NRC - Notice of Termination

[Gary Purdy <GWP1@nrc.gov>]

Due to the end of the strike at MDS Nordion, the NRC has issued a Notice of Termination of the May 15, 1998, *Notice of Intent to Exercise Temporary Enforcement Discretion.*  The following is the text from the "Notice."  For
further information, please contact Donna-Beth Howe at (301) 415-7848 or
DBH@NRC.GOV or your regional NRC office.



URGENT


TO ALL NRC MEDICAL LICENSEES, COMMERCIAL NUCLEAR PHARMACIES AND RADIOPHARMACEUTICAL MANUFACTURERS


Enclosed is a Notice of Termination of the May 15, 1998, *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.  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 molybdenum-99/ technetium-99m generators for the period from May 15, 1998, until June 15, 1998.

This Notice of Termination does not relieve licensees from license conditions or regulations  restricting  possession limits for molybdenum-99 for production of molybdenum-99/ technetium-99m generators, or possession limits for molybdenum-99/technetium-99m generators before May 15, 1998, or after June 15, 1998.  Licensees are not relieved from other applicable NRC requirements, or compliance with applicable Food and Drug Administration, other Federal, and State requirements governing radioactive drugs, before, during, or after the effective period of the May 15, 1998, *Notice of Intent to Exercise Temporary Enforcement Discretion.*

Because this Notice of Termination is effective June 15, 1998, it is important that you notify your appropriate personnel immediately, and retain this Notice of Termination with your license records.  Questions and comments may be directed to your NRC regional office.

						Sincerely,

						Original Signed by

						Malcolm R. Knapp, Acting Director
						Office of Nuclear Material Safety 
						   and Safeguards

Enclosure:  
Notice of Termination of the 
 May 15, 1998, *Notice of Intent to 
  Exercise Temporary Enforcement Discretion*	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"

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.  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 generators.  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 NRC exercised 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.

	II

Accordingly, the NRC has concluded, that after June 15, 1998, it will resume enforcement of 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

					Original Signed by

					Malcolm R. Knapp, Acting Director
					Office of Nuclear Material Safety 
					   and Safeguards

Dated at Rockville, Maryland
This  3rd   day of June 1998