[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR25.60]

[Page 249-250]
 
                        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;

[[Page 250]]

    (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.