Human Subject Experiments Which Are Air Tagged with Radioisotopes of 13N and 41R

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LAWRENCE LIVERMORE NATIONAL LABORATORY Operational Safety Procedure HUMAN SUBJECT EXPERIMENTS WHICH ARE AIR TAGGED WITH RADIOISOTOPES OF 13N and 41Ar The Laboratory's basic safety policy is that operations must be planned and conducted in a manner that will prevent injury to personnel or damage to accident-free work environment for the human subject experiments with air tagged with radioisotopes in Building 194 are stated in the Operational Safety Everyone in this building, i.e., visitor, maintenance and service employee, and regularly assigned employee, is required to abide by this procedure and the LLNL Health -and Safety Manual to protect himself and other personnel from injury. Regular building personnel are responsible for assisting others in the building to understand the safety regulations relating to what they are doing and to abide by the safety requirements. The minimum safety rules and practices necessary for achieving an This procedure was prepared by building management assisted by Hazards Control. Confer with the Hazards Control safety team assigned to this building for interpretation of this procedure and for planning your operations to comply with safety requirements. Each individual in this building shall use this guidance effectively to avoid injury. This Operational Safety Procedure has been reviewed by: This Operational Safety Procedure has been authorized by:

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Operational Safety Procedure HUMAN SUBJECT EXPERIMENTS WHICH ARE AIR TAGGED WITH RADIOISOTOPES OF I3N and 41Ar The purpose o f this study is to measure the rate of nitrogen and argon uptake and elimination in the body o f normal healthy humans. experiments will involve breathing of I3N and 41Ar labelled air for no more than 120 minutes. Any required change in operations that alters the scope or significantly decreases safety control will not be made until a revision or supplement to this procedure has been signed by the person authorized t o approve safety control may be made with the joint concurrence of the LINAC Operations Manager and the Hazards Control Safety Team Leader. Any required change in operations that does not decrease the 1. This procedure authorizes the exposure o f human subjects to the minutes with an accompanying lung dose o f approximately 400 mrem to

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The lung dose per mCi per liter (initial concentration) for 13N is approximately 1000 mrem for a 120 minute experiment and for 41Ar is approximately 6400 mrem for a 120 minute experiment. The actual lung dose to participants can be calculated as follows: The breathing gas concentrations will be: Half lives (T1/2) for the radionuclides are 13N: 10 min. and 41Ar: 109 min. Time elapsed from beam shut-off to administration of gas will be estimates at t=20 min. for 120 minute exposure. With this in mind, we then obtain the To generate the I 3 N isotope, high-purity N2 is irradiated with minimizing the presence of 02 in the nitrogen. Some trace of 02 always is present and in this ionizing The concentration is controlled by The Operational Controls i n section F will reduce the above hazards to an

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Operational Safety Procedure Paul Meyer (Ext. 2-9678) i s responsible for assuring that all work is performed in conformance with this OSP and the -LLNL Health and Safety responsible person will be trained for the experiment. In his absence, the experiment will be terminated and a All participating employees are responsible for performing their work according to the regulations of this OSP. reasonable precautions to protect themselves and their fellow employees and to perform only those tasks that they believe can be accomplished safely. When participants have any doubt regarding the safety of any phase of their work, they are expected to check with the project supervisor before proceeding. They are expected to take all The Hazards Control Safety Team assists management to institute and to maintain a low-risk work environment. In addition, Hazards Control may request that management or employees stop an operation when there appears to be an iminent danger to personnel or property (see Health -and Safetx Manual Section 1.06). 1. The target gases are: a) Ar: Zero grade argon b) N2: High purity nitrogen (silver colored bottles with pink top).

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Operational Safety Procedure 2. Waste gas disposal is achieved with a large volume blower which pumps gas from the site of the experiment to the outside of Bldg. 194 at the All human subjects shall receive a whole body radiation scan by Hazards Control in the Whole Body Counting Facility at Bldg. 253 before and after inhalation of radioactive gases. The radioactive gases shall be filtered with a HEPA filter before inhalation by the subjects. A visual inspection of the filter cartridge gaskets and canister will be made prior to filter installation. Only an approved and tested filter cartridge obtained from Hazards Control Respirator Branch will be installed in the filter canister. Radioactive gas preparation: The evacuated target gas bottle, located in the 0' cave, is filled from Zero grade Ar. Upon filling, the gas is irradiated with LINAC-produced In the case of N2 as target gas, any undesired by-products come from small oxygen concentrations in the gas bottle. This can lead, in principle, to NO2 and N20. Tests performed previously by Hazards Control personnel found concentrations of less than 1 ppm of NO2 and less than 22 pprn of N20 in an irradiated sample. will be routinely tested for NO2 before it is administered. The breathing mixture will be tested for NO and NO2 before the first experiment covered by this OSP. The breathing mixture 1. Evacuate target-gas bottle to less than or equal to 50 microns.

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Operational Safety Procedure Bleed radioactive gas, as described below, into plastic bag. Check mixture for N02. Human subjects will not be exposed to M i x activated N2 with clean 02 to 4 parts *N2 and 1 part 02 in plastic Navy personnel will continuously monitor and hold 02 concentration to approx i ma te 1 y 20%. A Victoreen 450 ionization chamber survey instrument will be positioned one meter from the center of the plastic bag throughout the 120-minute procedure. This instrument will provide a secondary check on the actjvity contained in the bag. survey instrument indicates a level in excess of 500 mR/hr at the The experiment shall not proceed if the The prepared and tested gas mixture is taken from Trailer 930 to the subject in Bldg. 194 in a plastic bag which is then connected to the breathing valve. The subject then breathes for 120 minutes from the bag. The exhaled gas is passed through a soda lime trap to remove all C02 before returning to the bag. A concentration of approximately 20% O2 is maintained in the bag and monitored with an oxygen meter during use by Navy personnel. At the end of the 120 minute period the bag is disconnected and the subject breathes room air with the washout being vented to the outside of Bldg. 194.