Description
The National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impacts of their actions and to ensure that the interested and affected public is informed of environmental analyses. The Food and Drug Administration (FDA) is required under NEPA to consider the environmental impacts of approving drug and biologics applications as an integral part of its regulatory process. FDA's regulations in 21 CFR part 25 specify that environmental assessments (EAs) must be submitted as part of certain new drug applications (NDAs), abbreviated applications, applications for marketing approval of a biologic product, supplements to such applications, investigational new drug applications (INDs) and for various other actions (see 21 CFR 25.20), unless the action qualifies for categorical exclusion.
Scope & Applicability
Product Classes
6Subject to categorical exclusion
formaldehyde as a drug product impurity
Defined in section 351 of the Public Health Service Act
Single product substituting for two approved products
Scope of the guidance
Medical gases are prescription drugs
Stakeholders
1Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
10concentration of sodium fluoride F18 at the point of entry into the aquatic environment
The ratio of chemical adsorbed per unit weight of organic carbon in soil or sediment to the concentration of the chemical in solution at equilibrium
For water 1 ng/L = 1 pptr; for tissue 1 ng/kg = 1 pptr
One unit of chemical per 1,000,000,000,000 units of medium
For water 1 mg/L = 1 ppm; for tissue 1 mg/kg = 1 µg/g = 1 ppm
One unit of chemical per 1,000,000 units of medium
One unit of chemical per 1,000,000,000 units of medium
Physical/chemical characterization parameter in the data summary table.
Required identification for substances in an EA
Used to determine if an action results in increased use
Identified Hazards
Hazards
7Assessed under NEPA for drug and biologics applications
Evaluation under EPA's Toxic Substances Control Act
Chronic toxicity testing should be considered if the compound has the potential to bioaccumulate.
The EA normally should focus on characterizing the fate and effects of the compound on environmental organisms.
Assessment of toxicity required in a 351(k) BLA
indicate that the specific proposed action could significantly affect the quality of the human environment
Conditions under which a categorical exclusion is not applicable
Related CFR Sections (13)
- 21CFR314.420§ 314.420 Drug master files.
(a) A drug master file is a submission of information to the Food and Drug Administration by a person (the drug master file holder) who intends it to be used for one of the following purposes: To permit the holder to incorporate the information by reference when the holder submits an investigationalRead full regulation →
- 21CFR314.3§ 314.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part and part 320 of this chapter .Read full regulation →
- 21CFR314.108§ 314.108 New drug product exclusivity.
(a) Definitions. The definitions in § 314.3 and the following definitions of terms apply to this section:Read full regulation →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
- 21CFR211.194§ 211.194 Laboratory records.
(a) Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays, as follows:Read full regulation →
- 21CFR314.101§ 314.101 Filing an NDA and receiving an ANDA.
(a) Filing an NDA.Read full regulation →
- 21CFR601.2§ 601.2 Applications for biologics licenses; procedures for filing.
(a) General. To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing aRead full regulation →
- 21CFR25.15§ 25.15 General procedures.
(a) All applications or petitions requesting agency action require the submission of an EA or a claim of categorical exclusion. A claim of categorical exclusion shall include a statement of compliance with the categorical exclusion criteria and shall state that to the applicant's knowledge, no extraRead full regulation →
- 21CFR25.31§ 25.31 Human drugs and biologics.
The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:Read full regulation →
- 21CFR25.30§ 25.30 General.
The classes of actions listed in this section and §§ 25.31 through 25.35 are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:Read full regulation →
- 21CFR25.21§ 25.21 Extraordinary circumstances.
As required under 40 CFR 1508.4 , FDA will require at least an EA for any specific action that ordinarily would be excluded if extraordinary circumstances indicate that the specific proposed action may significantly affect the quality of the human environment (see 40 CFR 1508.27 for examples of signRead full regulation →
- 21CFR25.40§ 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 secRead full regulation →
Related Warning Letters (10)
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
CCIC Huatongwei International Inspection Co., Ltd.
- 2025-08-26
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Jiangsu Kerbio Medical Technology Group Co.
- 2025-03-25
CGMP/Finished Pharmaceutical/API/Adulterated
Yangzhou Sion Commodity Co., Ltd.
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Mid-Link Testing Company, Ltd
- 2024-09-11
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
Sanitation & Environmental Technology Institute dba SDWH
- 2023-10-31
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Samm Solutions, Inc., d.b.a. BTS Research
- 2022-08-09
Bioresearch Monitoring Program
Valley Biosystems
- 2022-02-22
Good Laboratory Practice (GLP)
Toxikon Corporation/Labcorp Bedford LLC
- 2020-05-05
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
University of Kentucky
- 2020-04-07
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
Steiner Biotechnology, LLC
See Also (8)
- CVM GFI #57 Preparation and Submission of Veterinary Master Files (Status: Final)
- Drug Master Files for Bulk Antibiotic Drug Substances: Guidance for Industry (Status: Final)
- Early Development Considerations for Innovative Combination Products: Guidance for Industry and FDA Staff (Status: Final)
- PET Drug Applications - Content and Format for NDAs and ANDAs_2011 (Status: Final)
- IND Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry and FDA Staff (Status: Final)
- Immunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance for Industry (Status: Final)
- Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry (Status: Draft)
- Drug Master Files Guidance for Industry (Status: Draft)