ML20134D038
| ML20134D038 | |
| Person / Time | |
|---|---|
| Issue date: | 01/19/1995 |
| From: | Grobe J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | Finnigan M OHIO, STATE OF |
| Shared Package | |
| ML20134C763 | List: |
| References | |
| FOIA-96-444 NUDOCS 9702040268 | |
| Download: ML20134D038 (1) | |
Text
_ _ . _ - _ _ _ . . - . _ _ _ _ _ _ _ - -
January 19, 1995 Mrs. M. Finnigan ,
885 Rudyard Road J Cleveland, OH 44110 '
SUBJECT:
REPORT REGARDING SURVEYS AND SAMPLING AT THE ADVANCED MEDICAL SYSTEMS, INC. FACILITY (REPORT NO. 030-16055/94003(DRSS))
Dear Mrs. Finnigan:
This refers to the October 25, 1994, telephone conversation between yourself and Michael Kurth .of my staff. During this conversation, you requested that information be provided regarding surveys which were conducted during the summer and fall of -1994 outside of the Advanced Medical Systems, Inc. (AMS) facility,1020 London Road,. Cleveland, Ohio. Also discussed was your September 27, 1994, letter to the NRC formally requesting this. information.
The enclosed NRC report (Report No. 030-16055/94003(DRSS)) refers to surveys and sampling conducted at the AMS facility from August 17 through October 14, 1994. You agreed during the October 25, 1994, telephone conversation that the information provided in the attached report should satisfy your September 27, .
1994, formal request.
If you have questions regarding the report, please contact Michael Kurth of my staff at (708) 829-9869.
Sincerely, Original Signed By John A. Grobe, Chief-Nuclear Materials Inspection Section 2 i
Enclosure:
As stated cc w/o encl: M. Pearson, RIII DOCUMENT NAME: B:\ CITIZEN.LTR gr. . e.,y .e sne, 4.c t. t.dic.t. s. en. 6.. ca - c.,y stn t ets.ch/ et aca - c.,y witn tt.cn/ ei na -
0FFICE RIII O RIII N RIII ,
b (b1TT- b NAME Kurth N Snell' A s Grobe b5me h DATE 01/9/95 01/9/95 01//4/95 os/ d /W-0FFICIAL RECORD COPY !
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December 6, 1994 Advanced Medical Systems, Inc. !
ATTN: Mr. David Cesar, Treasurer
- 1020 London Road i Cleveland, Ohio 44110 1
SUBJECT:
RESULTS OF NRC RADIOLOGICAL SURVEY AND SAMPLE ANALYSIS OF
"; THE ADVANCE 0 MEDICAL SYSTEMS, INC. (AMS) WASTE WATER PIPING AND ITS OUTFALL INTO THE CITY OF CLEVELAND SEWER (REPORT NO. 030-16055/94003(DRSS))
Dear Mr. Cesar:
This refers to the special inspection conducted by Messrs. Michael Kurth and
< Edward Kulzer of this office from August 17 through October 14, 1994. The special inspection was conducted to examine the radiological conditions of
- waste water exiting your facility through your waste water piping 'and into the ,
City of Cleveland sewers in the vicinity of the sewage outfall from your I facility. The inspection was prompted by the identification of exposure rates above background in the City of Cleveland sewer at the Advanced Medical Systems, Inc. (AMS) outfall. The results of this inspection were discussed d
- with you at the conclusion of the inspection.
i As described in the enclosed report, extensive radiation surveys and sampling of solid and liquid materials were conducted identifying cobalt-60 in the solid sediment from the city sewers and your waste water piping. Also, cobalt-60 was being carried in the waste water from the AMS outfall into the j i city sewers. This appears to represent a violation of 10 CFR 20.2003 which I
! permits only the discharge of soluble material or readily dispersible j 4 biological material in water. The cobalt-60 emanating from your lateral is '
neither soluble or readily dispersible biological material.
i We plan to meet with you in the near future to discuss these inspection findings. We 'will contact you at a later date to schedule this meeting.
- Following our meeting, a decision will be made on the appropriate enforcement action regarding the apparent violation. As such, no Notice of Violation is
. being issued at this time. While no Notice is being issued and no written response is required, we expect that prompt action has been or will be taken to correct this apparent violation.
i i
i In accordance with 10 CFR 2.790 of the Commission's regulations, a copy of )
this letter and the enclosed inspection report will be placed in the NRC l i Public Document Room.
i i
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4 1
4 1
Mr. David Cesar .
We will gladly discuss any questions you have concerning this inspectijn.
Sincarely, Original Signed 8y R. J. Caniano for W. L. Axelson, Director
' Division of Radiation Safety and Safeguards i
License No. 34-19089-01 j Docket No. 030-16055
Enclosure:
Inspection Report No.
030-16055/94003(ORSS) 4 cc w/ encl: NE0RSD
-- City of Cleveland i bcc w/ enc 1: J. Turdici, OE00 $
' J. T. Greeves, NHSS E. W. Brach, NMSS
" J. H. Austin, NMSS T. C. Johnson, NMSS M. Nalluswami, NMSS C. G. Jones, NHSS
- R. L. Fonner, OGC PUBLIC (IE07) i 1
i q
- DOCUMENT NAME: B:\AMS94003. DSS I See Previous Concurrences
" Concurrence via e-mail r c.,,with.et.ca nti. i.. n . s .. ,
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- 0FFICE RIII l RIII l l l Slawinski Madera Grobe Shear NAME Kurth Kulzer
/94 12/ /94 12/ /94 12/- /94 12/ /94 12/ /94 i DATE 12/
CFICE RIII NMSS
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1 Paperiello Knapp Chandler
..AME Berson 12/ /94 12/ /94 12/ /94 12/4 /44 ~
DATE 12/ /94 J
Advanced Medical Systems, Inc. 2 We will gladly discuss any questions you have concerning this inspection.
4 Sincerely, W. L. Axelson, Director Division of Radiation Safety and Safeguards License No. 34-19089-01 Docket No. 030-16055
Enclosure:
Inspection Report No. 030-16055 l
/94003(DRSS) l cc w/ encl: NE0RSD City of Cleveland Ei
, bec w/ encl: J. Turdici, OE00 J. T. Greeves, NMSS E. W. Brach, HMSS J. H. Austin, HMSS T. C. Johnson, NMSS M. Nalluswami, NMSS C. G. Jones, NMSS R. L. Fonner, OGC PUBLIC (IE07) l 1
1 DOCUMENT NAME: B:\AMS3.ltr
" Concurrence via e-mail . c.,y wien .it nm.n f.o. .o,. u . s ..,y n . ..,, . iwi. 4 .$. io i.. . in is. 6..: e . c.,y .iin.oi .ii.cnm.o f.nci.. .
l0FFICE Rill & lE Rllit ? E RI I I,, ,\. l6 Rill g A 6 RIII ,.d. l 6 Rill l tJ Kurth KulzeFi' \,516fVski kladefg4 Grobi,E) Shear A5 INAME TE 12/J /94 12/5 /94 (12/ f /94 t'12/ 6 / /94 12/ 6 /94 12/ s /94 ,,
oC(f;Q l ts offlCE Rill [O l 6 NMSS/]C
- DWM A @ l.*.i OGC M l* RIII l Lewb , -
NAME Bersdrf Papedfello Knapp M P Chandle d llxelson l DATE 12/ )('/94 12/ t /94 12/ \'/9',4 #12/ 73/94,T# 12/ /M , -- < t& :lf c.v;p u # - po x -
U. S. NUCLEAR REGULATORY COMMISSION REGION 111 Report No. 030-16055/94003(0RSS) ,
i License No. 34-19089-01 Organization: Advanced Medical Systems, Inc. (AMS) 1020 London Road -
Cleveland, Ohio Inspection At: City of Cleveland sewer interceptor (sewer interceptor)
- Intersection of sewer interceptor under London Road,
' upstream and downstream manholes, and the AMS manhole Cleveland, Ohio' Inspection Conducted: August 17 through October 14, 1994 Inspectors: I \ b ik N Dats i Michhel Kurth y Radiation Sp ialist o
'db iz!$ d Dat'e '
Edwa'rd Kulzei-Radiation Specialist Reviewed by:
17)(['M
, hn R. Madera, Chief Date' aterials Licensing Section
/
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/7/6 4-Approved by: //chn A. Grobe, Chief Dat( /
VNuclear Materials Inspection Section 2 Inspecticn Summary Inspection on Auoust 17 throuah October 14. 1994 (Report No. 030-l'6055
/94003(DRSS))
Areas insoected: This was a special inspection conducted to perform surveys of the City of Cleveland sewer interceptor in the location of the AMS facility, Cleveland, Ohio, and in the AMS manhole. The inspection was prompted by the identification of elevated exposure rates on the sewer interceptor surface below the AMS lateral in July 1994. Samples of sewer debris, water effluent, and a series of wipes were collected for analyses. ..
Results: The NRC inspectors, accompanied by the Northeast Ohio Regional Sewer District (NE0RS0), and NE0RSD contractors, 8. Koh & Associates, Inc. ,
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1 identified four' areas of elevated exposure rates. These areas are located:
(1) below the intersection of the sewer interceptor and the AMS lateral; (2) within the processing drain line in the AMS sewer; (3) within the sanitary inlet into the AMS manhole; and (4) within the sanitary outlet from the AMS manhole into the sewer interceptor. The preliminary results of the sewer debris and wipe test analysis from the August 17, 1994 sampling identifjed '
positive cobalt-60 surface contamination levels ranging from 457 disintegrations per minute per 100 cm' (dpm/100 cm') to 2.7 x 10' dpm/100 cm',
partial levels which exceed the 1,000 dpm/100 cm' limit found in NRC's guidance document, " Guidelines for Decontamination of Facilities and Equipment Prior to Release for Unrestricted Use or Termination of Licenses for Byproduct, Sources, or Special Nuclear Materials," dated August 1987. Also, between July 5 and October 30, 1994, cobalt-60 was identified, by the NRC and the NE0RSO, in the water effluent discharged from the AMS lateral into the sewer interceptor. The September 20, 1994 sampling analysis verified prior indications of cobalt-60 contamination. However, further water discharge samples taken from the location on September 20 and October 4,1994, did not identify the presence of cobalt-60.
One apparent violation was identified:
Apparent failure to dispose of licensed material into the sanitary severage system that is readily soluble or is readily dispersible biological material in water is an apparent violation of 10 CFR 20.2003, which has been a requirement for this licensee since January 1, 1994 @
(Section 3. 8. of this report).
Also, given that cobalt-60, which is not considered to be readily soluble or readily dispersible biological material in water, was identified in effluent discharged from the AMS lateral and, that cobalt-60 was deemed to be removable within the AMS lateral through the conduct of wipe sampling, the probability exists that future effluent discharges may develop into the disposal of licensed material into tF' sanitary sewerage system.
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DETAILS
- 1. Persons Contacted Thomas Lenhart, Assistant General Counsel, NE0RSD .
- Lawrence English, Assistant General Counsel, NE0RSO Y~
- Richard Connelly, Manager Water Quality, NE0RSO
- Len Jufko, NE0RSD
- William Kasberg, NE0RSD
- Theodore Adams, Vice President, B. Koh & Associates, Inc.
- @ David Cesar, Treasurer, Advanced Medical Systems, Inc. (AMS) -
0 Joseph Michuta, Radiation Safety Officer, AMS 0 Robert Neschter, Senior Radiation Technician, AMS 0 Vincent Rocco, Radiation Technician, AMS
- Denotes those present at interceptor sewer survey conducted August 17.
and September 20, 1994.
0 Denotes those present at the sewer survey conducted September 20,199'.
- Denotes those present during the exit interview conducted by telephone on October 14, 1994.
- 2. Backaround A. General History 3, In 1959, the Atomic Energy Commission issued License No. 34-07225-09 i to Picker X-Ray Corporation (Picker Corp.), for the operation of an isotope manufacturing facility located at 1020 London Road, Cleveland, Ohio. The Picker Corp. license authorized possession of 150,000 curies of cobalt-60 and 3,000 curies of iridium-192 in solid metal form, and 40,000 curies and 100 curies of cesium-137 and thulium-170 respectively, as sealed sources. These licensed materials were authorized for: (1) processing incident to redistribution to authorized recipients; (2) radiation effects ,
l studies; and (3) research and development. The principal operation -
conducted under this license was the manufacture of cobalt-60 sealed sources for medical teletherapy and industrial radiography units, l l
and subsequent distribution of the sources to authorized recipients throughout the world.
In 1979, the Picker Corp. London Road facility was purchased by Advanced Medical Systems, Inc. (AMS). License No. 34-07225-09 was terminated on November 9, 1979, at which time all licensed material possessed was transferred to AMS.
The NRC issued License No. 34-19089-01 to AMS on November 2, 1979.
At this time, the licensed operations, facilities and equipment previously owned and operated by the Picker Corp. were assumed by AMS.
3
P Both operations had released cobalt-60 through the London Road facility lateral into the sanitary sewer under the provisions of 10 LiR 20.303, " Disposal by Release into Sanitary Sewerage Systems," which was in effect through December 31, 1993. The NRC inspection in 1988 confirmed cobalt-60 contamination in the AMS sewer manhole on AMS property. At that time the radiationdlevel ranged as high as 70 milliroentgen per hour (mR/hr) at the ' bottom of the manhole adjacent to the discharge pipe from the AMS building. The contaminated area was partially decontaminated and covered with a layer of concrete by the licensee. In May 1989, as stated in the NRC Inspection Report No. 030-16055/93002(DRSS),AMS discontinued the discharge of licensed material into the sanitary seweraga system. Also, AMS has not generated liquid waste for several years due to changes in its decontamination methods and termination of source manufacturing operations.
Beginning January 1,1994, NRC licensees were required to comply with the revised 10 CFR Part 20, which contains more restrictive requirements for sanitary sewer disposal of liquiri radioactive waste than previously existed.
The revised 10 CFR 20 specifies, in part, in 20.2003, " Disposal by Release into Sanitary Sewerage," that licensees may discharge licensed material into the sanitary sewerage system only if the M material is readily soluble or is readily dispersible biological material in water.
i In 1993, as documented in NRC Inspection Report No. 999-90003
/93010(DRSS), an NRC inspector measured the exposure rates in the downstream manhole from the AMS facility in the London Road sewer interceptor. No detectable radiation exposure rates above ,
i background were identified. The location where the elevated exposure rate was identified in July 1994 by the NE0RSO was ,
inaccessible at the time of the 1993 HRC inspection and the NRC was unaware, in 1993, of the manhole's existence. j B. Specific History Promotina this Special inspection on July 5,1994, surveys were conducted by the Northeast Ohio f' Regional Sewer District (NE0RS0) contractors, B. Koh & Associates, j Inc., along the City of Cleveland's interceptor sewer (interceptor l sewer) in an area connecting with the AMS lateral under London I Road. Elevated exposure rate readings ware identified below the AMS lateral on the sewer interceptor brick and iron rungs. The NE0RSO reported that the radiation exposure rate measured was l
approximately 7 mR/hr on contact. Residue deposits on the sewer interceptor brick and iron rungs below the AMs lateral were collected, resulting in the identification of cobalt-60 contamination ranging from 0.084 to 0.12 microcuries per gram.
Also, during the performance of the surveys, the NE0RSO discovered a manhole directly above the AMS lateral / sewer interceptor 4
.8 i
intersection which was buried below the London Road surface. The NE0RSD has since raised the level of the manhole to the stre'et surface.
Attachment No. 1 of this report illustrates the pathway and proximity of the AMS lateral in relation to the AMS faciliry. The approximate length of the lateral from the AMS manhole to the i sewer interceptor is 40 feet (12 m). The lateral is made of 4 to 5 foot (122-152 cm) long sections of precast clay / ceramic piping butted together forming the lateral. The lateral is approximately 18 inches (46 cm) in diameter. Attachment No. 2 contains a photograph of the AMS lateral protruding into the City of Cleveinnd sewer interceptor (sewer interceptor). The sewer j
interceptor is approximately 5 feet (1.5 m) in diameter and flows to the Easterly Wastewater Treatment Plant.
- 3. Survey and Sample Analysis Results A. Survey Results On August 17 and September 20, 1994, the NRC inspectors, accompanied by NE0RSD personnel and NE0RSD contractors, conducted a series of surveys in the sewer interceptor outside of the AMS facility under London Road. During those surveys there was a b_ '
significant flow rate of waste water emanating from the AMS lateral into the interceptor. An assessment of the waste water flow rates is contained in NRC Inspection Report No. 030-16055
/94004(DRSS) issued November 29, 1994. Also, on September 20, 1994, surveys were conducted in both manholes immediately upstream and downstream from the AMS facility along London Road, and in the AMS manhole. The survey instruments used were a Ludlum Model 19 Hicro R Meter, NRC. Tag No. 014808, a Ludlum Model 12 Count Ratemeter with attached pancake probe, NRC Tag No. 047068, a
'Bicron MicroRem, Serial No. 8709J, and a 'Ludlum Model No. 2221 Scaler Ratemeter (No Serial No. available) with attached pancake probe. 2 Thebacilgr'oundexposureratemeasuredattheLondonRoadstreet surface above the AMS lateral / sewer interceptor intersection was 12 'microroentgen per hour ( R/hr). The surveys conducted in the sewer interceptor demonstrated elevated exposure rate readings.
A sewer interceptor surface area approximately 1.5 feet (46 cm) by 3 feet (91 cm) located directly below the AMS lateral showed elevated readings averaging 1.0 to 10 mR/hr on contact with the sewer interceptor brick. Attachment No. 2 of this report
'This instrument is owned and' maintained by B. Koh & Associates, Inc.
'This instrument is owned and maintained by 8. Koh & Associates, Inc.
' Assume that I roentgen - 1 Rem. ..
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illustrates the location of the elevated exposure rates in the sewer interceptor. One spot was identified between the iron rungs on the sewer interceptor brick surface showing an exposure rate ranging from 20 to 25 mR/hr on xontact. Also, a spot was identified on the rung below the AMS lateral showing an elevated exposure rate of 14 mR/hr on contact. An average exposureirate of 0.5 mR/hr was identified both 3 feet (91 cm) upstream and downstream from the AMS lateral in the center of the. sewer interceptor. Also, an exposure rate ranging from 1.5 to 2.0 mR/hr was identified in the center of the sewer interceptor directly across (approximately 61 cm) from the elevated area below the AMS lateral. Attachment No. 3 of this report contains several photographs of the sewer interceptor wall in the area of the AMS lateral.
Surveys conducted of the first manholes immediately upstream and downstream from the AMS facility identified exposure rates ranging from 5 to 9 pR/hr on the surface of London Road next to the manholes. Exposure rates ranging from 14 to 19.5 pR/hr (includes l l
the background rate)_ were identified in the center of the sewer interceptor and on contact with the interceptor brick in both manholes. The slightly elevated exposure rates were attributed to naturally occurring radioactive materials (NORM) in the sewer brick. (NORM, such as potassium-40, radium-226, and thorium-232, '
are found in very small quantities in brick.) P Elevated exposure rates were identified in the AMS manhole.
Exposure rates ranging from 2 to 3 mR/hr were identified, on contact, approximately 2 to 4 inches (5 to 10 cm) into' the processing drain line, and the sanitary inlet and outlet in the AMS manhole. A survey instrument was lowered into the AMS manhole i demonstrating exposure rates of 0.5 to 1.0 mR/hr in the center of the AMS manhole. ,
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B. Samolina Analysis Results On July 5,1994, the NE0RSD collected three sediment samples from )
the sewer interceptor in the location of the A'iS lateral outfall.
Also, a water effluent sample was celiected from waste water discharging from the AMS lateral. The analytical results of the I sediment samples identified positive cobalt-60 concentrations ranging from 0.084 to 0.12 microcuries per gram. The result of the water sample identified a positive cobalt-60 concentration of 29 picocuries per liter (pCi/1).
The NRC collected numerous smears, sewage residues, and water samples on August 17 and September 20, 1994. Table No. 1 identifies the locations and analytical results of the smear and sewage residue samples collected on August 17, 1994. The samples were analyzed using the NRC Region Ill gamma spectroscopy system.
On August 17, 1994, a total 4 smears and 4 sewage residue samples were collected. ,, ,
6
i t
s' As illustrated in Table No.1, the analysis of .the sewage residus j
[ samples demonstrated cobalt-60 contamination ranging from 4.29 te
- 1,230 nanocuries. Two of the 4 smears collected identified cobalt-60 contamination ranging from 2,750 to 103,840
! Each smear collected
- disintegrations per 100 cm' (d was assumed to cover a 100 cm'pm/100 area. The acceptablecm').surfac) contamination level for removable cobalt-60 is 1,000 dpm/100 cm',
i as stated in the NRC document, " Guidelines for Decontamination of
?-
- ~ Facilities and Equipment Prior to Relene for Unrestricted Use or Termination of Licenses for Byproduct, Source, or Special Nuclear r Material," dated August 1987, which is included as Attachment l j.
No. 4 of this report. The water effluent sample collected !
demonstrated positive indications of cobalt-60 contamination of l 2 35 picocuries per liter (pCi/1). 4 i T-able No. 2 identifies the locations and analytical results of the i
NRC smears collected on September 20, 1994. As illustrated in l Table No. 2, a smear result of 16,852 dpm/100 cm' removable 4
l cobalt-60 ' contamination was identified on the sewer interceptor i
wall below the AMS lateral.
On September 20, 1994, smears were also collected from the sewer interceptor walls in the areas of the first sewer interceptor '
manholes immediately upstream and downstream from the AMS facility along London Road, and the AMS manhole. As illustrated in Table g l No. 2, general smears of the sewer interceptor walls from the i 1 sewer interceptor manholos located immediately upstream and i ' downstream from the AMS facility along London Road did not l
f identify removable cobalt-60 contamination. There was however, a j j
surface contamination level of 97 dpm/100 cm which was identified in the AMS manhole on the AMS lateral exiting into the sewer j interceptor.
Table No. 3 identifies the dates, locations, and analytical results of the water effluent collected by the NRC and the NE0R50.
j As illustrated in Table No. 3, water effluent samples taken from the upstream and downstream manholes, and from the AMS manhole, 4
did not demonstrate positive indications of cobalt-60. However, water effluent collected from the outfall of the AMS lateral into the sewer interceptor on July 5, August 17, September 28, October 4
1, and October 10, 1994, demonstrated positive concentrations of cobalt-60 ranging from 13 to 306 pCi/1. Given that removable 4
cobalt-60 was identified on the surface of the AMS lateral. it
! appears that the water effluent flowina throuah the AMS lateral slouahed the cobalt-60 from the lateral causina the release of l licensed material into the sanitary seweraae system. The ,
l discharae of licensed material. cobalt-60. which is not readily l
' soluble or is readily dispersible bioloaical material in water j into the sanitary seweraae system is an aooarent violation of t 10 CFR 20.2003 which has been a reauirement for this licensee since January 1. 1994.
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One apparent violation of NRC requirements was identified.
- 4. Exit Meetina During the performance of surveys and sample collecting, the preliminary findings were provided to those individuals present during the August 17 and September 20, 1994, on-site inspections, as identified in Section 1 l of this report. . A summary of the areas surveyed and the forthcoming letter were discussed. Also, on October 14, 1994, the results of this ;
inspection were discussed in a telephone conversation between Mr. Cesar and Mr. Caniano. The AMS and NE0RSD employees did not identify any information provided during the inspection as proprietary.
Attachments: 1. Illustration of pathway of AMS lateral into sewer i interceptor -
- 2. Diagram of sewer interceptor l
- 3. Series of photographs of sewer !
- 4. Guideline for the Decontamination of Facilities and Equipment Prior to Release for Unrestricted Use or Termination of Licenses for Byproduct, Source.or Special Nuclear Material 1
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TABLE NO. I NRC SEWER SAMPLE RESULTS SEWER SAMPLES FROM THE CITY OF CLEVELAND INTERCEPTOR IN THE IMMEDIATE AREA 0F THE AMS LATERAL ON LONDON RD SAMPLES TAKEN AUGUST 17, 1994
~
SAMPLE LOCATION RESULT
- 2o .
Debris and sludge from left (upstream) of '4,290 pCi 32 pCi 1.
rungs below the AMS lateral
- 2. Black debris off of top rung below the AMS '434,000 pCi lateral 3,000 pCi
- 3. Black debris off of brick wall below the AMS '1,230,000 pCi i lateral 7,000 pCi
- 4. Red debris off of rung above the AMS lateral '1,630 20 pCi i '
- 5. a. Smear: Rung immediately below the AMS less than 41 'dpm lateral 103,840 dpm i 167 3
- 5. b. Smear: NE0RSD Sewer wall (sewer brick) below the AMS lateral dpm l
- 5. c. Smear: NE0RSD Sewer wall (sewer brick) 2,750 mi.; _c 52 dp:a above the AMS lateral
- 5. d. Smear: Inside the AMS lateral 457 dpm 138 dpm
" Note: The reported uncertainty refers only to counting statistics.
.' Note:' Additional analysis error will be introduced due to the unique geometry associated with the debris. The geometry error is estimated to be less than 10 percent.
' Note: disintegration per minute - dpm. Also, each smear result is estimated to be averaged over a 100 cm' area.
b .
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TABLE NO. 2 NRC SMEAR RESULTS SEWER SAMPLES FROM THE CITY OF CLEVELAND SEWER INTERCEPT 0R IN THE AREA 0F THE AMS FACILITY ON' LONDON ROAD AND THE AMS SEWER SAMPLES TAKEN SEPTEMBER 20, 1994 LOCATION RESULT i 2c7 I 1 Smear: Iron Rung Directly Below the AMS '717 17 dpm Lateral 2 Smear: Sewer Interceptor Brick Directly Below 16,852 1 264 dpm the AMS Lateral (between lateral and 1" r rung f
3 Smear: Sewer Interceptor Brick Directly Above < 16 dpm the AMS Lateral 4 Smear: Approximately 1 foot inside the AMS 56 i 4 dpm Lateral between the positions of 12:00 g and 3:00 g : .-
5 Smear: Outer Surface of the AMS Lateral < 23 dpm s between the' positions of 12:00 and 3:00 '
t 6 Skipped No. 6 7 Smear: Outer Surface of the AMS Lateral at the 490 i 143 dpm 6:00 position h 8 Smear: Inside the AMS Lateral Approximately 1 161 1 7 dpm ;
foot at the 5:00 position (as close to i water line as possible) L 9 Smear: General Wipe of Upstream Sewer < 13 dpm Interceptor f s
10 Smear: General Wipe of Downstream Sewer < 14 dpm f Interceptor '
11 Smear: AMS Sewer- Floor of AMS Sewer < 13 dpm 12 Smear: AMS Sewer- Outlet from Processing Drain < 16 dpm (East Drain near waterline) t 13 Smear: AMS Sewer- General Wipe of Sewer Wall < 22 dpm f 14 Smear: < 23 dpm AMS Sewer- South Inlet to Manhole (near !
waterline) '
15 Smear: AMS Sewer- AMS Sewer Outlet to 97 6 dpm Interceptor (near waterline) ,,
l
- Note: The reported uncertainty refers only to counting statistics.
' Note: Disintegrations Also, each result is estimated to averaged over a 100 cm' per area. minute - dpm.
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TABLE NO. 3 NRC AND THE NE0RSD WATER EFFLUENT SAMPLE RESULTS SAMPLE DATE COLLECTED - LOCATION RESULT '2a 1 NE0RSD July 5,1994 - AMS lateral outflow to 29 pCi/l sewer interceptor 2
2 HRC August 17, 1994 - AMS lateral outflow 35 pCi/l i to sewer interceptor 0.4 pCi/l 3 NE0RSD August 17, 1994 - AMS lateral outflow 33 pCi/l to sewer interceptor 4 NRC September 20, 1994 - AMS lateral '
< 10.3 outflow to sewer interceptor pCi/l 5 NE0RSD September 20, 1994 - AMS lateral '
< 20 pCi/l outflow to sewer interceptor 3 l
6 NRC September 20, 1994 - AMS manhole "
< 9.3 pCi/l l 7 NRC September 20, 1994 - Upstream manhole '
< 8.9 pCi/l 8 NRC September 20, 1994 - Downstream ."< 9.1 pCi/l b manhole .
i 9 '
NE0RSD September 28, 1994 - AMS lateral 13 pCi/l outflow to sewer interceptor 10 NE0RSD October 1,1994 - AMS lateral outflow 86 pCi/l I to sewer interceptor l 11 NE0RSD October 4,1994 - AMS lateral outflow *
< 0.1 pCi/l to serier interceptor 12 NE0RSD October 10, 1994 - AMS lateral 306 pCi/l outflow to sewer interceptor
' Note: The reported uncertainty refers only to counting statistics.
' Note: The analytical results demonstrating the less the.n symbol, "<",
indicates that no measurable activity was identified ' elow u the minimum detectable level derived for that sample. The minimum detectable level for each sample in which no measurable activity was detected is recorded in the
" RESULT" column.
'This sample was analyzed by the NRC. After conducting the analysis, the sample was provided to the NE0RSD for analysis (Sample Result No. 3 of this ,,
table). Therefore, Sample Nos. 2 and 3 were the same samples analyzed independently.
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l ATTACHMENT N0. 1 ILLUSTRATION OF PATHWAY OF AMS LATERAL INTO SEWER INTERCEPTOR
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ATTACHMENT NO. 4 GUIDELINE FOR THE DECONTAMINATION OF FACILITIES AND EQUIPMENT !
PRIOR TO RELEASE FOR UNRESTRICTED USE OR TERMINATION OF LICENSES FOR BYPRODUCT, SOURCE, OR SPECIAL NUCLEAR MATERIAL
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GUIDELINES FOR DECONTAMINATION OF FACILITIES AND EQ -
PRIOR'TO RELEASE FOR UNRESTRICTED USE OR TERMINATION OF LICENSES FOR BYPRODUCT. SOURCE OR SPECIAL NUCLEAR MATERIAL 1
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I U.S. Nuclear Regulatory Comission Division of Industrial and Medical Nuclear Safety Washington, DC 20555 i August 1987 l
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.J The instructions in this guide, in conjunction with Table 1 specify the radionuclides and radiation exposure rate limits which should be used in decontamination and survey of surfaces or premises and equipment prior to abandonment or release for unrestricted use. The Itmits in Table 1 do not apply to premises, equipment, or scrap containing induced radioactivity for -
which the radiological considerations pertinent to their use may be different.
Thea release on of such case-by-case basis. facilities or items from regulatory control is considered 1.
The licensee shall aiake a reasonable effort to eliminate residual contamination.
2.
Radioactivity on equipment or surfaces shall not be covered by paint, plating, or other covering material unless contamination levels, as detennined by a survey and documented, are bel' o w the limits specified in Table 1 prior to the application of the covering. A reasonable effort must be made to minimize the contamination prior to use of any covering.
3.
The radioactivity on the interior surfaces of pipes, drain lines, or ductwork shall be determined by making measurements at all traps, and other appropriate access points, provided that contamination at these ; 6 locations is likely. to be rep'resentative of contamination on the interior of the pipes, drain lines, or ductwork. Surfaces of premises, equipment,
! i.
- or scrap which are likely to be contaminated but'are of such size..
! construction, or location, as to make the surface inaccessible for purposes I\ ef measurement shall be presumed to be contaminated in excess of the limits.
4.
Upon request, the Connission may authorize a licensee to relinquish possession or control of premises, equipment, or scrap having surfaces contaminated with materials in excess of the limits specified. This may include, but would not be limited to, special circumstances such as razing of buildings, transfer of premises to another organization continuing work with radioactive materials, or conversion of facilities to a long-term storage or standby status. Such requests must:
a.
Provide detailed, specific information describing the premises, equipment or scrap, radioactive contaminants, and the nature, e.xtent, and degree of residual surface contamination.
- b.
< Provide a detailed health and safety analysis which reflects that the residual amounts of materials on surface areas, together with other i considerations such as prospective use of the premises, equipment, or scrap, are unlikely to result in an unreasonable risk to the health and safety of the public.
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TA ' .
NUCL!DESa ACCEPTABLE SURFACE CONTAMINATION LEVELS .
AVERAGEbcf -
MAXINUMbd(
u-nat, u-235, U-230, and _
4..rsci.ited decay produc'ts REMOVABLEb e f 5.000 dpm a/100 cm2 _.__...
Iransuranics. Ra-226..Ra-228 15.000 dpm a/100 cm2 Th-230, Th-228, Pa-231 . 1.000 dpm a/100 cm2 Ac-227, I-125. 1-129 100 dpm/100 cm2 ,
300 dpm/100 cm,2 Ih-nat. Th-232. Sr-90 20 dps/100 cm2 Ra-223, Ra-224. U-232. 1-126 t-131, 1-133 1000.dpm/100 cm2 .
3000 dpm/100 cm2 Deta-gacma emitters (nuclides 200dpm/100c5 2 wi th decay modes other than alpha emission or spontaneous fission) except Sr-90 and 5000 dpm sy/100 cm2 3thers noted above. 15.000 dpm 87/100 cm2 1000 dph sy/100 cm2 Tuncre surface contamination by both al h .
i nucildes should apply independently. p a- and beta-gamma-emitting nuclides exists, se the limits establi h d --
for alpha- and beta-garru-emit t ing counts per minute observed by an appropriate detector for backgroAs used in this Measurements of average contaminant should not be a
.hould be derived for each. Such object.
und, efficiency, and geometric factors associated ng the umentation.
veraged over more than I square meter.
For objects of less surface area. the average The maximum contamination level applies to an area of not , .
more than 100 cm2 shsorbent
.r.own efficiency.
paper applying moderate pressureThe amount of removable radioactive material per 100 cm2 reportionally and the When removable entire surface should , and assessing the amount of radioactive material on the w contamination be wiped. on objects of less surface area i er or soft s determined, the pertinent levels should be reducedof nstrument Te average and maximum radiation levels associated with
.2 erad/hr at I cm and 1.0 mrad /hr at I cm. respectively, measured through not more than 7 surfac 2tal absorber.
. milligrams per square centimeter of
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5.
Prior to release of premises for unre i make a comprehensive r'adiation survey'stricted use, the licensee shall is within .the limits specif.ied in Table 1.which establishes that contamination A copy of the survey report U. S. Nuclear Regulatory Commission. Washing Administrator of the NRC Regional Office having jurisdiction.
The report The survey report shall:should be filed at least 30 days prior to the .
- a. Identify the premises.
b.
Show that contamination. reasonable effort has been made to eliminate resi c.
Describe the scope of the survey and general procedures followed .
d.
State the findings of the survey in units specified in the instruction. '
Folicwing facilities to review confinn of thethe report, the NRC will consider visiting the survey. $
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I *a ss4 UNITED STATES - ~
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%,,, / April 12, 1995 GE E L0 SEL Marshall E. Miller Dr. Harry Foreman Presiding Officer Special Assistant 1920 South Creek Boulevard 1564 Burton Avenue Spruce Creek Fly-In St. Paul, MN 55108 Daytona Beach, FL 32124 In the Matter of ADVANCED MEDICAL SYSTEMS, INC.
Material License No. 34-19089-01 Docket No. 30-16055-ML-REN
Dear Administrative Judges:
Pursuant to 10 C.F.R. 55 2.1231 and 2.1203(c), 1 am forwarding to you and the parties copies of the documents. set forth in tne attached Index which
(
comprise, as of this date, the hearing file for this proceeding. Please note that the Staff's review of the application for license renewal submitted by Advanced Medical Systems, Inc. (AMS) is not complete. At this time the Staff currently estimates that its review of the application will be completed within three to six months. The Staff will update the hearing file in accordance with 10 C.F.R. 5 2.1231(c).
Sincerely, a
Marian L. Zob e' Counsel for N taff
Enclosures:
As stated .
cc w/encls: Service List
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APR 2 0 19958 j Q~l k !Z lf
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!; AMS HEARING FILE INDEX
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April 12, 1995
- 1. Materials License Number 34-19089-01, as amended, September 27, 1994.
- 2. Letter to Mr. John R. Madera, Section Chief for Licensing, U.S. Nuclear Regulatory Comission from David Cesar, Treasurer, Advanced Medical Systems, Inc., Re:
Application for Renewal of Material License No.
34-19089-01, November 29, 1994.
- 3. Letter to Advanced Medical Systems, Inc., Attn: David Cesar, Treasurer from John A. Grobe, Chief, Nuclear Materials Inspection Section 2, Re: Application for Renewal of NRC License No. 34-19089-01, December 22, 1994 (without attachments). -
- 4. Letter to Mr. Jack Grobe, Nuclear Materials Inspection, Section 2, U.S. Nuclear Regulatory Comission from David Cesar, Treasurer, Advanced Medical Systems, Inc., Re:
Response to Letter dated December 22, 1994, December 29, 1994.
- 5. Letter to John A. Grobe, Chief, Nuclear Materials Inspection, Section 2, U.S. Nuclear Regulatory Commission from David Cesar, Treasurer, Advanced Medical Systems, Inc., Re: Application for Renewal of NRC License No. 34-19089-01, Control No. 397891, enclosing )
application for . renewal of NRC License, January 26, 1995, with enclosed application (three parts). Please i note that section 3, Decommissioning Cost Estimate for the London Road Site in Cleveland, Ohio, has been withheld, pursuant to the proprietary statement contained in the document until the Staff makes a determination with respect to the applicant's request to withhold this document. The Presiding Officer and parties will be promptly notified of the Staff's determination. -
i 1
- 6. Telefacsimile to John A. Grobe, Chief, Nuclear Materials !
Inspection, Section 2, U.S. Nuclear Regulatory Commission from David Cesar, Treasurer, Advanced Medical Systems, Inc., Re: W.H.U.T. Room report, March 6,1995.
- 7. Letter to John A. Grobe, Chief, Nuclear Materials Inspection, Section 2, U.S. Nuclear Regulatory Commission from David Cesar, Treasurer, Advanced Medical Systems, Inc., Re: enclosing two copies of W.H.U.T. Room Survey, with enclosed Survey, March 8, 1995. ,
- 8. Letter to Advanced Medical Systems, Inc., Attn: David (s Cesar, Treasurer from John A. Grobe, Chief, Nuclear
- . . . _ ~ - . - . - . . - . - . . . - . . ..- . . . . . . . . -
1 i
3 Materials Inspection Section 2, Re: Review of Decommission Funding Plan, March 13, 1995.
I 9. Materials License No. 34-19089-01, as amended, March 17, 1995.
- 10. Letter to Advanced Medical Systems, Inc., Attn: David Cesar, Treasurer from John . A. Grobe, Chief, Nuclear Materials. Inspection Section 2, Re: Cost Estimate for Decommissioning, March 30, 1995.
- 11. Letter to Advanced Medical Systems, Inc., Attn: David Cesar, Treasurer from John A. Grobe, Chief, Nuclear Materials Inspection Section 2, Re: Emergency Plan and Notice of Violation, March 31, 1995.
- 12. Letter to Distribution List from David Cesar, Treasurer, Advanced Medical Systems, Inc., Re: Enclosing copies of AMS' Emergency Plan, March 31, 1995.
- 13. Letter to Mr. John A. Grobe, Chief, Nuclear Materials Inspection,Section II, U.S. Nucl e'ar . Regulatory Commission From David Cesar, Treasurer, Advanced Medical Systems, Inc., Re: Modified and Restated Decommissioning
( Trust, March 31, 1995 (with enclosures). Please note that this document is a facsimile copy, a copy of the original document will be forwarded to the Presiding Officer and the parties as soon as possible.
%# x-
)) 7AI9 p On January 19, 1994, the Deputy Director, Division of Radiation Safety and
\. Safeguards, Region III, and members of the Region III staff conducted a site visit and inspection at the Advanced Medical Systems, Inc. facility in Cleveland, Ohio. The local sewer district has plugged thae facility sewer piping to the sewer interceptor due to concern over the discharge of cobalt-60 to the sewers. The purpose of the visit was to evaluate the resuongoing problems the facility is experiencing with ground water infiltration into the contamianted facility basement and to sample water that has accumulated in various locations within the facility, in above ground tanks, and in an on site man hole and sump pit.
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January 20, 1995 2
) Cuyahoga Emergency Management Assistance Center ATTN: Michael S. Kalstrom, Secretary Cuyahoga County local Emergency l Planning Committee l
1255 Euclid Ave ~nue Room # 102 '
Cleveland, Ohio 44115-1807 J
L
Dear Mr. Kalstrom:
This responds to your December 29, 1994 letter to me regarding the Advanced Hedical Systems, Inc. (AMS) facility at 1020 London Road, Cleveland, Ohio and ~
1 its Radiological Contingency Plan (RCP). Specifically, you questioned the
- adequacy of the existing RCP and expressed concern that the plan has not been
! . properly implemented. In addition, you pointed out that the NRC's Fire
! Protection Safety Evaluation Report (fire safety assessment) for the AMS facility did not include a complete hazards analysis of the AMS facility and ,
j possible community impacts from a major fire, explosion, tornado or other i
disaster. The committee which you represent requested'that the NRC conduct a t . thorough review of the risks posed by the facility, including a survivability assessment and hazards analysis of the hot cell, waste holdup room and other i
j (.
contaminated areas. You also requested a review of the RCP and its implementation.
As' b&ckground information, in 1985, the Radiological Assessment Program of Oak
' Ridge Associated Universities (0RAU) was contracted by the NRC to evaluate the AMS radiological and fire protection programs. A second similar ORAU evaluation was conducted in 1988. In June 1990, the NRC developed a fire i safety assessment, documenting NRC staff's evaluation of the fire protection )
and emergency planning programs for the AMS facility, and consolidating NRC
! fire protection recommendations. Our fire safety assessment was not a ;
1 j detailed hazards analysis of the entire AMS London Road facility. !
The 1990 assessment concluded that AMS's previously developed emergency pre-plan was inadequate and should be expanded to address those items outlined in
- 10 CFR 30.32. 10 CFR 30.32(1) is the regulation that addresses, in part, emergency plan requirements for domestic licensing of byproduct material under i the Atomic Energy Act of 1954, as amended. In January 1992, AMS developed an '
l RCP which addressed the items in 10 CFR 30.32(i). The plan was approved and incorporated into the AMS license through Amendment No. 25, dated July 30, l 1992. This plan continues to be referenced in License No. 34-19089-01. ,
License No. 34-19089-01 expired on December 31, 1994. A timely renewal i
application was-submitted to the NRC prior to the license expiration date.
Preliminary review of that application revealed that it was not adequate to meet our expectations. A deficiency letter was sent to the licensee and a i revised renewal package is due to be submitted by the end of January. Hazards 4
i
( assessment information is required to be submitted by the licensee in its license renewal application, along with an emergency plan that meets the L D 4
$ 6 0 lc R C i @ ; f _
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i n Cuyahoga Emergency Management I Assistance Center
$ current criteria of 10 CFR 30.32(i)(3)(11). As part of the license renewal process, the adequacy of the updated RCP will be reviewed for compliance with current emergency plan criteria of 10 CFR 30.32 and NRC standard review plan guidance (NUREG-0810).
We agree with your concern regarding AMS's implementation of its existing RCP. [
A routine NRC inspection of the AMS facility on October 11 and 12,1994, i revealed several weaknesses with the plan's implementation. The results of I
' our inspection were forwarded to the licensee in a letter dated November 29, 1994, and included three violations related to RCP implementation, three other !
specific concerns and an overall concern with inadequate AMS management !
oversight in the emergency planning area. These problems are currently being s addressed by the licensee. A copy of our November 29, 1994 correspondence is /
enclosed for your information.
/
On December 12, 1994, we met with representatives of the Cleveland Department of. the Environment, other state and local officials, and you to discuss the AMS facility and its emergency plan. On January 3, 1995, AMS representatives met with you and other state and city of Cleveland officials to further discuss emergency planning issues. As a result of these meetings, we
( understand that a radioactive material source term has been derived for the AMS facility and will be used by the Ohio EPA to assess offsite radiological impacts under various accident scenarios. We further understand that you will be a continuing participant in these meetings to review and evaluate the i AMS emergency planning capability. l In response to your concern regarding contaminated water runoff potentially resulting from fire fighting activities at the facility, we understand that the fire pre-plan being developed by the Cleveland Fire Department and AMS will include provisions for use of dry chemicals to fight fires in contaminated areas of the facility, as a preferred fire fighting technique in lieu. of water. Nevertheless, should water be necessary to extinguish a fire in the hot cell portion of the facility, this water would likely drain into the basement of the facility, which has no direct flow path to the sewer system or the environment. This water would need to be collected and disposed of pursuant to NRC regulations.
We appreciate your concern and interest in the AMS emergency plan. We will continue to cooperate with the committee you represent and other interested parties in resolving emergency planning concerns. Cuyahoga County is now on routine distribution of documents exchanged between NRC and AMS. I can assure you that the license for the AMS facility will not be renewed unless an emergency plan meeting the current criteria of 10 CFR 30.32(i) is in place.
Implementation of the plan will continue to be reviewed during NRC inspections of the AMS operations.
(.
Cuyahoga Emergency Management (' Assistance Center Please do not hesitate to contact me with any further questions.
- Sincerely, Original Signed by John A. Grobs John A. Grobe, Chief
- Nuclear Materials Inspection Section 2 License No. 34-19089-01 Docket No. 030-16055
Enclosure:
Letter and Notice of Violation dtd 11/29/94 See Attached Distribution DOCUMENT NAME: G:\LTRS2LIC\MTLS\030\95316055.LO3 n . n.eou e..n t.i,.m.t.hiin.wn: c . con wout .et.ce nu.nci. r - con e .etw.nci.. w . No con OFFICE RIII ,, y 6 NMSS gdy ,,vCs G OGC .A,, . .G RIII o, A 6 NAME LSlawinski:dpfN '
Combs 10'~ A '\'" i. Goldberg!- f' Awol'y ' Grobe W -J NTE ; 01/ Go /95 8 01/ p /95 01/ v/95' **V 01/qa f95 0FFICIAL RECORD COPY
. . _ __ _ _ . _ . _ . _ . . . . . _ _ _ _ _ . ~_
Cuyahoga Emergency Management - (- ,
Assistance Centor Distribution cc w/ enclosure:
Michael R. White, Mayor 4 City of Cleveland 601 Lakeside Avenue Cleveland, OH 44114 Lisa Mehringer City of Cleveland Law Department 601 Lakeside Avenue Room 106 Cleveland, OH 44114 Robert E. Owen, Administrator Radiological Health Program
. Department of Health 246 North High Street, 3rd Floor P.O. Box 118 Columbus, OH 43266
( Erv Ball, Deputy Director Cuyahoga County Board of Health 1375 Euclid Ave. Suite 524 Cleveland, OH 44115 Erwin' J. Odeal, Executive Director Northeast Ohio Regional Sewer District .
3826 Euclid Avenue -
CleveluA, OH. 44115 han_w/ enclosure:
Mike Stein, 0GC Cyndi G. Jones, NMSS John A. Grobe, RIII 8
PUBLIC IE07 E-mail:
Bill Axelson (WLA) John Madera (JRM4)
Bill Brach (EWB) Josie Piccone (JMP1)
Carl Papperiello (CJP1) Kevin Null (KGN)
Cyndi Jones (CGJ) Mike Stein (MHS)
. Fred Combs (FCC) Steve Lewis (SHL)
Jack Grobe (JAG) Tim Johnson (TCJ)
Jack Goldberg (JRG) Wayne Slawinski (WJS2)
Jim Caldwell (JLC1)
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- UNITED STATES NUCLEAR REGULATORY COMMISSION
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801 WARRENVILLE ROAD uSLE, ILUNOtS 60532-4351 I
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, November 29, 1994
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4 F Advanced Medical Systems, Inc.
l 3 ATIN: David Cesar i
i' Treasurer 121 North Eagle Street Geneva, OH 44041 1
4
Dear Mr. Cesar:
This refers to the routine safety inspection conducted by.Hr. Wayne Slawinski
' of the NRC Region III office and Mr. Robert Shewmaker of our headquarters office on October 11-12, 1994, to review certain aspects of your NRC licensed 2
' activities authorized by NRC Byproduct Material License No. 34-19089-01. This '
also refers to the discussion of our findings with Robert Meschter at the t conclusion of the site inspection on October 12, 1994 ~ and to the telecon with you on October-21, 1994.
The inspection was limited in scope _and included a review of: (1) the O implementation of your Radiological Emergency Contingency Plan; at (2) information relative to assessing the Waste Holdup Tank "
~
structural integrity; and (3) recent facility water usage pra(WHUT) ctices. room's The inspectors also met with Cleveland Fire Department representatives at your facility to discuss their readiness to respond to an event at your facility.
The enclosed copy of our inspection report identifies areas examined during '
the inspection. Within these areas, the inspection consisted of a selective examination of procedures and. representative records, observations, and interviews with personnel. Our assessment of the WHUT room's structural integrity is continuing. Assessment results will be provided under separate cover upon completion of our review.
During this inspection, certain of your activities were found to be in violation of NRC requirements, as specified in the enclosed Notice. In
. addition to the violations, we also identified the following other concerns during the inspection.
(1) The only available emergency contact person listed in your Radiological Contingency Plan who provides backup to the RSO is not sufficiently familiar with the plan.
(2), The Director of Regulatory Affairs has key responsibilities in the implementation of the Radiolo listed as a backup emergency.gical contact; Contingency however, thisPlan, including individual has been being on leave for more than one year and no other individual has fulfilled the director's role under this. plan.
(3) Your staff has not interfaced sufficiently with the Cleveland Fire
(' Department and other response organizations, to ensure they have an adequate understanding of your Radiological Contingency Plan and the facility.
Agg a a3a app
Advanced Medical Systems, Inc. f, (4) While routine radiation and contamination surveys are conducted in the vicinity of the WHUT room area, the specific WHUT room surveillances and radiation surveys described in your February 8,1988 letter to the NRC have not been conducted.
In addition to your response to the violations, please also respond to the four concerns noted above, indicating your corrective action and actions to prevent recurrence. Of particular concern is the status of your readiness to respond to an emergency. While we believe that your RSO is competent to respond to and support emergency response activities, the available backup for the RSO listed in your contingency plan is not fully cognizant of the plan.
It appears that your management oversight of this important aspect of your program has been ineffective. This area requires your prompt' attention to ensure you have: (1) a properly trained staff in emergency response positions; (2) appropriate equipment and supplies available; (3) effective audits and exercises to assess emergency response readiness; and (4) a productive relationship with offsite emergency response organizations.
Please ensure your response addresses these areas.
In accordance with 10 CFR 2.790 of 'the Commission's regulations, a copy of g this letter, the enclosures, and your response to this letter will be placed 6 in the NRC Public Document Room. -
The response directed by this letter and the accompanying Notice are not subject to the-clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, PL 96-511.
We will gladly discuss any questions you have concerning this inspection.
Sincerely, kb ohn A. Grobe, Chief Nuclear Materials Inspection Section 2 License No. 34-19089-01
- Docket No. 030-16055
Enclosures:
- 1. Notice of Violation
- 2. Inspectio1 Report No. 030-16055/94004 1
4 I
I w
November 29, 1994 s
Advanced Medical Systems, Inc. I ATTH: David Cesar Treasurer 121 North Eagle Street Geneva, OH 44041 l l
Dear Mr. Cesar:
This refers to the routine safety inspection conducted by Mr. Wayne Slawinski of the NRC Region III office and Mr. Robert Shewmaker of our headquarters office on October 11-12, 1994, to review certain aspects of your NRC licensed activities authorized by NRC Byproduct Material License No. 34-19089-01. This also refers to the discussion of our findings with Robert Meschter at the conclusion of the site inspection on October- 12, 1994 and to the telecon with you on October 21, 1994.
The inspection was limited in scope and included a review of: (1) the ,
Wig implementation of your Radiological Emergency Contingency Plan; -
l (2) information relative to assessing the Waste Holdup Tank (WHUT) room's
( '
structural integrity; and (3) recent facility water, usage practices. The )
inspectors also met with Cleveland Fire Department representatives at your facility to discuss their readiness to respond to an event at your facility.
The enclosed copy of our inspection report identifies areas examined during the inspection. W1 thin these areas, the inspection consisted of a selective examination of proculures and representative records, observations, and interviews with personnel. Our assessment of the WHUT room's structural integrity is continuing. Assessment results will be provided under separate cover upon completion of our review.
During this inspection, certair, of your activities were found to be in violation of NRC requirements, as specified in the enclosed Notice. In- 1 addition to the violations, we also identified the following other concerns during the inspection. l (1) The only available emergency contact person listed in your Radiological l Contingency Plan who provides backup to the RSO is not sufficiently familiar with the plan.
J (2) The Director of Regulatory Affairs has key responsibilities in the I implementation of the Radiological Contingency Plan, including being :
listed as a backup emergency contact; however, this individual has been on leave for more than one year and no other individual has fulfilled the director's role under this plan.
(
^
(3) Your staff has not interfaced sufficiently with the Cleveland Fire Department and other response organizations, to ensure they have an adequate understanding of your Radiological Contingency Plan and the facility.
@liw9??03b 4pp -
Advanced Medical Systems, Inc. '
(4) While routine radiation and contamination surveys are conducted in the vicinity of the WHUT room area, the specific WHUT room surveillances and radiation surveys described in your February 8,1988 letter to the NRC have not been conducted.
In addition to your response to the violations, please also respond to the four concerns noted above, indicating your corrective action and actions to 1' prevent recurrence. Of respond to an emergency.particular concern While we believe is your that the status RSO isofcompetent your readiness to to respond to and support emergency response activities, the available backup for the RSO listed in your contingency plan is not fully cognizant of the plan.
It appears that your management oversight of this important aspect of your program has been ineffective. This area requires your prompt attention to ensure you have: (1) a properly trained staff in emergency response ,
a positions; (2) appropriate equipment and supplies available; (3) effective i dudits and exercises to assess emergency response readiness and (4) a productive relationship with offsite emergency response orga;nizations.
Please ensure your response addresses these areas.
In accordance with 10 CFR 2.790 of the Commission's regulations, 'a copy of
- 4h this letter, the enclosures, and your response to this letter will be placed 5 in the NRC Public Document Room.
-( The respons'e directed by this letter and the accompanying Notice. are not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, PL 96-511.
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3 We will gladly discuss any questions you have concerning this inspection.
Sincerely, 4
Original signed by John A. Grobe John A. Grobe, Chief I Nuclear Materials Inspection Section 2 License No. 34-19089-01
- Docket tio. 030-16055 Enclotures: 1. Notice of Violation
- 2. Inspection Report No. 030-16055/94004 l bec w/encls: Robert Meschter, AMS k. u] d C.:5-~a , * 'S Capt. Thomas Root, Fire Marsha1J Tec A3$L T. biu , e55 Cleveland Fire Department v1. Anim, c4sg.
, PUBLIC IE07 NUMENT NAME: G:
a,....n.:w. \. INS.PRPTS\.MTLS\030\03016055.94
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NAME /DSLAWINSKI: Jaw JMADE44Y b JAGR0 bel-N ~
DATE U11/14/94 f 11/JG54 II/M/94 /
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4 NOTICE OF VIOLATION Advanced Medical Systems, Inc. License No. 34-19089-01 Cleveland, Ohio Docket No. 030-16055 4
During an NRC inspection conducted on October 11-12, 1994, violations of NRC requirements were identified. In accordance with the " General Statement of Policy and Procedure for NRC Enforcement Actions," 10 CFR Part 2, Appendix C (1994), the violations are listed below:
License Condition 18 requires that the licensee maintain and execute the response measures of their Emergency Plan dated October 25, 1991 and revised January 1992, May 27, 1992 and April 26, 1993.
A. Item 7.3 of the "0nsite Radiological Contingency Plan For The Cleveland, Ohio Facility," revised May 27, 1992 and April 26, 1993, requires that j the licensee conduct a full scale biennial exercise with offsite emergency response personnel.
2 Contrary to the above, from inception of this requirement in July 1992 to the date of this inspection on October 12,1994,' no full scale exercise involving offsite emergency response personnel has been .
A conducted. 3 This is a Severity Level IV violation (Supplement VI).
B. Item 7.5 of the "Onsite Radiological Contingency Plan For The Cleveland, Ohio Facility," revised May 27, 1992 and April 26, 1993, requires that the licensee conduct an annual audit to review the emergency response program, emergency plan procedures, training, equipment and supplies.
t Contrary to the above, from incep' tion of this requirement in July 1992 to the date of this inspection on October 12, 1994, no licensee audits of the emergency response program, emergency plan procedures or training has been performed.
This is a Severity Level IV violation (Supplement VI).
C. Items 6.3 and 6.4 of the "Onsite Radiological Contingency Plan For The Cleveland, Ohio Facility," revised May 27, 1992 and April 26, 1993, list the emergency response equipment and supplies located in the fire pumphouse. Item 7.6 requires that fire pumphouse emergency equipment and supplies be inventoried and checked quarterly, and that inoperable or missing equipment be repaired /re'placed.as soon as possible.
Contrary to the above, on October 12, 1994, certain emergency response supplies required to be located in the fire pumphouse were not available. Specifically, supplies absent included building keys, a current listing of emergency response personnel and corresponding telephone numbers, and $3.00 in quarters for pay phone usage.
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This is a Severity Level IV violation (Supplement VI).
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[ Notice of Violation 2 Pursuant to the provisions of 10 CFR 2.201, Advanced Medical Systems, Inc.
is hereby required to submit a written statement or explanation to the U.S.
Nuclear Regulatory Commission, Region III, 801 Warrenville Road, Lisle, Illinois, 60532-4351, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a j
" Reply to a Notice of Violation" and should include for each violation:
(1) the reason for the violation, or, if contested, the basis for disputing the violation, (2) the correctiva steps that have been taken and the results achieved, (3) the corrective stcps that will be taken to avoid further violations, and (4) the date when full compliance will be achieved. If an adequate reply is not received within the time specified in this Notice, an order or a demand for information may be issued as to why the license should not be modified, suspended, or revoked, or why such other action as may be ;
proper should not be taken. Where good cause is shown, consideration will be given to extending the response time.
Dated at 1. isle, Illinois this 338; day of November 1994 I '
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UNITED STATES NUCLEAR REGULATORY COMMISSION REGION III Report No. 030-16055/94004(DRSS)
License No. 34-19089-01 Priority I- Category B l
Docket No. 030-16055 Licensee: Advanced Medical Systems, Inc. (AMS) 1020 London Road Cleveland, OH 44110 l
Inspection At: Advanced Medical Systems, Inc. (AMS) l 1020 London Road Cleveland, OH 44110 .
Site Inspection Conducted: October 11-12, 1994 Inspectors: be M-Wayne 51awinski, Senior
//!13!V1 1 Date'
. . . Radiation Spec alist, Region III ;
[ Ctl a gbert Shewmaker, Senior Structural vinin .
Dath / !
, Jngineer, Office of Nuclear Material Safety and Safe uards Reviewed By: I l.d e' // g!'M John /Madera, Chief Dat'e Ma erials Licensing Section, Region III A f) ,
Approved By: ( b- h 79 7
'M n A. Grobe, Chief Date /
clear Materials Inspection Section 2 Region III InsDection Summary InsDection on October 11-12. 1994 (Report No. 030-16055/94004(DRSS))
Areas Inspected: Routine, announced inspection to evaluate certain limited aspects of the licensee's NRC-licensed program including a review of: (1) the implementation of the facility Radiological Contingency Plan; (2) information relative to assessing the WHUT room's structural integrity; and (3) recent facility water usage practices. One of the inspectors also met with
. representatives from the Cleveland Fire Department at the London Road facility
[N to discuss its radiological hazards and the licensee's Radiological Contingency Plan.
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Results:
( Three violations of Radiological Contingency Plan (RCP) requirements were identified as described in section 4(b). In addition, several RCP related concerns were noted including licensee personnel familiarity with the 2
plan and a lack of management oversight in the plan's implementation.
Similarly, the licensee has not adequately interfaced with local emergency I response officials to ensure they are fully cognizant of the facility's hazards and its RCP. The inspection also disclosed that a WHUT room.
surveillance and radiation survey program has not been implemented in i j
accordance with licensee commitments. <
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DETAILS
- 1. . Persons Contacted Licensee Representatives
+ David Cesar, Treasurer, AMS
- Robert Meschter, Radiation Safety Officer, AMS
, Vincent Rocco, Technician, AMS j ++Seymour Stein, Ph.D., President, AMS
, ++ Edward Svigel, Engineering Manager. AMS i William Muniak, Attorney, Arter & Hadden i Cleveland Fire Department Representatives i Reginald Keith, Lieutenant, Pre-Plan Office i~
William Little, Captain, Pre-Plan Office Thomas Root, Captain & Fire Marshal
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The inspectors also met with_other members of the Cleveland Fire Department during a meeting with Captain Root at the AMS facility on
! October 12, 1994.
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- Denotes presence at site exit meeting on October 12, 1994.
l (T + Denotes participation in the exit meeting teleconference on October 21, 1994. 1 J
++ Denotes telephone contacts only.
- 2. Purpose and Scope of Inspection l
4 This was a limited scope safety inspection conducted primarily to gather information and visually examine accessible areas of the London Road n
facility relative to assessing the Waste Holdup Tank (WHUT) room's j
structural integrity. Also reviewed, in part, was the implementation of the licensee's RCP for the London Road facility, including discussions t
' with the Cleveland Fire Department regarding the licensee's plan and related matters. Additionally, the inspectors reviewed the London Road i facility's recent water usage and sanitary sewer discharge practices.
- 3. WHUT Room Structural Assessment i '
As noted above, the primary purpose of this inspection was to assess the structural integrity of the London Road facility's WHUT room. The WHUT room is' a poured concrete structure located in the basement of the-facility beneath the hot cell, housing two liquid radwaste holdup tanks.
i.U The holdup tanks contain unknown quantities of cobalt-60 contaminated liquids and/or sediment. The WHUT room was isolated by the licensee 3
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/ beginning in 1988 in lieu of its decontamination, as described in the J- (
licensee's letter to the NRC dated February 8, 1988. The room's i
temporary isolationLwas. approved by the NRC in a letter dated
- October 20, 1988.
To assess the structural integrity of the WHUT. room, the inspectors -
reviewed information relative to the room's design and construction, and visually examined accessible exterior portions of the room'and ad,jacent structures. Original facility blueprints and construction photographs taken in approximately 1960 were also reviewed. Personnel
- entry into j
the WHUT room is currently' prohibited due to the room's existing
- radiological condition.
I The NRC's assessment of the WHUT room's integrity is continuing. The 1
licensee will be provided the results of the assessment when they become 4
available.
Licensee letter dated February 8,1988 describes the remedial actions
, for the WHUT room, including a description of the isolation methods proposed for the room and plans for monitoring the area after its isolation. Section H of the attachment to the February 8,1988 letter, )
entitled " Maintenance of the Isolated State," describes a monitoring and surveillance program to ensure the room remains properly isolated. . The 3
monitoring program is to include weekly radiological surveys of the ,, ,
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^ accessible exterior surfaces of the room. Specifically, the monitoring .'6 program is to consist of radiation level measurements and smears taken 1 -( in reproducible locations on the exterior walls, and smears of all access.ible penetration blocks. Section H further states that procedures i
addressing the room, its status and other specified information will be j . included in facility ISP procedures.
The inspection disclosed, however, that the commitments in Section H of the attachment to the February 8, 1988 letter have not been met. For
- example, as of October 12, 1994, ISP procedures do not address methods for verifying the integrity of WHUT room isolation. In addition .a radiation level measurement and contamination smear survey progra,m has
! not been implemented for the exterior walls of the WHUT room. Although
" no deliberate changes to the WHUT room and its contents have been made since the rooms isolation in 1988/89, a monitoring and surveillance program is necessary to ensure its continued proper isolation. ;
Subsequent to the inspection, the licensee performed radiation measurements on exterior portions of the WHUT room's walls. 'No evidence l of WHUT room integrity problems were identified.
No violation of regulatory requirements was identified; however, one concern was noted.
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- 4. Radiological Contingency Plan (RCP)
- a. Background Information In 1991, the licensee developed a RCP for its London Road Cleveland, Ohio facility, pursuant to 10 CFR 30.32(1). A RCP dated October 5, 1991, was submitted by the licensee for N.RC review, reportedly after incorporating comments / suggestions from ' j the Cleveland Fire Department, Police Department and Emergency '
Medical Services Agency. The RCP outlines licensee and certain offsite response organization responsibilities and describes its emergency plan for responding to fire, explosion or other events j that could result in a release of radioactive material.
The RCP developed by the licensee was reviewed and approved by the !
NRC and incorporated into License No. 34-19089-01 via Amendment i No. 25, dated July 30, 1992. License Condition No. 18 currently '
requires that the licensee maintain and execute the response measures of their Emergency Plan dated October 25, 1991 and revised January 1992, May 27, 1992 and April 26, 1993. ;
- b. Plan Implementation Portions if the RCPs implementation were evaluated during this
' inspection. Additionally, the plan and the London Road facility's !
radiological hazards were discussed with Cleveland Fire Department
-[ representatives during a meeting at the facility on October 12, 1994.
The inspection showed that the RCP has not been implemented as required. The inspection also disclosed licunsee management involvement and oversight of the plan's implementation to be weak, particularly within the last year since the licensee's Regulatory ;
Affairs Director has been on leave. Problems have been compounded by continued turnover in radiation safety officer staff. The 1 inspection identified several RCP implementation violations and I related concerns,' as described below.
Item 7.3 of the "0nsite Radiological Contingency Plan For The Cleveland, Ohio Facility," revised May 27, 1992 and April 26, 1993, requires that the licensee conduct a full scale biennial i exercise with offsite emergency response personnel. As described j above, the RCP was incorporated into License No. 34-19089-01 on July 30, 1992.
As of October 12, 1994, no full scale exercise involving offsite emergency response personnel has been conducted by the licensee.
Failure to conduct a full scale exercise is a violation of License Condition 18 which references the RCP.
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9 In a letter to the NRC dated September 22, 1993, the licensee informed the Commission of its intent to conduct the required exercise ~in December 1993. However, according to licensee representatives, the exercise was not conducted.
Item 7.5 of the RCP requires that the licensee audit to review the emergency response program, conduct and an annual emergency plan procedures, training, equipment and supplies.
As of October 12, 1994, no licensee audits of the emergency response program, emergency plan procedures or training have been conduct.ed.
Items 6.3 and 6.4 of the RCP list the licensee's emergency response equipment and supplies located in the fire pumphouse located approximately 300 feet. west of the London Road facility.
Item 7.6 of the RCP requires that fire pumphouse emergency equipment and supplies be inventoried and checked quarterly, and 1 thatpossible.
as inoperable or missing equipment be repaired / replaced as soon 4
- During the inspection on October 12, 1994, certain emergency
! response supplies required to be located in the fire pumphouse
' were not available. Specifically, supplies absent included London m
Road facility building keys, a current listing of emergency i response personnel and corresponding telephone numbers, and $3.00 e
(- in quarters.
In addition to the violations described above, other concerns j related to RCP implementation were identified. These concerns are described br;1ow.
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(1) Appendix A of the RCP includes a list of licensee " Emergency t Contact Personnel." The list was revised in September 1994 .-
! and includes the name of the RSO, Engineering Manager and Director of Regulatory Affairs. Inspector conversation with i the Engineering Manager revealed only a cursory familiarity with the RCP. Also, the revised emergency contact list i failed to include the correct telephone number for the NRC Operations Center and Region III office.
(2) The Regulatory Affairs Director has several responsibilities in the RCPs implementation. - However, the director has been on leave for over one year and no other individual (s) has i fulfilled the director's RCP responsibilities. {
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- { (3) An October 12, 1994 meeting with Cleveland Fire Department representatives revealed that the licensee has not i
< interfaced sufficiently with fire department personnel, to
. develop a thorough familiarity with the RCP and the licensee's facility. Subsequent to the inspection, the NRC learned that the fire department has classified the AMS '
j facility as an Extremely Hazardous Substances (EHS)-
facility. According to the Cleveland Fire Department, EHS
- facilities warrant an emergency pre-plan, detailing fire department procedures and planned actions for responding to facility emergencies.
i As of November 18, 1994, the fire department's first response :
l' units have toured the facility and been instructed by the licensee in its radiological hazards. The department's hazardous materials unit plans to tour the facility in.the near future. The fire department anticipates development of its e:nergency pre-plan by
- the end of 1994.
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Three violations of regulatory requirements and several concerns
{ were identified.
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- 5. Water Usage and Disoosal Practices i
j
- The inspectors reviewed City of Cleveland water billing records for the 5 London Road facility and discussed recent water usage practices with the j
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( licensee. ,
1 According to the current AMS facility RSO, no liquid radwaste has been '
} discharged into the sanitary sewer system since his employment initiated
'in July'1994.' The ltSO further stated that no liquid radwaste has been generated, other than on August 22, 1994, when an employee showered to l remove a small quantity of facial contamination. The facial contamination accurred during the decontamination of lead blankets in l
- the isotope shop. Approximately 2-3 gallons of water was reportedly '
used by the employee while showering in one of the facility's ,
designated decontamination showers. The decontamination showers drain j
' to a 200-gallon plastic tank located in the front basement of the facility. The liquid generated during the shower remained in the tank l and has since. evaporated.
i The licensee receives water billing and consumption information on a j
quarterly basis. Quarterly records for the London Road facility were reviewed by the inspectors for the period July 1992 through June 1994.
The records show, with one exception, quarterly water usage to range from about 45,000 ft' during the fourth quarter of 1992 to 83,000 ft*-
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( for6900 to the first gallonsquarter of 1994. This equates to a volume range of 3740 per day. '
quarter of 1993, when only 6000 ftTheexceptionoccurredduringthesecond <
i; (500 gallons / day) was used. Billing
' records show total water usage for the 12-month period July 1993 through June 1994, to be nearly twice that used during a corresponding period in 1992-1993. .
mid-1994 to escalating plumbing problems in the facility.The The reason j for1993 of the is relatively unknown.small volume of water used during the second quarter 4
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- According to the lit.ensee, facility water usage is primarily limited to j , general use purpose
- ;. of toilets, sinks and urinals for sanitary and consumption
- i. Since the facility is normally occupied by only two or three individuals for a single shift, typical daily water usage is expected to be only about 100-200 gallons. As noted above, the licensee's water '
)t usage expected. over the last two years has been significantly greater than facility for several years and have been allowed to continue unr i According to the licensee, the plumbing problems were continuous, paired.
i however, their severity could fluctuate day-to-day. The problems have worsened over the last 6-10 months. NRC inspectors have been aware of
{ some of these plumbing problems for over one year, including a
- continually men's lavatory.flushing toilet and leaking urinal flush mechanism in the Durint;
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j the inspector observed unexpectedly large quantities of wateran
- discnarging into the sewer system, when viewed from the manhole area just outside the facility. The July 1994 discharges were, at the time, 3
attributed by the licensee to the aforementioned plumbing problems.
This explanation was plausible since a stuck flush mechanism on the men's toilet was known to be a continuing problem.
)
! A standard toilet continuourly flushing at about 50% of its normal capacity can use roughly three gallons of water per minute or ,
i 4300 gallons per day. Therefore, the London Road facility's unusually
- large water' usage since 1992 appears to correlate with the plumbing problems. -
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. On or about September 29, 1994 and continuing the week of October 3, 1994, a contractor repaired the plumbing problems known to sxist at the i
L facility. The work included installation of two new urinals to existing i flush valves, and repair of a toilet flush valve. As a result of the i repairs, . facility water usage beginning the fourth quarter of 1994 1 should be significantly reduced. During the inspection on October 12, I 1994, the inspectors removed the manhole cover where discharges to the l sanitary. sewer system exit the London Road facility, and verified that discharges had ceased.
i fixtures and plumbing contractors billing record.The inspectors also observed 8
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{ No violations of regulatory requirements were identified
- 6. Exit Meetino The inspectors inspection on October met with the licensee's RSO at the conclusion 12, 1994, l the inspection. On October 21, 1994, and summarized the scope and findinegssite of between Cesar of AMS.Mr. Roy. Caniano and other NRC Region III staff and Mra
. David and the licensees. corrective action options were!
teleconference. i
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during the inspection was considered proprietary.TI I
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, IR,C,IMNS DIVISION TEL:301-504-5369 Feb 09'95 12:a5 ho.006 3.02
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j!!E3, Northeast Ohio Regional Sewer Distric': !
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, f 3826 Eucfid Avenua Daveirc ONo d4115 2504 2M-33 ^0 ^ #4 2"sS ';
t January 20,1995 1
Ms. Cynthia Jones U.S. Nuclear Regulatory Connission Mail Stop T-8F5 Washington, DC 20555 Re: Proceeding Transcript and Appellate Brief
Dear Cindy:
It was very nice meeting you a: the Region III Headquarters. I am glad we had the opportunity to discut.c arcas of mutual concern, and look forward to working with you toward +ht.f r resolution.
d Per your request of January 1,1995, enclosed please find copies of the transcripts of proceedings of December 13, 1994 before the Honorable George V. White, U.S. District Judge, Northern District of Ohio. Eastern Division. You may be particularly interested in several of
( the assertions by counsel for Advanced Medical Systems (AMS) contained theroin.
For example, at page 8, it asserted that the Waste Hold-Up Tank (WHUT) room may be compronised if further water enters the basement.
Counsci for AMS further asserts at page 29 that the compression plug in the AMS lateral "has the effect of making it impossible for us to do something about Uie accumulated water in our foundation' and that "there is a possibility that there will be a structural failure or structural damage to that building if that compromises that WHUT room". Further, at page 41-42, AMS counsel quotes an engineer as stating that the VHilT room is going to flood.
These statements are in distinct contrast to the assurances provided by Mr. Grobe at the January 11. 1995 meeting.
At page 20, counsel for AMS asserts that there are a number of licensees in the Greater Cleveland area that have been discharging Cobalt-60 into the sewer system.
This is in direct contradiction to the statements contained in the November 7,1994 NRC memorandum froa Roy J.
Cantano to W.L. Axelson. -
At page 28. counsel for AKS asserts that, as far as Cobalt-60 content is concerned, that the water in the AMS lateral meets safe drinking water standards.
Mr. Grobe's coments at the JanuaryThis assertion 11,1995 meeting.appears to be contradicted by The rnissan of the Northeast Ohio Regur.alSewerDistrictis to ennance public nea.tn ana weitere th:c.gr.
e."e:tn :onveyanc andtreatment at wastenates. Tt.:s is acccmplisted of r crgan.zat cn cecica:e::: c:ctess;cra!!v
- a wc; a% consis ency tha! anticicates and resocnds tc !ne chrg't'g enw:nsr:a! ++ : :' " + *,
sRD-
HRC'IMNS DIVISION TEL:301-504-5369 Feb'09'95
./** 12: 46 No.006 P.03 i
, Ms. Cindy Jones l \
U.S. Nuclear Regulatory Commission !
Janudry 20, 1995 Page Two I
These contradictions between the stated positions of the NRC and AbtS concern us greatly. l i
i We are further concerned that the NRC has left the evaluation of
- how to handle the present contamination to AMS, and will provide only a !
post-facto review of the evaluation presented by AMS. Mr. Grobe made it clear at the January 11. 1995 meeting that NRC would not be providing additional suggestions for programs to be reviewed for effectiveness, ;
cost-efficiency, man-Rem exposure. and so on. This appears to limit the options available to the NRC to those suggested by AMS. It also appears that this creates a suggestion of the homeowner to ask the raccoon how best to keep his garbage in his garbage cans.
l Counsel for AHS states at page 32 that if the water from AMS is i
required by the NRC "to be fil tered or processed, or something else,"
that AMS will comply. AMS counsel further states at page 42 that the NRC has the authority to make AMS "do anything." We would urgo you to take all appropriate steps to unilaterally ensure that all available treatment
- methods including 0.45 micron filtration, ion exchange, and evaporation -- are indeed explicitly evaluated.
Also per your request, enclosed please also find a copy of the NRC Office of the General Counsel Brief for Respondents filed in the Sixth l 1
Circuit Court of Appeals. In this October 1,1993 document, it is asserted by the NRC General Counsel that the AMS facility (with the )
l exception of the WHUT room) was completely decontaminated in 1989. See, i e.g. , page 5, footnote 2. If that was indeed true, then, apparently, i
i re-contamination of the facility has occurred since 1989.
According to the NRC Brief, "If AMS allowed its facility again to become contaninated with radiation, it would be subject to a new order
- requiring cleanup based on the new contamination." Counsel for AMS has i
conceded that the AMS lateral is indeed contaninated, and NRC has 4 established areas in the AMS facility other than tne WHUT roon which are contaninated. Please let us know when the new order requiring cleanup
- vill be implemented. '
Please call me at (216) 881-6600 if you have any questions or cocinents about the foregoing. '
Very o uly yours, M r2 4
T.'awrence K. Englie
. Assistant General, cunsel en e1.
, cc: Sara J. Fagnilli (w/o encl .)
Thomas E. Lenhart (w/o encl.)
~ - . . . - - . . - . . - . .- . ~ , .. - . . . _ -
CONVERSATION RECORD l TIME joATE 3:40 p.m. 1/20/95 f'
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O vis!T O CONFERENCE X TELEPHONE O INCOMING X OUTCOING f
NAME OF PERSON (S) CONTACTED OR IN CONTACT ORGANIZATION (OFFICE, DEPT.ETC.)
Larry English TELEPHONE No.
NEORSD 216-881-6600 SUBJEGI Public meeting and Excavation at AMS SunMARI l
I spoke with regarding AMS. Larry English about the postponement of the public meeting the excavation work at AMS.
I also thanked him for the 1/13/95 letter informing us of AMS is experiencing from the 3I & informed Larry about the difficulties that 1/2 inch rain and the subsequent influx of water into the basement. I shared with Larry.that I was onsite last Wednesday and inspected the excavation, indicating to Larry that the licensee the manhole.was constructing a separate under drain sump pit independent of Larry was appreciative of the call and requested that we notify the NEORSD when the meeting was rescheduled.
( AGIION RhGUIREDFile in AMS License File.
NAMt OF PERSON 9T_9tNilNG GUNVtR5ATION EIGNAIUML John A. Grobe DAlt l 1/23/95 ACIION TAK4N Filed in License File. Distributed to AMS team.
$1GNATURE '.
TITLE b A .
DATE / /3 O[
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_Ql4 Northeast Ohio Regional Sewer District 3826 Euclid Avenue Cleveland, Ohio 44115-2504 216 881 6600 FAX:216 881 9709 l January 13, 1995 Mr. John Grobe, Chief Nuclear Materials Inspection Section 2 i U. S. Nuclear Regulatory Comission Region III !
801 Warrenville Road Lisle, Illinois 60532-4351 Re: Excavation at 1020 London Road
Dear Mr. Grobe:
l Upon my return to Cleveland, I learned that there were excavation l activities ongoing at 1020 London Road. It appeared that the footers
( along the building's soudiecst wall were being dug up with a backhoe.
This work had apparently begun earlier this week.
8 At the time these activities were observed, the AMS Radiation Safety Of ficer was not present. The trenches, which are now covered over with boards or planks, appeared to be approximately four (4) feet deep.
I wanted to bring this to your attention, inasmuch as these activities were not mentioned during our January 11, 1995 meeting, nor do they appear to be contemplated by any of the d'eumentation you have provided to us.
Please call me if you have any questions about the foregoing.
Very truly your nec /
awrence K. Engli Assistant General Counsel
- At The r : : :n of the Northeast Ohio RegionalSewer Districtis to enhance public heal:h and welfare througn the elficient. cost-e:i,*
- - ::nveyance and treatment of wastewater. This is accomplished by an organization ded ca:ed :: professionalism M consistency tha! anticipat >s and responds to the changing environmbnta! needs of IN c 'nmunity. '
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January 24, 1995 l Advanced Medical Systems, Inc.
ATTN: Mr. David Cesar, Treasurer 121 N. Eagle Street Geneva, OH 44041 !
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Dear Mr. Cesar:
This is in response to the letter dated December 20, 1994, from Mr. Robert Heschter of your staff requesting information on NRC Region III contacts. I Please be advised that I will be your principal contact at the NRC Region III office concerning emergency planning and all other issues regarding your l licensed activities. Messrs. John R. Madera and Wayne J. Slawinski will be l alternate contacts if I am unavailable. 1 If you have any questions regarding this matter, please contact me at (708) 829-9806.
Sincerely, OriginalG .SI ned by John A. Grobe John A. Grobe,' Chief Nuclear Materials Inspection Section 2 l
License No.: 34-19089-01 Docket No.: 030-16055 ,
See Attached Distribution l
DOCUMENT NAME: G:\LTRS2LIC\MTLS\030\95316055.LO4 T3,eceive a copy of thle docurnant,lndcate in the box: 'C' = Copy without attachment / enclosure "E* = Copy wMh attachment / enclosure "N* = No copy l OFFICE RIII a 3p RIII RIII RIII NAME Grobe:d M N DATE 01/ 24 /9J 1 01/ /95 01/ /95 01/ /95
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OFFICIAL RECORD COPY geges0002 &eP i
l David Cesar Distribution
! gg:
- Michael R. White, Mayor City of Cleveland l 601 Lakeside Avenue
! Cleveland, OH 44114 '
Lisa Mehringer
' City of Cleveland Law Department 601 Lakeside Avenue Room 106 Cleveland, OH 44114 Robert E. Owen, Administrator Radiological Health Program Department of Health 246 North High Street, 3rd Floor P.O. Box 17.8 Columbus, OH 43265 Erv Ball, Deputy Director
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l Cuyahoga County Board of Health 1375 Euclid Ave. Suite 524
- s. Cleveland, OH 44115
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- Erwin J. Odeal, Executive Director ;
l Northeast Ohio Regional Sewer District l
3826 Euclid Avenue Cleveland, OH 44115
_c_q:
Mike Stein, OGC Cyndi G. Jones, NHSS John A. Grebe, RIII PUBLIC IE07 E-mail:
l Bill Axelson (WLA) Steve Lewis (SHL) 1.
1 Bill Brach (EWB) John Madera (JRM4)
Jim Caldwell (JLCl) Kevin Null (KGN)
! Fred Combs (FCC) Carl Papperiello (CJP1)
Jack Goldberg (JRG) Josie Piccone (JMP1)
Jack Grobe (JAG) !!ayne Slawinski (WJS2) i Tim Johnson (TCJ) Mike Stein (MHS)
( Cyndi Jones (CGJ) i
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- IE, Grk
. ..$E% Northeast Ohio Regional Sewer District J26 Euclid Avenue Cleveland, Ohio 44115-2504 216 881 6600 FAX:216 881 9709 January 25, 1995 John Grobe, Chief Nuclear Materials Inspection Section 2 U. S. Nuclear Regulatory Commission Region III 801 Warrenville Road Lisle, Illinois 60532-4351 Re: Cancellation of January 23, 1995 Meeting
Dear Mr. Grobe:
Thank you fcr infonning us late last Friday afternoon that the meeting scheduled for Monday (January 23, 1995) was canceled. If I understood you correctly, the meeting is now scheduled for February 6, 1995. Please advise us as to whether that is a firm date.
You mentioned that the reason for the cancellation of the scheduled meeting was that Advanced Medical Systems had eighteen (18) inches of water in its basement. Inasmuch as the Nuclear Regulatory Commission has been aware of the detailed configuration of the drainage about the facility at 1020. London Road since at least the time of your dye-testing thereof in Spring 1993 (see, e.g., page 15 of NRC Report No. 030-16055/
93002(DRSS)), it concerns us greatly that the NRC has neither developed nor implemented alternative water administration methods over the last couple of months.
Despite the ostensible seriousness of the water level in the AMS.
basement, it is apparently not so serious as to occasion any overtime efforts by the AMS personnel. The last worker appears to depart the 1020 London Road facility by 3:30 p.m. On the date of your call, for example, District personnel observed that no AMS personnel remained at the 1020 London Road facility beyond regular closing time.
You also mentioned that you were not aware of the excavation ongoing at the southeast corner of the AMS facility. You stated that you personally had been out to the site on Wednesday, January 18,1995, but did not mention the shed that has now been built in the approximate location of the excavation. This shed was also not mentioned during our January 11, 1995 meeting, nor does it appear to be contemplated by any of the documentation you have provided to us.
The miss:o n c!!he Northeast Ohio RegionalSewer Districtis ta enhancepublic health and we!!are througn the efficient. cost-cI! active c:m eyance and treatment of wastewater. This is accornalished by an organization decucaloc :o professionalism inarncss a n :Onsistency that anticip3tes and responds to the changing environmenta! nee:: ; 'tne c: :wundy.
Q 6090TO}3]~ e PO
5 <
John Grobe, Chief
- ' U. S. Nuclear Regulatory Commission '
January 25, 1995 Page Two .
This also concerns us. This licensee is excavating the foundation I of a building whose basement and interconnected sewer lines are known to i
harbor loose Cobalt-60 and to be subject to infiltration by water from i the outside. It is reasonable to assume that any wall that allows infiltration can also allow exffitration. Hence, it is possible that the
- 1. soil excavated may also contain Cobalt-60. Notwithstanding this obvious possibility, it does not appear that any of the soil removed from around the contaminated basement has been analyzed. Certainly, inasmuch as you were not aware of the excavation itself, the licensee is not under NRC orders to conduct such analysis. The soil is presently in a pile, I
exposed to the elements. It is not in any way protected from runoff.
This raises once again the issue of the lack of ongoing oversight
' of this licensee. That the licensee could be conducting outdoor 4
excavation of potentially contaminated soil with a backhoe without the knowledge of the NRC forces us to wonder what other, possibly smaller l scale operations may be ongoing at this facility.
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- These activities also hignlight the necessity of unilateral, affirmative requirements by the NRC of this licensee, and for rigorSus l
1 oversight thereof. As the NRC's present posture is to merely review the !
proposals of the licensee for the handling of this contaminated facility, it now appears possible and even likely that the licensee will merely not
(' inform you of operations it doubts will find your approval, operating on the assumption that these activities will n'ot be independently discovered by the NRC.
Please let us know if the February 6,1995 aeeting is confirmed. ;
i As always, please call me if you have any questions about the foregoing, Very truly yours, l
]p Q l>< 15 l Lawrence K. English
- Assistant General Counsel cc
- Richard N. Connelly Sara J. Fagnilli Thomas E. Lenhart i
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g Acvancec Mecica Systems,Inc.
ph Eagle Sheet . Geneva, Ohio 44o41 vo6 467 :
FAX (216) 466-o186
\ u January 26, 1995 (
l I
Mr. John A. Grobe, Chief Nuclear Materials Inspection sSection II U.S. Nuclear Region III Regulatory Commission
)
801 Warrenville Road Lisle, IL 60532-4351 a RE:
Application for Renewal of NRC License No. i Control No. 397891 34-19089 01
Dear Hr. Grobe:
[
Enclosed are two (2)
' referenced NRC License.copies of our Application for Renewal of our above- ii Advanced Medical Systems' The enclosed information describes all aspects of !
Procedures. licensed operations, Radiation Safety Program and !
Advanced Medical Systems' o renewal five (5) years ago,perations have changed significantly since the last Management Organization for i operations. The introduction discusses the Business Plan a Advanced Medical Systems given its current i!
Your correspondence dated December issues when submitting our License 22, Renewal.
1994 requested that we address specific Application for License Renewal.
This information is enclosed in the situation with water in the basement of theis the cense Renewal facilityThe o situation and is being addressed as a singular event. .
This~is an abnormal is appropriate for it to be a part of the License .
As such, I do not feel it '
If you have.any questions or require clarification on any contained 466-4671. within the Application for License Renewal, please contactof the me at (216)
Sincerely,
.y sw j
DAVID CESAR Treasurer
\ e (7C/mz .nclosures geonoo %
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( TABLE OF CONTENTS
(
MANAGEMENT ORGANIZATION AND DISCUSSION OF BUSINESS PLAN i SECTION 1 Application for Materials License j 1.1 Radioactive Material 1.2 Purpose for Which Licensed Material Will Be Used 1.3 Individuals Responsible for Radiation Safety Program and i
Their Training Experience 1.4 Training for Individuals Working In or Frequenting Restricted Areas 1.5 Facilities and Equipment r
1.6 Radiation Safety Program 1.7 Waste Management l
1.8 License Fees I l
[ 1.9 Service
( SECTION 2 Emergency Plan SECTION 3 Decommissioning Funding Plan SECTION 4 Waste Hold-Up Tank Room Integrity Evaluation l
SECTION 5 Financial Assurance
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i INTRODUCTION
( DISCUSSION OF BUSINESS PLAN AND MANAGDIENT ORGANIZATION f}usiness Plan Advanced Medical Systems' operations have changed since the last License Renewal.
Since its founding, when certain assets were acquired from Picker Corporation, Advanced Medical Systems has manufactured sealed sources, performed s' ervice work and manufactured a variety of teletherapy and radiography units.
Advanced Medical Systems' market has changed significantly as the domestic medical device field for teletherapy and radiography units has moved to more advanced technology - principally, linear accelerators. The domestic market for Advanced Medical Systems' products has significantly reduced. As the domestic market has shrunk, the export market has realized significant gains. Advanced Medical Systems has always sold and provided services for export primarily to developing countries.
Advanced Medical Systems has recently completed a reevaluation of its distributor base in various countries around the world and has made several changes. This evaluation is paying immediato gains. The company currently has Irrevocable Letters of Credit for six (6) machines with commitments of an additional eight (8) tender offers by the end of the year. Based upon sales projections provided by our, distributors, we anticipate a 400% sales increase within the next several years.
Along with the change in marketing strategy, the company has also made the f decision back in 1990 to no longer manufacture its own sealed sources.
Accordingly, the company has plans to' transfer to an authorized third party its current inventory of sealed sources and bulk cobalt. The authorized third parties that have already accepted shipments of existing inventory are Neutron Products and J.L. Shepherd, both of whom are NRC licensees. In addition, several foreign countries have expressed an interest in accepting the donation of low-level sources.
The termination of Advanced Medical Systems' source manufacturing operations drastically simplifies its operations. Advanced Medical Systems will purchase sealed sources from Theratronics and Neutron Products for use in its teletherapy , ,'
units. These sources, when they are received at the facility located at 1020 London Road, would have their source strength verified and then if they are going into a unit, installed and surveyed prior to shipment.
As Advanced Medical Systems' sales are principally derived from exporting complete units, domestic service will no longer be ordinarily handled internally. .
It is anticipated the majority of domestic service will be contracted out. I Export service is accomplished principally by our distributors and agents who l have been trained on Advanced Medical Systems' equipment and Advanced Medical l Systems' personnel provide support on an.as-needed basis.
In addition, Advanced Medical Systems will maintain its service technicians'
( training program to train service engineers from foreign countries.
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b 6DVANCED MEDICAL SYSTEMS. INC.
MANAGEMENT PLAN ORGANIZATION OF OPERATIONS I
( Descriptio_n of Management Controls and Operation Advanced Medical Systems, Inc. currently has two locations. These are as follows:
121 North Eagle Street 1020 London Road Geneva, Ohio 44041 Cleveland, OH 44110 The operations at the Geneva location include Engineering', Quality Control, Production, Purchasing and Sales. The operations at the London Road facility include Isotope handling, source surveys and receipt and shipment cf sources.
The Company's two facilities operate autonomously. Each department / facility head has the authority to manage their respective department / location. The Advanced Medical Systems Organization Chart is as follows:
PRESIDENT TREASURER I
, I
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MANAGEMENT TEAM l
ISOTOPE COMMITTEE l
SAFETY -
l COMMITTEE l
l ENGINEFRING MANAGER RADIATION SAFETY OFFICER -
SALES -
ENGINEERING IS01' OPE QUALITY HANDLERS -
CONTROL PRODUCTION TECHNICIANS -
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PURCHASING
. . _ . - _ . . -. . . _ _ - ~ - _ _ _ . - . - . _ . _ - _ - . - - . . - . . .- -. . _ _ - . -
l Page 2 of 4 Efanagement Team
( The Management Team of Advanced Medical Systems is responsible for the operations of the Company. The Management Team consists of the following department heads:
Radiation Safety Officer, Engineering Manager and Treasurer. This Team may .
change as the Company changes and different situations arise.
The Radiation Safety Officer (RS0) occupies a position on the Management Team as he is responsible for all operations at the Isotope Laboratory which is the principal licensee on the NRC's Material License and is also responsible for compliance with regulatory matters.
The Engineering Manager occupies a position 'on the Management Team as he is responsible for all medical device manufacturing, quality assurance and
- compliance with FDA regulations.
The Treasurer occupies the third position on the Management. Team and is
! responsible for overseeing sales and all financial functions of the Company.
Each of these individuals brings their own area of expertise to effectively make
- operating decisions regarding Advanced Medical Systems.
Isotope Committet l i
The Isotope Committee is responsible for overseeing all regulatory affairs of I Advanced Medical Systems with the Nuclear Regulatory Commission. The Isotope Committee is to meet on a quarterly basis and review the operations of the
{ Isotope Facility and compliance with current regulations. The Isotope Committee is chaired by the company's Radiation Safety Officer.
Safety Committee '
The Safety Committee is to meet quarterly and is chaired by the Engineering Manager. All safety issues regarding the medical devices manufactured by Advanced Medical Systems are to be discussed.
Facility Managers !
The Engineering Manager is responsible for the operations in Geneva. The Radiation Safety Officer is responsible for the operations at the Cleveland facility. As such, the RSO has complete authority and autonomy to manage the '
facility. Certain financial controls are in position to require approval from the Treasurer for all non-emergency expenditures in excess of $1,500. In emergency situations, corporate. approval is not required.
+
When a service call is received, the Engineering Manager will make the e determination to send an AMS service technician or contract the service request to a third party. It is anticipated the majority of the calls will be contracted. All Customer Service will require approval by the Engineering Manager. -
( The purpose of this structure of the service organization will allow for the selection of the best-suited individual or entity to be assigned the work. '
k '" Engineering also serves as a checkpoint for specific service problems.
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J Page 3 of 4 j ( An AMS employee will, upon completion of AMS performed service activity, record in detail a service report, the type and nature of the work assigned.
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Upon completion of each assignment, each Service Report for domestic service will be reviewed by the Engineering Manager and initialed.
For domestic service involving teletherapy equipment with radioactive material,
' the review and initials of the RSO is required. During regular- Isotope and Safety Committee Meetings, the results of the audits on all domestic Service Reports are reviewed.
When the Company subcontracts service work, the Company is acting solely as a sales representative and has no control over the third party's work.
3 AMS Service Technicians will be audited according to the following schedule if AMS utilizes each individual:
" FIELD SERVICE AUDITS" i Summary of Internal Service Audits i
- A. Field Service Audits O'n an annual basis, the RSO will audit the procedures and activities of each licensed service engineer as he performs his duties during a simulated service call or source exchange. An outline of the L audit parameters to be considered are attached. (The RSO may, in
( his discretion, alternatively or additionally audit the procedures and activities of each licensed service engineer as he performs his duties during a field service call.)
B. Service Report Audits Conducted by the Engineering Manager and RSO as domestic service reports are generated. Audit results will be entered on each
- domestic service report and signed.
C. Customer Unit Functions and Service Report Evaluation Conducted by a qualified member of the customer's staff for each domestic service call. This document will be attached to the AMS Service Report. In addition, a service evaluation questionnaire will be mailed to the facility following each service call. Any l adverse comments will immediately be brought to the attention of the Engineering Manager.
D. Safety Committee Meetings These meetings are held quarterly. The members include the AMS Engineering Manager, Radiation Safety Officer and corporate representative (Treasurer). Field Service Reports are reviewed. In
( addition, any incident reported during the quarter is also reviewed.
NOTE: Special Safety Committee Meetings will be held to review
( incident reports as necessary.
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Page 4 of 4 E. Isotope Committee Meetinas
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[ These meetings are held quarterly. The members include the l
Engineering Manager, Radiation Safety Officer and corporate l representative. Domestic Service Reports involving Cobalt unit installation, dismantling and maintenance are reviewed. In I addition, any pending issues relating to the operation of the l Isotope Facility or the manufacture of teletherapy equipment will be discussed. Records are maintained as Minutes of the Meeting. NOTE:
Special Isotope Committee Meetings will be held to review incident reports as necessary. -
SPECIAL NOTE: A corporate representative may or may not be present l at any meeting held within the Management Team. A copy of all documents and actions recommended are forwarded to the corporate representative for review. A copy initialed by all members of the !
Isotope Committee will be placed on permanent file. l External Audits of Service Activities and Documents: The company will engage an external consulting group every two (2) years to review all service l documents unless performed by contractors. Although this two-year audit will i encompass a complete review of records and documents, this audit deals l specifically with the service function.
Training and Oualifications of Service EnRineerS InvolvinR Radioactive Materials and Teletheraov Devices: The RSO will maintain a continuing training
( program in the areas of radiation safety and hazards to complement the existing medical device, mechanical and electrical, expertise presently in house. This
( program will follow the USNRC-authorized AMS training program (Section 1.9 of i
l Materials License Application pa:kage). The purpose of this program is to ensure AMS-licensed service engineers are qualified to conduct service work on Cobalt-60 teletherapy units. Under this plan, all service involving the handling of or direct exposure to radioactive materials in teletherapy units will be conducted only by or in the presence of a licensed person. It is equally important that i l
each service enginer has proven his knowledge of the mechanical and electrical I systems of the medical device.
Service of units who do not contain radioactive material sources and service of teletherapy units not involving licensed activity will be conducted by service engineers who have been thoroughly trained either by previous experience or within Advanced Medical Systems, Inc. These units do not require a service engineer licensed by the NRC.
Audits and Audit Control System: Audits and audit controls are described under separate cover. The types of audits conducted are listed below. See attachment.
Primary: 1. Customer unit function and Service Report Evaluation.
- 2. Service Report Audits.
- 3. Field audits by RSO.
( Final: 1. Safety Committee Meeting audits.
- 2. Isotope Committee Meeting audits.
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External audits by outside consultant.
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