[Title 21 CFR 25.24]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES]
[Subchapter A - GENERAL]
[Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS]
[Subpart B - Agency Actions Requiring Environmental Consideration]
[Sec. 25.24 - Categorical exclusions.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  1
  1996-04-01
  1996-04-01
  false
  
  25.24
  Sec. 25.24
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
    GENERAL
    ENVIRONMENTAL IMPACT CONSIDERATIONS
    Agency Actions Requiring Environmental Consideration
  


Sec. 25.24  Categorical exclusions.

    Certain FDA actions listed in this section are subject to 
categorical exclusions and, therefore, ordinarily do not require the 
preparation of an EA because, as a class, these actions 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. 
(These actions are listed in paragraphs (a) (1) through (3), (5), (7) 
through (9), (b) (1), (4) through (6), and 8(ii), (c) (3), (5), (8), 
(9), and (11), (d) (2), (3), and (5), (e) (1) through (3) and (5) of 
this section.) Additional exclusions for actions that will not result in 
the introduction of any substance into the environment are contained in 
Chapter 30-20-40 B.2. of the HHS General Administration Manual. Certain 
FDA actions listed in this section are subject to categorical exclusions 
and, therefore, ordinarily do not require the preparation of an EA 
because these actions meet specific criteria that are intended to ensure 
that they will not cause significant environmental effects. (These 
actions are listed in paragraphs (a) (4), (6), (10), and (11), (b) (2), 
(3), (7), (8)(i), and (9), (c) (1), (2), (4), (6), (7), and (10), (d) 
(1), (4), (6), and (7), (e) (4), (6), and (7) of this section.) Certain 
FDA actions listed in this section are subject to categorical exclusions 
and, therefore, ordinarily do not require the preparation of an EA 
because, as a class, these actions are routine maintenance or minor 
leasing or construction activities conducted or contracted for by FDA. 
(These actions are listed in paragraph (a)(12) of this section.) The 
classes of actions that are categorically excluded are as follows:
    (a) General. (1) Routine administrative and management activities, 
including inspections, and issuance of field compliance programs, 
program circulars, or field investigative assignments.
    (2) Recommendation for an enforcement action to be initiated in a 
Federal court.
    (3) Agency requests for initiation of recalls.
    (4) Destruction or disposition of any 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 material, 
will not result in the release of a toxic substance into the 
environment.
    (5) 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.
    (6) Extramural contracts, other agreements, and grants for research 
for such purposes as to develop analytical methods or other test 
methodologies if the waste from such research will be controlled or the 
amount of waste expected to enter the environment may reasonably be 
expected to be nontoxic.
    (7) Activities of voluntary Federal-State cooperative programs, 
including issuance of model regulations proposed for State adoption.
    (8) Issuance, amendment, or revocation of procedural or 
administrative regulations and guidelines, including procedures for 
submission of applications for product development, testing and 
investigational use, and approval.
    (9) Corrections and technical changes in regulations.
    (10) Promulgation of current good manufacturing practice (CGMP) 
regulations, establishment standards, emergency permit control 
regulations, and good laboratory practice (GLP) regulations, and 
issuance or denial of permits, exemptions, variances, or stays under 
these regulations, if there is no increase in the quantities or toxicity 
of wastes entering the environment as a direct or indirect result of the 
action.
    (11) Establishment or repeal by regulation of labeling requirements 
for

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marketing 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.
    (12) Routine maintenance and minor construction activities, except 
for properties listed on or eligible for listing on the National 
Register of Historic Places:
    (i) Repair to or replacement of equipment or structural components 
(doors, roof, window, etc.) of facilities controlled by FDA;
    (ii) Lease extensions, renewals, or succeeding leases;
    (iii) Construction or lease construction of 10,000 square feet or 
less of occupiable space;
    (iv) Relocation of employees into existing owned or currently leased 
space;
    (v) 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
    (vi) 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.
    (b) Foods, food additives, and color additives. (1) Promulgation, 
amendment, or repeal of a food standard.
    (2) Action on a request for exemption for investigational use of a 
food additive if the food additive to be shipped under the request is 
intended to be used for clinical studies or research in which waste will 
be controlled or the amount of waste expected to enter the environment 
may reasonably be expected to be nontoxic.
    (3) Approval of a color additive petition to change a provisionally 
listed color additive to permanent listing for use in food, drugs, 
devices, or cosmetics if data available to the agency do not establish 
that, at the expected levels of exposure, it may be toxic to organisms 
in the environment.
    (4) Testing and certification of batches of a color additive.
    (5) Promulgation of an interim food additive regulation.
    (6) Establishment of an action level under section 402(a) of the 
Federal Food, Drug, and Cosmetic Act for natural or unavoidable defects 
in food for humans or animals if these defects present no health hazard.
    (7) Affirmation of a food substance as generally recognized as safe 
(GRAS) for humans or animals on FDA's initiative or in response to a 
petition, under part 182, 184, 186, or 582, if the substance is already 
marketed for the use for which affirmation is sought and data available 
to the agency do not establish that, at the expected levels of exposure, 
the substance may be toxic to organisms in the environment.
    (8) Promulgation and enforcement of regulations relating to the 
control of communicable diseases or to interstate conveyance sanitation 
under:
    (i) Part 1240 if the method of control (including treatments, 
destruction, or disposition) of any animal or article, including 
packaging material, does not affect an endangered species or result in 
the release of a toxic substance into the environment; or
    (ii) Part 1250 if the corrective measures do not result in the 
release of a toxic substance into the environment.
    (9) Approval of a request for diversion of adulterated or misbranded 
food for humans or animals to use as animal feed if such disposition of 
the article, including packaging material, will not result in the 
release of a toxic substance into the environment.
    (c) Human drugs and biological products. (1) Action on an ANDA if 
the drug product will not be administered at higher dosage levels, for 
longer duration, or for different indications than were previously in 
effect and if data available to the agency do not establish that, at the 
expected level of exposure, the substance may be toxic to organisms in 
the environment.
    (2) Action on an amendment or supplement to an NDA of the following 
types if the drug product will not be administered at higher dosage 
levels, for longer duration, or for different indications than were 
previously in effect and if data available to the agency do not 
establish that, at the expected levels of exposure, the substance may be 
toxic to organisms in the environment.
    (i) Changes specified in Sec. 314.70 (c) or (d); or

[[Page 237]]

    (ii) Any other type of amendment or supplement to an NDA which meets 
the above criteria for exclusion.
    (3) Withdrawal of approval of an NDA or ANDA when the drug is no 
longer being marketed or at the request of the application holder.
    (4) Action on an Investigational New Drug Application (IND), if the 
drug shipped under such notice is intended to be used for clinical 
studies or research in which waste will be controlled or the amount of 
waste expected to enter the environment may reasonably be expected to be 
nontoxic.
    (5) Testing and certification of batches of an antibiotic or 
insulin.
    (6) Promulgation, revocation, or amendment of a monograph for a drug 
that is not a new drug, for an antibiotic drug, or for an over-the-
counter (OTC) drug, if the drug is already marketed for the proposed use 
and data available to the agency do not establish that, at the expected 
levels of exposure, the drug may be toxic to organisms in the 
environment.
    (7) Establishment of bioequivalence requirements for a marketed drug 
product if there is no change in the existing levels of use or intended 
uses of the product.
    (8) Action on changes in a biological product license or an 
establishment license reported under Sec. 601.12 of this chapter.
    (9) Revocation of a license for a biological product when it is no 
longer being marketed, or revocation of a biological product or 
establishment license at the request of the license holder.
    (10) Promulgation, amendment, or revocation of a standard for a 
licensed biological product or amendment of the license for a biological 
product if there is no change in the existing levels of use or intended 
uses of the product.
    (11) Action on a license application for transfusable blood or blood 
products.
    (d) Animal drugs. (1) Action on an NADA or supplemental NADA for a 
previously approved animal drug of the following types if the drug 
product will not be administered at higher dosage levels, for longer 
duration, or for different indications than were previously in effect 
and if data available to the agency do not establish that, at the 
expected level of exposure, the substance may be toxic to organisms in 
the environment:
    (i) An animal drug to be marketed under the same conditions of 
approval as a previously approved animal drug;
    (ii) A combination of previously approved animal drugs;
    (iii) A new premix or other formulation of a previously approved 
animal drug;
    (iv) Changes specified in Sec. 514.8(a) (5), (6), or (d);
    (v) A change of sponsor; or
    (vi) A previously approved animal drug to be contained in medicated 
feed blocks under Sec. 510.455 or as a liquid feed supplement under 
Sec. 558.5.
    (2) Approval of an animal feed bearing or containing a drug approved 
under Sec. 514.2 or 514.9.
    (3) Withdrawal of approval of an NADA when the drug is no longer 
being marketed or at the request of the application holder.
    (4) Action on a notice of claimed investigational exemption for a 
new animal drug (INAD) if the drug to be shipped under such notices is 
intended to be used for clinical studies or research in which waste will 
be controlled or the amount of waste expected to enter the environment 
may reasonably be expected to be nontoxic.
    (5) Testing and certification of batches of an antibiotic for animal 
use.
    (6) Promulgation, revocation, or amendment of a monograph for an 
animal drug that is not a new animal drug, if the drug is already being 
marketed for the proposed use and data available to the agency do not 
establish that, at the expected levels of exposure, the drug may be 
toxic to organisms in the environment.
    (7) Establishment of bioequivalence requirements for marketed animal 
drug products if there is no change in the existing levels of use or 
intended uses of the product.
    (e) Devices and electronic products. (1) Action on a device 
premarket notification submission under subpart E of part 807.
    (2) Classification or reclassification of a device under part 860.

[[Page 238]]

    (3) Issuance, amendment, or repeal of a standard for a class II 
medical device or an electronic product, and issuance of exemptions or 
variances from such a standard.
    (4) Approval of a premarket approval application (PMA) or a notice 
of completion of a product development protocol (PDP) or amended or 
supplemental applications or notices for a class III medical device if 
the device is of the same type and for the same use as a previously 
approved device and data available to the agency do not establish that 
approval of the PMA, or the notice of completion of the PDP or amended 
or supplemental applications or notices, will result in release of 
substances that, at the expected levels of exposure, may be toxic to 
organisms in the environment.
    (5) Changes in the PMA or a notice of completion of a PDP for a 
class III medical device that do not require submission of an amended or 
supplemental application or notice.
    (6) Promulgation of a restricted device regulation if it will not 
result in increases in the existing levels of use or changes in the 
intended uses of the product or its substitutes.
    (7) Action on an application for an Investigational Device Exemption 
(IDE) or an authorization to commence a clinical investigation under an 
approved Product Development Protocol (PDP), if the devices shipped 
under such notices are intended to be used for clinical studies or 
research in which waste will be controlled or the amount of waste 
expected to enter the environment may reasonably be expected to be 
nontoxic.
    (8) Promulgation of a regulation exempting from preemption a 
requirement of a State or political subdivision concerning a device, or 
a denial of an application for such exemption.

[50 FR 16656, Apr. 26, 1985, as amended at 54 FR 9038, Mar. 3, 1989; 61 
FR 14245, Apr. 1, 1996]