Activities conducted outside a structure.

(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.