ML20023C788
| ML20023C788 | |
| Person / Time | |
|---|---|
| Issue date: | 01/31/1980 |
| From: | Gamble D NRC OFFICE OF INSPECTOR & AUDITOR (OIA) |
| To: | Strickler L NRC OFFICE OF INSPECTOR & AUDITOR (OIA) |
| Shared Package | |
| ML20023A415 | List:
|
| References | |
| FOIA-82-515 NUDOCS 8305180013 | |
| Download: ML20023C788 (4) | |
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NUCL E AR REGUL A1ORY cot.'.t.U% ION
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Lawrence J. Strickler, Investicative flanacer MEMORANDUM FOR:
N Office of Inspector and Auditor
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DavidH. Gamble, Investigator (Q/\\O
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FROM:
/A Office of Inspector and Auditor v:>.,-c4 MEETING BETk'EEN NUCLEAR PHARMACY, INC. ARD NRC ON
SUBJECT:
JANUARY 21, 1980 As requested by a representative of the U.. S. Departnent of Justice, I interviewed James H. Sniezek, Director, Division of fuel facility and Materials Safety Inspection, Office of Inspection and Enforcement (IE) to obtain his recollection of the January 21 meeting on January 29, 1980, between representatives of Nuclear Phannacy, Inc. (NPI) and NRC.
Sniezek said the meeting had been called before Christmas and was finally He understood the meeting resulted from held on January 21, 1980.
telephone calls among NPI Attorney Vakerics, Victor Sniezek Chief Counsel, Office of the Executive Legal Director (ELD)).
said that the meeting was the first time he had 'ever met Vakerics, NPI President Sanchez, or the other' NPI representative present.
In response to a question as to what was covered in the meeting, Sniezek said that NPI merely reiterated everything they had written to IE in k' hen asked to be more specific, response to the riotice of violation.
Sniezek said that NPI wanted to convince IE not to go forward with the Sniezek said that, while not routine, IE often notice of violation.
receives (and entertains) requests for such meetings with alleged violators:
Sniczek did not feel that he said to refuse to so meet would be unfair.
MPI was using the meeting to detennine what information NRC had about them.
Sniezek recalled that Vakerics claimed the charges against NPI were not He recalled Sanchez' main argument as being that NPI does not need a New Drug Application (NDA) to handle the Xenon-133 in question valid.
and, furthennore, he (Sanchez) had never heard of a requirement for NPI Sniezek said to obtain material from a manufacturer possessing an NDA.
that he countered Sanchez' claim of lack of knowledge by giving him a copy of a letter from Gyarfas (FDA) to Sanchez dated May 9,1975 (atta which outlined the requirement for an NDA.
8305180013 830412 PDR FOIA EMSHWILB2-515 PDR e
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l asked Sniezet whether NPl. questioned,whether IE felt NPI had cont Sniczet indicated NP.'
anything to encanper the public health or saf ety.
did ask this and ne responded that IE has-never said this action i:
- harmful to health:
IE is saying that, by NPI's not complying with the.
FDA requirement to have an NDA, NRC did not have the affinnative assurance that NPI's operation was not a -health hazard.
I asked Sniezek what was NPI's coment on any recent amendments 'to their license.
He said NPI tried to make the araument that an amendment NRC made to their license subsequent to IE's notice of violation demonstrated -
the shortcomings of the license condition which NPI was being cited for violating.
Sniezek said he infomed NPI that the_ Office of Nuclear Materials-Safety and Safeguards made this same amendment to similar Sniezek licenses based upon a problem identified at another licensee.
said the timing of the amendment w'as unfortunate, but it was clear from the FDA letter that NPI was aware of the FDA requirement for an NDA.
I asked Sniezek what NPI's allegation was concerning the VA hospitals.
Sniezek only recalled that it was a gen,eral allegation that he felt encompassed drugs other than Xenon-133 (i.e., both radioactive and nonradioactive drugs). 'Sniezek told me that (1) NRC has no. interest in
-nonradioactive drugs and (2) the VA may also be procuring radioactive drugs for, e.g., animal experimentation, as opposed to NPI's human.use of Xenon-133.
Sniezek said he may have also infonned NPI of this - but he was not certain.
In response to my question, Sniezek said NPI alleged that, since NRC granted an exemption. from license condition 15 (i.e., the condition
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requiring compliance'with FDA requirements which'NPI allegedly violated)
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to Letterman Army Hospital,<it is not necessary fo~r NPI to comply with this condition.
Sniezek recalled. advising NPI that this conclusion did l
not follow because Letterman had a broad license and that prior to the exemption Letterman was required to submit their procedures to NRC for approval.
He said that this infonnation was supplied to IE by NMSS.
L Sniezek noted to me that NRC's exemption ldoes not necesarily relieve l
Letterman of their responsibilities to the FDA.
I asked Sniezek what NPI's argument was concerning lahcIling of the-Sniezek said he did not fully understand NPI's point, but they p roduct.
l said the package of Xenon-133 they received from Union Carbide was labelled for medical use.
Sniezek showed me a photocopy of some ' labels Sniezek recalled that NPI said they added their labels provided by NPI.
to the products before distributing them - but they claimed they did not Sniezek said Stello then asked him remove any Union Carbide labels.
(Sniezek) whether lE's checking determined that the Union Carbide labels were on 'or off the products.
Sniezek responded that he did not know.
Ilhen I asked Sniezek if he recalled NPI's allegation that an NRC inspector had infomally approved of NPI's procuring Xenon-133 from Union Carbide, Sniezek replied that the allegation is untrue.
Snicick said"that IE has located the inspector involved (in Region V) and the inspector's recollec-tion was that the NPI manager said they get their Xenon from Union l
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Carbide like everyone'else in: the industry.
Sniezek said the insoector val-he just
.did ~not say anything which could be construed as an a was therefore an improper source. Sniezek said that this inspector was apparently no one in'IE. picked up on this problem until the not alone:
. State of Texas. brought it to NRC's attention.
133 was approved by the FDA by virtue-of its be Sniezek said he immediately countered NPI's claim by informing them that the Drug Master File is only a registry and listing Master File.
thereon does not-constitute FDA approval.
I asked Sniezek what NPI's contention was regarding General Electric's s
1 He replied'that-NPI said GE purchases (GE) purchases of Xenon-133.
Xenon-133 from Union Carbide and does not do anything more to it before distributing it further; therefore, NPI is' entitled to do the Federal Government-(NDA) to process the Xenon-133 in a manner that the thing.
FDA has found to assure it is safe for human use.
I asked Sniezek whether Stello agreed to reconsider the notice of viola whether in fact the notice was being rewritten, and what understanding was reached whereby NRC agreed to let NPI revi l,
whether:IE discovered the Union Carbide labels to be on or o Stello did not in any way agree products after NPI. half distributed them:Sniezek, said that he lat'er (i.e., a to change the' notice.
meeting) determined that IE found products at hospital on information_from the meeting >Sni#ieksaid'itii6ne7f"Es~not ce Union Carbide labels.
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J he said this item will probably appear in the final o
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L Sniezek said, however, that a second how it went out in the notice.
,.f Sniczek said the item (with a proposed fine of $8,000) was dropped.
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decision to drop _- this item was made before the January 21 meeting; he
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said this item was dropped based upon review of the licensees written
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._Sniezek said Yakerics asked if it would be ok.gom response,_becausejt was an invaly citation ay if'fjp] saw in advance y
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Sniezek the wording in the letter and order imposing the civil penalty.
said Murray agreed to describe the contents of the letter and order to
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Sniezek Vakerics on the telephone just before it was mailed to NPI.
p said this is ccamon practice for NRC and is designed to prevent the licensee from hearing about the penalty from, e.g., the newspapers sin l
violation infonnation is released to the public a few days after mailing.
i Sniczek said that NRC'did not agree to let NPI have any input into the l
exact language of the final letter or order.
Sniezek recalled that Stello left the meeting first, thbn l'awrence Strick (01A) left at about 3:00 and they continued until about 4:15 with only i
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Sniezet said that during thit Hurray and himself repr_esenting tiRC.
Lperiod they rehashed the same points; li?] continued to make ocnera)
- claims ~ that-t ey try.to follow regulations.
h Attacirnent:
As stated.-
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