Chapter 13 - Select Agent Regulations

Abstract

The goals of the Select Agent Program are to regulate the possession, use, and transfer of select agents and toxins that have the potential to pose a severe threat to public health and safety, to animal health or animal products, and to plant health and plant products. Performing research on select agents and toxins is critical for the development of effective medical countermeasures and, ultimately, the development of effective vaccines. At the end of 2009, there were individuals at registered facilities with approved access to select agents. This group includes scientists, technicians, and support personnel. Approximately 400 entities are currently registered with the CDC or APHIS to possess, use, or transfer select agents. This community consists of a broad variety of institutions, including federal, state, and local research and public health laboratories, academic research institutions, and privately owned commercial research, development, production, and distribution facilities. The CDC and APHIS have developed a highly integrated regulatory oversight program, characterized by uniform regulations and a common database. On July 2, 2010, President Barak Obama signed an Executive Order that when implemented will create both an Interagency Council and a Federal Experts Advisory Panel to, respectively, coordinate security policies and practices among Federal Departments and agencies that fund work on select agents and advise agency Directors on such topics as physical security and ways of ensuring the reliability of key personnel.