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§ 40.52 Certain items containing source material; requirements for license to apply or initially transfer.

An application for a specific license to apply source material to, incorporate source material into, manufacture, process, or produce the products specified in § 40.13(c) or to initially transfer for sale or distribution any products containing source material for use under § 40.13(c) or equivalent provisions of an Agreement State will be approved if:

(a) The applicant satisfies the general requirements specified in § 40.32. However, the requirements of § 40.32(b) and (c) do not apply to an application for a license to transfer products manufactured, processed, or produced in accordance with a license issued by an Agreement State or to the import of finished products or parts.

(b) The applicant submits sufficient information regarding the product pertinent to the evaluation of the potential radiation exposures, including:

(1) Chemical and physical form and maximum quantity of source material in each product;

(2) Details of construction and design of each product, if applicable. For coated lenses, this must include a description of manufacturing methods that will ensure that the coatings are unlikely to be removed under the conditions expected to be encountered during handling and use;

(3) For products with applicable quantity or concentration limits, quality control procedures to be followed in the fabrication of production lots of the product and the quality control standards the product will be required to meet;

(4) The proposed method of labeling or marking each unit, and/or its container with the identification of the manufacturer or initial transferor of the product and the source material in the product; and

(5) The means of providing radiation safety precautions and instructions relating to handling, use, and storage of products to be used under § 40.13(c)(1)(i) and (c)(1)(iii).

(c) Each product will contain no more than the quantity or the concentration of source material specified for that product in § 40.13(c).

[76 FR 69122, Nov. 8, 2011; 76 FR 78805, Dec. 20, 2011; 78 FR 32340, May 29, 2013]

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