ML20134L355

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CONTENTS (continued)

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Page 4 ISSUANCE OF A LICENS E........................................................

14 5 DEFICIENCY IN THE APPLI' ATION................................................

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C 6 AMENDMENTS TO A LICENSE........................

15 7 RENEWAL O F A LI CENS E..........................................................

15 8 TERMINATION OF A LICENSE......................................................

17 APPENDICES 1

NRC Form 313, " Application for a Material License" 2

New Licensee Letter

-3 10 CFR 2.790 Withholding Letter 4-Information Needed from an Importer To Support Application for License Pursuant to 10 CFR 32.11 To Distribute Neutron-Irradiated Gems to Persons Exempt from Licensing

- (February 18,1988) 5 Information Needed from a Domestic Reactor To Support Application for License Pursuant to 10 CFR 32.11 To Distribute Neutron-Irradiated Gems to Persons Exempt from Licensing (February 25,1988) 6 Certification of Application / License Review - Section 30.14 Licenses 7

Certification of Application / License Redw - Section 30.15 Licenses I

8 Certification of Application / License Review - Section 30.16 Licenses 9

Instructions Relating to the Handling, Use, Storage, and Disposal of Radioactive Material 10 Certification of Application / License Review - Section 30.18 Licenses 11 Standard Requirements for Tritium Illuminated Gun Sights Containing Tritium Gas Sealed in Glass Vials 12 ~ Certification of Application / License Review - Section 30.19 Licenses 13 Certification of Application / License Review - Section 30.20 Licenses 14 Materials License - Sections 30.15,30.16, and 30,18 Licenses 15 NRC Form 374 License - Sections 30.14,30.19, and 30.20 Licenses 16 Deemed Timely Letter NUREG-1562 vi

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INTRODUCTION be made by per:mns who have a specific license from the Commission authorizing such distribution to persons exempt from the 1.1 Purpose of Document requirements for an NRC license. Except as provided in 9 30.18(a), these exemptions do not The purpose of this document is to provide exist for persons who manufacture, process, assistance to apphcants and bcensees m preparm.g produce, incorporate byproduct material intc,, or applications for new licenses, license amendmente, persons who initially transfer for sale or distribute or license renewals authorizing the distribution of products containing byproduct material.

byproduct material to persons exempt from the Therefore, those engaged in these activities must requirements (exempt distribution) for a Nuclear be licensed in order to initially tre.sfer or Regulatory Commission (NRC or Commission) distribute to persons exempt from licensing. The license pursuant to 10 CFR 30.14,30.15,30.16, distributor is required to assure the Commission 30.18,30.19, & 30.20. This document provides that all products are manufactured, tested, and guidance to applicants and describes the methods distributed in accordance with the specifications acceptable to NRC license reviewers for provided in its license application. These specific implementing the Commissions's regulations, licenses are issued by the Commission and are techniques used by the reviewers in evaluating referred to as " exempt distribution" or "E" specific problems or postulated problems, and licenses.

determining if the proposed exempt distribution activity is acceptable for licensing purposes.

1.2.2 Types of Exempt Distribution Licenses Exempt distribution licenses are based on the 1.2 Exeinpt Distribution Licenses-types of products to be distributed according to

Background

the 6 categories of exemptions. The following provides the applicable regulation and some 1.2.1 General examples of products distributed within each l

exemption category:

Exemptions from licensing requirements are based primarily on a determination by the S 30.14 - exempt concentrations:

Commission that the exempted classes of products silicon chips or wafers-isotopes e

or types of uses will not constitute an with atomic numbers between unreasonable risk to the common defense or 1-94, not to exceed quantities in 9 security or to public health and safety. Radiation 30.70, Schedule A safety is completely dependent on safety features topaz jewelry-isotopes with atomic e

built into the sealed source or device or on restnctions on the amount of radioactive matenal numbers between 1-83 not to which can be mitially distributed.10 CFR Part 30, exceed quantities in S 30.70' Schedule A

" Rules of General Applicability to Domestic Licensing of Byproduct Material," provides such 9 30.15 - certain items containing byproduct an exemption from the requirements for an NRC material:

heense to persons who receN, possess, use, o electron tubes-30 microcuries transfer, own, or acquire byproduct material in l

exempt distribution products such as silicon chips, krypton-85 electron tubes, resins, check sources, gunsights, timepieces containing luminous e

and smoke detectors. NRC applies regulatoiy paint-25 millicuries tritium control on the redistribution of products to ionizing radiation measuring e

i persons exempt from the requirements for a instruments-10 microcuries l

license through specific requirements on barium-133 i

distributors as defined in Subpart A,10 CFR Part 32.

e dosimeter calibrators-9 microcuries cesium-137 Generally, distribution of byproduct material to spark gap irradiators-1 microcurie e

persons exempt from regulatory authority can only cobalt-60 1

[

$ 30.16 - resins containing scandium-46 1.3.1 9 30.14 Exempt concentrations 9 30.18 - exempt quantities:

9 32.11 Introduction,of byproduct material j

encapsulated or check sources-in m exempt concentrations into products or e

quantities not exceeding 9 30.71, materials, and transfer or ownership or Schedule B: 10 microcuries Possession: Requirements for license.

cesimn-137 9 32.12 Same: Records and material 3

calibration or counting standards-transfer reports.

j in quantities not exceeding 9 30.71, i

Schedule B: 100 microcuries 9 32.13 Same: Prohibition ofintroduction.

j carbon-14 i

13.2 9 30.15 Certain items containing byproduct material

)

9 30.19 - self-luminous products containing tritium (vials filled with tritium gas)'

$ 32.14 Certain items containing byproduct material; requirements for hcense to apply krypton-85, or promethium-147:

or initially transfer.

watches-78 millicuries tritium 9 32.15 Same: Quality assurance, compasses-120 milh.cunes tritium prohibition of transfer, and labeling.

gunsights-20 millicuries tritium e

9 32.16 Certain items containing byproduct material: Records and reports of transfer.

9 30.20 - gas and aerosol detectors containing byproduct material (typically containing 133 9 30.16 Resins containing scandium-46

""d d'8I "'d I"' '*"d*"

d*'I*" I" #

8 foil sources of americium-241):

wells e smoke detectors-1.0 nuerocune americium-241 9 3217-Resins containing scandium-46 anti designed for sand-consolidation in oil chemical agent detectors-160 wells: requirements forlicense to e

microcuries americium-241 mulufacture, or initially transfer for sale or distribution.

explosives detectors-15 millicuries e

nickel-63 13.4 130.18 Exempt quantitles 6 32.18 Manufacture, distribution and 1.3 Applicable Regulations transfer of exempt quantities of byproduct material: Requirements for license.

The regulations applicable to persons exempt from the requirements for a license are located in 9 32.19 Same: Conditions oflicenses.

10 CFR Part 30. Part 32," Specific Domestic Licenses to Manufacture or Transfer Certain 9 32.20 Same: Records and material Items Containing Byproduct Material" outlines transfer reports.

the information required to be submitted for a specific license to apply or incorporate byproduct 13.5 9 30.19 Self-luminous products containing matenal into a product; to mitially transfer for sale or distribution products containing byproduct tritium, krypton-85, or promethium 147 material; or to manufacture, possess, produce, 9 32.22 Self-luminous products containing package or repackage products containing tritium, krypton-85, or promethium 147:

byproduct materir1. The following list identi6es Requirements for license to manufacture, the regulations providing the exemptions in process, produce, or initially transfer.

l Part 30 and the corresponding requirements on the distributorin Part 32.

9 32.23 Same: Safety criteria.

S 32.24 Same: Table of organ doses.

REVIEHERS:

The applicant should: befamiliar with the NRC g 32.25 Conditions oflicenses issued under regulations, requirements, andprocedures and S 32.22: Quality control, labeling, and understand that the exemptions authorized only teports of transfer.

apply to thosepersons not involved in the activities listed in 99 32.11, 32.14, 32.17, 32.18, 32.22, and 1.3.6 9 30.20 Gas and acrosol detectors 32.26. Licensees should also be aware that certain containing byproduct material restrictions also apply to the re-use of material under an exemption such as: byproduct material is not to 9 32.26 Gas and aerosol detectors be contained in anyproductfor ingestion, inhalation containing byproduct material:

or application to humans; licensees cannot combine Requirements for license to manufacture, exempt quantities of byproduct material; and process, produce, or mitially transfer.

products containi:rg byproduct material are not to be distributed forfrivolous purposes.

S 32.27 Same: Safety criteria.

1.4 Licensing and Registration S 32.28 Same: Table of organ doses.

Licensees are required to provide specific information about the sources and products as S 32.29 Conditions oflicenses issued under outlined in 99 32.11,32.14,32.17,32.18,32.22, and 9 32.26: Quality control, labeling, and 32.26 concerning the isotopes and actisities, reports of transfer.

containment and construction, labelling, quality controi and assurance programs, etc. In addition, The regulations concerning applicable fees for NRC's policy for 99 32.22 and 32.26 products exempt distribution licenses are found in 10 CFR requires that a safety evaluation be performed on Part 170, " Fees for Facilities, Materials, Import the sealed sources and devices prior to the and Export Ucenses and Other Regulatory issuance of a license. If the product is found Services Under the Atomic Energy Act of 1954, As acceptable for licensing purposes, a registration amended;" and 10 CFR Part 171, " Annual Fees for certificate is issued prior to granting license Reactor Operating Licenses, and Fuel Cycle authorization.

Licenses and Materials Licenses, Including Holders of Certificates of compliance, REI7EHER :

Registrations, and Quality Assurance Program Approvals and Government Agencies Licensed by The lime miewer is responsible for evaluatmg the NRC (see Section 2.5).

submitted information to ensure it meets all applicable standards and regulations; to correspond, ifnecessary, with the applicant to obtain additional Licensees are subject to all applicable provisions clanpcation or information; and, if necessary, of the regulations as they pertain to distribution of request a sealed source and device (SSD) evaluation byproduct material to persons exempt from pu,suant to a registration certipcate.

heensmg requirements. It is the responsibility of applicants and licensees to have copies, read, and Applications requiring SSD evaluations are cbide by each applicable regulation. Copies of the forwarded to the Sealed Source Safety Section regulations may be requested from NRC's (SSSS) as technical assistance requests, in Regional, Field or Headquarters Offices (see accordance with P&GD 84-5, Rev. 4, " Source and Figure 1, NRC Form 3, for addresses and Device Evaluation Technical Assistance Request."

telephone numbers). The two-volume bound The dnice evaluations will contain a review of the versions of Title 10, Code of Federal Regulations, type and quantity of byproduct material; the parts 0-50 and 51-199 may be ordered for a fee chemical andphysicalform of the byproduct from the U. S. Government Printing Office material; the solubility in water and bodyfluid of the (GPO), Superintendent of Documents, Post Office byproduct material the details of construction and Box 371954, Pittsburgh, Pennsylvania 15250 - 7954.

design of theproduct; the degree of access ofhuman GPO's order desk in Washington, DC can be beings to the product; the expected usefullife of the re:ched at (202) 512-1800.

product; the labeling of the product andpoint-of-sale 3

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package; the prototype testingprocedures and results; notifled of any changes or additions to the the required safety criteria; the QAlQCprocedures; information submitted in the application. While and theproposed uses. Upon completion of the SSD some changes may not result in an amendment to evaluation and issuance of a registration certificate, the license, licensees should not assume that an the registration certificate, including cover letter to amendment is not needed or an amendment the applicant and technical assistance request request has been granted until such time as a response will be returned to the license raiewer for written confirmation in the form of a letter or review. The license reviewer will raiew those license amendment has been received.

remaining items necessary to issue the license.

Agreement States may also license the distribution Thefollowing Policy and Guidance Directives of exempt concentrations as listed in 10 CFR (P& gds) and Standard Review Plan are designed 30.70, Schedule A, for applicants within their for the review of applications involving the jurisdiction, and exempt distribution products distribution and use of sealed sources or devices:

containing naturally occurring radioactive material P&GD 84-01, "Raiew Responsibility-not regulated by the NRC.

Manufacturing and Distribution ofProducts to Persons Exempt Pursuant to 10 CFR 32.11 Through In accordance with 10 CFR 150.15(a) and 32.26;" P&GD 84-22, "What Source and Device (b), persons in Agreement States are not exempt Designs Require an Evaluation;" P&GD 84-5, from NRC licensing and regulatory requirements,

" Source and Device Evaluation Technical Assistance with respect to the initial transfer of any Request"; and NUREG-1550 " Standard Review equipment, device, commodity, or other product Plan forApplications for Scaled Source and Device containing source material or byproduct material, Evaluations and Registrations."

whose subsequent possession, use, transfer, and disposal by all other persons are exempted from After the issuance of a license, licensees must NRC licensing and regulatory requirements.

conduct their programs for the manufacture Under 10 CFR 30.14 any person is exempt from and/or distribution of exempt distribution the requirements for a license to receive, possess, products in accordance with (1) the statements, use, transfer, own or acquire products or materials representations, and procedures contained in their containing byproduct material in concentrations application, and other correspondence with NRC, not in excess of those specified in 9 30.70, (2) the terms and conditions of the license, Schedule A. This exemption does not apply to the (3) device registration, if applicable, and transfer of byproduct material contained in any (4) applicable NRC regulations as discussed food, beverage, cosmetic, drug or other below. Section 9 30.9 of 10 CFR Part 30," Rules of commodity or product designed for ingestion or General Applicability to Domestic Licensing of inhalation by, or application to, a human being.

Byproduct Material," requires that the information provided in the application be The introduction of exempt concentrations of complete and accurate in all material respects.

byproduct material into products or materials for Information is considered to be material if it is transfer to persons exempt from licensing can be likely to change or affect an agency decision on authorized as a line item on the possession license issuing the license. Therefore, information by Agreement States for applicants within their provided in an application needs to be clear, jurisdiction and the regions. However, this is not specific, and accurate. 9 30.10, " Deliberate true for products such as silicon ships and topaz misconduct," provides that those providing because the introduction is by the use of a reactor.

information concerning a licensee's activities may The Agreement States do not have the authority not deliberately engage in misconduct or provide to regulate reactors; therefore, distributors of incomplete or inaccurate information to the NRC.

products with exempt concentrations introduced by a reactor must obtain an exempt distribution It is important that applicants and licensees license from NRC headquarters.

understand that the information provided in an application and tied down in the license is NRC's Headquarters Office issues all exempt considered as a limitation by NRC on the licensee distribution licenses except for products that to only engage in those activities and products as contain naturally occurring radioactive material described in the application. NRC should be which are regulated and licensed by the States, not NUREG-1562 4

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NRC, and for products containing exempt that give them the authority to license byproduct concentrations that are not reactor introduced.

material used or possessed within their borders. A non-Federal organization that wishes to possess or Foreign vendors are a unique problem for NRC in use licensed material in one of these Agreement that NRC has no jurisdiction over the foreign States needs to contact the responsible officials in entities. Pursuant to 10 CFR 110.53, " United that State for guidance on preparing an States address, records, and inspections," foreign application; these applications for possession and l

vendors or licensees involved in importing and use need to be filed with the State, not with the exporting nuclear material and equipment are NRC. A current list of these Agreement States required to establish an address in the United and their contact persons, addresses and phone States where papers may be served, where records numbers can be obtained, upon request, from the can be maintained, and where the NRC can NRC headquarters address listed on NRC Form inspect the applicant's activities and records as 313, Appendix 1.

necessary to accomplish its mission. Therefore, an exempt distribution license will not be issued to a foreign vendor unless the requirements set forth 2.2 Form 313 in 9110.53 have been satisfied.

As an applicant wishing to distribute or initially transfer products containing byproduct material to persons exempt from licensing, you should 2

FILING AN APPLICATION complete NRC Form 313," Application for Material License" (Appendix 1). An application for a distribution license should not contain 2.1 Possession Licenses information concerning the possession and use of Exempt distribution licenses only authorize the radioactive material covered in the possession product (s) to be distributed to persons exempt license. Since items 7 through 11 of NRC Form from licensing and generally do not authorize 313 pertain to possession and use license and are possession or use of radioactive material by the n t applicable to the exempt distribution license, l

distributor. Persons who manufacture, process, apphcants should only complete items 1 through 6, produce or initially transfer for sale products 12 and 13 on the application form itself. In l

containing byproduct material must meet the addition, applicants should submit the source and general requirements of 10 CFR 30.33 for Product information for the distribution license as possession and use oflicensed material on Federal utUned in the applicable section of 10 CFR l

property,in an Agreement State orin any State Part 32 (see Section 3.2).

subject to NRCjurisdiction; and be authorized under specific license for the possession and use REl7EMERS:

of byproduct material. Therefore, applicants for exempt distribution licenses may need to file a Appendix 2 contains a "new licensee" letter which separate application for a specific license provides the applicable regulations and requirements authorizing possession and use of byproduct for applyingfor an exempt distribution license.

material, incident to distribution, with the NRC l

Regional Office or Agreement State for the State Each separate sheet or document submitted with in which the material will be possessed and/or the application needs to be identified and keyed to used. The four regions and the Regional Offices the item number on the application or the section addresses are provided on NRC Form 3 or in in the regulations to which it refers. All typed l

10 CFR Part 20, Appendix D. NRC Form 3 also pages, sketches, or drawings should be on 8-1/2 x l

lists the Walnut Creek, California, Field Office, 11 inch paper to facilitate handling and resiew. If which can respond to routine telephone inquiries.

larger drawings are necessary, they should be An exempt distribution license will not be issued folded to 8-1/2 x 11 inches. Provide detailed until the applicant obtains a possession and use information concerning the sources and products license.

or product types and complete all items in the application in sufficient detail for the NRC to To date, twenty-nine states, called Agreement determine that the proposed products comply with States have entered into agreements with the NRC the regulatory requirements.

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Applications should be filed in duplicate, submittal ofsuch information is necessary to issue Applicants should retain one copy of the the license, the information should be raiewed by application, with all attachments, since the license the NRC's OfBee of the General Counsel (OGC) to will require, as a condition, that licensees follow determine if the information is indeed proprietary or the statements and representations set forth and conpdential and should be withheld from public committed to in the application and in any disclosure.

supplements to it.

Ifit is determined by OGC that the application or Please note that while it may be necessary when afpdavit are deBcient, i.e., do not contain the filing for a license to include information required information as outlined in 9 2.790(b)(4),

contained in other licensee's file (s) or registration the applicant should be notiped that additional certificate (s), current, retired or inactive, it is not information is needed and that the raiew of the acceptable to simply teference this information. If requestfor nithholding nill continue upon receipt of such information is pertinent to the application, the required information. Applicants :hould be the information should be submitted, in its informed that in orderfor the NRC to consider entirety, as part of the application.

withholding the information from public disclosure, it must review the information to ensure its status, The information collection requirements for the with respect to being withheld, and that the review of sections of Part 32 applicable to exempt their request for licensing action may continue; distribution licensing have been approved by however, a license cannot be issued untilreceipt, OMB under control number 3150-0001. The raiew, and resolution of the request to withhold information collection requirements in NRC Form information.

313 for 9 32.11 have been cleared under OMB i-Clearance No. 3150-0120.

Once OGC has reviewed the application and afpdavit and has been made a determination as to 2.3 ProprietaryInformation whether the information should or should not be withheld from public disclosure, the licensee should Please note that license applications are available be notiped by letter of the Commission 's agreement for review by the general public in the NRC Public or disagreement with their claim forproprietary Document Rooms; therefore, proprietary treatment and the appropriateness of their 9 2.790 information (i.e. information not to be disclosed afpdavit (see Appendir 3),

to the public), should not be included in an application unless absolutely necessary.

Insure that orplace the words " Proprietary Information considered to be proprietary or Information " on the top and bottom of the page on confidential should be clearly marked by the thefront ofeach document containingproprietary applicant as " proprietary," " confidential,"

information and cover with a Proprietary

" restricted," or "is the express property of Inforrnation cover sheet, NRC Form 190. Additional Company X," and include the information in procedures for the handling ofproprietary 10 CFR 2.790,"Public inspection, exemption, information can befound in Directive 12.6 requests for withholding." Failure to follow this (Formerly MC 2101), "NRC Sensitive Unclassiped procedure may result in disclosure of the Information Security Program."

proprietary information to the public or substantial delays in processing the application.

2.4 Where to File REVIEHER:

Requests for exempt distribution licenses and Applications containing information marked as device safety evaluations of scaled sources or

" proprietary," "conpdential," " restricted," or "is the devices are submitted directly to the Division of erpress property of Company X, " should be reviewed Industrial and Medical Nuclear Safety, Office of by the license reviewer to determine if the Nuclear Materials Safety and Safeguards, U.S.

information is necessary in order to issue the license.

Nuclear Regulatory Commission, Washington, DC The information determined not necessary Io issue 20555-0001 (address is also found at the top oi the license should be returned to the applicant. If the NRC Form 313).

NUREG-1562 6

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2.5 Application and Annual Fees Questions concerning fees should be directed to the Office of the Controller (OC), License Fee &

The regulations in 10 CFR Part 170 set out the Accounts Receivable Branch (LFARB) at the fees charged for licensing senices rendered by the above address. The telephone number is (301) 415 - 7554.

NRC and provisions regarding their payment, requiring that the appropriate license fee accompany all new applications, applications for REV1EMER:

license amendments and device reviews. Refer to After receipt of the application, the applications are 10 CFR 170.31," Schedule of fees for materials logged into the Licensing Tracking System where they licenses and other regulatory senices, including await assignment to a reviewer and the original copy inspections, and import and export h, censes," t of the application is sent to the LFARBfor determme the amount af the fee that must venfication that the appropriate application fees have accompany your application. Since fees are based been received. The license and device reviews may on the types of material and activities authorized, stan beforefees are collected; however, neither a the applicant should call the License Fee and device registration certificate nor an exempt Accounts Receivable Branch at (301) 415-7554 distribution license can be issued until the for assistance m deternunmg the applicable fee application fees are paid in full. LFARB will send the category and appropriate fee. Payment af fees application back to the SSSS or IMAB once the should be mailed along with the application (s) to appropriate fees have been collected.

the Division ofIndustrial and Medical Nuclear Safety,0ffice of Nuclear Material Safety and Ifreviewers have any questions ahut application or Safeguards, U.S. Nuclear Regulatory Commission, annualfees, they should contact the LFARB, Office Washington, DC 20555 - 0001.

of the Controller (OC), at (301) 415-734. All applicants having questions aboutpossession, exempt Once a license (possession and use, distribution) distribution and sealed source device fees should be and/or a registration cenificate are issued, the refend to the WRB at (301) 415-7554 licensees and registration holders are subject to annual fees assessed by NRC under 10 CFR 3

CONTENTS OF AN Part 171 for each license or registration certificate held by the licensee. The annual fees are in APPLICATION addition to the application, amendment, and registration fees specified in 10 CFR 170.31.

3.1 Informntion Required for all Exempt Distribution Licenses NRC conducts rulemaking each year to establish The following comments apply to the indicated the 10 CFR Part 171 annual fees and to make any items of NRC Form 313 (see Appendix 1).

necessary changes to the 10 CFR Part 170 licensing fees. The proposed changes to the fees Item 1-LICENSE INFORMATION are published in the Federal Register for pubhc comment, and a copy of the proposed rule is For a new license, check box A. For an mailed to alllicensees. After consideration of the amendment to an existing license, check box B.

comments received, a final rule is published in the For a renewal of an existing license, check box C.

Federal Register and a copy mailed to all licensees.

If you check box B or box C, enter the license Although the invoices are issued for the full number.

amount of the annual fee, the amount due may be reduced as provided in 10 CFR 171.16(c) if the Item 2-NAME AND MAILING ADDRESS OF licensee qualifies as a small entity under NRC's APPLICANT size standards and so certifies by completing and returning NRC Form 526,"Small Entity Individuals should only be designated as the Certification," which is enclosed with the first applicant if they are acting in a private capacity annual fee invoice. A new certification is required and the use of the radioactive material (product) to be submitted with the annual fee payment each is not connected with employment in a year.

corporation or other legal entity. Otherwise, the 7

legal name of the corporation or other legal entity Item 4-NAME OF PERSON TO BE with direct control over use of the radioactive CONTACTED ABOUT THIS APPLICATION material (product) should be listed as the applicant; a division or department within a legal entity may not be a licensee. The address specified Provide the name and telephone number of the here refers to the mailing address to which individual who can provide information and answer questions about the application and the correspondence should be sent. This may or may product (s) to be distributed. The NRC will contact not be the same as the address from which the material will be distributed, as specified in Item 3.

this individual ifit has questions about the application. It is not necessary for the contact person for an exempt distribution license to be the same person as the Radiation Safety Officer on REVIEMERS:

the possession license, as long as he or she is The applicant must be an entity such as a knowledgeable about the products being distributed. If the contact person changes, notify corporation, university, or research mstitun.on or an individual acting in a private capacity, the NRC. Notification af a contact person change s for information only and does not require a license amendment.

The applicant's mailing address typically requires no action. However, NMSS P&DG 84-2 addresses the irsue of Return Mail and actions to be taken should The individual named in Item 4 may or may not be the individual who signs the application in Item mail be returned and P&GD 86-02, " Processing 13 on behali of 6e applicant and who has the Material License Applications Involving Change of authority to make and implement commitments to Ownership" addresses changes ofownership and the NRC.

transfers ofcontrol. Reviewers should be sensitive to changes in addresses as possible indications of changes in licensed activities or ownership.

REVIEMERS:

While a US address is required in order to issue a This item isfor information only. No review of the license, it is acceptable for the licensee's mailing individuals training or aperience is necessary. For address and the state code in the license number to legalpurposes, shouldyou review a document signed

)

be based on an address located in Puerto Rico, by someone other than the original signatory of the Canada, and the Virgin Islands.

application or a management representative, request documentation from the applicantilicensee that this individualis au:horized to make legally binding Item 3-ADDRESS (ES) WHERE LICENSED commitments on the part of the licensee; otherwise, MATERIAL WILL BE USED OR POSSESSED it will be necessary to have another individual who is so authorized to sign the document.

An applicant for an exempt distribution license l

must be an organization with an address in the United States at which it will receive, possess, and Item 5-RADIOACTIVE MATERIAL 1

perform quality control checks on the products authorized for distribution and maintain records Applicants should determine what devices or relating to NRC-related activities, and from which products are to be distributed and proside i

it will distribute the items. Specify each and every information about each type of product, a list of facility used as a location from which dimibution the radionuclides (include manufacturer's name will occur by the street address, city, and State. A and model number,if applicable), the physical Post Office Box address is not acceptable. You form, and the maximum activity of radioactive should note that if the addresses listed are in material that will be used in each source for each Agreement States, an exempt distribution license product type. Activity may be specified either in will not be issued or amended until a copy of the terms of becquerels or in terms of curies. For corresponding possession license has been example, the maximum activity per check source is provided to NRC. Each point of distribution will 0.37 gigabecquerels or 10 millicuries of be listed on the license.

cesium-137.

NUREG-1562 8

Item 6-PURPOSE (S) FOR WHICH LICENSED writing a consultant to act as the representative able MATERIAL WILL BE USED to make commitments for the licensee.

Describe in general terms the purpose (s) for which the byproduct matenal will be used. For 3.2 Information Re9uired for S ecific

.P example: an americium-241 foil source to be Types of Exempt Distribution incorporated into a smoke detection device for Licenses distribution to persons exempt from licensing.

While the NRC staff only needs a general 3.2.1 General Information description of how the byproduct or licensed Frivolous use material will be used, applicants should provide detailed information about the fmal product to be distributed as discussed in Section 3.2.

NRC policy discourages the " frivolous" use of radioactive material pursuant to 9 30.19(c) and generally nsiders that products proposed for Item 12-LICENSE FEES distribution should be of some benefit or use to the public. Typically, the use of radioactive Applicants should be aware that they may be material in toys, novelties such as fishing lures, responsible for fees m each category applicable t and adornments have been considered to be of their application or license. Refer to Section 2.5 for more mformation.

marginal benefit. However, as an exception to this policy, in 1987, the Commission did review the NRC will begin review oflicensing requests issue of gymsmnes for distribution and by without the proper fees; however, NRC will not Conumssion Da, ective approved the mtroduction issue a new license, amendment or registration f byproduct mateial into gemstones for distribution under 9 30.14.

certificate prior to receipt of the appropriate fee.

Questions concerning fees should be directed to REI7EMERS:

the Office of the Controller (OC), License Fee Reviewers should identify any compler or unusual and Accounts Receivable Branch (LFARB) at the policy issues to NRC management. If the primary above address. OC's telephone number 1s (301) reviewer is not authorized to sign the distribution 415 - 7554.

License, the reviewer must ensure that the application is independently reviewed and the license signed by a Item 13-CERTIFICATION senior reviewer.

Individual applicants acting in a private capacity Sealed Source and Device Evaluations are required to sign and date the application form.

Otherwise, the application should be dated and Applicants wishing to distribute products pursuant signed by a representative of the applicant's to 99 32.22 and 32.26 must submit sufficient corporation or legal entity who is authorized to information concerning the product to make binding commitments and to sign Official demonstrate that the product will meet the safety documents on behalf of the applicant and to criteria set forth for that type of product. The certify that the application contains informafon submission should include information about the that is true and correct to the best of the signer's design and construction of the product, prototype knowledge and belief. Unsigned applications will testing, labeling, quality control (OA) procedures, not be reviewed and will be returned for proper safety criteria, etc. These products undergo a signature.

sealed source and/or device safety evaluation prior to the issuance of a license which is performed by REI7EHERS:

the Scaled Source and Safety Section.

Typically, theperson signing the application will have Regulatory Guides 10.10," Guide for the a position such as vice-president orpresident while Preparation of Applications for Radiation Safety theperson providing additionalinformation may be Evaluation and Registration of Derices the radiation safety officer orproduction manager or Containing Byproduct Material," and 10.11, engineer. Sometimes, licensees will designate in

" Guide for the Preparation of Applications for f

9 NUREG-1562

l Radiation Safety Evaluation and Registration of Applicants may submit a Quality Assurance (QA)

Scaled Sources Containing Byproduct Material,"

program instead of or in conjunction with a QC and NUREG-1550 " Standard Review Plan for program. The QA program should provide control Applications for Sealed Source and Device over all activities applicable to the design, l

Evaluations and Registrations," may be used by fabrication, inspection, testing, maintenance, applicants submitting a sealed source or device repair, modification, and distribution of the

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design for safety evaluation, registration and devices that contain byproduct material.

licensing.

Regulatory Guide 6.9 also provides information necessary to establish and implement a QA program that encompasses all of the QA and QC REVIElfERS:

requirements necessary for the manufacture and distribution of sealed sources and devices.

Applications requiring desice evaluations are forwarded to the SSSS as technical assistance Please note that the information in this guide is requests. Upon completion of the evaluation and not a substitute for developing and implementing i

registration, the registration certificate, including an eifective program for the manutacture and cover letter to the applicant and technical assistance distribution of exempt distribution products.

request response will be returned to the license However, if an application incorporates by reviewerfor review.

reference procedures in this or any other guide, then those procedures become a part of the The following Policy and Guidance Directives license conditions and regulatory requirements.

(P& gds) and Standard Review Plan are designed For example, if an application or license for the retiew of applications invoking the amendment states that "the manufacturer will distribution and use ofsealed sources or devices:

follow the acceptance sampling requirements for P&GD 84-01, dated April 9,1984, "Retiew removable contamination and design conformity Responsibility-Manufacturing and Distribution of as outlined in Regulatory Guide 6.9," then the Products to Persons Exempt Pursuant to 10 CFR licensee must adhere to the specifications 32.11 Through 32.26;"P&GD 84-22, "What contained in the teferenced document.

Source and Desice Designs Require an Evaluation;"

P&GD 84-5, " Source and Device Evaluation g5535pfERS:

Technical Assistance Request"; and NUREG-1550

" Standard Review Plan for Applications for Sealed Cunent practice allows acceptance of the submission Source and Device Evaluations and Registrations. "

of a QA program in lieu of a QCprogram because the QA program puts more emphasis on the overall management stntcture and on the program that Quality Assurance / Quality Control Programs covers constnection of the device from the time of initialdesign through distribution. Use ofa QA Quality control (OC) procedures to be followed in program allowsfor oversite when manufacturing is the fabrication of the product and the QC perfonned byforeign vendors where the licensee (US standards the product will be required to meet are distributor) is required to provide documentation and required to be submitted for products under procedures concerning theforeign vendors QA SS 32.14,32.22, and 32.26. Applicants should program; how the licensee will audit the vendor's develop and implement a QC program that will operations; and the licensee's QA program forfinal ensure that the product is manufactured in inspection of the product before distribution accordance with the information and (reference Reg Guide 6.9).

representations made in the application. At a minimum, the QC program should meet the Note: the evaluation of the QAlQCprogram ispart specifications similar to those provided in of the device evaluation performed by the Sealed Appendix C, " Quality Control Program Source Safety Section.

Specifications for Certain Exempt Products,"

Regulatory Guide 6.9," Establishing Quality Product Transfer Reports Assurance Programs for the Manufacture and Distribution of Scaled Sources and Devices Licensees are required to file a report concerning Containing Byproduct Material."

the kinds and quantities of byproduct material or NUREG-1562 10

products transferred within 30 days following: five not trueforgemstones because the introduction is by years since the preceding report, filing for the use of a reactor. The Agreement States do not renewal, and notification of termination of the have the authority to regulate reactors; therefore, license pursuant to SS 32.13,32.16,32.20,32.25, distn'butors ofgemstones must obtain an exempt and 32.29.

distribution license from NRC headquarters.

32.2 Exempt concentrations-Section 30.14 Appendir 6 contains a check list applicable to this l

License category of exempt distribution product for use in h

e n8 I eenSMPP cadons.

l Under 10 CFR 30.14, persons are exempted from licensing requirements if the byproduct material 3.2.3 Certain items containing byproduct contained in a product or material in material-Section 30.15 License concentrations not in excess of those specified in S 30.70, Schedule B, is introduced into the product Under 10 CFR 30.15, persons who apply or or material or transferred by a licensee holding a incorporate byproduct material into or who specific hcense issued pursuant to 10 CFR 32.11, initially transfer or distribute products such as

" Introduction of byproduct material in exempt electron tubes, watches with luminous paint, or concentrations into products or materials, and ionizing radiation measuring instruments transfer of ownership or possession: Requirements containing calibration sources to persons exempt for license." This means that the person who from licensing must have a license pursuant to introduces byproduct material into a product or 10 CFR 32.14, "Certain items containing material, such as silicon chips or wafers, or who byproduct material; requirements for license to initially transfers such a product, must have a apply or initially transfer". The product specific license authorizing distribution to persons information as outlined in SS 32.14,32.15, and exempt from licensing. The prohibition against the 32.16 must be provided for review in order to introduction of byproduct material into a product obtain an exempt distribution license, or material if there is knowledge or reason to believe that the product will be distributed or transferred to persons exempt from the Note: For those products requiring labeling, reqmrements for a heense under @ 30.14 is found NRC's policy on labeling is that the smallest item I,

m 9 32.13, Same: Prohibition ofintroduction.

distributed must contain the required label. If this is not possible, then the label should be placed as close as possible to the product. For example: if an To obtam authon.zation to distribute to persons electron tube is too small to label, then the label exempt from the requirements for an NRC should be placed on the next smallest container license, the manufacturer or distributor of the such as the bubble pack containing the electron product must provide the m, formation required to tube.

evaluate the products prior to the issuance of a license. The product information to be submitted for products containing exempt concentrations of For electron tubes, lamps, etc., applicants can use b prod material is outlined in SS 32.11,32.12, mathematical calculations or functionality tests to demonstrate and verify that each product contains no more than the quantity of byproduct material specified for that product, pursuant to S 32.14(c).

Appendix 4 and 5 contain specific m. formation The functionality test may involve the testing of needed from importers and domestic reactors to each tube or lamp to con 5rm that it works and support applications for license punuant to that the light output is within the range known for 10 CFR 32.11 to distribute neutron-irradiated that tube or lamp for which the specific actisity gems to persons exempt from licensing.

has been determined. Non-working product or below par output are considered indicative of REVIEHERS:

I'*k5"E '"b

Introduction for most S 30.14 products can be Appendix 7 contains a check list applicable to this authorized by the regions orAgreement States as a category of erempt distribution product for use in line item on thepossession license; however, this is reviewing the license application.

1 11 NUREG-1562

l l

1 l

l 3.2.4 Resins containing scandium-46 and submit information about the product as outlined designed for sand. consolidation in oil wells in SS 32.18,32.19,32.20. The submission should

-Section 30.16 License identify the byproduct material to be used and the type s) (i.e., disc check sources, rod sources, scint(illation counting standards) of product Under 10 CFR 30.16, persons who manufacture or amtially transfer or distribute resins contaimng intended for distribution and provide a drawing scandmm 46 to persons exempt from heensmg (or picture) of the product type (s). The drawing must be h, censed pursuant to S 32.17 or equivalent should indicate the location of the required label.

regulations of an Agreement State and must submit for review the product information as required in this section.

REVIEWERS:

Appendix 8 contains a check list applicable to this Applicants should only request authorization for the

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category of exempt distribution productfor use in is topes which are ofinterest but, if requested by li GPP cant, itis acceptable to reference the byproduct reviewing the license application.

material as: allisotopes not to exceed the activities listed in S 30.71, Schedule B.

3.2.5 Exempt quantities-Section 30.18 License The application should clearly state the form, Section 32.18(a),10 CFR Part 32," Manufacture, chemical and physical, of the byproduct material distribution and transfer of exempt quantities of and confirm that its intended use is for its byproduct material: Requirements for license" radioactive pr,operties and that it is not to be authorizes an exemption to persons who receive, incorporated mto any manufactured or assembled possess, use, transfer, own, or acquire byproduct commodity, product, or device intended for material in individual quantities not exceeding commercial distribution. The applicant should limits set in S 30.71, Schedule B. This exemption confirm that the named isotopes are not to be allows persons to receive, possess, use, own, or contained in any food, beverage, cosmetic, drug, acquire small quantities of byproduct material and or other commodity (product) designed for to transfer items such as wue samples and ingestion or inhalation by, or in an application to, counting standards to other unlicensed persons on a human being nor incorporated into any device.

an occasional basis, not for commercial benefit, without a distribution license.

Applications should contain copies of the required labels and product brochures to be distributed When the transfer of byproduct material in with the product. In addition to the required individual quantities not exceeding the limits set in statements in S 32.19(c) and (d), either the label 9 30.71, Schedule B, occurs for commercial or accompanying product brochure must contain benefit, then 30.18(c) and (d) apply and the additional basic radiation safety and good manufacture, transfer or distribution to persons laboratory practices and instructions pertaining to exempt from licensing requirements must be the proper handling, use, storage, and disposal of specifically licensed. Therefore, each person the radioactive material. The information engaging in the commercial transfer or included in the product brochure should be distribution of exempt distribution products must appropriate to the product and its use. Appendix 9 have a license authorizing distribution under provides an example of a product brochure to S 32.18. The commercial transfer of a product accompany an exempt quantity product.

refers to the introduction of a material into the market place, whether or not a charge is assessed Products authorized for exempt distribution are for that distribution. Commercial benefit does not received by persons exempt from the necessarily include a monetary exchange.

requirements for a license; therefore, the information provided to the licensee's customers Those persons wishing to distribute byprodcct should not imply regulatory restrictions. For material in individual quantities not in excess of example, statements in the product brochures to those listed in S 30.71, Schedule B, for commercial the effect that the products must be disposed ofin benefit, such as check sources and calibration a certain manner or returned to the licensee, etc.

l standards, to persons exempt from licensing must are inappropriate and should not be contained in NUREG-1562 12 l

l I

l the information provided to the licensee's of material used such as steel, aluminum, or customers.

plastic. The submission should include a list of the differences between the models in that series.

Appendix 11," STANDARD REQUIREMENTS REVIEHERS:

FOR TRITIUM ILLUMINATED GUN SIGHTS The submission of " generic" labels or a statement CONTAINING TRITIUM GAS SEALED IN indicating the required information that will be GLASS VIALS" should be used in preparing the contained on the labelis acceptable provided the license application.

required information remains as submitted and meets the necessary requirements. This allows REVIEWERS:

licensees to change information on the labels such as brand names or telephone numbers without having

,y, y,,,(,oggy,}p,,,,, y,,,g,,,,,g,,, e,,,,,, n y

to amend their hcense. For example, the hcensee may based on such differences as size, construction, and

-l state that the label on the check sources will contain source activity. For example, the Series 100 is a at least thefollowmg: the words " Radioactive "2-Dot" sight and the basic Series 200 is a "2-Bar" Material ', Radiossatope:

, and Activity: -

sight, and the Series 300 has a larger source activity microcuries.

per tritium source than either the 100 or 200 series.

Models contained withv. each series may be the Appendix 10 contains a check list applicable to this same basic model within the overall dimensions and category of exempt distribution product for use in tolerance ranges. For example, a basic model reviewing the hcense application.

designated c : the Series 100 with a minimum steel thickness of 0.01 to 0.02 st#el thickness is registered 3.2.6 Self-luminous products containing to include the 100A,;;odel with a 0.01 minimum tritium, krypton-85, or promethium-147-steel thickness and the 100B with a.018 minimum Section 30.19 License steelthickness.

Under 10 CFR 30.19, persons are exempt from I

the requirements for a license provided the Note: NRC's policy on labelm.g is that the smallest products, such as gunsights and watches, have item distributed must contam the required label.

been initially transferred or distributed in accordance with a license issued pursuant to REVIEMERS:

9 32.22. The information to be submitted is Acceptable procedures for testingfor leaking tritium outlined in SS 32.22,32.23,32.24, and 32.25, vial sources may include swipe resting as well as Self-luminous products contammg tritium, brightness, light output, or immersion testing based krypton-85 or promethmm-147: Requirements for on the rates of tritium leakage over a specific time bcense to manufacture, process, prodt.ce, or Period.

initially transfer." The products authorized under 5 32.22 undergo a scaled source and/or device Appendix 12 contains a check list applicable to this safety evaluatson pnor to the issuance of a hcense category of exempt distribution product for use in (see Section 3.2).

reviewing the license application.

Applicants should list all mo.iek of each type of 3.2.7 Gas and aerosol detectors containing product they wish to distribtite. Applicants may byproduct material-Section 30.20 License request to have a modellisted as a series. In order to have the modellisted as a c ries, there should Under 10 CFR 30.20, persons are exempt from be similarities in the design anu construction of the requirements for a license provided the the devices. Applicants should provide detailed products, such as smoke detectors, have been engineering drawings of each basic device series initially transferred or distributed in accordance containing the overall dimensions, the minimum with a license issued pursuant to S 32.26. The and maximum dimensions for each series type, the product information to be submitted is outlined in tolerances, describe or identify the construction SS 32.26,32.27,32.28, and 32.29," Gas and aerosol materials, and the source mounting detectors containing byproduct material:

configuration (s) to be used with each series type.

Requirements for license to manufacture, process, l

This information must be provided for each type produce, or initially transfer." The products 13 NUREG-1562 l

1 t

f authorized under S 32.26 undergo a device safety 4

ISSUANCE OF A LICENSE i

review and evaluation prior to the issuance of a license (see Section 3.2).

Licenses authorized pursuant to SS 32.11 (except for gemstones and silicon chips),32.14,32.17, and Applicants may reference NUREG/CR-1156, 32.18 are prepared using a letterhead format

" Environmental Assessment ofIonization (Appendix 14) and hcenses authorized under Chamber Smoke Detectors Containing Am-241"

$$ 32.11 (gemstones and silicon chips),32.22, and (Attachment 5 for additional information 32.26 are prepared usm, g NRC Form 374 concerning smo)ke detectors.

(Appendix 15). All beenses melude the licensee's i

name and mailm, g address; the expiration date and 4

docket number (assigned by NRC); the byproduct i

Applicants should list all models of each type of material and its chemical and/or physical form; product they wish to distribute. Applicants may ti,e authorized use; the products and maximum request to have a model listed as a series. In order activity per device; the locations from which to have the model listed as a series, there should exempt distribution products may be distributed; J

be similarities in the design and construction of and the statement that "this license does not i

the devices. Applicants should provide detailed authorize possession or use of licensed material."

engineering drawings of each basic device in each The license also contr. ins a general tie-down series with a list of the differences between the condition which commits the licensee to models in that series. The drawings should clearly conducting its program in accordance with the show all dimensions and tolerances, describe or statements, representations, r.nd procedures identify the construction materials, and provide contained in the documents, including any

- the details of the source mounting.

enclosures, submitted by the applicant.

REVIEHER:

The licensing assistant distributes completed licenses All basic models may be registered as a "sedes" issued by NRC to the licensees, NRC regions, i

based on such differences as size, construction, and Agreement States, and internal distribution to the source activity. For example, the Series 200 is larger LFARB, Nuclear Documents System (NUDOCS),

in size than the basic Series 100, and the Series 300 and the licenseple.

has a larger source activity than either the 100 or 200.

5 DEFICIENCY IN THE Models contained within each series are the same APPLICATION basic model with " cosmetic" difJerences, such as lights and timers. For example, a basic model Ifin the process of evaluating an application it is designated as the Series 100 is registered to include determmed that msufficient information has been the 100A model with a three second timer, and the submitted, the license reviewer will contact the 100B with a fve second timer, applicant to obtam the necessary information.

Depending on the type and complexity of the information needed, the reviewer may request the While it is not necessary that a sample of the additional information through a formal written actual smoke detector (s) be provided, applicants request or via telephone or electronic mail, or, for should submit a sample or drawing of the typical simple answers and clarifications, the reviewer or generic label and point-of-sale package showing may obtain the information'directly from the how the requirements of S 32.29(b) will be met.

licensee during a telephone conversation or via electronic mail.

REVIEHERS:

Appendir 13 contains a check list applicable to this Any sigmpcant or compler depciencies in an category of exempt distribution product for use in application must be setforth in aformal depciency reviewing the license application.

letter to the applicant. The letter to the applicant NUREG-1562 14

-vr-

should contain a statement that our review of the It is the licensee's obligation to keep the license licensing request will continue upon receipt of the current and anticipate the need for a license requested information and that a response should be amendment insofat as possible. If any of the received within 30 days, in duplicate, referencing the information provided in the application is to be Mail Control number associated with this action.

modifled or changed, submit an application for a license amendment. In the meantime, licensees Use of the telephone or electronic mailfor notifying must comply with the terms and conditions of the an applicant of depciencies must be limited to items license until the amendment is approved and 1

that are simple and such that they can be speciped amended; NRC regulations do not allow the l

simply and should be made part of the application licensee to implement changes on the basis of a Ble. If the depciency is a clanpcation ofinformation submission requesting an amendment to the provided in the application, it may not be necessary license.

to have the applicant respond in writing. However, the applicant's response, either via telephone or An application for a license amendment may be electronic mail must be documented and included Prepared either on the application form (NRC l

aspart of the application ple.

Form 313) or in a letter, and should be submitted in duplicate to the address specified in Section 2.4 in all cases, the telephone conversation or electronic of this guide. Retain one copy because the license l

mail transmitting depciencies to an applicant must will require that licensees conduct licensed be documented by theperson initiating the telephone activities m accordance with the statements and call. P&GD FC 83-11, "Depciency Letters and representations in the amendment application and Telephone Calls to Material License Applicants

in any supplements to it.

l provides guidelines forfollow-up on telephone call Applications should identify the license by license depciencies and depciency letters to applicants.

number and clearly describe the exact nature of the changes, additions, or deletions. References to Applicants may request an extension of time in previ usly submitted information and documents order to respond to any correspondence about its should be clear and specific and identify the application or requesting additional information Pertinent information by date, page, and provided it is determined that there is good cause Paragraph. Please note that amending the exempt to grant an extension and the additional time is of distribution heense may also require an a reasonable length. The request may be in writing amendment of the device registration sheet for or via the telephone. Typically, the reviewer those amendments requestmg additions, deletions, responds by telephone to notify the applicant that r m difications to models of sealed sources or an extension has been granted with the new devices to be distributed, proposed date.

The appropriate fee should accompany each REVIEIERS:

request for a license amendment (see Section 2.5).

All requests for extensions and the reviewers responses should be documented in a conversation 7

RENEWAL OF A LICENSE record.

The license expiration date is found in Item 4, NRC Form 374 i: cense (Appendix 15), and as the last condition on the letterhead license (Appendix 6

AMENDMENTS TO A LICENSE 14). Licensees should send an application for renewal, in duplicate, to the address specified in After the issuance of a license, licensees must Section 2 of this guide. Retain one copy because conduct the licensed activities for the manufacture the license will require that the licensee conduct and/or distribution of exempt distribution its activities in accordance with the statements and products in accordance with (1) the statements, representations made in the renewal request and representations, and procedures contained in your in any supplements to it.

application and other correspondence with NRC, (2) the terms and conditions of the license, and The regulations require that, at the time of (3) the NRC's regulations.

renewal, the licensee file a report with the NRC l

i 15 NUREG-1562 i

providing information on the products transferred

4) Upon completion of the licensee's review, to other persons per their exempt distribution submit NRC Form 313 or a letter to the NRC in license. The specific information to be included in duplicate, requesting renewal of the license and the product transfer report is outlined for each providing the information in items 1,2, and 3, as category of exempt product in the corresponding necessary; and regulations (S9 32.12,32.16,32.20,32.25, and 32.29).

5) Include the name and telephone number of the person to be contacted about the renewal APP cation and include a current mailing address li Licensees may submit an entirely new application for renewal as if it were an application for a new if it is not indicated correctly on the license.

license without referring to previously submitted If an application forlicense renewalis filed at mformation. This is the preferred method of least 30 days before the expiration date of the renewmg a heense, especially for those whose heenses reference a large number of documents or license, NRC will forward a " Deemed Timely" old documents. Submittmg an entirely new (Appendix 16) letter to the licensee confirming application allows the licensee to reevaluate it's that the application has been timely filed and the present license will remain in effect until the NRC program on a periodic basis, consolidate the description of the program into one or tw takes final action on the renewal application. A copy of this letter should be maintained until such up-to-date documents, and ensures that the time as the amended license is received. However, program contams all needed information as if a renewal application is filed, but is not received requested m current hcensmg gmdance.

by NRC before the expiration date, the licensee will be without a valid license when the license As an alternative, licensees may:

expires. If the license expires, exempt distribution activities are no longer authorized and the

1) Review the current license to determine licensee must cease all distribution activities until whether the infonnation accurately represents the such time as a new license can be obtained. Once current radiation safety program and the products the license expires, the licensee must submit an currently distributed. Identify any necessary application package for a new h,eense.

additions, deletions, or other changes and then Prepare mformation appropriate for the reqm, red Licensees nct wishing to renew their distribution license should send a letter to the NRC before the additions, deletions, or changes, expiration date of the license with a request that

2) Review the documents submitted to the NRC in the past to determine whether the information is up to date and accurately 8

TERMINATION OF A LICENSE represents the current h,eensed activities and products. The documents considered to represent You may request termination of your license at the current activities and products need to be any time. However,10 CFR 30.36(d) requires identified by date. Also identify any out-of-date licensees to notify the NRC, within 60 days of any and superseded documents and indicate the of several occurrences, including a decision to changes m, them that are necessary to reflect the permanently cease licensed activities and the lack current program. It is current policy that oflicensec activities for 24 months. (Carefully documents referenced in the h, cense should not be review the povisions of 10 CFR 30.36, which was older than the previous renewal request unless all ievised effective August 15,1994 (59 FR 36026).)

the m, formation m the document accurately This notification should include a request to represents your current program. If it is necessary terminate the license. If you intend to terminate to update this old information, beensees should your possession and use activities as well, you are submit a new application; also responsible for notifying the appropriate NRC or Agreement State authorities concerning

3) Review current NRC regulations to the disposition of your possession license and all i

ensure that any changes in the regulations are radioactive material. Note: a license is not appropriately covered in the program description; terminated until NRC takes action to terminate 1

NUREG-1562 16

t the license; therefore, an application for license the terms and conditions of the license until such termination does not relieve the licensee from its time as the license is terminated in writing by obligations to comply with NRC regulations and NRC.

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17 NUREG-1562

Appendix 1 l

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WhoNTHE AppucaMT 95 appuCapdf ANo ANv opF caal EXECuTBeo Thes CEst11FICAftoM oN MMALF oF Tbf AppucANT. NaaED N frEks 1 CMirTIrvTHAT Tbes AppuCATICIN $ pnEpMIED h couroftherry wtTM TrrLE it cooE oF PEoWIAL flSoLA.AitoNS, EMITS 3o,32. 38, u. E 30,3D ABO 40. AMoT>enT ALL seronMATIoN co8AASGo HWEEsN 5 TIILE aNo coIIRET To DE MST oF 1M IUsDNLeoof ase eELEF.

wafDeenr1 to u &CL MCTlose tops acT oFA8E R tems W WrAT. Te tsafma Fr A OtadesAL oPpWeETo meang A vsqLiptuY PALSE 3rATEMS# oR SIWhedeEstrATION To ANY oW>AstTtIENT on aoAssCv oF DE! upffE3 STA1ES AS To ANY hqATrWE Wffles fr3 a m=nritoN.

cer wvee crncet. Tvemosansaan unsa no mta anunTuns oATu i

FOR NRC USE ONLY l

TTes or pse custoo ren cAtwoon, a==r nacswau c.e msAmman cxmmens 8

Apossovso me oats is,rsoo necvcLeopar.t 4

.am,o s... g,

Appendix 1 1

t i

H Appendix 2 I

I (Date) l i

l (Applicant's Name) i l

(Street /P.O. Box) j L

(City, State Zip)

I Dear (

):

j This refers to our recent conversation concerning the application process for obtaining a license pursuant to Section 32.XX,10 CFR Part 32, authorizing the distribution of(product).

In order to possess and use byproduct material, you must first satisfy the general requiremcnts of 10 CFR

' 30.33. It is my understanding that you will be manufacturing and distributing from (Agreement State).

Therefore, you must apply for and obtain a specific license authorizing possession and use of byproduct material from the State of(

) by contacting:

(Agreement State Contact)

(Department Name)

(Street /P.O. Box)

(City, State Zip)

Tele: (

)

Fax: (

)

l 1

As an applicant wishing to distribute or initially transfer products containing byproduct material, such as (product), to persons exempt from licensing, you must also obtain an exempt distribution license from the i

U.S. Nuclear Regulatory Commission. (Prior to licensing your (product) for distribution, it will be necessary for our Scaled Source Safety Section to perform a device safety review pursuant to the issuance of a device registration sheet.) The product information to be submitted for your distribution license is i

outlined in 10 CFR Part 32, specifically in Sections 32.XX, 32.XX, and 32.XX, and in Regulatory Guide (s)

(6.9) 10.10. (While it is not necessary that you provide a sample of the (product), you should submit l

detailed drawings of the device and an example of the point-of-sale package.)

.Your application for a distribution license should not contain information concerning the possession and i

use of radioactive material as covered in your possession license. Therefore, you should only answer questions 1 through 6, and 12 and 13 on the enclosed NRC Form 313, " Application for Material License."

If you have questions or concerns regarding the fees required, you should contact (

) of the

- License Fee and Account. Receivable Branch at (301) 415-XXXX for fee information. Payment of the i

fee should be mailed with die application package to the U.S. Nuclear Regulatory Commission, Office of j

Nuclear Material Safety and Safeguards, Division ofIndustrial and Medical Nuclear Safety, Washington, DC 20555. Please note that this fee is only for a distribution license (and device registration).

t t

For your use in applying for a distribution license (and device registration), I have enclosed reference copies of:

Appendix 2 1

(Applicant's Name) l l

l

- (OC Program Requirements for the Manufacture and Distribution of Smoke Detectors;)

I

- Regulatory Guides (6.9) 10.7 and 10.10; and i

- 10 CFR Parts 2,19,20,30,32,170, and 171.

IfI can be of further assistance, please contact me at (301) 415-XXXX.

Sincerely,

{

1 (License Reviewer)

Enclosures:

1. NRC Form 313

2. (OC Program Requirements)

3. Reg Guides (6.9) 10.7 and 10.10 4.

10 CFR Parts 2,19,20,30,32,170, and 171 i

L i

Appendix 2

i Appendix 3 l

(Licensee's Name)

(ATTN: Contact Name)

City, State Zip Code

==Dear

==

SUBJECT:

REQUEST FOR WITHHOLDING INFORMATION CONTAINED IN LICENSE APPLICATION By NRC 313, " Application for Material License," or letter from (Licensee's Name) dated

,and affidavit dated

, you submitted proprietary material consisting of client information and requested it be withheld from public disclosure pursuant to 10 CFR 2.790.

j You stated that the submitted information should be considered exempt from public disclosure for the following reasons:

1.

2.

We have reviewed your application and the material in accordance with the requirements of 2.790 and, on j

the basis of your statements, (Have/Have Not) determined that the submitted information sought to be withheld contains proprietary commercial information.

Therefore, we have determined that the information contained in Items of NRC Form 313 orletter from (Licensee's name) dated

, marked as proprietary, will be withheld from public disclosure pursuant to 2.790(b)(5) and Section 103(b) of the Atomic Energy Act of 1954, as amended. Your request for withholding will be maintained by this Office indefinitely or for as long as you continue to hold NRC License No. -

- E.

Withholding from public inspection shall not affect the right, if any, of persons properly and directly concerned to inspect the documents. If the need arises, we may send copies of this information to our consultants working in this area. We will, of course, ensure that the consultants have signed the appropriate agreements for handling proprietary information.

If the basis for withholding this information from public inspect.n should change in the future such that the infonnation could then be made available for public inspection, you should promptly notify the NRC.

You should understand that the NRC may have cause to review this determination in the future, for example, if the scope of a Freedom of Information Act request includes your information. In all review situations, if the NRC makes a determination adverse to the above, you will be notified in advance of any public disclosure.

l Sincerely, (Reviewing Official) a Appendix 3 1

l l

l Appendix 4 l

l Information Needed from an Importer To Support Application for License Pursuant to 10 CFR 32.11 To Distribute Neutron-Irradiated Gems to Persons Exempt from Licensing (February 25,1988) l I.

INTRODUCTION 1

Gems such as topaz assume an attractive color when irradiated by neutrons in a reactor. These gems, l

which are used in jewelry (e.g., rings, pendants), become slightly radioactive as a result of the neutron I

irradiation.

Those who commercially import neutron-irradiated topaz into the United States need: (1) a " possession" license issued either by the Nuclear Regulatory Commission (NRC) or an Agreement State, depending on the geographic location of the importer and (2) a " distribution" license issued only by NRC.

" Agreement States" are those states, as shown in Enclosure 1, with which NRC or, previously, the Atomic Energy Commission has entered into an effective agreement under Subsection 274b of the Atomic Energy Act of 1954, as amended.

The " possession" license will authorize the importer to possess the radioactive material contained in neutron-irradiated gems and it will permit the importation of the radioactive gems into the United States in accordance with the provisions of 10 CFR 110.27(a)(3), copy enclosed. The " distribution" license will authorize the importer to transfer (i.e., sell) neutronirradiated gems to persons exempt from licensing, l

e.g., wholesalers, manufacturing jewelers, retail jewelers. So long as the importer has the required i

licenses, no one else in the distribution network needs a license.

This document outlines for importers the information needed to support applications for both

" possession" and " distribution" licenses. Importers located in non-Agreement States may combine the information for the two types oflicenses in one document and submit it to NRC as outlined in Section III of this document. Importers located in Agreement States should follow the instructions in Section IV of this document.

The information that must be included in the application can be categorized as: (1) basic information (e.g., name of applicant); (2) background information; (3) information specifically identified in the regulations (e.g.,10 CFR 30.33,32.11); (4) information on instrumentation, counting, sampling and quality assurance (QA) programs; (5) information needed to support a request for an exemption from that l

portion of 10 CFR 32.11(C) that prohibits use of exempt concentrations in products designed for application to a human being; and (6) fee information and signature.

4 Detailed information is needed to ensure a clear undernanding of the scope and intent of the applicant's l

proposed activities.

II.

CONTENT OF APPLICATION A.

Basic Information 1.

Specify name of applicant; j

2.

Specify applicant's mailing address; 3.

Identify the person with detailed knowledge of the application that the NRC staff can contact about the application, giving the person's:

Appendix 4 1

a.

Name b.

Title c.

Telephone number 4.

Specify the location (s):

At which gems will be received and possessed; I

a.

b.

From which irradiated gems will be distributed to persons exempt from licensing; At which records pertaining to possession and distribution ofirradiated gems will be c.

maintained.

B.

Background Information 1.

Describe the material to be imported, including:

a.

The type of gems (e.g., topaz) b.

Fxent to which gems have been processed before irradiation (e.g., cut and polished). Note Only timshed gems which do not require cutting, grinding, or polishing after irradiation will i

t e authorized for distribution to persons exempt from licensing.

c.

The type (s) and sequence (e.g., neutron-irradiation only; neutron followed by accelerator or gamma irradiation) ofirradiation or other treatment (e.g., heat) to which gems have been exposed before they are imported; d.

Where and by whom each irradiation or other treatment is performed before importation.

Identify U.S. reactors by name and location; identify foreign reactors by name and country.

(Note that gems irradiated with gamma radiation, with accelerator produced radiation, or both, do not contain radioactivity regulated by NRC. Accelerator-produced radioactivity is regulated by the individual states.)

If gems are exposed to additional irradiation or treatment after importation, the type (s) and e.

sequence and where and by wi.om each is performed; f.

How gems are handled to ensure grouping according to geologic origin of gems and type (s) ofirradiation or treatment to which gems have been exposed (significant variations in induced radionuclides will result from differences in gems' origin and type (s) ofirradiation or treatment received);

g.

Identification of all radionuclides with physical half-lives greater than 2 hours2.314815e-5 days 5.555556e-4 hours 3.306878e-6 weeks 7.61e-7 months (regardless of method of production) induced in gems and classification of each as either a " major" or

" minor" radionuclide depending on its contribution to total activity in gems to be distributed to persons exempt from licensing; h.

How the information provided in response to Item B.I.g above was obtained and how NRC can be assured that this information is representative of gems imported in the future; i.

The requested possession limit determined by multiplying the maximum number of gems to be possessed at one time by the maximum total activity anticipated in any one gem.

2.

Describe the handling of gems, including:

Appendix 4

I I

l l

Procedures used to ensure that each irradiated gem is free of removable contamination, a.

including a description of sampling, monitoring, counting, and statistical techniques used, specification of the criteria used to determine when gems are essentially " free of removable contamination," and a description of what will happen to gems exceeding the specified criteria.

b.

The processing ofirradiated gems at the importer's facility and the sequence of these activities (e.g., counting of gems and storage for physical decay; mounting in rings, pendants, or other settings);

The categories of unlicensed organizations to which irradiated gems will be transferred (e.g.,

c.

wholesaler; manufacturing jeweler; retail jeweler; individual consumer);

What will be done with gems whose concentrations exceed the criteria specified in response c.

l to Item C.2.e. below (Alternauves indude hold in storage for physical decay, transfer to a person specifically license I tc rccc.ive them, or disposal as radioactive waste in accordance l

with the requirements of D CFR Part 20 or equivalent regulations of an Agreement State.)

C.

Information Required by 10 CFR 32.11 1.

Paragraph 32.11(a) requires that the general requirements of 10 CFR 30.33 be satisfied. To comply with this requirement (or equivalent requirements of Agreement States), the applicant will:

Explain how the facilities and equipment proposed in the application are adequate to i

a.

protect health and minimize danger to life or property; specifically explain how irradiated gems will be stored and secured against unauthorized removal or, when not stored and secured, will be tended under the constant surveillance and immediate control of a knowledgeable, responsible person on the importer's staff.

l b.

Identify by name the individuals who will be responsible for handling, irradiating, storing, l

counting, evaluating, and controlling the release ofirradiated gems; correlate individuals' l

names with their responsibilities; and describe the training and experience of each of these individuals that assures protection of the Public health and safety.

2.

Paragraph 32.11(b) requires that certain information be provided. Ifinformation on one or more points has already been provided, reference the previous response by section and item number or provide a complete response. To comply with 10 CFR 32.11(b), the applicant will describe:

1 a.

The product or material into which byproduct material will be introduced (see response to B.1.a above);

b.

The intended use of the byproduct material and the product or material into which it is introduced; c.

The method of introduction (see response to B.2.c. and e. above);

d.

Initial concentration of byproduct material in the product or material; l

e.

Maximum concentration of the radioisotopes in the product or material at the time of transfer to persons exempt from licensing; I

f.

Control methods to assure that no more than the specified maximum concentration is in the product at time of transfer; g.

Estimated time interval between introduction and transfer of the product or material (i.e.,

between completion of all types ofirradiation and transfer to unlicensed person).

i Appendix 4 3

NUREG-1562 l

l

- 3.

Paragraph 32.11(c) requires applicants to provide reasonable assurance of the following:

1 H

a.

Concentrations of byproduct material at time of transfer will not exceed the concentrations in 10 CFR 30.70 (Note that the limit for a single radionuclide is given in 10 CFR 30.70; the limits for multiple radionuclides are calculated using the " sum of the ratios" method

' described in Note 2 of 10 CFR 30.70.);

l j

b.

Reconcentration of the byproduct material in concentrations exceeding those specified in 10 i

CFR 30.70 is not likely (e.g., in the case of gemstones, one could consider that neutron-irradiation followed by accelerator-irradiation could increase the induced activity l

and thus be considered " reconcentration")-

I i

Use of concentrations lower than those specified in response to Item C.2.e. are not feasible I

c.

i (i.e., why maximum values for a single radionuclide should not be lower; why values for multiple radionuclides should not be calculated by setting the " sum of the ratios" equal to a value less than unity);

d.

The product or material is not likely to be incorporated into any food, beverage, cosmetic, j

drug or other commodity or product designed for ingestion or inhalation by a human being.

)

i l

D.

Information on Quality Assurance (QA) Program Importers must have a OA program. If they do not wish to do the QA themselves, importers may contract this work to another organization. In this case the contract organization's identity, mailing address, location of work for the importer, etc. must be provided and all responses to the items listed l

below must clearly explain who (importer or contract orgamzation) will perform each function.

I Where a contract organization is employed to assist an importer (i.e., a licensee), the importer will still be responsible for proper performance of the QA program and must conduct appropriate audits and reviews to ensure that the QA program is being performed as described in the importer's i

i correspondence with NRC.

1.

Describe the radiation detection equipment and shielding associated with it that are to be used to identify and quantify the radioactivity induced in gems; l

- 2.

Specify the frequency, standards (including radionuclide, activity, and accuracy), and procedures l

used to calibrate such radiation detection equipment; 3.-

Describe counting procedures and how external measurements are converted to concentration values in terms of microcuries per gram. Your description should include, but is not limited to:

(a) selection of samples, (b) maximum and minimum sample size (in terms of number of stones and mass), (c) counting efficiency, (d) counting times, (e) counting geometry, (f) time of counting j

(in relation to completion ofirradiation and transfer to unlicensed persons), (g) lower limit of i

detection, (h) statistical methods for analyzing data, calculating background and lower level of detection, and determining confidence levels, (i) procedures for minimizing " false negatives"

' (i.e., failure to identify individual gems with radionuclide concentrations greater than those specified in response to Item C.2.e.), and (j) sample calculations.

As a minimum, your procedures must be sufficient to ensure that:

After each irradiation, measurements performed on gems are adequate to identify all induced radionuclides i

Before release to unlicensed persons, gems are analyzed to assure that the concentrations listed in 10 CFR 30.70 are not exceeded; because multiple radionuclides will normally be present, the " sum of the ratios" does not exceed unity. (In lieu of use of the " sum of the

{

ratios," it would be acceptable to assure that (1) induced beta and/or gamma emitting i

L NUREG-1562 4

Appendix 4

i byproduct material has a physical half-life less than 3 years and (2) concentration does not 1

exceed 1 x 10-6 Ci/gm.

If the activity is not quantitatively measured in each gem individually (i.e., if quantitative measurements are made on groups of gems), there is only 1 chance in a 1,000 that an outlier gem will contain no more than twice the appropriate 10 CFR 30.70 maximum value (for single or multiple radionuclides).

\\

4.

Specify who will be responsible for the QA program and describe this individual's training and experience in detection and analysis oflow-levels of radioactivity. If this individual was identified l

in response to Item C.I.b, it is not necessary to repeat the individual's qualifications,provided that the response to Item C.l.b. includes a clear description of the person's training and experience in low-level counting techniques.

i 5.

Describe the QA program used to assure reliable data, including:

a.

The standards, frequency and procedures used to perform constancy tests on the counting systems; b.

The methods and frequency ofintroducing " spiked" samples into the routine counting process to assure identification of gems with concentrations in excess of your criteria (i.e.,

response to Item C.2.e. above).

6.

Provide a commitment that, during the term of the license, the applicant will comply promptly with requests from NRC designed to monitor counting techniques. The general nature of these requests is outlined below:

a.

Upon request, the applicant will provide samples ofirradiated gems to NRC for independent verification of radionuclide identity and concentration. NRC's request will be in writing, signed by the appropriate Regional Administrator or the Director, Office of Nuclear Material Safety and Safeguards. The request will specify who (i.e., NRC representative, NRC contractor, or applicant) will select the samples for independent verification. After i

analysis, samples will be returned promptly to the applicant.

b.

Upon request, the applicant will analyze qualitatively, quantitatively, or both gems or groups of gems provided by NRC or its contractor. The request will be in writing, signed by the appropriate Regional Administrator or Director, Office of Nuclear Material Safety and Safeguards, will specify the type of analysis requested and techniques to be followed, and will provide instructions for reporting results and for returning gems.

E.

Information Needed to Support Request for Exemption from Portion of 10 CFR 32.11(c)

Note that 10 CFR 32.11(c), amon-

"r things, prohibits the incorporation of exempt concentrations into products or materials design s

. application to human beings. Neutron-irradiated gems with induced activity could be expectet

.s be set in jewehy and worn by consumers, i.e., " applied to human beings." In order to grant licenses authorizing distribution of these gems to unlicensed persons, it will be necessary to grant a limited exemption from the requirements of 10 CFR 32.11(c) as was directed by Commission. Section 30.11 provides for the granting of exemptions.

1.

To fulfill the requirements of 10 CFR 30.11, make a specific request for an exemption from that portion of 10 CFR 32.11(c) that prohibits incorporation of exempt concentrations in products or materials designed for application to a human being. Your request may be worded as follows: "If NRC considers gems to be products intended for application to human beings, then an exemption from this portion requirements in 10 CFR 32.11(c) is requested."

2.

Using a worst case scenario, calculate the annual radiation dose and assess the health risk to unlicensed persons. Calculate the dose at contact and at 4 cm from jewelry (e.g., pendant)

Appendix 4 5

~

t i

containing neutron-irradiated gems that is worn continuously (24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months per day,365 days per year). Assume that these gems contain those radionuclides (identified in your response to Item i

B.1.g) with the longest physical half-lives and highe:;t cr.crgy emissions at the maximum :

t concentrations (identified in your response to Item C.2.e.) you propose to release to unlicensed persons. Dose calculations must consider all types of emissions (e.g., beta, gamma) from the -

l

' identified radionuclides.

L 3.

Provide similar calculations and assessments for gems that are outliers (i.e., gems'with t

concentrations as much as twice the criteria you plan to use) 4.

Submit a copy of the labeling or other information provided to consumers at point-of-sale of -

neutron-irradiated gems that alerts purchasers of the presence oflow-levels of radioactivity so that they can make an informed decision at time of purchase.

3 L

l E

Fee Information and Signature 1.'

' Review 10 CFR 170.31 and specify the correct fee category for your application.

l 2.

Your request for a license should include the certification statement as shown below and must be dated and signed by a responsible individual who is empowered to make commitments to NRC that are binding upon the applicant.

i CERTIFICATION STATEMENT:

l I

l The applicant understands that all statements and representations made in this application are binding upon the application.

The applicant and any official executing this certification on behalf of the applicant, named in Item A.1, j

certify that this application is prepared in conformity with Title 10, Code of Federal Regulations, Parts 30,-

32,33,34,35, and 40 and,if applicable, equivalent regulations of Agreement States, and that all l

information contained herein, is true and correct to the best of their knowledge and belief.

l-Warning: 18 U.S.C. Section 1001 Act of June 25,1948,62 Stat,749 makes it a criminal offense to make a willfully false statement or representation to any department or agency of the United States as to any i

l matter within its jurisdiction.

SIGNATURE AND DATE:

l l

SIGNATURE-CERTIFYING OFFICER TYPED / PRINTED NAME TITLE DATE l

l III. ADMINISTRATIVE INSTRUCTIONS FOR APPLICATIONS FILED BYIMPORTERS LOCATED IN NON-AGREEMENT STATES j.

Prepare an original and two copies of your completed, signed request for a license.

A.

l B.

Mail the original and one copy with a check made payable to the U.S. Nuclear Regulatory 1

Commission in the amount of the appropriate fee (as determined from 10 CFR 170.31) to:

I NUREG-1562 6

Appendix 4

l U. S. Nuclear Regulatory Commission Division of Industrial and Medical Nuclear Safety Mail Stop TWFN-8F5 Washington, DC 20555-0001 C._

Retain the second copy in your files because the license, when issued, will require that you conduct your program in accordance with the statements, representations and procedures contained in your 1 request and any subsequent correspondence with NRC.

D.

NRC Contacts 1.

For questions r. bout fees, contact the Office of the Controller, Ucense Fee and Accounts l

Receivable Branch, at (301) 415-7554.

2.

For questions about licensing, contact the Medical, Academic, and Commercial Use Safety Branch at (301) 415-7217.

j i

l IV. ADMINISTRATIVE INSTRUCTIONS FOR APPLICATIONS FILED BY IMPORTERS i

LOCATED IN AGREEMENT STATES l

As indicted in Section I, importers located in Agreement States need to file requests for " possession"

- licenses with the appropriate Agreement State and requests for " distribution" licenses with NRC. Both the

' Agreement State and NRC need detailed information in order to understand all aspects of the applicant's proposed program. Thus, this document has not separated the information needed for each type of license. Rather, applicants should submit all of the information requested in this document to both NRC i and the Agreement States.

A.

Applications Directed to NRC Importers should follow the instructions in Section III for submitting applications to NRC and should add a cover letter requesting a " distribution" license from NRC and explaining that a request for a l

" possession" license has been filed with the appropriate Agreement States.

l' B.

Applications Directed to Agreement States l

Agreement State's regulations, information on its fee schedule (if any), and m) an Importers should contact the appropriate Agreement State (see Enclosure 1 structions for filing applications. Note that Agreement States may require the submission of more than one copy of exh application and may recommend that applicants mail applications to an address other than that shown in Enclosure 1.

l

' Applications filed with Agreement States should be accompanied by a cover letter requesting a

" possession" license from the Agreement State and explaining that a request for a " distribution" license has been filed with NRC.

l l

Enclosures:

l l

1.

List of Agreement States 2.

10 CFR Parts 20,30,32,110,170 i

t i

Appendix 4 7

l Appendix 5 Information Needed from a Domestic Reactor To Support Application for License Pursuant to 10 CFR 32.11 i

To Distribute Neutron-Irradiated Gems to Persons Exempt from Licensing (February 25,1988)

L I.

INTRODUCTION Generic Letter 88-4 (dated February 23,1988) discusses the Nuclear Regulatory Commission's (NRC's) position on distribution of neutron-irradiated topaz to unlicensed persons. As indicated in that Generic Letter and ander the authority of Section 81 of the Atomic Energy Act of 1954, as amended, the staff l

plans to control distribution of these gems at the source and envisions two principal groups of applicants, domestic reactors and commercial importers.

i This document outlines for domestic reactors the information needed to support applications for heenses i

to be issued pursuant to 10 CFR 32.11. The information that must be included in an application can be categorized as: (1) basic information (e.g., name of applicant); (2) background information; (3) iformation specifically identified in the regulations (e.g.,10 CFR 30.33, 32.11); (4) information on instrumentation, counting, sampling and quality assurance (QA) programs; (5) information needed to l

support a request for an exemption from that portion of 10 CFR 32.11(c) that prohibits use of exempt l

concentrations in products designed for application to a human being; and (6) fee information and j

signature. Detailed information is needed to ensure a clear understanding of the scone and intent of the 1

applicant's proposed activities.

II.

CONTENT OF APPLICATION i

A.

Basic Information i

1.

Specify name of applicant 2.

Specify applicant's mailing address 3.

Identify the person with detailed knowledge of the application that the NRC staff can contact about the application, giving the Person's:

a.

Name b.

Title l

c.

Telephone number 4.

Specify the location (s):

a.

At which gems will be irradiated l

b.

From which irradiated gems will be distributed to persons exempt from licensing 5.

Specify the docket number of your NRC reactor license.

6.

If your reactor is licensed pursuant to 10 CFh 50.21 in Class 104 status, provide information to demonstrate that less "than 50 percent of the annual cost of owning and operating the facility is devoted to the production of materials, products, or energy for sale or commercial distribution, or to the sale of services, other than research and development or education or training." [ Note:

i Appendix 5 1

i Regulation. If a license is issued to you pursuant to 10 CFR 32.11, it will require annual submission of similar information.)

B.

Background Information 1.

Describe what is to be irradiated, including:

)

a.

The type of gems (e.g., topaz) b.

Extent to which gems have been processed before irradiation (e.g., cut and polished). Note:

Only finished gems which do not require cutting, grinding or polishing after irradiation will be authorized for distribution to persons exempt from licensing.

Anticipated production (e.g., the estimated maximum number and mass (in gra ns) of gems c.

to be irradiated at one time and the estimated number of batches per year) 2.

Describe how gems are to be irradiated including:

How gems are handled to ensure grouping according to geologic origin of gems and type (s) a.

ofirradiation or treatment to which gems have been exposed (significant variations in induced radionuclides result from differences in gems' origin and type (s) ofirradiation received.)

b.

The type (s) ofirradiation and other types of treatment (e.g., hest) and their sequence (e.g.,

neutron-irradiation only; neutron followed by accelerator or gamma irradiation);

If gems are subjected to more than one type ofirradiation or treatment, where and by whom c.

the other irradiation or treatment is done; d.

How gems are prepared for irradiation (e.g., the number and mass (in grams) of gems irradiated at one time in one reactor port, type of container used);

e.

Procedures to be followed for irradiating gems; f.

The typical irradiation time, neutron energy, and neutron flux and how these are determined; g.

Identification of all radionuclides with physical half-lives greater than 2 hours2.314815e-5 days 5.555556e-4 hours 3.306878e-6 weeks 7.61e-7 months (regardless of l

the method of production) induced in gems and classification of each as either a " major" or i

" minor" radionuclide depending on its contribution to total activity in gems to be distributed to persons who are exempt from licensing; h.

How the information provided in response to Item B.2.g. above was obtained and how NRC can be assured that this information is representative of gems to be irradiated in the future.

3.

Describe the handling of gems after irradiation, including:

a.

Procedures used to ensure that each irradiated gem is free of removable contamination, including a description of sampling, monitoring, counting, and statistical techniques used, specification of the criteria used to determine when gems are essentially " free of removable contamination," and a description of what will happen to gems exceeding the specified criteria.

b.

The post-irradiation processing ofirradiated gems at the applicant recctor's facility and the sequence of these activities (e.g., counting of gems and storage for physical decay; mounting in rings, pendants, or other settings);

Appendix 5

l The categories of unlicensed organizations to which irradiated gems will be transferred (e.g.,

c.

wholesaler; manufacturing jeweler; retail jeweler; individual consumer).

l l

d.

What will be done with gems whose concentrations exceed the criteria specified in response l

to Item C.2.e. below (Alternatives include hold in storage for physical decay, transfer to a person specifically licensed to receive them, or disposal as radioactive waste in accordance with the requirements of 10 CFR Part 20).

l C.

Information Required by 10 CFR 32.11 l

1.

Paragraph 32.11(a) requires that the general requirements of 10 CFR 30.33 be satisfied. To comply with this requirement, the applicant will:

Explain how the facilities and equipment proposed in the application are adequate to a.

protect health and minimize danger to life or property with respect to activities to be conducted under this license; b.

Identify by name the individual who will be responsible for handling, irradiating, storing, l

counting, evaluating, etc., irradiated gems; correlate individuals' names with their l

responsibilities; and describe the training and experience of each that assures protection of the public health and safety.

2.

Paragraph 32.11(b) requires that certain information be provided. Ifinformation on one or more points has already been provided, reference the previous response by section and item number or provide a complete response. To comply with 10 CFR 32.11(b), the applicant will describe:

The product or material into which byproduct material will be introduced (see response to a.

B.1 above) b.

The intended use of the byproduct material and the product or material into which it is introduced c.

The method ofintroduction (see response to B.2 above) d.

Initial concentration of byproduct material in the product or material Maximum concentration of the radioisotopes in the product or material at the time of e.

transfer to persons exempt from licensing f.

Control methods to assure that no more than the specified maximum concentration is in the product at time of transfer g.

Estbuted time interval between introduction and transfer of the product or material (i.e.,

between completion of all types ofirradiation and transfer to unlicensed person) 3.

Paragraph 32.11(c) requires applicants to provide reasonable assurance of the following:

l Concentrations of byproduct material at time of transfer will not exceed the concentrttions a.

in 10 CFR 30.70. (Note that the limit for a single radionuclide is given in 10 CFR 30.70; the limits for multiple radionuclides are calculated using the " sum of the ratios" method described in Note 2 of 10 CFR 30.70.)

b.

Reconcentration of the byproduct material in concentrations exceeding those specified in 10 CFR 30.70 is not likely (e.g., in the case of gemstones, one could consider that neutron-irradiation followed by accelerator-irradiation could increase the induced activity and thus be considered " reconcentration");

l Appendix 5 3

i Use of concentrations lower than those specified in response to Item C.2.e are not feasible c.

(i.e., why maximum values for a single radionuclide should not be lower; why values for multiple radionuclides should not be calculated by setting the " sum of the ratios" equal to a value less than unity).

d.

The product or material is not likely to be incorporated into any food, beverage, cosmetic, drug or other commodity or product designed for ingestion or inhalation by a human being.

D.

Information on Quality Assurance (QA) Program 1.

Describe the radiation detection equipment and shielding associated with it that are to be used to identify and quantify the radioactivity induced in gems 2.

Specify the frequency, standards (including radionuclide, activity, and accuracy), and procedures used to calibrate such radiation detection equipment 3.

Describe counting procedures and how external measurements are converted to concentration values in terms of microcurie per gram. Your description should include, but is not limited to: (a) selection of samples, (b) maximum and minimum sample size (in terms of number of stones and mass), (c) counting efficiency, (d) counting times, (e) counting geometry, (f) time of counting (in relation to completion ofirradiation and transfer to unlicensed persons), (g) lower limit of detection, (h) statistical methods for analyzing data, calculating background and lower limit of detection, and determining confidence levels, (i) procedures for minimizing " false negatives" (i.e., failure to identify individual gems with radionuclide concentrations greater than those specified in response to Item C.2.e.), and (j) sample calculations.

As a minimum, your procedures must be sufficient to ensure that:

After each irradiation, measurements performed on gems are adequate to identify all induced radionuclides Before release to unlicensed persons, gems are analyzed to assure that: the concentrations e

listed in 10 CFR 30.70 are not exceeded; because multiple radionuclides will normally be present, the " sum of the ratios" does not exceed unity. (In lieu of use of the " sum of the ratios," it would be acceptable to assure that (1) induced beta and/or gamma emitting byproduct material has a physical half-life less than 3 years and (2) concentration does not exceed 1 x 10-6 Ci/gm.)

If the activity is not quantitatively measured in each gem individually (i.e., if quantitative e

measurements are made on groups of gems), there is only 1 chance in a 1000 that an outlier gem will contain no more than twice the appropriate 10 CFR 30.70 maximum value (for single or multiple radionuclides).

4.

Specify who will be responsible for the QA program and describe this individual's training and experience in detection and analysis oflow-levels of radioactivity. If this individual was identified in response to Item C.I.b, it is not necessary to repeat the individual's qualifications, provided that the response to Item C.1.b includes a clear description of the person's training and experience in low-level counting techniques.

5.

Describe the QA program used to assure reliable data, including:

The standards, frequency and procedures used to perform constancy tests on the counting a.

systems b.

The methods and frequency of introducing " spiked" samples into the routine counting process to assure identification of gems with concentrations in excess of your criteria (i.e.,

response to Item C.2.e. above).

Appendix 5

l l

6.

Provide a commitment that, during the term of the license, the applicant will comply promptly I

with requests from NRC designed to monitor counting techniques. The general nature of these requests is outlined below:

Upon request, the applicant will provide samples ofirradiated gems to NRC for I

a.

independent verification of radionuclide identity and concentration. NRC's request will be in vTiting, signed by the appropriate Regional Administrator or the Director, Office of Nuclear l

Material Safety and Safeguards. The request will specify who (i.e., NRC representative, l

NRC contractor, or applicant) will select the samples for independent verification. After j

analysis, samples will be returned promptly to the applicant.

l b.

Upon request, the applicant will analyze qualitatively, quantitatively, or both, gems or l

groups of gems provided by NRC or its contractor. The request will be in writing, signed by l

the appropriate Regional Administrator or Director, Office of Nuclear Material Safety and l

Safeguards, will specify the type of analysis requested and techniques to be followed, and l

will provide instructions for reporting results and for returning gems.

l l

E.

Information Nceded to Support Request for Exemption from Portion of 10 CFR 32.ll(c) i Note that 10 CFR 32.11(c), among other things, prohibits the incorporation of exempt concentrations into products or materials designed for application to human beings. Neutron-irradiated gems with induced activity could be expected to be set in jewelry and worn by consumers, i.e., " applied to human beings." In order to grant licenses authorizing distribution of these gems to unlicensed persons, it will be necessary to grant a limited exemption from the requirements of 10 CFR 32.ll(c) as was directed by the Commission. Section 30.11 provides for the granting of exemptions.

1.

To fulfill the requirements of 10 CFR 30.11, make a specific request for an exemption from that t

portion of 10 CFR 32.ll(c) that prohibits incorporation of exempt concentrations in products or materials designed for application to a human being. Your request may be worded as follows: "If NRC considers gems to be products intended for application to human beings, then an exemption from this portion of the requirements in 10 CFR 32.ll(c) is requested."

2.

Using a worst case scenario, calculate the annual radiation dose and assess the health risk to unlicensed persons. Calculate the dose at contact and at 4 cm from jewehy (e.g., pendant) containing neutron-irradiated gems that is worn continuously (24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months per day,365 days per year). Assume that these gems contain those radionuclides (identified in your response to Item l

B.2.g) with the longest physical half-lives and highest energy emissions at the maximum l

concentrations (identified in your response to Item C.2.e.) you propose to release to unlicensed persons. Dose calculations must consider all types of emissions (e.g., beta, qamma) from the j

identified radionuclides.

l 3.

Provide similar calculations and assessments for gems that are outliers (i.e., gems with l

concentrations as much as twice the criteria you plan to use) 4.

Submit a copy of the labeling or other inintmation provided to consumers at point-of-sale of neutron-irradiated gems that alerts purch ers of the presence oflow-levels of radioactivity so l

that they can make an informed decision dme of purchase.

E Fee Information and Signature 1.

Review 10 CFR 370.31 and specify the correct fee category for your application.

2.

Your request for a license should include the certification statement as shown below and must be dated and signed by a responsible individual who is empowered to make commitments to NRC that are binding upon the applicant.

Appendix 5 5

NUREG-1562 l

1

CERTIFICATION STATEMENT:

The applicant understands that all statements and representations made in this application are binding upon the applicant.

The applicant and any official executing this certification on behalf of the applicant, named in Item A.1, certify that this application is prepared inconformity with Title 10, Code of Federal Regulations, Parts 30, 32,33,34,35, and 40 and that allinformation contained herein,is true and correct to the best of their knowledge and belief.

Warning: 18 U.S.C. Section 1001 Act of June 25,1948,62 Stat,749 makes it a criminal offense to make a willfully false statement or representation to any department or agency of the United States as to any matter within its jurisdiction.

SIGNATURE AND DATE:

SIGNATURE-CERTIFYING OFFICER TYPED / PRINTED NAME TITLE DATE III. ADMINISTRATIVEINSTRUCTIONS A.

Prepare an original and two copies of your completed, signed request for a license.

B.

Mail the original and one copy with a check made payable to the U.S. Nuclear Regulatory Commission in the amount of the appropriate fee (as determined from 10 CFR 170.31) to-i U.S. Nuclear Regulatory Commission Division ofIndustrial and Medical Nuclear S tfety Mail Stop TWFN-8F5 Washington, DC 20555-0001 C.

Retain the second copy in your files because the license, when issued, will require that you conduct your program in accordance with the statements, representations, and procedures contained in your request and any subsequent correspondence with NRC.

D.

NRC contacts:

1.

For questions about fees, contact the Office of the Controller, License Fee and Accounts Receivable Branch, at (301) 415-7554, 2.

For questions about licensing, contact the Medical, Academic, and Commercial Use Safety Branch at (301) 415-7217.

Enclosures:

1.

Generic Letter 88-4 (dated February 23,1988) 2.

10 CFR Parts 20,30,32,170 NUREG-1562 6

Appendix 5

Appendix 6 j

Certification of Application / License Review j

for Part 32 Exempt Distribution Licenses Mail Control No.:

Amendment No.:

Expiration Date:

License No.:

Program Code:

Docket No.:

Reference No.:

Licensee Name:

Address:

Action Type:

New License New License / Licensee Renewal Product Transfer Report Amendment Termination I certify that I have reviewed the licensee's request dated

, as supplemented by any letters referenced in the license and in accordance with guidance provided by the Office of Nuclear Material Safety and Safeguards, appropriate Standard Review Plans and regulations, and the attache ( chei.2st.

/

~

REVIEWER DATE REVIEWED BY DATE PERSON SIGNING THE LICENSE DATE

GENERAL COMMENT

S:

Appendix 6 1

i Mail Control No.:

32.11: EXEMPT CONCENTRATIONS (30.14) l (a) Applicant satisfied general requirements in 30.33,10 CFR Part 30 COMMENTS:

(b) Provides a oescriptioa of the product, including:

1.

The product of material into which byproduct material will be introduced COMMENTS:

2.

Intended use of the byproduct material and the product or material into which 1

it is introduced COMMENTS:

3.

Method ofintroduction COMMENTS:

l 4.

Initial concentration of byproduct material in the product or material COMMENTS:

5.

Maximum concentration of the radioisotopes in the product or material at the time of transfer to persons exempt from licensing COMMENTS:

1 1

l 6.

Control methods to assure that no more than the specified maximum concentration i

l is m the product at the time of transfe.

j j

COMMENTS:

Appendix 6

l l

7.

Estimated time interval between introduction and transfer of the product or j

material COMMENTS:

(c) Provides reasonable assurance of the following:

1.

Concentrations of byproduct material at time of transfer will not exceed the concentrations in $30.70 COMMENTS:

2.

Reconcentration of the byproduct material in concentrations exceeding those specified in @30.70 is not likely COMMENTS:

I 3.

Use oflower concentrations is not feasible COMMENTS:

4.

The product or material is not likely to be incorporated in any food, beverage, cosmetic, dmg or other commodity or product designed for ingestion or inhalation by, or application to, a human being COMMENTS:

(d) Applicants must submit information on Quality Assurance (QA) Program, including:

COMMENTS:

1.

Describe radiation detection equipment and shielding used to identify and quantify the radioactivity induced in the product or material COMMENTS:

2.

Specify the frequency, standards and procedures used to calibrate such radioactive detection equipment i

Appendix 6 3

NUREO-15h2 i

COMMENTS:

3.

Describe counting procedures and how external measurements are converted to concentration values in terms of microcuries per gram COMMENTS:

Appendix 6

._= _ _

- - _ - ~ _. -. -

l l

i Appendix 7 i

Certification of Application / License Review for Part 32 Exempt Distribution Licenses Mail Control No.:

Amendment No.:

Expiration Date:

Ucense No.:

Program Code:

Docket No.:

Reference No.:

Licensee Name:

Address:

l f

Action Type:

New License New License / Licensee Renewal Product Transfer Report Amendment Termination I certify that I have reviewed the licensee's request dated

, as supplemented by any letters referenced in the license and in accordance with guidance provided by the Office of Nuclear Material Safety and Safeguards, appropriate Standard Review Plans and regulations, and the attached checklist.

REVIEWER DATE l

REVIEWED BY DATE PERSON SIGNING THE LICENSE DATE l

GENERAL COMMENT

S:

f F

Appendix 7 1

~

l i

Mail Control No.:

32.14: CERTAIN ITEMS (30.15)

- (a) Applicant satisfied general requirements in 30.33,10 CFR Part 30

' COMMENTS:

)

i.

(b) Applicant submits sufficient information regarding product pertinent to evaluation l

of potential radiation exposure, meluding:

l l

COMMENTS:

1.

Chemical and physical form and maximum quantity of BPM in each product i

COMMENTS-i l

2.

Details of construction and design of product COMMENTS:

I 3.

Method of containment or binding of BPM in product COMMENTS:

i 4.

Procedures for prototype testing to demo'nstrate that the material will not become detached from the product or that BPM will not be released under severe conditions COMMENTS:

5.

Results of prototype testing i

COMMENTS: _

\\

1 6.

Quality control procedures to be followed in the fabrication, and the quality control standards the product will be required to meet ($32.15)

Appendix 7 i

~... -.

l l

COMMENTS:

7.

Proposed method oflabeling or marking each unit, except for timepieces or hands or dials containing H-3 or Pm-147 and it's container with the identification of the manufacturer orinitial transferor and the BPM COMMENTS:

1 8.

For products with limits specified in 30.15, the radiation level and method of measurement COMMENTS:

1 l

9.

Any additional information, studies, and tests regarding product safety COMMENTS:

l l

(c) Each product will contain no more than the quantity of BPM specified for that product in 30.15 COMMENTS:

l

\\

l 32.14(1): 'I1mepieces Tritium is considered properly bound if no visible flaking and the totalloss of H-3 does not exceed 5% of total H-3 when subjected to the following tests:

COMMENTS:

1.

Vibration tests COMMENTS:

2.

Bending of hands or pointers over cylinder COMMEhTi 4

Appendix 7 3

i l

3.

Immersion tests COMME' TS:

1 i-32.40: Schedule A-Lock Illuminators Prototype testing for automobile lock illuminators must consist of the following tests:

COMMENTS:

1.

100 hours0.00116 days 0.0278 hours 1.653439e-4 weeks 3.805e-5 months of accelerated weathering COMMENTS:

2.

Dropped onto concrete or iron from 3 feet 100 times COMMENTS:

3.

Vibration tests COMMENTS:

4.

Immersion in 30 inches of water for 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months to include a pressure (bubble) test

]

COMMENTS:

5.

After each test, must be examined for evidence of physical damage COMMENTS:

I i

b i

l l

Appendix 7

Appendix 8 Certification of Application / License Review for Part 32 Exempt Distribution Licenses

(

Mail Control No.:

Amendment No.:

Expiration Date:

License No.:

Program Code:

Docket No.:

Reference No.:

Licensee Name:

Address:

Action Type:

New License i

New License / Licensee Renewal Product Transfer Report Amendment Termination I certify that I have reviewed the licensee's request dated

, as supplemented by any letters referenced in the license and in accordance with guidance provided by the Office of Nuclear Material Safety and Safeguards, appropriate Standard Review Plans and regulations, and the attached checklist.

REVIEWER DATE REVIEWED BY DATE PERSON SIGNING THE LICENSE DATE

GENERAL COMMENT

S:

Appendix 8 1

l l

i Mail Control No.:

32.17: RESINS CONTAINING SCANDIUM-46 (30.10)

(a) Applicant satisfied general requirements in 30.33 COMMENTF:

l j

(b) Product is designed to be used only for sand-consolidation in oil wells COMMENTS:

(c) Applicant must submit the following information:

1.

General description of product to be manufactured or transferred COMMENTS:

l i

2.

Description of control procedures for concentrations not to exceed 1.4 X 10-3 uCi/ml of final product COMMENTS:

l (d) Each container of such product must contain durable, legible label with the following information:

COMMENTS:

1.

Product name COMMENTS:

l 2.

State that product contains Scandium-46 and is designed only for sand-consolidation in oil wells COMMENTS:

l NUREG-1562 2

Appendix 8 l

i

_3.

_ Instruction for proper use COMMENTS:

t 4.

Manufacturer's name COMMENTS:

i i

i r

I I

I l

l l

t i

1

[

. i l

1 i

1 l

t i

l i

i l.

i I

L i

l l

i 4

1 i

i Appendix 8 3

NUREG-1562 e

h--

+r rf pwi.

y vr

+

e y

g

l Appendix 9 1

Instructions Relating to the l

Handling, Use, Storage, and Disposal of Radioactive Material 1.

Handling i

1 Although the quantities of radioactive material contained in these products is extremely small, the basic radiation principles of time, distance, and shielding should be practiced as effective methods for j

mimmizmg exposure.

Use of radioactive material should be only by responsible persons in authorized areas.

Eating, drinking, smoking and the application of cosmetics should be prohibited in areas of use.

Gloves and laboratory coats should be worn when working with liquid radioactive material.

2.

Use Exempt quantity licensed products containing radioactive material should be used only as intended by the manufacturer and in accordance with the instructions provided with the products.

3.

Storage All radioactive materials should be securely stored when not in use.

4.

Disposal These exempt distribution products may be disposed ofin regular waste without regard to their radioactive content providing the customer is not a spedfic licensee and all radiation symbols have been removed or defaced. If the customer (laboratory / academic institution) receiving the exempt quantity is a specific licensee, then the customer is subject to the requirements of 10 CFR Part 20 in areas where 10 CFR 30.18 is silent (e.g., waste disposal).

l l

l d

Appendix 9 1

NUREG-1562 i

l

Appendix 10 t

Certification of Application / License Review for Part 32 Exempt Distribution Licenses Mail Control No.:

Amendment No.:

Expiration Date:

License No.:

Program Code:

l Docket No.:

Reference No.:

Licensee Name:

Address:

Action Type:

New License New License / Licensee Renewal Product Transfer Report Amendment Termination I certify that I have reviewed the licensee's request dated

, as supplemented by any letters referenced in the license and in accordance with guidance provided by the Office of Nuclear Material Safety and Safeguards, appropriate Standard Review Plans and regulations, and the attached checklist.

REVIEWER DATE REVIEWED BY DATE PERSON SIGNING THE LICENSE DATE 1

GENERAL COMMENT

S:

l l

Appendix 10 1

Mail Control No.:

32.18: EXEMIFT QUANTITIES OF BYPRODUCT MATERIAL (30.18)

(a) Applicant satisfies 30.33 for the manufacture, distribution, and transfer of exempt quantities of BPM except for a license to transfer BPM manufactured, processed, produced, packaged, or repackaged pursuant to a license issued by an Agreement State COMMENTS:

(b) The BPM is not contained in any food, beverage, cosmetic, drug, or commodity designed for ingestion, inhalation by, or application to humans COMMENTS:

(c) The BPM is not incorporated into any manufactured or assembled commodity, product, or device intended for commercial distribution COMMENTS:

(d) Applicant submits copies of prototype labels and brochures for approval COMMENTS:

32.19: Conditions for License Under 32.I8 (a) No more than 10 exempt quantities set forth in 30.71, Schedule B shall be sold or transferred in any single transaction (an individual exempt quantity may be composed of fractional parts so that the sum does not exceed unity)

COMMENTS:

(b) Each quantity shall be separately and individually packaged with no more than 10 individual packages contained in any outer package for transfer. The external surface dose rate of the outer package must not exceed 0.5 mrem per hour COMMENTS:

l NUREO-1562 2

Appendix 10

(c) The immediate container shall bear a durable, legible label which:

COMMENTS:

1.

Identifies the radioisotope and quantity of activity COMMENTS:

2.

Bears the words, " RADIOACTIVE MATERIAI" COMMENTS:

(d) Label or accompanying brochure shall state:

COMMENTS:

1.

Contents are exempt from NRC or Agreement State licensing requirements COMMENTS:

2.

Bear the words," RADIOACTIVE MATERIAle-NOT FOR HUMAN USE INTRODUCTION INTO FOODS, BEVERAOES, COSMETICS, DRUOS, OR MEDICINALS, OR INTO PRODUCTS MANUFACTURED FOR COMMERCIAL DISTRIBUTION IS PROHIBITED-EXEMPT QUANTITIES SHOULD NOT BE COMBINED" COMMENTS:

3.

Set forth additional radiation safety precautions and instructions for handling, use, storage, and disposal of radioactive material COMMENTS:

Appendix 10 3

NUREO-1562

Appendix 11 Standard Requirements for 'lYitium Illuminated Gun Sights Containing Tritium Gas Scaled in Glass Vials 1

PURPOSE To set minimum performance requirements for gun sights containing tritium gas in glass vials for the purpose of producing light.

2 APPLICABILITY All tritium illuminated gun sights registered after the date of this document are required to adhere to the requirements of this document.

Furthermore, all tritium illuminated gun sights licensed, after the date of this document, for manufacture or distribution, are required to adhere to the requirements of this document.

New gun sights which can be shown, by engineering evaluation, to meet these criteria, because of similarity in design and assembly to gun sights passing this criteria, need not be subject to the prototype testing described in this document.

3 REQUIREMENTS An applicant for a license to manufacture, process, or distribute gun sights containing tritium gas in vials for the purpose of producing light shall submit the information required in 10 CFR 32.22. The labeling requirements and prototype testing procedures in this document are considered sufficient to meet the requirements described in 10 CFR 32.22(a)(2)(x) and 32.22(a)(2)(xi), respectively.

3.1 DESIGN Each gun sight is required to be designed so that:

3.1.1 In normal use and disposal of a single gun sig,ht, it is unlikely the external radiation dose in any one year, or the dose commitment resulting from the intake of radioactive material in any one year, to a suitable sample of the group ofindividuals expected to be most highly exposed to radiation or radioactive material from the gun sight will exceed the dose to the appropriate organ as specified in Column I of Table 1.

3.1.2 In normal handling and storage of the quantities of gun sights likely to accumulate in one location during marketing, distribution, installation, and servicing of the gun sights, it is unlikely that the external radiation dose in any one year, or the dose commitment resulting from the intake of radioactive material in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the gun sight will exceed the dose to the appropriate organ as specified in Column II of Table 1.

3.1.3 It is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the gun sight from wear and abuse likely to occur in normal handling and use of the gun sight during its useful life.

3.1.4 In use and disposal of a single gun sight, or in handling and storage of the quantities of gun sights likely to accumulate in one location during marketing, distribution, installation, and Appendix 11 1

servicing of the gun sight, the probability is low that the containment, shielding, or other safety features of the gun sight would fail under such circumstances that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ in Column III of Table 1, and the probability is negligible that a person would receive an external radiation dose or dose commitment in excess of the dose to the appropriate organ in Column IV of Table 1.

TABLE 1 Col. I Col. II Col. III Col. IV Part of Body (rem)

(rem)

Whole body; head and trunk; active 0.001 0.01 0.5 15 blood-forming organs; gonads; or lens of eye Hands and forearms; feet and anldes; 0.015 0.15 7.5 200 localized areas of skin averaged over areas no larger than 1 square centimeter Other organs 0.003 0.03 1.5 50 3.1.5 It is engraved with H3 and the name, registered trademark, or license number of the manufacturer, processor, producer, or initial transferor of the gun sight.

The gun sight may be labeled using paint or a durable metal foil label. However, the applicant must provide adequate information that the labeling will remain legible after being subject to the prototype testing described in this document.

3.2 PROTOTYPE TESTING At least five (5) gun sights of each model are to be subject to each of the tests described below. The same gun sight is to be used for each test. Order of the testing is not significant. Between each test the gun sights are to be visually inspected to ensure there have been no detrimental effects to the gun sights. The gun sights must not become loosened or detached from the guns (tests 3.2.7 & 3.2.8) and the light sources must not become loosened or detached from the gun sights as a result of any of the tests. Once all tests are completed, the gun sights are to be subject to the evaluation in section 3.2.9.

3.2.1 CHEMICAL The gun sight is to be immersed for 48 hours5.555556e-4 days 0.0133 hours 7.936508e-5 weeks 1.8264e-5 months at roo-temperature in each of the following:

gun oil e trichloroethane cleaning compound according to MIL-C-372B e

Appendix 11

3.2.2 TEMPERATURE High Temperature: The temperature of the gun sight is to be raised from ambient to 120 C and held at this temperature for one hour.

Low Temperature: The temperature of the gun sight is to be lowered from ambient to -46 C and held at this temperature for 48 hours5.555556e-4 days 0.0133 hours 7.936508e-5 weeks 1.8264e-5 months .

Relative Humidity: The gun sight is to be placed in an environment of 100% relative humidity and a temperature of 42*C and held in this emironment for 48 hours5.555556e-4 days 0.0133 hours 7.936508e-5 weeks 1.8264e-5 months .

3.2.3 TEMPERATURE SHOCK The gun sight is to be heated to 80C and held at this temperature for 15 minutes. The gun sight is to be transferred, within 15 seconds, to a cold chamber having a temperature of -46 C and held in this chamber for 15 minutes. If water is used as the cold chamber, it is to be flowing at a rate of at least 10 times the gun sight volume per minute. If the water is stationary, the water volume is to be at least 20 times the volume of the gun sight.

3.2.4 VIBRATION The gun sight is to be subject to simple harmonic motion having an amplitude of 0.075 cm.

The vibration cycle is to go from 10 Hz to 50 Hz and back again in approximately one (1) minute. This is to be carried out for 10 cycles. Aftenvards, the gun sight is to be subject to 30 minutes of vibration at resonance frequency.

This test is to be carried out in each of the three principal axes of the gun sight.

3.2.5 PRESSURE The gun sight is to be placed in a test chamber and exposed to 0.25 and 2.0 bars for four (4) periods of 15 minutes each, the pressure being returned to atmosphere between each period.

3.2.6 PENETRATION A hammer with a small point and weighing 10 g is to be dropped from a height of one (1) meter onto the exposed surface of the light source.

3.2.7 MECHANICAL SHOCK This test is to be performed with the gun sight attached to the gun which would have the most detrimental effects on the gun sight.

The gun is to be dropped from two (2) meters onto a hard surface (at least 1" thick 85 durometer rubber backed by concrete). The gun is to be dropped 60 times in such a manner that it strikes the surface ten times in each of the following attitudes:

a.

Barrel vertical, muzzle down.

b.

Barrel vertical, muzzle up.

c.

Barrel horizontal, bottom up.

d.

Barrel horizontal, bottom down.

Barrel horizontal, left side up.

e.

Appendix 11 3

I f.

Barrel horizontal, right side up.

3.2.8 FIRING This test is to be performed with the gun sight attached to the gun which would have the most detrimental effects on the gun sight. The gun is to sequentially fire 5000 rcunds of ammunition with lapses only sufficient to allow reloading (only one of each model site needs to be subjected to the firing test).

3.2.9 EVALUATION After each test the gun sight is to be immersed in water for 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months at ambient temperature.

The volume of the water is to be about equal to 10 times that of the volume of the gun sight.

After the gun sight is removed, the activity of the solution is to be measured. The activity of the solution is to be less than or equal 50 nanocuries.

REFERENCES Author, Title, (state pub: publisher, year) 1.

American National Standards Institute, Inc., ANSI /SAAMI Z299.5-1985 American National Standard Voluntag Industry Performance Standards Criteria of New Firearms Designs Under Conditions of Abusive Mishandling for the Use of Commercial Manufacturers (Connecticut: Sporting Arms and Ammunition Manufacturers' Institute, Inc.,1985) 2.

American National Standards Institute, American National Standard N540; Classification of Radioactive Self-Luminous Light Sources (Washington: U.S. Government Printing Office,1976) 3.

Department of the Army, US Army Weapons Command, Supplementary Quality Assurance Provisions No.12002965 Low Light Level Sight Kit; M16/M16Al Rifle 4.

DIN, Sealed Radioactive Sources, Requirements and Classifications, DIN No. 25426 (Germany) 5.

Fabrique Nationale h.:rstal S.A., Branche Defense Et Securite Procurement Quality Specification No. 390.700.501/1 Sights, Night Use (Belgium) 6.

International Atomic Energy Agency, Safety Series No. 23 Radiation Protection Standards for Radioluminous Timepieces (Vienna: International Atomic Energy Agency,1967) 7.

Ministry of Defence, Defence Standard 62-4/ Issue 3 Lamps / Nuclear (Gaseous Tritium Light Sources) (London: Ministry of Defence Directorate of Standardization,1976) 8.

Regulations Relating to the Radioactivity of Watches and Clocks (Germany:1984)

Appendix 11

\\

Sample Calculation of Maximum Dose Commitment:

Estimated radiation dose commitments 1.

Normal conditions a.

Normal use No radiation dose commitment is anticipated during normal use of the gunsight systems. External radiation dose rate at 25 cm is estimated to be less than 0.001 mrem /hr. The tritium gas is sealed in N

borosilicate glass, therefore no inhalation or ingestion of the radioactive material is expected in normal use.

b.

Storage Distilled water immersion tests on the sights indicated a leakage rate no greater than 1 E-5 uCi/ sight in 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months . Atsuming that 8000 units containing three tritium sources each and 2000 units containing one source each are stored in a 14 ft x 10 ft room in a 65,000 sq ft warehouse with an air exchange rate of 1 air change per hour, the calculated equilibrium concentrated of tritium is as follows:

l-C = AV where:

^

I = rate ofinflux of H-3 gas V = volume of the room A = air exchange rate C = equilibrium H-3 gas concentration I = 26:000 sights x 1 E-5 uCi/ sight-24 hr = 1.1 E-2 uCi/hr V = 1400 cubic ft x 2.83 E4 cc/ cubic foot = 3.96 E7 cc C=

= 2.7 E - 10 uCi/cc E

C = 2.7 E - 7 mci / cubic meter The concentration limit set in 10 CFR 20 Appendix B, Table II, Column 1 for H-3 in air is 2 E-7 uCi/ml.

The calculated equilibrium concentration in the storage area is less than 1% of the 10 CFR 20 concentration limit for a controlled area.

The annual dose commitment to a warehouse worker, working in the area for 1 hour1.157407e-5 days 2.777778e-4 hours 1.653439e-6 weeks 3.805e-7 months / day, 250 days / year is as follows:

Assume:

Appendix 11 5

l I

All H-3 gas is converted to tritiated water Total rate of absorption of tritiated water into body fluids (mci / minute) from inhalation and skin absorption is 3 E-2 C where C is the concentration of tritiated water in air in mci / cubic meter (ICRP 30)

Committed dose equivalent per unit intake of tritiated water is 1.7E-11 Sv/Bq (6.3 E-2 rem / mci)

Annual committed dose:

H = 2.7 E-7 mci / cubic meter x 3 E-2 mci-cubic meter / mci-minute x 60 minute / hour x 250 hr/yr x 6.3 E-2 rem / mci = 7.7 E-6 rem / year H = 0.008 mrem / year A similar type calculation in NUREG/CR-0215 " Estimates of Potential Radiation Doses from Wristwatches Containing Tritium Gas" yields a committed dose of 50 mrem from exposure to 2.5 E-5 uCi/cc for 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months or 8.3E4 mrem-cc/uCi-hr. Using that factor, the annual committed dose to a warehouse worker would be:

8.3E4 mrem-cc/uCi-hr x 250 hr/yr x 2.7 E-10 uCi/cc = 0.006 mrem c.

Transportation Assume a truck driver transports all sights to be stored in the warehouse in a single truckload and spends a total of two hours in the trailer loading and unloading.

V = 2.9 E7 cc (NUREG/CR-0215)

I = 1.1 E-2 uCi/hr A = 1 a ch/hr 1

3.8 E - 10 uCi/cc C

Dose commitment:

H = 3.8 E-7 mci / cubic meter x 3 E-2 mci-cubic meters / mci-minute x 2 hours2.314815e-5 days 5.555556e-4 hours 3.306878e-6 weeks 7.61e-7 months x 60 minutes / hour x 6.3E-2 rem / mci H = 8.6 E-8 rem = 8.6 E-5 mrem d.

All other situations during normal use, storage, and transportation involve smaller quantities of H-3 and/or shorter exposure times thus would result in negligible dose commitment.

e.

Disposal The gunsights are relatively expensive items and are unlikely to be inadvertently removed from the firearm and disposed of. The disposal of an intact firearm to normal trash is unlikely. Instructions accompanying the sights request return of damaged or defective sights to the distributor. Therefore, improper or careless disposal of the sights is unlikely to cause any significant radiation dose.

NUREG/CR-0215 estimates the dose commitment to the maximally exposed individual for burial of 500,000 tritium lighted wristwatches per year in landfills (20,000 in a single location) to be 0.1 mrcm/yr. If the sources are bumed a potential maximum dose commitment of 17 mrem /yr was estimated.

NUREG-1562 6

Appendix 11

The total number of gunsights potentially disposed ofin a single year would be much lower and the H-3 activity per unit also lower by a factor of seven than that postulated for watches containing H-3.

Therefore, disposal of gunsights will not present a radiation hazard to the general public.

2.

Accident conditions a.

Use The maximum credible accident involving the use of the gunsight system is rupture of the source and instantaneous release of the gas during firing. Only the rear sight is of consequence since it is much closer to the breathing zone of the user than the front sight.

Assume:

Rear sight contains a total of 12 mci of H-3 gas Rear sight is 15 cm from the user's face Breathing zone can be represented by a cone with apex at the source and base, a 10 cm diameter circle at the user's face All H-3 is converted to tritiated water instantly Effective half-time for tritiated water = 10 days Total absorption ofinhaled tritium in body fluids Mass of soft tissue = 63,000 g (ICRP 30)

Fraction of gas released in the direction of the breathing zone:

arxr p,43RxR where r = radius of the base of the cone R = distance from source to pose 3.14 x 5 x 5 sq ctn p, 4 x 3.14 x 15 x 15 sq cm = 0.03 Maximum estimated dose commitment to user assuming all H-3 gas is converted to tritiated water H = 12 mci x 0.03 x 6.3 E-2 rem / mci = 23 mrem For such an accidental instantaneous release, most of the gas would remain as elemental H-3. The dose commitment from H-3 gas would be approximately 1000 times less. The total estimated dose commitment would be 2% of the calculated value since up to 2% of the gas originally in the glass capsule could be in the form of tritiated water.

b.

Storage The maximum credible accident involving storage of the units would involve a tire in the storage area which niptures some of the borosilicate glass capsules. (A massive fire which would rupture all sources Appendix 11 7

would be likely to result in immediate dispersion of the H-3 gas and dilution with outside air, thus reducing the concentrations of H-3 gas in the storage area.

Assume:

50% of the sources ruptured Immediate dispersion of the gas within the storage area Conversion of all H-3 gas to tritiated water Total rate of absorption of tritiated water into body fluids (mci / minute) from inhalation and skin absorption is 3 E-2 C where C is the concentration of tritiated water in air in mci / cubic meter (ICRP 30)

C = 26

3.3 E - 6 Ci/cc

3 E

= 3.3 E3 mci / cubic meter Dose commitment:

H = 3.3E3 mci / cubic meter x 3 E-2 mci-cubic meter / mci-min x 6.3 E-2 rem / mci H = o.2 rem / minute Dose commitment to firerrus remaining in enclosed area without respiratory protection for 2 minutes for purpose of rescue = 12 rem This calculation greatly overestimates the true dose commitments in this situation. Air currents would disperse the gas very rapidly in the case of a fire, particularly one of such severity as to mpture 50% of the sources instantaneously. In addition, only a small frw;an of the H-3 gas is likely to be converted to tritiated water before venting to the outside.

A more n+sonable estimate of the dose commitment would be obtained using the maximum fraction of tritiated water in the source,0.02. If this value is used the dose commitments become 12 mrem for the occupant and 24 mrem for the fireman.

c.

Ingestion orinhalation of the entire H-3 content of the front sight (17 mci).

H = 17 mci x 6.3 E-2 rem / mci = 1.1 rem The calculation assumes the entire 17 mci H-3 gas is converted to tritiated water. H-3 gas is not absorbed readily in body fluids thus produces negligible dose. This postulated accident would require that l

an individual remove the source from the sight without damaging it, swallow it, and have the source rupture while in the digestive tract. Each of these conditions is highly improbable. The combination of all three occuning is nearly impossible.

l Compliance with 10 CFR 32.23 and 32.24 1.

Normal use and storage No radiation dose commitment is expect h normal use of the gunsight system. The maximum expected dose commitment to workers in the storage area is less than 1 mrem / year. This is within the limit set in Column II, Table 32.24.

NUREG-1562 8

Appendix 11

l 2.

Accidental release of the tritium gas a.

Under maximum credible conditions of use of the equipment, the dose commitment to an individual would not exceed 23 mrem, within the limits set in Column III, Table 32.24. In the highly improbable case where an individual ingested the contents of an entire source, the estimated dose commitment is I rem. This is within the limits set in Column IV, Table 32.24.

b.

Under extreme fire conditions in the storage area, the estimated maximum dose commitment to an occupant of the area is 6 rem; to a fireman in the process of rescue,12 rem. More reasonable values based on 2% of the H-3 gas being oxidized and remaining in the storage room are 12 mrem and 24 mrem respectively. However, even under the extreme conditions the dose commitments would be within the values in Table 32.24.

Disposal of tudts No significant radiation dose commitment is expected to result from disposal of the gunsights since rapid dispersion and dilution with the atmosphere would rapidly reduce tritium concentrations in air to i

background levels.

Users of the devices are instructed to return defective units and unwanted units to the distributor for disposal. The cost of this product is such that inadvertent or careless disposal is unlikely.

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Appendix 11 9

NUREG-1562 i

~

1 l

l Appendix 12 Certification of Application / License Review for Part 32 Exempt Distribution Licenses l

Mail Control No.:

Amendment No.:

Expiration Date:

License No.:

Program Code:

Docke,.o.:

Reference No.:

Licensee Name:

Address:

Action Type:

New License New License / Licensee Renewal Product Transfer Report Amendment Termination I certify that I have reviewed the licensee's request dated

, as supplemented by any letters referenced in the license and in accordance with guidance provided by the Office of Nuclear Material Safety and Safeguards, appropriate Standard Review Plans and regulations, and the attached checklist.

REVIEWER DATE REVIEWED BY DATE l

l l

PERSON SIGNING THE LICENSE DATE

GENERAL COMMENT

S:

i Appendix 12 1

l Mail Control No.:

32.22: SELF-LUMINOUS PRODUCTS (30.19) l Completed sealed source and device evaluation resulting in issuance of Registration Certificate No. NR-

-E COMMENTS:

To manufacture, process, produce, or initially transfer self-luminous products containing H-3, Kr-85, or Pm-147, the applicant must satisfy 30.33 (except in Agreement States) and provide the following information:

COMMENTS:

1 (a) Description of product and intended use COMMENTS:

i l

. (b) Type and quantity of BPM per unit l

COMMENTS:

(c) Chemical and physical form of BPM and changes that may occur during the useful life of the product COMMENTS:

l (d) Solubility in water and body fluids of the forms in (a) (2) (ii) l COMMENTS:

(e) Details of construction and design as related to containment and shielding and other safety features under normal and severe conditions of handling, storage, use, and disposal COMMENTS:

n i

Appendix 12

i (f). Maximum external radiation levels at 5 and 25cm from external surface of

)

product and the method of measurement COMMENTS:

1 (g) Degree of access to human beings during normal use COMMENTS:

(h) Total quantity of BPM expected to be distributed annually COMMENTS-l (i) Expected useful life of product COMMENTS:

1 (j) Proposed method oflabeling or marking each unit with:

COMMENTS:

1.

Manufacturer or initial transferor of product COMMENTS:

2.

BPM in product COMMENTS:

(k) Procedures for prototype testing (containment, shielding and otaer safety features) in both normal and severe conditions COMMENTS:

Appendix 12 3

(1) Results of prototype testing including any change in form, extent of release to environment, increase in radiation levels and changes in safety features COMMENTS:

(m) Estimated external radiation doses and dose commitments COMMENTS:

(n) A determination that the criteria of 32.23(d) will be met COMMENTS:

(o) Quality Control procedures followed in fabrication of production lots of product and Quality Control standards product must meet COMMENTS:

(p) 'Any additional studies and tests COMMENTS:

l i

Appendix 12

l l

Appendix 13 Certification of Application / License Review for Part 32 Exempt Distribution Licenses l

Mail Control No.:

t Amendment No.:

Expiration Date:

License No.:

Program Code:

l l

l Docket No.:

Reference No.:

Licensee Name:

Address:

Action Type:

New License New License / Licensee Renewal l

Product Transfer Report Amendment Termination I certify that I have reviewed the licensee's request dated

, as supplemented by any Ititers referenced in the license and in accordance with guidance provided by the Office of Nuclear Material l

Safety and Safeguards, appropriate Standard Review Plans and regulations, and the attached checklist.

1 l

1 i

REVIEWER DATE l

REVIEWED BY DATE l

l PERSON SIGNING THE LICENSE DATE

GENERAL COMMENT

S:

Appendix 13 1

Mail Control No.:

32.26: SMOKE DETECTORS (30.20)

To manufacture, process, or prods m gas and aerosol detectors containing BPM, and designed to protect from fi:e COMMENTS:

(a) Applicant must satisfy 30.33 (except in Agreement States)

COMMENTS:

(b) Submit the following information:

1.

Description of product and intended use COMMENTS:

2.

Type and quantity of BPM per unit COMMENTS:

3.

Chemical and physical form of BPM and changes that may occur during the usefullife of the product COMMENTS:

4.

Solubility in water and body fluids of the forms in (a)(2)(ii)

COMMENTS:

5.

Details of construction and design as related to containment and shielding and other safety features under normal and severe conditions of handling, storage, use, and disposal l

COMMENTS:

l l

l NUREG-1562 2

Appendix 13

i l

6.

Maximum external radiation levels at 5 and 25cm from external surface of i

. product and the method of measurement COMMENTS:

r 7.

Degree of access to human beings during normal use

- COMMENTS:

l 3

8.

Total quantity of BPM expected to be distributed annually

' COMMENTS:

)

9.

Expected usefullife of product COMMENTS:

l i

?

10. - Proposed method oflabeling nr marking (32.29(b))

COMMENTS:

l

11. Procedures for prototype testing (containment, shielding and other safety features) i COMMENTS:

12. Results of prototype testing including any change in form, extent of release to environment, increase in radiation levels, and changes in safety features COMMENTS:

I

13. Estimated external radiation doses and dose commitments COMMENTS:

Appendix 13 3

l i

14.. A determination that the criteria referred to in 32.27 and 32.28 will be met COMMENTS:

15. Quality Control procedures followed in fabrication of production lots of produ:t and Quality control standards the product must meet COMMENTS:

16. Any additional studies and tests COMMENTS:

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l p.

1 1

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i NUREG-1562 4

Appendix 13

i i

l 32c29(b): LABELS l

(a) Each detector must contain a durable, legible, readily visible label or marking on external surface of detector containing:

COMMENTS:

i I

1.

"CONTAINS RADIOACTIVE MATERIAll' COMMENTS:

i 2.

Name and quantity of activity of BPM 1

l COMMENTS:

l 3.

Identification of the person licensed for transfer COMMENTS:

l (b) Label or marking is located where it will be readily visible when the detector is

]

removed from its mounting COMMENTS:

(c) The external surface of the point-of-sale package has a legible, readily visible label or marking l

containing:

l COMMENTS:

1.

Name and quantity of activity of BPM COMMENTS:

l 2.

Identification oflicensed person COMMENTS:

Appendix 13 5

.7 TREG-1562

3.

The following or similar statement:

THIS DETECTOR CONTAINS RADIOACTIVE MATERIAL AND HAS BEEN MANUFACTURED IN COMPLIANCE WITH U.S. NRC SAFETY CRITERIA IN 10 CFR 32.27. THE PURCHASER IS EXEMPT FROM ANY REGULATORY REQUIREMENTS.

i COMMENTS:

4.

Each detector and point-of-sale package is provided with any information as may be required by the Commission COMMENTS:

1 4

k 5

Applicant must maintain records and product transfer reports COMMENTS:

i l

I NUREG-1562 6

Appendix 13

Appendix 14 Materials License (Licensee Name)

(Street Address /P.O. Box) l (City, State, Zip Code)

License No. XX-XXXXX-XXE Docket No. 030-XXXXX Amendment No. XX In accordance with application / letter dated

, NRC Ucense No. XX-XXXXX-XXE is hereby issued / renewed in its entirety to read as follows:

Pursuant to the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended (Public Law 93-438); 10 CFR Part 30," Rules of General Applicability to Domestic Licensing of Byproduct Material"; Section 32.XX,10 CFR Part 32," Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material"; application dated

and letters dated

and

a license is hereby issued to (Licensee's Name) to distribute (product such as calibration sources) containing (list radionuclides) in individual quantities not to exceed the amounts specified in Section 30.71, Schedule B,10 CFR Part 30 (may list specific ectivities), to persons exempt from licensing pursuant to Section 30.18,10 CFR Part 30, or equivalent provisions of the regulations of any Agreement State.

This license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and other applicable rules, regulations, and orders of the U.S. Nuclear Regulatory Commission, now or hereafter in effect, and to the following conditions:

1.

This license does not authorize possession or use oflicensed material.

i I

2.

The licensee is authorized to distribute only from its facility located at (locations or points-of-distribution).

l 3.

The licensee shall submit periodic material transfer reports as specified in Section 32.XX,10 CFR Part 32.

This license shall expire on (Expiration date).

FOR THE U.S. NUCLEAR REGULATORY COMMISSION l

DATE:

BY:

(Ucense Reviewer)

Medical, Academic, and Commercial Use Safety Branch Division ofIndustrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Washington, DC 20555 Appendix 14 1

4 l-1 L

Appendix 15

]

Amendment No. XX

)

-l l

(Ucensee's Name).

In accordance with application dated

,XX-XXXXX-XXEis hereby.

(Mailing Address) issued / amended to read as follows:

. (Street /P.O. Box)

(City, State, Zip)

(Expiration Date).

- 030-XXXXX L

A. Radionuclide A. Type of source (e.g A. Not applicable foil, vial) and model number (See Condition 10)

9. - Authorized Use t

Pursuant to Section 32.XX,10 CFR Part 32, the licensee is authorized to distribute (Product type, e.g.

gas and aerosol detectors) as specified in Condition 10 to persons exempt from the requirements for a license pursuant to Section 30.20,10 JR Part 30, or equivalent provisions of the regulations of any.

Agreement S* ate.

l l

CONDITIONS i

10.~ The following (Product type) may be distributed purcuant to this license provided the amount of (radionuclide) contained in the device does not exceed the amounts specified in the following table:

Device Model Marimum Onantity per Device Series 10 2.0 millicuries Series 20 5.0 millicuries l

11. This license dces not authorize possession or use oflicensed material.

12. The licensee may distribute only from its facility located at (Locations or pointsof-distribution).

13. The licensee shall file periodic reports as specified in Section 32.XX of 10 CFR Part 32.

14. Except as specifically provided otherwise by this license, the licensee shall conduct its program in j

accordance with the statements, representations, and procedures contained in the documents,

- including any enclosures, listed below. The U.S. Nuclear Regulatory Commission's regulations shall govern unless the statements, representations, and procedures in the licensee's application and correspondence are more restrictive than the regulations.

4 i

Appendix 15 1

- NUREG-1562

l CONDITIONS l

(Continued)

\\

l A. Application dated May 31,1995; B.

Letter dated March 29,1994, l

C.

Facsimile dated August 29,1995; and D. Letters referenced in Registration Certificate NR-174-D-101-E; FOR THE U.S. NUCLEAR REGULATORY COMMISSION l

DATE:'

BY:

)

(

(License Reviewer) l Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards l

Washington, DC 20555 i

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Appendix 15 4

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Appendix 16 l

(Date)

I i

License No. XX-XXXXX-XXE Docket No. 030-XXXXX Mail Control No. XXXXXX I

(Licensee's Name)

ATTN: (

)

(Street /P.O. Box)

(City, State Zip)

SUBJECT:

LICENSE RENEWAL APPLICATION Drar (

):

l.

This is to acknowledge receipt of your application for renewal of the materials license identified above.

Your application is deemed timely filed and, accordingly, the license will not expire until final action has i

been taken by this office.

l Any correspondence regarding the renewal application should reference your license number and the mail control number specified above.

Sinerely, l

l (Licensing Assistant) l l

a I

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Appendix 16 1

NUREG-1562 1

NRC FORM 335 U.S. NUCLEAR REGULATORY COMMISSION 1.

REPORT NUMBER GM (Ass gned try NRC, Add VOL.

Supp..

NRCM 1102.

Rev., and Addendum Numbers, C any.)

8' ' 8""2 BIBLIOGRAPHIC DATA SHEET (Sa miruceone on ihn rarie)