[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR25.42]

[Page 249]
 
                        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 D--Preparation of Environmental Documents
 
Sec. 25.42  Environmental impact statements.

    (a) As defined by CEQ regulations (40 CFR 1508.11) and section 
102(2)(C) of NEPA, an EIS should be a clear, concise, and detailed 
written statement describing:
    (1) The environmental impacts of a proposed action;
    (2) Any adverse effects that cannot be avoided if the action is 
implemented;
    (3) Alternatives to the action;
    (4) The relationship between local short-term uses of the 
environment and the maintenance and enhancement of long-term 
productivity; and
    (5) Any irreversible and irretrievable commitments of resources that 
would be involved in the proposed action should it be implemented.
    (b) The CEQ regulations (40 CFR 1501.7 and part 1502) describe the 
process for determining the scope of an EIS and provide detailed 
requirements for the preparation of draft and final EIS's. CEQ format 
and procedures for preparing EIS shall be followed.
    (c) Under the conditions prescribed in 40 CFR 1502.9, the agency 
will prepare a supplement for a draft or final EIS and introduce the 
supplement into the administrative record.