ML20217P716

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Final Response to FOIA Request for Documents.Documents Listed in App a Encl & Being Made Available to Public in Entirety
ML20217P716
Person / Time
Issue date: 04/30/1998
From: Racquel Powell
NRC OFFICE OF ADMINISTRATION (ADM)
To: Lance English
NORTHEAST OHIO REGIONAL SEWER DISTRICT
Shared Package
ML20217P721 List:
References
FOIA-98-125 NUDOCS 9805070038
Download: ML20217P716 (5)
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Text

NDD pptC FOftM 454 Part i U.S. NUCLEAR REGULATORY COMMISSION RESPONSE NUMBER cme) FOIAIPA 98-125 I

/ [ h* RESPONSE TO FREEDOM OF 2 5

INFORMATION ACT (FOIA) / PRIVACY RESPONSE I Q ]-

k* * . . *h)

REouESTER ACT (PA) REQUEST TYPE DATE1 TIAL l Larry English [8NRS01998 PART l. -INFORMATION RELEASED (See checked boxes)

] No additional agency records subject to the request have been located. '

] Requested records are available through another public distribution program. See Comments section. [

{ APPENDICES Agency records subject to the request that are identified in the listed appendices are already available for l public inspection and copying at the NRC Public Document Room. i r W'PENDICES Agency records subject to the request that are identified in the listed appendices are being made available for A public inspection and copying at the NRC Public Doce went Room.

] Document Room. 2120 L Street, NW, Washington, DC. Enclosed is information on how you may obtain access  ! to a

] ([

Q Agency records subject to the request are enclosed.

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L-' Records subject to the request that contain information originated by or of interest to another Federal agency have been -

referred to that agency (see comments section) for a disclosure determination and direct response to you. f d

l R We are continuing to process your request. j Q This completes NRC's action on your request. j

.__., PART 1.A - FEES h y Fees '(

[AmoDNf" Q You will be billed by NRC for the amount listed. ] None. Minimum fee threshold not met. k 112.72 You will receive a refund for the amount listed.

] Fees waived. f h

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O PART l.B -INFORMATION NOT LOCATED OR WITHHELD FROM DISCLOSURts  !

I C No agency records subject to the request have been located. i j g b] Certain information in the requested records is being withheld from disclosure pursuant to the exemptions described in and for the reasons stated in Part 11.

p' Washingt>n DC 20555-0001.This

-- determination may be appealed within 30 days by writing to the FOIA/PA Officer, Clearly state on the er:velope and in the letter that it is a "FCIA/PA Appeal."

PART 1.C ';OMMENT5 (Use attached Comments continuation page if required)

The fees for the processing of your request are:

Pr:fessional Search .5 hrs. @ $35.67 per hr. = $17.84 Clerical Search - 2.5 hrs. @ $17.39 per hr. = 43.48 (less 2 hrs @ no charge)

DIplication - 257 pgs. @ $0.20 per pg. = 51.40 0 f Tctal $112.72 f' .1 O I

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( SWW - D PRIVACY ACT Of fICER R s . Powell 9905070038 900430 '

J PDR FOIA 4

. ENGLISH98-125 PDR NRC FORM 464 Part 1 D-1998) PFJNTED ON RECYCLED PAPER This form was (fesianed usmo Informs

i Re: FOIA-98-125 APPENDIX A RECORDS BEING RELEASED IN THEIR ENTIRETY (if copyrighted identify with *)

lEL DATE DESCRIPTION /(PAGE COUNT)

1. License No. 34-26718-01 (3 pages)
2. License No. 34-26741-01 (2 pages)
3. License No. STB-1574 (2 pages)
4. License No. 34-18156-01 (8 pages) )

1

5. License No. 34-24816-01 (3 p'ages)
6. License No. 34-24887-01 (3 pages)
7. License No. 34-26121-01 (3 pages)
8. License No. 34-26496-01 (3 pages)
9. License No. 34-26756-01 (3 pages) e
10. License No. SUB-1522 (2 pages)
11. License No. SNM-1826 (4 pages)
12. License No. 34-26026-01 (3 pages)
13. License No. 34-00398-08 (3 pages)
14. License No. 34-00398-10 (2 pages)
15. License No. 34-18704-02 (3 pages)
16. License No. 34-00738-04 (5 pages)
17. License No. 34-00203-03 (6 pages) 1
18. License No. 34-05469-01 (9 pages) l
19. License No. 34-00738-07 (3 pages) '
20. License No. 34-24631-01 (2 pages) l

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21. License No. 34-00738-09 (3 pages) l
22. License No. 34-00738-10 (3 pages) l 23. License No. 34-25385-01 (4 pages) l
24. License No. 34-00746-02 (3 pages)
25. License No. 34-00746-03 (2 pages)
26. License No. 34-17967-01 (3 pages)
27. License No. 34-03749-10 (9 pages) l
28. License No. 34-01505-01 (4 pages) l
29. License No. 34-00054-05 (4 pages)
30. License No. 34-00054-04 (4 pages)
31. License No. 34-00054-06 (6 pages)
32. License No. SMB-191 (4 pages)
33. License No. 34-01869-01 (3 pages) l l 34.
  • License No. 34-16264-01 (4 pages)
35. License No. 34-26037-01 (4 pages)
36. License No. 34-01856-01 (6 pages) 1 *
37. License No. 34-09208-04 (5 pages)
38. License No. 34-24946-01 (4 pages) l
39. License No. 34-26286-01 (4 pages)
40. License No. 34-26649-01 -(3 pages) ..
41. License No. 34-26783-01 (2 pages)
42. License No. STB-1161 (3 pages)
43. ,

License No. 34-07198-03 (3 pages)

44. License No. 34-18843-01 (3 pages)
45. License No. 34-16201-01 (4 pages) i l

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46. License No. 34-12165-01 (3 pages)
47. License No. 34-26264-01 (2 pages)
48. License No. 34-09739-01 (5 pager'
49. License No. 34-26630-01 (3 peges) '
50. License No. 34-05382-01 (4 pages)  ;
51. License No. 34-26158-01 (5 pages) *
52. License No. 34-26063-10 (4 pages)
53. License No. 34-26629-01 (4 pages)
54. License No. 34-26645-01 (5 pages)
55. License No. 34-32025-01 (3 pages)
56. License No. 34-26555-01 (4 pages)
57. License No. 34-05582-01 (3 pages)
58. License No. 34-20322-01 (4 pages)
59. 1 License No. 34-23417-01 (3 pages)
60. License No. 34-01308-02 (5 pages)
61. License No. 34-08051-01(4 pages)
62. License No. 34-18514-01 (3 pages)
63. License No. 34-26092-01 (3 pages)
64. License No. 34-26390-01 (3 pages)
65. License No. 34-26706-01 (2 pages) -
66. License No. 34-16119-01 (5 pages)
67. License No. 34-00507-16 (4 pages)
68. ,

License No. 34-24777-01 (4 pages)

69. License No. 34-26529-01 (3 pages)

I

s 6

7 0. - License No. 34-06558-05 (6 pages)

71. License No.- 34-06558-07G (2 pages)
72. License No. 34-26659-01 (2 pages)
73. License No. 34-26760-01 (4 pages)
74. License No. 34-25386-01 (4 pages)
75. License No. STB-1575 (2 pages)
76. License No. 34-26426-01 (4 pages)
77. License No. 34-25957-01 (9 pages)
78. License No. SMC-1520 (3 pages)
79. License No.34-266S4-01 (3 pages)
80. License No. 34-20108-01 (4 pages)
81. License No. SUB-1464 (2 pages)
82. License No. 34-17835-01 (4 pages)

- B3. License No.- 34-07043-01 (3 pages)

S4. License No. 34-24963-01 (5 pagep) l 1

85. License No. 34-17783-01 (3 pages) )

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86. License No. 34-24569-01 (4 pages) i
87. License No. 34-26627-01 (3 pages)  !
88. License No. 34-26569-01 (5 pages) l l
89. , License No. SUB-1573 (3 pages) . .
90. License No. 34-26569-02 (3 pages)
91. License No. 34-00466-01 (11 pages)

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92. License No. 34-00466-05 (5 pages)
93. License No. 34-19089-01 (10 pages)
94. License No. 34-25834-01 (4 pages) 4

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)

L u.s. NUCLEAR RE!uLAToRY CoMZissioN

, Amendment No.1 Llewater MATERIALS LICENSE Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code j of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,38,39,40, and 70, and in reliance on statements and representations j heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special 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 i shall 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,and orders of the Nuclear Regt,'atory Commission now or hereafter in effect and to any conditions specified ,

below. I Ucensee in accordance with letter dited June 2,1997

1. Geo-Sci, Inc. 3. Ucense number 34-26716 01 is amended in its entirely to read as follows: l
2. 792 W. Bagley Road 4. Expiration date June 30,2001  !

1 Berea, OH 44017 5. Docket No. 030-31123 Reference No.

6. Byproduct, source, and/or special 7. Chemical and/or physical form 8. Maximum amount that licensee may nuclear material possess at any one time under this license A. Cesium-137 A. Sealed Source (Boart A. 10 sources not to exceed 10  !

Longyear Model No. CPN- millicuries each 131)

8. Americium-241 B. Sealed Source (Boart B. 10 sources not to exceed 50 Longyear Model No. CPN- millicuries each 131)

C. Cesium-137 C. Sealed Source (Humbolt C. 10 sources not to exceed 11 Scientific Model No. millicuries each 2200064)

D. Americium-241 D. Sealed Source (Humbolt D. 10 sources not to exceed 50 Scientific Model No. millicuries each 2200067)

9. Authorized Use:

A. and B. To be used in Boart Longyear Co. (formerly Campbell Pacific Nuclear Company) Model No. MC series or 500 series or AC series moisture / density gauges.

C. and D. To be used in Humboldt Scientific Model No. 5001 moisture / density gauges.

CONDITIONS

, 10. Licensed material may be stored at the licensee's facilities located at 792 W. Bagley Road, Berea, Ohio I and may be used at temporaryjob sites of the licensee anywhere in the United States where the U.S.

Nuclear Regulatory Commission maintains jurisdiction for regulating the use of licensed material.

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NRC FORM 374A u.S. NUCLEAR REIuLAToRY COMMISSION PAGE 2 of 4 PAGES

, License Number 34-28718-01 MATERIALS LICENSE DockaO Reference Number SUPPLEMENTARY SHEET 030-34123 Arnendment No.1 1

11. The Radiation Safety Officer for this license is George W. Aboumrad.
12. Licensed material shall only be used by, or under the supervision and in the physical presence of, George W. Aboumrad or individuals who have successfully completed the manufacturer's training program for gauge users, have been instructed in the licensee's routine and emergency operating procedures and who have been designated by the Radiation Safety Officer.
13. A. Sealed sources and detector cells shall be tested for leakage and/or contamination at intervals not to exceed 6 months or at such other intervals as specified by the certificate of registration referred to in 10 CFR 32.210. I B. In the absence of a certificate from a transferor indicating that a leak test has been made within 6 months prior to the transfer, a sealed source or detector cell received from another person shall not be put into use until tested.

C. Sealed sources need not be leak tested if.

(i) they contain only hydrogen-3; or (ii) they contain only a radioactive gas; or (iii) the half-life of the isotope is 30 days or less; or (iv) they contain not more than 100 microcuries of beta and/or gamma emitting material or not more than 10 microcuries of alpha emitting material; or (v) they are not designed to emit alpha particles, are in storage, and are not being used. However, when they are removed from storage for use or transferred 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. ,

D. The leak test shall be capable of detecting the presence of 0.005 microcurie of radioactive material l l 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 in accordance l l with 10 CFR 30.50(b)(2), and the source shall be removed immediately from service and )

decontaminated, repaired, or disposed of in accordance with Commission regulations. The report l i shall be filed within 5 days of the date the leak test result is known with the U.S. Nuclear Regulatory I Commission, Region lil, ATTN: Chief, Nuclear Materials Safety Branch,801 Warrenville Road, Lisle, i lilinois 60532-4351. The report shall specify the source involved, the test results, and corrective I action taken. 1 l

I E. The licensee is authorized to collect leak test samples for analysis by Boart Longyear Co. (foiTnerly Campbell Pacific Nuclear Co.). Altematively, tests for leakage and/or contamination may be

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1 i NRC FoRO 374A u.s. NUCLEAR REGULATORY Commission PAGE 3 of 4 PAGEs e Ucense Number 34-26718-01 MATERIALS LICENSE Docket or Reference Number i

l SUPPLEMENTARY SHEET 030-34123 l

l Amendment No.1 l

l pedorrr. ' by persons specifically licensed by the Commission or an Agreement State to perform i such services.

14. Sealed sources or detector cells containing licensed material shall not be opened or sources removed from source he!ders by the licensee.
15. When performing tests at tempq<y job sites, the authorized user shall not leave the moisture / density gauge unattended. Upon corapiMion of tests the device shall be locked in the licensee's vehicle or a secure building to prevent unauthorized use, loss, or theft.
16. The licensee shall conduct a physical inventory every 6 months to account for all sources and/or devices )

received and possessed under the license.

17. The licensee is authorized to transport licensed material only in accordance with the provisions of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material."  !
18. Each portable nuclear gauge shall have a lock or outer locked container designed to prevent unauthorized or accidental removal of the sealed source from its shielded position. The gauge or its container must be locked when in transport, storage, or when not under the direct surveillance of an authorized user.
19. Any cleaning, maintenance, or repair of the gauge (s) that requires removal of the source rod shall be performed only by the manufacturer or by other persons specifically licensed by the Commission or an Agreement State to perform such services.
20. 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 any enclosures, listed below. The U.S. Nuclear Regulatory Commission's regulations shall govem unless the statements, representations, and procedures in the licensee's application and correspondence are more restrictive than the regulations.

A. Application dated April 4,1996; and B. Letters dated May 21,1996 and June 2,1997.

FOR THE U.S. NUCLEAR REGULATORY COMMISSION (V,\. W D.y r ,

Date By Nuclear Materials Licensing Branch Region 111 l l

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u.S. NUCLEAR RE0uLAToRY Commission mendmen No.16 Licwater MATERIALS LICENSE Pursuantto 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 heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special 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 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 Regulatory Commission now or hereafter in effect and to any conditions specified below.

1 Licensee In accordance with application dated October 31,1997

1. GE/Reuter-Stokes, Inc. 3. Ucense number 34-18156-01 is amerMed in its entirety to read as follows:
2. 8499 Darrow Road 4. Expiration date January 31,2003 j Twinsburg, OH 44087 5. Docket No. 030-14608 (030-14418) ,

1 Reference No.

l

6. Byproduct, source, and/or special 7. Chemical and/or physical form 8. Maximum amount that licensee may nuclear material possess at any one time under this license A. Americium-241 A. Sealed source (registered A. Not to exceed 4 millicuries pursuant to Section 32.210 per source. Total possession of 10 CFR Part 32 or an not to exceed 21 millicuries Agreement State)

B. Americium-241 B. Foil sources (registered B. Not to exceed 0.02 pursuant to Section 32.210 microcuries per source. Total of 10 CFR Part 32 or an possession not to exceed Agreement State) 0.05 microcuries C. Any byproduct material C. Neutron activated C. Not to exceed 250 millicuries components D. Cadmium-109 D. Sealed source (registered D. Not to exceed 5 millicuries pursuant to Section 32.210 per source. Total possession of 10 CFR Part 32 or an not to exceed 10 millicuries Agreement State)

E. Cesium-137 E. Sealed source (registered E. Not to exceed 40 millicuries pursuant to Section 32.210 per source. Total possession of 10 CFR Part 32 or an not to exceed 81 millicuries Agreement State)

F. Cobalt-60 F. Sealed source (registered F. Not to exceed 60 curies per pursuant to Section 32.210 source. Total possession not of 10 CFR Part 32 or an to exceed 75 curies Agreement State)

G. Hydrogen-3 G. Any G. 820 millicuries I b

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P NRC FORM 374A u.S. NUCLEAR REluLAToRY CoMMrsloN PAGE 2 of 8 PAGES a

License Number 34-18156-01 MATERIALS LICENSE D eket or Reference Number SUPPLEMENTARY SHEET 030-14608 (030-14418)

Amendment No.16

6. Byproduct, source, and/or special 7. Chemicaland/orphysicalform 8. Maximum amount that licensee may nuclear material possess at any one time under this license H. Iron-55 H. Sealed source (registered H. Not to exceed 20 millicuries pursuant to Section 32.210 per source. Total possession of 10 CFR Part 32 or an not to exceed 300 millicuries Agreement State)
1. Krypton-85 1. Sealed source (registered I. One source not to exceed pursuant to Section 32.210 500 millicuries of 10 CFR Part 32 or an Agreement State)

J. Hydrogen-3 J. Gas J. Not to exceed 20 curies K. Hydrogen-3 K. Foil sources (registered K. Not to exceed 130 millicuries pursuant to Section 32.210 per foi!. Total possession not of 10 CFR Part 32 or an to exceed 260 millicuries Agreement State)

L. Americium-241 L. Sealed sources L. No single source to exceed (DuPont/New England 1.21 curies Nuclear Corporation Model 479C or Monsanto Research Corporation Model 2705)

M. Strontium-90 M. Calibration or Check M. No single source to exceed Sources (Isotope Products 1.4 microcuries Labs or Amersham Corp.)

N. Cobalt-60 N. Calibration or Check Source N. No single source to exceed (Isotope Products Labs or 2.2 microcuries Amersham Corp.)

O. Cobalt-60 O. Sealed sources (Amersham O. No single source to exceed Model CKC.K3105 or 400 microcuries Isotope Products Labs Model 3018)

P. Cesium-137 P. Sealed sources (Amersham P. No single source to exceed Corp. Model CDC.800) 2.3 millicuries Q. Cesium-137 Q. Sealed sources (Isotope Q. No single source to exceed 3 Products Labs Model No. millicuries,18 millicuries total HFG-137-2-3015)

4

  • NRC FORM 374A u.s. NUCLEAR RE!uLAToRY CoMMisSloN PAGE 3 ef 8 PAGEs l , Ucense Number 34-18156-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-14608 (030-14418)

Amendment No.16

6. Byproduct, source, and/or special 7. Chemical and/or physical form 8. Maximum amount that licensr.se may nuclear material possess at any one time under this license <

l

R. Cobalt-60 R. Sealed source (ICN Model R. 1.015 millicuries 375)

S. Cesiom-137 S. Sealed source (Isotope S. Two sources not to exceed Products Labs Model 193) 13.8 millicuries each

9. Authorized Use:

A. through I. For use in the testing of radiation detection instruments and in the development, testing and calibration of radiation monitors.

t J. To be used in the manufacture of Amphenol Bendix electrical connectors (surge arrestors).

j K. For use in gas chromatographs for sample analysis.

L. For use and/or possession incident to:  ;

(1) Research, development, manufacture (excluding source fabrication) and testing of the Reuter-Stokes Safety Ray devices listed in Condition 10.A. below.

l (2) Distribution in devices listed in Condition 10.A. below to persons authorized to receive the byproduct i material pursuant to terrns and conditions of specific licenses issued by the Nuclear Regulatory l Commission or any Agreement State.

(3) The performance of the following customer services for the devices listed in Condition 10.A. below:

Installation, relocation, removal, testing, repair, and maintenance of the devices and other services l as described in the licensee's letter dated February 28,1985 including radiation surveys and leak testing of sealed sources.

1 l (4) instruction and training in the safe use and handling of the sources and devices listed in Condition l

10.A. below.

l l (5) Receipt, possession and transfer of the devices listed in Condition 10.A. below from customers for i disposal purposes.

M. through Q. For manufacturer use and/or possession incident to:

(1) Distribution in devices listed in Condition 10.B. through E. below to nuclear power reactor facilities authorized to receive the byproduct material pursuant to terms and conditions of specific licenses issued by the Nuclear Regulatory Commission.

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o NRc FORM 374A U.S. NUCLEAR RE!ulAToRY Commission PAGE 4 of 8 PAGEs l , License Number 34-18156-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-14608 (030-14418)

Amendment No.16 I (2) Receipt, possession and transfer of the devices listed in Condition 10.B. through E. below from customers for disposal purposes.

R. and S. For instrument calibration.

l CONDITIONS l

DEVICE ISOTOPE MAXIMUM ACTIVITY PER DEVICE

10. A. Safety Ray (Model RSS- A. Americium-241 (New A. 1.21 curies 811 or RSS-811-1) England Nuclear Model NER 479C)  !

B. Sensor / Converter B.(1) Strontium-90 B.(1) 1.4 microcuries (calibration or check i sources fabricated by  !

Isotope Product Labs I or Gamma industries in accordance with Reuter-Stokes Part No.

16 7A2556)

(2) Cobalt-6 (2) 2.2 microcuries (Calibration or check sources fabricate by isotope Product Labs or Gamma Industries in accordance with Reuter-Stokes Part No.16 7A2556)

C. Portable calibration unit C. Cobalt-60 (Check C. 400 microcuries Dwg. No. 846D959) sources fabricated by isotope Products Labs or Gamma Industries, Inc. in accordance with Part No.176A1637)

D. Portable calibration unit D. Cesium-137 (Amersham D. 2.3 millicuries (Dwg. No. 846D959) Model CDC.800)

E. Portable calibration unit E. Cesium-137 (Isotope E. 3 millicuries Dwg. No. 846D959) Products Lab Model Number HFG-137 3015)

NRC FoRJ 374A u.S. NUCLEAR RE!uLAToRY CoMMISsloN PAGE 5 of 8 PAGEs

, Ucense Number 34-18156-01 MATERIALS LICENSE Docket r Reference Number SUPPLEMENTARY SHEET 030-14608 (030-14418)

Amendment No.16

11. Licensed material shall be used only at the licensee's facilities located at Edison Park,8499 Darrow Road, Twinsburg, Ohio.
12. A. Licensed material shall be used by, or under the supervision of, Lawrence W. Penman, Fred Glesius, Jan E. Orbin, Clark Gerber, Nathan H. Johnson, Patrick J. Coughlin, David O'Connor and Patrick M. Cowher.

B. The Radiation Safety Officer for this license is Patrick M. Cowher,

13. A. Sealed sources and detector cells shall be tested for leakage and/or contamination at intervals not to exceed 6 months or at such other intervals as specified by the certificate of registration referred to in 10 CFR 32.210.

B. Notwithstanding Paragraph A of this Condition, sealed sources designed to emit alpha particles shall be tested for leakage and/or contamination at intervals not to exceed 3 months.

C. In the absence of a certificate from a transferor indicating that a leak test has been made within 6 months prior to the transfer, a sealed source or detector cell received from another person shall not be put into use until tested.

D. Sealed sources need not be leak tested if:

(i) they contain only hydrogen-3; or (ii) they contain only a radioactive gas; or (iii) the half-life of the isotope is 30 days or less; or (iv) they contain not more than 100 microcuries of beta and/or gamma emitting material or not more than 10 microcuries of alpha emitting material; or (v) they are not designed to emit alpha particles, are in storage, and are not being used.

However, when they are removed from storage for use or transferred 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.

  • I NRC FORM 374A u.s. NUCLEAR RE2uLAToRY CoM1ssioN PAGE 6 of 8 PAGES

, Ucense Number 34-18156-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-14608 (030-14418)

Amendment No.16 E. The leak test shall be capable of detecting the presence of 0.005 microcurie of radioactive material on the test sample. Records of leak test results shall be kept in units of microcuries and shall be maintained for inspection by the Commission. 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 shall be removed immediately from service and decontaminated, repaired, or disposed of in accordance with Commission regulations. The report shall be filed within 5 days of the date the leak test result is known with the U.S. Nuclear Regulatory Commission, Region ill,801 Warrenville Road, Lisle, Illinois 60532-4351, ATTN: Chief, Nuclear Materials Safety Branch. The report snail specify the source involved, the test results, and corrective action taken.

Records of leak test results shall be kept in units of microcuries and shall be maintained for inspection by the Commission. Records may be disposed of following Commission inspection.

i. Tests for leakage and/or contamination shall be performed by the licensee or by other persons specifically licensed by the Commission or an Agreement State to perfoim such services.
14. Sealed sources or detector cells containing licensed material shall not be opened or sources removed from source holders by the licensee.
15. Licensed material shall not be used in or on human beings.
16. The licensee shall conduct a physical inventory every 6 months to account for all soaces and/or devices received and possessed under the license. Records of inventories shall be maintained for 5 years from the date of each inventory, and shall include the quantities and kinds of byproduct material, manufacturer's name and model numbers, location of the sources and/or devices, and the date of the inventory.
17. After installation of additional cobalt-60 sources greater than the quantity for which a previous radiation survey has been conducted, and prior to initiation of the irradiation program, a radiation survey shall be conducted to determine the maximum radiation levels in each area adjoining the irradiation room. A detailed report, in duplicate, of the results of the surveys shall be sent to the U.S. Nuclear Regulatory Commission, Region lil, 801 Warrenville Road, Lisle, Illinois 60532-4351, ATTN: Chief, Nuclear Materials Safety Branch, not later than thirty (30) days following installation of the sources.
18. The licensee shall not perform repairs or alterations of the irradiator involving removal of shielding or access to the licensed material. Removal, replacement, and disp,osal of sealed sources in the irradiator shall be performed by a person specifically licensed by the Commission or an Agreement State to perform such services.

i9. Maintenance, repair, cleaning, replacement, and disposal of foils contained in detector cells shall be performed only by the device manufacturer or other persons specifically authorized by the Commission or an Agreement State to perform such services.

a

. I NP.C FORM 374A u.s. NUCLEAR RE!uLAToRY coMINssioN PAGE 7 cf 8 PAGES e Uceuse Number 34-18156-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-14608(030-14418)

Amendment No.16 i

20. Each device distributed by the licensee shall bear a durable, clearly visible label containing the following:

A. The radiation caution symbol and the words " CAUTION, RADIOACTIVE MATERIAL";

B. The name of the radionuclide and quantity of activity; and C. The name of the manufacturer or initial transferor of the device.

21. The licensee may transport licensed materialin accordance with the provisions of 10 CFR Part 71,

" Packaging and Transportation of Radioactive Material."

. 22.. The licensee shall perform the following tests after each source holder exchange operation involving licensed material listed in Subitem 6.L. to verify that the source assembly meets specifications fumished to the Commission:

A. Radiation profiles of the new source holder with shutters in both the open and closed positions.

B. Visual or other quality control inspections to determine if cracks, voids or other manufacturing defects exist.

C. Shutter control operations (for the Model RSS-811-1 only).

D. Leak test for radiation leakage or contamination.

Copies of the testing procedures and the test results shall be maintained for inspection by the Commission.

23. In addition to the possession limits in item 8, the licensee shall further restrict the possession of licensed material in Subitems 6.L. through 6.Q. to quantities below the minimum limit specified in 10 CFR 30.35(d) for established decommissioning financial assurance.
24. 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 any enclosures, listed below. The U.S. Nuclear Regulatory Commission's regulations shall govem unless the statements, representations, and procedures in the licensee's application and correspondence are more restrictive than the regulations.

A. Applications dated July 25,1983 (with attachments), February 8,1985, April 16,1990, November 22,1991 (with attachments) and May 11,1994; and B. Letters datec' August 9,1984, February 28,1985, January 27,1986, February 17,1986, March 4, 1986, Noveniber 15,1989, November 30,1989, December 18,1989, May 22,1990, September 17, 1990, April 15,1991 (with attachment), April 26,1991 (with attachments), April 16,1992, October 7, 1992, December 22,1992, February 3,1993, May 11,1994, and August 8,1994.

e l NRC FORO 374A U.S. huCLEAR REIULATORY COMMISSION PAGE 8 of 8 PAGES

' Ucense Number 34-18156-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-14608 (030-14418)

Amendment No.16 l

l l

FOR THE U.S. NUCLEAR REGULATORY Date By d W[/

{V)['"N 7 Nuclear Materials Licensing Branch l

Region lli l

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{ u.s. NUCLEAR RE2uLAToRY CoMMisslON Am:ndm nt No. 7 y Llewr_t:r MATERIALS LICENSE CORRECTED COPY Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code cf Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations )

heretofore made by the licensee,a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special 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 authorizedto receive it in accordance with the regulationsof the applicable Part(s). This license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all i rpplicable rules, regulations,and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified j below.  !

Licensee in accordance with the letter dated i September 5,1997 l 1. Trionix Research Laboratory 3. Ucense number 34-24887-01 is amended l l in its entirety to read as follows:

2. 8037 Bavaria Road 4. Expiration date November 30,2002 )

l l Twinsburg, OH 44087 5. Docket No. 030-29809 Reference No.

! 6. Byproduct, source, and/or special 7. Chemical and/or physical form 8. Maximum amount that licensee may nuclear material possess at any one time under this license A. Technetium-99m A. Any A. 200 millicuries

(

l B. lodine-131 B. Any B. 3 millicuries C, Gadolinium-153 C. Sealed sources (Isotope C. Nine surces not to exceed 1  !

Product Laboratories Model curie each 3410)

! 9. Authorized Use:

A. To be used for instrument calibration and for the purpose of testing radiation imaging devices.

B. To be used for gamma camera resolution, calibration, and testing as stated in letter dated October 20,1995.

C. To be used for research, development and testing of gamma cameras.

CONDITIONS

10. Licensed material shall be used only at the licensee's facilities located at 8037 Bavaria Road, Twinsburg, Ohio,
11. A. The Radiation Safety Officer for this license is Chun Bin Lim, Ph.D.

B. Licensed material shall be used by, or under the supervision of, Chun Bin Lim, Ph.D., or Bruce Koval.

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Ucense Number p 34-24887-01 MATERIALS LICENSE o eket or Reference Number SUPPLEMENTARY SHEET 030-29809 l Amendment No. 7 CORRECTED COPY

12. A. Sealed sources and detector cells shall be tested for leakage and/or contamination at intervals not to exceed 6 months or at such other intervals as specified by the certificate of registration referred to in i

10 CFR 32.210.

B. In the absence of a certificate from a transferor indicating that a leak test has been made within 6 months prior to the transfer, a sealed source or detector cell received from another person shall not be put into use until tested.

j C. Sealed sources need not be leak tested if:

(i) they contain only hydrogen-3; or (ii) they contain only a radioactive gas; or (iii) the half-life of the isotope is 30 days or less; or

(iv) they contain not more than 100 microcuries of beta and/or gamma emitting material or not more than 10 microcuries of alpha emitting material; or (v) they are not designed to emit alpha particles, are in storage, and are not being used. However,
when they are removed from storage for use or transferred to another person, and have not l been tested within the required leak test interval, they shall be tested before use or transfer. No sealed source or detector cell shall bc stored for a period of more than 10 years without being  ;

tested for leakage and/or contamination.

D. The leak test shall be capable of detecting the presence of 0.005 microcurie of radioactive material ,

on the test sample. If the test reveP's thO presence of 0.005 microcurie or more of removable i contamination, a report shall be filed vdth th9 U.S. Nuclear Regulatory Commission in accordance with 10 CFR 30.50(b)(2), and the source shall be removed immediately from service and decontaminated, repaired, or disposed of in accordance with Commission regulations. The report shall be filed within 5 days of the date the leak test result is known with the U.S. Nuclear Regulatory j Commission, Region lil, A'ITN: Chief, Nuclear Materials Safety Branch,801 Warrenville Road, Lisle, '

lllinois 60532-4351. The report shall specify the source involved, the test results, and corrective action taken.

E. Tests for leakage and/or contamination shall be performed by persons specifically licensed by the Commission or an Agreement State to perform such services.
13. The licensee shall conduct a physical inventory every 6 months to account for all radioactive material received and possessed under the license. Records of inventories shall be maintained for 2 years from the date of each inventory.

i <

f Ucense Number p 34-24887-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-29809 Amendment No. 7 CORRECTED COPY

14. 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 any enclosures, listed below. The 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. Applications dated March 10,1987, April 25,1992 and August 14,1996; and B. Letters dated May 18,1987, April 10,1991, October 20,1995 (with attachments), October 1,1996, ay 1,1997 and September 5,1997.

FOR THE U.S. NUCLEAR REGULATORY COMMISSION

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Nuclear Materials Licensing Branch Region lil I

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, mendmen No.10 l Licwater MATERIALS LICENSE

! Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93A38), and Title 10, Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, j source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to l 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 specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all l applicable rules, regulations,and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified

below.

l l Licensee In accordance with letter dated January 26,1998

1. SMV America 3. Ucense number 34-26121-01 is amended in its entirety to read as follows:

l 2. 8380 Darrow Road 4. Expiration date September 30,2005 Twinsburg, OH 44087 5. Docket No. 030-31486 Reference No.

l 6. Byproduct, source, and/or special 7. Chemical and/or physical form 8. Maximum amount that licensee may l nuclear material possess at any one time under this ,

license l l

r A. Barium-133 A. Sealed Source A. 750 microcuries

! B. Technetium-99m B. Any B. 150 millicuries  !

C. Gadolinium-153 C. Sealed source (DuPont C, No single source to exceed i Merck Models NES-8412 150 millicuries,300 through NES-8425 or millicuries total l Isotope Products Labs Model 3410) i D. Barrium-133 D. Sealed source (DuPont D. No single source to exceed Merck Model NES-8060) 200 microcuries,2 millicuries total

9. Authorized Use:

A. through D. To be used for the calibration and testing of gamma cameras.

CONDITIONS l 10. Licensed material shall be used only at the licensee's facilities located at 2307 East Aurora Road, Suite l B8, Twinsburg, Ohio, and 8380 Darrow Road, Twinsburg, Ohio.

11. Licensed material shall be used by, or under the supervision and in the physical presence of, William Noble or individuals who have been trained as specified in application dated January 16,1990. The licensee shall maintain records of individuals designated as users.
12. The Radiation Safety Officer for this license is Charles Anthony Giomuso, n/f 99 % s su ,

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NRC FORM 374A - U.s. NUCLEAR RE2uLAToRY CoMMISSloN PAGE 2 of 3 PAGES License Number 34-26121-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-31486 Amendment No.10

13. A. Sealed sources and detector cells shall be tested for leakage and/or contamination at intervals not to exceed 6 months or at such other intervals as specified by the certificate of registration referred to in 10 CFR 32.210. -

B. In the absence of a certificate from a transferor indicating that a leak test has been made within 6 months prior to the transfer, a sealed source or detector cell received from another perscr siiail not be put into use until tested.~

C. Sealed sources need not be leak tested if:

(i) they contain only hydrogen-3; or

< (ii) they contain only a radioactive gas; or (iii) the half-life of the isotope is 30 days or less; or (iv) they contain not more than 100 microcuries of beta and/or gamma emitting material or not more than 10 microcuries of alpha emitting material; or (v) they are not designed to emit alpha particles, are in storage, and are not being used. However, when they are removed from storage for use or transferred 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.

D. The leak 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 in accordance with 10 CFR 30.50(b)(2), and the source shall be removed immediately from service and decontaminated, repaired, or disposed ofin accordance with Commission regulations. The report shall be filed within 5 days of the date the leak test result is known with the U.S. Nuclear Regulatory Commission, Region lil, ATTN: Chief, Nuclear Materials Safety Branch,801 Warrenville Road, Lisle, Illinois 60532-4351. The report shall specify the source involved, the test results, and corrective action taken.

E. Tests for leakage and/or contamination shall be performed by the licensee or by other persons specifically licensed by the Commission or an Agreement State to perform such services.

14. Sealed sources containing licensed material shall not be opened.
15. The licensee shall not use licensed material in or on human beings except as provided otherwise by specific condition of this license.
16. This license does not authorize commercial distribution of licensed material.

'*' l' NRC FORM 374A u.S. NUCLEAR RE!uLAToRY COMMISSION PAGE 3 of 3 PAGEs

~

License Number

~s 34-26121-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-31486 Amendment No.10

17. Except as specPc'ly provided otherwise in this license, the licensee shall conduct its program in 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.

A. Applications dated January 16,1990, April 25,1991, August 15,1994, January 23,1995, September 2,1997; and B. Letters dated July 11,1991, October 17,1994, January 23,1995, and August 15,1995 (with attachments), February 20,1996, April 4,1996, August 28,1996 and September 16,1996; May 12, 1997, December 2,1997; and C. Letter received June 7,1995.

FOR THE U.S. NUCLEAR REGULATORY COMMISSION a e[j; h u ,

u Date By Gidget M. Watson Nuclear Materials Licensing Branch Region lil

4 o I NRC FORM 374 PAGE 1 OF PAGEs Licwater MATERIALS LICENSE 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 heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to deliver or transfer such materialto persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license chall be deemed to contain the conditions specified in Section 183 of the Atornic Energy Act of 1954, as amended, and is subject to all c pplicable rules, regulations,and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.

Ucensee in accordance with letter dated September 20,1993

1. Trinitech International, Inc. 3. Ucense number 34-26496-01 is amended in its entirety to read as follows:
2. 2069 Midway Drive 4. Expiration date June 30,1998 Twinsburg, OH 44087 5. Docket No. 030-33167 Reference No.
6. Byproduct, source, and/or special 7. Chemical and/or physical form 8. Maximum amount that licensee may nuclear material possess at any one time under this license A. Cadmium-109 A. Sealed Source (Isotope A. 3 sources not to exceed 8 Products XFB; New millicuries each England Nuclear NER-465, NER-467; Amersham CUC.DI)

B. Americium-241 B. Sealed Source (Isotope B. 3 sources not to exceed 8 Products GFS; New millicuries each England Nuclear NER-478C; Amersham AMC 64, AMC 65) l

9. Authorized Use:

A. and B. To be used in Kevex Model 0202 X-ray fluorescing device. I CONDITIONS

10. Licensed material shall be used only at the licensee's facilities located at 2069 Midway Drive, Twinsburg, Ohio.  !
11. The Radiation Safety Officer for this license is Robert L. Raun.
12. Licensed material shall be used by, or under the supervision of, Robert L. Raun.

I

13. A. Sealed sources and detector cells shall be tested for leakage and/or contamination at intervals not to l I

exceed 6 months or at such other intervals as specified by the certificate of registration referred to in 10 CFR 32.210.

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f NRC FORM 374A U.S. NUCLEAR REIULAToRY CoMMtssioN PAGE 2 cf 3 PAGES s Ucense Number 34-26496-01 MATERIALS LICENSE Docket r Reference Number SUPPLEMENTARY SHEET 030-33167 Amendment No.1 B. Notwithstanding Paragraph A of this Condition, sealed sources designed to emit alpha particles shall be tested for leakage and/or contamination at intervals not to exceed 3 months.

C. In the absence of a certificate from a transferor ind!cating that a leak test has been made within 6 months prior to the transfer, a sealed source or detector cell received from another person shall not be put into use until tested. <

E. Sealed sources need not be leak tested if:

(i) they contain only hydrogen-3; or (ii) they contain only a radioactive gas; or 1

(iii) the half-life of the isotope is 30 days or less; or )

I (iv) they contain not more than 100 microcuries of beta and/or gamma emitting material or not more than 10 microcuries of alpha emitting material; or (v) they are not designed to emit alpha particles, are in storage, and are not being used. However, I when they are removed from storage for use or transferred 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.

F. The leak test shall be capable of detecting the presence of 0.005 microcurie of radioactive material on the test sample. Records of leak test results shall be kept in units of microcuries and shall be maintained for inspection by the Commission. 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 shall be removed immediately from service and decontaminated, repaired, or disposed of in accordance with Commission regulations. The report shall be filed within 5 days of the date the leak test result is known with the U.S. Nuclear Regulatory Commission, j Region Ill,799 Roosevelt Road, Glen Ellyn, Illinois 60137, ATTN: Chief, Nuclear Materials Safety 1 Branch. The report shall specify the source involved, the test results, and corrective action taken.

Records of leak test results shall be kept in units of microcuries and shall be maintained for inspection by the Commission. Records may be disposed of following Commission inspection.

G. The licensee is authorized to collect leak test samples for analysis by Applied Health Physics, Inc.

Alternatively, tests for leakage and/or contamination may be performed by persons specifically licensed by the Commission or an Agreement State to perform such services.

14. Sealed sources or detector cells containing licensed material shall not be opened or sources removed from source holders by the licensee.

4 i

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NRc FORM 374A U.s. NUCLEAR REIULAToRY Commission PAGE 3 of 3 PAGEs p Ucense Number 34-26496-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-33167 Amendment No.1

15. The licensee shall conduct a physical inventory every 6 months to account for all sources and/or devices received and possessed under the license Records of inventories shall be maintained for 5 years from the date of each inventory, and shallinclude the quantities and kinds of byproduct material, manufacturer's name and model numbers, location of the sources and/or devices, and the date of the inventory.

i

16. Installation, initial radiation survey, relocation, removal from service, maintenance, and repair of devices containing sealed sources shall be performed by Fission instruments or by persons specifically licensed by the Commission or an Agreement State to perform such services. Installation, replacement, and l disposal of sealed sources shall be performed only by persons specifically licensed by the Commission or j an Agreement State to perform such services. '
17. The licensee shall maintain records of information related to decommissioning at the location listed in item 2 of this license as specified in 10 CFR 30.35(g) until this license is terminated by the Commission.
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 any enclosures, listed below. The U.S. Nuclear Regulatory Commission's regulations shall govern unless the statements, representations, and procedures in the Lensee's application and correspondence are more restrictive than the regulations.

A. Application dated April 28,1993; and B. Letter dated September 20,1993.

4 FOR THE U.S. NUCLEAR REGULATORY COMMISSION .

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Date By nuclear Materials Licensing Branch Region lli

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,4

  • u.s. NUCLEAR REGULATORY CoMIlssioN j Amendment No.1 Licwater MATERIALS LICENSE j Pursuantto the Atomic Energy Act of 1954, as amended, the Energy Reorganization Ac: 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

! heretofore maae by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special 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 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 Regulatory Commission now or hereafter in effect and to any conditions specified below, ucensee in accordance with application dated October 15,1997

1. Hitachi Medical Corporation of America 3. Ucense number 34-26756-01 is amended in its entirety to read as follows:
2. 9177 Dutton Drive 4. Expiration date December 31,2001 Twinsburg, OH 44087 5. Docket No. 030-34248 Reference No.
6. Byproduct, source, and/or special 7. Chemical and/or physical form 8. Maximum amount that licensee may  !

nuclear material possess at any one time under this f license A. Technetium-99m A. Any A. 150 mil 5 curies B. lodine-131 B. Capsule form B. 30 microcuries C. Cesium-137 C. Sealed source C. 250 microcuries D. Barium-133 D. Sealed source D. 250 microcuries E. Gadolinium-153 E. Sealed source (DuPont E. One source not to exceed Merk Pharmaceuticals 480 millicuries Model No. NES-8423 l

9. Authorized Use: j A. through D. To be used for testing gamma cameras and coincidence counting / imaging units.

l l E. To be used for calibration. 1 CONDITIONS 1

l

10. Licensed material shall be used only at the licensee's facilities located at 9177 Dutton Drive, Twinsburg, Ohio.
11. The Radiation Safety Officer for this license is Gary W. Enos.
12. Licensed material shall be used by, or under the supervision of, Gary W. Enos or Helmich B. Visscher.

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1 NRC FORAI 374A u.s. NUCLEAR RE!uLAToRY CotAlfissioN PAGE 2 of 4 PAGES

4 Ownee Number 34 26756-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-34248 Amendment No.1
13. A. > Sealed sources and detector cells shall be tested for leakage and/or contamination at intervals not to exceed 6 months or at such other intervals as specified by the certificate of registration referred to in 10 CFR 32.210.

B. In the absence of a certificate from a transferorindicating that a leak test has been made within 6 months prior to the transfer, a sealed source or detector cell received from another person shall not be put into use until tested.

C. Sealed sources need not be leak tested if:

(i) they contain only hydrogen-3; or (ii) they contain only a radioactive gas; or (iii) the half-life of the isotope is 30 days or less; or ,

l (iv) they contain not more than 100 microcuries of beta and/or gamma emitting material or not more than 10 microcuries of alpha emitting material; or (v) they are not designed to emit alpha particles, are in storage, and are not being used. However, when they are removed from storage for use or transferred 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. I D. The leak 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 l contamination, a report shall be filed with the U.S. Nuclear Regulatory Commission in accordance with l 10 CFR 30.50(b)(2), and the source shall be removed immediately from service and decontaminated,  !

repaired, or disposed of in accordance with Commission regulations. The report shall be filed within 5  !

days of the date the leak test result is known with the U.S. Nuclear Regulatory Commission, Region ill, ATTN: Chief, Nuclear Materials Safety Branch, 801 Warrenville Road, Lisle, Illinois 60532-4351. The report shall specify the source involved, the test results, and corrective action taken.

E. The licensee is authorized to collect leak test samples for analysis by Universal Consultants, Inc.  !

Altematively, tests for leakage and/or contamination may be performed by persons specifically licensed ,

by the Commission or an Agreement State to perform such services. l

14. Sealed sources or detector cells containing licensed material shall not be opened or sources removed from source holders by the licensee.
15. The licensee may not possess and use materials authorized in items 6,7, and 8 until:

A. The licensee has constructed the facilities and obtained the equipment described in the application and I supporting documentation; and l l

I

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( License Number f

34-26756-01 MATERIALS LICENSE D eket r Reference Number SUPPLEMENTARY SHEU 030-34248 Amendment No.1 l

! B. The U. S. Nuclear Regulatory Commission, Region ill, ATTN: Chief, Materials Licensing Branch,801 Warrenville Road, Lisle, IL 60532-4351 has been notified that activities authorized by the license will be initiated.

l l 16. Within 30 days of the date of a decision not to complete the facility, acquire equipment, or possess and use l authorized material, the licensee must notify the Commission in writing, of the decision.

l 17. Licensed material shall not be used in or on human beings.

! 18. This license does not authorize commercial distribution of licensed material. 1 l

l 19. Except as specifically provided otherwise in this license, the licensee shall conduct its program in accordanz 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, i representations,and proceduresin the licensee's application and correspondence are more restrictive than l the regulations.

l A. Application dated September 18,1996; and

B. Letter dated December 10,1996.

l l

l l

l l

l FOR THE U.S. NUCLEAR REGULATORY COMMISSION

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Date By Nuclear Materials Licensing Branch i

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u.S. NUCLEAR REGULATORY CoMMISsloN Am5dm nt N . 3

/ Licwater MATERIALS LICENSE Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganiza' ion Act of 1974 (Public Law 93-438), and Title 10, Code of Fedemi Regulations, Chapter 1, Parta,30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nucisar 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 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 Regulatory Commission now or hereafter in effect and te .ny conditions specified beh w.

Ucensee in accordance with application dated October 31,1997

1. GE/Reuter Stokes, incorporated 3. License number SUB-1522 is amended in Edison Park its entirety to read as follows:
2. 8499 Darrow Road 4. Expiration date December 31,2003 Twinsburg, OH 44087 5. Docket No. 040-08965 Reference No.
6. Byproduct, source, and/or special 7. Chemicaland/orphysicalform 8. Maximum amount that licensee may nuclear material possess at any one time under this license A. Uranium (Depleted) A. Stainless steel plated A. 1,500 kilograms
9. Authorized Use:

A. To be used in the assembly of the licensees' Bottom Entry Disposal System (BEDS) and for distribution to NRC licensed nuclear power reactors.

CONDITIONS

10. Licensed material shall be used only at the licensee's facilities located at Edison Park,8499 Darrow Road, Twinsburg, Ohio.
11. A. Licensed material shall be used by, or under the supervision of Jon E. Orbin, Lawrence W. Penman, David O'Connor or Patrick M. Cowher.

B. The Radiation Safety Officer for this license is Pa. rick M. Cowher.

12. The licensee shall engrave each DU component with the following: Caution Radioactive Material- This Device Contains Depleted Uranium.

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, SUB-1522 MATERIALS LICENSE D eket r Reference Number SUPPLEMENTARY SHEET 040-08965 Amendment No. 3

13. Except as specifically provided othenvise in this license, the licensee shall conduct its program in 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.

A. Applications dated May 27,1993 and May 11,1994; and B. Letter dated May 11,1994.

FOR THE U.S. NUCLEAR REGULATORY COMMISSION g_ _ _ _ . . -

J l:

Date By Nuclear Materials Licensing Branch Region ill

e .

1 7 u.s. NUCLEAR REGULATORY Commission j AmIndment No.1 Llewater MATERIALS LICENSE  ;

j Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code l of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations 4 heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer bypWuct,

source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to j l deliver or transfer such materialto persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license

! shall 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,and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified j below.

Ucensee In accordance with letter dated December 22,1994 l

1. Alcon industries, Inc. 3. Ucense number 34-26026-01 is renewed in l its entirety to read as follows: I
2. 7990 Baker Avenue 4. Expiration date January 31,2000 Cleveland, OH 44102 5. Docket No. 030-31031

! Reference No. I

6. Byproduct, source, and/or special 7. Chemical and/or physical form 8. Maximum amount that licensee may nuclear material po'ssess at any one time under this i license i A. Cadmium-109 A. Sealed sources (Isotope A. Ten sources to exceed 15 Products Model 341 or millicuries each Amersham Model CUC.P1)

B. Americium-241 B. Sealed sources (Isotope B. Ten sources to exceed 15 l Products Model GFS or millicuries each Amersham Model AMC.P2) l

9. Authorized Use- J l

1 A. and B. Not to exceed 60 millicuries per device l A. and B. To be used in a Kevex Model 0402 energy dispersive x-ray analyzer for elemental analysis.

t CONDITIONS 1

l

10. Licensed material shall be used only at the licensee's facilities located at Alcon industries, Inc.,7990 Baker Avenue, Cleveland, Ohio.

l

11. Licensed material shall be used by, or under the supervision of, Lawrence Starat or Nicholas Piro.
12. The Radiation Safety Officer for this license is Nicholas Piro.

1

13. A. Sealed sources and detector cells shall be tested for leakage and/or contamination at intervals not to exceed 6 months or at such other intervals as specified by the certificate of registration referred to in ,

10 CFR 32.210.

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NRC FORM 374A u.s. NUCLEAR RE!uLAToRY Commission PAGE 2 of 4 PAGES

/ Ucense Number 34-26026-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-31031 Amendment No.1 I

B. In the absence of a certificate from a transferor indicating that a leak test has been made within 6 months prior to the transfer, a sealed source or detector cell received from another person shall not be put into use until tested.

C. Sealed sources need not be leak tested if:

(i) they contain only hydrogen-3; or (ii) they contain only a radioactive gas; or (iii) the half-i.fe of the isotope is 30 days or less; or (iv) they contain not more than 100 microcuries of beta and/or gamma emitting material or not more than 10 microcuries of alpha emitting material; or (v) they are not designed to emit alpha particles, are in storage, and are not being used. However, when they are removed from storage for use or transferred to another person, and have not i 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.

D. The leak 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 in accordance with 10 CFR 30.50(b)(2), and the source shall be removed immediately from service and decontaminated, repaired, or disposed of in accordance with Commission regulations. The report shall be filed within 5 days of the date the leak test result is known with the U.S. Nuclear Regulatory ,

Commission, Region 111, ATTN: Chief, Nuclear Materials Safety Branch,801 Warrenville Road, Lisle, lilinois 60532-4351. The report shall specify the source involved, the test results, and corrective action taken.

E. The licensee is authorized to collect leak test samples for analysis by tests for leakage and/or contamination shall be performed as described in application dated February 1,1989. Alternatively, tests for leakage and/or contamination may be performed by persons specifically licensed by the Commission or an Agreement State to perform such services.

14. Sealed sources or detector cells containing licensed material shall not be opened or sources removed from source holders by the licensee.
15. Installation, initial radiation survey, relocation, removal from service, maintenance, and repair of devices containing sealed sources shall be performed by persons specifically licensed by the Commission or an Agreement State to perform such services. Installation, replacement, and disposal of sealed sources shall be performed only by persons specifically licensed by the Commission or an Agreement State to perform such services. t

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1 NRC FORM 374A u.s. NUCLEAR REGULATORY CoMMisslON PAGE 3 of 4 PAGES

/ License Number 34-26026-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-31031 Amendment No.1

16. 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 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. Application dated February 1,1989; and B. Letter dated December 22,1994.

FOR THE U.S. NUCLEAR REGULATORY COMMISSION g, . - - ..

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Date By Nuclear Materials Licensing Branch Region 111

r 1 u.s. NuctsAn nazuLATORY CoMMisslON mendmen No. 41 Licwater MATERIALS LICENSE 4

Pursuantto 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

, heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct,

! source, and special 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 specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all

,- cpplicable rules, regulations,and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.

~

Ucensee In accordance with the application dated  ;

December 22,1997 l 1. St. Luke's Medical Center 3. Ucense number 34-00398-08 is amended in its entirety to read as follows:

2. 11311 Shaker Boulevard 4. Expiration date December 31,2004
Cleveland, OH 44104 5. Docket No. 030-02646 Reference No.

l 6. Byproduct, source, and/or special 7. Chemicaland/orphysicalform 8. Maximum amount that licensee may I

nuclear material possess at any one time under this

icense .

I

! A. Any byproduct material A. Any radiopharmaceutical A. As needed  ;

identified in 10 CFR 35.100 identified in 10 CFR 35.100 B. Any byproduct material B. Any radiopharmaceutical B. As needed identified in 10 CFR 35.200 identified in 10 CFR 35.200 C. Any byproduct material C Any radiopharmaceutical C. As needed identified in 10 CFR 35.300 identified in 10 CFR 35.300 D. Any byproduct material D. Any brachytherapy sources D. As needed identified in 10 CFR 35.400 identified in 10 CFR 35.400 E. Any byproduct material E. Prepackaged Kits E. As needed identified in 10 CFR 31.11
9. Authorized Use:

( A. Medical use described in 10 CFR 35.100.

B. Medical use described in 10 CFR 35.200.

C. Medical use described in 10 CFR 35.300.

D. Medical use described in 10 CFR 35.400.

E. In vitro studies.

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l NRc FORM 374A u.S. NUCLEAR RE2ULAToRY COMMISSION PAGE 2 of 3 PAGES

, License Number l 34-00398-08 MATERIALS LICENSE Ddet or Reference Number SUPPLEMENTARY SHEET 030-02646 l

Amendment No. 41 CONDITIONS

10. Licensed material shall be used only at the licensee's facilities located at 11311 Shaker Boulevard, Cleveland, Ohio.
11. Radiation Safety Officer: Mark Rosenfeld, M.D.
12. Licensed material listed in item 6 above is only authorized for use by, or under the supervision of, the following individuals for the materials and uses indicated:

Authorized Users Material and Use A. Gregory L. Arko, D.O. 10 CFR 35.100,35.200,35.300 and 31.11.

B. Carolyn Lee, M.D. 10 CFR 35.100,35.200 and 31.11.

C. Mark Rosenfeld, M.D. 10 CFR 35.100,35.200, 35.300 and 31.11.

D. Kenneth C. Lane, M.D. 10 CFR 35.400.

E. Phillip John Catanzaro, M.D. 10 CFR 35.400.

F. James S. Littman, M.D. 10 CFR 35.100,35.200,35.300 and 31.11.

G. Gary Davis, D.O. 10 CFR 35.100,35.200 and 31.11. l H. Matthew Passalacqua, D.O. 10 CFR 35.100,35.200,35.300 and 31.11. j

l. Brigid M. Poe, M.D. 10 CH 35.100 and 35.200. l l

J. Andrew P. Cook, M.D. 10 CFR 35.100 and 35.200.

13. In addition to the possession limits ii . Item 8, the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 10 CFR 30.35(d) for establishing l decommissioning financial assurance.

I

j. NRC FORM 374A U.S. NUCLEAR REOULAToRY Commission PAGE 3 of 3 PAGES License Number 34-00398-08 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-02646 Amendment No. 41
14. 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 any enclosures, listed below, except for minor changes in the medical use radiation safety procedures as provided in 10 CFR 35.31. The U.S. Nuclear Regulatory Coinmission's regulations shall govern unless the statements, representations, and procedures in the licensee's application and correspondence are more restrictive than the regulations.

A. Applications dated May 17,1994 and April 4,1995; and B. Lctiers &+ed November 21,1996 (excluding consultants report dated June 7,1996, excluding Escrow Agreement, excluding Amendment No.1 to Escrow Agreement and excluding Section V, Radioactive Waste Management Plan).

FOR THE U.S. NUCLEAR REGULATORY COMMISSION

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Date By Michael F. Weber Nuclear Materials Licensing Branch

I '

f4 u.s. NUCLEAR RE7uLAToRY Commission Amendment No.12 Llewater MATERIALS LICENSE Pursuantto 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 h:retofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct.

l source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to i 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 specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicablerules, regulations,anderders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below, i

i ucensee in accordance with the application dated December 22,1997

1. St. Luke's Medical Center 3. Ucense number 34-00398-10 is amended in its entirety to read as follows:

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2.11311 Shaker Boulevard ,. Expiration date April 30,2004 Cleveland, OH 44104 5. Docket No. 030-17512 Reference No.

6. Byproduct, source, and/or special 7. Chemicaland/orphysicalform 8. Maximum amount that licensee may nuclear material possess at any one time under this ,

license l i

A. Cobalt-60 A. Sealed source A. 10,000 curies per source (Theratronics Intemational Ltd. (AECL) C-146 or C-151)

8. Cobalt-60 B. Sealed source B. 7000 curies per source (Theratronics Intemational Ltd. (AECL) C-146 or C- 1 151)

C. Uranium depleted in C. Solid metal C. 275 kilograms total uranium-235 possession limit

9. Authorized Use:

A. and B. Medical use described in 10 CFR 35.600 in two (2) Theratronics intemational Ltd. (AECL) 780 teletherapy units.

C. Shielding in teletherapy units.

CONDITIONS l

10. A. Licensed material listed in Subitems 6.A. and 6.C. shall be used only at St. Luke's Medical Center, Cobalt Room 1516,11311 Shaker Blvd., Cleveland, Ohio.

B. Licensed material listed in Subitems 6.B. and 6.C. shall be used only at St. Luke's Medical Center, Room 108, 33001 Solon Road, Solon, Ohio. ,

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'O NRC FORM 374A U.S. NUCLEAR RE:llULAToRY CoMMISslON PAGE 2 of 2 PAGES e License Number 34-00398-10 MATERIALS LICENSE D cket r Reference Number SUPPLEMENTARY SHEET 030-17512 Amendment No.12

11. Radiation Safety Officer: Thomas K. Stet'anakos, M.S.N.E.

I

12. Authorized Users: Phillip Catanzaro, M.D., Kenneth C. Lane, M.D., Hae-Kyung Hong, M.D. and Dong Youn Kim, M.D.

Teletherapy Physicists: Thomas K. Stefanakos, M.S.N.E.

l

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

A. Letters dated July 26,1985; January 3,1986, July 7,1987, July 17,1987, October 6,1987, October 5,1992, November 21,1996 (excluding consultants report dated June 7,1996, excluding Escrow Agreement and Amsndment No.1 to the Escrow Agreement and excluding Section V, Radioactive Waste Management Plan), February 26,1997, February 27,1997, and March 21,1997.

l 1

FOR THE U.S. NUCLEAR REGULATORY COMMISSION l

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1-x.7 i

Date By '

Michael F. Weber

, Nuclear Materials Licensing Branch Region ill

3'

NRC FORM 374 PAGE 1 oF 4 PAGES u.s. NUCLEAR REGULATORY Commission

'o Amendment No.1 Llewater MATERIALS LICENSE Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code i cf Federal Regulations, Chapter 1. Parts 30,31,32,33,34,35,30,39,40, and 70. and in reliance on statements and representations heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire. possess, and transfer byproduct, source, and special nuclear material designated below; to use such material for tha purpose (s) and at the place (s) designated below; to deliver or transfer such material to persons authorized to receive it in accordance w 'e regulationsof the applicable Part(s). This license shall be deemed to contain the conditions specified in Section 183 of the Atomic E:nergy Act of 1954, as amended, and is subject to all l rpplicable rules, regulations,and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.

! Licensee In accordance with application dated June 12,1995

1. S. Wilkhoff and Sons Company 3. Ucense number 34-18704-02 is renewed in its entirety to read as follows:
2. 2700 East 47th Street 4. Expiration date August 31,2001 Cleveland, OH 44104 5. Docket No. 030-31754 Reference No.
6. Byproduct, source, and/or special 7. Chemical and/or physical form 8. Maximum amount that licensee may nuclear material possess at any one time under this license A. Cadmium-109 A. Sealed sources (Isotope A. Six sources not to exceed Products Laboratory Model 8 millicuries each, three No. XFB, NEN Model sources per device No. NER 465 or Amersham Model No. CUC.D1)

B. Americium-241 B. Sealed sources (Isotope B. Six sources not to exceed Products Laboratory Model 8 millicuries each, three No. NER-478 or Amersham sources per device Model No. AMC.64)

9. Authorized Use:

A. and B. To be used in a Kevex Corporation Mo'Jel 0202 x-ray fluorescence analyzer for alloy sorting and identification.

l CONDITIONS

10. Licensed material shall be used only at the licensee's facilities located at 2700 East 47th Street, i Cleveland, Ohio.

l

11. Licensed material shall be used by, or under the supervision of, James L. Wilkhoff, Karl Anderson, or Shannon Prince.
12. The Radiation Protection Officer for the activities authorized by this license is James L. Wilkhoff.

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.p NRC FoR*3 374A - u.s. NUCLEAR RE!uLAToRY CoANNssioN PAGE 2 (f 4 PAGES Ucense Number 34-18704-02 MATERIALS LICENSE D cm or Reference Nurnber SUPPLEMENTARY SHEET 030-31754 Amendment No.1

13. The sealed source / source holder assembly may be installed and removed by Karl Anderson or Shannon Prince as described in application dated June 12,1995, and letter received July 22,1996. Installation, initial radiation sunrey, relocation, removal from service, maintenance, and repair of devices containing sealed sources and installation, replacement, and disposal of sealed sources shall be performed only by persons specifically licensed by the Commission or an Agreement State to perform such services.
14. Except as otherwise specified in this license, the licensee shall have available and follow the instructions contained in the manufacturer's instruction manual.
15. The licensee shall conduct a physical inventory every 6 months to account for all sources and/or devices received and possessed under the license.
16. Scaled sources containing licensed material shall not be opened or removed from their respective source holders by the licensee.
17. The licensee shall dispose of sources by retuming to the manufacturer when their use has been discontinued.
18. A. Sealed sources and detector cells shall be tested for leakage and/or contamination at intervals not l to exceed 6 months or at such other intervals as specified by the certificate of registration referred to in 10 CFR 32.210.

B. Notwithstanding Paragraph A of this Condition, sealed sources designed to emit alpha particles shall be tested for leakage and/or contamination at intervals not to exceed 3 months.

C. In the absence of a certificate from a transferor indicating that a leak test has been made within 6 months prior to the transfer, a sealed source or detector cell received from another person shall not be put into use until tested.

. l D. Sealed sources need not be leak tested if: i (i) they contain only hydrogen-3; or ,

(ii) they contain only a radioactive gas; or (iii) the half-life of the isotope is 30 days or less; or (iv) they contain not more than 100 microcuries of beta and/or gamma emitting material or not more than 10 microcuries of alpha emitting material; or (v) they are not designed to emit alpha particles, are in storage, and are not being used.

However, when they are removed from storage for use or transferred 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.

5

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NRC FOR*J 374A U.s. NUCLEAR REIULAToRY CoMMisslON PAGE 3 of 4 PAGES r Ucense Number 34-18704-02 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-31754 Amendment No.1 1

E. The leak 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 in accordance with 10 CFR 30.50(b)(2), and the source shall be removed immediately from service and decontaminated, repaired, or disposed of in accordance with Commission regulations. The report shall be filed within 5 days of the date the leak test result is known with the U.S. Nuclear Regulatory Commission, Region ill, ATTN: Chief, Nuclear Materials Safety Branch,801 Warrenville Road, Lisle, Illinois 60532-4351. The report shall specify the source involved, the test results, and corrective action taken.

F. The !.censee is authorized to collect leak test samples for analysis by ICN Biomedicals.

Altematively, tests for leakage and/or contamination may be performed by persons specifically licensed by the Commission or an Agreement State to perform such services.

19. Except as specifically provided othenvise in this license, the licensee shall conduct its program in I accordance with the statements, representations, and procedures contained in the documents including any enclosures, listed below. The 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. Application dated June 12,1995; and B. Letter received July 22,1996.

t FOR THE U.S. NUCLEAR REGULATORY COMMISSION n . . - .. .

Date By ,

1 Nuclear Materials Licensing Branch

5 t

O""

u.s. NUCLEAR RE7uLAToRY Commission i

mendmen No. 59 Licwater MATERIALS LICENSE 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 heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, j source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to deliver or transfer such materialto persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license l

shall 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,and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below, Ucensee in accordance with letter dated November 12,1997

1. Case Westem Reserve University 3. Ucense number 34-00738-04 is amended in its entirety to read as follows:

2.10900 Euclid Avenue 4. Expiration date September 30,2005 Cleveland, OH 44106 5. Docket No. 030-00902 3 Reference No.

6. Byproduct, source, and/or special 7. Chemical and/or physical form 8. Maximum amount that licensee may nuclear material possess at any one time under this license A. Any byproduct material with A. Any A. 300 millicuries of each Atomic Nos. 3 through 84, isotope, not to exceed 16 inclusive curies, total; except as noted below and limited by Condition 16 l

B. Any oyproduct material with B. Sealed sources, foil sources B. 10 millicuries of each isotope Atomic Nos. 85 through 103, or targets inclusive C. Hydrogen-3 C. Any C. 20 curies D. Carbon-14 D. Any D. 2 curies E. Phosphorus-32 E. Any E. 4 curies F. Sulfur-35 F. Any F. 4.5 curies G. Strontium-90 G. Foil sources G. 1 curie H. lodine-125 H. Any H. 2 curies I, Chromium-51 1. Any 1. 500 millicuries J. Americium-241:Be J. Sealed source (Gammatron J. 750 millicuries AN-HPG) l K. Any byproduct materitI with K. Any K. 10 microcuries of each l Atomic Nos. 85 through 103, isotope inclusive ,

l l

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) i NRC FORM 374A U.s. NUCLEAR RE7ULAToRY Commission PAGE 2 of 5 PAGES

, License Nurrber 34-00738-04 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-00902 Amendment No. 59 I

9. Authorized Use: l A. through I. To be used for research and development as defined in 10 CFR Part 30, Section 30.4, including animal studies, student instruction, instrument calibration, and interim storage of waste.

J. To be used as described in application dated April 28,1994.

K. To be used for counting standards; and possession incident to the analysis of environmental samples.

CONDITIONS l 10. A. Licensed material shall be used only at the licensee's facilities located at the main campus at 10900 Euclid Avenue, Cleveland, Ohio, University Hospitals,2065 Adelbert Road, Cleveland, Ohio, and at the University Circle Research Center ll,11001 Cedar Avenue, Cleveland, Ohio.

B. Licensed material may be received and stored at the Case Westem Reserve University Cedar Service Center,10620 Cedar Avenue, Cleveland, Ohio.

I

11. Licensed material shall be used by, or under the supervision of, individuals designated by the University's Radiation Safety Committee, David S. Mcpheeters, Ph.D., Chairperson.

l 12. A. The Radiation Safety Officer for this license is W. David Sedwick, Ph.D.

l B. The Assistant Radiation Safety Officer for this license is Karl Von Ahn.

I 13. A. Sealed sources and detector cells shall be tested for leakage and/or contamination at intervals not to exceed 6 months or at such other intervals as specified by the certificate of registration referred to in 10 CFR 32.210.

l l B. Notwithstanding Paragraph A of this Condition, sealed sources designed to emit alpha particles l shall be tested for leakage and/or contamination at intervals not to exceed 3 months.

C. In the absence of a certificate from a transferor indicating that a leak test has been made within 6 months prior to the transfer, a sealed source or detector cell received from another person shall not be put into use until tested.

D. Each sealed source fabricated by the licensee shall be inspected and tested for construction defects, leakage, and contamination prior to any use or transfer as a sealed source.

i

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) 6 NRC FORA $ 3NA u.s. NUCLEAR RE!uLAToRY CottesissioN PAGE 3 of 5 PACES a Ucense Number 34-00738-04 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-00902 Amendment No. 59 E. Sealed sources need not be leak tested if:

1 (1) they contain only hydrogen-3; or (ii) they contain only a radioactive gas; or (iii) the half-life of the isotope is 30 days or less; or I l - (iv) they contain not more than 100 microcuries of beta and/or gamma emitting material or not l l more than .10 microcuries of alpha emitting material; or (v) they are not designed to emit alpha particles, are in storage, and are not being used.

L However, when they are removed from storage for use or transferred to another person, a'd j l . have not been tested within the required leak test interval, they shall be tested before use or  ;

l 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.

l F. The leak 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 in accordance -

with 10 CFR 30.50(b)(2), and the source shall be removed immediately from service and l decontaminated, repaired, or disposed of in accordance with Comm~ission regulations. The report 4 l shall be filed within 5 days of the date the leak test result is known with the U.S. Nuclear Regulatory Commission, Region ill, ATTN: Chief, Nuclear Materials Safety Branch,801 Warrenville Road, Lisle, Illinois 60532-4351. The report shall specify the source involved, the test results, and l corrective action taken.

G. Tests for leakage and/or contamination shall be performed by the licensee or by other persons l specifically licensed by the Commission or an Agreement State to Perform such services.

14. Sealed sources or detector cells containing licensed material shall not be opened or sources removed l- from source holders by the licensee.
15. A. Detector cells containing a titanium tritide foil or a scandium tritide foil shall only be used in .

conjunction with a properly operating temperature control mechanism which prevents the foil l temperature from exceeding that specified by the manufacturer and approved by U.S. Nuclear Regulatory Commission.

t B. When in use, detector cells containing a titanium tritide foil or a scandium tritide foil shall be vented to the outside.

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i' NRC FORM 374A U.s. NUCLEAR RE2uLAToRY Commission PAGE 4 of 5 PAGES

., Ucense Number 34-00738-04 l MATERIALS LICENSE Dochet or Reference Number 030-00902 j

SUPPLEMENTARY SHEET Amendment No. 59 l

16. In addition to the possession limits in item 8, the licensee shall further restrict the possession of unsealed licensed material (with half-lives greater than 120 days) to quantities less than 105 times the applicable limits in Appendix C of 10 CFR Part 20, per the provisions of TO CFR 30.35(d).
17. The licensee shall conduct a physical inventory every 6 months to account for all sources and/or devices l

received and possessed under the license. Records of inventories shall be maintained for 5 years from the date of each inventory, and shallinclude the quantities and kinds of byproduct material, l manufacturer's name and model numbers, location of the sources and/or devices, and the date of the

! inventory.

l l 18. The licensee is authorized to hold radioactive material with a physical half-life of less than 90 days for decay-in-storage before disposal in ordinary trash provided:

A. Radioactive waste to be disposed of in this manner shall be held for decay a minimum of 10 half-lives.

l B. Before disposal as ordinary trash, byproduct material shall be surveyed at the container surface with

! the appropriate survey meter set on its most sensitive scale and with no interposed shielding to determine that its radioactivity cannot be distinguished from background. All radiation labels shall be removed or obliterated.

C. A record of each disposal permitted under this License Condition shall be retained for three years.

l The record must include the date of disposal, the date on which the byproduct material was placed j in storage, the radionuclides disposed, the survey instrument used, the background dose rate, the dose rate measured at the surface of each waste container, and the name of the individual who i performed the disposal.

19. Except as specifically provided otherwise in this license, the licensee shall conduct its program in aconroance with the statements, representations, and procedures contained in the documents, including any enclosures, listed below. The U.S. Nuclear Regulatory Commission's regulations shall govem unless the statements, representations, and procedures in the licensee's application and correspondence are more restricth= than the regulations.

I

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, NRC FORM 374A u.s. NUCLEAR RE7uLATORY COMMISSION PAGE 5 of 5 PAGES

, License Number 34-00738-04 MATERIALS LICENSE Docket or Reference Number l SUPPLEMENTARY SHEET 030-00902 1

Amendment No. 59 l

l A. Applications dated October 15,1993 and April 28,1994; and B. Letters with attachments dated December 17,1993, April 28,1994 (with attached application received May 2,1994), October 1,1994, August 1,1995 (with attachments), July 7,1995, November 8,1995, December 28,1995, March 7,1996, July 18,1996, July 31,1996, November 25,1996, and March 7,1997.

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l FOR THE U.S. NUCLEAR REGULATORY COMMISSION i

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f i James R. Mullauer, M.H.S.

Nuclear Materials Licensing Branch Region 111 ,

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4 u.s. NUCLEAR REGULATORY Commission

, Amendment No. 57 i Licwater MATERIALS LICENSE 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 I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations i heretofore mac,s by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, I source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to deliveror transfer such material to persons authorized to receive it in accordancewith the regulations of the applicable Part(s). This license shall 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,and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below, ucensee in accordance with letters dated August 26,1997, October 8,1997 and October 9,1997

1. Department of Veteran Affairs 3. License number 34-00203-03 is amended in Medical Center its entirety as follows: l
2. 10701 East Boulevard 4. Expiration date September 30,2002 l Cleveland, OH 44106 5. Docket No. 030-02639 Reference No.
6. Byproduct, source, and/or special 7. Chemical and/or physical form 8. Maximum amount that licensee may nuclear material possess at any one time under this license A. Any byproduct material A. Any radiopharmaceutical A. As needed identified in 10 CFR 35.100 identified in 10 CFR 35.100 B. Any byproduct material B. Any radiopharmaceutical B. As needed identified in 10 CFR 35.200 identified in 10 CFR 35.200 (excluding generators)

C. Any byproduct material C. Any radiopharmaceutical C. As needed (Not to exceed identified in 10 CFR 35.300 identified in 10 CFR 35.300 1500 millicuries of iodine-131)

D. Any byproduct material D. Any brachytherapy sources D. 525 millicuries identified in 10 CFR 35.400 identified in 10 CFR 35.400 E. Any byproduct material E. Sealed sources identified in E. As needed identified in 10 CFR 35.500 10 CFR 35.500 F. Uranium depleted in F. Cadmium plated metal F. As needed Uranium-235 G. Any byproduct material with G. Any G. Not to exceed 40 millicuries Atomic Numbers 3 through per radionuclide, except as 83, inclusive, excluding listed below; alpha-emitters Hydrogen-3 900 millicuries Carbon-14 150 millicuries Phosphorus-32 80 millicuries Sulfur-35 120 millicuries lodine-125 65 millicuries Ah4

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NRC FORM 374A U.S. NUCLEAR REGULATORY COMMISSION PAGE 2 of 6 PAGES g Ucense Number 34-00203-03 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-02639 Amendment No. 57 l

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6. Byproduct, source, and/or special 7. Chemical and/or physical form 8. Maximum amount that licensee may i nuclear material possess at any one time under this license l H. Nickel-63 H. Foil sources in detector H. No single foil to exceed 15 cells, registered with the millicuries l NRC or an Agreement l State, in accordance with l 10 CFR 32.210 l l
9. Authorized Use:

A. Medical use described in 10 CFR 35.100.

l l B. Medical use described in 10 CFR 35.200 (excluding generators).

C. Medical use described in 10 CFR 35.300.

D. Medical use described in 10 CFR 35.400.

E. Medical use described in 10 CFR 35.500 in devices which have been evaluated and approved for licensing purposes by the U.S. Nuclear Regulatory Commission or an Agreement State.

F. Shielding in a linear accelerator.

G. To be used for medical research and research and development as defined in 10 CFR 30.4 including animal studies.

i H. To be used in gas chromatographs for sample analysis.

CONDITIONS

10. Licensed material shall be used only at the licensee's facilities located at 10701 East Boulevard, Cleveland, Ohio.
11. The Radiation Safety Officer for this license is Steven W. Landgraf, M.A.
12. A. Licensed material shall only be used by, or under the supervision of, individuals designated by the Radiation Safety Committee, Vasudeo G. Diwan, M.D., Chairman.

B. The use of lit:ensed material in or on humans shall be by a physician, dentist, or podiatrist as defined in 10 CFR 35.2.

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NRcFoRusnA u.s. NUCLEAR RE!uLAToRY CotARetssioN PAGE 3 of 6 PAGES

/ Uconee Number 34-00203-03 MATERIALS LICENSE DocW or Reference Number SUPPLEMENTARY SHEET 030-02639 Amendment No. 57 C. Physicians, dentists, or podiatrists designated to use licensed material in or on humans shall meet the training criteria established in 10 CFR 35, Subpart J and shall be designated by the licensee's

~ Radiation Safety Committee.

D. Individuals designated to use licensed material for research and development (excluding human use) shall meet the training and experience requirements in 10 CFR Part 33, Section 33.15(b),(1) and (2).

13. In addition to the possession limits in item 8, the licensee shall further restrict the possession of licensed material to quantities below the limits specified in 10 CFR 30.72 which require consideration of the need .

for an emergency plan for responding to a release of licensed material.

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14. In addition to the possession limits in item 8, the licensee shall further restrict the possession of licensed material to quantities below the minimum limit specified in 10 CFR 30.35(d) for establishing decommissioning financial assurance.
15. A; Sealed sources and detector cells shall be tested for leakage and/or contamination at intervals not to exceed 6 months or at such other intervals as specified by the certificate of registration referred to in 10 CFR 32.210.

B. In the absence of a certificate from a transferor indicating that a leak test has been made within 6 months prior to the transfer, a sealed source or detector cell received from another person shall not be put into use until tested.

C. Each sealed source fabricated by the licensee shall be inspected and tested for construction defects, leakage, and contamination prior to any use or transfer as a sealed source.-

D. Sealed sources need not be leak tested if:

(i) they contain only hydrogen-3; or (ii) they contain only a radioactive gas; or (iii) the half-life of the isotope is 30 days or less; or (iv) they contain not more than 100 microcuries of beta and/or gamma emitting material or not more than 10 microcuries of alpha emitting material; or ]

I (v) they are not designed to emit alpha particles, are in storage, and are not being used. However, when they are removed from storage for use or transferred 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 FORM 374A u.S. NUCLEAR REiuLAToRY Commission PAGE 4 cf 6 PAGES

/ License Number 34-00203-03 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-02639 Amendment No. 57 l 1 1

l E. The leak test shall be capable of detecting the presence of 0.005 microcurie of radioactive material I on the test sample. lithe 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 in accordance with 10 CFR 30.50(b)(2), and the source shall be removed immediatelf from service and decontaminated, repaired, or disposed of in accordance with Commission regulations. The report shall ba %d within 5 days of the date the leak test result is known with the U.S. Nuclear Regulatory Canmission, Region lil, ATTN: Chief, Nuclear Materials Safety Branch,801 Warrenville Road, Lisle, Illinois 60532-4351. The report shall specify the source involved, the test results, and corrective action taken.

F. Tests for leakage and/or contamination shall be performed by the licensee or by other persons specifically licensed by the Commission or an Agreement State to perform such services.

16. The licensee shall conduct a physical inventory every 3 months to account for all sources and/or devices received and possessed pursuant to 10 CFR 35.59,10 CFR 35.400 and 10 CFR 35.500 and every 6 months for all other sources and/or devices.
17. Sealed sources or detector cells containing licensed material shall not be opened or sources removed from source holders by the licensee.
18. Maintenance, repair, cleaning, replacement, and disposal of foils contained in detector cells shall be performed only by the device manufacturer or other persons specifically authorized by the Commission or an Agreement State to perform such services.
19. A. Detector cells containing a titanium tritide foil or a scandium tritide foil shall only be used in conjunction with a properly operating temperature control mechanism which prevents the foil temperature from exceeding that specified by the manufacturer and approved by NRC.

B. When in use, detector cells containing a titanium tritide foil or a scandium tritide foil shall be vented to the outside.

, 20. Except as otherwise specified in this license, the licensee shall have available and follow the instructions l contained in the manufacturer's instruction manual for the chromatography device.  ;

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21. Experimental animals, or the products from experimental animals, that have been administered licensed materials shall not be used for human consumption.
22. Notwithstanding the requirements of 10 CFR 35.49(a) and (b),10 CFR 35.100,10 CFR 35.200, 10 CFR 35.300,10 CFR 35.400, and 10 CFR 35.500, the licensee may use for any medical use any byproduct material or reagent kit. The licensee shall possess and use byproduct material for medical use l in accordance with the prescriptive and performance criteria in the other sections of 10 CFR 35. This )

does not relieve the licensee from complying with applicable United States Food and Drug  :

Administration (FDA) and other Federal and State requirements. j

23. The licensee shall not use licensed material in field applications where activity is released except as l

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.y NRC PoRM 374A u.s. NUCLEAR REIuLAToRY 'CohMNssioN PAGE 5 of 6 PAGES

/ Ucense Number -

34-00203-03 MATERIALS LICENSE DocM or RWence Number l 030-02639 t

SUPPLEMENTARY SHEET Amendment No. 57

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provided otherwise by specific condition of this license.

24. - The licensee is authorized to hold radioactive material with a physical half-life of less than 90 days for decay-in-storage before disposal in ordinary trash provided:

A. _ Radioactive waste to be disposed of in this manner shall be held for decay a minimum of 10 half-lives.

B. Before disposal as ordinary trash, byproduct material shall be surveyed at the container surface with the appropriate survey meter set on its most sensitive scale and with no interposed shielding to l determine that its radioactivity cannot be distinguished from background. All radiation labels shall be l removed or obliterated.

, C. A record of each disposal permitted under this License Condition shall be retained for three years.

The record must include the date of disposal, the date on which the byproduct material was placed in storage, the radionuclides disposed, the survey instrument used, the background dose rate, the dose rate measured at the surface of each waste container, and the name of the individual who performed the disposal.

25. 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 any enclosures, listed below, except for minor changes in the medical use radiation safety procedures as provided in 10 CFR 35.31. The Nuclear Regulatory Commission's regulations shall govem unless the statements, representations, and procedures in the licensee's application and correspondence are more restrictive than the regulations.

A. Letters dated April 18,1995, including attachments excluding attachment 10.3.2, item 9.1, all references to excepting human use areas from dose rate surveys and wipe tests when unsealed radioactive material was not used or disposed of during a week and excluding all references to generators; March 7,1996 (excluding request in item A. response for RSC to designate alternate RSO's intemally), September 11,1996, August 29,1997, August 26,1997, October 8,1997 and October 9,1997.

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( NRC FORM 374A U.S. NUCLEAR RE!ULATORY COMMISSION PAGE 6 of 6 PAGES

/ License Number '

34-00203-03 MATERIALS LICENSE Docket or Referenes Number i SUPPLEMENTARY SHEET 030-02639 Amendment No. 57 i

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Nuclear Materials Licensing Branch l' Region lll 1

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t' u.s. NuCUEAR RE!uLAToRY CotHAlsslON

{ mendme No.37 Licwater MATERIALS LICENSE Pursuantto 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 I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representatens heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear matenal designated below; to use such material for the purpose (s) and at the place (s) designated below; to delever or transfer such material to persons authonzed to recewe it in accordance with the regulations of the applicable Part(s). This license shall 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,and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.

Ucensee In accordance with the letter dated December 15,1997

1. University Hospitals of Cleveland 3. Ucense number 34-05469-01 is amended in its entirety to read as follows:

2.11100 Euclid Avenue 4. Expiration date July 31,2001 Cleveland, OH 44106 5. Docket No. 030-02745 Reference No.

6. Byproduct, source, and/or special 7. Chemical and/or physical form 8. Maximum amount that licensee may nuclear material possess at any one time under this license A. ' Any byproduct material with A. Any A. 50 millicuries each nuclide, atomic numbers 3 through total possession not to 83 exceed 4 curies B. Hydrogen-3 B. Any B. 50 millicuries -

C. Molybdenum-99 C. Any C. 6000 millicuries I

D. Technetium-99m D. Any D. 6000 millicules E. lodine-131 E. Any E. 1000 millicuries F. lodine-125 F. Any F. 500 millicuries G. Phosphorus-32 G. Any G. 500 millicuries H.- Palladium-103 H. Sealed sources H. 500 millicuries

1. Xenon-133 1. Any 1. 500 millicuries J. Cesium-137 ' J. Sealed sources J. 4000 millicuries

' K. Iridium-192 K. Sealed sources K. 1000 millicuries L. Gold-198 L. Sealed sources L. 1000 millicuries M. Samarium-153 M. Any M. 300 millicuries N. Strontium-90 N. Sealed sources N. 150 millicuries O. Cesium-137 O. Seales source (J.L. O. 3000 millicuries Shepherd Model No. 28-6B)

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  • NRC FORM 374A u.s. NUCLEAR RE!uLAToRY CoMMISSloN PAGE 2 of 8 PAGES l , License Number ,

l 34-05469-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-02745 Amendment No. 37

6. Byproduct, source, and/or special 7. Chemical and/or physical form B. Maximum amount that licensee may I

nuclear material possess at any one time under this license P. Cesium-137 P. Sealed sources (AECL type P. 2 sources- 720 curies each ISO-100082Cs) f Q. Americium-241 Q. Sealed sources (ICN Model Q. 5 millicuries 400) i R. Cobalt-60 R. Sealed sources (General R. 14,000 curies (402 sources Electric Co. AB Elekta not to exceed 35 curies Model No. 43047) each) l

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9. Authorized Use A. through M. Medical diagnosis, therapy and research in humans, research and development as l defined in 10 CFR 30.4 including instrument calibration (in-house only), and animal J studies.

N. Ophthalmic eye applicator for treatment of superficial eye conditions. I O. To be used for licensee's instrument calibration only.

P. To be used in an AECL Gammacell 1000 Model B irradiator for irradiation of medical specimens and i- research materials, except explosive or flammable materials.

Q. To be used for licensee's instrument calibration only.

R. For use, installation, source replacement, and temporary storage in a Leksell Gamma System Model 23004 Type B (a.k.a. Gamma Knife or Gamma Stereotactic Radiosurgery Unit) radiation therapy unit i for the treatment of humans, human research studies, and non-human research studies (including

, animals).

l l CONDITIONS i

10. Location of use: 11100 Euclid, Cleveland, Ohio. Licensed materiallisted in Subitem R. shall be used  !

only in Room B274 of the Bolwell Building at the University Hospitals of Cleveland,11100 Euclid Avenue,  ;

Cleveland, Ohio. Licensed materiallisted in 10 CFR 35.100 and 35.200 (excluding generators, Xe-133  :

and Tc-99m aerosols) may be used at The Parkway Medical Center, Suite 2109,3619 Park East Drive, B6::chwood, Ohio. ,

11. bJiation Safety Officer M. Pejavar Sridhar Rao. 4 j

e l NRC FORM 374A u.s. NUCLEAR RE!uLAToRY Commission PAGE' 3 (f 8 PAGES l , Woonse Number 34-05469-01 MATERIALS LICENSE D cW or RWrence Number SUPPLEMENTARY SHEET 030-02745 Amendment No. 37 l

12. A. The use of licensed material in or on humans shall be by a physician as defined in 10 CFR 35.2.

B. Physicians designated to use licensed material in or on humans shall meet the training criteria 1 established in 10 CFR 35, Subpart J and shall be designated by the licensee's Radiation Safety Committee. The licensee shall maintain records of physicians designated as users.

C. Physicians designated to use licenud material listed in Subitem 9.R., in or on humans, shall meet the training criteria established in 10 CFR 35, Subpart J and item 6.A. of letter dated December 15,1997, and shall be designated by the licensee's Radiation Safety Committee, A. R. Antunez, M.D., Chairperson.

D. Licensed material for other than human use shall be used by, or under the supervision of individuals designated by the Radiation Safety Committee, A. R. Antunez, M.D., Chairperson. The licensee shall maintain records of individuals designated as users.

13. In addition to the possession limits in item 8, the licensee shall further rat-ict the possession of licensed material to quantities below the limits specified in 10 CFR 30.72 which require consideration of the need for an emergency plan for responding to a release of licensed material, and shall further restrict the possession of unsealed licensed material to quantities below the minimum limit specified in 10 CFR 30.35(d) for establishing decommissioning financial assurance.
14. A. Sealed sources and detector cells shall be tested for leakage and/or contamination at intervals not to exceed 6 months or at such other intervals as specified by the certificate of registration, referred to in 10 CFR 32.210.

B. Notwithstanding Paragraph A of this condition, sealed sources designed to emit alpha particles shall be tested for leakage and/or contamination at intervals not to exceed 3 months. l C. In the absence of a certificate from a transferor indicating that a test has been made, a sealed source or detector cell received from another person shall not be put into use until tested.

'i D. Sealed sources need not be leak tested if: l (i) they contain only hydrogen-3; or I

(ii) they contain only krypton-85; or _

(iii) the half-life of the isotope is 30 days or less; or (iv) they contain not more than 100 microcuries of beta and/or gamma emitting material or not more than 10 microcuries alpha emitting materials; or l

a NRC FORM 374A u.s. NUCLEAR RE2uLAToRY Commission PAGE 4 of 8 PAGES

., License Number 34-05469-01 MATERIALS LICENSE oocket or R.ver.nce Number SUPPLEMENTARY SHEET 030-02745 Amendment No. 37

'(v) they are not designed to emit alpha particles, are in storage, and are not being used. However,-

when they are removed from storage for use or transferred 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.

E. The leak 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 shall be removed from service and decontaminated, repaired, or disposed of in accordance with Commission regulations. The report shall be filed within 5 days of the date the leak test result is known with the U.S. Nuclear Regulatory Commission, Region Ill,801 Warrenville Road, Lisle, Illinais 60532-4351, ATTN: Chief, Nuclear Materials Safety Branch. The report shall specify the source involved, the test results, and corrective action taken. . Records of leak test results shall be kept in units of microcuries and shall be maintained for inspection by the Commission. Records may be disposed of following Commission inspection.

F. Tests for leakage and/or contamination shall be performed by the licensee or by other persons specifically licensed by the Commission or an Agreement State to perform such services.

15. Pursuant to 10 CFR 40, " Domestic licensing of Source Material," the licensee is authorized to possess, use, transfer, and import up to 999 kilograms of depleted uranium contained as shielding material.

.16. Notwithstanding the requirements of 10 CFR 35.315(a)(4), the licensee may measure the dose rates in

. contiguous restricted and unrestricted areas in accordance with the procedures described in letters dated May 6,1996, and June 19,1996.

17. The licensu shall possess and use byproduct material for human research use in accordance with the prescriptive and performance enteria in all sections of 10 CFR Part 35 except sections 35.49(a) and (b),

35.100,35.200,35.300,35.400 and 35.500.

18. Notwithstanding the requirements of 10 CFR 35.49(a) and (b),10 CFR 35.100,10 CFR 35.200, 10 CFF. 35.300,10 CFR 35.400 and 10 CFR 35.500, the licensee may use for medical use any byproduct material or reagent kit. The licensee shall possess and use byproduct material for medical use in accordance with the prescriptive and performance criteria in the other sections of 10 CFR 35. This does .

not relieve the licensee from complying with applicable Food and Drug Administration (FDA) and other

~ Federal and Stata requirements.

19. Sealed sources or detector cells containing licensed material shall not be opened or sources removed from source holders or detector cells by the licensee.

1

l NRC FoRAI 3MA u.s. NUCLEAR REGULATORY CotillissioN PAGE 5 of 8 PAGES

, Ucense Number 34-05469-01 MATERIALS LICENSE M w Reference Number SUPPLEMENTARY SHEET 030-02745 Amendment No. 37

20. . The licensee is authorized to hold radioactive material with a physical half-life of less than 65 days for decay-in-storage before disposal in ordinary tiash provided:

A. Radioactive waste to be disposed of in this manner shall be held for decay a minimum of 10 half-lives.

B. Before disposal as normal waste, radioactive waste shall be surveyed to determine that its radioactivity cannot be distinguished from background. All radiation labels shall be removed or obliterated.

C. Generator columns shall be segregated so that they may be monitored separately to ensure decay to background levels prior to disposal.

21. The licensee shall not perform iodinations with iodine-131 or iodine-125 using quantities in excess of '

10 millicuries of iodine-131 or iodine-125 without specific written authorization from the U.S. Nuclear Regulatory Commission, Region lil, 801 Warrenville Road, Lisle, Illinois 60532-4351, ATTN: Chief, Division of Nuclear Materials Safety.

22. Experimental animals administered licensed materials or their products shall not be used for human consumption.
23. The licensee is exempted from decommissioning financial assurance requirements for possession of licensed material in sealed sources in quantities greater than the limits in 10 CFR 30.35(d) for the purpose of source changes only. This exemption is granted for no more than 30 days for any one source change.
24. The licensee is authorized to transport licensed material only in accordance with the provisions of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material."
25. This license does not authorize distribution to persons licensed pursuant to 10 CFR 35.14 and 35.100.
26. Notwithstanding the requirements of 10 CFR 35.400(d) and (g) the licensee may use iridium-192 as seeds encased in nylon ribbon for topical, interstitial, and intracavitary treatment of cancer. The licensee may deviate from the manufacturer's radiation safety and handling instructions to the extent that the instructions are not applicable to the type of use proposed by the licensee.

. 27. Notwithstanding the requirements of 10 CFR 35.415(a)(4), the licensee may measure the dose rates in contiguous restricted and unrestricted areas in accordance with procedures described in letters dated October 6,1994 and May 10,1995.

28. A. The Gamma Knife shall be tested for leakage and/ur contamination at intervals not to exceed six (6) months or at such other intervals as specified by the certificate or registration referred to in 10 CFR 32.210.

e NRC PoRM 374A - u.s. NUCLEAR RE7uLAToRY CohnAlssioN PAGE 6 of 8 PAGES

-a Woonee Number 34-05469-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-02745 Amendment No. 37 B. In the absence of a certificate from a transferor indicating that a leak test has been made within six (6) months prior to the transfer, a sealed source or detector cell received from another person shall not be put into use untiltested.

C. The test sample shall be taken from selected accessible surfaces of the Gamma Knife. The selected accessible surfaces should be those surfaces on which one might expect contamination (if there were to be leakage) to accumulated and shall include the inner surface of the most frequently used helmets. A minimum of a single wipe of the entire surface for the collimator will be taken.

D. The leak test shall be capable of detecting the oresence 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 in accordance with 10 CFR 30.52(b)(2), and the source shall be removed immediately from service and decontaminated, repaired, or disposed of in accordance with Commission regulations. The report shall be filed within 5 days of the date the leak test result is known with the U.S. Nuclear Regulatory Commission, Region lil, ATTN: Chief, Nuclear Materials Safety Branch, 801 Warrenville Road, Lisle, Illinois 60532-4351. The report shall specify the source involved, the test results and corrective action taken.

E. Tests for leakage and/or contamination shall be performed by the licensee or by other persons specifically licensed by the Commission and or an Agreement State to perform such services.

. 2g. A.- Access to the Gamma Knife room shall be controlled by a door at each entrance. Such doors shall be normally closed.

B. Each entrance to the Gamma Knife room shall be equipped with an electrical interlock system that will remove the patient from the focus beam of radiation upon opening of any entrance door. The interlock system shall be connected in such a manner that the patient cannot be returned to the focus beam until all treatment room entrance doors are closed and the control is reset at the control panel.

C. Electrical interlocks on entrance doors to the Gamma Knife room shall be tested for proper operation at least once every 6 months. Records of test results shall be maintained for inspection by the Commission. Records may be disposed of following Commission inspection.

D. In the event of malfunction of any door interlock, the Gamma Knife control shall be locked in the "off" condition and not used, except as may be necessary for repair or replacement of the interlock system, until the inte;1ock system is shown to be functioning properly.

30. A. Any changes made in the treatment room shielding, location of the unit within the treatment room, or use of the Gamma Knife unit that could result in increased radiation levels in areas outside the Gamma Knife treatment room shall be evaluated by a radiation survey made in accordance with Condition 31. and reported to the Commission within 30 days following completion of the change (s).

! B. Revocation of the Gamma Knife unit to a new facility is not permitted without prior approval of the

_ plans and details by the Commission. Following such approval and relocation, a radiation survey

I NRC FORM 374A u.s. NUCLEAR REGULATORY CoMMrsioN PAGE 7 of 8 PAGEs

, License Number 34-05469-01 MATERIALS LICENSE comet or R.rerence Number I SUPPLEMENTARY SHEET 030-02745 Amendment No. 37 1 l

l shall be made in accordance with Condition 31. and reported to the Commission within 30 days after completion of the move.

l l

l 31. Before initiation of a treatment program, and subsequent to each installation of a Gamma Knife source,  ;

radiation surveys and tests shall be performed in accordance with the following:  !

A. A radiation survey shall be made of:  ;

I l (i) The Gamma Knife source housing, with the shielding door closed. The maximum and average  !

radiation levels at 1 meter from the Gamma Knife housing in the closed position shall not l j exceed 10 milliroentgens per hour and 2 milliroentgens per hour, respectively. i (ii) All areas adjacent to the treatment room with the Gamma Knife shielding door in the open position. The survey shall be performed with a phantom in the focus beam of radiation and shall clearly establish: i l

(a) That radiation levels in restricted areas are not likely to cause personnel exposure in excess of the limits specified in Section 20.1201 of 10 CFR Part 20.

l (b) The quantities of radiation in unrestricted areas do not exceed the limits specified in l Section 20.1301 of 10 CFR Part 20.

B. Tests shall be made to determine proper operation of:

(i) Electrical interlocks on entrance doors to the Gamma Knife treatment room.

i (ii) The Gamma Knife treatment timing device.

l C. A report of the results of the above surveys and tests shall be sent to the U.S. Nuclear Regulatory Commission, Region 111, 801 Warrenville Road, Lisle, Illinois 60532-4351, ATTN: Chief, Materials Licensing Branch not more than 30 days after each installation of a Gamma Knife source.

32. The following shall be performed by the manufacturer or persons specifically licensed by the Commission l or an Agreement State to perform such services:

A. Installation, relocation, or removal of Gamma Knife units containing sources.

B. Source exchange.

C. Any maintenance or repair operations on the Gamma Knife unit involving a mechanism that could j expose the source, reduce the shielding around the sources, or compromise the safety of the unit and result in increased radiation levels.

t NRC FORM 374A u.S. NUCLEAR RE!uLATORY COMMISSION PAGE 8 of 8 PAGEs

, License Nurnber 34-05469-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-02745 Amendment No. 37

33. 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 any enclosures, listed below. The Nuclear Regula'.ory 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. Application dated February 20,1990; B. Letters dated June 4,1991 (except item xi iodine-131 is limited to use of 10 millicuries for iodination procedures), September 9,1991, October 6,1994, May 10,1995, February 2,1996 and May 6, 1996, June 19,1996, July 22,1997 and August 14,1997, September 9,1997 (with attachments),

l October 14,1997, November 3,1997, November 20,1997 and December 15,1997; and l

l C. Letter received October 25,1991.

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I FOR THE U.S. NUCLEAR REGULATORY COMMISSION

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I Date By

t NRC FORM 374A U.S. NUCLEAR REGULATORY COMWSSION PAGE 9 of 8

,. PAGES e Lloense Number 34-05469-01 MATERIALS LICENSE Docket or Reference Number SUPPLEMENTARY SHEET 030-02745 Amendment No. 37 Nuclear Materials Licensing Branch Region til i

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U.s. NUCLEAR REGULATORY Commission Amindm;nt No. 23 l Liewater MATERIALS LICENSE Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, Code l of Federal Regulations, Chapter 1, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations j heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to deliver or transfer such materialto persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all cpplicable rules, regule'. ions,and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.

Ucensee In accordance with letter dated March 7,1997

1. Case Western Reserve University 3. Ucense number 34-00738-07 is amended in Dept. of Occupational and its entirety to read as follows:

l 2. Environmental Safety 4. Expiration date October 31,2001 l 10900 Quail Building 5. Docket No. 030-07040 Cleveland, OH 44106 Reference No.

6. Byproduct, source, and/or special 7. Chemical and/or physical form 8. Maximum amount that license may nuclear material possess at any one time undt this license l

l A. Cobalt-60 A. Sealed source (U.S. A. 4,200 curies Nuclear Corp. Capsule Type 3251) 1

9. Authorized Use:

A. To be used in a U.S. Nuclear Corporation Model GR-9 Irradiator for radiobiological research and l

educational purposes (excluding irradiation of explosives and flammable materials).

CONDITIONS I

10. Licensed material shall be used only at the licensee's facilities located at Case Western Reserve University,10900 Euclid Avenue, Cleveland, Ohio.
11. Licensed material shall be used by, or under the supervision of, Oddvar F. Nygaard, Ph.D., Nancy L.

Oleinick, Ph.D., John W. Mulvibill, or Marie Vames, Ph.D.

l l 12. A. The Radiation Safety Officer for this license is W. David Sedwick, Ph.D.

i B. The Assistant Radiation Safety Officer for this license is Karl Von Ahn. )

13. Sealed sources containing licensed material shall not be opened or removed from the irradiator by the licensee.

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I susu, re-- Men - u.a. -L-'_ = = . rmt=_= i viu u _-_- raut a or a re_m L60ense Number y 34-00738-07 MATERIALS LICENSE DocW or RWmnoe Number SUPPLEMENTARY SHEET 030-07040 Amendment No. 23 l

l l 14. A. (1) The source (s) specified in item (s) 7.A. shall be tested for leakage and/or contamination at j intervals not to exceed 6 months. Any source received from another person which is not -

accompanied by a certificate indicating that a test was performed within 6 months before the transfer shall not be put into use until tested.

(2) Notwithstanding the periodic leak test required by this condition, any licensed sealed source is exempt from such leak tests when the source contains 100 microcuries or less of beta and/or gamma emitting material or 10 microcuries or less of alpha emitting material.

B. Any source in storage and not being used need not be tested. When the source is removed from l storage for use or transfer to another person, it shall be tested before use or transfer, f

j. C. 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 removat,;e contamination, the source shall be removed ' rom service and decontaminated, repaired, or disposed of in accordance with Commission regulatir es. A report shall be filed within 5 days of the date the
i. leak test result is known with the U.S. Nuc ear Regulatory Commission, Region Ill, 801 Warrenville Road, Lisle, Illinois 60532-4351, ATTN: Chief, Nuclear Materials Safety Branch. The report shall specify the source involved, the test results, and corrective action taken. Records of leak test results shall be kept in units of microcuries and shall be maintained for inspection by the Commission.

Records may be disposed of following Commission inspection.

!- D. Tests for leakage and/or contamination shall be performed by the licensee or by other persons specifically licensed by the Commission or an Agreement State to perform such services.

L15. The licensee shall not perform repairs or alterations of the irradiator involving removal of shielding or access to the licensed material. Removal, replacement, and disposal of sealed sources in the irradiator shall be performed by a person specifically licensed by the Commission or an Agreement State to perform such services.

16. The licensee shall maintain records of information important to safe and effective decommissioning at the address is Condition 10. per the provisions of 10 CFR 30.35(g) until this license is terminated by the Commission,
17. 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 any enclosures, listed below. The 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, i

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l ', nnu runin 374A u.a. NUELt*M MtWULAIvru LL rDIUM VAUt J 01 4 VAUtd l License Number g

34-00738-07 D eket or Reference Number MATERIALS LICENSE SUPPLEMENTARY SHEET 030-07040 l Amendment No. 23 l

l A. Applications dated April 22,1991 and October 15,1992 (excluding request to release old facility to unrestricted use); and B. Letters dated September 24,1991, October 3,1991, November 23,1992 (excluding request to release old facility to unrestricted use), December 28,1992 (with attachments), August 20,1993, July 25,1994, July 7,1995, November 8,1995, July 18,1996, July 31,1996, and March 7,1997.

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  • NRC FORM 374 PAGE 1 OF 3 PAGEs u.s. NUCLEAR REGULATORY COMMllsioN

} Amendment No.1 >

Llewater MATERIALS LICENSE 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 heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, ]

source, and special 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 thc :onddions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all l applicable rules, regulations,and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions speciried l below.

Licensee In accordance with application dated

! December 31,1990

1. The Cleveland Museum of Art 3. Ucense number 34-24631-01 is renewed in its entirety to read as follows:

l 2.11150 East Buulevard 4. Expiration date February 28,1996 Cleveland, OH 44106 5. Docket No. 030-18725 l Reference No.

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6. Byproduct, source, and/or siecial 7. Chemical and/or physical form 8. Maximum amount that licensee may i nuclear material possess at any one time under this  !

license l A. Carbon-14 A. Polymer source (Amersham A. 8 millicuries l CFP.22)

9. Authorized Use:

l A. To be used in the radiographic examination of watermarks in art works of paper or similar material.

CONDITIONS

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10. Licensed material shall be used only at the licensee's facilities located at 11150 East Boulevard, l
Cleveland, Ohio. I i 11 The Radiction Protection Officer for the attwities authorized by this license is Bruce Christman. ,

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12. Licensed material shall be used by Bruce Christmari, Charles Eiben and Jane Glaubinger.
13. A. (1) The source (s) specified in item (s) 7.A. shall be tested for leakage and/or contamination at intervals not to exceed 6 months. Any source received from another person which is not accompanied by a certificate indicating that a test was performed within 6 months before the transfer shall not be put into use until tested.

i (2) Notwithstanding the periodic leak tett required by this condition, any licensed sealed source is exempt from such leak tests when the source contains 100 microcuries or less of beta and/or gamma emitting material or 10 microcuries or less of alpha emitting material.

B. Any source in storage and not being used need not be tested. When the source is removed from j storage for use or transfer to another person, it shall be tested before use or transfer. j 4t$

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4 NRc FORM 374A u.s. NUCLEAR RE7uLAToRY Commission PAGE 2 of 3 PAGES f Ucense Number 34-24631-01 Docket or Reference Number

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MATERIALS LICENSE l SUPPLEMENTARY SHEET 030-18725 Amendment No.1 I

C. 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 l contamination, the source shall be removed from service and decontaminated, repaired, er  !

disposed of in accordance with Commission regulations. A report shall be filed within 5 days of the I date the leak test result is known with the U.S. Nuclear Re0ulatory Commission, Region Ili, 799 Roosevelt Road, Glen Ellyn, Illinois 60137, ATTN: Chief, Nuclear Materials Safety Branch. The report shall specify the source involved, the test results, and corrective action taken. Records of leak test results shall be kept in units of microcuries and shall be maintained for inspection by the Commission. Records may be disposed of following Commission inspe.ntion. D. Tests for leakage and/or contamination shall be performed by the licensee or by other persons specifically licensed by the Commission or an Agreement State to perforrn such services.

14. The licensee shall follow the instruction outlined in Amersham intemational Ltd. Product Specification  !

Data Sheet No.11268 dated September 1979.

15. Except as specifically provided otherwise in this license, the licensee shall conduct its program in accordance with the statements, re,nresentations; and procedures contained in the documents including any enclosures, listed below. The Nuclear Regulatory Ccmmission's regulations shall govern unless the ,

statements, representations and procedures in the licensee's application and correspondence are more restrictive than the regulations.

A. Application dated December 31,1990 (with attachments).

FOR THE U.S. NUCLEAR REGULATORY COMMISSION Date By Nuclear Materials Licensing Section Region lll

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6 u.S. NUCLEAR REGULATORY COMMIS31oN jj Amendment No.17 l Licwater MATERIALS LICENSE Pursuantto 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 I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and revesentations ,

l heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, anc* trancier byproduct, Il source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to i deliver or tmnsfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license 1 l Chall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as arr.anded, and is subject to all Cpplicable rules, regulations,and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.

Licensee in accordance with letter dated March 7,1997

1. Case Westem Reserve University 3. Ucense number 34-00738-09 is amended Department of Occupational & in its entirety to read as follows:
2. Environmenta' Safety 4. Expiration cale June 30,2002 Quail Building #216 5. Dochet No. 030-29480 Cleveland, OH 44106 Reference No.
6. Byproduct, source, and/or special 7. Chemicaland/orphysicalform 8. Maximum amount that licensee may nuclear material possess at any one time under this license I

.A. Cobalt-60 A. Sealed sources (AECL A. 7000 curies total o Model C-166, C-167, C-185 or C-198 source pencils)

9. Authorized Use:

A. To be used in an AECL Gammacell 220 irradiator for the irradiation of polymers, excluding flammables and explosives.

l CONDITIONS

10. Licensed material shall be used only at the licensee's facilities located at The Olin Research Building, 10900 Euclid Avenue, Cleveland, Ohio.
11. Licensed material shall be used by, or under the supervision of, Jerome B. Lando, Ph.D.

1

12. A. The Radiation Protection Officer for the activities authorized by this license is W. David Sedwick,

! Ph.D.

l B. The Assistant Radiation Protection Officer is Karl Von Ahn.

13. A. Sealed sources and detector cells shall be tested for leakage and/or contamination at intefvals not to exceed 6 months or at such other intervals as specified by the certificate of registration referred to in 10 CFR 32.210.

Ak/

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, 34-00738-09 MATERIALS LICENSE ' DocW or Memnos Number SUPPLEMENTARY SHEET 030-29480 Amendmsnt No.17 B. Sealed sources need not be leak tested if:

(i) they contain only hydrogen-3; or (ii) th6y contain only a radioactive gas; or (iii) the half-life of the isotope is 30 days or less; or (iv) they contain not more than 100 microcuries of beta and/or gamma emitting material or not more than 10 microcuries of alpha emitting material; or l

(v) they are not designed to emit alpha particles. are in storage, and are not being used. However, j when they are removed from storage for usu or transferred 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 celi shall be stored for a period of more than 10 years without being tested for leakage and/or contamination.

C.' The leak test shall be capable of detecting the presence of 0.005 microcurie of radioactive material l on the test sample. Records of leak test results shall be kept in units of microcuries and shall be maintained for inspection by he Commission. If the test reveals the presence of 0.005 microcurie or more of removable contamination, a report shall be removed immediately from service and l decontaminated, repaired, or disposed of in accordance with Commission regulations._ The report shall be filed within 5 days of the date the leak test result is known with the U.S. Nuclear Regulatory Commission, Region Ill, 801 Warrenville Road, Lisle, Illinois 60532-4351, ATTN: Chief, Nuclear ,

Materials Safety Branch, Division of Radiation Safety and Safeguards. The report shall specify the  !

source involved, the test results, and corrective action taken. Records of leak test results shall be kept in units of microcuries and shall be maintained for inspection by the Commission. Records may be dispos 6d of following Commission inspection.

l D. Tests for leakage and/or contamination shall be performed by the licensee or by other persons specifically licensed by the Commission or an Agreement State to perform such services.

14. The licensee shall not perform repairs or alterations of the irradiator involving removal of shielding or acces.s to the licensed material. Removal, replacement, and disposal of sealed sources in the irradiator

- shall be performed by a person specifica!!y licensed by the Commission or an Agreement State to perform such services.

L15. - The procedures contained in the AECL Gammacell instruction manual for the Model 220 device shall be l followed and a copy of this manual shall be made available to each person using or having responsibility for the use of the device.

18. Scaled sources containing licensed material shall not be opened or removed from the irradiator by the licensee, t

A' nm. rvn- uen u.a. nucun neuuw um ut-- - =wn raut a ei 4 rauts

. Ucense Number

, 34-00738-09 MATERIALS LICENSE D eket or Reference Number SUPPLEMENTARY SHEET 030-29480 Amendment No.17

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

A. Application dated November 17,1991; and B. Letter dated August 20,1993, July 25,1994, July 7,1995, November 8,1995, July 18,1996, July 31, 1 1996, and March 7,1997.

l FOR THE U.S. NUCLEAR REGULATO'RY COMMISSION

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By l Nuclear Materials Licensing Branch Region 111

I "m F U"" "" FAUT; 'I UP 4 PAut;b

,h . u.s. NUCLEAR RE!uLAToRY Commission 3 Am:ndmInt No.17 i Licwater MATERIALS LICENSE

! Pursuantto 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 heretofore made by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, posseu, and transfer byproduct, i source and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below; to l deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This license j shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all cpplicable rules, regulations,and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified I below.

I ucensee in accordance with letter dated l

March 7,1997 ,

1. Case Westem Reserve University 3. Ucense number 34-00738-10 is amended Dept. of Occupational in its entirety to read as follows:
2. and Environmental Safety 4. Expiration date December 31,2002 10900 Euclid Avenue 5. Docket No. 030-30177 Cleveland, OH 44106 Reference No.
6. Byproduct, source, and/or special 7. Chemical and/or physical form 8. Maximum amount that licensc% may nuclear material possess at any one tinc "*,ser this license A. Cesium-137 A. Sealed sources (J.L. A. 12,000 curies Shepherd Model No. 6810)
9. Authorized Use:

A. To be used in a J.L. Shepherd, Mark I, Model 68 self-contained irradiator for the irradiation of small animals, biological 4 nples, and inanimate objects (excluding explosive or flammable materials) for research purposes.

CONDITlOBS

10. LicerC material shall be used only at the licensee's facilities located at Case Westem Reserve University, Room B-47 of the Weam Building or Room 350 of the Biomedical Research Building, Cleveland, Ohio.
11. Licensed material shall be used by, or ur der the supervision of, Oddvar Nygaard, Nancy Oleinick, P.

Sridhar Rao, or Marie Vames. l t

12. The Radiation Safety Officer for this license is W. David Sedwick, Ph.D. The Assistant Radiation l i

Protection Officer for the activities authorized by this license is Karl Von Ahn. l 1 l i  :

13. A. Sealed sources and detector cells shall be tested for leakage and/or contamination at intervals not to l exceed 6 months or at such other intervals as specified by the certificate of registration referred to in 10 CFR 32.210. ,

i l B. In the absence of a certificate from a transferor indicating that a leak test has been made within 6 months prior to the transfer, a sealed source or detector cell received from another person shall not be put into use until tested.

A A l

smu rt = arga U.s. nt-- tm ns .-"L.= s uni tt _ _- PAue. z or 4 rau=- x License Number

( 34-00738-10 MATERIALS LICENSE Docw omdrence Number SUPPLEMENTARY SHEET 030-30177 Amendment No.17

.C. Sealed sources need not be leak tested if:

. (i) . they contain only hydrogen-3; or (ii) they contain only a radioactive gas; or

. (iii) the half-life of the isotope is 30 days or less; or (iv) they contain not more than 100 microcuries of beta and/or gamma emitting material or not more than 10 microcuries of alpha emitting material; or (v) they are not designed to emit alpha particles, are in storage, and are not being used. However, when they are removed from storage for use or transferred 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.

D. The leak test shall be capable of detecting the presence of 0.005 microcurie of radioactive material on the test sample. Records of leak test results shall be kept in units of microcuries and shall be

- maintained for inspection by the Commission. If the t est 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 shall be removed immediately from service and decontaminated,

. repaired, or disposed of in accordance with Commission regulations. The report shall be filed within 5 days of the date the leak test result is known with the U.S. Nuclear Regulatory Commission, Region lil,801 Warrenville Road, Lisle, Illinois 60532-4351, ATTN: Chief, Nuclear Materials Safety .

Branch. The report shall specify the source involved, the test results, and corrective action taken.

Records of leak test results shall be kept in units of microcuries and shall be maintained for inspection by the Commission. Records may be disposed of following Commission inspection.

E. Tests for leakage and/or contamination shall be performed by the licensee or by other persons specifically licensed by the Commission or an Agreement State to Perform such services.

l

14. The licensee shall not perform repairs or alterations of the irradiator involving removal of shielding or i access to the licensed material. Removal, replacement, and disposal of sealed sources in the irradiator  ;

shall be performed by a person specifically licensed by the Commission or an Agreement State to perform l

. such services.

15. The licensee shall provide written operating and emergency procedures to each individual that uses the ,

irradiator.  !

16. Except as specifics e orovided otherwise in this license, the licensee shall conduct its program in accordance with tL. natements, 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.  ;

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,h nrw rvrum 374A u.s. MucLt.AM neuuLA i unT et- seen PAut; a of 4 PAuts License Number 34-00738-10

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MATERIALS LICENSE Docket r Reference Number SUPPLEMENTARY SHEET 030-30177 Amendment No.17 A. Application dated September 17,1992 (with attachments); and B. Letters dated November 23,1992, August 20,1993 (with attachments) and July 25,1994, July 7,1995, November 8,1995, July 24,1996, July 31,1996, and March 7,1997.

FOR THE U.S. NUCLEAR REGULATORY COMMISSION Q ,Q ".= .7 l n ,; . . . i  ; ,

US . _

Date By Nuclear Materials Licensing Branch Region ill

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