40 CFR § 725.238 - Activities conducted outside a structure.

---
identifier: "/us/cfr/t40/s725.238"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "40 CFR § 725.238 - Activities conducted outside a structure."
title_number: 40
title_name: "Protection of Environment"
section_number: "725.238"
section_name: "Activities conducted outside a structure."
chapter_name: "ENVIRONMENTAL PROTECTION AGENCY"
subchapter_number: "R"
subchapter_name: "TOXIC SUBSTANCES CONTROL ACT"
part_number: "725"
part_name: "REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS"
positive_law: false
currency: "2026-03-24"
last_updated: "2026-03-24"
format_version: "1.1.0"
generator: "[email protected]"
authority: "15 U.S.C. 2604, 2607, 2613, and 2625."
regulatory_source: "62 FR 17932, Apr. 11, 1997, unless otherwise noted."
cfr_part: "725"
---


# 725.238 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.