Environmental Assessments

This site contains many Environmental Assessments (EAs), Findings of No Significant Impact (FONSIs), and Environmental Impact Statements (EISs) for actions by the Center for Veterinary Medicine (CVM) for New Animal Drug Applications (NADAs), Food Additive Petitions (FAPs), and Agency-initiated actions.

The Food and Drug Administration (FDA) is required under the National Environmental Policy Act of 1969 (NEPA) to evaluate all agency actions to determine if they will have a significant impact on the human environment. The FDA’s regulations for implementing NEPA are contained in Title 21 of the Code of Federal Regulations (CFR) Part 25. The most recent regulations were published in the Federal Register on April 1, 2010. Guidance documents for conducting environmental impact assessments for veterinary products were published on March 7, 2001. Primary guidances recommended for conducting Environmental Assessments are Guidance for Industry # 89 Phase I (VICH GL6).

Since the FDA must evaluate all Agency actions to determine whether they will have a significant environmental impact, every NADA and FAP submitted to the Center for Veterinary Medicine (CVM) requires the submission of either an environmental assessment or a claim for categorical exclusion. EAs are public documents that evaluate the potential risk for the drug to cause significant environmental impacts using fate, exposure, and effects data, and focus on relevant environmental issues relating to the use and disposal of veterinary drugs or feed additives. EAs serve to provide sufficient evidence and analysis for an Agency to determine whether significant environmental impacts may occur from the action. EAs are also prepared for certain Agency-initiated actions. If CVM determines that the information in the EA indicates that no significant environmental impacts are expected, then a FONSI is prepared. If significant environmental impacts are identified, then an Environmental Impact Statement (EIS) is prepared. Categorical exclusions are wavers from completing an EA or EIS because the Agency has predetermined that sufficient information exists to demonstrate that the use of the drug is not expected to have a significant environmental impact. A list of actions for animal drugs that generally are categorically excluded can be found under 21 CFR 25.33.

Many of the EAs on this site were prepared by the NADA or FAP sponsor and were scanned into pdf format. CVM conducted a limited quality assurance review of these documents. If significant errors are noted, please contact CVM.

Most EAs and FONSIs for approvals post-1995 are posted. The agency will be adding pre-1995 and new EAs and FONSIs as they become available electronically.