NCJ Number
191221
Date Published
2000
Length
15 pages
Annotation
This document is a summary of a satellite broadcast with information and the registration process of select agents, how to document their transfer, verification procedures, and agent disposal requirements, as well as research and clinical exemptions.
Abstract
The Department of Health and Human Services has published regulations regarding access, use, and transfer of select agents for research purposes. The regulations are designed to 1) ensure the infectious agents and toxins are shipped only to institutions or individuals equipped to handle them appropriately; 2) transfer of these agents is to those who have legitimate reasons to use them; and 3) a system is implemented whereby scientists and researchers involved in legitimate research may continue transferring the agents without undue burdens. The program will be of interest to laboratory researchers, safety officials, biotech firms, teaching institutions, veterinary institutions, pharmaceutical firms or other laboratories working with transferring any microorganisms or toxins classified as select agents. After completing the program, participants will be able to summarize the rationale for regulating the movement of biological agents, discuss the general requirements of the Select Agent Rule, determine whether their facility must register to comply with the regulations, complete an application packet, describe the components of a self-assessment in both BSL-2 and BSL-3 facilities and laboratories working with toxins, review the registration and inspection process, and complete the forms and package select agents necessary for transfer. The select agent rule includes six fundamental components: a list of biological agents, registration procedures for facilities, transfer requirements, verification procedures, agent disposal requirements, and research and clinical exemptions. The document provides a list of select agents, and summarizes transfer procedures.