UNITED STATES
 

NUCLEAR REGULATORY COMMISSION
 

WASHINGTON, D.C. 20555-0001 

July 16, 2009 1 

All 10 CFR Part 35 Licensees, Including
 

United States Nuclear Regulatory Commission (NRC)
 

Master Materials License 10 CFR Part 35 Permitees
 

SUBJECT:	 EXEMPTION FROM 10 CFR PART 32 AND 10 CFR PART 35
 

REQUIREMENTS ON PROCUREMENT AND TRANSFER OF
 

TECHNETIUM-99m, AND CALIBRATION OF INSTRUMENTATION
 

USING TECHNETIUM-99m
 II 

i 

NRC is issuing the enclosed Exemption from certain provisions in 10 CFR Parts 32 and 

35 to all NRC medical use licensees, including NRC Master Materials License medical 

use permittees, during times of molybdenum-99 shortages in the United States. The 

intent of the Exemption is to assure that the available technetium-99m is used for patient 

administrations. II 

I 

! 

I 

The supply chain for fission-produced medical isotopes is fragile and may shrink 

dramatically at any time when the aging international reactors that currently produce 

these isotopes are shut down for safety or routine maintenance. Therefore, this 

Exemption may be needed intermittently until the supply of molybdenum-99 permanently 

stabilizes. The Exemption should be kept with the license and discussed with the 

licensee's radiation safety officer and authorized users. The Exemption can only provide 

relief from the regulations; it does not provide relief from specific license conditions. 

Contact the Regional Office if you believe that there are license conditions that also 

affect the availability of technetium-99m for patient treatments or if there are any 

questions about the Exemption. 

Robert 

~~A J. Lewis, Director 

Division of Materials Safety 

and State Agreements 

Office of Federal and State Materials 

and Environmental Management Programs 

Enclosure: Exemption 
July 16, 2009 

UNITED STATES OF AMERICA 

NUCLEAR REGULATORY COMMISSION . 

In the Matter of 

All 10 CFR Part 35 Licensees, including NRC Master Materials Licensee 10 CFR Part 35 

Permittees 

EXEMPTION FROM 10 CFR PART 32 AND 10 CFR PART 35 REQUIREMENTS ON
 

PROCUREMENT AND TRANSFER OF TECHNETIUM-99m, AND CALIBRATION OF
 

INSTRUMENTATION USING TECHNETIUM-99m
 

I. INTRODUCTION 

All 10 CFR Part 35 licensees, including NRC Master Materials License 10 CFR Part 35 

permittees, are authorized for the medical use of byproduct material. 

II. DISCUSSION 

On May 14, 2009, the Chalk River National Research Universal reactor in Canada experienced 

an unexpected shutdown that has resulted in an extended shutdown for safety repairs. The 

Chalk River reactor produces approximately 50 percent of the United States supply of 

molybdenum-99 used to produce molybdenum-99/technetium-99m generators. This resulted in 

a United States and worldwide shortage of molybdenum-99 for generator production and 

technetium-99m for medical uses. The High Flux Reactor in Petten, Netherlands, also 

produces a substantial amount of molybdenum-99 used to produce generators in the United 

States and the world. The reactor in Petten is currently operating on a temporary operating 

permit and expected to be shutdown in early 2010 for a number of months for repairs. This will 

also cause molybdenum-99 and technetium-99m shortages in the United States and the world. 

The supply chain for fission-produced isotopes is fragile and may shrink dramatically at any 

time when these two, or the other three aging international reactors currently producing these 

isotopes, are shut down for safety or routine maintenance. 

The NRC is issuing exemptions from certain of its requirements in 10 CFR 32.72, 

10 CFR 35.60(b); and 10 CFR §§ 35.100(a)(1) and 35.200(a)(1), governing the sourcing and 

transfer of technetium-99m, and calibration of devices using technetium-99m. Each of these 

exemptions and the safety bases for exempting the licensee from these requirements is 

discussed below. 

10 CFR 32.72 

10 CFR 32.72 specifies the requirements for manufacturing and preparing radioactive drugs 

distributed to 10 CFR Part 35 licensees. Licenses issued pursuant to this regulation are for 

commercial distribution of radioactive drugs to medical use licensees.. Exempting the medical 
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use licensee from the requirements in 10 CFR 32.72 permits the medical use licensee to 

transfer surplus molybdenum-99/technetium-99m generators or technetium-99m, or 

technetium-99m radioactive drugs, to other medical use licensees for administration to patients 

without requiring the licensee to meet the requirements for a commercial distributor of 

radioactive drugs. During times of technetium-99m shortages, this exemption will facilitate the 

transfer of surplus from a licensee that does not need it to one with patients that need 

technetium-99m procedures. The material has to be prepared and transported in accordance 

with the radioactive materials transportation requirements using adequate shielding, appropriate 

containers, and the proper radioactive shipping labels. Further, the activities and short halflives of the molybdenum-99 and technetium-99m make it highly unlikely that granting this 

exemption will endanger life or property or common defense and security. The exemption is in 

the public interest because it makes needed radioactive material available for necessary patient 

treatment. 

10 CFR 35.60(b) 

10 CFR 35.60(b) requires licensees to calibrate instrumentation required in paragraph (a) of 

section 35.60 in accordance with nationally recognized standards. National standards specify 

that instruments used to measure patient dosages are checked for linearity at the maximum 

activities measured. The maximum activity may be for multidose vials, generator elutions, or 

high activity dosages of technetium-99m or other radionuclides, such as iodine-131. The 

calibration tests are most frequently performed with technetium-99m because it is normally 

easy to obtain from suppliers and has a short half-life. Under the exemption, the licensee will 

not be required to perform the calibration test at the maximum activity or at the time interval 

specified in the national standard if the licensee would use technetium-99m that is needed to 

administer to a patient to perform the calibration test. The exemption will only be in effect when 

the licensee is receiving reduced quantities of technetium-99m as a result of production 

shortages of molybdenum-99 affecting its generator or technetium-99m supplier, as 

documented in writing by the supplier. The licensee must perform the test when adequate 

supplies become available, and must document the results of the test in accordance with 10 

CFR 35.2060. During shortage periods, it is expected that the licensee will perform the test 

with lower activities if the test can be performed using material that is either not needed for 

patient administration or at the completion of the test can still be used for patient administration. 

In this case, the licensee will have confidence that over those ranges the instrument is still 

operational and calibrated. In times of extreme shortage, the licensee may have to postpone 

performing the test altogether. Most instruments used to measure patient dosages today are 

stable if not moved and provided with reasonable climate controls. Not granting the exemption 

will make fewer dosages available to patients and result in licensees not being able to use 

these instruments even though they are calibrated at the levels of routine technetium-99m 

dosages. Once adequate supplies become available and the licensee performs the tests in 

accordance with the national standards, the instruments that pass the calibration test at that 

time can be assumed to have been calibrated while the exemption was in effect. The world 

supply of molybdenum-99 is very fragile because it depends on aging reactors that may be shut 

down for safety or maintenance at any time. Therefore, because of the uncertainty of continued 

availability, the test must be performed as soon as adequate supplies are available, as 

indicated in the provisions of the exemption. The test must not be postponed to the next 

specified time interval, to avoid conflict with a subsequent shortage. For higher dosages 

requiring written directives the licensee will have to depend upon the activity provided with the 
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radioactive drug to assure patient safety associated with the administration. The exemption will 

not endanger life or property or common defense and security because it does not relieve the 

licensee from NRC requirements for worker dose or public dose, handling or securing the 

radioactive materials, or handling or securing radioactive waste associated with performing the 

test. All of those protections remain in place. Also, both molybdenum-99 and technetium-99m 

have short half-lives and the proposed exemption does not affect how the licensee handles 

these radionuclides. The exemption is in the public interest because it provides for performing 

calibration test at levels of activity being used, makes needed technetium-99m available to 

patients, and assures that when the supplies of technetium-99m become available, the 

calibration is performed in accordance with national standards. ' 

10 CFR 35.100(a)(1) and 10 CFR 35.200(a)(1) 

10 CFR 35.100(a)(1) and 35.200(a)(1) require medical use licensees to obtain unsealed 

byproduct material prepared for medical use for uptake, dilution, excretion, imaging or 

localization studies from a manufacturer or preparer licensed under § 32.72 of this chapter or 

equivalent Agreement State requirements. The exemption would permit the licensee to obtain 

the technetium-99m (or a technetium-99m radioactive drug) from another medical use licensee 

to administer to patients. This permits medical use licensees with patients that need 

technetium-99m procedures that cannot get technetium-99m from their normal supplier 

because of the shortage to obtain the needed technetium-99m from a local medical use 

licensee that has a surplus. This exemption will only be in effect when the licensee is unable to 

obtain technetium-99m (or a technetium-99m radioactive drug) from its normal supplier as a 

result of production shortages of molybdenum-99 affecting its generator or technetium-99m 

supplier, as documented in writing by the supplier. This exemption will give some relief on a 

case-by-case basis to a medical use licensee if its supplier is severely affected by the shortage 

but the other medical use licensee supplier is not. The activities and short half-lives of the 

molybdenum-99 and technetium-99m make it highly unlikely that granting this exemption will 

endanger life or property or common defense and security. The exemption is in the public 

interest because it makes needed radioactive material available for necessary patient 

treatment. . 

10 CFR 30.11 authorizes the NRC to issue exemptions from the requirements of, inter alia, 

10 CFR Parts 32 and 35. For the reasons set forth above, the Commission concludes that 

exemptions from the NRC requirements in 10 CFR 32.72, 10 CFR 35.60(b); and 

10 CFR §§ 35.100(a)(1) and 35.200(a)(1), as set forth below, are authorized by law and will not 

endanger life or property or the common defense and security, and are in the public interest. 

III. EXEMPTION 

1. Notwithstanding the requirements in 10 CFR 35.60(b) to calibrate the instrumentation 

required in paragraph (a) of this section in accordance with nationally recognized standards, the 

licensee is not required to perform the calibration test at the maximum activity or at the time 

interval specified in the national standard if: (i) the licensee would use technetium-99m that is 

needed to administer to a patient to perform the test; (ii) the licensee certifies in writing that the 

quantities of technetium-99m that it is receiving from it supplier is less than what the licensee 

has ordered or procured and is not sufficient to perform the test in accordance with the national 

standard; and (iii) the licensee's supplier provides written documentation, that the supplier is 
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providing reduced quantities of technetium-99m to the licensee as a result of production 

shortages of molybdenum-99 affecting its generator or technetium-99m. [NOTE: IF THERE IS 

A CALIBRATION LICENSE CONDITION, THE LICENSEE NEEDS TO TAKE AN ACTION TO 

AMEND THE CONDITION TO AllOW THE CHANGE IN CALIBRATION; THE EXEMPTION 

BY ITSELF Will NOT AllOW THE LICENSEE TO ACCOMPLISH THESE ACTIONS] The 

licensee must perform the calibration test as soon as adequate supplies become available, and 

document results of the test in accordance with 10 CFR 35.2060. If adequate supplies become 

available, the licensee cannot defer performing the tests until the next time interval. The 

licensee shall maintain records of its certification and the underlying documentation supporting 

the licensee's certification, and the supplier's written documentation for 3 years. 

2. Notwithstanding the requirements in 10 CFR 35.100(a)(1) and 35.200(a)(1) to obtain 

unsealed byproduct material prepared for medical use for uptake, dilution, excretion, imaging or 

localization studies from a manufacturer or preparer licensed under § 32.72 of this chapter or 

equivalent Agreement State requirements, the licensee may obtain technetium-99m, or 

dosages of technetium-99m radioactive drugs, from another NRC-licensed medical use 

licensee to administer to patients when the licensee is unable to obtain technetium-99m (or unit 

dosage of a technetium-99m radioactive drug) from its normal supplier as a result of production 

shortages of molybdenum-99 affecting its generator or technetium-99m supplier, as 

documented in writing by the supplier. The licensee shall certify in writing that it is receiving 

reduced qualities of technetium-99m from its supplier and did not have enough to provide the 

administration(s). The licensee shall maintain a record of the transfer, its certification and the 

underlying documentation supporting the licensee's certification, and the supplier's certification 

for 3 years. 

3. Notwithstanding the requirements in 10 CFR 32.72, the licensee may transfer surplus 

technetium-99m, or dosages of technetium-99m radioactive drugs, to other medical use 

licensees licensed by the NRC, for administration to patients, but only after the licensee obtains 

from the receiving medical use licensee a written certification that it is unable to obtain a 

generator, or technetium-99m or unit dosages of a technetium-99m radioactive drug from its 

normal supplier as a result of production shortages of molybdenum-99 affecting its generator or 

technetium-99m supplier. The licensee shall maintain a record of the transfer and the receiving 

licensee's certification for 3 years. 

4. Nothing in this exemption relieves the licensee from complying with the requirements in 

10 CFR35.7. 

5. This exemption is effective upon issuance and during periods of United States shortages of 

molybdenum-99 and technetium-99m as documented in writing by the suppliers of 

molybdenum-99/technetium-99m generators and technetium-99m radioactive drugs. 
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6. This exemption should be kept with the license and discussed with the licensee's Radiation 

Safety Officer and Authorized Users. 

Robert 

~~-r- J. Lewis, Director 

Division of Materials Safety 

and State Agreements 

Office of Federal and State Materials 

and Environmental Management Programs