OVERLAP AND 

DUPLICATION

Federal Inspections of 

Entities Registered 

with the Select Agent 

Program

Report to Congressional Committees

January 2013

GAO-13-154

United States Government Accountability Office

GAO
United States Government Accountability Office

Highlights of GAO-13-154, a report to 

congressional committees

January 2013

OVERLAP AND DUPLICATION 

Federal Inspections of Entities Registered with the 

Select Agent Program

Why GAO Did This Study

Between 2009 and 2011, there were 

roughly 374 entities across the United 

States conducting research with select 

agents such as anthrax, which have 

the potential to threaten health and 

safety. Inspections are one means of 

ensuring safety and compliance with 

regulations. However, several federal 

agencies—CDC, APHIS, DOT, DHS, 

and DOD—conduct such inspections, 

creating significant potential for overlap 

and duplication of effort. In this context, 

GAO was asked to assess (1) the 

extent of overlap and potential 

duplication in federal inspections of 

select agent entities, (2) the costs of 

such overlap and effects on laboratory

operations, and (3) actions to reduce 

the costs and negative effects of any 

overlap. To answer these objectives, 

GAO analyzed agency data, surveyed 

entities, held focus groups with lab 

staff, and interviewed agency officials.

What GAO Recommends

GAO recommends that CDC and 

APHIS work with DHS and DOD to 

coordinate inspections and ensure 

consistent application of inspection 

standards.

HHS, USDA, DHS, and DOD generally

agreed with our recommendations and 

noted various actions they have 

already taken, or plan to take, to 

coordinate inspection efforts. 

What GAO Found

About 15 percent of entities registered to work with select agents were subject to 

inspection overlap (multiple federal agencies inspecting within a 2-year period). 

Entities experiencing overlap tended to be larger ones, with more laboratories, 

principal investigators, and staff. Although there was overlap between 

Department of Transportation (DOT) inspections and those of the Centers for 

Disease Control and Prevention (CDC) and the Animal and Plant Health 

Inspection Service (APHIS), they were generally not duplicative because specific 

inspection activities tended to differ, according to GAO’s survey of entities 

experiencing overlap. For example, DOT inspections tended to focus on 

transportation issues, such as checking hazardous materials and transportation 

security plans, rather than general biosafety issues. The Department of 

Homeland Security (DHS) and Department of Defense (DOD) inspections, 

however, tended to be more duplicative with those of CDC and APHIS. For 

example, both review the same documents, require safety and security 

demonstrations, conduct inventory inspections and personnel interviews, and 

provide corrective action plans. While inspections are important for safety and 

compliance, there is no value added when federal agencies are expending 

resources to conduct the same work and, in some cases, reinspecting before 

entities have had time to respond to findings from a previous inspection.

The costs of overlapping federal inspections and effects on lab operations are 

difficult to quantify because agencies and entities generally do not track them 

and some costs are not quantifiable. Although GAO could not quantify the portion 

of federal and entity costs directly attributable to overlap, it could quantify the 

costs of inspections in general. According to agency data, the approximate 

overall federal cost for fiscal years 2010 and 2011 inspections was $2.1 million 

dollars. On average, the entity costs per inspection were nearly $15,000, and 

staff time per inspection was 380 hours, according to the GAO survey. While 

surveyed entities reported that inspections can help correct deficiencies and 

improve accountability, most reported moderate to significant nonquantifiable 

costs of inspections due to loss of productivity and delays in research. In 

addition, according to surveyed entities, overlapping inspections negatively 

affected lab productivity, staff morale, available time to complete research, and 

the research schedule. Because many of these entities are federal laboratories 

or are funded through federal grants, these costs are passed on to the federal 

government.

Actions to reduce the costs of overlapping and duplicative inspections include 

better coordination among federal agencies and greater consistency in the 

application of standards, according to various experts and surveyed entities. 

CDC has taken actions to better coordinate inspections with other agencies, for 

example, by increasing the use of joint inspections. But such actions, including 

joint inspections, do not fully address the negative effects of multiple inspections 

if agencies apply inconsistent standards and develop separate reports of 

findings. Well-trained inspectors, who apply consistent standards, are also 

needed. Collectively, these actions would reduce the negative effects of overlap 

and duplication and could increase agencies’ acceptance of each other’s 

inspection results.

View GAO-13-154. For more information, 

contact Nancy Kingsbury at (202) 512-2700 or 

kingsburyn@gao.gov.
Page i GAO-13-154 Overlap and Duplication

Letter 1 

Background 6

Some Overlap and Duplication Exist in Inspections of Select Agent 

Laboratories 11

While Difficult to Quantify, Overlap Adds to the Cost of Inspections 

and Can Negatively Impact Laboratory Operations 20

A Coordinated Approach with Consistently Applied Standards is 

Recommended by Earlier Reports and Surveyed Entities 28

Conclusions 32

Recommendations for Executive Action 33

Agency Comments and Our Evaluation 33

Appendix I Scope and Methodology 37

Appendix II Survey of Select Agent Entities 42

Appendix III Comments from the Department of Health and Human 

Services 64

Appendix IV Comments from the Department of Agriculture 67

Appendix V Comments from the Department of Homeland Security 69

Appendix VI Comments from the Department of Defense 71

Appendix VII GAO Contact and Staff Acknowledgments 76

Contents 
Page ii GAO-13-154 Overlap and Duplication

Tables

Table 1: Major Areas Covered in Agencies’ Inspections 3

Table 2: Number of Duplicative Preparation, Execution, and 

Closeout Activities: CDC or APHIS and DOT Inspections 15

Table 3: Number of Duplicative Preparation, Execution, and 

Closeout Activities: CDC or APHIS and DHS Inspections 16

Table 4: Number of Duplicative Preparation, Execution, and 

Closeout Activities: CDC or APHIS and DAIG Inspections 18

Table 5: Inspections and Reviews of One Army Laboratory, Fiscal 

Years 2009 to 2011 19

Table 6: Total Approximate Inspection Costs by Agency, Fiscal 

Year 2010 to August 2011 22

Table 7: Average Number of Staff, Labor Hours, and Salary Costs 

for a Select Agent Inspection, According to Surveyed 

Entities 23

Table 8: Nonquantifiable Costs of a Select Agent Inspection, 

According to Surveyed Entities 25

Table 9: Effects of Multiple inspections, According to Surveyed 

Entities 27

Table 10: Solutions to the Negative Effects of Multiple Inspections, 

According to Surveyed Entities 29

Figures

Figure 1: Federal Agencies That Inspect Select Agent Entities 6

Figure 2: Number and Percentage of Entities and Associated 

Laboratories Experiencing Overlapping Inspections, 

Fiscal Years 2009 to 2011 13

Figure 3: Number and Percentage of Staff, Principal Investigators, 

and Agents Affected by Overlapping Inspections, Fiscal 

Years 2009 to 2011 14
Page iii GAO-13-154 Overlap and Duplication

Abbreviations

ABSA American Biological Safety Association

APHIS Animal and Plant Health Inspection Service

ATEC Army Test and Evaluation Command

BMBL Biosafety in Microbiological and Biomedical Laboratories

BSL Biosafety Level

CDC Centers for Disease Control and Prevention

DAIG Department of the Army, Office of Inspector General

DHS Department of Homeland Security

DOD Department of Defense

DOE Department of Energy

DOJ Department of Justice

DOT Department of Transportation

FBI Federal Bureau of Investigation

FDA Food and Drug Administration

HHS Department of Health and Human Services 

MOU Memorandum of Understanding

NIH National Institutes of Health

OSHA Occupational Safety and Health Administration

PHMSA Pipeline and Hazardous Materials Safety 

 Administration

PPE personal protective equipment

PRP personnel reliability program

RO Responsible Official

SAP Select Agent Program 

SAR Select Agent Regulations

SAV Staff Assistance Visits

SMR Biosurety Management Reviews

UN United Nations

USDA United States Department of Agriculture

This is a work of the U.S. government and is not subject to copyright protection in the 

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Page 1 GAO-13-154 Overlap and Duplication

United States Government Accountability Office

Washington, DC 20548

January 31, 2013

The Honorable Fred Upton

Chairman

The Honorable Henry Waxman

Ranking Member

Committee on Energy and Commerce

House of Representatives

The Honorable Tim Murphy

Chairman

The Honorable Dianna DeGette

Ranking Member

Subcommittee on Oversight and Investigations

Committee on Energy and Commerce

House of Representatives

Between fiscal years 2009 and 2011, there were 374 entities registered 

with the federal Select Agent Program (SAP) that were home to over 

1,900 biosafety laboratories in the federal, academic, and private sectors 

across the United States.1 These laboratories conduct research with 

biological agents or toxins, known as “select agents,” such as anthrax,

which have the potential to severely threaten public health and safety, 

animal and plant health, and animal and plant products. Consequently, 

these issues are a key concern of entities and federal agencies 

conducting, funding, or overseeing select agent work. Inspections are one 

mechanism for ensuring that entities registered to work with select agents 

comply with Select Agent Regulations (SAR) for biosafety, biosecurity, 

and biocontainment. However, there are multiple federal agencies, as 

 

1

An entity is defined in the Select Agent Regulations (SAR) as any government agency 

(federal, state, or local), academic institution, corporation, company, partnership, society, 

association, firm, sole proprietorship, or other legal body. The number of laboratories at 

each entity registered with the Centers for Disease Control and Prevention (CDC) or 

Animal and Plant Health Inspection Service (APHIS) ranges from 1 to 124 laboratories. 

The term biosafety laboratory refers to biosafety level (BSL)-2, -3, and -4 laboratories, with 

4 being the maximum level. In the United States, laboratories working with human, plant, 

or animal pathogens are classified by the type of agents used; activities being conducted; 

and the risks those agents pose to laboratory personnel, the environment, and the 

community. For purposes of this report, we are using the term select agent laboratories to 

refer to BSL-2, -3, and -4 laboratories that work with select agents.

 
 

Page 2 GAO-13-154 Overlap and Duplication

well as state, local, and professional organizations, that currently inspect 

these entities, creating the potential for overlap and duplication of effort.

Various federal agencies have the authority to inspect entities that 

possess, use, or transfer select agents. The Department of Agriculture’s 

(USDA) Animal and Plant Health Inspection Service (APHIS) and the 

Department of Health and Human Services’ (HHS) Centers for Disease 

Control and Prevention (CDC) inspect entities under the SAR to ensure 

compliance with the SAP.2

 In addition, the Department of 

Transportation’s (DOT) Pipeline and Hazardous Materials Safety 

Administration’s (PHMSA), under DOT’s Hazardous Materials 

Regulations, has the authority to regulate the safe and secure 

transportation of all hazardous materials.3 Under the SAR, any entity that 

uses, possesses, or transfers select agents must (1) register with CDC or 

APHIS and (2) establish and implement plans to ensure the safety and 

security of its activities.4 Prior to issuing a certificate of registration, CDC 

and APHIS may inspect and evaluate the premises and records to ensure 

compliance with the SAR. In addition, CDC and APHIS may inspect any 

site, for compliance and other purposes, where activities regulated by the 

SAR are conducted. DOT’s PHMSA also has the authority to perform 

inspections pertaining to the transport of biological agents. Other federal 

agencies also inspect laboratories that work with select agents, including 

the Department of Defense (DOD) and its Army, Navy, and Air Force

Inspector General (IG) offices and the Department of Homeland Security 

(DHS). DOD inspects to ensure compliance with federal, DOD, and 

 

2 The Public Health Security and Bioterrorism Response Act of 2002 (Pub. L. No. 107-

188, title II, subtitle A,116 Stat. 594 (June 12, 2002)) expanded HHS’s authority to 

regulate biological select agents and toxins to include oversight of all entities that possess, 

use, and transfer select agents affecting public health and safety. The Agricultural 

Bioterrorism Protection Act of 2002 granted comparable authority to USDA for select 

agents posing a threat to plant or animal health or products. (Pub. L. No. 107-188, title II, 

subtitle B, 116 Stat. 594 (June 12, 2002)). CDC and APHIS were delegated authority by 

their respective departments to regulate the use, possession and transfer of select agents 

and thereafter issued nearly identical regulations. (42 C.F.R. part 73 [CDC]; 7 C.F.R. part 

331 [APHIS–plant]; 9 C.F.R. part 121 [APHIS–animal]).

3

49 C.F.R. parts 171 to 180. Under 49 U.S.C. § 5103, DOT has the primary authority to 

regulate the safe and secure transportation of all hazardous materials, including infectious 

materials, shipped in intrastate, interstate, and foreign commerce.

4

Requirements for security, biosafety and incident response plans are at 49 C.F.R. §§ 

73.11, 73.12, and 73.14 [CDC]; 7 C.F.R. §§ 331.11, 331.12, and 331.14 [APHIS–plant]; 9 

C.F.R. §§ 121.11, 121.12, and 121.14 [APHIS–animal]).
 

Page 3 GAO-13-154 Overlap and Duplication

military service component requirements as well as contract 

requirements. DHS conducts periodic inspections to ensure compliance 

with funding requirements of entities for which they have funded research.

These inspections, however, also generally cover compliance with the 

SAR. While DOD and DHS inspections assess compliance with the SAR, 

these departments do not have authority to regulate all entities 

possessing, using, or transferring select agents. Rather, these 

departments issue their own agency regulations and directives that allow 

them to inspect entities they own or fund (see table 1 for major areas 

covered in agencies’ inspections). In addition to these federal agencies, 

several others, such as the Occupational Safety and Health 

Administration (OSHA), the National Institutes of Health (NIH), and the 

Food and Drug Administration (FDA), may also inspect registered entities 

for a variety of reasons, such as ensuring employee safety and health or 

compliance with standards for recombinant DNA research. We did not 

include them in our review because these inspections generally do not 

focus on biosafety and biosecurity issues.

Table 1: Major Areas Covered in Agencies’ Inspections 

Agency Biosafety Biosecurity Biocontainment

CDC Yes a Yes Yes

APHIS Yes a Yes Yes

DOT Yes b Yes No

DHS Yes c Yes Yes

DOD Yes d Yes Yes

Source: GAO analysis of agency inspection practices.

a

CDC and APHIS inspect under the SAR. 

b

DOT inspects the shipping and packaging of biological agents under its Hazardous Materials 

Regulations.

d

DHS issues its own guidance requiring laboratories it owns or funds to undergo inspections. For 

example, Management Directive 026-03, Select Agents and Toxin Security, Mar. 11, 2007. 

d

DOD issues its own policies and regulations that DOD components, such as the service IGs and 

various major command and lower service-level organizations use to inspect laboratories owned or 

funded by DOD. For example, Department of the Army Pamphlet 385-69, Safety Standards for 

Microbiological and Biomedical Laboratories (May 6, 2009) and Army Regulation 385-10, The Army 

Safety Program.

In March 2011, we issued our first annual report to Congress on federal 

programs, agencies, offices, and initiatives, either within departments or 
 

Page 4 GAO-13-154 Overlap and Duplication

government-wide, that have duplicative goals or activities.5 The report 

highlighted instances of (1) overlap—two or more agencies or programs 

engaged in similar activities or providing similar services to similar 

beneficiaries; (2) duplication—two or more agencies or programs 

engaged in the same activities or providing the same services to the 

same beneficiaries; and (3) fragmentation—more than one federal 

agency engaged in similar activities, but not coordinating efforts. The 

number of federal agencies involved in inspections of select agent entities 

heightens the potential for overlap and duplication. Moreover, the 

increasing number of inspections further increases the potential for 

overlap. From fiscal year 2009 through 2011, CDC, APHIS, DOD, DHS, 

and DOT collectively conducted over 800 inspections of select agent 

entities.

In this context, you asked us to assess (1) the extent of overlap and 

potential duplication in federal agencies’ inspections of entities that work 

with select agents, (2) the costs of overlapping federal inspections and 

effects on laboratory operations, and (3) actions to reduce the costs and 

negative effects of overlapping inspections.

To answer these objectives, we interviewed agency officials and reviewed 

pertinent legislation, regulations, and agency documents. We also 

analyzed agency information on inspectors’ total compensation (salary 

and benefits), hours spent on inspection activities, the associated travel 

costs for inspections for fiscal years 2010 and 2011, and inspection data 

to identify entities that had been inspected by more than one agency in a 

2-year period (at any point between fiscal years 2009 and 2011). Using 

the definition of overlap from our 2011 report, in the context of SAR 

inspection requirements, we defined overlap as two or more federal 

agencies inspecting the same entity on separate occasions within a 2-

year period.6 Because CDC and APHIS manage the SAP jointly and 

 

5

GAO, Opportunities to Reduce Potential Duplication in Government Programs, Save Tax 

Dollars, and Enhance Revenue, GAO-11-318SP (Washington, D.C.: Mar. 1, 2011).

6

This is a somewhat conservative measure of overlap given the SAR requirements for 

certification renewal inspections every 3 years and the CDC’s and APHIS’s policy of 

inspecting before recertifying. However, because the CDC and APHIS can inspect 

between renewals, the 2-year time frame also captures overlap that may occur as a result 

of additional CDC/APHIS inspections within the 3-year period. All jointly conducted 

inspections were counted as a single inspection in our analysis of overlap. For example, a 

joint APHIS/DHS inspection or a joint CDC/ DAIG inspection would count as one 

inspection. 
 

Page 5 GAO-13-154 Overlap and Duplication

conduct joint inspections, where applicable, we collapse these agencies 

in reporting on overlap to show where DOT, DHS, or DOD inspections 

overlapped with either a CDC or APHIS inspection.7 We developed a 

detailed list of inspection activities and identified duplication where the 

two overlapping inspections covered the same activities. From the 374 

entities registered to work with select agents between fiscal years 2009 

and 2011, we identified entities that had been inspected on separate 

occasions by more than one agency in a 2-year period. We then 

conducted a web-based survey of all such entities to collect information 

on (1) the extent to which there was duplication in specific inspection 

activities related to the preparation, execution, and closeout phases of the 

two inspections undergone, (2) the costs and operational effects of 

inspections, (3) the solutions for mitigating the negative effects of multiple 

inspections, and (4) the positive and negative aspects of joint inspections. 

Our survey was sent to the responsible official (RO) of each entity that 

was subject to overlapping inspections, and we received an 85 percent 

response rate. To gather preliminary information and develop our survey, 

we conducted focus groups with about 50 laboratory workers from entities 

that have experienced federal inspections, including ROs, biosafety

officers, principal investigators, and technical staff from federal, 

academic, and private entities that work with select agents. We 

interviewed officials with CDC, APHIS, DHS, DOD, and DOT and 

examined inspection files to understand general and agency-specific 

inspection activities. We also spoke with professional organizations, such 

as the American Biological Safety Association (ABSA), the American 

Society for Microbiology, and experts in the safety of select agent 

laboratories. We determined that the data we used were sufficiently 

reliable for our purposes. (See app. I for a more-detailed discussion of our 

scope and methodology.)

We conducted our work from March 2011 through January 2013 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.

 

7

Consequently, in some summary analyses of overlap, we present CDC/APHIS survey 

results together.
 

Page 6 GAO-13-154 Overlap and Duplication

In 2007, GAO reported on issues associated with the proliferation of 

biosafety laboratories in the United States. In 2009, we noted that while 

proliferation of these laboratories was taking place in the federal, 

academic, and private sectors across the United States, the federal 

oversight of these laboratories was fragmented—there was not a single 

federal agency to provide oversight.8 As a result, numerous federal 

agencies could be involved in separate and independent inspections of 

these entities and their associated laboratories. The various agencies that 

have a role in the oversight of select agent entities and can conduct 

inspections are shown in figure 1. 

Figure 1: Federal Agencies That Inspect Select Agent Entities

 

8

GAO, High-Containment Biosafety Laboratories: Preliminary Observations on the 

Oversight of the Proliferation of BSL-3 and BSL-4 Laboratories in the United States, 

GAO-08-108T (Washington, D.C.: Oct 4, 2007). GAO, High-Containment Laboratories: 

National Strategy for Oversight Is Needed, GAO-09-1036T (Washington, D.C.: Sept 22, 

2009). 

Background 
 

Page 7 GAO-13-154 Overlap and Duplication

CDC and APHIS have regulatory authority to assess compliance with 

biosafety, biosecurity, and biocontainment requirements. Under the 

current SAR, entity registration must be renewed every 3 years, and CDC 

or APHIS may conduct an on-site inspection before the award of a new 

certificate of registration or the renewal of an existing registration.9 These 

inspections generally cover all aspects of the SAR. As a matter of policy, 

to ensure that the entity is compliant with the SAR, CDC or APHIS 

inspects the premises and records of applicants, including a review of all 

required plans, before issuing the initial certificate of registration. In 

addition, CDC or APHIS may conduct inspections to (1) respond to 

concerns about an entity’s compliance, (2) verify corrections of 

deficiencies identified through inspections or accomplishment of 

Performance Improvement Plan goals; or when (3) modifications are 

made to the entity’s registration, (4) a new building or laboratory is added, 

(5) a higher-risk agent or toxin is added, (6) a change is made in security 

infrastructure or policy and procedures, (7) a theft, loss, or release 

incident occurs, or (8) a violation is reported. Any entity where select 

agents are possessed, used, or transferred must allow CDC and APHIS 

to inspect, with or without prior notification.10 In addition to CDC or APHIS 

inspections, the SAR requires each registered entity to conduct annual 

self-inspections under the direction of the entity’s RO.11

DOT has the primary authority to regulate the safe and secure transport 

of all hazardous materials shipped intrastate, interstate, and in foreign 

commerce. Infectious substances, which include select agents, are 

regulated as hazardous materials by DOT. DOT regulates select agents

in commercial transportation to, from, and within the United States, and 

its oversight extends to all parts of the hazardous materials transportation 

system, including classification of materials, packaging, handling, moving, 

loading, and unloading of hazardous materials shipments in commerce. 

PHMSA is the component of DOT responsible for this oversight. As its 

authority is limited to transportation, its focus is on the shipping and 

 

9

42 C.F.R. §§ 73.7(f) & 73.18(b) (CDC); 9 C.F.R. §§ 121.7(f) & 121.18(b) (APHIS–animal); 

7 C.F.R. §§ 331.7(f) & 331.18(b) (APHIS–plant).

1042 C.F.R. § 73.18(a) (CDC); 9 C.F.R. § 121.18(a) (APHIS–animal); 7 C.F.R. § 331.18(a) 

(APHIS–plant). 

1142 C.F.R. § 73.9(a)(5) (CDC); 9 C.F.R. § 121.9(a)(5) (APHIS–animal); 7 C.F.R. § 

331.9(a)(5) (APHIS–plant); 49 U.S.C. § 5103.

CDC and APHIS 

Inspections 

DOT Inspections
 

Page 8 GAO-13-154 Overlap and Duplication

packaging aspects of biosafety and biosecurity requirements. 

Consequently, entities that are active in the transfer of select agents may 

have their shipping and handling facilities inspected by PHMSA.

DHS and DOD own or fund research at select agent entities, and these 

entities may undergo additional inspections from these agencies as part 

of the conditions of funding or based on the safety and security policies of 

the parent agency. For example, entities that receive funds from DHS to 

conduct laboratory work involving select agents are subject to on-site 

compliance reviews and inspections by the DHS Regulatory Compliance 

Office. In addition, select agent laboratories operated by DOD are subject 

to inspections by the service IGs and other commands.

DHS established a regulatory compliance program to facilitate 

department-wide implementation of and compliance with DHS policies for 

biosafety, select agent security, and the care and use of animals in 

research.12 DHS’s select agent research is subject to regulatory oversight 

by CDC and APHIS. In addition, entities that receive funding from DHS to 

conduct laboratory work involving select agents are subject to on-site 

compliance reviews and inspections based on DHS Management 

Directives.13 According to DHS, it “conducts significant additional 

oversight because of unique sensitivities related to biodefense research, 

as distinct from conventional public health research, and a desire to 

ensure complete transparency for senior management of the department 

about all ongoing biodefense efforts.” DHS also has responsibility for 

ensuring biosecurity compliance of DHS funded research under 

biodefense weapon treaties.

Through its long-standing Chemical and Biological Defense Program, the 

DOD supports research on detection, identification, and characterization 

of biological threats and the development of countermeasures against 

those threats. DOD research activities take place at numerous facilities, 

 

12APHIS Animal Care regulates the care and use of animals under the Animal Welfare 

Act. 

13DHS Management Directive 026-03, Select Agent and Toxin Security (Mar. 11, 2007); 

DHS Management Directive 066-02, Biosafety (Mar. 11, 2007); DHS Management 

Directive 026-01, Care and Use of Animals in Research (Mar. 11, 2007); and DHS 

Management Directive 041-01, Compliance with, and Implementation of, Arms Control 

Agreements (Aug. 26, 2005). 

DHS and DOD Inspections

DHS

DOD
 

Page 9 GAO-13-154 Overlap and Duplication

including military-owned entities as well as entities in academia and 

private industry supported by contracts. DOD entities that are registered 

with CDC or APHIS are required to follow SAR requirements as well as 

service-specific requirements derived from DOD requirements. DODrelated select agent entities can therefore be subject to inspections from 

CDC, APHIS, the service IGs, and other commands. Specifically, the 

Department of the Army Inspector General (DAIG) conducts inspections 

of five Army and contractor-owned entities, the Navy Medical IG (MEDIG) 

conducts inspections of two Navy laboratories located in the United 

States and three overseas, and the Air Force Materiel Command IG 

conducts inspections of one Air Force select agent facility. In addition to 

DAIG inspections, Army facilities are also subject to command/program 

office (PEO) reviews by (1) Army Material Command Surety Management 

Review Team, (2) Army Test and Evaluation Command (ATEC) Surety 

Management Review Team, (3) Army Medical Command (MEDCOM) 

Surety Management Review Team, and (4) Joint Program Office for 

Chemical and Biological Defense (JPEO-CBD) Surety Management 

Review Team. The DAIG and command/PEO teams each have a 2-year 

inspection cycle and stagger the inspections so that each entity is 

inspected once per year.

Other federal agencies, such as the NIH and USDA’s Agriculture 

Research Service, have their own internal offices that may perform 

inspections in addition to those performed by CDC or APHIS as part of 

the SAP. In many cases, these agencies have internal regulations or 

policies that are more prescriptive than the CDC or APHIS regulations, 

according to the Trans-Federal Task Force.14 In addition, as the agency 

responsible for the general oversight of workplace safety in the United 

States, OSHA has oversight authority for the safety and health of workers 

in all workplaces that fall under its jurisdiction, including individuals who 

work with hazardous biological agents or toxins in high- and maximumcontainment research facilities. This includes jurisdiction over the safety 

 

14Report of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment 

Oversight (July 2009). 

Other Federal Agencies 

Involved in Inspections
 

Page 10 GAO-13-154 Overlap and Duplication

and health of workers employed by privately owned entities and, under 

certain circumstances, federal high-containment facilities.15

Inspection activities are generally conducted in three phases: (1) 

preparation, (2) execution (the actual inspection), and (3) closeout 

(postinspection activities). In order to prepare for an inspection, entities 

conduct a variety of activities, such as responding to requests for 

documents related to the SAR; reviewing and updating guidance, records, 

and plans; and checking security and medical certifications of inspectors. 

In the execution phase, inspection activities include, for example, tours of 

the facility, document reviews, inventory audits, interviews of laboratory 

staff, equipment tests, and examinations of physical security and shipping 

and receiving of select agents. The closeout phase includes activities 

such as discussing the inspection findings and report, developing 

corrective action plans, and providing verification of corrective actions. 

(For a detailed list of inspection activities included in the survey, see 

app. II.)

Inspections consist of an extensive review of laboratory safety and 

security. CDC and APHIS use specific checklists, which they developed 

from the SAR, OSHA regulations, NIH guidelines for recombinant DNA 

research, and the Biosafety in Microbiological and Biomedical 

Laboratories (BMBL) manual, to guide their inspections. The BMBL 

provides guidance for standards of practice for laboratory principles, 

practices, and procedures. Other inspecting agencies also use the same 

or similar checklists for their inspections. DOT inspections, for example, 

are derived from PHMSA’s regulations for hazardous materials shipping, 

packaging, testing, certification, safety and security, and record keeping.

The scope of a DOD inspection covers a wide range of functional areas, 

such as security, safety and occupational health, surety management, 

emergency response, occupational medical requirements, and 

transportation.

 

15OSHA may only conduct inspections of federal high-containment facilities if (1) the 

agency has not established a health and safety committee, (2) half of the committee 

requests an inspection, or (3) an employee reports an imminent danger situation and the 

agency has not responded to the employee (29 C.F.R. § 1960.31). 

Inspection Activities
 

Page 11 GAO-13-154 Overlap and Duplication

The number of federal agencies involved in inspections of select agent 

entities increases the potential for overlap and duplication. Further adding 

to the potential for overlap is the increase in the number of inspections. 

These inspections have increased for a variety of reasons, such as 

heightened security concern in response to the events of September 

2001, as well as an increase in select agent research and the number of 

agencies funding the research. For example, in addition to announced 

inspections that generally take place with registration certification and 

renewal, the number of unannounced CDC inspections substantially 

increased from fewer than 5 in 2006–07 to nearly 80 in 2012, according to 

estimates from CDC. And while some federal agencies have increased 

the use of joint inspections, in which two agencies are on-site for an 

inspection at the same time, it is unclear whether this will address all of 

the negative aspects of duplication if compliance is still assessed 

separately.

About 15 percent of the 374 entities that were registered to work with 

select agents between fiscal years 2009 and 2011 were subject to 

inspection overlap. This means that in a 2-year period, these entities were 

inspected by more than one federal agency for biosafety, biosecurity, and 

biocontainment compliance.16 In addition, specific inspection activities 

were often duplicative, according to our survey of the 55 entities that were 

subject to overlapping inspections. While the percentage of entities 

affected by inspection overlap was relatively small, the entities affected 

tended to be larger ones that work with a greater variety of agents and 

with more laboratories, principal investigators, and laboratory staff. For 

example, entities with five or more laboratories are more likely to be 

subject to overlap than entities with fewer than five laboratories, 

controlling for biosafety level (BSL) and the number of agents. Similarly, 

entities working with five or more select agents are more likely to be 

subject to overlap than entities working with fewer than four select agents, 

controlling for the number of laboratories and BSL. As a result, the 

overlap affected roughly a third of all laboratories, principal investigators, 

and lab staff. Moreover, DOD-owned select agent entities are also subject 

to inspections from internal inspecting entities. These inspections can 

overlap with inspections from CDC, APHIS, and the service IGs. 

 

16The overlap could have occurred in any 2-year period between October 1, 2009, and 

July 30, 2011.

Overlap and Duplication

Some Overlap and 

Duplication Exist in 

Inspections of Select 

Agent Laboratories
 

Page 12 GAO-13-154 Overlap and Duplication

Concerning duplication, the entities often prepare the same documents 

for inspectors to review; conduct the same facility tours, inventory 

inspections, and personnel interviews; and go through the same exit 

conference and corrective action plan processes, according to survey 

results. Inspections conducted by DOT, however, were generally not 

duplicative of CDC and APHIS inspections because specific inspection 

activities tended to differ. According to surveyed entities, DOT inspections 

tended to focus narrowly on transportation issues—such as (1) checking 

hazardous material and transportation security plans and (2) verifying the 

labeling, testing, and assembly of United Nations (UN) certified

packagings—rather than general biosafety and biosecurity compliance. 

DHS and DOD’s DAIG inspections tended to be more duplicative with 

those of CDC and APHIS, in that numerous activities were the same 

across these inspections, according to survey results.

Fifty-five, or 15 percent, of entities registered between fiscal years 2009 

and 2011 were subject to overlapping inspections. Although the overlap 

appears to affect only a small portion of registered entities, these entities 

are home to 645 laboratories—roughly a third of all laboratories involved 

in select agent work (see fig. 2 for details). On the basis of logistic 

regression analysis, we found that the likelihood that an entity was 

subject to overlap in federal inspections depends on the number of 

laboratories, the highest BSL of its laboratories, and the number of select 

agents. Specifically, entities with five or more laboratories are more likely 

to be subject to overlap than entities with fewer than five, controlling for 

BSL and the number of agents.

Larger Entities Are More 

Likely to Experience 

Overlap in Inspections
 

Page 13 GAO-13-154 Overlap and Duplication

Figure 2: Number and Percentage of Entities and Associated Laboratories 

Experiencing Overlapping Inspections, Fiscal Years 2009 to 2011

In addition, entities with at least one BSL-4 lab are more likely to be 

subject to overlap than entities without a BSL-4 lab, controlling for the 

number of laboratories and the number of select agents.17 In addition, 

entities working with five or more select agents are more likely to be 

subject to overlap than entities working with fewer than four select agents, 

controlling for the number of laboratories and BSL. Finally, entities subject 

to overlap have, on average, more staff and more principal investigators 

(see fig. 3).

 

17There are only seven entities with a BSL-4 lab in the data. 
 

Page 14 GAO-13-154 Overlap and Duplication

Figure 3: Number and Percentage of Staff, Principal Investigators, and Agents 

Affected by Overlapping Inspections, Fiscal Years 2009 to 2011

Overlap in inspections occurred most frequently between CDC or APHIS 

and (1) DOT (34 overlapping inspections), (2) DAIG (13 overlapping 

inspections), and (3) DHS (8 overlapping inspections). Considering only 

CDC inspections, overlap occurred with 29 DOT inspections, 13 DAIG 

inspections, and 3 DHS inspections. However, overlapping inspections do 

not necessarily result in duplication. 

While the overlap in inspections occurs most frequently between CDC or 

APHIS and DOT, these inspections are not necessarily duplicative 

because the specific inspection activities tend to differ. The activities are 

likely to differ because the purpose of DOT inspections is narrowly 

focused on issues and areas related to the transport of select agents, 

whereas CDC and APHIS inspections are more-broadly focused. While 

there is less-frequent overlap between CDC or APHIS inspections and 

those of DHS or DOD, these inspections tend to be more duplicative, in 

that the inspection activities are similar, according to survey results.

According to DOT inspection data, DOT’s PHSMA conducted 83 

inspections of select agent entities between fiscal years 2009 and 2011. 

DOT coordinates its inspections with CDC and APHIS under a working 

DOT Inspections Are Less 

Duplicative Than DHS and 

DOD Inspections

DOT
 

Page 15 GAO-13-154 Overlap and Duplication

Memorandum of Understanding (MOU), which spells out the framework 

and responsibilities for the exchange and protection of information on 

transfer of select agents. Under the MOU, CDC and APHIS annually 

provide DOT with a list of registered entities that have transferred select 

agents during the 12 preceding months. DOT, in turn, notifies CDC and 

APHIS of any anticipated inspection of an entity 30 days before the 

inspection and also provides them with the inspection results. According 

to DOT officials, they try to coordinate joint inspections whenever 

possible. After CDC provides a list of scheduled inspections, DOT informs 

CDC about which inspections it will join. According to DOT officials, 

where possible, they coordinate joint inspections with CDC because (1) 

they learn things from each other, (2) with both agencies there at the 

same time it is more encompassing view of the process, and (3) it brings 

greater sophistication to inspections. Such coordination appears effective, 

given survey results of entities that experienced DOT inspections that 

overlapped with CDC or APHIS inspections. These entities reported little 

duplication in specific activities in the preparation, execution, and closeout 

phases of inspections (see table 2). Among the activities that tended to 

be duplicative were verifying the medical, security, or other credentials of 

inspectors in the preparation phase; participating in interviews with 

inspectors in the execution phase; and holding exit conferences with the 

inspecting agency in the closeout phase. Among the activities that tended 

to be DOT-specific were checking hazardous materials and transportation 

security plans and verifying the labeling, testing, and assembly of UNcertified packagings.

Table 2: Number of Duplicative Preparation, Execution, and Closeout Activities: 

CDC or APHIS and DOT Inspections 

 Preparation Execution Closeout

Total possible activities 18 9 8 

Average 2 3 2 

Median 1 3 2 

Range 0–7 0–8 0–6 

Source: GAO analysis of survey data. 

DHS identified 42 government, university, private, and not-for-profit 

entities that were receiving DHS funding for work involving select agents.

DHS’s Regulatory Compliance Office conducted or participated in 19 onsite inspections of 13 of these entities between fiscal years 2009 and 

2011. Of those 19 inspections, 8 were joint inspections, including: 5 joint 

inspections with CDC; 1 joint inspection with APHIS; and 2 joint 

DHS
 

Page 16 GAO-13-154 Overlap and Duplication

inspections with both CDC and APHIS. According to DHS officials, there 

are numerous reasons for DHS to visit a select agent entity that has also 

been inspected by CDC or APHIS. These reasons include, for example,

CDC or APHIS placing the entity on a Performance Improvement Plan or 

making substantial recommendations to correct regulatory 

noncompliance. If it appears that the compliance issues identified by CDC 

or APHIS could affect the DHS program, DHS may also make a site visit 

to understand the effect on DHS research and to assist the entity in 

mitigating the effect through appropriate corrective action.

According to DHS officials, their inspections are fundamentally different 

from CDC and APHIS inspections. DHS describes its compliance 

inspections as broader in some ways than those of CDC or APHIS, 

because they are designed to ensure that DHS-sponsored research 

activities not only comply with select agent requirements, but with other 

relevant regulations and guidelines as well. According to DHS officials, 

CDC and APHIS, as regulatory agencies, conduct more comprehensive 

inspections at the institutional level. DHS compliance inspections, 

however, go beyond compliance with select agent regulations to include 

general biosafety, animal care and use, research protocols and 

procedures, institutional review and oversight (for example, Institutional 

Biosafety Committees), and adherence to best practices. Nevertheless, 

survey responses from entities that experienced DHS inspections that 

overlapped with CDC or APHIS inspections reported some duplication in 

specific activities in the preparation, execution, and closeout phases of 

inspections (see table 3). Among the activities that tended to be 

duplicative were verifying medical, security, or other credentials of 

inspectors and arranging staff availability in the preparation phase;

participating in interviews with inspectors in the execution phase; and 

holding exit conferences and developing and implementing corrective 

action plans in the closeout phase.

Table 3: Number of Duplicative Preparation, Execution, and Closeout Activities: 

CDC or APHIS and DHS Inspections 

 Preparation Execution Closeout

Total possible activities 18 9 8 

Average 4 5 3 

Median 4 6 4 

Range 0–13 0–8 0–5 

Source: GAO analysis of survey data.
 

Page 17 GAO-13-154 Overlap and Duplication

According to DOD inspection data, the DAIG conducted 16 biosurety

inspections of its Army and contractor-owned entities between fiscal 

years 2009 and 2011, 5 of which were conducted jointly with CDC. Of the 

16 DAIG inspections, 13 overlapped with an inspection from another 

federal agency. The Navy IG conducted one inspection and the Air Force 

IG conducted two inspections between 2009 and 2011.18 These 

inspections did not overlap with an inspection from another federal 

agency.19 With respect to specific activities in the preparation, execution, 

and closeout phases of inspections, entities that experienced DAIG 

inspections that overlapped with CDC or APHIS inspections also reported 

substantial duplication in inspection activities (see table 4). Among the 

inspection activities that tended to be duplicative were arranging staff

availability in the preparation phase, holding entry meetings and escorting 

inspectors in the execution phase, and holding exit conferences in the 

closeout phase. However, according to DAIG officials, as required by 

Army directives and regulations, its biosurety inspections are morecomprehensive than CDC and APHIS inspections, covering biosafety, 

biosecurity, biocontainment, personnel reliability program (PRP), 

transportation, occupational medical requirements, and emergency 

response exercises.20 While DAIG officials acknowledge a level of overlap 

with CDC and APHIS inspections in terms of verifying compliance with

standards, DOD and the Department of the Army have developed specific 

requirements to implement those standards. In addition, until recently, 

CDC and APHIS inspections did not look at facility or department-specific 

requirements such as PRP.21

 

18Inspections of United States located entities only. 

19For entities still registered with the Select Agent Program at the time of our study.

20The Army’s Biosurety program is a system of control measures designed to provide 

protection to the local population, workers, and the environment by ensuring that select 

agent operations are conducted safely, that select agents are secure, and that personnel 

involved in those operations meet the highest standards of reliability. 

21HHS and USDA recently (Oct. 5, 2012) published the Select Agent Final Rules, which 

stipulate that the SAP will now review entities’ PRPs. 

DOD
 

Page 18 GAO-13-154 Overlap and Duplication

Table 4: Number of Duplicative Preparation, Execution, and Closeout Activities: 

CDC or APHIS and DAIG Inspections 

 Preparation Execution Closeout

Total possible activities 18 9 8 

Average 5 7 5 

Median 6 8 5 

Range 0–13 4–9 1–7 

Source: GAO analysis of survey data.

DOD-related select agent entities are also subject to inspections and 

reviews from internal organizations, which can overlap with inspections 

from CDC, APHIS, and the service IGs.22 For example, in addition to 

service IG inspections, DOD entities undergo Biosurety Management 

Reviews (SMR) and Biosurety Staff Assistance Visits (SAV). The SMRs 

are meant to verify the entity is managing its biosurety program according 

to standards. They allow the command to see how the surety program is 

being managed and where there may be deficiencies. According to Army 

lab officials, however, these inspections tend to be identical to service IG 

biological surety inspections. SAVs are an opportunity for the command 

to assist in fixing deficiencies or other lacking areas, and usually take 

place before another major inspection. SAVs are not biosurety 

inspections, nor are they required under DOD regulations. However, 

SAVs tend to be treated similarly to service IG inspections, according to 

Army lab officials. While SMRs and SAVs may be handled like an 

inspection with written reports of perceived deficiencies for which the 

entity makes a formal response and corrections for the identified 

deficiencies, DOD officials noted that entities may be self-imposing 

requirements or practices not required by regulation or the inspecting 

agency. As a result, these internal reviews can represent an additional 

area of overlap for DOD-owned and DOD-operated entities. For example, 

as shown in table 5, an Army entity underwent eight inspections or 

reviews, five of which were for compliance with select agent regulations 

between fiscal years 2009 and 2011.

 

22Although assessing internal agency duplication by means of survey analysis was 

outside the scope of our review for these DOD specific entities, we did gather some 

information about overlap through focus groups and interviews with some affected entities. 

Additional Overlap Can 

Occur with DOD Internal 

Inspection Authorities
 

Page 19 GAO-13-154 Overlap and Duplication

Table 5: Inspections and Reviews of One Army Laboratory, Fiscal Years 2009 to 2011

Inspection dates Inspecting agency Inspection type

March 2009 ATEC Biosurety Staff Assistance Visit (SAV)

March–April 2009

a

DAIG Biological Surety Inspection

June 2009 DOT Biological Shipping and Transportation

August 2009 CDC Verification

May 2010 ATEC Biosurety Management Review (SMR)

December 2010 ATEC Biosurety SAV 

February–March 2011 ATEC Biosurety SAV 

May 2011 DAIG and CDC Biological Surety Inspection 

Source: DOD

a

According to an official of this particular Army entity, many of the major 

command reviews and visits use up time and resources, fixing issues that 

are not value-added, or that are not looked at by other major inspections. 

In many cases, inspectors are focusing on minor issues, leaving the 

laboratory open for larger deficiencies on the major inspection. According 

to the DAIG Chief of Technical Inspections, a major cause of overlapping 

internal inspections is that there is no single entity within the DOD 

overseeing or coordinating inspections and that each service validates 

compliance very differently. The Army requires each major command to 

have its own internal biosurety team and, because the entities feel they 

should be prepared for higher-level reviews, the teams conduct 

inspections in preparation for higher-level inspections. For Army labs, the 

DAIG inspects an entity every 2 years, an internal command surety team, 

such as ATEC, conducts an SMR every 2 years (alternating with the 

DAIG inspection), and SAV reviews may be conducted before any 

inspection (DOD or otherwise). In an example of an extreme case, an 

Army select agent laboratory that conducts recombinant DNA research 

for DHS-funded projects and frequently transfers select agent materials to 

collaborators could theoretically be inspected by CDC/APHIS, DAIG, NIH, 

DHS, and DOT all within the same year. This could significantly hinder 

critical research productivity at the inspected laboratory because of the 

time dedicated to inspections, according to the report of the Working 

Group on Strengthening the Biosecurity of the United States. This is 

somewhat in contrast with inspections of the two Navy and one Air Force 

entities. For example, while the Navy can perform SAVs prior to 

inspections, they are not required like Army’s SMRs. In addition, rather 

than conducting its own inspection, the Air Force accepts the CDC 

SAVs are not inspections.
 

Page 20 GAO-13-154 Overlap and Duplication

inspection results and adds its own PRP review. This limited coordination 

among the inspection agencies was noted in the Working Group report. 

The costs of overlapping federal inspections and effects on lab operations 

are difficult to quantify because (1) agencies and entities generally do not 

track the costs or effects of inspections and (2) some costs are not 

quantifiable. Nevertheless, the costs and effects on lab operations are 

significant when considering (1) the cost of inspections to federal 

agencies, (2) both the quantifiable and nonquantifiable costs to the entity, 

and (3) surveyed entities’ perceptions of the negative effects of 

overlapping inspections on lab operations. Although we could not quantify 

the portion of federal and entity costs directly attributable to overlap, we 

could quantify the costs of inspections in general. For example, we 

estimate that for fiscal years 2010 through August 2011, individual 

agencies’ total inspection costs ranged from approximately $22,400 to 

over $900,000, according to agency data on the hours spent on 

inspection activities, inspector compensation (salaries and benefits) per 

labor hour, and travel. The approximate overall federal cost for fiscal year 

2010 and 2011 inspections was over $2.1 million dollars. On average, the 

entity costs per inspection were nearly $15,000 and 380 hours in staff 

time, according to our survey. The quantifiable cost of an inspection to a 

select agent entity depends on the number of laboratories and select 

agents, the complexity of the entity’s mission, its location, and whether it 

has a history of problems or violations of select agent regulations. In 

inspections of larger entities, there are higher inspection costs and a 

greater likelihood for overlap. The costs of overlap are therefore most 

likely higher as well. Entities also reported moderate to significant 

nonquantifiable costs of inspections when it comes to loss of productivity 

and delays in research. While inspections can help entities correct 

deficiencies, improve inventory management and accountability, and 

justify the need for resources to improve operations, most surveyed 

entities reported that overlapping inspections have negative effects on lab 

operations. According to surveyed entities, overlapping inspections 

negatively affected lab productivity, staff morale, available time to 

complete research, and the research schedule. And according to at least 

one-fifth of surveyed entities, overlapping inspections negatively affected 

the physical viability of inventory, staff retention, and competitiveness for 

research funds. Because many of these entities are federal laboratories 

or are funded through federal grants, these quantifiable and 

nonquantifiable costs are passed on to the federal government.

While Difficult to 

Quantify, Overlap 

Adds to the Cost of 

Inspections and Can 

Negatively Impact 

Laboratory 

Operations 
 

Page 21 GAO-13-154 Overlap and Duplication

Obtaining an accurate and complete picture of the costs of multiple 

inspections is difficult because entities generally do not track the costs of 

inspections and some of those costs are nonquantifiable. Nonetheless, 

federal agencies do incur quantifiable costs, including salaries, travel, and 

training of inspectors, and must purchase inspection equipment and pay 

staff to engage in inspection activities as opposed to research or other 

routine activities. Entities may also incur nonquantifiable costs of multiple 

inspections, such as loss of productivity, delays, and decreased time

available to complete research. In addition, because many of these 

entities are federally owned or funded, some portion of this cost is passed 

on to the federal government. These costs are affected by the number of 

inspectors, the time spent on an inspection, and the size of the entity 

being inspected.23 The larger the entity—in terms of laboratories, staff, 

and select agent research—the greater the cost of inspections. Given that 

inspections cost more for larger entities and overlap occurs more often for 

larger entities, the cost of overlap is greater than it would be if it were 

evenly distributed across entities of various sizes.

The approximate direct federal cost for fiscal years 2010 and 2011 

inspections was over $2.1 million, ranging from approximately $22,400 at

DOT to over $900,000 at CDC, according to agency data on the hours 

spent on inspection activities, inspector compensation (salaries and 

benefits) per labor hour, and travel. Specifically, APHIS’s total labor, 

travel, and other costs for inspections were $265,792; DOD’s costs were 

$697,744; DOT’s costs in 2010 were approximately $22, 444; and CDC’s 

costs were $903,475 (see table 6 for agency inspection costs). DHS 

estimates their inspection costs at about $250,000 for the 2-year period.24

Although we did not estimate indirect costs, the federal government also 

incurs costs from inspections because many select agent entities are 

either federally owned or funded. Consequently, the costs to entities, 

described in the sections below, also accrue to the federal government.

 

23In focus group discussions, laboratory workers said that an inspection can last from a 

few days to 2 weeks.

24According to DHS officials, DHS inspections of select agent laboratories are supported 

under a contract that does not provide breakdowns for labor hours and travel costs 

specifically associated with inspections. Labor hours for inspection activities are a small 

subset of the overall labor hours expended under the contract, which supports all DHS 

compliance-assurance efforts for biosafety, select agent and toxin security, and animal 

care and use in research.

While the Cost of Multiple 

Inspections Is Difficult to 

Quantify, Data from 

Inspecting Agencies and 

Entities Indicate They Are 

Significant 

Federal Inspection Costs
 

Page 22 GAO-13-154 Overlap and Duplication

Table 6: Total Approximate Inspection Costs by Agency, Fiscal Year 2010 to August 

2011 

Dollars

Inspecting agency 2010 

2011

(up to Aug. 31) Total

CDC $617,130 $286,345 $903,475

APHIS 173,486 a 92,396 265,792

DOT 22,444 b -- 22,444

DHS 190,000 60,000 250,000 

DOD 367,490 330,254 687,744

Total 2,129,455 

Source: GAO analysis of CDC, APHIS, DOT,DHS, and DOD data.

a

APHIS conducts inspections by calendar year coinciding with an entity’s renewal of registration. 

b

The cost of inspections to entities is also difficult to accurately determine 

because entities generally do not track inspection cost. However, 

according to focus group participants and entities we surveyed, entities 

do incur quantifiable and nonquantifiable costs with each inspection, 

some of which can be significant. Focus group participants and surveyed 

entities reported quantifiable costs, such as purchasing inspection 

equipment and salaries for staff involved in preparing for, carrying out, 

and responding to an inspection. Entities also reported less-easily 

measured, nonquantifiable costs, such as loss of productivity, delays, and 

decreased time to complete research, as well as loss of specimen viability 

from repeated thawing and freezing.

DOT provided total salary and benefits costs for 2010 inspections but did not provide 2011 data and

could not provide specific travel and other costs associated with inspections.

Staff time and lab resources are required for inspections, and that burden 

is increased with overlapping inspections. The actual cost of an 

inspection to a select agent entity will depend on the number of 

laboratories and select agents, the complexity of the entity’s mission, its 

location, and whether it has a history of problems or violations of select 

agent regulations. However, because overlap in inspections tends to 

occur more often for larger entities, the overall costs of overlap for these 

laboratories are likely higher as well. Entities that experienced an 

overlapping inspection spent, on average, 380 hours and nearly $15,000 

in staff time to engage in a federal inspection, according to survey data on 

the number of hours spent to prepare for, carry out, and close out 

inspections and the hourly salaries of laboratory staff involved (see table 

7 for average costs across occupational groups). See app. I for an 

explanation of how we calculated these costs.

Entity Inspection Costs

Quantifiable Costs
 

Page 23 GAO-13-154 Overlap and Duplication

Table 7: Average Number of Staff, Labor Hours, and Salary Costs for a Select Agent 

Inspection, According to Surveyed Entities

Occupation

Average 

number of staff

Average number 

of labor hours

Average salary 

cost (labor hours 

X average

hourly salary)

(Dollars)

Responsible official/ 

alternate responsible official 2 101 $4,987

Principal investigator 4 49 2,356

Owner or controller 1 7 355

Laboratory staff 24 140 4,767

Support staff 17 110 3,201

Total 48 380 $14,724

Source: GAO analysis of survey data.

Much of the time spent on inspections takes place in the preparation 

phase, according to focus groups of lab staff. For example, staff from 

Army laboratories noted that there is a period of 3 to 4 months of intense 

preparation for DAIG inspections and months of follow-up. During the 

preparation phase, lab staff perform numerous activities, including 

updating standard operating procedures and other documents and 

records; verifying inspectors’ health records and clearances; turning in 

unused equipment; holding meetings to prepare for the inspection; 

checking chemicals and agents in inventory; checking lab equipment; and 

inspecting, cleaning and painting floors, walls, and desk space. According 

to some focus group participants, in the weeks preceding an inspection, 

research is suspended and all staff time is directed toward inspection 

efforts. Scheduling for inspections can also create conflicts because 

experiments must be scheduled around the inspection, and key staff must 

be available during the inspection, regardless of personal plans or 

schedule.

During the inspection, lab staff are involved in activities that take time and 

resources. For example, staff conduct safety training for inspectors (how 

to wear safety suits and respirators and blood-borne pathogen and 

internal requirement training), issue safety equipment to the inspectors, 

clear inspectors through security, and provide escorts for inspectors. 

Safety equipment, such as personal protective equipment (PPE), gowns, 
 

Page 24 GAO-13-154 Overlap and Duplication

and footies are provided to inspectors at the entities’ expense, and these 

costs increase with larger inspection parties and when there is overlap 

because the equipment can not be shared or reused.25 Staff time for 

escorts can be significant in some cases. For example, Army lab 

inspection teams can have as many as 20 personnel and stay as long as 

2 weeks. According to one Army laboratory, it spent more than 7,305 

labor hours in activities related to preparing for, executing, and 

responding to six inspections during 2009 at a cost of $350,640. During 

2010, the laboratory estimated it spent 4,082 hours on these activities for 

three inspections, at a cost of $195,456.26 In addition, when joint 

inspections take place, the size of the inspection team may be too large 

for some entities to manage. For example, according to one survey 

respondent, the entity requested DHS and CDC not conduct a joint 

inspection because the inspection teams are too large to handle at one 

time. According to another survey respondent, the respondent’s

laboratory had to arrange for additional personnel to escort large teams of 

inspectors for multiple inspections. Laboratories also spend time and 

resources in the closeout phase of the inspection. For example, upperlevel staff attend meetings to discuss inspection results, and staff time 

and effort are required to respond to oral and written findings that may 

change or be added to even after the completion of the inspection. Of 

particular concern was that frequent inspections keep lab staff in a 

constant mode of preparing for the next inspection while responding to 

the last one, inhibiting their ability to respond to inspection findings and 

conduct research.

Laboratories also incur nonquantifiable costs from inspections, which can 

be exacerbated by overlapping inspections. While these costs tend to be 

small, according to most surveyed entities, for some they can be 

moderate to significant when it comes to loss of productivity, decreased 

time available to complete research, and delays (see table 8). Other costs 

noted by surveyed entities include stress and anxiety for lab staff, 

contractor and overtime costs, HVAC and equipment testing costs, and 

loss of focus and manufacturing time.

 

25Select Agent Program (CDC and APHIS) inspectors generally use their own PPE for

inspections. 

26The Army laboratory used a labor rate of $48 per hour to calculate its costs.

Nonquantifiable Costs
 

Page 25 GAO-13-154 Overlap and Duplication

Table 8: Nonquantifiable Costs of a Select Agent Inspection, According to Surveyed Entities

Moderate to 

Significant Cost Some Cost Negligible Cost

Don’t know/ 

Not checked

Q7A. Loss of productivity 18 13 15 1 

Q7D. Decreased time to complete research 8 16 22 1 

Q7B. Delays in funded research 6 11 28 2 

Q7E. Reduced viability of inventory 5 5 35 2 

Q7F. Reduced competitiveness for research funding 4 5 35 3 

Q7C. Dollars lost in funded research 3 3 35 6 

Q7G. Other cost 1 5 1 4 37

Q7H. Other cost 2 1 1 4 41 

Source: GAO analysis of survey data. 

Focus group participants noted a variety of nonquantifiable costs, such as 

the loss of productivity, recertifying equipment or bringing it offline for 

inspection, and loss of agent viability from repeated thawing and freezing 

of agents. Although only 5 (11 percent) of surveyed entities reported that 

reduced viability of inventory was a moderate to significant cost, a 

preliminary study at the Dugway Army Proving Ground on the viability of 

agent vials that had undergone multiple inspections found reductions in 

agent viability, with a 100 percent loss of viability in a few cases.27 While 

the costs of reduced or lost viability are difficult to determine, a strain that 

existed in only a single vial would be impossible to replace. Furthermore, 

loss of agent viability can damage research opportunities and 

experimental findings.

Focus group participants also noted that multiple inspections reduce an 

entity’s competitiveness for grant money, although most surveyed entities 

found this a negligible cost. In addition, inspection time must be factored 

into grant proposals. And because inspections affect the research cycle, 

the time it takes to complete research and the overall costs of the 

research increase when entities experience multiple inspections. For 

example, some participants noted the costs of their entity’s grant 

 

27Freezing and thawing have been shown to damage the cytoplasmic membrane, cell 

wall, and DNA. When the cytoplasmic membrane is damaged, low molecular weight 

materials (such as potassium and magnesium cations [K+, Mg2+], inorganic phosphate, 

and amino acids) are lost from the cell, and there is an increased penetrability of small 

molecular weight compounds, such as toxic metals, into the cell. Researchers have 

attributed cell death and injury to one or both of these processes. 
 

Page 26 GAO-13-154 Overlap and Duplication

proposals are higher than others’ because of the “overhead” costs they 

must build in for their multiple biosafety and biosecurity inspections. In 

addition, the time to conduct research is affected when laboratories have 

to suspend research for inspections. Undergoing multiple inspections 

exacerbates this problem. Some participants noted that the granting 

community knows that if laboratories are frequently inspected, the work 

will not get done by the desired deadlines, affecting the communities’ 

willingness to award grants to these entities.

Inspections are essential in ensuring biosafety and biosecurity 

requirements are met and SAR regulations are followed. Most surveyed 

entities reported that multiple inspections positively affect (1) actions to 

correct deficiencies, (2) coverage in helping to identify problems, (3) the 

strength of inventory management and accountability, and (4) justification 

for additional resources to improve operations. However, many entities 

also noted multiple inspections negatively affect lab operations. In 

particular, most surveyed entities reported that multiple inspections 

negatively affect (1) lab productivity, (2) staff morale, (3) the time to 

complete research, and (4) the research schedule. While some entities 

reported negative effects to (1) the physical viability of inventory, (2) staff 

retention, and (3) staff recruitment, a greater majority of entities reported 

these issues were unaffected by multiple inspections (see table 9 for 

effects of multiple inspections).

While Multiple Inspections 

Can Improve Lab 

Operations, They Can Also 

Negatively Impact Lab 

Operations 
 

Page 27 GAO-13-154 Overlap and Duplication

Table 9: Effects of Multiple inspections, According to Surveyed Entities 

Negative Effect No Effect Positive Effect

Don’t know/ 

Not checked

Q9B. Lab productivity 32 12 2 1 

Q9H. Staff morale 27 15 3 2 

Q9C. Time to complete research 25 18 1 3 

Q9D. Research schedule 22 20 1 4 

Q9E. Physical viability of inventory 12 31 1 3 

Q9F. Staff retention 10 34 0 3 

Q9A. Competitiveness for research funding 9 26 4 8 

Q9J. Actions to correct deficiencies 8 13 25 1 

Q9G. Staff recruitment 6 36 0 5 

Q9L. Ability to have specialized inspections in which 

agencies focus on different areas 4 25 11 2 

Q9M. Coverage in helping to identify problems 3 22 20 2 

Q9K. Justification for additional resources to improve 

operations 0 27 18 2 

Q9I. Strength of inventory management and accountability 1 25 20 1 

Q9N. Other effect 8 7 2 30 

Source: GAO analysis of survey data.

Focus group participants also noted some positive aspects of multiple 

inspections, among them having an “extra set of eyes” or a layer of 

oversight on laboratory operations to identify areas of need. In addition, 

inspection report findings, can provide funding justification for resources 

and staff, validate good laboratory practices, and identify needed quality 

assurance improvements. However, some focus groups participants also 

noted that the amount of time spent on inspections slows down the 

science and that while inspections may help get the laboratory renovated, 

they do not actually improve the science. Others participants noted that 

oversight functions in laboratories, such as quality assurance, are 

growing faster than the research community. Finally, one survey 

respondent noted that multiple inspections do not allow the laboratory to 

have the time necessary to implement lessons learned in a meaningful 

time frame.
 

Page 28 GAO-13-154 Overlap and Duplication

Actions to reduce the costs and negative effects of overlapping and 

duplicative inspections include better coordination and greater 

consistency in the application of standards, according to various experts 

and surveyed entities. Both the HHS-USDA Trans-Federal Task Force 

and the Executive Order Working Group on Strengthening the Biosecurity 

of the United States recommended enhancing the coordination of 

biosafety oversight activities, including inspections. In addition, our earlier 

work on select agent laboratories recommended a single coordinating 

agency as a means to improve coordination.28 Accordingly, CDC and 

APHIS have taken steps to better coordinate inspections with other 

agencies, for example, by increasing the use of joint inspections, signing 

MOUs for sharing inspection information with other agencies, establishing 

an inspector training program for federal partners, and developing a 

common “playbook” for inspection of registered entities.29 Such 

coordination efforts are important steps in reducing overlap and 

duplication. However, MOUs and joint inspections may not fully address 

the negative effects of overlap and duplication if inspectors are still 

applying standards inconsistently and preparing separate reports of 

findings. Specifically, according to surveyed entities, standards must be 

applied more consistently between agencies and from one inspection to 

another. It is this inconsistent application of standards that exacerbates 

the negative effects, including costs, of overlapping inspections. 

According to surveyed entities, the most effective actions for greater 

consistency in the application of standards include (1) ensuring inspectors 

are well trained and experienced, (2) establishing a single set of 

inspection standards that all agencies accept, (3) providing an opportunity 

to discuss, clarify, and rebut inspection findings, and (4) training 

inspectors to one set of standards with requirements for noncompliance 

findings (see table 10). Well-trained inspectors, who are able to apply 

consistent standards, would reduce the negative effects of overlapping 

inspections. In particular, they might reduce overlap by allowing federal 

agencies to accept each other’s inspection results. Such a result is 

facilitated by joint training, according to DOD officials. Without a 

consistent standard, however, highly trained inspectors would not be 

effective, according to some surveyed entities. In addition, according to 

 

28GAO, High-Containment Laboratories: National Strategy for Oversight Is Needed, 

GAO-09-574 (Washington, D.C.: Sept. 21, 2009). 

29Resource Manual for Agencies Conducting Site Visits of Entities with Biological Select 

Agents and Toxins. 

A Coordinated 

Approach with 

Consistently Applied 

Standards is 

Recommended by 

Earlier Reports and 

Surveyed Entities
 

Page 29 GAO-13-154 Overlap and Duplication

most surveyed entities, a 3-year federal inspection cycle for select agent 

entities was reasonable.30 Focus group participants also suggested 

options for minimizing the potential for overlapping or duplicative 

inspections and the associated burden, such as having a single 

inspecting agency whose findings are accepted by all other agencies and 

improving the knowledge and skills of inspectors.

Table 10: Solutions to the Negative Effects of Multiple Inspections, According to Surveyed Entities

Effective Neither Ineffective 

Don’t know/ 

Not checked

Q12G. Ensuring inspectors are well trained/experienced 45 1 1 0 

Q12D. Establishing a single set of inspection standards that all 

agencies accept (in areas where authorities overlap) 42 2 3 0 

Q12I. Providing an opportunity to discuss, clarify, and rebut 

inspection findings 42 4 1 0 

Q12F. Training inspectors to one set of standards with requirements 

for non-compliance findings 40 1 5 1 

Q12C. Designating a single agency with inspection authority 33 6 3 5 

Q12E. Inspecting to requirements rather than best practices 33 2 9 3 

Q12A. Conducting joint inspections 28 8 9 2 

Q12H. Training lab staff about the different agency missions and 

purposes for inspecting 28 9 10 0 

Q12B. Establishing an inspection czar (i.e., an individual who directs 

and coordinates SA inspection programs and strategy) 24 7 7 9 

Q12J. Other 5 2 0 5 

Source: GAO analysis of survey data.

In addition to scaled responses, surveyed entities provided written 

suggestions for reducing the negative effects of multiple inspections. 

While several entities expressed support for a single inspecting agency or 

joint inspections, others felt that addressing overlap alone would be 

insufficient when the same agency applies different standards in each

inspection. In support of inspections being conducted by a single agency, 

entities noted that at least the inconsistent application of standards across 

 

30The SAR does not define the frequency of inspections. However, to ensure that the 

entity is in compliance with the SAR, CDC or APHIS inspects the premises and records of 

applicants, including a review of all required plans, before issuing the initial certificate of 

registration or 3-year renewal.

Reducing the Negative 

Effects of Multiple 

Inspections 
 

Page 30 GAO-13-154 Overlap and Duplication

agencies and frustration over trying to comply with two different agency 

regulations would be minimized. Surveyed entities highlighted the 

inherent conflict that arises when agencies come to different conclusions 

about an entity’s compliance. For example, one noted that because there 

is no agency “in complete control,” entities cannot determine which 

agency is correct when there is conflict in inspection reports. And a DOD 

entity wondered about the implication for CDC—which approved the SAP 

registration—if DAIG recommends the shutdown of a lab. While some 

thought an independent agency or an inspection czar would be a useful 

neutral party, others expressed concern that such an entity would just add 

another level of bureaucracy or require unnecessary new legislation. 

Because of entities’ familiarity with CDC, one noted that they would not 

want to have a single agency unless it was CDC. However, another noted 

it was uncertain how useful a single agency with authority to audit would 

be because there would be a period of mixed messages while each 

agency has its say. And so far, the entity had not seen government 

agencies “play well together as a team.” 

In addition, while some thought joint inspections might address the 

negative effects of overlap, others thought they would exacerbate the 

problem because agency coordination—in terms of consistent 

interpretations and applications of standards—was still a concern.31 In 

support of joint inspections, some felt they facilitated agency coordination 

and reduced duplication. Others noted that joint inspections are a better 

use of time and resources, reducing disruption and burden. In addition, 

joint inspections could help bring more uniformity and clarity for the 

inspection agencies and entities. For example, according to DAIG 

officials, they have taken steps to address these issues in joint 

inspections with CDC and APHIS. During joint inspections, the agencies 

discuss and resolve differences of interpretation so there is one 

“inspector” face to the inspected facility, and except for major findings, 

DAIG does not duplicate the findings of the other agency. However, 

noting recent inspections by two different agencies, one entity reported 

that having them at the same time would have made the inspection longer 

and more grueling. Joint inspections also require the entity to provide 

escorts and enough PPE for everyone entering the facility, a large 

expense when considering how many PPEs and escorts are needed for 

 

31Only 34 percent (16) of surveyed entities had experienced a joint inspection.
 

Page 31 GAO-13-154 Overlap and Duplication

some joint inspections.32 In addition, (1) combined inspections may still 

result in multiple reports the entity must respond to and (2) having two 

teams do what a single team can do is still an additional burden on the 

taxpayer. Nonetheless, the burden that results from inconsistent 

application of standards could be minimized if agencies (1) conducting 

joint inspections issued a single report of findings or (2) instead of 

conducting a separate or joint inspection, accepted each others’ 

inspection findings in lieu of conducting their own inspections.

Regardless of whether a single agency is responsible or joint inspections 

are conducted, numerous respondents focused on the need for consistent 

application of standards by well-trained inspectors. Respondents’ 

concerns focused on the inconsistent application of standards that can 

occur, not only between agencies, but from one inspection to another.

While the problem may be exacerbated by overlapping inspections, the 

burden results from inconsistency, not overlap per se. For example, one 

entity noted that the biggest problem with multiple inspections by different 

agencies is that each has its own agenda, so establishing inspection 

standards that are accepted by all agencies would have the greatest 

effect on reducing the negative effects of multiple inspections. Another 

noted that a common set of requirements and interpretations would 

significantly reduce variation in compliance assessments. Reflecting on 

the additional burden to Army laboratories, one entity noted, “Ideally the 

set of standards that would be accepted would be the same federal 

standard that all organizations, not only DOD organizations, would be 

held to. This would not only reduce the burden of multiple inspections but 

also level the playing field between DOD and academia which would 

increase collaboration between laboratories.” Some noted that this might 

facilitate sufficient trust for agencies to accept each other’s inspection 

results. If all inspections were based on the same standard, with a 

checklist to keep them consistent, and all inspectors were trained 

together and required to use the published standard and checklist, the 

need for multiple inspections would be decreased or eliminated. Despite 

the support for greater consistency, some cautioned against the 

application of a “checklist mentality.” For example, one surveyed entity 

noted that too many inspectors for their select agent program had been 

 

32Select Agent Program (CDC and APHIS) inspectors generally use their own PPE for 

inspections

Training to Consistently 

Apply Standards Is Needed
 

Page 32 GAO-13-154 Overlap and Duplication

rigid and unbending, sticking to a checklist rather than common sense. 

Training can support efforts to consistently apply standards, while still 

allowing the flexibility for inspectors to have essential discussions with 

entities to establish rapport, exchange information, and understand why 

certain procedures and policies are in place in any given facility.

Surveyed entities offered a variety of other suggestions, such as (1) 

limiting the number of inspectors and days for inspections; (2) 

streamlining inspections, including the number of inspectors on the team, 

and coordinating areas of focus within the team to lessen the burden on 

the laboratories; (3) having an advisory group of ROs to give feedback to 

the inspection agency, regulatory agency, or GAO; (4) dividing inspection 

elements among the inspecting agencies, on the basis of their strengths; 

(5) staffing inspection teams for consistency and historical knowledge; (6) 

training all inspectors together to help ensure consistent inspections; and 

(7) giving entities credit for moving in the right direction. While none of the 

written comments suggested reducing the inspection cycle, almost half of 

surveyed entities noted that a 3-year federal inspection cycle for select 

agent laboratories was reasonable. The agencies have taken some steps 

to address these concerns. For example, after we had initiated our work, 

CDC and APHIS convened an Interagency Working Group that includes 

representatives from DHS and DOD, as well as other federal agencies. 

So that effective oversight can be achieved with minimal disruption, the 

working group is developing procedures and policies to better coordinate 

the inspections of entities that are federally owned or funded, improve 

information sharing between agencies, and implement other activities. For 

example, the working group has initiated a joint inspection program 

through which it has, so far, conducted 24 joint inspections. In addition, it 

has MOUs with DHS and DOD to share inspection data and an inspectortraining program to provide the knowledge, skills, and experience to 

federal agencies to enable them to conduct “internal” inspections of 

registered entities they own or fund or to conduct joint inspections with

CDC or APHIS.

Inspections are important for safety and compliance and can help 

improve laboratory procedures, infrastructure, and security. However, the 

value of inspections may be diminished when federal agencies are (1) 

expending resources to conduct the same or similar work and (2) 

burdening entities with overlapping or duplicative inspections. While one 

could argue that more-frequent inspections might be necessary to better 

ensure safety—in particular for larger entities—there is no apparent 

value-added when specific inspection activities are duplicative and occur, 

Conclusions 
 

Page 33 GAO-13-154 Overlap and Duplication

in some cases, before entities have had time to respond to findings from 

a previous inspection. In addition, most surveyed entities reported a 

federal inspection schedule of once every 3 years was reasonable; more 

frequent—especially duplicative—inspections waste federal dollars and 

can negatively affect lab operations. This effect on lab operations also 

wastes federal dollars because many of the laboratories are federally 

funded through grants or appropriations. To improve interagency 

coordination and reduce the potential for overlap and unnecessary 

duplication, a single coordinating agency could be helpful. Such a 

coordinating agency need not be responsible for conducting all 

inspections. Rather, where agencies can demonstrate that they meet 

SAR standards for their inspections, their inspections could be used in 

lieu of other agency inspections. Currently, the primary agencies with 

regulatory authority, CDC and APHIS, have taken steps toward better 

coordination through the interagency working group. However, CDC and 

APHIS have not been officially charged with overseeing or coordinating 

all inspection efforts and the other federal agencies may still inspect an 

entity regardless of how recently another agency has conducted an 

inspection. Moreover, consistent application of inspection standards—

both across and within the agencies—is needed to reduce the negative 

effects of multiple inspections on lab operations. Further, cross-agency 

training efforts could facilitate consistent learning and application of such 

standards. Agencies could then better target their inspection time and 

resources, and entities could better prepare for and respond to federal 

inspections.

In order to eliminate overlapping and potentially duplicative inspections, 

as well as reduce the burden of such overlap and duplication on select 

agent entities, we recommend that CDC and APHIS, as the primary 

agencies with regulatory authority, work with DHS and DOD to (1) 

coordinate inspections of select agent entities and (2) where possible, 

use mechanisms such as (a) joint inspections with a single report of 

findings, (b) acceptance of each other’s inspection results rather than 

independent inspections, and (c) cross-agency training opportunities to 

ensure consistent application of biosafety, biosecurity, and 

biocontainment inspection standards.

We provided a draft of this report to HHS, USDA, DOT, DHS, and DOD 

for review and comment. DOT did not provide any comments. In its 

written comments, reproduced in appendix III, HHS agreed with our 

recommendations. HHS noted that DOT, DHS, and DOD have different 

Recommendations for 

Executive Action

Agency Comments 

and Our Evaluation
 

Page 34 GAO-13-154 Overlap and Duplication

authorities than the federal select agent program (SAP), as we had 

outlined in the background section of this report. HHS stated that it 

already has a number of activities underway related to reducing overlap 

and duplication in inspections. Specifically, through the working group for 

Optimizing the Security of Biological Select Agents and Toxins in the 

United States, HHS’s Federal Select Agent Program has developed 

procedures and policies to better coordinate inspections of federally 

owned or funded entities and to improve information sharing between 

departments and agencies. HHS initiated three programs to accomplish 

these goals: (1) a joint inspection program, (2) inspection information 

sharing MOUs, and (3) an inspector training program. HHS has so far 

conducted 24 joint inspections, signed inspection information sharing 

MOUs with five agencies, and trained five individuals from DHS and four

individuals from DOD. HHS also plans another training session for spring 

2013 to educate federal agencies about recent revisions to select agent 

regulations. HHS also provided technical comments, which we 

incorporated as appropriate. 

In its written comments, reproduced in appendix IV, USDA agreed with 

our recommendations. Although USDA noted that it did not believe its 

activities were overlapping with DOD and DHS because of differences in 

inspection authorities and agency missions, it noted that it had a number 

of activities underway to reduce overlap and duplication in inspections. 

Along with CDC—USDA’s partner in overseeing the select agent 

program—USDA noted that it is conducting joint inspections to minimize 

the number of select agent inspections, signing information sharing 

MOUs with several agencies to share inspection data, and conducting 

inspector training programs to provide knowledge, skills, and experience 

to federal partners. USDA also provided technical comments, which we 

incorporated as appropriate. 

In its written comments, reproduced in appendix V, DHS agreed with our 

recommendations. DHS notes that its Regulatory Compliance Office 

collaborates with officials and inspectors at CDC and APHIS to plan joint 

inspections, share information, and consult on inspection findings in order 

to reduce the burden on inspected institutions. Specifically, DHS signed 

an MOU with CDC and APHIS that outlines how the parties will 

coordinate joint inspections in order to reduce the burden on entities and 

to facilitate coordination of oversight efforts between the agencies. In line 

with our recommendations, DHS now accepts the results of inspections 

conducted jointly with CDC or APHIS instead of conducting independent 

inspections or generating a DHS-specific report of findings. DHS has also 
 

Page 35 GAO-13-154 Overlap and Duplication

taken advantage of cross-agency training to ensure consistent application 

of biosafety, biosecurity, and biocontainment inspection standards. 

In its written comments, reproduced in appendix VI, DOD agreed with our 

recommendations. DOD noted that certain DOD regulations require 

compliance inspections for areas, such as the personnel reliability 

program (PRP), that are in addition to the SAR. We recognize some 

requirements are agency-specific and do not suggest that they be 

eliminated. We do recommend, however, that the burden on entities be 

reduced through coordination with other SAR inspection activities. In line 

with our recommendations, we are encouraged that DOD has several 

initiatives to coordinate with CDC and APHIS to reduce overlap and 

duplication of inspections. For example, the Army and Navy have signed 

information sharing memorandums of agreement and understanding with 

CDC and APHIS to coordinate inspections of select agent agencies, 

through which they conducted the first CDC, DOD, and Army joint 

inspection in spring 2011. Although the Air Force does not have an MOU 

with CDC or APHIS for its one facility, it accepts the CDC inspection 

results and performs its own PRP inspection. During joint inspections, 

DOD notes that it develops an inspection plan with CDC, APHIS, and the 

entity, and coordinates with the agencies to minimize entries into 

inspected areas by inspecting an area together. While two separate 

reports are written, the DAIG notes that it generally does not replicate 

CDC findings of noncompliance with SAR standards. Findings are 

discussed to ensure a common understanding of the standards and what 

was observed, and to delineate between what is required by the SAR, 

DOD, and DAIG. While DOD notes that it is unclear whether it would or 

could accept a CDC or APHIS inspection report in lieu of its own 

inspection, these joint efforts are still new and the issue will evolve with 

further collaboration. Additionally, DOD is revising its biological and 

chemical agent security policies in order to harmonize them with the 

recently revised SAR. DOD also noted other steps it has taken to 

coordinate oversight efforts though the Working Group, such as 

developing the charter and implementation plan for the current federal 

“joint” inspections process, and developing tools, such as the inspector 

training program and playbook, to administer the joint inspection process. 

DOD also made some technical comments, which we incorporated as 

appropriate. 

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 Health 
 

Page 36 GAO-13-154 Overlap and Duplication

and Human Services, Agriculture, Transportation, Homeland Security, 

and Defense, the appropriate congressional committees, and other 

interested parties. In addition, the report will be available at no charge on 

the GAO website at http://www.gao.gov. 

If you or your staff have any questions about this report, please contact 

me at (202) 512-2700 or kingsburyn@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 VII. 

Nancy Kingsbury, Managing Director

Applied Research and Methods
Appendix I: Scope and Methodology

Page 37 GAO-13-154 Overlap and Duplication

To assess (1) the extent of overlap and potential duplication in federal 

agencies’ inspections of entities that work with select agents, (2) the costs 

of overlapping federal inspections and effects on laboratory operations, 

and (3) actions to reduce the costs and negative effects of overlapping 

inspections, we interviewed agency officials, reviewed pertinent 

legislation, regulations, and agency documents. Specifically, we spoke 

with officials from the Center for Disease Control and Prevention (CDC) 

Division of Select Agents and Toxins, the Department of Agriculture’s 

Animal and Plant Health Inspection Service (APHIS), the Department of 

Transportation’s (DOT) Pipeline and Hazardous Materials Safety 

Administration (PHMSA), the Department of Defense (DOD) military 

service Inspector General’s offices, including the Department of the Army 

Inspector General (DAIG), Navy Inspector General, and Air Force 

Inspector General offices. We also spoke with interest groups, such as 

the American Biological Safety Association (ABSA), and officials at 

various Army, private, academic, and federal select agent entities.

To assess the extent of overlap and potential duplication in federal 

agencies’ inspections of entities that work with select agents, we (1) 

identified 374 entities registered to work with select agents between fiscal 

years 2009 and 2011, (2) analyzed inspection data to identify registered 

entities that had been inspected by more than one agency on separate 

occasions in a 2-year period (at any point between fiscal years 2009 and 

2011), and (3) surveyed those entities to assess the extent of duplication 

in inspection activities. In order to operationalize overlap, we relied on our 

2011 duplication report, in which we define overlap as multiple agencies 

or programs having similar goals, engaging in similar activities or 

strategies to achieve them, or targeting similar beneficiaries.1 CDC, 

APHIS, DHS, DOD, and DOT inspections are directed toward a similar 

goal—assessing biosafety and biosecurity compliance—and are 

accomplished through a similar strategy, the inspection process. When 

these inspections targeted the same entities, we counted the inspection 

as overlapping. Specifically, we analyzed fiscal year 2009 through July 

2011 inspection data from CDC, APHIS, DHS, DOD, and DOT, and 

identified any instances where two different agencies had inspected the 

same entity on separate occasions within 2 years of each other. We 

counted joint inspections as a single inspection in our analysis, regardless 

 

1

GAO, Opportunities to Reduce Potential Duplication in Government Programs, Save Tax 

Dollars, and Enhance Revenue, GAO-11-318SP (Washington D.C.: March 2011).

Appendix I: Scope and Methodology
Appendix I: Scope and Methodology

Page 38 GAO-13-154 Overlap and Duplication

of the agencies involved. For example, joint APHIS/DHS inspections or 

CDC/DAIG inspections were counted as one inspection. We chose the 2-

year time frame because the Select Agent Regulations (SAR) require 

certification renewal every 3 years and it is the policy of CDC and APHIS 

to inspect the entity before recertifying, this represents a somewhat 

conservative measure of overlap.2 Because CDC and APHIS manage the 

Select Agent Program (SAP) jointly and conduct joint inspections, where 

applicable, we collapse these agencies in reporting on overlap to show 

where DOT, DHS, or DOD inspections overlapped with either a CDC or 

APHIS inspection. We also relied on our 2011 report for our definition of 

duplication—when two or more agencies or programs are engaged in the 

same activities or provide the same services to the same beneficiaries. 

The entities experiencing overlap were identified from the population of 

374 entities registered with CDC or APHIS at any point in the 3-year

period. Some entities register and de-register each year, so the number 

of entities registered at any point in the 3-year period will differ from a 

single point-in-time number of registered entities. Using the number of 

entities registered at any point in the 3-year period, the extent of overlap 

as we have defined it is 15 percent. To estimate the likelihood that an 

entity would experience overlap in federal inspections, we developed a 

logistic regression model, using the following entity characteristics: the 

number of laboratories, the highest biosafety level (BSL) of laboratories 

within an entity, and the number of different select agents the entity works 

with. The model did not include the number of staff or the number of 

principal investigators, both of which are strongly correlated with the 

number of laboratories. We chose to include the number of laboratories in 

 

2

However, because the CDC and APHIS can inspect between renewals, the 2-year time 

frame also captures overlap that may occur as a result of additional CDC/APHIS 

inspections within the 3-year period.
Appendix I: Scope and Methodology

Page 39 GAO-13-154 Overlap and Duplication

the model because it was a stronger predictor of the likelihood, on the 

basis of the Wald chi-squared test, than these two characteristics.3

To assess the extent of duplication in the overlapping inspections, we 

surveyed the 55 entities that had been inspected by more than one 

agency in a 2-year period (that is, the population experiencing overlap).4

The web-based survey of all such entities gathered information on the (1) 

extent to which there was duplication in specific inspection activities 

related to the preparation, execution, and close-out phases of the two 

inspections the entities had undergone, (2) costs and operational effects 

of inspections, (3) solutions for mitigating the negative effects of multiple 

inspections, and (4) positive and negative aspects of joint inspections 

(see app. II for a copy of the survey).The survey was sent to the RO of 

each entity, and we received an 86 percent response rate, with 47 of the 

55 entities responding. To gather preliminary information and develop our 

survey, we conducted focus groups with about 50 laboratory workers from 

entities that have experienced federal inspections, including responsible 

officials, biosafety officers, principal investigators, and technical staff from 

federal, academic, and private entities that work with select agents. To 

understand general and agency specific inspection activities, we 

interviewed inspectors with CDC, APHIS, DHS, DOD service IGs, and 

DOT and examined inspection files. We also spoke with professional 

organizations such as the ABSA and the American Society for 

Microbiology and experts in the safety of select agent laboratories.

 

3

The goal of our logistic regression analysis was to model the likelihood that a lab 

received duplicate inspections. The duplicate inspection was the dependent variable in 

the analysis (duplicate inspection or not), with three independent variables; the (1) number 

of laboratories, (2) highest BSL level, and (3) number of different select agents. We did 

not include the number of staff and the number of principal investigators in the model 

because these variables were strongly correlated with the number of laboratories and the 

model only needed one of these three independent variables to explain much of the same 

variation in the dependent variable. To determine which of the three would be the best to 

include in the model, we first fit a bivariate logistic model separately for each of these 

three independent variables. Next, we fit three multivariable models by including the one 

of these three variables along with the highest BSL level, and the number of different 

select agents. We then compared the Wald chi-square estimates to determine which of 

the three was a stronger predictor of the likelihood of duplicate inspections. The number 

of laboratories was our final choice.

4

We did not count instances where an entity had been inspected by the same agency 

more than once in a 2 year time frame as overlapping. 
Appendix I: Scope and Methodology

Page 40 GAO-13-154 Overlap and Duplication

We took several steps to ensure the reliability of survey responses and 

the analytical process. To ensure the content and wording of the survey 

were clear, accurate, unbiased, and nonburdensome, we solicited 

subject-matter expert reviews from affected agencies (CDC, APHIS,

DAIG, and PHMSA), an interest group (ABSA), and an internal (GAO) 

survey expert. We also pretested the survey with lab staff from a variety 

of laboratories, including an Army lab, an academic lab, a private lab, and 

a large federal lab. The survey was deployed through the web, and each 

respondent had a unique user identification and password. To increase 

the response rate, follow-up e-mail and telephone calls were made to

nonrespondents. Once we had reached an 80 percent response rate, we

reviewed responses for (1) item nonresponse, (2) obvious errors or 

outliers in responses, and (3) “no” answers to question 1. We then 

followed up with respondents, as necessary, to get additional information 

and clarification. Changes identified through this process were recorded, 

and appropriate response cleaning was conducted in the analysis. To 

eliminate data-processing errors, the computer program that generated 

the survey results was independently verified by an internal SAS expert 

who was not involved in the engagement.

To assess the costs of overlapping federal inspections and the effects on 

laboratory operations, we (1) analyzed agency budget data and (2) 

gathered data from focus groups and our survey of entities on the costs 

and effects of inspections. Specifically, to assess the costs to the federal 

government, we requested information on the government and contracted 

staff involved in inspections and their total compensation (salary and 

benefits), the number of hours spent on inspection activities, and the 

associated travel costs for inspections for fiscal years 2010 and 2011.

DHS was unable to provide detailed cost data as requested because their 

inspections of select agent laboratories are provided under a contract that 

does not identify labor hours, hourly contract rates, salaries, and benefits. 

But DHS did provide an estimate of the cost of inspections for fiscal years 

2010 and 2011. This estimate was based on assumptions about typical 

staffing levels and costs for the most-common types of inspections, 

multiplied by the number of inspections conducted in each fiscal year. 

While DHS believes these estimations include travel costs, they do not 

include training costs. DOT was not able to provide cost data that include 

travel, because their system does not distinguish between inspection 

travel and other travel. As a result, DOT inspection amounts reflect only 

compensation costs. To assess the reliability of agency data on the costs 

of inspections, we provided the agencies with a detailed data-collection 

instrument with specific data requests and precalculated formulas. We 

reviewed the data for obvious errors, compared these data with cost data 
Appendix I: Scope and Methodology

Page 41 GAO-13-154 Overlap and Duplication

from earlier fiscal years, and followed up with officials to discuss data 

reliability, significant changes across fiscal years, obvious errors, or 

omissions. We determined these data were sufficiently reliable for our 

purposes, which was to provide the approximate aggregate federal costs 

of inspections for the four agencies.

To assess the costs to entities, we asked surveyed entities to provide 

labor and cost information about the most recent inspection identified in 

our overlap analysis (see app. II, question 6, for specific wording). 

Specifically, we requested data for five occupational groups that tend to 

be involved in federal inspections, including (1) ROs and Alternate 

Responsible Officials, (2) Principal Investigators, (3) owners or 

controllers, (4) laboratory staff, and (5) support staff (security, 

administrative, maintenance, and information technology). We asked 

entities to provide the number of staff involved and the total labor hours 

spent by each occupational group, as well as the average salary for each 

group. We used these data to develop overall averages of the personnel 

and labor costs entities experience as a result of inspections by each one 

of the five federal agencies in our review. For data reliability purposes, we 

checked for outliers or obvious errors and followed up where such issues 

were identified. We calculated the average cost of an inspection by 

dividing the average (yearly) salary by 2080 to get an hourly rate, and 

then multiplied that by the number of labor hours provided. We also 

surveyed entities about nonquanitifable costs and the operational effects 

of multiple inspections and analyzed comments related to costs from our 

focus groups of lab staff.

To assess actions to reduce the costs and negative effects of overlapping 

inspections, we interviewed agency officials and interest groups, reviewed 

key reports addressing the issue, and analyzed comments related to 

solutions from our focus groups of lab staff. In addition, in our survey, we 

sought entities’ opinions about solutions for overlapping inspections, 

including their experiences with joint inspections, which have been 

proposed as a solution for minimizing inspection duplication.

We conducted our work from March 2011 through January 2013 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.
Appendix II: Survey of Select Agent Entities Experiencing 

Overlapping Inspections 

Inspections of Select Agent Registered Entities 

U.S. Government Accountability Office 

Welcome to the GAO survey on inspections of Select Agent (SA) entities. To complete this survey, you may 

consult with others in your lab, as necessary. Your responses to this web-based survey are essential in order for 

us to provide complete and accurate information on these issues to Congress. 

We will use your responses, together with the responses of other recipients, to develop aggregate statistics, 

observations, and findings. The identities of individual respondents will not be disclosed in our final report. 

For questions, contact Jason Fong at fongj@gao.gov or 202-512-xxxx. 

If you experience technical problems with this web questionnaire, please contact Rebecca Shea at shear@gao.gov 

or 202-512-xxxx. 

Important! JavaScript must be enabled on your browser in order to use this web questionnaire. 

Survey Sections 

 

This survey has 7 main sections covering the following key issues: 

1. Inspecting Agencies 

2. Inspection Activities: 

 a. Preparation 

 b. Execution 

 c. Close-out/response 

3. Quantifiable Costs of Inspections 

4. Non-quantifiable Costs of Inspections 

5 Effects of Multiple Inspections 

6. Solutions 

7. Joint Inspections 

Click on "Menu" to the left of this screen to display a navigation panel that can be used to move from section to 

section. 

Click on the "Summary" to the left of this screen to print a copy of the survey. 

Page 42 GAO-13-154 Overlap and Duplication
Abbreviations and Scope 

 

AAALAC Association for Assessment and Accreditation of Laboratory Animal Care 

APHIS Department of Agriculture's Animal and Plant Health Inspection Service 

BSC Biosafety cabinet 

BSO Biosafety Officer 

CDC Department Health and Human Services' Centers for Disease Control and Prevention 

DAIG Department of the Army's Inspector General 

DHS Department of Homeland Security 

DOE Department of Energy 

DOT Department of Transportation 

EPA Environmental Protection Agency 

NIH National Institutes of Health 

OSHA Occupational Safety and Health Administration 

PI Principle investigator 

RO Responsible official (CDC designated) 

SA Select Agent 

UN certified packaging designed/tested in accordance with specifications of the United Nations Committee of 

Experts on the Transport of Dangerous Goods 

Unless otherwise specified, the questions in this survey apply only to inspections for biosafety and 

biosecurity as required under Select Agent regulations or by those agencies that own or fund your entities' 

Select Agent research. 

Respondent Information 

 

Please check the following information for accuracy. If you need to make changes, please do so in the 

appropriate editable field(s) below. 

 

 Respondent Name 

 

 

 Respondent Title 

 

 

 Respondent email address 

 

 

 Respondent telephone 

 

 

Page 43 GAO-13-154 Overlap and Duplication
Inspecting Agencies 

1. GAO received inspection data from CDC, APHIS, DHS, DOT, and DAIG, and identified your entity (lab) as 

one that has been inspected by more than one of these agencies within the past 2 years. Specifically, these data 

indicate your lab was inspected by the following agencies in the past 2 years: ______ in ______ and ______ in 

______. 

Is this correct? 

 

 Yes (GO TO QUESTION 2)

 No 

 Don't know 

 

1a. If the information above is not correct, please note the necessary corrections in the space below. 

 

2. States, local governments, accrediting bodies (such as AAALAC and the Joint Commission), military 

organizations (such as the Medical Command and Army Material Command), and other federal entities such as 

NIH, OSHA, EPA, and DOE might also inspect SA registered labs. 

If your lab was inspected in the past 2 years by any other entities (for SA compliance or other reasons), 

please provide the name of the inspecting entity and inspection date. 

 

2a. Other inspecting entity and date of inspection: 

2b. Other inspecting entity and date of inspection: 

2c. Other inspecting entity and date of inspection: 

2d. Other inspecting entity and date of inspection: 

2e. If you would like to describe any areas of overlap between these "other" inspections and the inspections 

your lab has received from CDC, APHIS, DAIG, DHS or DOT, please do so in the space below. 

 

Page 44 GAO-13-154 Overlap and Duplication
Inspection Activities: Preparation 

 Inspections can be seen as taking place in 3 broad phases--(1) preparation, (2) execution, and (3) 

closeout/response-- with specific activities occurring in each phase. 

 

3. Thinking about your lab's inspections by ______ in ______ and ______ in ______, please indicate 

whether you performed the following preparation activities as part of your routine activities, specifically 

for each inspection, or not at all. 

Please note: not all listed activities are required as part of routine activities or for inspections. 

 

 

3a. Update and/or confirm records related to Select Agents and Toxins are current 

and accurate (e.g., records for inventory, training, security, biosafety, etc.) 

Q3a1. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q3a2. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

3b. Prepare and send requested documents to inspecting agency (hardcopy or electronic) 

Q3b1. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q3b2. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

Page 45 GAO-13-154 Overlap and Duplication
3c. Prepare all needed documentation for inspectors to review during visit (hardcopy or 

electronic) 

Q3c1. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q3c2. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

3d. Revise and update written safety and security plans (e.g., biosafety, 

incident response plans, cyber, personnel and physical security) 

Q3d1. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q3d2. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

3e. Verify the medical, security, or other credentials of inspectors 

Q3le. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q3e2. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

Page 46 GAO-13-154 Overlap and Duplication
3f. Conduct refresher training/briefings to staff on the inspection process and possible 

questions they may be asked 

Q3f1. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q3f2. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

3g. Arrange for staff (Primary Investigators (PI), Responsible official (RO), Biosafety Officers 

(BSO), animal handlers, etc.) to be present and available during the inspectors' site visit 

Q3g1. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Qfg2. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

3h. Schedule/reschedule activities (e.g., animal inoculations, experiments) to take place before 

or after the inspectors' site visit 

Q3h1. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q3h2. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

Page 47 GAO-13-154 Overlap and Duplication
3i. Decontaminate and prepare labs (i.e., go from a hot lab to a cold lab) 

Q3i1. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q3i2. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

3j. Check equipment calibration, and operation (e.g., pressure monitors, autoclaves, BSCs, etc.) 

Q3j1. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q3j2. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

3k. Check operation of critical infrastructure and maintenance records/certifications 

Q3k1. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q3k2. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

Page 48 GAO-13-154 Overlap and Duplication
3l. Ensure entry and exit doors are secure and alarm systems operating properly 

Q3l1. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q3l2. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

3m. Check the operation and condition of personal protection equipment 

Q3m1. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q3m2. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

3n. Verify that UN certified packagings have been properly labeled, tested, and assembled and 

the personnel trained for the use of these packagings

Q3n1. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q3n2. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

Page 49 GAO-13-154 Overlap and Duplication
3o. Check the Hazmat shipping documents were properly prepared, signed and maintained as 

required 

Q3o1. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q3o2. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

3p. Check Hazmat training records/documents concerning transportation responsibilities are 

current and available (e.g., general security and safety awareness, function specific) 

Q3o1. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q3p2. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

3q. Check transportation security plans have been updated and trained accordingly 

Q3q1. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q3q2. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

Page 50 GAO-13-154 Overlap and Duplication
3r. Other (describe below) 

Q3r1. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q3r2. Inspection with ______: 

Performed as part of routine activities 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

Other--describe 

 

Inspection Activities: Execution 

4. Thinking about your lab's inspections by ______ in ______ and ______ 

in ______, please indicate whether you performed the following 

execution activities specifically for each inspection. 

Please note: not all listed activities are required for all inspections. 

Participants can include any lab employee (RO, BSO, PI, laboratorians, 

etc.). 

 

4a. Hold entry meeting with inspectors 

Q4a1. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q4a2. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

Page 51 GAO-13-154 Overlap and Duplication
4b. Train inspectors on the use of Personal Protective Equipment (PPE) 

Q4b1. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q4b2. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

4c. Train inspectors on other issues (e.g., entry/exit, lab hazards, decontamination 

requirements, emergency procedures, alarm sounds, etc.)

Q4c1. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q4c2. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

4d. Conduct facility tour 

Q4d1. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q4d2. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

4e. Escort inspectors during inspection 

Q4e1. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q4e2. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Page 52 GAO-13-154 Overlap and Duplication
4f. Participate in select agent inventory verification 

Q4f1. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q4f2. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

4g. Participate in interviews with inspectors (to answer inspector questions and explain lab 

procedures and operations) 

Q4g1. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q4g2. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

4h. Perform safety or security demonstrations (e.g., emergency response walk-through) 

Q4h1. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q4h2. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

4i. Other (describe below) 

Q4i1. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q4i2. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Page 53 GAO-13-154 Overlap and Duplication
Other--describe 

Inspection Activities: Close-out/Response 

5. Thinking about your lab's inspections by ______ in ______ and ______ 

in ______, please indicate whether you performed the following closeout/response activities specifically for each inspection. 

Please note: not all listed activities are required for all inspections.

 

5a. Hold close out/exit conference with inspecting agency (where agency tells the entity the 

results of the inspection in broad terms) 

Q5a1. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q5a2. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

5b. Develop corrective action plan/report based on inspection findings 

Q5b1. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q5b2. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

Page 54 GAO-13-154 Overlap and Duplication
5c. Implement corrective actions 

Q5c1. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q5c1. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

5d. Train on new procedures 

Q5d1. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q5d2. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

5e. Provide documents to agency to show corrective actions have been taken 

Q5e1. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q5e2. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

5f. Undergo limited follow-up inspection by agency to verify corrective actions have been made

Q5f1. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q5f2. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

Page 55 GAO-13-154 Overlap and Duplication
5g. Bring equipment back online (e.g., HVAC, biosafety cabinets) 

Q5g1. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q5g2. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

5h. Other (describe below) 

Q5h1. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

Q5h2. Inspection with ______: 

Performed specifically for this 

inspection 

Did not perform 

Not applicable 

Don't know 

 

Other--describe 

 

Page 56 GAO-13-154 Overlap and Duplication
Quantifiable Costs of Inspections 

6. Thinking about your lab's inspection by ______ in ______, and using the list of activities for 

the preparation, execution, and close-out phases listed above, please provide the following 

information for each occupational category: 

(1) total number of personnel involved, 

(2) total labor hours spent, and 

(3) average salary for the occupational category 

Please include only individuals involved in the inspection. If none enter "0" 

6a. Responsible Official (RO) and Alternate Responsible Official (ARO) 

(1) Number of RO/AROs 

involved 

 

(2) Labor hours spent 

 

(3) Average salary 

$ 

6b. Principal Investigators (PI) 

(1) Number of PIs involved 

 

(2) Labor hours spent 

 

(3) Average salary 

$ 

6c. Owner/Controller 

(1) Number of 

owner/controllers involved 

 

(2) Labor hours spent 

 

(3) Average salary 

$ 

6d. Laboratorians 

(1) Number of laboratorians 

involved 

 

(2) Labor hours spent 

 

(3) Average salary 

$ 

6e. Support Staff (e.g., IT, Security, Admin, Animal Care, Maintenance, Janitorial) 

(1) Number of support staff 

involved 

 

(2) Labor hours spent 

 

(3) Average salary 

$ 

Page 57 GAO-13-154 Overlap and Duplication
Non-quantifiable Costs of Inspections 

Labs can incur non-quantifiable costs, such as loss of competitiveness or 

down-times in research. We are interested in the significance of such costs 

that are incurred as a result of federal inspections. 

 

7. In your opinion, how significant a cost, if any, did your lab incur in the 

following areas as a result of the inspection by ______ in ______? 

 Negligible 

cost Some cost 

Moderate 

cost 

Significant 

cost Don't know 

7a. Loss of productivity 

7b. Delays in funded research 

7c. Dollars lost in funded research 

7d. Decreased time to complete research 

7e. Reduced viability of inventory 

7f. Reduced competitiveness for research 

funding 

7g. Other costs 1 (describe below) 

7h. Other costs 2 (describe below) 

7i. Other costs 3 (describe below) 

 

Other costs of inspections #1 

 

Other costs of inspections #2 

 

Other costs of inspections #3 

 

 

8. If you would like to provide additional information about the costs of 

inspections, or context for your responses, please do so in the space 

provided below. 

Page 58 GAO-13-154 Overlap and Duplication
Effects of Multiple Inspections 

9. Thinking about the overall impact of having more than one federal inspection within the 

past 2 years, has having multiple federal inspections positively or negatively affected your 

lab operations in the following areas? 

 Significant 

negative 

effect 

Some 

negative 

effect No effect 

Some 

positive 

effect 

Significant 

positive 

effect 

Don't 

know 

9a. Competitiveness for research funding 

9b. Lab productivity 

9c. Time to complete research 

9d. Research schedule 

9e. Physical viability of inventory (i.e., 

resilience of the biological sample) 

9f. Staff retention 

9g. Staff recruitment 

9h. Staff morale 

 

 Significant 

negative 

effect 

Some 

negative 

effect No effect 

Some 

positive 

effect 

Significant 

positive 

effect 

Don't 

know 

9i. Strength of inventory management and 

accountability 

9j. Actions to correct deficiencies 

9k. Justification for additional resources to 

improve operations 

9l. Ability to have specialized inspections in 

which agencies focus on different areas 

(e.g., biosafety, security, animal 

husbandry, SA transport) 

9m. "Coverage" in helping to identify 

problems (i.e., more than one set of "eyes 

on the problem") 

9n. Other effect (describe below) 

 

9o. Other--describe 

Page 59 GAO-13-154 Overlap and Duplication
10. 

If you would like to provide context for your responses or additional 

information about the positive or negative effects of multiple federal 

inspections, please do so in the space provided below. 

 

11. In your opinion, what is a reasonable federal inspection cycle for select 

agent laboratories? 

1. More than once per year 

2. Once per year 

3. Every other year 

4. Every three years 

5. As needed 

6. Other 

 

11a. Please explain your response. 

 

Page 60 GAO-13-154 Overlap and Duplication
Solutions 

12. In your opinion, how effective would the following actions be in reducing the negative 

effects of multiple federal inspections?

 Very 

ineffective 

Somewhat 

ineffective 

Neither 

effective 

nor 

ineffective 

Somewhat 

effective 

Very 

effective 

Don't 

know 

12a. Conducting joint inspections 

12b. Establishing an inspection czar (i.e., an 

individual who directs and coordinates 

SA inspection programs and strategy) 

12c. Designating a single agency with 

inspection authority 

12d. Establishing a single set of inspection 

standards that all agencies accept (in 

areas where authorities overlap) 

12e. Inspecting to requirements rather than 

best practices 

 

 Very 

ineffective 

Somewhat 

ineffective 

Neither 

effective 

nor 

ineffective 

Somewhat 

effective 

Very 

effective 

Don't 

know 

12f. Training inspectors to one set of 

standards with requirements for noncompliance findings 

12g. Ensuring inspectors are well 

trained/experienced 

12h. Training lab staff about the different 

agency missions and purposes for 

inspecting 

12i. Providing an opportunity to discuss, 

clarify, and rebut inspection findings 

12j. Other (describe) 

12k. Other--describe 

 

Page 61 GAO-13-154 Overlap and Duplication
13. Please explain why you think the actions above would or would not be 

effective at reducing the negative effects of multiple federal inspections.

 

14. If you would like to provide additional information about solutions for 

reducing the costs of multiple inspections, please do so in the space 

provided below. 

Joint Inspections 

15. Has your lab received a joint inspection (e.g., CDC/APHIS, CDC/DAIG, 

CDC/DHS, APHIS/DHS inspect concurrently)? 

1. Yes 

2. No (GO TO QUESTION 16)

3. Don't know (GO TO QUESTION 16)

 

15a. If so, what are the positive aspects of joint inspections compared to 

single agency inspections? 

 

15b. What are the negative aspects of joint inspections compared to 

single agency inspections? 

Page 62 GAO-13-154 Overlap and Duplication
Complete Opinion Survey 

16. If you would like to clarify any of your responses to this survey, or comment 

on any other related topic, please do so in the space below. 

 

17. If you have completed the questions in this survey, please move the check to 

the "Completed" button below. (Your answers will not be used until you have 

checked "Completed." 

1. Completed 

2. Not completed 

 

Getting a Copy of Your Responses 

You may view and print your completed survey by clicking on the Summary 

link in the menu to the left. When you are done, click on the "Exit" button below 

to exit the survey and send your responses to GAO. 

Thank you for your help. 

Page 63 GAO-13-154 Overlap and Duplication
Appendix III: Comments from the Department 

of Health and Human Services

Page 64 GAO-13-154 Overlap and Duplication

Appendix III: Comments from the 

Department of Health and Human Services
Appendix III: Comments from the Department 

of Health and Human Services

Page 65 GAO-13-154 Overlap and Duplication
Appendix III: Comments from the Department 

of Health and Human Services

Page 66 GAO-13-154 Overlap and Duplication
Appendix IV: Comments from the Department 

of Agriculture

Page 67 GAO-13-154 Overlap and Duplication

Appendix IV: Comments from the 

Department of Agriculture
Appendix IV: Comments from the Department 

of Agriculture

Page 68 GAO-13-154 Overlap and Duplication
Appendix V: Comments from the Department 

of Homeland Security

Page 69 GAO-13-154 Overlap and Duplication

Appendix V: Comments from the Department 

of Homeland Security
Appendix V: Comments from the Department 

of Homeland Security

Page 70 GAO-13-154 Overlap and Duplication
Appendix VI: Comments from the Department 

of Defense

Page 71 GAO-13-154 Overlap and Duplication

Appendix VI: Comments from the 

Department of Defense
Appendix VI: Comments from the Department 

of Defense

Page 72 GAO-13-154 Overlap and Duplication
Appendix VI: Comments from the Department 

of Defense

Page 73 GAO-13-154 Overlap and Duplication
Appendix VI: Comments from the Department 

of Defense

Page 74 GAO-13-154 Overlap and Duplication
Appendix VI: Comments from the Department 

of Defense

Page 75 GAO-13-154 Overlap and Duplication
Appendix VII: GAO Contact and Staff 

Acknowledgements

Page 76 GAO-13-154 Overlap and Duplication

Nancy Kingsbury, (202) 512-2700 or kingsburyn@gao.gov

In addition to the contact named above, Sushil Sharma, Assistant 

Director; Rebecca Shea; Jason Fong; Elaine Vaurio; Jim Ashley; and 

Laurel Rabin made key contributions to this report. 

Appendix VII: GAO Contact and Staff 

Acknowledgments 

GAO Contact

Staff 

Acknowledgments 

(460619)
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