[Federal Register Volume 74, Number 135 (Thursday, July 16, 2009)]
[Notices]
[Pages 34596-34597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-16916]


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NUCLEAR REGULATORY COMMISSION

[NRC-2009-0312; Docket No. 030-35985]


Environmental Assessment and Final Finding of No Significant 
Impact With Regard to Exemption From Certain Regulatory Requirements

Introduction

    The U.S. Nuclear Regulatory Commission (NRC) is proposing to exempt 
all NRC medical use licensees from certain requirements in 10 CFR 
35.60(b), 10 CFR 35.100(a)(1) and 35.200(a)(1), and 10 CFR 32.72. These 
requirements govern calibration tests that use technetium-99m, and 
distribution of molybdenum-99/technetium-99m generators and technetium-
99m radioactive drugs to and from medical use licensees. NRC is issuing 
these exemptions to ensure that available technetium-99 is being used 
for patient administrations during any period of United States and 
worldwide shortages of molybdenum-99, which is used to produce 
molybdenum-99/technetium-99m generators for medical use.
    These exemptions will be effective only when there are United 
States shortages of technetium-99m caused by production shortages of 
molybdenum-99, as documented in writing by the supplier of molybedenum-
99/technetium-99m generators or technetium-99m.

Environmental Assessment

Identification of the Proposed Action

    The NRC proposes to issue exemptions to all NRC medical use 
licensees from 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 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 needed for a patient administration 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 their generator or 
technetium-99m supplier, as documented in writing by the supplier. The 
licensee must perform the test when adequate supplies, as documented in 
writing by the technetium-99 supplier, become available, and document 
results of the test in accordance with 10 CFR 35.2060. Depending on the 
maximum activity needed to perform the calibration test and the 
activity of technetium-99m in the radioactive drug, this may make 
dosages available to 7-15 additional patients at the licensee's 
facility.
    The NRC proposes to issue exemptions to all NRC medical use 
licensees from 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 Sec.  32.72 of this chapter or 
equivalent Agreement State requirements, if the licensee obtains the 
technetium-99m (or a technetium-99m radioactive drug) from another 
medical use licensee to administer to patients. This permits medical 
use licensees that cannot get technetium-99m from their normal supplier 
because of the shortage to obtain some 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's supplier is not.
    The NRC proposes to issue exemptions to all NRC medical use 
licensees from requirements in 10 CFR 32.72, to permit the 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 to 
medical use licensees. This exemption will only be in effect when the 
receiving medical use licensee is unable to obtain a generator, or 
technetium-99m or technetium-99m radioactive drugs 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 facilitate and give relief 
on a case-by-case basis to a medical use licensee with a surplus of 
technetium-99m (or a technetium-99m radioactive drug) because its 
supplier is not affected by the shortage in the transfer of the 
technetium-99m to the other medical use licensee whose supplier is 
affected.

[[Page 34597]]

Need for the Proposed Action

    These exemptions are needed in times of molybdenum-99 shortages in 
the United States to ensure that available technetium-99m is used for 
patient treatment. 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, the 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 shut down 
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.

Environmental Impacts of the Proposed Action

    During times of supply shortages, there is less molybdenum-99 and 
technetium-99m available for molybdenum-99/technetium-99 generator 
production. There are also fewer generators to elute, and fewer 
technetium-99m radioactive drugs produced. The exemption will: (1) 
Allow lower quantities of technetium-99m to be used for calibrations 
and delay the calibration test, making quantities available for patient 
administrations; (2) allow a licensee to obtain unsealed byproduct 
material from another licensee other than directly from the 
manufacturer or commercial nuclear pharmacy; and (3) allow a licensee 
with sufficient product to transfer excess to another authorized 
licensee for patient administration. The exemptions do not relieve the 
licensee from NRC environmental release requirements or worker dose or 
public dose requirements associated with the elution of molybdenum-99/
technetium-99m generators, preparation of technetium-99m radioactive 
drugs, administration of the technetium-99m radioactive drugs to 
patients, handling of these radioactive materials, or handling of 
radioactive waste. All of those protections remain in place. Neither 
molybdenium-99 nor technetium-99m is a volatile radionuclide. 
Molybdenum-99 remains attached to the generator resins and technetium-
99m stays suspended in the eluent. Both radionuclides have short half-
lives. None of the proposed exemptions affects how the licensee handles 
these radionuclides. Their medical use when there are no shortages 
results in minimal impact on the environment and public dose exposures. 
During times of shortage, medical use licensees will have less 
technetium-99m to use and there will be fewer patients receiving 
technetium-99m radioactive drugs even when maximizing the medical use 
of available technetium-99m. Therefore, the proposed action will not 
result in an increase in the release of radioactive material into the 
environment or increase public radiation exposure. There will be no 
impact on the environment as a result of the proposed action.

Alternatives to the Proposed Action

    As required by Section 102(2)(E) of NEPA (42 U.S.C. 4322(2)(E)), 
possible alternatives to the final action have been considered. The NRC 
identified only one reasonable alternative for consideration: the no 
action alternative. This no action alternative would not result in any 
adverse impact on the environment but would negatively impact the 
medical use licensees' provision of medical care to their patients. 
During shortages in the United States and the world of molybdenum-99, 
the supply of technetium-99m available to administer to patients is 
less than the amount needed to perform important cardiac, cancer, and 
other imaging procedures. Using technetium-99m to perform calibration 
tests at maximum activities and at preset intervals instead of for 
patient administrations would prevent a number of patients from 
receiving these needed procedures. Temporary relief from the national 
standards should not result in significantly different patient 
radiation dosages because most instruments used to measure patient 
dosages today are stable if not moved and provided with reasonable 
climate controls. Also, performing the test at lower activity levels 
will provide confidence that the instrument is still calibrated over 
the levels of routine technetium-99m dosages. For higher dosages 
requiring written directives, the licensee can use the activity 
provided with the radioactive drug to assure patient safety. Not 
granting an exemption to permit distribution to and receipt of excess 
generators and technetium-99m by other authorized medical use licensees 
that do not have any also would reduce the number of patients receiving 
needed procedures. For these reasons, the NRC did not adopt the no 
action alternative.

Alternative Use of Resources

    No alternative use of resources was considered due to the reasons 
stated above.

Agencies and Persons Consulted

    No other agencies or persons were contacted regarding this proposed 
action.

Identification of Source Used

    None.

Finding of No Significant Impact

    Based on the above environmental assessment, the NRC finds that the 
proposed action will not have a significant effect on the quality of 
the human environment. Accordingly, the NRC has determined that a 
Finding of No Significant Impact is appropriate and preparation of an 
environmental impact statement is not warranted.

    Dated at Rockville, Maryland, this 10th day of July 2009.

For the Nuclear Regulatory Commission.
Duane E. White,
Acting Chief, Radioactive Materials Safety Branch, Division of 
Materials Safety and State Agreements, Office of Federal and State 
Materials and Environmental Management Programs Safety and Safeguards.
[FR Doc. E9-16916 Filed 7-15-09; 8:45 am]
BILLING CODE 7590-01-P