[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]


                   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
                           
                           
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                    COMMITTEE ON ENERGY AND COMMERCE

                          GREG WALDEN, Oregon
                                 Chairman
JOE BARTON, Texas                    FRANK PALLONE, Jr., New Jersey
  Vice Chairman                        Ranking Member
FRED UPTON, Michigan                 BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
MICHAEL C. BURGESS, Texas            ELIOT L. ENGEL, New York
MARSHA BLACKBURN, Tennessee          GENE GREEN, Texas
STEVE SCALISE, Louisiana             DIANA DeGETTE, Colorado
ROBERT E. LATTA, Ohio                MICHAEL F. DOYLE, Pennsylvania
CATHY McMORRIS RODGERS, Washington   JANICE D. SCHAKOWSKY, Illinois
GREGG HARPER, Mississippi            G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey            DORIS O. MATSUI, California
BRETT GUTHRIE, Kentucky              KATHY CASTOR, Florida
PETE OLSON, Texas                    JOHN P. SARBANES, Maryland
DAVID B. McKINLEY, West Virginia     JERRY McNERNEY, California
ADAM KINZINGER, Illinois             PETER WELCH, Vermont
H. MORGAN GRIFFITH, Virginia         BEN RAY LUJAN, New Mexico
GUS M. BILIRAKIS, Florida            PAUL TONKO, New York
BILL JOHNSON, Ohio                   YVETTE D. CLARKE, New York
BILLY LONG, Missouri                 DAVID LOEBSACK, Iowa
LARRY BUCSHON, Indiana               KURT SCHRADER, Oregon
BILL FLORES, Texas                   JOSEPH P. KENNEDY, III, 
SUSAN W. BROOKS, Indiana                 Massachusetts
MARKWAYNE MULLIN, Oklahoma           TONY CARDENAS, California
RICHARD HUDSON, North Carolina       RAUL RUIZ, California
CHRIS COLLINS, New York              SCOTT H. PETERS, California
KEVIN CRAMER, North Dakota           DEBBIE DINGELL, Michigan
TIM WALBERG, Michigan
MIMI WALTERS, California
RYAN A. COSTELLO, Pennsylvania
EARL L. ``BUDDY'' CARTER, Georgia
JEFF DUNCAN, South Carolina

              Subcommittee on Oversight and Investigations

                                VACANCY
                                 Chairman
H. MORGAN GRIFFITH, Virginia         DIANA DeGETTE, Colorado
  Vice Chairman                        Ranking Member
JOE BARTON, Texas                    JANICE D. SCHAKOWSKY, Illinois
MICHAEL C. BURGESS, Texas            KATHY CASTOR, Florida
SUSAN W. BROOKS, Indiana             PAUL TONKO, New York
CHRIS COLLINS, New York              YVETTE D. CLARKE, New York
TIM WALBERG, Michigan                RAUL RUIZ, California
MIMI WALTERS, California             SCOTT H. PETERS, California
RYAN A. COSTELLO, Pennsylvania       FRANK PALLONE, Jr., New Jersey (ex 
EARL L. ``BUDDY'' CARTER, Georgia        officio)
GREG WALDEN, Oregon (ex officio)
  
                             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

 
   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, 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 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 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 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.
    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 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.
    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 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 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.
    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 re-examine 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.
    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 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:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    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 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:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    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.
    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:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    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?
    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 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 both entities are inspecting their own labs, 
they have to have inspectors 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?
    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.
    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 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.
    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 expertise 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.
    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?
    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.
    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?
    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----
    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?
    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.
    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.
    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.]
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