The U.S. Food and Drug Administration (FDA) is required under the National Environmental Policy Act of 1969 (NEPA) to evaluate all major agency actions to determine if they will have a significant impact on the human environment. Federal agencies utilizes three methods to implement NEPA and evaluate the possibility for environmental impacts to occur. They include categorical exclusions, environmental assessments (EAs) and environmental impact statements (EISs).
To implement NEPA mandates, the FDA’s Center for Veterinary Medicine (CVM) requires sponsors to submit either an environmental assessment (EA) or a claim for categorical exclusion for the following actions:
- Investigational New Animal Drug exemptions [(J)INAD]
- New Animal Drug Application (NADA)
- Abbreviated New Animal Drug Application (ANADA)
- Food Additive Petition (FAP)
- Investigational Food Additive File (IFA)
- Supplemental applications submitted to an (A)NADA.
The Council of Environmental Quality (CEQ) coordinates the efforts of Federal agencies to comply with NEPA objectives. CEQ maintains a website and has published regulations related to NEPA in 40 CFR 1500. The FDA’s regulations for implementing NEPA are contained in Title 21 of the Code of Federal Regulations (CFR) Part 25.
A categorical exclusion is a category of actions that the agency has determined, based on past experience, do not individually or cumulatively have a significant effect on the human environment. As a result, neither an environmental assessment nor an environmental impact statement (EIS) is required for these actions. A list of actions for feed additives and animal drugs that generally are categorically excluded can be found under 21 CFR 25.32 and 25.33, respectively.
If extraordinary circumstances indicate a specific proposed action, that ordinarily would be excluded, may significantly affect the quality of the human environment, then an EA will be required (21 CFR 25.15 and 25.21). Examples of extraordinary circumstances are such that (a) there is the potential for serious harm to the environment at the expected level of exposure and (b) potential for adverse effects on a species, or on the critical habitat of an endangered or threatened species.
An EA is a concise public document that evaluates the potential risk for the drug or feed additive to cause significant environmental impacts using fate, exposure, and effects data, and focuses on relevant environmental issues relating to the use and disposal of veterinary drugs or feed additives (21 CFR 25.40). An EA serves to provide sufficient evidence and analysis for an agency to determine whether significant environmental impacts may occur from the action.
Each EA is usually prepared by the applicant (i.e., drug sponsor or feed additive petitioner) but the FDA is ultimately responsible for the scope and content of each EA. Two guidance documents are available that describe the EA process:
If CVM determines that the information in the EA demonstrates that no significant environmental impacts are expected, then a Finding of No Significant Impact (FONSI) is prepared. A FONSI is a document that summarizes reasons why the agency has concluded that no significant environmental impacts are expected to occur upon implementation of the action (21 CFR 25.41). Otherwise, if unacceptable risk is still expected to occur, risk mitigation options must be implemented, or an EIS will be required.
An EIS and a Record of Decision (ROD) are prepared when evaluation of data or information in an EA, or otherwise available to the agency, indicates that a proposed action may significantly affect the environment (21 CFR 25.42 and 25.43, respectively). An EIS describes a proposed action and alternatives. It allows for potential impacts to be disclosed and understood by the lead agency and public in advance of implementing of the action. The ROD states what the decision is, identifies the alternatives considered (including the environmentally preferred alternative), and discusses mitigation plans, such as any enforcement and monitoring commitments. It discusses all the factors that were contemplated when the decision was reached on whether, and how, to proceed with the proposed action as well as whether practical means to avoid or minimize environmental harm have been adopted, and if not, why they were not.