2015 Annual Report of the Federal Select Agent Program

The 2015 Annual Report of the Federal Select Agent Program is the Federal Select Agent Program (FSAP)’s first report of aggregate program data. These data provide further insight into work conducted with biological select agents and toxins at laboratories across the nation, as well as the regulatory functions of the FSAP. The report summarizes 2015 program data in areas such as:

• Numbers and types of registered entities
• Security risk assessments performed
• Number of inspections conducted
• Top select agents or toxins registered by entities
• Key observations related to inspection findings and compliance with the select agent regulations
• Identifications and transfers of select agents or toxins
• Thefts, losses, and releases of select agents or toxins

The report reflects FSAP’s ongoing commitment to increasing transparency of the program.

As a part of recent program reviews, two recommendations (CDC 90-Day #10pdf icon, FTAC #2pdf iconexternal icon) called for increased transparency within FSAP. Recommendations also called for a process that would ensure any published data would not lead to security vulnerabilities.

In response to these recommendations, the program developed this report. The security community was engaged in evaluating and addressing any potential security concerns. This is just one part of continued efforts to improve the program and enhance its ability to conduct quality oversight of laboratories working with potentially dangerous pathogens.

While publication of the report marks completion of these two specific program recommendations, FSAP is committed to sharing detailed program data on an ongoing basis, and plans to publish similar reports annually.

The program is managed jointly by the Centers for Disease Control and Prevention (CDC) through its Division of Select Agents and Toxins (DSAT) which is part of the Department of Health and Human Services, and the Animal and Plant Health Inspection Serviceexternal icon (APHIS) Agriculture Select Agent Services (AgSAS), which is part of the U.S. Department of Agriculture (USDA).

CDC, through the Division of Select Agents and Toxins (DSAT),  provides oversight for the select agents and toxins that cause diseases in humans.

Animal and Plant Health Inspection Serviceexternal icon (APHIS), through the Agriculture Select Agent Servicesexternal icon (AgSAS), provides oversight for select agents and toxins that cause diseases in animals and plants.

CDC and APHIS share the responsibility for agents that threaten both humans and animals, such as anthrax.

Entities that work with agents that affect both humans and animals (i.e., “overlap” agents) are able to choose with which agency they will register. DSAT and AgSAS work together to coordinate FSAP activities for these agents.

• The program regulates select agents and toxins through the development, implementation and enforcement of the Select Agent Regulations, which are requirements that must be followed by those who work with these potentially dangerous and threatening biological pathogens and poisons. Key regulatory functions and activities include:
• Maintaining a registry to ensure that the U.S. government has full awareness of entities in possession of these potentially dangerous biological agents and toxins
• Conducting inspections and approving registrations to make sure that appropriate measures are in place to prevent the unauthorized access, theft, loss, or release of select agents
• Approving individual access to select agents and toxins to guard against access to the agents by bioterrorists or any others who may wish to misuse the agents
• Receiving reports of a theft, loss, or release of a select agent or toxin to understand and help reduce risks posed by the situation, ensure proper action is taken and appropriate authorities have been notified, and help identify ways to prevent it from happening in the future
• Taking appropriate enforcement actions for violations to address the risk and increase future compliance with the regulations
• Serving as a resource on the regulations by providing guidance, trainings, and outreach to help entities meet the requirements of the regulations
• Collaborating with domestic and international partners to assist others with the development and implementation of appropriate biosafety and security oversight programs

These and other FSAP activities help to keep laboratory workers and communities safe by ensuring that the work conducted with these agents is done as safely and security as possible.

FSAP is a regulatory program. It was mandated by Congress to regulate the possession, use and transfer of biological select agents and toxins that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products. It does this through the development, implementation and enforcement of the Select Agent Regulations.

FSAP-regulated laboratories, sometimes referred to as a regulated entities, are those that work with select agents and toxins and must follow these regulations.  Types of laboratories registered with FSAP include academic, commercial, federal government, non-federal government, and private laboratories.

While potentially dangerous, work with select agents and toxins provides important scientific discoveries that have led to improved detection, prevention, diagnostic, and treatment options for diseases considered to be some of the most threatening to public health and agriculture. Research in this area saves lives, protects American agriculture, and helps protect the safety and security of the American people.

As of 2015, 291 labs were registered to work with the most deadly organisms and toxins. This means they have the systems in place to make sure workers and the surrounding communities stay safe, and that materials don’t fall into the wrong hands. Labs may be run by academic institutions, the government (federal or non-federal), or commercial or private entities.

In 2015, we conducted 216 inspections on registered labs. Inspections allow us to find and help labs fix any issues that could lead to unauthorized access, theft, loss, or release of select agents and toxins.

This helps guard against access by anyone who may wish to misuse the agents. In 2015, 4,426 security risk assessments were approved to allow individuals access to select agents or toxins; access was restricted for 16 people.

When regulations aren’t being followed, different levels of action are taken depending on the nature and severity of the violation. This can include a corrective action plan, suspension of lab activities, or referral for further investigation to the HHS Office of Inspector General, the APHIS Investigative and Enforcement Services, or the FBI.

In 2015, no potential exposures to select agents or toxins resulted in illness, death, or transmission among those working in the labs or in the surrounding communities.

In these cases, the lab must either register with the Federal Select Agent Program to keep the sample, transfer the sample to a registered lab, or destroy the sample. In 2015, the program approved 463 transfers of select agents or toxins. Approximately one-third of those were initiated by unregistered labs, mostly as a result of identifying an agent during diagnostic testing. Transferring these materials after identification ensures it goes to a registered lab capable of safely and securely handling that organism or toxin.