[Federal Register Volume 60, Number 129 (Thursday, July 6, 1995)]
[Notices]
[Pages 35191-35195]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16609]
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DEPARTMENT OF ENERGY
Environmental Impact Statement for Proposed Medical Isotope
Production
AGENCY: Department of Energy.
ACTION: Notice of Intent.
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SUMMARY: The Department of Energy (DOE) announces its intent to hold
scoping meetings and prepare an Environmental Impact Statement (EIS) on
the proposed domestic production of molybdenum-99 (Mo-99) and related
medical isotopes (iodine-125, iodine-131, and xenon-133). The EIS will
describe the need for and purpose of the proposed action, the
alternatives for satisfying the need (as well as a ``no action''
alternative), and analyze the impacts of producing Mo-99 and related
medical isotopes using reasonable alternative facilities.
DATES: Written comments must be postmarked not later than August 7,
1995 to ensure consideration. Comments received after that date will be
considered to the extent practicable. The locations, dates and times of
the public scoping meetings are included in the Supplementary
Information section of this notice, and will also be announced by
additional appropriate means. Oral and written comments will be
considered equally in the preparation of the EIS.
ADDRESSES: Written comments on the scope of the medical isotope
production EIS, or other matters regarding this environmental review,
should be addressed to: Mr. Wade Carroll, NEPA Document Manager, Office
of Isotope Production and Distribution, NE-70, U.S. Department of
Energy, 19901 Germantown Road, Germantown, Maryland, 20874, Attn:
Medical Isotope Production EIS. Mr. Carroll may be contacted by
telephone at (301) 903-7731, facsimile (301) 903-5434.
FOR FURTHER INFORMATION CONTACT: For general information on the DOE
NEPA
[[Page 35192]]
process, please contact: Ms. Carol M. Borgstrom, Director, Office of
NEPA Policy and Assistance, EH-42, Department of Energy, 1000
Independence Ave. SW, Washington, D.C. 20585. Ms. Borgstrom may be
contacted by leaving a message at (800) 472-2756 or by calling (202)
586-4600. For general information on the DOE isotope production
program, please contact: Mr. Owen W. Lowe, Associate Director, Office
of Isotope Production and Distribution, NE-70, U.S. Department of
Energy, 19901 Germantown Road, Germantown, MD 20874. Mr. Lowe may be
contacted by calling (301) 903-5161.
SUPPLEMENTARY INFORMATION:
Background
For more than forty years, DOE and its predecessor agencies have
produced and distributed isotopes for medical and industrial
applications through the Department's national laboratories. In 1990,
the Congress established the Isotope Production and Distribution
Program (IPDP), bringing together under one program all DOE isotope
production activities.
Among other activities, the IPDP has been assigned responsibility
for ensuring a stable supply of Mo-99 to the United States medical care
community. Mo-99 is a short-lived radioactive isotope of molybdenum
that results from the fission of uranium atoms. Technetium-99m (Tc-
99m), the most widely used medical radioisotope, is a decay
product of Mo-99. Tc-99m has broad nuclear medicine applications
in the areas of diagnostic procedures and medical laboratory tests. The
use of Tc-99m for diagnosis enables definition of conditions in
the body that are not currently achievable with any other means except
invasive surgery. Also, Tc-99m concentrates in the area of the
body that is of interest, and its short life 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 United
States medical community accounts for about 60 percent of the worldwide
demand for Mo-99/Tc-99m, yet there is no current domestic 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
``targets'' in a reactor, and later removing the Mo-99 from the
targets. In 1989, Cintichem discontinued operation of its production
reactor. Since then, the United States has relied on Canadian
production reactors for its supply of Mo-99.
Prior to 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 raw Mo-99 from the targets
and provided it to Nordion International, who purified the Mo-99 and
shipped it to radiopharmaceutical manufacturers. In 1993, one of the
two Canadian reactors was permanently shut down, leaving only the
second reactor operating. Any shutdown or extended outage of this
nearly 40-year-old reactor would jeopardize the U.S. supply of Mo-99,
resulting in a drastic effect on this nation's medical patients who
need nuclear medicine care. In April 1995, this reactor suffered an
unplanned shutdown for four days. European sources were able to
temporarily increase their production enough to cover the European
demand normally supplied by Nordion, and Nordion had sufficient product
in process to meet the United States demand during this period.
However, it was expected that shortages would have begun in the United
States if the Canadian reactor had remained out of service for one or
two more days.
AECL is considering building two modern 10 megawatt reactors as
replacements for the existing reactor. One new plant initially was
planned to be put in service by 1998. However, the funding to complete
construction of even one of these plants has not yet been identified
and committed. In any case, there are apparently no plans to operate
the existing reactor beyond the year 2000. Thus, there is a ``window of
vulnerability'' for the United States medical community until a new or
reliable backup source of Mo-99 can be put in place.
The uncertainties and liabilities of constructing and operating a
nuclear reactor have prevented and will likely continue to prevent
private companies in the United States from developing a domestic
source of Mo-99 to replace the Cintichem reactor. Congress has
acknowledged the danger of United States dependence upon a single
foreign source for its supply of Mo-99, and has supported DOE's efforts
to ensure that a backup capability will be available to produce Mo-99
to meet the needs of the United States medical care community should
the Canadian source fail. In Senate Report No. 103-291 accompanying the
Energy and Water Development Appropriations Act, 1995, the Committee on
Appropriations stated that ``[t]he the United States is fully dependent
for 100 percent of the supply of molybdenum-99 and technetium-99m,
both important to nuclear medicine, on sources in Canada which produces
(sic) these isotopes in aging facilities. Of particular concern is the
lack, since 1990, of a domestic source of molybdenum-99, an isotope
used to produce technetium-99m which is used in approximately
36,000 medical diagnoses per day. The Committee notes that the
Department 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 the Department progresses.'' Congress provided $7.6 million
for this effort for Fiscal Year (FY) 1995, and the President requested
$12 million for FY 1996.
Production Processes
Mo-99 can be produced by a number of processes. However, only two
processes have been approved by the Food and Drug Administration for
Mo-99 sold in the United States: the proprietary process used by
Nordion, and the Cintichem process. Both processes produce Mo-99 in a
reactor. The Nordion process results in substantial quantities of
liquid radioactive waste, while the Cintichem process produces largely
solid waste, which is much easier to manage and dispose.
In November, 1991, DOE purchased the Cintichem technology and
equipment for $750,000 plus an agreement to pay Cintichem a 4 percent
royalty on the first 5 years of sales of Mo-99 and other isotopes
produced in the Cintichem process. In addition, DOE agreed to accept
the spent nuclear fuel from the Cintichem reactor. Subsequently, the
reactor was decommissioned.
Environmental Assessment
A draft environmental assessment (EA), dated February 7, 1995, was
prepared and issued for public comment on the proposed action to
produce medical isotopes using the Chemistry and Metallurgy Research
facility at Los Alamos National Laboratory, in Los Alamos, New Mexico
(for target fabrication), and the Annular Core Research Reactor (ACRR)
(a small, open pool research reactor of 2 megawatts) and its associated
hot cell facilities at the Sandia National Laboratories/New Mexico (for
target irradiation and isotope extraction). The public review and
comment period for the draft EA ended on May 1, 1995. Based on the
[[Page 35193]]
draft EA and comments received, the Department decided that it would be
appropriate to prepare an Environmental Impact Statement.
Within DOE, the ACRR at SNL/NM and its associated hot cell
facilities are managed by the Office of Defense Programs because the
principal use of these facilities has been to support defense research
needs. There is a defense-related experiment in progress in the ACRR
that is scheduled to be completed in mid-August 1995. Beyond that, the
Office of Defense Programs has not currently identified any follow-on
work; however, the ACRR must be available to support DP missions in
time of emergency for national security reasons. DOE has not yet
decided on any specific other uses for the ACRR, although a range of
activities are possible for a reactor of this type. These activities
could involve other DOE program areas besides the production of Mo-99
and related medical isotopes, as well as work performed for other
agencies or organizations, such as the past work performed for the
Nuclear Regulatory Commission. In the interim, DOE will physically
maintain the reactor, hot cells and associated facilities, and will
continue to train the operating staff to maintain their proficiency to
meet safe operating standards. DOE will also complete installation of a
new control system designed to meet today's standards. In addition,
SNL/NM will clean out ``legacy'' waste materials that remain,
principally in the hot cells and storage areas adjacent to the reactor.
Proposed Action
The proposed action is for DOE to establish within two years a
medical radioisotope production program that would ensure the domestic
capability to produce a continual supply of Mo-99 and related medical
isotopes (iodine-125, iodine-131, and xenon-133) for United States
medical community use. The near-term goal of DOE is to provide a backup
capability to supply a baseline production level of 10 to 30 percent of
current United States demand for Mo-99 and 100 percent of the United
States 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
United States demand on an as-needed basis. The longer term objective
is to transfer the process to private industry.
The United States demand is presently 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 pharmaceutical
manufacturers also require that the specific activity of the product
must be at least 10,000 curies of activity per gram of molybdenum when
it arrives at the manufacturer's dock.
Proposed Process
DOE proposes to use the Cintichem process as the most expeditious
way to satisfy the goals of the proposed action. A brief description of
the steps in the process follows.
As the initial step in the proposed Mo-99 production program,
targets containing highly enriched uranium would be fabricated, tested
and shipped to the reactor facility for irradiation. Target elements
would be manufactured by electroplating highly enriched uranium oxide
on the inner wall of stainless steel tubes, and then sealing the ends
with custom fittings.
At the reactor facility, the targets would be irradiated for
several days depending on the power level. Upon removal from the
reactor, the irradiated targets would be transferred in a shielded cask
to an appropriate hot cell facility, preferably located immediately
adjacent to or near the reactor facility because of the short half-life
of Mo-99. Within the hot cells, the isotopes of interest would be
extracted from the fission product inventory by chemical dissolution
and precipitation procedures. The isotopes would be further refined and
would undergo strict quality control procedures to meet FDA standards.
Because Mo-99 decays at the rate of about 1 percent per hour, all
steps after irradiation of the target and shipment of the product must
be expedited. The isotopes would be packaged in Department of
Transportation-approved packaging for shipment by air freight 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 in St. Louis, Missouri. Air express class
shipments would be used.
The radioactive waste would be both low-level waste (LLW) and spent
nuclear fuel. Both types of waste would be managed, stored and
eventually disposed of in accordance with applicable requirements and
regulations.
Although no mixed waste (waste that is both radioactive and
chemically hazardous) would be generated in the isotope extraction
process, small amounts of mixed waste would be produced during target
fabrication. These mixed waste streams would be managed, stored and
disposed of in accordance with applicable requirements and regulations.
During the preparation of the EIS, the Department will conduct
laboratory-scale process validation tests to help ensure that the
Cintichem process can be accurately reproduced. The results of these
tests would be applicable to any site for Mo-99 production using the
Cintichem process.
Alternatives
DOE has identified a number of alternatives for the production of
Mo-99. Others may be identified during the scoping process. All
alternatives will be evaluated against the purpose and need for the
proposed action, and those that meet the goals of the proposal will be
addressed in detail in the EIS. At this time, DOE's preferred
alternative is to use the Cintichem process with Mo-99 target
fabrication in the CMR at LANL and target irradiation and isotope
separation in the ACRR and associated hot-cell facilities at SNL .
No Action
The Council on Environmental Quality regulations implementing NEPA
require that an agency analyze the impacts of not taking the proposed
action (the ``No Action Alternative''). In this case, the No Action
Alternative would mean that DOE would not establish a backup production
capability for Mo-99. The United States medical community would
continue to rely on the current Canadian source, or other foreign
sources, of radioisotopes.
Alternatives to Accomplish the Proposed Action
There are several existing federally-owned facilities that could be
configured to produce Mo-99 and other medical isotopes. Previous
studies which narrowed the possible alternatives to a single reactor
facility, the ACRR, will be revisited and re-evaluated. Possible
additional DOE facilities include:
(1) Omega West Reactor at LANL
(2) Advanced Test Reactor at the Idaho National Engineering Laboratory
(INEL)
(3) High Flux Isotope Reactor at the Oak Ridge National Laboratory
(ORNL)
The possibility of using non-DOE federally-owned facilities will
also be examined.
Alternatives to the Proposed Action
There may be ways to accomplish the goal of the proposed action
(i.e., establish a source for the domestic
[[Page 35194]]
production of Mo-99) that would use private rather than federally-owned
facilities. However, some or all of these alternatives would not be
able to meet this goal within the time desired. The alternatives
identified below, as well as others which may be identified in the
scoping process, will be considered.
(1) University Reactors: Several United States universities
currently operate research reactors, which are typically small and
relatively simple. They also typically do not have hot cell facilities
or radio-chemical process facilities. However, in some cases,
university reactors have already produced other radioisotopes, and they
will be re-evaluated. Universities which have reactor facilities that
are of particular interest are listed below:
The University of Missouri.
Rhode Island Nuclear Science Center.
Georgia Institute of Technology.
Massachusetts Institute of Technology.
(2) New Concepts: New concepts which have been proposed for the
production of Mo-99 will be considered. Examples of these new concepts
include:
Medical Isotope Production Reactor (MIPR): The Babcock and
Wilcox Corporation (B&W) has submitted an unsolicited proposal to DOE
to design, construct and operate a new and unproven reactor concept
that uses an aqueous solution of uranyl nitrate contained in an
aluminum or stainless steel vessel immersed in a large pool of water to
provide both shielding and heat exchange. The reactor could be operated
with low-enriched fuel. The Mo-99 would be obtained by on-line
extraction of a portion of the uranyl nitrate and passing it through an
ion exchange column, where the Mo-99 would be deposited. The uranyl
nitrate would then be returned to the reactor. Wastes could be
substantially reduced with this concept. B&W believes that a MIPR Mo-99
facility could be run as a profitable business. However, to date, the
perceived risks have prevented them from making a corporate commitment
to fund such an enterprise without substantial government support.
Isotopes U.S.A.: Personnel from DOE's Idaho National
Engineering Laboratory (INEL) and the University of Idaho have
developed a concept, referred to as Isotopes U.S.A. Under this concept,
a not-for-profit corporation would be established dedicated to
education, research and other scientific purposes relevant to the
production and use of stable and radioactive isotopes. The concept
includes isotope production and distribution, isotope research,
education and training, administration and for-profit isotope ventures.
This concept, should it be implemented, could privatize most, if not
all, of the current IPDP functions, including the production of Mo-99.
Partial Alternatives
Some alternatives to meet individual portions of the proposed
action will be considered in combination with other appropriate
processing and irradiation facilities.
Examples are: (1) Alternative Target Fabrication Sites: Alternate
target fabrication sites include DOE facilities at LANL, SNL/NM, or
ORNL or commercial facilities such as Babcock and Wilcox in Lynchburg,
Virginia; Nuclear Fuel Services in Erwin, Tennessee; and General
Atomics in San Diego, California. Any alternate fabrication site would
manufacture the same target using the selected process.
(2) Alternate Target Processing Sites: Some hot cell facilities may
be more effective for post-irradiation processing than the hot cells
that are near a candidate reactor, although such arrangements would
have to consider the short half-life of Mo-99. Also, if the targets
were fabricated at the same facility where the post-irradiation
processing is done, there would be the potential that unfissioned
uranium from the targets could be recycled back into new targets.
Preliminary Identification of Environmental Issues
The issues listed below have been tentatively identified for
analysis in the Medical Isotope Production EIS. This list is presented
to facilitate public comment on the scope of the EIS. It is not
intended to be all-inclusive or to predetermine the potential impacts
of any of the alternatives. DOE seeks public comment on the adequacy
and inclusiveness of these issues:
(1) Potential impacts on natural ecosystems, including air quality,
surface and ground water quality, and plants and animals;
(2) Potential health and safety impacts to on-site workers and to
the public resulting from operations, including reasonable postulated
accidents;
(3) Potential health and safety, environmental and other impacts
related to the transport of targets and radioisotopes;
(4) Waste management considerations related to the generation,
storage and disposal of hazardous waste, LLW, mixed waste and spent
nuclear fuel;
(5) Potential cumulative impacts of Mo-99 production operations,
including relevant impacts from other past present and reasonably
foreseeable activities at the production site;
(6) Potential impacts on cultural resources;
(7) Potential socioeconomic impacts, including any disproportionate
impacts on minority and low income populations; and
(8) Potential economic impacts, including those from producing
radioisotopes for commercial sector use.
Related NEPA Documentation
NEPA documents that have been or are being prepared for activities
related to the proposed action include, but are not limited to, the
following:
(1) The LANL Site Wide EIS (a Notice of Intent was published at 60
FR 25697, May 12, 1995) will analyze the cumulative impacts of
operations and planned activities foreseen at LANL within the next 5 to
10 years.
(2) An Environmental Assessment for SNL/NM Offsite Transportation
of Low-Level Radioactive Waste is currently being prepared which will
evaluate the shipment of both existing inventories of LLW accumulated
at SNL/NM since 1988 and LLW projected to be newly generated at SNL/NM
in the foreseeable future.
(3) The Programmatic Environmental Impact Statement for Waste
Management will address waste management alternatives for existing and
proposed actions and DOE complex-wide issues associated with long-term
waste management policies and practices. An Implementation Plan for
this Programmatic EIS was issued in January 1994.
(4) The Programmatic Environmental Impact Statement for Spent
Nuclear Fuel Management and Idaho National Engineering Laboratory
Environmental Restoration and Waste Management addresses the management
of DOE-owned spent nuclear fuel. A Record of Decision for the
Programmatic EIS was published in the Federal Register on June 1, 1995.
Public Involvement Opportunities
DOE will develop a public (``stakeholder'') involvement plan for
this EIS process. To assist with developing the stakeholder involvement
plan, the DOE requests suggestions by the public on how this EIS
process should be conducted, including suggestions regarding the type,
format, and conduct of public involvement opportunities.
Through this notice, the DOE formally invites States, tribes, other
government agencies, and the public to comment on the scope of this
EIS. The locations,
[[Page 35195]]
dates and times for these public meetings are:
Idaho National Engineering Laboratory--July 24, 1995, 1:00 p.m. to 4:00
p.m. and 7:00 p.m. to 10:00 p.m., Shilo Inn, 780 Lindsay Blvd., Idaho
Falls, ID 83402, Ph. (208) 536-0805
Oak Ridge National Laboratory--July 26, 1995, 1:00 p.m. to 4:00 p.m.
and 7:00 p.m. to 10:00 p.m., Pollard Auditorium, 210 Badger Avenue, Oak
Ridge, TN 37830, Ph. (615) 576-0885
Sandia National Laboratories/Albuquerque--July 31, 1995, 1:00 p.m. to
4:00 p.m. and 7:00 p.m. to 10:00 p.m., Albuquerque Convention Center,
Cochiti/Taos Rooms, 401 2nd Street, N.W., Albuquerque, NM 87102, Ph.
(505) 845-6094
Los Alamos National Laboratory--August 1, 1995, 1:00 p.m. to 4:00 p.m.
and 7:00 p.m. to 10:00 p.m., Hilltop House, 400 Trinity Drive, Los
Alamos, NM 87544, Ph. (505) 665-4400
A second formal opportunity for comment will be provided after DOE
issues the Draft EIS. Public hearings will be held in conjunction with
the comment period for the Draft EIS.
In addition to formal opportunities for comment, anyone may submit
comments at any time during the NEPA process; however, to ensure that
comments are considered at specific points in the NEPA review process,
and to best assist DOE, the public is encouraged to comment during the
formally established comment periods.
Copies of design and other background documents, written comments,
records of public meetings, and other materials related to the
development of the EIS have been and are being placed in DOE Reading
Rooms at the following locations:
DOE Headquarters, 1000 Independence Avenue, S.W., Room 1E-190,
Washington, D.C., 20585, phone (202) 586-3142;
National Atomic Museum, Building 20358, Wyoming Blvd., Kirtland Air
Force Base, New Mexico 87185, phone (505) 845-4378;
Los Alamos National Laboratory Community Reading Room, 1450 Central
Avenue, Suite 101, Los Alamos, New Mexico 87544, phone (505) 665-2127;
Idaho Operations Office, Idaho Public Reading Room, 1776 Science Center
Drive, Idaho Falls, Idaho, 83402, phone (208) 526-0271; and
Oak Ridge Operations Office, Public Reading Room, 55 Jefferson Circle,
Room 112, Oak Ridge, Tennessee, 37831, (615) 241-4780.
Issued in Washington, D.C., this 30th day of June 1995, for the
United States Department of Energy.
Peter N. Brush,
Principal Deputy Assistant Secretary, Environment, Safety and Health.
[FR Doc. 95-16609 Filed 7-5-95; 8:45 am]
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