DISCLAIMER The following is a staff memorandum or other working document prepared for the members of the Advisory Committee on Human Radiation Experiments. It should not be construed as representing the final conclusions of fact or interpretation of the issues. All staff memoranda are subject to revision based on further information and analysis. For conclusions and recommendations of the Advisory Committee, readers are advised to consult the Final Report to be published in 1995. TAB G þþþDRAFT þ FOR DISCUSSION PURPOSES ONLYþþþ MEMORANDUM TO: Members of the Advisory Committee on Human Radiation Experiments FROM: Advisory Committee Staff DATE: September 1, 1994 RE: Management Theme Case Study: A Brief Overview of Los Alamos The Department of Energy's Los Alamos, New Mexico site is, along with Oak Ridge and Hanford, one of the three original atomic energy communities. Los Alamos was the name of a boys school that was located on the site which, according to lore, was suggested by Robert Oppenheimer as the base of Southwestern research operations for the Manhattan Project. The University of California was selected to operate the site on contract. Los Alamos served as the staging ground for the initial atomic bomb test. Following the war, Los Alamos continued as a center of weapons research. In the 1950's, when Nevada was selected as the site for Continental U.S. nuclear weapons tests, Los Alamos played a continued and primary role in weapons test activities. Also, in addition to its weapons research work, the "Los Alamos Scientific Laboratory" (now the Los Alamos National Laboratory) housed biomedical research. Los Alamos, "was, of course, a mecca for work in the physics and chemistry of plutonium," writes Stannard, in his 1988 text (Radioactivity and Health: A History). "During the war years, its biomedical program was centered largely around the health care of the workers there and ways to estimate body content from measurement of excretion (bioassay)." Stannard, at 347. Wright Langham, who headed biomedical research, was sometimes referred to as "Mr. Plutonium." (In a paper he drafted in the early 1950's, he claimed a central role in the plutonium injection experiments.) Health work was centered in the Health Division (known as the "H" division).1 {1 However, biomedical work related to the bomb tests may have involved the "J" Division as well. (We have asked DOE for additional information about the "J" Division.) In an April 1949 letter, Chairman Lillienthal recorded that: "Dr. Shields Warren and his staff in the Division of Biology and Medicine are presently engaged in drawing up plans for the biological and medical activities in future tests. A representative of the Los Alamos Scientific Laboratory is participating in the biological and medical discussions in the 'J' Division at Los Alamos and discussions have been held by the Division with representatives of the Armed Forces."} 1 Its components included: monitoring (H-1); occupational health (H-2); safety (H-3); biomedical research (H-4); industrial hygiene (H-5); environmental radiation (radiological physics in earlier years) (H-6); and industrial waste (H-7). During the 1950's, personnel reached over 250. Stannard records (at 452): "Through the foresight of Langham and Hempelmann, a nucleus of wartime workers was earmarked for a prospective study of amounts of plutonium present and possible effects. . .sizeable groups were also gradually developed in molecular and cellular radiation biology. . . .The Health Division added considerable work in mammalian radiobiology using external radiation sources, included dogs and monkeys on occasion, plus an isotope application section. In later years, an environmental studies section was formed. . . ." The DOE/Los Alamos records search identified groups of experiments (i.e., a number of the groups include many activities that might be individually termed experiments, but according to Los Alamos, may be viewed as a group). They include: ù Thyroid function measurements using radioiodine; ù The use AEC fireman as volunteers in the cross- calibration of a human counter ("HUMCO II"); ù Tracer studies with various radionuclides; ù Gastrointestinal transmit time of microspheres; ù Absorption, distribution, and excretion of tritium; ù Retention and excretion of selected radionuclides; ù Skin absorption of selected radionuclides; ù Open air, high explosive testing involving radiolanthanum; ù Pion therapies; and ù Plutonium injection studies. In addition to the experiments formally identified by Los Alamos' search group, documentation indicates Los Alamos may have been involved in other experiments. For example, a "rolling uranium experiment" is referred to in a 1950's, H-Division Report. It is not yet clear what this refers to. Los Alamos appears on the list of entities that were included in the retrospective study of total body irradiation, co-sponsored by NASA and the AEC. (See Briefing Book No. 5, at Tab H). However, Los Alamos reports that it has not found evidence that Total Body Irradiation was conducted at the Los Alamos Medical Center (LAMC) or elsewhere in Los Alamos. Los Alamos suggests that the inclusion may refer to instances of accidental radiation of workers during the Manhattan Project. 2 Los Alamos' initial search did not encompass activities related to bomb tests. Staff has provided documentation of Los Alamos' role in the human fly-throughs of atomic clouds, and has requested further documentation. Los Alamos was also involved in studies related to fallout, including Project Sunshine, a major AEC effort to study fallouts. (DOE/Los Alamos did provide Project Sunshine-related documentation.) Los Alamos reports that it is near completion of its initial search for documentation related to human experimentation. The search has been conducted with the assistance of present and former employees with knowledge of many of the activities referred to the documents. Staff has discussed the search and documentation with representatives of the Los Alamos search staff, and has transmitted requests for further information. The Committee (or staff) has been invited to visit Los Alamos to interview individuals with knowledge of the past events. The documentation provided by Los Alamos is quite useful and presents many areas for further inquiry. These include, for example: 1. The evolution of informed consent policies and practices. A July 5, 1956 letter from the Director of the Atomic Energy Commission Division of Biology and Medicine to the Health Division Leader at Los Alamos stated that subjects in tracer experiments should be "bona fide volunteers and fully informed as to the procedure involved. . . ." However, Los Alamos has reported that it has yet to find substantial documentation showing how a commitment to this principle was implemented (e.g., documentation of the terms of disclosure and consent for a particular experiment, or consent agreements). 2. The stimulus to Los Alamos' earliest documented interest in consent policies. In a 1951 letter to a Los Alamos official, which purported to respond to Los Alamos' inquiry, the AEC indicated that written informed consent should accompany human experimentation.2 {2 This letter appears in the Briefing Book No. 4; Tab L,Attachment L. } The AEC letter was addressed to an employee who is not known to have worked in biomedical research, and was located at a division ("D") other than the division associated with such work ("H"). Los Alamos reports that it does not yet know why the individual would have been involved in the correspondence, and what activities prompted it. 3 3. The method for selection of subjects and the extent to which the same rules applied to all subjects. Los Alamos' documents indicate that lab employees were often used as experimental subjects. In addition, the documents indicate that community residents, indigent patients, and children were used. What was the basis for selecting subjects? Did the consent requirements referred to in Los Alamos documents apply to subjects referred from off-site (e.g., to Los Alamos Medical Center hospital patients, as well as healthy lab employees)? 4. The role of Los Alamos in human experimentation conducted in connection with bomb tests. Los Alamos played a seemingly key role in connection with the atomic cloud air sampling in which human air and ground crews were exposed to radiation. One purpose of the fly-through was to measure human exposure. Los Alamos' role is discussed at some length in an Air Force history of the cloud sampling program, which includes a discussion of a debate between Los Alamos and the Air Force about the need for decontamination measures to reduce human exposures. Further DOE documents indicate that Los Alamos was represented on a committee that was convened to consider the biomedical components of bomb tests and that Los Alamos was involved in the biomedical program associated with the tests that irradiated the Marshall Islands. DOE/Los Alamos' initial search did not encompass bomb test related activities. However, Los Alamos has stated that these materials should be readily retrievable. 5. The number of intentional releases, and the extent to which they were planned to effect, or did effect, communities or individuals. Los Alamos has now stated that over 200 "intentional releases" took place. However, basic data regarding most of these releases remain classified. (See Tab L of the Briefing Book summarizing intentional releases.) 6. The purpose(s) for Los Alamos' experiments and the extent to which the planned purposes were met. Los Alamos has provided documentation identifying many experiments. However, in many cases there is still need for documentation (or other data) showing why the experiment was performed, and the results. 4 7. The relation among what was publicly known, what is known and what remains to be known. Available documentation leaves questions about the extent to which what is now known about human experimentation was made public contemporaneously. In addition, in at least the case of intentional releases and bomb test related experimentation, it appears that much remains to be learned. 8. The full-range of Los Alamos' policies and practices regarding human tissue research. Beginning in approximately the 1950's Los Alamos was involved in the sampling of human tissues for research purposes. The origins of these efforts, the procedures for selecting subjects, and the use of results, the numbers of these programs, and the extent to which they were known to the public and the AEC remains to be told. Los Alamos reports that it is investigating the tissue collection history, and expects to prepare a summary or report 9. The relation between experimentation and instrumentation. Los Alamos developed the whole body counter. Many experiments performed there used this instrumentation. 5 c:\wpwin60\wpdocs\6briefin\losal2.wpd (tcs)