REQUIREMENTS OF THE FDA FOR THE ENVIRONMENTAL ASSESSMENT OF ANIMAL HEALTH PRODUCTS

Under the National Environmental Policy Act, the Center for Veterinary Medicine (the Center) at the Food and Drug Administration (FDA) assesses the potential environmental impact of a wide variety of animal health products. The FDA considers the manufacture, use, and disposal of these products. Environmental assessments of some products, for example, products that may cause indirect or secondary effects or products used in aquaculture, are particularly challenging. For actions not categorically excluded, sponsors of animal drug products must prepare either complete or abbreviated environmental assessments (EAs), depending upon the nature of the requested action. Complete EAs must address potential impacts caused by manufacture, use, and disposal of the product. Data from environmental testing are used in the development of complete EAs. Good Laboratory Practice (GLP) regulations and inspections are used to ensure the accuracy and data integrity of environmental information submitted for EAs. Potential impacts from manufacture of the product must be considered in both complete and abbreviated EAs. Good Manufacturing Practice (GMP) inspections are used to verify manufacturing information provided in environmental assessments. Efficient development of complete EAs requires making use of the tiered testing system, starting the environmental assessment early in the drug approval pro. cess, and communicating with the FDA Center for Veterinary Medicine when questions arise.