ML20206F630

Responds to FOIA Request for Radiological Insp Repts. Forwards App a Documents.Documents Also Available in Pdr. Records Re Items 3,4,5 & 7 Should Be Obtained from Agreement States.No Documents Re Item 6 Found

ML20206F630
Person / Time
Issue date:	06/19/1986
From:	Grimsley D NRC OFFICE OF ADMINISTRATION (ADM)
To:	Rose R FOI SERVICES
Shared Package
ML20206F633	List: IA-86-390, Responds to FOIA Request for Radiological Insp Repts. Forwards App a Documents.Documents Also Available in Pdr. Records Re Items 3,4,5 & 7 Should Be Obtained from Agreement States.No Documents Re Item 6 Found ML20206F630
References
FOIA-86-390 4956, NUDOCS 8606240540
Download: ML20206F630 (2)

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M 191986 Mr. Ronald A. Rose F01 Services Incorporated IN RESPONSE REFER 12315 Wilkins Avenue TO F01A-86-390 Rockville, MD 20852-1877 CONTROL NO. 4956

Dear Mr. Rose:

This is in response to your letter dated May 20, 1986, in which you requested, pursuant to the Freedom of Information Act (F0IA), copies of the latest radiological inspection reports for seven specified Ethicon (J&J) facilities.

The enclosed appendix identifies documents which are being made available for your inspection and copying at the NRC Public Document Room (PDR), 1717 H Street, NW, Washington, DC 20555. The documents will be filed in PDR folder F01A-86-390 under your name. A search of pertinent files indicated that the NRC is not in possession of documents pertaining to item 6 of your request.

For your information, Georgia, New Mexico, Texas, and North Carolina are Agreement States. Therefore, the NRC has no documents pertaining to items 3, 4, 5, and 7 of your request. Enclosed is a listing of Agreement States for your assistance in writing to State officials for records in which you are interested.

If you have any questions regarding this response to your request, you may telephone Mr. Richard Lavins on 492-9564.

Sincerely, M'

V)

Donnie H. Grimsley, Director Division of Rules and Records I

Office of Administration

Enclosures:

As stated 8606240540 860619 PDR FOIA ROSE 86-390 PDR

1 Re:

F01A-86-390 Appendix A 1.

3/12/85 NRC Ethicon. Inc.

Inspection Report 30-06990

& 30-05284/85-01 (3 pages) 2.

3/26/85 Ethicon, Inc. NRC Responses to Inspection 85-01, with attachment (4 pages) 3.

5/14/85 NRC Ethicon, Inc.

Response to Letter dated 3/26/85 (1page) 4.

04/05/76 NRC Johnson & Johnson Correspondence and report concerning inspection conducted 02/25/76 (16 pages) f J

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MAR 121985 Docket Nos. 030 0699 License Nos. 29-02786-03 0

29-02786-06 /

y 528, Ethicon, Incorporated ATTN: Mr. S. Wool Manager, Safety and Health Route 22 Somerville, New Jersey 08876 Gentlemen:

Subject:

Inspection No. 85-01 This refers to the routine safety inspection conducted by Mr. J. McFadden of this office on February 6,1985 of activities authorized by NRC License Nos.

29-02786-03 and 29-02786-06 and to' the discussions of our findings held by Mr. McFadden and yourself with Messrs. W. Komf anos and V. Foerst, of your staff, at the conclusion of the inspection, and to a subsequent telephone discussion between Mr. McFadden and Mr. Foerst on February 11, 1985.

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 the conditions of your licenses. The inspection consisted of selective examinations of procedures and representative records, interviews with personnel, measurements made by the inspector, and observations by the inspector.

Based on the results of this inspection, it appears that one of your activities was not conducted in full compliance with NRC requirements, as set forth in the Notice of Violation, enclosed herewith as Appendix A.

This violation has been categorized by severity level in accordance with the revised NRC Enforcement Policy (10 CFR 2, Appendix C) published in the Federal Register Notice (49 FR 8583) dated March 8,1984.

You are required to respond to this letter and in preparing your response, you should follow the instructions in Appendix A.

In accordance with Section 2.790 of the NRC's " Rules of Practice," Part 2, Title 10, Code of Federal Regulations, a copy of this letter and your reply 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.

sw OFFICIAL RECORD COPY DL30-06990/85 0001.0.0 02/16/85 gange opvarmt To U

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h!AR 121985121985Ethiconi Incorporated 2

i Your cooperation with us in this matter is appreciated.

Sincerely, original Signed Ett Johnp..Kinnoman John D. Kinneman, Chief Nuclear Materials Section A Nuclear Materials Safety & Safeguards Branch Division of Radiation Safety & Safeguards

Enclosure:

Appendix A, Notice of Violation cc w/ encl:

Public Document Room (PDR)

Nuclear Safety Information Center (NSIC)

State of New Jersey bec w/ enc 1:

Region I Docket Room (w/ concurrences)

Senior Operations Officer (w/o encl)

J. McFadden, DRSS-RI l

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785 3/]/85 0FFICIAL RECORD COPY DL30-06990/85 0002.0.0 02/16/85 o

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t APPENDIX A NOTICE OF VIOLATION Ethicon, Incorporated Docket No. 030-06990 Somerville, New Jersey 08876 License No. 29-02786-03 As a result of the inspection conducted on February 6,1985, and in accordance with the NRC Enforcement Policy (10 CFR 2, Appendix C), the following violation was identified:

10 CFR 20.203(c)(6)(vii) -equires that each area, in which there may exist radiation levels in excess of 500 rems in one hour at one meter from a sealed radioactive soucce that is used to irradiate materials, have entry control

devices, as required in 10 CFR 20.203(c)(6)(1), and that these entry control devices be tested for proper functioning prior to initial operation with such source of radiation on any day that operations are not uninterruptedly continued from the previous day.

Contrary to the above,' as of February 6,

1985, the entry control device had not been tested for proper functioning prior to initial i

operation with such source of radiation on numerous days that operations had not been uninterruptedly continued from the previous day.

This is a Severity Level IV violation.

(Supplement IV)

Pursuant to the provisions of 10 CFR 2.201, Ethicon, Incorporated is hereby required to submit to this office within thirty days of the date of the letter which transmitted this Notice, a written statement or explanation in reply, including: (1) the corrective steps which have been taken 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. Where good cause is i

shown, consideration will be given to extending this response time.

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0FFICIAL RECORD COPY DL30-06990/85 0003.0.0 02/16/85

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SOMERVILLE NEW JERSEY - 08876 0151 March 26, 1985 Mr. J. D. Kinneman, Chief Nuclear Materials Section A Division of Radiation Safety and Safeguards j

U.S. Nuclear Regulatory Commission - Region 1 631 Park Avenue King of Prussia, PA 19406

Subject:

Inspection No. #85-01, Docket No. #030-06990

Dear Mr. Kinneman,

In reference to the violation received as a result of the routine safety inspection conducted by Dr. J. McFadden on February 6, 1985, the following corrective actions have been/will be taken:

1)

The primary entrance interlocks will be tested before the first start up of the day.

Or, if the irradiator has been running continuously from the previous day, the primary interlock will be tested after the first unintended shutdown of the day.

2)

All such tests will be recorded in the daily log book kept in the irradiator, console room (see attachment for sample log page and test procedure), effective immediately.

3)

The Cobalt operators have been trained on the interlock test procedures, and a copy of the procedure is located in the console room of the irradiator.

Please contact me at (201) 524-3927 if you have any questions.

Sincerely,

. L. Komiano, CIH Radiation Safety Officer Attachment kg 0306x65

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Cobalt Irradiator Safety Procedure Primary Interlock Test Procedure

1) Check that the L118 cell monitor is operating properly, a)

Press monitor test button until the rate meter reading exceeds a reading of "8" on the dial.

The monitor alarm will sound and the ALARM and ALARM MEMORY Lamps will light.

b)

Release the " Monitor TEST" button.

The button will illuminate, the rate meter will return to a reading of approximately "1" and the alarm will stop.

Press reset button.

2)

Entse the contro1 area by means of the operating key (attached to

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meter).

3) Check the radiation monitor against tHe test source which is situated just inside the control area door.

NCIE:

If, for any reason, the preceding sequence of events involved in steps 1, or 3 is broken, or if the control room door is closed before entering the control room, all above steps must be repeated.

4) Open the maze barrier by pressing the button at the entrance and enter the cell area.

The maze barrier has to be opened, otherwise, the source interlocks cannot be set.

If you notice an increase in audible signals from your meter as you enter, leave the maze immediately and contact:

Mr. V. Foerst 13654 Mr. W. Komianos X3927 5)

If normal, proceed into the irradiaticn room. There should be no personnel in the. area. However, a check must now be made to ensure that the room is vacated.

6)

Insert the key (attached to meter) into the acaing mechanism located at the end of the irradiation room.

Turn the key. An audible and visible alarm will sound when the key is turned.

Remove key.

7)

Leave the irradiation room (at a normal walking pace), step on safety mat and close the maze barrier.

8) Manually-hold in the main door interlock.

9)

Insert key into console and turn.

The source should begin to rise.

(A bell-will be ringing, and a beacon will be flashing during times of source movement).

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10) After approximately 10 seconds, release the main door interlock.

The source should begin lowsring into the storage pool.

Source travel will be indicated on the operator's console.

If source does not lower into pool, shut down unit immediately, then call V. Foerst 13654 or W. Komianos 13927.

11) If test is normal, close the main door.

12) Press the reset button. The source should now rise to the "up" position and normal operations can bogia-i Attachment 0306K70 Approved 3/22/85 RSD s ',.).}

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MAY 141985 Docket Nos. 30-06990 License Nos. 29-n? %

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29-02786-0

$0 Ethicon, Inc.

ATTN: Mr. S. Wool Manager-Safety and Health Route 22 Somerville, New Jersey 08876-0151 Gentlemen:

Subject:

Inspection Report No. 85-01 This refers to your letter dated March 26, 1985, in r.esponse to our letter dated March 12, 1985.

Thank you for informing us of the corrective and preventive actions documented in your letter. These actions will be examined during a future inspection of your licensed program.

Your cooperation with us is appreciated.

Sincerely, O*'isinez gf A k D. ki.

t John D. Kinneman, Chief Nuclear Materials Section A Division of Radiation Safety and Safeguards cc:

Public Document Room (PDR)

Nuclear Safety Information Center (NSIC)

State of New Jersey bec:

Region I Docket Room (w/ concurrences)

W.L. Komianos, CIH Radiation Safety ffic RI:DRSS

%I:DRSS JMcFadden JKinneman h J/85

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OFFICIAL RECORD COPY RL ETHICON 85 0001.0.0 04/24/85

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