ML20248K337
| ML20248K337 | |
| Person / Time | |
|---|---|
| Issue date: | 06/03/1998 |
| From: | Knapp M NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| Shared Package | |
| ML20248K324 | List: |
| References | |
| NUDOCS 9806100077 | |
| Download: ML20248K337 (1) | |
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UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS WASHINGTON, D.C. 20555 NOTICE OF TERMINATION OF THE
" 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 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 radiopharnaceutical production, the major supplier for the United States is MDS Nordion in Canada. The Labor strike from May 18,1998, until May 23,1998, at the NRU reactor at the Chalk River Laboratories of the Atomic Energy of Canada Limited, which produces molybdenum-99 for MDS Nordion, caused some disruptions of the supply of radiopharmaceuticals needed for medical diagnosis. The Nuclear Regulatory Commission (NRC) recognized that in anticipation of a strike, manufacturing licensees may have needed to stockpile molybdenum-99 or other licensees may have needed to stockpile molybdenum-99/ technetium-99m generators in order to mitigate disruption in the manufacture, supply, or use of the gcnerators. The Director, Office of Nuclear Material Safety and Safeguards, found that if a strike occurred that disrupted the production of molybdenum-99, the public health, safety, and interest would be adversely affected and the NRCexercised its discretion to not enforce certain requirements as provided in the " Notice of Intent to Exercise Temporary Enforcement Discretion" that was effective for the period of May 15,1998, through the end of the strike and production disruption. The strike ended May 23,1998, when both parties accepted binding arbitration. The May 15,1998, " Notice of Intent to Exercise Temporary Enforcement Discretion" will terminate on June 15,1998, to allow time for production to return to normal.
11 Accordingly, the NRC has concluded, that after June 15,1998, it will resume enforcement of 1 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.
FOR THE NUCLEAR REGULATORY COMMISSION Malcolm R. Knapp, Acting Director Office of Nuclear Material Safety and Safeguards Dated a",Rockville, Maryland This[ day of June,1998 9906100077 900603 PDR ORG NOMA L ,
- @ uc y* +4 UNITED STATES a E NUCLEAR REGULATORY COMMISSION E, k) E wAssincToN D.C. 20565-0001 p8 May 15, 1998
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URGENT TO ALL NRC MEDICAL LICENSEES, COMMERCIAL NUCLEAR PHARMACIES AND RADIOPHARMACEUTICAL MANUFACTURERS Enclosed is a Notice of Intent to Exercise Temporary Enforcement Discretion for licensees authorized 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. Until further notice, the Nuclear Regulatory Commission (NRC) 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 molybdenurn-59/ technetium-99m generators.
This Notice of intent to Exercise Temporary Enforcement Discretion does not relieve licensees from current molybdenum-99 breakthrough testing requirements, other applicable NRC requirements, or maintaining compliance with applicable Food and Drug Administration, other Federal, and State requirements governing radioactive drugs.
Because this Notice of Intent to Exercise Temporary Enforcement Discretion is effective immediately, it is important that you notify your appropriate personnel immediately, and retain this Notice of intent to Exercise Temporary Enforcement Discreten 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.
Sincere!
Carl J. Paperiello, Director Office of Nuclear Material Safety and Safeguards
Enclosure:
Notice of Intent to Exercise Temporary Enforcement Discretion
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UNITED STATES OF AMERICA NUCLEAR PEGULATORY 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
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 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 dockpile nolybdenum-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 j strike or the end of the strike and production disruption, whichever comes first. j 11 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 THE UCLEAR REGULATORY COMMISSION l
Carl J. Paperiello, Director Office of Nuclear Material Safety and Safeguards Dated at Rockville, Maryland
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This 15th day of May 1998 pCL6 DON ^ !/