2016 Annual Report of the
Federal Select Agent Program
The 2016 Annual Report of the Federal Select Agent Program, released in October 2017, summarizes 2016 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. FSAP is a partnership between HHS’s Centers for Disease Control and Prevention and USDA’s Animal and Plant Health Inspection Service.
The 2016 annual report is FSAP’s second report of aggregate program data, and reflects the program’s ongoing commitment to increasing transparency and understanding of the program. While similar in content to the information contained in last year’s report, the data provide continued insight into the work conducted with select agents and toxins at laboratories across the nation, as well as how the program provides regulation and oversight of these laboratories.
- As of December 31, 2016, 276 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).
- 181 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.
- Laboratories that work with select agents and toxins range from biosafety level 2 (BSL-2) to maximum containment at biosafety level 4 (BSL-4). At each containment level, there is an equivalent set of biosafety guidelines for work with animals, designated as animal biosafety level (ABSL). Entities may be registered for multiple biosafety level laboratories. In 2016:
- 32% had BSL-2 and/or ABSL-2 laboratories
- 80% had BSL-3 and/or ABSL-3 laboratories
- 3% had BSL-4 and/or ABSL-4 laboratories
- After undergoing a security risk assessment, 3,982 individuals were approved in 2016 to have access to select agents or toxins; access was denied to 10 individuals based on results from a security risk assessment.
- FSAP was notified of 177 separate incidents resulting in potential occupational exposure to workers. As a result of these incidents, 998 laboratory workers were monitored for illness. None of these workers developed illness or transmitted a pathogen to others, either inside or outside of the laboratory.
- Eight reports of select agent or toxin inventory losses were investigated by FBI. All were determined to be the result of records management errors. No thefts of select agents or toxins were reported.
- The vast majority of laboratories are doing well in following the select agent regulations. When particularly serious deficiencies in biosafety or security measures are identified, FSAP can take additional actions to address an identified risk and bring the entity back into compliance with the select agent regulations. In 2016:
- Five entities agreed to participate in the corrective action plan (CAP) program
- Three entities were placed under suspension
- Three entities were referred to the HHS Office of Inspector General or APHIS Investigative and Enforcement Services for possible civil penalties.
- No instances of criminal intent were found for the 12 matters of which FBI was notified.
- In 2016, FSAP approved 260 transfers of select agents or toxins. Thirty-eight percent of those transfers involved unregistered entities transferring to registered entities, mostly as a result of the identification of a select agent in a diagnostic specimen.
Questions & Answers
What is this report and what does it show?
The 2016 Annual Report of the Federal Select Agent Program is the FSAP’s second annual report of aggregate program data. These data provide further insight into work conducted with select agents and toxins at laboratories across the nation, as well as the regulatory functions of the FSAP. The report summarizes 2016 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 transparency.
Why does FSAP publish this data?
As a part of program reviews released in October 2015, two recommendations (CDC 90-Day Internal Review #10, Fast Track Action Committee #2) called for increased transparency within FSAP. Since the recommendations also called for a process that would ensure any published data would not lead to security vulnerabilities, the security community was engaged in evaluating and addressing any potential security concerns with this aggregate report.
In response to these recommendations, FSAP developed this report, which is now an annual publication. The new report marks the second annual report. The previous report is available here.
These reports are 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.
This is FSAP’s second annual report. When will you be able to look at trends?
While it’s too early to see definitive trends in the data, there are a few key differences between the 2015 and 2016 reports. For example, this year’s report includes several new sections containing information that was not previously reported (such as the percentage of entities with registered laboratories by biosafety level), and differences in data between the two reports are noted. As we have standardized data available for additional years, we will be better able to analyze long-term trends over time.
Which federal agencies are involved in this program?
FSAP 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 have joint oversight of these entities 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:
- Providing oversight of possession to ensure that the U.S. government has full awareness of entities in possession of these potentially dangerous select 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 securely 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 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 regulated entities, are those that work with select agents and toxins and must follow these regulations. Types of entities 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 to Know
Laboratories must register with the Federal Select Agent Program
to possess select agents and toxins
As of 2016, 276 labs were registered to work with the most deadly organisms and toxins. Registration means they have the systems in place to make sure workers, the environment, and the surrounding communities stay safe, and that materials don’t fall into the wrong hands. Laboratories may be run by academic institutions, the government (federal or non-federal), commercial or private entities.
Registered laboratories undergo inspections in order to
make sure the right precautions are in place
In 2016, FSAP conducted 181 inspections of registered laboratories. Inspections allow us to find and help laboratories fix any issues that could lead to unauthorized access, theft, loss, or release of select agents and toxins.
Anyone who wishes to 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 2016, 3,982 individuals were approved by FSAP to have access to select agents and toxins after undergoing a security risk assessment; access was denied to 10 people based on these security risk assessments. An individual may be approved to work at more than one facility.
It is encouraging that the vast majority of laboratories
continue to do well in following the regulations
When regulations aren’t being followed, different levels of action are taken by FSAP depending on the nature and severity of the violation. This can include a corrective action plan, suspension of laboratory activities, or referral to the HHS Office of Inspector General or the APHIS Investigative and Enforcement Services. If FSAP identifies a potential criminal violation, FBI is notified of the matter for investigation.
Good news is that this work remains safe to both those in
the laboratories and the surrounding communities
When the Federal Select Agent Program is notified of a potential exposure, action is taken to help reduce risks and prevent it from happening in the future.
As in the previous year, none of the potential exposures reported to the Federal Select Agent Program resulted in illness, death, or transmission among those working in the labs or in the surrounding communities.
Unregistered laboratories continue to represent a significant
proportion of those laboratories that identify a select agent
A laboratory that is not registered with the Federal Select Agent Program may identify a select agent in the course of normal activities, like when diagnosing samples from hospital patients. In these cases, the laboratory must either register with the program to keep the sample, transfer the sample to a FSAP-registered laboratory, or destroy the sample.
In 2016, the program approved 260 transfers of select agents or toxins. A substantial proportion (38 percent) of those transfers involved unregistered entities transferring to registered entities, mostly as a result of identifying a select agent during diagnostic testing. Transferring these materials after identification ensures it goes to a registered laboratory capable of safely and securely handling that organism or toxin.