§70.19. General license for calibration or reference sources. — Inbound Citations

(a) An application for a specific license to manufacture or initially transfer calibration or reference sources containing plutonium, for distribution to persons generally licensed under § 70.19, will be approved if:

(1) The applicant satisfies the general requirements of § 70.23.

(2) The applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including:

(i) Chemical and physical form and maximum quantity of plutonium in the source;

(ii) Details of construction and design;

(iii) Details of the method of incorporation and binding of the plutonium in the source;

(iv) Procedures for and results of prototype testing of sources, which are designed to contain more than 0.005 microcurie of plutonium, to demonstrate that the plutonium contained in each source will not be released or be removed from the source under normal conditions of use;

(v) Details of quality control procedures to be followed in manufacture of the source;

(vi) Description of labeling to be affixed to the source or the storage container for the source;

(vii) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the source.

(3) Each source will contain no more than 5 microcuries of plutonium.

(4) The Commission determines, with respect to any type of source containing more than 0.005 microcurie of plutonium, that:

(i) The method of incorporation and binding of the plutonium in the source is such that the plutonium will not be released or be removed from the source under normal conditions of use and handling of the source; and

(ii) The source has been subjected to and has satisfactorily passed the prototype tests prescribed by paragraph (a)(5) of this section.

(5) For any type of source which is designed to contain more than 0.005 microcurie of plutonium, the applicant has conducted prototype tests, in the order listed, on each of five prototypes of such source, which contains more than 0.005 microcurie of plutonium, as follows:

(i) The quantity of radioactive material deposited on the source shall be measured by direct counting of the source.

(ii) The entire radioactive surface of the source shall be wiped with filter paper with the application of moderate finger pressure. Removal of radioactive material from the source shall be determined by measuring the radioactivity on the filter paper or by direct measurement of the radioactivity on the source following the dry wipe.

(iii) The entire radioactive surface of the source shall be wiped with filter paper, moistened with water, with the application of moderate finger pressure. Removal of radioactive material from the source shall be determined by measuring the radioactivity on the filter paper after it has dried or by direct measurement of the radioactivity on the source following the wet wipe.

(iv) The source shall be immersed in water at room temperature for a period of 24 consecutive hours. The source shall then be removed from the water. Removal of radioactive material from the source shall be determined by direct measurement of the radioactivity on the source after it has dried or by measuring the radioactivity in the residue obtained by evaporation of the water in which the source was immersed.

(v) On completion of the preceding tests in paragraphs (a)(5)(i) through (iv) of this section, the dry wipe test described in paragraph (a)(5)(ii) of this section shall be repeated.

(vi) Removal of more than 0.005 microcurie of radioactivity in any test prescribed by this paragraph shall be cause for rejection of the source design. Results of prototype tests submitted to the Commission shall be given in terms of radioactivity in microcuries and percent of removal from the total amount of radioactive material deposited on the source.

(b) The approved information collection requirements contained in this part appear in §§ 70.9, 70.17, 70.19, 70.20a, 70.20b, 70.21, 70.22, 70.24, 70.25, 70.32, 70.33, 70.34, 70.38, 70.39, 70.42, 70.50, 70.51, 70.52, 70.59, 70.61, 70.62, 70.64, 70.65, 70.72, 70.73, 70.74, and appendix A.