ML20153B054
| ML20153B054 | |
| Person / Time | |
|---|---|
| Issue date: | 11/17/1978 |
| From: | Oplinger G NRC OFFICE OF INTERNATIONAL PROGRAMS (OIP) |
| To: | NRC OFFICE OF INTERNATIONAL PROGRAMS (OIP) |
| References | |
| NUDOCS 7811290391 | |
| Download: ML20153B054 (1) | |
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Radiation Technolog, Inc.
LAKE DENMARK ROAD, ROCKAWAY, N.J. o7866 A
(201) 627-2900 June 26, 1978 Mr. Boyce H. Grier, Director l
Region I U. S. Nuclear Regulatory Comission King of Prussia, PA 19406
SUBJECT:
Inspection 30-7022/78-01
Dear Mr. Grier:
l We take this opportunity to reply to your letter of June 21, 1978 con-l taining a number of alleged infractions and violations during the scheduled visit. We must express our serious concern over NRC procedures concerning some of the alleged infractions since our company has been in constant contact with the NRC since the overexposure incident took place in September 1977, and each and every one of the alleged infractions had been discussed with the NRC. inspectors and with NRC staff personnel since that time and we must infer that the recent hearing which had been concluded and which
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addressed itself to some of the very same points may very wil have some-thing to do with the timing of the alleged infractions.
I will, however, take this opportunity to reply to each of the alleged infractions one by one.
With regard to your Appendix A, paragraph A, referring to license conditions 12A and 12B dealing with licensed operators.
The alleged infractions relates to the operation of the in-air irradiator by Mr. Robert Buckley, supervisor of radiation operations.
I would like to point out that on this date, June 26, 1978, we received License Amendment #13 in which Mr. Robert Buckley has been approved as an pperator under license conditions 12A and 12B.
It is significant to point out that the original request for this license amendment was made on September 16, 1977 and followed with a letter on December 23, 1977.
Further, we had been informed by the NRC inspectors, namely Mr. Slobodein that the NRC was aware that Mr. Buckley had been made supervisor of radiation operations and that a license amendment request had been made many months ago.
Mr. Slobodein was of the opinion that the licensing branch required additional information showing Mr. Buckley's training and we were specifically asked to refer the date of the letter to him in which Mr. Buckley's training was submitted to the licensing branch.
frat letter was our December 23, 1977 letter.
Further, as far as I know, Buckley had been operating the facility only while a licensed operator u s physically present in the building. Mr. Buckley has had more in-depth i
training on the in-af-irradiator than any person who has ever been trained at Radiation Technology, Inc. As supervisor of radiation operations, he i
RADIATION RESEQCH & PROCESSING FOR INDUSIRY SINCE 1968 7811290Ml
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has made himself intimately familiar with the total workings of the facility 1
and has, in fact, been responsible for the maintenance and overhaul of the entire system.
The fact that your inspectors were on hand when Mr. Buckley operated the console does not constitute a violation since Mr. Buckley had also operated the console during previous inspections that had been conducted by Mr. McClintock.
Because Radiation Technology, Inc. had made direct application to the licensing branch concerning Mr. Buckley and indicating the position that Mr. Buckley would fill at Radiation Technology, Inc. we had been inLrmed as long ago as October of 1977 by the Region I inspectors i
that Mr. Buckley was considered to be a licensed operator. We view the timing and the alleged infraction itself to be highly suspect and we would request that your office initiate imediate inquiry into this type of action on the part of your inspectors.
I would also like to point out that we i
have made repeated requests with the materials licensing branch that Radiation Technology Inc. be allowed to appoint its own operators without the necessity of having to wait 6-7 months for an answer from the licensing branch concerning a routine request as we have made many times in the past.
We are also aware that other companies do not require the licensing branch approval of each operator requested but that they can name their own operators based on their own internal training program.
If this infraction is not voidea, it is our intention to appeal this particular citation.
With regard to your Appendix A, Paragraph B, concerning License Condition 16A, we once again take exception with the alleged infraction citation. As was explained to the inspectors during the date of the visit, the wording r
that " prior to initial operations of the in-air irradiator on any given
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day, the licensed operator will perform and interlock check in accordance with the stated procedure." This sentence was written by me and as explained to the inspectors, I know exactly what I had in mind when I wrote the sentence.
The language "on any given day" refers to any given day chosen by the licensee.
It does not refer to every single day that the irradiator is operated.
This matter was discussed in great detail with the inspectors.
Since the installation of the conveyor system interlocks, the procedures that we have outlined have been followed.
In order to clarify the situation, interlock test procedures were written and included in the Operating Procedures manual in April 1978.
Since May of 1978, we have made it mandatory that the operators who perform the interlock tests initial the operations notebook. We therefore take exception with the finding of the inspectors that an infraction had existed.
Under Item 2 of Paragraph B, notice was made that the upper conveyor interlock door switch failed to oerate during an NRC test during the inspection.
It was found that a roller switch had been stuck and the switch was quickly released and the test performed successfully. Although the upper conveyor door is checked as part of the interlock check program, it should be pointed out that the in-air irradiator is not now utilizing the upper conveyor as an automatic feed-in conveyor. We do not interpret anything in the NRC regulations that would indicate that an infraction exists during the performance of a test in which the interlock is found to be jammed. That is the purpose of making the interlock test.
I therefore disagree with the inspectors report that an infraction exists.
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Under Item 3 of Paragraph B, the question is brought up concerning the size of the water sample taken for analysis of the cobalt in our pool water systems.
The inspector's report indicates that 40 ml samples are taken rather than the 100ml samples which we had indicated that we would take according to our license application.
The inspectors have not understood our test pro-cedure since they would understand that we do in fact take 100 m1 samples of water from the pools for test, but that the 100 m1 samples are placed in 40 ml containers so that we can have a calibrated geometry for use in our counting system. The NRC has been intimately involved with our methods of counting pool activity since 1975 and at no time, did anyone question the procedures being utilized.
In fact, on the date of the inspection, the NRC staff brought with them calibration samples so that they could check out our counting equipment. The procedure being utilized by the company which involves either a scaler system or a multi-channel analyzer, is con-sidered to be much safer to use over the boiled-down system that had originally been suggested.
Further, since there is always a chance of losing some material during the boil-down to dryness, the method now employed is considered to be much more satisfactory.
Since the NRC has been aware of the procedures that we have been using for over three years, we do not believe that on the basis of technicality that an infraction does in fact exist.
Should this infraction not be overturned, it is our intent to appeal this question. We would also like to add that durir.g the date of the inspection, Mr. Slobodein mentioned a new proposed requirement that would have automatic irradiator systems monitor the totes leaving the irradiator to make certain that no activity is being brought out of the cell. At the suggestion of Mr. Slobodein, a letter was sent to the appropriate NRC office explaining our situation and suggesting that the new regulation would not apply in our case.
Subsequently we have received information from that office.
I point this out only because the NRC inspectors had never suggested that there may be some " technicality" involved in the assay procedures being used by the company as against what had been written in the license.
We wonder whether the NPC might not be involved in some sort of entrapment proceedings.
We hope that that is not the case and we hope that this matter can be aborted before it leads to a long and involved hearing.
With regard to Item 4 of Paragraph B, we state that the NRC inspectors have been aware of this situation which hcs been brought on by a problem with the demineralization system.
It took many months to obtain the part from Canada which has now been installed and we are simply awaiting some valve assemblies so that the regeneration process can be put into routine operation.
Water checks have been taken as required by our licence and the NRC has been aware of the conductivity of the water for at least the past six months or so.
It is my understanding that the valve assemblies are due to be delivered within the next week, Conductivity of the water should be brought into specification within the next 30 days or so. Although the pH and conductivity values had been taken on a routine basis, they had not previously been recorded in a systematic manner.
Our laboratory has now set up a water notebook in which these values are duly recorded as required.
Since the NRC had been aware of the water condition and since they were aware that repair and maintenance work were under way, we cannot
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RADIATION T CHNOLOGY, INC.
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'see how the inspectors could cite us for an infraction.
Although
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conductivity and pH measurements have always been taken in accordance with our license condition, we have now set up the water chemistry notebook maintained by our laboratory so that each reading could be dated and initialed by the operator taking the data.
Under Paragraph B, Item 5, we wish to point out that during the point in time that the demineralizer system was inoperative, surveys were made as required by our license on the pumps and filter systems which run continuously in our plant. Aside from these surveys, the NRC inspectors are aware of the procedures utilized by the company for the disposal of any filter cartridges which require careful checking for any con-tamination.
Further, during this period of time, pool water samples have been taken on a very intensified basis which serves as a much more accurate check of any possible cobalt leakage than might be obtained by surveying the demineralization system.
Since the NRC was totally aware of the situation for better than six months and since nothing had ever been said to us concerning the procedures that we had been utilizing, we feel that the NRC is being perhaps overzealous issuing a citation of this type.
Radiation Technology, Inc. does not believe any infraction occurred. As soon as the demineralization system is put back into operation, the company will revert to the weekly surveys of the denineralizer as per the license condition.
Under Paragraph B, Item 6, concerning training, the company does not agree that any deficiency exists in the training program being performed by the i
company.
During the date of the inspection, I was not asked whether I had any recordt concerning the training of any of the employees.
Since the introduction of our October 12, 1977 letter, the training program at 4
Radiation Technology has been greatly intensified and has included the issuance of study documents to all personnel, the giving of written test examinations to determine levels of competence, as well as the continuing on-going on-the-job training.
It is the position of Radiation Technology, Inc.
that the training program now in effect at our company is exactly in compliance with our letter of October 12, 1977.
If the NRC would like l
to make any suggestions concerning methods of documentation or implementation, that are better than the system now being utilized by the company, we would be very happy to consider it.
It is the posture of Radiation Technology, Inc. that no deficiency exists.
Aside from our comments concerning the alleged infractions, I would also like to comment on Inspection 30-7022/78-01 which took place on April 6 1
and 26,1978.
It is interesting to point out that a number of statements in the report urder " DETAILS" have not been substantiated by conversations with party who wac attributed to having made the statement.
For example, under Paragraph 3, your-inspector indicated "Mr. Buckley stated that the continuous mode of operation had been tested." Mr. Buckley's coment concerning that statement was " BULL!".. With regard to Paragraph _4, the inspector stated "R. Buckely stated that he did not conduct nor was he aware of any other individual conducting interlock tests each month since December 1977." The comment made by Mr. Buckley concerning this statement was "BULLl".
RADIATION TECHNOLOGY, INC.
PAGE Also, Under Item 5, the inspectors report states "From a review of licensee records and discussions with R. Buckley it was determined that the contamina-E tion and radiation surveys of the irradiator areas and demineralizer room
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required to be performed on a quarterly frequency had last been performed on December 17, 1977." The comment made by Mr. Buckley concerning this statement was " BULL!".
Further, in conversations with Dr. Welt and the inspectors, it was stated that Dr. Welt had made surveys as had Mr. Buckley and so had various shift superintendents in the various areas questioned.
It is inconceivable that the inspectors could have come away from their meeting with the understanding that no surveys had been made in a period of four months.
Further a statement attributed to Mr. Buckley that "Mr. Buckley stated that contamination ar.d pool water surveys had not been made in recent weeks because the counting equipment was not operating."
It is true that the counting equipment had not been operative for a period of time around the inspection period, however, it should not be inferred that the equipment had been inoperative for a period of four months.
At the time of the inspection, two pieces of electronic equipment were out for repair and one of the items was returned shortly after the inspection, thereby permitting the assays to be conducted in accordance with our license.
With regard to Paragraph 6 of the inspectors report, it was noted that tigarette butts were littering floor of the R & D pool area," and further, "The room is prominently posted as a no smoking area, since work is done with flamable methyl methacrylate in the area."
I was not aware that either of the inspectors were competent in the field of organic chemistry and further they should have been aware that no work is performed in the R & D room with flamable MMA. Although it may be possible that cigarette butts were on the floor of the R & D room, I could not get anyone in the plant to agree that the floor was " littered with cigarette butts." It is possible that upon entering the R & D Room some of the men who are smoking do put their cigarettes out on the floor, even though sand filled containers are available at the entrance way to the R & D pool area.
I do not find any evidence in the inspectors report that they observed anyone smoking in that area.
Further, under the same paragraph the inspectors discuss the testing of the area alarm in the R & D room.
We have previously written to your office concerning this instrument which had been working without problem up until a piror visit and inspection in which Mr. Robert McClintock insisted that the instrument was not working properly and requested that we prove that the instrument was working before permitting the facility to be put in operation.
You are well aware of what took place.
With regard to Paragraph 9, it was stated that Dr. Welt has held training sessions with employees regarding r#ation safety and it was further stated that none of the sessions were documcated.
The training sessions conducted by myself have been documented and further, the training manual dealing with biological aspects and shown to the inspectors on the date of their visit, is being signed by each employee after they have had a chance to review the particular document. That particular document on biological aspects of radiation has been part of our training program since October 1977.
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Under Paragrpah 10, it was stated that "Dr. Welt was advised by the inspectors
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that an evaluation of dose received under those circumstances must be made and include all other data available to the licensee." To my knowledge, the inspectors never made such a statement to me and since the overexposure episode has been totally documented by our our analyses as well as by the report made by Dr. Dave Steidley for St.
Barnabas Hospital, I can see no reason for submitting additional evaluations. We would appreciate clarification from your office concerning what your inspector meant and what he was expecting from us.
I would also suggest that someone in the NRC become aware of the staff limitations placed on small business corporations by virtue of their size and financial resources and that non-essential studies are not the most productive things for small business corporations to engage in.
With regard to Item 12, regulatory changes, these items were discussed at great length and it was our understanding that the differences in interpretation by the licensee and inspectors would be reviewed by Region I who would then contact us so that a mutual interpretation could be afforded to those sections of our license. As it turns out, between the April 6 inspection and the receipt of your notices of alleged violations dated July 21, we were not given the courtesy of any call from your office concerning matters of interpretation.
With regard to Paragraph 13, exit interview, lt should be pointed out that at my suggestion the inspectors had prenared written notes of the interview and their inspection and that upon presentation to me for signing to show my agreement with what they found, I told them I could not as I was not in agreement with the recollections they had made.
I had suggested a format comparable to that used by the Food and Drug Administration where the inspectors prepare an inspection report that is jointly submitted so that statements and findings are agreed to between the inspector and licensee.
This was not done in this particular inspection.
In conclusion, we do not believe that any of the allegations found in the April 1978 inspections are valid.
We further can only believe that there may be some tie-in between the handling of the April inspections and the hearing which is now being adjucated by the Honorable Samuel Jensch concerning prior alleged infractions.
Also, in spite of the fact that Mr. Robert Buckley had been carefully scrutinized by both the Region I office and the licensing personnel concerning his suitability as supervisor of radiation operations, and after continued assurances by the Region I staff that Robert Buckley was acceptable as an operator and in spite of the fact that the Region I staff had indicated their willingness to check with licensing to see why the formality of the license amendment had not been issued, we were still cited for having Mr. Buckley operate without his name being aoded to our license. The inspectors have no information to indicate that Mr. Buckley oeprated the facility without a licensed operator being present in the facility and this matter is now being considered by Judge Jensch in one of the previous alleged citations which are part of the current hearing. The fact that the license amendment including Robert Buckley's name was received by the company on only this date, just a few days after
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the-notice of the April inspection causes us to be highly suspicious concerning the motives.
We strongly suggest that your office in conjunction with Inspection and Enforcement staff reconsider the actions being taken as it is our feeling that a very dangerous precedent may be in the offing concerning the over abuse of regulatory powers by a regulatory agency.
We sincerely hope that future hearings on matters of thi sort can be avoided.
Yours v
- truly, Martin A. Welt, PhD.
President MAW: men j
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