U.S. GOVERNMENT PUBLISHING OFFICE

28–141 WASHINGTON : 2018

CONCERNS OVER FEDERAL SELECT AGENT 

PROGRAM OVERSIGHT OF DANGEROUS 

PATHOGENS 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FIFTEENTH CONGRESS 

FIRST SESSION 

NOVEMBER 2, 2017 

Serial No. 115–73 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

(II) 

COMMITTEE ON ENERGY AND COMMERCE 

GREG WALDEN, Oregon 

Chairman 

JOE BARTON, Texas 

Vice Chairman 

FRED UPTON, Michigan 

JOHN SHIMKUS, Illinois 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

LARRY BUCSHON, Indiana 

BILL FLORES, Texas 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

KEVIN CRAMER, North Dakota 

TIM WALBERG, Michigan 

MIMI WALTERS, California 

RYAN A. COSTELLO, Pennsylvania 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

JEFF DUNCAN, South Carolina 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

PETER WELCH, Vermont 

BEN RAY LUJA ́ N, New Mexico 

PAUL TONKO, New York 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

RAUL RUIZ, California 

SCOTT H. PETERS, California 

DEBBIE DINGELL, Michigan 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

VACANCY 

Chairman 

H. MORGAN GRIFFITH, Virginia 

Vice Chairman 

JOE BARTON, Texas 

MICHAEL C. BURGESS, Texas 

SUSAN W. BROOKS, Indiana 

CHRIS COLLINS, New York 

TIM WALBERG, Michigan 

MIMI WALTERS, California 

RYAN A. COSTELLO, Pennsylvania 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

GREG WALDEN, Oregon (ex officio) 

DIANA DEGETTE, Colorado 

Ranking Member 

JANICE D. SCHAKOWSKY, Illinois 

KATHY CASTOR, Florida 

PAUL TONKO, New York 

YVETTE D. CLARKE, New York 

RAUL RUIZ, California 

SCOTT H. PETERS, California 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(III) 

C O N T E N T S 

Page 

Hon. H. Morgan Griffith, a Representative in Congress from the Commonwealth of Virginia, opening statement ............................................................... 1 

Prepared statement .......................................................................................... 3 

Hon. Diana DeGette, a Representative in Congress from the state of Colorado, 

opening statement ................................................................................................ 4 

Hon. Greg Walden, a Representative in Congress from the State of Oregon, 

opening statement ................................................................................................ 6 

Prepared statement .......................................................................................... 7 

WITNESSES

Mary Denigan-Macauley, Acting Director, Health Care, Government Accountability Office ......................................................................................................... 9 

Prepared statement .......................................................................................... 11 

Answers to submitted questions ...................................................................... 67 

Samuel Edwin, Director, Division of Select Agents and Toxins, Centers for 

Disease Control and Prevention ......................................................................... 24 

Prepared statement .......................................................................................... 26 

Answers to submitted questions ...................................................................... 71 

Freeda Isaac, Director, Agriculture Select Agent Services, Animal and Plant 

Health Inspection Service .................................................................................... 36 

Prepared statement .......................................................................................... 38 

Answers to submitted questions ...................................................................... 77 

SUBMITTED MATERIAL

Committee memorandum ........................................................................................ 58 

(1) 

CONCERNS OVER FEDERAL SELECT AGENT 

PROGRAM OVERSIGHT OF DANGEROUS 

PATHOGENS 

THURSDAY, NOVEMBER 2, 2017 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 10:45 a.m., in room 

2322 Rayburn House Office Building, Hon. Morgan Griffith (vice 

chairman of the subcommittee) presiding. 

Members present: Representatives Griffith, Burgess, Brooks, Collins, Barton, Walberg, Walters, Costello, Carter, Walden (ex officio), 

DeGette, Tonko, and Ruiz. 

Staff present: Jennifer Barblan, Chief Counsel, Oversight & Investigations; Kelly Collins, Staff Assistant; Zachary Dareshori, 

Staff Assistant; Ali Fulling, Legislative Clerk, Oversight & Investigations, Digital Commerce and Consumer Protection; Brighton 

Haslett, Counsel, Oversight & Investigations; Katie McKeogh, 

Press Assistant; Jennifer Sherman, Press Secretary; Alan Slobodin, 

Chief Investigative Counsel, Oversight & Investigations; Hamlin 

Wade, Special Advisor, External Affairs; Everett Winnick, Director 

of Information Technology; Christina Calce, Minority Counsel; 

Chris Knauer, Minority Oversight Staff Director; and Miles 

Lichtman, Minority Policy Analyst. 

OPENING STATEMENT OF HON. H. MORGAN GRIFFITH, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH 

OF VIRGINIA 

Mr. GRIFFITH. Good morning. I call the meeting of the Oversight 

Subcommittee to order. 

Today the subcommittee examines the concerns over federal 

oversights of labs working with dangerous viruses and bacteria for 

research needed to protect public health and national security. 

The Federal Select Agent Program under the joint management 

of the CDC and the USDA’s Animal and Plant Health Inspection 

Services was established by legislation enacted in 2002, shortly 

after the 9/11 attacks and the anthrax mailings. These events supported Congress to conclude that certain dangerous pathogens, 

such as anthrax, smallpox, and plagues called select agents and 

toxins required regulation of its possession, use, and transfer. 

The program oversees 276 registered laboratories and almost 

4,000 individuals involved with vital research in the diagnostics, 

2 

vaccines, and medical countermeasures that save lives, protect 

American agriculture, and help protect the safety and security of 

the American people. In 2016, the program conducted 181 inspections of registered laboratories, and was notified of 177 separate incidents involving potential exposures with 998 lab workers monitored but, fortunately, with no illnesses developed. 

Because of the importance of this work and its potential dangers, 

this subcommittee has convened hearings in recent years on safety 

lapses in federal high-containment laboratories: the anthrax incident at CDC that potentially exposed more than 80 CDC workers; 

a mistaken CDC shipment of deadly bird flu to a USDA lab; a U.S. 

Army lab’s mistaken shipments of live anthrax samples for a decade to almost 200 different locations in the United States and 

around the world; and the FDA’s discovery of decades-old, 

undeclared, and unregistered smallpox vials in a storage room the 

FDA had been renting from NIH and was missed by annual NIH 

safety inspections. 

The pattern has been: incident involving handling of select 

agents, news stories, committee hearings, outrage, reaction, and 

short-term reform. Wash, rinse, repeat. The question before the 

subcommittee this morning is how do we break this pattern and instill a systematic approach toward oversight of federal select agents 

that improves safety and enhances the public’s confidence. 

The GAO’s latest report adds urgency to this question. The GAO 

found that the program did not fully meet all key elements of effective oversight. That is troubling. Select agents are dangerous materials, posing a severe threat to human and animal health. One 

would have assumed that the oversight program for select agents 

would meet at least some of the effective oversight elements found 

at other government oversight programs for dangerous research, 

such as work involving radioactive materials and nuclear weapons. 

That is not the case. 

For example, the GAO concluded that the program is not independent. Both CDC and APHIS, the joint managers of the program, 

have high-containment laboratories registered with the program. 

As a result, experts advise the GAO that the program cannot be 

entirely independent, as oversight of their own laboratories may 

represent a conflict of interest. One wonders whether or how this 

has impacted the program’s oversight. Two years ago, the HHS Office of Inspector General reported to the committee was the CDC 

was the entity with the most referrals to the program—for program 

violations. 

The GAO also found that experts and laboratory representatives 

raised concerns that the program’s reviews did not target the highest-risk activities, such as anthrax inactivation, in part because it 

has not formally assessed which activities pose the highest risk. 

Thus, lab representatives told the GAO that the program focused 

on inventory controls and conducted time-consuming reviews so 

that nicknames such as Rob matched with registered names such 

as Robert. 

On the other hand, as the subcommittee learned at its hearing 

in September of 2016, the incomplete inactivation of select agents, 

particularly anthrax, was a recurring problem in recent high-profile lab incidents. Unfortunately, the program has not focused on 

3 

the need for more specific reporting and investigation of incomplete 

inactivation of anthrax. 

Technical expertise is another concern. Even with the recent 

extra hires, workforce and training gaps remain. The GAO has also 

noted the program did not have joint strategic planning documents 

to guide its oversight. It is perplexing how the CDC and APHIS operated for nearly 15 years without a joint strategic plan. 

Finally, the GAO reviewed effective oversight approaches in selected foreign countries and regulatory sectors. For example, in 

Great Britain, oversight of laboratories that work with pathogens 

is under an independent government agency focused on health and 

safety. Under this structure, the agency has direct access to a department head with control over defining its own budget and staffing need without organizational conflict of interest. 

The subcommittee will examine whether administrative responses are sufficient to help the program meet the key elements 

of effective oversight. However, it is also fair to ask whether Congress has a legislative role. This Program, at its inception, was created in a fragmented state, a marriage of two divisions from two 

sub-Cabinet agencies in different Cabinet departments. The program was created with a security emphasis of guards/guns/gates in 

response to terrorist attacks. Fifteen years later, does this regulatory model for bioresearch laboratories make the most sense with 

more concern about biosafety and the growing public health threat 

of emerging infectious diseases? 

I welcome and thank our witnesses for appearing here today. I 

look forward to their testimony. 

And with that, I yield back and now recognize the ranking member of the subcommittee, Ms. DeGette of Colorado. 

[The prepared statement of Mr. Griffith follows:] 

PREPARED STATEMENT OF HON. H. MORGAN GRIFFITH

Today, the subcommittee examines the concerns over federal oversight of labs 

working with dangerous viruses and bacteria for research needed to protect public 

health and national security. 

The Federal Select Agent Program (‘‘Program’’) under the joint management of 

the CDC and the USDA’s Animal and Plant Health Inspection Service was established by legislation enacted in 2002, shortly after the 9/11 attacks and the anthrax 

mailings. These events spurred Congress to conclude that certain dangerous pathogens such as anthrax, smallpox and plague—called select agents and toxins—required regulation of its possession, use and transfer. 

The Program oversees 276 registered laboratories and almost 4,000 individuals involved with vital research into diagnostics, vaccines, and medical countermeasures 

that saves lives, protects American agriculture, and helps protect the safety and security of the American people. In 2016, the Program conducted 181 inspections of 

registered laboratories, and was notified of 177 separate incidents involving potential exposures with 998 lab workers monitored but fortunately with no illnesses developed. 

Because of the importance of this work and its potential dangers, this Subcommittee has convened hearings in recent years on safety lapses in federal highcontainment laboratories: 

• the anthrax incident at CDC that potentially exposed more than 80 CDC workers; 

• a mistaken CDC shipment of deadly bird flu to a USDA lab; 

• a U.S. Army lab’s mistaken shipments of live anthrax samples for a decade to 

almost 200 different locations in the U.S. and around the world; and 

• the FDA’s discovery of decades-old, undeclared and unregistered smallpox vials 

in a storage room that FDA had been renting from NIH and was missed by annual 

NIH safety inspections. 

4 

The pattern has been: incident involving handling of select agents, news stories, 

committee hearing, outrage, reaction, and short-term reform. Wash, rinse, repeat. 

The question before the subcommittee this morning is how do we break this pattern, 

and instill a systematic approach toward oversight of federal select agents that improves safety and enhances public confidence. 

The GAO’s latest report adds urgency to this question. The GAO found that the 

Program did not fully meet all key elements of effective oversight. That is troubling. 

Select agents are dangerous materials, posing a severe threat to human or animal 

health. One would have assumed that the oversight program for select agents would 

meet at least some of the effective oversight elements found at other government 

oversight programs for dangerous research, such as work involving radioactive materials and nuclear weapons. That is not the case. For example, the GAO concluded 

that the Program is not independent. Both CDC and APHIS, the joint managers of 

the Program, have high-containment laboratories registered with the Program. As 

a result, experts advised the GAO that the Program cannot be entirely independent 

as oversight of their own laboratories may represent a conflict of interest. One wonders whether or how this has impacted the Program’s oversight. Two years ago, the 

HHS Office of Inspector General reported to the committee that the CDC was the 

entity with the most referrals for Program violations. 

The GAO also found that experts and laboratory representatives raised concerns 

that the Program’s reviews did not target the highest-risk activities such as anthrax 

inactivation, in part because it has not formally assessed which activities pose the 

highest risk. Thus, lab representatives told the GAO that the Program focused on 

inventory controls and conducted time-consuming reviews so that nicknames such 

as ‘‘Rob’’ matched with registered names such as ‘‘Robert.’’ On the other hand, as 

the subcommittee learned at its hearing in September 2016, the incomplete inactivation of select agents (particularly anthrax) was a recurring problem in recent 

high-profile lab incidents. Unfortunately, the Program had not focused on the need 

for more specific reporting and investigation of incomplete inactivation of anthrax. 

Technical expertise is another concern. Even with recent extra hires, workforce 

and training gaps remain. 

The GAO also noted the Program did not have joint strategic planning documents 

to guide its oversight. It is perplexing how the CDC and APHIS operated for nearly 

15 years without a joint strategic plan. 

Finally, the GAO reviewed effective oversight approaches in selected foreign countries and regulatory sectors. For example, in Great Britain, oversight of laboratories 

that work with pathogens is under an independent government agency focused on 

health and safety. Under this structure, the agency has direct access to a department head, with control over defining its own budget and staffing needs without organizational conflict of interest. 

The subcommittee will examine whether administrative responses are sufficient 

to help the Program meet the key elements of effective oversight. However, it is also 

fair to ask whether Congress has a legislative role. This Program at its inception 

was created in a fragmented state—a marriage of two divisions from two subcabinet 

agencies in different Cabinet departments. The Program was created with a security 

emphasis of guards/guns/gates in response to terrorist attacks. Fifteen years later, 

does this regulatory model for bio-research laboratories make the most sense with 

more concern about biosafety and the growing public health threat of emerging infectious diseases? 

I welcome and thank our witnesses for appearing here today. I look forward to 

the testimony. 

OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO 

Ms. DEGETTE. Thank you, Mr. Chairman. 

Well, I can’t really agree with you more that we need to look at 

this. You talk about when these protocols were put into place 15 

years ago. I was on this subcommittee 15 years ago when we started having these hearings. And we have had quite a number of 

these hearings. Over the years, I have had quite a number of visits 

to the CDC in Atlanta. I was regaling Democratic committee staff 

last night with my stories of when I went to the former CDC lab 

up in Fort Collins, which deals with vector-borne diseases and 

5 

where they had these vector-borne diseases, aka West Nile, stored 

in modular units behind the building. And the units had grass 

growing up through the boards of the trailers and there were flies 

flying around in the trailers. 

I am pleased to say that the Congressman from that area at that 

time, Bob Schaffer, and I were able to secure funding for a beautiful new facility up there in Fort Collins and they do have the vector-borne agents stored appropriately now. 

But this just goes on and on and it is something that this subcommittee has to revisit over and over again. We have had so many 

near misses, as the chairman said, with pathogens like live anthrax, Ebola, most recently last November, the toxic form of ricin 

that was sent to a FEMA training center multiple times between 

2011 and 2016. 

At some point, something very bad is going to happen unless the 

CDC acts. And if that means that Congress has to assist in streamlining and improving the way that we handle these agents, then 

this committee and, I am sure—I see the chairman of the full committee here. I am sure the full committee would be eager to help 

because we can’t just keep stumbling along like this from year to 

year. 

The Select Agent Program has the vital task of ensuring that 

critical biodefense research proceeds without any danger to the 

health and safety of American citizens. And the Centers of Disease 

Control and the Animal and Plant Inspection Service, which jointly 

oversee the program, have to make sure that there is adequate 

oversight. But as the chairman just said, we are left today with the 

question of whether oversight of the Select Agent Program by both 

of these agencies is sufficient to guarantee that, on a consistent 

and long-term level, these high-containment labs are safely managing pathogens. 

We have to remind ourselves that these pathogens have to be 

handled every time with utmost safety and security. We don’t have 

room for error. We don’t have room for accidental shipment of ricin 

here, hither, and yon. If these pathogens fall into the wrong hands 

or if infection occurs in the general public, it literally will be very 

difficult to put that genie back in the bottle. And so any amount 

of uncertainty in this area is just unacceptable. 

I am glad that the GAO is here again today to discuss the most 

recent report on the Select Agent Program’s oversight of dangerous 

pathogens. Like all of us, I am concerned about some of the findings of this report, particularly GAO’s observation that the Select 

Agent Program may still not be applying the most effective approach to oversight at the laboratories that handle these programs. 

For example, GAO concluded in the report, ‘‘The Program’s reviews may not target the highest-risk activities, in part, because it 

has not formally assessed which activities pose the highest risk.’’ 

According to the report, the Select Agent Program inspectors 

may focus on concerns at laboratories, such as measures to deter 

theft, to the exclusion of biosafety concerns like how to handle or 

transfer pathogens. Both safety and security are essential concerns 

and both of these things are things that we have to work on together. 

6 

Now, I also want assurances that certain components of the CDC 

and APHIS are adequately staffed to oversee the Select Agent Program. For example, according to the GAO report, there has been 

a shortage of inspectors which has delayed the issuance of a number of post-inspection reports. If that is true, then some laboratories are allowing poor practices to continue for a longer period 

than necessary. 

There are a number of other issues that are identified in the 

GAO’s report that I am eager to hear the agency’s response to. And 

in conclusion, I am pleased that they have continued their report 

on behalf of this committee to examine safety and oversight issues. 

I am looking forward to hearing from everybody so that we don’t 

have to come back here again next year or the year after, so that 

our constituents can rest easy and take this off of their ever-growing list of things that keep them up at night. 

And with that, I yield back. 

Mr. GRIFFITH. I thank the gentlelady. 

I now recognize the chairman of the full committee, Mr. Walden 

of Oregon. 

OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF OREGON 

Mr. WALDEN. Thank you, Mr. Vice Chairman, for holding this 

hearing on a really important issue involving how we can improve 

federal oversight of high-containment laboratories working with 

dangerous pathogens such as anthrax. 

Our Federal Government needs to conduct critical research on diagnostic tests or vaccines to protect us from diseases, while safeguarding national security against bioterrorism. These are twin 

goals that are very important. To ensure the safety of lab scientists 

and the public, while also building confidence and support for this 

research, oversight of federal select agents is a matter that we need 

to make sure that we all get right. 

In recent years, this subcommittee has held hearings on several 

safety lapses at federal labs that potentially exposed federal personnel and other individuals to hazardous biological agents. While 

the executive branch has taken several steps to improve lab safety 

since these lapses were first detected, the GAO’s report on the Federal Select Agents Program oversight of dangerous pathogens 

shows that there are fundamental problems that have not been addressed by reactive short-term responses. 

After nearly 15 years of existence, the program does not meet 

key elements of effective oversight and the co-managers of the program, the Centers for Disease Control and the USDA’s Animal and 

Plant Health Inspection Service, lack a joint strategic document. 

The GAO’s past work has found that such strategic planning is an 

essential tool to help agencies align their workforces with their 

missions and develop long-term strategies for recruiting, training, 

and retaining staff. 

The GAO’s report also provides potential solutions for improving 

select agent oversight. The Government Accountability Office reviewed alternative effective oversight approaches from the selected 

foreign countries. For example in Great Britain, oversight of the 

labs that work with pathogens is under an independent governVerDate Nov 24 2008 14:57 Oct 02, 2018 Jkt 037690 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-73 CHRIS
7 

ment agency. Both Great Britain and Canada focus their oversight 

on biological safety, as opposed to the emphasis on biosecurity in 

the Federal Select Agent Program. Other regulatory sectors, such 

as the regulation of nuclear reactors, also offer potential solutions 

for improvement. 

Finally, the GAO findings also suggest that it may be time for 

Congress to reexamine the structure and operations of the Federal 

Select Agent Program. Currently, the program is run by two different sub-Cabinet agencies from two different departments. Both 

agencies have high-containment labs registered with the Select 

Agent Program, an organizational conflict of interest because the 

overseers are not structurally distinct and separate from all the 

labs they oversee. So to address these concerns, the subcommittee 

needs to consider whether a legislative restructuring of the program is in order. 

This program was also created in the immediate aftermath of 9/ 

11 and those attacks and the attacks through anthrax mailings, 

with an understandable emphasis on biosecurity and close scrutiny 

of those who possess and transfer select agents and how the agents 

are secured. I was here when all that happened and, in fact, excluded from my own office because the anthrax had made its way 

into the Longworth Building. 

However, nearly 15 years later, incidents at the high-containment labs have shown that primary risk lies with maintaining 

safety in the handling of these dangerous pathogens. And at a time 

of increased risk of emerging infectious diseases and the advent of 

gene editing, does an overhaul of the Federal Select Agent Program 

require legislation? 

That is why we are here today, is to learn more from those of 

you involved. And I certainly appreciate the great work of the GAO 

so I want to thank you all for your participation and look forward 

to working in a bipartisan way to improve the Federal Select Agent 

Program. 

With that, Mr. Vice Chair, I yield back the balance of my time. 

[Prepared statement of Mr. Walden follows:] 

PREPARED STATEMENT OF HON. GREG WALDEN

Thank you, Mr. Vice Chairman, for holding this hearing on the very important 

issue of improving federal oversight of high-containment laboratories working with 

dangerous pathogens such as anthrax. 

Our federal government needs to conduct critical research on diagnostic tests or 

vaccines to protect us from diseases while safeguarding national security against 

bioterrorism. To ensure the safety of lab scientists and the public, while also building confidence and support for this research, oversight of federal select agents is a 

matter we need to get right. 

In recent years, this subcommittee held hearings on several safety lapses at federal labs that potentially exposed federal personnel and other individuals to hazardous biological agents. While the executive branch has taken several steps to improve lab safety since these lapses were detected, the GAO’s report on the Federal 

Select Agents Program oversight of dangerous pathogens shows that there are fundamental problems that have not been addressed by reactive, short-term responses. 

After nearly 15 years of existence, the program does not meet key elements of effective oversight, and the co-managers of the program—the Centers for Disease Control and the USDA’s Animal and Plant Health Inspection Service—lack a joint strategic document. The GAO’s past work has found that such strategic planning is an 

essential tool to help agencies align their workforces with their missions and develop long-term strategies for recruiting, training, and retaining staff. 

8 

The GAO’s report also provides potential solutions for improving select agent 

oversight. The GAO reviewed alternative effective oversight approaches from the selected foreign countries. For example, in Great Britain, oversight of labs that work 

with pathogens is under an independent government agency. Both Great Britain 

and Canada focus their oversight on biological safety, as opposed to the emphasis 

on biosecurity in the Federal Select Agent Program. Other regulatory sectors such 

as the regulation of nuclear reactors also offer potential solutions for improvement. 

Finally, the GAO findings also suggest that it may be time for Congress to reexamine the structure and the operations of the Federal Select Agent Program. Currently, the program is run by two different subcabinet agencies from two different 

departments. Both agencies have high-containment labs registered with the Select 

Agent Program, an organizational conflict of interest because the overseers are not 

structurally distinct and separate from all of the labs they oversee. To address these 

concerns, the subcommittee needs to consider whether a legislative restructuring of 

the program is in order. 

This program was also created in the immediate aftermath of the 9/11 attacks and 

anthrax mailings, with an understandable emphasis on biosecurity and close scrutiny of those who possess and transfer select agents and how the agents are secured. 

However, nearly 15 years later, incidents at the high-containment labs have 

shown that the primary risk lies with maintaining safety in the handling of these 

dangerous pathogens. At a time of increasing risks of emerging infectious diseases 

and the advent of gene-editing, does an overhaul of the Federal Select Agent Program require legislation? 

I thank the witnesses for their participation, and look forward to working in a 

bipartisan way to improve the Federal Select Agent Program. 

Mr. GRIFFITH. Thank you very much, Mr. Chairman. I appreciate 

that. 

I would ask unanimous consent that members’ written opening 

statements may be made part of the record. Without objection, they 

will be entered into the record. 

I would now like to introduce our panel of witnesses for today’s 

hearing. First we have Dr. Mary Denigan-Macauley, the Acting Director for Health Care at the Government Accountability Office. 

Next, is Dr. Samuel Edwin, who serves as the Director of the Division of Select Agents and Toxins at the Centers for Disease Control 

and Prevention. And finally, we have Dr. Freeda Isaac, who is the 

Director of Agriculture Select Agent Services at the Animal and 

Plant Health Inspection Service. 

Thank you all for being here today and providing testimony. We 

look forward to the opportunity to discuss concerns, and hopefully 

solutions, over the Federal Select Agent Program. As you are 

aware, the committee is holding an investigative hearing and when 

doing so, we have the practice of taking testimony under oath. Do 

any of you have objection to testifying under oath? 

Seeing no objection, the Chair then advises you that you are 

under the rules of the House and the rules of the committee. You 

are entitled to be accompanied by counsel. Do any of you desire to 

be accompanied by counsel during your testimony today? 

Again, seeing a negative response that they do not wish to have 

counsel, I would then, in that case, ask you if you would please rise 

and raise your right hand. 

[Witnesses sworn.] 

Mr. GRIFFITH. All right, thank you very much. I am putting this 

down for the record that each of the witnesses has responded in the 

affirmative. 

You are now under oath and subject to the penalties set forth in 

Title 18, Section 1001 of the United States Code. You may now give 

a 5-minute summary of your written statement. 

9 

Ms. DEGETTE. Mr. Chairman? 

Mr. GRIFFITH. Yes. 

Ms. DEGETTE. Before we start with the statements, can I ask 

unanimous consent to put Mr. Pallone’s opening statement in the 

record? 

Mr. GRIFFITH. Absolutely. Without objection, Mr. Pallone’s opening statement is placed into the record. 

All right, we are going to start with Dr. Denigan-Macauley. If 

you would, give your 5-minute opening statement. 

STATEMENTS OF MARY DENIGAN-MACAULEY, ACTING DIRECTOR, HEALTH CARE, GOVERNMENT ACCOUNTABILITY OFFICE; SAMUEL EDWIN, DIRECTOR, DIVISION OF SELECT 

AGENTS AND TOXINS, CENTERS FOR DISEASE CONTROL 

AND PREVENTION; AND DR. FREEDA ISAAC, DIRECTOR, AGRICULTURE SELECT AGENT SERVICES, ANIMAL AND PLANT 

HEALTH INSPECTION SERVICE 

STATEMENT OF MARY DENIGAN-MACAULEY 

Ms. DENIGAN-MACAULEY. Good morning, Vice Chairman Griffith, 

Ranking Member DeGette, and other subcommittee members. 

Thank you for the opportunity to testify today on the federal oversight of the Select Agent Program. 

GAO has, for many years, identified challenges and recommended ways for improving the oversight of high-containment 

labs. These labs work with the most dangerous pathogens, such as 

the Ebola virus, requiring the highest safeguards. Agencies have 

made progress implementing our recommendation. However, my 

main point today is that oversight of these pathogens is not as 

strong as it should be, potentially allowing for grave consequences. 

In our most recent review, we found that the Federal Select 

Agent Program does not meet criteria for effective oversight. These 

criteria have been used to assess oversight of other areas with low 

probability adverse events that can have significant consequences. 

An example of such an event is the Fukushima Daiichi nuclear accident in Japan in 2011. 

Of the five criteria, I would like to highlight two this morning: 

independence and the ability to perform reviews. 

First, according to our criteria, the organization conducting oversight should be structurally distinct and separate from the entities 

it oversees. The Select Agent Program is not. Both CDC and 

APHIS have labs registered with the program. CDC and APHIS 

have taken steps to reduce conflicts of interest. For example, in 

2012, the agencies developed an MOU under which APHIS leads 

inspections of CDC labs. However, there was no reciprocal agreement for CDC to lead inspections of APHIS labs until 3 years later 

and we found that the agreement was not always followed. 

Second, according to our criteria, the organization conducting 

oversight should have the ability to perform reviews. The Select 

Agent Program performs several types of reviews, including inspections. There is concern, however, that inspections do not target the 

highest risk activities. The program, in its current form, was borne 

from the horrific incidents of 9/11. Therefore, it is focused on security and inspectors spend considerable time assessing compliance 

10 

with inventory controls and reviewing records. While this can be 

helpful to know what is stored in the lab, it does little to reduce 

the risk of theft. 

Very small amounts of material can be removed from vials and 

replicated without being detected. Moreover, recent high-profile incidents have been related to biosafety rather than security and no 

thefts have been reported in well over a decade. 

It’s interesting to note that other countries and regulatory sectors we reviewed approach oversight differently. For example in 

Great Britain, an independent government agency oversees labs 

and they apply a risk-based approach to inspections, targeting 

those with a history of performance issues or those conducting 

higher risk activities. They also focus on biosafety rather than biosecurity. 

Besides not meeting the criteria, the program also does not have 

joint planning documents to guide its oversight efforts. Notably, it 

does not have a joint workforce plan to help it manage workforce 

challenges that we found. For example, CDC and APHIS have 

faced challenges hiring and retaining sufficient staff with the necessary expertise. Inspectors have a large workload and intensive 

travel schedule that has led to delays in issuing inspection reports. 

In 2016, CDC took up to 224 days to issue some of its inspection 

reports, far exceeding the program’s 30-day target and delaying 

fixes to any identified problems. Workload issues have also sometimes resulted in staff from APHIS being assigned responsibilities 

outside their area of expertise. 

In conclusion, CDC and APHIS share a critical role ensuring that 

important work with select agents can be conducted in a safe and 

secure manner. The bottom line is that oversight needs to be 

strengthened. 

Moving forward, the Federal Select Agent Program needs to take 

several steps, including assessing the potential risks posed by placing the program within APHIS and CDC, identifying and aligning 

efforts with activities that carry the highest risks, and developing 

a joint workforce plan. As these steps are taken, consideration 

could also be given to alternate oversight approaches. 

Vice Chairman Griffith, Ranking Member DeGette, and other 

subcommittee members, this concludes my statement. I look forward to your questions. 

[The prepared statement of Ms. Denigan-Macauley follows:] 

11 


28141.001

For Release on Delivery 

Expected at 10:15 a.m. ET 

Thursday, November 2, 2017 

GA0-18-197T 

United States Government Accountability Office 

Testimony 

Before the Subcommittee on Oversight 

and Investigations, Committee on 

Energy and Commerce, 

House of Representatives 

HIGH-CONTAINMENT 

LABORATORIES 

Coordinated Efforts 

Needed to Further 

Strengthen Oversight 

of Select Agents 

Statement of Mary Denigan-Macauley, Ph.D. 

Acting Director, Health Care 
12 


28141.002

Vice Chairman Griffith, Ranking Member DeGette, and Members of the 

Subcommittee: 

I am pleased to be here today to discuss our recent work on the oversight 

of select agents in high-containment laboratories in the United States. 1 

Safety lapses have occurred at laboratories in the United States that 

conduct research on hazardous pathogens and toxins (known as select 

agents) that may pose a serious threat to humans, animals, or plants.' 

These lapses raise concerns about whether federal oversight of these 

laboratories is effective. For example, in November 2016, the Department 

of Homeland Security discovered that a private laboratory had 

inadvertently sent a toxic form of ricin (a potentially lethal poison) to one 

of its training centers multiple times since 2011, potentially putting training 

participants at risk. In May 2015, the Department of Defense (DOD) 

discovered that a DOD laboratory had inadvertently shipped live anthrax 

bacteria to nearly 200 other laboratories worldwide over the course of 12 

years. And in July 2014, the National Institutes of Health discovered 

decades-old vials of smallpox in a storage room of a Food and Drug 

Administration laboratory on its campus.' 

We have, for many years, identified challenges and areas for 

improvement related to the safety, security, and oversight of highcontainment laboratories. In 2009, for example, we found a proliferation of 

high-containment laboratories across the United States, with the number 

of such laboratories in the government, academic, and private sectors 

1

GAO, High-Containment Laboratories: Coordinated Actions Needed to Enhance the Select Agent Program's Oversight of Hazardous Pathogens, GA0-18-145 (Washington, 

D.C.: Oct 19, 2017). Laboratories that conduct research on pathogens fa!! into one of four 

biological safety levels (BSL), with those at BSL-3 and -4 referred to as high-containment 

laboratories for the purpose of this statement Each level of containment describes the 

laboratory practices, safety equipment, and facility safeguards for the level of risk 

associated with handling particular agents. BSL-3 laboratories work with indigenous or 

exotic agents with known potential for airborne transmission or pathogens that may cause 

serious and potentially lethal infections. BSL-4-laboratories work with exotic agents that 

pose a high individual risk of life-threatening disease by airborne transmission and for 

which treatment may not be available. 

2As of March 2017, 66 agents and toxins have been designated as ~select agents and 

toxinsff -that is, as needing specific types of safeguards and oversight. For the purpose of 

this statement, we use the term ~select agents" to encompass both designated agents and 

toxins. 

3

According to agency documents, none of these three incidents resulted in human 

infection, severe illness, or death. 

Page1 GA0-18-197T High-Containment Laboratories 
13 


28141.003

increasing since 2001.' In addition, we found that there was no single 

entity overseeing this proliferation, and that no federal agency knew how 

many such laboratories existed in the United States or the aggregate 

risks associated with the proliferation. We also found in 2009 and 2014 

that, for the subset of these laboratories subject to federal oversight, the 

oversight was duplicative, fragmented, and dependent on self-policing. 5 

More recently, we found in 2016 that stronger oversight mechanisms for 

federal high-containment laboratories were needed at the individual 

federal department and component agency levels• We have made 

numerous recommendations over the years, including that a single entity 

be identified to determine the number of high-containment laboratories 

needed to meet national goals, the aggregate risks associated with the 

proliferation of laboratories, and the type of oversight needed_? Federal 

departments have made some progress in implementing 

recommendations from our past reports, including addressing issues we 

identified regarding duplicative oversight. However, the United States still 

has not identified a single entity to perform the functions we 

recommended. 

All high-containment laboratories in the United States that register to work 

with select agents are regulated by the Federal Select Agent Program 

(which this statement subsequently refers to as the Select Agent 

Program),' through which two agencies share oversight responsibility. 

4GAO, High-Containment Laboratories: National Strategy for Oversight Is Needed, 

GA0-09-574 (Washington, D.C.: Sept 21, 2009). 

5GAO, Overlap and Duplication: Federal fnspections of Entities Registered with the Select 

Agent Program, GA0-13-154 (Washington, D.C .. Jan. 31, 2014) and GA0-09-574. 

According to our past work, fragmentation refers to those circumstances in which more 

than one federal agency (or more than one organization within an agency) is involved in 

the same broad area of national need and opportunities exist to improve seNice delivery. 

GAO, 2017 Annual Report: Additional Opportunities to Reduce Fragmentation, Overlap, 

and Duplication and Achieve Other Financial Benefits, GA0~17-491SP (Washington, D.C.: 

Apr. 26, 2017). 

6GAO, High~Containment Laboratories: Comprehensive and Up~to~Date Policies and 

Stronger Oversight Mechanisms Needed to Improve Safety, GAO~ 16-305 (Washington, 

D.C.: Mar 21, 2016). 

7GA0-09-574. 

8Entities that register with the Select Agent Program may include a single laboratory or 

multiple laboratories under one registration. For the purpose of this statement, we refer to 

aU entities registered with the program as "laboratories.~ Some BSL-2 laboratories are 

registered with the Select Agent Program, but most registered entities are BSL-3 and -4 

high-containment laboratories. For our October 2017 report, we focused on oversight of 

select agents in high~containment laboratories. 

Page 2 GAOM1S..197T High-Containment Laboratories 
14 


28141.004

Specifically, oversight is shared by the Division of Select Agents and 

Toxins within the Department of Health and Human Services' (HHS) 

Centers for Disease Control and Prevention (CDC) and the Agriculture 

Select Agent Services within the U.S. Department of Agriculture's (USDA) 

Animal and Plant Health Inspection Service (APHIS). The program was 

established to regulate the possession, use, and transfer of select agents 

in response to security concerns following bioterrorism attacks in the 

1990s and early 2000s. 

Other countries also regulate and oversee hazardous pathogens handled 

in high-containment laboratories, and they sometimes take approaches 

that differ from that of the United States. Moreover, other high-risk sectors 

in the United States, such as the nuclear industry, sometimes take 

different approaches to oversight. Notwithstanding such differences, our 

past work reviewing some of these sectors has identified five key 

elements of effective oversight in areas where low-probability adverse 

events can have significant and far-reaching effects. 9 These elements are 

as follows: 

Independence: The organization conducting oversight should be 

structurally distinct and separate from the entities it oversees. 

Ability to perform reviews: The organization should have the access 

and working knowledge necessary to review compliance with 

requirements. 

Technical expertise: The organization should have sufficient staff 

with the expertise to perform sound safety and security assessments. 

Transparency: The organization should provide access to key 

information, as applicable, to those most affected by operations. 

Enforcement authority: The organization should have clear and 

sufficient authority to require that entities achieve compliance with 

requirements. 

My remarks today are based on our October 2017 report on the oversight 

of select agents in high-containment laboratories. Our report 

91n particular, we have used these elements for reviews related to oversight of nuclear 

safety and oil and gas management. See GAO, Nuclear Safety: Department of Energy 

Needs to Strengthen Its Independent Oversight of Nuclear Facilities and Operations, 

GA0-09-61 (Washington. D.C.: Oct. 23, 2008) and Oil and Gas Management: Key 

Elements to Consider for Providing Assurance of Effective Independent Oversight, 

GA0-10-852T (Washington, D.C.: June 17, 2010). 

Page 3 GA0-18-197T High-Containment Laboratories 
15 


28141.005

(1) examined the extent to which the Select Agent Program has the 

elements of effective oversight and has strategic planning documents to 

guide its oversight efforts, and (2) described approaches that selected 

countries and regulatory sectors have used to promote effective 

oversight Today, I will discuss key findings and recommendations from 

that report. 

For our report, we discussed the five key elements of effective oversight 

above with agency officials, experts, and representatives from 

nongovernmental organizations to ensure their applicability to the 

oversight of select agents. We reviewed laws, regulations, and 

documents related to the Select Agent Program to determine the extent to 

which the program met the key elements. We also interviewed officials 

from CDC and APHIS and registered laboratories to discuss the 

program's inspections and other oversight responsibilities and other 

issues related to the five key elements. To obtain expert views on the 

effectiveness of the approaches the Select Agent Program and other 

selected countries and regulatory sectors have used to promote effective 

oversight, we worked with the National Academy of Sciences to convene 

a 2-day meeting with 18 experts. We also reviewed relevant 

documentation and interviewed regulatory officials from selected 

countries-including the United Kingdom and Canada-and other sectors 

such as nuclear energy. More detailed information on the scope and 

methodology of our work can be found in the October report. The work 

upon which this statement is based was conducted in accordance with 

generally accepted government auditing standards. 

In summary, we found that the Select Agent Program does not fully meet 

all key elements of effective oversight. For example, the program is not 

structurally distinct and separate from all laboratories it oversees and, 

therefore, does not meet the key element of independence. Regarding 

another key element-the ability to perform reviews-some experts and 

laboratory representatives raised concerns that the program's reviews 

may not target the highest-risk activities, in part because it has not 

formally assessed which activities pose the highest risk. Moreover, the 

program does not have joint strategic planning documents, including a 

joint workforce plan, to guide its shared oversight efforts. We made 11 

recommendations to address these issues. HHS and USDA agreed with 

our recommendations and outlined actions they are taking, or plan to 

take, to address them. 

Page4 GA0-18-191T High-Containment laboratories 
16 


28141.006

Select Agent Program 

Does Not Fully Meet 

Key Elements of 

Effective Oversight or 

Have Joint Strategic 

Planning Documents 

to Guide Its Efforts 

The Select Agent Program does not fully meet key elements of effective 

oversight. In particular, the program has oversight shortcomings related to 

each of our five key elements: independence, performing reviews, 

technical expertise, transparency, and enforcement. In addition, the 

program does not have joint strategic planning documents to guide its 

oversight efforts, such as a joint strategic plan and workforce plan. It did, 

however, begin taking steps to develop a joint strategic plan during the 

summer of2017. 

First, regarding independence, the Select Agent Program is not 

structurally distinct and separate from all of the laboratories it oversees 

because the two components of the Select Agent Program are located in 

CDC and APHIS, both of which also have high-containment laboratories 

registered with the program. Many experts at our meeting raised 

concerns that the Select Agent Program cannot be entirely independent 

in its oversight of CDC and APHIS laboratories because the Select Agent 

Program is composed of divisions of those agencies. To help reduce 

conflicts of interest, the program has taken steps such as having APHIS 

lead inspections of CDC laboratories. However, it has generally done so 

in response to concerns raised by others. The program itself has not 

formally assessed all potential risks posed by its current structure and the 

effectiveness of its mechanisms to address those risks. The Office of 

Management and Budget's Circular A-123 requires federal agencies to 

integrate risk management activities into their program management to 

help ensure they are effectively managing risks that could affect the 

achievement.of agency objectives. 10 In addition, federal internal control 

standards state that management should identify, analyze, and respond 

to risks related to achieving defined objectives. 11 Without (1) regularly 

assessing the potential risks posed by the program's current structure 

and the effectiveness of its mechanisms to address them and (2) taking 

actions as necessary to ensure any identified risks are addressed, the 

100ffice of Management and Budget, Management's Responsibility for Enterprise Risk 

Management and Internal Control (Washington, D.C.: July 15, 2016). 

11GAO, Standards for Internal Control in the Federal Government, GAO/A!MD~00-21.3.1 

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

Government. GA0-14-704G (Washington, D.C.: September 2014). GAOIAIMD-00-21.3.1 

was effective through the end of fiscal year 2015 (Sept. 30, 2015). GA0-14-704G is the 

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

2016 (Oct. 1, 2015). 

Page5 GA0~18~197T High~Contalnment Laboratories 
17 


28141.007

program may not be aware of or effectively mitigate impairments to its 

independence that could affect its ability to achieve its objectives. 

Second, regarding the ability to perform reviews, we found that the Select 

Agent Program performs several types of reviews to ensure compliance 

with regulatory and program requirements. However, the program may 

not target the highest-risk activities in its inspections, in part because it 

has not formally assessed which activities pose the highest risk to 

biological safety and security. 12 For example, many experts at our 

meeting and laboratory representatives we interviewed raised concerns 

about the amount of time inspectors spend assessing compliance with 

inventory controls (e.g., by counting and examining vials containing select 

agents) and reviewing inventory records during the inspection process, 

which takes time away from inspecting other aspects of biological safety 

and security. Experts at our meeting said that these activities do little to 

reduce the risk of theft of select agents (a security concern) because 

samples could be clandestinely removed from vials and replicated without 

being detected by the inventory controls currently in place. Further, other 

laboratory representatives told us that activities to assess compliance 

with certain program requirements, such as time-consuming reviews of 

records, did little to reduce risk and were unnecessarily burdensome to 

both researchers and inspectors. These inspection activities are generally 

intended to address biological security concerns; however, recent highprofile incidents at registered laboratories have concerned biological 

safety rather than security. 

To improve the inspection process and identify trends and associations 

between inspection findings and risk, a 2015 internal review of the CDC 

component of the Select Agent Program recommended that the CDC and 

APHIS components of the program work together to analyze inspection 

and investigation data. According to program officials, they have not yet 

addressed the recommendation because they do not currently have 

adequate tools to do so, but the program is transitioning to a new 

database that will enhance their ability to identify trends and associations 

and thereby guide improvements to the inspection process. However, the 

program did not provide a plan for when or how the program will carry out 

12We found in our past work that, according to experts and CDC officials, there is a 

baseline risk associated with any high-containment laboratory and that the risks from 

accidental exposure or release can never be completely eliminated. GAO, HighContainment Laboratories: Recent Incidents of Biosafety Lapses, GA0-14-785T 

(Washington, D.C.: July 16, 2014). 

Page 6 GA0-18-197T High-Containment Laboratories 
18 


28141.008

these analyses to improve the inspection process. Federal internal control 

standards state that management should identify, analyze, and respond 

to risks related to achieving defined objectives. 13 Without developing and 

implementing a plan to identify which laboratory activities carry the 

highest biological safety and security risks and to respond to those risks 

by aligning inspections and other oversight efforts to target those 

activities, the Select Agent Program will not have assurance that it is 

effectively balancing the potential safety and security gains from its 

oversight efforts against the use of program resources and the effect on 

laboratories' research. 

We also found that the Select Agent Program did not fully meet the other 

three key elements of effective oversight: technical expertise, 

transparency, and enforcement For example, although the program has 

taken steps to hire additional staff and enhance the technical expertise of 

its staff, workforce and training gaps remain. In addition, although the 

program has increased transparency about registered laboratories and 

violations of the select agent regulations to the public and registered 

laboratories since 2016, the information it shares is limited and there is no 

consensus about what additional information could be shared, given 

security concerns. Lastly, although the program has authority to enforce 

compliance with program requirements, it is still working to address past 

concerns about the need for greater consistency and clarity in actions it 

takes in exercising this authority. 

In addition to not fully meeting the five key elements of effective oversight, 

we found that the Select Agent Program does not have joint strategic 

planning documents to guide its shared oversight efforts across CDC and 

APHIS. For example, the program does not have a joint mission 

statement to collectively define what the program seeks to accomplish 

through its oversight It also does not yet have a strategic plan. Agencies 

can use strategic plans to set goals and identify performance measures 

for gauging progress towards those goals. Strategic plans can also 

outline how agencies plan to collaborate with each other to help achieve 

goals and objectives. The program began taking steps to develop a joint 

strategic plan during the course of our review and, in August 2017, began 

soliciting bids from contractors for the plan's development. The statement 

of work for the contract stipulates that the contractor shall develop guiding 

principles for the Select Agent Program along with a mission statement 

13GAO/AIMD-00-21.3.1 and GA0-14-704G 

Page7 GA0·18w197T High~Contalnment Laboratories 
19 


28141.009

Selected Countries 

and Regulatory 

Sectors Employ Other 

Approaches to 

Promote Effective 

Oversight 

and strategic goals and objectives, among other requirements. However, 

it does not have any requirements related to development of a joint 

workforce plan. We have found in the past that agencies' strategic 

workforce planning should be clearly linked to the agency's mission and 

long-term goals developed during the strategic planning process. 14 

Developing a joint workforce plan that assesses workforce and training 

needs for the program as a whole would help the program to better 

manage fragmentation by improving how it leverages resources to ensure 

all workforce and training needs are met. Leveraging resources is 

especially important given fiscal constraints. 

In our report, we recommended that CDC and APHIS take several steps 

to address these findings. First, we made five recommendations to 

improve independence, including that CDC and APHIS regularly assess 

the potential risks posed by the program's structure and the effectiveness 

of its mechanisms to address those risks, and take actions as necessary 

to ensure any identified risks are addressed so that impairments to 

independence do not affect its ability to achieve its objectives. Second, to 

improve the ability to perform reviews, we recommended that the 

directors of the Select Agent Program work together to develop and 

implement a plan to identify which laboratory activities carry the highest 

biological safety and security risks and to respond to those risks by 

aligning inspections and other oversight efforts to target those activities. 

We also made several other recommendations, including recommending 

that the directors of the Select Agent Program develop a joint workforce 

plan that assesses workforce and training needs for the program as a 

whole. 

Selected countries and regulatory sectors employ approaches to promote 

effective oversight that sometimes differ from those of the Select Agent 

Program by, for example, having regulatory bodies that are structurally 

independent from the entities they oversee or taking a risk-based 

approach to performing reviews. To illustrate, with regard to 

independence, Great Britain's Health and Safety Executive, whose 

mission is to protect worker and public health and safety and which 

oversees laboratories that work with pathogens, is an independent 

government agency. According to officials from the Health and Safety 

14GAO, Human Capital: Key Principles for Effective Strategic Workforce Planning, 

GA0-04-39 (Washington, D.C .. Dec. 11, 2003). 

Page 8 GA0~18-197T High-Containment Laboratories 
20 


28141.010

Executive and laboratory representatives, one strength of this approach is 

that it avoids potential organizational conflicts of interest because none of 

the laboratories it oversees are part of the same agency. Some other 

regulatory sectors in the United States, including the Nuclear Regulatory 

Commission (NRC), are also structurally independent from regulated 

facilities as a mechanism to ensure independence. Prior to the creation of 

NRC in 1974, the U.S. Atomic Energy Commission was responsible for 

both promotion and oversight of the nuclear industry. The Energy 

Reorganization Act of 1974 established NRC as a separate, independent 

entity. According to a Senate committee report, this was a response to 

growing criticism that there was a basic conflict between the U.S. Atomic 

Energy Commission's regulation of the nuclear power industry and its 

development and promotion of new technology for the industry. 15 

Related to the ability to perform reviews, regulators in Great Britain and 

Canada apply a risk-based approach by targeting laboratories with a 

documented history of performance issues or those conducting higherrisk activities. In both Great Britain and Canada, the organizations that 

oversee laboratories generally focus their oversight on (1) biological 

safety, and (2) regulation of all potentially hazardous pathogens in 

laboratories. In contrast, the Select Agent Program originated from 

security-related concerns and regulates only those pathogens identified 

on the U.S. select agent list and no other pathogens that may be handled 

in high-containment but are not select agents, such as West Nile virus. 

Other differences we found in approaches include relying on scientists 

and other laboratory personnel to have requisite technical expertise on 

the pathogens and activities in their laboratories, sharing incident 

information on their public websites, and having prosecutoria! authority 

when incidents occur. 

In conclusion, CDC and APHIS share a critical role in ensuring that 

important research on select agents can be conducted in highcontainment laboratories in a safe and secure manner. The Select Agent 

Program has made a number of improvements over the past few years, 

such as hiring additional staff and improving training to enhance 

expertise. Nevertheless, the program does not fully meet all key elements 

of effective oversight and more is needed to develop joint strategic plans 

15S. Rep. No. 93-980 at 2 (1974). 

Page9 GA0~18-197T High-Containment Laboratories 
21 


28141.011

GAO Contacts and 

Staff 

Acknowledgments 

(102355) 

to collectively guide its shared oversight efforts. In our prior work, we 

have found that existing federal oversight of high-containment 

laboratories is fragmented and largely self-policing, among other things. 

Our October 2017 report, in combination with these past findings, 

continues to raise questions about whether the current government 

framework and oversight are adequate. 

Vice Chairman Griffith, Ranking Member DeGette, and Members of the 

Subcommittee, this concludes our prepared statement. We would be 

pleased to respond to any questions that you may have at this time. 

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

contact Mary Denigan-Macauley, Ph.D., Acting Director, Health Care, at 

(202) 512-7114 or deniganmacauleym@gao.gov. Contact points for our 

Offices of Congressional Relations and Public Affairs may be found on 

the last page of this statement. Individuals who made key contributions to 

this statement include Sushi! Sharma, Ph.D., Dr. PH (Assistant Director); 

Amy Bowser; Caitlin Dardenne, Ph.D.; John Neumann; Cynthia Norris; 

Timothy M. Persons, Ph.D.; and Lesley Rinner. Staff who made key 

contributions to the report(s) cited in the statement are identified in the 

source products. 

Page 10 GA0-18-197T High-Containment Laboratories 
22 


28141.012

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28141.013

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24 

Mr. GRIFFITH. I thank the gentlelady for yielding back. 

I now recognize Dr. Edwin for a 5-minute opening statement. 

STATEMENT OF SAMUEL EDWIN 

Mr. EDWIN. Thank you, Mr. Chairman, Ranking Member 

DeGette, and members of the subcommittee. I am Dr. Sam Edwin, 

Director of the Division of Select Agent and Toxins, which resides 

within the Office of Public Health Preparedness and Response at 

the Centers for Disease Control and Prevention. I, along with my 

counterpart, Dr. Freeda Isaac, direct the Federal Select Agent Program. 

I have held this position for just over 1 year and welcome this 

opportunity to testify before you. I appreciate the subcommittee’s 

continued interest in improving oversight of laboratories that work 

with select agents and toxins. 

Laboratory research on select agents and toxins plays a critical 

role in saving lives and protecting Americans. It is also an important part of our nation’s contribution to support preparedness and 

defense against naturally-occurring diseases and potential bioterrorism events. Maximizing safety and security through our oversight is a complex and unending endeavor, not something that can 

be checked off a list. 

I would like to acknowledge the important contributions that 

GAO’s continued engagement and recommendations have made in 

our work to improve the program. We accept and will implement 

each of the five recommendations for CDC in the current GAO report. This morning, I will highlight actions that we have already 

taken in several of the areas addressed in the report. 

First, our program has taken a number of steps to identify highest risk activities conducted at the registered laboratories and ensure that these activities are targeted during inspections. We determined risk based on the type of work being done by a particular 

entity and modify the frequency and focus of the inspections based 

on the findings at each inspection. When our program identifies 

what appears to be a commonly used processes that present a high 

risk, we target inspection to reduce that risk across all of the registered entities. 

We are in the process of transitioning to a new electronic information system which will provide real-time access to each registered entity’s key program information and documents. After it is 

fully implemented, we will have the ability to monitor and analyze 

the data in real-time to identify potential risks, improve the inspection process, and continually enhance overall biosafety and security 

oversight. 

Second, in the area of enforcement authority, we are taking steps 

to assess risk from violations at individual facilities, as well as 

identify and address recurring violations. We recently finalized an 

effort to evaluate categories of noncompliance with select agent regulations, group them according to the level of severity, and enforcement options. We used this information to ensure consistency between inspections. 

Third, regarding the technical expertise, our program has inspectors who have the necessary practical experience and advanced professional degrees. That said, continued training of inspection staff 

25 

is a key priority that we continually refine to address training 

needs. 

In addition, we are in the early stages of developing a joint strategic plan for the Federal Select Agent Program. This includes assessment of workforce and training needs for staff across the program. 

Fourth, we have taken a number of steps to increase transparency and collaboration with the regulated community, including 

developing a process where we respond to requests for clarification 

regarding the select agent regulations. We also share draft policies 

and guidance documents for their input prior to finalizing, and we 

also implemented a process for dispute of inspection findings, and 

analyzing and reporting of the aggregate program data annually. 

The most recent report was just published last week. 

We are committed to further strengthening oversight of laboratories that handle select agents and toxins and appreciate the involvement of GAO and others that have provided recommendations 

toward that end. We value of the subcommittee’s input as we continue to improve our oversight and enhance the safety and security 

of this work. 

Thank you for the opportunity to testify. I would be glad to answer any questions that you may have. 

[The prepared statement of Mr. Edwin follows:] 

26 


28141.014

#'51\RVIQs" 

.l ~ Written Testimony 

; House Committee on Energy and 

~ ::j~ Commerce, Subcommittee on Oversight 

"'1-_,.•",_ ~ and Investigations ~""<i.rcr 

Oversight of Hazardous Pathogens under the Federal 

Select Agent Program 

Statement of 

Samuel S. Edwin, PhD 

Director, Division of Select Agents and Toxins 

Office ofPublic Health Preparedness and Response 

Centers for Disease Control and Prevention 

Department of Health and Human Services 

For Release upon Delivery 

Expected at 10:15 a.m. 

Tbursday November 2, 2017 

1 
27 


28141.015

Mr. Chairman, Ranking Member DeGette, and Members of the Subcommittee. I am Dr. 

SamuelS. Edwin, Director of the Division of Select Agents and Toxins (DSAT), which resides 

within the Office of Public Health Preparedness and Response at the Centers for Disease Control 

and Prevention (CDC). I-- along with my counterpart at the U.S. Department of 

Agriculture's (USDA) Animal and Plant Health Inspection Service/ Agriculture Select Agent 

Services (AgSAS), Dr. Freeda Isaac-- direct the Federal Select Agent Program (FSAP or 

program). I have held this position for just over one year, and welcome this opportunity to testify 

before you. I appreciate the Subcommittee's continued interest in improving oversight of 

laboratories that work with select agents and toxins to ensure that this important work is done in 

as safe and secure a manner as possible. 

Laboratory research on biological select agents and toxins plays a critical role in saving 

lives and protecting Americans. It is also an important part of our nation's contribution to 

support preparedness and defense against naturally occurring diseases and potential bioterrorism 

events. However, the nature of scientific laboratory work with these materials means that some 

risk is always present. Our goal is to reduce risk to the maximum extent possible. 

I will provide a brief background of our program and CDC's role and responsibilities 

implementing the FSAP, followed by a discussion of steps taken to strengthen the FSAP and 

enhance the safety and security of high-containment laboratories regulated under this program. 

Background on the Federal Select Agent Program 

The regulation of select agents and toxins is a shared federal responsibility involving the 

Department of Health and Human Services (HHS), Department of Agriculture, and Department 

of Justice (DOJ). The Public Health Security and Bioterrorism Preparedness and 

Response Act of2002 (P.L. 107-188) authorizes HHS to regulate the possession, use, and 

2 
28 


28141.016

transfer of biological agents and toxins that have the potential to pose a severe threat to public 

health and safety. The Secretary ofHHS delegated this authority to CDC. USDA was given 

similar authority to regulate select agents and toxins that have the potential to pose a severe 

threat to animal and plant health and/or animal and plant products. DOJ is responsible for 

conducting security risk assessments of entities and individuals prior to their possession, use, or 

transfer of select agents or toxins. DOJ delegated this authority to the Federal Bureau of 

Investigation (FBI). This oversight helps prevent access to these pathogens and toxins by 

terrorists or others who may wish to misuse them. 

The FSAP promotes laboratory biosafety and security through: (l) promulgating, 

implementing, and enforcing the select agent regulations ( 42 CFR Part 73, 9 CFR Part 121, and 7 

CFR 331 ); (2) providing guidance to the regulated community; and (3) inspecting facilities that 

work with select agents and toxins to verify that the laboratories meet safety, security and recordkeeping requirements. Under these regulations, entities must undergo a rigorous registration 

process and obtain approval before they can possess and work with select agents and toxins. At 

the end of2016, 276 entities-- including academic, non-federal government, federal 

government, and private laboratories --were registered with the FSAP to possess select agents 

and toxins. The program currently regulates 66 select agents and toxins. The list of biological 

select agents and toxins is reviewed at least once every two years to determine if agents or toxins 

need to be added to or deleted from the list. 

Key functions and activities of the FSAP include: 

• Maintaining a national database of entities and individuals authorized to work with select 

agents and toxins. This database serves several functions, including: allowing the 

program to proactively reach out to entities in advance of and following natural disasters 

3 
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28141.017

or other events to ensure all select agents and toxins are properly secured; and enabling 

the federal government to quickly identify those authorized to have access to particular 

agents, when needed, in connection with an investigation; 

• Establishing requirements to prevent unauthorized access to, or theft, loss, or release of, 

select agents and toxins, and assessing compliance of registered entities with these 

requirements; 

• Receiving reports of theft, loss, or release, following up with each entity to ensure 

appropriate actions are taken to prevent similar incidents from happening in the future, 

and notifying appropriate authorities; 

• Taking appropriate enforcement action when deficiencies in biosafety or security 

measures are identified, including referring a matter to the HHS Inspector General (I UIS 

IG) or the FBI, to address the risk and increase compliance with regulations in the future; 

and 

• Serving as a resource on the regulations by providing guidance to those working with 

select agents and toxins, interpreting the regulations to help entities follow the 

requirements, and conducting training and outreach to increase knowledge of and 

compliance with the regulations. 

Strengthening Oversight under the FSAP Program 

Maximizing safety and security through oversight at the FSAP-regulated laboratories is 

an unending endeavor, not something that can be checked off a list. I would like to acknowledge 

the important contribution that the Government Accountability Office's (GAO) continued 

engagement and recommendations for FSAP have made in our work to improve the program. 

4 
30 


28141.018

DSAT accepts and will implement all of GAO's recommendations in its current report, Below I 

will highlight some steps that DSA T, in partnership with USDA, has taken to strengthen 

oversight of facilities registered to work with select agents and toxins. And you have my 

commitment to continue efforts to improve the system for oversight of these facilities. 

Independence: 

To ensure our independence in regard to our role in regulating laboratories, DSAT 

entered into a Memorandum of Understanding (MOU) with AgSAS in 2012, under which 

AgSAS leads all select agent inspections of CDC laboratories. AgSAS and DSA T recently 

modified the MOU by strengthening procedures to delineate roles and responsibilities to ensure 

each component of the FSAP carries out its inspection responsibilities as outlined in the MOU. 

The MOU supplements structural safeguards that have been in place since 2003: DSA Tis 

located within the Office of Public Health Preparedness and Response (OPHPR), a part of CDC 

that does not include any laboratories and has a separate reporting line to the CDC Director. We 

believe that the MOU designating AgSAS as the lead inspector for CDC laboratories, and the 

organizational separation between DSA T and CDC's regulated laboratories, provide strong 

protections against any actual or perceived conflict of interest. 

Ability to PerfOrm Reviews: Risk-Based Oversight: 

The FSAP has taken a number of steps to identify the highest risk activities conducted at 

registered entities and ensure that these activities are targeted in inspections. 

As part of the initial inspection to determine whether to approve an entity's application 

for FSAP registration, which authorizes the entity to conduct specified work with select agents 

and toxins, the FSAP establishes a baseline that identifies the biological safety and security risk 

of the work to be done with each select agent or toxin the entity will possess. The program can 

5 
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28141.019

then, based on findings in the course of follow-up inspections, reassess the baseline risk, the 

mitigation factors in place to reduce the risk, and the residual risk such as any identified 

departures from the biosafety and security requirements of the select agent regulations. FSAP 

can determine the frequency of verification inspections at an entity based on the initial risk 

assessment, in conjunction with any findings or assessments from subsequent inspections or 

reassessments, incidents or compliance matters. In addition, FSAP identifies inspection findings 

as having a low, moderate, or high severity, based on the risk they pose. This contributes to the 

assessment of risk at an individual facility and enhances our ability to identify and address across 

the regulated community recurring violations that pose the greatest risk. 

Also at a programmatic level, when FSAP identifies processes that present a high risk, the 

FSAP works to reduce that risk across registered entities, as applicable. Such was the case in 

response to incidents in 2014 2015 involving incomplete inactivation of Bacillus anthracis spore: 

that are produced by the bacteria that causes anthrax. FSAP requested that registered entities 

observe a voluntary moratorium on the transfer and use of anthrax samples that had undergone 

inactivation, and subsequently amended the select agent regulations to specifically address 

inactivation. On January 19, 2017, FSAP published the Final Rule "Possession, Use, and Transfer 

of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and 

Enhanced Biosafety Requirements" that included additional biosafety requirements and specific 

provisions for the inactivation of select agents. In conjunction with publication of the new 

regulatory provisions, FSAP published a guidance document on the inactivation or removal of 

select agents and toxins for future use. 

In addition, FSAP is in the process of transitioning to a new electronic information system, 

cFSAP. This system will allow the regulated community to interact with the program more 

6 
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28141.020

efficiently and allow for better and faster reporting of issues of potential public health concern. 

After eFSAP is implemented, FSAP will have greater real-time access to programmatic data such as 

registration amendments to change the number of select agents used at a facility, changes in 

personnel authorized to work with select agents and toxins, transfers of select agents to other 

facilities, and inspection reports. This access will expedite and enhance the ability ofF SAP to 

monitor and analyze the data and identify potential risk, and thereby continually enhance oversight 

ofbiosafety and security. 

Technical Expertise: 

FSAP inspectors have the practical experience and advanced professional degrees (e.g., 

microbiology and veterinary medicine) necessary to perform reviews of select agent laboratories. 

That said, continued training of inspection staff is a key priority for the FSAP, and we have a 

robust training program for inspectors that we continually refine to address unmet training needs. 

FSAP training initiatives include sending staff to a multi-day in-person training course on 

biosafety level-3 (BSL-3) safety training and expanded opportunities for intensive BSL-4 

training. In addition, FSAP holds regularly scheduled inspector training opportunities, occurring 

monthly or more frequently depending on the topic covered. Topics for these sessions include 

natural disaster response, facility reviews, facility security, and biosafety issues of interest. FSAP 

also organizes annual inspector trainings for both DSA T and AgSAS inspectors. The annual 

FSAP inspector training for 2017 is scheduled for this week (November 1-3, 20 17). In addition, 

the FSAP is in the early stages of developing a joint DSAT (public health) and AgSAS 

(agriculture) strategic plan that includes assessment of workforce and training needs for staff 

across the program. 

7 
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28141.021

Transparency: 

The FSAP has taken a number of steps to increase transparency and collaboration with 

the regulated community, including: 

• Developing a formal process to publicly respond to requests for clarification regarding 

the select agent regulations (i.e., provide regulatory interpretations). 

• As appropriate, sharing draft regulatory policies and interpretations, guidance documents, 

and intended actions with the regulated community before these efforts are finalized. This 

builds credibility and allows our stakeholders to provide valuable input into those issues 

that will affect their work. 

• Implementing a formal dispute resolution process, which allows registered entities to 

dispute specific inspection findings. 

• Hosting a three-day, in-person Responsible Officials training workshop in December 

2016, which included the opportunity for peer-to-peer engagement of the regulated 

community with the FSAP, as well as networking between colleagues. The FSAP will 

host another Responsible Official workshop at the end of this month (November 20 17). 

• Establishing an independent forum, through the American Biological Safety Association 

(ABSA) International, to encourage routine peer-to-peer sharing regarding best practices 

among those working with select agents and toxins. ABSA International has supported 

online discussions, an in-person workshop, and webinars, thereby allowing the regulated 

community to share information and best practices with each other independent of the 

FSAP. 

8 
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28141.022

• Developing a post-inspection survey that allows registered entities the opportunity to 

provide feedback on their inspection experience. 

• Continuing to create other opportunities to engage stakeholders through analysis and 

reporting of our program's findings, such as the reporting of aggregate program data via 

the FSAP Annual Report and the annual analysis of data related to the timeliness of 

inspection report processing via publication of the DSAT Inspection Report Processing 

Annual Summaries. 

We also are exploring avenues for disseminating further information regarding common 

deficiencies identified during inspections, and an analysis of data related to potential 

occupational exposures to select agents and toxins, from which we are able to identify common 

causes and provide recommendations for prevention. 

EnfOrcement Authority: 

FSAP recently finalized the Severity Spectrum oUnspection Departures and EnfOrcement 

Actions. which outlines categories of noncompliance with regulations related to biosafety and 

security, grouped according to the level of severity, as well as related enforcement options that 

may be applied. The document provides awareness of how FSAP considers the severity of 

inspection findings. As I mentioned earlier, regulatory violations (departures) are now grouped 

into a three-tier risk scoring system in the categories of low, moderate, and serious severity 

levels. We provided the regulated community an opportunity for input and feedback during the 

development process, and posted the final version on the FSAP website. FSAP is also using this 

information to help ensure consistency between inspections. For example, analysis of this data 

informed training initiatives to reduce variability between inspectors. The training will be 

completed at our joint inspection training November 1-3, 2017. 

9 
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28141.023

Conclusion 

FSAP is committed to further strengthening oversight of laboratories that handle select 

agents and toxins, and appreciates the input of GAO and other entities that have provided 

recommendations toward that end. We have and will continue to work diligently, thoughtfully, 

and collaborativcly with our federal partners and others who share in our commitment to protect 

Americans from biological threats. We value the Subcommittee's input as we continue to 

improve our oversight and enhance the safety and security of laboratories working with select 

agents and toxins. 

Thank you for the opportunity to testify. I would be glad to answer to any questions you 

may have. 

10 
36 

Mr. GRIFFITH. Thank you so much. 

I now recognize Dr. Isaac for a 5-minute opening statement. 

STATEMENT OF DR. FREEDA ISAAC 

Dr. ISAAC. Mr. Chairman and members of the subcommittee, I 

appreciate the opportunity to testify at today’s important hearing. 

I am Dr. Freeda Isaac. I am the Director of USDA Animal and 

Plant Health Inspection Service, Agriculture Select Agent Services. 

AGSAS, along with our counterparts at the Centers for Disease 

Control and Prevention oversee the Federal Select Agent Program. 

Together, our two agencies oversee the possession, use, and transfer of biological select agents and toxins. These select agents and 

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

or plant health, or to animal and plant products. I can assure you 

that this is a mission we take very seriously. Our goal is the same 

as yours. We want to have a program that allows our nation’s scientists and researchers to safely and securely conduct important 

work and development with select agents and toxins. 

Over the last few years, we have worked hard to strengthen our 

oversight of this program. Aside from our own efforts, we have received recommendations from outside experts, such as from GAO 

and the Federal experts Security Advisory Panel. We take these 

recommendations very seriously and we have used them to improve 

oversight of our program. I can confidently say that biosecurity and 

biosafety are stronger today than they were when I started. 

I do appreciate this latest GAO report on our select agent program. We cooperated fully with the audit, and agree with its recommendations, and we have already taken steps towards implementing them. 

We agree with the report that the independence of the Select 

Agent Program is important and that we must minimize potential 

conflicts of interest. We had taken steps in the past to reduce potential conflicts of interest. Notably, APHIS inspects CDC laboratories that use select agents and toxins and CDC inspects ours. 

We also agree with the recommendation to develop a plan to 

identify the types of laboratory activities that pose the most safety 

and security risks and to align inspection and assessment activities 

in line with those risks. However, I will note that our current inspection process does include some efforts to evaluate and analyze 

risk. For example, we analyze safety and security risks based upon 

the type of laboratory and agents it works with and we changed 

the frequency of inspections, based upon a facility’s compliance history. 

Another recommendation urges us to improve transparency with 

the regulated community. This has been a priority for us. We want 

these labs to clearly know what is expected of them and to understand how to properly secure select agents. 

We helped establish an independent forum to foster industry collaboration. We have set up new processes that allow stakeholders 

to review and provide input on program documents and policies. 

This extra communication and transparency helps them to understand their role and helps create a culture of safety in these facilities. 

37 

APHIS and CDC are committed to having the strongest possible 

Select Agent Program. We take these GAO recommendations seriously and we will use them, as we have all those previous reviews, 

to make this program stronger. 

This concludes my testimony. I would be happy to answer any 

questions you or the members of the subcommittee may have. 

[The prepared statement of Dr. Isaac follows:] 

38 


28141.024

Testimony of 

Dr. Freeda Isaac 

Director, Agriculture Select Agent Services 

Animal and Plant Health Inspection Service 

U.S Department of Agriculture 

Before the House Committee on Energy and Commerce 

Subcommittee on Oversight and Investigations 

November 2, 2017 

Mr. Chairman and Members of the Subcommittee: 

Thank you for the opportunity to testify today about the role of the U.S. Department of 

Agriculture's Animal and Plant Health Inspection Service (APHIS) and its operation of the 

Federal Select Agent Program (FSAP). APHIS, through its Agriculture Select Agent Services 

(AgSAS), and the Centers for Disease Control and Prevention (CDC) Division of Select Agents 

and Toxins jointly oversee the possession, use, and transfer of biological select agents and toxins 

that have the potential to pose a severe threat to the public, animal or plant health, or to animal or 

plant products. 

As director of the program, I can assure you that this is a mission that we take very seriously. 

We all recognize the importance of ensuring the safety, security, and proper use of these 

potentially dangerous agents. Every day, I and our employees, are working directly with 

laboratories and researchers to ensure they understand our select agent regulations and that they 

are following all proper protocols. Aside from developing and enforcing the select agent 

regulations, we provide guidance and clarification to laboratories about best practices and 

regulatory compliance. We want to make sure that the facilities we regulate are doing things 

right and that they can safely use and adequately secure these potentially deadly agents. 

Over the last few years, we have received a number of recommendations from organizations that 

have evaluated the efficacy of our biosecurity and biosafety programs, and we have diligently 

worked to implement as many of those recommendations as we can. Whether it was the Federal 

Experts Security Advisory Panel (FESAP), the Fast Track Action Committee on the Select Agent 

Regulations (FTAC-SAR) or any of the recent Government Accountability Office (GAO) 

reviews, we have taken these recommendations seriously and used them to make the FSAP 

stronger and more accountable. I can confidently say that biosecurity and biosafety are stronger 

today than they were when I started. 

Current Activities 

We appreciate continued support from Congress for the Federal Select Agent Program. An 

increase in funding in FY 2017 allowed APHIS to strengthen the program's scientific and 
39 


28141.025

technical capabilities. This funding has allowed APHIS to hire eight additional expert personnel 

who will increase the scientific and technical capabilities of AgSAS. One benefit is that more 

scientific and technical personnel will be involved in complex inspections, improving both the 

inspections' efficiency and the technical knowledge and knowledge transfer among our 

personnel. The additional staff will also allow us to improve our timeliness for registrations and 

renewals for new and existing facilities and individuals. 

With the additional funding, we will also continue working to update and modernize the National 

Select Agent Registry (NSAR) database- APHIS/CDC's joint FSAP database. The two 

agencies are creating a new, more efficient and user-friendly platform that allows stakeholders to 

safely and more securely submit entity information directly. An improved database will also 

give us better and more real-time data to analyze for any potential risks, allowing us to fix 

potential problems before issues arise. The database and our other efforts will move us toward 

the goal of having aligning APHIS and CDC processes so that there is consistency across FSAP. 

On the stakeholder front, we now have dedicated staff focused on improving our communication 

and training with registered entities to ensure that those we regulate fully understand their 

obligations under the select agent regulations. 

The November GAO Audit on High-Containment Laboratories 

We appreciate this latest GAO report on our select agent program. This is the most recent in a 

series of evaluations GAO has conducted of our program, and their past recommendations have 

helped to make this program stronger. We cooperated fully with this audit, agree with its 

recommendations, and have already taken steps toward implementing them. 

Broadly, the audit determined that APHIS and CDC need to improve our coordination and 

ensure the independence of our programs within our Departments. We will continue work in 

carrying out these recommendations in the coming weeks and months. 

Specifically, here is an update on what we will do in response to those recommendations for 

APHIS: 

We agree that the independence of the select agent program is important, and think that 

minimizing any potential conflicts of interest with USDA laboratories is essential. In practice, I 

regularly meet with the APHIS Administrator's office to provide updates on the select agent 

program major activities, enforcement actions, and overall administration of the program. We 

are developing a document that will formally outline this relationship. 

We also agree with the recommendation to work with CDC to establish control activities to help 

ensure each component of the program carries out its inspection responsibilities as outlined in the 

program's memorandum of understanding. While we have made great strides in aligning our 

two programs and improving consistency of inspections and operation, updating our joint formal 

standard operation procedure will greatly improve our ability to meet this goal. 
40 


28141.026

We agree that we should regularly assess, such as through an external review, the potential risks 

posed by the program's structure and the effectiveness of its mechanisms to address those risks 

and take actions as necessary. We have a track record of both evaluating our own program and 

working with experts to develop recommendations for strengthening our program. We arc 

considering various options with CDC to review the current structure. 

We will work to carry out the recommendation to work with CDC to develop and implement a 

plan to identify which laboratory activities carry the highest biological safety and security risks 

and to respond to those risks by aligning inspections and other oversight efforts to target those 

activities. However, I think it is important to note that the current inspection process does 

include some risk assessment and analysis activities. This includes establishing a baseline 

assessment that identifies the safety and security risk based on the work being performed and for 

which select agents and toxins the entity uses. We also determine the frequency of inspections 

dependent upon the risks of that facility combined with any incidents or compliance issues we 

have previously identified. 

We have already worked very hard on the recommendation to improve transparency and 

increased our communications with stakeholders so they better understand the program and how 

to properly secure and use select agents and toxins. 

Our efforts include our work to establish an independent forum to foster peer-to-peer sharing at 

workshops and webinars on best practices; the development of a formal process to respond to 

questions and provide guidance and interpretation about the select agent regulations; and the 

sharing of draft policies, interpretations and guidance documents with industry for feedback and 

clarification. 

Lastly, to improve technical expertise and overcome fragmentation, we have already hired a 

contractor to help us prepare a joint strategic plan that will incorporate these recommendations, 

and have held several initial meetings with them. 

Conclusion 

APHIS and CDC are committed to having the strongest possible FSAP. We will take these GAO 

recommendations very seriously, as we have previous GAO recommendations and those of the 

other panels that have reviewed this program. 

Our goal is the same as theirs: We want a program that allows our nation's scientists and 

researchers to be able to safely and securely conduct important work and development with 

select agent and toxins to advance human, animal, and plant safety. 

I appreciate the opportunity to testify. I would be happy to answer any questions you or the 

members of this subcommittee may have. 
41 

Mr. GRIFFITH. Thank you very much and I will now recognize 

myself for 5 minutes to start the committee questioning. 

Dr. Denigan-Macauley, GAO found that the Select Agent Program does not have a joint mission statement. Do CDC and APHIS 

have the same missions stating what the program seeks to achieve; 

yes or no? 

Ms. DENIGAN-MACAULEY. No. 

Mr. GRIFFITH. Thank you. The Government Performance and Results Act of 1993 requires agencies to develop strategic plans that 

include documents and planning tools, such as mission statements, 

strategic goals, and objectives and performance measures. Is that 

correct; yes, or no? 

Ms. DENIGAN-MACAULEY. Yes. 

Mr. GRIFFITH. Thank you. Although not binding to the Federal 

Select Agent Program, these requirements have been found by the 

GAO to serve as leading practices for individual programs. Is that 

also correct; yes or no? 

Ms. DENIGAN-MACAULEY. Yes. 

Mr. GRIFFITH. Both CDC and APHIS have performance measures 

for their activities and select programs. Isn’t that correct? 

Ms. DENIGAN-MACAULEY. Yes. 

Mr. GRIFFITH. Are their performance measures the same? 

Ms. DENIGAN-MACAULEY. No. 

Mr. GRIFFITH. Is there any overlap of the performance measures 

each agency uses? 

Ms. DENIGAN-MACAULEY. No. 

Mr. GRIFFITH. So CDC and APHIS are using different metrics to 

measure their own performance in the Select Agent Program. Is 

that correct? 

Ms. DENIGAN-MACAULEY. Yes. 

Mr. GRIFFITH. How about collectivity? Does the Federal Select 

Agent Program have performance measures to track its progress? 

Ms. DENIGAN-MACAULEY. No. 

Mr. GRIFFITH. Dr. Edwin, the GAO found that the Federal Select 

Agent Program does not have a joint strategic plan. Is the program 

taking steps to develop a joint strategic plan; yes or no? 

Mr. EDWIN. Yes. 

Mr. GRIFFITH. Good. Did the program take these steps before the 

GAO raised the issue with CDC and APHIS? 

Mr. EDWIN. We have individual strategic plans but not a joint 

one and we are working on a joint strategic plan. 

Mr. GRIFFITH. But you didn’t take that action before you got the 

GAO report. 

Mr. EDWIN. That is correct. 

Mr. GRIFFITH. And I am glad you are following some of those 

suggestions and both agencies have agreed that the suggestions 

make sense. So I appreciate that. 

Would such a step, including hiring an outside contractor to develop the joint strategic plan—would such a step include hiring an 

outside contract to help to develop the joint strategic plan; yes or 

no? 

Mr. EDWIN. Yes. 

Mr. GRIFFITH. And has such an outside contractor been hired 

yet? 

42 

Mr. EDWIN. Yes. 

Mr. GRIFFITH. Good. Has the outside contractor prepared a joint 

strategic plan? 

Mr. EDWIN. He is working towards preparing that, been in place 

for a month or so. 

Mr. GRIFFITH. OK but we don’t have a plan yet. When do you expect one? 

Mr. EDWIN. We are having, actually, meetings with the leadership, and the staff, and their coordinator. And they are in the process of developing one, probably within the next few weeks. 

Mr. GRIFFITH. OK, will you let the committee know when that 

has happened? 

Mr. EDWIN. Yes. 

Mr. GRIFFITH. Thank you. 

To avoid a conflict of interest with inspecting CDC labs, the CDC 

signed a memorandum of understanding with APHIS in 2012 so 

that APHIS would take the lead on select agent inspections of CDC 

labs. Isn’t that correct? 

Mr. EDWIN. That is correct. 

Mr. GRIFFITH. And so for most of the decade, the CDC was inspecting its own labs. Is that correct, 2003 to 2012? 

Mr. EDWIN. Yes. 

Mr. GRIFFITH. OK. And isn’t it true that the CDC signed a 

memorandum of understanding to avoid the conflict after the press 

and this committee raised concerns about CDC inspecting itself? 

Mr. EDWIN. That is correct. After receiving guidance, we have 

taken that step. 

Mr. GRIFFITH. OK, I appreciate that. 

Dr. Isaac, APHIS signed an MOU with CDC in 2012 so that 

APHIS would take the lead on select agent inspections of CDC 

labs, however, it was not until 2015 that you all signed a reciprocal 

MOU with CDC so that CDC would take the lead on select agent 

inspections of your labs. Isn’t that correct? 

Dr. ISAAC. Yes, that is correct. 

Mr. GRIFFITH. Thank you. At the briefing with the committee 

staff last week, you could not explain the 3-year delay on the MOU 

for the APHIS lab inspections. Isn’t that correct? 

Dr. ISAAC. That is correct. 

Mr. GRIFFITH. And now that you have had time to research it 

and think about it, are you in a position today to explain the 3- 

year delay? 

Dr. ISAAC. Yes. At that time, after discussing it with my staff, 

we did have some concerns regarding the authority of CDC to oversee some of the APHIS laboratories because those laboratories contained USDA-only agents and the CDC laboratories that APHIS 

takes the lead on have either overlap or USDA-only agents. So the 

authority is clear that APHIS has that authority. 

After we discussed that, I think the reason that we have changed 

the MOU is that administratively, consulting with our counsel, we 

determined that we could administratively have CDC oversee the 

inspections and sign the reports, as long it is done jointly with 

APHIS. 

Mr. GRIFFITH. OK and so I have only got a few seconds left and 

I appreciated your statement that things are safer now that you 

43 

are there. I appreciate that. I think that is right. We want to get 

it even better but I do find it curious that we had an MOU in place 

for over a decade with one of the agencies and your legal staff took 

about 10 years to come up with the opinion you now have. Oh, 3 

years. OK, excuse me, 3 years to come up with the plan you now 

have. They seemed to have drug their feet a little bit with that. 

I have to yield back and now recognize the ranking member, Ms. 

DeGette, for 5 minutes of questioning. 

Ms. DEGETTE. Thank you, Mr. Chairman. 

Dr. Denigan-Macauley, the laboratories we are talking about 

hold high-risk biological agents. If improperly handled, these could 

result in serious or lethal infection of lab workers or even the general public. Is that correct? 

Ms. DENIGAN-MACAULEY. Yes. 

Ms. DEGETTE. And in other words, if we don’t operate these programs with precision, with pretty much zero room for error, theoretically, we could have risk to both public health and national security. Is that correct? 

Ms. DENIGAN-MACAULEY. Yes, it is. 

Ms. DEGETTE. Now in your most recent audit, you found there 

were still problems with the Select Agent Program. In particular, 

you found that the program may not be sufficiently independent 

from the Centers for Disease Control and Prevention and the U.S. 

Department of Agriculture that it may not have enough inspectors 

and the inspectors it does have may not be targeting the most 

high-risk activities when they examine laboratories. Is that an accurate summary of your conclusions? 

Ms. DENIGAN-MACAULEY. Yes, it is. 

Ms. DEGETTE. And as you heard in my opening statement, I have 

been on this committee a long time, this is not the first time we 

have had these hearings. What do you think are the primary or 

root cause reasons we keep seeing this happen over and over again 

with respect to this program? 

Ms. DENIGAN-MACAULEY. Yes, thank you for the question. There 

will never be zero risk, unfortunately. There will always be some 

risk that has to be taken but we do believe strongly that the oversight needs to be strengthened to prevent these safety lapses from 

happening. And we do also believe, as our report states, that they 

really need to look at the highest risk activities and make that formal determination. While some steps have been taken, it has not 

been a full formal assessment to best understand what those activities are. 

Ms. DEGETTE. And I know you made a number of recommendations regarding the Federal Select Agent Program. The CDC and 

USDA have taken steps to implement the recommendations but 

your report shows that there is still work to be done. So my question is, Can you prioritize the recommendations that you have 

made? Which ones are the highest priority to make this a safer 

program with the greatest expediency and why? 

Ms. DENIGAN-MACAULEY. Generally, GAO does not prioritize our 

recommendations. However, today I highlighted two that we feel 

very strongly about. The fact that they are not independent, that 

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spectors there, according to the agencies because of the necessary 

expertise. So we definitely raised that as a concern. 

And we also raised the concern about not knowing what the 

highest risk activities are. 

Ms. DEGETTE. Dr. Ewin, what is your agency’s response to those 

two particular issues? 

Mr. EDWIN. So we are actually looking at risk. Our assessment 

of risk—— 

Ms. DEGETTE. Well, number one, about having independent inspectors. What is your agency’s response to that? 

Mr. EDWIN. So in order to do the inspections, we really do need 

the expertise of the agents that we—you know the public health 

agents are agents that are involving animal and plant health. And 

we are structurally separate from the main CDC and we work 

closely, almost on a weekly basis, on compliance and other issues 

with the—— 

Ms. DEGETTE. You don’t think you can have independent inspectors because of the level of—I don’t understand your answer to my 

question. 

Dr. Denigan-Macauley, the GAO, said number one, independent 

inspectors. And what you are saying is well, the inspectors have to 

have, obviously, the level of training. Does that mean you can’t 

have independent inspectors? 

Mr. EDWIN. Oh, I am not saying that at all. 

Ms. DEGETTE. Then what are you saying? I have got 50 seconds 

left. 

Mr. EDWIN. I think you know our inspectors are professionals, no 

matter if you are looking at CDC—— 

Ms. DEGETTE. All right, can you have independent inspectors, as 

the GAO is requiring? 

Mr. EDWIN. Yes. 

Ms. DEGETTE. Thank you. 

Now, the second recommendation was that we focus on the most 

high-risk activities. Are you implementing that recommendation? 

Mr. EDWIN. We are focused and look at all the high-risk activities, including the type of the agent. 

Ms. DEGETTE. So are you implementing that? 

Mr. EDWIN. Yes. 

Ms. DEGETTE. Thank you. 

Mr. EDWIN. Yes. 

Ms. DEGETTE. What about you, Dr. Isaac, your agency? What is 

your agency’s response to her first highest priority, the independence issue? 

Dr. ISAAC. Yes, we already currently have two things in place, 

which is our reporting structure within APHIS, where the program 

reports directly to the APHIS administrator. We also have CDC inspect APHIS laboratories. 

We also are, as the recommendation is, we are pursuing an option to have an external review of our program to identify the risks 

of how we are structured and to develop options to be able to take 

care of that risk. 

Ms. DEGETTE. And quickly, with respect to her second most important recommendation that we look at the most high-risk activities, is your agency also beginning to work on that? 

45 

Dr. ISAAC. Yes, we are. 

Ms. DEGETTE. Thank you. That will work. 

I yield back. 

Mr. GRIFFITH. I thank the gentlelady. 

I now recognize the vice chairman of the full committee, Mr. Barton of Texas. 

Mr. BARTON. Thank you, Chairman and thank you and Ms. 

DeGette for organizing and holding this hearing. 

We have kind of been here before. It looks like every 2 or 3 years 

we get a GAO report and the subcommittee has a hearing and you 

all come and say the appropriate things. And then we wait another 

2 or 3 years and we have another hearing. Maybe this time it is 

different. You know I can’t speak for anybody else but I am ready 

to, if necessary, legislate to change the law and actually put in the 

statute some of the recommendations of the GAO. 

My first question is just a generic question. In one of the footnotes it says that we think we have 276 laboratories in the United 

States that handle these toxins. Why do we need 276 laboratories 

to handle, or study, or whatever something that is so dangerous? 

Does anybody want to answer that? 

Mr. EDWIN. The number of laboratories that are registered with 

the Select Agent Program have been decreasing but we, our authority doesn’t dictate the number of laboratories. 

And when you talk about the laboratory, when we talk about the 

laboratory numbers, there are only a few laboratories that work 

with these highly pathogenic—— 

Mr. BARTON. Well 276 is more than a few. 

Mr. EDWIN. Yes. 

Mr. BARTON. Do you dispute that number? 

Mr. EDWIN. No, I do not dispute the number but not all of them 

work with all of the agents that we regulate. Some are just working with—— 

Mr. BARTON. Can anybody start one of these laboratories? Do one 

of your agencies have to issue a license? I mean if Diana DeGette 

and I decided to quit Congress and go into business and create one 

of these laboratories—— 

Ms. DEGETTE. A very highly unlike scenario. 

Mr. BARTON [continuing]. What would we have to do? Could we 

just start it up or do we have to go to CDC or the Ag Department? 

Mr. EDWIN. So depending on the agents that you are applying to 

work with, there is an initial registration process that involves a 

very comprehensive—— 

Mr. BARTON. Registration with who? 

Mr. EDWIN. If you are working with agents of public health concern, with CDC. And if it is a USDA agent—— 

Mr. BARTON. Can you reject the application? 

Mr. EDWIN. If the measures that are not in place to safely and 

securely handle these agents, yes. 

Mr. BARTON. But if they appear to be willing to comply, there is 

no limit on how many people can set up these laboratories, if they, 

on paper, agree to comply with your requirements. Is that correct? 

Mr. EDWIN. So on paper and also the physical inspection of the 

facilities to have all of these measures in place. 

46 

Mr. BARTON. Well, I guess to get to the bottom line, should we 

put a limit on the number of these laboratories that handle these 

highly dangerous materials? 

Mr. EDWIN. I think that is a bigger question that involves multiple parties in biodefense and the scientific community to 

make—— 

Mr. BARTON. I don’t have any frame of reference but it would appear to me, when you see the potential danger and you see the way 

some of these agents have been accidently transported and handled, I would think it might be advisable to put some sort of a limit 

or to go in and really, really look at the existing facilities with the 

potential to literally close some of them. 

Because I was stunned. I thought we had maybe 10 or 15 and 

that they were all highly classified and under control with the Department of Defense or some really, really high security areas. And 

apparently, anybody that wants to, any pharmaceutical company, 

any agriculture company, if they are willing to put the money up 

and at least pay lip service, can set up one of these laboratories. 

Mr. EDWIN. When the program first started, I think the number 

was close to 400. And because of all the requirements, the number 

has actually gradually been coming down. 

Mr. BARTON. Do either of your agencies have the ability to absolutely close one of these facilities? If you feel they are totally in 

noncompliance, can you shut it down permanently? 

Mr. EDWIN. We can suspend and revoke their registration to 

work with select agents and toxins. 

Mr. BARTON. You can suspend their registration? 

Mr. EDWIN. Yes. 

Mr. BARTON. OK. Last question and my time is about to expire. 

And Ms. DeGette and I think Mr. Griffith both alluded to this. 

GAO says there needs to be independence. Why couldn’t we just 

create a separate agency that all it does is inspect these, take both 

of your inspection groups and combine them to a totally independent group? What would be wrong with that idea? 

Dr. ISAAC. So—— 

Mr. BARTON. I might even let GAO answer that. 

Ms. DENIGAN-MACAULEY. Yes, we offer many oversight alternative approaches. We review the program in its current form but 

that was one of the reasons our methodology included going out. 

For example, the Nuclear Regulatory Commission is an independent and it was decided years ago that that needed to be made. 

And several laboratories in other countries such as Great Britain 

are in that—— 

Mr. BARTON. So that is a feasible alternative? 

Ms. DENIGAN-MACAULEY. It is a feasible alternative but not 

something that we looked at in detail to know the cost associated 

with that. 

Mr. BARTON. Do either of you want to comment on that before 

I yield back? 

Dr. ISAAC. So if I could just offer a comment is that because of 

the extreme scientific technical nature of the work that we do, and 

part of our oversight is to understand the research and the type of 

work that is being done with these agents, and understanding the 

proper use of the agent, where we are situated within HHS and 

47 

USDA, we are able to share resources within those departments for 

that technical expertise, as well as administrative and emergency 

response activities. We are able to tap into experts to implement 

regulations very quickly that require immediate implementation. 

Mr. BARTON. Well that begs the question an independent agency 

could do the same thing. 

I yield back. 

Mr. GRIFFITH. I thank the gentleman for yielding back. 

I would make a point of clarification. Dr. Denigan-Macauley, we 

have been talking about 276 labs but so that people who may 

watch this now or later will know, 276 labs are actually entities 

and those entities may have multiple labs. So we could actually be 

talking about 1200 or more labs. Is that correct? 

Ms. DENIGAN-MACAULEY. That is correct. 

Mr. BARTON. I appreciate that. Thank you. 

And now we will yield or recognize Mr. Tonko, the gentleman 

from New York, for 5 minutes of questioning. 

Mr. TONKO. Thank you, Mr. Chair. 

Five of GAO’s eleven recommendations concern the need to improve the independence of the Federal Select Agent Program. As 

we know, the Federal Select Agent Program is not an independent 

agency but a program managed jointly by the Centers for Disease 

Control and Prevention and an agency under the United States Department of Agriculture called the Animal and Plant Health Inspection Service or APHIS. 

GAO’s report states that while CDC and APHIS have taken steps 

to reduce conflicts of interest potentially posed by this structure, 

more can be done in this area. So, GAO, let’s start with you. 

Dr. Denigan-Macauley, can you please explain why GAO believes 

independence is important for an entity like the Federal Select 

Agent Program? 

Ms. DENIGAN-MACAULEY. Sure. We have previously used these 

criteria to look at adverse events with low probability and can have 

high consequence. So for example, the foot and mouth disease outbreak that happened over in the United Kingdom was a very tragic 

event, a low probability that it would occur. The Fukushima 

Diiachi nuclear reactor incident in 2011 is another example. 

While much research is conducted in this country very safely and 

securely, the probability is horrific if something were to happen. 

So, therefore, the criteria fit. And we also vetted the criteria with 

numerous folks that are experts within this field. 

Mr. TONKO. Thank you. I would like to learn more about what 

CDC and APHIS have already done to enhance the independence 

of the Select Agent Program. 

So, Dr. Edwin, what actions have you taken to reduce conflicts 

of interest between FSAP and CDC? 

Mr. EDWIN. So the Division of Select Agents and Toxins is located in the Office of Public Health and Preparedness. And the reporting lines to the CDC chief is a separate thing for us. 

And also, being in that particular office, they do not have any 

laboratories that we regulate. Being in that office, it helps us to 

pivot because the Emergency Operations is also under the same office. If there is a national incident, then we can immediately pivot 

and the entire structure is there to support such an activity. 

48 

So I see that as a very huge advantage that we have and I have 

direct access to the CDC Director, if there is anything that I need 

to engage with her on. 

Mr. TONKO. OK, thank you. 

And Dr. Isaac, the same question. What have you done to reduce 

conflicts of interest between FSAP and APHIS? 

Dr. ISAAC. Yes, operationally, the Agriculture Select Agent Program, we report directly to the APHIS administrator. We have a 

face-to-face briefing with the administrator every month, where we 

update him on the program activities and other incidents and enforcement issues that occur with all USDA laboratories. 

And even though under the administrator, there is other laboratories because of the chain of command of those laboratories is separate from our chain of command. So with that direct link, it highlights how important the program is to APHIS. 

The other aspect that we do is we utilize CDC as part of any concerns we have with USDA laboratories. They accompany us on 

those inspections and they will assist us in enforcement actions or 

they may actually take the enforcement action themselves. 

Mr. TONKO. OK and turning back to GAO, in terms of the independence here, Dr. Denigan-Macauley, can you broadly discuss 

GAO’s recommendations to increasing the independence of the Select Agent Program? And how would those ideas benefit the program? 

Ms. DENIGAN-MACAULEY. Sure. Dr. Isaac is correct that they do 

report directly to their director. However, this was not on paper. 

It is not known if it was actually being done. So that is one of our 

recommendations is to ensure that this is documented formally 

that this is done. 

One of the concerns that we have about not being independent 

is that this is a small community and they are there on each other’s inspections. They say that the expertise is needed. We understand that this is a very technical field, however, there are other 

options for, that we talk about in the report, reaching out. Other 

sectors have come up with other options such as advisory panels 

to be able to bring in that expertise so that they can focus on the 

regulations and the expertise can be brought in. 

Mr. TONKO. Thank you very much. 

I yield back, Mr. Chair. 

Mr. GRIFFITH. Thank you very much. 

I now recognize Dr. Burgess of Texas for 5 minutes of questions. 

Mr. BURGESS. Thank you, Mr. Chairman and thanks to our witnesses for being here today. 

Dr. Denigan, if I could just continue on Mr. Tonko’s line of questioning for a moment. So the independent inspectors would, of necessity, come from other laboratories or entities and people would 

cross-check each other? 

Ms. DENIGAN-MACAULEY. My apologies. Could you repeat the 

question? 

Mr. BURGESS. Well, just where are the independent inspectors, 

where are we to get them? 

Ms. DENIGAN-MACAULEY. There are some advisory committees 

here, even in the United States, that could be expanded to provide 

that level of expertise. We are not prescriptive in how that experVerDate Nov 24 2008 14:57 Oct 02, 2018 Jkt 037690 PO 00000 Frm 00052 Fmt 6633 Sfmt 6633 I:\MY DOCS\HEARINGS 115\HEARINGS\115-73 CHRIS
49 

tise would be obtained. Rather, we ask them to look at approaches 

using other regulatory sectors and other countries to determine 

how they gather that expertise. 

For example, some folks also put more emphasis on the actual 

labs to provide their own level of expertise and they require certification of the biosafety officers. 

So there are many different approaches that are out there. This 

is not the only one. 

Mr. BURGESS. It seems to me, and I don’t know that I am sure 

about this, but for it to truly be an independent inspector, it probably couldn’t be within the agency itself. That is one part of 

HHS’—or one part of CDC inspect another part. Is that a concern? 

Ms. DENIGAN-MACAULEY. Yes, it is and that is something that we 

noted in our report because the budget still comes from CDC and 

it still comes from APHIS. And so the decisionmaking process is 

coming from the CDC and APHIS. And this is one small program, 

amongst all the other activities that they have to consider. 

So yes, our criteria is that they must be structurally independent 

and separate. 

Mr. BURGESS. Thank you for that. 

Dr. Edwin, let me just ask you. It may be a little bit off topic 

but you talked in your written statement, on page 4, receiving reports of theft, loss, or release, and the bottom of the paragraph, notifying appropriate authorities. 

I was not in Congress when the anthrax event happened. I came 

the subsequent year after that but I remember reading about it in 

the newspapers and how horrific it was because anthrax, the early 

symptoms, are the symptoms of common cold, flu. And the ER doctor, one of the ER doctors, of the story that is seared into my memory, the ER doctor had seen a lot of cases of flu that day and this 

was another case of flu, until it turned out to be something much, 

much worse. 

So is there any method of notification, be on the lookout for, 

when—not for perhaps that situation but if you have got a breach, 

if someone finds that ricin has been shipped around the country, 

is there a dissemination of this knowledge to first responders and 

medical experts in emergency rooms so that perhaps the unusual 

symptoms they are seeing is something that must need to be considered? 

Mr. EDWIN. So this is one example where you know we have 

pivoted to our emergency operations that was providing exactly 

that information and connecting them to not only the subject matter expertise within the CDC, and other departments but also that 

the public health officials, and stuff and exactly providing that information on those types of incidents. 

On small ones that occur that we have reported in this, we make 

sure that if they need assistance from one of our SMEs on the list 

on that particular potential exposure, we try to connect them. And 

they, in turn, make sure that a person is taken care of the way he 

should. 

So because the local physicians that may be treating won’t have 

that particular expertise, we make sure that we connect the SMEs 

with the treating physicians. 

50 

Mr. BURGESS. At that time, in fact it was the Thanksgiving holiday of that year, and I was in labor and delivery. And the emergency room brought up a pregnant woman who was 28 weeks and 

for all the world looked like she had viral gastroenteritis. So I did 

the normal treatment and was fixing to sign her out and release 

her and she said, ‘‘Is it important that I tell you that my grandfather is a member of President Bush’s Cabinet?’’ And I thought for 

a minute and I thought it may be. 

So in short order, I was able to call some people and get some 

idea about whether or not these GI symptoms could be related to 

the same concern that was going in the Nation’s Capital. 

But it certainly brought home to me had she not mentioned that 

casual reference, I wouldn’t have known to look. Now, as it turned 

out, it was unimportant. It didn’t impact her clinical course but it 

could have is the point. And then I would have been just the same 

as that poor ER doctor that I read about who attended the unfortunate postal worker. He has got to live with that for the rest of his 

life that he missed that diagnosis. If there is anything we can do 

to help people come to the right conclusion more quickly, I think 

we should. 

Thank you, Mr. Chairman. I will yield back. 

Mr. GRIFFITH. Thank you very much, Dr. Burgess. That was compelling testimony of why this is so important, all of this. 

With that, I recognize the gentlelady from Indiana, Ms. Brooks, 

for 5 minutes of questions. 

Mrs. BROOKS. Thank you, Mr. Chairman, and thanks so much to 

our witnesses for sharing with us this important testimony. 

Going back, actually, to that time frame, I happened to be a U.S. 

Attorney in Southern District of Indiana during the anthrax attacks. And so government offices all across the country were, rightfully, really alarmed and concerned and, in fact, received often fake 

or hoax anthrax packets, including my own office at that time. 

And Dr. Edwin, as I have learned in preparation for today, prior 

to your role with the Select Agent Program, you served from 2008 

to 2016 as the responsible official and Biological Surety Officer for 

the Select Agent Program at the U.S. Army Medical Research Institute of Infectious Diseases. And it was from that place in July 

of 2008 that a biodefense researcher from your institution, Bruce 

Ivins, died from an apparent suicide after learning that the FBI 

was going to file criminal charges against him for the 2001 anthrax 

attacks. 

In August of 2008, the FBI and Department of Justice announced 

that Dr. Ivins was likely solely responsible for the five deaths and 

the injuries caused by the anthrax mailings but in May of 2011, a 

panel of the National Academy of Sciences, at the request of the 

FBI, reviewed the scientific work and concluded the FBI might 

have overstated the genetic analysis linking the mailed anthrax to 

a flax of anthrax kept by Ivins. 

So my question, Dr. Edwin, is, on July 10th of 2008, when Dr. 

Ivins lost his security—he lost his security clearance, as I understand. And as you were the responsible official for the Select Agent 

Program at that time, were you aware of any concerns about Dr. 

Ivins prior to that date and why he lost his security clearance on 

that date? 

51 

Mr. EDWIN. So, I was the alternate responsible official and there 

was a military officer that was the responsible official at that time. 

And it was also just you know I started in January and this is the 

suitability assessments that the Army does. Every individual that 

accesses select agents in the containment labs have personnel reliability program. So that is a certifying official that Dr. Ivins was 

under decertified him from entering the laboratory. 

Mrs. BROOKS. Thank you. And I would like to talk a little bit 

about this issue because it involves insider threats in the information. Is there enough information sharing with the Select Agent 

Program about potential or actual insider threats? 

Mr. EDWIN. So we require insider threat awareness training for 

all the entities and this is one place where agent accountability 

plays a very important role. You know we make sure that the 

agents that they have recorded and what they are working with. 

Not only does it help with the insider threat, it also gives safety 

priority, biosafety because we know where the agents are and the 

people inside the lab that are working are also aware where they 

are. 

Mrs. BROOKS. But what I am concerned about that is incredibly 

important I am concerned about the focus on the personnel that 

have access to these agents. 

And so have there been improvements made in reviewing the 

suitability of the personnel who are registered to work with the select agents? Is there baseline psychological testing? Are there two 

rules in the biocontainment suite? Are there reassessments of their 

security clearances? 

Mr. EDWIN. Yes, all of those are true and continuous monitoring 

is also in place for people that are working with the highest threat 

or tier 1 agents that we call it. 

Mrs. BROOKS. And since I have learned that there are so many 

different places where these labs exist, is this happening? And are 

you all confident, including the GAO, with respect to the amount 

of oversight there is of what Dr. Edwin just stated is happening? 

Is this happening in all of the labs? 

Dr. ISAAC. Yes, in 2012 we did publish a new regulation which 

required for all tier 1 pathogens, which are the highest risk pathogens, that every entity has a suitability program. And that is what 

is part of our inspection process, that we ensure that they have a 

robust review of their personnel suitability and take action. 

It is also a requirement in the regulations that if they remove 

access for any reason, that that is reported to the Federal Select 

Agent Program and that the reason for a person’s removal is reported to us. 

Mrs. BROOKS. Thank you. 

Doctor? 

Ms. DENIGAN-MACAULEY. Yes, thank you. In 2009, GAO reported 

that we did not have a single entity overseeing all of these labs. 

It is important to note today that what we are discussing is the 

Federal Select Agent Program. There are other pathogens, other 

diseases, viruses, bacteria, toxins that do not fall into the Select 

Agent Program, such as tuberculosis. 

So I do not have confidence that we have a good understanding 

of this robust program being implemented in all of the labs. 

52 

Mrs. BROOKS. Thank you. And thank you all for your work. It is 

critically important for the country. 

I yield. 

Mr. GRIFFITH. The gentlelady yields back. 

I now recognize Mr. Walberg of Michigan for 5 minutes. 

Mr. WALBERG. Thank you, Mr. Chairman. Thanks to the panel 

for being here. 

According to GAO’s report, both witness agencies have faced 

challenges in hiring and retaining a sufficient number of staff with 

appropriate expertise. The report outlined some of the negative 

consequences of insufficient staffing, including inability to meet 

deadlines and lack of expertise. 

But Dr. Denigan-Macauley, could you explain in greater detail 

the downfalls your team saw as a result of these staffing challenges? 

Ms. DENIGAN-MACAULEY. Sure. I should mention, again, that 

these are very challenging jobs that do require a high level of expertise and, in general, the program is working to ensure that they 

have that level of expertise. However, we did find that not all folks 

had the same level of expertise and sometimes, because of staffing 

issues, we are pushed out of their area where they had that level 

of expertise. 

So these are real. On paper it looks like an FTE but these are 

real problems that put people in a difficult situation. And not having these labs, this program sufficient staffed is very challenging. 

Mr. WALBERG. I understand both the CDC and APHIS have 

taken steps to hire more staff in the past few years and, specifically, have begun to fill vacancies at their respective agencies since 

this report was completed. 

I see from the report that the CDC developed a formal workforce 

plan for its component of the program in 2016 and was working to 

fill those positions. Dr. Edwin, would you tell us a little more about 

the workforce plan, and the hiring that you have done since that 

plan was developed, and the full size of your program staff? 

Mr. EDWIN. So in the last 14 months, we filled 17 positions, including my position. And we also have started with Dr. Isaac and 

their staff, the Strategic Workforce Plan that includes both training 

and workforce of the entire Federal Select Agent Program. 

Mr. WALBERG. With regards to the number of FTEs, are all of 

those individuals inspectors? 

Mr. EDWIN. We have 51 inspector positions and the others are 

support staff that look at different security requirements and other 

associated tasks within the division. 

So when I started with CDC they already had identified this deficiency and we were given the 16 some positions to fill, which we 

successfully filled. 

And I also want to say that most of our inspectors have come 

from the laboratories, select agent laboratories, and over 50 percent, about 65 percent or so have Ph.Ds. and the others have master’s degrees. So you know we do have that intellectual capital in 

the inspectors. 

Mr. WALBERG. So more specifically then, based upon that with 

the academic qualifications they have, the experience they have, 

what steps is the agency taking to address workload issues? 

53 

Mr. EDWIN. So you know with the addition of the inspectors, the 

estimated amount of time for travel and inspections outside has decreased by about 20 percent. It used to be about 45 and with the 

estimate, with the current inspection staff, there is about 25 percent the last time I spoke to our operations chief, which was a couple days ago. 

And in addition, with the new information system that we are 

developing, it is capturing a lot of efficiencies and it is going to provide the time, additional time for inspectors to be able to expediently do the inspection reports and increase efficiency on the performance of our program. 

Mr. WALBERG. So going in a positive direction. 

Mr. EDWIN. Yes. 

Mr. WALBERG. Thank you. 

Similarly, APHIS developed a 5-year business plan, which included a plan to hire additional staff. Dr. Isaac, would you tell us 

about the 5-year plan and the hiring you have done since the plan 

was developed and the full size of your program staff? 

Dr. ISAAC. Yes. In 2015 we developed a 5-year plan, which highlighted, essentially, the goals of the program, and where we wanted 

to be, and the type of staffing that we would need to be able to 

fully meet all of our goals. 

As a result of that, we were able to, and we are very thankful 

to Congress, we were able to get additional funds this year that allowed us to hire eight additional technical staff. So with that technical staff, we were able to create several new positions, including 

a science officer position that deals with a lot of the in-depth technical scientific questions, as well as a dedicated facility specialist 

who has expertise in that area, additional security specialist, training specialist, and policy analyst. And we are very grateful for that 

and we believe that that is going to help us fulfill and meet all of 

our goals for effective oversight. 

Mr. WALBERG. Thank you. I yield back. 

Mr. GRIFFITH. I thank the gentleman for yielding back. 

I now recognize Mr. Carter of Georgia for 5 minutes of questioning. 

Mr. CARTER. Thank you, Mr. Chairman, and thank each of you 

for being here. 

Dr. Denigan-Macauley, just a second ago I believe that Representative Brooks asked you about the—or you made the comment 

about the pathogens that are covered under the Special Agent Program—the Select Agent Program. Who makes that decision on 

what is covered and what is not covered? 

Ms. DENIGAN-MACAULEY. So CDC and APHIS are probably better 

in a position to answer that. However, collectively, they review 

what goes in, I believe it is every 2 years or so. But it is a Board 

of folks that make that decision. 

Mr. CARTER. A Board of folks? 

Ms. DENIGAN-MACAULEY. Experts in the field, APHIS and CDC 

collectively. 

Mr. CARTER. Dr. Edwin, do you want to expand on that? 

Mr. EDWIN. Are we talking about the review of the—— 

54 

Mr. CARTER. No, I am talking about the Board that makes that 

decision on what is in the Select Agent Program and what is not 

in it. 

Mr. EDWIN. Oh, so the biennial review. We call that process the 

biennial review. 

Mr. CARTER. Right. 

Mr. EDWIN. It is a group of individuals from various government 

agencies. 

Mr. CARTER. I am sorry. 

Mr. EDWIN. It is a group of individuals from various government 

agencies that look at this you know every 2 years and give us the 

guidance to make the changes that are necessary. 

Mr. CARTER. OK. In your opinion, is there anything in there that 

should be in there or anything that shouldn’t be in there? 

Mr. EDWIN. So you know we look at this every 2 years. 

Mr. CARTER. I understand you look at it but I am talking about 

now, today. 

Mr. EDWIN. I think that there are some agents that probably we 

need to relook at but we are approaching that with the committees. 

Mr. CARTER. When is the next time it will be up? 

Mr. EDWIN. It will be in a year and a half. 

Mr. CARTER. OK, Dr. Isaac—— 

Mr. EDWIN. We do a lot of preparation before we get to that. 

Mr. CARTER. All right. Anything that you think that probably 

ought to be in there that is not? 

Dr. ISAAC. We published a regulation this year and we will start 

a review process on the select agent list. We did receive some recommendations from our scientists, scientific experts who assess the 

list of select agents and make recommendations for removal or addition. 

And in this last published, we elected not to remove any agents 

based on some concerns regarding security and policy issues. So we 

will, this coming year, we will be doing that assessment again and 

working through not only our subject matter panel experts, scientific experts that we work with, but also interagency experts. 

Mr. CARTER. OK. Anything, Doctor, that you think? 

Ms. DENIGAN-MACAULEY. No, I think that the point the GAO has 

made in the past is that our oversight of pathogens in general, 

pathogens and toxins—— 

Mr. CARTER. Right. 

Ms. DENIGAN-MACAULEY. Is not comprehensive. 

Mr. CARTER. OK. 

Ms. DENIGAN-MACAULEY. And that is not the same with other 

countries. 

Mr. CARTER. All right, I want to go to something real quick and 

that is the incident reporting forms. From what I understand, between 2003 and 2015 there is a little bit of controversy as to exactly how many incidents we had. I think it was reported we had 

10 and then they identified 11 more. And then I believe that GAO 

made the recommendation that we improve the incident reporting 

forms. And I am just wondering, have we done that? How is that 

progressing? How are we doing? 

55 

Mr. EDWIN. So we have made the changes. One of the significant 

changes is now if there is an inactivation failure, at least it can be 

formally reported to the program, which was not part of that form. 

It is just 2 weeks ago I was approved by the OMB and we have 

that in place. 

Mr. CARTER. So you have it in place and it is working now. 

Just out of curiosity, because there was a little bit of confusion 

as to how many incidents actually took place between that time 

frame between 2003 and 2015, it was either 10 or 21, which there 

is a big difference between those. You believe it was 21. 

Since that time, how many have we had, do you have any idea? 

Since 2015, how many incidents have we had? 

Ms. DENIGAN-MACAULEY. GAO reported that we had 21 incidents 

of inactivation and it is the Form 3. We have not done work to understand how many more may have occurred since then. 

Mr. CARTER. Since that time you came up with the 21? 

Ms. DENIGAN-MACAULEY. Correct. 

Mr. CARTER. OK. OK, Dr. Denigan-Macauley, just last month I 

believe you came out with a report about the way that other countries are doing this, going about this process. It seems to me like 

the one thing that we are lacking here in America is that we don’t 

have a national strategy. 

Did we learn anything from other countries? I believe you looked 

at Great Britain and maybe Canada. Are they doing things that we 

need to be doing? 

Ms. DENIGAN-MACAULEY. Yes, we did, actually. We looked at a 

variety of different countries and they have very different approaches that are outlined in our report. 

And for example, as I mentioned, Great Britain has a separate 

entity that oversees it. It is similar to an OSHA but with much 

more teeth and they oversee the safety and security of a variety of 

different fields. 

So yes, we do outline many options. 

Mr. CARTER. Are you going to make those recommendations that 

we need to be following? 

Ms. DENIGAN-MACAULEY. We made the recommendation that 

these other oversight approaches should be taken into consideration as they move forward. 

Mr. CARTER. OK. 

Ms. DENIGAN-MACAULEY. We did not make a specific recommendation on a specific change. That is the dialogue that we believe needs to happen now. 

Mr. CARTER. OK. All right, thank you very much. 

Mr. Chairman, I yield back. 

Mr. GRIFFITH. I thank the gentleman very much. 

Ms. DeGette and I have agreed that I can ask a couple of oddball 

science questions. So if you all will bear with me, I am trying to 

educate myself. 

So you all have all of these pathogens—and I am asking both Dr. 

Isaac and Dr. Edwin—and I assume that many of them are live or 

living organisms. Is that correct? 

Mr. EDWIN. That is correct. 

Dr. ISAAC. Yes. 

56 

Mr. GRIFFITH. And when your inspectors are going in, are they 

looking for any mutations or to make sure that there is no possibility of, for lack of a better term, I am going to say cross-pollination? 

And the reason for this is I have just read this fascinating read 

called Inheritors of the Earth by Chris Thomas, a British scientist, 

who is talking about all kinds of things. And in there, he talks 

about a plant that comes over from Sicily, creates a hybrid, which 

becomes a separate species in Great Britain. It took about 300 

years. But then, once the railroads came to town, they have discovered it created another hybrid in York in a matter of just maybe 

a few decades. 

And so I am worried that we have got all these dangerous things. 

Are we making sure there are no mutations or that there isn’t 

something else going on? Because, apparently, organisms, as complicated, these are all ragworts and groundsel species. Well, they 

are a lot more complicated than some of the microorganisms. Are 

we making sure? Is that part of the inspection, that we are making 

sure we don’t have mutations or hybridization going on within our 

own labs? 

Mr. EDWIN. So we have a process to capture what you are describing, a strain within an organism and variants. You know there 

is that opportunity for them to—our database captures that information. And as we inspect and look at the inventories, we also pay 

attention to that. 

It is an ongoing process and we encourage, anytime that there 

are differences, to be able to get that. And some of them actually 

need approval if they are making an antibiotic-resistant strain. So 

it needs to go through the Institutional Biosafety Committees that 

have experts locally at the entity and then the process comes here. 

And we have an expert panel of experts from various agencies. We 

call these sometimes and they provide us the guidance as well as 

we look at it internally as well. 

So we are paying attention to those, especially since science is 

evolving rapidly. 

Mr. GRIFFITH. I appreciate that because the concern has a little 

bit different look to it and all of a sudden, we have accidently created something even worse than the original. 

Dr. Isaac, are you all doing similar things? 

Dr. ISAAC. Yes, we are doing similar things. We require that individual strains be registered and that if there are variations within 

their research protocol as to the type of virus that they are working 

or creating, and the type of species, animal species that they are 

working with, that they also report that to us. And we review those 

research protocols. 

And that is the same for animal pathogens and plant pathogens. 

Mr. GRIFFITH. All right. With that, I yield back. 

Any additional questions, Ms. DeGette? 

Ms. DEGETTE. No, thank you. 

Mr. GRIFFITH. All right. Well, that concludes this hearing. It was, 

hopefully, not too painful but we do want to make sure we keep 

the American public protected and we appreciate the work of the 

GAO in helping us with that and your cooperation with them. 

57 

In conclusion, I thank all of you. And the members who participated in today’s hearing. I remind members they have 10 business 

days to submit questions for the record and I ask that the witnesses all agree to respond promptly to the questions. 

And with that, this hearing is adjourned. 

[Whereupon, at 12:05 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

58 


28141.027

E~C U.S. HOUSE OF REPRESENTATIVES 

COMMITTEE ON ENERGY AND COMMERCE 

EST. 1795 

TO: 

FROM: 

RE: 

October 31, 2017 

Members, Subcommittee on Oversight and Investigations 

Committee Majority Staff 

Hearing entitled "Concerns over Federal Select Agent Program Oversight of 

Dangerous Pathogens" 

The Subcommittee on Oversight and Investigations will hold a hearing on Thursday, 

November 2, 2017, at 10:15 a.m. in 2322 Rayburn House Office Building, entitled "Concerns 

over Federal Select Agent Program Oversight of Dangerous Pathogens." The Subcommittee will 

hear testimony on the Government Accountability Office's (GAO) recent report on the need for 

coordinated actions needed to enhance the Federal Select Agent Program's (FSAP) oversight of 

hazardous pathogens. In recent years, the Subcommittee has examined numerous safety lapses at 

high-containment laboratories and ways to enhance U.S. biosafety and biosccurity under the 

FSAP. 1 

I. WITNESSES 

• Mary Denigan-Macauley, Ph.D., Acting Director, Health Care, Government 

Accountability Office; 

• SamuelS. Edwin, Ph.D., Director, Division of Select Agents and Toxins, Centers for 

Disease Control and Prevention; and 

• Freeda E. Isaac, DVM, Director, Agriculture Select Agent Services, Animal and Plant 

Health Inspection Service, U.S. Department of Agriculture. 

II. BACKGROUND 

The purpose of this hearing is to examine the conclusions of a recent GAO report on the 

coordinated actions needed to enhance the Federal Select Agent Program's oversight of 

hazardous pathogens. 

The Committee requested this report in May 2015 after several incidents involving the 

mishandling of hazardous biological agents raised questions about Federal policies for managing 

hazardous biological agents in high-containment laboratories. In this bipartisan request, the 

Committee asked GAO to analyze the policies and procedures in place at Federal agencies to 

ensure the proper management of pathogens and the steps taken to improve their inventory 

1 The Select Agent Program is operated by the Departments of llealth and Human Services and Agriculture to 

oversee certain dangerous pathogens, known as select agents. 
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Majority Memorandum for November 2, 2017, Subcommittee on Oversight and Investigations 

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management of pathogens. The Committee also requested that GAO assess how the agencies 

evaluate the effectiveness of their policies and procedures relating to pathogen management.2 

The Subcommittee has previously held multiple hearings on security lapses at highcontainment laboratories. In July 20\4, the Subcommittee on Oversight and Investigations held 

a hearing examining an incident that occurred in June 2014 at the Centers for Disease Control 

and Prevention's (CDC) laboratory where as many as 84 CDC employees were exposed to live 

anthrax, because established safety practices were not followed. 3 The incident led CDC Director 

Thomas Frieden to shut down the Bioterror Rapid Response and Advance Technology (BRRA T) 

laboratory until certain issues were resolved and issued a moratorium on transfers of biological 

material leaving any CDC high-containment lab until adequate measures were in place.4 The 

hearing also examined other incidents, including a spring 2014 cross-contamination involving 

H5N I influenza virus at the CDC influenza laboratory and the discovery of decades-old vials of 

smallpox in a Food and Drug Administration (FDA) lab on the National Institutes of Health's 

(NIH) campus that were only discovered while employees were preparing for the lab's move to 

the FDA's main campus in White Oak, Maryland. 

In July 2015, the Subcommittee held a hearing on the Department of Defense's (DOD) 

acknowledgement that the Dugway Proving Ground (Dugway), an Army facility in Utah, had 

inadvertently shipped live anthrax to a commercial laboratory in Maryland as well as to other 

contract labs. 5 These shipments revealed that Dugway's process for inactivating anthrax with 

radiation was unreliable, and that sterility testing used to validate and ensure that the inactivation 

process was working had failed to detect the live anthrax spores. 

On April20, 2016, the Subcommittee held a hearing on the GAO report on the need for 

comprehensive policies and stronger oversight at high-containment laboratories,6 as well as the 

steps taken by the National Institutes of Health (NIH), the CDC, the FDA, and the DOD to 

strengthen their policies. GAO found that stronger oversight mechanisms for federal highcontainment laboratories were needed at the individual federal department and component level. 

2 Letter from Hon. Fred Upton, Chairman, Hon. Tim Murphy, Frank Pallone, Jr., Ranking Member, lion. Diana 

DeGette, II. Comm. on Energy & Commerce, to Hon. Gene Dodaro, Comptroller Gen., U.S. Gov't Accountability 

Office (May 7, 2015). This letter requested an examination of the sufficiency of inactivation protocols and 

procedures for studying dangerous pathogens. The request included a part relating to how other countries addressed 

this issue, which was separated from the scope of the first report and deferred for later work. On July 28, 2016, 

GAO met with bipartisan committee staff and agreed that for part two of the inactivation request, we needed to 

broaden the scope and focus on current and alternative oversight structures for select agents in high-containment 

laboratories. 

3 Review of CDC Anthrax Lab Incident: Hearing before the Subcomm. on Oversight and Investigations. H. Comm. 

on Energy & Commerce, !13th Cong. (20 14). 4 On June 8, 2015, the BRRAT Laboratory received approval from CDC's internal Laboratory Safety Improvement 

Workgroup and CDC leadership to reopen. The lab is currently conducting laboratory training and validation of 

new laboratory procedures in preparation of resuming fall operations. 5 Continuing Concerns with the Federal Select Agent Program: Department of Defense Shipments of Live Anthrax: 

Hearing before the Subcomm. on Oversight & Investigations. H. Comm. on Energy & Commerce, I I 41

h Con g. 

(2015). 

6 Laboratories that conduct research on ha?llrdous biological agents are assigned one of four biosafety levels (BSL ). 

Labs at BSL-3 and BSL-4, the highest risk ofthe four levels, are known as "high-containment laboratories." 
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Majority Memorandum for November 2, 2017, Subcommittee on Oversight and Investigations 

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On September 23,2016, the Subcommittee heard testimony on GAO's report on the need 

for improving the Federal Select Agent Program's oversight of incomplete inactivation, 7 as well 

as the steps taken by CDC, the U.S. Department of Agriculture (USDA), the NIH, and the DOD 

to strengthen their policies. 

a. Federal Select Agent Program 

Following the Oklahoma City bombing in 1995, the Antiterrorism and Effective Death 

Penalty Act of 1996 established the Federal Select Agent Program. This law required the 

Department of Health and Human Services (HHS) to identify a list of organisms and toxins 

(known as select agents) that could potentially be used for bioterrorist attacks and to regulate 

their transfer, though not their possession. The FSAP regulates 66 select agents and toxins. The 

select agent list is reviewed at least every two years to determine if agents need to be added to or 

deleted from the list. 8 Examples of some select agents are anthrax, tularemia, smallpox, and 

plague. 

The September ll, 200 l terrorist attacks and the 200 I anthrax mailings increased the 

Federal government's interest in the threat ofbioterrorism. The USA Patriot Act made it a 

criminal offense for certain restricted persons, including some foreign aliens, persons with 

criminal records, and those with mental defects, to transport or receive select agents. 9 The USA 

Patriot Act also made it a criminal offense for any individual knowingly to possess any 

biological agent, toxin, or delivery system in type or quantity not justified by a peaceful 

purpose. 10 

Congress later enacted the Public Health Security and Bioterrorism Preparedness and 

Response Act of 2002, which (I) expanded the FSAP to include the regulation of the transfer and 

the use and possession of select agents and (2) increased safeguards and security requirements. 11 

The 2002 Act also established civil money penalties for persons violating the regulations and 

additional criminal penalties for knowingly possessing a select agent or toxin without registering 

it or knowingly transferring a select agent or toxin to an unregistered person. 12 

b. High Containment Laboratories 

High containment laboratories, which conduct research on bioweapon agents, have 

proliferated since the 200 I anthrax attacks in which spores were mailed to news media offices 

7 Inactivation can be defined as a process used in laboratories to render pathogens unable to cause disease, but 

retaining characteristics of interest for future use, such as for vaccine development. 8 Federal Select Agent Program, About Us, http://www.selectagents.gov/about.html. 9 USA Patriot Act of2001, Pub. L. No. 107-56, 115 Stat. 272 (2001). 

10 /d. 

11 42 U.S.C. § 262a. 

12 /d. 
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and two U.S. senators, killing five people and infected 17 othcrs. 13 In February 2013, GAO 

reported to the bipartisan leadership of the Committee that there was an increased risk of 

laboratory accidents given weaknesses in lab oversight and the lack of national safety 

standards. 14 GAO had recommended in 200915 that the National Security Advisor make a single 

Federal agency responsible for assessing lab standards, but in its 2013 report, GAO noted that 

the National Security Staff and the Office of Science and Technology Policy (OSTP) rejected the 

recommendation as "unnecessarily broad and cumbersome." 16 

CDC and NIH have established four main levels of biosafety (BSL-l to BSL-4) to guide 

laboratory researchers in the safe handling of biological agents. 17 Each biosafety level is 

associated with specific physical and procedural protections. In general, the more dangerous the 

pathogen is to public health, the higher its recommended biosafety level. Procedures deemed 

unlikely to produce disease in healthy humans should be conducted at BSL-1. Those that may 

cause disease in healthy humans, but for which immunization or antibiotic treatment is available, 

should be conducted at BSL-2. Procedures that may cause serious or potentially lethal diseases 

as a result of pathogen inhalation should be conducted at BSL-3. Procedures that pose a high 

individual risk of aerosol-transmitted laboratory infections and life-threatening disease should be 

conducted at BSL-4. Generally, the term "high-containment laboratory" refers to BSL-3 and 

BSL-4 laboratories. 

The GAO has conducted comprehensive work on the oversight of high-containment 

laboratories. In 2009, GAO noted that the number of high-containment laboratories was 

increasing in different sectors throughout the United States. 18 The expansion began in response 

to the need to develop medical countermeasures and better risk evaluations after the anthrax 

attacks in 2001. 19 And since no single agency is in charge of the expansion, no Federal agency 

can determine the associated risk posed by the expansion.20 GAO has continued to recommend a 

government-wide strategy for the requirements of high-containment laboratories and the need for 

national standards for designing, constructing, commissioning, and maintaining such 

laboratories.21 

13 In 2009, there were over 240 entities with at least 1,362 BSL-3 laboratories in the United States registered under 

the Federal select agent program. This expansion has continued and somewhat plateaued. In the latest report, GAO 

stated that there are 276 entities registered. 14 GAO, "High-Containment Laboratories: Assessment of the Nation's Need Is Missing," GA0-13-466R (February 

25, 20 13) http://gao.gov/assets/660/652308.pdf. 15 GAO, "High-Containment Laboratories: National Strategy for Oversight Is Needed," GA0-09-I036T (September 

21, 2009) http://gao.gov/assets/130/123358.pdf. 16 GAO, "Overlap and Duplication: Federal Inspections ofEntities Registered with the Select Agent Program," 

GA0-13-154 (January 20 13) http://gao.gov/assets/660/651730.pdf. 17 Department of Health and Human Services, Centers for Disease Control and Prevention and National Institutes of 

Health, Biosafety in Biomedical and Microbiological Laboratories (BMBL), 5th edition, 2009. 

http://www.cdc.gov/biosafety/publications/bmbl5/. 

18 GAO, "High-Containment Laboratories: National Strategy for Oversight Is Needed," GA0-09-1036T (September 

21, 2009) htto://gao.gov/assets/130/123358.pdf. 

19 Id. 

zo Id. 

21 Id. 
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c. GAO Report on the Federal Select Agent Program 

In response to the Committee's request, GAO reviewed the effectiveness of current 

oversight procedures within the Federal Select Agent Program and oversight procedures from 

other countries and regulatory sectors. GAO also examined strategic planning documents at both 

the CDC and APHIS. 

GAO found that the oversight procedures in the FSAP did not meet the criteria for 

effective oversight as determined by GAO. That is, the program is lacking in each of the five 

elements identified by GAO as critical to effective oversight:22 

• Independence: The organization conducting oversight should be structurally distinct and 

separate from the entities it oversees. 

• Ability to perform reviews: The organization should have the access and working 

knowledge necessary to review compliance with requirements. 

• Technical expertise: The organization should have sufficient staff with the expertise to 

perform sound safety and security assessments. 

• Transparency: The organization should provide access to key information, as applicable, 

to those most affected by operations. 

• Enforcement authority: The organization should have clear and sufficient authority to 

require that entities achieve compliance with requirements. 

GAO determined that the FSAP is not independent from the entities it oversees. To be 

considered independent, the agencies cannot regulate themselves, but both the CDC and the 

USDA's Animal and Plant Health Inspection Service (APHIS) oversee laboratories within their 

agencies.23 However, the GAO cited some benefits to the current structure of the FSAP, 

including the program officials' ability to access experts within the CDC and APH!S.24 The 

FSAP has taken some steps to reduce potential conflicts of interest, but those steps are not 

sufficient to ensure independence. For example, both CDC and APHIS have made structural 

changes to increase independence, such as relocating a program component to an office that does 

not have a laboratory, and APHIS has made organizational changes, such as realigning 

supervisory responsibilities such that the FSAP does not report to a division director whose 

office included a laboratory.25 Further, both CDC and APHIS signed a memorandum of 

22 GAO, "High-Containment Laboratories: Coordinated Actions Needed to Enhance the Select Agent Program's 

Oversight of Hazardous Pathogens," GA0-18-145 (October 2017). https://www.gao.gov/assets/690/687868.pdf. 23 /d. at 15. 

"Jd .. 25 Id. at 15-16. 
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understanding in 2012 to reduce organizational conflicts of interest at the CDC.26 However, in 

practice, neither CDC nor APHIS always follow this memorandumP Finally, while the FSAP 

has taken steps to reduce conflicts of interest, those steps are generally taken in response to a 

concern raised by others; the program itself has not proactively assessed potential risks that could 

arise due to the lack of independencc.28 

GAO also found that while the Select Agent Program performs several types of reviews 

to ensure compliance with regulatory and program requirements, those reviews are not tailored to 

target the highest-risk activities in the program. 29 The failure to use a targeted review process 

was partly due to the fact that the FSAP has not formally assessed which activities arc high 

risk.30 Additionally, inspections sometimes focused on verifying information that had little to do 

with reducing risk, such as reviewing records to match nicknames with full names and counting 

vials without verifying that the contents of the vials were uncompromised. 31 Further, GAO 

found that FSAP reviews were generally more focused on security concerns, like preventing 

theft, than on biological safety, like reducing the risk of researcher exposure to select agents, 

despite the fact that biological safety incidents may be more likely to occur. 32 A 2015 report 

recommended that CDC and APHIS collaborate to identify high risk areas in order to improve 

the inspection process, but that recommendation has not yet been addressedY 

GAO further found that the CDC and APHIS lack a workforce of sufficient size and 

training. While both agencies have increased the number of full time inspectors since 2016, the 

FSAP still may not have adequate staff to complete work in a timely fashion. The lack of staff 

results in high workloads, which creates additional problems, including low staff retention rates, 

staff being assigned work outside oftheir areas of expertise, and delays in issuing inspection 

reports.34 Roughly 27 percent of reports exceeded the 30 day target. 35 This delay in issuing 

reports in turn delays the implementation of corrective safety measures. 36 GAO also determined 

that inspectors from both agencies lacked sufficient knowledge about their regulatory 

responsibilities, but that training opportunities were not always readily available to those 

inspectors.37 Gaps in training could be attributed in part to the inspectors' inability to devote 

time to training due to high workloads. 38 Both agencies are in the process of improving training 

for program staff, including by hiring additional training specialists. 39 

26 APHIS would provide the lead inspector for all inspections of registered laboratories owned by CDC. In March 

2015, the memorandum was amended to state that CC would lead inspections of all USDA-owned laboratories./d. 

at 19-20. 

27 !d. 

"!d. at 20-21. 29 !d. at 23. 30 !d. at 24. 31 !d. at 24-25. 32 !d. at 25. 33 !d. at 26. 34 ld. at 28. 35 !d. at 27. 36 !d. at 28. 37 !d. at 30. 38 !d. at 31. 

39 !d. 
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GAO found that the Select Agent Program shares limited information with the public, 

primarily due to security concerns. While the FSAP has recently increased its transparency, 

including by issuing its first public report on the program in 2016, GAO found that in order to 

increase public trust, there should be more transparency to the public about activities conducted 

at laboratory.40 In addition, GAO found that more transparency for laboratories, including by 

sharing information between laboratories about research and incidents, would allow laboratories 

to learn from each other and improve their operations and biological safety and security. 41 

In response to a program violation, the Select Agent Program may take administrative 

action such as suspending or revoking a laboratory's registration, refer the violation to HHS 

Office oflnspector General or APHIS's Investigative and Enforcement Services, or refer 

violations to the Federal Bureau oflnvestigations.42 The program has taken enforcement actions 

in the past, but has done so inconsistently and without a set of criteria.43 In 2016, GAO 

recommended that the FSAP develop and implement criteria.44 The CDC finalized and 

implemented such criteria in June of2017, and in September 2017, the program finalized 

guidance on when to refer laboratories for violations and enforcemcnt.45 

GAO also found that the Select Agent Program lacks joint strategic planning documents 

to guide its oversight efforts. While each component has some form of strategic planning 

documents, they are fragmented in their goals and performance measures.46 Strategic planning 

documents could improve oversight by enabling the program to set goals, measure progress, and 

collaborate across agencies. The FSAP is in the process of developing a joint strategic plan, and 

began soliciting bids for the plans development in August 2017.47 

GAO also examined the oversight procedures at regulatory bodies in other countries and 

the other regulatory sectors in the United States. GAO found that in some regulatory sectors in 

both Great Britain and the United States, regulatory bodies benefit from structural independence 

from the entities they oversee. GAO examined Great Britain's Health and Safety Executive and 

the U.S. Atomic Energy Commission, and found that independence promoted objectivity and 

reduced potential conflicts of interest. 48 

GAO found that other countries, such as Great Britain and Canada target their reviews 

based on a history of laboratory incidents or to laboratories conducting high-risk activities.49 

40 !d. at 33. 41 !d. at 34. 42 Id. at 35. 47 !d. at 36. 

44 Jd. 

45 ld. at 37. 46 ld. at 38. 47 Id. at 39. 48 !d. at 41-42. 49 !d. at 43-44. 
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Similarly, the Nuclear Regulatory Commission focuses its oversight on facilities that handle the 

most high-risk materials. 50 

To ensure that regulatory staff have appropriate expertise, regulatory bodies in Great 

Britain, France, and Germany rely on expert advisory committees that serve as a resource to 

staff. 5

1 In Canada and the Netherlands, laboratory personnel are primarily responsible for 

understanding and addressing the risks associated with the laboratory work.52 

With respect to transparency, most countries and regulatory bodies tried to balance safety 

concerns with public trust. Great Britain's Health and Safety Executive, the Nuclear Regulatory 

Commission, and the Federal Aviation Administration share certain information about registered 

facilities, investigations and incidents, and safety data to inform the public, while still protecting 

information that could be misused. 53 The Netherlands also shares such information with the 

public, as well as making it available upon request. 5

4 Switzerland primarily makes such 

information available only by request. 5

5 

Regarding enforcement actions, GAO found that in the countries they reviewed, each had 

the ability to suspend or close laboratories for violations, and pursue criminal prosecution for 

serious violations. 56 In Canada, laboratory staff are sometimes given immunity from prosecution 

if they voluntarily report certain incidents. 57 

GAO made 11 recommendations to both agencies involved in overseeing the Select 

Agent Program. With respect to APHIS, GAO recommended: 

• To improve independence, the Administrator of APHIS should formally document the 

reporting structure for the APHIS component of the Select Agent Program from the 

APHIS director of the program to the Administrator of APHIS. 

With respect to both APHIS and CDC, GAO recommended that: 

• To improve independence, the two agencies should work together to establish control 

activities to help ensure that each component of the program carries out its inspection 

responsibilities as outlined in the program's memorandum of understanding. 

• To improve independence, the two agencies should work together to assess regularly the 

potential risks posed by the FSAP' s structure and the effectiveness of its mechanisms to 

50 !d. at 46. 51 !d. at 48. 52 !d. at 49. 53 !d. at 50-51. 54 !d. at 50. 

55 !d. 

56 !d. at 51. 57 !d. at 52. 
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address those risks, and take actions as necessary to ensure that any identified risks are 

addressed. 

• To improve the ability to perform reviews, the two agencies should work together to 

develop and implement a plan to identify which laboratory activities carry the highest 

biological safety and security risks by aligning oversight efforts to target those activities. 

• To improve transparency, the two agencies should work together to determine what 

additional information about laboratories' use of select agents, incidents, and violations 

of the select agent regulations is appropriate for the program to share with registered 

laboratories. 

• To improve technical expertise and overcome fragmentation, in conjunction with 

development oftbe strategic plan, the two agencies should work together to develop a 

joint workforce plan that assesses workforce and training needs for the program as a 

whole. 

III. ISSUES 

The following issues may be examined at the hearing: 

How do CDC and APHIS determine whether the federal select agent inspections they 

conduct are effective in improving biosecurity and biosafety at high-containment 

laboratories? 

Does the Federal Select Agent Program place too much emphasis in its inspections on 

biosecurity at the expense of biosafety? 

Is the organizational conflict-of-interest in the Federal Select Agent Program an 

acceptable cost for the access to technical expertise? 

Is legislation needed to help the Federal Select Agent Program meet the key elements 

of effective oversight? 

IV. STAFF CONTACTS 

If you have any questions regarding the hearing, please contact Alan Slobodin or 

Brighton Haslett at (202) 225-2927. 
67 


28141.036

GREG WALDEN, OREGON 

CHAIRMAN 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

ONE HUNDRED FIFTEENTH CONGRESS 

(!Congrt£)£) of tbe Wniteb $tates 

j!,Jou%c of l\cprc%cntattbc% 

COMMITIEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 

Dr. Mary Denigan-Macauley 

Acting Director 

Government Accountability Office 

441 G Street, N.W. 

Washington, DC 20548 

Dear Dr. Denigan-Macauley: 

Majority (202) 225-2927 

Minority \202) 225-3641 

December 5, 2017 

Thank you for appearing before the Subcommittee on Oversight and Investigations on Thursday, 

November 2, 2017, to testifY at the hearing entitled "Concerns Over Federal Select Agent Program 

Oversight of Dangerous Pathogens." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (l) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on Friday, December 15, 2017. Your responses should be 

mailed to Ali Fulling, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House 

Office Building, Washington, DC 20515 and e-mailed in Word format to Ali.Fullingl{ilmail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

Sincerely, 

bl!~ Chairman 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachment 
68 


28141.037

GAO u.s. GOVERNMENT ACCOUNTABILITY OFFICE 

441 GSt. N.W. 

Washington, DC 20548 

December 15, 2017 

The Honorable Greg Walden 

Chairman 

Committee on Energy and Commerce 

House of Representatives 

Subject: Select Agent Oversight- GAO Responses to Questions for the Record 

This letter notifies you of our enclosed responses to questions for the record following the 

November 2, 2017 hearing titled "Concerns Over Federal Select Agent Program Oversight of 

Dangerous Pathogens." I am pleased to be able to provide you with the requested information. 

If you or your staff have any questions about our responses, please contact me at (202) 512-

7114 or deniganmacauleym@gao.gov. 

Sincerely yours, 

~~ \)wF~ \-\_~--

Mary Denigan-Macauley, Ph.D. 

Acting Director, Health Care 

Enclosure 
69 


28141.038

The Honorable Morgan Griffith 

1. In addition to facing challenges in hiring staff, GAO's report noted that some staff 

lack technical expertise. Specifically, one of the problems arising from the small 

workforce was that staff were sometimes assigned tasks outside of their area of 

expertise. One example noted in the report was a security specialist being 

assigned to inspect ventilation systems. 

a. How often does this happen- an employee being assigned work that he or 

she is not qualified for, or at the very least, for which he or she lacks 

expertise? 

b. Can you provide any other examples? 

Analysis of the frequency and extent of staff being assigned work for which they are unqualified 

was beyond the scope of our review. However, during the course of our review, in the fall of 

2016, a number of APHIS officials were performing multiple roles to help the APHIS component 

of the Federal Select Agent Program carry out its duties with its available staff, according to 

officials we interviewed. For example, a manager within the program was taking on the role of 

the training specialist, and the role of the scientific officer was being carried out by another 

manager. APHIS is aware of these gaps and, as we reported, added several new positions in 

2017, including a scientific officer, a security manager, and a training specialist' We are not 

aware of similar examples within the CDC component of the program. 

2. Both agencies reported to GAO that additional training opportunities were needed 

for their staff. According to the report, both agencies are in the process of 

improving training for program staff, including by hiring additional training 

specialists. 

a. Have those training specialists begun employment yet? 

b. What will the role of those specialists be? How specifically will they help 

staff find training opportunities or gain technical expertise? 

As of December 2017, CDC was in the process of hiring an additional training specialist and 

was using two detailees from CDC's Office of Public Health Preparedness and Response to 

assist with training until it selects someone, according to officials. Once hired, the training 

specialist will be responsible for leading and coordinating the design and development of 

instructional activities to address the training needs of Federal Select Agent Program staff, 

according to an agency document In addition, in September 2017, CDC awarded a contract to 

further assist the program with training. According to the contract's performance work 

statement, the contractor is responsible for assessing training needs and gaps and developing a 

custom training program for both new and experienced inspectors. 

APHIS hired its first training specialist for its component of the Federal Select Agent Program in 

November 2017, according to APHIS officials. The new training specialist is responsible for 

developing and coordinating training activities to increase the technical abilities of program staff 

and help ensure APHIS inspectors' training needs are met, according to an agency document 

and officials. As we noted in our October 2017 report, APHIS's animal inspection training needs 

have not been explicitly addressed in the past when CDC has taken the lead on training. 

However, both agencies agreed with our recommendation to develop a joint workforce plan that 

1

GAO, High-Containment Laboratories: Coordinated Actions Needed to Enhance the Select Agent Program's 

Oversight of Hazardous Pathogens, GA0-18-145 (Washington, D.C.: Oct. 19, 2017). 
70 


28141.039

assesses workforce and training needs for the program as a whole and are planning to assess 

training needs as part of their joint strategic planning efforts. 

3. GAO's report noted that one way CDC and APHIS work to mitigate the 

organizational conflicts of interest issue is to allow the agency partner to take the 

lead in inspecting their own laboratories. So CDC would take the lead in 

overseeing APHIS's labs in select agent inspections and vice versa. 

a. Please explain in greater detail what it means to allow the partner agency to 

"take the lead" in those inspections. 

b. How could those inspections be truly effective, if CDC's area of expertise is 

overseeing federal select agents that pose a severe threat to human health, 

while APHIS's area is federal select agents that pose a severe threat to 

animal health? How could each of the agencies be qualified to inspect labs 

handling select agents that are not in their area of expertise? 

When one of the agencies from the Federal Select Agent Program takes the lead on an 

inspection, that agency is responsible for coordinating all inspection activities and writing the 

inspection report. For example, the lead agency is responsible for organizing the inspection 

before it takes place, such as determining the number of inspectors needed and notifying the 

laboratory of the inspection. During the inspection, the lead agency leads the opening and 

closing meetings with the inspected laboratory while the joint inspection team, composed of 

both CDC and APHIS inspectors, works together to conduct the inspection. Following the 

inspection, the lead agency drafts the inspection report and is the point of contact for the 

laboratory to submit any responses related to the report. Regardless of the lead agency, CDC 

generally conducts the legal reviews of joint inspection reports because of staffing constraints at 

APHIS, according to program officials. 

To ensure the Federal Select Agent Program has the appropriate expertise to conduct effective 

inspections, CDC inspectors participate in inspections of CDC-owned laboratories to provide 

expertise in human pathogens, and APHIS inspectors participate in inspections of APHISowned laboratories to provide expertise in animal and plant pathogens. In addition, CDC and 

APHIS conduct many joint inspections of laboratories that work with select agents that affect 

both humans and animals, thus facilitating collaboration and enhancing expertise. However, as 

we reported, the Federal Select Agent Program has not formally assessed all potential risks 

posed by its current structure, including potential conflicts of interest arising from the need to 

draw on the expertise of inspectors from the agencies that own the laboratories. Nor has it 

assessed the effectiveness of mechanisms it uses to address those risks, including having 

APHIS lead inspections of CDC-owned laboratories and CDC lead inspections of APHIS-owned 

laboratories. We recommended that CDC and APHIS regularly assess such risks and the 

effectiveness of its mechanisms to address them and take actions as necessary to ensure any 

identified risks are addressed. Both agencies agreed with our recommendation and are 

exploring options to ensure potential risks are assessed and addressed. 
71 


28141.040

GREG WALDEN, OREGON 

CHAIRMAN 

Dr. Samuel S. Edwin 

Director 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

ONE HUNDRED FIFTEENTH CONGRESS 

<!Congrc})}) of tbc mnttcb ~tate}) 

~ouse of l\epresentattbes 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLOING 

WASHINGTON, DC 20515-6115 Majority {202) 225--2927 

Minority (202) 225--3641 

December 5, 2017 

Division of Select Agents and Toxins 

Centers for Disease Control and Prevention 

1600 Clifton Road 

Atlanta, GA 30329 

Dear Dr. Edwin: 

Thank you for appearing before the Subcommittee on Oversight and Investigations on Thursday, 

November 2, 2017, to testifY at the hearing entitled "Concems Over Federal Select Agent Program 

Oversight of Dangerous Pathogens." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (1) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on Friday, December J 5, 2017. Your responses should be 

mailed to Ali Fulling, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House 

Office Building, Washington, DC 20515 and e-mailed in Word fonnat to AILFulling@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

Sincerely, 

~i!~ Chainnan 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachment 
72 


28141.041

Responses to Questions for the Record 

Dr. Samuel Edwin, Centers for Disease Control and Prevention 

Energy and Commerce Committee's Subcommittee on Oversight and Investigations bearing 

entitled "Concerns Over Federal Select Agent Program Oversight of Dangerous Pathogens" 

(November 2, 2017) 

The Honorable Morgan Griffith 

1. How does the CDC Division of Select Agents and Toxins (DSAT) determine whether the 

Select Agent Program inspections DSA T conducts are effective in improving biosecurity 

and biosafety at high-containment laboratories? 

DSA T co-directs the Federal Select Agent Program (FSAP) along with its colleagues at the 

Agriculture Select Agent Services located within U.S. Department of Agriculture (USDA). 

FSAP is charged with administering the FSAP, including inspecting entities' compliance with 

select agent regulations to ensure they have appropriate measures in place to deter the 

unauthorized access, theft, loss, or release of biological select agents and toxins (BSAT). 

FSAP is committed to maximizing the effectiveness of the inspection process in improving 

biosafety and biosecurity at high-containment laboratories that handle select agents and toxins. 

Toward that end, the program is engaged in ongoing efforts to further strengthen the inspection 

process, including: 

Regularly scheduled inspector training opportunities, occurring monthly or more 

frequently depending on the topic covered. Topics for these sessions include natural 

disaster response, facility reviews, facility security, and biosafety issues of interest. FSAP 

also organizes annual inspector trainings for both DSAT and AgSAS inspectors 

Sending staff to a multi-day in-person training course on Biosafety Level (BSL) -3 safety 

training and expanded opportunities for intensive BSL-4 training. 

Development of a joint DSAT (public health) and AgSAS (agriculture) strategic plan that 

includes assessment of workforce and training needs for staff across the program. 

Implementing practices to emphasize activities and conditions likely to pose the greatest 

risk. 

FSAP has developed program measures to track and evaluate aspects of our effectiveness 

regarding oversight, including: 

Frequency of inspections (e.g., making sure we conduct inspections on time, according to 

program goals, such as conducting a renewal inspection every three years) 

• Timeliness of inspection reports (e.g., evaluating how quickly we are able to provide 

important inspection findings back to the entities so that they can take any key actions 

needed) 

Departures from the regulations identified during inspections are used to correct practices and 

procedures at the entity to ensure that the safety and security is commensurate with the risk of the 

work being conducted with select agents and toxins at the facility, the adequacy of mitigation 

measures in place, and the frequency and type of future inspections at an entity. 

Additionally, we work to ensure expedited completion of any necessary follow-up or actions 

needed to mitigate the situation, for entities engaged in high-risk activities or any incident 

involving a select agent or toxin. 

1 
73 


28141.042

To further improve the effectiveness of the inspection process, FSAP recently developed a new 

information management system that, over time, will allow FSAP staff to perform data analytics 

and trend analysis on inspection findings. This, along with the implementation of a departure 

severity matrix, will allow tracking over time of both the number and seriousness of deficiencies 

for individual entities and across the regulated community. We will be examining trends and 

associations between inspection findings and risk in order to better understand and anticipate 

actions most strongly and most often associated with poor outcomes; ultimately we will use this 

information to improve biosafety and biosecurity practices across regulated entities and improve 

the inspection process. 

Facility inspections are just one aspect of FSAP oversight of laboratories. The program provides 

consistent and ongoing engagement with regulated entities before, during, and after inspections. 

FSAP works with laboratories on multiple fronts (e.g., through the entity registration process, and 

providing technical assistance and guidance to registered entities to promote laboratory safety and 

security), including quickly addressing and responding to emerging issues. Another aspect of 

FSAP's oversight role is to authorize individuals to work with select agents and toxins following 

a security risk assessment performed by the Federal Bureau oflnvestigation. The assessment is 

to determine whether an entity or an individual who wishes to register to possess, use or transfer a 

select agent or toxin, or an individual who has been identified by a registered entity as having a 

legitimate need to access a select agent or toxin, meets one of the statutory restrictors which 

would either prohibit registration or restrict access, respectively. FSAP shares many of its 

activities and measures regularly with the public (such as through the publication of the 2016 

DSAT Inspection Report Processing Annual Summarv and the 2016 Annual Report of the 

Federal Select Agent Program). FSAP Directors also regularly attend and present at various 

meetings and interact with laboratory leadership. 

2. Should theft-loss-release reports be used to measure the performance of the Federal Select 

Agent Program? 

No, we suggest that the theft, loss, and release reports not be used to measure FSAP's 

performance. Use of theft-loss-release reports to measure performance of the FSAP program 

could undercut one of the primary uses of these reports. We encourage laboratories working with 

select agents and toxins to report all incidents involving select agents and toxins- even ones that 

may not meet the legal criteria to require reporting- to increase the amount of information 

available for analysis, which in turn will improve our ability to take or recommend actions to 

protect laboratory personnel, staff and the community. Anything that discourages entities from 

submitting reports - such as using them as performance measures in ways that could penalize the 

entities making them - will hamper our ability to analyze potentially hazardous situations and 

recommend improvements. Laboratory research on biological select agents and toxins is an 

important part of our nation's contribution to support preparedness and defense against naturally 

occurring diseases and potential bioterrorism events. However, the nature of scientific laboratory 

work with these materials means that some risk is always present. Our goal is to reduce risk to the 

maximum extent possible. 

FSAP views reports on releases and losses as a good oversight tool. These reports assist us with 

gauging what is occurring at the entity, identifying common causes of safety and security lapses, 

and providing recommendations to entities to minimize risk and keep these situations from 

happening in the future. 

However, the theft, loss, and release reports are not a good measure of the performance of the 

FSAP as a whole. Many reports oflosses and releases are due to human error rather than 

2 
74 


28141.043

institutional or system failure, which no amount of regulation or oversight can totally prevent. 

FSAP' s role is to ensure that if such an event happens, the entity has plans and training in place to 

mitigate the impact of the event (e.g., minimize harm to lab workers and prevent the spread of the 

agent or toxin outside the facility), and to eliminate or reduce the likelihood of recurrence. 

3. The Select Agent Program has a mandate to protect biosecurity (i.e., prevent bad actors 

from possessing or accessing select agents). Should the Select Agent Program also have a 

mandate to protect biosafcty (i.e., protect the safety of the research scientist in the lab)? 

We believe that the Federal Select Agent Program does have such a mandate. Section 35!A of 

the Public Health Service Act provides that the HHS Secretary shall by regulation provide for !he 

establishment and enforcement of safety procedures for the possession, use, and transfer of select 

agents and toxins, including measures to ensure the proper training and appropriate skills to 

handle such agents and toxins, and the proper laboratory facilities to contain and dispose of such 

agents and toxins. The Secretary of Agriculture has a parallel mandate in the Agricultural 

Bioterrorism Protection Act of2002. 

The select agents and toxins biosafcty regulations for the Department of Health and Human 

Services can be found in section 73.12 of Title 42, Code of Federal Regulations, and those for the 

Department of Agriculture can be found in section 331.12 of Title 7 and section 12Ll2 of Title 9, 

Code of Federal Regulations. These provisions require that a biosafety plan be written that is 

commensurate with the risk of the select agent or toxin, given its intended use. These provisions 

emphasize safe work practices, appropriate containment equipment, well-designed facilities, and 

administrative controls based on the work with BSAT to minimize risks of unintentional infection 

of laboratory workers and to prevent possible release of select agents or toxins to the outside 

environment. 

Both biosafety and security are absolutely critical, requiring dedicated attention on the part of 

both inspectors and those working with these materials to ensure that this work remains as safe 

and secure as possible. 

4. Both CDC and APHIS have noted the benefits to the Select Agent Program's current 

structure, including access to experts and other support from your respective divisions. For 

example, according to the GAO report (p.IS) select agent program inspectors sometimes 

obtain technical assistance from experts in CDC and APHIS, such as in cases where the 

inspectors are not familiar with certain techniques or equipment being used in a registered 

laboratory. Are any of these experts registered with the select agent program, or are they 

otherwise subject to select agent program regulation and oversight? 

Yes. Some of the subject matter experts (SMEs) that provide technical assistance on specific 

agents are employed by an entity registered with FSAP and are subject to select agent regulations 

and oversight. When SMEs from the regulated entities are consulted, FSAP obtains assistance 

regarding technical issues associated with the select agents or toxins themselves or the systems 

and procedures used to work with them, not guidance on the regulatory treatment or oversight of 

these agents or toxins. In terms of regulatory compliance, FSAP inspectors have the practical 

experience and advanced professional degrees (e.g., microbiology and veterinary medicine) 

necessary to perform reviews of select agent laboratories. FSAP training includes all aspects to 

assess the entity's compliance with the Si(lect agent regulations (e.g., security and biosafety 

training). FSAP training initiatives also include sending staff to a multi-day in-person training 

3 
75 


28141.044

course on Biosafety Level (BSL) -3 safety training and expanded opportunities for intensive 

BSL-4 training. 

However, given the complexity and high risk inherent in this work and the evolving scientific 

research and expertise that is required, FSAP must sometimes rely on technical scientific 

information provided by subject matter experts outside of the regulatory program, including from 

researchers that are themselves doing some of the leading work in the area of select agents and/or 

toxins. FSAP also consults with outside subject matter experts when needed, through venues such 

as the CDC's lntragovernmental Select Agents and Toxins Technical Advisory Committee. This 

advisory committee provides recommendations and guidance to FSAP, although any 

recommendations to change to the regulations are made by the FSAP Directors, and must be 

approved by the Secretary of Health and Human Services or the Administrator of USDA's 

Animal and Plant Health Inspection Service, as appropriate. 

The Honorable Buddy Carter 

1. In January and March .2017, HHS and USDA issued updated select agent regulations and 

guidance that included clear definitions of inactivation and a validated inactivation 

procedure that are consistent across the Federal Select Agent Program. Moreover, NIH and 

CDC stated that it plans to include a new appendix in the revised Biosafety in 

Microbiological and Biomedical Laboratories manual that specifically addresses the 

development, validation, and implementation of inactivation protocols, which they 

anticipate releasing in 2 to 3 years. 

a. Why is it going to take you three years to issue the revised Biosafety in 

Microbiological and Biomedical Laboratories manual? 

Since 1984, CDC and the National Institutes of Health (NIH) have partnered to co-author 

the Biosafety in Microbiological and Biomedical Laboratories (BMBL), a comprehensive 

guide on biosafety practices and policies for laboratories working with pathogens. The 

BMBL provides the foundational guidance used in laboratories across the U.S. Currently 

in its fifth edition, CDC and NIH are revising the more than 400 page guide with up-todate information on current best practices and the newest technologies for biosafety. 

Given the wider laboratory community's reliance on the BMBL and the level of detail 

provided by the guide, preparing a new edition of the BMBL is a major undertaking. 

The 5th edition was issued in December 2009, more than I 0 years after the 4th edition 

(April 1999). For the fifth edition, CDC and NIH reached out to more than 200 scientific 

and biosafety experts to ensure that the BMBL captures the best available guidance and 

evidence, and the agencies are engaged in a similarly comprehensive and exhaustive 

process for the sixth edition. The process of gathering this input, reviewing available 

evidence, and developing reliable new guidance is time consuming. CDC and NIH are 

deep into the process for writing the sixth edition and expect to publish the updated 

guidance in 20 I 9. 

b. Can you guarantee this committee that the guidance and training you have today is 

sufficient to prevent any future failed deactivations of pathogens? 

On January 19, 2017, FSAP published the Final Rule "Possession, Use, and Transfer of 

Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and 

4 
76 


28141.045

Enhanced Biosafety Requirements" that added specific regulatory requirements that must 

be followed for the inactivation of select agents. In conjunction with the publication of 

the Final Rule, FSAP also published guidance to help entities implement these 

provisions, the "Guidance on the Inactivation or Removal of Select Agents and Toxins 

for Future Use." The guidance is available at https://www.selectagents.gov/irgchanges.html. In addition, FSAP has provided guidance through its outreach to the 

regulated community including the most recent training workshop for Responsible 

Officials held during the week November 27. While this work does not come without 

risk, the efforts of FSAP continue to focus on helping to minimize this risk, and therefore 

ensure that this important research can be conducted in a way that is as safe and secure as 

possible. 

5 
77 


28141.046

GREG WALDEN, OREGON 

CHAIRMAN 

Dr. Freeda E. Isaac 

Director 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

ONE HUNDRED FIFTEENTH CONGnt:;:,;:, 

(!Congress of tbe Wniteb ~tates 

r!}oUl~e of l\epresentatibes 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 Majority \202)225-2927 

Minority \202) 225-3641 

December 5, 2017 

Agriculture Select Agent Services 

Animal and Plant Health Inspection Service 

14 700 River Road 

Riverdale, MD 20737 

Dear Dr. Isaac: 

Thank you for appearing before the Subcommittee on Oversight and Investigations on Thursday, 

November 2, 2017, to testify at the hearing entitled "Concems Over Federal Select Agent Program 

Oversight of Dangerous Pathogens." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (l) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on Friday, December 15, 2017. Your responses should be 

mailed to Ali Fulling, Legislative Clerk, Committee on Energy and Commerce, 2125 Raybum House 

Office Building, Washington, DC 20515 and e-mailed in Word format to Ali.Ftl!li.ng@mail.hous£,gQ_\::. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

Sincerely, 

~~ Chairman 

cc: The Honorable Diana DeGette, Ranking Member, Subcommittee on Oversight and Investigations 

Attachment 
78 


28141.047

USDA APHIS Questions for the Record 

House Committee on Energy and Commerce 

Hearing on "Concerns Over Federal Select Agent Program Oversight of Dangerous 

Pathogens" 

November 2, 2017 

Dr. Freeda Isaac 

The Honorable Morgan Griffith 

1. How does the USDA Animal and Plant Health Inspection Service determine whether the 

Select Agent Program inspections APHIS conducts are improving biosecurity and biosafety 

at high-containment laboratories. 

The inspections that APHIS conducts as part of the select agent program are intended to improve 

biosecurity and biosafety of high-containment laboratories by focusing on the highest risk 

activities and mitigations, and through inspections tailored to the baseline risk assessments for 

each registered entity. APHIS is confident that these inspection procedures ensure that regulated 

entities are properly securing and using these potentially damaging agents and toxins. 

Nevertheless, APHIS is constantly looking for improvements, and the Agency believes that its 

new select agent database will yield additional data and information that it can use to improve its 

oversight of select agents and toxins to strengthen biosecurity and biosafety. 

2. Should theft-loss-release reports be used to measure the performance of the Federal 

Select Agent Program? 

No, APHIS does not believe that these reports are an appropriate metric for the program. The 

joint APHIS/CDC forms, Report of Theft, Loss or Release of Select Agents and Toxins, are 

submitted to APHIS or CDC by both registered and non-registered entities upon discovery of a 

theft (unauthorized removal of select agent or toxin), loss (failure to account for select agent or 

toxin), or release (occupational exposure or release of an agent or toxin outside of the primary 

barriers of the biocontainment area) of a select agent or toxin. These reports are an essential 

oversight tool that provides important information about what registered entities are doing and to 

help the program identify any potential weaknesses. If these reports were used as a direct 

performance metric, it could disincentive self-reporting by regulated entities and give the 

program less information. 

3. The Select Agent Program has a mandate to protect biosecurity (i.e., prevent bad actors 

from possessing or accessing select agents). Should the Select Agent Program also have a 

mandate to protect biosafety (i.e., protect the safety of the research scientists in the lab)? 

Biosafety has always been a key component of the select agent program. The Public Health 

Security and Bioterrorism Preparedness and Response Act of2002 (P.L. 107-188) includes a 

mandate for biosafety. The select agent regulations have incorporated biosafety since the 

program was created, and FSAP adds biosafety regulations (including most recently in 2017) 

when necessary to further protect laboratory workers and researchers. 
79 

Æ 


28141.048

4. Both CDC and APHIS have noted the benefits to the Select Agent Program's current 

structure, including access to experts and other support from your respective divisions. For 

example, according to the GAO report (p. 15) select agent program inspectors sometimes 

obtain technical assistance from experts in CDC and APHIS, such as in cases where the 

inspectors are not familiar with certain techniques or equipment being used in a registered 

laboratory. Are any of those experts registered with the select agent program, or are they 

otherwise subject to select agent program regulation and oversight? 

The technical experts on which the select agent program relies are not necessarily registered with 

the program. The select agent program selects technical experts based on their academic 

expertise, training, or previous experience working with select agents and toxins; only those who 

are actively possessing, using, or transferring select agents or toxins are subject to our 

regulations. In instances where the program requests the technical assistance of experts regulated 

by the program, the program uses venues such as the Intra-governmental Select Agents and 

Toxins Technical Advisory Committee to manage the input and provide a comprehensive 

recommendation, which alleviates individual conflicts of interest between the regulatory 

authority and regulated personnel.