ML20128Q105
| ML20128Q105 | |
| Person / Time | |
|---|---|
| Issue date: | 08/14/1974 |
| From: | Schultz W NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML19270G011 | List: |
| References | |
| FOIA-84-705 NUDOCS 8507130373 | |
| Download: ML20128Q105 (10) | |
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- U. S. ATOMIC ENERGT COMMISSION
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DIRECTORATE OF P.EGULATORY OPERATIONS REGION III EO Inspection Report No. 74-01 .
Licensee: Isomedix Incorporated License No. 29-15354-02 25 Eastaans Road -
Priority: III
. P. O. Box 177 Category: E Parsippany, New Jersey 07054 .
Type of Licenses: Irradiator
. Type of Inspection: Announced - Initial
,' Date of Inspection: June 14 and 21, 1974
.. Princpal Inspector:
f6.M W. H. Schultz u
8 fili!"N (Date)
Accompanying Inspectors: None w
.Other Accompanying Personnel None g.4.'yl,,, t.: .
Reviewed By: C. E. Norelius, Senior Health Physicist 8!'4I !"Ill Materials Radiological Protection Section (Data) kDk ho ] 3 050502 GIDWANIO4-705 PDR
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i - SID9fARY OF FINDINGS
- . . 1 gaforcement Action During this inspection four items of noncompliance were noted.
, 1. Contrary to 10 CFR 19.11, the licensee did not post notices to i workers. . (Paragraph 9)
. 2. Contrary to License Item No. 7 and 10 CFR 30.3, the licensee possessed i
8,000 Ci of cobalt 60 as sealed sources which were received from Gamma Process Company. These sealed sources are not authorized by i .this license. (Paragraph 13)
- 3. Contrary to license' Condition 13.A. the licensee put cobalt 60 sealed sources into use without being leak tested and without a certificate
- from the transferor indicating that a test had been made within six
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months prior to the transfer. (Paragraph 33)
- 4. Contrary to License Condition No. 14 which states the AECL instruction
- i assual for the IR68 Cobalt 60 Irradiation Unit shall be followed, the lI licensee did not post the emergency procedures as required. (Paragraph 11)'
Lie ===ee Action on Previousiv Identified Enforcement Items There were no previously identified enforcement items.
Unusual occurrences c ,
No unusual occurrences were reported or identified.
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1 A. Current Findinas
- 1. During the inspection the AEC representative discussed the possibility of unauthorized personnel removing the shielding plugs from outside the South wall of the irradiation facility. The licensee representative agreed to have the steel jacketed plugs welded to the steel liners to prevent removal of the plugs. (Paragraph 20)
- 2. During the inspection the AEC representative discussed the need for a radiation monitoring system which would function at all times sad not only when the cobalt 60 source assembly is in a stored position. The licensee representative agreed to review this '
matter. (Paragraph 23) l e
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- 3. h 1ved Items: None. .
Management Interview At the conclusion of the inspection the AEC representative discussed the inspectica findings with Mr. Wolford. He was informed that four items of monecupliance were noted. He was also informed these items of noncompliance would be forwarded to the licensee in writing.
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REPORT DETAILS .
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- Persons Contacted ?
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- 1. Mr. Otto C. Wolford, General Manager, was contacted by'talephone on June 14, 1974 and on' that date a partial inspection was made to
' review the adequacy of ' interlocks asid safety equipment at the licensee's I8811187* ', e
- 2. Mr. Wolford was contacted by telephone on June 20, l'974 and the initial inspection wes~ completed on June. 21, 1974., -,
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- 3. The 7114=ais State Health Departarar was ' cont.nted by telephoes',4 how-ever, no representative from that asp:ncy was 'present ,during t'.te ~
inspection. . ,
. c SEBRESA. ,
- 4. This was an sanounced initial,ir.spection of the licansee's byproduct .
material program. Areas of ::eview included organization and art =4nistrativc
> control, design and construn: ton of the facility, byproduct material a"
! inventory, personnel monitoring, radiation surveys, leak tests, source tj loading, emergency and operating proceduru, instrumentation, radi.stion "
. safety practices, and records. o pi f
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---=-- nt Control e t f / y
- 5. The president of Isomediz, $ac. is Mr./ George R. Diets. His off :s i's' located at Parsippany, New Jerseyi The licensee's facility is' located at 6401 Oakton Street, Morton Gron, Illinois. This facility has v;nly i
two employees. Mr. Wo11%rd is General Manager and Radiation Safety ) '
Officer. He is assisted by Mr. Zikar M. rhanani. Mr. Wolford .repo'.ts '
directly to Mr. Diets. ,[ ,. 1
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- 6. Licensee personnel at the Morton Grove facility J. ave available wrt':.t.en instructions and operating procedures," Instruction Manus 1 IR68 Cotalc
. 60 Irradiation Unit". Edition No. 1, March 1973% These giccedures are.
as submitted with the license application dated July 18, 1973. "
- 7. Licensee personnel have available copies of the AEC license and<
appropriate AEC regulations. ,
- 8. Form AEC-3, " Notice to Employees" was posted in the office area. t
- 9. It was noted the licensee had not posted copies of 10 CFR Parts 19 and 20 the license, and related documents and procedures paferenced in the license nor was a notice posted whi.'.h described the doct4y; ass and stated where they may be examined. ' Dis constitutes noncpliaele%ith 10 CFR 19.11. " Posting of notices to woe'ars." Y <
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/ /,t 10. During the two inspection visits the licensee representative described l
\'; and demonstrated the operation of.the irradiation facility. Based on ;
e his statements and observations by the AEC representative it appears I the operation of the unit is in conformance with the licensee's j y written procedures.
t 11. License Condition No. 14 states, in part, the procedures contained in AECL's instruction manual for the "IR68 Cobalt 60 Irradiation Unit" shall be followed. The instruction manual contains emergency instructions N which, according to the manual, should be posted in a prominent position close to tha control station. During the inspection it was noted the emergency instruction were not posted at the control station. This con-stitutes noncompliance with License Condition No. 14.
/ Uses of Materials. Physical Facilities and Equipment W-
- 12. The licensee uses byproduct material procured under this license for
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commercial irradiation of products and calibration of radiation detection instruments. At the time of the inspection the licenses had the following
' byproduct material on hand:
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l\ (a) 137,510 C1 (2-12-74) of cobalt 60 as sealed sources received on 3-1-74. The sources are AECL Model C-188, Type 3.
The activity is comprised of 26 individual source elements.
(b) Two cobalt 60 sealed sources (1.3 uci each).
e (c) One cobalt 60 sealed source (1.3 mci).
(d) One cobalt 60 sealed source (about 40 Ci) contained in a BNL self-shielded irradiator. This unit will be disposed in the near future. .
- 5. ; (e) Approximately 8,000 Ci of cobalt 60 contained in a large shipping cask. This material was received from Gamma Process Company, the former occupants of the building. This material
. is presently in storage and awaiting disposal.
(f) One 4 uCi strontium 90 sealed source contained in a Jordan Radector survey meter.
(g) One 3 uCi strontium 90 sealed source contained in a Jordan RAMS II monitor. This deiice is not being used.
- 13. This license does not authorize the possession and storage of the 8000 C1 of cobalt 60 which formerly was licensed by Gamma Process Company.
This constitutes noncoupliance with License Item 7 and 10 CFR 30.3.
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- 14. h shielded facility contains and AECL IR68 Cobalt 60 Irradiation Unit.
h unit arrived August 22, 1973 and was assembled and tested by AECL
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personnal. h Cobalt 60 sealed' sources were loaded into the unit on March 4, 1974, h system was tested under actual operating conditions on March 6,1974 and on the same day commercial operation of the unit was started. ,
- 15. h irradiation facility has been licensed continuously since March 20, 1957, however, it was not put into use by Isomedix, Inc. until March 6, 1974. During the period March 20, 1957 through May 3, 1967 the program was covered by a license issued to Cook Electric Company.
During the period May 4, 1967 through January 28, 1974 the program was covered by a license issued to Gassa Process Company. Since January
- 29. 1974 the program has been covered by a license issued to Isomediz, --
Inc.
- 16. Details of the building, hot cou, can door, water conditioning equip-
, meat.. water level controls, source storage pool, and ventination systems have not been altered since installation in 1957c
- 17. h facility is intended to be a service irradiator, wherein products
. of other companies wi n be received and irradiated to specified doses.
{ either on a test or production basis. A secondary use is for radiation sterilization of medical supplies.
- - 18. A drawing of the radiation room and adjacent areas is attached to .this report as Exhibit A.
- 19. h building is one story, rectangular is shape, approximately 58' I 53' enclosed by standard cement block wans. h irradiator is set in the souteest corner of the building. h irradiation room is a cube siz-team feet on each side. The. two side walls (east and west) and the back wall (south) are 68 inchma thick of' poured-in-place reinforced standard concrete. The c=414== is 48 inches of poured-in-place steel reinforced standard concrete. h front (north) wa n and cell door are 48 inches of angnacite concrete poured in steel shells. In addition to the access door, the front van of the een contains a leaded glass viewing window, a pair of mester-slave manipulators, and several cylinderical access ports. The rear van (south) contains five cylinderical access ports, h cell access door and all other penetrations of the biological shield are stepped to, reduce radiation leakage. During the inspection it was noted the five access ports in the south van have a steel liner which is plugged with a stepped steel pipe fined with concrete. The plugs l are designed to be removed from the outside but the handles have been l partiany removed leaving only two stubs about an inch long on each plug.
Also, each plug is secured with a padlock.
- 20. During the inspection the licenses representative agreed to remove the t padlocks, remove the r===ining stubs and weld the plugs into the steel ]
liners which pass through the biological shield.
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. k 21. During the inspection it was noted the licensee's facilities and the l AECL irradiator are as described in the license application.
- 22. During the inspection the licensee's facilities were reviewed. This included the water conditioning equipment, water level controls and ventillation systems. It was noted these are as described in this
- license application, dated July 18, 1973, and as described in license applications submitted by former users of the shielded facility.
- 23. The AECL Irradiator is provided with a geiger type radiation monitor.
which is operational only when the cobalt 60 sources are in the storage position. In the source exposed position the facility has no operational radiation monitor. This matter was reviewed with the licensee representative and he stated he would consider the possibility of tas*=114= a radiation monitoring system which would be operational at all times.
- 24. A Berthold RAT 0/F survey meter is used by operating personnel to check radiation levels before entering the hot cell. This instrument has five ranges with full-scale readings of 1. 10, and 100 mR/hr and 1 and 10 i R/hr. The instrument was calibrated by Wolford on June 20, 1974. Only
! the first three ranges of the instrument are calibrated because of the limited strength of the calibration source.
- Personnel Radiation Protection ,
- 25. Licensee personnel wear film badges which are sent to R.! S. Landauer on
- a bi-weekly basis. Victoreen indirect reading (0-200 ar) dosimeters are available but are not routinely used. Licensee personnel use dosimeters-only when h eing sources. Film badge records were reviewed and it was noted the ===4=u= total exposure for the year 1974 was 30 area.
Form AEC-4 has been completed for both licensee personnel and Form ABC-5 is being meinem4=ad.
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- 26. Poeting and labeling is in accordance with the applicable sections of
. 10 CFR 20.203. The door to the hot call is posted Caution-Radioactive l Meterial and Caution-High Radiation Area. A Caution-High Radiation l t Area sign is mounted above the cell entrance door. This sign is Q 111minated whenever the cobalt 60 source assembly is not in a completely down position.- The sign is energized with a mechanical switch and not by the presence of radiation.
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- 27. The AECL Irradiator is provided with a series of interlock devices which will prevent a person from entering a High Radiation Area. When the source is in an exposed position the entrance door to the cell cannot be opened. The door to the cell can be opened only by a large electrical drive motor which is interlocked with various safety circuits. However, if someone should be inside the exposure room when the source is raised to an exposed position a manual switch can be operated which by-passes all safety circuits and permits the person inside the room to 9
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open the door to the cell. This cannot occur from outside the exposure room. There are no provisions fce by-passing the safety circuits from outside the exposure room.
- 28. A complete survey of the shielded facility was made by AECL eersonnel during the period October 29-31, 1973 prior to the installs *.1oa of the AECL IR68 Irradiator. The survey results were submitted so AEC en
- November 15, 1973. No significant cone ==4 nation was detected.
- 29. AECL personnel made a direct r== dine survey on March 7, 1974 after in ~
st=11=e4a= of the cobalt 60 sources. The radiation level in unrestricted areas outside the h41 ding walls was less than 0.1 ar/hr. The manimum radiation Invel on the roof (where the source cable passes through the shimidi was 1.5 ar/hr. Radiation levels inside the building were also measured. The ==w1== level detected was 50 ar/hr at the manipulator port opening. The ===4== radiation level at the call door was 1.8 ar/br.
Waste Disoosal ,
- 30. The licensee's investory includes a number of sealed sources which will s be disposed of in the near future. These sources will be shipped either to a supplier or a licensed wasta disposal agency. The licensee has made no disposals or radioactive wasta since the issuance of this
, license.
Leak Tests
- 31. The 26 cobalt 60 sealed sources were put into commercial use on March 6, 1974. Novever, the liaa-a did not receive a leak test certificate from AECL prior to using the sealed sources. At the time of the source
-1 ande h gross leak test by pouring water into the
. loading AECL F _
source cavity of the shipping cask then collecting the water and checking it with a survey meter. Nothing above background was noted. AECL personnel informed the licensee the water would be returned to AECL for analysis and a report of the test results would be issued. The licenses did not receive this report.
- 32. On May 10, 1974 the licensee representative made a Isak test by wiping l
the 26 sealed cobalt 60 sources with a single paper towel. The towe.l.
was analyzed with a ses flow proportional counter and showed less .than 0.001 uCi of removsble cone ==4== tion.
- 33. Although the cobalt 60 sealed sources were put into use on March 6,1974 no leak test results were available until May 10, 1974. This constitutes acaccepliance with License Condition No.13.A. in that, the licenses put 26 cobalt 60 seeled sources into use without =*4ag 'a leak test and without a certificate from AECL indicating a test had been made within 6 months prior to transfer to the licensee.
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- 34. A review of the leak test records during this inspection showed all sealed sources in the licensee's inventory were leak tested on May 10,'1974 and all showed less than 0.001 uci of removable contamination.
Independent Measurements
- 35. During the inspection the AEC representative made direct reading radiation surveys with an Eberline Model E-500 B survey meter. The maximum radiation level at 12 inches from the surface of the shipping cask m *=4=4=g 8000 C1 of cobalt 60 was 7 mr/hr. The mar 1== radiation ,
level at 12 inches from the surface of the BNL irradiator was 4 mr/hr.'
Additional measurements were made at various other locations throughout the licensee's facilities and all agreed closely with the survey made by AECL personnel on March 7, 1974.
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