21 C.F.R. § 25.60 Environmental effects abroad of major agency actions.
(a) In accordance with Executive Order 12114, “Environmental Effects Abroad of Major Federal Actions” of January 4, 1979 (44 FR 1957, January 9, 1979), the responsible agency official, in analyzing actions under his or her program, shall consider the environmental effects abroad, including whether the actions involve:
(1) Potential environmental effects on the global commons and areas outside the jurisdiction of any nation, e.g., oceans and the upper atmosphere.
(2) Potential environmental effects on a foreign nation not participating with or otherwise involved in an FDA activity.
(3) The export of products (or emissions) that in the United States are prohibited or strictly regulated because their effects on the environment create a serious public health risk.
(4) Potential environmental effects on natural and ecological resources of global importance designated under the Executive Order.
(b) Before deciding on any action falling into the categories specified in paragraph (a) of this section, the responsible agency official shall determine, in accordance with section 2-3 of the Executive Order, whether such actions may have a significant environmental effect abroad.
(c) If the responsible agency official determines that an action may have a significant environmental effect abroad, the responsible agency official shall determine, in accordance with section 2-4 (a) and (b) of the Executive Order, whether the subject action calls for:
(1) An EIS;
(2) A bilateral or multilateral environmental study; or
(3) A concise environmental review.
(d) In preparing environmental documents under this subpart, the responsible official shall:
(1) Determine, as provided in section 2-5 of the Executive Order, whether proposed actions are subject to the exemptions, exclusions, and modification in contents, timing, and availability of documents.
(2) Coordinate all communications with foreign governments concerning environmental agreements and other arrangements in implementing the Executive Order.