DOE/EIS-0249-IP
Public Reading Rim .P11, ment of Filwiro U. S Medical Isotopes Production Project: k'• Molybdenum-99 and Related Isotopes Environmental Impact Statement IMPLEMENTATION PLAN
U.S. Department of Energy Office of Nuclear Energy, Science and Technology Washington, D.C.
September 1995 This report has been reproduced directly from the best copy available.
Available to DOE and DOE contractors from the Office of Scientific and Technical Information, P.O. Box 62, Oak Ridge, TN
Available to the public from the National Technical Information Service, U.S. Department of Commerce, 5285 Port Royal Road, Springfield, VA 22161.
Copies of this document are available (while supplies last) upon written request to:
U.S. Department of Energy Office of Nuclear Energy, Science and Technology 1000 Independence Avenue Washington, D.C. 20585 Implementation Plan
for the
Medical Isotopes Production Project: Molybdenum-99 and Related Isotopes
Environmental Impact Statement
PREPARED BY:
The United States Department of Energy Office of Nuclear Energy, Science and Technology
APPROVED BY:
-I Terry R. Lash Director Office of Nuclear Energy, Science and Technology
The United States Department of Energy 1000 Independence Avenue Washington, D.C. 20585 Contents
1.0 Introduction 1 1.1 Identification of DOE's Proposed Action 1 1.2 Background 1 1.3 Purpose of the Implementation Plan 2
2.0 Purpose of and Need for DOE's Proposed Action 5
3.0 Planned Scope and Content of the EIS 7 3.1 Specific Alternatives to be Considered in the EIS 7 3.2 Alternatives Considered but Eliminated from Detailed Study 8 3.3 Other Issues Related to Alternatives 11
4.0 Scoping Process and Results 12 4.1 Scoping Process 12 4.2 Public Scoping Meetings 12 4.3 Scoping Results 13
5.0 Schedule for Preparation of the EIS 14
6.0 Environmental Review and Consultation 15
References 17
Appendix A - Notice of Intent A.1
Appendix B - Medical Isotopes Production Project EIS Outline B.1
Appendix C - Summary of Scoping Comments and Disposition C.1
Appendix D - Disclosure Statement D.1
iii 1.0 Introduction
The U.S. Department of Energy's (DOE)Medical Isotopes Production Project: Molybdenum-99 and Related Isotopes Environmental Impact Statement (EIS) is being prepared according to the Council . on Environmental Quality's (CEQ) regulations, 40 Code of Federal Regulations (CFR) Part 1500- 1508; the National Environmental Policy Act (NEPA); and DOE's NEPA implementing procedures, 10 CFR Part 1021.
1.1 Identification of DOE's Proposed Action
DOE proposes to establish, as soon as possible, a medical isotope production project that would establish a reliable domestic capability to produce molybdenum-99 (Mo-99) and related medical isotopes (iodine-125, iodine-131 and xenon-133). On July 6, 1995, DOE published a notice of intent (NOI) in the Federal Register (FR) to prepare an EIS for implementing its action (60 FR 35191).
1.2 Background
DOE and its predecessor agencies have produced and distributed medical and industrial isotopes through the Department's national laboratories for more than 40 years. In 1990, Congress consolidated all DOE isotope production activities under the Isotope Production and Distribution Program (IPDP). One of this program's primary responsibilities is ensuring that the U.S. health care community has a reliable supply of Mo-99. Mo-99 is a short-lived (66-hour half-life) radioactive isotope of molybdenum that is produced by modifying the nucleus of a stable isotope. A few days after its production, Mo-99 decays to form technetium-99m (Tc-99m). Tc-99m is the most widely used radioactive medical isotope in the United States because of its broad nuclear medicine applications in diagnostic procedures and medical laboratory tests.
According to the U.S. Council for Energy Awareness, approximately 36,000 diagnostic procedures using radioactive isotopes were performed daily in the United States in 1993. Most of these proCedures used Tc-99m, enabling physicians to diagnose conditions that would otherwise require exploratory surgery. Often, even surgery cannot provide the information that can be obtained through diagnostic procedures using Tc-99m. The isotope's half-life of only 6 hours minimizes the patient's radiation dose. Because the half-life of this highly perishable isotope is so short, steady production and distribution is required to maintain the stable supply that is critical for medical use.
Prior to 1989, the sole producer of Mo-99 in the U.S. was Cintichem, Inc. Cintichem produced approximately half of the Tc-99m used in the United States from 1970 to 1989. In 1989, Cintichem discontinued operation of its production reactor, and in 1991 DOE purchased Cintichem's patented technology and equipment, and Cintichem's reactor was decommissioned. Since 1989, the United States has been totally reliant on a Canadian source, Nordion International, for all of its Mo-99 and Tc-99m. Nordion produces approximately 85 percent of the Mo-99 sold worldwide; the remaining 15 percent is produced by a variety of sources, mostly European.
Nordion obtains Mo-99 from Atomic Energy of Canada Limited (AECL), purifies it, and ships it to radiopharmaceutical manufacturers. Prior to 1993, AECL operated two reactors that were available to produce Mo-99. In 1993, however, one of two Canadian reactors that had been producing Mo-99 was permanently shut down. In April 1995, the remaining AECL reactor had to be shut down unexpectedly for four days. European sources were able to temporarily increase their production to replace the Mo- 99 normally supplied to non-U.S. customers by Nordion. This allowed Nordion to use the Mo-99 product it had in process to meet the U.S. demand during this period. 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. Although AECL is considering building two new replacement reactors to produce Mo- 99, final agreement between Nordion and AECL has not been reached, and AECL apparently does not plan to operate its existing reactor beyond the year 2000.
On February 7, 1995, DOE issued a draft Environmental Assessment of Medical Isotope Production at Sandia National Laboratories/New Mexico and Los Alamos National Laboratory for public com- ment. The draft environmental assessment examined DOE's proposal to produce'medical isotopes using the Cintichem process at existing facilities at Los Alamos National Laboratory in Los Alamos, New Mexico, and at Sandia National Laboratories in Albuquerque, New Mexico. Based on the draft environmental assessment and the public comments, DOE decided to prepare an EIS on the proposed domestic production of Mo-99 and related medical isotopes.
Although Mo-99 can be produced by a number of processes, only the Cintichem process and the proprietary process used by Nordion have been approved by the Food and Drug Administration for Mo-99 sold in the United States. Both processes produce Mo-99 in a reactor. The Nordion process results in substantial quantities of liquid radioactive waste. The Cintichem process generates primarily solid waste, which can be managed and disposed of more easily. In both processes, the Mo-99 is shipped by air to radiopharmaceutical manufacturers, who package the product so that the Tc-99m can be extracted for use at medical facilities. The Cintichem process also can be used to produce certain other isotopes (iodine-125, iodine-131 and xenon-133) with medical applications.
1.3 Purpose of the Implementation Plan
This Medical Isotopes Production Project: Molybdenum-99 and Related Isotopes Environmental Impact Statement Implementation Plan has been prepared to
• report the results of the environmental impact statement scoping process
• provide guidance for preparing the environmental impact statement.
2 This plan has been prepared according to 10 CFR Part 1021, and includes the following parts:
• Section 1
DOE's proposed action explanation of the purpose of the implementation plan description of the locations where the public may review this implementation plan and transcripts of the public scoping meetings summary of the background for the NEPA review of DOE's proposal to establish a medical isotope production project.
• Section 2 - purpose of and need for DOE's proposed action
• Section 3 - outline of the planned scope and content of the EIS, including specific alternatives
• Section 4 - description of the scoping process and the results of public scoping for the EIS
• Section 5 - schedule for the preparation of the EIS
• Section 6 - anticipated environmental reviews and consultations
• Appendix A - DOE's July 6, 1995 NOI
• Appendix B - outline of the EIS
• Appendix C - summaries of the public scoping comments and DOE disposition arranged by topic
• Appendix D - contractor disclosure statement.
This implementation plan and transcripts from the public scoping meetings are available at the following locations:
DOE Headquarters National Atomic Museum Freedom of Information Building 20358 Reading Room, 1E-190 Wyoming Blvd. Forrestal Building Kirtland AFB, New Mexico 87185 1000 Independence Ave., S.W. (505) 845-4378 Washington, D.C. 20585 (202) 586-6020 r Los Alamos National Laboratory Idaho Operations Office Community Reading Room Idaho Public Reading Room 1450 Central Ave., Suite 101 1776 Science Center Drive Los Alamos, New Mexico 87544 Idaho Falls, Idaho 83402 (505) 665-2127 (208) 526-0271
Oak Ridge Operations Office Mr. Richard Leacy Public Reading Room, 112 Library 55 Jefferson Circle Georgia Institute of Technology Oak Ridge, Tennessee 37831 Atlanta, Georgia 30332-0900 (615) 241-4780 (404) 894-4519
Ms. Marsha Levine Ms. Ronita Dinger Nuclear Reactor Laboratory Research Reactor Facility, Room 229 Massachusetts Institute of Technology Research Park Mail Stop - NW 12-208 University of Missouri-Columbia 138 Albany Street Columbia, Missouri 65211 Cambridge, Massachusetts 02139 (314) 882-5318 (617) 253-4202
Mr. Terry Tehan Rhode Island Nuclear Science Center South Ferry Road Narragansett, Rhode Island 02882 (401) 789-9391
Other documents that are related to, but not within the proposed scope of, the EIS are described in the NOI (Appendix A). These documents and other related information are also available for inspection at the DOE reading rooms at DOE Headquarters, the Oak Ridge Operations Office, the Idaho Operations Office, the National Atomic Museum, and the Los Alamos National Laboratory.
Requests for copies of this implementation plan should be directed to: Wade Carroll, NEPA Document Manager, Office of Isotope Production and Distribution, NE-70, U.S. Department of Energy, 19901 Germantown Road, Germantown, MD, 20874.
4 2.0 Purpose of and Need for DOE's Proposed Action
The purpose of the proposed action is to ensure that the United States has a reliable supply of Mo- 99 and related medical isotopes available for use by the U.S. health care community. The near-term (over the next 5 to 10 years) goal is to provide a backup capability to production in Canada by supplying a baseline production level of 10 to 30 percent of the current U.S. demand for Mo-99, with the capability to supply 100 percent of the U.S. demand if the Canadian source becomes unavailable. Because it is essential to establish a backup capacity as soon as possible, DOE proposes the use of existing and proven processes, specifically an FDA-approved Mo-99 production process, to avoid the need to undergo an FDA product approval process.
The U.S. medical community accounts for about 60 percent of the worldwide use of Mo-99 and Tc-99m, yet no current domestic production source is available for these isotopes. Because the worldwide medical isotope market is influenced by forces other than narrow market forces, such as national interest and government subsidies, full cost recovery of investment is often infeasible. In addition to market vagaries, the uncertainties and liabilities associated with 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. AECL and Nordion are discussing building two modern ten megawatt reactors in Canada as replacements for the existing reactor; however, there is a window of vulnerability for the U.S. medical community until a new or reliable backup source of Mo-99 can be established. An Independent Assessment of the DOE Plan to Establish a U.S. Production Sourcefor Molybdenum-99, conducted by Integrated Resources Group, Inc., and JUPITER Corporation, dated September 30, 1994, concluded that "there is a critical need for a stable supply of Mo-99 in the United States.
Although Mo-99 production sources in Europe could increase their production rates in the event of a shutdown of the Canadian reactor, the Independent Assessment of the DOE Plan to Establish a U.S. Production Sourcefor Molybdenum-99 found that "[while the European sources] do offer some potential for the near-term [supply of Mo-99]...European capacity can only supply a portion of the U.S. demand." If the Canadian production source were to become unavailable, the supply of Mo-99 to the United States would be substantially reduced. This reduction would limit the number of diagnostic procedures that could be conducted using Tc-99m. The result would be less effective diagnoses each day of the medical conditions of thousands of medical patients in the United States. The reduction in Mo-99 supply would also notably result in a cost increase to patients for diagnostic procedures that involve Tc-99m. This could serve to make these important medical procedures unaffordable for many Americans. In short, the loss of the Mo-99 production source in Canada would likely reduce the quality and increase the cost of health care for thousands of medical patients in the United States each day.
Because the U.S. medical community has been without a reliable backup supply of Mo-99 and related medical isotopes since the shutdown of the Canadian reactor in 1993, DOE is addressing the critical need to provide a reliable backup supply of Mo-99 and related medical isotopes for domestic
5 use. In Senate Report No. 103-291 accompanying the Energy and Water Development Appropriations Act of 1995, the Committee on Appropriations stated that "[t]he 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."
The need for a domestic production source for Mo-99 has been echoed by the U.S. medical and scientific communities. Response to a statement in a December 1994 report by the Institute of Medicine's Committee on Biomedical Isotopes that the short-term Mo-99 supply situation is "no longer precarious" has been particularly strong. In a February 1995 report entitled Study Report to the House Committee on Science, Subcommittee on Energy and Environment, on the Department ofEnergy's Isotope Production and Distribution Program, the volunteer organization Senior Scientists and Engineers stated that "[i]n our only disagreement with that distinguished [Institute of Medicine] committee, we believe that their report is over optimistic on the molybdenum-99 situation, now and future...," and that "the Mo-99 problem...must be [solved] if the U.S. is to have a reliable supply of its most important non-military isotope." Also, the Position Statement on Isotope Availability issued by the Society of Nuclear Medicine and the American College of Nuclear Physicians in May 1995 stated that "it is particularly urgent that the U.S. Government work to establish a reliable uninterrupted supply of Mo-99, as the source of Tb-99m, the main radioactive isotope used in diagnostic Nuclear Medicine."
For the long-term (beyond 5 to 10 years), the Department's position is that the production of Mo-99 in the United States should be conducted by the private sector. This is consistent with the U.S. Department ofEnergy National Isotope Strategy, issued in August 1994. To that end, the Department intends to encourage the development of private sources in the United States for long-term production of Mo-99. However, the establishment of private sector production in the long-term is not within the scope of this environmental impact statement, and does not eliminate the need for a stable supply of Mo-99 in the short-term. Accordingly, as recommended by the Independent Assessment ofthe DOE Plan to Establish a U.S. Production Sourcefor Molybdenum-99, the Department plans to "move immediately to narrow this [short-term] window of risk" regarding the domestic supply of Mo-99.
6 3.0 Planned Scope and Content of the EIS
The Medical Isotope Production Project EIS will evaluate the environmental effects of DOE's proposal to establish a domestic capability to produce Mo-99 and related medical isotopes. A broad range of alternatives has been evaluated against the purpose of and need for the proposed action to determine what reasonable alternatives exist for accomplishing the proposed action. The results of this evaluation are discussed in Section 3.1. The EIS will contain a detailed evaluation of DOE's preferred alternative and the reasonable alternatives for implementing the proposed action. A No Action alternative will also be evaluated, as required by 40 CFR Part 1502.14. The EIS *ill incorporate, as appropriate, information contained in the Independent Assessment of the DOE Plan to Establish a U.S. Production Sourcefor Molybdenum-99 and the U.S. Department ofEnergy Isotope Production and Distribution Program, Management Study, issued by Arthur Anderson & Co. in March 1993.
3.1 Specific Alternatives to be Considered in the EIS
The following alternatives will be evaluated in detail in the EIS:
No Action Alternative:
Under this alternative, DOE would not establish a production capability for Mo-99 and related medical isotopes. The U.S. medical community would continue to rely on the current Canadian source or other foreign sources for these medical radioisotopes. The evaluation of this alternative will contain a discussion of the current foreign Mo-99 supply situation.
DOE Facilities:
Each of the following facilities is capable of producing a baseline production level of 10 to 30 per- cent of the U.S. demand for Mo-99, and has the capability to produce 100 percent of the U.S. demand if the Canadian source becomes unavailable.
• Existing facilities at Los Alamos National Laboratory and Sandia National Laboratories/New Mexico: DOE would establish a production capability for Mo-99 and related medical isotopes by configuring the Chemical and Metallurgy Research facility at Los Alamos to fabricate targets and the Annular Core Research Reactor and associated hot cell facility at Sandia National Laboratories/New Mexico to irradiate the targets and extract the isotopes using the Cintichem process. This is DOE's preferred alternative. An option also exists to fabricate the targets using facilities located at Sandia, and this option will be evaluated in the EIS.
7 • Power Burst Facility at the Idaho National Engineering Laboratory: DOE would establish a pioduction capability for Mo-99 and related medical isotopes by configuring and restarting the Power Burst Facility to irradiate targets. The targets would be fabricated, and isotopes would be extracted using the Cintichem process, in facilities located at the Idaho National Engineering Laboratory.
• Omega West Reactor at Los Alamos National Laboratory: DOE would establish a production capability for Mo-99 and related medical isotopes by configuring and restarting the Omega-West Reactor to irradiate targets. The targets would be fabricated, and isotopes would be extracted using the Cintichem process, in the Chemistry and Metallurgy Research facility at Los Alamos.
• Bulk Shielding Reactor or the Oak Ridge Research Reactor at Oak Ridge National Laboratory: DOE would establish a production capability for Mo-99 and related medical isotopes by configuring and restarting the Bulk Shielding Reactor or the Oak Ridge Research Reactor to irradiate targets. The targets would be fabricated, and isotopes would be extracted using the Cintichem process, in hot cell facilities located at Oak Ridge National Engineering Laboratory.
3.2 Alternatives Considered but Eliminated from Detailed Study
Other alternatives for producing Mo-99 and related medical isotopes exist, but do not appear to satisfy the purpose of and need for DOE's proposed action. These alternatives, and the reasons why they do not satisfy the purpose of and need for the proposed action, will be presented in the EIS. However, these alternatives will not be evaluated in detail in the EIS. The alternatives that were considered but dismissed were:
Federal Facilities:
• Advanced Test Reactor at the Idaho National Engineering Laboratory and the High Flux Isotope Reactor at the Oak Ridge National Laboratory: The nature of the operations at these reactors, including the operating cycle times and the length of refueling outages, would not support production of 100 percent of the U.S. demand for Mo-99.
• Fast Flux Test Facility at the Hanford Site: The Fast Flux Test Facility is a 400 megawatt, sodium-cooled reactor. In comparison, the reactor that Cintichem, Inc., used to produce Mo-99 was a 5 megawatt reactor. Using a reactor the size of the Fast Flux Test Facility to produce Mo-99 would result in generation of a disproportionate amount of spent fuel and radioactive waste, and would be extremely expensive and inefficient to operate. Therefore, the Fast Flux Test Facility does not represent a viable option for the production of Mo-99.
8 • National Institute of Standards and Technology Reactor: The National Institute of Standards and Technology Reactor does not have sufficient hot cell facilities available within the proximity necessary to reasonably produce 100 percent of the U.S. demand for Mo-99.
• Hanford TRIGA Reactor: The Hanford TRIGA does not provide enough neutrons (i.e. neutron flux) to produce 100 percent of the U.S. demand for Mo-99.
• DOE-Owned Accelerator Facilities: Due to present technical limitations on the ability to transfer heat from Mo-99 production targets, existing accelerator facilities cannot produce 100 percent of the U.S. demand for Mo-99.
University Reactors:
• University of Missouri Research Reactor at the University of Missouri at Columbia: The University of Missouri reactor operates using highly-enriched uranium fuel, which is provided by DOE. The University of Missouri has proposed that the spent fuel from their research reactor be processed by DOE to extract Mo-99. This proposal is not considered a reasonable alternative for the production of Mo-99 for several reasons.
First, the University does not have the hot cell facilities required to process the fuel bundles. The lack of hot cells would require the shipment of one freshly irradiated (i.e. minimal cooling time allowed) fuel bundle per week to a distant hot cell facility. The nearest hot cells available to handle the fuel bundles are located at Los Alamos National Laboratory, about 900 miles from the reactor. Due to the short half-life of Mo-99, the travel time required would significantly reduce the quantity of Mo-99 that could be extracted from the fuel.
Second, because Mo-99 decays so rapidly, "fresh" Mo-99 is usually made available several days each week to the pharmaceutical companies and the medical community. The reason that this is necessary is because other, non-radioactive isotopes of molybdenum (i.e., Mo-95, -96, -97, -98, and -100) are produced during the production of Mo-99. When the Mo-99 is extracted for use, these other isotopes of molybdenum are extracted as well. As the radioactive Mo-99 decays, the concentration of Mo-99 drops relative to the non-radioactive isotopes of molybdenum. At a certain point, the concentration of Mo-99 is insufficient for medical purposes, and fresh Mo-99 must be provided. The Missouri proposal calls for one fuel bundle a week to be removed from the reactor for processing. Thus the proposal would allow fresh Mo-99 to be provided only once per week. This does not meet the needs of the pharmaceutical companies and the medical community, that need to be able to get fresh Mo-99 throughout the week.
9 Finally, the fuel would have to be processed. using a process similar to the one used by Nordion, Inc. In this process, the fuel bundle would be dissolved in an acid, and the Mo-99 would be extracted from the solution. This type of processing results in the generation of a significant amount of radioactive liquid waste, on the order of 100 times greater than the amount of liquid waste that would be produced using the Cintichem process.
For these reasons, the University of Missouri proposal is not considered a reasonable alternative for the production of Mo-99. It should also be noted that the U.S. does not encourage the use of highly enriched uranium in research and test reactors, and has established the Reduced Enrichment for Research and Test Reactors (RERTR)Program to develop low-enriched uranium fuels for use in these reactors. In essence, the University of Missouri proposal is in conflict with the goals of RERTR program, in that it would make the department dependent on the highly enriched uranium fuel for its supply of Mo-99.
• Georgia Institute of Technology, Massachusetts Institute of Technology, and Rhode Island Nuclear Science Center: The reactors at each of these facilities operate on schedules that are generally incompatible with production of Mo-99, and sufficient hot cell facilities are not available within the proximity necessary to reasonably produce 100 percent of the U.S. demand for Mo-99.
• University-based TRIGA reactors: University-based TRIGA reactors in general do not provide sufficient neutrons (i.e., neutron flux) to produce 100 percent of the U.S. demand for Mo-99.
Other Alternatives:
• Babcock & Wilcox, Inc. Proposed Medical Isotope Production Reactor: This reactor concept would use a liquid-fueled reactor to produce Mo-99, and it may offer some advantages over the Cintichem process, especially in the area of waste minimization. However, the reactor concept is still at the conceptual design and feasibility demonstration stage, and therefore does not represent a reasonable near-term production source of Mo-99.
• Isotopes USA: Isotopes USA is a proposed management concept that would privatize most or all functions of the DOE Isotope Production.and Distribution Program. Because it is a management concept and not a production concept, it involves no plans to produce Mo-99 outside of privatizing any production capability that DOE may establish. Therefore, this concept by itself is not a viable alternative for the production of Mo-99.
• Use of Multiple Reactors to Provide 100% Production Capability: Multiple reactors, which individually cannot produce 100 percent of the U.S. demand for Mo-99, could be used in combina- tion to meet the 100 percent requirement. However, this is not considered a reasonable alternative for the production of Mo-99 for several reasons.
10 First, this would require that Mo-99 processing lines be established at two different facilities, or that irradiated targets be shipped from one (or both) reactors to a common processing facility. This would either roughly double processing facility costs, or would necessitate routine shipment of freshly irradiated targets. Due to the time-sensitive nature of Mo-99 production, it is desirable to avoid having to ship irradiated targets by collocating the processing facility with the irradiation facility.
Second, it is important to maintain the capability of the facilities and personnel to produce 100 per- cent of the U.S. demand for Mo-99 if necessary. Therefore, under a two-reactor scenario, both reactors (and both processing facilities, if applicable) would have to be operated routinely in a standby mode. This would require that two full reactor staffs and facilities be maintained, which would increase the cost of the Mo-99 production capability.
• Thermo Technology Ventures, Inc.: Thermo Technology Ventures is developing a concept that would allow for accelerator-based production of Tc-99m onsite at medical facilities. This concept may prove to be an effective way of producing Tc-99m. However, the concept is still at the con- ceptual design and feasibility demonstration stage, and therefore does not represent a reasonable near-term production source of Mo-99.
3.3 Other Issues Related to Alternatives
All of the alternative facilities that meet the purpose of and need for the proposed action would produce Mo-99 and related medical isotopes using the Cintichem process. The Cintichem process will be described in the EIS. Waste generation, management, storage, and disposition; transportation of targets from the fabrication facility to the production facility (where required); packaging and trans- portation of the Mo-99 and related isotopes to the distribution point; and shipment of the Mo-99 and related isotopes will be considered.
If the Department decides to produce Mo-99 in a facility that would use the Cintichem process, there may be private companies that would be interested in fabricating the targets. The Department plans to issue a sources sought notice to determine if there is any commercial interest in fabricating the targets.
Production processes other than the Cintichem process will be discussed in the EIS; these processes include the production of Mo-99 in accelerator facilities and production through the chemical pro- cessing of irradiated nuclear fuel. However, because the alternatives that would produce Mo-99 using these processes do not satisfy the purpose of and need for the proposed action, the environmental impacts of these processes will not be evaluated in detail in the EIS.
11 4.0 Scoping Process and Results
This section contains a description of the public scoping process for the EIS and a summary of the results of scoping.
4.1 Scoping Process
Scoping is an open process for determining the scope of issues to be addressed in an EIS and for identifying the significant issues related to a proposed action. As part of the scoping process, DOE invites comments and suggestions from affected and interested parties on the scope of the EIS. The scope consists of the range of actions, alternatives, and potential impacts to be considered (40 CFR 1508.25).
DOE's NOI to prepare the Medical Isotopes Production Project EIS was published in accordance with 40 CFR 1501.7, 40 CFR 1508.22, and 10 CFR 1021.311 (see Appendix A). The NOI announced the following public scoping process for the EIS:
• Public comment period from July 6, 1995 to August 7, 1995
• Public scoping meetings held at
- Idaho Falls, Idaho on July 24, 1995 - Oak Ridge, Tennessee on July 26, 1995 - Albuquerque, New Mexico on July 31, 1995 - Los Alamos, New Mexico on August 1, 1995.
Oral and written comments were received at the public scoping meetings. DOE also accepted written comments by mail. Written comments postmarked by August 7, 1995 were considered. Comments postmarked after August 7 were considered to the extent practicable. Oral and written comments will be given equal consideration in preparing the EIS.
4.2 Public Scoping Meetings
The scoping meetings were held twice daily on each of the announced dates. Each meeting began with a short presentation by a DOE official on the EIS process and the proposed medical isotope production project. Technical considerations for Mo-99 production in each specific locale were presented by local technical experts. The meetings were conducted by a neutral moderator. A question-and-answer session was held prior to the official comment portion of the meeting. Commen- tors, representing themselves or organizations, were heard in the order of their registration and were
12 encouraged to provide written versions of their oral comments for the record. Oral comments were recorded by a court reporter and made part of the official scoping meeting record. Informational literature was available, and opportunities were provided at each meeting for informal discussion about DOE's proposed action and the scope and content of the EIS.'
4.3 Scoping Results
Twenty-six people provided oral comments during the public scoping meetings, three of whom also provided written comments. Nineteen people who did not comment orally submitted written comments. In addition to themselves, commentors represented state agencies, local governmental bodies, and citizens' organizations. All comments were analyzed, and a total of 234 comments were identified among nine comment categories. A summary Of the comments by category and DOE disposition are contained in Appendix C.
13 5.0 Schedule for Preparation of the EIS
The target schedule for publication of the draft and final EIS, public and agency reviews, and publication of DOE's record of decision is as follows:
• July 6, 1995 - NOI published.
• August 7, 1995 - Complete public scoping period and begin preparation of Draft EIS.
• October 1995 - Publish Draft EIS (DEIS) and notice of availability.
• November/December 1995 - Hold public hearings on DEIS during the 45-day public comment period.
• Publish the Final EIS (FEIS) and notice of availability following DEIS the 45 day public comment period.
• Publish the record of decision following the FEIS 30 day waiting period.
14 6.0 Environmental Review and Consultation
The Draft EIS will be coordinated with other governmental agencies as appropriate to integrate the NEPA process and compliance with other environmental review requirements in accordance with DOE's NEPA regulations (10 CFR 1021.34), CEQ regulations (40 CFR 1502.25), and other statutes such as the Fish and Wildlife Coordination Act (16 U.S.C. 661 et seq.), the National Historic Preservation Act of 1966 (16 U.S.C. 470 et seq.), and the Endangered Species Act of 1973 (16 U.S.C. 1531 et seq.). DOE will consult with regulatory agencies as appropriate.
Copies of the Draft EIS will be sent to appropriate Native American tribes, federal, state, county, and city agencies, as well as advisory groups. Copies will also be sent to all other agencies and persons who have requested them. Recipients of copies of the Draft EIS may include, but will not necessarily be limited to the following organizations or groups:
Native American Groups:
• Isleta Pueblo • Tesuque Pueblo • San Ildefonso Pueblo • Cochiti Pueblo • Jemez Pueblo • Santa Clara Pueblo
Federal Agencies:
• U.S. Environmental Protection Agency • U.S. Department of the Interior - U.S. Fish and Wildlife Service - U.S. Bureau of Indian Affairs • U.S. Food and Drug Administration • U.S. Air Force, Kirtland Air Force Base
State Agencies:
• State of New Mexico Department of Public Safety • New Mexico Environment Department • State of Tennessee Department of Environment and Conservation • State of Tennessee Department of Economic and Community Development • State of Idaho Department of Health and Welfare
15 Local and County Governmental Bodies:
• City of Albuquerque, NM • Los Alamos, NM • City of Santa Fe, NM • City of Idaho Falls, ID • City of Oak Ridge, TN • Los Alamos County Council
Other:
• Cintichem, Inc. • Federal Express • Babcock & Wilcox • Nordion, Inc. • Albuquerque International Airport • Dupont Merck • Mallinckrodt • University of New Mexico, School of Medicine (New Mexico Tumor Registry) • Los Alamos Study Group • New Mexico Physicians for Social Responsibility • Concerned Citizens for Nuclear Safety • Citizens Against Radioactive Dumping • Southwest Organizing Project • Land and Water Fund of the Rockies References
60 FR 35191-35195, July 6, 1995. "Notice of Intent to an Environmental Impact Statement for Proposed Medical Isotope Production." Federal Register.
Study Report to the House Committee on Science, Subcommittee on Energy and Environment, on the Department of Energy's Isotope Production and Distribution Program. February 1995.
U.S. Department of Energy (DOE). 1995. Draft Environmental Assessment ofMedical Isotope Production at Sandia National Laboratories/New Mexico and Los Alamos National Laboratory.
Savoie, Robert A., and Singh, B. P. Independent Assessment ofthe DOE Plan to Establish a U.S. Production Servicefor Molybdenum-99. JUPITER Corporation. September 30, 1994.
Position Statement on Isotope Availability, Society of Nuclear Medicine, American College of Nuclear Physicians. May 1, 1995.
17 Appendix A
Notice of Intent APPENDIX A NOTICE OF INTENT
This appendix presents the entire text of the Notice of Intent that appeared in Volume 60, Number 129 of the Federal Register on July 6, 1995, pages 35191-35195.*
D.C. 20585. Ms. Borgstrom may be Prior to 1989, Mo-99 was produced in Statement for leaving a message at(800) Environmental Impact contacted by the United States by a single supplier, Proposed Medical Isotope Production 472-2756 or by calling (202) 586-4600. Cintichem, Inc. Cintichem produced on the DOE For general information Mo-99 by irradiating "targets" in a AGENCY: Department of Energy. isotope production program, please reactor, and later removing the Mo-99 ACTION: Notice of Intent. Lowe, Associate 413 5 1 9 1 1 contact: Mr. Owen W. from the targets. In 1989, Cintichem Director, Office of Isotope Production SUMMARY: The Department of Energy discontinued operation of its production and Distribution, NE-70, U.S. (DOE) its intent to hold reactor. Since then, the United States announces Department of Energy, 19901 scoping meetings and prepare an has relied on Canadian production Germantown, MD Environmental Impact Statement (EIS) Germantown Road, reactors for its supply of Mo-99. 20874. Mr. Lowe may be contacted by on the proposed domestic production of Prior to 1993, two Canadian reactors, molybdenum-99 (Mo-99) and related calling (301) 903-5161. operated by Atomic Energy of Canada, medical isotopes (iodine-125, iodine- SUPPLEMENTARY INFORMATION: Limited (AECL) at the Chalk River site (located about 100 miles from Ottawa, 131, and xenon-133). The EIS will Background *[35192] describe the need for and purpose of the Canada) were available to produce Mo- proposed action, the alternatives for For more than forty years, DOE and its 99 through the irradiation of targets. satisfying the need (as well as a "no predecessor agencies have produced AECL extracted the raw Mo-99 from the action" alternative), and analyze the and distributed isotopes for medical and targets and provided it to Nordion impacts of producing Mo-99 and related industrial applications through the International, who purified the Mo-99 medical isotopes using reasonable Department's national laboratories. In and shipped it to radiopharmaceutical alternative facilities. 1990, the Congress established the manufacturers. In 1993, one of the two DATES: Written comments must be Isotope Production and Distribution Canadian reactors was permanently shut postmarked not later than August 7, Program (IPDPJ, bringing together under down, leaving only the second reactor 1995 to ensure consideration. one program all DOE isotope production operating. Any shutdown or extended Comments received after that date will activities. outage of this nearly 40-year-old reactor be considered to the extent practicable. Among other activities, the IPDP has would jeopardize the U.S. supply of Mo- The locations, dates and times of the been assigned responsibility for . 99, resulting in a drastic effect on this public scoping meetings are included in ensuring a stable supply of Mo-99 to the nation's medical patients who need the Supplementary Information section United States medical care community. nuclear medicine care. In April 1995, of this notice, and will also be Mo-99 is a short-lived radioactive this reactor suffered an unplanned announced by additional appropriate isotope of molybdenum that results shutdown for four days. European means. Oral and written comments will from the fission of uranium atoms. sources were able to temporarily be considered equally in the preparation Technetium-99m (Tc-99,^), the most increase their production enough to of the EIS. widely used medical radioisotope, is a cover the European demand normally decay product of Mo-99. Tc-99m has supplied by Nordion, and ADDRESSES: Written comments on the Nordion had broad nuclear medicine applications sufficient product in scope of the medical isotope production in process to meet the the areas of diagnostic procedures and United States demand during this EIS, or other matters regarding this medical laboratory tests. The use of Tc- period. However, it was environmental review, should be expected that 99m for diagnosis enables shortages would have begun in addressed to: Mr. Wade Carroll, NEPA definition of the conditions in the body that are not United States if the Canadian Document Manager, Office of reactor Isotope currently achievable with any other had remained out of service for one or Production and Distribution, NE-70, means except invasive surgery. Also, two more days. U.S. Department of Energy, 19901 Tc-99,"concentrates in the area of the AECL is considering building two Germantown Road, Germantown, body that is of interest, and its short life modern 10 megawatt reactors as Maryland, 20874, Attn: Medical Isotope minimizes the radiation dose received replacements for the existing reactor. Production EIS. Mr. Carroll may be by the patient. Because these isotopes One new plant initially was planned to contacted by telephone at (301)903- are highly perishable with short be'put in service by 1998. However,the 7731, facsimile (301) 903-5434. lifetimes (the half-lives of Mo-99 and funding to complete construction of FOR FURTHER INFORMATION CONTACT: For Tc-99n, are 66 hours and 6 hours,' even one of these plants has not yet general information on the DOE NEPA respectively), the need to ensure a been identified and committed. In any process, please contact: Ms. Carol M. stable, continuous supply for medical case, there are apparently no plans to Borgstrom, Director, Office of NEPA use is critical. The United States operate the existing reactor beyond the Policy and Assistance, EH-42, medical community accounts for about year 2000. Thus,there is a "window of Department of Energy, 1000 60 percent of the worldwide demand for vulnerability" for the United States Independence Ave. SW,Washington, Mo-99/Tc-99m, yet there is no current medical community until a new or domestic source for these isotopes. reliable backup source of Mo-99 can be put in place. A.1 The uncertainties and liabilities of Environmental Assessment *[35193 125, iodine-131, and xenon-133) for constructing and operating a nuclear United States medical community use. reactor have prevented and will likely A draft environmental assessment The near-term goal of DOE is to provide continue to prevent private companies (EA), dated February 7, 1995, was a backup capability to supply a baseline in the United States from developing a prepared and issued for public comment production level of 10 to 30 percent of domestic source of Mo-99 to replace the on the proposed action to produce current United States demand for Mo-99 Cintichem reactor. Congress has medical isotopes using the Chemistry and 100 percent of the United States acknowledged the danger of United and Metallurgy Research facility at Los demand should the Canadian source be States dependence upon a single foreign Alamos National Laboratory, in Los unavailable. The baseline production source for its supply of Mo-99, and has Alamos, New Mexico (for target level would serve to maintain the supported DOE's efforts to ensure that a fabrication), and the Annular Core capabilities of the facilities and staff to backup capability will be available to Research Reactor(ACRR) (a small, open respond on short notice to supply the produce Mo-99 to meet the needs of the pool research reactor of 2 megawatts) entire United States demand on an as- United States medical care community and its associated hot cell facilities at needed basis. The longer term objective should the Canadian source fail. In the Sandia National Laboratories/New is to transfer the process to private Senate Report No. 103-291 Mexico (for target irradiation and industry. accompanying the Energy and Water isotope extraction). The public review • The United States demand is Development Appropriations Act, 1995, and comment period for the draft EA presently about 3,000 6-day curies per the Committee on Appropriations stated ended on May 1, 1995. Based on the week; a 6-day curie is defined as the that "Mlle the United States is fully draft EA and comments received, the amount of product, measured in curies, dependent for 100 percent of the supply Department decided that it would be remaining 6 days after the product of molybdenum-99 and technetium-99,n, appropriate to prepare an arrives on the radiopharmaceutical both important to nuclear medicine, on Environmental Impact Statement. manufacturer's dock. The sources in Canada which produces (sic) Within DOE, the ACRR at SNL/NM pharmaceutical manufacturers also these isotopes in aging facilities. Of and its associated hot cell facilities.are require that the specific activity of the particular concern is the lack, since managed by the Office of Defense product must be at least 10,000 curies 1990, of a domestic source of Programs because the principal use of of activity per gram of molybdenum molybdenum-99, an isotope used to these facilities has been to support when it arrives at the manufacturer's produce technetium-99m which is used defense research needs. There is a dock. in approximately 36,000 medical defense-related experiment in progress diagnoses per day. The Committee notes in the ACRR that is scheduled to be Proposed Process that the Department is taking steps completed in mid-August 1995. Beyond DOE proposes to use the Cintichem to . . . produce molybdenum-99 and that, the Office of Defense Programs has process as the most expeditious way to related medical isotopes to ensure that not currently identified any follow-on satisfy the goals of the proposed action. there are no inadequacies of supply for work; however, the ACRR must be A brief description of the steps in the domestic use. The committee supports available to support DP missions in time process follows. this effort and wishes to be kept of emergency for national security As the initial step in the proposed informed as the Department reasons. DOE has not yet decided on Mo-99 production program, targets progresses." Congress provided $7.6 any specific other uses for the ACRR, containing highly enriched uranium million for this effort for Fiscal Year although a range of activities are would be fabricated, tested and shipped (FY)1995, and the President requested possible for a reactor of this type. These to the reactor facility for irradiation. $12 million for FY 1996. activities could involve other DOE Target elements would be manufactured program areas besides the production of by electroplating highly enriched Production Processes Mo-99 and related medical isotopes, as uranium oxide on the inner wall of Mo-99 can be produced by a number well as work performed for other stainless steel tubes, and then sealing of processes. However, only two agencies or organizations, such as the the ends with custom fittings. processes have been approved by the past work performed for the Nuclear At the reactor facility, thetargets Food and Drug Administration for Mo- Regulatory Commission. In the interim, would be irradiated for several days 99 sold in the United States: the DOE will physically maintain the depending on the power level. Upon proprietary process used by Nordion, reactor, hot cells and associated removal from the reactor, the irradiated and the Cintichem process. Both facilities, and will continue to train the targets would be transferred in a processes produce Mo-99 in a reactor. operating staff to maintain their shielded cask to an appropriate hot cell The Nordion process results in proficiency to meet safe operating facility, preferably located immediately substantial quantities of liquid standards. DOE will also complete adjacent to or near the reactor facility radioactive waste, while the Cintichem installation of a new control system because of the short half-life of Mo-99. process produces largely solid waste, designed to meet today's standards. In Within the hot cells, the•isotopes of which is much easier to manage and addition, SNL/NM will clean out interest would be extracted from the dispose. "legacy" waste materials that remain, fission product inventory by chemical In November, 1991, DOE purchased principally in the hot cells and storage dissolution and precipitation the Cintichem technology and areas adjacent to the reactor. procedures. The isotopes would be equipment for $750,000 plus an Proposed Action further refined and would undergo strict agreement to pay Cintichem a 4 percent quality control procedures to meet FDA royalty on the first 5 years of sales of The proposed action is for DOE to standards. - Mo-99 and other isotopes producedin establish within two years a medical Because Mo-99 decays at the rate of the Cintichem process. In addition, DOE radioisotope production program that about 1 percent per hour, all steps after agreed to accept the spent nuclear fuel would ensure the domestic capability to irradiation of the target and shipment of from the Cintichem reactor. produce a continual supply of Mo-99 the product must be expedited. The Subsequently, the reactor was and related medical isotopes (iodine- isotopes would be packaged in decommissioned. A.2 Alternatives to Accomplish the Proposed Action There are several existing federally- would be obtained by on-line extraction Department of Transportation-approved owned facilities that could be of a portion of the uranyl nitrate and packaging for shipment by air freight on configured to produce Mo-99 and other passing it through an ion exchange a daily basis to any of the three medical isotopes. Previous studies column, where the Mo-99 would be currently known potential customers: which narrowed the possible deposited. The uranyl nitrate would DuPont -Merck in Boston, alternatives to a single reactor facility, then be returned to the reactor. Wastes Massachusetts; Amersham Mediphysics ACRR, will be revisited and re- could be substantially reduced with this in the Chicago, Illinois; and Mallinckrodt in evaluated. Possible additional DOE concept. B&W believes that a MIPR Mo- St. Louis, Missouri. Air express class facilities include: 99 facility could be run as a profitable shipments would be used. LANL business. However, to date, the The radioactive waste would (1) Omega West Reactor at be both (2) Advanced Test Reactor at the Idaho perceived risks have prevented them low-level waste(LLW) and spent National Engineering Laboratory from making a corporate commitment to nuclear fuel. Both types of waste would fund such an enterprise without be managed, stored (INEL) and eventually (3) High Flux Isotope Reactor at the Oak substantial government support. disposed of in accordance with Ridge National Laboratory(ORNL) • Isotopes U.S.A.: Personnel from applicable requirements and DOE's Idaho National Engineering regulations. The possibility of using non-DOE federally-owned facilities will also be Laboratory (INEL) and the University of Although no mixed waste (waste that Idaho have developed a concept, is both examined. *[35194] radioactive and chemically referred to as Isotopes U.S.A. Under this hazardous) would be generated in the Alternatives to the Proposed Action concept, a not-for-profit corporation isotope extraction process, small There may be ways to accomplish the would be established dedicated to amounts of mixed waste would be goal of the proposed action (i.e., education, research and other scientific produced during target fabrication. source for the domestic purposes relevant to the production and These mixed establish a waste streams would he use of stable and radioactive isotopes. managed, stored production of Mo-99) that would use and disposed of in The concept includes isotope accordance with private rather than federally-owned applicable production and distribution, isotope requirements and facilities. However, some or all of these regulations. research, education and training, During the preparation of the EIS, the alternatives would not be able to meet administration and for-profit isotope Department will conduct laboratory- this goal within the time desired. The ventures. This concept, should it be scale process validation tests to help alternatives identified below, as well as implemented, could privatize most, if ensure that the Cintichem process can others which may be identified in the not all, of the current IPDP functions, be accurately reproduced. The results of scoping process, will be considered. including the production of Mo-99. these tests would be applicable to any (1) University Reactors: Several site for Mo-99 production using the United States universities currently Partial Alternatives Cintichem process. operate research reactors, which are typically small and relatively simple. Some alternatives to meet individual Alternatives They also typically do not have hot cell portions of the proposed action will be DOE has identified a number of facilities or radio-chemical process considered in combination with other alternatives for the production of Mo-99. facilities. However,in some cases, appropriate processing and irradiation Others may be identified during the university reactors have already facilities. Target scoping process. All alternatives will be produced other radioisotopes, and they Examples are:(1) Alternative target evaluated against the purpose and need will be re-evaluated. Universities which Fabrication Sites: Alternate for the proposed action, and those that have reactor facilities that are of fabrication sites include DOE facilities meet the goals of the proposal will be particular interest are listed below: at LANL, SNL/NM,or ORNL or addressed in detail in the EIS. At this • The University of Missouri. commercial facilities such as Babcock time, DOE's preferred alternative is to • Rhode Island Nuclear Science and Wilcox in Lynchburg, Virginia; use the Cintichem process with Mo-99 Center. Nuclear Fuel Services in Erwin, target fabrication in the CMR at • Georgia Institute of Technology. Tennessee; and General Atomics in San LANL • Massachusetts Institute of and target irradiation and isotope Diego, California. Any alternate separation in the ACRR and Technology. fabrication site would manufacture the associated (2) New Concepts: New concepts hot-cell facilities at SNL. same target using the selected process. which have been proposed for the (2) Alternate Target Processing Sites: No Action production of Mo-99 will be considered. .Some hot cell facilities may be more The Council on Environmental Examples of these new concepts • effective for post-irradiation processing Quality regulations implementing NEPA include: than the hot cells that are near a require that an agency analyze the • Medical Isotope Production Reactor candidate reactor, although such (MIPR): The Babcock and Wilcox impacts of not taking the proposed arrangements would have to consider action (the "No Action Corporation(B&W) has submitted an the short half-life of Mo-99. Also, if the Alternative"). In unsolicited proposal to DOE this case, the No Action Alternative to design, targets were fabricated at the same construct and operate a new and would mean that DOE would not facility where the post-irradiation establish a backup production unproven reactor concept that uses an processing is done, there would be the capability aqueous solution of uranyl nitrate for Mo-99. The United States medical potential that unfissioned uranium from contained in an aluminum or stainless community would continue to rely on the targets could be recycled back into steel vessel immersed in a large pool of the current Canadian source, or other new targets. water to provide both shielding and heat foreign sources, of radioisotopes. exchange. The reactor could be operated with low-enriched fuel. The Mo-99
A.3 Preliminary Identification of (3) The Programmatic Environmental In addition to formal opportunities for Environmental Issues Impact Statement for Waste comment, anyone may submit The issues listed below have been Management will address waste comments at any time during the NEPA tentatively identified for analysis in the management alternatives for existing process; however, to ensure that Medical Isotope Production EIS. This and proposed actions and DOE comments are considered at specific list is presented to facilitate public complex-wide issues associated with points in the NEPA review process, and comment on the scope of the EIS. It is long-term waste management policies to best assist DOE,the public is not intended to be all-inclusive or to and practices. An Implementation Plan encouraged to comment during the predetermine the potential impacts of for this Programmatic EIS was issued in formally established comment periods. any of the alternatives. DOE seeks January 1994. Copies of design and other public comment on the adequacy and (4) The Programmatic Environmental background documents, written inclusiveness of these issues: Impact Statement for Spent Nuclear comments, records of public meetings, (1) Potential impacts on natural Fuel Management and Idaho National and other materials related to the ecosystems, including air quality, Engineering Laboratory Environmental development of the EIS have been and surface and ground water quality, and Restoration and Waste Management are being placed in DOE Reading Rooms plants and animals; addresses the management of DOE- at the following locations: (2) Potential health and safety impacts owned spent nuclear fuel. A Record of DOE Headquarters, 1000 Independence to on-site workers and to the public Decision for the Programmatic EIS was Avenue; S.W., Room 1E-190, resulting from operations, including published in the Federal Register on Washington, D.C., 20585, phone (202) reasonable postulated accidents; June 1, 1995. 586-3142; (3) Potential health and safety. *[35195] Public Involvement Opportunities National Atomic Museum, Building environmental and other impacts 20358, Wyoming Blvd., Kirtland Air related to the transport of targets and DOE will develop a public Force Base, New Mexico 87185, radioisotopes; ("stakeholder") involvement plan for phone (505) 845-4378; this EIS (4) Waste management considerations process. To assist with Los Alamos National Laboratory related to the generation, storage and developing the stakeholder involvement Community Reading Room, 1450 plan, disposal of hazardous waste, LLW, the DOE requests suggestions by Central Avenue, Suite 101, Los the mixed waste and spent nuclear fuel; public on how this EIS process Alamos, New Mexico 87544, phone (5) Potential cumulative impacts of should be conducted, including (505) 665-2127; Mo-99 production operations, including suggestions regarding the type, format, Idaho Operations Office, Idaho Public relevant impacts from other past present and conduct of public involvement and Reading Room,1776 Science Center , reasonably foreseeable activities at opportunities. Drive, Idaho Falls, Idaho, the 83402, production site; Through this notice, the DOE formally phone (208) 526-0271; and (6) Potential impacts on cultural invites States, tribes, other government Oak Ridge Operations Office, Public agencies, resources; and the public to comment on Reading Room,55 Jefferson Circle, (7) the scope of this EIS. The Potential socioeconomic impacts, locations, Room 112, Oak Ridge, Tennessee, including any disproportionate impacts dates and times for these public 37831,(615) 241-4780. on minority and low income meetings are: Issued in Washington, D.C., this 30th day populations; and Idaho National Engineering of June 1995, for the United States (8) Potential economic impacts, Laboratory—July 24, 1995, 1:00 p.m. Department of Energy. including those from producing to 4:00 p.m. and 7:00 p.m. to 10:00 Peter N. Brush, radioisotopes for commercial sector use. p.m., Shilo Inn, 780 Lindsay Blvd., Principal Deputy Assistant Secretary, Related NEPA Documentation Idaho Falls, ID 83402,Ph. (208) 536- Environment, Safety and Health. 0805 (FR Doc. 95-16609 Filed 7-5-95; 8:45 aml NEPA documents that have been or Oak Ridge National Laboratory—July 26, BILUNG CODE 6450-01-P are being prepared for activities related 1995, 1:00 p.m. to 4:00 p.m. and 7:00 to the proposed action include, but are p.m. to 10:00 p.m., Pollard not limited to, the following: Auditorium, 210 Badger Avenue, Oak (1) The LANL Site Wide EIS (a Notice Ridge, TN 37830, Ph.(615) 576-0885 of Intent was published at 60 FR 25697, Sandia National Laboratories/ May 12, 1995) will analyze the Albuquerque—July 31, 1995, 1:00 cumulative impacts of operations and p.m. to 4:00 p.m. and 7:00 p.m. to • planned activities foreseen at LANL 10:00 p.m., Albuquerque Convention within the next 5 to 10 years. Center, Cochiti/Taos Rooms,401 2nd (2) An Environmental Assessment for Street, N.W., Albuquerque, NM SNL/NM Offsite Transportation of Low- 87102,Ph. (505) 845-6094 Level Radioactive Waste is currently Los Alamos National Laboratory— being prepared which will evaluate the August 1, 1995, 1:00 p.m. to 4:00 p.m. shipment of both existing inventories of and 7:00 p.m. to LLW 10:00 p.m., Hilltop . accumulated at SNL/NM since House,400 Trinity Drive, Los 1988 and LLW Alamos, projected to be newly NM 87544,Ph. (505) 665-4400 generated at SNUNM in the foreseeable future. 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. A.4 Appendix B
Medical Isotopes Production Project: Molybdenum-99 and Related Isotopes Environmental Impact Statement Outline Appendix B
Medical Isotopes Production Project: Molybdenum-99 and Related Isotopes Environmental Impact Statement Outline
Cover Sheet
Executive Summary
Acronyms
Table of Contents
1.0 Introduction 1.1 Overview 1.2 Organization of this EIS 1.3 Alternatives Analyzed 1.4 Laws and Regulations 1.5 Invitation to Comment 1.6 Next Steps
2.0 Purpose of and Need for Action 2.1 Background 2.2 Purpose and Need
3.0 Alternatives 3.1 Overview 3.1.1 Chapter Description/Overview 3.1.2 Approach to Determine the Reasonable Range of Alternatives 3.1.2.1 Molybdenum-99 Generation Facility(s) Needs 3.1.2.2 Molybdenum-99 Separation Facility Needs 3.2 Alternatives and Actions 3.2.1 No Action Alternative 3.2.1,1 Description of the Alternative 3.2.1.2 Impacts of the No-Action Alternative 3.2.2 Proposed Action 3.3 Facilities supporting the Proposed Action that use the Cintichem Process 3.3.1 ACRR—Sandia 3.3.1.1 Description of the Alternative 3.3.1.2 Existing Facilities 3.3.1.3 Target Fabrication at LANL 3.3.1.4 Target Shipment to SNL 3.3.1.5 Target Fabrication at SNL
B.1 3.3.1.6 Target Irradiation Activities 3.3.1.7 Target Transfer to Hot Cell Facility 3.3.1.8 Isotope Extraction at Hot Cell Facility 3.3.1.9 Product Shipment 3.3.1.10 Waste Handling 3.3.1.11 Low level Waste 3.3.1.12 Decontamination 3.3.1.13 Spent Fuel 3.3.1.14 Required Modifications 3.3.1.15 Required CMR Facility Modifications at LANL 3.3.1.16 Required ACRR Facility Modifications at SNL 3.3.1.17 Required Hot Cell Facility Modifications 3.3.1.18 Prototype and Proof-of-Principle Testing 3.3.1.19 Conversion of ACRR to Support Defense Program (DP) Mission 3.3.1.20 Estimated Construction Schedule 3.3.1.21 Waste Management 3.3.1.22 Management of Low Level Wastes 3.3.1.23 Management of Spent Fuel 3.3.2 Los Alamos and the Omega West Reactor 3.3.2.1 Description of the Alternative 3.3.2.2 Existing Facilities 3.3.2.3 Target Fabrication 3.3.2.4 Target Irradiation Facility Description 3.3.2.5 Events Leading to the Shutdown of the Omega West Reactor 3.3.2.6 Irradiation Process Description 3.3.2.7 Molybdenum-99 Recovery Process Description 3.3.2.8 Shipment 3.3.2.9 Waste Handling 3.3.2.10 Storage Facilities 3.3.2.11 Required Modifications 3.3.2.12 Estimated Construction Schedule 3.3.2.13 Waste Management 3.3.3 ORR/BSR—Oak Ridge 3.3.3.1 Description of the Alternative 3.3.3.2 Existing Facilities 3.3.3.3 Target Fabrication 3.3.3.4 Target Irradiation Facility 3.3.3.5 The Oak Ridge Research Reactor 3.3.3.6 Bulk Shielding Reactor 3.3.3.7 Irradiation Process Description 3.3.3.8 Irradiation at Oak Ridge Research Reactor 3.3.3.9 Irradiation at Bulk Shielding Reactor 3.3.3.10 Molybdenum-99 Recovery Process Description 3.3.3.11 Molybdenum-99 Shipment 3.3.3.12 Waste Handling 3.3.3.13 Required Modifications
B.2 3.3.3.14 Estimated Construction Schedule 3.3.3.15 Waste Management 3.3.4 Idaho National Engineering LabOratory - Power Burst Facility 3.3.4.1 Introduction and INEL History 3.3.4.2 Medical Isotope Production at INEL 3.3.4.3 Existing Facilities 3.3.4.4 Target Fabrication Facility and Process Description 3.3.4.5 Target Irradiation Facility Description 3.3.4.6 Current Status of PBF 3.3.4.7 PBF Reactor Details 3.3.4.8 PBF molybdenum-99 Production Capabilities 3.3.4.9 ATR Molybdenum-99 Production Capabilities 3.3.4.10 Molybdenum-99 Recovery Process Description and Facilities 3.3.4.11 Shipping of Molybdenum-99 3.3.4.12 Waste Management 3.3.4.13 Storage Facilities 3.3.4.14 Required Modifications 3.3.4.15 Estimated Schedule for Modifications 3.3.4.16 Estimated Cost of Modifications 3.3.4.17 Anticipated Radiation Environment 3.4 Alternatives Considered but Dismissed from Detailed Consideration 3.4.1 Other Federal Reactors 3.4.1.1 Advanced Test Reactor - Idaho National Engineering Laboratory 3.4.1.2 NIST Reactor/AFFRI Hot Cell Facilities 3.4.1.3 TRIGA Reactors, Including Hanford and/or Washington State University 3.4.1.4 Oak Ridge and the High Flux Isotope Reactor (HFIR) 3.4.1.5 FFTF—Hanford 3.4.1.6 Accelerator Facilities (Los Alamos and others) 3.4.2 University Reactors 3.4.2.1 University of Missouri(MURR) 3.4.3 Other Public/Private Options 3.4.3.1 Isotopes USA 3.4.3.2 Babcox and Wilcox MIPR
4.0 Affected Environment 4.1 No Action Alternative 4.2 Albuquerque Environment 4.2.1 Overview 4.2.2 Land Use 4.2.2.1 Albuquerque Area 4.2.2.2 Sandia National Laboratories 4.2.2.3 Technical Area V 4.2.3 Socioeconomic Environment 4.2.3.1 Demographic Characteristics 4.2.3.2 Economic Base 4.2.3.3 Community Infrastructure and Social Services
B.3 4.2.4 Cultural Resources 4.2.5 Aesthetic and Scenic Resources 4.2.6 Geologic Resources 4.2.6.1 General Geology 4.2.6.2 Mineral Resources 4.2.6.3 Site Stability 4.2.7 Air Quality 4.2.7.1 Radioactive Effluent Monitoring at SNL/NM 4.2.7.2 Climatology and Meteorology 4.2.7.3 Nonradiological Air Quality 4.2.8 Water Quality 4.2.8.1 Surface Water 4.2.8.2 Groundwater 4.2.9 Ecological Resources 4.2.9.1 Terrestrial Resources 4.2.9.2 Aquatic Resources 4.2.9.3 Wetlands 4.2.9.4 Threatened and Endangered Species 4.2.10 Noise 4.2.10.1 Noise Measurements 4.2.10.2 Annular Core Research Reactor Noise Analysis 4.2.11 Transportation 4.2.11.1 Roadways 4.2.11.2 Airports and Air Traffic 4.2.12 Occupational and Public Health and Safety 4.2.12.1 Current Radiation Environment 4.2.12.2 Present Radiological Exposures of Workers in Technical Area V 4.2.13 Site Services 4.2.14 Waste Management 4.2.14.1 Introduction 4.2.14.2 Low-Level Waste 4.2.14.3 Low-Level Mixed Waste 4.2.14.4 Hazardous Waste 4.2.14.5 Non Hazardous - Industrial and Sanitary Solid Waste 4.3 Los Alamos Environment 4.3.1 Overview 4.3.2 Land Use 4.3.2.1 Los Alamos Area 4.3.2.2 Los Alamos National Laboratories 4.3.2.3 Technical Area 2 4.3.3 Socioeconomic Environment 4.3.3.1 Demographic Characteristics 4.3.3.2 Economic Base 4.3.3.3 Community Infrastructure and Social Services 4.3.4 Cultural Resources 4.3.5 Aesthetic and Scenic Resources 4.3.6 Geology Resources
B.4 4.3.6.1 General Geology 4.3.6.2 Mineral Resources 4.3.6.3 Site Stability 4.3.7 Air Quality 4.3.7.1 Routine Air, Water, and Foodstuffs Monitoring 4.3.7.2 Climatology and Meteorology 4.3.7.3 Nonradiological Air Quality 4.3.8 Water Quality 4.3.8.1 Surface Water 4.3.8.2 Groundwater 4.3.9 Ecological Resources 4.3.9.1 Terrestrial Resources 4.3.9.2 Aquatic Resources 4.3.9.3 Wetlands 4.3.9.4 Threatened and Endangered Species 4.3.10 Noise 4.3.11 Transportation 4.3.11.1 Roadways 4.3.11.2 Airports and Air Traffic 4.3.12 Occupational and Public Health and Safety 4.3.12.1 Current Radiation Environment 4.3.13 Site Services 4.3.14 Waste Management 4.3.14.1 Spent Nuclear Fuel 4.3.14.2 Transuranic Waste (TRU) 4.3.14.3 Low-Level Waste 4.3.14.4 Low-Level Mixed Waste 4.3.14.5 Hazardous Waste 4.3.14.6 Non Hazardous - Industrial and Sanitary Solid Waste 4.4 Oak Ridge Environment 4.4.1 Overview 4.4.2 Land Use 4.4.2.1 Oak Ridge Area 4.4.2.2 Oak Ridge Reservation 4.4.2.3 Oak Ridge National Laboratory 4.4.3 Socioeconomic and Environment Justice 4.4.3.1 Demographic Characteristics 4.4.3.2 Economic Characteristics 4.4.3.3 Community Infrastructure and Social Services 4.4.4 Cultural Resources 4.4.5 Aesthetic and Scenic Resources 4.4.6 Geologic Resources 4.4.6.1 General Geology 4.4.6.2 Mineral Resources 4.4.6.3 Site Stability
B.5 4.4.7 Air Quality 4.4.7.1 Climatology and Meteorology 4.4.7.2 Nonradiological Air Quality 4.4.8 Water Quality 4.4.8.1 Surface Water 4.4.8.2 Groundwater 4.4.9 Ecological Resources 4.4.9.1 Terrestrial Resources 4.4.9.2 Aquatic Resources 4.4.9.3 Wetlands 4.4.9.4 Threatened and Endangered Species 4.4.10 Noise 4.4.11 Transportation 4.4.11.1 Roadways 4.4.11.2 Airports and Air Traffic 4.4.12 Occupational and Public Health and Safety 4.4.13 Site Services 4.4.14 Waste Management 4.4.14.1 Spent Nuclear Fuel 4.4.14.2 Transuranic Waste 4.4.14.3 Low-Level Waste 4.4.14.4 Low-Level Mixed Waste 4.4.14.5 Hazardous Waste 4.4.14.6 Non Hazardous - Industrial and Sanitary Solid Waste 4.4.14.7 Hazardous Materials 4.5 Idaho Falls Environment 4.5.1 Overview 4.5.2 Land Use 4.5.2.1 Regional Area 4.5.2.2 Idaho National Engineering Laboratory 4.5.2.3 Power Burst Facility 4.5.3 Socioeconomic Environment 4.5.3.1 Demographic Characteristics 4.5.3.2 Economic Base 4.5.3.3 Community Infrastructure and Social Services 4.5.4 Cultural Resources 4.5.5 Aesthetic and Scenic Resources 4.5.6 Geologic Resources 4.5.6.1 General Geology 4.5.6.2 Mineral Resources 4.5.6.3 Site Stability 4.5.7 Air Quality 4.5.7.1 Climatology and Meteorology 4.5.7.2 Nonradiological Air Quality 4.5.8 Water Quality 4.5.8.1 Surface Water 4.5.8.2 Groundwater
B.6 4.5.9 Ecological Resources 4.5.9.1 Terrestrial Resources 4.5.9.2 Aquatic Resources 4.5.9.3 Wetlands 4.5.9.4 Threatened and Endangered Species 4.5.10 Noise 4.5.11 Transportation 4.5.11.1 Roadways 4.5.11.2 Airports and Air Traffic 4.5.12 Occupational and Public Health and Safety 4.5.13 Site Services 4.5.14 Materials and Waste Management 4.5.14.1 High-Level Waste 4.5.14.2 Spent Nuclear Fuel 4.5.14.3 Transuranic Waste 4.5.14.4 Low-Level Waste 4.5.14.5 Low-Level Mixed Waste 4.5.14.6 Hazardous Waste 4.5.14.7 Non Hazardous - Industrial and Sanitary Solid Waste 4.5.14.8 Hazardous Materials
5.0 Environmental Consequences 5.1 Overview 5.2 Land Use 5.2.1 SNL/NM Annular Core Research Reactor Alternative 5.2.2 LANL — Omega West Reactor Alternative 5.2.3 ORR -- Oak Ridge Research Reactor\Bulk Shielding Reactor Alternative 5.2.4 INEL -- Power Burst Facility Alternative 5.3 Socioeconomics 5.3.1 No Action Alternative 5.3.2 SNL/NM — Annular Core Research Reactor Alternative 5.3.3 LANL — Omega West Reactor Alternative 5.3.4 ORR — Oak Ridge Research Reactor\Bulk Shielding Reactor Alternative 5.3.5 INEL — Power Burst Facility Alternative 5.4 Cultural Resources 5.5 Aesthetic and Scenic Resources 5.5.1 SNL/NM — Annular Core Research Reactor Alternative 5.5.2 LANL — Omega West Reactor Alternative 5.5.3 ORR — Oak Ridge Research Reactor\Bulk Shielding Reactor Alternative 5.5.4 INEL — Power Burst Facility Alternative 5.6 Geologic Resources 5.7 Air Quality 5.7.1 SNL/NM — Annular Core Research Reactor Alternative 5.7.2 LANL — Omega West Reactor Alternative 5.7.3 ORR — Oak Ridge Research Reactor\Bulk Shielding Reactor Alternative 5.7.4 INEL — Power Burst Facility Alternative 5.8 Water Quality
B.7 5.9 Ecological Resources 5.9.1 SNL/NM -- Annular Core Research Reactor Alternative 5.9.2 LANL -- Omega West Reactor Alternative 5.9.3 ORR -- Oak Ridge Research Reactor\Bulk Shielding Reactor Alternative 5.9.4 INEL -- Power Burst Facility Alternative 5.10 Noise 5.10.1 SNL/NM -- Annular Core Research Reactor Alternative 5.10.2 LANL -- Omega West Reactor Alternative 5.10.3 ORR -- Oak Ridge Research Reactor\Bulk Shielding Reactor Alternative 5.10.4 INEL -- Power Burst Facility Alternative 5.11 Transportation 5.11.1 Methods and Assumptions 5.11.2 Routine or Incident-free Transportation Impacts 5.11.3 Transportation Accident Impacts 5.12 Occupational and Public Health and Safety 5.12.1 Radiological Consequences 5.12.2 Nonradiological Consequences 5.13 Site Services and Resources 5.13.1 SNL/NM — Annular Core Research Reactor Alternative 5.13.2 LANL -- Omega West Reactor Alternative 5.13.3 ORR -- Oak Ridge Research Reactor\Bulk Shielding Reactor Alternative 5.13.4 INEL -- Power Burst Facility Alternative 5.14 Waste Management 5.14.1 SNL/NM — Annular Core Research Reactor Alternative 5.14.2 LANL -- Omega West Reactor Alternative 5.14.3 ORR — Oak Ridge Research Reactor\Bulk Shielding Reactor Alternative 5.14.4 INEL — Power Burst Facility Alternative 5.15 Facility Accidents 5.15.1 SNL/NM -- Annular Core Research Reactor Alternative 5.15.2 LANL -- Omega West Reactor Alternative 5.15.3 ORR -- Oak Ridge Research Reactor\Bulk Shielding Reactor Alternative 5.15.4 INEL — Power Burst Facility Alternative 5.16 Cumulative Impacts 5.16.1 SNL/NM — Annular Core Research Reactor Alternative 5.16.2 LANL -- Omega West Reactor Alternative 5.16.3 ORR — Oak Ridge Research Reactor\Bulk Shielding Reactor Alternative 5.16.4 INEL — Power Burst Facility Alternative 5.17 Adverse Environmental Impacts that Cannot be Avoided 5.18 Relationship Between Short-Term Uses of the Environment and the Maintenance and Enhancement of Long-Term Productivity 5.19 Irreversible and Irretrievable Commitment of Resources 5.20 Potential Mitigation Measures 5.20.1 Pollution Prevention/Waste Minimization 5.20.2 Socioeconomics 5.20.3 Cultural (Including Archaeological, Historical, and Cultural) Resources 5.20.4 Air Resources' 5.20.5 Water Resources
B.8 5.20.6 Ecology 5.20.7 Noise 5.20.8 Traffic and Transportation 5.20.9 Occupational and Public Health and Safety 5.20.10 Site Utilities and Support Services 5.20.11 Accidents 5.21 Environmental .Justice 5.21.1 Annual Core Research Reactor Alternative 5.21.2 Omega West Reactor Alternative 5.21.3 Oak Ridge Research Reactor/Bulk Shielding Reactor Alternative 5.21.4 Power Burst Facility Alternative 5.22 Costs 5.22.1 SNL/NM -- Annular Core Research Reactor Alternative 5.22.2 LANL -- Omega West Reactor Alternative 5.22.3 ORR -- Oak Ridge Research Reactor\Bulk Shielding Reactor Alternative 5.22.4 INEL — Power Burst Facility Alternative
6.0 Regulatory Requirements 6.1 Radiological Safety Oversight 6.2 Food and Drug Administration Approvals 6.3 Transportation Requirements 6.4 Occupational Safety and Radiation Exposure 6.5 Radiation Exposure to Members of the Public 6.6 Noise 6.7 Floodplains and Wetlands 6.8 Species Protection 6.9 Native American, Archaeological, and Historic Preservation Statutes 6.10 Environmental Justice 6.11 Recreational Fisheries 6.12 Chemical and Material Storage 6.13 Waste Management 6.14 Emergency Planning and Community Right-to-Know 6.15 Pollution Prevention 6.16 Radioactive Air Emissions 6.17 Nonradioactive Air Emissions 6.18 Liquid Discharges to the Ground or Publicly Owned Treatment Works
Technical Appendix
B.9 Appendix C
Summary of Scoping Comments and DOE Disposition Index to Appendix C Summary of Scoping Comments and DOE Disposition
1.0 Comments on Purpose and Need C.1 Disposition C.7
2.0 Comments on Alternatives C.8 Disposition C 13
3.0 Comments on Waste Generation/Management C 13 Disposition C 16
4.0 Comments on Transportation C 16 Disposition C17
5.0 Comments on the NEPA Process C 17 Disposition C 22
6.0 Comments on General Health and Safety C 22 Disposition C 28
7.0 Comments on Environmental Justice C 28 Disposition C 29
8.0 Comments on Cost and Schedule C 29 Disposition C31
9.0 Comments on Socioeconomic Impacts C31 Disposition C 32 Appendix C
Summary of Scoping Comments and DOE Disposition
The Council on Environmental Quality's regulations for implementing the National Environmental Policy Act state that "there shall be an early and open protess for determining the scope of issues to be addressed and for identifying the significant issues related to a proposed action. This process shall be termed "scoping" (40 CFR 1501.7). The purpose of scoping is to determine the "range of actions, alternatives, and impacts to be considered in an environmental impact statement" (40 CFR 1508.25). In this appendix all of the comments received by DOE during the scoping period are listed and grouped into broad categories. DOE's responses follow each category. The statements, for the most part, address comments that identify actions, alternatives, and impacts to be considered in the Medical Isotopes Production Project Environmental Impact Statement.
1.0 Comments on the Purpose and Need
1. We reviewed the draft Environmental Assessment (EA)for the program and determined that the program entailed no significant environmental or health impacts. As a result,...[we] support the program and its necessity.
2. mhe two-year requirement...appears to be...an artificial requirement which may limit the options in a technical sense, if you have to start up another new reactor...I would ask that the time be stated in a broader way, such that a hundred percent production would be capable of being achieved prior to the year 2000 and a demonstration of some percentage be achievable by, maybe, a year or two before that.
3. For years the medical community has been aware of the precarious nature of the medical isotope supply for this country. Depending on one, out-of-country source for these vital diagnostic and treatment materials is at best risky, at worst foolhardy.
4. The [relative) risk to patients of not having Mo-99ITc-99m available for therapy and treatment, as well as the relative cost of having the isotopes produced in various alternate locations, must be considered.
5. As a former patient who has [received diagnostic work] using radioactive isotopes, I can speak from personal experience that this is something we've got the begin to address in this country and we have not done.
6. Medical isotopes helped to save my son's life. What was indistinguishable on the barium x-rays was easily diagnosed with the technetium-99 procedure. The proposed production program lists technetium-99 as one of the isotopes that would be generated. I want it.
C.1 7. The American Society of Health-System Pharmacists (ASHP) supports DOE's proposed action to established within two years a medical radioisotope production program...as a vital goal in terms of public health and patient care. The lack of domestic production of these isotopes places the future provision of important nuclear medicine diagnostic procedures in jeopardy, and the DOE's alternatives to getting isotope production started within the United States are reasonable in terms of a short-term solution.
8. [A]bout 3 percent of the population in the United States has medical isotopes given to them each year. Three percent is a large number. I think some things have to be funded by the government...
9. It does need to be in the public sector until it gets going because if you look at...oil-[o]il has been turned over tho the private sector, [and] [nifty percent of it is imported...[A]lmost all of the uranium is imported. That is in the private sector.
10. Conclusions of [the Jupiter Report and the report from the Committee on Biomedical Isotopes] contradict conclusions by DOE about the availability of medical isotopes and the need for the public to subsidize the project.
11. I'd ... suggest that DOE be very open about the Anderson and Jupiter studies.
12. There are a lot of places you can get Mo-99. Some of them are on line, some are coming on line,...so I don't think it's quite as desperate that if we don't do this, we are out of this stuff.
13. Mo-99 is part of a national isotope strategy, and that is the framework within which the various alternatives should be considered. I believe the DOE has once again failed to adequately identify the proposed action, which is implementation of this national isotope strategy with Mo- 99 as one of several isotopes being produced for a need which we heard a very extensive discussion of. Part of the strategy is identifying facilities which can produce a number of the isotopes incorporating the strategy rather than the more individual isotope-by-isotope concept as we see discussed.
14. Suggest that for the long term, research be sponsored by DOE to determine other radioisotopes which can be used in addition to or in place of Tc-99m. I believe the medical industry is comfortable with Tc-99m, but that doesn't mean that we should produce Mo-99, a not particularly clean processing procedure; other means of supplying the requisite radiation produced by Tc-99m should be actively investigated.
15. The background information presented and the rationale for the proposed program contain the incorrect assumption that if technetium were not available there would be a nuclear medicine catastrophe...[I]n fact, there are Federal Drug Administration (FDA)-approved alternatives to Tc-99m for every nuclear medicine procedure that I can think of. A few of them may be even more reliably diagnostic...than technetium. Most of these products are not currently marketed because they are marginally more expensive than tech products. If the loss of Tc-99m would not result in loss of quality in patient diagnosis and care and so is not a "crisis'" is this an urgent project?
C.2 16. [The Environmental Impact Statement (EIS) should address] the long term need for [Tc-99m] by the medical community given technical developments such as magnetic resonance imaging.
17. I favor development of a continued dependable supply of medical isotopes. Combined efforts with private sources or with Canada should be fully explored, [and I] support the most economical methods that develop the least amount of waste.
18. What is so dangerous about a Canadian source of Mo-99, or a European source for that matter?
19. What is the status of the Canadian operation to produce medical isotopes? Are there still plans to discontinue this operation? When might the facility be closed?
20. How will DOE justify producing 10-30% of the U.S. demand routinely when there is a commercial producer in Canada?
21. The short-term solution is also best met from the private sector solution. Nordion, the supplier of some 90 percent of the world's Mo-99 market, has entered into contracts with European companies to serve as a reliable backup to the reactor. Nordion is also planning to construct not one but two reactors in Canada to ensure their place as the leader in providing Mo-99 to the world...I don't understand some of the statements in the NOI and some statements here today that seem to say that Nordion is going to abandon the Mo-99 market. We don't think that is a reasonable conclusion to be drawn from the facts.
22. I am in agreement with the rationale put forward in the NOI. Not only is the Canadian Reactor that produces Mo-99 near the projected end of its useful life, but supply of any commodity by Canada to the United States is never assured, and I am sure that this is true of Europe. [T]he Canadian government and provincial governments make decisions without consulting affected Americans, as is their right to do.
23. [I]t is important that in the case of the Canadian reactor there were labor problems which prevented it from being up for a substantial amount of time...[I]f we don't have a good source of it in the United States, we cannot always depend on Europe or Canada or Russia to do it for us. We need to have that capability here in the United States, we need to have it readily available, able to boost up in case there are problems in the rest of the country.
24. Can the backup supply for North America be from Europe? Is the new Mallinckrodt plant located at the reactor in Holland capable of supplying the need in an emergency?
25. I would like the EIS to address the FDA procedures in allowing the European system to be accommodated, actually put down how long they think it would take to do it, is it possible to be able to do it, if so, can we manufacture parts of that stuff? I would like this particular scope of the EIS to address a giant venture between Canada and the United States as to whether there is and alternative to doing it only in the U.S., and why we can't do it together.
26. From what I could tell, a very small amount of Mo-99 satisfies the needs of this country...I cannot believe that we can't work out something in which the European isotopes could be licensed in this country.
C.3 27. We are aware there is plenty of Moly 99 in. Europe, and there is absolutely no need to manufacture any here; especially near a large city and the Isleta Pueblo.
28. [T]he public had not yet been clearly convinced about the need for a facility such as possibly the one in Albuquerque or...that any of these reactors are necessary, and Omega West Reactor (OWR)should definitely not be included. [DOE] should look at alternative technology such as perhaps laser application or continuing with some of the foreign markets...[A]pparently...the fabrication facilities in Europe are actually quite extensive, and I do believe DOE should continue to look into that.
29. Mallinckrodt, a company that holds some 25 percent of the U.S. market for Mo-99, has entered into agreements with the European reactor to secure its own source. This decision shows the private sector can and will respond to current and changing market conditions. DOE's decision to abandon full cost recovery for the production of Mo-99 has not been discussed in any of the environmental documents released to the public so far.
30. I want to have all necessary medical isotopes produced in this country. I want this country to have a reliable source of medical isotopes. If we don't produce medical isotopes in this country, we will be buying all of them from overseas in 10 years...I don't want to rely on some flaky foreign government...It needs to be done here.
31. In the near term, we have no backup capability in the U.S. I do applaud DOE's effort to establish some emergency backup-capability...The only concern that I have...is that in our attempt to establish that capability, we may deny ourselves the opportunity to look effectively at the longer term issue...From the long-term point of view, there are a lot of factors that I believe have not been adequately addressed by the Department...[Mo-99] is a major medical isotope for diagnostic purposes, and that's a given as far as talking about far longer than ten or fifteen years worth of production...So, therefore, multiple supplies—multiple sources are vitally important if your reliability or supply is a key issue.
32. It is...a very good opportunity, we feel, for some technology transfer from DOE and DOD to the public sector, and for that reason, the Chamber supports it.
33. I would like to work a phased program with the DOE to determine what funding is available...[to assist the private sector in developing accelerator technology] in order to encourage the private sector to develop the required infrastructure to produce Tc-99m.
34. The proposed production of Mo-99 in the Sandia ACR reactor or at other federal sites will severely impact our [Thermo Technology Ventures, Inc. (Thermo)] private production plans and the ability to raise venture capital for this venture. Our project is depending upon the government providing private enterprise with its traditional incentives to enter into production of Tc-99m. Also, our project will provide the American people with the right amount of surety that there will be an uninterrupted supply of this needed isotope at reasonable prices.
C.4 35. This project fails the most basic test of fairness and priority in this new period of declining federal expenditures. This test is simply can the private sector provide the financing for the program? That answer is clearly yes...The private sector can provide the money and do it more effectively than DOE. DOE knows this, as their private consultants Arthur Andersen and Company and the Jupiter Corporation have already advised DOE that from a long-term perspective, a private sector solution is most likely to succeed. We are disturbed that throughout all of the public process so far, DOE has failed to report any of this information.
36. DOE recognizes the need for a private sector solution in its national isotope strategies, and this issue must be given careful consideration in the draft environmental impact statement. We would ask that the Arthur Andersen studies, and...the Jupiter Corporation study and their findings also be included in the draft EIS.
37. Are there options for privatizing the medical isotope production operation? Have any private companies expressed interest in the production of these materials without a government subsidy?
38. I want to look to see whether private industry has any alternatives to manufacturing other than having the government do it and all the attendant risk that goes with taxpayer dollars and everything else, plus the environmental impact.
39. A realistic market price is necessary to save the life of the Mo-99 market... It should reduce the amount of corporate welfare that the subsidies provide,...that is provided to some of the richest corporations in the world...Government subsidies will only keep the Mo-99 market vulnerable and dependent on increasingly scarce federal dollars. That is not a solution. This issue must be addressed in the draft EIS.
40. [W]hat I see of this Idaho consortium and what I see of this Babcock and Wilcox proposal is that private industry is beginning to think that there might be a market out there that they are willing to fill. Private industry, in my experience usually does a much better job of that than DOE does...If private industry is interested in doing it, let them do it. They probably can do it for half the price that DOE can do it. I am a taxpayer. I don't particularly want to subsidize this baby for $3 million a year on into the indefinite future...DOE, Sandia, even Los Alamos, has an interest in doing it in their shop because it means jobs and income...[G]et free of that bias to give private industry a good solid look.
41. [W]ould it even be appropriate for Oak Ridge National Laboratory (ORNL)to "compete with commercial manufacturers of the alternative products?...This is not to say that the US should not have the capability to produce Mo-99. However, ... we should lobby for exploration of cleaner, more advanced technology to achieve that capability. It sounds to me as though development of that technology would be a better utilization of the capabilities of ORNL, as well.
42. Using a reactor for production rather than research will preclude its use for other activities for the life of the project. [DOE should] assess, [based on 1995 data], the impact on research of removing the SNL reactor from the inventory versus reactivating [the] Oak Ridge reactor.
C.5 43. [T]here are a number of people here in the Oak Ridge area that would be most anxious to start a private business building and operating a supply of Mo-99 with one of these liquid fuel reactors if, in fact, the Department would lead in doing the experimental work to establish this as a viable technology...and let the business community take over the business activity and run it as an effective business.
44. There is something wrong with the economic thinking in this project, and I can only think it has something to do with the benefit of companies like the DuPont Company, and I don't want my taxpayer dollars benefiting the DuPont Company. I am tired of corporate welfare, and I thought the current Congress was tired too, so the idea that this project is up for approval when what it fundamentally is corporate welfare is very puzzling to me.
45. This pharmaceutical industry seems to still be dependent on the government to this day...This is a very fully developed commercial technology that was being brought back from private industry. It is not an innovative technology where research and development money is going to find a replacement for the isotopes in some sorts of scanning. In fact, we are backing up and subsidizing it...Mhis is a process that doesn't have an industrial partner putting in funds, even though the benefits to the industry are clear. The process of going to the public with this kind of program makes clear the way that federal money is being spent on this. It is certainly up to some scrutiny and criticism and concern.
46. [Are 30-60 jobs at the production site] worth the hundreds of millions of dollars, taxpayer dollars, needed for this project? We think it is not. The draft EIS should address the job issue and state the amount of subsidy per job provided...In the U.S., the Clinton administration seems to prefer government subsidies, what we call corporate welfare. We think it is unacceptable.
47. When [large corporations] are making big bucks, they are making it off the American people...[I think DOE has to] pull back and see what you want to give and who you want to give it to and not just keep scratching the industry's back.
48. DOE must include in its Environmental Assessment all private, for-profit corporations that stand to profit from this project. This is corporate welfare straight up, no question about it. We are subsidizing DuPont and other corporations to make huge profits...for the sale of isotopes, so major corporations are going to make major money, and we are going to pay for it.
49. The Federal Government has purchased the technology they are using, and it is fully commercialized with a mature market...There is, I think, a real shortsighted approach of investing in this transition period for a technology which has already been commercialized and already been applied in apparently a reactor which was not adequately designed to fill the market...It seems to me unwise to invest in a backup approach when there is good wisdom from industry and good wisdom from the community that says it should be a commercialized operation...I believe in looking at private and public partnerships, and their variation does provide reasonable alternatives within the National Environmental Policy Act(NEPA) framework.
C.6 50. I think...the idea that medical uses can be good...is not part of the subject of an EIS. I feel it is very inappropriate to fail to balance a discussion in an informational nature with this very narrow view of the overall technology and the production of Mo-99 which is being proposed...It seems to me to be a very shortsighted approach to fund this one thing as opposed to is this the best use of DOE's development dollar when we are trying to bring innovative technology to solve yet-to-be-resolved problems?
51. Here we are investing in an already mature technology with an already mature market and mature delivery system. The idea that the pharmaceutical industry will not invest in the production itself, I think is very telling and should be evaluated further since they are asking for the products which are marketed at a very lucrative rate but not willing to pay the front-end development costs that we are asking taxpayers to do.
52. I am not sure that [putting it in private industry] is a good idea...Mhat is what part of the labs are for, because the people that work at Sandia and Los Alamos Labs really care about what happens to this country. We are not going to go on strike...1 think that it is very important to keep this in the public sector for a while, and I think that is where it should start, and I think we should start as soon as possible...
53. [It] is the responsible approach of a responsible DOE to look at...what's the right technology as far as long-term assurance of reliable supply at a reasonable cost with a licensed facility in the private sector, Nuclear Regulatory Commission (NRC) licensed private business, which is where it should be in the first place...And if we do the study first, then it's appropriate to make a long-term investment to ensure that the technology is brought forward.
54. I find this proposal outrageous, and will continue to speak out against this Moly 99 isotope reactor.
Disposition of Continents on Purpose and Need:
The EIS will contain a discussion and description of the purpose of and need for the DOE to take action. This discussion will address use of other medical isotopes to substitute for Mo-99 as well as the ability of worldwide producers of Mo-99 to reliably supply the United States demand. The EIS will focus on the short term "window of vulnerability" facing the United States medical community. The record of decision on this EIS should not be viewed as the Department's long term solution or impact pursuit of a long term solution to maintaining a reliable domestic supply of Mo-99. These long term solutions may include both public and/or private production of Mo- 99 as well as continued research and development for alternatives to the use of Mo-99. However, evaluation of specific long term solutions is not within the scope of the EIS.
The EIS will draw on information contained in the Independent Assessment ofthe DOE Plan to Establish a United States Production Sourcefor Molybdenum-99 (the JUPITER Report), issued in September 1994, and the U.S. Department ofEnergy Isotope Production and Distribution Program, Management Study, issued by Arthur Anderson & Co. in March 1993.
C.7 2.0 Comments on the Alternatives
General
1. [T]wo plants formerly making ['`'Mo] have closed because of "leakage in the production system." This leaves just one plant in Canada still operating, and apparently it is considering closing for that and other concerns. [H]as this problem in production been solved, or will the proposed plant perhaps be in the same boat twenty years down the road?
2. DOE [should] provide the necessary funding to do an objective technical assessment of the production methods that are out there that could be used for producing Mo-99...to ensure that we have the best long-term solution to that issue.
3. [The EIS should address the] present demand/alternatives for other potential isotopes that may be products of[Mo-99] production.
4. Solution Reactors present alternatives to the target irradiation process...The target is no different from the fuel material, therefore eliminating the need for target fabrication and subsequent dissolution. Mo-99 will undergo an on-line extraction process making nearly 100 percent of the fissions available for producing the product...The solution reactor can operate at power levels approximately 50 times less than the conventional reactor and requires about 300 times less uranium to produce 80 percent more product.
5. [S]olution reactors possess some distinct advantages...in the area of waste minimization. The fact that no fuel assemblies are generated will significantly decrease the environmental impact of reactor operation...[T]he time has come to look into the future and design a process that maximizes the product while minimizing the waste.
6. [A] solution reactor [is an alternate technology to the Cintichem process] which would run at very low power, low temperature, and directly fission uranium atoms to produce the Mo-99 product...[The] Russians [concluded] that the best way to [produce Mo-99 long-term] was to use a small liquid fuel reactor...They don't generate a lot of waste...Mhese facilities are small, relatively inexpensive facilities, that would be possible to put in place in multiple units...I don't wish to contend that this concept has been thoroughly investigated and laid on the street and ready to use. It's clearly not...Babcock and Wilcox...has been promoting this same idea for a couple of years...[W]e must look at this.
7. There is an issue in our society today about high enriched uranium, ninety-three percent enriched uranium. The supply of Mo-99...involves a process that's approved for ninety-three percent enriched uranium targets...[N]inety-three percent may be unacceptable in the future. At that point you no longer have an approved process. FDA approval is required...So I would look at the technology issues of enrichment as a key factor.
C.8 8. The EIS should address the use of low enriche[d] uranium (LEU) in targets instead of high enriched uranium (HEU) in accord with U.S. non-proliferation policies, and for the preferred alternative of HEU usage, the fact that the amount of HEU to be used does not present an obvious danger of diversion to possible proliferants.
9. [D]ocument diagnostic imaging products for nuclear medicine procedures that are alternatives to Tc-99m produced from Mo-99...[These] products are accelerator-produced, with generally fewer and shorter-lived by-products and waste than the extraction from "the fission product inventory" of reactor-produced Mo-99.
10. [Look at] isotope delivery method[s] similar to the BNCT concept [in which the patient ingests] a non-radioactive material best absorbed by the organ to be investigated, [and the material is irradiated] to produce the desired radioisotope in place. [Irradiation would not necessarily be accomplished by neutrons or at. a reactor since other machines (e.g., accelerator) might be used to irradiate the material for diagnostic purposes.]
11. Reactor production of isotopes may not be the only technological option for isotope production...Mhe Clean Water Fund of North Carolina (Fund) believes that the EIS should consider a full range of technical options for medical isotope production, including accelerator production. For options which are technically feasible but currently unapproved, it may be appropriate to examine the possibility of seeking FDA approval.
12. Thermo is in the process of evaluating an alternative production method for Tc-99m, the daughter product of Mo-99. Our approach is to use linear accelerators to directly produce Tc- 99m...Mhis approach offers reduced costs and greater flexibility to address the national need for product.
13. I want to make sure that when you do this EIS, you look at alternative manufacturing methods including the accelerator, including any other process we can find in today's technology. There are alternatives, and I want them explored.
14. I want to look at the alternatives to medicine or support on Mo-99 to see if there are other ways of doing something identical to what Mo-99 might do. Even though it may be more sophisticated and more complicated, there is a good chance it might be a lot safer and easier to use.
15. I have no doubt that we will find a wide variety of other technologies that will give us important information about the body beyond what we can currently get with these elements. For my taxpayer's money, I would rather see the 30 million dollars go into research, into innovative technology to be able to provide advanced sturdies that don't have this particular risk of toxicity at any stage of the process...I think there [are] going to be a lot more technologies that are really desperate for the money to move forward.
16. mhe scope of this EIS must explore the alternatives...very, very thoroughly.
17. Although medical treatment alternatives to Mo-99/Tc-99m should be part of the EIS scope, the most likely alternative to U.S. production is foreign production.
C.9 18. [W]e feel that the scope of what is proposed does not consider alternative solutions that could meet the need for Mo-99 with a lesser environmental impact. Are there alternatives...that do not require the generation of additional reactor spent fuel and the continuous waste stream from processing 10-30% of the current baseline U.S. demand?
19. mhe EIS should provide an analysis of alternatives greatly improved from that in the draft EA...DOE must consider, at a minimum, alternative producers, alternative production levels, alternative production sites, alternative production processes and alternative target fabrication sites.
20. The economics of this project should raise the likelihood of a no-action alternative as the most fiscally prudent cost. No action by DOE would require the private sector to take the needed action to produce Mo-99.
21. I would like to see a really good analysis of the no-action alternative which would, in effect, leave DOE out of it and let private industry resolve it. And also, the other alternatives that you mentioned, like the universities and private industry, I would really appreciate a good solid effort on that part.
Albuquerque
22. What functions does the Annular Core Research Reactor (ACRR) now perform? Will Sandia be able to continue these uses under the medical isotope production schedule?
23. Concerned Citizens for Nuclear Safety [is not] in favor of using the reactor at Sandia. From everything that I can tell, the need for that reactor to be on 24 hours a day during a period of time when the targets are irradiated would cause considerable emissions and disturb and distress the public around that facility.
24. Many people in Albuquerque will...be concerned ...about what might happen in the future if they are looking for a larger reactor to replace the ACRR. There will be a tendency to build a new reactor in Albuquerque where the existing expertise is already here. I think many of us would have [fewer] objections to isotopes being produced in an inactive reactor than looking at a new reactor that could be produced in the future.
25. I think in the No Action Alternative there ought to be for Albuquerque a specific look at the closing down of the ACRR now that it's exhausted its defense program missions. That should be spelled out in more detail, not just looking at comparing this to other sites.
26. [O]nce again, New Mexico and New Mexico citizens are being asked to sacrifice to the good of the world...It is time this will stop. We need to look out for ourselves, not for industry's ambitions, government contractors or the agendas of everybody but us. The people of Sandia can make a living anywhere...You don't have to do this, and you don't have to do it to us. This is too near a large population center, and you shouldn't even be considering it.
C.10 Los Alamos
27. I am strongly in favor of this program. The public meetings held to date have shown the strong local support for the project and communicated the risks to the populace very well.
28. I think it would be good [public relations] for us to have Atoms for Peace, a medical use going on with this reactor.
29. From the national point of view, I think Los Alamos would be a logical place because we can consolidate the entire operation.
30. I would prefer it was in Los Alamos...We have a full-level disposal site, we store fuel [rods] here, we have all the facilities necessary for production...[D]o it here; do it at Sandia; do it at Oak Ridge...[D]o it somewhere in the United States...Just do it.
31. The EIS should address the following points:
- Secondary beneficial uses of the ACRR or Omega West Reactor (OWR)if used for [Mo-99] and related isotope production. Examples being educational or neutron activation services. - Possible impacts of [the] Chemical Metallurgy Research (CMR)facility upgrades on [the] preferred or [the] OWR production alternative. - Time impact on [the] OWR production alternative or OWR restart requirements.
32. While OWR may be capable of meeting the short-term need, the production capability needs to be addressed for the long-term. The [Medical Isotope Production Reactor (MIPR)],...a Babcock and Wilcox [solution reactor] concept, is discussed in the [Jupiter Corporation report]...Mhe solution reactor reduces waste by about a factor of five...[Although, significant technical challenges remain...[and] realistic production is six years away,...this time frame could be reduced if...DOE [would] aid in the development of a private long-term source [as recommended in the Jupiter Report]...Babcock and Wilcox stands ready to implement a research and development effort, and a solution reactor named ARGUS which produces medical radioisotopes, is already operating in Russia.
33. [Use of the OWR] is practically impossible for various reasons. One is the history of contamination which has resulted from operations which caused this facility to be closed down...I think it is very clear that there is tremendous public resistance to reopening this reactor, and I think it would be foolish to do so. The major contamination...was a coolant leak which...may have been in existence for the entire lifetime of the OWR...Mhere [have] also been considerable air emissions...The thyroid cancer rate in Los Alamos is four times the general average for both men and women...So for all those reasons, I think that the alternative of possibly using the OWR really should be struck from the scope of the EIS.
34. mhe pre-decisional draft EA, dated February 1995, only discusses the SHEBA solution reactor located here in Los Alamos. mhe SHEBA reactor was designed as a critical assembly for use in experiments and clearly cannot achieve a production mission without major system • Modifications. The EIS should not spend time studying the SHEBA reactor but focus on the [Babcock and Wilcox] medical isotope production reactor design concept.
C.11 Oak Ridge
35. I believe that the project...should use this site exclusively as, really, the law requires.
36. [W]e have in the Oak Ridge area a plant over here called the Y-12 plant who's lifelong business has been handling uranium solutions. We know a lot about uranium solutions. We have people here...who are extremely knowledgeable and literally wrote the book on liquid fuel reactors. I think we have the expertise here to be a significant player and lead in evaluation of that technology option.
37. I would like to ask that the Oak Ridge Research Reactor be specifically added to the list of alternatives being considered in this EIS. And I also would like to request that the scope be broadened to add the Y-12 as a potential target fabrication site.
38. I would like to ask and have it inserted into the record that we included members of the medical processing industry, the free process houses that takes this product, as well as members of the distribution community who employ these procedures, to give us their guidance and their input into the decision process so that we may more fully take a look at the entire chain from the inception of the product to the actual retail use of the product to come up with the best decision for the Department.
39. The state of Tennessee's position is that the inclusion of the High Flux Isotope Reactor at the Oak Ridge National Laboratory should be considered as a viable alternative and be given serious and objective consideration within the context of efficient uses of existing facilities, cost savings and reduction activities and potential for long term success. We expect a fair assessment that includes a determination of all costs associated with the development, construction, management, maintenance and future use of the facilities considered.
Hanford
40. [The EIS should include consideration of the Fast Flux Test Facility (FF11() as an alternative.] FFTF is not out of the question until the sodium has been removed. We Must Require an immediate halt to currently scheduled sodium removal until completion of this EIS. [The] major reasons [for considering FFTF are that it]:
...can make all reactor produced medical isotopes..., ...can produce a variety of [isotopes for other uses], ...has the capability for isotope and other research, ...is only 15 years old, with a clean safety record, ...solves short..AND long term medical isotope production requirements, ...is a unique facility [worldwide], ...is along-term option as reasonable as the older, less capable, short-term options. (Detailed comments on FFTF benefits included.)
41. This EIS is not truly complete unless ALL reasonable options are considered. [I]t is penny-wise and pound foolish to shut down a facility of such great technical potential as FFTF in favor of old, short-term facilities of far inferior capabilities.
C.12 Idaho Falls
42. The Idaho National Engineering Laboratory (INEL) has been proposed as a logical place for U.S. production of medical isotopes. INEL has the facilities and the people to establish the medical isotope production program. I totally support the development of ... the program at INEL.
Universities
43. [The EIS should address the] alternative of multiple commercial/university small scale producers instead of a single commercial/university U.S. producer.
44. Can the North American need be met in an emergency by shipping a University of Missouri Research Reactor (MURR)fuel element to be processed using the same process currently being used at Chalk River to supply the need? Calculations indicate that a MURR element after one week's run plus the decay time needed to ship it for processing can provide the national need for Mo-99 activity. Can this fuel element be processed at Chalk River or a DOE lab?
Disposition of Comments on Alternatives:
The EIS will consider reasonable alternatives for satisfying the purpose of and need for action, including the no-action alternative. Each alternative will be subjected to thorough technical analysis and scrutiny. The EIS will describe the results of the environmental analysis, as well as the proposed process and operation, for each reasonable alternative.
The EIS will contain a description of the proposed use of facilities at the University of Missouri, INEL, Sandia National Laboratory (SNL), ORNL, Los Alamos National Laboratory (LANL), and Hanford. The EIS will also discuss the proposed use of accelerators, solution- fueled reactors, and multiple reactors to satisfy the purpose of and need for the proposed action.
3.0 Comments on Waste Generation/Management
General
1. Mhere are environmental impacts associated with reactor operation, including the generation of waste for which no current disposal exists. In view of an ongoing failure to guarantee safe and permanent isolation of such wastes from the biosphere in a deep geologic repository, environmental impacts may plausibly result from long term containment failure and release of these wastes with consequent environmental damages. In particular, it is an unattractive but perhaps credible scenario that wastes will ultimately be abandoned onsite, resulting in long term environmental damages.
2. [I]f you're talking about producing the U.S. supply of Mo-99 in the reactor, you're talking about multiple megawatts using the Cintichem process...To be fair and objective about the amount of waste, you're going to have to look at the waste fuel from the operation of the
C.13 reactor, in addition to the handling of the capsules, to get an accurate assessment of the waste derived from the Mo-99 and the cost associated with that overall program that has to be recovered through the Mo-99 sales if you're going to subsidize this with a federal subsidy for cost to recover the operation.
3. I would like to see some real thorough studies done [on the amount waste left from this project]...mt ought to be done on a global basis because a 212,000-year half-life is around for over a million years. Whether it comes out in urine, or it is in the cadaver that goes into the ground, or if it goes into the garbage from the hospitals—...none of this is put into low-level waste. Currently, it goes into little black garbage pails, and they get taken to the landfills...I'd love to see that somehow introduced in this new EIS.
4. I found no information on the environmental effects of this project. I feel that some information should be provided describing the amount of waste generated at each proposed site. [The answers to the following questions should] be made available to the public before an informed decision can be made:
- Will the stainless steel targets be reused or disposed of? - What is the anticipated volume/weight of stainless steel waste? Will the stainless [steel] be recycled? - What are the volumes of liquid waste generated at each site? - How will the liquid waste be handled at each site? - Will there be chemicals used that may be harmful to the community around the project, and if so, how will each site reduce the risk to the public? - How will hazardous chemicals be disposed of or treated?
5. The fact that alternatives that might minimize waste for this particular project were so minimally explored is very distressing to me, and the fact that we are not receiving answers to the questions that we raised in the Environmental Assessment process at this meeting...is extremely frustrating...The Scope of this EIS must explore the alternatives...very, very thoroughly.
6. There do appear to be some opportunities for waste minimization beyond the Cintichem model...I believe there should be an emphasis on this waste minimization and materials reuse beyond the blanket approach of using concrete and storing it until a waste site is permanent.
7. I'd like risk assessment being conducted on the temporary waste storage problem...The problem for me is now, and I'd like to see what that is. I'd like to see the attendant risk keeping it and moving it and where you are going to move it, no matter which site you are at.
8. [T]he greatest risk from transportation of the facility's waste is to the public near the waste disposal site, and that is probably of little significance *compared to the risk to the public from all the other waste that comes to that site. Waste disposal will not distinguish very much among the sites in the United States.
9. [The EIS should address the] manner in which Tc-99m users in the medical community dispose of the T-99m daughter, i.e., a cradle to grave pathway for the product.
C.14 10. 1 squirm to see 99.5% of the uranium wasted, and am not convinced that a simple uranium extraction process or a suitable solidified form for transportation cannot be identified.
11. DOE should address both on-site and off-site waste management issues.
12. DOE again and again comes up with projects which not only produce waste themselves but then offer another possibility to transform that waste, which also produces waste, so I really think it is time to listen to the public which is saying over and over again in an incredible number of hearings of this type, "We do not want this to continue."...I think there is something wrong with the kind of thinking that says we should start a process that produces a waste stream and expect that that is okay and then expect that we will produce more waste streams from further generations of that process. That is definitely flawed thinking.
Albuquerque
13. On the average, how much waste as represented by spent fuel will be created per year? How will this waste be stored? How will it be disposed? When will disposal be available? Who will pay for the disposal, at what cost?
14. On a typical year, how much low level radioactive waste will be created by this operation? How will this waste be stored? How will it be disposed? Do these plans involve the City's solid waste landfill or the wastewater treatment system? Who will pay for disposal, at what cost?
Los Alamos
15. I want to make sure that the EIS truly addresses the relative amounts of waste generated by these options. Running a low wattage reactor [such as the ACRR] means you must irradiate the target longer, which means you must make more by-products than a higher wattage reactor [such as the reactor at Idaho Falls]. That is one of the things, in fact, that is an advantage of running something of the eight megawatt level here.
Oak Ridge
16. The distribution network affects the amount of product required to meet the 3000 6-day curies per week demand. [DOE should], assess [based on 1995 data], the impact of distribution on the amount of production required and its subsequent waste stream. Compare the assessment between SNL and ORNL.
17. Disposal of waste to DOE permanent storage sites cannot be guaranteed because of various jurisdictional factors. [DOE should] analyze, compare and assess, [based on 1995 data], the waste storage capability of SNL and ORNL over a five, ten and fifteen year operational cycle. To be commercially viable reactor operators may need to expand to serve other markets. The above comparisons should be made at increased levels of production.
C.15 Disposition of comments on Waste Generation.and Management:
Waste generation and management for each alternative will be considered in the EIS. Potential impacts of waste generation, removal, storage and disposal will be discussed. The EIS will include an identification and description of the waste generated during each phase (target fabrication, irradiation, processing) which will be applicable to each alternative). Previous DOE determinations and analyses for waste management and spent fuel management will be incorporated as appropriate. Evaluation of isotope and waste disposal by medical users is not within the scope of the EIS.
4.0 Comments on Transportation
General
1. 1 support...careful consideration of the transportation risks, particularly those involving emergency response. My own experience suggests that transportation is essentially a "non- problem" for the materials associated with the Moly-99 process, but thorough analysis and documentation is essential for public acceptance.
2. I want the EIS scope to describe each route for each alternative site as to where it goes, map it out so each of the locations can understand where you are taking the thing from the manufacturing site to the distribution site. I want the scope to do a risk assessment on each population center for each route by manufacturing, by transportation and distribution, delivering of waste and where it goes and the delivery of new materials to do this process.
3. [The EIS should address the] ability of approved shipping casks to prevent emission of gaseous/noble gas fission products to the environment during shipping.
4. Because the medical isotopes that the reactor is to produce are shipped all over the United States by truck and cargo air, the primary difference among sites with respect to transportation risk is the distance from the reactor to the nearest distribution terminal and the population density along that particular route. In considering alternatives, this is really the only transportation effect that needs to be considered.
Albuquerque
5. The movement of materials from Sandia Area V to the air carriers withput access to city streets is a sound step. But the analysis needs to take into account that much of the Sandia/Kirtland/Albuquerque Sunport complex is essentially open to public access.
6. [T]he EA had the transport of the isotopes from Sandia Labs to the airport via city streets. I believe I believe I heard a comment earlier here that they were going to be confined within the boundaries of Kirtland. We would certainly applaud that. We feel like if we can stay on the ramps, stay within the confines of Kirtland and on to the ramp of Albuquerque International, we would certainly minimize the risk to the numbers of people that could possibly be exposed.
C.16 Oak Ridge
7. The transportation of targets and bulk Mo-99 stock must be planned to minimize risk of exposure or leakage. ...DOE should assess, [based on 1995 data], the risk of transport between reactor and hot cell as well as shipment of the stock, [and should] consult air carriers for their requirements pertaining to shipment of bulk Mo-99. Compare these factors at SNL and ORNL. Identify a backup reactor in case of substantial downtime and assess the same factors and perform the same comparisons (to include the use of current or shared facilities).
Disposition of Comments on Transportation:
Both truck and air transportation will be evaluated in the EIS. The EIS will consider potential risks associated with the transportation of nonirradiated targets from fabrication to processing facilities, from irradiated targets to hot cells, and transportation of products. The EIS will evaluate transportation risks and describe packaging of material to minimize the risk to the public exposure during transportation. DOE will comply with laws and regulations applicable to packaging and transportation of targets and product. An examination of the routine methods used by common air carriers, who must also follow applicable laws and regulations, to ship product to pharmaceutical manufacturers is not within the scope of the EIS.
5.0 Comments on the NEPA Process
General
1. I am concerned about the announced schedule for the draft EIS. It is difficult to see how inputs from the scoping meetings can be reasonably addressed in time to produce a draft EIS in the fall of 1995. While I agree that there is significant material in the EA that can and should be used in the EIS, there are additional analyses required that should not be "shortchanged" just to meet an arbitrary schedule.
2. I recommend that [the following issues] be considered as the EIS is prepared:
- terms and acronyms are properly and adequately defined, - consistent units are used in exposure calculations, - populations at risk are clearly and consistently defined, and - subjective qualifiers that can lead to erroneous interpretation ...are avoided.
3. ASHP is concerned...regarding the DOE's decision to conduct public meetings and the intent to file an EIS on the proposed project. It is hoped that an inordinate amount of time and money will not be expended on these analyses. The processes for isotope production have been ongoing in various facilities producing other isotopes for more than forty years; the environmental impacts of these processes are well known, and their further study would be wasteful in time and money.
C.17 4. We would like to propose an alternative approach. As much as possible, identify issues and data pertaining to the most likely candidate reactors. Then allow companies and or communities a period of time to forward proposals. This approach will maximize the involvement of industry and community. DOE will preclude charges of forcing a project (with attendant waste streams) on a community. It may also create opportunities for public/private partnerships which could spin off into other areas.
5. In terms of public participation, DOE's track record in this process has been horrendous...Mhe agency is still attempting to cut corners on public participation and bypass public review and oversight of the proposed project. The scoping meetings took place only 18 days after the NOI was published in the Federal Register...Four scoping meetings are to be held in two days in New Mexico. How do you expect people to fully participate in this process on this short of notice and rushing it through? The answer is simple: You don't.
6. Communities targeted for final disposal of the waste are not included in the scoping meeting process such as the Western Shoshone and other communities in Nevada and Yakima and communities near the Hanford facility.
7. I'd like to commend DOE for the clear and adequate public notice of this meeting, and I encourage them to announce all public meetings in this way, even though it may not be required by law or regulation.
8. I found the information presented in the draft EA to be perfectly adequate for a Finding of No Significant Impact. I hope sincerely that the proposed EIS, which is expensive and time consuming, is not being done to satisfy some political pressure but that a real need for an EIS can be demonstrated.
9. I am particularly disappointed in the DOE approach to stakeholder involvement...I would think that the DOE would make an active effort to talk directly to the commentators, convene some meetings to explore the differences of opinion between the various commentators so they were actually involving stakeholders in discussion as opposed to providing opportunity to comment...I believe a dialog would be a wiser investment of time.
10. The EA was quite cavalier in its characterization of the communities that surround the proposed site and the communities through which the waste will be transported. Those communities will be directly affected by a proposal...So the failure to identify those communities, have direct contact with them, that ought to be able to be upgraded in a stakeholder involvement program that was sincere and designed to investigate the potential impacts.
11. I'd like to see addressed in the EIS that we have more than one public hearing...Whatever site you pick this to be, whether Idaho, California or here, I would like you to address having more public hearings for participation.
12. I feel DOE needs critiquing by the citizenry. Even though you are making it very difficult for us by this process of information sharing, I think it is important to do so...
C.18 13. I believe these sorts of proceedings are very important, not just for the ideas and the public concern, but for the participatory democracy...[W]e are realizing it comes to dealing with citizens about environmental and health risks. I feel this process is valuable, whether or not the technical issues change significantly as we move through the discussions.
Albuquerque
14. The decision to go beyond an Environmental Assessment and prepare and EIS will cause 'unfortunate delays in the conversion [of the ACRR]facility.
15. Information meetings of the type that have been held in Albuquerque and Santa Fe should be sufficient. Extensive "hearings" and comment periods are "overkill." One tour of the ACRR and a medical application facility was held... Other tours should be held.
16. I would like to compliment the DOE staff for the professional, businesslike, and patient manner in which the public meeting held July 31, 1995 in Albuquerque was conducted.
17. On three occasions I have attended DOE presentations on the medical isotope production and distribution here in Albuquerque and provided written and verbal requests for information which has never been provided. It is my impression that your citizen involvement in program review is not serious and the decision on this project has in the main been made already.
18. In my opinion, the DOE has "caved in" to a very small group of environmental radicals here in Albuquerque and is wasting the taxpayers money by any further study. The country and future patients need this project to ensure a reliable supply of radioisotopes. Any shortage in supply and subsequent harm that comes to patients will be the fault of DOE and the eco-fascists. Compared to the minuscule risks,. there are numerous benefits from the program - no further study is needed. I urge you to limit the scope of the EIS and GET ON WITH IT!
19. We are deeply disturbed by the decision to prepare an EIS for the proposed Medical Isotope Production Program.
20. How are you justifying the expenditure of millions of dollars to prepare an unnecessary EIS and support idle workers when a real need for backup production activity exists and there is a need for fiscal restraint? Unless the EA portrayed a false picture of environmental impacts, we see no reason for the decision to prepare an EIS. If there is indeed an urgent need to produce medical isotopes domestically, then we must question the DOE's decision to prepare an EIS.
21. We request that you provide us with an explanation of exactly why the decision was made to prepare an EIS. A response that general issues needed further analysis will not be acceptable...[W]e want to know exactly what impacts, if any, are significant enough to require the EIS. If the decision to prepare the EIS was made simply on the basis to temporarily mollify some advocacy groups, then we demand to know...We recognize that controversy over a major federal action can force an EIS but the controversy must be over the technical analysis, not just complaints over a project.
C.19 22. Since there were no significant environmental issues involved in this program, we ask that the DOE stop efforts on the EIS, issue a Finding of No Significant Impact, and simply proceed with the program DOE claims is so important.
23. I am so thrilled that you are doing the EIS instead of the EA,...and I think that there are a lot of things that need to be looked at.
24. I think you ought to advertise these meetings a little bit more ahead of time and a little bit more often. I think it would be a good idea to put a couple of ads in the papers and not to forget Santa Fe, which is right in the middle of these two places.
25. DOE seems to have a remarkably difficult time following through on issues of process and public participation...I commend DOE for holding four [public scoping meetings]. I must object, however, to DOE's notification of these meeting...Effective Public Participation Under NEPA,...1994 , counsels that the agency should provide for more than the required minimum...[The Federal Register notice gave only three extra days, and there was no notification in the papers] until July 19th, in Albuquerque, July 24th, in Santa Fe, 26th, 28th and 30th...I am afraid that DOE is a slow learner on how to provide for adequate public participation...VW DOE is going to follow through on effective public participation, we cannot rely on things like the Federal Register notice...DOE's Effective Public Participation document counsels should be made readily available and well in advance of public meetings..., including providing for information in languages other than English where appropriate. I notice on the back table some information in Spanish.
26. DOE's mention of stakeholder participation is a step in the right direction, but the path to effective public participation never ends...Mhere has been no stakeholder involvement so far—in fact, as far as I understand, there has been no involvement by the citizens advisory boards (CAB). I am concerned that this may be little more than an empty promise.
27. SWOP and the LAW Fund requested a copy of the public comments submitted on the draft EA. We have yet to receive them...You should put those comments together and make them readily available for public review...In their entirety, I believe many of the comments on the draft EA call upon DOE to be honest in its discussion of the issues surrounding the proposal...[I]f DOE heeds that advice, it can go a long way toward providing an effective and appropriate decision- making and appropriate decision-making environment.
28. The CAB has been ignored in this process.
29. DOE should extend the time frame for the scoping meeting process and include all communities that are going to be affected by the project and also that the CAB should be included in review of the proposal.
C.20 30. The other thing that is extremely flawed is the public participation process, because despite the fact that we have a really terrific facilitator here,...we are not getting anywhere. We are wasting a lot of our citizens' time. I don't agree...that this notice was adequately given...[To be here] on this one particular day in order to do this in the middle of summer, [is not easy for me and]... a whole lot of other people who aren't here. I don't think that the public participation process is user friendly to the public, and I think we ought to do something about that.
31. The CAB is now meeting, but this process didn't pay any attention to its existence, never consulted with that board and never worked with anybody on that board as to how to do the public participation, so there is a big disconnect going on here between the DOE and the people who care about what is going on in the environment. There is not a facilitating process going on, and I really want to object to that.
Los Alamos
32. DOE is basically behaving as a private enterprise,...proposing to operate a reactor facility for the purposes of producing commercial product, Mo-99 and other by-products. If you read the regulations that establish the Nuclear Regulatory Commission (NRC), the exemption granted to DOE is for the purposes of doing defense-related-activities...Mhese reactors were primarily producing defense product...[and] research and development in regard to weapons, and the by- product was radioisotopes. They are proposing to do just the opposite. The issue really becomes should the NRC be the regulatory agency, not DOE... I ask you to take a close look at the regulatory climate.
Oak Ridge
33. I am specifically concerned that your announcement of this Notice and lack of attention to proper notification of the Public Scoping Meeting delayed our response. To my knowledge, no agency of the state government received direct notice. Your previously stated reliance on the Federal Register as a sole means of communication is not acceptable and will not be acceptable for future NEPA notices. I would appreciate your forwarding any future correspondence to the primary contacts and/or secondary contacts attached.
34. Given the previous delays and poor communication, I urge you to give thorough consideration to this and each additional state agency response you receive within reasonable range of your deadline.
Idaho Falls
35. I did enjoy the presentation made in Idaho Falls. I felt that it was informative and was conducted in a professional manner. I believe that the moderator was neutral and that his general attitude encouraged public comments.
36. DOE must be honest and thorough in providing the public with information and opportunities to make informed decisions in this process. DOE has had a history of deceiving the public...very often by not telling the whole truth.
C.21 Disposition of Comments on the NEPA Process:
The Medical Isotopes Production Project EIS will be prepared in accordance with the regulations of the Council on Environmental Quality (CEQ) in 40 CFR 1500-1508, which apply to all federal agencies. These regulations provide for public participation in the scoping process (completed) and in the process of commenting on the draft EIS. Some commentors were pleased with DOE's public scoping process, while others felt there was insufficient notice and too few scoping meetings. DOE is committed to improving its public involvement activities, and welcomes feedback on its process for obtaining public comment. DOE will facilitate the opportunity for public comment on the draft EIS.
Several conunentors endorsed the preparation of the EIS; others felt that the EIS was a waste of time and taxpayer money. The Secretary of Energy is committed to adhering to the NEPA guidelines issued by the Department, as well as to public involvement and voluntary disclosure of environmental, health, safety and socioeconomic impacts associated with DOE actions. Proceeding with an EIS was deemed appropriate based on comments received on the draft environmental assessment prepared for production of Mo-99 at Sandia National Laboratories/New Mexico and Los Alamos National Laboratory. The Department is striving to meet the expectations of the public by providing ample opportunity for public involvement while containing the costs of preparing an EIS.
6.0 Comments on General Health and Safety
General
1. The benefits of the medical isotope program far outweigh any environmental degradation that would take place. Any slight degradation of the of the environment, and minor pollution, had been far outweighed by the benefits reaped, outweighed a million to one.
2. The eight listed potential adverse issues are adequate. One issue that is not on the list is: "Potential consequences of no-build or delay in build." ...Mhe potential interruption of the medical isotope availability is a very definite environmental impact affecting the health and lives of our citizens to a far greater extent than any of the listed minor potential adverse impacts!
3. DOE has identified eight issues to be addressed in the NOI. I found many of them troubling for their lack of specificity...Mhere is a real likelihood that many issues will be avoided entirely.
4. The EIS,should thoroughly examine the environmental impact on populations including that of air emissions, operational exposures, waste disposal, and transportation.
C.22 5. mhe proper analysis of the environmental impacts connected with medical isotopes must include consideration of the hazards associated with the production, processing, transportation, and administration of such isotopes...These include the possibility of production , processing, and transportation accidents, as well as the possibility of incorrect administration (including administration of an incorrect radiopharmaceutical or incorrect dosage to a patient, as well as administration of a radiopharmaceutical to an incorrect patient), and the doses to members of an outpatient's family or other members of the general public associated with radiopharmaceutical administration.
6. Clearly, the safety of the system is of very high importance because these facilities will have to be located in some community. And the safety of the system is very much related to technology used in producing the material.
7. Misadventures, misfortunes, and mishaps are not hypothetical. [They] may be common [and] occur frequently in the production, processing, transport, and administration of radiopharmaceutical,...[and are documented in the public record]. The preparers of the EIS should examine...the last five years of radiopharmaceutical history in an effort to evaluated the actual environmental impacts associated with radiopharmaceutical usage...Mthe EIS...should also include credibly accurate estimates of the numbers of incorrect administrations and the associated doses.
8. I share...concerns about people all along the production process pathway, as well as the ultimate waste management and disposal...
9. [P]otential health and safety impacts from operations [is] an extremely important inquiry in light of DOE's proposal to produce, handle, store and transport radioactive materials and other hazardous materials and waste and to do so by changing the current processes of these facilities significantly.
10. DOE should not treat safety issues with the unsupported scenarios found in the draft EA. Accident scenarios should be considered in light of a number of factors including,...the track records of like facilities and operations. Additionally, the potential for multiple unplanned mishaps and the cumulative effects of mishaps and other events upon affected populations from DOE and non-DOE activities.
11. [The EIS should] include an honest assessment of the health and safety impacts from radioactive materials and wastes, including a clear recognition and discussion of the production, handling and disposal of strontium and cesium, a discussion of generated high-level wastes and their disposal,...analysis of risks associated with fuel elements, a discussion of the monitoring of exposures to workers and other affected parties, and a discussion of the wastes associated with the fission processes inside the targets.
12. [A]n accurate analysis of the environmental impacts and health costs or benefits associated with radiopharmaceutical usage could actually show that medical diagnosis or treatment by radioprescription has negative effects on public health.
C.23 13. The use of medical isotopes further results in doses to individuals other than patients receiving radio prescriptions...estimates of exposure to other members of the public may underestimate those exposures if the estimates assume that all appropriate isolation instruction is provided, understood and followed. The EIS should therefore include credibly accurate estimates of doses associated with the exposure of individuals other than the direct prescription recipient.
14. [A]ccurate assessment of environmental and public health effects of radiation exposure must consider population dose. However,...the Department has traditionally used an estimate of one fatal cancer per 2500 person-rem as the basis of its radiological impact assessments...[T]he actual induced cancer rate substantially exceeds this figure...Moreover, not all human health effects are fatal cancers and...significant loss of work time and recreation time, significant personal impact, and significant resultant psychological distress can be associated with even nonfatal cancers...Mherefore,...the EIS should consider all plausible health effects from general population exposures associated with the various alternatives, including the total social economic effect of such exposures.
15. [T]he average dose and risk to the public from operating the proposed facility, the average individual dose is the same no matter where the facility is located. The population dose and population risk depend, of course, on the population near the site. Every population is equally deserving of environmental and public health protection...Implementing different levels of protection depending on past environmental conditions, ethnicity or socioeconomic status for a population that relocates about every five years is virtually impossible and ethically highly questionable. Taking past exposure into account makes sense only in the context of occupational exposure.
16. The individual occupational dose and risk from operating the proposed facility are the same no matter where the facility is located, and all the workers deserve equal environmental and health protection no matter what state or country they happen to be working in.
17. Location on a university campus, which is mentioned in the Notice of Intent (NOI) is a distinct disadvantage. Concern about off-site public exposure, which in this instance I don't believe is particularly warranted, ought to be for university students, who are, in fact, more vulnerable to radiation exposure, because of their ages, than the general population.
18. The EIS should consider relative risks and not consequence alone. The consequences of this facility's operation are the same wherever it is located and cannot distinguish among sites.
19. I found no information concerning what effect the project would have on the public in the form of increased radiation exposure. ...There definitely was not enough information to understand the risks involved. ...[The] following items and [answers to the following questions need to be provided to] help public.
C.24 - A discussion diagram, illustration...explaining the relationship between z"U fission and the production of "mTc. - The decay of 99Mo should be described so that the public knows why DOE wants "'"Tc but collects "Mo. - It was incorrectly stated that'It was the isotope of medical importance. It is 9'Tc that is medically important. - A brief explanation of when "Mo decays, "inTc is generated. - [Some long lived isotopes will be generated ;"Tc is not medically important and has a half life of 214,000 years. - What quantity of"Tc will be released into the environment from the proposed sites? - What quantities of 9'c will be released to the environment through the usage of 99Mo for medical purposes? - What steps may be taken to reduce the release of"Tc from medical procedures? - What is the estimated radiation dose to the public from the release of these isotopes into the environment after being used medically? - How is "Tc disposed of by medical facilities that have kept 99Mo so long that it is of no medical value? - How will each proposed site handle the fission and activation products remaining after their separation from the medically important isotopes?
20. I believe that the information (on the generation of 99Mo and its decay to 9'Tc which then goes through and isometric transition to "Tc) should be made available to the public so that those who wish to understand the process will have the necessary information. Tc" has an extremely low specific activity, however, the public needs to see that DOE has looked and quantified Tc" released and concluded that they are insignificant. In addition to calculating activity in curies, the mass of Mo", Tc99m and Tc" is useful.
21. It should be noted that this reactor, like any other,- must meet the airborne radioactivity standards of 40 CFR Part 61, no matter where it is located.
Albuquerque
22. The use of the ACRR for isotope production represents a significant change in operation of this reactor in several ways. For the most part, prior activities have been on a very intermittent basis...The reactor has not been run continuously for extended periods. Therefore, the anticipated long-term physical effects of around-the-clock operation ought to be thoroughly addressed.
23. [T]he transition from defense-related research/development testing to isotope production represents a major paradigm shift for the Sandia staff. A staff with a strong background in and commitment to research and development may not be attuned to the more prosaic and routine activities associated with extended steady-state operation of the reactor. This needs to be carefully considered in the EIS.
C.25 24. mhe ACRR...has never run continuously.. It has never been run 24 hours a day, year-round like what is being proposed here. The upgrade to produce Mo-99 would be a significant change in its mission and use...We don't even know if the reactor is going to be able to stand up to 24- hour-a-day use.
25. I think there should be some comparison of the [ACRR] and other reactors of this type in terms of safety problems that may have developed in the past, including a look at the age of this reactor and possible problems that may come up as you take a somewhat older reactor and put it into a level of use that it has never seen to this point. I don't have a great deal of confidence in...assurances of safety. I don't think that we have a history that gives us confidence, and I think when you are talking about increasing the production of radionuclides near to centers of population, Santa Fe, and in this case inside Albuquerque, that we should not be too smug about this, and we are also talking about the transport of radioactive materials between these two facilities, which, as I understand, comes right through the interstate in Santa Fe.
26. Will the medical isotope operation have any impact on the funds available for environmental clean up at Sandia/Kirtland?
27. [W]e are told repeatedly that this area already has a high level of radioactivity from past reactor tests, leaks, accidents and the high altitude. Your EA...confirms [that the reactor will add to the background level of radiation in our environment here] and states that there are 8 other hazardous sources of radionuclides at the Kirtland AFB/Sandia National Lab complex. Therefore, it goes against common sense to place the isotope production here, which is a truly good medical tool.
28. Nuclear waste from the isotope production will be discharged into the surrounding environment, no matter what scrubbers you claim to put on to protect the public. [We know from past experience that minute particles will be emitted into our atmosphere. Dr. Charles Massey, a SNL spokesman even said the isotope reactor would definitely increase the amount of radiation released into our environment. He said not to worry. We do worry, and insist this project be cancelled.
29. We know we have radioactive releases coming from SNL and Kirtland Underground Munitions Storage Complex.
30. DOE has had a problem in protecting workers in the community from chemical and radioactive hazards in the past. Workers at Sandia Labs have been exposed to radioactivity at the hot cell facility during routine maintenance operations.
31. Los Alamos and Sandia have been cited hundreds of thousands of dollars for violations in handling and disposal of mixed and hazardous waste. It isn't talked about publicly, but several workers have been severely poisoned in semiconductor research using dangerous chemicals.
C.26 32. Your overall program of activities treats New Mexico as a vacant desert state and the city of Albuquerque likewise. This is not true...[T]he reactor is within eyesight of a metropolitan area of nearly 600,000...people, and within a "stone's throw" is the Veterans Administration Hospital and Lovelace Hospital in which are people who are usually in states of health most vulnerable to contaminations. Several public schools and a major airport terminal...are within the same visual range. In my opinion, it is foolhardy, dangerous and disregardful of public health to place another radioactive emitter source such as the medical isotope reactor in this area.
33. [T]he Sandia Isotope reactor project is dangerous to public health. The proposed Moly 99 Medical Isotope Reactor, planned by Sandia National Labs will put the surrounding metropolitan area of 600,000 people here in Albuquerque at great risk with the reactor, planned to run 24 hours a day.
34. We demand an EIS on the assessment of toxic chemicals known to synergistically react with radioactivity in the human body to weaken resistance to other diseases, like AIDS.
35. A 1994 study of Bernalillo County white female breast cancer deaths, by epidemiologist Jay M. Gould, found a 26.7% mortality increase over the past 30 years. Gould says New Mexico has the highest, 31%, increase of any state in the Union.
36. We ... have the problem of isotopes and waste on city and state roads, as people receive doses while next to these trucks.
37. The Sandia location inside Kirtland Air Force Base provides an advantage [in minimizing population exposure by locating the reactor and its products in an area to which access is limited.
38. mhe Chamber feels like the production of the targets at Los Alamos Labs, the irradiation of them at Sandia Labs and transport them out to the airport pose very little risk to the community of Albuquerque and the general population at large.
39. We feel that the people, the laboratories, the people in those laboratories, are well trained. The facilities are there, the procedures are there, and the know-how is there to handle this task in a safe and efficient manner.
40. [I]n the EA there [were] a lot of comments about how you would handle emergencies, catastrophic failure type of things. All we can say is that we reviewed those. [W]e feel like they are adequate, but we urge you to make sure you look at those very closely again to preserve our air quality and our water quality to ensure that they do not get contaminated.
Los Alamos
41. In a small town like this,[OWR] is run by my friends. I trust them. Their families live here, • and they are taking care of our city, and so I don't have any worry there. There is much more risk in me driving through Santa Fe, or Albuquerque especially, than there is in living in Los • Alamos, so I hive no worries along those lines.
C.27 42. OWR has safely operated nearly 40 years.without problems outside of the technical area. It is a proven quantity that is in there...Mt is my experience and belief that LANL can safely do this job and do it well.
43. I believe LANL has the proven capability to repair this cooling water leak that came out and to properly monitor the water line where this came out and develop it. LANL has the techniques to do that, and it can do it...
Disposition of Comments on Gerneral Health and Safety:
The EIS will consider chemical and radiological risks to the environment and ecosystem, induding air, surface and ground water, workers and the general public from target fabrication through shipment of products. Potential accidents and associated impacts will be considered in the EIS, induding seismically induced accidents. Use and administration of isotopes by the medical community are not within the scope of the EIS.
7.0 Comments on Environmental Justice
General
1. Environmental justice considerations should not be relegated to merely issues of socioeconomic...[E]nvironmental justice should be part of all of the issues.
2. [DOE's draft environmental justice strategy contains] several important strategies applicable to the NEPA process...Mhe EIS should identify and analyze the disproportionately high and adverse impacts, including providing for stakeholder reviews and considering unique factors like multiple contaminations and exposures. The EIS should address the institutionalization of pollution prevention, including promoting reductions in hazardous waste and toxic emissions, and the EIS should provide for and reflect research and collection of data on disproportionate impacts.
3. The economics of this situation needs to be understood by the citizens.
4. I guess more cancer is good for business. Too many decisions are based on finances for corporate profit with no concern for the public.
Albuquerque
5. It is my opinion that the interests of [the Western Shoshone and Yakama tribes in Nevada and Washington] are more properly addressed by assessments related to the Nevada Test Site and the Hanford Reservation.
6. The environmental justice section of the EA is laughable. All New Mexicans are going to be burdened with the cost of this facility, and most will not realize the benefits of it unless we pay for it twice, through our tax dollars and when we go to the hospital to receive our treatments.
C.28 That is an environmental justice issue which DOE should recognize. [The] per capita income is one of the lowest of the 50 states. People here do not receive adequate medical treatment, and still, people are going to bear the burden again of another nuclear facility in the State of New Mexico. The scope of environmental justice concerns should be brought not just to look at Four Hills, not to look at the immediate surrounding communities, but the impact on the state[of] another facility and looking at the cumulative effects of radiation facilities that are being added to New Mexico.
Disposition of Comments on Environmental Justice:
The Department is committed to fulfilling both the letter and the spirit of the President's executive order on environmental justice. As a result, the EIS will consider the potential impacts for all phases of each alternative on all affected populations, to include natural and cultural resources. No alternative in this EIS is intended to create a new adverse impact on any Native American treaty rights.
8.0 Comments on Cost and Schedule
General
1. [The EIS should include] full cost information for all options considered, [including] full costs of getting each option up and running by a target date...; costs of operating each option each year after it becomes operational...; costs of building a new reactor(s) if (when) it is found that private industry cannot [assume responsibility for production] when the preferred option old reactor must be shut down; [and] full integration of these costs into the socii-economic section of the EIS on a national scale...
2. The true cost of this program should be outlined in the draft EIS. These cost figures should include the cost of storage, transportation and disposal of spent fuel and low-level radioactive waste to be generated from this project.
3. As a recommendation, DOE should include in the EIS the total cost to the taxpayers to date on this proposed project, the accomplishments and products realized to date and a complete cost/benefit analysis of the proposed project.
4. DOE is engaged in a number of radioisotope production programs for medical isotope purposes. There is other work [at LLNL and]...There has been work in the past at Brookhaven. As a taxpayer, it would seem that the least impact and the most cost-effective program is an integrated one. Rather than look at Mo-99 as a stand-alone-project, consider it to be part of the larger business plan of DOE operating a business, which is what it is. This is basically a government-owned corporation in this case which would not exist...if it was economical for private industry to do it. [I]n that regard I highly support what you are all about, but you need to keep that in mind. There are significant differences in operating a private business, and the public ought to be looking at the entire scope.
C.29 5. The scope should be explained somewhat to include at least initial cost estimates because some of these items or projects that are considered right now will be prohibitively expensive...As a result, some of the other projects that might be considered under other circumstances are not coming to the forefront because they are not included, because the other projects that are readily available but might be overly expensive are not excluded.
6. [Proposing to] restart reactors or significantly modifying the Sandia reactor and effectively restart it in order to reach that production level..are cost drivers of all of these sites, and it will be of a differing nature at all of these sites. So I ask you to take a close look at...particular issue.
7. There is no discussion of the overall cost of the technology versus the cost of the medical applications and how the U.S. Government, the taxpayers, will be fully compensated for these costs. We don't get the cost of building the reactor back at 1.5 million, and we have no discussion of the eventual decontamination and decommission costs of this very modest size and heavily engineered reactor, and these costs are essential to understanding the long-term commitment.
8. DOE has spent at least 5 million dollars on lessons learned regarding M0-99 production and has yet to produce a single isotope...DOE structure, organization and processes are not conducive to a long-term solution.
9. According to the Jupiter report, DOE has spent 5 million dollars on this so far and has not produced one isotope. Can we trust DOE with our tax dollars at this point?
10. The EIS should deal with the economics of this proposal, including the alternatives. Why should the taxpayer foot the bill for items that will reap income for the distributors? Why are we unwilling to have the public sector support a health care system but ready to finance private distributors? At a time when all expenditures are being scrutinized, $30 million seems like a lot of money for this project.
Los Alamos
11. I think if you do a cost analysis, it would be much cheaper going with this reactor.
Idaho Falls
12. Facilities exist [at INEL] would require modification, but [I assume] that it would be less expensive than starting from scratch.
C.30 Disposition of Comments on Cost and Schedule:
Chapters 3 and 5 of the EIS will discuss the estimated cost and schedule for implementation of the various alternatives.
9.0 Comments on Socioeconomic Impacts
General
1. [I]f socioeconomic impacts are to be considered, occupational experience is a benefit in this, as in any other, occupation.
2. The socioeconomic benefit provided by the facility to the community must also be considered in the scope, particularly at sites where the jobs of experienced workers may be at risk because of budget cuts.
3. I believe that we need to look at the environmental economics of this proposal in a much more thorough way than DOE attempted. We have on the order of 1.2 million applications of this technology per year, 35,000 per day...If [the medical procedure]is merely $100, that is 1.2 billion [dollars] per year in the Mo-99 economy.
4. [The mandate of the isotope production and distribution program] was to achieve full cost recovery. The program never achieved this goal. In response, DOE requested changes in the IPDP charter to provide commercial products at a subsidized price. This decision and the resulting economic impacts should be addressed in the draft EIS.
5. I hope DOE will address its economic assumptions honestly and not use the rosiest scenario it can find for such a consideration. DOE should recognize and discuss controversies surrounding economic considerations.
6. I think that if you look at the cost of Mo-99 on the world market today, the big problem with the supply of Mo-99 today is that cost of M0-99 on the market is too low to justify the cost of producing Mo-99 with the current technology, what I'll call the Cintichem-type technology. That's one problem that I think the pharmaceutical industry could solve rather easily by recognizing the reality and agreeing to pay a higher price to attract more reliable supply.
7. For the purposes of any required cost benefit analysis,..it would be inappropriate to discount the costs associated with potential long term damages, because it is reasonable to expect that uncontaminated land in the future will be generally less available and therefore more valuable than is presently the case, that ecosystems will be more stressed and less resilient than is presently the case, and that species diversity will be reduced (relative to present diversity) as a result of continuing faunal and floral extirpation, resulting in a greater relative loss of property values associated with contamination than is presently the case, higher costs associated with ,ecosystem restoration efforts than is presently the case, and increased difficulty protecting threatened and endangered species (relative to the present difficulty).
C.31 8. Therefore,...it would be prudent to presume that remedial costs might increase at a rate in excess of the inflation rate.
9. Any...analysis [of the economic impact of privatization of isotope production] should also include a consideration of the likelihood that any U.S. corporation would be willing to undertake the design, construction, and licensing of a new reactor under existing regulation and in the current public antinuclear climate.
Albuquerque
10. Hospitals could charge our insurance company a hefty price for the DOE/University of New Mexico (UNM)isotopes. This is pure corporate welfare.
11. Taxpayers must pick-up research and liability costs for accidents at the nuclear reactor...I do not believe the public wants to accept this responsibility.
Los Alamos
12. [The OWR] will provide jobs in Los Alamos.
13. I think it is vital for this community as to whether we can provide more jobs. Our major employer, who is LANL can provide a few jobs, this will help. It will not only help LANL. It will help the Santa Fe, Espanola, Tesuque, Bernalillo area because every job we have here in Los Alamos promotes about three jobs throughout our service community. The dollar goes three times [farther] than that.
Oak Ridge
14. Potential commercial impacts should include effects of increases in production (and subsequent waste streams) to meet increased requirement for product (to serve Canadian market as well as Central & South American; identification issues relating to the integration of a privatized production operation into ongoing installation research operations.
Idaho Falls
15. The socioeconomic impacts to the region would be positive as opposed to negative, and the region will be able to easily absorb them, especially in light of cutbacks in INEL programs and employment which have and may continue to occur.
Disposition of Comments on Socioeconomic Impacts:
Socioeconomic impacts of each alternative to local communities, states, and to the nation will be considered in the EIS to the extent practicable.
C.32 Appendix D
NEPA Disclosure Statement for Preparation of Environmental Impact Statement for the Medical Isotopes Production Project: Molybdenum-99 and Related Isotopes APPENDIX D
7441110'Battelle Pacific Northwest Laboratories Battelle Boulevard P.O. Box 999 Richland, Washington 99352 Telephone (509) 375-2921 June 30, 1995
Dr. Terry Lash Office of Nuclear Energy U.S. Department of Energy 1000 Independence Avenue S.W. Washington, D.C. 20585
Dear Dr. Lash:
DISCLOSURE OF ACTIVITIES ASSOCIATED WITH MEDICAL ISOTOPE PRODUCTION AT HANFORD
This letter is to communicate activities in which Pacific Northwest Laboratory (PNL) has been engaged prior to being tasked to write the Environmental Impact Statement (EIS) for Medical Isotope Production. It is the opinion of PNL that these activities in no way represent a conflict of interest with providing an objective EIS for the U.S. Department of Energy (DOE) Office of Nuclear Energy (NE).
PNL's prior activities involved developing a concept for operating DOE's TRIGA Reactor (currently operated by Westinghouse Hanford Company and located in Hanford's 300 Area [308 Building]) for production of "Mo followed by chemical processing of targets in DOE's 325 Building hot cells (operated by PNL). An initial presentation of this concept was provided to you on March 29, 1995, during your visit to Hanford. Subsequently, intermittent development of the concept continued until June 20, 1995, when all work on the concept was terminated after PNL was asked to begin work on the EIS for DOE/NE. The Hanford TRIGA reactor does not meet the requirements documented in the Notice of Intent (NOI) to be issued by the DOE early in July 1995, since it can not produce 100% of the U.S. demand for "Mo and, therefore, will not be considered in the EIS. Hence, PNL's prior activities do not represent a conflict of interest. It should be noted that all other TRIGA reactors of comparable class would also fail to meet this requirement.
Should the requirements of the NOI that preclude consideration of small TRIGAs be challenged during NOI scoping, evaluation of Hanford's TRIGA (and others) may be necessary. Under these unlikely circumstances, there is the risk of a perception of a conflict of interest, if it were determined that processing of irradiated targets were to occur at PNL. Should this situation arise, it will be necessary to revisit the issue at that time.
D.1 Dr. Terry Lash g"‘e.Battelle June 30, 1995 Page 2
Should you have any questions, please feel free to contact either Dr. Jerry L. Ethridge on (509) 372-4991, or Ms. Karen Hoewing of PNL's Legal Office on (509) 375-2216.
Very truly yours, I
B. D. Shipp G. H. Cunni am Associate Laboratory Director 'General Counsel Environmental Technology Division
BDS:GHC/slm cc: W. P. Carroll, DOE/NE W. J. Dennison, DOE/GC S. E. Ferguson, DOE/GC R. A. Hunter, DOE/NE J. F. Kotek, DOE/NE