HIGHCONTAINMENT 

LABORATORIES

Comprehensive and 

Up-to-Date Policies 

and Stronger 

Oversight 

Mechanisms Needed 

to Improve Safety

Report to Congressional Requesters

March 2016

GAO-16-305

United States Government Accountability Office
 

United States Government Accountability Office

Highlights of GAO-16-305, a report to 

congressional requesters

March 2016

HIGH-CONTAINMENT LABORATORIES

Comprehensive and Up-to-Date Policies and Stronger

Oversight Mechanisms Needed to Improve Safety

Why GAO Did This Study

Safety lapses at federal highcontainment laboratories in 2014 and 

2015 raised concerns about federal 

departments’ oversight of these 

laboratories. These laboratories work 

with hazardous biological agents to 

develop measures to protect public 

and animal health and the food supply 

against these agents. GAO was asked 

to review oversight at federal highcontainment laboratories. 

This report examines (1) the extent to 

which federal agencies have

comprehensive and up-to-date policies 

for managing biological agents in these

laboratories, (2) how they oversee

laboratories, and (3) the extent to 

which HHS and DOD have 

implemented recommendations from 

laboratory safety reviews. GAO 

assessed policies and oversight 

activities at 8 departments and their 15 

component agencies that own and 

operate high-containment laboratories 

against federal internal control 

standards and program management 

leading practices, reviewed plans for 

implementing laboratory safety 

recommendations, and interviewed 

federal officials.

What GAO Recommends

GAO is making 33 recommendations, 

including that departments develop

and update policies to include missing 

elements, ensure that oversight activity 

results are reported to senior officials, 

and develop plans with time frames for

implementing safety recommendations. 

Six departments generally agreed with 

all recommendations; two departments 

stated that no further action was 

needed for some of them. As 

discussed in the report, GAO maintains 

that these actions are needed. 

What GAO Found

Most of the 8 departments and 15 agencies that GAO reviewed had policies that 

were not comprehensive, and some departments and agencies had policies that 

were not up to date. Specifically, policies at 5 departments and 9 agencies were 

not comprehensive because they did not contain all six elements that GAO 

identified as key for managing biological agents in high-containment laboratories. 

These elements are incident reporting, roles and responsibilities, training, 

inventory control, inspections, and requiring adherence to or referencing leading 

laboratory safety guidance. Three of the 8 departments and 5 of the 15 agencies 

did not have policies. In addition, as of December 2015, 2 departments and 5 

agencies did not have up-to-date policies. Comprehensive policies that contain

all six key elements and that are reviewed and updated regularly would help 

departments reduce the risk of mismanaging hazardous biological agents and 

ensure that their policies convey consistent requirements for oversight, reflect 

current guidance, and address emerging threats.

The departments and agencies GAO reviewed were primarily using inspections 

to oversee their high-containment laboratories, but some of them were not 

routinely reporting inspection results, laboratory incidents, and other oversight 

activities, such as trend analyses, to senior officials. Specifically, 3 of the 8 

departments and 13 of the 14 agencies that were operating high-containment 

laboratories at the time of GAO’s review conducted routine laboratory

inspections. Of those departments and agencies that routinely inspected 

laboratories, 1 department and 5 agencies did not conduct trend analyses of 

inspection results; senior officials at 5 departments and 8 agencies did not 

routinely receive inspection results; and senior officials at 4 departments did not 

routinely receive incident reports. These departments and agencies typically did 

not report this information because there was no requirement for them to do so. 

Routinely analyzing inspection results and incident reports and sending this 

information to senior officials—consistent with federal internal control standards 

for monitoring—would help them identify laboratory safety trends, determine 

whether safety lapses reflect systemic issues, and make necessary 

improvements.

The Department of Health and Human Services (HHS) and Department of 

Defense (DOD) had a number of serious laboratory safety lapses in 2014 and 

2015 and were making progress in implementing recommendations from the

reviews of these lapses. As of November 2015, HHS agencies—the Centers for 

Disease Control and Prevention (CDC) and Food and Drug Administration 

(FDA)—reported implementing 91 and 6 recommendations, respectively, and 

were taking steps to implement others, and the National Institutes of Health (NIH) 

reported implementing all of its recommendations. DOD reported implementing 

one recommendation from its review and was taking steps to implement others. 

HHS and DOD have developed plans to track implementation of these

recommendations, but CDC’s, DOD’s, and Army’s plans lacked some 

implementation time frames. Plans that include time frames are consistent with 

federal internal control standards and leading practices for program management

and would give HHS and DOD better assurance that they can implement these 

recommendations in a timely manner and assess their progress in doing so.

View GAO-16-305. For more information, 

contact Marcia Crosse at (202) 512-7114 or 

crossem@gao.gov or John Neumann at (202) 

512-3841 or neumannj@gao.gov. 
Page i GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Letter 1

Background 8

Most Departments and Agencies Have Policies for Managing 

Hazardous Biological Agents in High-Containment Laboratories 

That Are Not Comprehensive or Up to Date 12

Departments and Agencies Use Inspections as Their Primary 

Oversight Activity, but Results Are Not Routinely Reported to 

Senior Officials 23

HHS and DOD Have Made Some Progress in Implementing 

Recommendations from Laboratory Safety Reviews, but Have 

Not Developed Sufficient Implementation Plans 35

Conclusions 42

Recommendations for Executive Action 43

Agency Comments and Our Evaluation 47

Appendix I Department of Health and Human Services Laboratory Oversight 

during the 2014 Smallpox Safety Incident 53

Appendix II Description and Sources of the Six Policy Elements That Are Key 

for Managing High-Containment Laboratories 54

Appendix III Timeline of Recent Centers for Disease Control and Prevention 

Safety Lapses and Related Federal Assessments 56

Appendix IV Comments from the Department of Agriculture 57

Appendix V Comments from the Department of Defense 61

Appendix VI Comments from the Department of Energy 64

Contents
Page ii GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Appendix VII Comments from the Department of Health and Human Services 67

Appendix VIII Comments from the Department of Homeland Security 73

Appendix IX Comments from the Department of the Interior 76

Appendix X Comments from the Department of Veterans Affairs 78

Appendix XI Comments from the Environmental Protection Agency 81

Appendix XII GAO Contacts and Staff Acknowledgments 85

Related GAO Products 86

Tables

Table 1: Research Responsibilities of Federal Department and 

Agency High-Containment Laboratories 8

Table 2: Summary of Six Elements Key for Managing Hazardous 

Biological Agents in High-Containment Laboratories 

Contained in Department and Agency Policies, as of 

December 2015 13

Table 3: Status of Department and Agency Policies for Managing 

High-Containment Laboratories, as of December 2015 20

Table 4: Department and Agency Activities Used to Oversee the 

Management of Hazardous Biological Agents in HighContainment Laboratories, as of December 2015 24

Table 5: Steps Taken by Certain Departments and Agencies to 

Strengthen Inventory Management Controls, as of 

December 2015 28
Page iii GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Table 6: Implementation Status of Recommendations from 2014 

and 2015 Reviews of the Department of Health and 

Human Services (HHS) Laboratory Safety Programs by 

Component Agency, as of November 2015 36

Table 7: Examples of Recommendations from the 2014 and 2015 

Reviews of the Department of Health and Human 

Services (HHS) and Department of Defense (DOD) 

Laboratory Safety Programs 39

Abbreviations

APHIS Animal and Plant Health Inspection Service

BMBL Biosafety in Microbiological and Biomedical Laboratories

BSL biosafety level

CDC Centers for Disease Control and Prevention

DHS Department of Homeland Security

DOD Department of Defense

DOE Department of Energy

DOI Department of the Interior

EPA Environmental Protection Agency

FDA Food and Drug Administration

HHS Department of Health and Human Services

NIH National Institutes of Health

USDA United States Department of Agriculture

VA Department of Veterans Affairs

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Page 1 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

441 G St. N.W.

Washington, DC 20548

March 21, 2016

Congressional Requesters

The United States faces current and emerging threats to public and 

animal health, the food supply, and the economy from the release of 

hazardous biological agents. Such agents may include Bacillus anthracis, 

the bacterium that causes anthrax; Variola virus, the virus that causes 

smallpox; and other naturally-occurring or emerging infectious disease 

agents, such as highly pathogenic influenza viruses that cause influenza 

in humans and animals.1 To address these threats, federal departments 

own and operate laboratories to identify the characteristics of these 

agents and develop countermeasures to mitigate or prevent illness or 

death.2 Laboratories that conduct research on hazardous biological 

agents are assigned one of four biosafety levels (BSL), with those at BSL3 and BSL-4 referred to as high-containment laboratories for the 

purposes of this report.3

In 2014 and 2015, two federal departments reported multiple lapses in 

laboratory safety that could have exposed personnel and other individuals 

to hazardous biological agents. For example, within the Department of 

Health and Human Services (HHS), the Centers for Disease Control and 

 

1

According to the Centers for Disease Control and Prevention (CDC), an emerging 

infectious disease is a disease whose incidence in humans has increased in the past two 

decades or threatens to increase in the near future. 

2

Researchers in these laboratories may also be at risk of accidental exposure to the 

hazardous biological agents with which they work.

3

Each level of containment describes the laboratory practices, safety equipment, and 

facility safeguards for the level of risk associated with handling particular biological agents. 

BSL-3 laboratories work with indigenous or exotic agents with known potential for airborne 

transmission or those agents that may cause serious and potentially lethal infections. 

BSL-4 laboratories work with exotic agents that pose a high individual risk of lifethreatening disease by airborne transmission and for which treatment may not be 

available. The designations of animal BSL-3 and 4 are used for laboratories that work with 

animals infected with indigenous or exotic agents. The term BSL-3 Agriculture is used to 

describe laboratories where studies are conducted on agents of high consequence to 

agriculture employing large or loose-housed animals. For the purposes of this report, we 

are using the term high-containment laboratories to refer to all laboratories at designated 

safety levels 3 and 4, regardless of whether they are animal, agriculture, or human health 

laboratories.

Letter
Page 2 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Prevention (CDC) reported an incident in June 2014 that had the potential 

to expose laboratory personnel to live anthrax bacteria, and in July 2014, 

boxes containing decades-old vials of smallpox—some of which 

contained live virus—and other hazardous biological agents were found in 

a storage space of a Food and Drug Administration (FDA) laboratory on 

the National Institutes of Health (NIH) campus. In May 2015, the 

Department of Defense (DOD) reported safety lapses at one of its highcontainment laboratories stemming from inadequate procedures to fully 

inactivate anthrax that resulted in DOD shipping live anthrax to other 

laboratories.4

Federal departments’ management of hazardous biological agents in their 

laboratories is primarily guided by the principles and practices of biosafety 

and biosecurity, as well as federal regulations governing biological select 

agents and toxins. The principles and practices of biosafety and 

biosecurity are outlined in the widely-accepted leading guidance for 

laboratories, Biosafety in Microbiological and Biomedical Laboratories

(BMBL), published in partnership by CDC and NIH.5 Biosafety practices 

are intended to reduce or eliminate exposure of individuals and the 

environment to potentially hazardous biological agents. Biosecurity 

practices are intended to prevent the loss, theft, release, or misuse of 

hazardous biological agents and research-related information by limiting 

access to facilities and this information. In addition, certain hazardous 

biological agents and toxins are subject to specific rules and regulations. 

Select agent regulations govern the possession, use, and transfer of 

certain hazardous biological agents and toxins—designated as 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.6

 

4

For the purposes of this report, inactivation is defined as a procedure to render 

hazardous biological agents unable to cause disease but still useful for research 

purposes, including, for example, vaccine and diagnostic development. 

5

Department of Health and Human Services, Centers for Disease Control and Prevention 

and National Institutes of Health, Biosafety in Microbiological and Biomedical 

Laboratories, 5th ed. (Washington, D.C.: December 2009). In addition to the BMBL, 

certain laboratory research on biological agents is subject to additional NIH oversight. See 

Department of Health and Human Services, National Institutes of Health, NIH Guidelines 

for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (Bethesda, Md.: 

November 2013). 

6

For select agent regulations, see 7 C.F.R. Part 331, 9 C.F.R. Part 121, and 42 C.F.R. 

Part 73 (2015). Research on select agents and toxins may require BSL-3 or BSL-4 

containment. 
Page 3 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

The 2014 and 2015 safety lapses illustrated multiple breakdowns in 

compliance with established policies and inadequate oversight, as well as 

scientific gaps in effective procedures to inactivate hazardous biological 

agents. These safety lapses raised questions about how federal 

departments and agencies manage hazardous biological agents at their 

high-containment laboratories, and led to several federal government 

reviews of laboratory programs.

• White House review. In August 2014, the White House urged all 

federal departments and agencies that possess, use, or transfer 

select agents and toxins to conduct a “safety stand-down” to inventory 

their laboratories and also established a federal review to identify 

needed improvements to biosafety and biosecurity practices.7 In 

October 2015, the White House issued a report on the results of this 

review that included recommendations for enhancing biosafety and 

biosecurity for those entities that conduct research using select 

agents and toxins.8 In addition, the report stated that while its findings 

were specific to select agents and toxins, they should also be applied 

to any biological agent that could pose a serious threat to public 

health or agriculture.

• HHS reviews. In 2014 and 2015, HHS’s component agency, CDC, 

conducted reviews of the July 2014 anthrax safety lapse and other 

individual laboratory safety lapses. CDC also conducted a review of 

its laboratory safety program and convened an external advisory 

 

7

The White House, “Enhancing Biosafety and Biosecurity in the United States,” 

(Washington, D.C.: Aug. 18, 2014). 

8

The White House, “Next Steps to Enhance Biosafety and Biosecurity in the United 

States,” (Washington, D.C.: Oct. 29, 2015). The White House recommendations 

highlighted the need for a transparent U.S. laboratory system and called for identifying an 

approach to determine the appropriate number of high-containment laboratories that 

conduct work on select agents and toxins, along with improved incident reporting and 

accountability and inventory management and control. If carried out, the White House’s 

call for identifying an approach to determine the appropriate number of select agentregistered high-containment laboratories will, in part, effectively implement our 2009 

recommendation that the National Security Advisor, in consultation with relevant 

department secretaries, identify a single entity charged with periodic government-wide 

strategic evaluation of high-containment laboratories to determine the number, location, 

and mission of the laboratories needed to effectively meet national goals to counter 

hazardous biological agents. GAO, High-Containment Laboratories: National Strategy for 

Oversight Is Needed, GAO-09-574 (Washington, D.C.: Sept. 21, 2009). We did not 

examine the status of efforts to implement the White House’s recommendations in this 

review. 
Page 4 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

group that also conducted reviews of CDC’s, FDA’s, and NIH’s 

laboratory safety programs. CDC and the external advisory group 

issued reports on the results of these reviews, which included 

recommendations to improve the agencies’ laboratory biosafety

programs. 

• DOD review. In May 2015, DOD convened a committee to conduct a 

comprehensive review of procedures, processes, and protocols in 

place for inactivating live anthrax spores across Army and Navy 

laboratories and issued a report on its results in July 2015, which 

included recommendations to enhance laboratory protocols and 

safety.

Congress has also examined the management of hazardous biological 

agents in high-containment laboratories.9

You asked us to examine federal protocols and oversight for the biosafety 

and biosecurity of hazardous biological agents. This report addresses

1. the extent to which federal departments and agencies have 

comprehensive and up-to-date policies for managing hazardous 

biological agents in high-containment laboratories,

2. how federal departments and agencies oversee the management of 

hazardous biological agents in high-containment laboratories, and

3. the extent to which HHS and DOD have implemented 

recommendations from laboratory safety reviews that are intended to 

improve their management of hazardous biological agents in highcontainment laboratories.

As you requested, we also provide further information in appendix I on 

FDA’s and NIH’s oversight mechanisms in place specifically during the 

2014 smallpox safety incident.

To determine the extent to which federal departments and agencies had 

comprehensive and up-to-date policies for managing hazardous biological 

 

9

Review of CDC Anthrax Lab Incident, Before the Subcomm. on Oversight and 

Investigations, H. Comm. on Energy and Commerce, 113th Cong. (2014), and Continuing 

Concerns with the Federal Select Agent Program: Department of Defense Shipments of 

Live Anthrax, Before the Subcomm. on Oversight and Investigations, H. Comm. on Energy 

and Commerce, 114th Cong. (2015).
Page 5 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

agents in high-containment laboratories, we identified the 8 federal 

departments and their 15 component agencies that owned and operated 

all of the government’s high-containment laboratories (BSL-3, BSL-4, or 

both).10 We obtained their policies that were generally related to biosafety 

and biosecurity in high-containment laboratories between February 2015 

and December 2015. We assessed whether these policies specifically 

addressed the management of hazardous biological agents and applied 

to high-containment laboratories, and we excluded policies that we 

determined were not specific to managing hazardous biological agents in 

high-containment laboratories.11 To examine whether these policies were 

comprehensive, we first identified six elements that are key for the 

management of high-containment laboratories and are consistent with 

federal standards for internal control—specifically the standards for 

control environment, control activities, monitoring, and information and 

communications.12 These six key elements were also identified as areas 

of concern in the safety lapses of 2014 and 2015 and are identified in the 

 

10These federal departments and their component agencies are DOD and its departments 

of the Army, Navy, and Air Force; HHS and its CDC, FDA, and NIH; Department of Energy 

(DOE) and its National Nuclear Security Administration and Office of Science; Department 

of Homeland Security (DHS); Department of the Interior (DOI) and its Fish and Wildlife 

Service and U.S. Geological Survey; Department of Veterans Affairs (VA) and its Veterans 

Health Administration; Environmental Protection Agency (EPA) and its Office of Pesticide 

Programs; and United States Department of Agriculture (USDA) and its Animal and Plant 

Health Inspection Service (APHIS), Agricultural Research Service, and Food Safety and 

Inspection Service. Federal departments have various terms for their component 

agencies. For example, DOI refers to its agencies as “bureaus.” For the purposes of this 

report, we refer to the departments’ components as “agencies.” 

11For example, some departments and agencies provided policies for broad occupational 

safety and health programs or policies for employees to obtain identification badges to 

enter federal facilities. We excluded these, and similar policies, because they were not 

specific to managing biological agents in high-containment laboratories. 

12GAO, Standards for Internal Control in the Federal Government, GAO/AIMD-00-21.3.1

(Washington, D.C.: November 1999), and Standards for Internal Control in the Federal 

Government, GAO-14-704G (Washington, D.C.: September 2014). GAO/AIMD-00-21.3.1 

was effective through the end of fiscal year 2015 (Sept. 30, 2015). GAO-14-704G is the 

2014 revision of GAO/AIMD-00-21.3.1 and became effective the first day of fiscal year 

2016 (Oct. 1, 2015). Internal control is synonymous with management control and 

comprises the plans, methods, and procedures used to meet missions, goals, and 

objectives. Federal internal control standards for control environment and control activities 

state that management is responsible for developing the detailed policies, procedures, 

and practices to fit their agency’s operations and call for appropriate lines of reporting. The 

control standard for monitoring calls for assessing the quality of performance over time. 

The control standard for information and communications calls for information to be 

communicated to management within a time frame that enables them to carry out their 

responsibilities. 
Page 6 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

BMBL—the leading biosafety guidance—as important for management 

oversight of biosafety and biosecurity at high-containment laboratories. 

We then assessed whether all six key elements were contained in either 

department-level policy or in each of a department’s component agencies’ 

policies. (For more information about the six key policy elements, their 

description, and the sources we used to identify them, see app. II.) To 

determine whether departments’ and agencies’ policies were up to date, 

we evaluated whether their policies had been updated according to their 

own written requirements for reviewing and updating policies. We also 

interviewed officials from each of the 8 departments and 15 agencies to 

obtain additional information about department and agency policies.

To determine how federal departments and agencies oversee the 

management of hazardous biological agents in high-containment 

laboratories, we reviewed available department and component agency 

documents that outlined requirements and processes related to oversight 

activities, and interviewed department and agency officials to obtain 

information on their oversight activities in practice as of December 2015.13

We excluded DOE’s Office of Science from this part of our review, as the 

agency has not operated its laboratory at a high-containment level since 

2006, which reduced the number of agencies for which we reviewed 

oversight activities to 14.14 We compared departments’ and agencies’ 

oversight activities with the federal internal control standard for 

monitoring, as well as with department and agency policies.15 Generally, 

we considered the oversight activities to be in accordance with internal 

controls if either a department or each of its component agencies 

conducted the activities. We conducted site visits to three department and 

component agency locations with BSL-3 and BSL-4 laboratories to 

observe laboratory and oversight activities in practice. In determining 

which locations to visit, we considered (1) the number of laboratories 

 

13This report examines the overall oversight activities conducted by the 8 departments 

and 15 agencies in our review for their high-containment laboratories regardless of their 

select agent registration status and does not examine these departments’ and agencies’ 

compliance with select agent regulations. 

14According to officials from DOE’s Office of Science, although there are no immediate 

plans to conduct BSL-3 work at its laboratory, the agency plans to maintain BSL-3 

capability at this laboratory should the need to work with hazardous biological agents arise 

in the future. 

15GAO/AIMD-00-21.3.1 and GAO-14-704G. The internal control standard for monitoring 

calls for agencies to assess the quality of performance over time and ensure that the 

findings of audits and other reviews are promptly resolved.
Page 7 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

owned by each department and component agency, (2) the type of 

laboratory (human or animal), and (3) whether more than one department 

operates laboratories at the same site. Based on these factors, we 

selected three locations for our site visits—CDC laboratories in Atlanta, 

Georgia; United States Department of Agriculture (USDA) laboratories in 

Ames, Iowa; and the National Interagency Biodefense Campus 

(laboratories of DOD’s departments of the Army and Navy, USDA’s 

Agricultural Research Service, CDC, Department of Homeland Security, 

and NIH) at Ft. Detrick in Frederick, Maryland.

To determine the extent to which HHS and DOD have implemented 

recommendations from laboratory safety reviews, we reviewed HHS 

component agency—CDC, FDA, and NIH—and DOD reports and afteraction assessments from their reviews of the 2014 and 2015 safety 

lapses to identify any recommendations intended to improve or enhance 

their management of hazardous biological agents in high-containment 

laboratories. We obtained and analyzed CDC, FDA, NIH, and DOD plans 

for addressing and implementing these recommendations to determine 

whether HHS and DOD had made progress in implementing 

recommendations and whether the plans contained time frames for 

implementing them as of November 2015 for HHS and December 2015 

for DOD (the date of the most recent information available for each 

department). We compared agency plans to the federal internal control 

standards for control activities and monitoring and with leading practices 

identified in the Project Management Institute’s The Standard for Program 

Management—which calls for the development of timelines and 

milestones as program management leading practices—to determine 

whether federal agencies have appropriate controls in place to oversee 

the implementation of the recommendations.16

To provide information on the oversight mechanisms in place at HHS 

component agencies, FDA and NIH, during the 2014 smallpox incident 

described in appendix I, we obtained and reviewed FDA and NIH 

laboratory inspection checklists and protocols in place during the 

smallpox incident and any changes made to these checklists and 

protocols as a result of the incident. We interviewed NIH officials to 

assess whether and how NIH inspectors used results of prior inspections 

to inform current and future inspections and communicated inspection 

 

16See GAO/AIMD-00-21.3.1 and GAO-14-704G and the Project Management Institute, 

The Standard for Program Management, 3rd ed. (Newton Square, Pa.: 2013).
Page 8 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

results to FDA, including the discovery of vials containing smallpox and 

other select agents. We also interviewed FDA and NIH officials to obtain 

information on how the agencies coordinated with each other to identify 

and resolve deficiencies in inspection and inventory management 

protocols and made any changes to address these deficiencies.

We conducted this performance audit from February 2015 to March 2016 

in accordance with generally accepted government auditing standards. 

Those standards require that we plan and perform the audit to obtain 

sufficient, appropriate evidence to provide a reasonable basis for our 

findings and conclusions based on our audit objectives. We believe that 

the evidence obtained provides a reasonable basis for our findings and 

conclusions based on our audit objectives.

Many federal departments and agencies own and operate highcontainment laboratories in the United States and abroad. See table 1 for 

the research responsibilities of these departments’ and agencies’ highcontainment laboratories.

Table 1: Research Responsibilities of Federal Department and Agency High-Containment Laboratories

Department

Agency Research responsibilities of high-containment laboratories

DHS Conducts research to support bioforensic operations and biological threat characterization and 

foreign animal disease diagnostics and vaccine development.

DOD

Air Force

Army 

Navy

Conducts and supports research on detection, identification, and characterization of biological 

threats that pose risks to servicemembers and the development of medical countermeasures for 

those threats.

DOE

National Nuclear Security 

Administration

Conducts research to develop detection and response systems to improve preparedness for a 

biological attack.

Office of Science Conducts experiments with hazardous biological agents, such as human, animal, or plant viruses 

and toxins, to understand basic biological, chemical, and physical processes.

DOI

Fish and Wildlife Service Conducts testing of evidence to assist with law enforcement investigations of crimes against 

wildlife. 

Background

Federal Roles and 

Responsibilities
Page 9 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Department

Agency Research responsibilities of high-containment laboratories

U.S. Geological Survey Conducts diagnostic investigations of wildlife deaths, research to characterize emerging and other 

priority wildlife pathogens, susceptibility testing of terrestrial and aquatic wildlife for emerging and 

invasive pathogens, and offers disease consultation services to external partners.

EPA

Office of Pesticide 

Programs 

Conducts applied research on methods used to evaluate the efficacy of public health antimicrobial 

products.

HHS

CDC Conducts research to detect, identify, and characterize hazardous biological agents of public 

health importance.

FDA Conducts research to support the evaluation and regulation of medical, food, and tobacco 

products, including testing the safety, toxicity, and efficacy of human and animal drug products.

NIH Conducts internal biomedical research, in addition to providing funding to external partners to 

conduct biomedical research.

USDA

APHIS Conducts diagnostic testing for domestic and foreign animal diseases and plant pests and

diseases. 

Agricultural Research Service Conducts basic and applied research on high-priority livestock diseases, among other diseases.

Food Safety and Inspection 

Service 

Conducts diagnostic testing to identify potential foodborne hazards, estimate risk to human 

health, and respond to threats to the food supply.

VA

Veterans Health 

Administration

Conducts diagnostic testing and research on health issues at its VA medical center laboratories.

Legend

APHIS Animal and Plant Health Inspection Service

CDC Centers for Disease Control and Prevention

DHS Department of Homeland Security

DOD Department of Defense

DOE Department of Energy

DOI Department of the Interior

EPA Environmental Protection Agency

FDA Food and Drug Administration

HHS Department of Health and Human Services

NIH National Institutes of Health

USDA United States Department of Agriculture

VA Department of Veterans Affairs

Source: GAO analysis of department and agency information. | GAO-16-305

As part of their oversight responsibilities under the federal select agent 

program, CDC and the Animal and Plant Health Inspection Service 

(APHIS) regulate facilities—including conducting inspections and other 

activities—that possess, use, or transfer biological select agents and 
Page 10 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

toxins, which have the potential to pose a severe threat to public, animal, 

or plant health or to animal or plant products.17

In addition to the 2014 anthrax and smallpox safety lapses at CDC and 

NIH, respectively, CDC and DOD reported other laboratory safety lapses. 

Specifically, CDC reported two other incidents in 2014 that had the 

potential to expose laboratory personnel to highly pathogenic avian 

influenza and live Ebola virus. In July 2014, CDC also reported that at 

least four additional safety lapses had occurred at its high-containment 

laboratories in the past 10 years, all of which were the result of improperly 

inactivated hazardous biological agents. (See app. III for a timeline of the 

CDC safety lapses and federal assessments of these lapses.) During its 

investigation of the May 2015 anthrax safety lapse, DOD confirmed that 

safety lapses at one of its high-containment laboratories as a result of 

improper inactivation of hazardous biological agents had occurred for as 

many as 10 years prior to the discovery of improper anthrax inactivation 

in 2015.

HHS and DOD have conducted reviews of the 2014 and 2015 safety 

lapses identified at their laboratories that contained recommendations to 

enhance or improve policies and oversight, in addition to other agency 

activities.

In 2014 and 2015, HHS conducted reviews of its laboratory safety 

programs at CDC, NIH, and FDA.

• CDC after-action assessments. CDC conducted after-action 

assessments of the individual anthrax, avian influenza, and Ebola 

safety lapses and issued reports on these assessments, all three of 

 

17CDC and APHIS were delegated authority by their respective department secretaries to 

regulate the use, possession, and transfer of select agents. As part of that oversight, CDC 

and APHIS maintain a list of select agents and toxins, which they must review and update 

at least every 2 years. Generally, entities (including federal agencies and private 

institutions) and individuals that possess, use, or transfer these select agents must 

register with CDC or APHIS and must renew their registration every 3 years. CDC or 

APHIS conducts an on-site inspection before issuing a new certificate of registration or 

renewing an existing registration. 42 C.F.R. §§ 73.7(f) & 73.18(b); 9 C.F.R. §§ 121.7(f) & 

121.18(b); 7 C.F.R. §§ 331.7(f) & 331.18(b) (2015). CDC and APHIS may also conduct 

interim inspections, such as annual inspections, to assess compliance with select agent 

regulations.

Laboratory Safety Lapses

and Reviews

HHS Laboratory Safety 

Reviews
Page 11 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

which contained a total of 42 recommendations to address the July 

2014, August 2014, and February 2015 respective findings.18

• CDC internal workgroup review. In October 2014, an internal 

workgroup established by CDC issued a report from its review of the 

2014 safety lapses and CDC’s laboratory safety program, which 

contained 96 recommendations to address its findings.

• CDC external advisory group review. CDC also convened an 

external advisory group to review the agency’s laboratory safety 

program, and the advisory group issued its report, which contained 19 

recommendations to address its findings in January 2015.

• NIH and FDA laboratory reviews. CDC’s external advisory group 

also conducted reviews of NIH’s and FDA’s laboratory safety 

programs. In April 2015, the advisory group issued its report on NIH, 

which contained 10 recommendations, and in July 2015, the advisory 

group issued its report on FDA, which contained 27 recommendations 

to address its findings.

In May 2015, DOD convened a committee to conduct a comprehensive 

review of procedures, processes, and protocols for inactivating live 

anthrax spores across Army and Navy laboratories.19 The committee 

issued a report on the results of its review containing 22 

recommendations to address its findings in July 2015.20 In September 

2015, DOD issued a memo directing all department laboratories working 

with select agents and toxins to conduct an immediate safety review and 

report on their results within 10 days. DOD did not issue any 

recommendations as a result of this review but has established a 

workgroup to study the results of the review and potentially develop 

additional recommendations in the future. 

 

18APHIS’s select agent office also conducted reviews of the select agent laboratories 

involved in each of the safety lapses and issued reports containing recommendations to 

address its findings for each incident.

19According to officials, DOD did not include Air Force in its review because its highcontainment laboratory does not conduct anthrax inactivation. 

20Department of Defense, Review Committee Report: Inadvertent Shipment of Live 

Bacillus anthracis Spores by DoD (Washington, D.C.: July 13, 2015).

DOD Laboratory Safety 

Review
Page 12 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Most of the departments and agencies we reviewed did not have 

comprehensive policies—that is, policies did not contain all of the six 

elements that we identified as key for managing these laboratories. In 

addition, some departments and agencies did not have up-to-date 

policies.

Most of the departments and agencies we reviewed had policies for 

managing hazardous biological agents in high-containment laboratories, 

but those policies were not comprehensive—that is, they lacked some of 

the six elements that we identified as key for managing these 

laboratories. These key policy elements are

1. incident reporting—establishing appropriate lines of reporting for 

incidents involving hazardous biological agents, including the type of 

incident, to whom to report, and when;

2. roles and responsibilities—defining roles and responsibilities of 

department, agency, or laboratory personnel;

3. training—establishing training for personnel handling hazardous 

biological agents;

4. inventory control—requiring an inventory of all hazardous biological 

agents;

5. inspections—ongoing monitoring in the course of normal laboratory 

operations; and

6. BMBL—requiring adherence to, or referencing, the BMBL.

For each of the 8 departments and 15 component agencies we reviewed, 

we examined department- or agency-level policies for laboratory 

management to determine whether they contained these six key 

elements. We considered a department’s policies to be comprehensive if 

requirements for all six key elements existed in department-level policies 

or in agency-level policies for each of the department’s component 

Most Departments 

and Agencies Have 

Policies for Managing 

Hazardous Biological 

Agents in HighContainment 

Laboratories That Are 

Not Comprehensive 

or Up to Date

Most Department and 

Agency Policies Were Not 

Comprehensive and Did 

Not Contain All Six Key 

Elements for Managing 

High-Containment 

Laboratories
Page 13 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

agencies. In addition, for the incident reporting element, if departmentlevel policies did not contain requirements for reporting incidents to senior 

department officials, our assessment required agency-level policies to do 

so.

Our review found that most departments and agencies had policies for 

managing hazardous biological agents in high-containment laboratories—

at either the department level, the agency level, or in the case of DOD, 

EPA, and USDA, both. Five of the 8 departments had department-level 

policies, and 10 of the 15 agencies had agency-level policies.21 These 

department and agency policies contained at least one of the key 

elements. One department, DOI, did not have laboratory management 

policies at either the department or agency level. Table 2 shows the 

extent to which the 8 departments and 15 agencies we reviewed had 

policies that contained each of the six key elements as of December 

2015.

Table 2: Summary of Six Elements Key for Managing Hazardous Biological Agents in High-Containment Laboratories

Contained in Department and Agency Policies, as of December 2015

Department

Agency

Incident 

reporting

Roles and

responsibilities Training 

Inventory 

control Inspections BMBL

Key elements 

(count) 

DHSa

   ◐   5

DOD    ◐   5

Air Forcea  ◐ ◐ ◐ ◐  1

Army    ◐   5

Navy ◐ ◐ ◐ ◐ ◐  1

DOEa       5

National Nuclear Security 

Administration – – – – – – -

Office of Science – – – – – – -

DOI – – – – – – -

Fish and Wildlife Service – – – – – – -

 

21The 5 departments with department-level policies are DHS, DOD, DOE, EPA, and 

USDA. The 10 agencies with agency-level policies are DOD’s Air Force, Army, and Navy; 

EPA’s Office of Pesticide Programs; HHS’s CDC, FDA, and NIH; USDA’s APHIS and 

Agricultural Research Service; and VA’s Veterans Health Administration. 
Page 14 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Department

Agency

Incident 

reporting

Roles and

responsibilities Training 

Inventory 

control Inspections BMBL

Key elements 

(count) 

U.S. Geological Survey – – – – – – -

EPA       4

Office of Pesticide 

Programs      

2

HHS – – – – – – -

CDC b  ◐  ◐  3

FDA       5

NIH       6

USDA       5

APHIS       2

Agricultural Research

Service      

5

Food Safety and

Inspection Servicea – – – – – – -

VA – – – – – – -

Veterans Health

Administration    ◐c  

4

Legend:

 Policies contained requirement for key element for all high-containment laboratories. 

◐ Policies contained requirement for key element only for select agent-registered laboratories. 

 Policies required adherence to the BMBL or referenced it as guidance. 

 Policies did not contain key element. 

– Department or agency did not have policies.

APHIS Animal and Plant Health Inspection Service

BMBL Biosafety in Microbiological and Biomedical Laboratories

CDC Centers for Disease Control and Prevention

DHS Department of Homeland Security

DOD Department of Defense

DOE Department of Energy

DOI Department of the Interior

EPA Environmental Protection Agency

FDA Food and Drug Administration

HHS Department of Health and Human Services

NIH National Institutes of Health

USDA United States Department of Agriculture

VA Department of Veterans Affairs

Source: GAO analysis of department and agency information. | GAO-16-305

a

Departments’ and agencies’ high-containment laboratories are all select agent-registered 

laboratories, according to officials.

b

In July 2015, CDC issued a memorandum to agency personnel that included incident reporting 

procedures and a risk assessment flow chart for reporting potential incidents in its select agent and 

infectious disease laboratories, and officials stated that these requirements are available on the 
Page 15 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

agency’s internal laboratory safety website. However, CDC has not incorporated these requirements 

into agency-level laboratory safety policies.

c

According to officials from VA’s Veterans Health Administration, the agency’s BSL-3 capable clinical 

laboratory is not permitted to store biological inventory.

We found that department and agency policies were not comprehensive 

because they either did not contain all six key elements or were not 

applicable to all of a department’s or agency’s high-containment 

laboratories.

• DHS. We did not consider DHS’s policies to be comprehensive 

because department-level policies did not contain all six key policy 

elements and did not apply to all of the department’s highcontainment laboratories. Specifically, DHS’s policies contained 

requirements for inventory control but only for the department’s select 

agent-registered laboratories. At the time of this review, all of DHS’s 

high-containment laboratories were registered with the select agent 

program. However, should the registration status of these laboratories 

change, or should DHS open new, nonregistered high-containment 

laboratories in the future, they would not be covered by department 

policy.

• DOD. We did not consider DOD’s policies to be comprehensive 

because policies containing some key elements applied only to DOD’s

select agent-registered laboratories. Furthermore, DOD’s component 

agencies (Air Force, Army, and Navy) had policies that contained one 

to five of the key policy elements, but the policies were missing other 

elements or applied only to the agencies’ select agent-registered 

laboratories. For example, DOD’s and its component agencies’ 

policies contained requirements for inventory control but only for their 

select agent-registered laboratories, and Air Force’s and Navy’s 

policies contained requirements for training and inspections only for 

their select agent-registered laboratories. The department has highcontainment laboratories that are not registered with the select agent 

program but conduct research on other potentially hazardous 

biological agents to which these policies would not apply, according to 

officials.

• DOE. We did not consider DOE’s policies to be comprehensive 

because department-level policies did not contain all six key policy 

elements. Specifically, we found that DOE’s policies did not contain 

requirements for laboratory inspections. Furthermore, DOE’s 

component agencies—National Nuclear Security Administration and 
Page 16 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Office of Science—did not have agency-level policies for managing 

hazardous biological agents in their high-containment laboratories.22

• DOI. We did not consider DOI’s policies to be comprehensive 

because, as previously stated, DOI did not have policies for managing 

biological agents in its high-containment laboratories at either the 

department or agency level.

• EPA. We did not consider EPA’s policies to be comprehensive 

because they did not contain all six key policy elements. Specifically, 

we found that EPA’s policies did not contain requirements for 

inventory control or reference the BMBL. Furthermore, the Office of 

Pesticide Programs’ policies did not contain four of the six key policy 

elements, including requirements for inventory control and referencing 

the BMBL. 

• HHS. We did not consider HHS’s policies to be comprehensive 

because HHS did not have department-level policies, and two of its 

three component agencies did not have all six key elements in their 

agency-level policies. Specifically, CDC’s policies contained three of 

the six key policy elements, but policies that contained the 

requirements for training and inspections applied only to the agency’s 

select agent-registered laboratories. We also found that CDC’s and 

FDA’s policies did not contain requirements for incident reporting to 

senior department officials. In contrast, we considered NIH’s policies 

for laboratory management to be comprehensive because the 

agency’s policies contained all six key elements, including reporting 

incidents to senior department officials.

• USDA. We did not consider USDA’s policies to be comprehensive 

because they did not contain all six key policy elements, and two of its 

three component agencies did not have all six key elements in their 

policies or did not have agency policies. Specifically, USDA’s policies 

did not contain requirements for reporting laboratory incidents to 

senior department officials, including the types of incidents that should 

be reported, to whom, and when. In addition, APHIS’s policies did not 

contain requirements to report laboratory incidents to senior 

 

22According to officials, DOE’s Office of Science had one laboratory that was capable of 

operating at BSL-3 but was not operating as a high-containment laboratory as of 

December 2015. However, officials told us that the laboratory could become operational 

as a high-containment laboratory, if needed.
Page 17 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

department officials, and Food Safety and Inspection Service did not 

have agency policies for managing biological agents in highcontainment laboratories. At the time of our review, APHIS was in the 

process of revising and finalizing its agency-level biosafety policy. 

APHIS finalized this policy in February 2016, after we completed our 

analysis, and the revised policy contains new requirements for the key 

elements of incident reporting, inventory control, inspections, and the 

BMBL.

• VA. VA did not have department-level policies for managing biological 

agents in high-containment laboratories. Furthermore, we did not 

consider VA’s Veterans Health Administration policies to be 

comprehensive because the agency had requirements for all six key 

elements in agency-level policies for its high-containment research 

laboratories but lacked requirements for incident reporting in policies 

for its high-containment clinical laboratory, and requirements for 

inventory control applied only to select agents for this laboratory.23

Department and agency officials we spoke to provided multiple reasons 

why they do not have policies that contain all six of the key elements. DOI 

officials told us that the department defers to its component agencies to 

set appropriate policies for the agencies’ biosafety programs, and the 

agencies delegate this responsibility to subject-matter experts at the 

laboratories. Officials at USDA, which did not have department-level 

policies that contained the key element of incident reporting, told us that 

the department delegates responsibility for policy development, including 

any requirements contained in these policies, to its component agencies. 

In addition, officials at DOE and USDA’s Agricultural Research Service 

generally noted that responsibility for policy development, including any 

requirements contained in these policies, is delegated to their 

laboratories.

In addition, some departments and agencies did not address all six key 

elements in policy but told us that they may conduct certain oversight 

activities, such as inspections and incident reporting, even when 

requirements for these activities are not specified in policy. For example, 

 

23According to officials, VA’s Veterans Health Administration had one clinical laboratory 

that was capable of operating at BSL-3 but was not currently operating as a highcontainment laboratory, as of December 2015. However, Veteran’s Health Administration 

officials told us that the laboratory could become operational as a high-containment 

laboratory as needed, such as during a public health emergency. 
Page 18 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

DOE’s policies did not contain requirements for departmental inspections, 

and its National Nuclear Security Administration did not have agencylevel policies. However, National Nuclear Security Administration officials 

told us that the agency conducts inspections of its high-containment 

laboratories on a regular basis in conjunction with laboratory personnel. 

Additionally, CDC’s policies did not contain requirements for incident 

reporting, but the agency has taken related actions. Specifically, CDC 

distributed incident reporting procedures and a risk assessment flow chart 

for reporting potential incidents in its select agent and infectious disease 

laboratories to agency personnel in a July 2015 memorandum. Officials 

also stated that these requirements are available on the agency’s internal 

laboratory safety website.

The lack of department- and component agency-level policies that contain 

all six elements we identified as key for managing biological agents in 

high-containment laboratories may hinder effective oversight of the 

laboratories and conflicts with federal internal control standards. 

According to federal internal control standards, agencies should have 

control activities in place to ensure that management’s directives, such as 

policies and procedures for managing their programs, are carried out.24

These standards also state that information should be recorded and 

communicated to management and other responsible officials in a form 

and within a time frame that enables them to carry out their internal 

control and other responsibilities. Developing comprehensive policies that 

contain requirements for all six key elements and apply to all highcontainment laboratories would help departments and agencies reduce 

the risk of mismanaging hazardous biological agents by ensuring that 

policies convey consistent requirements for oversight, reflect current 

biosafety and biosecurity guidance, and address emerging threats and 

needed improvements. In addition, developing policies that contain these 

key elements for those departments and agencies with laboratories that 

are capable of operating as high-containment laboratories during public 

health or other emergencies would help departments and agencies 

ensure that they set policy expectations in advance of emergency 

response activities. Furthermore, policies for incident reporting that 

specify the type of incidents to report, to whom to report, and when would 

help ensure that senior department officials are consistently made aware 

of serious laboratory safety incidents at their high-containment 

laboratories.

 

24GAO/AIMD-00-21.3.1 and GAO-14-704G. 
Page 19 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Of the 5 departments and 10 agencies that had policies for managing 

high-containment laboratories, 2 departments and 5 agencies had not 

updated all of their policies consistent with their internal review schedules 

as of December 2015.25 Specifically, DOE and USDA had one or more 

department-level policies that were not up to date. In addition, DOD’s Air 

Force and Army, HHS’s NIH, USDA’s Agricultural Research Service, and 

VA’s Veterans Health Administration had one or more agency-level 

policies that were not up to date.

We found that most departments and agencies had general requirements 

and time frames for reviewing and updating their policies or their policies 

included specific expiration or recertification dates. However, other 

departments and agencies lacked either general requirements and time 

frames for reviewing and updating policies or specific policy expiration or 

recertification dates; these departments and agencies—DHS, EPA, 

HHS’s FDA, and USDA’s APHIS—review their policies on an as-needed 

basis, according to officials. We considered each department and each of 

its agencies separately and assessed their policies according to their own 

review schedules. We considered a department’s or agency’s policies to 

be up to date if they had been reviewed within general department or 

agency review time frames or before the policy’s specific expiration or 

recertification date. See table 3 for the status of department and agency 

policies for managing high-containment laboratories as of December 

2015.

 

25As shown in table 3, DOI, HHS, and VA did not have department-level policies for 

managing biological agents in high-containment laboratories at the time of our review. In 

addition, five component agencies—DOE’s National Nuclear Security Administration and 

Office of Science, DOI’s Fish and Wildlife Service and U.S. Geological Survey, and 

USDA’s Food Safety and Inspection Service—did not have agency-level policies.

Some Departments and 

Agencies Do Not Have 

Up-to-Date Policies for 

Managing Hazardous 

Biological Agents in HighContainment Laboratories
Page 20 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Table 3: Status of Department and Agency Policies for Managing High-Containment 

Laboratories, as of December 2015

Department

Agency Status of policies

DHSa ?

DOD 

Air Force ◒

Army ◒

Navy 

DOE ◒

National Nuclear Security Administration –

Office of Science –

DOI –

Fish and Wildlife Service – 

U.S. Geological Survey – 

EPAa ? 

Office of Pesticide Programsa 

HHS –

CDC 

FDAa 

NIH ◒

USDA 

APHISa ? 

Agricultural Research Service 

Food Safety and Inspection Service – 

VA –

Veterans Health Administration ◒

Legend:

? Unable to determine—department or agency did not have documented review time frames and policies did not include specific 

expiration or recertification dates.

 All policies were up to date. 

◒ Not all policies were up to date. 

 No policies were up to date. 

– Department or agency did not have policies. 

APHIS Animal and Plant Health Inspection Service

CDC Centers for Disease Control and Prevention

DHS Department of Homeland Security

DOD Department of Defense

DOE Department of Energy
Page 21 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

DOI Department of the Interior

EPA Environmental Protection Agency

FDA Food and Drug Administration

HHS Department of Health and Human Services

NIH National Institutes of Health

USDA United States Department of Agriculture

VA Department of Veterans Affairs

Source: GAO analysis of department and agency information. | GAO-16-305

a

The department or component agency reviews policies on an as-needed basis.

Of the three departments with specified review time frames for their 

policies (DOD, DOE, and USDA), we found that only DOD had reviewed 

and updated all department-level policies according to DOD review time 

frames, as of December 2015. Of the seven agencies with specified 

review time frames for their policies—DOD’s Air Force, Army, and Navy; 

HHS’s CDC and NIH; USDA’s Agricultural Research Service; and VA’s 

Veterans Health Administration—only Navy and CDC had reviewed and 

updated all agency-level policies according to their review time frames, as 

of December 2015.26 In addition, for the two departments and three 

agencies that review policies on an as-needed basis—DHS, EPA and its 

Office of Pesticide Programs, HHS’s FDA, and USDA’s APHIS—we 

determined that EPA’s Office of Pesticide Programs and FDA also had

up-to-date policies. We considered these agencies’ policies to be up to 

date because the agencies made them effective in 2015. We were unable 

to determine whether DHS, EPA, and APHIS have up-to-date policies 

because they did not have documented review time frames and their 

policies did not include specific expiration or recertification dates. For 

example, DHS’s two policies, Biosafety and Select Agent and Toxin 

Security, are each dated March 2007 and did not appear to have been 

updated since then. According to DHS officials, the department has 

reviewed these policies periodically since 2007 and has begun to update 

them, but officials did not provide a completion date. EPA officials told us 

that, in calendar year 2016, they expect to finalize new requirements for 

updating safety, health, and sustainability policy orders at least every 3 

years. In addition, APHIS officials told us that they review their policies on 

an as-needed basis whenever changes to regulations occur.

 

26For the purposes of this section of the report, we looked only at whether existing policies 

were up to date. Five component agencies—DOE’s National Nuclear Security 

Administration and Office of Science, DOI’s Fish and Wildlife Service and U.S. Geological 

Survey, and USDA’s Food Safety and Inspection service—did not have any agency-level 

policies for managing biological agents in high-containment laboratories. 
Page 22 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Some of the other departments we reviewed also were reviewing their 

policies as of December 2015. For example, DOD’s policies, 

Safeguarding Biological Select Agents and Toxins and Minimum Security 

Standards for Safeguarding Biological Select Agents and Toxins, were up 

to date at the time of our review, but DOD officials told us that DOD is 

reviewing them following an office reorganization and revisions to select 

agent regulations.27 In this case, we found that DOD’s review has resulted 

in its component agencies waiting to update their policies until after the 

department has completed its reviews and updates. For example, Army’s 

policy Biological Surety, dated July 2008, states that it is to be updated 

every 3 years, and, therefore, we considered it to be not up to date. Army 

officials told us that the Army was currently reviewing the policy. 

However, because the Army policy implements DOD policy, Army officials 

said that the service would complete its review after DOD’s revised policy 

was finalized. In addition, VA’s Veterans Health Administration is also 

reviewing its policies, but officials were unable to tell us when they would 

be finalized. Officials told us that hiring freezes and staff vacancies have 

affected the agency’s ability to update its policies according to their 

recertification dates. 

Federal internal control standards state that agencies should accurately 

document internal control activities, such as reviews and updates of their 

policies.28 Regular reviews and any needed updates would help 

departments and agencies ensure that their policies are current and 

address any new emerging threats, improved scientific understanding of 

hazardous biological agents, and lessons learned from reviews of safety 

lapses at high-containment laboratories.

 

27According to DOD officials, the review will streamline Safeguarding Biological Select 

Agents and Toxins and Minimum Security Standards for Safeguarding Biological Select 

Agents and Toxins into one policy document.

28GAO/AIMD-00-21.3.1 and GAO-14-704G. 
Page 23 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Departments and agencies were using inspections as the primary activity 

to oversee the management of hazardous biological agents in highcontainment laboratories. However, some departments and agencies did 

not routinely report the results of these inspections and other oversight 

activities to senior department or agency officials.

We found that as of December 2015, the 8 departments and 14 agencies 

we reviewed were using inspections or audits as the primary activity to 

oversee the management of hazardous biological agents in highcontainment laboratories, and some department and agencies were also 

using additional oversight activities.29 Additional oversight activities 

included reviewing training records and verifying laboratories’ inventory of 

hazardous biological agents, both of which may occur as part of 

inspection or audit activities. Some departments and agencies were also 

analyzing safety data—including inspection results and incident reports—

to identify trends or recurring issues in laboratory safety or security. See 

table 4 for an overview of department and agency activities for overseeing 

the management of hazardous biological agents in high-containment 

laboratories as of December 2015.

 

29We excluded DOE’s Office of Science from this part of our review because the agency 

has not operated its laboratory at a high-containment level since 2006; this exclusion 

reduced the number of agencies for which we reviewed oversight activities from 15 to 14.

Departments and 

Agencies Use 

Inspections as Their 

Primary Oversight 

Activity, but Results 

Are Not Routinely 

Reported to Senior 

Officials

Departments and 

Agencies Use Inspections 

as the Primary Activity to 

Oversee the Management 

of Hazardous Biological 

Agents in HighContainment Laboratories
Page 24 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Table 4: Department and Agency Activities Used to Oversee the Management of Hazardous Biological Agents in HighContainment Laboratories, as of December 2015

Department

Agency

Routine inspections 

or audits

Training 

records review 

Inventory 

verification

Trend analysis of 

inspection results or 

incident reports

DHS  a a 

DOD —b — c —

Air Force  a a 

Army  a a d

Navy  a a —

DOE —e — — —

National Nuclear Security Administration   a 

DOI —e — — — 

Fish and Wildlife Service    —

U.S. Geological Survey  a a —

EPA  — — 

Office of Pesticide Programs    —

HHS — — — —

CDC  a  

FDA    

NIH  a a 

USDA f —  —

APHIS —g —  

Agricultural Research Service  a  

Food Safety and Inspection Service  a  

VA — — — — 

Veterans Health Administration  a a 

Departments (count) 3 1 3 2

Agencies (count) 13 13 14 10

Legend:

 Department or agency conducted activity. 

— Department or agency did not conduct activity. 

APHIS Animal and Plant Health Inspection Service

CDC Centers for Disease Control and Prevention

DHS Department of Homeland Security

DOD Department of Defense

DOE Department of Energy

DOI Department of the Interior

EPA Environmental Protection Agency

FDA Food and Drug Administration

HHS Department of Health and Human Services

NIH National Institutes of Health

USDA United States Department of Agriculture

VA Department of Veterans Affairs

Source: GAO analysis of department and agency information | GAO-16-305
Page 25 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

a

This activity was conducted during regular inspections and audits.

b

The department delegated responsibility for conducting laboratory inspections to its agencies.

c

The department assessed its inventory of select agents only; officials said the department has no 

plans to assess the inventory of non-select agents.

d

The agency conducted trend analyses of incident reports but did not analyze inspection results.

e

The department did not conduct formal, periodic laboratory inspections but may evaluate some 

laboratory activities as part of broader reviews of the overall program under which the laboratory 

resides.

f

The department’s inspections of high-containment laboratories were primarily focused on securityrelated issues, such as access to the facility, facility security systems, and security operations and 

administration.

g

The agency conducted inspections but not on a routine schedule.

Inspections. We found that 3 of the 8 departments and 13 of the 14 

agencies with currently operating high-containment laboratories inspected

or audited their high-containment laboratories on a routine basis. 

Inspections help departments and agencies determine whether laboratory 

personnel are following policies for managing hazardous biological 

agents, as well as identify any deficiencies or areas for improvement. For 

example, according to agency officials, CDC conducted annual 

inspections of its high-containment laboratories that consisted of 

walkthroughs of laboratory spaces, surveys of laboratory personnel, and 

reviews of the safety procedures outlined in laboratory biosafety manuals. 

Officials from the remaining agency—USDA’s APHIS—told us that the 

agency’s inspections have not occurred on a routine basis because the 

frequency of the inspections has depended in part on the availability of 

travel funds. APHIS officials initially told us that the agency planned to 

formalize its laboratory inspection process, and in February 2016, officials 

reported that APHIS had established a regular inspection schedule.

For the five departments that did not conduct routine inspections of their 

high-containment laboratories, we found that their component agencies 

conducted these routine inspections. DOD had policies that required 

laboratory inspections but delegated responsibility for conducting these 

inspections to its agencies (Air Force, Army, Navy), all of which 

conducted regular inspections. DOE, DOI, HHS, and VA did not have 

policies explicitly requiring laboratory inspections. Rather, these four 

departments left responsibility for conducting inspections to the discretion 

of their component agencies, all of which conducted routine inspections.30

 

30These component agencies were DOE’s National Nuclear Security Administration; DOI’s 

Fish and Wildlife Service and U.S. Geological Survey; HHS’s CDC, FDA, and NIH; and 

VA’s Veterans Health Administration.
Page 26 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

DOE and DOI officials told us that the departments may include audits of 

their high-containment laboratories as part of broader reviews of 

programs under which laboratories reside, in addition to any laboratory 

inspections their agencies conduct. For example, DOE officials told us 

that the department may audit any safety and health program when the 

need arises, separate from the routine inspections conducted by its 

component agency. DOE officials said that, as of December 2015, the 

department was auditing all of its laboratories that conduct biological 

research, including the high-containment laboratory operated by DOE’s 

National Nuclear Security Administration. Additionally, DOI officials told 

us that the department’s triennial evaluations of its component agencies 

could include spot-checks of their high-containment laboratories; 

however, officials said that DOI’s triennial evaluations conducted to date 

have not included any laboratory spot-checks. 

Review of training records. We found that 1 of the 8 departments and 

13 of the 14 agencies routinely reviewed training records to monitor 

whether personnel were completing laboratory training intended to 

reinforce policies for managing hazardous biological agents. These 

departments and agencies typically reviewed training records during 

inspections. However, officials with one agency—HHS’s FDA—told us 

that this review occurred outside of inspections; details related to training 

compliance were included in a certified annual report prepared by each of 

the agency’s centers and submitted to FDA’s designated safety and 

health official. Officials with another agency—DOI’s Fish and Wildlife 

Service—said that the agency verified training records before it allowed 

personnel to work in its high-containment laboratory. In contrast, officials 

from one agency—USDA’s APHIS—told us that they could use USDA’s 

electronic training system—through which APHIS makes training, 

including laboratory training, available to all APHIS personnel—to monitor 

whether personnel were completing this training. However, we could not 

determine whether APHIS was doing so, and USDA officials told us that 

the department did not track the completion of laboratory training taken by 

APHIS personnel. The lack of oversight for laboratory training is 

inconsistent with federal internal control standards that state that 

management should establish and operate activities to monitor the 

internal control system.31 APHIS officials said that laboratory supervisors 

have been responsible for assigning and tracking laboratory training, and 

facility biosafety officers may have access to training documentation. 

 

31GAO/AIMD-00-21.3.1 and GAO-14-704G. 
Page 27 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

However, APHIS officials told us that the agency intends to include a 

review of training records as part of the formal laboratory inspections that 

the agency is planning. 

Inventory verification. We found that 3 of the 8 departments and all 14 

agencies had mechanisms in place to routinely verify the accuracy of 

laboratories’ biological inventories. These departments and agencies 

verified inventory using mechanisms such as spot-checks of inventory 

during laboratory inspections or by requiring laboratories to annually 

verify their inventory. For example, NIH conducted spot-checks of 

biological inventory as part of its annual inspection process and quarterly 

inventories of stored select agents. FDA and Navy required senior 

laboratory supervisors to submit annual certifications verifying that 

inventory is current and accurate. Officials from 1 of these 3 

departments—DOD—and 5 of these 14 agencies—HHS’s CDC, FDA, 

and NIH; EPA’s Office of Pesticide Programs; and USDA’s Food Safety 

and Inspection Service—told us that the departments and agencies have 

taken steps to strengthen inventory management controls to better 

oversee their inventories of hazardous biological agents. However, DOD 

and 3 of the 5 component agencies—HHS’s CDC and FDA and USDA’s 

Food Safety and Inspection Service—had not fully implemented their 

systems for these controls as of December 2015. For example, in March 

2015, CDC launched a new, centralized electronic specimen 

management system to inventory hazardous biological agents in all of its 

infectious disease laboratories. However, CDC had not made the new 

system available to all of its laboratories; officials said that the agency 

expects to do so within the next 2 years. See table 5 for the steps these 

departments and component agencies have taken to strengthen inventory 

management controls and their progress toward completing these steps.
Page 28 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Table 5: Steps Taken by Certain Departments and Agencies to Strengthen Inventory Management Controls, as of December 

2015

Department

Agency Activity Complete

DOD DOD is working with Air Force, Army, and Navy laboratories to establish a database that 

will centralize the select agent inventory of all DOD laboratories into one system.a Officials 

expect to finalize an implementation schedule for this system by the end of 2015. 

N

EPA

Office of Pesticide 

Programs 

In January 2015, the Office of Pesticide Programs transitioned to a bar-coded inventory 

system to manage its hazardous biological agents.

Y 

In July 2015, the office revised the standard operating procedure that provides guidance 

for establishing the receipt, expiration dates, and disposal of biological inventory used in 

the laboratory.

Y

In August 2015, the office instituted quarterly management reviews of its biological 

inventory.

Y

HHS

CDC In February 2015, CDC developed a new procedure for scientists separating from the 

agency to account for any biological specimens they may have been researching.

Y

In March 2015, CDC launched a centralized electronic system to manage inventory of 

hazardous biological agents in all of CDCs infectious disease laboratories, with plans to 

roll the system out to all of the agency’s laboratories within 2 years.

N 

FDA In October 2015, FDA introduced an electronic inventory control and management system 

to track the agency’s radiological, chemical, and biological materials but does not plan to 

fully implement this system until the first quarter of fiscal year 2017.

N

NIH As of March 2015, NIH implemented a revision to its safety audit inspection checklists that 

include documentation of inventory spot-checks during annual laboratory audits.

Y

In September 2014, NIH established a database to record all hazardous biological agents 

in long-term storage at the agency as a supplement to its existing database for biological 

agents in active use by research staff.

Y

USDA

Food Safety and 

Inspection Service

Food Safety and Inspection Service assigned staff to lead an initiative for all agency 

laboratories to have an electronic system in place for select agent inventory by September 

2016 and an electronic system in place for all biological inventory by September 2017.

N

Legend

CDC Centers for Disease Control and Prevention

DOD Department of Defense

FDA Food and Drug Administration

HHS Department of Health and Human Services

NIH National Institutes of Health

USDA United States Department of Agriculture

Source: GAO analysis of department and agency information | GAO-16-305

a

Officials said that the department has no plans to implement a similar system for its non-select agent 

biological inventory that would still require at least biosafety level 3 containment.
Page 29 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Trend analysis. We found that 2 departments and 10 agencies 

conducted analyses of inspection results or incident reports to identify 

potential trends that may highlight recurring laboratory safety or security 

issues.32 For example, DHS officials said that the department analyzed 

each laboratory inspection and incident report to identify recurring issues 

that needed to be addressed, determine that the necessary corrective 

actions had been implemented, and ensure lessons learned were 

disseminated to laboratory personnel. NIH officials told us that the agency 

collected and analyzed accident and injury data to identify potential trends 

and conducted annual analyses of audit results to identify the most 

common deficiencies. Additionally, officials from USDA’s APHIS and 

Agricultural Research Service said that the agencies investigated all 

incidents and accidents with the goal of identifying causal factors in order 

to prevent recurrence. The Agricultural Research Service communicated 

lessons learned from these investigations broadly throughout the agency, 

including through discussions of incidents during monthly teleconferences 

with laboratory personnel to discuss issues related to biosafety and 

safety, health, and environmental management; presentations at agency 

conferences; and, more recently, through agency safety bulletins. 

Federal internal control standards state that management should assess 

the quality of performance over time and ensure that the findings of audits 

and other reviews are promptly resolved.

33 Of the departments and 

agencies that conducted laboratory inspections, officials from one 

department—USDA—and five agencies—DOD’s Army and Navy, DOI’s 

Fish and Wildlife Service and U.S. Geological Survey, and EPA’s Office 

of Pesticide Programs—said the department and agencies did not 

conduct any trend analyses of the results. USDA officials said that 

although the department conducted inspections, it provided the results to 

its component agencies for any additional analysis and did not conduct 

further analysis of the results. Army officials told us that the agency 

conducted trend analysis of incident reports, though the agency did not 

perform any trend analysis of inspection results, as the agency’s 

assumption had been that the laboratories would review inspection 

results to identify systemic findings that would require remediation. Army 

 

32DOD officials told us that the recent anthrax incident prompted the department to collect 

information on other safety incidents at Air Force, Army, and Navy laboratories. After 

completing its review of the anthrax incident, DOD intends to review these past safety 

incidents to identify potential trends and determine whether the department needs to 

address them. 

33GAO/AIMD-00-21.3.1 and GAO-14-704G. 
Page 30 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

officials said that the agency intends to start publishing a report that will 

identify recurring issues, trends, lessons learned, and best practices, but 

did not say when the agency would begin to publish such a report. 

Officials from DOI’s Fish and Wildlife Service told us that inspections of 

the agency’s one high-containment laboratory identified too few findings 

to perform any trend analyses, while U.S. Geological Survey officials said 

that the agency did not conduct formal analyses of laboratory inspection 

results as they have not historically identified any recurring gaps or 

issues. However, U.S. Geological Survey officials told us that based on 

our review, the agency had identified the lack of any trend analyses of 

inspection results as a potential gap and were developing a process to 

analyze inspection results. Officials from EPA’s Office of Pesticide 

Programs said that laboratory personnel reviewed the results of each 

inspection, but neither the personnel nor the agency conducted formal 

analyses of the results. Officials said that there was little data in the 

inspection reports to analyze, and any issues identified during an 

inspection were usually corrected on the spot and did not recur in 

subsequent inspections. Routinely conducting such analyses would allow 

these departments and agencies to identify trends in laboratory safety 

and security data and determine whether individual lapses are isolated 

incidents or whether they suggest more systemic problems in their 

laboratories’ management of hazardous biological agents.

As of December 2015, senior officials at 5 departments and 8 agencies 

did not routinely receive the results of inspections, and senior officials at 4 

departments did not routinely receive reports of laboratory safety or 

security incidents occurring at agency laboratories.

Department and agency inspection results. Although 3 departments 

and all 14 agencies inspected their high-containment laboratories, they 

did not always report the results of these inspections to senior department 

or agency officials.34 Specifically, of the 3 departments that conducted 

inspections—DHS, EPA, and USDA—we found that only DHS routinely 

reported the results of these inspections to senior department officials.35

 

34For the purposes of this report, “senior officials” refers to department and agency senior 

executive leadership. 

35Officials from EPA and USDA told us that the results of their departments’ inspections of 

high-containment laboratories were reported to senior agency officials but not to senior 

department officials. 

Some Departments and 

Agencies Do Not 

Routinely Report the 

Results of Inspections and 

Other Oversight Activities 

to Senior Officials
Page 31 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Four agencies—DOD’s Air Force, DOI’s Fish and Wildlife Service, EPA’s 

Office of Pesticide Programs, and USDA’s Agricultural Research 

Service—said that they routinely reported inspection results to senior 

agency officials but not to senior department officials. Eight agencies—

DOD’s Army and Navy; DOI’s U.S. Geological Survey; HHS’s CDC, FDA, 

and NIH; and USDA’s APHIS and Food Safety and Inspection Service—

did not routinely report the results of internal inspections to either senior 

agency or senior department officials.36 Only DOE’s National Nuclear 

Security Administration and VA’s Veteran’s Health Administration

routinely reported inspection results to both senior agency and senior 

department officials. For those departments and agencies that delegated 

responsibility for inspections to lower-level offices, these offices may not 

report the results of these inspections to senior officials because the 

department or agency does not require them to do so. For example, DOD 

officials told us that the department did not require its Army, Navy, or Air 

Force high-containment laboratories that are not registered with the select 

agent program to report the results of any agency inspections to DOD 

and has no plans to implement such a requirement. Navy officials said 

that laboratory personnel made the results of inspections available to 

senior agency officials upon request but did not proactively report these 

results to them. FDA’s centers, which are located below the agency level, 

were responsible for conducting laboratory inspections, but according to 

FDA officials, the centers did not share the results of these inspections 

with senior agency officials.37 According to CDC officials, the office that 

conducted inspections of the agency’s laboratories provided the results of 

those inspections to the laboratory supervisor only. However, CDC 

officials said that following the realignment of key laboratory safety 

functions to a newly-created laboratory safety oversight office, 

laboratories will report the results of inspections to senior agency officials 

beginning in January 2016.

 

36Officials from DOD’s Army, DOI’s U.S. Geological Survey, HHS’s NIH, and USDA’s 

APHIS and Food Safety and Inspection Service told us the agencies reported the results 

of inspections on an as-needed basis, such as when the inspection identified significant 

issues at the laboratory. 

37FDA officials said that the agency is exploring creating an ongoing oversight role for the 

agency’s Laboratory Safety Practices and Policies Workgroup, which it established to 

conduct its laboratory sweeps for the White House’s August 2014 safety stand-down. 

Possible oversight roles for the workgroup could include reviewing internal laboratory 

inspection results and conducting its own reviews of FDA’s select agent-registered 

laboratories. However, FDA officials were unable to tell us when it would make a decision 

regarding the workgroup’s oversight role. 
Page 32 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Select agent program inspection results. For those departments and 

agencies that operated laboratories registered with and inspected by the 

select agent program, only DHS and DOE’s National Nuclear Security

Administration routinely reported the results of these inspections to senior 

department and agency officials. Officials from three agencies—DOI’s 

U.S. Geological Survey, HHS’s FDA, and USDA’s Food Safety and 

Inspection Service—told us that the results of select agent inspections 

had not been routinely reported to senior department or agency officials

because there was no requirement for laboratory personnel to do so. 

However, officials from DOI’s U.S. Geological Survey said that the 

agency reported inspection results to senior department and agency 

officials on an as-needed basis, such as when there were significant 

issues identified during the inspection. Similarly, officials from USDA’s 

Food Safety and Inspection Service said that its laboratory reported 

select agent inspection results to senior agency officials on an as-needed 

basis but did not report results to senior department officials because the 

department did not require or request its agencies to report the results of 

select agent inspections to it. FDA officials said that the agency did not 

require or expect its laboratory personnel to submit select agent 

inspection reports to senior agency officials, and HHS officials neither 

received nor requested the results.

DOD’s Air Force, Army, and Navy laboratories routinely reported the 

results of select agent inspections to senior department officials, but not 

all of its agencies also reported the results to senior agency officials. DOD 

officials told us that, following the May 2015 anthrax incident, the 

department began to require Air Force, Army, and Navy laboratories to 

routinely report the results of select agent inspections to senior 

department officials. However, only Air Force laboratories routinely 

reported these results to senior agency officials, and Army and Navy 

laboratories did not. Navy officials said that laboratory personnel did not 

report the results of select agent inspections to senior agency officials, 

but inspection results would be made available up the chain of command 

if requested. Army officials said that the agency’s laboratories reported 

results of select agent inspections to senior agency officials on an asneeded basis, such as when there were significant issues identified 

during the inspection.

Officials from five agencies—HHS’s CDC and NIH, USDA’s Agricultural 

Research Service and APHIS, and EPA’s Office of Pesticide Programs—

told us that the agencies routinely reported the results of select agent 

inspections to senior agency officials. However, they did not report the 

results to senior department officials, either because the department did 

not require the reporting of select agent inspection results to department 
Page 33 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

officials or because of an expectation that providing the results of such 

inspections should be limited to those officials with a “need-to-know” 

basis. For example, officials from CDC and NIH told us that HHS neither 

received nor requested the results of select agent inspections. As 

previously noted, USDA officials said that the department did not require 

or request its agencies to report the results of select agent inspections of 

its registered laboratories. Officials from EPA’s Office of Pesticide 

Programs said that synopses of the results of any select agent 

inspections were included in the laboratory division’s weekly report to 

senior agency officials; however, officials said that inspection results were 

not provided to senior EPA officials because of sensitivity requirements 

imposed by the select agent program. We found that other departments 

and agencies did not cite sensitivity requirements as a reason for not 

reporting the results of select agent inspections to senior officials, and 

these departments and agencies had mechanisms in place specifically to 

share this information with senior officials. For example, DHS has a 

memorandum of understanding with CDC’s and APHIS’s select agent 

offices, through which the results of these inspections were provided to 

department officials with primary laboratory oversight responsibilities. 

DHS officials told us that the DHS office that conducted joint select agent 

inspections then briefed senior DHS officials, such as the department’s 

chief of staff, on the results of the inspection, any corrective actions 

taken, and the implementation of any lessons learned. Senior department 

officials, such as a department administrator, his or her deputy, or chief of 

staff, by virtue of their stature and rank within a department should 

understand the requirements and responsibilities for safeguarding 

sensitive department information.

Laboratory incidents. In addition to inspection results, we found that all 

14 agencies reported laboratory safety and security incidents to senior 

officials within their own agencies, but senior officials at 4 departments—

DOD, DOI, HHS, and USDA—did not routinely receive reports of any 

safety and security incidents that occurred at agency laboratories. As 

noted previously, 2 of these departments—DOI and HHS—did not have 

any department policies for managing hazardous biological agents, or, in 

the case of USDA, departmental policies did not contain requirements for 

incident reporting. HHS officials told us that, while it did not require its 

agencies to report every laboratory incident, the agencies would report 

major incidents to the department. However, HHS did not have a formal 
Page 34 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

definition of what it considers to be major incidents.38 USDA officials said 

that incidents were reported through supervisory channels to senior 

agency officials, who would inform senior department officials as 

necessary; officials agreed that there was no written guidance or directive 

on incident reporting at the department level and that documentation of 

this requirement could be stronger. Additionally, only one of USDA’s 

agencies—Agricultural Research Service—told us that the agency 

routinely reported laboratory incidents to senior department officials. DOI 

officials said that all accidents and illnesses were reported through a 

dedicated DOI system, but also told us there was no guarantee that 

senior officials would receive notice of laboratory incidents through this 

system because the determination of whether an incident should be 

flagged for attention by senior officials depended on the judgment of the 

staff monitoring the system. Instead, officials said that it was likely that 

department officials would hear of high-containment laboratory incidents 

through informal channels.39 DOD had department-level policies that 

contained requirements for laboratory personnel to report incidents to 

their respective senior agency (Air Force, Army, and Navy) officials, but 

these policies required that only serious mishaps be reported to senior 

DOD safety officials.40 DOD officials said that a pending update to its 

biosecurity policy will require laboratories to report all incidents involving 

select agents to the DOD office with primary responsibility for oversight of 

the department’s select agent laboratories, but this requirement will not 

apply to the department’s high-containment laboratories that are not 

registered with the select agent program.

 

38Officials told us that in October 2015, HHS established a biosafety and biosecurity 

council composed of representatives from CDC, FDA, NIH, and other HHS agencies and 

offices. The council is intended to promote interagency coordination and facilitate sharing 

of best practices for biosafety and biosecurity matters. According to officials, the council is 

also considering developing a notification system for laboratory incidents.

39Officials from DOI’s U.S. Geological Survey told us that the agency had a formal 

process in place to notify senior agency and department officials of safety or security 

incidents that occur in a high-containment laboratory. Specifically, such incidents would be 

reported from the laboratory, through U.S. Geological Survey’s headquarters, to DOI 

senior management. U.S. Geological Survey officials also told us the agency was 

finalizing an incident reporting policy that documents this process, with an anticipated 

completion date of no later than January 2016. 

40According to DOD policy, a serious mishap would include an accident that results in 

death, permanent total disability, hospitalization for inpatient care of three or more 

individuals, damage equal to or greater than $2 million, or destroyed aircraft. 
Page 35 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Federal internal control standards call for information to be communicated 

to senior management and others within the entity who need it and in a 

form and within a time frame that enables them to carry out their 

responsibilities.41 Routinely reporting inspection results and laboratory 

incidents to senior officials, as well as regularly analyzing this 

information—consistent with federal internal control standards for 

monitoring—would help these officials identify trends in laboratory safety

and determine whether safety lapses reflect systemic issues. Reporting 

laboratory incidents to senior department officials, regardless of the 

severity, is especially important, as even near misses or potential 

exposures may highlight laboratory deficiencies that, if not addressed, 

could lead to more serious problems that could put the safety or security 

of laboratory personnel and the general public at risk. Additionally, the 

analysis of reported inspection results and laboratory incidents would help 

senior officials take appropriate measures to improve the management of 

hazardous biological agents in their high-containment laboratories, help 

ensure the safety and security of personnel working in these laboratories, 

and could be used to assure Congress and the American people that 

federal officials are working to protect the safety and security of laboratory 

personnel and of the general public.

HHS and DOD were making progress in implementing recommendations 

intended to help them strengthen their policies and oversight for 

managing their high-containment laboratories, among other safety 

activities, from the laboratory safety reviews they conducted after the 

2014 and 2015 safety lapses. However, HHS and DOD had not 

developed specific time frames for implementing some recommendations.

 

41GAO/AIMD-00-21.3.1 and GAO-14-704G. 

HHS and DOD Have 

Made Some Progress 

in Implementing 

Recommendations 

from Laboratory 

Safety Reviews, but 

Have Not Developed 

Sufficient 

Implementation Plans
Page 36 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

HHS component agencies have made varying progress in implementing 

recommendations from their laboratory safety reviews, as of November 

2015 (the date of the most recent information available). CDC reported 

implementing a total of 91 recommendations from 209 recommendations 

made across all of its internal and external reviews. FDA reported 

implementing 6 of 30 recommendations from its external laboratory safety 

review and taking steps to implement others, and NIH reported 

implementing 9 of 10 recommendations from the external laboratory 

safety review of that agency.42 NIH officials said the agency did not plan 

to implement the remaining recommendation because it believed that 

current agency processes adequately addressed the advisory group’s 

concerns. Table 6 lists the number of recommendations included in the 

various HHS laboratory safety reviews and the number of 

recommendations that CDC, FDA, and NIH reported as implemented, as 

of November 2015.

Table 6: Implementation Status of Recommendations from 2014 and 2015 Reviews of the Department of Health and Human 

Services (HHS) Laboratory Safety Programs by Component Agency, as of November 2015 

Review Number of recommendations made

Number of implemented 

recommendations

Centers for Disease Control and Prevention (CDC)

January 2015 external advisory group report 19 10

February 2015 after-action assessment of the Ebola 

safety incident 

8 8

October 2014 internal workgroup report 148a 43

August 2014 after-action assessment of the avian 

influenza safety incident

26 23

July 2014 after-action assessment of the anthrax 

safety incident

8 7

Food and Drug Administration (FDA)

July 2015 external advisory group report 30b 6

National Institutes of Health (NIH)

April 2015 external advisory group report 10 9c

Source: GAO summary of HHS data. | GAO-16-305

a

The internal workgroup made 96 recommendations to CDC, some of which included multiple actions 

or activities. For those recommendations, CDC counted the individual actions and activities as 

separate recommendations.

 

42The agencies were reporting their progress to HHS in monthly status updates.

HHS and DOD Have 

Made Progress in 

Implementing 

Recommendations from 

Laboratory Safety 

Reviews
Page 37 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

b

The advisory group made 27 explicit recommendations to FDA. Officials told us that the agency 

identified three additional, unnumbered recommendations in the text of the group’s findings.

c

NIH considered all recommendations to be implemented. Agency officials told us that NIH is not 

implementing one of the advisory group’s recommendations because officials believe the agency’s 

current processes adequately address the advisory group’s concerns.

As of December 2015 (the date of the most recent information available), 

we found that DOD reported implementing one recommendation from its 

July 2015 report on the anthrax safety lapse and was taking steps to 

implement the remaining 21 recommendations. DOD convened a 

committee to review the May 2015 anthrax incident, which issued a report 

in July 2015 containing 19 recommendations in three overarching areas—

quality assurance, scientific peer review, and program management for 

inactivation and viability testing of anthrax bacteria—and 3 broad 

recommendations related to laboratory procedures for select agents and 

toxins, chains of command, and budgets. For example, DOD’s July 2015 

report on the anthrax incident found that laboratory practices across the 

department were inconsistent and recommended that DOD review its 

laboratory chains of command and pursue consistent safety practices. In 

the same month, DOD issued a departmental memorandum assigning 

responsibility for implementing the committee’s recommendations to DOD 

senior offices and the Secretary of the Army, including for the Secretary 

to develop an implementation plan. The memo also tasked DOD and 

Army with additional activities, such as reviewing and revising as 

necessary DOD’s biosafety and biosecurity policies and ensuring their 

consistent application across DOD laboratories and assessing the optimal 

distribution of research, development, and production of medical 

countermeasures at DOD’s biological and chemical laboratories. As of 

December 2015, Army reported implementing the recommendation to 

review laboratory missions and chains of command and provide 

appropriate policy and organizational recommendations to ensure 

consistent application of biosafety and biosecurity across all of its 

laboratories. Army also reported developing recommendations of 

proposed alternatives to the distribution of medical countermeasure 

research, development, and production across all of its agencies’ 

laboratories. DOD has not fully implemented any of the 19 quality 

assurance, peer review, or program management recommendations but 

has convened DOD and Army workgroups that are taking steps to do so. 

For example, for the quality assurance recommendation to standardize 

anthrax inactivation procedures across all DOD laboratories, DOD has 

developed a scientific study plan, which was undergoing final review at 

the time of this report, and anticipates beginning those studies in 

February 2016.
Page 38 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

DOD was also taking other steps generally to address weaknesses in 

laboratory safety that were not outlined in its July 2015 report or in its 

implementation plan. We previously reported on DOD’s preliminary 

progress in addressing weaknesses in the management of its highcontainment laboratories and found that DOD had begun revising some 

policies, such as its select agent security policy, to address these 

weaknesses prior to the July 2015 review but had not finalized them prior 

to the May 2015 anthrax safety lapse.43 According to officials, DOD plans 

to finalize its select agent security policy by the end of 2015. However, 

DOD officials told us that the department plans to make further revisions 

to this policy as a result of the anthrax safety lapse after the first set of 

revisions are finalized, but DOD did not know when it would finalize these 

subsequent changes.

Some actions taken by HHS’s component agencies and DOD to address 

laboratory safety review recommendations—such as FDA’s 

implementation of an electronic inventory system capable of tracking the 

agency’s radiological, chemical, and biological material—address 

oversight activities for management of high-containment laboratories that 

we identified previously in this report. Other recommendations, such as 

for CDC to establish an agency-wide standardized safety curriculum, 

address other gaps in departments’ and agencies’ laboratory 

management. Table 7 provides additional information on HHS’s and 

DOD’s safety reviews and examples of the resulting recommendations 

from these reviews.

 

43GAO, High-Containment Laboratories: Preliminary Observations on Federal Efforts to 

Address Weaknesses Exposed by Recent Safety Lapses, GAO-15-792T (Washington, 

D.C.: July 28, 2015). 
Page 39 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Table 7: Examples of Recommendations from the 2014 and 2015 Reviews of the Department of Health and Human Services 

(HHS) and Department of Defense (DOD) Laboratory Safety Programs

Review Recommendation areas

Example of recommendations from 

laboratory safety reviews

HHS laboratory safety reviewsa

Centers for Disease Control and 

Prevention (CDC) January 2015 

external advisory group report

To address the findings in its report, the 

external advisory group made

recommendations in 7 areas, including areas of 

particular relevance to our review: leadership, 

training, and accountability. Some of the 

advisory group’s findings and recommendations 

echoed the findings and recommendations from 

CDC’s October 2014 internal workgroup report, 

such as those recommendations in the areas of 

leadership and training.

Establish a CDC brand and communicate, from 

the top down, a “CDC Way” that is the 

performance of responsible science practiced in 

a consistently safe manner. As part of this 

effort, better mechanisms should be established 

for sharing information about safety incidents 

across CDC to promote transparency at all 

levels.

Establish a standardized, agency-wide 

laboratory safety curriculum.

CDC October 2014 internal 

workgroup report

As a result of its review, the advisory group 

found weaknesses in six functional areas, 

including areas of particular relevance to our 

review: leadership, staffing, and organizational 

structure; policy, authority, and enforcement; 

and training and education. To address its 

findings, the internal workgroup made 

recommendations in 31 areas to improve safety 

and CDC’s management of its laboratories—

including areas such as exercising authority and 

providing leadership for laboratory science and 

safety, establishing and enforcing agency safety 

policies, and leading and monitoring world-class 

training. The recommendations were targeted to 

specific CDC offices and divisions, and 14 

recommendations included multiple actions or 

activities.

Establish and implement a laboratory safety 

strategic plan that (1) defines tangible safety 

and quality objectives; (2) focuses on high 

quality, sustainable safety initiatives; and (3) 

ensures implementation and sustainability of 

new safety and quality initiatives.

Improve data management systems including 

those for training and competency records, 

equipment maintenance and monitoring, and 

specimen inventory, and make systems 

electronic, integrated, user-friendly, flexible, 

fast, and accessible.

Food and Drug Administration 

(FDA) July 2015 external advisory 

group report

To address the findings in its July 2015 report 

on FDA’s laboratory safety program, the 

external advisory group made 

recommendations to the agency in areas such 

as laboratory safety leadership, inventory 

management, training, and communication.

Establish a single electronic biological inventory 

system throughout the agency.

Increase the visibility of signs and phone 

numbers that people can use to call with any 

safety concerns.

National Institutes of Health (NIH) 

April 2015 external advisory group 

report

To address the findings in its April 2015 report 

on NIH’s laboratory safety program, the external 

advisory group made recommendations in 

areas such as governance and staff recognition, 

responsibilities and processes for conducting 

risk assessments, and competency testing and 

documentation.

Develop a laboratory safety survey tool to 

accurately gauge areas for improvement in 

laboratory and research safety programs 

currently and over time.

Establish regular opportunities and mechanisms 

to improve communications between laboratory 

managers across NIH.

DOD laboratory safety review
Page 40 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Review Recommendation areas

Example of recommendations from 

laboratory safety reviews

DOD July 2015 committee report To address its findings, the committee made 

detailed recommendations in three areas: (1) 

enhancement of quality assurance, (2) more 

extensive scientific peer review processes, and 

(3) improvements in program management for 

anthrax inactivation and validation testing. In 

addition to these recommendations, the 

committee also recommended that DOD review 

all laboratory procedures for select agents and 

that Army, Navy, and the Office of the Secretary 

of Defense review their chains of command and 

pursue consistent safety practices.b

Army, Navy, and Office of the Secretary of 

Defense should review the chain of command 

and pursue consistent safety practices.

In the area of quality assurance, establish and 

manage an environmental surface sampling 

program and develop procedures for 

laboratories to document, investigate, and 

report contamination found outside primary 

containment areas during environmental 

sampling. The procedures, at a minimum, 

should include notification protocols, including 

notification of the safety manager of that 

location, results and follow-up actions taken.

Source: GAO summary of HHS and DOD information. | GAO-16-305

a

We excluded from this table the three after-action assessments of laboratory safety incidents 

(anthrax, Ebola, and avian influenza) that CDC conducted during this period because many of these 

recommendations were specific to the individual laboratories in which the incidents occurred.

b

In July 2015, DOD issued a departmental memorandum assigning responsibility for implementing the 

committee’s recommendations to the Under Secretary of Defense for Acquisition, Technology, and 

Logistics and the Secretary of the Army. The memo also tasked Army with additional activities, such 

as assessing the optimal distribution of research and development at DOD’s biological and chemical 

laboratories. Army, as directed by DOD, developed implementation plans in August 2015 to address 

the internal committee’s recommendations in its May 2015 report and additional activities included in 

the July 2015 memorandum.

HHS and DOD have developed planning documents to track and manage 

implementation of the recommendations from laboratory reviews, but 

CDC’s, DOD’s, and Army’s planning documents lack some time frames 

for implementing these recommendations. CDC and DOD officials told us 

that they plan to address all of the recommendations from the safety 

reviews. CDC has developed time frames for implementing open 

recommendations from the January 2015 external advisory group report 

and CDC’s July 2014 anthrax, August 2014 avian influenza, and February 

2015 Ebola after-action assessments but has not developed time frames 

for implementing the recommendations from the agency’s October 2014 

internal working group report. DOD’s and Army’s implementation plans for 

the recommendations made in the July 2015 report include time frames 

for the three overarching areas in which the internal workgroup made 

recommendations—quality assurance, scientific peer review, and 

program management for inactivation and viability testing of anthrax 

bacteria—as well as for the additional tasks assigned to DOD and Army, 

such as reviewing and revising as necessary DOD’s biosafety and 

biosecurity policies. However, the DOD and Army implementation plans 

and other planning documents do not include time frames for each of the 

HHS and DOD Planning 

Documents Lack Some 

Time Frames for 

Implementing 

Recommendations from 

Laboratory Safety 

Reviews
Page 41 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

detailed 19 recommendations in the three areas. DOD officials told us 

that the Army workgroup is responsible for overseeing the implementation 

of only some of the 19 recommendations, while senior DOD workgroups 

are responsible for overseeing the implementation of the remaining 

recommendations. Officials also said that DOD is unable to establish time 

frames for certain recommendations because their completion is 

dependent upon the success of the research into inactivation and related 

procedures called for in them. However, some of the 19 

recommendations do not require the completion of research studies. For 

example, one quality assurance recommendation calls for DOD to 

establish an environmental surface sampling program to establish written 

laboratory procedures to document, investigate, and report contamination 

found outside of primary containment areas. Another recommendation, in 

the area of program management for anthrax inactivation, calls for DOD 

to establish an oversight group to ensure effective and persistent 

implementation of corrective actions by actively engaging in tracking 

standards, processes, and procedures throughout department 

laboratories.

CDC’s, DOD’s, and Army’s lack of implementation plans with time frames 

for all recommendations is inconsistent with federal internal control 

standards for monitoring that state that departments and agencies should 

establish policies and procedures for ensuring that the findings of audits 

and other reviews are promptly resolved.44 These standards also state 

that managers should promptly evaluate findings from audits and other 

reviews and determine proper actions in response to those findings and 

subsequent recommendations. In addition, the Project Management 

Institute’s The Standard for Program Management calls for development 

of timelines and milestones as a leading practice to ensure organizational 

activities are completed.45 Developing plans that include specific time 

frames would provide CDC, DOD, and Army with assurance that they can 

implement recommendations and associated activities in a timely manner 

to fully address weaknesses identified during safety reviews and 

determine whether they are making progress, including identifying any 

potential barriers to implementation.

 

44GAO/AIMD-00-21.3.1 and GAO-14-704G. 

45See Project Management Institute, The Standard for Program Management, 3rd ed. 

(Newton Square, Pa.: 2013). 
Page 42 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

The safety lapses of 2014 and 2015 continue to raise questions about the 

adequacy of federal policies for managing hazardous biological agents in 

high-containment laboratories and department and agency oversight 

activities, including appropriate levels of senior management involvement. 

Given the threat that hazardous biological agents pose to public and 

animal health and the U.S. economy, federal departments and agencies 

need to strengthen oversight of their high-containment laboratories. To 

that end, federal reviews—including those by HHS, DOD, and the White 

House—have made recommendations intended to strengthen federal and 

national oversight. These recommendations are an important step in 

addressing the weaknesses identified in the 2014 and 2015 safety lapses.

Nonetheless, we continued to find certain deficiencies in departments’ 

and agencies’ internal controls for the management of their highcontainment laboratories, as well as opportunities for improvement. Most 

of the 8 departments and 15 agencies we reviewed had policies for 

management of their high-containment laboratories, but the policies were 

not comprehensive because they lacked key safety elements or did not 

apply to all high-containment laboratories. In addition, most departments 

and agencies have not kept their policies up to date, so that the most 

recent safety guidance, protocols, or improvements may not be 

incorporated into department or agency management practices. 

Moreover, departments and agencies used inspections as their primary 

activity to oversee their laboratories’ handling of hazardous biological 

agents, but inspection findings and necessary corrective actions were not 

routinely transmitted to senior officials, who could use them to identify 

trends and ensure that improvements to the management of biosafety 

and biosecurity are implemented across all of their high-containment 

laboratories. In the absence of up-to-date policies for managing these 

agents that include all six of the key elements we identified, routine 

oversight of laboratories’ compliance with these policies through regular 

inspections, and analysis of safety data to identify trends, departments 

and agencies cannot assure the safety of laboratory personnel and the 

public, and help prevent the loss, theft, or misuse of hazardous biological 

agents. Furthermore, absent routine reporting of the results of inspections 

and trend analyses, senior department and agency officials are hindered 

in their ability to recognize when individual safety lapses that appear to be 

isolated incidents point to systemic weaknesses and thus to identify 

needed improvements and corrective actions.

In addition, although HHS and DOD are making progress in implementing 

the recommendations to improve their laboratory safety programs 

resulting from reviews of the 2014 and 2015 safety lapses, they have not 

developed time frames for all of these recommendations. Without 

Conclusions
Page 43 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

implementation plans that include time frames, their ability to gauge 

performance and track progress toward implementing these important 

improvements will be hampered.

To ensure that federal departments and agencies have comprehensive 

and up-to-date policies and stronger oversight mechanisms in place for 

managing hazardous biological agents in high-containment laboratories 

and are fully addressing weaknesses identified after laboratory safety 

lapses, we are making the following 33 recommendations.

We recommend that the Secretary of Agriculture

• revise existing department policies for managing hazardous 

biological agents in high-containment laboratories to contain 

specific requirements for reporting laboratory incidents to senior 

department officials, including the types of incidents that should be 

reported, to whom, and when, or direct the Administrator of the 

Food Safety and Inspection Service to develop agency policies 

that contain these requirements;

• review and update outdated department policies for managing 

hazardous biological agents in high-containment laboratories and 

direct the Administrators of APHIS and Agricultural Research 

Service to update their policies and, in the case of APHIS, 

establish a regular review schedule;

• routinely analyze results of the department’s laboratory 

inspections and incident reports to identify potential trends that 

may highlight recurring laboratory safety or security issues and 

share lessons learned with laboratory personnel;

• require routine reporting of the results of department, agency, and 

select agent laboratory inspections to senior department officials; 

and

• require routine reporting of incidents at agency laboratories to 

senior department officials.

We recommend that the Secretary of Defense

• revise existing department policies for managing hazardous 

biological agents in high-containment laboratories to contain 

Recommendations for 

Executive Action
Page 44 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

specific requirements for inventory control for all of DOD’s highcontainment laboratories, not just for its select agent-registered 

laboratories, or direct the Secretaries of the Air Force, Army, and 

Navy to revise their existing, respective policies to contain these 

requirements;

• direct the Secretaries of the Air Force and Army to review and 

update their respective outdated policies for managing hazardous 

biological agents in high-containment laboratories;

• routinely analyze agencies’ inspection results and incident reports 

to identify potential trends that may highlight recurring laboratory 

safety or security issues and share lessons learned with 

laboratory personnel, or direct the Secretaries of the Army and 

Navy to do so;

• require routine reporting of the results of Air Force, Army, and 

Navy inspections of non-select agent registered laboratories to 

senior department officials;

• require routine reporting of laboratory incidents at Air Force, Army, 

and Navy non-select agent registered laboratories to senior 

department officials;

• direct the Secretaries of the Army and Navy to require reporting of 

agency and select agent laboratory inspection results to senior 

agency officials; and

• develop time frames for the 19 specific recommendations from the 

July 2015 review, or direct the Secretary of the Army to do so.

We recommend that the Secretary of Energy

• revise existing department policies for managing hazardous 

biological agents in high-containment laboratories to contain 

specific requirements for inspections, or direct the Administrator of 

the National Nuclear Security Administration and the Director of 

the Office of Science to develop agency policies that contain this 

requirement; and

• review and update its outdated policies for managing hazardous 

biological agents in high-containment laboratories.
Page 45 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

We recommend that the Administrator of EPA

• revise existing EPA policies for managing hazardous biological 

agents in high-containment laboratories to contain specific 

requirements for inventory control, or direct the Director of the 

Office of Pesticide Programs to incorporate this requirement into 

its policy; 

• review and update EPA’s outdated policies for managing 

hazardous biological agents in high-containment laboratories and 

establish a regular schedule for reviewing and updating EPA and 

Office of Pesticide Programs policies; and

• require routine reporting of the results of department, agency, and 

select agent laboratory inspections to senior department officials.

We recommend that the Secretary of Health and Human Services

• develop department policies for managing hazardous biological 

agents in high-containment laboratories that contain specific 

requirements for reporting laboratory incidents to senior 

department officials, including the types of incidents that should be 

reported, to whom, and when, or direct the Director of CDC and 

the Commissioner of FDA to incorporate these requirements into 

their respective policies;

• develop department policies for managing hazardous biological 

agents in high-containment laboratories that contain specific 

requirements for training and inspections for all high-containment 

component agency laboratories and not just for their select-agentregistered laboratories; or direct the Director of CDC to provide 

these requirements in agency policies;

• direct the Director of NIH to review and update the agency’s 

outdated policies for managing hazardous biological agents in 

high-containment laboratories;

• direct the Commissioner of FDA to establish a regular schedule 

for reviewing and updating agency policies for managing 

hazardous biological agents in high-containment laboratories;

• require routine reporting of the results of agency and select agent 

laboratory inspections to senior department officials;
Page 46 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

• direct the Director of NIH and the Commissioner of FDA to require 

routine reporting of the results of agency laboratory inspections—

and in the case of FDA, require routine reporting of select agent 

inspection results—to senior agency officials;

• require routine reporting of incidents at CDC, FDA, and NIH 

laboratories to senior department officials; and

• direct the Director of CDC to develop time frames for the 

recommendations from the internal workgroup review.

We recommend that the Secretary of Homeland Security

• revise existing policies for managing hazardous biological agents 

in high-containment laboratories to contain specific requirements 

for inventory control that would apply to all high-containment 

laboratories, not just select agent-registered laboratories; and

• review and update its outdated policies for managing highcontainment laboratories and establish a regular schedule for 

reviewing and updating these policies.

We recommend that the Secretary of the Interior

• develop department policies, or direct the Directors of Fish and 

Wildlife Service and U.S. Geological Survey to develop agency 

policies for managing hazardous biological agents in highcontainment laboratories that contain specific requirements for 

reporting laboratory incidents to senior department officials—

including the types of incidents that should be reported, to whom, 

and when—and specific requirements for roles and 

responsibilities, training, inventory control, and inspections;

• routinely analyze the results of the agency’s laboratory inspections 

and incident reports to identify potential trends that may highlight 

recurring laboratory safety or security issues and share lessons 

learned with laboratory personnel, or direct the Directors of Fish 

and Wildlife Service and U.S. Geological Survey to do so;

• require routine reporting of the results of agency and select agent 

inspections to senior department officials; and
Page 47 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

• direct the Director of the U.S. Geological Survey to require routine 

reporting of the results of agency and select agent laboratory 

inspections to senior agency officials.

We recommend that the Secretary of Veterans Affairs

• develop department policies for managing hazardous biological 

agents in high-containment laboratories that contain specific 

requirements for reporting laboratory incidents to senior 

department officials—including the types of incidents that should 

be reported, to whom, and when—and requirements for inventory 

control for all of its high-containment laboratories, including its 

select agent-registered clinical laboratory, or direct the Under 

Secretary of Health to incorporate these requirements into its 

policies; and

• direct the Under Secretary of Health to review and update 

outdated agency policies for managing hazardous biological 

agents in high-containment laboratories.

We sent draft copies of this report to the eight departments in our review. 

Written responses from these departments are reprinted in appendixes IV 

through XI. Of the eight departments to which we made 

recommendations, six (DHS, DOD, DOI, HHS, USDA, and VA) generally 

agreed with all of our recommendations for them. The remaining two 

departments (DOE and EPA) did not believe that further action was 

needed to respond to some of the recommendations directed to them. In 

addition, DHS provided clarifying information, HHS provided additional 

information on its laboratory oversight activities, and USDA and VA 

provided information regarding specific actions they have taken or plan on 

taking to address portions of our recommendations. In cases in which 

departments also provided technical comments, we incorporated them as 

appropriate.

DOE disagreed that further action was needed for our recommendation to 

incorporate requirements for inspections into its department or agency 

policies. DOE stated that its current policies, including departmental 

orders and regulations, provide it with the authority to conduct inspections 

of both department and contractor laboratories as the department deems 

necessary and appropriate and take action in cases of noncompliance. 

However, the DOE orders are for overarching department oversight, and 

we believe that the language DOE cited in the policies, orders, and 

regulations is broad. This language may allow for DOE and its 

Agency Comments 

and Our Evaluation
Page 48 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

components to conduct inspections, but it does not provide specific 

requirements for inspection frequency; nor is the order specific to 

managing biological agents in high-containment laboratories. As we state 

in the report, inspections help departments and agencies determine 

whether laboratory personnel are following policies for managing 

hazardous biological agents, as well as identify any deficiencies or areas 

for improvement. Therefore, we maintain that DOE should incorporate 

more specific requirements for laboratory inspections—for example, how 

often they should be conducted and processes for managing their results 

and resolving any deficiencies identified during these inspections—into 

DOE policies or regulations for managing high-containment laboratories.

EPA disagreed that further action was needed for our recommendations 

to include specific requirements for inventory control and to review and 

update policies for managing hazardous biological agents in highcontainment laboratories. EPA believes it has current policies that comply 

with these recommendations and provided us with additional information 

to support its belief. We updated our analysis to include the Office of 

Pesticide Programs policy that EPA provided. This policy contains 

requirements for two of the elements we identified as key in our review—

roles and responsibilities and training. Accordingly, we revised our 

recommendation to EPA to reflect this information. We determined that 

the other policies EPA provided were laboratory-level policies, 

procedures, or protocols and, hence, did not provide department or 

agency-level requirements for managing hazardous biological agents in 

all high-containment laboratories within EPA or the Office of Pesticide 

Programs. In addition, EPA reported that its inventory control policy 

requirement was complete given the Office of Pesticide Programs’ 

inventory control program. However, EPA was silent on any plans to 

incorporate inventory control requirements into EPA or Office of Pesticide 

Programs policy. We maintain that EPA should incorporate the missing 

inventory control element into overarching, up-to-date EPA or Office of 

Pesticide Programs policies to document key requirements in order to 

demonstrate support for laboratory safety from senior EPA or Office of 

Pesticide Programs officials. 

In response to our draft recommendation to revise existing policies to 

include requirements for inspections and inventory control, DHS provided 

clarifying information to show that its policies contained requirements for 

inspections. We updated our analysis to reflect this information and 

revised our recommendation to DHS accordingly. 

In its written response, HHS provided additional information about the 

goals and responsibilities of its intradepartmental biosafety and 
Page 49 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

biosecurity council, which HHS established in October 2015. HHS 

reported that the council will work with CDC, FDA, and NIH to determine 

appropriate criteria and procedures for reporting incidents to HHS, as well 

as assess whether department-wide incident reporting policies could be 

modeled on agency policies. In addition, HHS stated that the council will 

work with CDC to determine appropriate criteria and procedures for 

reporting inspection results to HHS, and FDA plans to submit inspection 

findings annually to HHS as part of the regulatory compliance and 

assurance program the agency plans to establish. However, HHS was 

silent on whether it will require NIH to report the results of its laboratory 

inspections to senior agency officials, and the results of select agent 

inspections to senior department officials; as we found in the report, NIH’s 

current practice is to notify only senior agency officials of select agent 

inspections and their results. We maintain that the reporting of all 

inspection results to senior agency and department officials is important, 

especially in light of the HHS biosafety and biosecurity council’s planned 

efforts to coordinate and improve biosafety and biosecurity standards and 

activities across the department and its plans for CDC and FDA to share 

inspection results routinely with HHS. HHS also provided us with an 

updated report on the progress CDC has made in implementing the 

recommendations from its internal workgroup review as of the beginning 

of February 2016.

In response to our draft recommendation that USDA revise existing 

department policies to contain specific requirements for reporting

laboratory incidents to senior department officials or direct the 

Administrator of APHIS to do so, APHIS provided its updated biosafety 

policy, issued February 2016, which contains the incident reporting key 

element and the other five elements that we identified as key for 

laboratory management. Accordingly, we revised our recommendation to 

USDA. In response to the recommendation for USDA to direct the 

Administrator of the Food Safety and Inspection Service to incorporate 

requirements for incident reporting into its policies if the department does 

not, USDA stated that because the Food Safety and Inspection Service’s 

high-containment laboratory was registered with the select agent 

program, it was therefore required by the select agent regulations to have 

policies at the laboratory level. However, USDA was silent on its plans to 

incorporate requirements for incident reporting into either department or 

Food Safety and Inspection Service policy. We maintain that it is 

important for the department to document key requirements in 

overarching department or agency policies in order to demonstrate 

support for laboratory safety from senior department officials. USDA also 

provided information on the steps APHIS is taking that address our other 

recommendations, such as routinely reporting the results of laboratory 
Page 50 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

inspections and incidents to senior department officials. However, USDA 

was silent on steps it is taking for three of our recommendations—for the 

department to routinely analyze laboratory inspections and incident 

reports to identify potential trends across the department, require routine 

reporting of the results of laboratory inspections to senior department 

officials, and require routine reporting of laboratory incidents to senior 

department officials. We reiterate that USDA should implement these 

recommendations that are intended to establish and strengthen 

consistent department oversight of laboratory safety across all USDA 

agencies.

In response to our recommendation to update Veterans Health 

Administration policies, VA reported that the Veterans Health 

Administration updated its agency-level policy for management of its 

clinical laboratories in January 2016 and shared a copy of the updated 

policy with us. However, VA did not provide further information on when 

the Veterans Health Administration plans to finalize agency policies for its 

research laboratories. We believe that the Veterans Health Administration 

should also update its outdated policies for its research laboratories in a 

timely manner.

As agreed with your offices, unless you publicly announce the contents of

this report earlier, we plan no further distribution until 30 days from the 

report date. At that time, we will send copies to the Secretaries of 

Agriculture, Defense, Energy, Health and Human Services, Homeland 

Security, Interior, and Veterans Affairs; and the Administrator of EPA. In 

addition, the report is available at no charge on the GAO website at 

http://www.gao.gov. 

If you or your staff have any questions concerning this report, please 

contact Marcia Crosse, Director, Health Care at (202) 512-7114 or 

crossem@gao.gov or John Neumann, Director, Natural Resources and 

Environment at (202) 512-3841 or neumannj@gao.gov. Contact points for 

our Offices of Congressional Relations and Public Affairs may be found 

on the last page of this report. GAO staff who made key contributions to 

this report are listed in appendix XII. 

Marcia Crosse

Director, Health Care
Page 51 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

John Neumann

Director, Natural Resources and Environment
Page 52 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

List of Requesters

The Honorable Fred Upton

Chairman

The Honorable Frank Pallone, Jr.

Ranking Member

Committee on Energy and Commerce

House of Representatives

The Honorable Tim Murphy

Chairman

The Honorable Diana DeGette

Ranking Member

Subcommittee on Oversight and Investigations

Committee on Energy and Commerce

House of Representatives

The Honorable Joseph R. Pitts

Chairman

Subcommittee on Health

Committee on Energy and Commerce

House of Representatives
Appendix I: Department of Health and Human 

Services Laboratory Oversight during the 2014 

Smallpox Safety Incident

Page 53 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

In July 2014, decades-old vials of smallpox, some of which contained live 

virus, were found in a storage space of a former Food and Drug 

Administration (FDA) laboratory on the National Institutes of Health (NIH) 

campus, within the Department of Health and Human Services. FDA and 

NIH had gaps in their inspection and inventory management protocols, 

which resulted in the vials of smallpox remaining undiscovered. Neither 

NIH nor FDA claimed responsibility for the boxes; therefore, neither 

agency looked in the unlabeled boxes in which the vials of smallpox were 

stored until FDA was cleaning out its inventory in preparation for a move 

to its new location at FDA headquarters. During the period when FDA 

was leasing laboratory facilities from NIH, NIH and FDA officials told us 

that NIH was responsible for conducting inspections of FDA-leased 

laboratories and their associated spaces, including the cold storage room 

where the smallpox vials were found in unlabeled cardboard boxes. 

However, the NIH inspection checklists did not require inspectors to 

review the types of containers laboratory personnel used to store their 

inventory of hazardous biological agents, nor were inspectors required to 

check the contents of materials in the cold storage room. NIH officials told 

us that the agency did not have responsibility for the contents of any 

boxes stored in the FDA-leased cold storage spaces. Further, NIH 

officials told us that the agency notes the presence of cardboard in 

storage from a safety perspective only, such as when cardboard on the 

floor represents a tripping hazard or wet cardboard represents a mold 

hazard.1 FDA officials told us that FDA’s laboratory personnel were 

responsible for their own hazardous biological agents but did not claim 

responsibility for the boxes in which the vials were discovered because 

they were not being used in active research.

NIH and FDA have taken steps to address gaps in their inspection and 

inventory management protocols in response to the discovery of smallpox 

vials in 2014. Specifically, the FDA center that had responsibility for the 

leased NIH cold storage space developed three new procedures for 

handling inventory in common rooms, cold rooms, and shared freezer 

spaces, all of which require personnel to look at all contents of boxes and 

storage compartments in these rooms. In addition, NIH conducted a 

sweep of its laboratories to identify any select agents stored in them and 

revised its inspection checklist, effective as of April 2015, to more clearly 

state when cardboard in cold storage rooms presents a safety hazard.

 

1

According to NIH officials, inspections did not identify as a safety concern any cardboard 

boxes used for storage or identify the contents of storage boxes.

Appendix I: Department of Health and 

Human Services Laboratory Oversight 

during the 2014 Smallpox Safety Incident
Appendix II: Description and Sources of the 

Six Policy Elements That Are Key for Managing 

High-Containment Laboratories

Page 54 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Key element Description Source

Incident reporting Policies establish appropriate lines of reporting for 

incidents involving hazardous biological agents in 

high-containment laboratories within their 

organizational structure that include the timely 

notification of laboratory and program officials, 

institution management, and any relevant 

regulatory or public authorities. We assessed 

whether policies contained incident reporting 

requirements and, specifically (1) what laboratory 

incidents should be reported, (2) to whom reports 

should be sent, and (3) time frames for reporting. 

We determined that policies addressed the key 

element, incident reporting, if at least one 

department or agency policy contained the three 

pieces of information.

GAO, Standards for Internal Control in the Federal 

Government, GAO/AIMD-00-21.3.1 (Washington, 

D.C.: November 1999); GAO, Standards for Internal 

Control in the Federal Government, GAO-14-704G 

(Washington, D.C.: September 2014); Department of 

Health and Human Services, Centers for Disease 

Control and Prevention and National Institutes of 

Health, Biosafety in Microbiological and Biomedical 

Laboratories, 5th ed. (Washington, D.C.: December 

2009); Centers for Disease Control and Prevention, 

Report on the Inadvertent Cross-Contamination and 

Shipment of a Laboratory Specimen with Influenza 

Virus H5N1 (Atlanta, Ga.: Aug. 15, 2014).

Roles and responsibilities Policies clearly define key areas of authority and 

responsibility for operating activities, including a 

designated individual for reviewing and approving 

laboratory safety protocols, practices, and 

procedures. Biosafety in Microbiological and 

Biomedical Laboratories (BMBL) identifies 

positions such as the laboratory director, a 

biological safety officer, and an institutional 

biosafety committee. We determined that policies 

contained the key element, roles and 

responsibilities, if they provided a specific role for 

the review and approval of standard operating 

procedures or biosafety plans for highcontainment laboratories.

GAO/AIMD-00-21.3.1; GAO-14-704G; Department 

of Health and Human Services, Centers for Disease 

Control and Prevention and National Institutes of 

Health, Biosafety in Microbiological and Biomedical 

Laboratories; Centers for Disease Control and 

Prevention, Report on the Inadvertent CrossContamination and Shipment of a Laboratory 

Specimen with Influenza Virus H5N1; Centers for 

Disease Control and Prevention, Report on the 

Potential Exposure to Anthrax (Atlanta, Ga.: July 11, 

2014); Department of Defense, Review Committee 

Report: Inadvertent Shipment of Live Bacillus 

anthracis Spores by DoD (Washington, D.C.: July 

13, 2015).

Training Policies identify appropriate knowledge and skills 

needed for various jobs, including potential 

hazards, and provide needed training, including 

the practices and techniques required to handle 

hazardous biological agents safely, as well as 

candid and constructive counseling and 

performance appraisals. We determined that 

policies contained the key element, training, if 

they included requirements for training specific to 

the hazards and safety concerns of hazardous 

biological agents in high-containment 

laboratories.

GAO/AIMD-00-21.3.1; GAO-14-704G; Department 

of Health and Human Services, Centers for Disease 

Control and Prevention and National Institutes of 

Health, Biosafety in Microbiological and Biomedical 

Laboratories; Centers for Disease Control and 

Prevention, Report on the Inadvertent CrossContamination and Shipment of a Laboratory 

Specimen with Influenza Virus H5N1. 

Appendix II: Description and Sources of the

Six Policy Elements That Are Key for 

Managing High-Containment Laboratories
Appendix II: Description and Sources of the 

Six Policy Elements That Are Key for Managing 

High-Containment Laboratories

Page 55 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Key element Description Source

Inventory control Policies establish physical control to secure and 

safeguard vulnerable assets, including 

inventories. The BMBL suggests procedures to 

track the inventory, storage, use, transfer and 

destruction of hazardous biological materials and 

assets when no longer needed. We determined

that policies contained the key element, inventory 

control, if they included requirements for an 

inventory of all hazardous biological agents, 

including, but not limited to, those identified by the 

select agent program.

GAO/AIMD-00-21.3.1; GAO-14-704G; Department 

of Health and Human Services, Centers for Disease 

Control and Prevention and National Institutes of 

Health, Biosafety in Microbiological and Biomedical 

Laboratories; The White House, Enhancing 

Biosafety and Biosecurity in the United States

(Washington, D.C.: Aug. 18, 2014); The White 

House, Next Steps to Enhance Biosafety and 

Biosecurity in the United States (Washington, D.C.: 

Oct. 29, 2015).

Inspections Policies establish ongoing monitoring in the 

course of normal laboratory operations. 

Evaluations may take the form of selfassessments as well as review of control design. 

We determined that policies contained the key 

element, inspections, if they included 

requirements for a self-administered inspection, 

which could be in addition to inspections 

conducted for the select agent program as 

applicable.

GAO/AIMD-00-21.3.1; GAO-14-704G; Department 

of Health and Human Services, Report of the TransFederal Task Force on Optimizing Biosafety and 

Biocontainment Oversight (Washington, D.C.: July 

2009); Department of Health and Human Services, 

Centers for Disease Control and Prevention and 

National Institutes of Health, Biosafety in 

Microbiological and Biomedical Laboratories; The 

White House, Next Steps to Enhance Biosafety and 

Biosecurity in the United States. 

Biosafety in Microbiological 

and Biomedical 

Laboratories

Policies address the widely-accepted leading 

guidance on the principles and practices of 

biosafety and biosecurity in biological 

laboratories, including practices for training, 

inventory control, and inspections. We determined 

that policies contained the key element, BMBL, if 

they included a statement specifically requiring 

adherence to the laboratory procedures outlined 

in the BMBL or listed the BMBL as a reference or 

authority.

Department of Health and Human Services, Centers 

for Disease Control and Prevention and National 

Institutes of Health, Biosafety in Microbiological and 

Biomedical Laboratories; Department of Health and 

Human Services, Report of the Trans-Federal Task 

Force on Optimizing Biosafety and Biocontainment 

Oversight. 

Source: GAO analysis of source documents. | GAO-16-305
Appendix III: Timeline of Recent Centers for 

Disease Control and Prevention Safety Lapses 

and Related Federal Assessments

Page 56 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Appendix III: Timeline of Recent Centers for 

Disease Control and Prevention Safety 

Lapses and Related Federal Assessments
Appendix IV: Comments from the Department 

of Agriculture

Page 57 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Appendix IV: Comments from the 

Department of Agriculture 
Appendix IV: Comments from the Department 

of Agriculture

Page 58 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 
Appendix IV: Comments from the Department 

of Agriculture

Page 59 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 
Appendix IV: Comments from the Department 

of Agriculture

Page 60 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 
Appendix V: Comments from the Department 

of Defense

Page 61 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Appendix V: Comments from the Department 

of Defense
Appendix V: Comments from the Department 

of Defense

Page 62 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 
Page 63 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 
Appendix VI: Comments from 

the Department of Energy

Page 64 GAO-16-305 Federal Laboratory Biosafety and Biosec

Appendix VI: Comments from the 

Department of Energy
Appendix VI: Comments from 

the Department of Energy

Page 65 GAO-16-305 Federal Laboratory Biosafety and Biosec
Appendix VI: Comments from 

the Department of Energy

Page 66 GAO-16-305 Federal Laboratory Biosafety and Biosec
Appendix VII: Comments from the Department 

of Health and Human Services

Page 67 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Appendix VII: Comments from the 

Department of Health and Human Services
Appendix VII: Comments from the Department 

of Health and Human Services

Page 68 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 
Appendix VII: Comments from the Department 

of Health and Human Services

Page 69 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 
Appendix VII: Comments from the Department 

of Health and Human Services

Page 70 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 
Appendix VII: Comments from the Department 

of Health and Human Services

Page 71 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 
Appendix VII: Comments from the Department 

of Health and Human Services

Page 72 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 
Appendix VIII: Comments from the Department 

of Homeland Security

Page 73 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Appendix VIII: Comments from the 

Department of Homeland Security 
Appendix VIII: Comments from the Department 

of Homeland Security

Page 74 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 
Appendix VIII: Comments from the Department 

of Homeland Security

Page 75 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 
Appendix IX: Comments from the Department 

of the Interior

Page 76 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Appendix IX: Comments from the 

Department of the Interior
Appendix IX: Comments from the Department 

of the Interior

Page 77 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 
Appendix X: Comments from the Department 

of Veterans Affairs

Page 78 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Appendix X: Comments from the Department 

of Veterans Affairs
Appendix X: Comments from the Department

of Veterans Affairs

Page 79 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 
Appendix X: Comments from the Department 

of Veterans Affairs

Page 80 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 
Appendix XI : Comments from the 

Environmental Protection Agency

Page 81 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Appendix XI : Comments from the 

Environmental Protection Agency
Appendix XI : Comments from the 

Environmental Protection Agency

Page 82 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 
Appendix XI : Comments from the 

Environmental Protection Agency

Page 83 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 
Appendix XI : Comments from the 

Environmental Protection Agency

Page 84 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 
Appendix XII: GAO Contacts and Staff 

Acknowledgments

Page 85 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

Marcia Crosse, (202) 512-7114 or crossem@gao.gov

John Neumann, (202) 512-3841 or neumannj@gao.gov

In addition to the contacts named above, GAO staff who made significant 

contributions to this report include Mary Denigan-Macauley, Assistant 

Director; Karen Doran, Assistant Director; Cheryl Arvidson; Nick Bartine; 

Colleen Corcoran; Shana R. Deitch; Melissa Duong; Cathy Hamann; 

Terrance Horner, Jr.; Dan Royer; Sara Sullivan; and Jennifer Whitworth.

Appendix XII: GAO Contacts and Staff 

Acknowledgments

GAO Contacts

Staff 

Acknowledgments
Related GAO Products

Page 86 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

High-Containment Laboratories: Preliminary Observations on 

Federal Efforts to Address Weaknesses Exposed by Recent Safety 

Lapses. GAO-15-792T. Washington, D.C.: July 28, 2015.

Chemical and Biological Defense: Designated Entity Needed to 

Identify, Align, and Manage DOD’s Infrastructure. GAO-15-257. 

Washington, D.C.: June 25, 2015.

High-Containment Laboratories: Recent Incidents of Biosafety 

Lapses. GAO-14-785T. Washington, D.C.: July 16, 2014.

High-Containment Laboratories: Assessment of the Nation’s Need Is 

Missing. GAO-13-466R. Washington, D.C.: February 25, 2013.

Biological Laboratories: Design and Implementation Considerations for 

Safety Reporting Systems. GAO-10-850. Washington, D.C.: September 

10, 2010.

High-Containment Laboratories: National Strategy for Oversight Is 

Needed. GAO-09-574. Washington, D.C.: September 21, 2009.

Related GAO Products

(291264)
Related GAO Products

Page 87 GAO-16-305 Federal Laboratory Biosafety and Biosecurity 

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