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S. HRG. 111–353 

STRENGTHENING SECURITY AND OVERSIGHT AT 

BIOLOGICAL RESEARCH LABORATORIES 

HEARING 

BEFORE THE

SUBCOMMITTEE ON TERRORISM 

AND HOMELAND SECURITY 

OF THE

COMMITTEE ON THE JUDICIARY 

UNITED STATES SENATE 

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

SEPTEMBER 22, 2009 

Serial No. J–111–48 

Printed for the use of the Committee on the Judiciary 

( 

(II) 

COMMITTEE ON THE JUDICIARY 

PATRICK J. LEAHY, Vermont, Chairman 

HERB KOHL, Wisconsin 

DIANNE FEINSTEIN, California 

RUSSELL D. FEINGOLD, Wisconsin 

CHARLES E. SCHUMER, New York 

RICHARD J. DURBIN, Illinois 

BENJAMIN L. CARDIN, Maryland 

SHELDON WHITEHOUSE, Rhode Island 

AMY KLOBUCHAR, Minnesota 

EDWARD E. KAUFMAN, Delaware 

ARLEN SPECTER, Pennsylvania 

AL FRANKEN, Minnesota 

JEFF SESSIONS, Alabama 

ORRIN G. HATCH, Utah 

CHARLES E. GRASSLEY, Iowa 

JON KYL, Arizona 

LINDSEY GRAHAM, South Carolina 

JOHN CORNYN, Texas 

TOM COBURN, Oklahoma 

BRUCE A. COHEN, Chief Counsel and Staff Director 

MATT MINER, Republican Chief Counsel 

SUBCOMMITTEE ON TERRORISM AND HOMELAND SECURITY

BENJAMIN L. CARDIN, Maryland, Chairman 

HERB KOHL, Wisconsin 

DIANNE FEINSTEIN, California 

CHARLES E. SCHUMER, New York 

RICHARD J. DURBIN, Illinois 

AL FRANKEN, Minnesota 

EDWARD E. KAUFMAN, Delaware 

JON KYL, Arizona 

ORRIN G. HATCH, Utah 

JEFF SESSIONS, Alabama 

JOHN CORNYN, Texas 

TOM COBURN, Oklahoma 

BILL VAN HORNE, Democratic Chief Counsel 

STEPHEN HIGGINS, Republican Chief Counsel 

(III) 

C O N T E N T S 

STATEMENTS OF COMMITTEE MEMBERS 

Page 

Cardin, Hon. Benjamin L., a U.S. Senator from the State of Maryland ............. 1 

prepared statement .......................................................................................... 33 

WITNESSES 

Graham, Hon. Robert, former U.S. Senator from the State of Florida, Chair, 

Commission for the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, Washington, D.C., statement ............................................ 17 

Greenberger, Michael, Founder and Director, University of Maryland Center 

for Health and Homeland Security, and Law School Professor, University 

of Maryland School of Law, Baltimore, Maryland, statement ......................... 23 

Kingsbury, Nancy, Ph.D., Managing Director, Applied Research and Methods, 

Government Accountability Office, Washington, D.C., statement ................... 20 

Pasco, Brandt, Compliance Assurance Program Manager, Department of 

Homeland Security, Washington, D.C. ............................................................... 8 

Reed, Jean, Deputy Assistant to the Secretary of Defense, Chemical and 

Biological Defense, Chemical Demilitarization, Department of Defense, Arlington, Virginia ................................................................................................... 5 

Roberts, Daniel D., Criminal Justice Information Services, Federal Bureau 

of Investigation, Department of Justice, Washington, D.C. ............................. 3 

SUBMISSIONS FOR THE RECORD 

Center for Disease Control and Prevention, Select Agent Program, Washington, D.C., statement ........................................................................................ 35 

Graham, Hon. Robert, former U.S. Senator from the State of Florida, Chair, 

Commission for the Prevention Weapons of Mass Destruction Proliferation 

and Terrorism, Washington, D.C., statement .................................................... 38 

Greenberger, Michael, Founder and Director, University of Maryland Center 

for Health and Homeland Security, and Law School Professor, University 

of Maryland School of Law, Baltimore, Maryland, statement ......................... 43 

Kingsbury, Nancy, Ph.D., Managing Director, Applied Research and Methods, 

Government Accountability Office, Washington, D.C., statement ................... 73 

Pasco, Brandt, Compliance Assurance Program Manager, Department of 

Homeland Security, Washington, D.C. ............................................................... 81 

Reed, Jean D., Deputy Assistant to the Secretary of Defense, Chemical and 

Biological Defense/Chemical Demilitarization, Department of Defense, Arlington, Virginia, statement ................................................................................ 86 

Roberts, Daniel D., Assistant Director, Criminal Justice Information Services 

Division, Federal Bureau of Investigation, Department of Justice, Washington, D.C., statement ........................................................................................ 93 

(1) 

STRENGTHENING SECURITY AND OVERSIGHT 

AT BIOLOGICAL RESEARCH LABORATORIES 

TUESDAY, SEPTEMBER 22, 2009 

U.S. SENATE, 

SUBCOMMITTEE ON TERRORISM AND HOMELAND SECURITY, 

COMMITTEE ON THE JUDICIARY, 

Washington, DC 

The Subcommittee met, pursuant to notice, at 2:42 p.m., Room 

226, Dirksen Senate Office Building, Hon. Benjamin Cardin, Chairman of the Subcommittee, presiding. 

OPENING STATEMENT OF HON. BENJAMIN L. CARDIN, A U.S. 

SENATOR FROM THE STATE OF MARYLAND, CHAIRMAN, 

SUBCOMMITTEE ON TERRORISM AND HOMELAND SECURITY 

Senator CARDIN. Well, the Subcommittee will come to order. Let 

me apologize for being a few minutes late. The Senate was taking 

its traditional every, I think, 2-year photograph, so that’s one of the 

busy moments on the floor of the U.S. Senate. So, I apologize for 

the late start. 

I also want to express Senator Kyl’s regrets. He’s going to try to 

come by. He is involved in the Senate Finance Committee right 

now on health care reform, and obviously is very busy on that 

issue. So he’s going to try to come by, but he wanted me to express 

his strong support for this hearing, the oversight role that the Judiciary Committee needs to play on the labs that we have, the biological research laboratories in this country, and he is very much 

interested in the recommendations that are coming out from the 

various workgroups and commissions that are looking into this 

matter. 

After the 9/11 terrorist attacks, Americans suffered another type 

of terrorist attack in October of 2001: the biological attacks. Letters 

were mailed to Members of Congress using the U.S. Postal Service, 

ultimately resulting in the death and sickening of dozens of individuals. The Federal Government responded by increasing funds 

for bio-defense. Congress also implemented the 9/11 Commission 

recommendations, which called for the creation of the Department 

of Homeland Security and urged the government to take stronger 

measures to deny weapons of mass destruction to terrorists. 

High-containment laboratories played a critical role in the bio-defense effort and evolved collaborative efforts between the public 

and private sectors, military and civilian communities, as well as 

our international partners. At the same time, increasing the number of personnel in laboratories with access to these deadly agents 

2 

may increase the chances of accidental or deliberate misuse of hazardous materials, posing a significant public health threat. 

Today’s hearing will examine the current security measures at 

our laboratories, including both physical security and personnel reliability, and look at the best practices in both the government and 

private sector, including our Nation’s preeminent research laboratories. 

We will also examine the various government agencies that have 

oversight responsibilities for these programs, as well as recommendations from organizations as to how to strengthen and improve our security at these laboratories, while not unduly chilling 

innovation, research, and collaborative efforts with our international allies. 

The FBI recently concluded that the October 2001 anthrax attacks were carried out by a government scientist working in a biological research lab at Ft. Detrick, in my own State of Maryland. 

I have visited this military base on numerous occasions. Just last 

month, the Army broke ground on a new $680 million headquarters 

building for the U.S. Army Medical Research Institute for Infectious Diseases at Ft. Detrick, Maryland, which will house the most 

cutting-edge research on dangerous biological organisms in the 

highest possible bio-safety space known as a Bio-Safety Level IV, 

BSL–IV. This precaution is being used in order to protect the workers at Ft. Detrick and the surrounding communities in Frederick, 

Maryland. 

The laboratories will conduct research on the most deadly pathogens known to mankind, including anthrax, the plague, and the 

Ebola virus. I know that our Ft. Detrick employees have also been 

working to help the government to combat swine flu and the West 

Nile virus, among others. 

Panel one this afternoon will examine the executive branch’s current efforts to strengthen and improve bio-security and bio-safety 

at laboratories, including personnel reliability, physical and perimeter security, and inventory control. I look forward to hearing from 

the witnesses from the Departments of Justice, Defense, and 

Homeland Security. 

In panel two, we will receive testimony from outside experts, including the recent report on the Commission on the Prevention of 

Weapons of Mass Destruction, chaired by the distinguished former 

Senator from Florida, Senator Graham, who has also served as 

Chairman of the Senate Intelligence Committee. We will also receive testimony from the Government Accountability Office and the 

Center for Health and Homeland Security at the University of 

Maryland at Baltimore. 

With that, we will go directly to our first panel, who will consist 

of Daniel Roberts, who is the Assistant Director of the FBI’s largest 

division, the Criminal Justice Information Services Division, established in 1992 to serve as the focal point and central repository for 

Criminal Justice Information Services in the FBI. 

Jean Reed is the Deputy Assistant to the Secretary of Defense 

for Chemical and Biological Defense and Chemical Demilitarization 

in the Office of the Assistant to the Secretary of Defense for Nuclear, Chemical, and Biological Programs. 

3 

Brandt Pasco was appointed to be the Deputy Secretary to be the 

DHS Compliance Assurance Program Manager. He is an attorney 

in the Department of Homeland Security, Office of General Counsel, who supports the Science and Technology Directorate, managing an office with 14 staff. 

With that, if I could ask the three of you to please stand in order 

to take the traditional oath of our Committee, and then we’ll get 

started with your testimony. 

[Whereupon, the witnesses were duly sworn.] 

Senator CARDIN. Thank you all very much. Please have a seat. 

Mr. Roberts, we are glad to hear from you. 

STATEMENT OF DANIEL D. ROBERTS, CRIMINAL JUSTICE INFORMATION SERVICES, FEDERAL BUREAU OF INVESTIGATION, U.S. DEPARTMENT OF JUSTICE, WASHINGTON, DC 

Mr. ROBERTS. Good afternoon, Chairman Cardin, Ranking Member Kyl, and the distinguished members of the Subcommittee on 

Terrorism and Homeland Security. I am Daniel D. Roberts, Assistant Director of the FBI’s Criminal Justice Information Services Division, or CJIS, located in Clarksburg, West Virginia. I have served 

in the FBI for over 22 years, but have only held my current position since June of 2009. I thank you for the opportunity to appear 

before this Subcommittee. 

The CJIS Division maintains oversight of two major background 

assessment programs: the more commonly known, National Instant 

Criminal Background Check System, assesses a person’s eligibility 

to possess a firearm or explosive; the lesser known program, the 

Bio-Terrorism Risk Assessment Group, or BRAG, is similar in mission. BRAG’s role is to enhance national security and public safety 

by providing the timely and accurate determination of an individual’s eligibility to use, possess, or transfer select agents and toxins. 

Candidates are evaluated for access to select agents and toxins 

against criteria delineated within the Public Health, Security, and 

Bio-Terrorism Preparedness and Response Act of 2002, and against 

prohibitive categories defining a restricted person within the USA 

Patriot Act. Pursuant to the Bio-Terrorism Act, the Attorney General of the United States is charged with using criminal, immigration, national security, and other electronic data bases to determine 

whether an entity or an individual is a restricted person. 

The Attorney General delegated this authority to the Director of 

the Federal Bureau of Investigation in January of 2003. The BRAG 

began conducting Security Risk Assessments, or SRAs, in collaboration with officials from the Department of Health and Human 

Services and the Department of Agriculture in April of 2003. 

SRAs are conducted on entities, except Federal, State, and local 

government agencies, including public accredited academic institutions, any individual who owns or controls the entity, responsible 

officials, and alternate responsible officials managing entity operations every 3 years. 

SRAs are conducted not less frequently than once every 5 years 

on individuals requiring access to select agents and toxins. A typical SRA takes about 1 month to complete. The SRA is different 

than a full background investigation, such as those conducted for 

4 

security clearances, and complies with the requirements of the BioTerrorism Act. 

The SRA commences when BRAG receives a candidate’s Form 

FD–961 and two legible fingerprint cards. The fingerprint cards are 

processed by the FBI’s integrated automated fingerprint identification system and flagged to identify the record as belonging to an 

individual who underwent an SRA. The FD–961 data, supplied by 

the candidate in response to questions directly concerning each 

prohibitor, is then entered into BRAG’s stand-alone bio-terrorism 

data base maintained by CJIS. 

The candidate’s case is subsequently assigned to a BRAG personnel security specialist for research. Upon completion of all data 

base searches, the candidate’s status is determined and the results 

are submitted to the sponsoring agency. The sponsor provides, in 

writing, the decision indicating denial or approval of access to the 

candidate. 

If the access is denied, the candidate is advised of the specific 

prohibiting factor applied to them. Candidates may appeal the decision via their sponsor within 30 days of notification of denial. The 

sponsor will forward a statement of factual basis for the appeal and 

supporting documentation provided by the candidate to the FBI for 

reconsideration. 

The FBI will review the candidate’s documentation and research 

the appropriate data bases. The FBI will either overturn the results of the original SRA or sustain the original determination of 

status. The sponsor is again advised of the results and, in turn, notifies the candidate in writing of the decision. 

Since the inception of the program, the BRAG has completed 

32,742 SRAs; 208 individuals have been restricted. The CJIS Division, in close coordination with the Centers for Disease Control and 

Prevention and the Animal and Plant Health Inspection Service, is 

continually scrutinizing and evaluating the SRA process. Efforts 

are ongoing to automate the workflow and improve information 

sharing capabilities. 

Mr. Chairman, I would like to conclude by thanking you, Ranking Member Kyl, and this Subcommittee for your service and support. I look forward to working with you in the years to come as 

we continue to counter bio-security threats of the future. I would 

also like to personally thank the Department of Health and Human 

Services, Centers for Disease Control and Prevention, and the Department of Agriculture’s Animal and Plant Health Inspection 

Service for years of unwavering support. 

Thank you for the opportunity to appear before your Subcommittee, and I look forward to answering any questions you may 

have. 

[The prepared statement of Mr. Roberts appears as a submission 

for the record.] 

Senator CARDIN. Thank you very much for your testimony. 

Mr. Reed. 

5 

STATEMENT OF JEAN REED, DEPUTY ASSISTANT TO THE SECRETARY OF DEFENSE, CHEMICAL AND BIOLOGICAL DEFENSE/CHEMICAL DEMILITARIZATION, U.S. DEPARTMENT 

OF DEFENSE, ARLINGTON, VA 

Mr. REED. Chairman Cardin, I would request that my printed 

statement be entered in the record. 

Senator CARDIN. Without objection, the full statements of all of 

the witnesses will be included in the record today. 

[The prepared statement of Mr. Reed appears as a submission for 

the record.] 

Mr. REED. Mr. Chairman, it’s a pleasure to testify before the 

Committee today. I’m accompanied by Major General James Gilman, Commanding General, U.S. Army Medical Research and Materiel Command in Ft. Detrick; and Colonel John Skvorak, Commander of the U.S. Army Medical Research Institute for Infectious 

Diseases, whom I believe you know; and also by Captain Kenneth 

Cole, who’s the Medical Director for the Chemical/Biological Defense program, and they’re here to bail me out if I get in trouble, 

so I would beg leave to perhaps have them provide some of the detailed answers to the questions. 

Senator CARDIN. You’ve got a good support team. 

Mr. REED. Great. They are good people. 

It’s a pleasure, again, to be able to have the opportunity to discuss with you the safety and security of our Nation’s biological research laboratories. They are a keystone to our Nation’s life science 

research and are essential to developing public health infrastructure and medical countermeasures crucial to protecting U.S. citizens from biological threats, whether as a result of natural or intentional actions. 

Today I will briefly discuss Department of Defense regulations, 

practices, and procedures put in place since the 2001 anthrax incidents that can be applied to improve laboratory bio-security. It is 

imperative that the implementation of best practices on a national 

scale optimize the security of biological agents, while providing 

minimal impact on that life science research necessary to develop 

public health and medical countermeasures against these agents. I 

will provide an overview of how DOD regulations came into existence, how they have been implemented, their proposed integration 

into current national efforts, and a possible way forward to develop 

best practices and procedures for Bio-Safety Level, BSL–IV, laboratory safety and security. 

Our BSL–III and BSL–IV laboratories operate as a critical element of our bio-defense efforts to understand pathogens of concern 

and to develop medical countermeasures to defeat these pathogens, 

whether they are biological warfare agents, or are infectious diseases to which our armed forces may be exposed. 

Following the 2001 anthrax incidents, Congress passed a series 

of legislative initiatives to control human, plant, and animal pathogens of concern. This legislation led to the expansion of Select 

Agent Regulations, which require each Federal agency to conduct 

safety and risk assessments, but did not preclude agencies from implementing efforts above and beyond those required by the regulations for safeguarding biological select agents and toxins. 

6 

The term ‘‘select agent’’ refers to a specific group of chemical or 

biological agents that historically have been evaluated and developed for use in weapons. Although the United States does not have 

a biological weapons program, the use of this term and its historical connotation as being associated with weapons programs heavily influenced the direction the Department would take to safeguard biological agents in its laboratories. 

Accordingly, the Department drew, from its current chemical and 

nuclear programs, safeguarding measures in developing the regulations for so-called biological select agents and toxins, which the Department uses only for basic and applied research in the development of vaccines, therapeutics, and protective countermeasures. 

The current DOD risk management framework for safeguarding 

select agents and toxins consists of a fourfold approach: bio-safety, 

bio-security, personal reliability, and agent accountability. 

Bio-safety consists of the application of knowledge, techniques, 

and equipment to prevent personal, laboratory, and environmental 

exposure to potentially infectious agents or bio-hazards. Bio-security refers to the protection, control, and accountability of high consequence biological agents and toxins, critical relevant biological 

materials and information within laboratories to prevent unauthorized possession, loss, theft, misuse, diversion, or intentional release. The biological personal reliability program consists of security background investigations, as well as medical, mental health, 

and drug screening. 

Agent accountability consists of the registration of agents, personnel, entities, and locations, agent inventory control, and limiting 

access to registered personnel. 

All of the above measures implemented by the Department of Defense exceed the prescribed requirements of the Select Agent Rules. 

This does not mean that the additional measures constitute a series of best practices and procedures, but only represents the extrapolation of the DOD current weapon materiel safeguarding policies as applied against biological agents. In fact, they highlight the 

challenges that arise from the direct application of DOD current 

policies for safeguarding weapons materiel to the unique situation 

of defense research on biological organisms. 

Biological agents differ from nuclear and chemical threats by 

their nature and by virtue of their context. Nuclear and chemical 

agents are entirely man-made; biological agents are found throughout nature and exist in the context of infectious disease and public 

health threats, notwithstanding that they can be potentially used 

for hostile purposes. 

This is not to say that there are elements of these regulations 

that could not be incorporated into best practices. However, a series of studies, both within the DOD and externally, suggest that 

some elements of this program may be too extreme and could not 

be implemented by other agencies or the civilian sector without severe impact. 

For example, the use of Single-Scope Background Investigations 

precludes foreign nationals or personnel having limiting factors, 

such as financial difficulties or prior non-criminal legal actions, 

from working with select agents. Such background investigations 

are time-intensive and expensive. 

7 

Additionally, they would preclude a large segment of exceptionally qualified and talented researchers, particularly foreign national researchers who currently make daily contributions to the 

advancement of medical or other life science research, from participating in this activity that is so important to the Nation. 

Several recent studies highlight the lack of data to demonstrate 

that such detailed background investigations provide substantial 

value over the current Department of Justice Security Risk Assessment. There have been a number of internal DOD studies and external studies over the past 2 years that have explored the efficacy 

and efficiency of current and proposed regulations and policies to 

strengthen laboratory bio-security. 

Reports from the National Science Advisory Board for Bio-Security and the Defense Science Board were submitted to the executive 

branch with a series of recommendations and policy options that 

can be applied to establishing best practices and procedures for the 

Nation. Reports of Executive Order 13486 Working Group on 

Strengthening the Laboratory Bio-Security of the United States 

and the National Academy of Sciences are in their final stage of 

staffing and will be submitted to the executive branch in the very 

near future. Additionally, the Trans-Federal Task Force on Optimizing Bio-Safety and Bio-Containment Oversight is soon submitting its report to the executive branch. 

A potential way forward would be to allow the National Security 

Council to use its interagency policy committee process in conjunction with input from industry and academia, to review the recommendations and policy options from the collective reports, and 

develop an approach for the Nation that optimizes the balance between science and security. Once such an approach is identified, 

legislative action could be well-targeted to ensure the full range of 

helpful measures needed to enable its implementation. 

In summary, the current DOD safety and security measures for 

safeguarding biologicals, select agents, and toxins are derived from 

its protocols that were originally developed to safeguard nuclear 

and chemical weapons materiels, and not the biological organisms 

that are critical to developing defenses against our adversaries’ biological weapons and naturally-occurring infectious diseases. 

Although these practices derive from a robust history of security, 

they might not constitute the basis for best practices and procedures for the Nation, as they could discourage participation by critical organizations and could be limiting to medical and other life 

sciences research programs. 

A more prudent approach would be to exploit the information 

gathered by the various studies conducted over the past 2 years, 

develop a series of appropriately tailored policies and practices that 

balance between safety and security and the pursuit of a robust biological research and development program necessary to ensure the 

ability to respond to naturally-occurring pathogens, defense of the 

U.S. homeland, and protection of our service members. 

Senator, thank you for this opportunity to address you on this 

matter of national importance, as well as your continued support 

to the Department of Defense. I would be happy to answer any 

questions the Subcommittee may have. 

Senator CARDIN. Thank you very much, Mr. Reed. 

8 

Mr. Pasco. 

STATEMENT OF BRANDT PASCO, COMPLIANCE ASSURANCE 

PROGRAM MANAGER, U.S. DEPARTMENT OF HOMELAND SECURITY, WASHINGTON, DC 

Mr. PASCO. Chairman Cardin, Ranking Member Kyl, and distinguished Senators, thank you for the opportunity to talk about the 

good work being done today at DHS related to bio-security. It’s a 

pleasure to be back in the U.S. Senate, where I started my professional life. I have submitted testimony for the record, so I will be 

brief to ensure there’s time for questions. 

By way of introduction, allow me to explain, briefly, my role at 

DHS. I was appointed by the Deputy Secretary to be the Department’s Compliance Assurance Program Manager. I’m an attorney 

in the Office of the General Counsel, who supports the Science and 

Technology Directorate. I manage an office with 14 staff and an fiscal year ‘09 budget of approximately $2.8 million, and I oversee 

compliance efforts at the Science and Technology Directorate, including for biological safety and security. 

DHS’s compliance program provides an objective and independent review of all ongoing DHS life science programs. It is a 

complete programmatic life cycle review. Treaty compliance is ensured both at the program’s inception and when significant changes 

are proposed. Regulatory compliance is checked throughout the life 

of project execution, and information generated by the program is 

continually reviewed for national security concerns. 

The cornerstone of the process is the Department’s Compliance 

Review Group, which oversees arms control treaty compliance. The 

Compliance Review Group is comprised of DHS senior leadership 

and chaired by the Deputy Secretary. All biological research conducted by the Department must be determined by the Compliance 

Review Group to be compliant with U.S. law and our international 

obligations. 

In generating compliance assessments for the Compliance Review 

Group, projects fall within one of three categories. Category 1 

projects, as presented, do not raise compliance concerns. Three 

hundred and sixty-eight Category 1 projects have been approved by 

the Compliance Review Group to date. 

Category 2 projects, as presented, might reasonably raise the 

perception of a compliance issue but do not involve the National 

Science Advisory Board for Bio-Security Research concern. Eighteen Category 2 projects have been approved by the Compliance Review Group to date. 

Category 3 projects, as presented, might reasonably raise a perception of compliance and likely do involve research of concern. 

Twenty-two Category 3 projects have been approved by the Compliance Review Group to date. 

DHS has established a regulatory compliance program for biosafety, select agent and toxin security, and the care and use of animals in research. DHS’s select agent and toxin research is subject 

to the regulatory control of the Centers for Disease Control and 

Prevention and Animal and Plant Health Inspection Service. At 

DHS, we conduct significant additional oversight because of unique 

9 

sensitivities related to bio-defense research, as distinct from conventional public health research. 

The regulatory compliance program is significantly driven by our 

treaty compliance efforts. Laboratories conducting Category 2 or 3 

projects are subject to onsite inspections. Other laboratories are 

visited because we have some indication that there may be problems with non-compliance. 

To assist the Under Secretary in exercising original classification 

authority, the Science and Technology Directorate established the 

Classification Review Panel, which I co-chair with the Director of 

Security. DHS has a significant priority in maintaining openness in 

life science research, but the nature of bio-defense threat characterization studies requires that some elements remain classified to 

protect the public from harm. The Classification Review Panel cochairs are responsible for ensuring that all Science and Technology 

Directorate programs have, and are appropriately applying, classification guidance. 

In conclusion, DHS has an exceptionally effective record at 

strengthening biological safety and security in DHS-funded laboratories. I thank you for your attention and I would be pleased to 

take any questions you may have. 

[The prepared statement of Mr. Pasco appears as a submission 

for the record.] 

Senator CARDIN. Well, once again, let me thank all three of you 

for being here and the work that each of your agencies do. I have 

been to Detrick, as I said in my opening comments. I’ve seen the 

work that’s being done there, the dedicated men and women who 

are serving our country in a very dangerous situation, and we very 

much appreciate their professionalism and their dedication to trying to deal with these extremely difficult subjects. 

I know that we have a working group that is prepared to make 

recommendations, or at least make a report to the administration, 

and we’re looking forward to receiving that report. Quite frankly, 

we thought it would be available by now, but we do have at least 

some of the information that’s coming out of their work, which I 

think is useful for us today. 

Let me just raise the first fundamental issue. There are about 15 

Federal agencies that deal with labs and no one agency has primary or full responsibility here. So I listened to your testimony. I 

see Department of Justice indicating that they’ve done Security 

Risk Assessments on about 32,000 individuals. 

I listened to what Department of Homeland Security said, that 

they’re dealing with 42 labs and have done 23 onsite inspections. 

My staff tells me that when we take a look at the information on 

select agents regulations, that there are 390 entities that have gotten registered, with 15,000 employees. So these numbers seem to 

be not totally consistent. 

I guess my concern is, I don’t know who to ask the question for 

in the Federal Government as to, where are the labs? Are we satisfied they’re properly secure, that are dealing with agents that we 

have concerns about? Does anyone have a handle on the inventories we have on these agents, select agents that we’re concerned 

about? Is anyone primarily responsible to make sure that we have 

10 

adequate securities in place dealing with these labs? Shouldn’t we 

have more direct responsibility? 

I know that, again, I expect that the working group is going to 

deal with this. We have some recommendations from other groups 

that have looked at it. Mr. Pasco, most will turn to Department of 

Homeland Security and say that’s the logical place to have the responsibility. I had a chance to talk to Director Mueller at the FBI. 

He said his role is pretty limited. He does the reviews, gets the information out, but he’s certainly not responsible for the labs. 

Mr. PASCO. Thank you, Senator. It’s an important question and 

I understand why you would be concerned. The Department of 

Homeland Security is, at this point, a funding agency. That is to 

say, we conducted research. My job as the Compliance Assurance 

Program Manager is to ensure that that research is compliant with 

existing regulatory standards. So we have 42 laboratories that are 

currently or have recently been involved in DHS-funded research. 

As I indicated, we prioritized those for inspections based on the 

nature of the work that’s being done there, and then also if we 

have reason to think that there may be compliance issues. But our 

inspections are essentially under authorities granted by the FAR, 

that we would have to inspect work that’s being performed under 

contract. So we don’t have distinct regulatory authority for this 

type of thing. 

Senator CARDIN. I understand that the authority is not there. 

The question is, should you have the authority? Should you be able 

to track what is happening in our Nation on those who handle select agents so that we have some understanding of the training, 

some understanding of the best practices. 

Let me just give you one example. You might visit a lab and see 

a procedure that’s used for a select agent that is worthy of being 

utilized in more labs around this Nation for the purposes of protecting the workforce and protecting the public. Is there a mechanism where that information gets out, where we can share that 

type of security information? A university may not be dealing with 

you. They may not be one of the 42 that you’re talking about, and 

that’s certainly one that you haven’t inspected, but they may be 

dealing with the same pathogens. How do we coordinate and make 

sure that we are dealing with these pathogens in the safest possible way? Mr. Reed? 

Mr. REED. Sir, the Centers for Disease Control, Department of 

Health and Human Services, and the Animal and Plant Health Inspection Service, Department of Agriculture have the responsibility 

for inspecting all facilities for compliance with the select agent programs and maintain—— 

Senator CARDIN. How did I know that you would mention one of 

the agencies we didn’t have at the table today as the responsible—— 

[Laughter.] 

Mr. REED. Well, you know, it gives the staff something to work 

on. 

Senator CARDIN. We could have had 15 of you up there. My point 

is, there’s 15 agencies that do have some responsibility. 

Mr. REED. Right. And I want to come to that point in just a moment. Those two activities maintain a listing of each Biological SeVerDate Nov 24 2008 14:15 Apr 19, 2010 Jkt 055644 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\55644.TXT SJUD1 PsN: CMORC
11 

lect Agent being operated on at each laboratory, the personnel who 

are cleared for handling of BSAT and inventories, and approve 

transfers of BSAT between laboratories. What we have been doing 

as a body within the interagency for about a year now is to review 

these issues. (And you just alluded to the report that has been provided in draft to the administration in response to the President’s 

Executive Order is going through its final coordination with the 

interagency.) There needs to be, clearly, someone in overall charge 

of directing that oversight. 

All of the reports that are coming forward note the need for activity that can bring that all together. But what we’re looking for, 

quite frankly, is the development of, if you will, a set of minimal 

requirements in terms of personnel reliability, accounting, security, 

training, best laboratory practices that take into account the views 

of all the stakeholders, and then bringing that together and saying, 

okay, here’s what we have done that does represent that balance 

between the critical elements of security for the select agents, 

which quite frankly are of varying degrees of virulence. So, you 

might come out with the idea of a stratified system that one might 

use. 

Senator CARDIN. The Commission to prevent the proliferation of 

weapons of mass destruction has suggested a tier approach. 

Mr. REED. Yes. 

Senator CARDIN. I think there are 80 agents today that are of 

concern that are under the regulation. They are suggesting tier one 

would be about eight. 

Mr. REED. Yes, sir. 

Senator CARDIN. Does that make sense? Does that make it easier 

for you to be able to really track those agents that are of the most 

concern, those pathogens that require much closer scrutiny on inventory and access? 

Mr. REED. With my colleagues who have been participating in 

those studies, there would be agreement—yes, there would be. It 

then becomes a question of, what goes in what bin: the guidelines 

for what in terms of the BSL Levels I through IV agent categories. 

Senator CARDIN. Mr. Roberts, you talked about the background 

checks that you do in regards to the regulations. If I understand 

that correctly—and you were very clear, it’s not at all the same as 

what we do for people who need clearance. That’s a different type 

of a background check—it seemed like what you were describing is 

mostly getting information from the applicant and checking your 

data bank. 

But do you actually go out in the field? Do you do interviews? 

Is there anything more done as far as checking the person’s psychological capacities, weaknesses, or checking their sources to make 

sure that it’s accurate, the information they’ve given you, which is 

what we do on clearance where there is more direct contact? 

Mr. ROBERTS. You’re right, Mr. Chairman. There is quite a bit 

of difference between what we do for an SRA and what we would 

do for a Top Secret security clearance, for example. No. To answer 

your question, we don’t do any interviews, neighborhood interviews 

or interviews of friends or associates of the individuals. We do more 

than just data base checks of FBI data bases. We, for example, will 

check the terror screening center data bases, which has access to 

12 

the entire intelligence community. Much of it also filters through 

ICE and their law enforcement center in Vermont as well, so it’s 

not just the FBI data base. 

However, I will tell you that the FBI has a very robust fingerprint data base, maybe the most robust in the world when it comes 

to criminals being stored—fingerprints being stored. We have 60 

million-plus fingerprints of subjects on record with us at CJIS in 

West Virginia. So it is a wealth of information that we do tap into 

when we receive the individual’s SRA package. That’s the first 

place we will start, but it isn’t the last. But you are correct, sir, 

that it is just a data base check. We do not do further checks in 

terms of information of the individual more than data bases. 

Senator CARDIN. And after the person has been cleared by the review that you do, what would trigger you looking at that person 

again, if anything? 

Mr. ROBERTS. There is something. Actually, what we do is we put 

a stop on the individual’s fingerprint records. So if, for example, 

any of the 18,000-plus law enforcement agencies that are in the 

United States were to arrest an individual who had been through 

an SRA, we would be notified of that. We place what would be a 

stop in our systems so that we are notified anytime they are arrested, and then we would then notify the sponsoring agency of 

that arrest. 

Senator CARDIN. So you’re actually putting their fingerprints into 

the data bank then, I take it? 

Mr. ROBERTS. We’re actually putting stops into the data bank, 

yes. We’re not putting their fingerprints into the whole criminal 

data base, no. We’re just putting stops against them, their names. 

Senator CARDIN. So it’s a name? I’m a little confused as to how 

that would come—— 

Mr. ROBERTS. Yes. I’m sorry. 

Senator CARDIN. How would they know that’s the person? 

Mr. ROBERTS. Yes. It would be a biographic. It would be a biographic, not a biometric. It would be a name search. 

Senator CARDIN. And then you would confirm that’s the right 

person before, I take it, you would take action? 

Mr. ROBERTS. Absolutely. 

Senator CARDIN. But as a matter of routine, if the person was 

hospitalized for a mental condition, that would not come to your attention, would it? 

Mr. ROBERTS. That is correct, sir. That is a gap in the system. 

If you ask my personal opinion, we have no national data base of 

mental health records that we can lean on. As you know, we also 

manage the firearms check program for the FBI as well, and that 

is also a prohibiting factor for purchasing firearms. 

We have some records that have been submitted to us in the firearms programs from hospitals, such as the VA hospitals, for example, but we are not allowed to share, by law, that firearms individual with the BRAG group that does the SRAs. 

So you’re correct in that there’s a gap there, that we rely a great 

deal on the person’s self-admission to a mental problem. There are 

some criminal histories which do identify the fact that the individual arrested may have a mental deficiency if you query that person and they have a criminal record, but beyond that, there isn’t 

13 

much information there available, other than what the person selfreports. 

Senator CARDIN. So let me come back to Mr. Reed for a moment. 

If we were to use a tiered approach as far as regulatory responsibilities, is it conceivable that the background check could be—you 

could differentiate between those that are handling the pathogens 

that are in tier one to require a more sophisticated background 

check for those that have access to those types of agents? 

Mr. REED. I think, Senator, that would quite possibly be something one might choose to employ. You would also have different 

levels of security in terms of how the agents are handled and 

stored. In all cases, there would have to be the matter of training 

of the individual investigator in terms of the safety and security 

that had to be employed within the laboratory, and there could be 

very well gradations of that. 

One example that has been used in transferring from the socalled ‘‘two-man’’ rule of nuclear practice—nuclear weapons practice or of chemical weapons practice, where you had to have two 

fully qualified individuals, one to check the other and to report on 

the other. 

There are cases, particularly in terms of working with the Level 

I biological agents, if you will, in particular, where (in order to reduce the potential for exposure and reduce the potential for a mistake, one worker getting in the way of the other while working in 

a quite tight situation) you would have a single individual, but 

under observation remotely. So there are a whole series of gradations that could be applied, but the issue of training, of oversight 

by the supervisors and peer review, and then self-reporting if an 

individual felt that they were getting stressed out and incapable of 

operating properly. 

Senator CARDIN. I think that’s very—that’s the types of observations I think we need to take a look at. The burden to have you 

do security clearances on every person that would be—you couldn’t 

handle that, I understand that. But I think we have to have a more 

sophisticated way in which we look at those that are handling the 

most dangerous of the pathogens. 

I think there are some common-sense ways that we can differentiate here and could have that done. I know at Ft. Detrick there 

was an issue concerning the inventory of the pathogens. I don’t 

know who I want to ask this question to. It’s not really specific to 

Ft. Detrick. It’s more general as to inventory. 

Are you confident that we know where these pathogens are in 

this country and that we have inventory controls, and that if something is missing there are adequate procedures in place to find out 

where those pathogens are at all times? It’s really, I think, a 

Homeland Security issue more so than a specific agency, but I’d be 

more than happy to let Defense also have a crack at it. 

Mr. PASCO. Thank you, Senator. For DHS-funded programs, we 

spend quite a lot of attention on inventory issues. It’s one of the 

reasons—— 

Senator CARDIN. That’s not the real question. The real question 

is, Homeland Security is responsible for homeland security. We 

don’t really care whether you’re giving money to a different group 

or not. If they have control over a pathogen that can be used for 

14 

biological mischief to America, we want to make sure that you 

know where that pathogen is at all times, at least our government 

knows where those pathogens are at all times. 

Mr. PASCO. Thank you, sir. You’re right, that is the question that 

is underlying it. The Department of Homeland Security only has 

visibility into the programs that we fund as far as pathogen inventories. Of course, all of the select agent inventories are subject to 

Centers for Disease Control and APHIS regulatory process, but the 

Department of Homeland Security only reviews inventory processes 

of our own laboratories and programs that we are funding. 

Senator CARDIN. Well, that’s clearly inadequate. I assume, DOD, 

you take responsibility for your own labs? Is that what you’re—— 

Mr. REED. Yes, sir. But also in the context, we are subject to the 

CDC and APHIS oversight. But it really becomes a question of discipline and a culture of safety and security at the individual installations. Of course, they’re subject to inspection on an annual basis 

by the other two activities, and DOD labs in particular, and John 

Skvorak can probably testify to it, and the subject to inspections 

within the Department as well. 

The key issue from my perspective—and I hearken back to my 

experience as an artillery battalion commander—is standards—a 

common set of standards that one can work towards—and a common set of inspections and inspection criteria. In order to facilitate 

the research, a common view is that there be a minimum standard 

possible in order to give you the flexibility you need, but it needs 

to be a standard that we apply and that we arrive at, I think, administratively and through rulemaking, as opposed to through legislation. 

Senator CARDIN. Yes. Certainly? 

Mr. REED. John, do you want to comment on that at all? 

Colonel SKVORAK. I think, Senator Cardin—— 

Senator CARDIN. Could you just state your name for the record? 

Colonel SKVORAK. I’m John Skvorak, Colonel John Skvorak. 

Senator CARDIN. Yes. 

Colonel SKVORAK. Mr. Reed, in his opening statement, explained 

a little bit of the challenge that biological agents represent as far 

as inventory relative to chemical and nuclear, being naturally occurring and replicating. You know, the inspections are a very important part of our ability to maintain an accurate inventory. We 

have the CDC inspections and the Army IG inspections. We do 100 

percent inventories annually. We do disinterested party audits of 

our inventories within the Institute. 

We have different categories of agents as far as long-term and 

working stocks that present unique problems, and we have to find 

unique solutions to inventory those. We have developed an in-house 

data base for us to help maintain and to track inventory. 

Obviously the folks at USAMRID understand how important inventory is, with the inventory stand-down that we did back in February through about 4 months for us to complete that process. It 

is a difficult challenge, but it is, as also was said, a cultural change 

that has to be instituted within the laboratory. It’s a leadership 

issue and it’s something we can just continue to enforce, continue 

to monitor, and continue to use the peer review and outside reviews to make sure that we can maintain accurate inventories. 

15 

Senator CARDIN. Well, thank you for that. We will wait for the 

recommendations of the in-house working group, but there really 

needs to be better lines of responsibility here. I think we all would 

appreciate having those lines understood. I think we also need to 

differentiate between the different types of pathogens as far as the 

degree of interest. 

Mr. Pasco, I come back to your point. You’re giving money to a 

particular entity, let’s say, a research lab on a particular campus. 

I’ve been told that there’s a lot of collaboration among different institutions on a lot of the pathogens, and therefore I assume it’s possible, though the funds go to one lab, there may be more than one 

lab involved in the work that’s being done. 

In fact, it may be done outside the United States. I know there’s 

a lot of—so I’m not sure I understand your responsibility, even 

under the limited requirements, limited authority that you have. 

Are you just reviewing the work at the lab that is the recipient of 

your grants? You certainly are not—are you looking at who they’re 

working with? Do you have any responsibility outside of the United 

States, if they’re collaborating with an entity outside of our country? 

Mr. PASCO. Thank you, sir. Yes. In fact, we follow the money 

where it goes through the chain of providers. So it is, indeed, possible that you would have—for example, NBAC, the national biodefense laboratory that we’re building at Ft. Detrick, would have 

as a subcontractor other companies or laboratories around the 

country, and that they in turn might subcontract with laboratories 

either elsewhere in the country or outside of the United States. 

That certainly does happen. So it becomes my responsibility to 

make sure that we are examining the work where it’s being done. 

We have not—typically, to address specifically your point on international work, we do make sure that, to the greatest extent possible, things are being done in a safe way, wherever it happens to 

be done. Is that responsive to your question, sir? 

Senator CARDIN. Well, you mentioned 42 labs. 

Mr. PASCO. Yes, sir. 

Senator CARDIN. And that you do physical inspections on 23, because I assume you have reason—you said you had reason to go onsite. Are those 42 labs all located in the United States? 

Mr. PASCO. Yes, sir. 

Senator CARDIN. So then, in fact, if the collaboration is outside 

of the United States, you really don’t have much ability to follow 

that money. 

Mr. PASCO. Well, what we would likely be doing is probably a 

paper-based review. That is to say, we would ask the laboratory— 

whether it’s in the United States or not, we would ask them to provide certain basic documents to us. We’d like to see what their security protocols are, what their safety protocols are, what is the 

type of training that they require for their staffs? 

Information could be requested about the basic facility. And you 

can learn a lot about the health of a program by that type of documentation review, and we would use that, whether the lab was in 

the United States or not, to understand the management practices 

of that facility and whether we would have a reason to want to 

send inspectors to physically visit. 

16 

Senator CARDIN. Let me ask one last question on perimeter security for our government labs. Is there a uniform protocol for perimeter security if you’re dealing with the Level IV labs? Is that established? Is there a need for a review of that, considering the higher 

risk factors today in regards to those interested in weapons of mass 

destruction? 

Mr. REED. Let me attempt to respond to that in a general sense 

in terms of what needs to be there, if I may. We have a bio-defense 

campus that you’re very familiar with that is being established at 

Ft. Detrick, where we’re having laboratories from Department of 

Homeland Security, from the Department of Health and Human 

Services, and from the Department of Defense co-located and contiguous. 

If we do not have a common approach to the establishment of security for that laboratory, that laboratory complex, we will have 

three independent laboratories that are not able to coordinate their 

activities in the way that I think was originally intended when that 

was established in concept. 

And so from that standpoint, I think that’s one of the key things 

that we really need to get to, and then to extend those sorts of 

standards, those sorts of requirements really throughout so we 

know the way the various materials are being protected and we 

have an ability to inspect against that. 

I’m going to ask Captain Cole to respond, if I may, just for a moment from the standpoint of the international issue. 

Ken. 

Captain COLE. I am Captain Kenneth Cole. I’m the Medical Director of the Chemical/Biological Defense Program within DOD. 

With respect to your question of overseas labs, of course, the DOD 

does operate several overseas labs. These laboratories—our primary mission is bio-surveillance, for the protection of not only our 

service members overseas, but for also providing data for the World 

Health Organization, as well as our own public health infrastructure in the United States on emerging diseases, as well as endemic 

diseases like the seasonal flu, among other things. 

Part of the agreements we have with the countries which we participate in is to have full and open collaboration with those countries in terms of the monitoring and the exchange of information, 

as well as exchange and collaboration of samples with those laboratories. So in those aspects, we do inspect those laboratories on our 

own for compliance with select agent rules and the DOD regulations. 

However, we do have to put into certain places waivers to certain 

exemptions of the requirements in order to allow, under treaties 

and other agreements we have with these countries, the exchange 

of information, as well as exchange of samples that are required to 

have a rapid response to an emerging or endemic disease outbreak. 

Senator CARDIN. Well, let me thank you again for your testimony 

and answering our questions. This is an ongoing interest to our 

Committee. I know there are other committees in the Senate that 

are also interested. We’re going to try to coordinate our response. 

We clearly are interested in the recommendations that come out of 

the working group and we’ll look forward to not only their report, 

but the administration’s response to those reports. 

17 

We will follow up with Health and Human Services to get their 

feedback. I know we’re all interested in protecting the security of 

our country. These labs, they do extremely important work and we 

want to make sure there’s a working ability to get the job done, but 

with maximum protection to the public and the security of our 

country. So, thank you all very much. Appreciate it. 

Our second panel will consist of Hon. Bob Graham, our former 

colleague and Chairman of the Commission for the Prevention of 

Weapons of Mass Destruction Proliferation and Terrorism. He has 

spent a total of 38 years in public service; a two-term Governor of 

the State of Florida, before serving for 18 years in the U.S. Senate. 

He’s also spent 12 years in the Florida State legislature. Senator 

Graham is recognized for his leadership on issues ranging from 

health care and environmental preservation to his 10 years of service on the Senate Select Committee on Intelligence, including 18 

months as its chair from 2001 to 2002. 

We also welcome Dr. Nancy Kingsbury, who’s the Managing Director for Applied Research and Methods at the U.S. Government 

Accountability Office, where she is responsible for managing GAO’s 

advanced analytical staff, including economists, computer engineers, statisticians, social scientists, analysts, program evaluation 

experts, and scientific specialists. 

And last, let me welcome back Michael Greenberger, who’s the 

Director of the Center for Health and Homeland Security at the 

University of Maryland, and a professor at the School of Law. The 

center works on a broad range of homeland security and emergency 

response issues for the Federal, State, and local governmental 

agencies, as well as medical researchers. It’s a pleasure to have all 

three of you. 

As is the tradition of the Judiciary Committee, if I could ask you 

to stand for the oath, and then we can get on with your testimony. 

Thank you. 

[Whereupon, the witnesses were duly sworn.] 

Senator CARDIN. Thank you all very much. Please have a seat. 

Senator Graham, it’s a pleasure to have you back here in the 

U.S. Senate. I miss your good advice that I remember with fondness, working with you when I was in that other body that, quite 

frankly, I don’t understand why we need today now that I’m over 

in the Senate. 

[Laughter.] 

Senator CARDIN. But it’s a pleasure to have you before our Committee. 

STATEMENT OF HON. ROBERT GRAHAM, FORMER U.S. SENATOR FROM FLORIDA, CHAIR, COMMISSION FOR THE PREVENTION OF WEAPONS OF MASS DESTRUCTION PROLIFERATION AND TERRORISM, WASHINGTON, DC 

Senator GRAHAM. Thank you very much, Mr. Chairman. And no 

comment on your last comment. 

[Laughter.] 

Senator GRAHAM. Mr. Chairman, I appreciate the opportunity to 

testify before your Subcommittee today. 

First, a little background. The Commission that I chair was 

founded by the Congress at the suggestion of the 9/11 Commission, 

18 

which had found that the ultimate catastrophe for this country 

would be when the worst weapons fell into the worst hands. The 

response of the Congress was to establish a commission to review 

our current policies to avoid proliferation and make recommendations for the future. 

We did so in a report entitled, ‘‘World At Risk’’, which was published in December of ’08. Then the Congress asked us if we would 

stay for another year and work with it, as well as the administration, in implementing our recommendations, which we were honored to do, and I appreciate the opportunity that you are affording 

me today on behalf of the Commission to do so. 

I would like to use my time to give somewhat of an overview of 

where I see the issue of biological weapons fitting into the larger 

picture of preventing the proliferation of weapons of mass destruction. 

Mr. Chairman, our Commission made three basic findings. One, 

that since 9/11, we have become less safe, not because we have not 

been diligent in executing policies designed to increase our security, but because our adversaries have been moving at a more rapid 

pace and the environment in which this competition is occurring 

gives an advantage to the kind of people that our adversaries are. 

The second finding was that, without urgent action, that it is 

more likely than not that a weapon of mass destruction will be 

used someplace on earth between December 2008 and the end of 

2013. That was an assessment reached after consultation with a 

wide range of scientific, intelligence and law enforcement experts 

in this country and abroad. We were given some underpinning in 

that recommendation when, two weeks after our report was issued, 

the then-Director of National Intelligence, Mike McConnell, made 

almost precisely the same prediction. 

The third, is that a weapon of mass destruction is more likely to 

be a biological weapon than a nuclear weapon, for reasons that I 

will comment on in my further statement. 

I believe that there are three clocks running. The first clock is 

a 2013 clock. As I stated, the Commission concluded that it was 

more likely than not that a weapon of mass destruction would be 

used by 2013. The second clock is a 2010 clock. Under the principal 

international treaty for nuclear proliferation avoidance, the nonproliferation agreement, there is, every 5 years, a meeting of the 

signatories to review what’s happened in the last 5 years and make 

recommendations for the future. 2010 will be such a year. We believe it is critically important that 2010 be used aggressively to 

deal with some of the current gaps and weaknesses in our international treaty on nuclear proliferation. 

That issue is primarily in the executive branch. The Congress 

has legislated extensively in the area of nuclear proliferation. Most 

of the heavy lifting to be done must be accomplished by the executive branch. I’d like to commend President Obama for his initiative, 

the statements that he has made, such as that that he made in 

Prague, and calling for a summit in March of 2010 to precede the 

conference of the signatories to the nonproliferation treaty that 

should energize the work of that conference. 

The third clock is a 2011 clock. As the nonproliferation treaty is 

the basic document for nuclear nonproliferation, the Biological 

19 

Weapons Convention of 1972 has the same role for biologicals. It 

also has provision for periodic review. The next review will take 

place in 2011. 

We believe it is imperative that the United States use its influence in order to achieve some significant reform in the structure 

of our dealings with biological proliferation. In many ways, the biological treaty is in greater need of amending than the nuclear treaty. We also believe that, for the United States to play that role of 

leader, we must lead by example. 

This issue is primarily a Congressional issue. We believe that the 

legislation that Congress, hopefully, will enact in the next few 

months will set the gold standard of what a country should do to 

avoid the proliferation of biological weapons, and that that will put 

us on the moral high ground as we go into the 2011 convention to 

get other countries to see our standard as one to which they should 

also aspire. 

Mr. Chairman, we have felt that there were two principal strategies for biological defense against proliferation. One, is very similar 

to the basic strategy for nuclear, which is to avoid the terrorists 

getting access to the materials necessary to make, and then distribute and disseminate, biological materials. 

This is a much more difficult issue in biological than it is in nuclear because the biological materials are so ubiquitous, and they 

do not require the same skill level or the technology. They can be 

transported more readily; a mere vial of the right pathogen can do 

enormous damage. 

The second strategy which is peculiar to biologicals is a deter-bybeing-prepared strategy. In our discussions, including some recent 

discussions within the intelligence community, the feeling is that 

if an adversary, particularly a non-state actor, were to get access 

to the materials for a weapon, they would use it fairly quickly. 

Unlike North Korea, which has a strategy of stockpiling the nuclear bombs that it’s developing because they want to have a second-strike capability, a typical non-state terrorist would want to 

use the material quickly, in part because of safety concerns, and 

second, because it fulfills their rationale for wanting to use a weapon of mass destruction. 

The adversary would be looking at a number of potential targets 

to use their biological materials. We think that they would be inclined to want to use it against the target where they felt they 

would have the greatest consequence, the greatest number of casualties. So the degree to which a community has prepared itself not 

only for a terrorist attack, but also for an epidemic, such as what 

we might be dealing with this year with swine flu, that preparation 

is one of the best deterrents that a community can have. The issue 

that you’re discussing today, lab security, touches on both of those 

strategies. 

Lab security is a fundamental part of preventing weapons of 

mass destruction from falling into the wrong hands. Also, lab security procedures play an important role in our continuing ability to 

be creative and innovative in developing the vaccines and other 

pharmaceuticals that will be a key part of our ability to reduce the 

consequences of the use of a biological weapon of mass destruction. 

20 

Mr. Chairman, that is sort of the broad framework. I would just 

conclude by mentioning three areas of action. One, the need to 

have an overall strategy of how we’re going to deal with the biological issue. I testified earlier today where a representative of the 

Government Accountability Office presented a report which had the 

headline of, ‘‘We Do Not Have Anyone in Charge of Our Biological 

Response.’’ It’s now been 8 years since the attack that occurred, in 

part, in this very building, was launched. It is inexcusable that we 

don’t have an overall strategy, and I think it’s incumbent upon the 

Congress to take those steps to demand that the executive branch 

establish such a strategy. 

Second is the international dimension. The title of our report was 

consciously selected. It is: ‘‘World at Risk,’’ underscoring the fact 

that this is not a problem that the United States can solve in isolation. We’ve got to see this as a global threat. The 2011 conference, 

and our preparation for it, will be key. 

Finally, returning to the three clocks, we don’t have an indefinite 

amount of time. This is my assessment, not the Commission’s. The 

Commission assessed that, as of December 2008, there was better 

than a 50/50 chance that there would be a weapon of mass destruction used between that date and the end of 2013. 

It would be my assessment today, on the 22nd of September of 

2009, that the chances of there being a successful use of a weapon 

of mass destruction are greater than they were even last December. 

That is a testimony to the alacrity and the commitment of our opponents, our adversaries, to achieve and use this technology. 

So, Mr. Chairman, I thank you for the opportunity to share these 

thoughts on behalf of the Commission. I would be pleased to answer any questions. 

[The prepared statement of Senator Graham appears as a submission for the record.] 

Senator CARDIN. Well, again, thank you very much for your testimony. It’s very, very helpful. 

Dr. Kingsbury. 

STATEMENT OF DR. NANCY KINGSBURY, MANAGING DIRECTOR, APPLIED RESEARCH AND METHODS, UNITED STATES 

GOVERNMENT ACCOUNTABILITY OFFICE, WASHINGTON, DC 

Dr. KINGSBURY. OK. I’ll try to be brief, if I can get my microphone on. 

We’re very pleased to be here to discuss the report that we 

issued yesterday on the need for a national strategy for high-containment laboratories in the United States. High-containment laboratories have proliferated in recent years. In 2007, we reported on 

several issues associated with the proliferation of these labs in the 

United States, and some of the risk posed by bio-safety incidents 

that occurred in the past. 

The FBI’s allegation in August of 2008 that a DOD scientist was 

the sole perpetrator of the 2001 anthrax attacks raised additional 

concerns about the possibility of insider misuse of high-containment laboratory facilities, material, and technology. 

Highly publicized laboratory errors and controversies about 

where high-containment labs should be located have raised quesVerDate Nov 24 2008 14:15 Apr 19, 2010 Jkt 055644 PO 00000 Frm 00024 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\55644.TXT SJUD1 PsN: CMORC
21 

tions about whether the governing framework, oversight, and 

standards for bio-safety and bio-security are adequate. 

We have three findings to report. First, since 2001, the number 

of BSL–III and BSL–IV labs in the United States has increased, 

and this expansion has taken place across Federal, State, academic, and private sectors. By increase, we have some data in our 

report that would suggest it’s more than doubled in terms of the 

numbers. 

Information about the number, location, activities, and ownership is available for high-containment labs that are registered with 

CDC’s or USDA’s select agent programs, but not for those outside 

those outside those programs. The expansion that began after the 

anthrax attacks in 2001 lacked a clear, coordinated national strategy. 

Decisions to fund the construction of high-containment labs were 

made by multiple Federal agencies in multiple budget cycles. Federal and State agencies, academia, and the private sector considered their own individual requirements, but an assessment of national needs was lacking. Even now after more than 7 years, we 

were unable to find any projections based on a government-initiated strategic evaluation of current and future capacity requirements linked to national public health goals, or for that matter, 

weapons of mass destruction goals. Such information is needed to 

ensure that the U.S. will have facilities in the right place with the 

right research capabilities. 

Second, no executive or legislative mandate directs any Federal 

agency to track the expansion of all high-containment laboratories. 

Accordingly, no Federal agency knows how many such labs exist in 

the United States, and no single agency is responsible for determining, or able to determine, the aggregate risks associated with 

the expansion of these labs. Consequently, no Federal agency can 

determine whether high-containment lab capacity is now less than, 

meets, or exceeds the national need. 

Finally, four highly publicized bio-safety incidents in high-containment laboratories, as well as evidence from scientific literature, 

demonstrate that, while laboratory accidents are rare, they do 

occur, primarily due to human error or system failure. One of the 

incidents we reviewed involved the allegations that Dr. Bruce Ivins 

of DOD was the source of the 2001 anthrax attack. 

These allegations highlighted two lessons: first, an ill-intentioned 

insider could pose a risk by removing dangerous material from a 

high-containment laboratory; and second, it is impossible to have 

100 percent effective inventory control of biological material with 

currently available technologies. 

At Ft. Detrick, ineffective procedures for the control of inventories and the unrestricted use of lab facilities allegedly allowed Dr. 

Ivins the opportunity to pursue his own ends. As the number of 

high-containment labs increases, there will inevitably be an increase in the pool of scientists with expertise and, thus, the corresponding risk from insiders is likely to increase. 

Taken as a whole, the incidents we reviewed demonstrated failures of systems and procedures meant to maintain bio-safety in 

high-containment labs. They revealed the failure to comply with 

regulatory requirements, safety measures that were not commensuVerDate Nov 24 2008 14:15 Apr 19, 2010 Jkt 055644 PO 00000 Frm 00025 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\55644.TXT SJUD1 PsN: CMORC
22 

rate with the level of risk to public health posed by lab workers 

and the pathogens in those labs, and the failure to fund ongoing 

facility maintenance and monitoring the operational effectiveness 

of lab physical infrastructure. 

In conclusion, I want to stress that oversight plays a critical role 

in improving bio-safety and ensuring that high-containment labs 

comply with regulations. However, some aspects of the current 

oversight programs provided by CDC and USDA are dependent 

upon entities monitoring themselves and reporting incidents to 

Federal regulators. 

Furthermore, personal reliability programs have been established 

since 2001 to counter insider risks, but their cost-effectiveness and 

programmatic impact has not been evaluated. We would note that 

the incident at Ft. Detrick is the only known incident of insider behavior. 

If an agency were tasked or a mechanism were established with 

the purpose of overseeing the expansion of high-containment labs, 

it could develop a strategic plan to ensure that the number and capabilities of potentially dangerous high-containment labs are no 

greater or less than necessary, it could balance the risks and benefits of expanding such labs, and it could determine the type of oversight needed. 

To address these issues, we recommended that the National Security Advisor, in consultation with the Secretaries of Health and 

Human Services, Agriculture, Defense, and Homeland Security, 

along with the National Intelligence Council and other executive 

departments as appropriate, identify a single entity charged with 

periodic strategic evaluation of high-containment labs that will determine the number, location, and mission of the laboratories needed to effectively meet national goals to counter bio-threats, the existing laboratory capacity within the United States, the aggregate 

risks associated with the laboratories’ expansion, and the type of 

oversight needed. 

It would also develop, in consultation with the scientific community, national standards for the design, construction, commissioning, and operation of high-containment laboratories, specifically 

and importantly including provisions for long-term maintenance. 

We also recommend that the Secretaries of HHS and Agriculture 

develop a clear definition of exposure to select agents. The voluntary reports that come back from labs obviously demonstrate 

that there is some confusion about that issue. They can also develop a mechanism for sharing lessons learned from reported laboratory accidents so that best practices for other operators of highcontainment laboratories can be identified. 

Recognizing that biological agent inventories cannot be completely controlled at present, we also recommended that the Secretaries of HHS and Agriculture review existing inventory control 

systems and invest in, and develop, appropriate technologies to 

minimize the potential for the insider misuse of biologic agents. 

Finally, should the Secretaries consider implementing a more 

stringent personnel reliability program for high-containment laboratory employees to deal with insider risk, we recommend that 

they evaluate and document the cost-effectiveness and programmatic impact of such a program. In an earlier hearing today, 

23 

a representative of the American Society for Microbiologists emphasized quite a bit the need to balance the security factors and the 

ability for researchers to do their work. 

Mr. Chairman, that’s my prepared statement and I’ll be happy 

to answer your questions. 

[The prepared statement of Dr. Kingsbury appears as a submission for the record.] 

Senator CARDIN. That’s very helpful. Thank you very much. 

Mr. Greenberger. 

STATEMENT OF MICHAEL GREENBERGER, DIRECTOR, CENTER FOR HEALTH AND HOMELAND SECURITY, UNIVERSITY 

OF MARYLAND, BALTIMORE BALTIMORE, MD 

Mr. GREENBERGER. Thank you, Chairman Cardin. And I want to 

congratulate you and the Subcommittee for holding this hearing 

today. If we’ve learned any lesson from our National security perspective, and maybe even from our financial perspective, is that 

when you don’t pay attention to issues we tend to get banged in 

the side of the head. You can go all the way back to the Great Depression and Pearl Harbor or you can look at the 9/11 attacks or 

the anthrax attacks. 

I know the Senate’s docket is very, very busy, and I know that, 

for example, Ranking Member Kyl is understandably preoccupied 

with health reform, and you’ve got global warming, reform of the 

Financial Regulatory System, and a host of international relations 

issues, Afghanistan probably being at the top. But I think your 

Subcommittee’s wisdom in looking at an issue that can come back 

to bite us big-time is to be congratulated. 

I have had the fortune, as the Director of the Center for Health 

and Homeland Security at the University of Maryland, of working 

with medical researchers at the School of Medicine and their collaborative, the Mid-Atlantic Regional Center of Excellence, which 

deals with bio-defense and emerging infectious diseases issues. 

Let me say in the first instance, the money that is being spent 

by the Federal Government for this research is money that is well 

spent. We only have to look at the fact that we are going to have 

an H1N1 vaccine in October. When things go well we don’t tend to 

congratulate people. The fact that that vaccine is available, given 

scientific and commercial problems in the vaccine industry, is nothing more than a minor miracle and shows what scientific research 

can do to be of assistance to the United States. 

However, the anthrax episode at Ft. Detrick demonstrates that, 

imbedded within all of that good work can be very dangerous activity. It is a high irony that the anthrax episode of 2001 was the 

principal motivator for all of this research, and then we found out 

a year ago that the researchers may have been the problem of the 

anthrax incident itself. 

Now, let me say, I have studied the Ft. Detrick situation. I’m not 

at all convinced that Dr. Ivins is necessarily the perpetrator, and 

I think it was unfortunate that, after his suicide, blame was 

heaped upon him. But I am convinced, based on the DNA evidence 

that was done, that the source of the anthrax emanated from a 

flask at Ft. Detrick. Somebody got access to that information. 

24 

And while Senator Graham makes the excellent point that we 

have to worry about outsiders doing damage to us, this provokes 

the classic Pogo commentary that ‘‘We have found the enemy and 

he is us’’. It was an insider, one of our researchers, that perpetrated maybe the third serious terrorist attack on the United 

States that got access to that flask. 

I think we have, in our testimony to you today, made six recommendations. I think there is a consensus here: you must have 

somebody in charge of this situation. I would take some—I would 

quibble somewhat with the DOD’s testimony today. I think having 

an interagency task force do this is a big mistake. I think putting 

it in the National Security Council is a big mistake. 

If there were a spill, or the stealth of, say, Ebola bacteria from 

a laboratory, somebody in Congress would right away want to 

know, what has happened? I think what we’ve learned today is, we 

wouldn’t know which of the 15 different agencies in the Federal 

Government to call up here, and we all know the difficulty of getting the National Security Advisor up here. No blame to the National Security Advisor, but he has a lot of things on his plate. 

There must be somebody in the Federal Government that assumes 

overall responsibility. 

The BSL labs, unlike any professional institution, are not required to be accredited. Right now, my own law school is worried 

about an accreditation process that is going to happen over a year 

from now. That is forcing our school, medical schools, all kinds of 

institutions who have to be accredited to do the most thorough selfevaluation to meet that accreditation. 

The single regulator must set up an accrediting process. We’ve 

heard that there’s 1-year inspections, some inspections, what have 

you. But the four big episodes that are identified as the cause of 

our concern, starting with anthrax and some of the other universities, were people reporting to a regulator a problem, not the fact 

that the inspectors found the problem. You have to have a system 

that goes through an accreditation process. 

Also, what has been said today, we agree with: mishaps at the 

laboratories are not promptly and fully reported to the Federal 

Government, and even worse, the experience from those mishaps is 

not sent out to the other laboratories as a ‘‘lessons learned’’ modality. It’s a very incomplete process and it’s a very slow process, and 

again, a single overseer could fix that problem. 

The final thing that’s been talked about today that I think is 

very important, you have military laboratories on one extreme and 

university laboratories on another extreme. It is impossible—and I 

was pleased to see the Department of Defense advocate—to apply 

military precision and security to a university laboratory, not just 

because you don’t have the resources, but most medical researchers 

at universities would say that there is an element of the openness 

of those labs that would be defeated by a super-security process. 

I think many people have testified, some of the committees that 

have issued reports today have testified, that you can reach the security goals here without developing a full military security apparatus, and not using some of the techniques like psychological testing of researchers and other things that would only hinder being 

able to bring the best researchers to the table. 

25 

I’ve cited the University of Maryland, Baltimore. They supervise 

1,500 laboratories, some of them are BSL laboratories. They use 

guidelines that have been developed by CDC and NIH. They are 

very serious about the work they do. Those guidelines can be applied institution to institution to assure safety and security. There 

has never been a leak or stolen materials from the BSL. That’s the 

next-highest secure laboratory at the University of Maryland. 

Through a single regulator, accreditation, the use of the best practices within university industries, we can have the best of both 

worlds: good science and good security. 

Thank you. 

[The prepared statement of Mr. Greenberger appears as a submission for the record.] 

Senator CARDIN. Well, thank you very much. In fact, thank all 

three of you. It’s a pretty direct presentation of the risk factors that 

we confront. Senator Graham, I think it’s very sobering, your predictions that your Commission came up with, the vulnerability of 

the United States to weapons of mass destruction, and most likely 

the biological being the more likely vulnerability. It puts additional 

attention on the subject that we have here today, which is the security of our containment labs. 

You all are raising the same point. You’re saying we need to 

have a coordinated strategy. That is one of the points that, Senator 

Graham, you pointed out that is missing, an overall strategy. It’s 

difficult for us to look at who is responsible on biological containment labs’ security when there’s 15 agencies involved and they 

each have different responsibilities. 

Quite frankly, some of these labs are dealing with a lot of agents 

that are not a particular interest, or they’re important to keep control over them, don’t get me wrong, but they’re not going to fall into 

the category that you are concerned about, Senator, about being 

used as a weapon of mass destruction. 

That’s why I thought one of the recommendations I believe that 

your Commission has made that I found very helpful is to have 

tiers of interest in regards to the agents, the pathogens that are 

of the most concern, tier one, would be categorized in that way so 

it would get the special attention. Then you could do what Mr. 

Greenberger is suggesting as far as being able to trace those types 

of agents. 

At the same time, I am concerned with the point that Dr. 

Kingsbury raised about, how do you do this in a climate that allows 

the type of collaboration among our universities and private entities and international partners that are going to be important for 

the type of academic work necessary to prepare us, as you pointed 

out, so that we are prepared to deal with the risks that are out 

there. 

So let me start off with that recommendation on the tiering of 

the pathogens. The previous panel seemed also to support that type 

of concept. You indicate you might be able to limit to eight—at 

least that’s what I thought I saw in the Commission’s report. Is 

that a reasonable number that you think would end up in tier one? 

And what is your criteria for tier one? 

Senator GRAHAM. Mr. Chairman, the criteria for inclusion in tier 

one are those pathogens that are the most deadly and the most 

26 

readily weaponized. The scientific community that we consulted 

with felt that that might be as few as eight pathogens. There are 

now, I think, over 80 that are on the special agent list, so it would 

be a very focused group of pathogens which could have the highest 

level of security. 

We also propose that there be two other tiers, a tier two which 

would be those pathogens that have great potential, but are not at 

this point as amenable to weaponization as those that would be in 

tier one. They would get the second level of review. Then tier three 

would be everything else, including some items that are of lesser 

potential threat, but maybe more ubiquitously distributed around 

the world. 

Senator CARDIN. And I want to point out, I think we need protection on all of the pathogens because it could be extremely dangerous for those who are handling it. It may well not be suitable 

as a weapon of mass destruction, but it is an agent that requires 

special attention. We should know where they are, how they’re 

being used, and there should be certain standardized protections. 

Senator GRAHAM. Yes. I think there is a difference between the 

regulatory pattern for safety, which might be more common across 

those three tiers. As an example, there was a story yesterday or 

today about a scientist at the University of Chicago who has died, 

and there is the possibility that he died because he was handling 

an agent which is generally thought of to be relatively mild in 

terms of its potential. We’ll learn more about the full circumstances 

of this gentleman’s death. 

But safety is one concern for which there’s probably not the need 

or desirability for such high levels of stratification, but the security 

level, we want to be able to put our maximum attention on those 

pathogens that have the greatest potential to be converted into 

weapons. 

Senator CARDIN. Dr. Kingsbury, you raised the issue of the freedom, academic freedom and the ability to work with your colleagues around the world. How do you balance that? 

Dr. KINGSBURY. Well, I think it’s just a factor that needs to be 

taken into account. With respect to the tiering question, while I 

have a fair amount of sympathy for the importance of the security 

of those highly vulnerable pathogens, I’m not sure we know enough 

about the mix of pathogens in different laboratories to have a view 

yet of whether that kind of strategy would actually work. If you’re 

working with anthrax or whatever else is on that list of eight, but 

you’re also working on something else that’s more benign or not 

likely to—or there are treatments for it, and so they’re inventing 

new treatments, it’s not sure how that relationship would work and 

I’d just be interested in knowing more about it. 

Senator CARDIN. I also think we need to know, of all the people 

who registered, how many would have had to have registered for 

tier one if we had a different registration system. 

Dr. KINGSBURY. Yes. 

Senator CARDIN. I don’t know if we know that or not, because 

we—— 

Dr. KINGSBURY. We don’t, I don’t think. Do we? No. OK. We 

don’t. 

27 

Senator CARDIN. One of the issues here is budget and workload 

as to—— 

Dr. KINGSBURY. Oh, sure. Sure. Absolutely. Several months 

ago—a couple of months ago—we issued a report looking at the 

question of the building of the national agro and bio-defense facility 

that the Department of Homeland Security is proposing, and there 

we limited our whole analysis to the issue of foot-and-mouth disease and whether the Department of Homeland Security had adequately demonstrated that foot-and-mouth disease, which does not 

affect humans—OK, so I don’t think it would be a very good weapon, except economically—whether or not the ability to control escape of that pathogen from a lab that is built in the middle of the 

most prolific cow country in the country, and we reported, frankly, 

that we didn’t think DHS had demonstrated that. It doesn’t mean 

it can’t be done, perhaps. I have my own concerns about that. But 

they haven’t demonstrated it yet, and it’s clear they’re going to go 

ahead with the decision. 

But we thought focusing on that, because it is economically so 

significant and because the virus is so infectious—it’s the single 

most infectious virus on the planet. If it starts getting into cattle 

herds, the cost associated with both the trade impact of that event 

and the cost of cleaning it up is really important to think about. 

There may be special circumstances around some of these other select agents that might need the same kind of analysis. 

Senator CARDIN. Mr. Greenberger, you don’t believe the best solution is the interagency approach. Do you have a specific recommendation as to how the line of responsibility should work in 

this area? 

Mr. GREENBERGER. Well, I think the two principal agencies that 

have had regulatory responsibility—in other words, DHS came before you today and said, effectively, they’re supervising researchers. 

They’re overseeing their researchers in the 42 labs. But the people 

who have had over-arching responsibility are CDC and the Department of Agriculture for plants and animals. I think in all candor, 

you’d have to say the record here is that CDC is the superior 

record. There have been problems with the Department of Agriculture. It’s own Inspector General has identified it. 

This reminds me very much of the Hurricane Katrina problem 

when, after the clean-up of Hurricane Katrina, there was this big 

debate whether the Department of Homeland Security was in 

charge as the then-national response plan indicated, or whether 

HHS, because of the public health factors in the clean-up, should 

be in charge. 

In December 2006, Congress passed the Pandemic and All Hazards Preparedness Act, took the responsibility away from DHS and 

gave it to HHS, and created a separate Assistant Secretary within 

HHS to oversee catastrophic public health experiences. Now, one 

thing I would say about that: oversight is very important. It took 

13 months to get a Director of that agency. But I think that that 

kind of episode—I think this is a public health situation. I think 

you should look to HHS as the overriding regulator here. They 

should be in charge. 

Whether CDC, who’s now overloaded with H1N1 problems, has 

enough resources to do this, I don’t know, but I would start with 

28 

them. They should be established—they should be the single agency setting up standards, both safety standards, security standards 

for all these laboratories, having the entire inventory, being responsible for having evidence of mishaps, and setting up an accreditation process. And by the way, the accreditation process doesn’t necessarily have to be completely public. You can get the best universities who have proven laboratory experience here to be the accrediting committees, and change them from time to time. 

As I said, your worry about the tension between security and 

openness, I think, is being met in the vast majority of universities 

who have laboratory issues today. They are following NIH/CDC 

guidelines, they are deadly serious about a deadly issue, they have 

training programs, and they hold their researchers accountable. As 

the National Science Advisory Board on Biologics report says, we 

have to get that culture in the good institutions imbedded throughout. The single regulator should be the one who does that. It can 

be done without converting universities into military operations. 

Senator CARDIN. I think we all agree with that. 

I think, Senator Graham, your report sort of points to Department of Homeland Security as the key agency. 

Senator GRAHAM. Our recommendation in this area, Mr. Chairman, is on page 29 of our report. It says, ‘‘The Department of 

Health and Human Services, in coordination with the Department 

of Homeland Security, should lead an interagency effort to tighten 

government oversight of high-containment laboratories. So our recommendation was that it be interagency in nature with the Department of Health and Human Services in the lead. 

In addition to the factors that Professor Greenberger has just 

outlined, I would add another: that is, urgency. It would be our 

hope that the Congress would act in sufficient time that the administration could show some actual results of your actions in terms 

of standards for high-containment laboratories before that 2011 

conference. 

We think the United States needs to be in the strongest position 

of leadership before that conference in order to be able to have the 

influence that we think is critical in order to strengthen the global 

network against the proliferation of biological material. We must 

lead by example. 

Senator CARDIN. So there is some agreement here between the 

two, HHS. How about the GAO? 

Dr. KINGSBURY. Well, if I could add two things. One is, as a part 

of our work on the report that we issued yesterday, we did talk to 

all of the agencies who have an interest in this oversight question. 

All of them told us they didn’t feel they had the authority to take 

a leadership role. That’s why we think there is some action that 

needs to be taken here. It’s the lack of authority to direct another 

agency how to spend its appropriations that is the sort of weakness 

in—— 

Senator CARDIN. That’s our responsibility. 

Dr. KINGSBURY. That’s your responsibility. 

Senator CARDIN. I understand that. That’s our responsibility to 

clarify. I’m trying to get the best advice, if there is consensus in 

Congress to give a lead agency, who that lead agency should be. It 

seems like Senator—— 

29 

Dr. KINGSBURY. Well, for exactly the reasons that Dr. 

Greenberger said, HHS is at least a leading candidate here. I 

would put it at the HHS level, not the CDC level, because of NIH 

and the other places in HHS where these laboratories go. 

Senator CARDIN. So let me just get back to Senator Graham, 

then, on what your thought is, using the interagency. But you still 

want the responsibility to be with HHS, if I understand correctly? 

Senator GRAHAM. Yes. 

Dr. KINGSBURY. If I could offer up one other example. We are 

aware that the United Kingdom has completely centralized oversight of these laboratories in an organization called the Health and 

Safety Executive. There were two different—like we have with 

CDC and APHIS, there were two different organizations with 

somewhat different approaches and standards and so forth dealing 

with the animal and plant side, and with the human side, and they 

made a decision, after the outbreak of foot-and-mouth disease in 

Pirbright, to centralize all of it in the Health and Safety Executive 

and operate by the same standards. 

Senator CARDIN. Senator, as I understood, you’re suggesting that 

this type of action would be very helpful for the United States to 

complete prior to going to the review conference? 

Senator GRAHAM. Yes. And I think that the Department of HHS, 

because of the reasons that have been stated, is the one most likely 

to be able to show some quick results of being assigned this leadership role. 

Senator CARDIN. Let me ask one last question generally of whoever wants to respond to it. That is whether it is useful for us to 

pursue a more sophisticated way of doing background checks on 

those who have access to the most dangerous pathogens. Mr. 

Greenberger, you raise a very valid point, that the attack on our 

country, the third most serious, was from within and that the person who—at least, one of the—the person who has been labeled responsible had certain issues that could have been discovered 

through a background or a review of his current situation. 

Is it feasible and the right use of resources to try to develop a 

more sophisticated way to license those who have access to the 

most dangerous pathogens, or are we in an area that to do more 

than is currently being done is probably not realistic to expect? 

Mr. GREENBERGER. If I can take a crack at that. I think that the 

National Science Advisory Board on Biology, which has one of the 

big reports on this, if you read their message between the lines, is 

that the present system for non-military facilities, mostly university facilities, has to be fine-tuned. Some of it is too stringent. Even 

as the Department of Defense testified today, there are too many 

foreign nationals that are excluded only because they’re foreign nationals and not because they’re a threat to the country, and that’s 

hurting our scientific effort. 

Some of the—for example, the Dr. Ivins thing might suggest that 

some of the things the military uses as a screening device, which 

are psychological profiling, might be appropriate. I agree with the 

National Science Advisory Committee that that is a mistake. I 

think, anecdotally, many of us have had the experience of people 

being disqualified from national security clearances for unknown 

30 

reasons for failure of the psychological profiling, and I don’t think 

there’s a lot of confidence in it. 

The National Science Advisory Board, for example, expressly 

says that should not be used for the university system. On the 

other hand, if you have a single regulator establishing standards, 

it certainly would be appropriate to have them report on somebody 

who’s been experiencing in the real world some kind of psychological difficulty. Now, that’s a very sensitive issue. It raises all 

sorts of privacy points. 

But here you have to balance the Nation’s security in a Dr. Ivinslike situation against privacy concerns. It’s a delicate balance. But 

a single regulator, with the advice of an interagency consultation 

and the best private minds, I think, can draw up regulations that 

assure privacy but do the reporting so that those kinds of issues 

do dwell up to the top. 

Right now, in fact, all the building blocks are there. They’re 

spread among 15 different agencies. Nobody—even the tiering 

issue, I think, is—I agree that that is a good response and it could 

easily be done, but nobody has been assigned the responsibility of 

doing it. I think all these things can be accomplished. You’ve got 

to find somebody to take charge, given them general guidelines. 

Senator CARDIN. Your point is, you would, as part of this overall 

structural change, give HHS the authority to revise or change the 

current structure that’s in place where the Department of Justice 

is doing these background checks for those that are dealing with 

agents. 

Mr. GREENBERGER. Yes. And I think that you can set the goals. 

The general goal is assuring security without undercutting private 

research. You’ve got the best—the National Science Advisory Board 

has already laid out parameters where this fine-tuning can take 

place. 

Senator CARDIN. Do better in some cases, but in some cases we’re 

over-restricted. 

Mr. GREENBERGER. I agree. 

Senator CARDIN. Senator Graham. 

Senator GRAHAM. I would agree with Professor Greenberger’s assessment. I would also say that, of the various ways in which the 

materials for a biological weapon of mass destruction might fall 

into evil hands, such as being produced outside the country and 

brought into the country, or someone driving a truck through a 

fence at a secured facility, or a person on the inside turning and 

becoming a rogue scientist, I think that third option is the most 

likely option. It happens to be the only option which has actually 

been utilized in recent history. 

So I think it’s a very important question. I would associate myself with the sophisticated recommendation that the Professor has 

made as to how to go about balancing all of those interests. 

Senator CARDIN. Doctor. 

Dr. KINGSBURY. I think we would agree that if you’re going to do 

a personnel security program with uniform requirements across the 

whole community, some kind of collaborative way of doing it is certainly absolutely needed. But it’s not going to come cheap. As you 

well know, the government is facing considerable budgetary presVerDate Nov 24 2008 14:15 Apr 19, 2010 Jkt 055644 PO 00000 Frm 00034 Fmt 6633 Sfmt 6633 S:\GPO\HEARINGS\55644.TXT SJUD1 PsN: CMORC
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sure these days. I would not want to think about that personnel 

security program in complete isolation. 

I think there is not a lot of evidence about its being successful 

in what it sets out to do. The case at Ft. Detrick is the only known 

case of an insider doing the sorts of things that he did. Yet, there 

are, what, 1,600 of these laboratories around the country. So 

whether you want to get into the business of doing that without, 

as we recommend in our report, looking at what the costs are going 

to be, looking at what the benefits are going to be and evaluating 

it—we are aware, for example, of a case at the University of Texas 

at Austin where they are trying to hire a couple of very high-end 

scientists from Brazil, and they’re having to wait 18 months. They 

haven’t been cleared to come into the country even, let alone to 

work at the laboratory. So all those issues need to be worked 

through with the scientific community. 

Senator CARDIN. I don’t think we’re going to be able to resolve 

the problems of people getting visas to come to America at this 

hearing. 

Dr. KINGSBURY. Probably not. 

Senator CARDIN. But I think you raise a very valid point on cost. 

My point is this. I think what Professor Greenberger is saying is 

that we might be able to get savings by doing this more efficiently 

than we we’re doing it today and that, if we have a tier approach, 

there may well be a less costly way to deal with the majority of 

people that are dealing with pathogens at our labs or the type of 

lab they’re dealing with, the type of work that they’re dealing with, 

that there should be more sophistication in the way that we go 

about doing it. 

I expect, if HHS had the authority, they could then have more 

impact on DOJ, if that’s the agency that’s actually going to be 

doing the reviews for the process, and they may be able to avoid 

some of the time delays that we have. At least, I would hope that 

would be part of the game plan that would be developed. 

But I must tell you, someone who is dealing with anthrax and 

the potential danger that that can cause, the potential risk factor 

of a weapon of mass destruction, it seems to me that we have a 

responsibility to the public that someone who could have access to 

remove anthrax from a lab, that that person is scrutinized at a 

much higher level, including their psychological make-up, so that 

we do protect the public from that type of attack that we had here 

in the U.S. Senate and in our country. 

With that, let me thank all three of you for adding to this discussion. As I said at the beginning, there are other committees that 

are interested in this subject, and we do expect that the Congress 

is going to want to continue this effort. I thank all three of you for 

your contribution. 

Senator Graham, the work of your Commission, which was, as 

you pointed out, set up by Congress, is a valued part of our process. 

There’s been a lot of discussion about it among your former colleagues, so we appreciate your continued contribution to this very 

important debate, and we look forward to this continued dialog 

with all three of you as we try to get this right for the sake of our 

National security and the safety of Americans. 

32 

With that, the Subcommittee will keep the record open for 1 

week for questions that members of the Committee might wish to 

pose. With that, the Subcommittee will stand adjourned. 

[Whereupon, at 4:32 p.m. the Committee was adjourned.] 

[Submissions for the record follow.] 

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Æ 


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