SELF-CERTIFICATION IN THE VOLUNTARY COMPLIANCE PROGRAM1

Abstract

In 1964, the Food and Drug Administration (FDA) embarked on a voluntary Compliance Program designed to assist and encourage the regulated industries to adopt concepts of self-regulation. Administered by the Bureau of Voluntary Compliance, this program is aimed at providing industry with facts and techniques that will give industry the greatest opportunity to comply with FDA regulations and standards. FDA will do all it can to provide industry with: (a) advisory assistance and information, (b) an explanation of how laws and regulations affect it, (c) results of our scientific research and improved analytical methodology, and (d) recommendations for controlling bacterial contamination and adopting good manufacturing practices. FDA's traditional reliance on enforcement through its own staff is being reinforced to include an Industry-State-FDA partnership. Self-Certification, an example of such a partnership, is a co-operative approach of Government and industry to assure the quality of our American food supp...