View source for IA-84-705, Final Response to FOIA Request for Info on Sites in Us Involved in Commercial Irradiation of Medical Instruments, Wood & Wood Flooring & Consumer Products.App 4 Documents Encl.Portion of App 5 Document Withheld (FOIA Exemption 4)

{{Adams
| number = ML20136H982
| issue date = 07/17/1985
| title = Final Response to FOIA Request for Info on Sites in Us Involved in Commercial Irradiation of Medical Instruments, Wood & Wood Flooring & Consumer Products.App 4 Documents Encl.Portion of App 5 Document Withheld (FOIA Exemption 4)
| author name = Felton J
| author affiliation = NRC OFFICE OF ADMINISTRATION (ADM)
| addressee name = Gidwani B
| addressee affiliation = KIDDER, PEABODY &amp; CO.
| docket = 
| license number = 
| contact person = 
| case reference number = FOIA-84-705
| document report number = NUDOCS 8508200570
| package number = ML20136A665
| document type = CORRESPONDENCE-LETTERS, NRC TO ENGINEERING/CONSTRUCTION/CONSULTING FIRM, OUTGOING CORRESPONDENCE
| page count = 4
| project = 
| stage = Other
}}

=Text=
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o UNITED STATES pp%-%
             "3 8"            7,             NUCLEAR REGULATORY COMMISSION h                                   W ASHINGTON, D. C. 20555
  \...../                                   a . ', as Mr. Bahar Gidwani Kidder, Pgabody & Co., Incorporated 10 Hanover Square                                             IN RESPONSE REFER New York, NY 10005                                            TO FOIA-84-705

==Dear Mr. Gidwani:==

This is the final response to your letter dated August 23, 1984, in which you requested, pursuant to the Freedom of Information Act (FOIA), information on sites in the U.S. involved in commercial irradiation of medical instruments, wood and wood flooring, consumer products, food and spices, and infonnation on any accident or safety violatior of these facilities from 1974 to the present.
Copies of the documents listed on the enclosed Appendix 4 are enclosed.
A portion of the document listed on Appendix 5 contains information which Isomedix, Inc., considers confidential business proprietary and is being with-held from public disclosure pursuant to Exemption (4) of the FOIA (5 U.S.C.
552(b)(4)) and 10 CFR 9.5(b)(4) of the Comission's regulations. A copy of the releasable portion of the document is enclosed.
Pursuant to 10 CFR 9.9 of the Comission's regulations, it has been determined that the information withheld is exempt from production or disclosure, and that its production or disclosure is contrary to the public interest. The persons responsib'e for this denial are the undersigned and Mr. Thomas E.
Murley, Administrator, NRC Region I.
This denial may be appealed to the Corinission's Executive Director for Operations within 30 days from the receipt of this letter. As provided in 10 CFR 9.11, any such appeal must be in writing, addressed to the Executive Director for Operations, U.S. Nuclear Regulatory Comission. Washington, DC 20555, and should clearly state on the envelope and in the letter that it is an
      " Appeal from an Initial FOIA Decision."
The charge for reproducing records not located in the NRC Public Document Room (PDR) is currently five cents ($0.05) per page, as specified in 10 CFR 9.14(b).
Accordingly, the cost of reproducing the enclosed 95 pages is $4.75. You will be billed for the total amount of pages reproduced by our Division of Accounting and Finance.
Sincerely.
                                                         . Felton, Director Division of Rules and Pecords Office of Administration

==Enclosures:==
As stated l
l l                    850820g570850717 o$$   IN-705 PDR

F0!A-84-705 Appendix 4 l
Radiation Sterilizers, Inc. - Schaumburg, IL
: 1. 01/06/83 Ltr.w/ enc 1.-recordofinspectionWiedemantoChin(2pgs).
: 2. 01/31/83 Ltr. Chin to Wiedeman - response to enforcement action (1 pg).
: 3. 02/03/83 Ltr. Wiedeman to Chin - acknowledging receipt of 1/31/83 Itr.
(1pg).
Isomedix, Inc. - Whippany, NJ
: 4. 03/08/83 Ltr. Wiedeman to Dietz - report of inspection (w/ encl.) (12 pgs).
: 5. 04/21/83 Ltr. Dietz to Wiedeman - responding to enforcement action (1pg).
: 6. 04/29/83 Ltr. Wiedeman to Dietz - acknowledging receipt of 4/21/83 Itr.
(1pg).
Isomedix, Inc. - Parsippany, NJ (Morton Grove, IL)
: 7. 06/14/74 News Release - K. Abraham - overexposure at Isomedix (1 pg).
: 8. 06/14/74 News Release - K. Abraham - shutdown of Isomedix (1 pg).
: 9. 06/19/74 Memorandum Davis to Knuth - re: order suspending operations at Isomedix(3pgs).
: 10. 06/20/74 Order further modifying order issued 6/14/74 (e/ encl.) (9 pgs).
: 11. 07/09/74 News Release - K. Abraham re: order suspending operations (1pg).
: 12. 08/15/74 Ltr.KepplertoDietz-reportofinspection(w/ encl.)(15pgs).
: 13. 09/06/74 Ltr. Dietz to keppler - responding to enforcement action     with response
( 3 pgs).
: 14. 09/23/74 Ltr. O'Reilly to Dietz w/ attached 9/10/74 inspection report 29-15364-01(11pgs.)
: 15. Undated     LetterKnuthtoBauser(w/OrderstoIsomedixattached)(7pgs).
MATERIALS LICENSES
: 16. Radiation Sterilizers, Inc.                    License # 04-19644-01 300 San Hill Circle #2-190                    and Amendment No. 3 Menlo Park, CA 94025                          (5pages)
: 17. Isomedix. Inc.                                License # 29-02786-06 800 South Jefferson Road                      (3pages)
Whippany, NJ 07981

F l
  .                                                    Re: F01A-84-705 APPENDIX 4 (Continued) j     18. Ethicon. Inc.                          License # 29-02786-06 l          Route 22                              and Amendment 11 Somerville, NJ 08876                  (4 pages)
: 19. Becton-Dickinsen                       Lice.ise #06-13514-01  .
Route 7 and Grace Way                 Amendments 12-15 North Canaan CN 06018                 (6pages)
: 20. Permagrain, Products, Inc.             License #37-17860-01 22 West State Street                  Amendments 2 - 4 Media, PA 19063                       (8pages)              !
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i                                                            l l                                            F0!A-84-705 Appendix 5
: 1. 10/08/74 Ltr. to D. F. Knuth froic G. R. Dietz (3 pgs).
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[       Kidder, Peabody B Co.
Incorporated 7 ' ' ass New vonn     . mostow . PMSAc aL>ws A c wicAo o . SAN r=ANcisco . Los ANostas                      10 HANOVER SQUARE ATLANTA    . oALLAs    . RANsAs CITY he O.                NEW YoRm, N. Y. looo5 August 23,1984 Freedom of Information Act Officer Division of Fuel Cycle and Material Safety U.S. Nuclear Regulatory Commission                                   forR-Ri '70$
Washington, D.C. 20555                                               QQgggQ

==Dear Sir:==

In support of research I am doing on the commercial use of radiation in the U.S., I would like to request the following information under the Freedom of Information Act:
: 1. The name of owner, location, date of establishment, and licensed capacity to hold radioactive material for all sites in the U.S. actively involved in or currently applying for permission to begin commercial irradiation of medical Instruments, wood and wood flooring, consumer products, and food and spices. Most of these facilities use Cobalt 60 or Cesulm 137. Iattach a list of those facilities I arr already aware of, in order to facilitate your research. The total number of facilities in question should be less than 50.
: 2. The location, date, description, and disposition of any accident or safety violation related to the above-described irradiation facilities for the period from 1974 to the present. Please include in this reponse a description of any situations in which the NRC was forced to take legal action to correct a known or alleged safety problem.
Please contact me at 212-747-2792 If this request requires clarification.
Thank you for your help on this matter. Ilook forward to your response.
Sincerely, e      A Bahar Gidwani BG/ lab o
  ,ySo/93              h N

TAnLE 1 (continuedi Contract canna Ster 111:ers                                                     Capacity Primary Product    (kcil _
Irradiator TYPE           Cont'ainer Sise        _
Location                                                                 -~
                                                                                                                                                             " ~ ~ ~ ~
                                                                                                                                                                        ~~
Medical               1,008 rited singdom                                                                                    seeding , (Tilehurst)    Continuous p ot                                                           3,000
     - Gamme mediation-Services -                                                                                                                                                  Medical / Chemical 445_x_660    x 915 aus                           2,000 C'ontinuous,-tote 4 45 x 660Y1,105-%      edical/
M      Chemical Cirewteel/Maglical    3,000 match, tote Zecediated Products. Ltd..                                                               Suindon                  Continuous, tote         445 x 560 x 955 aus                                  ~~~.-
Incadiated Prroducts,. Ltd.                                                              Bradford Ir                                                                                                                                                                    Medical, Misc.            500 underwater, batch       14 x 50 x 100*
mited rtates                                                                                     Lynchburg, VA                                                                 Medical               3,000 Appised Radiant Energy Corp.                                                                                                              12 cubic feet (total                                 600  .
Irvine, CA               match and continuous    Adjustable                  Bulk materials            750 International Nutronics, Inc.                                                           Dover, NJ                Batch                    9 x 9 x 15"                Medical Intcrnational Nutronics, Inc.                                                           Falo Alto, CA            Batch or continuous                                 Med ical              2,000 International Mutronics Inc.                                                                                     Continuous, tote         18 x 22 x 37*              Medical                   500
                                                                                                    - Columbus, MS              Batch, tote              19 x 23 x 36"              Medical               3,000 Isomediu, Inc.                                                                          Morton Grove IL          satch, carrier           25 x 37 x S4*               Medical & Misc.      2,000 I m dis. Inc.                                                                          Northborough, MA         Satch, carrier           25 x 37 x 58*               Medical               3,000 Isomedia, Inc.                                                                         Parsippany, NJ           continuous, carrier      25 x 37 x 120"              Medical, Consumer     4,000 Isomedix, Inc.                                                                        Puerto Rico               Continuous, carrier     25 x 34 x 120*              Medical, Consumer     3,000 Isomedix, Inc.                                                                        Spartanburg, SC           natch, carrier          25 x 37 x 84*
Isomedia. Inc.                                                                        whippany, M.I                                                                 Medical               1,000 Inomedix, Inc.
Satch or continuous      la x 24 x 10S*             Medical, Misc.            200 Neutron Products, Inc.                                                                 Dickerson, MO Satch, carrier           24" diameter x 04*
Dickerson, MD                                                                                       3,000 Neutron Products, Inc.                                                                                                                   20 x 25 x 36*             Medical                5,000 Tustin, CA   .
Continuous, tote 23 x 32 x 37*              Medical mediation Sters11:ers. Inc.                                                  Inc. Schaumberg, IL       - Continuous, tote 3,000 mediation Sterilizers                                                                                                                    40 x 48 x 96*              Food                  3,000 O Continuous, pat tet                                 Food Badiation Technology. Inc.
Durlington, NC           continuous, pallet       40 x 40 x 96*              Medical, Misc         2,000h
                 -padiatica Technology, Inc.
Providence, RI Continuous, tote         24 x 26 x 36"              Food, Medical         2,000 w Dockaway, NJ                                      28 x 52 x e4"                                           w sadiation Technology, Inc.                                                            West Memphis, TN         Continuous, pattet pSdiation Technology Inc.                                                                                                                                          Medical                3,000y Continuous, tote          18 x 23 x 38*                                          -
Brookings, SD                                                                                             O 3M Company                                                            -
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l         Radiation Sterilizers, Inc.
* Licenso No. 04-19644-0_1 l         ATTN: Mr. Allan Chin, Ph.D.
l         1401 Morgan Circle l         Tustin, CA 92680 l
Genticuen:
This refers to the routino safety inspection conducted by Mr. C. T. Oborg of this office on December 21, 1982, of activities authorized by NRC Byproduct Material License No. 04-19644-01 located at 711 E. Cooper Court, Schaumburg, Illinois and to the discussion of our findings with Mr. T. Hurley at the conclusion of the inspection.
* The inspection was an examination of activities conducted under your license as they relate to radiation safety and to compliance with the Commission's
* rules and regulations and with the conditions of your license. The inspec-tion consisted of a selective examination of procedures and representative records, observations, independent measurements, and interviews with personnel.                                                                             .   .
During this inspection, certain of your activities appeared to be in non-                                       ;
compliance with NRC requirements, as specified in the enclosed Appendix.
A written response is required.                                                                                -
The responses directed by this letter (and the accompanying Notice) are-not subject to the clearance procedures of the Of fice 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.                                      i Sinc ely
                                                                         ,   . ' ,/   M"               .
D. G. Wiedeman, Chief Materials Radiation Protection Section 1 Enclosuret Appendix, Notice of Violation                                                                                         c cc w/encle                                                                                                     ;
Mr. T. Hurley, RSO General Manager                                                                             !
J. Hartranft, R.S.
DMB/ Document Control D sk (RIDS)
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Appendix NOTICE OF VIDI.ATION Radiation Sterilizers, Inc.                             License No. 04-19644-01 As a result of the inspection conducted on December 21, 1982, and in accordance with the NRC Enforcement Policy, 47 FR 9987 (?! arch 9, 1982), the following violation was identified:
License Condition No. 12 states, licensedmateri$1shallbeusedbyorunder the supervision and in the physical presence of, Allen Chin, Bruce C. ?!cyer, or Steven Smith.
Contrary to this requirement, through the date of this inspection, the indivi-duals specified were not located in the Chicago area such that license material l             was used in their physical presence. Platerial was being used under the super-l             vision and physical presence of the General tfanager and RSO for this site, an l             individual not delineated in the license.
This is a Severity heval IV violation (Supplement VI).
Puisuint to the provis ions of 10 CFR 2.201, ye : are required to submit to this of fice within thirty days of the date of this Notice a written state-ment or explanat ion in reply, including for cach item of noncompliance:
(1) corrective action taken and the results echieved; (2) corrective action to be taken to avoid further noncompliance; and (3) the date when full com-t             pliance will be achieved. Con,ideration may be given to extending your l             response time for good cause shown.                                        ~~
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l             Dated                                             D. G. k'iedemar:, Chief
                                                                ?!aterfals Radlation Protection Section 1 l
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                                       .                        January 31, 1983
* Mr. Darrel Wiedeman Materials Radiation Protection Section NRC Region III                                               '
799 Roosevelt Rd.
Glen Ellen, IL              60137                                .
* i             .                    .
Ref: Licenso No. 04-19644-01 Dear Mr. Wiedeman l
l                     In response to your communication n16 nod January 6,1983 rogarding the item of noncompliance, observed during the safety inspection
'                     by Mr. C.T. Oberg, 12/21/82, wo are amending the information in our licenso so that full compliance will be achieved in the
* id'entification of all users and operators of the licensed material.
To correct the noncomplianco item, Monses. T.W. !!urley and T.J. Mates, key management personnel at the RSI Schaumburg facility will   be added to the list of authorized uuors of the licensed material. Mr. T.W.                 !!urley will also be identified as the RSO for the facility.
This amended informat. ion along with certain additional clarifi-                                                    i cation amendments to the licenso doncription will be submitted in writing to your offico no lator than February 7,                                 1983.
Sincoroly,                     t
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Thomas W. Iturley.
Conoral Manager cc: Mr. Allan Chin, President RSI                                              <
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Radiation Sterillects incorporaled,711 E. Cooper Crt., Schautoburg, Illinois 60195 / Telephone (312) 843 0999
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Radiation Sterilizers, Inc.                                                      License No. Oh-196hh-01 ATIN: Mr. Allan Chin, Ph.D...                                                                               -
President                           ..
IkOl Morgan Circle                               ..                    , ,
Tustin, CA 92680                                 ..
Centlemen:
Thank you for your letter dated January 31, 1983, informing us 'of the -
steps you have taken to correct the noncompliance identified in our letter dated January 6, 1983.. While your letter states that you have                                               '
filed an application for nn appropriate amendment to achieve corrective action for the item of noncot:pliance, it should be underntood that no activity is in nccord with NRC regulatory requirements unleco and until it is specifically authorized in an NRC license. Steps should be taken to ensure that NRC-licenced r.aterials nre herenfter poncensed and used only as authorized by your license. We vill examino this tr.atter during a future inspection.                             ..
Your cooperation with us is appreciated.
Sincerely,                    .
                                                                                                 /
                                                                                 . D. G. Wiedernan, Chief
                                                                         .. .      Materinic Radiation Protection
                                                                          ..          Section 1 cc:     T.V. Hurley, Gen. Mgr.
Schaumberg, IL                      ..
cc w/ltr Sta 1/31/83:
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              !            )*                     ATOMIC ENERGY COMMISSION
* bI                                    WASHINGTON, D.C. 20545
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              %,              i Qe -g June 19, 1974 i?y.]fh,
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hssi D. F. Knuth, Director of Regulatory Operations INFOPJfATION ON ISOMFDIX, INC., PARSIPPANY, NEW JERSEY Cl -                     An Order suspending operations at Isomedix, Inc., Parsippany,
* Neu Jersey (License No. 29-15364-01 which authorizes radiation sterilization of medical supplies at Parsippany, New Jersey) and a similar facility at Ibrton Grove, Illinois (License No.
29-15364-02) was issued on Jiiiic'14,1974. The basis for this issuance was the ovarexposure of a worker at the Parsippany plant apparently due to the failure of the facility to have a fail safe interlock on its hot cell.                                            .
In examining the license for the Morton Grove, Illinois facility, it was detemined that a fail safe interlock was required on its
    ~
hot ec11. The license for the Parsippany, New Jersey facility did not cicarly cxpress such a requirement. On the evening of June 14, 1974, inspectors from Region III were dispatched to the 1.-'                    Morton Grove, Illinois facility to detemine whether, in fact, a fail safe interlock existed on that facility. Later in the evening of June 14, I was infomed by Region III that the facility Jid possess a fail safe interlock which functioned properly and M5NN that there was no reason, from the standpoint of the facility, to continue the suspense Order in effect for the Morton Grove, Illinois
* facility.                                                                            ,
On Saturday, June 15, 1974, an Order was issued suspending the
  ~                         initial order insofar as the !brton Grove, Illinois facility was concerned. The original order of June 14 continues in effect J                   for the Parsippany, New Jersey facility. J. P. O'Reilly, Region I, C'
   *"-                      contacted the President of Isomedix and infomed him of the Order                                                                -
pomitting resumption of operations at the Morton Grove, Illinois facility. O'Reilly informed the president of Isomedix that the suspense Order continues in effect for the Parsippany, New Jcracy facility. A press release was prepared for release through the Chicago office concerning the suspension of the June 14 Order to Isomedix. It was detomined by the Region III office that Isomedix, Morton Grove, Illinois, does not nomally operate on Saturday and Sunday. Consequently, tho Order of June 14, 1974, did not interrupt operations on June 15, 1974.
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l                  ..                            C                                    C D. F. Knuth                                               June 19,1974 ,
In discussions with Paul Nelson on June 15, it was determined that the exposed individual showed the following lymphocyte count: 6/13 - 1568; 6/14 - 1027,1048,1349 (1:00 PM). Nelson stated that -reported values of 700 and of 900 were incorrect.
Neil Wald, M.D. , the AEC consultant in this mattir, will be in New Jersey on Sunday, June 16, to examine the patient.              It takes          '
  "EEEE                   about 48 hours, according to Uald, to see stabilization in the lymphocyte count.           The normal for lymphocytes is about 1500 to 3000,- Once the exposed individual-is examined, Wald will make a determination as to whether he should go elsewhere for treatment.
    '$fdhj                Nelson stated that the exposed individual was lucid and in good spirits.
!                       '&t June 16, Nelson stated that Wald had visited the patient on June 16, and that the lymphocyte count had stabilized about 1000. Wald stated that, based on the blood picture of the indi-vidual and his response, it would appear that an exposure of 300 Rem or less seems probable.            However, Wald is uneasy regard-ing the film badge exposure.
I Chromosomal studies were initiated by the hospital on Saturday
''"'~^                  with initial results due Tuesday, June 18. Unid has taken                               '
samples so that he can initiate his own studies upon his return to Pittsburgh on Monday, June 17.
j . * .L -
The individual's film badge was damaged by stapling it to a report form for mailing to the processing laboratory. R. S. Landauer in I                       Chict.go reported results on the film badge on Saturday night. If dEEEE                 no light contribution is considered in the interpretation of the badge', the badge shows about 2000 (I 500) Rems exposure. If it is assured that there is 50% light contribution, the exposure would be
       +6C              approximately 1000 Rems Landauer estimates 1000 to 2000 Rems exposure to the film badge. However, he does not have high confidence
* in this result. On June 17, Landauer will attempt to reproduce the exposure patterns, particularly, a reproduction of the contribution of the light from the stapling of the badge.
  . aa.
Nelson reported that there is some possibility that the exposure was not a uniform whole body exposure; that the can of teflon that was to be irradiated at the time of the exposure of the individual may have partially shleided the lower torso of the individual by an equivalent of about 6 inches of water. Such shielding would be significant in the clinical response of the individual.
I l
WNEMB A__.-__-_-___---____________

                                                   ,. . w D. F. Knuth                                                             June 19, 1974
;-                                                                                On June 16, the exposed individual was in good spirits and lucid l.-                                                                               and Dr. Wald reported his clinical condition was about that which
!"                                                                               would be expected from approximately 300 Rem exposure. There is no evidence of nerve damage which, apparently, would be evident if he had suffered the exposure estimated from the film badge.
g                                                                              Additional information will be developed on this case.
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John G.              a is, Deputy Director                       '
for Field Operations cc:        B. H. Crier C. W. Kuhlman J. P. O'ReIlly, RO:I J. G. Keppler, RO:III H. D. Thornburg W. P. Ellis F. A. Dreher
      .rce.                                                                                 G. Smith
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                                            .r 3           ;.gaf UNITED STATES OF A!! ERICA                   -
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t-  a         UG; i AT0111C ENERGY C0lt!ISSION                 '
b IN Tile MATTER OF )                                         BYPRODUCT MATERIAL ISOMEDIX, INC.      )                                               '        *~              ~
LICENSE No. 29-15364-02 ORDER FURTilER MODIFYING ORDER ISSUED JUNE 14. 1974 W                                                                              I Isomedix, Inc., 25 Eastmans Road, Parsippany, New Jersey, 07054,
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("the licensec") is the holder of Byproduct Material Licensco Nos.
?--
29-15364-01 and 29-15364-02 ("the licenses") issued by the Atomic u.
Energy Conniscion ("the Cormaission") . The licenses authorize the licensee to possess and use byproduct material for the purpose of the irradiation of materials.         License No. 29-15364-01 was issued
,               .                                                                                            s                         ,
on August 13, 1973, and the expiration date is June 30, 1978.                                 .c
        ' ' ' ~
Licence No. 29-15364-02 was facued on January 29, 1974, for use of                             .
material at Morton Grove, Illinois, and the expiration date is January 31, 1979.
M                                                                             II on June 14, 1974, the Director of Regulatory Operations, after de-ternining that potentially hazardous conditions may exist at the
        ,a licensco's Parolppany, New Jersey, and Morton Grovo, Illinois,                               .
   ,jf,7 *                                                                                                                                                        '
facilitics, issued an Order to Show.Cause suspending all use by the l
licenoco of byproduct material under Licence Non. 29-15364-01 and 29-15364-02 pending further order. Tho Order to Show Cause and the suspenofon of activition contemplated thoroin, were mado effective immediately.                           .
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c III On June 15, 1974, the Director of Regulatory Operations, after determining that the public health, safety or interest no longer required the suspension of use of byproduct material at the
                /
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s licensce's !!orton Grove, Illinois facility under License No.
29-15364-02, ordered that the Order issued June 14, 1974, insofar
  '4' as it suspended all use of byproduct material at the licensco's                                                          ,
                                    !!orton Grove, Illinois facility be rescinded. The Order issued June 14, 1974, insofar as it suspended all use of byproduct material under License No. 29-15364-01 at the licensce's Parsippany, New Jersey facility remains in effect.                                                                                       -
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By tologram dated June 19, 1974, from George Dietz, President.
Isomedix, Inc. to Donald F. Knuth, Director of Regulatory Operations, the licensec requested that the June 14, 1974, order be amended to authorize the movement of the source assembly containing fifty thousand Curies of cobalt 60 and now located in Cell No.1 of the licensce's facility, from Cell No. I to Cell No. 2 in order to permit access to the roof area and the cell interior for installation                                                       '
of new safety equipment, and the subsequent return of the: source assembly to Cell No. 1. The telegram alno references written l
procedures for the accomplishment of these movements which vere provided to AEC inspectors who were at the licensco's facility on June 18, 1974.
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                                  ,                   The Director of Regulatory Operations has reviewed the request
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and has-determined that the proposed movements of the source assembly in order to accomplish the installation of additional i'
                                                   ' safety equipment is not contrary to the ptiblic health, safety
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or interest, WilEREFORE:         IT IS HEREBY ORDERED Tl!AT:
The Order issued June 14, 1974, IN THE MATTER OF ISOMEDIX, INC.               *
               !.[                                                                                                                     ,
is hereby further modified to permit the single transfer l                                             by the licensee of the fifty thousand-Curie cobalt 60 source plaque from Cell No. 1 to Cell No. 2, and to permit l                 ,
a subsequent single transfer of the source plaque from Cell No. 2           .
back to Cell No. 1, for the purposo described in the telegram        -
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dated June 19, 1974, from the licenice to the Commission,
    .U.                                                     provided:
: 1.        The two source transfer operations shall be performed as
: g.                                                                  described in the written procedures entitled " Procedure cer
                                                                   ,;to Move Singer Source", and given to AEC inspectors on        -
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June 18, 1974; and 2:        Prior to performing each transfer operation and prior to
* 4                                                              ' any subsequent personnel entry into either cell, the gamma radiation alarm system shall be confirmed to be operable; and                                       '"
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: 3.            Prior to any,personnci entry into either cell or the areas
                                                                            *-                                        ;                                              f.
above either cell, a physical radiatien surycy shall be peifomed by the Radiation Protection Officot to confim
                          -                                                that such entry c'an be accomplished without causing any i                                                                                                  '
g,                                                                       in'dividual to' receive a radiation dose in excess of
,                  I; ,     ,
established AEC limits; and                                                                                     ,
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Source transfer operations shall be perfomed only in the
: 4.                                                                                                                         -
l l                                                                          physical presence of both Coorge Dietz and George Karl;
                                                                                                                                                             ' r and                                                              .
e
: 5.              If the procedure should be interrupted while the source is in the pass-through port, no personnel entries shall bc                                                      .
made into the cells or the areas above the cells whil'a the                                           '
source is in this' condition; and                                            '
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            '~
: 6.              Prior to the perforr.ance of each of the two described source transfer operations, the licensee shall notify
.M                                                                           the Region I offico of the Directorate of Regulatory l                                                                                                                                   <
l                                                                           Operations by, telephone at least 12 hours in advance of the date and cpproximate time that such operations                ,
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are to take place.
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               '                                                                                                    '                  .               4 All other provisions of the June 14, 1974 Order as heretofore addifiedshallremainineffectandnomovementorhandlingof-
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any byproduct material possessed pursuant to AEC License No.             .
29-15364-01 other than that described herein is authorized with-out prior approval of the Director of Regulatory Operations.
ex
                                                                         .L    ~5 s~<:>s. 6 lNwCCE-Donald F. Knuth camens Director of Regulatory Operations s..
FOR Tile ATO lIC ENERGY C0!DIISSION DATED AT BET 11ESDA, MARYLAND Tills 20T11 DAY OF JUNE 1974 er J4 sh N
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rsotydix, Inc.
Order Further Modifying Order Issued June 14, 1974 bec: u/ copy of telegram dtd 6/19/74 and copy of " Procedure to Move Singer Source" t                                       PDR l
NSIC no:I                        -
R0 III RO:IV RO:V
       '"(,                             OIS
* DR Central Files RO: Files
                   .                    J. P. Murray, GC II, K. Shapar, CC S. 11. Sniley, L B. Singer, L N. Bassin, L G. A. Blanc, L                                         .
C. U. Kuhlmn, RO l
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It,X A0 47 t!AUD33(0943)(B-D07013El 70 30 06/1 V/7 4 0943                                                                      -
ICS IPMMTZZ CSP                                         ,
2018874700 TDM1 PARSIPPANY NJ 76 06-19 0943 EDT                                                                                                 -
m-                v. PiiS D KN(fTHa DLR                                                                                                                      '
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DlHECTON OF LICENSING US ATOMIC ENERGY COM.$f!$SION WASittl4GTON DC 20545 IEUULS1 AMENDMENT TO CEASE OPERATION O. R. DER, PAltS!PPANY, AU
                                                                                                                                                       .                    ~.
WWetE                 I'/JVEMENT OF $B 1HOUSAND Cl 00-60 SOURC( PLAQUE FNOM CELL ! TO CELL 2 AND LATF.R FR0li CELL 2 TO CCLt.1,. SoliHOE I40VEMENT IS NECESSARY 10    ALLOV E'XCESS TO ROOF AND CELL FOR INSTALLATION OF NEW INTEltLOCKS, TC.                                                                                                                  *
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:            WR111EN PROCEDURES I,N POSSCSSION '0F REGION I PERSONELL.
OPE RATI O.9
                    ' TG DE PERFORMED BY GCollGE KARL, UNDER DIltECT SUPERVISI ON OF GEORG                                                                                                                     ,
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SOURCE MOVEMEN1 WILL BE L!fil1ED TO HIN!!iUth GEORGE DIETZ
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With right ranipuistor
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s,through. and'. roar port                                 k. ith Tray,                     'both canipulato.rs".                                     .
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                              ' ,: 5.                         'Close p.u.s through~. port d o o r..
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: d.                            16 trach lifc hook and manually lif t source rack onto tray.
                         <              :5.                     ?ush tray and. source into pass through port.
                                                                                                                                                                                                                                                                                                                                                                            '                                   ~
A                      Cloce pm through port door.                                                                                                                                                          .
J icomadix Inc ..                                                                 25 Eastmam Poa:1. Pars                                                 t pDany. Ncn Jmry Telenber,e (E) 087-4703
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AUG 1 5 19N E
i Isomedix, Incorporated appese                      ATTN: Mr. George R. Dietz President 25 Eastmans Road
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Post Office Eox 177 Parsippany, New Jersey 07054
                                              /'l,,.,re .:).p-f, w .> 4.) Y g' Gentlenen:
This refers to the inspection conducted by Mr. W. H. Schultz of this office on June 14 and 21, 1974, of activities authorized by AEC Byproduct Material License No. 29-15354-02, and to the discussion of our findings held with Mr. Otto Wolford at the conclusion of the inspection.
Areas examined during this inspection are described in the enclosed inspec-
!                             tion report. Within these areas, the inspection consisted of selective jw                            examinations of procedures and representative records, discussions with Mr. Wolford and observations by the inspector, j~" A                         During this inspection it was found that certain of your activities
!                             appear to be in violation of AEC requirements. The items and reference to the pertinent requirements are listed in the enclosure to this letter.
1                                                                                                 .
 ,g                           This notice is sent to you pursuant to the provisions of Section 2.201 of                                    '
the AEC's " Rules of Practice," Part 2. Title 10, code of Federal Regulations.
Secelon 2.201 requires you to submit to this office within twenty days of i
your receipt of this notice, a written statement or explanation in reply.
including: (1) corrective steps which have been taken by you, and the results achieved; (2) corrective steps which will be taken to avoid further
;                             violations; and (3) the date when full compliance will be achieved. Such I.                            a statement or explanation should be provided for each of the items listed.
i Two additional itecs of interest were discussed during the inspection.
These are identified under the heading of "Other Significant Findings" in the enclosed inspection report. With regard to these items, it is our understanding that: (1) the steel jacketed plugs in the south wall of the not cell will be welded to the steel liners to prevent removal; and (2) the need for a conitoring system to function continuously in the       t cell will be reviewed. As a part of your response to this latter, please dvise us of action which has been taken on these matters.
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I h                               {s Isomedix, Incorporated                                       ,
AllG 1 5 19N
* I In accordance with Section 2.790 of the AEC's " Rules of Practice," Part 2, Title 10, Code of Federal Regulations, a copy of this letter with the
             -f                            enclosed inspection report and your response to this notice will be placed
                        !                  in the AEC's Public Document Room. However, if the inspection report i                  contains information which you believe to be proprietary, it is necessary that you submit a written application to this office, within 20 days of sensus                                  the date of this letter, requesting that such information be withheld
                        !                  from public disclosure. If such an application is submitted, it must
                        !                  identify the basis for which information is claimed to be proprietary
             -                             and should be prepared so that proprietary information identified is contained in a separate part of the document since the application, j                  excluding this separate parc, will also be placed in the Public Document Room. If we do not receive an application to withhold information or l                  are not otherwise contacted within the specified time period, the j                  enclosed report will be placed in the Public Document Room with a copy 1,                 of this letter.
I
                        ;                  Should you have any questions concerning this inspection, we will be glad to discuss them with you.
                        ,                                                         Sincerely yours,
                  .- J i
i James C. Keppler
                       ;                                                          Regional Director i                                                                                                                 i iM                                        Enclosures-                                                                                   '
                   ''                                                                                                                    I
: l. Description of Violation Items
;                                           2. RO Inspection Rpt No. 74-01 e
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           .        .!                      bec: R0 Chief, FS&EB RO:HQ (4)
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(,.                                    c ENCLOSURE I
Isomedix, Incorporated License No. 29-15354-02 t
Certain activities under your license appear to be in violation of AEC
                !                      requireseents.
A. The violations considered to be of Category II severity are as follows:
: 1. 10 CFR 30.3, " Activities requiring license," requires that except for persons exempt as provided in this part and Part 150 of this
     '' j                                          chapter, no person shall manufacture, produce, transfer, receivo, i
acquire, own, possess, use, import or export byproduct material except as authorized in a specific or general license issued t                                  pursuant to the regulations in this chapter.
i j                                 License Item 7.A through 7.D authorizes AECL Hodel C-188 cobalt 60 sealed sources and various small cobalt 60 sealed sources for instrument calibration.
Contrary to the above, your inventory of byproduct material included
                ,                                  ripproximately 8,000 curies of cobalt 60 as sealed sources which were obtained from Caama Process Company. These sealed sources are not:.
4                                     authorized by this license.
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: 2. License Condition No. 13.A states each sealed source containing i                                  byproduct material shall be tested for leakage and/or contamination at intervals not to exceed six months. In the absence of a certifi-cate from a transferor indicating that a test has been made within six months prior to the transfer, the sealed source shall not be Q                                              put into use until tested.
I Contrary to the above, the AECL cobalt 60 sealed sources were put -
c)                                     into use without being leak, tested and without a certificate from I                                   the transferor indicating that a test had been made within six
     -. .l                                         nonths prior to the transfer.
    ~%!                                     3. License condition No. 14 states, in part, the procedures contained
    .s in AECL's instruction manual for the "IR68 Cobalt 60 Irradiation Unit" shall be followed. The instruction manual contains emergency instructions which, according to the manual, should be posted in a prominent position close to the control station.
i Contrary to the above, the emergency instructions were not posted at the time of this inspection.
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                !                    B. A violation ebasidered to be of Category III severity is as follows:
    .l 10 CFR 19.11. " Posting of notices to workers," requires in part ,
l                           that each licensee post current copies of 10 CFR Parts 19 and 20, l'                           the license,, and related documents and procedures referenced in the license. If posting of the above documents is not practicable, N                                           a notice may be posted which describes the documents and states
                 !                          where they nay be examined.
1 Contrary to the above, the documents identified above were not i; ' i:)!                                   posted nor was any notice posted which described where they may l                          be found.
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UNITED STATES
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j f Ye           .                ATOMIC ENERGY COMMISSION
                                        .T                DIRECTORATE OF REGULATONY OPERATIONS
                             'g'o "*'Is o"                               REGION lli 799 ROOSEVELT ROAD GLEN ELLYN ILLINOIS Go137                       (312) est asee
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O A. RO Inspection Report No.         74-01
  #19R59 Transmittal Date         :       August 15, 1974 9;9p;:
    '~
Distribution:                                Distribution:
RO Chief, FS&EB                              R0 Chief, FS&EB RO:HQ (5)                                    RO:HQ (4)
I DR Central Files                             L:D/D for Fuels & Materials Regulatory Standards (3)                     DR Central Files Licensing (13)                               RO Files RO Files B. RO Inquiry Report No.
Transmittal Date      :
  =L::.9 Distribution:                                Distribution:
RO Chief FS&EB                               R0 Chief, FS&EB RO:HQ (5)                                    RO:HQ DR Central Files                             DR Central Files Regulatory Standards (3)                     RO Files Licensing (13) g                                           RO Files
      ,                                    C. Incident Notification From:
(Licensee & Docke,t No. (or License No.)
Transmittal.Date              :
    ^' 3                                      Distribution:                                Distribution:
RO Chief, FS&EB                              RO Chief, FS&EB RO:HQ (4)                                    RO:HQ (4)
Licensing (4)                                L:D/D for Fuels & Materials DR Central Files                             DR Central Files RO Files'                                    RO Files I
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U. S. ATOMIC ENERGY COMMISSION
* DIRECTORATE OF REGULATORY OPERATIONS REGION III RD-Inspection Report No. 74-01 Licensee: Isomedix, Incorporated                 License No. 29-15354-02 25 Eastmans Road                     Priority:   III
""''                                P. O. Box 177                        Category: E Parsippany, New Jersey 07054 Type of Licensee:              Irradiator Type of Inspection:           Announced - Initial Date of Inspection:           June 14 and 21, 1974 f h?. Y cre k     .'?
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Princpal Inspector: W.H.Schultzf                                      !
8fid 74 (Date)
Accompanying Inspectors: None Other Accompanying Personnel: None d.Y,       eLtJLb dBEEN                   Reviewed By:   C. E. Norelius, Senior Health Physicist           8!h/ lll Materials Radiological Protection Section         (Date)
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==SUMMARY==
OF FINDINGS                                    ,
i                                                                                                                        i Enforcement Action During this inspection four items of noncompliance were noted.
: 1. Contrary to 10 CFR 19.11, the licensee did not post notices to workers.   (Paragraph 9)
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 ;                       2. Contrary to License Item No. 7 and 10 CFR 30.3, the licensee possessed 8,000 Ci of cobalt 60 as sealed sources which were receivel from Camma Process Company. These sealed sources are not authorized by e
        .__.                  this license.    (Paragraph 13)
: 3. Contrary te license Condition 13.A, the licensee put cobalt 60 sealed sources into use without being leak tested and without a certificate i
from the transferor indicating that a test had been made within six months prior to the transfer.    (Paragraph 33)
: 4. Contrary to License Condition No. 14 which states the AECL instruction manual for the IR68 Cobalt 60 Irradiation Unit shall be followed, the licensee did not post the emergency procedures as required.                 (Paragraph 11)
                                                                                                            /
Licensee Action on Previously Identified Enforcement Items
   ~'~~~
There were no p'eviously identified enforcement items.
i
              ,          Unusual Occurrances No unusual occurrences were reported or identified.
J'         Other Significant Findings
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 !                       A. Current Findings
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: 1. During the inspection the AEC representative discussed the possibility of unauthorized personnel removing the shielding plugs from outside
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the South wall of the irradiation facility. The licensee representative               ,
          .,                       agreed to have the steel jacketed plugs welded to the steel liners
    ;;,,;                          to prevent removal of the plugs.     (Paragraph 20)
: 2. During the inspection the AEC representative discussed the need for a radiation monitoring system which would function at all times and not only when the cobalt 60 source assembly is in a stored position. The licensee representative agreed to review this matter.   (Paragraph 23) l
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B. Unresolved Items: None.                                                   .
Management-Interview i
At the conclusion of the inspection the AEC representative discussed the inspection findings with Mr. Wolford. He was informed that four items of noncompliance were noted. He was also informed these items of noncompliance j                          would be forwarded to the licensee in writing.
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REPORT DETAILS                         .
Persons Contacted
: 1. Mr. Otto C. Wolford, General Manager, was contacted by telephone on June 14, 1974 and on that date a partial inspection was made to review the adequccy of interlocks and safety equipment at the licensee's facility.
: 2. Mr. Wolford was contacted by telephone on June 20, 1974 and the M                           initial inspection was completed on June 21, 1974.
     ~~ .'
: 3. The Illinois State Health Department was contacted by telephone, how-ever, no representative from that agency was present during tha inspection.
General
: 4. This was an announced initial inspection of the licensee's byproduct material program. Areas of review included organization and administrative-control, design and construction of the facility, byproduct material inventory, personnel monitoring, radiation surveys, leak tests, source loading, emergency and operating procedures, instrumentation, radiation m,,..,                   safety practices, and records.
Management Control
: 5. The president of Isomedix, Inc. is Mr. George R. Dietz. His office is located at Parsippany, New Jersey. The licensee's facility is located at 6401 Oakton Street, Morton Grove, Illinois. This facility has only two employees. Mr. Wolford is General Manager and Radiation Safety Officer. He is assisted by Mr. Zikar M. Khanani. Mr. Wolford reports M                           directly to Mr. Dietz.
: 6. Licensee personnel at the Morton Grove facility have available written instructions and operating procedures," Instruction Manual IR68 Cobalt 60 Irradiation Unit", Edition No. 1, March 1973. These procedures are as submitted with the license application dated July 18, 1973.
C .-                 7. Licensee personnel have available copies of the AEC license and
 ~
appropriate AEC regulations.
: 8. Form AEC-3, " Notice to Employees" was posted in the office area.
: 9. It was noted the licensee had not posted copies of 10 CFR Parts 19 and 20, the license, and related documents and procedures referenced in the license nor was a notice posted which described the documents and stated where they may be examined. This constitutes noncompliance with 10 CFR 19.11. " Posting of notices to workers."
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: 10. During the two inspection visits the licensee representative described and demonstrated the operation of the irradiation facility. Based on his statements and observations by the AEC representative it appears the operation of the unit is in conformance with the licensee's written procedures.
: 11. License Condition No. 14 states, in part, the procedures contained in AECL's instruction manual for the "IR68 Cobalt 60 Irradiation Unit" shall be followed. The instruction manual contains emergency instructions which, according to the manual, should be posted in a prominent position among                        close to the control station. During the inspection it was noted the emergency instruction were not posted at the control station. This con-stitutes noncompliance with License Condition No. 14.
Uses of Materials. Physical Facilities and Equipment
: 12. The licensee uses byproduct material procured under this license for commercial irradiation of products and calibration of radiation detection instruments. At the time of the inspection the licensee had the following byproduct material on hand:
(a) 137,510 C1 (2-12-74) of cobalt 60 as sealed sources received on 3-1-74. The sources are AECL Model C-188, Type 3.
The activity is comprised of 26 individual source elements.
(b) Two cobalt 60 sealed sources (1.3 uCi each).
 ,                                  (c) One cobalt 60 sealed source (1.3 mci).
(d) One cobalt 60 sealed source (about 40 Ci) contained in a BNL self-shielded irradiator. This unit will be disposed in the near future.
GiEnd4 (e) Approximately 8,000 Ci of cobalt 60 contained in a large shipping cask. This material was received from Camma Process Company, the former occupants of the building. This material is presently in storage and awaiting disposal.                   1 (f) One 4 uCi strontium 90 sealed source contained in a Jordan
   .                                     Radector survey meter.                               .
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(g) One 3 uCi strontium 90 sealed source contained in a Jordan RAMS II monitor. This device is not being used.
: 13. This license does not authorize the possession and storage of the 8000 Ci of cobalt 60 which formerly was licensed by Camma Process Company.
This constitutes noncompliance with License Item 7 and 10 CFR 30.3.
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: 14. The shielded facility contains and AECL IR68 Cobalt 60 Irradiation Unit.
The unit arrived August 22, 1973 and was assembled and tested by AECL                                                                                 '
personnel. The Cobalt 60 sealed sources were loaded into the unit on March 4, 1974. The system was tested under actual operating conditions j                                     on March 6, 1974 and on the same day commercial operation of the unit j                                    was started.
: 15. The irradiation facility has been licensed continuously since March                                                                                  ;
;                                     20, 1957, however, it was not put into use by Isomedix, Inc. until                                                                                 !
March 6, 1974. During the period March 20, 1957 through May 3, 1967                                                                                 i the program was covered by a license issued to Cook Electric Company.                                                                              '
)%gggg ,                             During the period May 4, 1967 through January 28, 1974 the program was                                                                              :
covered by a license issued to Gamma Process Company. Since January
, .w" ~ a                             29, 1974 the program has been covered by a license issued to Isomedix,                                                                             l j           ;
Inc.                                                                                                                                               !
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: 16. Details of the building, hot cell, cell door, water conditioning equip-3 ment, water level controls, source storage pool, and venti 11ation systems                                                                          I have not been altered since installation in 1957.                                                                                                   '
: 17. The facility is intended to be a service irradiator, wherein products of other companies will be received and irradiated to specified doses,
<                                     either on a test or production basis. - A secondary use is for radiation j                                     sterilization of medical supplies.
1          .
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              ,                 18. A drawing of the radiation room and adjacent areas is attached to this                                                                               i report as Exhibit A.
i'                                                                                                                                                                                       i
: 19. The building is one story, rectangular is shape, approxinately 58' X 53' enclosed by standard cement block walls. The irradiator is set in the                                                                               i
!                                    souteast corner of the building. The irradiation room is a cube six-                                                                                l l
teen feet on each side. The two side walls (east and west) and the back                                                                            !
jg                                  wall (south) are 68 inches thick of poured-in-place reinforced standard concrete. The ceiling is 48 inches of poured-in-place steel reinforced i                                                                                                                                                                                       '
i                                    standard concrete. The front (north) wall and cell door are 48 inches j,                                   of magnetite concrete poured in steel shells. In addition to the access j'
door, the front wall of the cell contains a leaded glass viewing window, a pair of master-slave manipulators, and several cylinderical access
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j                                   ports. The rear wall (south) contains five cylinderical access ports.
!- a ...                            The cell access door and all other penetrations of the biological shield j j                                 are stepped to reduce radiation leakage. During the inspection it was noted the five access ports in the south wall have a steel liner which is plugged with a stepped steel pipe filled with concrete. The plugs                                                                                !
are designed to be removed from the outside but the handles have been                                                                                ;
i                                   partially removed leaving only two stubs about an inch long on each plug.                                                                            }
: j.                                  Also, each plug is secured with a padlock.
i l                               20. During the inspection the-licensee representative agreed to remove the
!                                    padlocks, remove the remaining stubs and weld the plugs into the steel                                                                              !
j                                    liners which pass through the biological shield.
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: 21. During the inspection it was noted the licensee's facilities and' the AECL irradiator are as described in the license application.
: 22. During the inspection the licensee's facilities were reviewed. This included the water conditioning equipment, water level controls and vent 111ation systems. It was noted these are as described in this license application, dated July 18, 1973, and as described in license applications submitted by former users of the shielded facility.
: 23. The AECL Irradiator is provided with a geiger type radiation monitor MENNEE                         which is operational only when the cobalt 60 sources are in the storage position. In the source exposed position the facility has no operational radiation monitor. This matter was reviewed with the licensee 1                           representative and he stated he would consider the possibility of installing a radiation monitoring system which would be operational at all times.
: 24. A Berthold RAT 0/F survey meter is used by operating personnel to check radiation levels before entering the hot cell. This instrument has five ranges with full scale readings of 1, 10, and 100 mR/hr and 1 and 10 R/hr. The instrument was calibrated by Wolford on June 20, 1974. Only the first three ranges of the instrument are calibrated because of the limited strength of the calibratien source.
Personnel Radiation Protection
: 25. Licensee personnel wear film badges which are sent to R. S. Landauer on a bi-weekly basis. Victoreen indirect reading (0-200 mr) dosimeters are available but are not routinely used. Licensee personnel use dosimeters only when changing sources. Film badge records were reviewed and it was noted the maximum total exposure for the year 1974 was 30 mrem.
Form AEC-4 has been completed for both licensee personnel and Form g                              AEC-5 1s being maintained.
: 26. Posting and labeling is in accordance with the applicable sections of 10 CFR 20.203     The door to the hot cell is posted Caution-Radioactive Material and Caution-High Radiation Area. A Caution-High Radiation
   -         _                 Area sign is mounted above the cell entrance door. This sign is illuminated whenever the cobalt 60 source assembly is not in a LO'~                   completely down positiou. The sign is energized with a mechanical switch
 ~_ 4                          and not by the presence of radiation.
: 27. The AECL Irradiator is provided with a series of interlock devices which will prevent a person from entering a High Radiation Area. When the source is in an exposed position the entrance door to the cell cannot be opened. The door to the cell can be opened only by a large electrical drive motor which is interlocked with various safety circuits. However, if someone should be inside the exposure room when the source is raised to an exposed position a manual switch can be operated which by-passes all safety circuits and permits the person inside the room to  ,
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open the door to the cell. This cannot occur from outside the exposure room. There are no provisions for by-passing the safety circuits from outside the exposure room.
: 28. A complete survey of the shielded facility was made by AECL personnel
:_          u.               during the period October 29-31, 1973 prior to the installation of the AECL IR68 Irradiator. The survey resuits were submitted to AEC on November 15, 1973. No significant contamination was detected.
: 29. AECL personnel made a direct reading survey on March 7, 1974 after in-
 'dEENW4                      stallation of the cobalt 60 sources. The radiation level in unrestricted areas outside the building walls was less tha n 0.1 mr/hr. The maximum radiation level on the roof (where the source cable passes l 'illc;
* through the shield) was 1.5 mr/hr. Radiation levels inside the building were also measured. The maximum level detected was 50 mr/hr at the              l manipulator port opening. The maximum radiation level at the cell door was 1.8 mr/hr.
l Waste Disposal
: 30. The licensee's inventory includes a number of sealed sources which will 4
be disposed of in the near future. These sources will be shipped either
!                              to a supplier or a licensed waste disposal agency. The licensee has made no disposals or radioactive wasta since the issuance of this license.
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Leak Tests I"                        31. The 26 cobalt 60 sealed sources were put into commercial use on March 6, 1974. However, the licensee did not receive a leak test certificate i                              from AECL prior to using the sealed sources. At the time of the source loading AECL personnel made a gross leak test by pouring water into the idggggd source cavity of the shipping cask then collecting the water and checking it with a survey meter. Nothing above background was noted. AECL 4
personnel informed the licensee the water would be returned to AECL for
; g. ; ,                      analysis and a report of the test results would be issued. The licensee did not receive this report.
: 32. On May 10, 1974 the licensee representative made a leak test by wiping
                             .the 26 sealed cobalt 60 sources with a single paper towel. The towel
. ~;i_L1                      was analyzed with a gas flow proportional counter and showed less than 0.001 uci of removable contamination.
: 33. Although the cobalt 60 sealed sources were put into use on March 6, 1974 no leak test results were available until May 10, 1974. This constitutes        i noncompliance with License Condition No. 13.A. in that, the licensea            l put 26 cobalt 60 sealed sources into use without making a leak test and without a certificate from AECL indicating a test had been made             ,
within 6 months prior to transfer to the licensee.
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: 34. A review of the leak test records during this inspection showed all sealed sources in the licensee's inventory were leak tested on May 10, 1974 and all showed less than 0.001 uCi of removable contamination.
Independent Measurements
   " '                      35. During the inspection the AEC representative made direct reading radiation surveys with an Eberline Model E-500 B survey meter. The maximum radiation level at 12 inches from the surface of the shipping cask containing 8000 Ci of. cobalt 60 was 7 mr/hr. The maximum radiation aguggg                          level at 12 inches from the surface of the BNL irradiator was 4 mr/hr.
Additional measurements were made at various other locations throughout the licensee's facilities and all agreed closely with the survey made
     . ,9.,                     by AECL personnel on March 7, 1974.

==Attachment:==

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_~          . w.i ISOMEDIX                                                      ,
September 6, 1974                                                        '
Mr. James G. Keppler Regional Director.
Atomic Energy Commission Directorate of Regulatory Operations Region III 799 Roosevelt Road Glen Ellyn, Illinois 60137

==Dear Mr. Keppler:==

i        This is in response to your August 15, 1974 letter to Isomedix 1
regarding the inspection made of our Chicag'o facility under license i        number 29-15345-02 on June 14 and 21, 1974. Our response to the                                                       f
{         specific items noted to be in violation of'AEC requirements follow:
I A.
: 1. A letter,was submitted on June 24, 1974 to AEC, Division
;                   of Material Licensing , 'reques ting that the 8,000 curies in
{                   question be added to our license. To date, there has been j                   no response.
I
: 2. The sealed sources were put into use after verbal                                                    ,
assurance by-AECL that their standard seven day leak test                                                   f I
had been completed.within six months prior to the time of installation.        A copy of the certificate from AECL has been                                           .
received, which confirms the verbal assurance previously                                                    '
given. AECL states that a written certificate accompanied their cobalt shipment; however, we have'no record of its receipt.
                                                                                                              ~
: 3.    . Emergency instructions were posted on June 21, 1974.
             -B.
                  ' Notices to workers,. Including current copies of 10CI'R, parts 19 and 20, as well as information specifying where the license and related documents could be reviewed were posted on June 22, 1974.                                                                                              ;
Two other items discussed during the inspection and our actions we , as follows:        ,
(g((fn)%        Iso 4ldix inc. 2; n:wni .ns Hoad, Panippany, flew J. erst y T. le prionw (20118814700      a%
                                                                                                                      .1 J 3>                                 .. .u -, os,w. , .   .,o o. . .c. n.3, ur. .. . .,v,s... ,.o.,oras.
Isomedix Limited            eeno:t *Jerwt. Mont. St. Hibire. ca.tuc, canada Telephone 1514 467 1211       ,
w.n a44,.w eo. ion.c.u..r,u. ... m.o.c.c n.4.

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                  ~
                                    - (.                            c Mr. James G. Keppler                          September 6,.1974 l
: 1. The steel jacketed plugs in the front     wall were to be welded to the liners to prevent removal.       Our target date for completing this task is September 30,      1974. At this point, the plugs are still locked closed,      and are severly          ,
rusted into their-liners.
: 2. A remote area monitor will be installed outside of the chamber and will function at all times. It's location will be near the point where the door first opens. Its purpose will be to interrupt power to the door. opening motor at the first. sign of a higher than preset radiation. level. A target date for installation has not yet been received.
Very truly yours, (f            s     ,
(4*L O f C
                                                  &                    l
                                             ' George R..- -Dietz President GRD:dp a
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I Isomadix Incorporated                                   License No. 29-15345-02 ATIN: Mr. George R. Dietz President 25 Eastmans Roads P. O. Box 177                                                                                   ,
    'Tj                               Parsippany, New Jersey       07054 d
                 ,                    Centlement i
j                 .
Thank you for your letter dated September'6, 1974, informing us of the j                l                     stape you have taken to correct the violations which we brought to your attention in our letter dated August 15, 1974. Khile your letter states
 ;               i                     that you have filed an application for an appropriate aumendment to
                 ;                     achieve corrective action for the violation designated as A.1 in our August 15, 1974, letter, it should be understood that no activity is in accord with AEC regulatory requirer.mnts unless and until it is specifically l......                               authorized in an AEC license. Steps should be taken to assure that AEC
   ''~9                                licensed materials are hereafter possessed and used only as authorized i                    by your license. We will exmine these matters during our next inspection.
i
                 .                    Tour cooperation with us is appreciated.
i Sincerely yours, eletA l
u, m James G. Kappler Ragionsi Director
   -.y...=4 1
              -2 bec w/1tr dtd 9/6/74:
4.%                               RO Chief, FS&E3 RO:HQ (4) i                                     L D/D for Fuels & Materials i
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     ,          ,                                                                            w iyyA       bL p q                                    UNITED STATES                      -
                                                                                                            /
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ATOMIC ENERGY COMMISSION l'.                         WASH mGTON, D.C. 20545
                                                                                             , Qr >2 t
[596 Mr. Edward J. Bauser                                 --
                                                                                                                /
Executive Director e          f 6                                 Joint Committee on Atomic Energy                     q g  s,,3          ;y Congress of the United States                               g[Q     UNJ gly  l Afilc3       f  .

==Dear Mr. Baucer:==
g This is to inform the Joint Committee Staff that I have issued two Orders to Isomedix, Inc., a licensee authorized to use byproduct caterials for iWadiation of materials at facilities located in Parsippany, New Jersey, and Morton Grove, Illinois.
The first Order was issued on June 14, 1974, and required that all operations involving the use of byproduct material be suspended immediately at both facilities. This action followed an incident that occurred in the licensce's Parsippany, New Jersey facility on June 13, 1974, when an employee entered a hot cell
-~
in which approximately 130,000 Curies of Cobalt 60 was exposed.
The employee received a dose to the whole body of several hundred Rems. The Order was issued on the basis that the licensee's impicmentation of operating procedures which are conditions of the license was inadequate and, therefore, potentially hazardous conditions may have existed at the licensee's facilitics in Parsippany, New Jersey, and Morton Grove, Illinois.
Subscquent to the issuance of this Order, an investigation at the licensce's Morton Grove, Illinois facility revealed that
_                         the licensee did not rely on administrative controls to preclude entry into the hot cell when the source was in an exposed condition.
Rather, the licensee had incorporated inter 1nck provisions into the design of the system to make it impossibic to enter the cell
  ~ ' - ^ -
area when the source was exposed, so long as the interlock system was operative. Our investigation showed that the interlock system operated as designed. On the basis that potentially hazardous conditions did not exist at the licencec's Morton Grove, Illinois
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                                                                                   .4
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Edvard J. Bauser                                                                            facility, a accend Order uns isaued on June 15, 1974, uhich rescinded the Order suspending use of byproduct nntorial at the l'orton Grove, Illinois facility. The Order suspending use of byproduct natorial at the Paraippany, "eu Jersey facility remains in offect.
e muut Sincerely, Donald F. Enuth Director of Regulatory Operations Enclo::ures :                                       -
: 1. Order dated 6/14/74
: 2. Order dated 6/15/74 bec with enclosures:
Chaircan Ray (2)
Commissioner Larson Commissioner Doub Commissioner Kriegsman Commissioner Anders L. M. Muntzing, DR (2)
L. V. Gossick, ADR
             '                          !!. K. Shapar, GC(2)                                                                       ,
6                                      OCR (2)
DR Central Files R0 Files OIS J. F. O' Leary, L S.11. Smiley, L
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UNITED STATES OF AMERICA                                 .
ATO)1IC ENERGY C01D1ISSION IN THE MATTER OF)                                   BYPRODUCT MATERIAL
                                                   )                                 LICENSE No. 29-15364-01 AND ISOMEDIX, INC. )                                    LICENSE NO. 29-15364-02 sqe*W                                        ORDER TO SIIOW CAUSE AND ORDER SUSPENDING LICENSE I
: ~
Isomedix, Inc., 25 Eastmans Road, Parsippany, New Jersey, 07054,
("the licensce") is the holder of Byproduct Material Licenses Nos.
29-15364-01 and 29-15364-02 ("the licenses") issued by cl.e Atomic Energy Commission ("the Commission").       The licenses authorize the licensee to possess and use byproduct material for the purpose of
    , _ _ ,                      the irradistica of materials. License No. 29-15364-01 was issued on August 13, 1973, and the expiration date is Jur.e 30, 1978.
                 .               License No. 29-15364-02 was issued on January 29, 1974, for use of material at tbeton Grove, Illinois, and the expiration date is
                   ,             January 31, 1979.
         ..y_                                                            II
  .._                            On June 13, 1974, an employee of the licensee entered a cell located
    - , -                        at the licensce's Parsippany, New Jersey facility in which approximately 130,000 curies of Cobalt 60 was exposed and received a high radiation dose to the whole body in excess of the conditions of the license and 10 CFR, Section 20.101 of the Commission's regulations.           The details 1
of this incident are currently under investigation by the Commission.
However, owing to the nature of the incident, it is apparent that the a
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licensde's implementation of operating procedures which are conditions of the licenses arc inadequate and, therefore, potentially' hazardous i
conditions may exist at the licensce's Parsippany, New Jersey facility supeut                       and Morton Grove, Illinois facility.
III
     ':(D
* In view of the foregoing, the Director of Regulatory Operations finds that the public health, safety or interest requires that no prior notice as provided in'10 CFR 2.201 and 10 CFR 30.61 is necessary and that, pursuant to 10 CFR 2.202(f), use of byproduct material under Licenses Nos. 29-15364-01 and 29-15364-02 should be suspended effective i,'_,            _
immediately.
IV In view of the foregoing and pursuant to the Atomic Energy Act of 1954,
      ~
 '                               as amended, and the regulations in 10 CFR Parts 2, 20, and 30, IT IS E                             HEREBY ORDERED TIIAT:
: 1. All use of byproduct materials under Licenses Nos. 29-15364-01 and 29-15364-02 is suspended effcetive immediately pending further order of the Director of Regulatory Operations.
      ~'I~"
      .                           2. All byproduct material subject to these licenses shall be stored under lock and key pending furth'er Order of the Director of Regulatory Operations.
The licensee may, within twenty (20) days of the date of receipt of this Order, file a written answer to this Order under Oath of Affirmation and e     e M
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t may also request a hearing within said twenty (20) day period.                                                 If a 4# .4 hearing sis requested, the Commission will issue an Order designating the, time and place of hearing.                                                 ,
 . ausgeh In the event the licensee files a timely request for hearing within
.;                                   .e
 '7,.,.,..,                           the time s.,pecified,        the issues to be considered at such hearing shall 7,            .. e be (1) whether the . licensee violated the Coiraission's regulations and conditio'ns of Licenses Nos. 29-15364-01 and 29-15364-02 as specified 1
in Section II above; and (2) whether, on the basis of such violations                                                  ,
this Order should be sustained.                                                             -
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             ~                           ,                                                     t*vN C A d                  .         *%4 *' -
                                           '                                             Donald F. Knuth Director of Regulatory Operations
                                                                                                          't
; s FOR THE ATOMIC ENERGY C01 MISSION
,                                    DATED AT BETHESDA, }RRYLAND                                                                        <;
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                                                                                                                              '                ^
4,s                               THIS 14TH DAY OF JUNE 1974                                                    e'
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UNITED STATES OF AMERICA ATOMIC ENERGY CO'CIISSION IN THE MATTER OF )                                       BYPRODUCT MATERIAL ISOMEDIX, INC.                                           LICENSE No. 29-15364-01 and
                                                  )
LICENSE NO. 29-15364-02 48R858l ORDER TO SHOW CAUSE AND ORDER SUSPENDING LICENSE I
x , .y,.,
Isomedix, Inc., 25 Eastmans Road, Parsippany, New Jersey, 07054,
("the licensce") is the holder of Byproduct Material Licenses Nos.
29-15364-01 and 29-15364-02 ("the licenses") issued by the Atomic Energy Commission ("the Commission"). The licenses authorize the licensee to possess and use byproduct material for the purpose of
             ,              the irradiation of materials. License No. 29-15364-01 was issued on August 13, 1973, and the expiration date is June 30, 1978.
License No. 29-15364-02 was issued on January 29, 1974, for use of material at Morton Grove, Illinois, and the expiration date is M                           January 31, 1979.
2.~~   ,                                                            II
_ _ . . _ _ _               On June 14, 1974, the Director of Regulatory Operations, after de-
_;-                        termining that potentially hazardous conditions may exist at the licensee's Parsippany, New Jersey, and Morton Grove, Illinois, facilities, issued an Order to Show Cause suspending all use by the licensee of byproduct material under License Nos. 29-15364-01 and 29-15364-02 pending further order.        The Order to Show Cause and the suspension of activities contemplated therete were made effective Immediately.
W e

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                                           >3  1 III The Director of Regulatory Operations has completed preliminary s
investigation at the li,censee's Morton- Grove facility and has determined that the public health, safety or interest no longer .
requires immediate suspension ~ of use of byproduce material under License'No. 29-15364-02. WIEREFORE: -IT IS ORDERED TIIAT The Order to Show Cause issued June 14, 1974, insofar as it 7.h .-                        suspends all use of byproduct material uader License No.                               -
29-15364-02 at the licensee's Morton Grove, Illinois facility, is hereby rescinded. The Order to Show Cause, insofar as it suspends all use of byproduct material under License No.                      .
29-15364-01 at the licensee's Parsippany, New Jersey facility, i
shall remain in effect pending further order by the Director
   ~~~                                           i of Regulatory Operations.
(Jewc.s'E (?
Donald F.'Knuth w. ((-
Director of Regulatory Operat' ions FOR TIIE AT03!IC ENERGY COLDilSSION DATED AT BETilESDA, MARYLAND
     + , .~
TilIS 15Til DAY OF JUNE 1974
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IS O M E D IX b
October 8, 1974 Mr. Donald F. Knuth Director of Regulatory Operations U.S. Atomic Energy Commission Washington, D.C. 20545                                                                                       '
Re:     Your letter, September 23, 1974 and License No. 29-15354-01                                        i

==Dear Mr. Knuth:==

This is our reply concerning corrective action taken on items noted to be in non-compliance as detailed in your letter of September 23, 1974, to Isomedix.
Item 1:      No additional response requested.
Item 2:      The switch in question enabled the remote area audihie alarm to be turned either on or,off.                              The switch has been re-
:soved, and the cemne alors can no longer ce turneo orr. ra :.s item was confirmed in our Inspection No. 74-02 on July 8-9, 1974 Item 3:
: a. No additional response requested.
: b. No additional response requested.
c.
All authorized users have been instructed that only routine service irradiation activities are one-man opera-tions, and that all other operations, including manipula-tion of any other source, require two users to open a cell door following such activities.                                  To ensure two man participation, a false " source up" key lock has been in-stalled in both hot cell opening interlocks and its activation overrides the normal opening sequence. The key to this lock is Controlled by the RPG. The lock is activated at the beginning of all irradiation activities except routins service irradiation.                                Hence, the opening cf the door requires the presence of the RPO and the authoris-ed user.
d.. No additional response requested.
: e. No additional response requested.
Isomedix inc. 25 Eastr x; Rc4c. P3.siccar:v ar.v Jersey Te eonone (201; 887-4700 Ya: ting Ace'ess. 8ast O*f .e d o s 1
* T. 8ar t sca n . . No .v ..r sd e 0 7C2 4 Isomedix Limited        ace
                            \,                                              st eer. P.to,t. St. +'a;re. Quece:. Canad: Teennore P 4 457 :M v.m. a 4 aa,.u. a i.s o n.c. e o      7. a. o.... a m :.c. . ,,.e.
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                                                                                                                                                  ~

e Mr. Donald F. Knuth                            October 8, 1974 f.
A film badge and dosimeter. rack has been installed near the entrance to the her ce lls , and badges and dosimeters are stored on it when not in use. A log book requiring the sign-out for dosimeters is also on the rack, and records name, date, dosimeter number, time in and out, and differential dosimeter reading.      This system became operational on June 15, 1974, and was con-firmed during our Inspection 74-02.
4.
All authorized users, key personnel (Mase field , Owens, Perrin) and other administrative personnel (accountant, secretary, shipping clerk) have been briefed on the require-ment to immediately notify the Region I Office of actual or suspected overexposures of personnel. Typewritten notices, including the Region I telephone number, have been placed in several conspicuous places, and the aforementioned personnel instructed of their presence.          Additionally, two copies of AEC-3 are conspicuously posted near restricted areas.
A po'  r tion of.your letter indicated concern about management control systems implemented to prevent any similar incident.
The effectiveness of this control system has been improved through the following actions:
a.
Laily, weekly, monthly and quarterly inspections    are required to verify the functional capability of the electro-mechanical system recently installed to control cell entry.
Signed inspection records are retained, and available for review.
b.
An independent inspection and evaluation of the safety system is conducted at least quarterly by Mr. John Masefield, whose qualifications have previously been submitted.
c.
Isomedix has contracted with Health Physics Staff of Isotopes, Inc. to perform quarterly or as-needed in-strumentation calibration. During calibration of the fixed monitor system, the Isotopes personnel accompany Mr.
Masefield and participate in an inspection of the Isomedix facilities, with the view of offering constructive comments on possible improvement of the safety system.
: d.                                                                !
Isomedix contracted the services of Atomic Energy of      I Canada, Ltd. (AECL) to review both mechanical and operat-ing procedures related to hot cell procedures. These reviews are continued periodically on an informal basis,
: e.      A formal training prograd (outlined in the modified
             -01 license) has been instituted, and as of this time, six hours of instruction has been given to both authorized users, and several other key personnel. It is Isomedix' intent to instill in its employees both an appreciation of and a high respect for its irradiation activities.
r

e
       */
              .Mr. Donald T. Knuth                      October 8, 1974
: f. The recent overexposure incident has left a rather profound mark on all Isomedix employees. It has induced a spontaneous atmosphere of checks and cross-checks on irradiatien operations and authorized users, even by non-users. The portrayal of this general attitude defies a precise written description; it is however, an attitude that Isomedix will endeavor to maintain. It does, without doubt, improve the effectiveness of our general management control sys tem in implementing full compliance with our license conditions.
On the matter of the civil monetary penalty proposed, it is not our intent to contest it in whole or in part.
            #                                                         _-...__]
t
[L Very truly yours, o
c.fa-a., ? !  $. ' '
George R.7Dietz President GRD:dp I
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1

5:ptzmber 24,1974 l        1     Note to File l
ISOMEDIX FINE This is to formalize the fact that I colled Mr. John Mosefield, President, Isomedix, Inc.,
on the mornirs of September 23. The purpose of the call was to inform isomedix that the proposed intent to issue a civil penalty against Isomedix was mailed to isomedix this date.
Mr. Mosefield was upset, but had no particular problem with the issue, it is my guestimate that he will pay the fine. I discussed Mr. McKimm, also. He informed me that Mr. McKimm is doing well, but that Mr. McKimm is weak and is not working 1
as on operator for Isomedix. Mr. Mosefield led me to believe that Mr. McKimm may very well retire.
                                                        \<
Dictated by JPO'R                         Ji cc: Nelson McClintock i
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                       .                   c                                 c.
                                        ,                MAR 8  1983 s                                                        .
Isomedix, Incorporated                               License No. 29-15364-02 ATTN:   Mr. George R. Dietz President
                .80 South Jefferson Road 3O-/OO3b Whippany, NI 07981 Gentlemen:
This refers to the routine safety inspection conducted by Mr. J. L. Lynch of this office on February 15 and 16,1983, of activities authorized by NRC Byproduct Material License No. 29-15364-02 and to the discussion of our findings with Mr. O. C. Wolford at the conclusion of the inspection.
The enclosed copy of our inspection report identifies areas examined during the inspeution. Within these areas, the inspection consisted of a selective examination of procedures and representative records, observations, inde-pendent measurements, and interviews with personnel.
During this inspection, certain of your activities appeared to be in non-compliance with NRC requirements, as specified in the enclosed Appendix.
A written response is required.
In accordance with 10 CFR 2.790 of the Commission's regulations, a copy of this letter, the enclosures, and your response to this letter will be placed in the NRC's Public Document Room. If this report contains any information that you (or your contractors) believe to be exempt from disclosure under 10 CFR 9.5(a)(4), it is necessary that you (a) notify this office by tele-phone within ten (10) days from thu date of this letter of your intention to file a request for withholding; and (b) submit within twenty-five (25) days from the date of this letter a written application to this office to withhold such information. If your receipt of this letter has been delayed such that less than seven (7) days are available for your review, please notify this of fice promptly so that a new due date may be estab-lished. Consistent with Section 2.790(b)(1), any such application must be accompanied by an af fidavit executed by the owner of the information which identifies the document or part sought to be withheld, and which contains a full statement of the reasons which are the bases for the claim that the information should be withheld from public disclosure.
This section further requires the statement to address with specificity the considerations listed in 10 CFR 2.790(b)(4). The information sought to be withheld shall be incorporated as f ar as possible into a separate h c opy G30429 40 830308 NMS LIC 29-15364-           PDR                                                     4 DMG: zed]
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1 Isomedix, Incorporated                     2                        MAR 8  1983 If part of the affidavit. If we do not hear from you in this regard within the specified periods noted above, a copy of this letter, the enclosures, and your response to this letter will be placed in the Public Document Room.
The responses 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,
                                                              .  .   'W            .'
D. G. Wiedeman, Chief Materials Radiation Protection             l Section 1                                !

==Enclosures:==
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: 1. Appendix, Notice                                                               '
of Violation
: 2. Inspection Report                                                            i No. 03010036-83-01(DRMS) t cc w/encls:
Mr. Otto C. Wolford, General Manager DMB/ Document Control Desk (RIDS) l
                  ""'epk                  6.6p Lynch //p       Wiedeman 3/3/83 w.

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Appendix               .
NOTICE OF VIOLATION Isomedix, Incorporated                                 License No. 29-15364-02        '
As a result of the inspection conducted on February 15-16, 1983, and in
* accordance with the NRC Enforcement Policy, 47 FR 9987 (March 9, 1032),                ,
the following violations were identified:
: 1.      10 CFR 19.12 requires that all individuals working in or frequenting l                      any portion of a restricted area be kept informed of the storage, transfer, or use of radioactive materials or of radiation in such portions of the restricted area; be instructed in the health protec-tion problems associated with exposu're to such radioactive materials or radiation, in precautions or procedures to minimize exposure, and -
in the purposes and functions of protective devices employed; and be instructed in, and instructed to observe, to the extent within the worker's control, the applicable provisions of Commission regulations and licenses for the protection of personnel from exposure to radia-tion or radioactive materials occurring in such area.
Contrary to these requirements, an individual employed to provide pest control services enters the utility room restricted area approximately on a monthly basis without supervision. This individual is not trained in the above areas as is required in 10 CFR 19.12.
This is a Severity Level IV violation (Supplement VI).
: 2.      License Condition No. 18 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in letter dated November 30, 1977 and other referenced documents.
The above letter states that a plan dealing with radiation overexposure emergencies is being prepared in conjuction with a local hospital.
Contrary to the above, as of the date of this inspection, a radiation l                      overexposure emergency plan has not been established for the Morton Grove facility.
1 This is a Severity Level IV violation (Supplement VI).
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  .         Appendix                                  2 l
           ' Pursuant to the provisions of 10 CFR 2.201, you are required to submit to l            this office within thirty days of the date of this Notice a written state-ment or explanation in reply, including for each item of noncompliance:
(1) corrective action taken and the results achieved; (2) corrective action to be taken to avoid further noncompliance; and (3) the date when full com-pliance will be achieved. Consideration may be given to extending your response time for good cause shown.
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C    46'si D. G. Wiedeman,(phief O
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Materials Radiation Protection Section 1 I
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l U.S. NUCLEAR REGULATORY COMMISSION j                                                REGION III
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Report No. 03010036/83-01(DRMSP) i l            Docket No. 03010036 l
License No. 29-15364-02           Category E3               Priority I Licensee:   Isomedix, Incorporated l                        80 South Jefferson Road Whippany, New Jersey 07981 Inspection At: Isomedix, Incorporated 7828 Nagle Street Morton Grove, IL 60053 Inspection Con et     :     b ary 15-16, 1983 l                                      ~/ _ -
Inspector: James L.
Radiat on nch                                     EI eci .1 Approved by:
D. G. Wiedeman, Chief j-f-/]
Materials Radiation Protection Section 1 Inspection Summary Inspection on February 15-16, 1983 (Report No. 03010036/83-01(DRMSP))
Areas Insoected: Routine, announced inspection of activities conducted under License No. 29-15364-02 including organization; internal audits;
!            training, retraining, and instructions to workers; radiological protection j            procedures; facilities and equipment; instrumentation; security of material; posting and labeling; surveys; leak tests; waste disposal; personnel moni-coring; notifications and reports; receipt and transfer; and confirmatory measurements. The inspection involved 15 inspector-hours onsite by one NRC inspector.
Results: Of the areas inspected, two items of noncompliance were identified
,            against License No. 29-15364-02:      (1) training of service personnel inade-l            quate (paragraph 6); (2) emergency plan not established (patagraph 7).
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l                                                           DETAILS
: 1. Persons Contacted
                             *0tto C. Wolford, General Manager and Local Radiation Safety Officer (RS0)
* Attended exit interview on February 16,'1983,
: 2.      Purpose of_ Inspection This was a routine safety inspection of the industrial Category E3, Priority I license issued January 29, 1974. The license~ authorizes the possession and use of cobalt-60 in a large walk-in-type irradiator.
The inspection consisted of a review of licensen operations and current radiation safety program.
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: 3.      Inspection History
: a.      Inspection:        June 14 and 21, 1974.
* Results:           4 items of noncompliance.
Comments:          Interlock system and saiety equipment inspected after overposure incident in the licensee's facility in Parsippany, New Jersey.
: b.      Inspection:        January 6, 1978.
Results:           No items of noncompliance.
: c.      Inspection:        February 15 and 16, 1983.
Results:           2 items of noncompliance.
Comments:          License category and priority changed from E-IV to E3-I.
: 4.      Organization George R Dietz is the President and Corporate Radiation Safety Officer of Isemedix, Incorporated. His office is located at the corporate headquarters in Whippany, NJ. Otto C. Wolford is the General Manager and RSO at the Morton Grove facility.
No violations were identified.
                   ' 5.      Internal Audits or Inspections The license contains no specific requirements for internal inspections.
The. local RSO, Otto Wolford, reviews the radiation safety program on a continuous basis with occasional assistance from the corporate RSO, George Dietz.
No violations were identified.
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: 6. Training, Retraining, and Instruction to Workers The licensee conducts on-the-job training for all personnel regarding      .
radiation safety and emergency procedures.      In addition, a ten hour' training course on radiation is given to qualify individuals for posi-tions as irradiator operators. The course includes instruction on radiation theory, hazards, instrumentation, personnel monitoring, and safety. Dccumentation of the training is maintained in personnel folders.
At the time of the inspection, the inspector determined that the training of service personnel was not adequate. 10 CFR 19.12 re-quires that all individuals working in or frequenting any portion of a restricted area shall be kept informed of the storage, transfer, or use of radioactive materials or of radiation in such . portions of the restricted area; be instructed in the health protection problems associated with exposure to such radioactive materials or radiation, in precautions or procedures to minimize exposure, and in the purposes and functions of protective devices employed.
Contrary to these requirements, an individual employed to provide pest control seivices enters the utility room restricted area approximately monthly without supervision. This individual is not trained as required by 10 CFR 19.12.
One violation was identified.
: 7. Radiological Protection Procedures Procedures in Atomic Energy of Canada, Ltd. (AECL) instruction manual "IR 68, Cobalt 60 Irradiation L* nit, 1somedix, Chicago" dated March 1973, are followed for safe use of the irradiator. The licensee also indicated in a letter dated Nove=ber 30, 1977, that a plan dealing with radiation overexposure emergencies was being prepared in conjunction with a local hospital. This letter is a referenced part of the license as indicated in License Condition No. 18.
Contrary to this requirement, a plan for emergency care of overexposure victims has not been established to date at any local hospital.
One violation was identified.
: 8. Facilities and Equioment The Isomedix, Incorporated facility is located in a single story building owned by the City of Morton Grove. It includes an irradiator room (with a 37 ton motor driven door), control area, utility room, staging areas, shipping and receiving areas, and of fices.
The irradiator source rack is in a 5 meter deep, water filled well with the top of the rack located 4 meters below the floor. An air activated hoist system raises and lowers the sources for the irradiation process.
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The irradiator is an AECL ?!odel 6300, modified for automated batch production and optimized for medical product sterilization. The irradiator can utilize up to 500,000 curies of cobalt-60, and at       .
maximum capacity will process about sixty cubic feet of material per hour. The material to be, irradiated is placed in carriers.having dimensions of 23.5" by 19.0" by 35.5". Twenty one carriers follow a set sequence around the exposed source rack.
Water f1cus continuously from the well to storage tanks in a closed system. It is deionized and filtered before it is returned to the well.
The irradiator cell is equipped with a lead glass viewing window allowing the operator to view the irradiator and aid in the use of two manipulator arms located above the window at a height of three meters. The manipulators are used to transfer sources in the irra-diator by operators in the control area. The arms may be extended to the middle of the cell. The window is normally blocked with lead bricks to prevent glass darkening and to reduce exposure to personnel.
To bring the sources into an exposed position and thus operate the irradiator, the following sequence must be initiated:
: a. The irradiator key (attached to survey instrument) must be used to activate a switch in the irradiator cell. At this point, visible and audible alarms sound until the operation begins.
: b. The door must be closed using the button outside the cell.
: c. The lever on the air line must be moved to the operation mode,
: d. A switch at the control console must be keyed from " test" to
                       " automatic" mode.
If any of the above procedures are omitted or the entire sequence is not completed within ninety seconds, the irradiator will not operate and the sequence must be repeated.
A high radiation area had existed in the control area around the manipulator portholes. Radiation beams stream through the portholes and across the room (a distance of about 10 meters), at a height of three meters off the floor. Radiation levels between 500 and 600 mR/hr were detected at the base of the manipulators in 1979. The licensee has since packed lead wool in the portholes and significantly decreased the radiation levels to approximately 50 mR/hr. The impinging beams on the opposite wall were about 4.5 mR/hr. Personnel do not enter this area in the course of their duties.
No violations were identified.
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: 9.                 Instrumentation i                                                  Three survey instruments are available for use at the facility. The                                               ,
instrument used for the majority of surveys performed is a Berthold RAT 0/F instrument which has the irradiator startup key attached.
l'                                                 Backup instruments are a Jordon Electronics Inc. AGB-50 and a civil defense CDV-700 meter, i                                                  Survey instruments are calibrated on a semiannual frequency. All three instruments were last calibrated in December 1982. Calibration is only done on two scales to 50 mR/hr.                                         Mr. Wolford stated that future calibrations will include the third. scale to 1 R/hr.
No violations were identified.
l                                10.               Security of Material All licensed material was secured against unauthorized removal. The facility is constantly supervised when the office is open and doors are locked during off hours..
The irradiator sources and the 400 millicurie cobalt-60 calibration source are stored in the irradiator room. The calibration source is stored in a floor pit. The door to this room cannot be opened without the proper key, l
!                                                 The 30 curie cobalt-60 source in,the liquid irradiator is stored in the utility room (a restricted area). This device is a massive cask l                                                 with lead shielding built around the source.
1 l                                                 The large cobalt-60 source indicated on the license for storage only l                                                 has decayed to approximately 2400 curies.                                          It is kept in the storage
!                                                  room behind a wall of concrete shielding. A safe with the small cobalt-60 and strontium-90 calibration sources is kept in this room also. Both the safe and the room are kept locked when not in use.
No violations were identified.
l                                11.               Posting and Labeling l                                                  Posting of radioactive caution and warning signs in the facility appeared to be adequate. Posting of notices was also adequate as required by 10 CFR 19.11.
No violations were identified.
,                                12.              Surveys Surveys of areas adjacent to the irradiator room are performed each time sources are added to or removed from the irradiator as is required by License Condition No. 16. The last such survey was completed on July 17, 1981 with results submitted to the NRC.
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L                The water deionizing and filtering systems are surveyed on a weekly l       .        basis as is required by letter dated December 17, 1973.
No violations were identified.
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: 13. Leak Tests Leak tests are performed semiannually on the main irradiator sources, the liquid irradiator, two cobalt-60 calibration sources, two stron-tium-90 calibration sources and the large cobalt-60 source in storage.
The last leak test was done in December 1982 following AECL procedures.
Leak test samples of the main irradiator sources are analyzed in the Morton Grove facility with the Berthold survey instrument. The other samples are sent to the corporate headquarters in New Jersey for analysis.
No violations were identified.
: 14. Waste Disoosal Radioactive waste has not been shipped from this facility to date.
When the licensee wishes to dispose of licensed material, AECL will be notified and the material transferred to that license or to a commercial disposal company.
No violations were identified.
: 15. Personnel Monitoring Evaluations of whole body exposures are performed using film badges supplied bi-weekly by the R. S. Landauer, Jr. Company. All employees routinely working in the vicinity of radioactive material are supplied with the badges.
Film badge reports from August 1973 through December 1982 were reviewed.
;                The maximum quarterly exposure for this period was noted to be 1.150 l                rem for the third quarter of 1973. This exposure was the result of cleanup operations performed in the facility of the previous cwner's radioactive wasta. Since that time, the highest quarterly exposure has been 120 mrem.,
NRC-4 and NRC-5 forms are kept for each badged employee in addition j                to the bi-weekly reports from the badge supplier.
Several incidents have occurred in the past years in which employees have dropped film badges in the irradiator room only to find them at a later time. These incidents were documented and the film badge supplier was notified not to include the resulting exposures in the employees' records.
No violations were identified.
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: 16. Notifications and Reports                                                                         ,
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No reportable incidents have occurred under the license.                                     !
The licensee does send a survey report to the NRC as required (see Surveys).
No violations were identified.
: 17.      Receipt and Transfer l
Material is received periodically when the irradiator source is upgraded. AECL delivers and installs the sources. The required surveys and documentation are also provided by AECL.
No violations were identified.
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: 18. . Confirmatory Measurements The inspector made independent measurements during the inspection                            l using a Xetex-305B, NRC Serial No. 008994, calibrated on December 18,                        t 1982.                                                                        .
The results were as follows (maximum readings):
: a. Irradiator room (in off position):
(1) well surface - 0.7 mR/hr (2) doorway - 0.3 mR/hr (3) storage floor pit - 0.5 mR/hr
: b. Control area (in on position):
(1) console - 0.2 mR/hr                                                                !
(2)    irradiator doorway      2.8 mR/hr (3) door end at track       .1.7 mR/hr (4) manipulator ports - 48.0 mR/hr and 39.0 mR/hr
: c. Staging areas (1) wall struck by radiation beams - 4.5 mR/hr
: d. Utility rocm:
i (1)    irradiator wall - 7.1 mR/hr I                                                                  (2) water filter /delonizer - 0.2 mR/hr (3) liquid irradiator - 1.8 mR/hr t
: e. Storage room:
(1) stored source shielding wall - 6.9 mR/hr (2) storage safe, exterior - 3.8 mR/hr (3) - storage safe, interior - 4.3 mR/hr l
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     .                      s f.. Offices - 0.1 mR/hr No violations were identified.                                            *                        '.
: 19. Exit Interview On February 16, 1983, an exit interview was held at the conclusion of the inspection with Mr. Otto Wolford, local RSO. The apparent items of noncompliance and other recommendations were reviewed.
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isommoix                                                           .
April 21, 1983 l
Mr. D. G. Wiedeman, Chief Materials Radiation Protection Section 1 U. S. Nuclear Regulatory Commission Region III 799 Roosevelt Road Glen Ellyn, Illinoin 60137

==Dear Mr. Wiedeman:==
License No. 29-15364-02 l
This is in response to your letter of March 8, 1983, regarding the results of an inspection conducted by your office on February 15 and 16.
Regarding violation number 1, a notice has been posted and brought to the attention of all employees, that any visitor to our f acility who enters the restricted area must be escorted at all times. This procedure was implemented on February 23, 1983.
Regarding violation number 2, we have contacted l             the appropriate individual at Lutheran General Hospital,
!             who will be our contact for radiation overexposure emer-l             gencies. The hospital already has in place emergency room procedures for handling both contaminated and over-exposed individuals.
Our posted Emergency Plan has been updated accordingly.
Very truly yours,
,                                                   ISOMEDIX, INC.
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George R. Dietz           .
President GRDiof cc    Mr. Otto Wolford General Manager i   khg52 06 830429 l   29-1S364-         PDR               isemeClX lNC.
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APR 2 01983                                                                                                                 l
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Isomedix, Incorporated                                                                              License No. 29-15364-02 ATnl      Mr. George R. Diets President 80 South Jefferson Road Whippany, New Jersey 07981 Centlement Thank you for your letter dated April 21, 1983, informing us of the steps you have taken to correct the noncompliance which we brought to your attention in our letter dated March 8, 1983. We will examine these matters during a future inspection.
Your cooperation with us is appreciated.
Since oly, c
D. G. Wiedeman, Chief Haterials Radiation Protection Section 1 cc     Mr. Otto Wolford General Manager ec w/itr dtd 4/21/83:
D:!B/ Document Control Desk (RIDS) b$
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