U.S. EPA regulatory challenges and review.

Regulatory and program developments during the past year are reviewed. These include the Good Laboratory Practices (GLP) enforcement case initiative, the implications of the Bio-Tek Industries decision, and the status of the Craven Laboratories case. The status of the Agency's laboratory accreditation workgroup is discussed, as well as the responses to date to the Inspector General's reports on EPA's GLP program. Internal improvements in GLP inspection procedures and the case review process are highlighted. The year's noteworthy events in the international arena conclude the talk.