STATEMENT OF PURPOSE The mission of the Food and Drug Administration is to ensure that (1) food is safe, pure, and wholesome; (2) cosmetics are safe; (3) human and animal drugs, biological products, and therapeutic devices are safe and effective; and (4) radiological products and use procedures do not result in unnecessary exposure to radiation. Under the Foods program, FDA sets food standards; evaluates food additives and packaging for potential health hazards; conducts research to reduce foodborne disease, to determine specific health impacts of hazardous substances in foods and to develop methods for detecting them in foods; and maintains surveillance over foods through plant inspections, laboratory analyses, and legal action where necessary. The Drugs program includes the premarket review of human drugs and biological products in order to ensure their safety and efficacy, and the post-marketing monitoring of drug experience. FDA conducts manufacturer inspections and sample examinations to ensure industry compliance. Included under this program activity is the similar regulation of animal drugs, devices, and feeds as well as a program to assure the safety of animal-derived human foods. The Devices and Radiological Products program conducts premarket review and postmarket surveillance of medical devices to determine their safety and efficacy, and sets standards for the manufacture and use of radiological products to protect the public from unnecessary exposure to radiation. FDA monitors experience with medical devices, and conducts inspections of manufacturing plants and tests of radiological products to ensure compliance with regulations and standards. For these three major product-oriented programs, the Agency utilizes a wide variety of scientific skills to deal with the many types of products regulated and the many scientific decisions FDA must make. These skills range from field investigators, all of whom must have education in the physical or biological sciences, to chemists, microbiologists, engineers, medical officers and scientists from many other disciplines. Similarly, FDA utilizes a variety of laboratory facilities, both to test products for safety and to conduct the research necessary to evaluate health hazards and to develop the means to detect product hazards and prevent them. In addition, the National Center for Toxicological Research in Jefferson, Arkansas, serves as a specialized resource for FDA's other program elements by advancing the science of toxicology. This facility conducts research to improve the base of scientific knowledge on which the Agency makes decisions in assessing the risks of potentially toxic substances. DESCRIPTION OF FIELD ACTIVITIES FDA's field workforce, which comprises nearly 40 percent of FDA's total staffing, performs inspections, sample collections and analyses, and initiates enforcement actions. This workforce not only conducts regular surveillance over regulated products but also serves as the critical response capability when the Agency must respond to crises and immediately investigate reports of product problems, such as tampering incidents. Both the field and headquarters are involved in informing business firms and consumers about FDA-related topics, and in working with State and local agencies to develop programs that make the best use of Federal, State, and local resources in protecting the public health. FDA's Field force conducts investigational and laboratory functions for all of FDA's major product areas--Foods, Human Drugs, Animal Drugs & Feeds, and Medical Devices and Radiological Products. With a highly-trained staff versed in all of FDA's product responsibilities, the Agency can respond rapidly to various types of emergencies, and can also redirect Field efforts from time to time during the year among FDA's different programs, as changing inspection and product testing needs arise. Field facilities include Regional Offices, District Offices and laboratories, and resident posts. Regional Offices are staff offices which coordinate FDA activities, and also coordinate with State authorities, in the ten DHHS regions. All District Offices serve as offices for investigators and compliance action staff, and are the main control point for day-to-day operations in their assigned areas. The 18 District Laboratories provide FDA's basic field product testing capability. In addition, a number of these laboratories serve as specialized facilities for certain important types of testing and research. In addition to these facilities, FDA maintains over 130 resident posts distributed widely throughout the nation. These are smaller offices which serve as a base for investigators, so that FDA can have investigative staff widely dispersed to respond to emergencies, as well as to save inspectional travel costs and time. With all of these field facilities combined, FDA maintains offices and staff in 48 of the States, and in the District of Columbia and Puerto Rico. (List of FDA facilities follows) GEOGRAPHICAL DISTRIBUTION OF FDA FACILITIES Location Washington, D.C. area: Washington, D.C. Silver Spring, MD Beltsville, MD Activities FDA headquarters and headquarters operations of the Foods program headquarters and laboratories Foods and Veterinary Medical research facilities Field Operations Facilities: Buffalo, NY San Juan, PR East Orange, NJ Philadelphia, PA Baltimore, MD Orlando, FL Atlanta, GA Chicago, IL Cincinnati, OH Detroit, MI Minneapolis, MN Dallas/Houston, TX Kansas City, MO Denver, CO San Francisco, CA Other Specialized Jefferson, AR Cincinnati, OH St. Louis, MO Regional Office and District Office and laboratory District Office and laboratory District Office and laboratory (special emphasis in Regional Office, District Office and laboratory Regional Office, District Office and laboratory Regional Office, District Office and laboratory facilities: Dauphin Island, AL Winchester, MA National Center for Toxicological Research Specialized human drug product testing laboratory Specialized facility for shellfish field surveys Winchester Engineering and Analytical Center 2/ Personnel within the Parklawn Computer Center are administratively assigned to FDA. However, the Center is financed through a revolving fund, and is supported entirely by charges for services to the agencies using the Center. 3/ FDA certifies batches of insulin and of color additives used in foods, drugs, medical devices, and cosmetics. These services are financed wholly from fees paid by the industries affected. 2/ 1988 Estimate includes projected user charge collections of $33,800,000 (proposed legislation). -14 |