December 16, 2014 

FACT SHEET: Biosafety and Biosecurity in the United 

States

In the summer of 2014, lapses in biosafety practices in Federal laboratories served as a reminder of the importance 

of constant vigilance over the implementation of biosafety standards. 

As a result of these biosafety lapses, on August 18, 2014, Assistant to the President for Homeland Security and 

Counterterrorism Lisa Monaco and Assistant to the President for Science and Technology John Holdren issued a 

memorandum, titled, “Enhancing Biosafety and Biosecurity in the United States,” which urged all United States 

Government departments and agencies that work with infectious agents to take immediate and long-term steps to 

enhance safety and security of research to minimize the potential for future incidents. All United States Government 

departments and agencies that possess, use, or transfer human, animal, or plant infectious agents or toxins were 

urged to perform a Safety Stand-Down, to include an immediate sweep of their facilities to verify that all Biological 

Select Agents and Toxins (BSAT) in their possession were appropriately registered, stored, and disposed of in 

accordance with applicable regulations. 

Departments and agencies provided written documentation of activities, including facility sweeps, comprehensive 

safety, security and inventory activities, and captured best practices and plans for systemic strengthening of biosafety 

oversight. These results are summarized below. Staff from across the United States Government embraced this 

effort. Going forward, the United States Government will support and reinforce this strong culture of responsibility, 

which is essential to protecting laboratory personnel and the public. 

Overall findings

During the Safety Stand-Down, departments and agencies conducted sweeps at over 4,000 facilities across the 

United States and in U.S. facilities abroad, which included examining inventory and documentation for over 40 million 

samples. As a result of this comprehensive review, there were 27 instances in which BSAT materials, while safely 

and securely stored, were not properly registered with the United States Federal Select Agent Program (FSAP). In 

each instance, departments and agencies reported the adjudication and final disposition for the materials, and there 

were no indications of human exposure, including staff or the general public, to any of these agents or toxins. In 

accordance with standing protocol, the FSAP shared information about the select agent material that was identified 

during the Safety Stand-Down period with the Federal Bureau of Investigation (FBI), and none of the reported 

violations resulted in an FBI investigation. 

Plans for Sustained Inventory Monitoring 

As part of the Safety Stand-Down, departments and agencies were requested to report actions taken to improve 

inventory management practices and to identify excess biological agents and equipment for disposal. Examples 

include: 

 The Food and Drug Administration (FDA) will implement a new data management system to facilitate automated

inventory of long-term stored biological materials, creating a uniform inventory system at FDA that will document

and monitor specimens maintained by FDA laboratories in a single database.

 The Centers for Disease Control and Prevention (CDC) is now implementing revised procedures to improve

inventory management and will implement enhanced out-processing procedures for departing staff that will

include accounting for samples put into storage during that person’s tenure, to ensure proper subsequent

disposition of samples.

 CDC’s laboratories are also implementing an electronic inventory system for all diagnostic specimens, human

and animal sera, and potentially hazardous biological materials requiring biosafety level-2 (BSL-2) or greater

containment that are not BSAT.

 The National Institutes of Health (NIH) will develop a method to maintain inventories, institute spot checks during

annual laboratory inspections, and develop a procedure for the transfer of ownership/responsibility for an

inventory should a researcher leave the NIH facility. Quality assurance is an important purpose of these

activities, which will aim to validate initial findings and to ensure nothing was missed during the first phase of the

inventory.
 Department of Defense (DOD) laboratory leadership re-assessed biosafety and biosecurity operating 

procedures, training, and inventory management practices, and many DOD laboratories have decided to 

increase the frequency of their inventory sweeps and add monitoring of inventory sweeps to their quality control 

programs. 

 The Department of Homeland Security (DHS) has updated inventory software and is evaluating additional ways 

to improve the effectiveness of inventory management going forward. 

 The Department of Energy (DOE) improved standardization for elements of its inventory management process 

and DOE National Laboratories paused BSAT activities until a comprehensive sweep was conducted. 

 As a result of rigorous effort to advance biosafety and inventory management, the Department of Commerce 

National Institute of Standards and Technology tracks all chemical and biological samples on campus and 

conducts an annual audit of the database contents.

In addition to reports received from federal agencies, the United States Government also received reports from 

entities outside of the federal government, which conducted independent inventory reviews during the 2014 Federal 

Safety Stand Down period, and some reported updates for training and inventory management and undertook

campus-wide sweeps. The United States Government received 15 of these reports from 13 different organizations. 

In all cases, the FSAP worked with these organizations to ensure that all select agents and toxins discovered were 

either destroyed on site or transferred to an organization registered to possess select agents and toxins. 

Comprehensive Review of Current Biosafety and Biosecurity Protocols

As a result of the Safety Stand-Down, departments and agencies are updating laboratory protocols and expanding 

training programs to advance best practices in biosafety and biosecurity. Examples include:

 An audit of all training records performed by the DHS National Biodefense Analysis and Countermeasure Center 

verified 100 percent completion of mandatory training and mentorship participation, and all staff at the Plum 

Island Animal Disease Center completed additional training even though no improperly stored BSAT was 

discovered. 

 CDC ceased all transfers of biological materials from all BSL-3 and BSL-4 laboratories at all CDC facilities until 

each laboratory individually documented its practices and received approval to resume transfers of biological 

materials. In addition, CDC established an external workgroup to examine laboratory safety and security.

 NIH performed a review of NIH policies that govern the use of biological materials, and NIH will finalize a new 

manual chapter on internal biosafety and biosecurity policy to strengthen and enhance the oversight of high risk 

biological materials.

 The Department of Veterans Affairs (VA) convened a Biosafety and Biosecurity Advisory Group to identify best 

practices and areas for enhancement of the existing VA Research Safety and Security Programs, including an 

existing centralized system for reporting research noncompliance and/or unexpected adverse events and plans 

to clarify oversight for VA research conducted in non-VA facilities.

 The U.S. Department of Agriculture reported strengthened awareness about biosafety, biosecurity, and inventory 

management as a result of Safety Stand-Down, including participation from both management and staff. 

 The Environmental Protection Agency (EPA) is evaluating procedural and operational enhancements to its 

existing laboratory-safety and security program. Currently, EPA laboratories are required to complete an annual 

safety, health and environmental self-assessment including the topics of proper handling, storage, inventory and 

disposal of infectious and hazardous materials.

 The FDA has established an agency-wide Laboratory Safety Policies and Practices Workgroup to conduct a 

comprehensive review of laboratory safety and security policies and procedures, including inventory 

management, identify and address any gaps in policies and procedures, and standardize safety and security 

practices across the agency’s laboratories.
Opportunities for Improving Research Safety and Local Oversight Systems

Departments and agencies also hosted sessions with laboratory researchers and other staff to elicit input and to 

emphasize the importance of rigorously adhering to established practices for storing, handling, and working with 

infectious agents, toxins, and other biological derived materials. For example:

 During the month of September 2014, CDC, NIH, and FDA featured a National Biosafety Stewardship Month to 

raise awareness of activities undertaken during the Safety Stand-Down, and to promote safety programs and 

initiatives for all employees, including an HHS Safety Managers Meeting, a Biological Risk Mitigation Strategies 

online training course for 200 safety personnel, and provided laboratory-specific fora to elicit suggestions and 

concerns from staff regarding laboratory safety. 

 The DHS Plum Island Animal Disease Center is implementing a program to track training requirements and 

completion, expanding information technology infrastructure to biocontainment areas for real-time select agent 

tracking, improving oversight of shared biosafety level 2 facilities and cold storage areas, and updating their 

security and laboratory access policies. DHS has also developed an “Accountability” module to be added to 

annual performance evaluations and appraisal trainings for supervisors.

 OSTP is coordinating across the interagency on the implementation of key actions called for in a memorandum 

sent by Assistant to the President for Science and Technology John Holdren in March 2014 to all departments 

and agencies that hold scientific collections, including infectious disease agents, including to develop a 

comprehensive electronic management policy and systems to improve collection, long-term preservation, and 

accessibility. Full federal implementation of this policy allows for transparent accountability of federally owned 

scientific collections and serves as platform for advancing inventory management and strengthening federal 

biosafety and biosecurity.

Next Steps to Implement Best Practices

Moving forward, departments and agencies will work to implement the lessons learned from the Safety Stand-Down,

including:

 Identifying best practices to standardize electronic inventory documentation and management systems in

BSAT and non-BSAT laboratories;

 Enhancing biosafety and biosecurity training for laboratory staff, leadership, students, and management;

 Clarifying policies regarding handling and disposition of remaining laboratory samples when researchers, 

staff members or trainees depart from positions overseeing BSAT; and 

 Implementing mechanisms to designate responsible individuals to oversee samples stored in common 

storage areas, including for non-BSAT facilities. 

In addition, the United States Government is conducting parallel federal and non-federal reviews that will result in 

specific recommendations to strengthen the government’s biosafety and biosecurity practices and oversight system 

for federally funded activities. Through the Federal Experts Security Advisory Panel (FESAP), the United States 

Government is conducting a coordinated Federal review to: 1) identify needs and gaps and make recommendations 

to optimize biosafety, biosecurity, oversight and inventory management and control for BSAT; 2) identify actions and 

any regulatory changes necessary to improve biosafety and biosecurity; and 3) identify an approach to determine the 

appropriate number of high-containment U.S. laboratories required to possess, use, or transfer BSAT. In addition, 

the National Science and Technology Council has established an interagency Fast Track Action Committee to 

conduct a comprehensive review of the impact that the Select Agent Regulations have had on science, technology, 

and national security. The recommendations from these reviews will inform future policy to advance biosafety and 

biosecurity. Finally, the United States Government is committed to advancing biosafety and biosecurity in the United 

States and around the world as an integral component of the Global Health Security Agenda (GHSA). The Ebola 

epidemic has highlighted the importance of this effort, and we will achieve – domestically and with partners around 

the world – the measurable target we have set forward through the GHSA to advance national biosafety and

biosecurity systems. 
2014 Federal Safety Stand Down: Summary of Biological Select Agent and Toxin Materials Reported to the 

Federal Select Agent Program

During the “Safety Stand Down” period, multiple government institutions identified biological select agents and 

toxins (BSAT) in areas not registered with the Federal Select Agent Program (FSAP). The FSAP is a collaboration 

between the Centers for Disease Control and Prevention (CDC), Division of Select Agents and Toxins (DSAT) and 

the Animal and Plant Health Inspection Service (APHIS) Agriculture Select Agent Services (AgSAS) to regulate the 

possession, use, and transfer of BSAT listed in 7 C.F.R. Part 331, 9 C.F.R. Part 121, and 42 C.F.R. Part 73 (select 

agents and toxins). In accordance with the select agent regulations, these discoveries were reported to the 

FSAP. 

During the Safety Stand-Down, the FSAP received a total of 38 discovery reports from federal entities. 

Departments and agencies conducted sweeps at over 4,000 facilities across the United States and overseas, 

which included examining inventory and documentation for over 40 million samples. As a result of this 

comprehensive review, there were 27 instances in which BSAT materials, while safely and securely stored, were 

not properly registered with the United States FSAP. In each instance, departments and agencies reported the 

adjudication and final disposition for the materials, and there were no indications of human exposure, including 

staff or the general public, to any of these agents or toxins. All discovered BSAT were located in secure 

laboratory space with multiple layers of access control and there were no indications of human exposure to any 

of these agents or toxins. Many of the agents and toxins identified were from studies associated with personnel 

who have left their agencies and the custodianship of the samples was not reassigned. Some of these materials 

were labeled with obsolete pathogen names, while other material was found in laboratories where their active 

use had ceased, in some cases, decades prior to the establishment of the select agent regulations. All of these 

materials have been either safely destroyed on site or transferred to either registered areas or a registered 

facility. In accordance with standing protocol, the FSAP shared information about the select agent material that 

was identified during the Safety Stand-Down period with the Federal Bureau of Investigation (FBI), and none of 

the reported violations resulted in an FBI investigation.

Each report received by the FSAP is summarized in Table 1 below. As noted below, reports were received from 

agencies in the Department of Health and Human Services (HHS) including CDC, the National Institutes of Health 

(NIH), and Food and Drug Administration (FDA); the Department of Agriculture (USDA) Animal and Plant Health 

Inspection Services (APHIS); the Department of Veterans Affairs (VA); and the Interior Department’s United 

States Geological Survey (USGS). No reports of discovery were received from any other federal department or 

agency.

Table 1. Confirmed Select Agents and Toxins* reported to the Federal Select Agent Program during the 

September 2014 Federal Safety Stand Down period.

*Sweeps were conducted at over 4,000 facilities, which included examining inventory and documentation for over 40 million samples.

Entity Discovery 

Date

Discovered Agent or 

Toxin

Quantity (out 

of over 40 

million samples 

examined)

Resolution of Sample Indication of 

human exposure

prior to or during 

BSAT discovery

CDC 9/17/2014 Clostridium botulinum 8 vials Destroyed No

CDC 9/17/2014 Burkholderia 

pseudomallei

1 vial Transferred to 

registered laboratory

No

CDC 9/17/2014 Brucella abortus, B. 

melitensis & B. suis

6 vials Destroyed No
CDC 9/18/2014 Francisella tularensis 3 vials Destroyed No

CDC 9/25/2014 Clostridium botulinum, 

Francisella tularensis, 

Bacillus anthracis, 

Yersinia, pestis, 

Burkholderia 

pseudomallei, B. 

mallei, Brucella 

abortus, B. melitensis 

& B. suis

27 vials Transferred to 

registered laboratory

No

CDC 9/26/2014 Burkholderia 

pseudomallei, 

Clostridium botulinum, 

Brucella melitensis & 

B. suis

14 vials Transferred to 

registered laboratory

No

CDC 9/30/2014 Bacillus anthracis, 

Burkholderia 

pseudomallei, Brucella 

abortus, and B. 

melitensis

5 vials Transferred to 

registered laboratory

No

CDC 9/30/2014 Clostridium botulinum, 

Francisella tularensis, 

Bacillus anthracis, 

Burkholderia 

pseudomallei, B. 

mallei, Brucella 

abortus, B. melitensis 

& B. suis

36 vials Transferred to 

registered laboratory

No

FDA 7/15/2014 Staphylococcal 

enterotoxin

8 mg Destroyed No

FDA 9/7/2014 Clostridium botulinum 3 vials Destroyed No

VA 

Medical 

Center

9/3/2014 Brucella melitensis 1 vial Destroyed No

VA 

Medical 

Center

9/8/2014 Brucella abortus 1 vial Destroyed No

NIH 7/29/2014

8/11/2014

Botulinum neurotoxin 2 vials, 0.9

mg total

Destroyed* No

NIH 8/14/2014 Burkholderia 

pseudomallei

2 vials Destroyed* No

NIH 8/27/2014 Ricin 5g Destroyed* No

USDA 

APHIS 

9/11/2014 Botulinum neurotoxin 2 vials Destroyed No
USDA 

APHIS

9/17/2014 Avian influenza virus 

and Newcastle disease 

virus

2 vials Destroyed No

USDA 

APHIS

9/24/2014 Classical swine fever 

virus

13 vials Destroyed No

USDA 

APHIS

9/15/2014 Brucella abortus 10 vials Destroyed No

USDA 

APHIS

9/26/2014 Newcastle disease 

virus

1 vials Transferred to 

registered laboratory

No

USGS 10/1/2014 Eastern Equine 

Encephalitis virus

1 bird Destroyed No

USGS 9/22/2014 Newcastle disease 

virus

Tissue from 

infected bird

Destroyed No

USDA 

ARS

9/11/14 Avian influenza virus 1 vial Destroyed No

USDA 

ARS

9/11/14 Newcastle disease 

virus (Pigeon 

Paramyxovirus)

55 Transferred to 

registered laboratory

No

USDA 

ARS 

9/15/2014 Ricin 13-20 g Destroyed material to 

possess excluded 

amounts

No

USDA 

ARS

10/7/2014 T-2 Toxin 3766 mg Destroyed material to 

possess excluded 

amounts

No

USDA 

ARS

10/3/2014 T-2 Toxin 1161 mg Destroyed material to 

possess excluded 

amounts

No

* Previously publicly disclosed in 9/5/2014 midterm report 

There were 11 reports of material that, upon investigation by the FSAP, were determined to not be a select 

agent or toxin. These materials included attenuated strains (previously rendered less pathogenic) that are

excluded from the select agent and toxin regulations; strains that were contained in USDA or FDA licensed 

products; samples, such as antiserum, that were found to contain no agent or toxin; or toxins in amounts below 

the threshold for regulation. These reports are summarized in Table 2 below.

Table 2. Reports from federal agencies to the Federal Select Agent Program during the 2014 Federal Safety 

Stand Down period that were found upon subsequent investigation not to be select agents or toxins. 

Entity Discovery 

Date

Discovered Agent or Toxin Quantity Resolution of Sample

National Institutes 

of Health

8/19/2014 Francisella tularensis & 

Yersinia pestis

5 vials Not select agent: 

excluded strain*

National Institutes 

of Health

8/26/2014 Yersinia pestis 1 vial Not select agent: 

excluded strain*

USDA APHIS 9/9/2014 Foot-and-mouth disease virus 

& Classical swine fever virus

20 vials Not select agent 

sample, does not 

contain agent
USDA APHIS 9/12/2014 Classical swine fever virus 16 vials Not select agent 

sample, does not 

contain agent

USDA APHIS 9/24/2014 Classical swine fever virus 2 Vials Not a select agent; 

USDA licensed vaccine

USDA ARS 9/9/2014 Ricin 0.9 mg Not a select toxin: less 

than regulated 

amount (<100mg)

USDA ARS 9/9/2014 Diacetoxyscirpenol 3.2 mg Not a select toxin: less 

than regulated 

amount (<1000mg)

USDA ARS 9/9/2014 Ricin 3.2 mg Not a select toxin: less 

than regulated 

amount (<100mg) 

USDA ARS 9/4/2014 Ralstonia solanaceaurm 1 vial Not a select agent: 

excluded strain

USDA ARS 9/10/2014 Ralstonia solanaceaurm 10 vials Not a select agent; 

excluded strains 

USDA ARS 9/10/2014 Ralstonia solanaceaurm 10 vials Not a select agent: 

excluded strains

* Publicly disclosed in 9/5/2014 midterm report, determined later to not be a select agent violation

In addition to reports received from federal agencies, the FSAP also received reports from proactive entities 

outside of the federal government who did their own inventory reviews during the 2014 Federal Safety Stand 

Down period. The FSAP received 15 of these reports from 13 different organizations. In all cases, the FSAP 

worked with these organizations to ensure that all select agents and toxins discovered were either destroyed on 

site or transferred to an organization registered to possess select agents and toxins. As with the federal entity 

discovery reports, these non-federal entity reports were referred to the FBI’s Weapons of Mass Destruction 

Directorate per the standard protocol in order to assess whether there was any criminal or malicious activity 

associated with the finding; the FBI did not find any criminal activity.