Environmental Impact Statement for Proposed Medical Isotope Production

Federal RegisterJul 6, 1995

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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

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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

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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.