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3

CHALLENGES TO THE BIOMEDICAL INVESTIGATOR

Regulation

Biomedical research that uses radioactive materials operates in a highly regulated environment. Three agencies regulate LLRW: the US Nuclear Regulatory Commission (USNRC), the Environmental Protection Agency (EPA), and the Department of Transportation (DOT). The US Nuclear Regulatory Commission, under its authority from the Atomic Energy Act of 1954 and amendments, regulates the use of source, byproduct, and special nuclear material. It has delegated its authority to over 35 states, which are known as “agreement states”. Agreement states retain the authority to regulate everything except nuclear power and other reactors regardless of location and to regulate special nuclear material in quantities over 350 grams. The regulations of the agreement states must be compatible with those of the US Nuclear Regulatory Commission. EPA develops general standards for radiation protection of the general public. DOT regulates the shipment of LLRW and all radioactive materials. Other federal and state agencies regulate and provide guidance on the use and control of radiation-producing devices and radioactive material. For example, the US Geological Survey has been involved in the High-Level Waste Repository Project at Yucca Mountain, and the US Postal Service regulates traffic of radioactive materials through the US mail system.

Disposal of radioactive materials is governed by the Code of Federal Regulations 10 CFR 20.2001-20.2006 (USNRC, 1991a) and by 10 CFR Part 61.1-61.84 (USNRC, 1983). These regulations are quoted verbatim here, as understanding these regulations is central to understanding the nature of the disposal issue. The regulations specify:

    (a) A licensee shall dispose of radioactive materials:

      (1) By transfer to an authorized recipient as provided in 20.2006 or in the regulations in parts 10 CFR 30, 40, 60, 61, 70, or 72;

      (2) By decay in storage;

      (3) By release in effluents within the limits in §20.1301; or

      (4) As authorized under 20.2002, 20.2003, 20.2004, or 20.2005.

    (b) A person must be specifically licensed to receive waste containing licensed material from other persons for:

      (1) Treatment prior to disposal;

      (2) Treatment or disposal by incineration;

      (3) Decay in storage;

      (4) Disposal at a land disposal facility licensed under 10 CFR 61; or

      (5) Disposal at a geologic repository under 10 CFR 60.



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Page 12 3 CHALLENGES TO THE BIOMEDICAL INVESTIGATOR Regulation Biomedical research that uses radioactive materials operates in a highly regulated environment. Three agencies regulate LLRW: the US Nuclear Regulatory Commission (USNRC), the Environmental Protection Agency (EPA), and the Department of Transportation (DOT). The US Nuclear Regulatory Commission, under its authority from the Atomic Energy Act of 1954 and amendments, regulates the use of source, byproduct, and special nuclear material. It has delegated its authority to over 35 states, which are known as “agreement states”. Agreement states retain the authority to regulate everything except nuclear power and other reactors regardless of location and to regulate special nuclear material in quantities over 350 grams. The regulations of the agreement states must be compatible with those of the US Nuclear Regulatory Commission. EPA develops general standards for radiation protection of the general public. DOT regulates the shipment of LLRW and all radioactive materials. Other federal and state agencies regulate and provide guidance on the use and control of radiation-producing devices and radioactive material. For example, the US Geological Survey has been involved in the High-Level Waste Repository Project at Yucca Mountain, and the US Postal Service regulates traffic of radioactive materials through the US mail system. Disposal of radioactive materials is governed by the Code of Federal Regulations 10 CFR 20.2001-20.2006 (USNRC, 1991a) and by 10 CFR Part 61.1-61.84 (USNRC, 1983). These regulations are quoted verbatim here, as understanding these regulations is central to understanding the nature of the disposal issue. The regulations specify: (a) A licensee shall dispose of radioactive materials: (1) By transfer to an authorized recipient as provided in 20.2006 or in the regulations in parts 10 CFR 30, 40, 60, 61, 70, or 72; (2) By decay in storage; (3) By release in effluents within the limits in §20.1301; or (4) As authorized under 20.2002, 20.2003, 20.2004, or 20.2005. (b) A person must be specifically licensed to receive waste containing licensed material from other persons for: (1) Treatment prior to disposal; (2) Treatment or disposal by incineration; (3) Decay in storage; (4) Disposal at a land disposal facility licensed under 10 CFR 61; or (5) Disposal at a geologic repository under 10 CFR 60.

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Page 13 A licensee or applicant for a license may apply to the Commission for approval of proposed procedures, not otherwise authorized in the regulations in this chapter; to dispose of licensed material generated in the licensee's activities, each application shall include: (a) A description of the waste containing licensed material to be disposed of, including the physical and chemical properties important to risk evaluation, and the proposed manner and conditions of waste disposal; (b) An analysis and evaluation of pertinent information on the nature of the environment; (c) The nature and location of other potentially affected licensed and unlicensed facilities; and (d) Analyses and procedures to ensure that doses are maintained ALARA a and within the dose limits in this part. Provisions for disposal by release into sanitary sewerage are prescribed in 10 CFR 20.2003 and provide that: (a) A licensee may discharge licensed material into sanitary sewerage if each of the following conditions is satisfied: (1) The material is readily soluble (or is readily dispersible biological material) in water; (2) The quantity of licensed or other radioactive material that the licensee releases into the sewer in 1 month divided by the average monthly volume of water released into the sewer by the licensee does not exceed the concentration listed in table 3 of Appendix B to part 20; and (3) If more than one radionuclide is released, the following conditions must also be satisfied: (i) The licensee shall determine the fraction of the limit in table 3 of Appendix B to part 20 (USNRC, 1991b) represented by discharges into sanitary sewerage by dividing the actual monthly average concentration of each radionuclide released by the licensee into the sewer by the concentration of that radionuclide listed in table 3 of appendix B to 10 CFR part 20; and (ii) The sum of the fractions for each radionuclide required by paragraph (a)(3)(i) of this section does not exceed unity; and (4) The total quantity of licensed and other radioactive material that the licensee releases into the sanitary sewerage system in a year does not exceed 5 curies (185 GBq) of hydrogen-3, 1 curie (37 GBq) of carbon-14, and 1 curie (37 GBq) of all other radioactive materials combined. (b) Excreta from individuals undergoing medical diagnosis or therapy with radioactive material are not subject to the limitations contained in paragraph (a) of this section. Treatment or disposal by incineration are provided in 10 CFR 20.2004 which prescribe that: a As low as reasonably achievable

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Page 14 (a) A licensee may treat or dispose of licensed material by incineration only: (1) As authorized by paragraph (b) of this section; or (2) If the material is in a form and concentration specified in 10 CFR 20.2005; or (3) As specifically approved by the Commission pursuant to 10 CFR 20.2002. (b) (1) Waste oils (petroleum derived or synthetic oils used principally as lubricants, coolants, hydraulic or insulating fluids, or metalworking oils) that have been radioactively contaminated in the course of the operation or maintenance of a nuclear power reactor licensed under 10 CFR 50 may be incinerated on the site where generated provided that the total radioactive effluents from the facility, including the effluents from such incineration, conform to the requirements of Appendix I to 10 CFR 50 and the effluent release limits contained in applicable license conditions other than effluent limits specifically related to incineration of waste oil. The licensee shall report any changes or additions to the information supplied under 10 CFR 50.34 and 50.34a of this chapter associated with this incineration pursuant to 10 CFR 50.71 of this chapter, as appropriate. The licensee shall also follow the procedures of 10 CFR 50.59 of this chapter with respect to such changes to the facility or procedures. (2) Solid residues produced in the process of incinerating waste oils must be disposed of as provided by 10 CFR 20.2001. (3) The provisions of this section authorize onsite waste oil incineration under the terms of this section and supersede any provision in an individual plant license or technical specification that may be inconsistent. Provisions for disposal of specific wastes most commonly found in the biomedical and research communities are provided in 10 CFR 20.2005: (a) A licensee may dispose of the following licensed material as if it were not radioactive: (1) 0.05 microcurie (1.85 kBq), or less, of hydrogen-3 or carbon-14 per gram of medium used for liquid scintillation counting; and (2) 0.05 microcurie (1.85 kBq), or less, of hydrogen-3 or carbon-14 per gram of animal tissue, averaged over the weight of the entire animal. (b) A licensee may not dispose of tissue under paragraph (a)(2) of this section in a manner that would permit its use either as food for humans or as animal feed. (c) The licensee shall maintain records in accordance with 10 CFR 20.2108. Provisions for transfer for disposal and manifest for radioactive waste 10 CFR 20.2006: (a) The requirements of this section and Appendix G to 10 CFR Part 20 are designed to: (1) Control transfers of low-level radioactive waste by any waste generator, waste collector, or waste processor licensee, as defined in this part, who ships low-level waste either directly, or indirectly through a waste collector or waste processor, to a licensed low-level waste land disposal facility (as defined in 10 CFR Part 61);

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Page 15 (2) Establish a manifest tracking system; and (3) Supplement existing requirements concerning transfers and record keeping for those wastes. (b) Any licensee shipping radioactive waste intended for ultimate disposal at a licensed land disposal facility must document the information required on US Nuclear Regulatory Commission's Uniform Low-Level Radioactive Waste Manifest and transfer this recorded manifest information to the intended consignee in accordance with Appendix G to 10 CFR Part 20. (c) Each shipment manifest must include a certification by the waste generator as specified in Section II of Appendix G to 10 CFR Part 20. (d) Each person involved in the transfer for disposal and disposal of waste, including the waste generator, waste collector, waste processor, and disposal facility operator, shall comply with the requirements specified in Section III of Appendix G to 10 CFR Part 20. General provisions, for compliance with environmental and health protection regulations are provided in 10 CFR 20.2007. Nothing in this subpart relieves the licensee from complying with other applicable federal, state, and local regulations governing any other toxic or hazardous properties of materials that may be disposed of under this subpart. In summary, US Nuclear Regulatory Commission and Agreement State licensees that store mixed waste must comply with the regulations under the Resources Conservation and Recovery Act (RCRA). Specific guidance is available in NRC/EPA Draft Storage Guidance (available: http://www.epa.gov/radiation/mixed-waste/mw_p27.htm ). EPA has extended its policy of non-enforcement of RCRA section 3004(j), “Storage Prohibition at Facilities Generating Mixed Radioactive/Hazardous Waste”, until October 31, 2001 (BRER staff personal communication with Nancy Hunt, 2000), for facilities generating mixed waste for which there is no available option for treatment or disposal. The policy recognized that treatment and disposal options for such mixed wastes were limited, and it recognized that ultimate treatment and disposal for some materials might not occur within the 90-day treatment time required. Disposal Cost The direct costs for disposing of LLRW have risen sharply in the last 25 years from about $1/ft3 to around $400/ft3, and projected costs for new sites suggest further increases to well over $1,000/ft3 (Ryan and Newcomb, 2000). Table 2 shows the disposal fees for the Barnwell site, operated by Chem-Nuclear and now owned by GTS Duratek. Permission was obtained from Henry Porter to publish

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Page 16 Table 2. Disposal Fees for Barnwell Facility—Effective July 1, 2000 (Porter, 2000) Minimum charge per shipment for all shipments, excluding surcharges and specific other charges, is $1000. Extended Care Fund, and Site Stabilization and Closure Fund both included in base disposal charge rates. Base Disposal Charges: Standard and Special-Nuclear-Material Waste from “Uniform Schedule of Maximum Disposal Rates for Atlantic Compact Regional Waste” from “Disposal Rate Schedule for Non-Atlantic Compact Waste” Weight – Density Range Atlantic Compact Rate Non-Atlantic Compact Rate Equal to or greater than 120 lbs./ft3 $ 4.40 per pound $ 4.40 per pound Equal to or greater than 75 lbs./ft3 and less than 120 lbs./ft3 $ 4.84 per pound $ 4.84 per pound Equal to or greater than 60 lbs./ft3 and less than 75 lbs./ft3 $ 5.94 per pound $ 5.94 per pound Equal to or greater than 45 lbs./ft3 and less than 60 lbs./ft3 $ 7.70 per pound $ 7.70 per pound Less than 45 lbs./ft3 $ 7.70 per pound times the ratio of 45 lbs./ft3 divided by package density $ 7.70 per pound times the ratio of 45 lbs./ft3 divided by package density Millicurie Charge $ 0.33 per millicurie (b.1) or $0.66 per millicurie for radionuclides with greater than 5-year half lives (b.2) Option b.1 will apply unless generator specifically elects option b.2 for all of its shipments at the beginning of a fiscal year maximum millicurie charge is $132,000/shipment $0.36 per millicurie maximum millicurie charge is $144,000/shipment Base Disposal Charges: Biological Waste $1.00 per pound in addition to above rates $1.00 per pound in addition to above rates Dose Rate Surcharge Atlantic Compact Multiplier of Base Weight Rate Non-Atlantic Compact Multiplier of Base Weight Rate Dose Level 0 mR/hr - 200 mR/hr 1.00 1.00 >200 mR/hr - 1 R/hr 1.08 1.08 >1R/hr - 2R/hr 1.12 1.12 >2R/hr - 3R/hr 1.17 1.17 >3R/hr - 4R/hr 1.22 1.22 >4R/hr - 5R/hr 1.27 1.27 >5R/hr - 10R/hr 1.32 1.32 >10R/hr - 25R/hr 1.37 1.37 >25R/hr - 50R/hr 1.42 1.42 >50R/hr 1.48 1.48 Irradiated Hardware Charges (applicable only where shipment requires shut-down of other disposal operations) Includes irradiated cask-handling fee. $50,000.00 per shipment $50,000.00 per shipment Special Nuclear Material Surcharge $10.00 per gram $10.00 per gram Atlantic Compact Commission Administrative Surcharge $4.00 per cubic foot Subject to change during year $4.00 per cubic foot Subject to change during year   Underlining indicates a difference

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Page 17 the latest site availability charge for the Barnwell facility (Porter, 2000). Base charges range from about $350/ft3 to above $500/ft3, depending on weight. Table 3 shows the rate schedule for the Richland site a . Richland site availability charges are in the range of $20-27/ft3 per year, depending on volume and radiation levels. Additional charges include volume, shipment, container, and exposure charges, which can vary substantially. For example, a 100-ft3 shipment with 500-mR/h exposure would cost about $100/ft3; storing this shipment for 20 years would cost about $600/ft3 (undiscounted). Table 4 shows the current charges for disposal of biomedical LLRW at the Richland facility. Disposal is only one component of the total cost of LLRW management. It is instructive to examine two cases of radioactive-waste management activities. The first is in a university setting (Osborne, 2000), the second is in a research-hospital setting (Miller, 2000). Both cases were presented to the committee. Osborne provided the following information regarding annual LLRW management costs at the University of Iowa: 1. Disposal $62,000 2. Support staff Three staff members in the Radiation Protection Office, part of whose duty is LLRW management 3. Storage facility 16,000 ft2 building, about half of which is used for LLRW storage 4. Faculty part of whose time is spent on several committees To obtain an approximate estimate of the total annual cost of LLRW management, we make some conservative (low-end cost) assumptions. If we estimate the average salary and fringe benefits of each of the support staff at $40,000 and if we assume that they spend about 50% of their time on LLRW management, the annual staff-support cost would be $60,000. The annual cost of the storage facility can be calculated by using the square-footage cost for a leased building, for example, $10/ft2 per year. That would mean $80,000 per year for half the 16,000-ft2 facility. Faculty time and its equivalent cost are more difficult to estimate. The University of Iowa has four committees related to radiation protection with a total of some 20 members (Osborne, 2000). Assuming that members spend, on the average, 10 days per year on committee duty, and that 50% of this duty is related to radioactive-waste management, 100 person-days of faculty time would be spent on radioactive-waste management. With an average salary of $80,000 and 200 days of academic-year work, that would mean another $40,000 per year. a The committee does not have data from Envirocare of Utah. The Envirocare facility does not publish a rate schedule due to the range of radioactive and mixed waste licenses and the diversity of the needs of Envirocare's customers.

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Page 18 Table 3. Site Availability Charge for Richland Facility—Effective May 1, 2000 a SITE AVAILABILITY CHARGE       Rates   Block Block Criteria Annual Charge per Generator 0 No site use at all $100 1 Greater than zero but less than or equal to 10 ft3 and 50 mR/h $211 2 Greater than 10 ft3 or 50 mR/h * but less than or equal to 20 ft3 and 100 mR/h * $404 3 Greater than 20 ft3 or 100 mR/h * but less than or equal to 40 ft3 and 200 mR/h * $776 4 Greater than 40 ft3 or 200 mR/h * but less than or equal to 80 ft3 and 400 mR/h * $1,491 5 Greater than 80 ft3 or 400 mR/h * but less than or equal to 160 ft3 and 800 mR/h * $2,868 6 Greater than 160 ft3 or 800 mR/h * but less than or equal to 320 ft3 and 1,600 mR/h * $5,513 7 Greater than 320 ft3 or 1,600 mR/h * but less than or equal to 640 ft3 and 3,200 mR/h * $10,597 8 Greater than 640 ft3 or 3,200 mR/h * but less than or equal to 1,280 ft3 and 6,400 mR/h * $20,372 9 Greater than 1,280 ft3 or 6,400 mR/h * but less than or equal to 2,560 ft3 and 12,800 mR/h * $39,167 10 Greater than 2,560 ft3 or 12,800 mR/h * but less than or equal to 5,120 ft3 and 25,600 mR/h * $75,288 11 Greater than 5,120 ft3 or 25,600 mR/h * $143,234 * For purposes of determining the site availability charge, mR/h is calculated by surmuing the mR per hour at container surface of all containers received during the year. a Permission was obtained from US Ecology, Inc. to publish the latest site availability charge for Richland facility (personal communication with Arvil Crase, 2000).

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Page 19 Table 4. Current Charges For Biomedical Low-Level Radioactive Waste At US Ecology's Richland Facility—Effective May 1, 2000 a COMPONENT RATE UNITS TOTAL Site availability fee $10,597.00 BLOCK 7 $ 10,597.00 Volume (cu ft) 22.90 500.00 $ 11,450.00 Shipments 4,228.00 1 $ 4,228.00 Containers 1,449.00 5 $ 7,245.00 Dose rate/container (mR/hr at container)     <200 16.00 5 $ 80.00 >200 - <1,000 1,150   $ - >1,000 - <10,000 4,550   $ - >10,000 - <100,000 6,950   $ >100,000 116,500   $ - TOTAL US ECOLOGY     $ 33,600.00 TAXES & FEES       (1) PERPETUAL CARE FEE $ 1.75 500.00 $ 875.00 (2) B & O TAX 3.3% 33,600.00 $ 1,108.80 (3) SITE SURVEILLANCE 6.00 500.00 $ 3,000.00 (4) SURCHARGE 6.50 500.00 $ 3,250.00 (5) WUTC FEE 1.00% 33,600.00 $ 336.00 TOTAL TAXES & FEES     $ 8,569.80 TOTAL CHARGES     $ 42,169.80 (1) Perpetual care fee - $1.75 per ft3 (2) B & O Tax - 3.45% of US Ecology charges (3) Site surveillance - $6.00 per ft3 (4) Surcharge - $6.00 per ft3 (5) WUTC fee - 1.0 % of US Ecology charges Assumptions:    500 ft3, 1 shipment 5 containers under 200 mR/hr Dose The average charge for disposal of biomedical LLRW from 1996-1999 is $47.00 per ft3 a Permission was obtained from US Ecology, Inc. to publish current charges for biomedical low-level radioactive waste at US Ecology's Richland facility (personal communication with Arvil Crase, 2000).

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Page 20 Using those assumptions, the total annual cost of radioactive-waste management at this institution would be $242,000, of which $62,000, or 26% would be for disposal itself. The University of Iowa produces about 20,000 kg (44,000 lb) of radioactive waste per year. The overall management costs thus translate into $5.50/lb. Depending on the density of packing, that could be between $275/ft3 (at 50 lb/ft3) and $550/ft3 (at 100 lb/ft3). Because most of our assumptions are conservative, those estimates are probably a lower bound of the actual costs attributable to radioactive-waste management. Data provided by Miller for the Hershey Medical Center at Pennsylvania State University tell a similar story. His estimates of annual costs are as follows: 1. Employee $57,577 2. Disposal $36,500 3. Disposal supplies $ 2,800 4. Storage space 1,505 ft2 Again assuming $10/ft2 per year for the storage facility, we estimate a total of about $112,000/year, of which about 33% is for disposal itself. That does not include faculty time, which could not be estimated on the basis of data available to the committee. The total annual volume of radioactive waste at the Hershey Center is 33,270 lb. Thus, the annual cost for radioactive waste management is $3.37/pound. Again assuming a range of 50-100 lb/ft3, this translates into $168/ft3 to $337/ft3, respectively. That superficial cost analysis clarifies two issues. First, the overall annual cost to the generating institutions for radioactive-waste management is not insignificant. Although perhaps small relative to the revenues generated by the research or other activities that create the waste, it is likely to be an important portion of the institutions' overhead income associated with these activities. It would displace the use of overhead income for other competing purposes. The problem is compounded by Office of Management and Budget Circular A-21, which limits recovery of the administrative component of overhead to 20% of direct costs. Rising costs for radioactive-waste disposal are included in a category with rising costs for animal care, human-subjects protection, and other complex compliance issues; and revenues to reimburse such cost are constrained by federal policy. This situation throws some of the costs for radioactive-waste management directly on to the institution in competition with other research priorities. Second, the disposal component of the costs is substantial (26-33% of total annual cost for the two sites described above). This suggests that longer-term onsite storage may be cost-beneficial, at least for the short-lived radionuclides, as illustrated by the following simple calculation. If storage space is leased at $10/ft2 per year and if a 100 ft2 area can hold 500 ft3 of radioactive material (piled 10 ft high, but using only 50% of the space to allow for space between packages and access), the cost of storage would be $1,000/year for 500 ft3 of material or $2/ft3 per year, or $40/ft3 for 20 years. That is well below the

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Page 21 cost of disposal at the Barnwell or Richland site. Even including other waste-management costs, the annual costs of long-term onsite storage are likely to be lower than the cost of permanent disposal. Access to Disposal Legal Framework In the early 1970s, six commercial LLRW disposal sites in the United States handled the needs of industrial, utility, medical, and research waste producers. By 1978, three had closed, and the governors of the three states with remaining operating sites, Nevada, South Carolina, and Washington, put the rest of the country on notice that they wanted the other states to take responsibility for their own waste. With the strong backing of the National Governor's Association, the National Conference of State Legislatures, and most state governments, Congress reacted by passing the LLRWPA (Public Law 96-573) in 1980. The act gave the states responsibility for ensuring adequate disposal capacity for commercial LLRW generated within their borders, except for waste generated by federal weapons or research and development activities. It also encouraged states to enter into multistate compacts to manage the waste safely and efficiently on a regional basis, subject to congressional approval, and it allowed a compact region to exclude low-level waste generated outside the region from its disposal site after January 1, 1986. However, because of the difficulty that states were experiencing in siting new facilities as the 1986 deadline approached, Congress passed the LLRWPAA of 1985 (Public Law 99-240), effective January 15, 1986. That act includes incentives and penalties to prod states and regions without disposal sites to build new disposal facilities. In addition, the three states with existing sites were to remain open to all states through December 1992. Waste producers could be denied access to existing sites if their states were not making adequate progress toward building disposal facilities. Current Status of Disposal In spite of the incentives and penalties for States under the Low-Level Radioactive Waste Disposal Policy Amendments Act, which have not been enforced, no new sites have opened. The Beatty, Nevada site, which was the first commercial disposal site to open, was closed in 1993 after 30 years of operation, and a site in Utah, operated by Envirocare, opened in 1991. All states have access to one or more of the existing disposal sites in Washington, Utah, and South Carolina. The Richland site, in Washington, opened in 1965 and operated by US Ecology, is restricted for use by the states of the Northwest Compact and Rocky Mountain Compact. Washington, Oregon, Idaho, Montana, Utah, Wyoming, Alaska, and Hawaii are in the

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Page 22 Northwest Compact; Nevada, Colorado, and New Mexico are in the Rocky Mountain Compact. The site is expected to remain open until 2056. Recently, the Northwest Compact approved a resolution reflecting its continuing support for the 1985 Low-Level Radioactive Waste Policy Amendments Act and urging other states and compacts to provide disposal capacity (LLRW Management Summary Report, 1999). The Barnwell, South Carolina, site, opened in 1971 and operated by Chem-Nuclear, and now owned by GTS Duratek, receives Class A, B, and C waste from most of the rest of the nation. The Tooele County (Clive), Utah, site, opened in 1991, receives only Class A LLRW. Envirocare of Utah, the site operator has applied for a license expansion to allow it to include Class B and C wastes. Testing the System: Closures of Barnwell In trying to visualize future constraints on the LLRW management system, we can look at what has happened when access to facilities has been denied. The Barnwell site has been the only site to which almost all states have had access for most of the 30-year period when new sites were to have been built and opened. However, Michigan and North Carolina were denied access to it because they were not making progress toward building new disposal sites. Barnwell was also closed to all out-of-compact waste from July 1, 1994, to July 1, 1995, in anticipation of the site closure when North Carolina was to open its new site for the Southeast Compact. Michigan Michigan, which was the first host state for the Midwest Compact's LLRW disposal facility, was denied access to Barnwell from 1991 to 1996 because of lack of progress in developing the facility. During that time, generators apparently were able to store their waste (LLW Forum Summary Report, 1998). At the University of Michigan, for example, waste was minimized and substitutes were used for long-lived radionuclides were methods employed to reduce the volume and radioactivity of the waste produced. Waste segregation was also used (BRER staff personal communication with Tim Cullen, University of Michigan Hazardous Materials Management, 1998). With these changes, it was possible to maintain the research effort. Smaller institutions, such as smaller colleges and pharmaceutical companies, have eliminated the use of nonessential radioactive materials; such as for teaching purposes, but lack of sufficient storage space is a problem for them (BRER staff personal communication with Thor Strong, Michigan representative to LLRW Forum, 1998).

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Page 23 Larger facilities—such as hospitals, research institutions, and industry—use onsite storage and have modified practices rather than eliminating them. Health-care facilities apparently did not have a problem with storing their relatively small amounts of therapeutic and diagnostic waste. However, they are concerned about the long-term implications of adding waste-storage costs to waste-disposal costs. North Carolina North Carolina, which was to have opened the Southeast Compact's disposal facility after the Barnwell facility was scheduled to close, was denied access to Barnwell in 1998 because of lack of progress in developing the facility. It regained access in July 2000. North Carolina's response was similar to Michigan's. Generators used one or more of the following: changing radioactive-material processes, minimizing waste, increasing storage capacity for LLRW, looking for other disposal options, reducing volume, buying waste compactors for onsite use, and storing waste until another disposal option became available (Fry, 2000). As in Michigan, most large generators in North Carolina have capacity to store their own waste or have built new storage facilities. One of the large generators, the University of North Carolina at Chapel Hill, stores short-lived waste for decay, but ships long-lived waste to GTS Duratek (formerly Scientific Ecology Group-SEG) for volume reduction through incineration. However, because North Carolina did not have access to Barnwell, the ashes were sent back to North Carolina for storage until access to a disposal facility was regained. Although the waste volume was reduced, there was an additional cost for storing the waste that would not have been incurred if they had been able to ship the ash for disposal. The University's branches cannot use Chapel Hill's storage facility, because Chapel Hill is not licensed as a waste processor and disposal facility, so storage-to-decay poses a problem for them. They also have fewer personnel to handle the waste (BRER staff personal communication with Bob Wilson, Director, Radiation Safety, 1998). Principal investigators at Chapel Hill were apparently relatively unaffected by the lack of access to Barnwell because steps were taken to alleviate problems, such as an aggressive volume-reduction effort. The cost of disposing of longer-lived radionuclides has forced investigators to use nonradioactive substitutes. East Carolina University, the fourth-largest university generator, stores short-lived wastes to decay and sends some short-lived wastes to Envirocare. Incineration is the primary means of disposal of long-lived waste. It also ships to GTS Duratek for reduction, although a vigorous onsite volume-reduction program has been successful. Substitution of nonradioactive material has not been promoted (BRER staff personal communication with Daniel Sprau, Director, Radiation Safety, 1998).

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Page 24 Smaller pharmaceutical companies were forced to seek alternatives to disposal at Barnwell, including finding ways to increase the efficiency or size of onsite storage and using their own storage, treatment, or other disposal facilities. Researchers continued to use both radionuclides and other methods of detection, such as fluorescence. Some waste processing and storage facilities were available, but long-term storage was a problem. Envirocare is not an option for smaller generators, because of its volume requirements, radioactivity-concentration limits, and other restrictions. North Carolina generators managed their waste by a combination of processing and treatment options and disposal at the Envirocare facility. Most are using brokers to package their waste for shipment for out-of-state processing or disposal. However, there is concern about the future. If access to out-of-state processing and disposal facilities were restricted, most generators would soon have to create more storage capacity; some generators stated that they could store waste for only a few months before having to add capacity (North Carolina Radiation Protection Survey by phone, 1999). Barnwell DisposalSite Closure: 1994-1995 When the Barnwell facility was closed to all out-of-compact states from July 1, 1994, to July 1, 1995, an estimated 3,000 companies and institutions that were using radioactive materials and generating LLRW in 31 states were affected. Organizations United, a radioactive-materials users organization, sponsored a survey to ascertain the likely consequences if new facilities were not opened to replace the Barnwell facility (Organizations United Report, 1996). From a list of companies and institutions that had sent low-level waste to disposal facilities in the recent past, 680 LLRW managers were randomly selected to be interviewed from February 1995 through early July 1995. They included 271 research companies, 212 medical institutions, 54 government facilities, and 39 electric companies. The survey verified that without access to a disposal facility, managers mobilize a variety of resources to manage the waste problem temporarily, but that long-term effects would be more difficult to manage. Many of those companies and institutions who foresaw adverse effects if lack of access to offsite disposal continued for another 5 years (to the year 2000) were in the health field. Five medical institutions had been forced to refer patients to other facilities because of cuts in diagnostic procedures. Another 30 said that they would probably have to refer patients elsewhere if the situation continued for another 5 years. A majority of the institutions had already incurred higher operating costs, and some reported a loss of revenue. Most companies or institutions had made physical, structural, or personnel adaptations, such as adding or expanding onsite storage equipment and space and adding or reassigning personnel to manage radioactive materials onsite. Most of them already

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Page 25 had waste-minimization and volume-reduction programs in place, but 103 companies or institutions initiated these programs after they lost access to disposal. Only 33 companies or institutions discontinued the use of radioactive materials altogether. Some were able to eliminate some uses, and some made at least some substitutions. However, 37 of them said the change increased the cost of their services and/or had a negative effect on the quality of their services. Nearly three-fourths of those surveyed considered loss of disposal access to be a major problem. Among the reasons cited were inadequate onsite storage capacity, increased potential for environmental and safety problems, and adverse effects on consumers. Changes – Barnwell and Envirocare Two recent developments will affect access to disposal sites for states not in the Northwest Compact states of Washington, Oregon, Idaho, Montana, Utah, Wyoming, Alaska, and Hawaii; the Rocky Mountain Compact states of Nevada, Colorado, and New Mexico; or the Atlantic Compact states of South Carolina, New Jersey, and Connecticut. South Carolina recently passed legislation that established the three-state Atlantic Compact and would eventually close the Barnwell facility to all out-of-compact states except New Jersey and Connecticut, formerly the Northeast Compact (South Carolina Compact Law – A357, R376, S1129). Of the remaining 3 million cubic feet of capacity at Barnwell, up to 800,000 ft3 is reserved for waste from New Jersey and Connecticut. (The compact commission could revise the estimate of need downward by unanimous consent.) After 2008, the Barnwell facility will no longer accept out-of-compact waste. The Barnwell facility's schedule is as follows (Porter, 2000): 2001 – 160,000 ft3 2002 – 80,000 ft3 2003 – 70,000 ft3 2004 – 60,000 ft3 2005 – 50,000 ft3 2006 – 45,000 ft3 2007 – 40,000 ft3 2008 – 35,000 ft3 Furthermore, although the legislation allows the compact commission to vote to admit new member states to the compact, a state seeking admission to the compact would be required to host a new regional disposal facility. In Utah, Envirocare has applied for permits and licenses to accept Class B and Class C wastes in addition to the Class A waste that it is now licensed to accept. It has received approval from the Tooele County Commission to accept Class B and C waste, but it must still receive siting and license approval from the Utah Division of Radiation Control and approval from the governor and the legislature in its next session, which begins in January 2001 (Israelsen, 2000).

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Page 26 If Envirocare's license expansion is approved, an option to dispose of Class B and Class C waste other than at Barnwell would be open to generators throughout the nation, but it might be especially attractive to those in western states. Some potential users of the site have said that they do not and will not send their LLRW to Envirocare, because of possible liability problems related to how the site has been operated. Any generator that has used the site might be considered a responsible party if the site becomes a Superfund site. Cost might also enter the picture, depending on the disposal rates set by Envirocare. Although it is certain that there will be no access to Barnwell for most states in the near future, it is not certain that the Envirocare facility will become available or acceptable to all LLRW generators. That uncertainty makes long-term planning for LLRW disposal difficult.