34596 Federal Register / Vol. 74, No. 135 / Thursday, July 16, 2009 / Notices 

the Atomic Safety and Licensing Board 

that the request and/or petition should 

be granted and/or the contentions 

should be admitted, based on a 

balancing of the factors specified in 10 

CFR 2.309(c)(1)(i)–(viii). 

Documents submitted in adjudicatory 

proceedings will appear in NRC’s 

electronic hearing docket which is 

available to the public at http:// 

ehd.nrc.gov/ehd_proceeding/home.asp, 

unless excluded pursuant to an order of 

the Commission, an Atomic Safety and 

Licensing Board, or a Presiding Officer. 

Participants are requested not to include 

personal privacy information, such as 

social security numbers, home 

addresses, or home phone numbers in 

their filings, unless an NRC regulation 

or other law requires submission of such 

information. With respect to 

copyrighted works, except for limited 

excerpts that serve the purpose of the 

adjudicatory filings and would 

constitute a Fair Use application, 

participants are requested not to include 

copyrighted materials in their 

submissions. 

For further details with respect to this 

license amendment application, see the 

application for amendment dated June 

15, 2009, as supplemented by letters 

dated June 20 and June 23, 2009, which 

are available for public inspection at the 

Commission’s PDR, located at One 

White Flint North, Public File Area O1 

F21, 11555 Rockville Pike (first floor), 

Rockville, Maryland. Publicly available 

records will be accessible electronically 

from the ADAMS Public Electronic 

Reading Room on the Internet at the 

NRC Web site, http://www.nrc.gov/ 

reading-rm/adams.html. Persons who 

do not have access to ADAMS or who 

encounter problems in accessing the 

documents located in ADAMS should 

contact the NRC PDR Reference staff by 

telephone at 1–800–397–4209, or 301– 

415–4737, or by e-mail to 

pdr.resource@nrc.gov. 

Attorney for licensee: Mr. Bradley J. 

Fewell, Associate General Counsel, 

Exelon Generation Company, LLC, 4300 

Winfield Road, Warrenville, IL 60555. 

Dated at Rockville, Maryland, this 10th day 

of July 2009. 

For the Nuclear Regulatory Commission. 

Stephen P. Sands, 

Project Manager, Plant Licensing Branch 

3–2, Division of Operating Reactor Licensing, 

Office of Nuclear Reactor Regulation. 

[FR Doc. E9–16918 Filed 7–15–09; 8:45 am] 

BILLING CODE 7590–01–P 

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 molybdenum99, 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 technetium99m 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 § 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 technetium99m 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/technetium99m 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 technetium99m supplier, as documented in writing 

by the supplier. This exemption will 

facilitate and give relief on a case-bycase 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. 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 74, No. 135 / Thursday, July 16, 2009 / Notices 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 technetium99m 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/technetium99m 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 technetium99m. 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 molybdenum99, 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 technetium99m 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 

NUCLEAR REGULATORY 

COMMISSION 

[NRC–2009–0313] 

License Renewal Interim Staff 

Guidance LR–ISG–2006–02: Staff 

Guidance Regarding the Acceptance 

Reviews for Environmental 

Requirements for License Renewal 

Applications; Notice of Withdrawal 

AGENCY: U.S. Nuclear Regulatory 

Commission (NRC). 

ACTION: Notice of withdrawal. 

SUMMARY: The NRC is withdrawing its 

proposed License Renewal Interim Staff 

Guidance (LR–ISG), LR–ISG–2006–02, 

‘‘Staff Guidance on Acceptance Review 

for Environmental Reports for License 

Renewal Applications,’’ which was 

noticed in the Federal Register (72 FR 

7694 on February 16, 2007). This 


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