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                Development & Approval Process

Development & Approval Process

                        Environmental Impact Considerations
          Food Additive Petitions for Animal Food
          Public Master Files (PMFs) Supporting Applications for Major Use and Major Species Drugs
          Veterinary Feed Directive (VFD)
          Veterinary Master Files


                        Abbreviated New Animal Drug Applications
          Modernizing FDA’s and EPA’s Approach to Oversight of Products for Animals Regulated as Pesticides or New Animal Drugs
          Aquaculture
          Biotechnology Products at CVM: Animals and Animal Food
          Electronic Submissions
          Minor Use/Minor Species
          New Animal Drug Applications
          User Fees Home
          Animal & Veterinary
          Development & Approval Process
          Environmental Impact ConsiderationsDevelopment & Approval Process Environmental Impact Considerations
  
  	
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    PrintDiagram of the Environmental Impact Evaluation ProcessCategorical ExclusionEnvironmental Assessment and Finding of No Significant ImpactEnvironmental Impact Statement and Record of DecisionRelated Resources

The listing of EAs and FONSIs by established or chemical name has been relocated to Animal Drugs @ FDA.

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 utilize 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 EA or a claim for categorical exclusion for the following actions:

Investigational New Animal Drug [(J)INAD] exemptions
	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
	Request to establish an Import Tolerance.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.

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Categorical Exclusion

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 EA nor an EIS is required for these actions. A list of actions for feed additives and animal drugs that, in general, 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 include actions where there is the potential for serious harm to the environment and actions that adversely affect a threatened or endangered species.

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Environmental Assessment and Finding of No Significant Impact

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, the EA focuses on relevant environmental issues relating to the use and disposal of 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 proposed action.

While an EA is usually prepared by the applicant (i.e., drug sponsor or feed additive petitioner), the FDA is ultimately responsible for its scope and content. Two guidance documents are available that describe the environmental impact assessment process:

Guidance for Industry # 89 Phase I (VICH GL6) and
	Guidance for Industry #166 Phase II (VICH GL 38).If CVM determines that the information in the EA demonstrates that no significant environmental impacts are expected for the proposed action, 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 (21 CFR 25.41). In some cases, risk mitigation measures may be required before a FONSI can be prepared. If significant environmental impacts are expected, an EIS will be required.

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Environmental Impact Statement and Record of Decision

An EIS and a Record of Decision (ROD) are prepared when data or information indicate that a proposed action will significantly affect the human environment (21 CFR 25.42 and 25.43). An EIS describes a proposed action and possible alternatives to the action. It allows for impacts to be disclosed and understood by the lead agency and public. 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.

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Related Resources

Guidance for Industry #89 Phase I
	Guidance for Industry #166 Phase II
	21 CFR Part 25 - Environmental Impact Considerations
	40 CFR 1500 - Regulations for Implementing NEPABack to the top

                                                                                  Content current as of:
      02/10/2023Development & Approval Process

          
                        Environmental Impact Considerations
          Food Additive Petitions for Animal Food
          Public Master Files (PMFs) Supporting Applications for Major Use and Major Species Drugs
          Veterinary Feed Directive (VFD)
          Veterinary Master Files


                        Abbreviated New Animal Drug Applications
          Modernizing FDA’s and EPA’s Approach to Oversight for Animal Products
          Aquaculture
          Biotechnology Products at CVM: Animals and Animal Food
          Electronic Submissions
          Minor Use/Minor Species
          New Animal Drug Applications
          User Fees
 
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