The Subcommittee on Human Applications Minutes of the Meeting Dec 3-4, 1954 (Redacted)

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OFFICIAL USE ONLY UNITED STATES ATOMIC ENERGY COMMISSION TFiE SUBCOMMITTEE ON HUMAN APPLICATIONS MINUTES OF THE MEETING U. 6. Atomic Energy Commission OFFICIAL USE ONLY

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OFFICIAL USE ONLY MESTING OF SUBCOMMITTEE O N HUMAN APPLICATIONS LOS ANGELES, CALIFORNIA The meeting of the Subcommittee on Human Applications was called the Biltmore Hotel, Los Angeles, California. The following persons attended the meeting: Members ofthe Subcommittee: Representatives of the Isotopes Division : Dr. Raymond Libby, University of California, Loa Angeles Dr. Asa Seeds, Vancouver, Washington Dr. Marshall Brucer, Medical Division, Oak Ridge Institute of Nuclear Studies, Oak Ridge, Tennessee Training Recommendations for Medical Use o f Radioisotope8 Dr. Aebersold reviewed the Atomic Energy Act o f 1954 and its relationship to the isotope distribution program, remarked that there vie ed Act charges the Commission with the responsibility to license persons to possess and

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This is contrasted to the present procedures whereby persons are authorized toro cure and use radioisotopes. Under the Atomic Energy Act bo f 19 the Commission was not delegated specific authority to authorize the procurement and use of radioisotopes but was charged with the responsibility of assuring that these materials would be used ina manner cons is tent with good radiological health safety practices. Dr. Aebersold stated that the new Act places the Commission ina novel position among Federal agencies with respect to the licensing of the use of drugs in the practice of medicine. Such licensing might be considered t o be unconstitutional if the Federal government did not own the physical plant and source material used in the production of radioisotopes. following general administrative changes to result from Atomic Energy Act o f 1954 were outlined by Dr. Aebersold: A " specific license " will be required to possess and use radioisotopes and such license will not be surrendered to a distributor or secondary supplier of these materials as is the case with the present authorization. The vehicle for procurement will be a certificate. The new licensing procedure will require modification of the present application, Form AEC-313, as well as the preparation of a license to replace the present author i - z ation for radioisotope procurement, Form AEC-374. As stated above a " certificate " t o be used for procurement of radioisotopes is being designed for publication in the Federal Register. The certificate - will be reproduced and made available to persons holding valid Atomic Energy Commission licenses.In executing the certificate by signature, the user represents to the distributor or secondary suppliers that he holds a valid license from the Commission authorizing him,in accordance with the regulations of the Commission to possess and use radioisotopes and that the amount and chemical form ordered is within the limits permitted by his license. The distributor or secondary supplier upon receiving the properly executed certificate may without benefit of receipt of a copy o f the license transfer radioisotopes i n accordance with the certificate. Dr. Aebersold indicated that this is indirect variance to the present authorization procedure whereby the distributor and/or secondary supplier must not only assure himself that a valid authorization exists,but he must also assume responsibility for determining that the quantity of radio - isotope made available does not exceed the allocated amount. Conventionally the distributor and/or supplier requires that the signed original copy of the authorization be

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surrendered and records of shipments against the author i - z ation are maintained by the distributor and/or supplier. Dr. Aebersold emphasized that the li cm sing contemplated under the new Code of Regulations for Radioisotope Distribution would considerably reduce the burden of record keeping presently assumed by a distributor or secondary supplier. Dr. Aebersold remarked that the new Act also enables the Commission to issue what i s termed a " general license " , under which radioisotopes may be obtained,Conditions characterizing experience or other factors peculiar to the general license are defined by publication in the Federal Register. Persons meeting these published conditions may possess and use radio - isotopes in accordance with the conditions of the general license without submitting a special application for radio - isotopes to the Commission. Such a general license would be comparabl2 to the authorization exempt quantities of radio - isotopes currently provided for under the present Code of Regulations for Radioisotope Distribution.Dr. Aebersold stated,for example, that a general license could be issued for clinical uses of radioisotopes which had become sufficiently well defined t o be considered routine in their application. Tne Act further charges that the Commission shall establish an Inspection Division. The functions of the Inspection Division, while not clearly defined at this time, would presumably, require review o f Commission contractor operations, off Commission reactor programs, etc.Dr. Aebersold stated that the possibility arises of incl'usion of the inspection functions of the Isotope Division ' s Radiological Safety Branch within the scope af the Inspection Division.Dr, Aebersold presented numerous objections to divorcing the Radiological Safety Branch from the Licensing functions of the Isotopes In conclusion,Dr. Aebersold requested the Subcommittee t o consider and make recommendations with respect to : 1. A draft prepared by the Isotopes Division of a general license for possession and use of Iodine 131 for the diagnosis of thyroid function. See Appendix 1. 2. The concept that the licensing and inspection functions for the isotopes distribution program can best be kept as an integrated function within the Isotopes Division. Dr. Chamberlain asked the Subcommittee to consider a general license to use Iodine 131 for diagnosis of thyroid function. He stated he felt that the problems associated with

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the use of Iodine 131 for thyroid function studies are sufficiently complex as to render this clinical use of radioisotopes unsuitable for consideration under the general Dr. Aebersold questioned whether there is not a useful level of Iodine 131 for thyroid diagnosis which does not present a health hazard. Dr. Aebersold emphasized that the single basis for consideration of the feasibility of such a license is health safety. Dr. Chamberlain stated he did not consider any clinical app li - cation of radioisotopes in human subjects to be entirely free from hazard t o the patient. Dr. Quimby remarked that 1.5 micro curies of Iodine 131 results i n the maximum permissible exposure of 1500 milli rad s per week t o the thyroid gland. Dr. Chamberlain remarked that because o f the micro curie dose of Iodine 131 required to deliver the maximum permissible exposure to the critical organ there is not a reasonable level which one might consider suitable for conducting a thyroid test under routine conditions of measurement and atthe same time be free from hazard to the patient. He stated that, perhaps, another radioisotope used for diagnostic purposes would be more desirable for consideration,for example, Chromium 51 for blood determinations. Dr. Aebersold questioned whether the Subcommittee might consider favorably the general licensing of Iodine 131 t o conduct thyroid diagnosis is the conditions set forth in the license included the present requirements of training of the Commission, that is, 30 hours collaboration in a medical program where radio iodine is being used for thyroid diagnosis,during which period of time the physician actively participates in atleast 10 thyroid studies. The Subcommittee made the following recommendations: The Isotopes Division present the concept of a general license for use of Iodine 131 for diagnosis of thyroid function to clinical groups holding medical general authorizations,alternates to members ofthe Subcommittee and physician visitors to the present meeting ofthe Committee. The Isotopes Division should also prepare a firm propose1 for a general license for Chromium 51 for blood determinations. The Isotopes Division is also requested to study other radioisotopes and clinical situations which miRht be included under this type o f

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Dr. Chamberlain asked the Subcommittee to consider the request that a formal recommendation be made concurring that the Allocations Branch and the Radiological Sq fe ty Branch be retained as on integrated function within the Isotopes Dr. Jacobson questioned whether this was a matter for formal consideration by the Subcommittee. Dr. Chamberlain stated he considered it necessary to retain the Allocations Branch as a function of the Isotopes Division. However, he remarked that conditions might arise which would make it desirable to include the Radiological Safety Branch within the Inspection Division. The Branch could be physically located within the Isotopes Division for convenience butat the same time the group would also be available to perform other inspection functions upon request. The Subcommittee concluded that since the question of disposition of the inspection functions of the Isotopes Li vision is a policy matter of the Atomic Energy Co mission they did not consider it appropriate to make afirm recommendation in this regard. Dr. Crompton stated that in view of the meeting concerning training requirements for physicians t o be held in the after - Dr. Eiaymond Libby of the University of California, it seemed important for the Subcommittee to give immediate consideration to their acceptance of the recommendations and requirements for train ink set forth in Appendix C of the The 3ubcommi ttee recommended, after a general consideration of t ppen aix C that it be reconstructed and submitted t o the Subcommittee for final approval. Individual Medical Practice Criteria Mr. Fowler reviewed witn the Subcommittee the increasing trend for individual physicians engaged i n group practices to establish a medical isotope committee among themselves. This is being done i n an effort to be considered under the less stringent requirements of an institutional program rather than those for individual medical practice. He

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questioned whether the Subcommittee considered such group practice adequate to satisfy the original concept of a n institutional radioisotope program conventionally associated witha medical school or hospital. The Subcommittee stated that such an arrangement i s satisfactory and is i n compliance with the intent of recommendations established for institutional use i n so long a s evidence o f group medical practice as a clinic is presented and i s supported by satisfactory details out lin in a the function of the medical isotopes committee. Agenda Item IB and I C Basic Instruction in Principles of Radioactivity as Part of Clinical Isotope Preceptor ship Mr. Fowler asked the Subcommittee to express their opinion concerning the adequacy of the present medical preceptor arrangement for providing satisfactory instruction to physicians in the basic principles of radioactivity.He stated that in the majority of cases information submitted in support of a physician ' s proposal of use of radioisotopes clinically does not include details of the degree of instruction in physical principles of radioactivity nor the physician ' s proficiency in this regard. leveled against the informal arrangement of the medical preceptor ship and its inadequacy from the standpoint of provi ding the physician trainee with a working knowledge of the basic concepts of radio ac - t iv it y. Dr. Crompton stated that in recent conversations with Dr. Raymond Libby, University of California, Los Angeles, Dr. Libby had urged the Atomic Energy Commission to require physicians to complete a formal training course such asthe one given by the Oak Ridge Institute of Nuclear Studies,or its equivalent,as an ad junction to their clinical work. that numerous physicians have come to his attention who have completed their medical isotope preceptor ship with little evidence of such instruction. On recent occasion criticism has been Dr. Chamberlain stated that he was under the impression that satisfactory instruction was being given to physicians in the physical principles of radioactivity. He cited the type of training given to physicians serving a preceptor ship at the University of Pennsylvania and at other institutions. Dr. Aebersold asked the Subcommittee ifit would not be desirable to establish criteria as a guide tothe degree of

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instruction in physical principles of radioactivity considered necessary for a physician to satisfactorily carryout a clinical radioisotope program. Dr. Chamberlain reviewed a paper which he had recently published entitled "Training the Radiological Resident in the Use of Radioisotopes." Dr. Chamberlain reviewed the conditions set forth in the paper with respect to training in the physical principles of radiations and suggested they might be adopted as apart of the medical preceptor statement. ACTION : ALLOCATIONS BRANCH Dr. Crompton asked the Subcommittee for an expression of opinion concerning a medical preceptor ship being served with a physician in his individual medical practice rather than in an institutional type program. The Subcommittee concluded that it is not necessary to serve a medical preceptor ship in an institutional program. The Committee stated that in some instances it may be Fefe r able to serve a medical preceptor ship with an rn divi dual physician who i s conducting a clinical radioisotope program of interest to the physician trainee. such collaboration mag; even permit the physician to receive more specialized training. Friday Afternoon, December 3, 1954. Training Recommendations for Medical Use of Radioisotopes Dr. Chamberlain welcomed on behalf of the Subcommittee Dr.Joseph Hamilton, University of California, Berkeley; Dr. Raymond L. Libby, University of California, Los Angeles; and D r . Asa Seeds, Vancouver, Washington. The discussion centered around the present procedure ofthe Atomic Energy Commission for certification of physicians under the medical preceptor arrangement, the criticism of this procedure and the desirability of a licensing arrangement for radioisotopes to be used i n medicine based upon a