I. INTRODUCTION

This document is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterized cell lines of human or animal origin (i.e., mammalian, avian, insect), and outlines data that should be submitted in the marketing application/registration package. For the purposes of this document, the term virus excludes nonconventional transmissible agents like those associated with Bovine Spongiform Encephalopathy (BSE) and scrapie. Applicants are encouraged to discuss issues associated with BSE with the regulatory authorities.