed source. For example, if the appli-cant distributes a sealed source manufactured by the XYZ Company, state that XYZ Company is the manufacturer and give the XYZ Company's mailing address.

3.1.6 Radionuclide and Maximum Activity List the radionuclides you propose to use in the sealed source and the maximum proposed activity level in curies, millicuries, or microcuries for each radionuclide.6 If the application concerns a series of sources that are

• If desired, the. activity may be stated in both curies (or subunits thereof) g and becquerels. In such case, please state the number of curies and then the number of becquerels with the number of becquerels enclosed in parentheses.

10.11-8

l l

l essentially identical, maximum activities may be stated for subgroups within the series. For example, the XYZ Company's Series 200 cobalt-60 teletherapy l sources all have the same external dimensions, but within the series the Model l 201 source has an active diameter of 1.5 cm and maximum activity of 1,500 Ci,  ;

the Nodel 202 source has an active diameter of 2.0 cm and maximum activity of 3,000 C1, etc.

3.1.7 Leak-Test Frequency State the proposed frequency for testing the sealed source for possible leakage of radioactive material. (Guidance on leak testing is presented in Section 3.3.7.)

t 3.1.8 Principal Use Codes Select from Appendix C to this guide, " Principal Use Codes and Definitions i

for Sealed Sources and Devices," the code that most accurately describes the i principal or predominant use for the sealed source. State whether the sealed source is proposed for use under (1) a specific license, (2) a general license, i (3) an exemption from regulatory requirements, or (4) a ctdination of 1, 2, or 3. If the sealed source is proposed for use under a general license or an 3

exemption, indicate the primary section of NRC regulations applicable to its use.

3.1.9 Custom Sealed Source

Indicate whether the sealed source is a custom source. A sealed source specifically designed and constructed according to the order of a single license applicant may be considered a custom sealed source that warrants an NRC review

,l that is tailored to the particular applicant. Sealed sources designed and con-structed as off-the-shelf items or for use by more than a single license appli-cant are not considered custom sealed sources.

! 3.1.10 Custom User If this is a custom sealed source, give the name and address of the user and a contact (individual's name or title and telephone number) for the user.

3.2

SUMMARY

DESCRIPTION This section should include a short discussion of what the sealed source will be used for and its radiation safety features. This information frequently is found in a manufacturer's sales brochures and pamphlets. Such documents may be useful in presenting the summary description.

3.2.1 Written Description Provide a brief written description of the sealed source, including information on the chemical and physical form of the radioactive material, mate-i rials of construction, dimensions (including wall and window thicknesses), and methods for fabricating and sealing the source. State the radioactive source 10.11-9

classification according to the system in ANSI N542, " Sealed Radioactive Sources.

Classification."'

The application may concern a series of sources that are substantially the same. This series may be divided into subgroups that differ only with respect to identified properties. Each subgroup and its unique properties should be described.

3.2.2 Drawina Provide an annotated sketch, photograph, or isometric projection or drawing showing components pertinent to radiation safety such as well and window thick-nesses, approximate dimensions, and label location (if any). The drawing, sketch, or photograph should be no larger than about 4 in, by 6 in, and should be clear, legible, and suitable for photocopying. (The NRC may include a copy of the drawing, sketch, or photograph in the Certificate of Registration that is dis-cussed in Section 4 of th<s guide.)

3.3 DETAILS ON CONSTRUCTION AND USE This section should ture, prototype testing, provide detailedleak quality control, infomation testing,on the design, labels, manufac-proposed uses, and potential hazards of the sealed source. The information presented should provide reasonable assurance that the sealed source will maintain its contain-ment integrity and can be used without exceeding applicable radiation exposure standards. The following sections outline the type of detailed information that should be submitted.

3.3.1 Conditions of Use Describe the planned use of the sealed source and identify the extremes of environment and operating conditions (e.g., temperature, corrosive atmosphere, vibration) expected during normal use. Include descriptions of the types of users and locations of use. List any stress limitations you have prescribed for use of the sealed source. Also describe the probable effects of severe conditions, including fires.

'In 11eu of stating an AN$1 N542 classification, an applicant may provide a classification under the International standards Organization (IS0) standard I$0.2919, "$ealed Radioactive Sources--Classification." ANSI M542 and ISO.2919 are closely related. Each standard establishes a system of classification of sealed radioactive sources based on performance specifications related to radi-ation safety. Each provides a manufacturer of sealed sources with a series of tests for evaluating the safety of the product under specified conditions.

Tests are prescribed for temperature, external pressure, impact, vibration, and puncture over a range of severity. $ealed source performance tests are iden-tified for a variety of source applications, together with the degree of sever-ity of each test. Both standards cover selecting a source for a particular application insofar as maintenance of source integrity is concerned. The ISO standard and ANSI N542 may be obtained from the American National Standards Institute, 1430 Broadway, New York, NY 10018. t 10.11-10

3.3.2 Details of construction Submit engineering drawings or annotated sketches or drawings of the sealed source that describe all materials of construction, dimensions, methods of fabrication, and methods of sealing the source capsules. Describe in detail all special design features, such as recessing of the primary radiation beam window, that help prevent damage to vulnerable portions of the sealed source.

3.3.3 Labeling Describe how (e.g. , etched, engraved, or imprinted) and with what informa-tion the source will be labeled (e.g. , the words " Caution - Radioactive Material,"

the manufacturer's name or trademark, model number or unique serial number, radionuclide, assay date, radiation symbol). If labeling the sealed source is impracticable, explain how safety-related information such as the above will be provided to the user (e.g., a tag attached to the source, a label on the storage container or other device containing the source).

3.3.4 Testing of Prototypes?

Describe the tests performed on each prototype sealed source and submit the test results that establish the integrity of the radiation safety features of the sealed source under the conditions of use to which the source is likely tobesubjected. For example, describe the testing performed to establish the source classification stated in Section 3.2.1.

7For many sealed sources, guidance on design considerations, tests of prototypes, and quality control programs is provided in industry or consensus standards.

Applicants for safety evaluations are encouraged to consider such guidance.

Some particularly useful standards are (1) for sealed radioactive source clas-sification, ANSI H542, " Sealed Radioactive Sources, Classification," and 150.2919-1980, " Sealed Radioactive Sources--Classification," (2) for brachy-therapy, ANSI N44.1-1973, " Integrity and Test Specifications for Selected Brachytherapy Sources," (3) for radtography, ANSI N432, " Radiological Safety for the Design and Construction of Apparatus for Gamma Radiography," (4) for gauges, ANSI N538, " Classification of Industrial Ionizing Radiation Gauging Devices," (5) for irradiators, ANSI N433.1, " Safe Design and Use of Self-Contained Dry Source Storage Gamma Irradiators (Category 1)," and ANSI N43.10 "SafeDesIgnandUseofPanoramic,WetSourceStorageGammaIrradiators(Cate-gory IV)," (6) for self-luminous light sources, ANSI H540, " Classification of Radioactive Self-Luminous Light Sources," (7) for teletherapy, National Council on Radiation Protection and Measurements (NCRP) Report No. 33, " Medical X-Ray and Ganna-Ray Protection for Energies up to 10 MeV," and (8) for smoke detec-tors, Nuclear Energy Agency (NEA) " Recommendations for Ionization Chamber Smoke Detectors in Implementation of Radiation Protection Standards" (1977). If there is no specific industry or consensus standard for your sealed source, you may obtain useful general guidance from a standard for a comparable source.

ANSI H538 may be particularly useful for general guidance on quality control.

ANS! and ISO standards are available from the American National Standards Institute, 1430 Broadway, New York, NY 10018. NCRP reports are available from the National Council on Radiation Protection and Measurements, 7910 Woodsont Ave. Washington, DC 20014. HEA reports are available from the Organization for Economic Cooperation and Development (DECD) Publications and Information Center, Suite 1207, 1750 Pennsylvania Ave., NW., Washington, DC 20006.

10.11-11

In some instances, engineering analyses may be an acceptable alternative to testing of prototypes. For example, engineering analyses may be appropriate for custos sealed sources, sources expected to have limited distribution or low p potential hazard, or sources that are quite similar to previously tested proto-types. Even in these instances, the applicant should submit historical use data er data from tests en prototypes of similar sources to reinforce findings resulting from engineering analyses.

Source manufacturers frequently evaluate their products to determine the effects of the tests for special fore radioactive material (see 5 71.77 of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material"). If these tests are performed, the results of the tests should be submitted. If a national competent authority has issued a certificate stating that the sealed source satisfies the special fem requirements for transportation purposes, a copy of that certificate should be included in the application for safety evaluation and registration.

3.3.5 Radiation Levels submit radiation profiles or other statement of radiation levels associated with the sealed source. Radiation levels should be determined using the nextaum activity of each nuclide expected to be used in the source. In general, the distances for determining the radiation levels are 5 cm, 30 cm, and 100 ce from the source to the effect've center of the radiation measuring chamber. A description of the method and instrumentation used to measure the radiation levels or the bases for calculations used to determine the levels should be included.

For a sealed source that emits more than one type of radiation, the contri-bution of each type should be provided as well as the total radiation level.

For example, for an americium-241/bery111um neutron source used in well logging, both the gamma contribution and the neutron contribution should be provided.

This information is important in determining radiation levels external to well logging tools and storage containers.

Occasionally a source may contain a radioactive contaminant, or the prin-cipal radionuclide may not be in equilibrium with its daughter products at the time of initial determination of radiation levels. Accordingly, subsequent determinations may show radiation levels that are significantly different from levels calculated by adjusting the initial determination for decay of the prin- <

cipal radionuclide. If this condition applies to your sealed source, you should '

describe the expected changes in the energy spectrum and radiation levels during the probable useful life of the source.

3.3.6 Quality Control?

Describe the quality control program and the procedures to be followed to ensure that each finished sealed source meets specifications furnished to the NRC. Even for a custom sealed source, you should provide a copy of the proce-dures to be followed or tests to be performed to ensure that the finished custom sealed source meets your design specifications.

D 10.11-12

You should include a description of the assay methoo used to determine the radioactive content of the sealed source. This method is expected to be trace-able to a national standard.

A particularly important portion of the quality control program is ensuring that the sealed source is not leaking and is free of contamination at the time of transfer to the user. Generally, this means the absence of 0.005 microcurie or more of removable radioactive material.

3.3.7 Leak Testina Durina Use The NRC requires, with certain exceptions, that sealed sources or devices containing sealed sources be tested periodically for possible leakage of radio-active material at intervals not to exceed 6 months.a However, an applicant may request a longer interval for NRC consideration. A request for an interval greater than 6 months (both for sources and devices used under a specific license end for devices used under a general Itcense) should address the subjects listed

, in paragraph 32.51(b) of 10 CFR Part 32 and the quality control measures that ensure an absence of leakage and contamination.

The NRC does not require periodic leak testing of a sealed source or device during use if the sealed source or device contains only (1) hydrogen-3, (2) radioactive material with a half-life less than 30 days, (3) radioactive material in the form of gas, (4) less than 100 microcuries of beta- or gamma-emitting material, or (5) less than 10 microcuries of alpha-emitting material.

However, distributors of such sealed sources and devices must ensure that they are free of leakage and contamination when transferred.

3.3.8 Documentation Accompanyina the Sealed Source 1

You should submit a sample of or describe radiation-safety-related documen-tation that you will supply with the sealed source. Examples of such documenta-tion are (1) a certificate providing the date and results of the most recent leak test and contamination check, (2) a statement of the primary radionuclide and its quantity and the identity and quantity of other radionuclides (e.g.,

cesium-134 content of a nominal cesium-137 teletherapy source) in the sealed source, (3) a copy of a "special form" certificate issued by a national comp'e-tent authority or an evaluation indicating that the source is "special form as defined in S 71.4 of 10 CFR Part 71, (4) a statement of the ANSI or ISO source classification, (5) a statement of the radiation output of the source, and (6) any safety recommendations or warnings with respect to unpacking, handling, storing, etc., to be used to minimize exposure to user personnel.

tin most cases the user's test interval depends on the device (e.g., gauge, teletherapy unit) containing the sealed source and how that device is used.

The NRC has issued Regulatory Guide 10.10 " Guide for the Preparation of Appli-cations for Radiation Safety Evaluation and Registration of Devices Containing Byproduct Material," that discusses NRC's device evaluations. A registration certificate for a sealed source may specify a 6-month leak-test interval, but a particular device containing that source may specify a 3 year interval.

When the source is used in that device, leak tests are required only at 3 year intervals.

10.11-13

I Appendix 0 of this guide, " Check List for Sealed Source Radiation Safety Evaluation," may be helpful to you when pre tion safety evaluation of a sealed source. paring an application for a radia-This check list does not need to 5 be submitted with the application.

4. CERTIFICATE OF REGISTRATION Following a determination that you have submitted all the necessary infor-motion and after a satisfactory evaluation of your application, the NRC will issue you a numbered certificate of registration that specifically identifies the sealed source by type and model, series, or drawing number. This certifi-cate will, among other tnings, summarize the information submitted in response to Section 3 of this guide and will specify any limitations and considerations on the use of the sealed source such as (1) to whom the sealed source may be distributed (for example, persons generally licensed pursuant to 5 31.8 or persons specifically licensed pursuant to 5 30.33), (2) leak-test requirements, and (3) restrictions on environmental conditions of use.

The NRC will provide copies of the registration certificate to regulatory authorities in the Agreement States for their use in granting licensing approval to users within their respective states.

A manufacturer or distributor of a sealed source may be asked b customer to identify its product (by model number or serial number) soythat its this information can be referenced in the customer's application for a license. The customer should identify the sealed source exactly as it is identified in the manufacturer's or distributor's registration certificate. This will enable the licensing reviewer to relate the customer's application to the information in the registration certificate.

5. AMENDMENTS TO REGISTRATION CERTIFICATES ren 3EALED souncts It is your obligation to keep your registration certificate current. If the infomation you provided in the application or set out in the certificate is modified or changed, you should submit an application for an amendment to  :

your certificate.

In the meantime, you are obliged to comply with the informa-tion in your certificate untti the certificate is amended. You are encouraged  !

to anticipate the need for certificate amendments insofar as possible, i

An application to amend a certificate should be prepared in triplicate.

You should retain one copy for your records and submit the original and one additional copy to the address specified in this guide in Section 2.5, "Where to File." Your application should identify your registration certificate by nimber and should clearly describe the changes and the effects of the changes on the safety properties of the sealed source. For example, if you intend to change the radionuclide or increase the radioactivity limit and source dison-siens, your application for an amendment should identify the new radionuclide or quantity limit, state the new radiation levels, and state the effects on the ANSI classification for the source. References to previously submitted infor-motion should be clear and specific and should identify that information by date, document title, and page number.

10.11-14

You must send the appropriate fee for a certificate amendment with your application. You should refer to 5 170.31, " Schedule of Fees for Materials Licenses and Other Regulatory Services," of 10 CFR Part 170 to determine the amount of the fee that must accompany your request for a certificate amendment.

The NRC will not process an application for certificate amendment before the proper fee is paid in accordance with $ 170.12.

Please note that if the sealed source is to be used for medical purposes and is subject to regulation by the Food and Drug Administration (FDA), the application for a certificate amendment should include an appropriate FDA 510k Certificate or similar indication of marketing approval by the FDA.

6. RESPONSIBILITY OF REGISTRANT After you are issued a registration certificate, you are obligated to manufacture or distribute your sealed source in accordance with (1) the state-ments and representations contained in your application for safety review and registration (2) the provisions of the registration certificate, and (3) the NRC's regulations.

7. IMPLEMENTATION The purpose of this section is to provide information to applicants for radiation safety evaluation and registration of sealed sources containing by-product material and to registrants of such sources about the NRC staff's plans for using this regulatory guide.

This guide reflects current practices of the NRC staff for evaluating and registering radiation safety information about sealed sources. The informa-tion in this guide is guidance, not requirements. This guidance is intended to assist manufacturers and distributors in preparing and submitting infomation that describes and demonstrates the adequacy of radiation safety properties of a sealed source.

The NRC staff dcas not plan to use this guide to re-evaluate a presently registered sealed source unless the registrant requests an amendment of flied information. An applicant for amendment of information about a registered sealed source is encouraged by the staff to consider this guide when demonstrat-ing the continued adequacy of radiation safety properties of the source.

J l

I 10.11-15 4

[

i APPENDIX A AGREEMENT STATES Became Agreement STATE PHONE ADDRESS State On Alabama 205-261-5313 Mr. Aubrey Godwin, Chief 10/1/66 Bureau of Radiological Health Environmental Health Adminis.

Room 314, State Office Building Montgomery, Alabama 36130 Arizona 602-255-4845 Mr. Charles F. Tedford, Director 5/15/67 Arizona Radiation Regulatory Agency 4815 South 40th Street Phoenix, Arizona 85040 Arkansas 501-661-2301 Ms. Greta Dicus, Director 7/1/63 Div. of Radiation Control and Emergency Management j Arkansas Dept. of Health

! 4815 West Markham Little Rock, Arkansas 72205 California 916-445-0931 Mr. Joe Ward, Chief (916-322-2073) 9/1/62 Radiologic Health Section i Department of Health 714 P Street, Room 498 Sacramento, California 95814 Colorado 303-331-4800 Mr. Albert J. Hazle, Director 2/1/68

( Radiation Control Division Amended Office of Health Protection 4/20/82 Department of Public Health 4210 East lith Avenue Denver, Colorado 80220 Florida 904-487-1004 Lyle E. Jerrett, Ph.D., Director 7/1/64 Office of Radiation Control .

Dept. of Health & Rehabilitative  !

Service 1323 Winewood Blvd.

Tallahassee, Florida 32301 Georata 404-894-7610 Mr. T. E. Hill, Acting Director 12/15/69 Radiological Health Section Department of Human Resources 878 Peachtree Street

! Atlanta, Georgia 30309 A-1

Became STATE PHONE Agreement.

ADDRESS State On I-Idaho 208-334-5879 Mr. Mark Torf, Manager Compliance Section 10/1/68 Idaho Department of Health and Welfare Statehouse Boise, Idaho 83720 Iowa 515-281-4928 Mr. John A. Eure, Director 1/1/86 Environmental Health Section Iowa Department of Health Lucas State Office Building Des Moines, Iowa 50319 Kansas 913-862-9360 Mr. David Ramono, Manager Ext. 284 1/1/65.

Bureau of Air Quality and Radiation Control  ;

l Dept. of Health & Environment l Buf1 ding 740, Forbes Field Topeka, Kansas 66620

_ Kentucky 502-564-3700 Mr. Donald Hughes, Supvr. 3/26/62 Radiation Control Section Dept. of Health Services 275 East Main Street Frankfort, Kentucky 40621 Louisiana 504-925-4518 Mr. William H. Spell, 5/1/67 Administrator Nuclear Energy Division Office of Air Quality and Nuclear Energy P.O. Box 14690 Baton Rouge, Louisiana 70898 Maryland 301-333-3130 Mr. Roland G. Fletcher, Chief 1/1/71 Division of Radiation Control Dept. of Health and Mental Hygiene 201 W. Preston Street Baltimore, Maryland 21201 Mississippi 601-354- Mr. Eddie S. Fuente, Director 6657/6670 7/1/62 Division of Radiological Health 2423 North State Street P.O. Box 1700 Jackson, Mississippi 39205 s

A-2

Became t Agreement

. STATE PHONE ADDRESS State On j

! Nebraska 402-471-2168 Mr. Harold Borchert, Director 10/1/66 i Division of Radiological Health

! State Department of Health 301 Centennial Mall South 1

P.O. Box 95007 Lincoln, Nebraska 68509

Nevada 702-885-5394 Mr. Stanley R. Marshall, Supervisor 7/1/72 i Radiological Health Section Health Division i Department of Human Resources j 505 E. King Street Carson City, Nevada 89710 I New Hampshire 603-271-4587 Ms. Diane Tefft, Program Manager 5/16/66 Radiological Health Program

, Bureau of Environmental Health Health & Welfare Bldg., Hazen Drive t Concord, New Hampshire 03301 New Mexico 505-827-2959 Mr. Michael Brown 5/1/74 Radiation Protection Bureau Environmental Improvement Div.

P.O. Box 968 l Santa Fe, New Mexico 87504

New York 518-474-2178 Mr. Jay Dunkleberger, Director 10/15/62 i Bureau of Nuclear Operation

] New York State Energy Office

! Agency Building 2 2

2 Rockefeller Plaza Albany, New York 12223 North Carolina 919-733-4283 Mr. Dayne H. Brown, Chief 8/1/64

, Radiation Protection Section j Division of Facility Service i

701 Barbour Drive Raleigh, North Carolina 27603 i North Dakota 701-224-2348 Mr. Dana Mount, Director 9/1/69

Div. of Environmental Engineering i Radiological Health Program 1200 Missouri Avenue

Bismarck, North Dakota 58501 4

A-3 l

i

- - . . . , - _ - , - . . . , . . . . - - - . . , - - . - - - , - - , - - - - . . , - - - - - - - - - - -- - .- ~ .- - , .. -,- - -

g .

> ~ Became Agreement STATE ' fHONE ADDRESS State On Oregon 503-229-5797 Mr. R'ay Paris, Manager 7/1/65 Radiation Control Section

_ Dept. of Hagan Resources 1,1400.S.outhWestFifthAvenue Portladd, Oregon 97201 ,

Rhode Island 401-277-2438 'Mr." James E. Hickey, Chief- 1/1/80 Div. of Occupational Health and Radiation Control Rhode Island Dept. of Health 75 Davis Street Providence, Rhode Island 02908 South Carolinc 803-734-4700 Mr. Heyward Shealy, Chief _

9/15/69 Bureau of Radiological Health State Department of Health and -

Environmental Control 2600 Bull Street

Columbia, South Carolina 29201' .

l Tennessee 615-741-7812 Mr. Michcel H. Mobley, Director 9/1/65 Division of Radiological Health Department of Pdblic Health Cordell Hull State Office Building Nashville, Tennessee 37219 Texas 512-835-7000 Mr. David K. Lacker, Chief 3/1/63 Bureau of Radiation Control Amended

'- Texas Department of Health 3/24/82 1100 W. 49th Street (mail only)

Austin, Texas 78756 Utah 801-538-6734 Mr. Larry Anderson, Director. 4/1/84 Bureau of Radiation Control "

C State Department of Health 1

298 North, 1460 West

. P.O. Box 16700-0700 Salt Lake City, Utah 84116 Washington 206-753-3459 Mr. Terry R. Strong, Head 12/31/66 ,

Radiation Control Section ,

Amended

+ Department of Social and Health 2/19/82 Services Mail Stop LF-13 Airdustrial Park Olympia, Washington 98504

's Note: This list is subject to change. The NRC's Office of Governmental and ',

PiiliTic Affairs, Washington, DC 20555, maintains an up-to-date list and may be contacted for the current phone r. umber and address if you are unable to locate the regulatory authority in a particular State.

A-4 ,

4 a, - - , .- ._. ,. ._ -.. , - - . . *f_,., .,,-e. . , , . ,

I APPENDIX B PROPRIETARY INFORMATION AVAILABILITY OF 0FFICIAL RECORDS Certain portions of Part 2, " Rules of Practice for Domestic Licensing Proceedings," and Part 9, "Public Records," of Title 10 of the Code of Federal Regulations are reproduced here because they are particularly important to applicants for radiation safety evaluation.or registration of sealed sources containing byproduct material.

$ 2.790 Public Inspections, Exemptions, Requests for Withholdina (a) Subject to the provisions of paragraphs (b), (d), and (e) of this sec-tion, final NRC records and documents,* including but not limited to correspon-dence to and from the NRC regarding the issuance, denial, amendment, transfer, renewal, modification, suspension, revocation, or violation of a license, per-mit, or order, or regarding a rule making proceeding subject to this part shall not, in the absence of a compelling reason for nondisclosure after a balancing of the interests of the person or agency urging nondisclosure and the public interest in disclosure, be exempt from disclosure and will be made available for inspection and copying in the NRC Public Document Room, except for matters that are:

• a (4) Trade secrets and commercial or financial information obtained from a person and privileged or confidential;

• A *

(b)(1) A person who proposes that a document or a part be withheld in whole or part from public disclosure on the ground that it contains trade secrets or privileged or confidential commercial or financial information shall submit an application for withholding accompanied by an affidavit which:

(i) Identifies the document or part sought to be withheld and the position of the person making the affidavit, and (ii) Contains a full statement of the reasons on the basis of which it is claimed that~the information should be withheld from public disclosure. Such statement shall address with specificity the considerations listed in paragraph (b)(4) of this section.

"Such records and documents do not include handwritten notes and drafts.

B-1 4

In the case of an affidavit submitted by a company, the affidavit shall be exe-cuted by an officer or upper-level management official who has been specifically delegated the function of reviewing the information sought to be withheld and authorized to apply for its withholding on behalf of the company. The affi-davit shall be executed by the owner of the information, even though the infor-nation sought to be withheld is submitted to the Commission by another person. j The application and affidavit shall be submitted at the time of filing the i information sought to be withheld. The information sought to be withheld shall  !

be incorporated, as far as possible, into a separate paper.

The affiant may designate with appropriate markiilgs information submitted in 1

the affidavit as a trade secret or confidential or privileged commercial or financial information within the meaning of 9 9.S(a)(4) of this chapter and such information shall be subject to disclosure only in accordance with the provisions of $ 9.12 of this chapter.

, (2) A person who submits commercial or financial information believed to be privileged or confidential or a trade secret shall be on notice that it is the policy of the Commission to achieve an effective balance between legitimate concerns for protection of competitive positions and the right of the public to be fully apprised as to the basis for and effects of licensing or rule making actions, and that it is within the discretion of the Commission to withhold such information from public disclosure.

(3) The Commission shall determine whether information sought to be withheld from public disclosure pursuant to this paragraph: (i) is a trade secret or confidential or privileged commercial or financial information; and ,

(ii) if so, should be withheld from public disclosure.

(4) In making the determination required by paragraph (b)(3)(i) of this section, the Commission will consider:

(i) Whether the information has been held in confidence by its owner; (ii) Whether the information is of a type customarily held in confidence by its owner and whether there is a rational basis therefor:

(iii) Whether the infomation was transmitted to and received by the Commission in confidence; (iv) Whether the information is available in public sources; (v) Whether public disclosure of the information sought to be withheld is likely to cause substantial harm to the competitive position of the owner of the information, taking into account the value of the information to the owner; the amount of effort or money, if any, expended by the owner in developing the information; and the ease or difficulty with which the information could be q properly acquired or duplicated by others.

(5) If the Commission determines, pursuant to paragraph (b)(4) of this '

section, that the record or document contains trade secrets or privileged or confidential commercial or financial information, the Commission will then determine (i) whether the right of the public to be fully apprised as to the '

bases for and effects of the proposed action outweighs the demonstrated concern 4

l B-2

Vor protecticn or d:cument forb3 withhold from public diof a comp irralevant or returned to the unneces which applicantwithholding is soughtsticsure aragraph.

pur matio any (6) sary to the performance of iiss ondee 1

ts functions, it shal 3

q Comm,ission may require or i fof person 1 confidential (i) Under commercial rectly concerned to inspec o e cials and n a protective agreement ormation claimed to thebe at document.r other underthan NRCrofficials; financial (,iiinformation rade e secret or toprivile b

1 sion(of iii) protective publicly available or whthe be withheld from publi e matter If en Commission order, a decis by by contractor parties of to whether a proceeding, on the subject or personne th government to ins pendin informatio off c

whenthe Commission closed the c information disclosure.

subsequentl made pu,blicly availablethe information In camera ion has sought sessions been should bema of ormation and arings maythe to she et he be h. t' (c) ranscript of such in camer is denied, the CommissionIf a requestrmation shou a

forsession will be withthirty than a statement (30) days s.willof withholding pursuant to p reason notify an applicant f aragraph (b) of this or the applicantafter requestsplaced theThe ument Room.

date notice of indenial the Public withholding willof Doc sectide the placed in the Public Doc vided of the notice, when specify the do not let a time, .

that information withdrawal If, within of the thedocument time specificument will be forms ,the basis for th by the Commission submitted in a,urned rule the makingume document to the will not be applicant:

application for withholdi e will finalnot rule will not be with a request the Commission for and withholding p be returnedheld t from public Pro-ently d informationwill fromnotify public dithe applicantng o the applicent after deni submitte ao ure l

• sclosure.

with histhat information. f an If S 9.5

• of its determination to withsec Exemptions

• hold the under 9. w ng types

'i a of records are exempt fro 4 m public disclosure a pers(on) and privileged that which is c orTrade

• secrets and com

• but is not limited to: customarily confidential held inmatter subjectal or financ (O Inform confidence by the to this obtained from originat and discoveries,ation or. exemption is It includes, '

and proprietary data; received in confidence

, such as trade secrets, inventions

\

B-3

(ii) Technical reports and data, designs, drawings, specifications, formu-lae, or other types of proprietary information which are generated or developed by the NRC or for the NRC under contract;  ;

i (iii) Statistical data or information concerning contract performance, income, profits, losses, and expenditures, if received in confidence from a contractor or potential contractor.

j i

1 1

B-4

APPENDIX C

\

f.0DE PRINCIPAL USE COD EVICES

\

\

A

\

Industrial Radiography by nondestructive method- The examinatio material.

IC B images toMedical Radiography Medical Teletherapy from patient.

a controlled e process sourcee treatment of of the es. - Thassist in me of

-of mate radioactive Th s mma ray

\

D of radiation located at aradiation ddisea ness, densityGama Gauges - The use istance from t level E chemical compo,sition.s, interface measureor locatiof gam Beta Gauges - The use ness, density on, radiation leakagecontr , or levels F chemical compo,sition. , interface sure or locatiof beta that may contain radiWell on, radiationLogging leakagecontro

- The

, or the purpo G

formation.se of obtaining informationoactive r well basesng devices or or tools Portable Moisture Denabout i the welladjacent or cavities fo active sealed source of mate sources, rial. to d H Includes hand-held etermine or measure theauges andthatds usety a raG I

General Neutron Sourc olly-transported devicescon reactor with '

Calibration Sourcesstartup g, that use a cations and exc well loggine i in known purity and activit(Activity neutrongreater so,urce.ept th \

accuracy of am J correction factors.easuring instrumenty that Sources are used to d and to rmine the of a Gamma source is Irradiator t

ascertain necessaryvariation!

materials, access to the completely contained a

or in in a dCategor \

(

is the sealed source is shielded at allry containerwhich sealed the

) K not physically possible bsealed source and the vol Gamma in Irradiator ecause of umes constructed times and human of solid which the the designundergoing, of irradiation sea $ed source of solid materials, is f l A controll within isCategory II the irradiator.

a by an radiation volumeu ly shielded t whencontained ed a dryhuman cont access in or irradia entry control system. hat is maintained and is inot in use,a(

C-1 exposed naccessible during use \'

j

i L

Gamma Irradiator, Category III - An irradiator in which the sealed source is contained in a storage pool (usually containing water), l the sealed source is shielded at all times, and human access to the sealed source and the volume undergoing irradiation is physically restricted in its designed configuration and proper mode of use.

M Gamma Irradiator, Cateaory IV - A controlled human access irradiator in which the sealed source is contained in a storage pool (usually containing water), is fully shielded when not in use, and is exposed within a radiation volume that is maintained inaccessible during use by an entry control system.

N Ion Generators, Chromatogra?hy - The use of an ion generating source and a device to determine t1e chemical composition of material.

O Ion Generators Static Eliminators - The use of an ion generating source and a device to eliminate static electricity on a surface or a surrounding area.

P Ion Generators, Smoke Detectors - The use of an ion generating source and a device to detect gases and particles created by combustion.

Thermal Generator - The use of a radioisotope and a device to produce Q

heat to produce energy.

R Gas Sources - Sealed sources containing radioactive gas such as krypton-85 or hydrogen-3.

S Foil Sources - Sources that are constructed using thin metal foil.

The radioactive material may be secured to the foil in a number of ways, for example, plating, laminating, or cold welding.

T Other - All uses not covered in other categories.

U X-Ray Fluorescence - Sources and devices that use radioactive material to excite the atoms of samples that in turn emit characteristic x-rays and thereby provide a means for sample analysis.

V General Medical Use - Includes diagnostic sources and devices such as bone mineral analyzers and therapeutic sources and devices such as interstitial needles, therapeutic seeds, and ophthalmic applicators.

W Self-Luminous Light Source - A source consisting of a radioactive nuclide or nuclides incorporated in solid inactive materials or sealed in a protective envelope and incorporating a phosphor to emit light.

X Medical Reference Sources - Includes flood sources, instrument check sources, spot markers.

Y Calibrators - Devices containing calibration sources that are used to determine the variation in accuracy of a measuring instrument and to determine necessary correction factors, g C-2

l APPENDIX D I

for This check listu tomay DIATION a sealed source be helpfSAFETY lCHEC EV mitted with the app safety e all sealed sources,lication.

e.g. valuation. an applicant w detector nor a 2 millicur,iCertain items in this list neither a 0.1source microcu to be s.

for these sourcesquired e gaseousto e user.

be leak tritium tested areby self-luminou th not appropriate 1 i Leak-Test Frequenc,y. entriesAccordin ofe"Not Applicabl used in a s

" gly,iswhen s light source reac u would be made as appro

,,_ _ Registrant's name and address nt Manufacturer's (May be same name and address

_,_,_,,, Sealed source typeas registrant)

._ _, Sealed source model

_,,___ Radionuclide(s) and maximum activit

__ _ Leak-test frequency y (of each)

__,,,,,, Description

.,_ _ Written description

.___ Small drawing

__ _, ANSI N542 classification

____ Conditions of use

___ Details of construction

'"~ ~~ Radioactive material

, (Chemical and physical rm:

fo possible radioactive contaminants)

,_,,,_ Materials of construction

_ _ _ Dimensions

_ Labeling _ _ _ Fabrication and sealing methods

_ _,_ Radiation levels

_ _,,, Quality control and methods of determination (Including leak /contaminati 1

,_,,_ Documentation accompanying source:on test limits)

D-I

, . 1 this A draft value .VALUE/ IMPACT STATEM \

O ide

\

\

regulatory gu/ impact statement w public comment in Dece,mbe value/ impact statement r 1986. fo the draft value/ impact fee r the final guideshed hasNo with the changes s op were I necessary i statement is DC, under Task FC 603-4.at the Commission's so .

available for inspection A copy and c

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