A process for reducing the licensing burden for new products containing depleted uranium.

This report is intended to provide guidance on the process for petitioning the U.S. Nuclear Regulatory Commission (NRC) to initiate a rulemaking that could reduce the licensing burden for new products containing depleted uranium (DU), which are being investigated by the DU Uses Research and Development (R&D) Program at Oak Ridge National Laboratory (ORNL). The focus is on requirements of the NRC rulemaking process applicable to establishing new exemptions or general licenses for products and devices containing source material. NRC policies and guidance regarding such requirements are described, including a 1965 policy statement on approval of new exemptions for products containing radionuclides (''Federal Register'', Volume 30, page 3462 [30 FR 3462]; March 16, 1965) and Regulatory Guide 6.7, which addresses the contents of environmental reports that support rulemaking petitions seeking exemptions for radionuclide-containing products. Methodologies for calculating radiological and nonradiological impacts on human health (i.e., risks) associated with distributing, using, and disposing of DU-containing products are presented. Also, methodologies for completing assessments of the potential effects of accidents involving new DU-containing products and of product misuse are described. The report recommends that the U.S. Department of Energy formulate a regulatory plan for deployment of DU-containing products in areas that are not already radiologically controlled. Such a plan is needed because deployment of new DU-containing products may be difficult under existing NRC licensing requirements. To provide a basis for the regulatory plan, it is recommended that detailed assessments of the radiological and nonradiological risks of distributing, using, and disposing of DU-containing products be conducted. Such assessments should be initiated as soon as sufficient data are available from the ongoing DU Uses R&D Program at ORNL to support the analyses

Accelerating RCRA corrective action: The principles of the DOE approach

The US Department of Energy (DOE) is involved in the remediation of environmental contamination at many of its facilities under the Resource Conservation and Recovery Act (RCRA). RCRA`s corrective action provisions were established by the Hazardous and Solid Waste Amendments of 1984 (HSWA). In response to the HSWA mandate, EPA established a program for the conduct of RCRA corrective action that was similar to that established under the Comprehensive Environmental Response Compensation and Liability Act (CERCLA). In addition, EPA developed and implemented its ``stabilization`` initiative as a means of quickly addressing immediate risks posed by releases until long term solutions can be applied. To improve the efficiency of environmental restoration at its facilities, DOE is developing guidance and training programs on accelerated environmental restoration under RCRA. A RCRA guidance document, entitled ``Accelerating RCRA Corrective Action at DOE Facilities,`` is currently being developed by DOE`s Office of Environmental Policy and Assistance. The new guidance document will outline a decision-making process for determining if acceleration is appropriate for individual facilities, for identifying, evaluating, and selecting options for program acceleration, and for implementing selected acceleration options. The document will also discuss management and planning strategies that provide a firm foundation for accelerating RCRA corrective action. These strategies include a number of very basic principles that have proven effective at DOE and other federal facilities, as well as some new approaches. The purpose of this paper is to introduce DOE`s new guidance document, discuss the general approach presented in the guidance for accelerating RCRA corrective action, and to emphasize some of the more important principles of effective management and planning

Release process for non-real property containing residual radioactive material

It is DOE`s objective to operate its facilities and to conduct its activities so that radiation exposures to members of the public are maintained within acceptable limits and exposures to residual radioactive materials are controlled. To accomplish this, DOE has adopted Order DOE 5400.51 `Radiation Protection of the Public and the Environment`, and will be promulgating IO CR Part 834 to codify and clarify the requirements of DOE 5400.5. Under both DOE 5400.5 and 10 CR Part 834, radioactively contaminated DOE property is prohibited from release unless specific actions have been completed prior to the release. This paper outlines a ten-step process that, if followed, will assist DOE Operations and contractor personnel in ensuring that the required actions established by Order DOE 5400.5 and 10 CR Part 834 have been appropriately completed prior to the release for reuse or recycle of non-real property (e.g., office furniture, computers, hand tools, machinery, vehicles and scrap metal). Following the process will assist in ensuring that radiological doses to the public from the released materials will meet applicable regulatory standards and be as low as reasonably achievable (ALARA)

Abstracts from the 8th International Conference on cGMP Generators, Effectors and Therapeutic Implications

This work was supported by a restricted research grant of Bayer AG

Regulation of new depleted uranium uses.

This report evaluates how the existing U.S. Nuclear Regulatory Commission (NRC) regulatory structure and pending modifications would affect full deployment into radiologically uncontrolled areas of certain new depleted uranium (DU) uses being studied as part of the U.S. Department of Energy's DU uses research and development program. Such new DU uses include as catalysts (for destroying volatile organic compounds in off-gases from industrial processes and for hydrodesulfurization [HDS] of petroleum fuels), semiconductors (for fabricating integrated circuits, solar cells, or thermoelectric devices, especially if such articles are expected to have service in hostile environments), and electrodes (for service in solid oxide fuel cells, in photoelectrochemical cells used to produce hydrogen, and in batteries). The report describes each new DU use and provides a detailed analysis of whether any existing NRC licensing exemption or general license would be available to users of products and devices manufactured to deploy the new use. Although one existing licensing exemption was found to be possibly available for catalysts used for HDS of petroleum fuels and one general license was found to be possibly available for catalysts, semiconductors, and electrodes used in hydrogen production or batteries, existing regulations would require most users of products and devices deploying new DU uses to obtain specific source material licenses from the NRC or an Agreement State. This situation would not be improved by pending regulatory modifications. Thus, deployment of new DU uses may be limited because persons having no previous experience with NRC or Agreement State regulations may be hesitant to incur the costs and inconvenience of regulatory compliance, unless using a DU-containing product or device offers a substantial economic benefit over nonradioactive alternatives. Accordingly, estimating the risk of deploying new DU-containing products and devices in certain radiologically uncontrolled areas is recommended. If the estimated risks of such deployment are found to be acceptable, then it may be possible to justify adding new exemptions or general licenses to the NRC regulations

Permitting mixed waste treatment, storage and disposal facilities: A mixed bag

The Federal Facility Compliance Act of 1992 (FFCAct) requires the U.S. Department of Energy (DOE) to make a comprehensive national inventory of its mixed wastes (i.e., wastes that contain both a hazardous component that meets the Resource Conservation and Recovery Act (RCRA) definition of hazardous waste and a radioactive component consisting of source, special nuclear, or byproduct material regulated under the Atomic Energy Act (AEA)), and of its mixed waste treatment technologies and facilities. It also requires each DOE facility that stores or generates mixed waste to develop a treatment plan that includes, in part, a schedule for constructing units to treat those wastes that can be treated using existing technologies. Inherent in constructing treatment units for mixed wastes is, of course, permitting. This paper identifies Federal regulatory program requirements that are likely to apply to new DOE mixed waste treatment units. The paper concentrates on showing how RCRA permitting requirements interrelate with the permitting or licensing requirements of such other laws as the Atomic Energy Act, the Clean Water Act, and the Clean Air Act. Documentation needed to support permit applications under these laws are compared with RCRA permit application documentation. National Environmental Policy Act (NEPA) documentation requirements are also addressed, and throughout the paper, suggestions are made for managing the permitting process

Galactose elimination capacity as a prognostic index in patients with fulminant liver failure.

In 25 patients with fulminant hepatic failure the prognostic value of a quantitative liver function test, the galactose elimination capacity, was assessed and comapred with routine liver function tests and clinical features. The galactose elimination capacity was significantly higher (P less than 0-05) in the five patients who survived than in the 20 patients who died. None of the other liver function tests, was significantly different. The values of the galactose elimination capacity overlapped considerably between survivors and non-survivors, but all patients with a galactose elimination capacity below 12-8 mumol galactose/min and kg body weight died. The disease among most patients who died having a galactose elimination capacity greater than 13 mumol ran a subacute course. It is suggested that quantitative liver function tests be included when new treatments of fulminant hepatic failure are investigated