ML20209J108
| ML20209J108 | |
| Person / Time | |
|---|---|
| Site: | 07000687 |
| Issue date: | 04/23/1987 |
| From: | Mcgovern J CINTICHEM, INC. |
| To: | Lieberman J NRC OFFICE OF ENFORCEMENT (OE) |
| References | |
| EA-87-030, EA-87-30, NUDOCS 8705040205 | |
| Download: ML20209J108 (10) | |
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ClNTICHEM, INC.
j e wholly owned subsidary of Medi-Physics, Inc.
p.o. sox eie. Tuxeoo. NEW YoAK 109e7 1914]351-2131 ApriI 23, 1987 James Lieberman, Esq.
Director of inspection and Enforcement Office i
U.S. Nuclear Regulatory Commission Washington D.C.
20555
Dear Mr. Lieberman:
Ret Cintichem, Inc.
(Sterling Forest Facillity)
Docket No.70-687 License No. SNM-639. EA 87-30 Cintichem, Inc., the holder of Nuclear Regulatory Commission
("NRC") License No. SNM-639, encloses herewith a check payable to The Treasurer of the United States in the amount of $12,500.00, the civil penalty proposed in the Notice of Violation and Proposed imposition of Civil Penalty (NRC Inspection No. 87-01) dated March 26, 1987.
Additionally, Cintichem, Inc. files the following responses to sold notice:
Violation A l
A.
10 CFR 20.101(a) limits the total occupational radiation exposure to the hands of an Individual in a restricted area to 18.75 rem per calendar quarter.
Contrary to the above, during the third calendar quarter of l
1985, a maintenance worker received a cumulative exposure to the left hand of 21.453 rem whIle performing repairs on mechanical manipulator hands in the Radiopharmaceutical Laboratory, a restricted area.
1 Violation 0:
B.
10 CFR 20.405(a) requires that each licenses shall notify the NRC in writing within 30 days of an exposure of an Individual to radiation in excess of the applicable limits j
set forth in 10 CFR 20.101.
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Contrary to the above, during the third calendar quarter of i
1985, a maintenance worker performing repairs on mechanical manipulator hands in the Radiopharmaceutical Laboratory, a restricted area, received a cumulative exposure to the left hand of 21.453 rem, an amount in excess of the limit set forth in 20.101, and the NRC was not notified of tha exposure.
Responses to Violations A and B:
Cintichem, Inc. admits the allegations contained in Violation A but submits that there are extenuating circumstances for denying the allegations of Violation 8:
The cumulative third quarter 1985 exposure of 21.453 rem measured by a TLD ring dosimeter resulted from working on a manipulator hand contaminated with radioactive material from our hot cells.
The hot cells are used to separate and purify medically useful by-product material from the wide spectrum of isotopes produced by the fission of U-235.
During processing, radioactivity within the hot cells is 99.99998% by-product material.
At the time of this exposure, Cintichem believed that because this function has historically been regulated under the New York State by-product materials license and because the radioactivity was essentially all by-product material licensed by New York State, the State quarterly reporting limit of 25 rem applied.
This belief was also based on statements contained in the 5/13/82 letter from NRC Indicating that where by-product material is essentially completely separated from special nuclear material, processing will be under the regulatory control of the Agreement State.
This same letter also stated that the basis for NRC regulatory authority over co-mingled material was safety considerations in handling of the special nuclear material.
During processing in Cintichem's hot cells, the ratlo of by-product material radio-activity to special nuclear material radioactivity is approxi-mately 5,500,000:1.
This is confirmed by Clntichem's long-term experience of not detecting alpha radioactivity in contamination from the hot cells.
Cintichem management could not conceive of any situation where there would be a need for extra safety pre-l cautions because of the small amount of SNM that might be in the I
contamination from our hot cells.
Cintichem was so accustomed to this function being regulated under New York State Code Rule l
38 that it believed this was a clear-cut case of by-product material jurisdiction and therefore did not consider the lower quartorly reporting limits of the NRC.
The exposure was recorded openly and clearly for review by both Federal and State agencies.
l The high quarterly result was controlled so that by year-end the total annual extremity exposure to the Individual was less than 50% of the regulatory limit.
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The unusually high exposure to the hand of a Cintichem employee while performing maintenance work on a remote manipulator was identified promptly and it was recorded as such.
The initial high exposure was totally unexpected and since the ratio of the ring monitor to wrist monitor readings was not consistent with previous monitoring data on this job, It was believed to be an aberration.
Clntichem was unsuccessful in identifying the cause of this exposure after en Initial Investigation.
The second unusual exposure reported on the ring badge on September 10, 1905, came about two months after the Initial high exposure which resulted in exceeding the NRC limit but not excocoding the NYS Code Rule 38 limit.
If we considered this exposure to be within the NRC jurisdiction, it would have boon reported promptly.
Although it is not directly related to this incident we think that it is important to state that our radiation exposure history for the worker population at Clntichem shows a consistent reduc-tion in exposure over the past soveral years.
This is true also of our environmental releases.
This exposuro incident is atypical and it does not reflect our overall commitment to "ALARA."
In the future, CIntichem will comply with the limits and report-Ing requiroments in 10 CFR 20.101(a) and 10 CFR 20.405(a) as well as NYS Code Rule 38 for all of its employees working with by-product motorial when it is co-mingled with SNM.
In addition, C!ntichem has implomonted a requirement for a writton Investiga-tion of all extremity monitoring results in excess of 500 mrom por day or 5 rom por month.
The written report will be prepared by the Cintichem Health Physics group and submitted to the Individual's supervisor and to the plant managor.
All extremity exposures excooding 5 rom por month will also be reviewed by the sito Safoty Committoo.
Vlointion C:
1 C.
10 CFR 20.202(a)(1) requires that occh licensoo shall supply and require the uso of appropriato monitoring equipment by each Individual who ontors a rostricted area under such circumstancos that he recolves, or is likely to rocolvo, a deso in any colondar quarter in excess of 25 porcont of the applicablo value speciflod in 20.101(a).
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O 4
Contrary to the above, on several occasions during 1985 and 1986, an Individual entered the Radiopharmaceutical I
Laboratory, a restricted area, where he was likely to receive a radiation exposure to the hands in excess of 25 percent of the limits set forth in 20.101(a) during the performance of maintenance on highly contaminated manipulator hands, and the Individual was not required to use appropriate personnel monitoring equipment (TLD rings) on the hands to measure the radiation received from this activity.
Response to Violation C Cintichem, Inc. dentes the allegations contained in Violation C and submits the following in explanation of such denial:
The individual was required to use a TLD wrist dostmeter while working on manipulator hands.
The use of wrist dosimeters to evaluate radiation exposure to the hands and forearms had been reviewed and was not questioned during previous inspections.
Cintichem considered that wrist dosimeters were appropriate based on a determination that for many exposure situations the critical organ is the red bone marrow located in the fore-arms.
For other exposure situations where exposure to the skin was considered to be the critical dose-limiting concern, Cintichem required the use of ring dosimeters in addition to wrist dosimeters.
Cintichem is now requiring the use of TLD rings in addition to the wrist dosimeter for repair work on manipulator hands.
This will provide more complete data on the radiation dose to the hands and forearms and will enable an evaluation of unusual exposure more accurately.
Clntichem is also expanding its use of TLD ring dosimeters in other jobs (such as all manipulator work, 1-125 dispensing, QC laboratory work, 1-125 manufacturing) that have a potential for significant finger exposure.
Violation 0:
D.
10 CFR 20.201(b) requires that each licensee make surveys as may be necessary to comply with the regulationn in Part 20 and are reasonable to evaluate the extent of radiation hazards that may be present.
10 CFR 20.201(a) defines
" survey" as an evaluation of the radiation hazards incident to the production, use, release, disposal and presence of radioactive materials.
Contrary to the above, adequate surveys or evaluations to assuro compliance with the regulations were not performed I
5 to evaluate the radiological hazards associated with and the radiation exposure received from operations involving the repair of manipulator hands.
Specifically, although the ring badge of a maintenance worker performing repairs of manipulator hands on July 2, September 10, and November 15, 1985 Indicated radiation exposures of 13.9 rem, 5.8 rem, and 15.6 rem, respectively, to the hands, amounts significantly in excess of amounts normally received, a subsequent timely, in-depth survey was not performed to evaluate the work practices associated with this activity and its associated radiation hazards.
Furthermore, a timely evaluation was not performed to determine the actual dose to the worker's hand or to identify the cause of the increase in exposure, in order to prevent subsequent over-exposure and to assure compliance with the limits of 10 CFR 20.101.
Response to Violation De Cintichem, Inc. admits the allegations contained in Ylolation D and further responds as follows:
The radiation exposure history at the Sterling Forest facility associated with the manipulator hand repalr work did not Indicate a trend toward increased exposures.
The unusual TLD ring results on the three occasions in question were evaluated within one week of the exposures.
The evaluations consisted of Interviews with the worker and his supervisor.
These exposures were discussed among the Health Physics personnel and subsequently in Safety Committee meetings.
Cintichem was unable to confirm or deny the validity of the Indicated exposure.
These Investigations were not documented.
As stated in response to Violations A & B above, investigations will be conducted of any hand exposures in excess of 500 mrem in a day or 5 rom in a month as soon as possible after such expo-sures become known and writton reports will be made by the Health Physics group to supervision and to the Plant Manager.
Vlointion E:
E.
20 CFR 20.401(b) requires each licensoo to maintain records showing the results of surveys required by 20 CFR 20.20l(b).
Contrary to the above, records woro not maintained of l
surveys of manipulator hands removed from the hot colls l
during the third and fourth calendar quarters of 1985.
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6 Response to Violation Et Cintichem, Inc. admits the allegations contained in Violation E.
Such documentation and records are now being maintained in accordance with the provisions of 10 CFR 20.401(b) of the NRC regulations.
1 Violation F:
F.
10 CFR 19.12 requires in part that all Individuals working in or frequenting any portion of a restricted area shall be Instructed in precautions and procedures to minimize expo-sure, in the purposes and function of protective devices employed, and in the applicable provisions of Commission regulations and IIcenses for the protection of personnel.
4 Contrary to the above, during the third and fourth calendar quarters of 1985, two individuals performed repair activi-ties of radioactively contaminated manipulator hands in the Radiopharmaceutical Laboratory, a restricted area, without having been adequately Instructed in (1) procedures for performing surveys of radioactive material, as well as Instruments and technique to be used; and (2) appropriate criteria and actions to be taken in response to the results of survey measurements; and (3) NRC extremity dose limits in Part 20.
Response to Violation F:
Cintichem, Inc. dentes the allegations contained in Violation F.
All employees receive basic training in avoiding radiation expo-sure.
Prior to allowing employees to work in radiation areas, they are Instructed in the basic principles of radiation protection through a training manual that was written specifi-cally for our laboratory.
Each person also spends time working in the H.P. group for on-the-job training for performing routine j
surveys and learning the use of survey equipment.
The amount of time in training depends on one's progress and one's ultimate work assignment.
A written test is administered to measure l
the sufficiency of one's training prior to assignment to a j
permanent work station.
The current retraining program, which is primarily corrective in nature, will be expanded to include pre-
{
ventive Instruction as well.
This will be implemented by December 31, 1987.
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Work procedures were etablished for the manipulator repair work j
which, until these unusually high exposures were recorded, appeared effective in maintaining extremity exposures at fairly l
stable levels.
This was apparent from the radiation exposure l
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7 history for this job.
The Individual who received the high ring badge exposures was temporarily removed from this job after the second exposure in September 1985.
He was permanently reassigned to a position not primarily involved with radiation exposure after the unusual ring exposure was recorded in November 1985.
All individuals currently performing repair activities of radio-tivity contaminated manipulator hands have received retraining i
in precautions and procedures to minimize exposure, including proper survey instrumentation and techniques, appropriate crl-teria and actions to be taken in response io the results of survey measurements, and NRC extremity dose limits.
Each Indi-vidual was also given a written summary of the training program.
This job, and others, have been designated to require a radiation work permit prior to start of work.
Therefore, it will be pre-viewed and monitored by H.P. more closely each time that it is performed.
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l Violation G:
G.
10 CFR 20.202(b)(3) defines a "High radiation area" as any area accessible to personnel in which there exists radia-tion originating in whole or in part within licensed material at such levels that a major portion of the body could receive in any one hour a dose in excess of 100 millirem.
i 10 CFR 20.203(c)(1) requires that each high radiation area shall be conspicuously posted with a sign or signs bearing the radiation caution symbol and the words " Caution (or Danger) - High Radiation Area."
i Contrary to the above, l
1.
On December 16, 1987, a high-radiation area existed in the yard area outside the Waste Storage Building In which a B-25 shipping container filled with radio-1 active waste was located, and the " Caution - High Radiation Area" sign was posted inside the 100 mR/hr 1
boundary and thus was not serving as a warning to anyone approaching the boundary.
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On January 15, 1987, a high radiation area existed j
Inside the hot cell conveyor station within Building 2, j
and neither the upper hatch nor lower door access to i
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8 the conveyor station were posted with a " Caution -
High Radiation Area" sign.
Radiation levels in the general area of the conveyor station were as high as 900 mR/hr.
Response to Violation G:
Cintichem, Inc. admits the allegations contained in Violation G(1) and G(2) and responds further as follows:
Violation G(1):
4 The B-25 shipping container was located within a locked fenced-in area and roped off and posted with a sign bearing the radiation caution symbol and the words " Caution High Radiation Area."
The sign also indicated that the dose rate at the sign was 150 mrem /hr.
The violation exisied because the sign was not at the 100 mrem /hr boundary.
When this deficiency was brought to our attention, we moved the sign 18" further away from the container and achieved full compilance.
Under field conditions, it is sometimes difficult to position a sign at the exact 100 mrem /hr boundary.
This was the reason for the additional warning on the sign Indicating the approach to a 150 mrem /hr boundary.
C!ntichem submits that the Intent of the regulation was satis-fled in that the area was posted and the actual radiation dose rate was posted which increased people's awareness rather than to mislead them into an inadvertent, more hazardous situation, in the future, Cintichem shall attempt to be more exact and, if exact posting is not possible, the sign will be located out-side the 100 mrem /hr boundary.
Violation G(2):
The high radiation area that exists within the Hot Cell conveyor station is completely shielded with two movable lead shields that serve as access ports for sending non-radioactive material into the hot cells and removing finished radioactive products from the cells.
The upper access port is a 12" square hinged door which is Interlocked with radiation monitors located inside of the conveyor station.
The Interlock will not allow the door to be opened if the radiation level inside the conveyor station exceeds the set point.
This door is fitted with a high density glass viewing window and a master slave manipulator for handling material used in the conveyor station.
The routine procedure for putting material into the cells is to place items immediately inside the access port and move them from there with the manipu-lator with the port closed.
The lower access port is a sliding lead panel that is 24" square at floor level.
Shielded con-tainers are rolled into the bottom of the conveyor station through this panel.
Radioactive material is lowered into the
9 shielded containers remotely while the access ports are closed.
Shielded containers are covered remotely before access ports are opened to remove them.
Area radiation monitors outside the conveyor station are set to alarm in the event of higher than normal radiation levels exist in the occupied area.
Cintichem had never considered the conveyor station to require the con-trols prescribed by the regulations because, although it was accessible to personnel, our employees were aware of the potential exposure by the monitors provided.
The size and location of the access ports made it difficult for a major por-tion of anyone's body to be exposed inadvertently.
The conveyor station is within a restricted area - accessible only to trained radiation workers or visitors with a trained escort.
During off hours, the entire building is secured and an intrusion alarm is activated.
When this violation was brought to our attention, we immediately posted a " Caution High Radiation" sign and subsequently installed an alarm light to warn the Individual and his supervisor when the shields are moved.
We are now In full compliance with 10 CFR 20.203(c)(2)(iii).
Violation H:
H.
10 CFR 20.203(c)(2)(III) requires that each entrance or access point to a high-radiation area shall be maintained locked except during periods when access to the area is required, with positive control over each Individual entry.
Contrary to the above, on January 15, 1987, a high radiation area existed inside the hot cell conveyor station within Building 2, and neither the upper hatch nor lower door access to the hot cell conveyor station was locked or guarded.
Response to Violation H:
Cintichem, Inc. admits the allegations contained in Violation H and references the Information in its response to Violation G(2),
above to prevent recurrence in the future, i
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Per the Instructions contained-In the referenced Notice of Violation, Cintichem elects to pay the proposed civil penalty and a check for the amount of $12,500.00 is enclosed.
We believe that the corrective and preventative measures des-cribed for each of the non-compliance items will prevent their recurrence and will afford full compliance with pertinent NRC requirements.
Additional steps, including internal and exter:sl audits and organizational changes, have been Implemented to Im-prove the effectiveness of the Health Physics program.
Cintichem Intends to continue strengthening its radiation protection pro-gram as opportunities arise to prevent, to the fullest extent possible, future violations.
Respectfully submitted, N
A J.
cGovern Plant Manager JJMcG:eb Enc. Cintichem check No. 1815 cc:
Regional Administrator U.S.
Nuclear Regulatory Commission Region 1 631 Park Avenue King of Prussia, PA 19406
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