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Machine-read from the scan, so expect some errors. Lines that couldn’t be read are left out.
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HUMAN SUBJECT EXPERIMENTS WITH AIR TAGGED LJITH RADIOISOTOPES 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 The minimum safety rules and practices necessary for achieving an 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 & Safety Manual to ctrotect himse7f 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. Th is procedure was prepared by building management assisted by Hazards Control. Confer with the Hazards Control safety team assigned t o this building for interpretation o f this procedure and f o r planning your operations to comply with safety requirements. use this guidance effectively to avoid injury. Each individual in this building shall This Operational Safety Procedure has been reviewed by: This Operational Safety Procedure Insti tuti onal Review Board IRB Protocol File Decompression Sickness Studies with Radioactive Gases
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HUMAN SUBJECT EXPERIMENTS WITH AIR TAGGED WITH RADIOISOTOPES 13N and 41Ar The purpose of this study is t o measure the rate of nitrogen and Argon uptake and elimination i n the body o f normal healthy humans. The 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 o r significantly decreases safety control will not be made until a revision o r supplement t o this procedure has been signed by the person authorized t o approve this OSP. operations that does not decrease the safety control may b e made with the j o i n t concurrence of the LINAC Operations Manager and the Hazards Control Safety Team Leader. Any required change i n 1 . This procedure authorizes the exposure of human subjects t o the a ) Breathing ofair tagged with 13N and 41Ar for up to 120 minutes with an accompanying dose of approximately 400 mRem t o the participants. See attached letter from the Human Subjects
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Estimates of the radiation dose from 13N and 41Ar activities in the breathing mixture are based on calculations by Hazards Control's Health Physics Group (see letter from K. Shingleton of April 12, 1982). The dose per mCi per liter (initial concentration) for 13N is Q 1000 mRem for a 120 minute experiment and for 41Ar is approximately 6400 mRem for a 120 minute experiment. The actualhdose to participants can be calculated as follows: The breathing gas concentrations will be: Half lives ( T r I 2 ) for the isotopes are 13N: 10 min. and 41Ar: t=20 min. for 120 minute exposure. Time elapsed from beam shut-off to administration will be With this in mind we then obtain the estimates at To generate the controlled by minimizing the presence of O2 in the nitrogen. Some trace of O2 always is present and in this The concentration is The Operational Controls in paragraph F will reduce the above hazards to an acceptable level.
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Paul Meyer i s responsible for assuring that ail work i s performed i n conformance w i t h this OSP and the LLNL Health & Safety Manual. h i s absence, the experiment will be terminated and a responsible person will be trained for the exper.iment. A1 1 participating employees are responsible for performing their work according t o the regulations o f this OSP. all reasonable precautions t o protect themselves and their fellow employees and t o perform only those tasks t h a t they believe can be safety of any phase o f their work, they are expected t o check with t h e project supervjsor before proceeding. They are expected t o take When participants have any doubt regarding t h e The Hazards Control Safety Team assists management t o institute and t o maintain a low-risk work environment. Control may request that management or employees stop an operation when there appears t o be an imminent danger t o personnel o r property ( s e e Health & Safety Manual Section 1.06). In addition, Hazards 1. The target gases are: a ) Ar: Zero grade Argon b ) N2: High purity nitrogen (silver colored bottles with pink
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Procedure No. 194.29 -4- Issued: 4/20/82 2. Waste gas disposal is achieved with large volume blower which pumps gas from the site of the experiment to the outside of Bldg. 194 at the roof level. 1. : -All human subjects shall receive a whole body radiation scan by. . Hazards Control before and after inhalation of radioactive gases. 2. 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 from Hazards Control Respirator Branch will be installed in the Only an approved and tested filter cartridge obtained 3. Radioactive gas preparation: The evacuated target gas bottle, located in the 0' cave, is filled from a standard gas cylinder containing either high-purity nitrogen (N2) or Zero grade Ar. by LINAC bremsstrahlung. Upon filling, the gas is being irradiated In the case o f N2 as target gas, any undesired by-products come from small oxygen concentrations in the gas bottle. This can lead, Hazards Control personnel, found concentrations of less than 1 ppm o f NO2 and less than 22 ppm of N20 in an irradiated sample. breathing mixture will be tested for NO2 and ozone before it is Tests performed previously by a) Evacuate target-gas bottle to 5 50 microns.
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Procedure No. 194.29 -5 - Issued: 4/20/82 c ) Bleed radioactive gas as described below, into plastic bag. d ) Check mixture for NO2 and 03. Human subjects will not be exposed to concentrations o f NO2 in plastic bag. f) Navy personnel will continuously monitor and hold O2 concentration to approximately 20%. The prepared and tested gas mixture is taken from Trailer 930 to the subject in B l d g , 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 a11 Co2 before returning t o the bag. O2 is maintained in the bag and monitored with a bio-marine oxygen deficiency meter or equivalent during use by Navy personnel. At the end o f the 120 minute period the bag is disconnected and the subject breathes room air with the washout being vented to the outside of Fire Safety Group (3)