Nordion Strike - NRC Exercise of Enforcement Discretion

[Brian Smith <BWS1@nrc.gov>]

Due to the possible strike at MDS Nordion, the majority supplier of Mo-99 to
the United States, the NRC has issued a Notice of Intent to Exercise
Temporary Enforcement Discretion, Effective May 15, 1998.  It will remain
effective until further notice.  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.


UNITED STATES
NUCLEAR REGULATORY COMMISSION
Washington, DC  20555-0001

May 15, 1998

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 molybdenum-99/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 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.

						Sincerely,


						(orig.  signed by  William Kane, for)
						Carl J. Paperiello, Director
						Office of Nuclear Material Safety 
						  and Safeguards

Enclosure:  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 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 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.

	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 THE NUCLEAR REGULATORY COMMISSION


					(orig.  signed by William Kane, for)
					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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