TA5 Ecotoxicity and Environmental Chemistry of Antibiotics
Room 17A/B, Level 4
8:00 AM - 12:00 PM, Tuesday, 11 November 2003
Chair: Aga, Diana ,
(201) Environmental Safety Review of Veterinary Pharmaceuticals and Food Additives at the Food and Drug Administration.
Bloom, R1, 1 Food and Drug Administration, Rockville, MD, USA
ABSTRACT- The Center for Veterinary Medicine (CVM) of the Food and Drug Administration (FDA) regulates the manufacture and distribution of pharmaceuticals and food additives administered to companion (pet) and food animals (e.g., cattle, poultry, swine, fish, shellfish). Under the policies of the National Environmental Policy Act (NEPA) and beginning in the early 1980s, CVM has required drug sponsors to submit information on environmental introductions, chemical fate, and ecotoxicity to evaluate the potential for environmental impacts from use of such products. At CVM, NEPA compliance is documented in the Environmental Assessment (EA) section of the drug or food additive application. EAs have been submitted for many products including anthelmintics, growth promotants, hormones, coccidiostats and antibiotics. In order to provide environmental documentation in a form accessible to the public and decision-makers, the Agency has launched a new web site at http://www.fda.gov/cvm/efoi/ea/ea.htm. 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 documents on this site provide a wealth of information on the ecotoxicity and environmental chemistry of numerous compounds, including veterinary antibiotics.
Key words: FDA, antibiotics, environmental, ecotoxicity