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HUMAN SUBJECT EXPERIMENTS WITH The Laboratory's basic safety policy is that operations must b e planned and cm duct ed in a manner that will prevent injury to personnel o r damage t o accident - free work environment for the human subject experiments with air tagged with radioisotopes in Sui l ding 194 are stated in the Operational Safety The miniinurn 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 protect himself and other personnel frm injury. Regular building personnel are responsible for assisting others in the building to understand the safety regulations relating to what they are doing and t o abide by the safety requirements. This procedure was prepared by building management assisted by Hazards Control. Confer with t h ? Hazards Control safety team assigned to this building for interpretation of tn is procedcre and for planning your operations t o cornply with safety requirements. use tnis guidance effectively to avoid injury. Each individual in this building s!iall This Gperational Safety Procedure has been reviewed by: A.J. Toy Hazards Control This Op rational Safety Procedure i s approved by:
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Oper a't i o na 1 Safety AIR TAGGED WITH RADIOISOTOPES I3N and 41Ar The purpose of this study is to measure the rate of nitrogen and Argon uptake and elimination in the body of normal healthy hunans. The experiiwnts will involve breathing of I3N and 41Ar lab2lled 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 or supplement to 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 joint concurrence o f the LINAC Operations Manager and the Hazards Control Safety Teain Leader. Any required change in 1 . This procedure authorizes the exposure o f hunan subjects to the a ) Breathing ofair tagged with 13N and 41Ar for up to 120
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per i t iona 1 sa :e ty 41Estimates o f the radiation dose from 13N and the breathing mixture are based on calculations by Hazards Control’s Health Physics Group (see letter from K. Shingleton o f April 12, 4’Ar: 6400 rnr. To obtain extimates of the expected dose we take the gas mixes and decay activities into account as seen below: Ar activities in The dose per rnCi per liter for I3N is - 1000 m r and for The breathing gas concentrations will be: 109 nin. Tiine elapsed from bean shut-off to administration will be - 20 minutes. With this in mind we obtain the estimates at t=20 min. for 120 minute exposure. csntrolled by minimizing the presence o - i O 2 in the nitrogen. Some trace o f O 2 aliu.ays is present and in this The concentration is The O?erational Controls in paragraph F will reduce the abov? hazards
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" pe rational Safety Paul Meyer is responsible for assuring that all work i s Derformed in conformance with this OSP and the LLNL Health & Safety Manual. his absence, the experiinent will be terininated and a responsible person will be trained for the experiment. All participating employees are responsible for perforining their work according to the regulations of this OSP. all reasonable precautions to protect themselves and their fellow einployees and t o perform only those tasks that they believe can be s are ty of any phase of their work, they are expected t o check with the project supervisor before proceeding. They are expected to take When participants have any doubt regarding the The Hazards Control Safety Team assists management to institute and t o maintain alow - risk work environment. In addition, Hazards Control may reqEest that management o r employees stop an operation when there appears t o be an imminent danger t o personnel o r property (see Health & Safety Planual Section 1.06). 1 . The target gases are : a ) AR: Zero grade b ) R2: High purity nitrogen (silver colored bottles with pink
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2. Ilaste gas disposal i s achieved with large vol um n blower svhich pumps gas fro i the site of the experiinent to the outside of Bldg. 194 a t the roof level. 1 . All hurnari 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 Service will be installed in the Only an approved and tested filter cartridge obtained 3. Radioactive gas preparation : The evacuated target gas bottle,located in th20 cave, is filled froma standard gas cylinder containing either hign-purity nitrogen (N2) o r Zero grade Ar. Upon filling, the gas i s being irradiated In the case of N2 as target gas, any undesired by-products come from small oxygen concentrations in the gas bottle. Hazards Ccntrol personnel, found concentrations of less than 1 ppm of f402 and less than 22 ppm o f M20 i n an irradiated sample. breathing mixture will be tested for NO2 and ozone before itis adni nis tered . This can lead, Tests performed previously by s ) Evacuate target - gas bottle in 0’ cave t o -< 50 microns.
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a per dt ional Safety c ) Bleed radioactive gas a s described below, into plastic bag. in p last i ‘ c bag. f ) Navy personnel w i l l continuously monitor and hold O2 The prepared and tested gas mixture i s taken from Trailer 930 tothe subject in Bldg. 194 in a plastic bag which i s then connected t o the breathing valve. The subject then breathes for 120 minutes from the all Co2 before returning to the bag. deficiency meter or equivalent during use Sy Navy personnel. Atthe end o f the 120 minute period the bag i s disconnected and the subject breathes room air with the washout being vented to the outside of The exhaled gas i s passed through a soda lime trap to remove i s maintained inthe bag and monitored with a bio-marine oxygen2