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(a) Exemption. (1) Research and development activities involving intentional testing in the environment of certain microorganisms listed in §725.239 may be conducted without prior review by EPA if all of the conditions of this section and §725.239 are met.
(2) The research and development activity involving a microorganism listed in §725.239 must be conducted by, or directly under the supervision of, a technically qualified individual, as defined in §725.3.
(b) Certification. To be eligible for the exemption under this section, a manufacturer or importer must submit to EPA prior to initiation of the activity a document signed by an authorized official containing the following information:
(1) Name, address, and telephone number of the manufacturer or importer.
(2) Location, estimated duration, and planned start date of the test.
(3) Certification of the following:
(i) Compliance with the conditions of the exemption specified for the microorganism in §725.239.
(ii) If state and/or local authorities have been notified of the activity, evidence of notification.
(c) Recordkeeping. Persons who conduct research and development activities under this section must comply with the recordkeeping requirements of §725.65 and retain documentation that supports their compliance with the requirements of this section and the specific requirements for the microorganism listed in §725.239.
[62 FR 17948, Apr. 11, 1997]