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15 U.S.C. 2604, 2607, 2613, and 2625.
62 FR 17932, Apr. 11, 1997, unless otherwise noted.
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Persons submitting a MCAN for a significant new use of a microorganism must comply with the recordkeeping requirements of § 725.65. In addition, the following requirements apply:
(a) At the time EPA adds a microorganism to subpart M of this part, EPA may specify appropriate recordkeeping requirements. Each manufacturer, importer, and processor of the microorganism shall maintain the records for 3 years from the date of their creation.
(b) The records required to be maintained under this section may include the following:
(1) Records documenting the information contained in the MCAN submitted to EPA.
(2) Records documenting the manufacture and importation volume of the microorganism and the corresponding dates of manufacture and import.
(3) Records documenting volumes of the microorganism purchased domestically by processors of the microorganism, names and addresses of suppliers and corresponding dates of purchase.
(4) Records documenting the names and addresses (including shipment destination address, if different) of all persons outside the site of manufacture or import to whom the manufacturer, importer, or processor directly sells or transfers the microorganism, the date of each sale or transfer, and the quantity of the microorganism sold or transferred on such date.