2015 Annual Report of the
Federal Select Agent Program
The 2015 Annual Report of the Federal Select Agent Program, released in June 2016, summarizes 2015 data for the Federal Select Agent Program (FSAP), which regulates the possession, use and transfer of biological select agents and toxins so that important work with potentially dangerous and deadly pathogens is conducted as safely and securely as possible. This program is a partnership between CDC and USDA.
Our activities include registering and inspecting labs where select agents are handled, conducting security checks on workers who are trusted with these organisms, and making sure that materials are transferred safely from one lab to another.
This first annual report is part of the program’s ongoing commitment to increasing transparency and understanding of the program. The data in the report provide insight into work conducted with biological select agents and toxins at laboratories across the nation, as well as the how the program provides regulation and oversight of these labs.
Key Scientific Findings
- As of December 31, 2015, 291 entities were registered with FSAP to possess a select agent or toxin. Most were from academic (32 percent) or non-federal government (29 percent) institutes, with the remaining from commercial (18 percent), federal government (15 percent), or private entities (6 percent).
- 216 inspections of registered entities were conducted by FSAP. The average length of an inspection was 3 days, with a range of 1 to 8 days.
- After undergoing security risk assessments, 4,426 individuals were approved in 2015 to have access to select agents or toxins; access was restricted for 16 individuals.
- FSAP was notified of 199 separate incidents resulting in potential occupational exposure to workers. These incidents resulted in the monitoring of 908 laboratory workers. None of these workers developed illness or transmitted a virus to others, either inside or outside of the laboratory.
- 12 reports of losses were received in 2015. All were determined to be the result of records management errors or samples that were mistakenly destroyed as waste. No thefts of select agents or toxins were reported.
- The vast majority of labs are doing well in following the select agent regulations. When a violation is identified, enforcement actions are determined according to the level of severity of the situation. In 2015:
- 6 entities agreed to participate in a corrective action plan
- 3 entities were put under suspension
- 16 entities were referred to FBI (no criminal intent found)
- 4 entities were referred to the HHS Office of Inspector General or APHIS Investigative and Enforcement Services
- In 2015, FSAP approved 463 transfers of select agents or toxins. Approximately one-third of those (32 percent) were initiated by unregistered entities, mostly as a result of the identification of an agent in a diagnostic specimen.
Questions & Answers
What is this report and what does it show?
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.
Why was it published?
As a part of recent program reviews, two recommendations (CDC 90-Day #10, FTAC #2) 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.
Which federal agencies are involved in this program?
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 Service (APHIS) Agriculture Select Agent Services (AgSAS), which is part of the U.S. Department of Agriculture (USDA).
What are the roles of the federal agencies in this program?
CDC, through the Division of Select Agents and Toxins (DSAT), provides oversight for the select agents and toxins that cause diseases in humans.
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.
How does the Federal Select Agent Program regulate laboratories?
- 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.
What is the difference between the Federal Select Agent Program (the regulator) and a regulated laboratory?
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.
Why is this work important?
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.
Six Things You Need to Know About the Annual Report
Before routinely handling select agents, labs must register with the Federal Select Agent Program
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.
Registered labs undergo inspections to make sure the right precautions are in place
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.
All individuals who work with select agents and toxins must first undergo a security risk assessment performed by the FBI
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.
The good news is that the vast majority of labs are doing well in following the regulations
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 the event that a potential exposure occurs, the Federal Select Agent Program is notified and takes action to help reduce risks and prevent it from happening in the future
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.
Sometimes, a lab that isn’t registered may identify a select agent in the course of normal activities, like when diagnosing samples from sick patients
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.