ML20023C914
| ML20023C914 | |
| Person / Time | |
|---|---|
| Issue date: | 11/25/1980 |
| From: | Fortuna R NRC OFFICE OF INSPECTOR & AUDITOR (OIA) |
| To: | Greenspun J JUSTICE, DEPT. OF |
| Shared Package | |
| ML20023A415 | List:
|
| References | |
| FOIA-82-515 NUDOCS 8305180291 | |
| Download: ML20023C914 (10) | |
Text
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NOV 2 5 1980 fir. Julian Greenspun Deputy Chief for Litigation Criminal Division U.S. Department of Justice Washington, D.C. 20530
Dear Julian:
The six enclosed interview sumaries were obtained and prepared by an Investigator with the riRC's Region III, Office of Inspection and Enforcement, Glen..Ellyn, Illinois. They relate to the apparent conflict of interest by:
who, at the time of the referred to activi ty, was empl.,._. _.. _oyed as Chief, riaterial Radiological Protection Service, with 11RC's Region I, Office of Inspection and Enforcement, King of Prussia, Pennsylvania.
Based on the summaries, it appears as ifi who was in the employ of the flRC until !! arch 15, 1980, visited t'hi Chicago, Illinois, facilities of fluclear Phannacy, Inc. (fiPI), in January or February 19Rn I
and, with tipi's President, observed liPI's Chicago operations.
apparently made this trip on his personal time and his official leave record, which is also attached, shows that he took two days plus two hours annual leave during the last three work days of pay period 04 of 1980 (pay period 04 encompasses the period frcxn January 27-February 9, 1980). While in Chicago,['T~.i i ~ Smet with fiPI's pharmacy staff and discussed basic radiation safety techniques with them, advising then to follow these techniques.
The interview summaries also indicate that an East doast 14RC employee tipped off I;PI's management that its Chicago operation would be inspected by the !!RC on January 22, 1980.
It was, however, inspected on January 21, 1980.
It is llRC's policy to conduct such inspections without prior notification to the licensee.
0n February 19,1980,j
_ executed a Personnel 5ction Request to notify the llRC that he Vo..uld be resigning, effective Parch 15.
lie confinned in writing, at that time, that he was leaving to accept a position with flPI.
8305180291 830412 PDR FOIA Sincerely, EMSHWIL82-515 PDR O
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Distribution:
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e OIA 79-54 01A Reading RFortuna Roger A. Fortuna, Assistant Director
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LJStrickler for Investigations 0 fice of Inspector and Auditor
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Enclosure s
m-RESUI.TS OF INTERVIEW WITH
' AS RECORDED BY J. B. McCAETEN 0::
SEPTE'BER 23, 1980
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On Sept ember 23, 19 80,,f Pharmacy ?!anager, Nuc3 ear Pharr.acy Incorporated (NPI), Chicago was interviewed by }ir. J. B.
- McCarten, Investigator, U.
S. Nuclear Regulatory Comission.
During this inter-viev Storey related the following information:
f tstated in. January 1980l
_ _. _,,,_. _,, NPI 's Co r po r a t e Ra d i a-tion Safety Of ficer, visited NPI's Chicago Water Tower f acility while still ecployed with the Nuclear Regulatory Commission. l
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-' 7 along with the Co pany President, Robert' Sanchez, were
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there to observe _1JPI's Chicago operations.
He stated apparently, at
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' was considering employment with NPI in the pos_i-tion of Corporate Radiation Safety Officer.
Later in lisy 1980, left the NRC and accepted this position with NPI.
also stated apparent 1v !k.
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appeared concerned with the propriety of his visit.
He said he doul'd only ask questions of NPI offi-cials, but vould not give advice to these officials concerning the firm's safety program.
END OF REStr1.TS OF INTERVIEW WITH ON SEPTE'5ER 2 3, 1980 Signed:
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' Enclosure RES"ULTS OF INTERVIEW WITH [ _.-
. __._. _ _J AS RECORDED BY J. B. McCARI
'INVES12CATOR, U. S. NUCLEAR REGULATORY C0!D11SSION
- former Of fice Manager, NPI, ' Chicago, On September 23, 1980.j _
was interviewed by J. B. McCarten, Investigator, U. S. Nuclear Regulatory Cor: mission.
During the intervice Triebus related the following information:
She stated for a one-week period in January or Tebruary of 1980f
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NPI's current corporate Radiation Safety Officer visited the Chicago facility while he was still ecployed by the Nuclear Regulatory Cor:nission. Ms.]
said he visited the f acility and made various recoc:mendations to NPI District Manager, Nunzio DeSantis, concerning the firm's radiation safety program.
Ms.
also recalled that in' January 1980 two days prior to the NRC inspection of NPI Nunzio DeSantis told NPI lab employees that he had been tipped off about an upcoming NRC inspection of the Chicago operation by a friend of his who was with the NRC on the " east coast".
DeSantis said the inspection was to be on January 22, 1980 and a meeting of all lab employees was scheduled for the evening of the 21st.
The NRC inspection however was conducted on the morning of the 21st and MPI was not prepared for it.
She said this result ed in-the NRC inspectors finding various deficiencies in' NPI's radiation safety program during the course of; this
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inspection.
. END OF RESULTS OF INTERVIE'1 WITH!
___._.._, AS RECORDED BY J. B. McCARTEN ~
U. S. NDCLEAR REGULATORY COMMISSION 7
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B. McCarten vestigstor f
T.nclosure 2 Paca 1 of I
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Enclosure RESULTS OT INTERVIEW UITH,I
.AS RECORDED BY J. E. 21cCARTEN, IN-VESTICATOR, U.S. N11 CLEAR REGULATORY CO.911SS10N
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On October 2, 1980,I
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fomer Pharcacist, NPI, Chicago, was
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interviewed by J.
B'.' 11cCar' ten, Investigator, U. S. Nuclear Regulatory Com=3ssion.
During this interview he related the following infomation:
He stated in January 1980, he was working in the Chicago laboratory when j
Pharr:acy l'.anager, told lab e=ployees that Nunzio D2Santis, NPI's District l'.anager had a friend in the Nuc1 car Regulat ory Commission who had tipped him off concerning an upcocing NRC inspection of NPI's Chicago operation.
Lee related thatl
' told lab personnel to get records ready for the inspection and i.ake sure that they were "up-to-date".
also saiLradiation safety training was given one day prior to this inspection.'
_ _: could provide no further information concerning this natter and the interview vas ended at this point.
END OT RESULTS OF INTERVIEW WITH,'
ON OCTOBER 2, 1980.
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Signed:
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Encl os ur e RES,ULTS OF INTERVIDO WITH
' AS RECnRDED BY J. B. McCARTE!;,
INVESTIGATOR, U. S. NUCLEAR REGULATORY CO.TIISSIO!;
On Septerber 25, 1980 former Pharcacist, NPI, Chicago was interviewed by J. B. McCarten, Investigator, U. S. Nuclear Regula-tory Cocnission.
During the interview related the following
,irl orma tJ on.,F stated he recalled'that in Tebruary 1980 E ~ ~
f currently NPI's Corporate Radiation Safety Of ficer had visited j
the Cnicago f acility while still e= ployed by the Nucicar Regulatory Co=aission.
He said the purpose of the visit was to look over the Chicago operation, and meet with NPI's, president concerning his f uture encloyn_ent wi th the fim. {
isaid he was unaware of any teeting
, held with NPI's pharmacy staff concerning the radiation safety 1
progran.l could provide no further per tinent inforcation regardinr this matter.
J END OF RESULTS OF INTERVIDJ WITHf SEPIDIBER 25, 1980.
Signed:
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O RESULTS OP INTERVIEW VITH,r
. AS RECORDED BY J. B. McCARTES, INVESTIGATOR, U.
S. NUCLEAR REGULATORY. CO'NISSION On September 24, 1980f j f; - }., Pharmacist, Nuclear Pharmacy, Incorp-orated, Chicago, was interviewed by
.1. B. McCarten, Investigation Specialist, U. S. Nuclear Regulatory Cornission.
During this interview Sobel related the following information:
stated for a one-week period in January 1980,!
currently NPI's Corporate Radiation Saf ety Officer visit ed NPI's Chicago Water Tower facility to look over the operation, apparently while he vas still ecployed with the U. S. Nuclear Regulatory Cor:nission. f, stated at the conclusion of this visit he held a meeting with the pharmacy staff and discussed basic radiation safety techniques and also advised
,emplovees to follow these techniques. [ _
- said during this meeting discussed tiie proper use of lead gloves and syrinse shields as to'ols t'o keep radiation exposures down.
He also relatedt advised NPI management to 'use syringe shields at all times, and to purchase shields that were 100% glass to provide maximum protection against un.
necessary radiation exposure, f
'related he was not sure if Mr./
is still working with t1 e_Nucicar Regulatory Com:nission at the' time of this 3
meeting, but later Mr.'
left the NRC to accept a position of.
Corporate Radiation Safety Officer with Euclear Pharmacy. [
could provide no further information of pertinence to this investigation..
END OP RESULTS OF INTERVIER WITH:
ON SEPTDIBER 25, 1080.
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Signed:
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CALEliDAR YEAR 1979 b'
PAY $ERIODSCHEDULE NY' fit Y tt! :I Pay Period Dates Date Paid Remarks 55$
26/78 Dec. 03 - Dec. 16 Dec. 26 4th Quarter - End of Pay Year m
MF 5111:
W 01/79 Dec. 17 - Dec. 30 Jan. 09 02/79 Dec. 31 - Jan.13 Jan. 23 End of Leave Year is]
03/79 Jan.14 - Jan. 27 Feb. 06 Begin Leave Year 04/79 Jan. 28 - Feb.10 Feb. 20 '
l, 4 Ar 05/79 Feb. 11 - Feb. 24 Mar. 06 D
06/79 Feb. 25 - Mar. 10 Mar. 20 1st Quarter M
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07/79 Mar.11 - Mar. 24 Apr. 03 hy 08/79 Mar. 25 - Apr. 07 Aor. 17 e
09/79 Apr. 08 - Apr. 21 May 01
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11/79 May 06 - May 19 May 29 815 12/79 May 20 - June 02 June 12
$3 13/79 June 03 - June 16 June 26 2nd Quarter
+xb K's 14/79 June 17 - June 30 July 10 1$]
15/79 July 01 - July 14 July 24 k
16/79 July 15 - July 28 Aug. 07 F4 17/79 July 29 - Aug,11 Aug. 21 h
18/79 Aug. 12 - Aug. 25 Sep. 04 MD.
19/79 Aug. 26 - Sep. 08 Sep. 18 3rd Quarter bE F.m 20/79 Sep. 09 - Sep. 22 Oct. 02 Id 21/79 Sep. 23 - Oct. 06 Oct. 16 s2 22/79 Oct. 07 - Oct. 20 Oct. 30 il 23/79 Oct. 21 - tiov. 03 fiov. 13
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.O Dec. 30 - Jan. 12 Jan. 22 03/80 Jan. 13 - Jan. 26 Feb. 05 End of Leave Year i?'5j 04/80 Jan. 27 - Feb. 09 Feb. 19 Begin Leave Year
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06/80 Feb. 24 - Mar. 08 Mar. 18
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08/80 Mar. 23 - Apr. 05 Apr. 15 2Ef 09/80 Apr. 06 - Apr. 19 Apr. 29
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10/80 Apr. 20 - May 03 May 13
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12/80 May 18 - May 31 June 10 E
13/80 June 01 - June 14 June 24 2nd Quabter E1 14/80 June 15 - June 28 July 08 ffj 15/80 June 29 - July 12 July 22 16/8Q July 13 - July 26 Aug. 05 em 17/80 July 27 - Aug. 09 Aug. 19 Eg 18/80 Aug. 10 - Aug. 23 Sep. 02 ry 19/80 Aug. 24 - Sep. 06 Sep. 16 F;E 20/80 Sep. 07 - Sep. 20 Sep. 30 3rd Quarter h-$
h 21/80 Sep. 21 - Oct. 04 Oct. 14 N
22/80 Oct. 05 - Oct. 18 Oct. 28 Fj 23/80 Oct.19 - Nov. 01 Nov. 10**
p 24/80 Nov. 02 - Nov. 15 Nov. 25 W
25/80 Nov.16 - Nov. 29 Dec. 09
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26/80 Nov. 30 - Dec.13 Dec. 23 4th Quarter - End of Pay Year A
01/81 Dec. 14 - Dec. 27 Jan. 06 02/81 Dec. 28 - Jan. 10 Jan. 20 End of Leave Year
- Due to the Christmas holiday, payday will be the second Monday after t y
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- Due to Veterans' Day, payday will be the second Monday a f ter the pay perio l
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0 LL.JG:DEF:pb 146-41-15-3344 liDV 2 01991 Thomas V. Vakerics, Esq.
O'Connor & Hannan 1919 Pennsylvania Avenue, H. W.
Washington, D.
C.
20006 Re:
Nuclear Pharmacy, Inc., Milwaukee Office; License No. 48-17466-OlMD
Dear Mr. Vakerics:
As you are aware the Nuclear Regulato'r. Commission (NRC) 2 ili the fall of 1979 requested the Criminal Division of the
.Departnent of Justiceoto review certain activities and conduct Tengaged in-by'NPI's Miluaukee nucle'ar pharmacy,' which nuclear pharmacy has operated since May 25, 1977, under a license (No. 48-1746G-OlMD) issued by the NRC.
This criminal referral primarily arose from the alleged sale by NPI of chemical grade Xenon-133 which had been purchased from a supplier, Union Carbide (UC),which had not sought and obtained a new drug application (NDA) from the Food and Drug Administration (FDA), which activity was in violation of condition #15 of NPI's license.
The Xenon-133, a radioactive substance, was allegedly sold by NPI to hos-pitals in either bulk or unit do ses as a radiopharmaceutical despite the fact that UC did not nave a UDA for the chemical and the fact that NPI did not procure the Xenon-133 from an approved source.
Another aspect of the NRC referral involved NPI's allegedly reusing unit dose vials (dose containers for Xenon-133) pre-viously provided to NPI's hospital customers.
In come instances these vials bore the logo of the New England Nuclear Co. (UEN),
which company had an NDA for th'eir Xenon-133.
This activity allegedly led the hospitals to believe that they were obtaining FDA approved Xenon-133 from NEU, when in fact the Xenon was pro-duced by a supplier, UC, which did not have an HDA with the FDA.
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. Based upon our review of the applicable statutes and regulations, as well as subnissions by the NRC and NPI to the Departaent, we have decided to defer prosecution of this matter.
This decision is substantially based upon NPI's representation that it has rectified the activities in question and will con-tinue to comply with NRC rules and regulations.
Sincerely, LAITRENCE LIPPU, Chief General Litigation and Legal Advice Section Criminal Division Ey:
JULIAN GREENSPUN Deputy Chief for Litigation cc:
James J.
Cummings, Director Office of Inspector & Auditor Huclear Regulatory Commission Joseph P.
Stadtmueller United States Attorney Milwaukee, Wisconsin
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.J FLS M-Gk' License Nc. 48-17466 01MD Nuclear Pharmacy, Inc.
ATTN:
Robert Sanchez, President P. O. Box 25141 Albuquerque, NM 87215 Gentlemen:
This is in reference to your letter of October 22, 1979, in response to the Notice of Violation and Notice of Proposed Imposition of Civil Penalties sent to you with our letter dated August 17, 1979.
The notices concerned items of noncompliance found during an NRC inspection conducted on January 16 and 17, 1979, of activities under NRC License No. 48-17466-01MD at your facility in Milwaukee, Wisconsin.
Your counsel, Mr. Vakerics, was informed formally by Mr. Stello's letter dated March 3,1980, that the NRC had postponed further action on the proposed civil penalty at the request of the U. S. Department of Justice.
The Justice Jepartment recently informed us that we could resume our consideration of civil administrative action against NPI.
In a letter dated November 20, 1981, to Mr. Yakerics, the Justice Department stated that it nad decided to defer prosecution of alleged criminal violations of NPI's license conditions.
This decision was, "...substantially based upon NPI's representation that it has rectified the activities in question and will continue to comply with NRC rules and regulations."
In your letter of October 22, 1979, you denied tL two alleged items of noncompliance and protested the proposed imposition of civil penalties.
With regard to the first item of noncompliance, License Condition 15 does require in our view that NPI procure all radioactive gases intended for human use from a supplier that has an FDA approved "New Drug Application" (NDA) or an
" Investigational Exemption for a New Drug" (IND) for the isotope involved.
Our view is based on the fact that the FDA has generally defined radioactive drugs as new drugs.
See 40 FR 31298 (July 25, 1975).
Moreover, the FDA specifically identified xenon-133 as a new drug on November 3,1971.
See 36 FR 2106; 21 CFR 310.503(c).
The Federal Food, Drug, and Cosmetic Act prohibits the introduction or delivery for introduction into interstate commerce of any new drug unless an approval of an NDA is effective with respect to the drug or an acceptable IND which permits the investigational use of the drug is on file with the FDA.
See 21 U.S.C. 355(a), (b), and (i).
Although we have sustained the first item of noncompliance, we recategorized this item as an infraction in accordance with the Criteria for Determining Enforcement Action and Categories of Noncompliance with AEC Regulatory Require-ments, dated December 31, 1974, and we have determined to mitigate the civil Y "0 " &
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Nuclear Pharmacy, Inc..
penalty to Two Thousand Dollars for the occurrences cited in Item 1.
This mitigation is appropriate in view of the absence of harm to public health and safety associated with these particular violations, NPI's enforcement history in the three years since the violations occurred, and our consideration of the circumstances surrounding the violations. While we have mitigated the civil penalty, we intend to closely monitor your activities in the future.
Future violations similar to that described in Item 1 may result in license suspension or revocation.
With respect to the second item of noncompliance, you averred that the transferees were authorized to receive xenon-133 of the type, form, and quantity that was transferred to them by NPI and, therefore, NPI did not make unauthorized transfers of radioactive material.
Upon further review, we agree that NPI was only required to verify the type, form, and quantity of xenon-133 that was listed in the licenses of the hospitals for which the transfers were made. This apparently was done.
Therefore, we are withdrawing the item of noncompliance and its proposed civil penalty.
1 Accordingly, after careful consideration of your response to the Notice of Violation and Notice of Proposed Imposition of Civil Penalties, we have determined to impose a civil penalty in the amount o,f $2000 for the first item of noncompliance set.forth in the Notice of Violation. We hereby serve the enclosed Order Imposing.a Civil Monetary Penalty.
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Sincerely, Richard C. DeYoung, Director Office of Inspection and Enforcement
Enclosure:
Order cc: Thomas V. Vakerics, Esquire Suite 800 1919 Pennsylvania Avenue, N. W.
Washington, D. C.
20006 i
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$V i ;sr.4 ES:IE D:ES ELD', s;O DD:IE D:IE EFlack/jh JLieberman JMurray JHSniezek RCDeYoung 02/02/82 02/ /82 02/ :/82 02/1/82 02/ /82 i
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- Nuclear. Pharmacy, Inc.
3-Distribution PDR NSIC TIC-SECY VStello, DED/ROGR RCDeYoung, IE JHSniezek, IE LCobb, IE CA APuglise, CON L-316 FIngram, PA DNussbaumer, OSP El Reading File EDO Reading File i
VMiller, NMSS JCrooks, AE0D JCummings, OIA JMurray ELD (3)
JLieberman, ES:IE TWBrockett, IE
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Enforcement Dirctors-RI, RII, RIII,,RIV, RV 4
IE Files Central File CP Book l
Department of Health & Social Services ATTN:
Lawrence T. McDonnell,' Chief Radiation Protection Section
~ Division of Health P. O. Box-309 Madison, WI-53701 Department of Health and Environment ATTH:
T. Wolff, Environmental' Manager i
Radiation Portection Bureau P. O. 968 I
Santa Fe, NH 87503 f
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0FFICE OF INSPECTION AND ENFORCEMENT NOTIFICATION OF SIGNIFICANT ENFORCEMENT ACTION l
Licensee: Nuclear Pharmacy, Incorporated, Milwaukee, WI 1
License No. 48-17466-01MD
Subject:
Imposition of Civil Penalties - $2,000 By EN 79-09, dated August 15, 1979, the Conmission was notified of the intent of IE to issue a Notice of Violation and Proposed Imposition of Civil Penalties in the amount of Twenty Four Thousand Dollars to Nuclear Pharmacy, Incorporated (NPI). The proposed penalties were based on alleged items of noncompliance with NRC regulations and license conditions. 'The first item of noncompliance was related to, (1) the improper procurement of non-radiopharmaceutical grade xenon-133 (2) the improper repackaging and relabeling of the product, and (3) the subsequent distribution of the material. The second item of noncompliance concerned bulk quantities of xenon-133, that were transferred to licensed medical institutions not authorized to receive such material.
Following an NRC inspection on January 13, 1979, Nuclear Pharmacy, Inc., immediately stopped this practice.
There has been no report of any patient reaction as the result of the human use of the material. The case was also referred to the Department of Justice (D0J) for review of alleged criminality implications.
The licensee responded to the Notice in a letter dated October 22, 1979, in which the two items of noncompliance were denied.
The Director of Inspection and Enforcement informed the licensee in a letter dated March 3,1980, that NRC had postponed further action on the proposed civil penalties at the request of D0J.
In a letter dated November 20, 1981, to Mr. Vakerics, attorney for the licensee, g
D0J stated that it had decided to defer prosecution of alleged criminal violations.
This decision was based on NPI's representation that it had rectified the activities in question and will continue to compl3 with NRC's rules and regulations.
After consideration of the licensee's response, IE has concluded that one violation should be withdrawn (the transfer of bulk quantities of xenon-133 to medical institutions that were later found to be authorized to receive the material).
In addition IE has concluded that, although the first item of noncompliance i
did occur, consideration should be given to the licensee's arguments in favor of mitigation. Mitigation is considered appropriate in view of absence of harm to the public health and safety, NPI's enforcement history in the three years since the violations occurred, and consideration of c'ircumstances surround-ing the case. Accordingly, the civil penalty for the first item of noncompliance has been mitigated to Two Thousand Dollars and an Order Imposing a Civil Monetary Penalty has been issued today.
The letter transmitting the civil penalty Order will infonn the licensee that similar violations in the future may result in license suspension er revocation. The licensee and the State of Wisconsin are being informed by telephone.
Since this matter involves mitigation of one item and withdrawal of another, a press release has been prepared and will be mailed five days following mailing of the Order.
Page 1 of 2 pages 0 G5 - a 9
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February 24, 1962
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EN 79-09A Under the terms of the Order, the licensee may, within 30 days of the date of the Order, pay the civil penalty or request a hearing.
Contacts:
E. Flack, IE 24900 J. Lieberman, IE 24909 Distribution:f MNBB: /.2 : o TPhillips:/0:/o E/W:
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