ML20148Q499

From kanterella
Jump to navigation Jump to search
Forwards State Agreements Program Info Re Technical Info on 99Mo/99mTC Generator Mfgs Strike on 970619.Temporary Waiver of Compliance Also Encl
ML20148Q499
Person / Time
Issue date: 06/20/1997
From: Lohaus P
NRC OFFICE OF STATE PROGRAMS (OSP)
To:
GENERAL, OHIO, STATE OF, OKLAHOMA, STATE OF, PENNSYLVANIA, COMMONWEALTH OF
References
SP-97-047, SP-97-47, NUDOCS 9707070116
Download: ML20148Q499 (15)
v • d • e


Text

. .- - -_ ..

, o . *.

ru 3

[fu k

, NUCLEAR REGULATORY COMMISSION UNITED STATES e & WASHINGTON. D.c. 20666-0001

! June 20, 1997 l  %****+

l l

l ALL AGREEMENT STATES OHIO, OKLAHOMA, PENNSYLVANIA TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP-97-047) ,

l Your attention is invited to the enclosed correspondence which contains:

l INCIDENT AND EVENT INFORMATION.......... ..

PROGRAM MANAGEMENT INFORMATION.... ..

TRAINING COURSE INFORMATION..................

TECH NICAL INFORM ATION............................ XX 99MO/99mTC SUPPLIES INTERRUPTED OT H E R I N FO R M ATI O N . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .

l Supplementary information: MDS Nordion of Canada, a major North American supplier of molybdenum to U.S. 99Mo/99mTc generator manufacturers, announced that a strike on Thursday June 19,1997 has closed its medical production reactor interrupting supplies of molybdenum. U.S. generator manufacturers are seeking alternative sources of molybdenum from foreign suppliers. We understand, however, that foreign suppliers may not be able to meet the North American demand (Starting on Tuesday June 24 the supply  ;

to the United States may be only 30-70% of United States needs.) l 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 These inserts contained an expiration date for the generators beyond which 99mTc could no longer be withdrawn from the generator.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 ' l amended by the Radiopharmacy Rule to remove the requirement that package inserts be t followed. Given that most States may not have adopted the Radiopharmacy Rule, you may

{

want to evaluate and consider the need to issue such a waiver to your licensees. A copy of the 1991 NRC waiver and a MDS Nordion communique are enclosed for your use.

030071 30 BM @@IES M 9707070116 970620 6- [1 ['

PDR STPRG ESGGEN l l ,ll l l

', e ',

l

! SP-97-047 2 JUN 2 01997 l 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 y \

~N O Paul H. Lohaus, Deputy Director came l O'..' ice of State Programs Enclosure s:

As stated l

l l

.. - ~ . - - . . - -- .-. .. . ..

l l SP-97-047 !dDN 2 01997 l

If you have any questions regarding this correspondence, please contact me or the l l individual named below.

POINT OF CONTACT: Lloyd A. Bolling TELEPHONE: (301) 415-2327 FAX: (301) 415-3502 INTERNET: LAB @NRC. GOV l

l

! Origlf*]sigM Br. j PAULH.LOHAUS Paul H. Lohaus, Deputy Director i Office of State Programs l l

Enclosures:

As stated  ;

l l

I Distribution:

DIR RF DCD (SP03) FAXED TO STATES: 6/20/97 SDroggitis PDR (YES/)

All A/S File DOCUMENT NAME: G:\ LAB \SP97_TC.LpB, p /

Tm receive a copy of this document, indicate in the boa: "C'pf op'r fvithout attachment / enclosure AE' = Copy with attachrnant/ enclosure *N" = No copy OFFICE gg l OSQTChl OSP:D //,7  ;

NAME LABqtyf fg(g) ) PHLohdus' T RLBangart/ 4f/) I i DATE 06ppp/97 06/dO/97 0Q90/97 OSP :lLE CODE: SP-A L I

ps uruq

,[ k, UNITED STATES E o NUCLEAR REGULATORY COMMISSION D E WASHINGTON, D. C. 20655 J

URGENT l

l 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.

The enclosed waiver does not relieve licensees from current molybdenum-99 l 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 1 important that you notify your appropriate personnel immediately, and retain this Temporary Waiver of Compliance with your license records. Questions and .

comments may be directed to your nearest NRC regional office. l d

This Temporary Waiver of Compliance is effective through February 4,1991. I i

Sincerely, l A --

Rober t M. Bernero, Director Office of Nuclear Material Safety and Safeguards

Enclosure:

Temporary Waiver of I Compliance  !

l

\

1

1 i t'

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)

I l

The Commission authorizes licensees to possess and use molybdenum-99m 1 generators and prepare reagent kits, by license condition and regulations in

l. accordance with the manufacturer's instructions.

II There is no domestic supply of molybdenum-99 for radiopharmaceutical production and tne sole source for the Unitej States is Atomic Energy of l

l Canada Limited (AECL). Because of problems affecting molybdenum-99 production, at tr.e AECL NRU facility at Chalk River Laboratories, there is a potential for ,

disruption of the supply of radiopharmaceuticals needed for medical diagnosis. *

Accordingly, the P. rector, Office of Nuclear Material Safety and Safeguards, L has found that the public health, safety, and interest requires that this ,

l Temporary Waiver of Compliance be made effective for the period January 15, 1991, through February 4,1991, inclusive. ]

, III I

l Accordingly, the Nuclear Regulatory Commission has concluded that it will  !

not enforce license conditions or regulations requiring licensees authorized to l 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 10 CFR 35.204(a) and 10 CFR 30.34(g);
b. aluminum breakthrough testing is performed as currently

! required; and 1 1

c. preparation of each " super kit" includes radiochemical purity

(% Tag) testing 20 minutes after each preparation. l l 1 l

i I - .-. - _ . . _ _ _ _ _ . _.  !

7

.- . 1 I

?

IV 9 I

This does not' relieve licensees from maintaining compliance with the  !

rules and regulations of the Food and Drug Administration (FDA). , l i

f I

l FOR THE NUCLEAR REGULATORY COMMISSION f =_ e s l

Robert M. Bernero, Director Office of Nuclear Material Safety and Safeguards i Dated at Rockville, Maryland This j f' day of January,1991 i

t l

l 1

I l

i

! Jt.Ii 20 '97 12:2EP11 PET CEI11ER F. lei u

JUN 19'97 17:22 FR TO 19107165839 P.01/01

! M7 March Road r_~a Ceual.t K2KIxt l /

Post-it* Fax Note 7671 0*** 97. g ./ 7 jge3> R D i MDS Nordion e u~c e. c. wo c l t Science Advancing Health **'* * **-

~'

  • 4/3 .fl2 2?ro f**
  • 9/O 'f/f QQ ' Fsse

. COMMUN10UA STRIKE AT CNATilt RTVFD I.ARORATORIFC i

1.

The Atomic Energy Allied Council (a group of several unions, primarily support services such as electdcians, security, bus ddvers etc.) at Atomic Energy of Canada's Chalk River LaboratoI a legal strike at 00 01 Thursday June 19.

2.

AECL and the Allied Council had reached a tentative agreement which was subsequently rejected the union membership. {

l 3.

l In anticipagon of a stdke AECL began the orderly shutdown of the NRU reaitor (at Chalk Ri Juncl2.JAs a consequence, the' production ofkey medical isotopes - Mo-99, I-125.1 131 and Xe fhas stopped at Chalk River. '

4 MD5 Nordion is attempting to purchase Mo-99 from other suppliers but the quantities available to us l

will meet only a portion of our requirements. We are making plans to source I-131 and Xe-133 from our facilities in Belgium. Isotopes such as tr 192 (for gamma radiogra'phy sources) and I-125 r.re l being sought g other suppliers. i 4

MDS Nordion ' supplies greater than 60k of the molybdenum 99 for use in the production of radiopharmaceutleals in North America. Pisnt are in place to meet all requirements for Mo-99 up to and including Sunday June 22. Starting June 23 product will be on allocation.

5.

More than 90% of the radiopharmaceutical medical procedures performed use technetium-99m (a denvative of molybdenum 99). These include various diagnostic procedures relating to cancer.

AIDS, heart disease and other illnesses. This equates to 9 million medical procedures per year, or 36.000 per day.

6.

Tbc major radiopharmaceutical manufacturers in the United States are: Amersham Medi Physics:

DuPont Merck: and Malli:wkrodt Medical.

7.

MDS Nordion has a fleet of approved type a shipping containers that it will make available to potential suppliers in order to facilitate shipments.

l 8.

Your Account Manager and Customer Representative will be in touch with you to discuss funher deutils on supply.

  • l S.C. Deans Dated 19 June 1997 MhnagDCommercial Operations us .*. Canaca e

i J

1?

!1- _ - _ _ _ _ _ _ _ _ _ - _ _ _ - _ _ _ _ _ _ _ _ _ .

- _ . - . - . ~ - - - - . - - . - - - -

_ _ . _ _ . . . - . - . _ _ ~ _ _ - . - . - - . . . . - _ . - - - . . . _ - - - . . - - -

.e, U. S. NUCLEAR REGULATORY COMMISSION OFFICE OF STATE PROGRAMS OFFICE OF STATE PROGRAMS FAX: (301) 415-3502 NUMBER OF PAGES: 7 including this page l l

l i

l l DATE: JUNE 20,1997 l l

l TO: RADIATION CONTROL PROGRAM DIRECTORS IN AGREEMENT STATES, OHIO, OKLAHOMA, PENNSYLVANIA I l .

NRC REGIONAL STATE AGREEMENTS OFFICERS NRC REGIONAL STATE LIAISON OFFICERS 1

1 FROM: PAUL H. LOHAUS, DEPUTY DIRECTOR OFFICE OF STATE PROGRAMS

SUBJECT:

SP-97-047 99Mo/99mTc SUPPLIES INTERRUPTED i

i VER FICATION - 415-3340 l

1 l

l

i

?

< TRANSACTION REPORT > 06-20-1997(FRI) 19:44 '

C BROADCAST '3 NO. DATE TIME DESTINATION STATION' PG. DURATION MODE RESULT 32800 6-20 18:15 610 337 5324 7 O'02*44" NORM.E OK-

'32801 18:18 404 562'4955 7 O'02'50' NORM.E OK ,

32802 18:21 =7085151096- 7 O'05'17* NORM E OK- -l 32803 18:26 817 860 8122 7 O*02'41". NORM.E OK 32804 18:29 5109750381 7 O'03'07" NORM.E- OK

'32805 18:33 334 613 5387 7 O*04*54" NORM.E OK =

32806 18:38 602 437 0705 7 0'02'50" NORM.E OK ]

32807 18:41 .5016612468 7 O*03'03" NORM.E ' OK 32808 18:45 0111916 3243610 7 O*02'43' NORM.E OK 32809 18:48 303 343 3697 7. O*03'04" NORM.E~ OK

]

32810 18:51 904 487 0435 -8f-- MNd- h 5 0'02'34" NORM.E UO10 32811 18:54 404 362 2653 7 O'02*44" NORM.E OK 32812 18:57 217 524 4724 7 0*02*49* NORM.E OK 32813 19:00 515 242 6284 7 O*02'45" NORM.E OK 32814 19:03 913 296 0984 7 0*O2*57* NORM.E OK 32815 19:07 502 564 6533 7 0*02*44" NORM.E OK 32816 19:10 LOU!SIANA 7 0'03'05" ' NORM.E OK l 32817 19:13 MA1NE 7 0*04*33* NORMAL OK l 32818 19:18 410 631 3198 '7 ~ O'03*09" NORMAL OK {

32819 19:21 601+354+6167 7 O'04'15" NORMAL OK 32020 19:26 402 471 9449 7 O*02'43" NORM.E OK

'32821 19:29 7026875751 7 O' 04'17" NORMAL OK I 32822 19:34 603 225-2325 7 O'02*49" NORM.E OK 32823 19:37 5058271544 7 O'04*08" NORMAL OK 32824 19:41 518 458 6434 7 0'02'47* NORM.E OK 173 1*21'32*

1 I

l 1

6' 1  :

l

4 4

< TRANSACTION REPORT > ,,_,,_1,,,,y,,, ,,,,,

4

! C BROADCAST 3 1

2 NO. DATE TIME DESTINATION STATION PO. DURATION MODE RESULT 32825 6-20 19:45 91F,571 4148 7 O*02'46' NORM.E OK

32826 19:46. 701 328 5200 7 O' 02 ' 40" ^ NORM. E OK 32827 19:51 50?! 731 4081 7 O*02'40" NORM.E OK j- 32828' 19:54 40'. E77 2456 7 O'04*43* NORM.E OK 32829 19:59 B037377412 7 O'02*48" NORM.E OK j 32830 20:02 615 532.7938 7 O*O2'47" NORM.E OK 1 32831 20:05 5128346708 7 O'02'57' NORM.E OK 32832 20:08 801 533 4097. 7 O'03*28* NORM.E OK i

32833 20:12 360 753 1496 7 O 02'40" NORt1. E OK 32834 20:15 '518 457 2225 7 O'02*46" NORM.E OK

4. .
i. -32835 20:18 518 457 5545 7 O' 03' 06
  • NORM.E OK

! 32836 20:22 'NEW YORK CITY 7 O*02'47" NORM.E OK 32837 20:25 502 227 7862 7 O'03'18' NORMAL OK

32838 20:29 AECB (613) 995-5086 7 O'03'05" NORMAL OK
32839 20
32 WASHINGTON DC 7 O'02'41" NORM.E OK i

32840 20:35 7996726 7 O*02'43' NORM.E OK i 32841 20:38 217 782 1328 7 O'03'24' NORM.E OK-1 32842 20:42 512 239 6362 7 O*02'50" . NORM.E OK E

}'

32843~ 20:45, 4024714840- 7 O'04'05' -NORMAL OK

] 32844 20:53 912 262 3143 7 O'03'14" NORMAL OK j 140 1*01'28" I

k i  ;

1 i

I

i

< TRANSACTION REPORT > 06-20-1997(FRI) 17:06 l

l

[ SROADCAST J l NO. DATE TIME DESTINATION STATION PO. DURATION MODE RESULT 32796 6-20 16:44 OHIO 7 0 02'49" NORM.E OK 32797 16:48 405 271 8425 7 0 02'39' NORM.E OK 32798 17:04 PENNSYLVANIA O UOOO 32799 17:06 MASSACHSETTS-4ki.b,l. 0 UOOO 14 0"O5'28" l

l I

i l

1 l

i

)

i I

< TRANSACTION REPORT > 06-23-1997(MON) 07:11 C TRANSMIT 3 NO. DATE TIME DESTINATION STATION PO. DURATION MODE RESULT 32847 6-23 07:08 NYSERDA 7 o 03*2S" NORMAL OK

()g/j , d 7 O'03'2S"

( i~l I

I 1

j l

\

< TRANSACTION REPORT > Oe_21_1es7< san 02 30 C TRANSMIT J NO. DATE TIME DESTINATION STATION PO. OURATION t100E RESULT 32845 6-21 09:27 004 487 0435 7 O*02'55" NORM.E OK

((c,,l({x- 7 O*O2'55*

1 l

l l

1 l

l 1

e 1

l l

(- .

< TRANSACTION REPORT > o,_31_13,,<3,,, o,3, E TRANSMIT 3 NO. DATE TIME DESTINATION STATIOJ PO. DURATION r10DE RESULT 32846 6-21 09:33 617 522 0860 7 O*04'05" NORMAL OK N7n ifr , !t[4JP g 7 O'04'05"

< TRANSACTION REPORT > 06-23-1997(t1CWO 09:OG E TRANSMIT 3 NO. DATE tit 1E DESTINATION STATION PG. DURATION MODE RESULT 32851 6-23 09:03 PENNSYLVANIA 7 O*02'58' NORt1. E OK 7 O*O2'58"

.

Retrieved from "https://kanterella.com/w/index.php?title=ML20148Q499&oldid=2845314"