ML20023C847
| ML20023C847 | |
| Person / Time | |
|---|---|
| Issue date: | 02/04/1981 |
| From: | Sinclair J NRC OFFICE OF INSPECTOR & AUDITOR (OIA) |
| To: | Strickler L NRC OFFICE OF INSPECTOR & AUDITOR (OIA) |
| Shared Package | |
| ML20023A415 | List:
|
| References | |
| FOIA-82-515 NUDOCS 8305180100 | |
| Download: ML20023C847 (3) | |
Text
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Lawrence J. Strickler, Investigative lianager (
11EliORANDU:1 FOR:
Office of ]nspector and Auditor
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John R. Sinclair, Investigator FROM:
Office of Inspector and Auditor f ItiTERVIEW OF JAllES 11URRAY, ELD, CONCERtilNG JANUARY 2 1980,11EETING WITH REPRESEt.'TATIVES OF NUCLEAR PHA
SUBJECT:
INC.
At the request of the Department of Just' ice (DOJ), !!r. James llurray, Director and Chief Counsel, Division of Rulemaking and Enforcement, Office of Executive Legal Director (ELD), was interviewed on January 28, 1980, by John R. Sinclair, Investigator with the Office of Inspector and Auditor (OIA), concerning his participation in a meeting conducted on with representatives of Nuclear pharmacy, Inc. (N,I),
a firm holding a license with the Nuclear Regulatory Commission (NRC).
January 21, 1980, liurray explained in, response to questions by Sinclair that the meeting with NPI was the result of a request initia'ted by 11r. Vakerics, an According to 11urray, Vakerics had provided NRC with a written response to a proposed tiotice of Violation and had also tele-attorney for flPI.
phonically contacted liurray on at least two occasions attemptin elaborate upon NPI's position.
reauest of Vakerics who wanted his client (NPI) to have the opportunity flurray explained that existing of talking to NRC officials in person.
procedures regarding enforcement actions which result in a proposed Notice of Violation have always afforded the licensee the right to present information in response to the notice prior to a requested liurray further explained that he was not aware of any new or 11urray then hearing.
additional infonaation which was to be presented by NPI.
stated that he considered the meeting more of a courtesy to listen to11r.11u what the licensee and their attorney had to say.
by stating that NRC had never refused to listen to a licensee or prev the licensee from presenting their position in a meeting.
According to l'urray, flPI had already been advised that any action whi had,been proposed by llRC was on " hold" due to the fact that there current interest by the 00J.
to NPI it was assumed that the purpose of the meeting was simply to' furnish a forum to hear the' licensee's position.
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0305180100 830412 PDR FOIA PDR ENSHWIL82-515 ENCLOSURE 4 e
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7-During the meeting Murray stated that Vakeric's challenged the word of the proposed Hotice of Violation because it implied, by statinc
" unfit for human use" that the product was distributed disreg public health and safety.
As notice was too strano and could almost be. construed as " libelous Murray recalls, this' claim did not alter NRC's ' position concerning the Murray did state, however, that Notice of Violation or its wording.
Victor Stello, Director, Office of Inspection and Enforcement (IE), did respond to NPI by stating something to the' effect that "the pr'oposed notice of Violation represented the facts which were available at the time" and then Stello explained that he would review the_ proposed notice Murray did not recall any statements by NRC_ representatives again.
indicating that the Notice of Violation was going to be rewritten,or.~
that.NPI was_.g'oing_to be involved in _the review process..- ]n reviewing this statement )forraj~a'g/ee'd that 'there was seme'di'scussion about dropp f
- However,
\\ the. penalty for the second item in the Notice of Violation.
^ this discussion was, he believes, in the' context of a preliminary. non-f consideration -
, final conclusion reached while the NRC staff was in the middl
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no certain,gspgn_se,/ i ce thty that such a conclusion would be unalt of,_N,P,I.'s r 2
Murray added NRC ever resumes consideration of its enforcement action.
merely related to their ability to. continue.to pres Nurray also recalls that following the: -
1 supported the NPI claims.
discussion surrounding the Notice the NPI officials were advised that action in the event NRC should be cleared by DOJ l
of such action.
Mr. lfurray further explained that a portion of the meeting also pertained NPI claimed that the language to questions about NRC license conditions.
in license condition 15 was unclear and that their claim was supported According to Murray NPI by the fact that NRC had changed the language.
was attempting to establish a position that they did not i
At some time during the supplier with an NDA or IND authorization.
discussion Sniezek presented NPI officials with a letter sent to the firm several years ago from the Food and Drug Adminis,tration (FDA) which l
Subsequent can be read as, in effect, informing them of the requirement.
to this information being discussed Sniezek provided a copy of the letter to NPI at their request.
pertained to challenges of the NRC license to lette i
and ~an allegation that every Veterans Administration. Hosp country is in violation.the license for letterman was a " broad" license and dif W
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It was also ex91ained that NRC had not been aware of One i. sued to NPI.
- any problems concerning the VA hospitals but it would be looked into.,
In addition to the challenges to license condition 15,.NP]41so claimed that Xenon-133 was listed on the FDA Drug liaster file (DMF) and this represented evidence that the product was approved by FDA within the meaning of license condition 15 calling for the obtaining of Xenon-133 fro 71 an FDA approved source.
NRC response to that position was something to the effect that merely because the drug was listed on the DMF did not s
mean that the product was from an FDA approved source.
Murray also i
stated that the General Electric Corporntion (GE) did recalled that NP]
not do any additional testing on products bought from Union Carbide.
Murray stated that he did not recall much of the specific conversation He which had taken pla:e and had not taken any notes of the meeting.
(Murray) reiterated that the meeting was held as a courtesy to hear NPI's position and not for any purpose of exchanging infonnation or
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presenting NRC's position. Because of the length of the meeting there.
was some infonratio.. exchanged, however, Murray stated that NRC's position remained unchanged.
Murray explained that NPI was advised that NRC was, not taking any additional action until DOJ completed its review.
Murray did recall that NPI did attempt to solicit NRC support for attempting to speed up DOJ review.
The attorney for NPI stated that it was going to take D0J months to' arrive at a decision and that the time involved Mr. Murray explained that he did not recall was costly to his client.
how the request was,specifically responded tb but recalls he said something to Mr. Vakerics like *"that's your problem."
According to Murray, Stello lef t the meeting at approximately 2:30 and As he recalls some of the Strickler from OIA left sometime thereafter.
same issues were brought up again by NPI and at some point he (Murray) suggested that.they were.merely recycling the issues.
Murray does not remember exactly when the meeting ended bet. believes that-he arrived Mr. Murray back at his office sometime between 3:45 p.m. and 4:00 p.m.
l could not recall any additional infonnation concerning the discussion i
which took place during the meeting.
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