Laboratory accreditation.

Abstract

An investigation of alleged data fraud at a pesticide analytical laboratory led EPA to take a closer look at the Good Laboratory Practice (GLP) inspection program. There was special focus on changes which might be made in the program to enhance the chances of detecting fraud in regulated studies. To this end, the Assistant Administrator of the Office of Prevention, Pesticides and Toxic Substances (OPPTS) requested EPA's Office of Inspector General (OIG) to examine the GLP program. Several reports were issued by the OIG, including the recommendation that a laboratory accreditation program be adopted. EPA has been examining ways to implement the OIG's recommendations, including (1) laboratory accreditation consisting of three components: document submission and assessment, site visit and assessment, and proficiency assessment; and (2) mandatory registration of all facilities participating in GLP-regulated studies, based on document submission and assessment. These two alternatives are compared, and the advantages and disadvantages of each are discussed.