40 CFR §725.238

1. (a)Exemption.
   1. (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. (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.
2. (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. (1)Name, address, and telephone number of the manufacturer or importer.
   2. (2)Location, estimated duration, and planned start date of the test.
   3. (3)Certification of the following:
      1. (i)Compliance with the conditions of the exemption specified for the microorganism in § 725.239.
      2. (ii)If state and/or local authorities have been notified of the activity, evidence of notification.
3. (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.