Regulatory Agencies
United States Department of Health and Human Services
Food and Drug Administration
The Center for Food Safety and Applied Nutrition (CFSAN) located in the Office of the Food and Drug Administration (FDA) in the Department of Health and Human Services is the the primary Federal office with the responsibility for the assurance of seafood safety. The Center houses a wide range of programs devoted to the research and management of seafood, including aquaculture products. The FDA derives its authority for such programs primarily through two statutes: 1) the Federal Food, Drug, and Cosmetics Act (FFDCA: 21 U.S.C. 301 et. seq.), and 2) the Public Health Service Act (PHSA:42 U.S.C. 262, 294 et seq.). Under the FFDCA, the FDA is assigned responsibility to ensure that seafood shipped or received in interstate commerce is "safe, wholesome, and not misbranded or deceptively packaged." Under PHSA, FDA is empowered to control the spread of communicable diseases from one State, territory, or possession to another.
The Center for Veterinary Medicine (CVM) is responsible for the regulation of animal drugs, animal feeds, and veterinary medical devices. CVM's involvement in aquaculture is concentrated in four main areas: Approval of Animal Drugs and Feeds - Under the provisions of the Federal Food, Drug and Cosmetic Act, animal drugs must ordinarily be approved before distribution and use. Manufacture of medicated feeds may require separate approval. Nondrug feed additives also fall under FDA regulation and ordinarily require approval prior to use. CVM actions must comply with the provisions of the National Environmental Policy Act. Additionally, CVM supports the NRSP-7 program relating to the development of new animal drugs for minor species and minor uses (including aquacultural). Oversight of Drug Distribution and Use - CVM conducts surveillance and compliance programs relating to animal drugs, animal feeds, and other veterinary medical matters, and coordinates the veterinary medical aspects of FDA inspections. Research - CVM conducts biological and chemical research to support the food safety of new animal drugs and feeds. Initiatives - CVM works with the industry to develop quality assurance programs and educational materials to assist producers in using drugs and chemicals safely in animal production systems.
For Further Information About CVM Contact: General Information, Educational Initiatives, and Mailing Address: Communications Staff, HFV-12, Office of Management, Center for Veterinary Medicine, Food and Drug Administration, U.S. Department of Health and Human Services, 7500 Standish Place Rockville, MD 20855 . Ms. Linda Grassie, Deputy Director (301) 827-6513 -FAX (301) 594-1831 Email - lgrassie@cvm.fda.gov. New Animal Drug Approval: Division of Therapeutic Drugs for Food Animals, HFV-100 Office of New Animal Drug Evaluation. Dr. Joan Gotthardt, (301) 594-1646 - FAX (301) 295-8297. Educational Email - jgotthar@cvm.fda.gov. Oversight of Drug Use: Division of Compliance, HFV-235, Office of Surveillance and Compliance, Ms. Fran Pell, Consumer Safety Officer, (301)295-8761 - FAX (301)594-1812. Email - fpell@cvm.fda.gov. Approval of Animal Feeds: Nutrition and Labeling Team, HFV-220. Division of Animal Feeds Dr. John P. Machado, Veterinary Medical Officer, (301)827-0281. - FAX (301)594-1812. Email - jmachado@cvm.fda.gov. Research: Office of Research, HFV-500, Dr. David B. Batson, Health Science Administrator, (301)827-0281, - FAX (301)827-8250. Email - dbatson@cvm.fda.gov.
Environmental Protection Agency
The U.S. Environmental Protection Agency has several programs involved in aquaculture. The proper management of effluents and residual wastes should be a major consideration of aquaculture systems in assuring the protection of the environment. EPA's Water Quality Programs are concerned with setting Water Quality Criteria, Monitoring Shellfish Waters and Effluent Discharge Standards for assuring the protection of the nation's waterways and water supplies. The National Pollutant Discharge Elimination System (NPDES) issues Permits for the discharge of wastewaters to surface waters, including discharges from aquaculture systems in many cases. Permits are also available from this program to use wastes as nutrients in public waters for aquaculture purposes. Wastewater Treatment in publicly owned treatment works is amenable to the use of aquaculture systems funded, in part, by EPA's State Revolving Fund (SRF) Program. In conjunction with the U.S. Army Corps of Engineers, EPA also implements the Clean Water Act Section 404 Wetlands Protection Program aimed at protecting natural wetlands from the impacts of dredging and filling. Chemicals and other materials to be used in aquaculture are subject to Pesticide Registration by EPA prior to marketing to the user.
For Further Information Contact: EPA JSA Representative - Bob Bastian (Tele: 202/260-7378)(Fax: 202/260-1827) (E-mail: bastian.robert@epa.gov) Mailing address: U.S. Environmental Protection Agency, OWM (4204), 401 M Street, SW, Washington, D.C. 20460
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