[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 

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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, 

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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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