Environmental Assessments

This site contains Environmental Assessments (EAs), Findings of No Significant Impact (FONSIs), and Environmental Impact Statements (EISs) 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 assess environmental impacts from their actions. 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 July 29, 1997 (62 FR 40569) and became effective on August 28, 1997. A guidance document for conducting environmental impact assessments was published on March 7, 2001.

NADAs and FAPs submitted to the Center for Veterinary Medicine (CVM) must include a claim for categorical exclusion or an environmental assessment. EAs focus on relevant environmental issues relating to the use and disposal of veterinary drugs or feed additives. 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.

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.