§ 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 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 § 314.70 (c) or (d); or

(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 § 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 § 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 § 510.455 or as a liquid feed supplement under § 558.5.

(2) Approval of an animal feed bearing or containing a drug approved under § 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.

(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.