ML20210G176

Matls Licensing Package for Amend 25 to License SNM-1319 for Biocontrol Technology,Inc.Control:126847

ML20210G176
Person / Time
Site:	07001342
Issue date:	05/18/1999
From:	Henderson P NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:
References
126847, NUDOCS 9908030024
Download: ML20210G176 (23)

Text

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U.s. NUCLEAR REGULATORY Commission MATERIALS LICEN3E l Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code of Federal Regulations, Chapter 1, Parts 30, 31, 32, 33, 34, 35, 36, 39,40, and 70, and in reliance on statements and representations heritofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byprodud,

, sourte, and special nuclear material designated below; to use such material for the purpose (t.) and at the place (s) designated below; to dilivIr or transfer such material to persons authorized to recer.e it in accordance with the regula! ions of the applicable Part(s). This license shill be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations und orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified bilow.

Ucensee In accordance with the letter dated May 3,1999,

1. Biocontrol Technology, Inc. 3. License number SNM-1319 is amended in g pF E er;ti; to read as foiiows:

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2. 625 Kolter Drive j 4. Expiration date October 31, 2003 Indiana, Pennsylvania 15701 Y 5. Docket No. 07041342 h) Reference No,.

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6. f , ChAmical and/oTppysica'l fo'rm .[8. bla imum amount that licensee may Byproduct, source, and/or sp* ial Wf /g nuclear material , f; - - +g possess at any one time under this r- u

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A. Plutonium (Principal v. 'AESealed sourcesT l g? A. 250 milligrams of 23sP per radionuclide: Plutoniumi238)

B. Plutonium 238

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.solirce and 290 grams total

\ BU Sealed neutron sourceg B, 73 curies h/M '{ M bonshhEi)])@[ 'yj g . W * 'd 7. O g(

F , 275 milligrams)

9. Authorized use: '/

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A. (1) For recovery as a component or as a complete pacemaker of explanted Coratomic Model C-100, C-101, C-101-P, and Pulsar-N1 pacem4ers transferred from specific licensees.

(2) For storage as a sealed source, or battery component, or battery, or as a complete pacemaker of Coratomic Model C-100, C-101, C-101-P, and Pulsar-N1 pacemakers.

L (3) For storage of Hittman Atomcell batteries.

B. For storage only.

CONDITIONS

10. Licensed material may be received and stored only at the licensee's facilities located at 625 Kolter Drive and 300 Indian Springs Road, Indiana, Pennsylvania.

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• NRC FORM 3744 U.s. NUCLEAR REGULATORY Commission PAGE 2 of 4 PAGEs l

Licensa Number SNM-1319

. . MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 070-0W2

, Amendment No. 25

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11. A. Licensed material shall be received and stored by, or under the supervision of, Joseph N. Klingensmith.

B. The Radiation Safety Officer for this license is Joseph N. Klingensmith.

12. A. Sealed sources and detector cells containing licensed material shall be tested for leakage and/or contamination at intervals not to exceed;six m' o,nths or,at such other intervals as are specified by the certificate of registration referred fir 810 CFR 32.210l n'ot to exceed three years.

B.

Q' ' d gy Notwithstanding ParagraphA of this Condition, sealed sources ciesigned to emit alpha particles shall be tested for leakage and/or contamination at intervals not to exce% three months.

C.

Go h In the absence of a certificate from a transferor indicating that a leak test has been made within six months prior to the't'ransfe'rta s'ealed source or detectordll received from another person shall not be put into use uniif' tested. Gk < i9 (~)

T k.h by the li)censee.shall M[fde i D. Each sealed source fabrict.ted beO insp' cted and tested for con l

Sealed s,outus an'd7 detect q meeg y' /," ussioftrans'fdr leakage, and contaryiinatiof'p)r3r.tcian'y D

n as^a seale E. ils peedfoNida'ki st d.lf h kkhh Jf)hk they contain only h drogen{3 h$

(i) y CO (ii) they contain only a rad;ioactive gas; ort 4 (iii) the half-life of the isotopeny isI3,0 days orless;nor $1 (iv) they contain not more than 100 microcuries of beta and/or gamma emitting material or not more than 10 microcuries of alpha emittint aterial; or (v) they are not c'esigned to emit alpha particles, are in storage, and are not being used. However, when they are removed from storage for use or transfer to another person, and have not been tested within the required leak test interval, they shall be tested before use or transfer. No sealed source or detector cell shall be stored for a period of more than 10 years without being tested for leakage and/or contamination.

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• NRC FdRM 37M' u.s. NUCLEAR RE3uLAToRY CoMMGsioN PAGE 3 or 4 PAGES LicIrme Number SNM-1319 r . . MATERIALS LICENSE D chet or Reference Number SUPPLEMENTARY SHEET 070-01342 l

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Amendment No. 25 F. The test shall be capable of detecting the presence of 0.005 microcurie of radioactive material on the test sample. If the test reveals the presence of 0.005 microcurie or more of removable contamination,

a report shall be filed with the U.S. Nuclear Regulatory Commission and the source or detector cell shall be removed immediately from service and decontaminated, repaired, or disposed of in accordance with Commission regulations. The report shall be filed within five days of the date the leak test result is known with the appropriate U. S. Nuclear Regulatory Commission, Regional Office referenced in Appendix D of 10 CFR Pag s 20.[Ttje:r,eport shall specify the source or detector cell involved, the test results, and corInctNe action taken:7 [f l

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Q* 74 The licensee is authorize (to collect leak test samples for analy, sis by the licensee. Altematively, tests cifically licensed by the for leakage and/or conta'mination may be performed by perso Commission or an Agreement State to perform such services, to r~ f .4

13. The licensee shall cond0ct a physicInl inventory every six moryths,;or at other interval approved by NRC, to d

account for all  % sealed sources an' }l /dr Mvicas Q received andp}osl

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14. The licensee shall maintain legible Written recodis o iall receipts, transfers, and dlsposals of special l nuclear material possessed under his'liMee.4Tidficen'see sh'all maintairitiiese records until the license is terminated by the Commissif Y $ g i

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15. At twelve month intervalsphe li sh W% [h%

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.llect aridhly d$ta from all' medical institutions with respect to: (a) accountability, removal, an "rf/(b before malfunction; and (c) th na!(if uYe'3fhalf@)<lyratibn'of'sa6sfacto a  !

100, C-101, C-101-P, and PufsIsr-N1 nuclear e g pogged pac @ makers. With l month period ending August 3i,/a copy of the report must be sentio the U.S. Nuclear Regulatory 1 Commission, Region I, Division of Nuclear '

Materials Safety [475 Allendale Road, King of Prussia, Pennsylvania,19406. "T X &

16. This license does not authorize the implantation of pacemakers into humans or animals.

17. The licensee is authorized to transport licensed material in accordance with the provisions of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material." , )

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• NRC FdRM 374A' U.s. NUCLEAR F.ZGulAToRY Commission PAGE 4 of 4 PAGEs Lic;nsa Numb:r SNM-1319

. . MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 070-01342

. Amendment No. 25

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

accordance with the statements, representations, and procedures contained in the documents, including j 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.

A. Letter dated August 27,1990 B. Letter dated September 22,1993h g Q g y[f 1 C. Letter dated May 3,1999 @ -

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yPyggP For the U.S. Nuclear Regulatory Commission Original signed by Pamela J. Henderson Dite May 18 1999 By Pamela J. Henderson Nuclear Materials Safety Branch 2 l Division of Nuclear Materials Safety Region 1 King of Prussia, Pennsylvania 19406 I

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.- 4 May 18,1999 D'ocket No. 070-01342 License No. SNM-1319 Control No. 126847 David L. Purdy President, Chairman of the Board, Treasurer, Director Biocontrol Technology, Inc.

625 Kotter Drive Indiana, PA 15701

Dear Mr. Purdy:

This refers to your license amendment request. Enclosed with this letter is the amended license. Please note that as part of this Amendment, in accordance with 10 CFR 30.36,

~effective February 15,1996, the expiration date of your license has been extended by a period of five years. Your new expiration date is stated in item 4 of the license. This Amendment adds the new fac;lity'as requested to enable you to move your licensed activities. Prior to release of your current facility for unrestricted use, you must receive an Amendment removing your current facility from your license include in the request, the results of surveys demonstrating that the levels of residual activity in the facility are acceptable. When you submit the Amendment request please refer to the Control Number at the top of this letter.

Please review the enclosed document carefully and be sure that you understand ed fully implement all the conditions incorporated into the amended license. If there are any erors or questions, please notify the U.S. Nuclear Regulatory Commission, Region 1 Office, Licensing Assistance Team, (610) 337-5093 or 5239, so that we can provide appropriate corrections and answers.

Thank you for your cooperation.

Sincerely, Original signed by Pamela J. Henderson

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Pamela J. Henderson Senior Health Physicist Nuclear Materials Safety Branch 2 Division of Nuclear Materials Safety

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D. Purdy 2

• Biocontrol Technology, Inc.

Enclosures:

1- - Amendment No. 25

2. 10 CFR Pad 30

3. - Guidelines for Decontamination of Facilities and Equipment I

cc: Joseph N. Klingensmith, Radiation Safety Officer i

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J D. Purdy 3 Biocontrol Technology, Inc.

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l DOCUMENT NAME: B:\DNMS Documents \Lic Cover Letter \LSNM-1319.wpd 89159057 To receive a cop r of this document. Indicate in the box:'C's Copy w/o amWd *E's Copy wt attach /end *N's No copy OFFICE DNMS/Rl lN DNMS/RI l [ l NAME PHenderson l DATE 05/18/99' 05/ /99 05/ /99 05/ /99  !

OFFICIAL RECORD COPY l 1

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This is to acknowledge the receipt of your letter / application dated

[ /97 , and to inform you that the initial processing which l includes an administrative review has been performed.

1 Arso.ed. 3N/*f- /9/7 There were no administrative omissions. Your application was assigned to a f

' technical reviewer. Please note that the technical review may identify additional omissions or require additionalinformation.

j Please provide to this office within 30 days of your receipt of this card 4

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A copy of your action has been forwarded to our License Fee & Accounts i Receivable Branch, who will contact you separa'ely if there is a fee issue involved.

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l Your action h'as been assigned Mail Control Number l2OO47 When calling to inquire about this action, please refer to this control number.

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't You may call us on (610) 337-5398, or 337-5260.

acemw m ni Sincerely, is em Licensing Assistance Team Leader

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BIOCONTROL.TsenwOLOov, Inc.

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300 Indian Springs Road, Indiana, PA 15701 (724) 349-1811. Fax (724) 349-8610 www.bico.com

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May 3,1999 U.S. Nuclear Regule. tory Commission Region I Nuclear Material Section B 475 Allendale Road King of Prussia, PA 19406 re: Request to Amend NRC License SNM-1319

Dear Region I Licensing Branch:

Enclosed are six copies of a license amendment to change the location of Biocontrol Technology, Inc.

NRC licensed activities in Indiana, Pennsylvania from 300 Indian Springs Road to 625 Kolter Drive.

Also enclosed is check no. 230525 payable to the U.S. Nuclear Regulatory Commission for the license amendment fee of $290 per 10 CFR 170.31, l.D.

If you have any questions regarding this amendment request, please contact Joseph N. Klingensmith at 724-349-1811 (phone) or 724-349-8610 (fax).

l Sincerel

& $v Y wY a Joseph N. Kimgensmith Radiation Safety Officer 128847 0FFICIALfiECORDCOPY MAY l 2 L999 ML10 m

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Request to Amend License Number SNM-1319 May 3,1999

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Biocontrol Technology, Inc.

300 Indian Springs Road Indiana,PA 15701 -

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F Requist to Amend Lic:nsa Number SNM-1319 May 3.1999 Amendment Request Biocontrol Technology, Inc. (Biodontrol) requests an amendment to special nuclear materials license rmmber'SNM-1319 to change the location of NRC licensed activities in Indiana, Pennsylvania from 300 Indian Springs Road to 625 Kolter Drive.

A copy oflicense SNM-1319, Amendment 24,is contained in Attachment 1. Specifically, Biocontrol requests a change of address in item 2 and Item 10 of SNM-1319 from "300 Indian Springs Road" to

_ "625 Kolter Drive."

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It is Biocontrol's understanding that the 625 Kolter Drive location will be added to SNM-1319 first, and after transfer of all isotopic material (in compliance with 10 CFR 71 and 49 CFR 177) from 300 Indian Springs Road to 625 Kolter Drive, and after a close out survey verifies that se 300 Indian Springs Road location is free ofisotopic material, then the 300 Indian Springs Road location will be removed from SNM-1319. It is also Biocontrol's understanding that this is accomplished by a single license amendment request, requiring a single license amendment fee of $290 per 10 CFR 170.31, l.D.

Backernund

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Special nuclear materials license number SNM-1319 was issued to Biocontrol Technology, Inc. (then Coratomic,Inc.)in the early 1970's. Since 1978, all Biocontrol SNM-1319 licensed activity has taken place at 300 Indian Springs Road, Indiana, Pennsylvania,15701. In October of 1994, Biocontrol began operating a new facility in Indiana, Pennsylvania at 625 Kolter Drive. All NRC licensed activity continued to take place only at 300 Indian Springs Road, as stipulated in SNM-1319. Biocontrol now intends to move all operations, including NRC licensed activity, to the 625 Kolter Drive facility.

Content of Amendment Request per 10 CFR 70.22 Company Information (10 CFR 70.22(a)(1))

Biocontrol Technology, Inc. was incorporated in the Commonwealth of Pennsylvania in 1972 as Coratomic, Inc. The corporate name was changed from Coratomic, Inc. to Biocontrol Technology, Inc.

in 1986. Biocontrol Technology, Inc. is a publici, 'wned company. No one person or group owns more that 1% of the outstanding shares of common stock as of December 31,1998, to the best of the company's knowledge. Also to the best of the company's knowledge, there is no control or significant ownership of the company by any alien, foreign corporation, or foreign government.

Corporate Officers are:

Name Title Address Citizenshin David L. Purdy President, Chairman of the Board, 625 Kolter Drive USA Treasurer Director Fred E. Cooper Chief Executive Officer, Executive 2275 Swallow 11i11 Road USA Vice President, Director Anthony J. Feola Senior Vice President, Director 2275 Swallow Ilill Road USA Glenn Keeling Vice President, Director 200 Julrich Drive, USA McMurray, PA 15317 The company corporate office is located at Biocontrol Technology, Inc.,2275 Swallow 11i11 Road, Bldg.

2500,2nd Floor, Pittsburgh, PA,15220. NRC licensed activity does not take place at this location.

Brocontrol Technology, Inc. Page 2 of 4

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.- .. ., , Requxt to Amend Lic ns3 Number SNM-1319 May 3,1999

. All SNM-1319 licensed ac,tivity takes. place at Biocontrol Technology, Inc.,300 Indian Springs Road.

Indiana, Pennsylvania,15701. Tliis amendment requests a change in licensed activity location from 300 indian Springs Road to 625 Kolter Drive, also in Indiana, PA.

Use of Special Nuclear Material (10 CFR 70.22(a)(2))

Authorized use of special nuclear material, as stated in item 9 of SNM-1319, remains the same.

Time Period of License (10 CFR 70.22(a)(3)) i Biocontrol Technology, h :. intends to maintain a special nuclear materials license until all of the following conditions are met:

1. All Biocontrol isotopic powered pacemakers are removed from patients and returned to Biocontrol (or removed from patients and disposed of by the licensed hospital responsible for the pacemaker).

2. All Biocontrol isotopic sources are transferred to a licensed facility for disposal.

3. A close out survey verifies the Biocontrol facility is free ofisotopic material.

Specification of Special Nuclear Material (10 CFR 70.22(a)(4))

The special nuclear material name, form, and amount stated in Items 6,7, and 8, respectively, of SNM-1319, remain the same.

. Technical Oualifications of Staff (10 CFR 70.22(a)(6))

The stafT, including the radiation safety officer, remain the same.

Description of Facilities and Eauipment (10 CFR 70.22(a)(7))

l Facilities l

Attachment II contains the facility layout of 300 Indian Springs Road and 625 Kolter Drive.

l The 300 Indian Springs Road facility is 120 feet by 170 feet, with a five foot one inch by five foot nine i inch isotopic material storage room (room 064B on facility layout). The 625 Kolter Drive facility is 100 j feet by 225 feet, with an eight foot by ten foot isotopic material storage room. The larger isotopic l matenal storage room at the 625 Ko!ter Drive facility will reduce radiation levels surrounding the room.

Packages containing isotopic material are preferably received in the shipping / receiving area (" Loading Dock" at 300 Indian Springs Road, " Receiving" at 625 Kolter Drive), and are immediately taken to the Quality Assurance Lab ("049A" at 300 Indian Springs Road,"QC Inspection" at 625 Kolter Drive) via Path "A" on the facility layout drawings. Alternately, packages containing isotopic material may be received at the Main Visitor Entrance, and immediately taken to the Quality Assurance Lab via Path "B".

In the Quality Assurance Lab, a package survey is performed before the package containing isotopic

. material is opened. The package is then carefully opened, and the returned isotopic powered pacemaker is visually examined. If the peceroaker hermetically sealed titanium case appears intact, the pacemaker is biologically decontaminated using cold cerilant, wipe tested for leakage of radioactive material, and electrically tested for pring characteristics. If the pacemaker hermetically sealed titanium case does not Biocontrol Technology,Inc. Page 3 of 4

.. ., , R:qtest to Amend Lic:nss Number SNM-1319 May 3,1999 appear intact, the pacemaker is wipe tested for leakage of radioactive material first, and if no leakage is detected, the pacemaker is,then biologically decontaminated using cold sterilant, and electrically tested for pacing characteristics. Ifleakdge of radioactive material is detected, the leaking source is contained and isolated, and the NRC is notified.

. When testing in the Quality Assurance Lab is complete, the retumed isotopic powered pacemaker is taken to the isotopic Material Storage Room ("064B" at 300 Indian Springs Road, " Isotopic Material Storage Room" at 625 Kolter Drive) via Path "C" on the facilities layout drawings. The Isotopic Material Storage Room is kept locked at all times, except for taking inventory or adding or removing sources, during which time the room is never left unattended. The radiation safety officer and his super nr have keys to the Isotopic Material Storage Room.

Security is the same at both facilities. During business hours, all doors to the facility are locked, except for the Main Visitor Entrance, which has a receptionist on duty. All visitors must sign in and out, wear a visitors badge, and be accompanied by a Biocontrol employee while in the facility. All employees must wear their photo identification badge while in the facility. After business hours, all doors to the facility are locked, and the facility is protected by an alam. qstem.

Eauipment The equipment for handling and monitoring radioaaive material remains the same.

. Victorcen Model 488 A Radiation Survey Meter, S/N 467 (neutron radiation)

. Victoreen Model 490 Radiation Survey Meter, S/N 2341, w/ Model 489-35 Probe, S/N x2341 (alpha, beta, gamma radiation)

. Eberline Model SAC-4 Scintillation Alpha Counter, S/N 164 (alpha radiation, wipe tests)

. 15" Tongs (for handling and holding Pu-Be neutron source during wipe testing)

. 12" Tweezers (for holding wipe test paper while wipe testing Pu-Be neutron source) l

. 6' Pole with Ilook (for removing storage containers from and returning storage containers to the l Isotopic Material Storage Room, minimizing operator radiation exposure)

The Victoreen Survey Meters are calibrated annually by Victorcen. The Eberline Alpha Counter is calibrated every six months to an alpha source which is periodically sent out for calibration.

Radiation Safety (10 CFR 70.22(a)(81)

The radiation safety program and the radiation safety officer remain the same.

The radiation safety officer is currently the only person who performs the following isotopic material handling duties: received package radiation survey, package opening, wipe test for leakage, cleaning and testing of returned isotopic powered pacemakers, storage ofisotopic material, physical inventory of isotopic material, and periodic radiation surveys. Any employee other than the radiatior. safety officer will receive specific training before being permitted to perform a duty listed above. Receptionists and shipping and receiving personnel, who may briefly handle received packages containing isotopic material, are periodically trained on the proper handling ofisotepic material.

gf[ g Amendment Submitted by:

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David L. Purdy, P esident F Date Biocontrol Technology, Inc. Page 4 of 4

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9 Attachment I l

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p NnC FORM 374 . .

PAGE 1 OF 3 PAGES g 00 8% U.S. NUCLEAR REGULATORY COMMISSION l

. I g . .

y MATERIALS LICENSE Amendment No. 24  !

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\Q g Pursuan: to the Atomic Energy Act of 1954, as ameaded, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10. g

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Code of Federal Regulations, Chapter I, Parts 30. 31,32,33,34,35,39,40 and 70, and in reliance on statements and representations heren: fore d, made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special I nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shall be deemed to contain the conditions j, specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations and orders of the Nuclear is y

g Regulatory Commission now or hereafter in effect and to any conditions specified below.

N t P I Licensee '

9 In accordance with letter dated E June 23, 1994, .

l 1. Biocontrol Technology, Inc. 3. Ucense number SNM-1319 is amended in its entirety to read as follows:

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g 2 300 Indian Springs Road -

i 8 Indiana, Pennsylvania 15701 _

4. Expiratica date October 31, 1998  ;

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g_ Reference No ' 070-01342 {

l 6. Byproduct, source, and/or 4 7. Chemical and/or physical - 8. Maximum amount that licensee [n I form may possess at any one time f

special nuclear material -

under this license g .

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E A. Plutonium (Principal . Sealed sources A. Not to exceed l>

g radionuclide: '

2 -(Plutonium batteries) 250 milligrams of '"Pu !g g plutonium 238) - per sealed source and !g 290 grams total N

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1 B. Plutonium 238 B. Sealed neutron source B. 4.73 curies (275 milligrams) ,l $,

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e.n_-.,.wjs i g A. (1) For recovery as a ::omponent or as a comple~te pacemaker of explanted Coratomic E Model C-100, C-101, C-101-P, and Pulsar-N1 pacemakers transferred from specific l l I licensees. 'O ~.

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8, (2) For storage as a seai^ed source, or battery component, or battery, or as a l lg complete pacemaker of Coratomic Model C-1,00, C-101, C-101-P, r d Pulsar-N1 {i g pacemakers.  !

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(3) For storage of Hittman Atomcell batteries.

l B. For storage only y CONDITIONS p I d i 10. Licensed material may be received and stored only at the licensee's facilities 1 located at 300 Indian Springs Road, Indiana, Pennsylvania. %p l N

A. Licensed material shall be received and stored by, or under the supervision of, l 11. Joseph N. Klingensmith. l, g

E I B. The Radiation Safety Officer for this license is Joseph N. Klingensmith.  ;#

I I 12. A. Sealed sources and detector cells shall be tested for leakage and/ or :N.

l contamination at intervals not to exceed 6 months or at such other intervais as' i g I -

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Amendment No. 24 i I (12.' Cor.tinued) CONDITIONS 1

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1. are specified by the certificate of registration referred to in 10 CFR 32.210, bP not to exceed 3 years.

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q B. Notwithstanding Paragraph A of this Condition, sealed sources designed to emit 4 alpha particles shall be tested for leakage and/or contami j to exceed 3 months. iE i.

C. Intheabsenceofacertificatefromatransferorindicatingthatatesthasbeen{<

l made within six months prior to the transfer, a sealed source or detector cell  !

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g received from another person shall not be put into use until tested. lg j$ )

i j 1 D. Each sealed source fabricated by the licensee shall be inspected and tested for  ;$

1 construction defects, leakage, and contamination prior to any use or transfer as #l l l a sealed source. y {

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E. Sealed sources and detector cells need not be leak tested if:

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N they contain not more than 100 microcuries of beta and/or gamma emitting (iv) material ld i

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E or not inore than'10 microcuries,of alpha emitting material; og $r j -

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lg (v) they are not.de. signed to emit alpha particles, are tin storage, and are not i; ,

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g being used. 'However, when they are removed from ~ storage for use or transfer l  :

I to another person,.and have not been tested within the required leak test 4 interval, they shall be tested before use or transfer. No sealed source or $,

E detector cell shall be stored for a period of more than 10 years without i5!

being tested for leakage and/or. contamination. l4 l

R q F. The test shall be capable of detecting the presence of 0.005 nicrocurie of N

radioactive material on the test sample. Records of leak test results shall be 's$

l N kept in units of microcuries and shall be maintained for inspection by the lF! i

'E Commission. If the test reveals the presence of 0.005 microcurie or more of I

8 removable contamination, a report shall be filed with the U.S. Nuclear R 1 l Commission and the source shall be removed from service and decontaminated, .g l g repaired, or disposed of in accordance with Commission regulations. The report ip*

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N shall be filed within 5 days of the date the leak test result is known with the l '

I U.S. Nuclear Regulatory Commission, Region I, ATTN: Chief, Nuclear Materials , i 8l Safety Branch, 475 Allendale Road, King of Prussia, Pennsylvania 19406. The 4 report shall specify the source involved, the test results, and corrective action p. i l taken. .pj l

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I G. The licensee is authorized to collect leak test samples for analysis by the +$

I licensee. Alternatively, tests for leakage and/or contamination may be performed F:  !

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U.S. NUCLEAR REGULATORY COMMISSION PAGE OF PAGES

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SUPPLEMENTARY SHEET oocket or Reference nuh0-01342 i

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Amendment No. 24 f, l ,

g-(Continued) q CONDITIONS  ;

I j N 13. The licensee shall conduct a physical inventory every six months to account for all  ! ',

8 sealed sources and devices containing licensed material received and possessed under lE; b

i the license. Records of inventories shall be maintained for five years from the date i Mg 8 of each inventory, and shall include the quantities and kinds of byproduct material, 9 manufacturer name and model numbers, location of sources and/or devices, and the date y 4

of the inventory, p 4

R 14. The licensee shall maintain legible written records of all receipts, transfers, and  !'

I disposals of special nuclear material possessed under this license. The licensee l shall maintain these records until the license is terminated by the Commission. },

l 9 R

y 15. At twelve month intervals, the' licensee shall collect and tally data from all medical I institutions with respect _to: (a) accountability, removal, and recovery; (b) duration l!l 1 of satisfactory performance or the time of service before malfunction; and (c) the i 8 nature of malfunctions (if appropriate) of all implanted Coratomic Model C-100, C-101, f I C-101P, and Fulsar-N1 nuclear-powered pacemakers. Within ninety (90) days of the i l

l twelve month period ending August 31, a copy of the report must be sent to the U.S. j q

W Nuclear Regulatory Commission, Region I,- Nuclear Materials Safety Branch, 475 fl#

M Allendale Road, King of Prussia,1 Pennsylvania 19406. _  %;i

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i R 16. This license does not authorize the implantation of pacemakers into humans or animals. ;  !

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! 17. The licensee is auth'orized to transport licenssti material in accordance with ~the

,j g provisions of 10 CFR .71, " Packaging and Transportation of Radioactive Material." ;q

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d 18. Except as specifically provide'd 'otherwise in this' license, the licensee shall conduct !Ei 8 its program in accordance with the statements, representations, and procedures $"

! contained in the documents, including any enclosures, listed below. The Nuclear  ?;

j Regulatory Commission's regulations shall govern unless the stataments, I g representations, and procedures in the licensee's application and correspondence are E more restrictive than the regulations. M4F

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2 j NUCLliEAR REGULATORY CC)MMISSION WASHINGTON, D.C. 30566-0001

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BIOCONTROL TECHNOLOGY, INC.

ATTN: Mr. JOSEPH N. KLINGENSHITH 1'

Radiation Safety Officer

, 300 INDIAN SPRINGS ROAD INDIANA. PA 15701

SUBJECT:

ONE-TIME EXTENSION OF LICENSE EXPIRATION DATE LICENSE NUMBER SNM 1319. DOCKET NUMBER 7001342 Dear Mr. JOSEPH N. KLINGENSMITH On January 16, 1996, the Nuclear Regulatory Commission (NRC) amended its regulations in 10 CFR 30, 40, and 70 to extend the expiration date of certain byproduct. source, and special nuclear material licenses by five years (61 FR 1109). The above referenced license was extended by this ru'iimaking and will now expire on October 31. 2003. Your license will not be amended to show this extended date until the next

. routine licensing action. Until then, you may provide copies of this letter to vendors and other interested parties as evidence that the license has been extended as a result of the rule.

The extended license authorizes the same activities and contains the same limitations as it previously did. There will be no change in the frequency that the NRC inspects activities authorized by this license.

' The amended rules state that in the case of licensees who are granted extensions and who have a currently pending renewal application for that extended license, the application will be considered withdrawn by the licensee and any renewal fees paid by the licensee for that application will be refunded. This will apply to licenses with expiration dates after July 1.1995. for which renewal applications and the appropriate fees have been submitted and the renewal is still pending. Refinds will be mailed to l licensees under separate cover.

All licensees including those whose renewal applications were withdrawn by this rulemaking, who wish to change their radiation safety programs must request amendment of their licenses to reflect these changes. Amendment requests must include the correct amendment fee since the NRC cannot apply pending renewal refund balances toward amendment fees.

If you have any questions regarding this letter, please contact the individual below.

John D. Kinneman, Chief Branch 2 - (610) 337-5252

.l Thank you for your cooperation in this matter.

Sincerely,

~

Donald A. Cool. Director Division of Industrial and Medical Nuclear Safety .

Office of Nuclear Materials Safety and Safeguards l u

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" e- .  : INFORMATION FROM LTS BETWEEN.s  : --------------------

' L icense Fee. Management Branch , ARM  : Program Code: 23300 l and  : Status Code: O i'Ragional Licensing Sections .

Fee Category: 1D g  : Exp. Date: 20031031

Fee Comments: _______________________q

Decom Fin Assur Reqd: N i LICENSE FEE TRANSMITTAL-i 1

A. REGION-  % .

1 l 1. APPLICATION ATTACHED l

Applicant / Licensee: BIOCONTROL TECHNOLOGY, INC.

-Received Date: 19990512 Docket No: ' 7001342 )

Control No.: 126847 License No.: SNM-1319 Action Type Amendment 1

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B. LICENSE FEE MANAGEMENT. BRANCH (Check when milestone 03 is entered / d/)

1. . Fee Category and Amount: ___ ___ -________________________ __

2. Correct Fee Paid. App p ation may be processed for:

Amendment ______________

Renewal ______________

License ______________

3. OTHER ________________ - _______________

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