[Federal Register Volume 61, Number 181 (Tuesday, September 17, 1996)]
[Notices]
[Pages 48921-48929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-23738]
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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
