ML20248G022
| ML20248G022 | |
| Person / Time | |
|---|---|
| Issue date: | 05/18/1998 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | GENERAL, OHIO, STATE OF, OKLAHOMA, STATE OF, PENNSYLVANIA, COMMONWEALTH OF |
| References | |
| SP-98-044, SP-98-44, NUDOCS 9806050065 | |
| Download: ML20248G022 (14) | |
Text
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UNITED STATES y
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NUCLEAR REGULATORY COMMISSION
>t WASHINGTON, D.C. 20555 0001
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May 18, 1998 ALL AGREEMENT STATES OHIO, OKLAHOMA, PENNSYLVANIA TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP-98-044)
Your attention is invited to the enclosed correspondence which contains:
INCIDENT AND EVENT INFORMATION......
PROGRAM MANAGEMENT INFORMATION.,
TRAINING COURSE INFORMATION.......
TECHNICAL INFORMATION..
XX 99MO/99mTC SUPPLIES MAY BE INTERRUPTED OTHER INFORMATION.....
1 Supplementary information: A labor dispute between Atomic Energy of Canada Limited (AECL),
MDS Nordion of Canada Limited (MDS), the major North American supplier of molybdanum to U.S. 99 Moi 99mTc generator manufacturers, and the Chalk River Technician / Technologist's Union could lead to a strike at the NRU medical production reactor at Chalk River. On May 15, 1998, the Union was in a legal position to strike or be locked out. The NRU reactor at Chalk River was powered down on May 14 and AECL will conduct routine reactor maintenance. In the event of settlement being reached, the reactor can begin operations almost immediately. If mediation is not successful, the strike occurs, and the reactor remains shutdown, supphes of molybdenum will be interrupted. U.S. generator manufacturers are seeking alternative sources of molybdenum from foreign suppliers. We understand, however, that foreign suppliers may_n_ot be able to meet the North American demand. The supply to the United States may be only 30-70% of United States needs, if the strike occurs, in 1991, when a similar interruption was expected, NRC took action to issue a temporary waiver to allow licensees to elute generators beyond the manufacturers' recommended expiration date.
At that time, NRC regulations required radiopharmacies and hospitals to follow the package inserts in the 99Mo/99mTc generators. These inserts contained an expiration date for the generators beyond which 99mTc could no longer be withdrawn from the generator. Such action by NRC today is not needed because 10 CFR 35.200 was amended by the Radiopharmacy Rule to remove the requirement that package inserts be followed. In the event that some States may not yet have adopted the Radiopharmacy Rule, we are enclosing a copy (Enclosure 1) of the 1991 waiver for your information and possible use. Also enclosed (Enclosure 2) is a copy of l
NRC's May 15,1998 letter to medical licensees, nuclear pharmacies, and radiopharmaceutical 9f l
manufacturers that addresses this matter.
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i The information in this letter is current as of Monday morning, May 18,1998.
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SP 044 If you have any questions regarding this correspondence, please contact me or the individual named below.
' POINT OF CONTACT:
Lloyd A. Bolling TELEPHONE:
(301) 415-2327 FAX:
(301) 415-3502 INTERNET:
LAB @f GOV 0\\difvf[
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kaul H. Lohaus,' Deputy Director Office of State Programs l
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Enclosures:
i As stated
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SP 044 MAY 18 FA if you have any questions regarding this correspondence, please contact me or the individual named below.
l POINT OF CONTACT:
Lloyd A. Bolling TELEPHONE:
(301) 415-2327 FAX:
(301) 415-3502 INTERNET:
LAB @NRC. GOV i
Oricitalsigned sy:
FAug.H.LOHAUS l
Paul H. Lohaus, Deputy Director Office of State Programs -
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Enclosures:
As stated i
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I Distribution:
DIR RF DCD (SP03)
SDroggitis PDR (YESd ) (NO__)
A/S File FAXED TO STATES:
DOCUMENT NAME: G:\\ LAB \\SP98 044. LAB Tm receive a copo of this document. Indicate in the box: "C" a CQpy etho)lt attachment / enclosure "E",5 Copu with attachment / enclosure "N" = No copy OFFICE OSP p_
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OSP:Q[&
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LBolling:nbD).
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DATE 05/ 4
/98 05/ l3 /98 05/ / 7 /98 OSP FILE CODE: SP-A-4
..-__________________________o
l RE!
- o, UNITED STATES
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p, NUCLEAR REGULATORY COMMISSION 5
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URGENT TO ALL NRC MEDICAL LICENSEES, NUCLEAR PHARMACIES AND RADI0 PHARMACEUTICAL MANUFACTURERS Enclosed is Temporary Waiver of Compliance for licensees authorized to possess and use molybdenum-99/ technetium-99m generators and prepare reagent kits.
4 The e'1 closed waiver does not relieve licensees ' rom current molybdenum-99 f
breakthrough testing or maintaining compliance with the rules and regulations of the Food and Drug Administration.
Because this Temporary Waiver of Compliance is effective immediately, it is important that you notify your appropriate personnei immediately, and retain this Temporary Waiver of Compliance with your license records. Questions and comments may be directed to your nearest NRC regional office.
This Temporary Waiver of Coi.q11ance is effective through[Feb'ruary;4[1991C Sincerely, r
Robert M. Bernero, Director Office of Nuclear Material Safety and Safeguards
Enclosure:
Temporary Waiver of Compliance
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l ENCLOSURE 1 S
11at aTc3V7 //-
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UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS WASHINGTON, D.C.
20555 TEMPORARY WAIVER OF COMPLIANCE (EFFECTIVE JANUARY 15. 1991)
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.The Commission authorizes licensees to possess and use molybdenum-99m generators and prepare reagent kits, by license condition and regulations in accordance with the manufacturer's instructions.
II There is no domestic supply of molybdenum-99 for radiopharmaceutical production and tne sole source for the Unite. States is Atomic Energy of Canada Limited (AECL).
Because of problems affecting molybdenum-99 production, at tne AECL NRU facility at Chalk River Laboratories, there is a potential for disruption of the supply of radiopharmaceuticals needed for medical diagnosis.
1 Accordingly, the Director, Office of Nuclear Material Safety and Safeguards, has found that the public health, safety, and interest requires that this Temporary Waiver of Compliance be made effective for the period January 15, 1991, through February 4,1991, inclusive.
III-Accordingly, the Nuclear Regulatory Commission has concluded that it will not enforce license conditions or regulations requiring licensees authorized to possess and use molybdenum-99/ technetium-99m generators and prepare reagent kits to follow manufacturer's instructions to allcw use of generators for up to 21 days, use of technetium-99m eluant for up to 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />, and preparation of pooled reagent kits (" super kits"), provided that:
a.
the molybdenum-99 concentration is determined for each technetium-99m eluate and meets the requirements of 10CFR35.204(a)and10CFR30.34(g);
b.
aluminum breakthrough testing is performed as currently required; and c.
preparation of each " super kit" includes radiochemical purity
(% Tag) testing 20 minutes after each preparation.
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This does not relieve licensees from maintaining compliance with the I
rules and regulations of the Food and Drug Administration (FDA).
~ OR THE NUCLEAR REGULATORY COMMISSION F
f n= ss Robert M.,Bernero, Director Office of Nuclear Material Safety and Safeguards Dated at Rockville, Maryland This j f day of January,1991 l
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3 UMITED STATES g
NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 205t&0001
,o*g May 15, 1998 i
i URGENT l
TO ALL NRC MEDICAL LICENSEES, COMMERCIAL NUCLEAR PHARMAClES AND RADIOPHARMACEUTICAL MANUFACTURERS I
Enclosed is a Notice of Intent to Exercise Temporary Enforcement Discretion for licensees l
authorized to possess and use molybdenum-99 for the manufacture of molybdenum-99/ technetium-l 99m generators and to possess and use molybdenum-99/ technetium-99m generators. Until further l
notice, the Nuclear Regulatory Commission (NRC) will not enforce license conditions or regulations l
restricting radiopharmaceutical manufacturing, commercial nuclear pharmacy, and medical use I
licensees' possession limits for molybdenum-99 for production of molybdenum-99/ technetium-99m generators, or possession limits for molybdenum-99/ technetium-99m generators.
l This Notice of Intent to Exercise Temporary Enforcement Discretion does not relieve licensees from current molybdenum-99 breakthrough testing requirements, other applicable NRC l
requirements, or maintaining compliance with applicable Food and Drug Administration, other i
Federal, and State requirements governing radioactive drugs.
Because this Notice of Intent to Exercise Temporary Enforcement Discretion is effective i
immediately, it is important that you notify your appropriate personnel immediately, and retain this Notice of Intent to Exercise Temporary Enforcement Discretion with your license records.
Questions and comments may be directed to your nearest NRC regional office.
This Notice of Intent to Exercise Temporary Enforcement Discretion is effective until further notice.
l Sincerel Carl J. Papenello, Director Office of Nuclear Material Safety and Safeguards
Enclosure:
Notice of intent to Exercise Temporary Enforcement Discretion f
ENCLOSURE 2
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UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS WASHINGTON, D.C. 20555 NOTICE OF INTENT TO EXERCISE TEMPORARY ENFORCEMENT DISCRETION
_ EFFECTIVE MAY 15.1998 I
Pursurnt to Title 10 Code of Federal Regulations Parts 30,32, and 35, the Commission authorizes radiopharmaceutical manufacturing, commercial nuclear pharmacy, and medical use licensees to possess and use molybdenum-99 for the manufacture of molybdenum-99/ technetium-99m generators and to possess and use molybdenum-99/ technetium-99m generators by Ocense condition. Because there is no domestic supply of molybdenum-99 for r.diopharmaceutical production, the major supplier for the United States is MDS Nordion in Canada. Labor conditions at the NRU reactor at the Chalk River Laboratories of the Atomic Energy of Canada Limited, which produces molybdenum-99 for MDS Nordion, have a potential for disruption of the supply of radiopharmaceuticals needed for medical diagnosis. In i
anticipation of a strike, it may be necessary for manufacturing licensees to stockpile molybdenum-99 or fer other licensees to stockpile molybdenum-99/ technetium-99m generators in order to mitigata disruption in the manufacture, supply, or use of the generators'. The Director, Office of Nuclear Material Safety and Safeguards, has found that if a strike occurred that disrupted the production of molybdenum-99, the public health, safety, and interest would be adversely affected. Therefore, the public health, safety, and interest require that the Nuclear Regulatory Commission (NRC) exercise its discretion to not enforce certain requirements as provided below, and require that this Notice of intent to Exercise Temporary Enforcement Discretion be made effective for the period of May 15,1998, through the end of the threat of a strike or the end of the strike and production disruption, whichever comes first.
II Accordingly, the NRC has concluded until further notice, that it will not enforce license conditions or regulations restricting radiopharmaceutical manufacturing, commercial nuclear pharmacy, and medical use licensees' possession limits for molybdenum-99 for production of molybdenum-99/ technetium-99m generators, or possession limits for molybdenum-99/ technetium-99m generators, provided that:
a.
the molybdenum-99 concentration is determined for each technetium-99m eluate and meets the requirements of 10 CFR 35.204(a) and 10 CFR 30.34(g), and b.
licensees comply with all other applicable requirements.
FOR THEfUCLEAR REGULATORY COMMISSION (NW f
Carl J. Paperiello, Director Office of Nuclear Material Safety and Safeguards Dated at Rockville, Maryland This 15th day of May 1998
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PLEASE FORWARD IMMEDIATELY l
U. S. NUCLEAR REGULATORY COMMISSION OFFICE OF STATE PROGRAMS OFFICE OF STATE PROGRAMS FAX: (301)415-3502 l
l NUMBER OF PAGES: 8 including this page DATE:
MAY 18,1998
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TO:
RADIATION CONTROL PROGRAM DIRECTORS IN AGREEMENT STATES, OHIO, OKLAHOMA, PENNSYLVANIA NRC REGIONAL STATE AGREEMENTS OFFICERS NRC REGIONAL STATE LIAISON OFFICERS j
I FROM:
PAUL H. LOHAUS, DEPUTY DIRECTOR OFFICE OF STATE PROGRAMS
SUBJECT:
SP-98-044 99MO/99mTC SUPPLIES MAY BE INTERRUPTED i
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l VERIFICATION - 301-415-3340 l
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< TRANSACTION REPORT >
05-18-1998(MOtO 12:14 C
BROAOCAST 3
NO.
DATE Tltf DESTINATION STATION PO.
DURATION MODE RESULT 1964 5-18 11:52 334 206 5387 - Ol-B O'03'31' NORM.E OK 1065 11258 602 437 0705
- 2._
8 o*o3'34*
NORM.E OK 1066 12:03 303 343 3697 dd 8
0*03'50' NORM.E OK 1067 12:07-1 501 661 2468 b
B O*03'25" NORM.E OK 1068 12:11 0111916 3243610- d A
'8 O*03'41*
NORM.E OK -
40 O*18'01-1 t
1
< TRANSACTION REPORT >
05-18-1998(MON) 12:38 C
ESROAOCAST 3
NO.
DATE TIME DESTINATION STATION PO.
DURATION MODE RESULT 1069 5-18 12:18 303 782 5083-de k/ASTG 8
O'03'25' NORM.E OK 1V70 12:22 904 487 0435 FL-8 O*04'05*
NORM.E OK 1071 12:26 404 362 2653 4 A B
O*03*26*
NORM.E OK 1072 12:30 IA 8
O*03'27' NORM.E OK 1073 12:34 217 524 4724 Zb 8
O*03'30' NORM.E OK 40 O*17'53'
)
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<. TRANSACTION REPORT >
l 05-18-1998(MON) 13:08 i
C BROADCAST 3
l NO.
DATE Tite DESTINATION STATION PO.
DURATION MODE RESULT 1074 5-18 12:48 913 296 0984 - K5 8
O*03'41*
NORM.E OK 1075 12:52 502 227 7862 6 [2 / O 0
0'04'00" NORMAL OK 1076 12:56 502 564 6533 f:LY 8
0'03'26" NORM.E OK i
l
'1077 13:00 LA 8
0'04'22" NORM.E OK l
'1078 13:04 6177272096 g)[4 6
O'03'52" NORM.E OK 40 O*19'21" l
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< TRANSACTION REPORT >
05-18-1998(MON) 13:48 C
BROAOCAST 3
NO.
DATE TIME DESTINATION STATION PO.
DURATION MODE RESULT 1980 5-18 13:19 410 631 3198 EID 8
0*03'53" NORMAL OK 1981 13:23 ft
- 8. O'05*30" NORMAL OK hb 1082 13:30 919 571 4148 8
0*03'57" NORMAL OK 1083 13:39 601+354+6167 /T)h 8
0*05'12" NORMAL OK 1064 13:44 701 328 5200 jp[)
8 0'03*23" NORM.E OK 40 0*21'55" l
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_ _ _ - -. _ = - - _ - _ _ _ - _ -. - - _ - - -. _ _
< TRANSACTION REPORT >
l' l
C BROAOCAST 3
NO.
DATE TIME DESTINATION STATION PO.
DURATION MODE RESULT 1085 5-18 13:56 402 471 9449 ME 8
O*03'25' NORM.E OK 1986 13:59 603 225 2325 N #
8 0*03'33" NORM.E OK 1987 14:03 5058271544 N/r?
8 0'04'57*
NORMAL OK 1988 14:08 7026875751 MN/
8 0*05'10" NORMAL OK 1989 14:14 518 485 7406 N V ' DOL _
8 0*03'32' NORM.E OK 40 0*20'37" l
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'< TRANSACTION REPORT >
05-18-1998(MON) 15125 f
C ESROADCAST 3
NO.
DATE TIME DESTINATION STATION PO.
DURATION MODE RESULT 1090 5-18 15:06 NYSERDA 8
O*03'59' NORMAL OK 1991 15:10 518 457 2225 MN80 8
O*03'30' NORM. E - OK 1092 15:14 5184586434-Mf00f}
8 0*03'32' NORM.E OK 1093 15:18 NY CITY 8
O*03'32' NORM.E OK 1994 15122 OH 8
O'03*37*
NORM.E OK 40 O*18'10" l
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< TRANSACTION REPORT >
05-18-1998(MON) 15:53 C
EBROADCAST J
- NO.
DATE TIME DESTINATION STATION PQ.
DURATION MODE RESULT 1095 5-18 15:35 OK 8
O'03*41" NORM.E OK 1096 15:39 503 731 4081 O O 8
O'03'24" NORM.E OK 1997 15:42 PA 8
0'03'27*
NORM.E OK 1098 15:46 401 277 2456-M 8
0'03'28" NORM.E OK 1099 15:50 7996726 46 /g)g 8
O'03'25" NORM.E OK 40 O'17'25" i
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< ' TRANSACTION REPORT >
05-18-1998(MON) 16:29 C
SROADCAST 3
i NO.
DATE Tite DESTINATION STATION PO.
DURATION NODE RESULT 1100 5-18 16:05 8037377412 D
8 0'03'30" NORM.E OK 1101 16:11 512 239 2007 T/
8 0*03'32' NORM.E OK 1102 16:15 5128546708 TX S M 8
0*03'53' NORM.E
'OK 1103 16:19 801 533 4097 MT 8
O'04*05*' NORM.E OK 615 532 7938 f h 1104 16:25 8
0'03'28" NORM.E OK 40 0'18'28' i
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< TRANSACTION REPORT >
05-18-1998(MON) 17:06 C
BROADCAST 3
NO.
DATE T!tE DESTINATION STATION PC.
DURATION MODE RESULT 1106 5-18 16:43 610 337 5269 ff 4 8
0*03'28" NORM.E OK 1107 16:47 404 562 4955 8
0'03*26" NORM.E OK 1108 18:51 7085151096 8
0*04'18" NORM.E OK 1109 16:55 817 860 8122 SIY ESL.O 8
0*03'24" NORM.E OK 1110 17:01 360 753 1496 (dh 8
0*05'00" NORM.E OK 40 O'19'36-1 l
i
< TRANSACTION REPORT >
05-16-1998010N) 17:19 C
BROAOCASr 3
l NO.
DATE TIME DESTINATION STATION PG.
DURATION MODE RESULT 1111 5-18 17:11 8608188 I WI6AO 8
O*03'25" NORM.E OK 1112 17:15 5109750381 flg/ k)(;
8 O*03'34" NORM.E OK 16 0*06'59" i
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