[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR25.40]

[Page 242-243]
 
                        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.  25.40  Environmental assessments.


    (a) As defined by CEQ in 40 CFR 1508.9, an EA is a concise public 
document that serves to provide sufficient evidence and analysis for an 
agency to determine whether to prepare an EIS or a FONSI. The EA shall 
include brief discussions of the need for the proposal, of alternatives 
as required by section 102(2)(E) of NEPA, of the environmental impacts 
of the proposed action and alternatives, and a listing of agencies and 
persons consulted. An EA shall be prepared for each action not 
categorically excluded in Sec. Sec.  25.30, 25.31, 25.32, 25.33, or 
25.34. The EA shall focus on relevant environmental issues relating to 
the use and disposal from use of FDA-regulated articles and shall be a 
concise, objective, and well-balanced

[[Page 243]]

document that allows the public to understand the agency's decision. If 
potentially adverse environmental impacts are identified for an action 
or a group of related actions, the EA shall discuss any reasonable 
alternative course of action that offers less environmental risk or that 
is environmentally preferable to the proposed action. The use of a 
scientifically justified tiered testing approach, in which testing may 
be stopped when the results suggest that no significant impact will 
occur, is an acceptable approach.
    (b) Generally, FDA requires an applicant to prepare an EA and make 
necessary corrections to it. Ultimately, FDA is responsible for the 
scope and content of EA's and may include additional information in 
environmental documents when warranted.
    (c) Information concerning the nature and scope of information that 
an applicant or petitioner shall submit in an EA may be obtained from 
the center or other office of the agency having responsibility for the 
action that is the subject of the environmental evaluation. Applicants 
and petitioners are encouraged to submit proposed protocols for 
environmental studies for technical review by agency staff. Applicants 
and petitioners also are encouraged to consult applicable FDA EA 
guidance documents, which provide additional advice on how to comply 
with FDA regulations.
    (d) Consistent with 40 CFR 1500.4(j) and 1502.21, EA's may 
incorporate by reference information presented in other documents that 
are available to FDA and to the public.
    (e) The agency evaluates the information contained in an EA and any 
public input to determine whether it is accurate and objective, whether 
the proposed action may significantly affect the quality of the human 
environment, and whether an EIS or a FONSI will be prepared. The 
responsible agency official examines the environmental risks of the 
proposed action and the alternative courses of action, selects a course 
of action, and ensures that any necessary mitigating measures are 
implemented as a condition for approving the selected course of action.

[62 FR 40592, July 29, 1997, as amended at 69 FR 17291, Apr. 2, 2004]