Record of Decision for the Medical Isotopes Production Project: Molybdenum-99 and Related Isotopes

DEPARTMENT OF ENERGY

Record of Decision for the Medical Isotopes Production Project:

Molybdenum-99 and Related Isotopes

AGENCY: Department of Energy.

ACTION: Record of decision.

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SUMMARY: The Department of Energy (DOE) is issuing this Record of

Decision regarding DOE's proposal to establish a production capability

for molybdenum-99 (Mo-99) and related medical isotopes. DOE has decided

to proceed with the proposed action using the preferred alternative

identified in the Medical Isotopes Production Project: Molybdenum-99

and Related Isotopes Environmental Impact Statement (DOE/EIS-0249F).

The selected facilities are located at Sandia National Laboratories in

Albuquerque, New Mexico (SNL/NM), and Los Alamos National Laboratory

(LANL) in Los Alamos, New Mexico.

FOR FURTHER INFORMATION CONTACT: Further information on the

environmental impact statement (EIS) can be obtained by contacting: Mr.

Wade P. Carroll, MIPP EIS Document Manager, Office of Nuclear Energy,

Science and Technology, NE-70, U.S. Department of Energy, 19901

Germantown Road, Germantown, MD 20874, Telephone: (301) 903-7731;

facsimile: (301) 903-5434.

[[Page 48922]]

General information on the DOE National Environmental Policy Act

(NEPA) process can be obtained by contacting: Ms. Carol M. Borgstrom,

Director, Office of NEPA Policy and Assistance, EH-42, U.S. Department

of Energy, 1000 Independence Avenue, S.W., Washington, D.C. 20585,

Telephone: (202) 586-4600, or leave message at (800) 472-2756.

For general information on the DOE isotope production program,

please contact: Mr. Owen W. Lowe, Associate Director for Isotope

Production and Distribution, NE-70, U.S. Department of Energy, 19901

Germantown Road, Germantown, MD 20874, Telephone: (301) 903-5161.

SUPPLEMENTARY INFORMATION: DOE has prepared this Record of Decision

pursuant to the Council on Environmental Quality (CEQ) Regulations for

implementing the procedural provisions of NEPA (40 CFR Parts 1500-1508)

and DOE regulations implementing NEPA (10 CFR Part 1021). This Record

of Decision is based on the final EIS, Medical Isotopes Production

Project: Molybdenum-99 and Related Isotopes Environmental Impact

Statement (DOE/EIS-0249F). The Notice of Availability of this final EIS

was published in the Federal Register on May 3, 1996 (61 FR 19931).

Several comment letters, discussed in the Comments on the Final EIS

section of this document, were received after the final EIS was

published. These comments were taken into consideration in preparing

this Record of Decision.

DOE initially prepared, and released for public comment, a draft

environmental assessment (EA) dated February 7, 1995, on the proposed

action of producing medical isotopes using the Annular Core Research

Reactor (ACRR) and the adjacent Hot Cell Facility at SNL/NM for target

irradiation and isotope extraction, and the Chemistry and Metallurgy

Research Facility at LANL in New Mexico for target fabrication. The

public review and comment period for the draft EA ended on May 1, 1995.

Based on the draft EA and comments received, DOE decided to prepare an

EIS. The Notice of Intent to prepare the EIS was published in the

Federal Register on July 6, 1995 (60 FR 35191). The draft EIS was

published in December 1995, and the Notice of Availability of the draft

EIS was published in the Federal Register on December 22, 1995 (60 FR

66542).

Background

For more than 40 years, DOE and its predecessor agencies have

produced and distributed isotopes through DOE's national laboratories.

In 1990, Congress established the Isotope Production and Distribution

Program (IPDP), combining under one program all DOE isotope production

activities.

Among other activities, IPDP has responsibility for ensuring a

stable supply of Mo-99 to the U.S. medical community. Mo-99 is a

radioactive isotope of molybdenum that results from the fission of

uranium atoms or from the irradiation of stable isotopes of molybdenum,

such as Mo-98. Technetium-99m (Tc-99m) is a decay product of Mo-99.

Approximately 38,000 diagnostic procedures involving radioactive

isotopes are performed each day in the United States. Most of these

procedures use Tc-99m. Diagnoses using Tc-99m make it possible to

define internal conditions of the body that often cannot be determined

through any other means except invasive surgery. The short life of Tc-

99m minimizes the radiation dose received by the patient. Because these

isotopes are highly perishable with short lifetimes (the half-lives of

Mo-99 and Tc-99m are 66 hours and 6 hours, respectively), the need to

ensure a stable, continuous supply for medical use is critical. The

U.S. medical community accounts for about 60 percent of the worldwide

demand for Mo-99/Tc-99m, yet there is no current domestic production

source for these isotopes.

Prior to 1989, Mo-99 was produced in the United States by a single

supplier, Cintichem, Inc. Cintichem produced Mo-99 by irradiating

uranium deposited on the inside of stainless steel tubes, called

targets, in a reactor and then chemically separating the Mo-99 from the

targets and purifying it. In 1989, Cintichem discontinued operation of

its production reactor. Since then, the United States has relied on

production reactors in Canada for its supply of Mo-99.

Until 1993, two Canadian reactors, operated by Atomic Energy of

Canada Limited (AECL) at the Chalk River site (located about 100 miles

from Ottawa, Canada), were available to produce Mo-99 through the

irradiation of targets. AECL extracted the Mo-99 from the targets and

provided it to Nordion International. Nordion then purified the Mo-99

and shipped it to radiopharmaceutical manufacturers. In 1993, one of

the Canadian reactors was permanently shut down leaving only one

operating reactor, the National Research Universal (NRU) reactor. A

shutdown of this single remaining reactor would jeopardize the U.S.

supply of Mo-99. In April 1995, this reactor suffered an unplanned

shutdown for four days. European sources were able temporarily to

increase their production enough to cover the European demand normally

supplied by Nordion, and Nordion had sufficient product in process to

meet the U.S. demand during this brief period. However, shortages would

have begun in the United States had the Canadian reactor remained out

of service for only one or two more days.

Nordion has announced its intention to build two modern ten-

megawatt reactors to replace the NRU reactor. However, the earliest

that one of the new plants could be producing Mo-99 is mid-1999. Thus,

a window of vulnerability for the U.S. medical community exists until a

reliable backup source of Mo-99 is available. In addition, AECL has

committed to the Canadian nuclear regulatory authority, the Atomic

Energy Control Board, to shut down the NRU reactor in the year 2000.

This action would extend the dependence of the United States on a

single source of supply if only one new Canadian reactor were available

at that time and would create immediate shortages if no new reactors

were ready to operate at that time.

As a general policy, DOE would favor medical isotope production by

the private sector. However, because the medical radioisotope market is

influenced by forces other than traditional market forces (e.g.,

support from national governments), full-cost recovery of investment is

often not possible. In addition to these considerations, the

uncertainties and liabilities of constructing and operating a nuclear

reactor have prevented and will likely continue to prevent private

companies from providing a U.S. domestic source of Mo-99 in the near

term. In the 1992 hearings on the condition of the IPDP before the

House Environment, Energy, and Natural Resources Subcommittee of the

Committee on Government Operations, testimony addressed the danger of

U.S. dependence upon a single foreign source for its supply of the

critical Mo-99 radioisotope and reaffirmed the need for DOE to become a

Mo-99 supplier. Congress provided $7.6 million for this effort for

fiscal year 1995, and $12 million for fiscal year 1996. In its report

(S. Rep. No. 103-291) accompanying the Energy and Water Development

Appropriations Act, 1995, the Senate Committee on Appropriations noted

``that DOE is taking steps to * * * produce molybdenum-99 and related

medical isotopes to ensure that there are no inadequacies of supply for

domestic use. The committee supports this effort and wishes to be kept

informed as DOE progresses.''

[[Page 48923]]

Production Processes

Mo-99 can be produced by different processes. However, only two

processes have been approved by the U.S. Food and Drug Administration

(FDA) for Mo-99 sold in the United States: the proprietary process used

by Nordion and the Cintichem process. DOE owns the rights to the

Cintichem process. Both processes produce Mo-99 in a reactor. The

Nordion process results in substantial quantities of liquid radioactive

waste; the Cintichem process produces largely solid radioactive waste

that is much easier to manage and dispose of.

In November 1991, DOE purchased the Cintichem technology,

equipment, and the FDA Drug Master Files for the production of Mo-99,

iodine-125 (I-125), iodine-131 (I-131), and xenon-133 (Xe-133) for

$750,000 plus an agreement to pay Cintichem a four percent royalty on

the first five years of sales of Mo-99 and the other isotopes produced

by DOE using the Cintichem technology. In addition, DOE agreed to

accept the spent nuclear fuel from the Cintichem reactor for disposal.

Related Isotopes

The proposed action analyzed in the EIS is the production of Mo-99

and related isotopes. While the focus of the proposed project is the

production of Mo-99, related isotopes, I-125, I-131, and Xe-133, could

be produced at any of the alternative production sites to offset the

costs of Mo-99 production. Isotopes I-125 and I-131 are used in the

treatment of thyroid conditions such as Graves' disease. Xe-133 is used

in the diagnosis of lung maladies. As noted above, DOE purchased the

rights to produce each of these isotopes using Cintichem's technology

along with the right to produce Mo-99. Each of these isotopes can be

made at any of the reactors under consideration and each can be

processed, packaged, and distributed by the same production team. I-131

and Xe-133 are essentially byproducts generated during the processing

of Mo-99. I-125 is produced by irradiating a separate target containing

nonradioactive xenon-124 in the same reactor. This isotope would be

extracted separately and in a manner that would not interefere with Mo-

99 processing.

DOE Mo-99 Project History

In 1991, in response to the shutdown of the Cintichem reactor, DOE

identified the Omega West Reactor at LANL as the proposed facility to

provide a backup supply of Mo-99. In December 1992, however, the Omega

West Reactor experienced an unplanned shutdown. While the reactor was

shut down, a leak in the primary cooling system was identified, and the

reactor was not restarted.

The search for an alternate facility to produce Mo-99 led to the

identification of ACRR at SNL/NM as a suitable candidate for Mo-99

production. Within DOE, ACRR and its associated Hot Cell Facility are

managed by the Office of Defense Programs to provide for defense

research needs. Defense-related experiments conducted in ACRR were

completed in 1995. As mentioned previously, DOE issued a draft EA for

public comment on the proposed action of producing medical isotopes

using ACRR and its associated Hot Cell Facility at SNL/NM and the

Chemistry and Metallurgy Research Facility at LANL. Based on the draft

EA and comments received, DOE decided to prepare an EIS.

Mo-99 Market

The current U.S. demand for Mo-99 is about 3,000 6-day curies per

week. A 6-day curie is defined as the amount of product, measured in

curies, remaining 6 days after the product arrives on the

radiopharmaceutical manufacturer's dock. The radiopharmaceutical

manufacturers also require that specific activity of the product be at

least 250 curies of activity per gram of aqueous molybdenum solution at

delivery.

The current supply of Mo-99 from Canada would be interrupted if the

NRU reactor experiences a shutdown of approximately five days or longer

for any reason. The NRU reactor must operate continuously for 12 or 13

days of each 15-day operating period in order to maintain a continuous

supply of Mo-99. Down time of 2 to 3 days every 15 days is normally

required for maintenance, repairs, and target replacement. For many

years, the NRU reactor has met this operating schedule to supply the

U.S. and Canadian demands for Mo-99 and to ship Mo-99 to numerous other

countries.

If the NRU reactor were to shut down for reasons other than routine

maintenance, it might not be restarted. The reactor was commissioned in

1957, and an aggressive maintenance program is in place to keep it

operating. However, no plans exist to continue operation beyond the

year 2000 because of the reactor's age and lack of storage capacity for

waste generated by the isotope separation process. Any major problem at

the reactor requiring significant time and resources to repair would

probably result in a permanent shutdown, terminating this source of

supply.

In the mid 1980s, Nordion and AECL began the planning and

construction of a new isotope production and research reactor, Maple X,

to replace the NRU reactor. However, AECL decided to halt construction

of the Maple X reactor in 1993 for economic reasons. Nordion's parent

company, MDS Health Group Ltd. of Canada, subsequently filed a breach

of contract lawsuit against AECL, and the two sides agreed to

arbitration hearings to resolve the dispute. The dispute has been

resolved and Nordion apparently now plans to contract with AECL for the

construction and operation of two new reactors (Maple I, a continuation

of the Maple X project, and Maple II) dedicated to isotope production,

and a radiochemical separation facility. These facilities would use a

Mo-99 production and separation process similar to the Cintichem

process to reduce the amounts of radioactive waste generated. Nordion

recently announced that it will restart project planning and design

activities for the two reactors and the radiochemical separation

facility. The sale in the United States of Mo-99 produced at the Maple

reactor complex cannot begin until at least one reactor and the

radiochemical separation facility are completed and licensed. In

addition, FDA must approve the product before Nordion can supply it to

U.S. pharmaceutical companies.

Nordion currently plans to build two reactors. However, if only one

reactor is built, the situation of dependence on a sole source of

supply would remain unchanged for nuclear medicine physicians in the

United States as well as the related vulnerability to an interruption

of supply. Nordion and AECL estimate that the time required to complete

the necessary environmental and construction permitting process, to

construct and commission one of the reactors, and to construct the

radiochemical separation facility is about three years from the time

the project is resumed. Construction and commissioning of the second

reactor, if pursued, would proceed simultaneously and would be

completed about one year after the first reactor is commissioned. Full-

scale Mo-99 production and its sale in the United States would probably

require an additional several months at each of the reactors.

Nordion has established a European subsidiary by acquiring the

radiopharmaceutical department of the Institut National des Radio-

elements (IRE) in Fleurus, Belgium, but IRE (fully owned by the Belgian

Federal Government) remains the owner of Mo-99 production. IRE and

Nordion have signed a mutual Mo-99 backup

[[Page 48924]]

agreement to avoid a complete shortage of Mo-99 in case of an

unscheduled shutdown of the Canadian NRU reactor. DOE has been informed

that the current contractual backup arrangement requires IRE to supply

Nordion with the excess capacity of its facility for up to eight weeks

in the event of a shutdown.

It is unlikely, however, that Nordion could immediately respond to

a U.S. shortage of Mo-99 through its backup arrangement with IRE.

Although IRE has informed DOE that IRE has a sufficient number of

certified transport casks to ship the Mo-99 from Europe directly to the

U.S. radiopharmaceutical companies, Mo-99 from the Belgian source has

never been sold in the United States. Use of IRE's Mo-99 in the United

States would depend on IRE's ability to obtain FDA approval. IRE

submitted a Drug Master File to the FDA in 1991, and Mo-99 samples were

sent to the U.S. radiopharmaceutical companies (DuPont-Merck, Amersham

Mediphysics, and Mallinckrodt Medical) so that they could support IRE's

request for FDA approval. However, the FDA approval process on the

submittal has proceeded slowly because IRE has no established U.S.

customers.

Mallinckrodt Medical is currently working with the High Flux

Reactor (HFR) at Petten in the Netherlands to secure a backup supply in

1996 for its European needs and for its U.S. operations, dependent upon

FDA approval. While production at the Petten HFR could be increased

beyond European needs, it would not be expected to meet the U.S. demand

if the supply from Nordion is interrupted.

Mo-99 is produced in numerous other countries. These include

reactor production facilities in Australia, Indonesia, Japan, Peru,

Argentina, Russia, China, and South Africa. For the most part, they are

small, government-run production facilities, and the Mo-99 is produced

for local use rather than international export. None of these foreign

sources, most running sporadically, could meet a significant portion of

the U.S. demand for Mo-99/Tc-99m generators. Moreover, the foreign

governments are reluctant to meet stringent FDA requirements for export

to the United States. Transportation difficulties also limit the

ability of foreign producers to supply Mo-99 to the United States.

Thermo Technology Ventures, Inc., a U.S. company, is investigating

a concept for direct production of Tc-99m using small particle

accelerators. If successful in developing this concept and financing

the operation of numerous facilities, Thermo Technology Ventures might

be able to supply a significant quantity of Tc-99m to the U.S. medical

community in the future.

Proposed Action

The proposed action is for DOE to establish, as soon as

practicable, a domestic U.S. production capability that would ensure a

reliable supply of Mo-99 and related medical isotopes (I-125, I-131,

and Xe-133) for use by the U.S. medical community. DOE's near-term goal

is to provide a backup capability to Canadian production by supplying a

baseline production level of 10 to 30 percent of current U.S. demand

for Mo-99 with the capability to increase production rapidly to supply

100 percent of the U.S. demand should the Canadian source be

unavailable. The baseline production level would serve to maintain the

capabilities of the facilities and staff to respond on short notice to

supply the entire U.S. demand on an as-needed basis.

Each of the alternatives, described in the next section, for

accomplishing the proposed action would use the Cintichem process for

the production of Mo-99 and related isotopes. A brief description of

the steps in the process follows.

As the initial step in the proposed production of Mo-99, targets

would be fabricated, tested, and shipped to the reactor facility for

irradiation. Targets would be manufactured by coating the inner walls

of stainless steel tubes with highly enriched uranium oxide and then

sealing the ends of the tubes with custom fittings.

At the reactor facility, the targets would be irradiated for

several days. Because Mo-99 decays at the rate of about one percent per

hour, all steps following irradiation of the targets must be expedited.

Upon removal from the reactor, the irradiated targets would be

transferred in a shielded cask to an appropriate hot cell facility,

preferably located adjacent to or near the reactor facility. Mo-99, I-

131, and Xe-133 would be extracted from the fission product inventory

by chemical dissolution and precipitation reactions within the hot

cells. The isotopes would be further refined and would undergo strict

quality control procedures to meet FDA standards.

The production of I-125 requires the irradiation of a different

type of target than that used for the production of Mo-99. These

targets would be irradiated in the same reactor selected for Mo-99

production, but the targets would be processed separately and in a

manner that would not interfere with Mo-99 processing.

The isotopes would be packaged in Department of Transportation-

approved packaging for shipment by air on a daily basis to any of the

three currently known potential customers: DuPont-Merck in Boston,

Massachusetts; Amersham Mediphysics in Chicago, Illinois; and

Mallinckrodt Medical in St. Louis, Missouri; or to Nordion

International in Canada for final processing and distribution. Air

express class shipments would be used.

The radioactive waste generated during the production of the

medical isotopes would be primarily low level waste. This waste and the

spent nuclear fuel from the reactor would be managed, stored, and

eventually disposed of in accordance with applicable regulatory

requirements.

Alternatives Considered

This section describes the alternatives evaluated in the EIS.

1. No Action

Consideration of the No Action alternative is required by CEQ

Regulations, and provides a baseline for comparison with the action

alternatives. If the No Action alternative were selected, there would

be no environmental impacts in the United States due to the production

of Mo-99. However, the United States would continue to be vulnerable to

a Mo-99 supply shortage due to the future uncertainties faced by the

sole Canadian supplier.

2. Preferred Alternative--Annular Core Research Reactor and Hot Cell

Facility at Sandia National Laboratories/New Mexico and Chemistry and

Metallurgy Research Facility at Los Alamos National Laboratory

Under this alternative, DOE would use the Chemistry and Metallurgy

Research Facility to fabricate the targets containing highly enriched

uranium. The targets would be shipped to the ACRR at SNL/NM for

irradiation, and the irradiated targets would be processed in the

adjacent Hot Cell Facility. Low level radioactive wastes from target

fabrication at LANL would be disposed of on site. Low level radioactive

wastes from the Mo-99 production at SNL/NM would be transported to the

Nevada Test Site for disposal. Spent nuclear fuel generated during the

isotope production activities would first be stored on site and later

shipped to the Idaho National Engineering Laboratory (INEL) for storage

in accordance with the Records of Decision on the DOE Programmatic

Spent Nuclear Fuel Management and Idaho National Engineering Laboratory

[[Page 48925]]

Environmental Restoration and Waste Management Programs Environmental

Impact Statement (SNF PEIS) (DOE/EIS-0203-F).

To produce Mo-99 and related medical isotopes under this

alternative, modifications would be required to the Chemistry and

Metallurgy Research Facility, the ACRR, and Hot Cell Facility. The

modifications required to fabricate targets at the Chemistry and

Metallurgy Research Facility are relatively minor. Some interior walls

would be removed, doors would be relocated, and glove boxes with

filtered exhaust systems would be installed.

The ACRR is operational but has historically operated in a pulsed

mode or in a steady-state mode for about a week at a time, whereas

continuous operation would be required for isotope production. To be

able to meet 100 percent of the U.S. demand for Mo-99, the reactor

would be modified to allow steady-state operation at four megawatts and

to allow irradiation of a sufficient number of targets. The required

modifications include installation of heat exchangers and cooling

towers, removal of a stainless steel tube from the center of the

reactor core, and various hardware upgrades. In addition, an air lock

would be installed to minimize airborne releases during the transfer of

irradiated targets, and ventilation and electrical systems would be

upgraded. Following each modification to the reactor, a readiness

assessment would need to be satisfactorily completed for the reactor to

continue operations. When all the reactor modifications were completed,

a determination of readiness would be made to establish whether there

is a need for an operational readiness review.

The existing Hot Cell Facility adjacent to the ACRR, with the

addition of more shielding, could be used to produce approximately 10

percent of the current U.S. demand for Mo-99 on a steady-state basis or

30 percent of the demand for short periods. To meet greater than 10

percent of U.S. demand on a continuous basis, a new hot cell consisting

of five workstations would be constructed within the existing Hot Cell

Facility. In addition, the Hot Cell Facility floor plan would be

reconfigured, and the facility ventilation system would be upgraded.

As noted above, the ACRR is currently managed by DOE's Office of

Defense Programs. If responsibility for the ACRR is transferred to the

DOE Office of Nuclear Energy, Science and Technology, then the Office

of Defense Programs has expressed an interest in retaining the right to

have the reactor available to support defense missions in times of

national emergency to address security concerns. Under such an

arrangement, the ACRR would technically be subject to recall for

defense-related activities if required. DOE has determined that the

probability of recalling the ACRR to support Defense Programs' needs is

so remote as not to preclude the ACRR as an alternative. Also, if it

were recalled to support defense-related activities, the reactor could

be reconverted for the production of Mo-99 in a week, if necessary.

On April 15, 1996, the Pueblo of Isleta and the Southwest Research

and Information Center filed a complaint against DOE in the United

States District Court for the District of New Mexico challenging DOE's

lack of a sitewide EIS for SNL/NM and continued reliance upon the 1977

sitewide EA. Pueblo of Isleta v. Dep't of Energy, No. 96-0508 (D. N.M.

filed Apr. 15, 1996). Plaintiffs allege that NEPA documents prepared at

SNL/NM since 1977 do not adequately analyze the cumulative

environmental impacts of other past, present, and reasonably

foreseeable actions at SNL/NM and seek to enjoin DOE from tiering any

projects from the 1977 EA. The complaint lists the Draft Medical

Isotopes Production Project EIS among the nuclear reactor research

programs at SNL/NM. Plaintiffs do not seek to enjoin any current

activity at SNL/NM. DOE believes that this litigation is moot because

DOE has already sought congressional funding to begin preparing a

sitewide EIS at SNL/NM in 1997. Any action at SNL/NM with respect to

the production of Mo-99 and related isotopes would be supported by the

final Medical Isotopes Production Project EIS and would not be tiered

from or dependent on the 1977 EA.

3. Omega West Reactor and Chemistry and Metallurgy Research Facility at

Los Alamos National Laboratory

Under this alternative, the Chemistry and Metallurgy Research

Facility would be used to fabricate the targets as described for

alternative 2. The targets would be transported to the Omega West

Reactor for irradiation, and the irradiated targets would be

transported back to the Chemistry and Metallurgy Research Facility for

processing. Low level radioactive wastes from Mo-99 production would be

disposed of on site. Spent nuclear fuel generated during the isotope

production activities would first be stored on site and later shipped

to the Savannah River Site for storage in accordance with the Records

of Decision on the SNF PEIS.

To produce Mo-99 and related medical isotopes under this

alternative, modifications would be required to the Chemistry and

Metallurgy Research Facility and the Omega West Reactor. As discussed

previously, the modifications required to fabricate targets at the

Chemistry and Metallurgy Research Facility are relatively minor. Some

interior walls would be removed, doors would be relocated, and glove

boxes with filtered exhaust systems would be installed. Modifications

required to support target processing operations would likewise be

minor.

The Omega West Reactor is shut down and would need to be restarted

to support isotope production. Restarting the reactor would involve

replacing an underground cooling water pipe, upgrading reactor cooling

and air monitoring systems, and updating the required facility safety

documentation. An operational readiness review for restart of the

reactor would have to be satisfactorily completed before operations

could resume.

4. Oak Ridge Research Reactor and Radioisotope Development Laboratory

at Oak Ridge National Laboratory (ORNL)

Under this alternative, the targets would be fabricated at the ORNL

Radioisotope Development Laboratory. The targets would be transported

to the Oak Ridge Research Reactor for irradiation, and the irradiated

targets would be transported back to the Radioisotope Development

Laboratory for processing. Low level radioactive wastes from Mo-99

production at ORNL would be transported to the Nevada Test Site for

disposal. Spent nuclear fuel generated during the isotope production

activities would first be stored on site and later shipped to the

Savannah River Site for storage in accordance with the Records of

Decision on the SNF PEIS.

To produce Mo-99 and related medical isotopes under this

alternative, modifications would be required to the Radioisotope

Development Laboratory and the Oak Ridge Research Reactor. The

modifications required to fabricate and process targets at the

Radioisotope Development Laboratory are relatively minor and include

appropriate upgrades to facility ventilation and waste management

systems.

The Oak Ridge Research Reactor is shut down and would need to be

restarted to support isotope production. Restarting the reactor would

involve upgrading the reactor cooling system, installing new reflectors

in the reactor core, upgrading or repairing out-of-service equipment,

and upgrading the required facility safety documentation. An

operational readiness review for restart of the reactor would have to

be

[[Page 48926]]

satisfactorily completed before operations could resume.

5. Power Burst Facility and Test Area North Hot Cells at Idaho National

Engineering Laboratory

Under this alternative, the targets would be fabricated at a

facility on site such as the Experimental Test Reactor Critical

Facility annex in the Test Reactor Area. The targets would be

transported to the Power Burst Facility for irradiation, and the

irradiated targets would be transported to the Test Area North Hot

Cells or a comparable hot cell facility on site for processing. Low

level radioactive wastes from Mo-99 production would be disposed on

site. Spent nuclear fuel generated during the isotope production

activities would be stored on site in accordance with the Records of

Decision on the SNF PEIS.

To produce Mo-99 and related medical isotopes under this

alternative, modifications would be required to the Experimental Test

Reactor Critical Facility annex, the Power Burst Facility, and the Test

Area North Hot Cells. The required modifications at the Experimental

Test Reactor Critical Facility annex are relatively minor and would

include installation of glove boxes with filtered exhaust systems.

The Power Burst Facility is in standby mode and would need to be

restarted to support isotope production. Restarting the reactor would

involve replacing a significant portion of the reactor instrumentation,

modifying the reactor core to allow for target insertion, and updating

the required facility safety documentation. An operational readiness

review for restart of the reactor would have to be satisfactorily

completed before operations could resume.

The Test Area North Hot Cells would require only minor

modifications to support Mo-99 target processing.

Evaluation

This section describes the results of DOE's evaluation of each of

the alternatives. It summarizes their environmental impacts, costs, and

schedules and concludes by addressing the issue of privatization.

Environmental Impacts

The environmental impacts of producing enough Mo-99 to meet 100

percent of the U.S. demand were assessed in the EIS. However, since DOE

currently proposes only to provide a backup capability that would be

operating to meet 10 percent to 30 percent of the annual U.S. Mo-99

demand, the actual consequences would be lower than the estimated

levels presented in the EIS and described in this section unless there

were an interruption of the Canadian supply for the entire year. The

analyses in the EIS indicate that environmental impacts of any of the

production alternatives would be minimal and well within applicable

regulatory guidelines. Each of the action alternatives would use

essentially the same technology for the production of Mo-99 and related

medical isotopes. Minor differences in environmental impacts among the

alternatives relate primarily to the type and status of the existing

facilities, the modifications required to prepare the facilities for

production, the quantities of low level waste generated, how those

wastes would be managed, and the location of the production facilities

with respect to the surrounding population and to the medical isotope

distributors. All of the production alternatives discussed in the EIS

would use existing facilities with relatively minor modifications and

would have negligible consequences with respect to land use, cultural

resources, aesthetic resources, geologic resources, water quality,

ecological resources, or noise. In the category of regional

socioeconomics, the sum of primary and secondary employment impacts

ranged from 100 to 300 total regional jobs and from $3 million to $6

million in annual regional income, generally less that 0.1 percent of

the corresponding regional totals. Thus, the potential impacts on the

adequacy of community resources and services would be negligible under

any alternative.

The environmental analyses revealed some differences in the

radiological impacts to the public and to workers resulting from the

design and location of particular facilities, but the consequences

would be within regulatory limits in all cases. The analyses did not

identify any alternative that provided a substantial advantage in terms

of environmental consequences. For example, the combined collective

radiation dose to the public from facility operations and

transportation (including crew dose) in person-rem per year ranged from

64 for ORNL to 89 for SNL/NM, and the radiological dose to project

workers in person-rem per year was estimated to range from 9 to 12 for

LANL to 22 to 25 for SNL/NM.1 As shown in the EIS, these doses

would not be expected to result in latent fatal cancers for either

workers or the public, and doses to exposed individuals would be well

within regulatory limits. In addition, because all of the production

alternatives would use small research reactors and comparable target

fabrication and processing facilities, the risk of human health effects

from credible facility accidents is very low, and the consequences of

those accidents would be within DOE safety guidelines.

---------------------------------------------------------------------------

\1\ The facility and transportation values were derived from

Table S-2 on page xiv of the EIS by adding the radiological dose to

the population within 80 km (50 miles) from target irradiation and

processing to the transportation radiological dose to the crew and

public. The dose to project workers was taken from Table 3-1 on page

3.61 of the EIS.

---------------------------------------------------------------------------

Production of low level radioactive waste would be less than 85

cubic meters per year, and spent nuclear fuel would be generated at the

rate of 16 to 32 kilograms per year under any alternative. These

quantities of waste and spent nuclear fuel are small compared to the

quantities of similar materials at the DOE facilities where they would

ultimately be managed. All of the alternative sites have sufficient

waste management capability either on site or through existing

arrangements with other DOE sites to dispose of low level waste

generated by the proposed activity. All alternative sites have adequate

capabilities for storage of spent fuel for at least five years, if

necessary, before the spent fuel is shipped to the Savannah River Site

or INEL for storage in accordance with the Records of Decision on the

SNF PEIS.

Cumulative impacts on site and community infrastructure would be

negligible because the medical isotope production process would use

existing facilities and a relatively small staff. The quantities of

radioactive waste generated annually, radiological facility emissions,

and radiation dose to workers would increase compared to current or

historical DOE operations at each of the sites considered in the EIS.

Some sites would experience a large percentage increase in some impact

categories; however, the absolute quantities are low and the

consequences are generally small compared to current or historical DOE

operations. For example, the quantity of solid low level waste that

would be generated annually at SNL/NM would represent a 50 percent

increase over historical generation levels, but the absolute quantity

of waste generated is relatively small (49 cubic meters). Even with

these increases, the cumulative regional emissions, doses, or other

impacts would not exceed any regulatory limits at any of the

alternative sites.

The consequences of the No Action alternative would consist of

those associated with ongoing production of medical isotopes at the

Canadian facilities and transportation of medical isotopes to the

current U.S. suppliers and their customers. The No Action alternative

would also result in a

[[Page 48927]]

continued risk to the U.S. health care community and its consumers. If

the sole Canadian source of Mo-99 became unavailable for an extended

time, certain medical procedures could not be offered, and the cost of

some diagnostic procedures and medical risk to patients would likely

increase substantially.

Costs

All cost analyses presented in the EIS were performed based on the

operational capabilities required by each of the alternative sites to

produce 100 percent of the U.S. demand for Mo-99 as quickly as

possible. Cost estimates for each alternative include estimated

expenditures to (1) prepare the reactor facility for startup, (2)

operate the reactor to irradiate targets, (3) prepare the hot cell

facility for processing irradiated targets, (4) process the targets to

obtain the desired product, (5) prepare the target fabrication facility

for production, and (6) fabricate targets. Preparation costs include

estimated expenditures associated with site- specific process

verification and document preparation. Operations costs were estimated

on an annual basis and include estimated expenditures associated with

radioactive waste management processes. The cost estimates do not

include current expenditures that are being incurred by each of the

sites to maintain their facilities, general isotope research (including

Mo-99) and process experimentation costs being incurred, or planned

decommissioning costs.

Both the estimated preparation costs and operations costs are of

similar magnitude among the alternatives. The estimated preparation

costs range from $17.2 million for INEL to $21.0 million for ORNL. The

estimated preparation costs for both the SNL/NM and LANL alternatives

are $19.6 million. The estimated annual operating costs range from $8.4

million for INEL to $12.8 million for SNL/NM. The estimated annual

operating costs for ORNL and LANL are $9.6 million and $11.0 million,

respectively.

DOE recognized the varying degrees of confidence associated with

these estimates and, therefore, commissioned an evaluation of the level

of uncertainty associated with each of the estimates. The evaluation

was performed by Jupiter Corporation and is presented in the report,

Cost and Schedule Evaluation of Mo-99 Production Options Identified in

the Environmental Impact Statement, June 3, 1996. This evaluation

produced a range of likely costs and schedules for each of the

production alternatives identified in the EIS. The SNL/NM estimates of

schedule and cost are based on a detailed, integrated schedule with

corresponding resource requirements. The Jupiter report estimated the

costs for SNL/NM to have an uncertainty of about 10 percent. The LANL

estimates are also based on a detailed, integrated schedule and have a

similar level of accuracy as the SNL/NM estimates for the activities

that LANL has identified. However, a greater level of schedule and cost

uncertainty exists for the LANL alternative because of unanticipated

delays and facility costs that are likely to be encountered in the

restart and operation of the Omega West Reactor. The Jupiter report

estimated that the costs for LANL have the potential to increase by

about 25 percent for preparation cost and 9 percent for annual

operating cost.

The level of uncertainty is also greater in the case of estimated

expenditures for ORNL and INEL due to cost projections made at a less

detailed level than for the other two sites. Also for ORNL,

uncertainties exist in the cost and schedule for restart of the Oak

Ridge Research Reactor that has been shut down since 1987. The Jupiter

report estimated that the ORNL reactor preparation costs have the

potential to increase by over 25 percent and the operating costs have a

20 percent uncertainty. In the case of INEL, Power Burst Facility

replacement fuel costs were not included in the EIS estimate for

operating costs. On a yearly basis, this added cost is likely to be in

the range of $1 million to $1.5 million. In addition, the uncertainty

in restart requirements and the likelihood of increased operational

costs contribute to Jupiter's estimate of potential cost increases of

over 35 percent for both facility preparations and operations. When all

of these cost uncertainties are taken into consideration, the likely

costs of preparation and operation would be of similar magnitude for

each alternative.

Schedules

Three milestones were compared in the EIS for each of the

alternative Mo-99 production sites. The first milestone is reached when

the alternative could begin initial production of Mo-99. Initial

production is defined as the ability to reliably irradiate and process

a limited number of targets (one or more per week). The ability to

reach this milestone quickly is particularly important, because its

attainment would allow DOE to initiate the FDA approval process and

achieve an emergency production capability for some quantity of Mo-99.

The second milestone is completion of all necessary facility

modifications (reactor and hot cell) and process equipment

construction. The final milestone is achievement of both an FDA-

approved production capacity and trained staff to meet 100 percent of

the U.S. demand for Mo-99 on a continuous basis.

Based on the schedules prepared by the potential host sites, the

first milestone could be reached by SNL/NM in 6 months from the Record

of Decision, in 13 months by LANL, 22 months by INEL, and 24 months by

ORNL. The time estimated to complete facility modifications and thus

meet the second milestone is 18 months from the Record of Decision for

LANL, 22 months for both SNL/NM and INEL, and 24 months for ORNL.

Finally, full production capability, the third milestone, is estimated

to be reached 20 months from the Record of Decision for LANL, 28 months

for both SNL/NM and INEL, and 30 months for ORNL.

As in the case of cost estimates, the foregoing schedules are

subject to varying degrees of confidence. The Jupiter Corporation

evaluation of the schedules for each of the production alternatives

identified a 10 percent uncertainty level in the SNL/NM schedule

estimates for the reasons stated previously. Based on uncertainties in

restarting the reactors at LANL, ORNL, and INEL, Jupiter estimated that

the LANL schedule estimates had the potential to extend by 6 to 24

months, and that both the ORNL and INEL schedule estimates had the

potential to increase by 6 to 12 months.

The uncertainties in the restart of reactors arises from the need

for these nuclear facilities to have approved safety analysis reports

(SAR) and to satisfactorily complete an operational readiness review.

It is the policy of the Department that nuclear facilities and

operations be analyzed to identify all hazards and potential accidents

associated with the facility and the process systems, components,

equipment, or structures, and to establish design and operational means

to mitigate these hazards and potential accidents. A SAR documents the

results of these analyses and their adequacy to ensure that the

facility can be constructed, operated, maintained, shut down, and

decommissioned safely and in compliance with applicable requirements.

These detailed documents must be reviewed and approved by DOE. The

current DOE standard for SARs is presented in DOE Order 5480.23. Of the

alternatives evaluated in the EIS, the ACRR at SNL/NM is the only

reactor with an approved SAR that complies with this order. Initial Mo-

99 production activities could proceed under the current ACRR SAR,

although

[[Page 48928]]

the document would need to be amended in the future to analyze

modifications necessary to support full Mo-99 production capability

while the reactor continues to operate. The other reactors have

previously approved SARs, but they are now out of date and not in

compliance with the current DOE order. To operate those reactors, the

operating laboratory would need to either demonstrate equivalence of

the reactor's approved SAR to DOE Order 5480.23 or update the reactor's

approved SAR to comply with the order. The Omega West Reactor at LANL

has a draft SAR written in compliance with DOE Order 5480.23, but the

approval process was stopped in 1993 after the reactor was placed in

safe shutdown. The time and cost to revise existing SARs to meet DOE

Order 5480.23 and obtain DOE approval varies according to the type and

size of the nuclear facility. The need to update an SAR before a

reactor can return to operation creates the potential for schedule

delays, cost increases, and facility modifications to resolve

unanticipated safety concerns. Significant updating of a reactor SAR to

meet the current order and obtaining DOE review and approval typically

costs several millions of dollars and takes over two years to complete.

These potential schedule and cost impacts were considered in the

uncertainty evaluation performed by Jupiter.

Similarly, the need to conduct readiness reviews introduces cost

and schedule uncertainties that could be significant depending on the

level of review required. DOE Order 425.1 establishes the requirements

for the restart of existing nuclear facilities that have been shut

down. The requirements specify an independent readiness review process

to demonstrate that it is safe to restart the facility. The order

provides for two levels of review: an operational readiness review or a

readiness assessment. DOE determines whether and which of these reviews

need to be performed prior to the restart of a nuclear facility that

has experienced conditions such as an unplanned shutdown, an extended

shutdown (12 months for the category of reactors considered as Mo-99

production alternatives), or after substantial facility modifications

that require changes in the safety basis previously approved by DOE.

The breadth and depth of the review required determines the amount of

uncertainty introduced into cost and schedule estimates for restarting

the reactor.

Generally, an operational readiness review does the following:

(1) Assesses the physical condition of the nuclear facility;

(2) Assures that the facility drawings are a reflection of the

current design of the facility;

(3) Assures that the procedures reflect the facility as it

currently exists and can be conducted as written;

(4) Assures that the safety documentation is a reflection of the

current design of the plant and adequately defines the envelope of the

safe operating domain;

(5) Assures that the personnel operating and managing the facility

have the appropriate and/or required background and training to safely

conduct operations and management of the facility; and

(6) Assures that the facility has achieved a state of emergency

preparedness that is acceptable, and that the facility can

appropriately conduct the steps of the site emergency procedures.

A minimum set of requirements for an operational readiness review

is presented in section 4.d. of DOE Order 425.1, but the full set of

review requirements is initially defined by DOE management and may be

expanded by the operational readiness review team during the review if

appropriate. The length of time required to conduct an operational

readiness review depends on the review requirements ultimately

established and could take between 6 and 24 months.

In contrast, a readiness assessment generally focuses on a few

specific areas of review and is often less time and resource intensive

than an operational readiness review. Depending on the causes and

duration of the shutdown and the modifications accomplished during the

shutdown, a readiness assessment may be as short and simple as a

restart check procedure, or it may approach the breadth and depth of an

operational readiness review. As in the case of the preparation of

safety documentation, the potential schedule and cost impacts of

readiness reviews were considered in the uncertainty evaluation

performed by Jupiter.

Privatization

DOE's objective is to establish a reliable backup Mo-99 production

capability as soon as practicable. From the inception of the EIS

process, DOE has stated that while it prefers that Mo-99 be produced

for the long term by the private sector, establishment of long-term

private sector production is not within the scope of the EIS. In the

long term, DOE will explore the possibility of private sector

participation in the production of Mo-99 consistent with the DOE

National Isotope Strategy. As discussed in the Background section of

this document, however, it is unlikely that a private domestic source

of Mo-99 is attainable in the near term to address the current

vulnerability of the U.S. supply. For this reason, the long-term goal

of privatization of Mo-99 production was expressly excluded from

consideration in the EIS. DOE published in Commerce Business Daily on

December 5, 1995, and in the Federal Register (60 FR 63515) on December

11, 1995, a Notice for Expressions of Interest regarding the possible

privatization of all of DOE's isotope activities. The Expressions of

Interest were requested by March 29, 1996. Expressions of Interest that

could apply to the production of Mo-99 and related isotopes were

received for review during April 1996. Some of these Expressions of

Interest are general in nature and do not focus on a particular site of

interest for Mo-99 production activities. Several others are site

specific and are directed toward either the use of the ACRR at SNL/NM

or the Omega West Reactor at LANL. Because these Expressions of

Interest are proprietary and are still under review, it is not

appropriate to elaborate on their contents. However, the decision DOE

is making here will not preclude privatization in the long term.

Comments on the Final EIS

DOE received three comment letters after it issued the final EIS

and has responded to them individually. Two letters were from residents

of Albuquerque, New Mexico, who expressed concern regarding the

handling and management of waste and spent nuclear fuel, topics

addressed in the final EIS. The third letter was from Senator Dirk

Kempthorne of Idaho who urged the selection of INEL as the site for Mo-

99 production and included a critique of the EIS. Most of the issues

raised in this letter concern the relative strengths and capabilities

of INEL as an alternative and the limitations of the preferred

alternative including the potential for the ACRR to be recalled for

defense-related testing, the agency's motivation for preparing the EIS,

and the suitability of the ACRR for privatization. All of these topics

are addressed in the final EIS.

Several concerns presented in Senator Kempthorne's letter warrant a

response here. First, the Department has considered and recognizes

INEL's long history of medical isotope production and the significant

historical contributions of INEL to DOE's missions. In the final EIS,

DOE has recognized the relative strengths and the desire of each

alternative location to host the Mo-99 mission. The

[[Page 48929]]

Department has been committed to giving each alternative location a

fair and careful look.

The potential recall of the ACRR for a defense mission also

deserves particular comment. When it issued the final EIS, DOE believed

that the chance of the ACRR being recalled for defense missions in time

of national emergency was sufficiently low so as not to disqualify the

ACRR as an alternative. Based on extensive discussions between the

Office of Defense Programs and the Office of Nuclear Energy, Science

and Technology, DOE continues to believe that the likelihood of a

defense-related national emergency occurring that would require the use

of the ACRR within the next several years is remote. DOE also believes

that the critical need to establish a backup supply of Mo-99 in the

shortest possible time far outweighs the minimal risk that this reactor

would be recalled for defense-related emergencies.

Environmentally Preferable Alternative

With respect to the establishment of a production capability for

Mo-99 and related medical isotopes, the No Action alternative is the

environmentally preferable alternative. Under the No Action

alternative, the U.S. medical community would continue to rely on the

single existing supply source for Mo-99, and any environmental impacts

would occur primarily outside the United States. The No Action

alternative, however, leaves the U.S. medical community vulnerable to a

shortage of Mo-99 that could have a significant negative impact on the

quality of health care received by thousands of U.S. medical patients

each day. Therefore, the No Action alternative was not selected.

Of the alternatives that would satisfy the purpose and need for

action, the potential environmental impacts are generally small and of

similar magnitude. Each of the action alternatives would use

essentially the same technology for the production of Mo-99 and related

medical isotopes. Minor differences among the action alternatives

relate primarily to the type and status of the existing facilities, the

modifications required to prepare the facilities for isotope

production, and amounts of low level waste generated and how those

wastes would be managed. No single alternative has the least impact in

all of the categories analyzed in the EIS. For example, ORNL has the

lowest collective radiation dose to the public; however, it could

generate the second highest volume of low level waste. Similarly, SNL/

NM has the lowest utilization of uranium in fuel, and water usage, of

all the sites considered but has a slightly higher worker dose during

processing and operation. However, these differences and the others

identified in the EIS are very minor and do not provide a basis for

selecting an environmentally preferred alternative among those

alternatives that satisfy the purpose and need for action.

Decision

DOE has decided to implement the proposed project as specified in

the preferred alternative in the EIS, that is, to produce Mo-99 and

related isotopes at the ACRR and Hot Cell Facility at SNL/NM and to

fabricate targets at the Chemistry and Metallurgy Research Facility at

LANL. The basis for this decision rests on DOE's determination that it

is essential to address as soon as possible the U.S. vulnerability to

the failure of its sole source of supply of Mo-99, an isotope vitally

necessary for the medical diagnosis of thousands of patients every day.

Failure of the sole Canadian supply would leave the United States with

critical shortages of Mo-99 within a week.

The analyses of the alternatives in the EIS demonstrate that the

impacts on the environment, involved workers, and the residents in the

affected communities would be very small and within applicable

regulatory limits and would not provide a basis for discrimination

among the alternatives. The ACRR is the only reactor among all of the

alternatives that is presently operating, and the ACRR can provide the

earliest possible production of Mo-99 in the event that the Canadian

supply becomes unavailable. The ACRR also has the most reliable

projections of costs and schedules for meeting the planned production

goals.

The Department recognizes that the Office of Defense Programs has

expressed interest in retaining the capability to use the ACRR in the

event of a national emergency. The Department considers the likelihood

of such an emergency in the next several years to be highly unlikely.

DOE has decided that the critical need to establish a backup supply of

Mo-99 in the shortest possible time far outweighs the minimal risk that

this reactor would be recalled for defense-related emergencies.

This decision is not affected by the litigation in Pueblo of Isleta

v. Dep't of Energy, No. 96-0508 (D. N.M. filed Apr. 15, 1996). The

Medical Isotopes Production Project is based upon its own final EIS

that evaluates the cumulative impacts of the proposed action at SNL/NM

as well as all of the other proposed alternatives. Neither that EIS nor

this decision is dependent in any way upon the 1977 SNL/NM sitewide EA

that the plaintiffs seek to enjoin reliance upon. Moreover, DOE

believes that this litigation is moot because DOE has already sought

congressional funding to begin preparing a sitewide EIS at SNL/NM in

1997.

Use of all Practicable Means To Avoid or Minimize Harm

Implementation of this decision will result in low environmental

and health impacts. Mitigation measures typically applied to the

operation of small research reactors and to the activities necessary to

fabricate, irradiate, and process the Mo-99 targets will be applied

throughout the project. These measures include filtration of air

emissions from target fabrication, irradiation, and processing

activities in accordance with applicable requirements and as low as

reasonably achievable principles. Accordingly, no mitigation action

plan is necessary.

The Medical Isotopes Production Project: Molybdenum-99 and Related

Isotopes will be initiated at the preferred alternative facilities

under the program direction of the Office of Nuclear Energy, Science

and Technology and the Kirtland Area Office, Albuquerque Operations

Office.

Issued in Washington, D.C., this 11th day of September 1996.

Terry R. Lash,

Director, Office of Nuclear Energy, Science and Technology.

[FR Doc. 96-23738 Filed 9-16-96; 8:45 am]

BILLING CODE 6450-01-P