[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR25.60]
[Page 245]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 25 ENVIRONMENTAL IMPACT CONSIDERATIONS--Table of Contents
Subpart F Other Requirements
Sec. 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.
[[Page 246]]
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