[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: 21CFR25.30]
[Page 238-239]
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 C Categorical Exclusions
Sec. 25.30 General.
The classes of actions listed in this section and Sec. Sec. 25.31
through 25.34 are categorically excluded and, therefore, ordinarily do
not require the preparation of an EA or an EIS:
(a) Routine administrative and management activities, including
inspections, and issuance of field compliance programs, program
circulars, or field investigative assignments.
(b) Recommendation for an enforcement action to be initiated in a
Federal court.
(c) Agency requests for initiation of recalls.
(d) Destruction or disposition of any FDA-regulated article
condemned after seizure or the distribution or use of which has been
enjoined or following detention or recall at agency request if the
method of destruction or disposition of the article, including packaging
[[Page 239]]
material, is in compliance with all Federal, State, and local
requirements.
(e) Extramural contracts, other agreements, or grants for
statistical and epidemiological studies, surveys and inventories,
literature searches, and report and manual preparation, or any other
studies that will not result in the production or distribution of any
substance and, therefore, will not result in the introduction of any
substance into the environment.
(f) Extramural contracts, other agreements, and grants for research
for such purposes as to develop analytical methods or other test
methodologies.
(g) Activities of voluntary Federal-State cooperative programs,
including issuance of model regulations proposed for State adoption.
(h) Issuance, amendment, or revocation of procedural or
administrative regulations and guidance documents, including procedures
for submission of applications for product development, testing and
investigational use, and approval.
(i) Corrections and technical changes in regulations.
(j) Issuance of CGMP regulations, HACCP regulations, establishment
standards, emergency permit control regulations, GLP regulations, and
issuance or denial of permits, exemptions, variances, or stays under
these regulations.
(k) Establishment or repeal by regulation of labeling requirements
for marketed articles if there will be no increase in the existing
levels of use or change in the intended uses of the product or its
substitutes.
(l) Routine maintenance and minor construction activities such as:
(1) Repair to or replacement of equipment or structural components
(e.g., door, roof, or window) of facilities controlled by FDA;
(2) Lease extensions, renewals, or succeeding leases;
(3) Construction or lease construction of 10,000 square feet or less
of occupiable space;
(4) Relocation of employees into existing owned or currently leased
space;
(5) Acquisition of 20,000 square feet or less of occupiable space in
a structure that was substantially completed before the issuance of
solicitation for offers; and
(6) Acquisition of between 20,000 square feet and 40,000 square feet
of occupiable space if it constitutes less than 40 percent of the
occupiable space in a structure that was substantially completed before
the solicitation for offers.
(m) Disposal of low-level radioactive waste materials (as defined in
the Nuclear Regulatory Commission regulations at 10 CFR 61.2) and
chemical waste materials generated in the laboratories serviced by the
contracts administered by FDA, if the waste is disposed of in compliance
with all applicable Federal, State, and local requirements.
[62 FR 40592, July 29, 1997, as amended at 65 FR 56479, Sept. 19, 2000]
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