Animal & Veterinary
NEW CVM INTERNET SITE PROVIDES EA DOCUMENTS
by Raanan A. Bloom, Ph.D.
FDA Veterinarian Newsletter 2002 Volume XVI, No V
The Food and Drug Administration's (FDA's) Center for Veterinary Medicine (CVM) has launched a new internet web site that provides 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 site may be found at CVM's FOI page.
Some of the more requested documents on this site include EAs for bovine somatotropin, ractopamine, ivermectin, enrofloxacin, melengestrol acetate, progesterone and estradiol, and EISs for chloroflurocarbons, antibiotics in animal feed, and selenium.
FDA is required under the National Environmental Policy Act of 1969 (NEPA) to assess potential 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.
NADAs and FAPs submitted to CVM must include a claim for categorical exclusion or an environmental assessment. EAs focus on relevant issues related to the use and disposal of veterinary drugs or feed additives and provide information on soil and water concentrations, environmental fate, and potential effects of compounds released into the environment. 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 EIS is prepared.
Most EAs and FONSIs for post-1995 approvals are posted. The Agency will be adding pre-1995 and new EAs and FONSIs as they become available electronically. 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. Contact the Environmental Safety Staff (HFV-103) with comments or questions about this web site.
Dr. Bloom is a Physical Scientist in CVM's Environmental Assessment Team.