September 1949 Supplement No. 1 To Catalogue and Price List No. 3 Atomic Energy Commission, Isotopes Division ISOTOPES SUPPLEMENT NO. 1 NAV1.941208.088 September 1949 TO CATALOGUE AND PRICE LIST NO. 3 July 1949 CONTENTS Distribution of Isotopes for Cancer Research 1 Use of Radioisotopes in Tracer Studies in Human Subjects 2 Field and Industrial Uses of Long-lived Radioisotopes 5 ISOTOPES DIVISION U.S. ATOMIC ENERGY COMMISSION OAK RIDGE, TENNESSEE AEC, Oak Ridge, Tenn.-9-22-49-5,000-A13284 DISTRIBUTION OF ISOTOPES FOR CANCER RESEARCH References: Isotopes Division Catalogue and Price List No. 3, July 1949, page 7, "Radioisotopes Free of Production Costs for Cancer Research." Cancer research is interpreted to include the following: 1. Investigation of the basic aspects of normal and abnormal cellular growth. 2. The development and evaluation of therapeutic and diagnostic procedures for cancer and allied diseases. Considerable interest has been expressed concerning the use of Cobalt 60 as a radiation source in the treatment of cancer. The use of Cobalt 60 needles is not considered research by the Subcommittee on Human Applications unless the needles are of some unusual design, or incorporate some unusual feature. Similarly, if multicurie sources of Cobalt 60 are considered as substitutes for other high energy gamma or X-ray sources for teletherapy units, the proposed use would be looked upon as cancer research only if the techniques to be employed departed from those already established for the gamma or X-ray sources, or if a considerable program is to be undertaken with the unit on the biological effects of radiation. 1 THE USE OF RADIOISOTOPES IN TRACER STUDIES IN HUMAN SUBJECTS Reference: Isotopes Division Catalogue and Price List No. 3, July 1949, page 30, "Allocation Policy for Radioisotopes for Use in Medicine. I. NORMAL ADULTS A. Beta and Gamma Emitters with a Biological Half-Life of 20 Days or less. Applicants who desire to use radioisotopes in normal adults should submit a statement of the results of animal experiments, or adequate reference to the literature, concerning the following points: 1. Metabolism and distribution of the radiomaterial in the form administered. 2. The tissue of highest concentration and the relative concentration therein. 3. The relative concentrations in the tissue of interest and particularly radiosensitive tissues such as the gonads and hematopoietic system. 4. The biological half-life of the radioisotope in the tissue of highest concentration, the tissue of interest and the particularly radiosensitive tissues. B. Beta and Gamma Emitters with a Biological Half-Life Greater than 20 Days. In general, for isotopes with a biological half-life greater than 20 days, the dosage in the critical tissues should be such as to conform to the limitations which will be set by the National Committee on radiation Protection. In special cases, however, the Subcommittee on Human Applications may permit the use of such radioisotopes in higher dosages. In view of recently accumulated information, the Subcommittee on Human Applications is prepared to consider applications for use of certain Carbon 14 compounds in human subjects. 2 Each request for "long-lived" radioisotopes to be used in human will be reviewed separately by the Subcommittee on Human Applications. II. NORMAL CHILDREN In general the use of radioisotopes in normal children is discouraged. However, the Subcommittee on Human Applications will consider proposals for such use in important researches, provided the problem cannot be studied properly by other methods and provided the radiation dosage level in any tissue is low enough to be considered harmless. It should be noted that in general the amount of radiative material per kilogram of body weight must be smaller in children than that required for similar studies in the adult. III. NORMAL PREGNANCY The Subcommittee on Human Applications feels that the use of radioactive materials in all normal pregnancies should be strongly discouraged where no therapeutic benefit is to be derived. V. SPECIAL PATHOLOGICAL CONDITIONS It is recognized that there may be instances in which the disease from which a patient is suffering permits the administration, for investigative purposes, of doses larger than those recommended above for use in normal subjects. Applications for such uses of radioisotopes will be given special consideration by the Subcommittee on Human Applications, providing: 1. Full responsibility for conduct of the work is assumed by a special committee of at least three competent physicians in the institution in which the work is to be done. This will not necessarily be the local Radioisotope Committee. 3 2. The subject has given his consent to the procedure. 3. There is no reasonable likelihood of producing manifest injury by the radioisotope to be employed. FIELD AND INDUSTRIAL USES OF LONG-LIVED RADIOISOTOPES The primary problem involved in field and industrial uses of radioisotopes is that of safety control and accountability. If a radioisotopes is to be used under other than laboratory conditions, the plan should provide for long-term control of the activity. The amount of activity involved is an important consideration. So also is the type of radiation emitted by the radioisotope in question. The likelihood of exposure to radiation of persons who could have no knowledge of the presence of the radioactive material, or of its potential danger, must always be considered. 4 FIELD USES An application for use of a radioisotope in a field study should usually be supported by: 1. A detailed outline of the experiment. 2. A map of the area, showing topography. 3. A full description of the distribution of the human population and the livestock population in and near the experimental areas. 4. A statement concerning the relationship of the experimental area to water-sheds from which domestic water supplies are collected. 5. A description of the underground strata with reference to likelihood of movement of water and fixation of activity by mineral components. 6. A statement regarding the degree of control which can and will be maintained over the experimental area. 5 INDUSTRIAL USES Industrial applications of radioisotopes fall into three general groups: 1. Cases in which the activity is mounted in a device used to control industrial processes. 2. Cases in which the activity is used in a process, but does not appear in any product sold to the public. 3. Cases in which the activity would be present in products sold to the public. In the first situation the factors to be considered are much the same as are pertinent to use of radioisotopes in laboratories. If the activity is well shielded, otherwise controlled, and under the supervision of trained workers, the use would be considered feasible. The third case raises the question as to the level of activity which might be permitted in products sold to the public. The situation is somewhat different for beta emitters than for gamma emitters. a. Beta ray emitters. Proposals to incorporate beta emitting radioisotopes in products offered for sale can be approved if (1) the radioactive substance is in insoluble form and incorporated permanently in inert material, and (2) the product produces no more radiation than 0.3 rep per week at the surface. b. Gamma ray emitters. Products containing gamma emitters must meet the conditions outlined above for beta emitters. In addition, when products are stored in warehouses, monitoring must be done to show that the radiation level is in accord with the limits stated in the handbook, "Safe Handling of Radioisotopes," issued by the National Committee on Radiation Protection. 6