[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: 21CFR25.40]
[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 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
[[Page 243]]
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]
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