ML20247L706
| ML20247L706 | |
| Person / Time | |
|---|---|
| Issue date: | 05/15/1998 |
| From: | Paperiello C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| Shared Package | |
| ML20247L672 | List: |
| References | |
| NUDOCS 9805260051 | |
| Download: ML20247L706 (2) | |
Text
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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 l
Pursuant to Title 10 Code of Federal Regulations Parts 30,32, and 35, the Commission authorizes radiopharmaceutical manufacturing, commercial nucIear pharmacy, and medical use
' licensees to possess and use molybdenum-99 for the manufacture of molybdenum-99/ technetium-99tn generators and to possess and use molybdenum-99/ technetium-99m generators by license condition. Because there is no domestic supply of molybdenum-99 for radiopharmaceutical 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 '
anticipation of a strike, it may be necessary for manufacturing licensees to stockpile molybdenum-99 or for other licensees to stockpile molybdenum-99/ technetium-99m generators in order to mitigate 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.
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Accordingly, the NRC has concluded, until further notice, that it will not enforce license
{
- conditions or regulations restricting radiopharmaceutical manufacturing, commercial nuclear 1 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 i
- b. _ licensees comply with all other applicable requirements.
i 1
FOR THE UCLEAR REGULATORY COMMISSION i f
i Carl J. Paperiello, Director Office of Nuclear Material Safety and Safeguards l Dated at Rockville, Maryland I'
This 15th day of May 1998 i 9905260051 980515 Y POR INE MISC PDR &
, 'y UNITED STATES OF AMERICdi NUCLEAR REGULATORY COMMISSION -
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS WASHINGTON, D.C. 20555 NQECE OF INTENT TO EXERCISE TEMPORARY ENFORCEMENT DISCRETlON EFFECTIVE MAY 15.1998 I
Pursuant 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 license condition. Because there is no domestic supply of molybdenum-99 for l
radiopharmaceutical 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 anticipation of a strike, it may be necessary for manufacturing licensees to stockpile molybdenum-99 or for other licensees to stockpile molybdenum-99/ technetium-99m generators in order to mitigate 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 productior: 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, thro' ugh the end of the threat of a '
strike or the end of the strike and production disruption, whichever comes first.
ll Accordingly, the NRC has concluded, until further notice, that it will not enforce license i l conditions or regulations restricting radiopharmaceutical manufacturing, commercial nuclear i pharmacy, and medical use licensees' possession limits for molybdenum-99 for production of
- j. molybdenum-99/ technetium-99m generators, or possession limits for molybdenum-99/ technetium-99m generators, provided that.
i 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 j l \
- b. licensees comply with all other applicable requirements.
l l FOR THE . UCLEAR REGULATORY COMMISSION I
I Carl J. Paperiello, Director I Office of Nuclear Material Safety
' and Safeguards Dated at Rockville, Maryland This 15th day of May 1998
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