[House Hearing, 118 Congress]
[From the U.S. Government Publishing Office]
THE BIOSAFETY OF RISKY RESEARCH: EXAMINING
IF SCIENCE IS OUTPACING POLICY AND SAFETY
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND
INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTEENTH CONGRESS
FIRST SESSION
__________
APRIL 27, 2023
__________
Serial No. 118-30
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Published for the use of the Committee on Energy and Commerce
govinfo.gov/committee/house-energy
energycommerce.house.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
55-663 PDF WASHINGTON : 2025
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COMMITTEE ON ENERGY AND COMMERCE
CATHY McMORRIS RODGERS, Washington
Chair
MICHAEL C. BURGESS, Texas FRANK PALLONE, Jr., New Jersey
ROBERT E. LATTA, Ohio Ranking Member
BRETT GUTHRIE, Kentucky ANNA G. ESHOO, California
H. MORGAN GRIFFITH, Virginia DIANA DeGETTE, Colorado
GUS M. BILIRAKIS, Florida JAN SCHAKOWSKY, Illinois
BILL JOHNSON, Ohio DORIS O. MATSUI, California
LARRY BUCSHON, Indiana KATHY CASTOR, Florida
RICHARD HUDSON, North Carolina JOHN P. SARBANES, Maryland
TIM WALBERG, Michigan PAUL TONKO, New York
EARL L. ``BUDDY'' CARTER, Georgia YVETTE D. CLARKE, New York
JEFF DUNCAN, South Carolina TONY CARDENAS, California
GARY J. PALMER, Alabama RAUL RUIZ, California
NEAL P. DUNN, Florida SCOTT H. PETERS, California
JOHN R. CURTIS, Utah DEBBIE DINGELL, Michigan
DEBBBIE LESKO, Arizona MARC A. VEASEY, Texas
GREG PENCE, Indiana ANN M. KUSTER, New Hampshire
DAN CRENSHAW, Texas ROBIN L. KELLY, Illinois
JOHN JOYCE, Pennsylvania NANETTE DIAZ BARRAGAN, California
KELLY ARMSTRONG, North Dakota, Vice LISA BLUNT ROCHESTER, Delaware
Chair DARREN SOTO, Florida
RANDY K. WEBER, Sr., Texas ANGIE CRAIG, Minnesota
RICK W. ALLEN, Georgia KIM SCHRIER, Washington
TROY BALDERSON, Ohio LORI TRAHAN, Massachusetts
RUSS FULCHER, Idaho LIZZIE FLETCHER, Texas
AUGUST PFLUGER, Texas
DIANA HARSHBARGER, Tennessee
MARIANNETTE MILLER-MEEKS, Iowa
KAT CAMMACK, Florida
JAY OBERNOLTE, California
------
Professional Staff
NATE HODSON, Staff Director
SARAH BURKE, Deputy Staff Director
TIFFANY GUARASCIO, Minority Staff Director
Subcommittee on Oversight and Investigations
H. MORGAN GRIFFITH, Virginia
Chairman
MICHAEL C. BURGESS, Texas KATHY CASTOR, Florida
BRETT GUTHRIE, Kentucky Ranking Member
JEFF DUNCAN, South Carolina DIANA DeGETTE, Colorado
GARY J. PALMER, Alabama JAN SCHAKOWSKY, Illinois
DEBBIE LESKO, Arizona, Vice Chair PAUL TONKO, New York
DAN CRENSHAW, Texas RAUL RUIZ, California
KELLY ARMSTRONG, North Dakota SCOTT H. PETERS, California
KAT CAMMACK, Florida FRANK PALLONE, Jr., New Jersey (ex
CATHY McMORRIS RODGERS, Washington officio)
(ex officio)
C O N T E N T S
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Page
Hon. H. Morgan Griffith, a Representative in Congress from the
Commonwealth of Virginia, opening statement.................... 1
Prepared statement........................................... 4
Hon. Kathy Castor, a Representative in Congress from the State of
Florida, opening statement..................................... 10
Prepared statement........................................... 12
Hon. Cathy McMorris Rodgers, a Representative in Congress from
the State of Washington, opening statement..................... 14
Prepared statement........................................... 16
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 19
Prepared statement........................................... 21
Witnesses
Rocco Casagrande, Ph.D., Board Chair, Gryphon Scientific......... 24
Prepared statement........................................... 27
Answers to submitted questions............................... 99
Gregory D. Koblentz, Ph.D., Associate Professor and Director,
Biodefense Graduate Programs, George Mason University.......... 32
Prepared statement........................................... 35
Answers to submitted questions............................... 102
Andy Pekosz, Ph.D., Professor of Molecular Microbiology and
Immunology, Johns Hopkins University Bloomberg School of Public
Health......................................................... 59
Prepared statement........................................... 61
Answers to submitted questions............................... 108
Robert J. Hawley, Ph.D., Consultant, Biological Safety and
Security....................................................... 67
Prepared statement........................................... 69
Submitted Material
Inclusion of the following was approved by unanimous consent.
Letter of April 26, 2023, from Melanie Anne Egorin, Assistant
Secretary for Legislation, Department of Health and Human
Services, to Mrs. Rodgers...................................... 95
THE BIOSAFETY OF RISKY RESEARCH: EXAMINING IF SCIENCE IS OUTPACING
POLICY AND SAFETY
----------
THURSDAY, APRIL 27, 2023
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 2:29 p.m. in
room 2322, Rayburn House Office Building, Hon. H. Morgan
Griffith (chairman of the subcommittee) presiding.
Members present: Representatives Griffith, Burgess,
Guthrie, Duncan, Palmer, Lesko, Cammack, Rodgers (ex officio),
Castor (subcommittee ranking member), DeGette, Tonko, Ruiz, and
Pallone (ex officio).
Staff present: Sean Brebbia, Chief Counsel, Oversight and
Investigations; Lauren Eriksen, Clerk, Oversight and
Investigations; Peter Kielty, General Counsel; Emily King,
Member Services Director; Chris Krepich, Press Secretary; Alan
Slobodin, Chief Investigative Counsel, Oversight and
Investigations; John Strom, Counsel, Oversight and
Investigations; Austin Flack, Minority Junior Professional
Staff Member; Waverly Gordon, Minority Deputy Staff Director
and General Counsel; Liz Johns, Minority GAO Detailee; Will
McAuliffe, Minority Chief Counsel, Oversight and
Investigations; Christina Parisi, Minority Professional Staff
Member; Greg Pugh, Minority Staff Assistant; Harry Samuels,
Minority Oversight Counsel; and Caroline Wood, Minority
Research Analyst.
Mr. Griffith. The Subcommittee on Oversight and
Investigations will now come to order, and the Chair recognizes
himself for a 5-minute opening statement.
OPENING STATEMENT OF HON. H. MORGAN GRIFFITH, A REPRESENTATIVE
IN CONGRESS FROM THE COMMONWEALTH OF VIRGINIA
Good afternoon. Welcome to today's hearing. The
subcommittee previously held a hearing on how quickly--how to
quickly identify the root cause of a disease outbreak. Today's
hearing will examine biosafety practices at high-containment
laboratories handling dangerous pathogens. We will focus on
addressing whether advancements in biotech have outpaced our
existing biosafety guidelines, and whether or not we are
following those guidelines.
The NIH clearly did not enforce those guidelines with
research being done for it by EcoHealth Alliance and the Wuhan
Institute of Virology into novel coronaviruses. Our examination
of biosafety has to be informed by the real possibility that a
pandemic which killed over 1 million Americans was the result
of an incident at a laboratory that received NIH funding.
As I have said at past hearings, I believe the available
evidence favors COVID-19 emerging due to a lab-related
incident. My belief that COVID-19 came from a lab leak is now
shared by the Department of Energy and the FBI. But regardless
of our individual opinions as to the origins of COVID-19, we in
Congress have a responsibility to understand the potential
benefits and perils of this type of research. As the committee
with authorizing jurisdiction over Federal biomedical research,
all of us here today have a special responsibility to grapple
with these issues.
High-containment biosafety labs are expensive and complex
to build, maintain, and run. Research conducted in these
laboratories involves pathogens that can cause serious,
potentially life-threatening diseases--and in the case of
biosafety level 4, BSL-4, laboratories, diseases which--for
which no vaccine or therapy exists.
It is crazy to me that the Wuhan Institute of Virology
appears to have conducted at least some high-risk coronavirus
research at a biosafety level 2 lab, and did so with U.S.
dollars. In 2000 there were less than 10 BSL-4 labs in the
world. There are now 59 in operation, under construction, or
planned. In the United States alone, there are over 1,500
biosafety level 3 facilities.
Rapid advances in biotechnology have opened up potential
new cures and expanded our scientific knowledge. But this has
also led to the proliferation of new technologies and research
techniques that are inherently dual-use and potentially
dangerous if done in inappropriate biosafety conditions.
Balancing safety with innovation is an enduring challenge.
Our existing oversight framework for risky research isn't
working. Whether we call it gain of function research or
whether it is called research with enhanced potential pandemic
pathogens, I fear we have not kept pace. The United States
doesn't have a comprehensive regulatory system for high-
containment laboratories. Practically speaking, the research
institutions, companies, and universities that operate these
facilities police themselves.
Back in 2017, the White House's Office of Science and
Technology Policy issued guidance, the Potential Pandemic
Pathogen Care and Oversight Framework, but it was intended to
apply to all Executive agencies. However, it has only been
implemented by one department, Health and Human Services. And
HHS has largely delegated implementation to the NIH, a funding
entity who has shown a lack of significant oversight towards
riskier research with their grantee, EcoHealth Alliance, and
subgrantee, Wuhan Institute of Virology.
As the debacle with EcoHealth Alliance and the Wuhan
Institute of Virology makes clear, NIH is neither inclined nor
equipped to exercise oversight of the risky research it funds
within the United States or abroad. NIH is not only indifferent
but reflexively hostile to outside oversight. NIH has
stonewalled and slow-walked our document requests related to
EcoHealth Alliance grants.
Further, how many accidents at high-containment labs go
unreported? There does not appear to be a governmentwide effort
to understand the frequency and nature of laboratory accidents.
Since last October, NIH has not provided key information about
an in-house National Institute of Allergy and Infectious
Disease gain-of-function experiment involving a highly lethal
clade of monkeypox. NIH won't even tell us about its
deliberations about this experiment. It makes me wonder what
the NIH has to hide. How bad is it, when they won't even engage
with the authorizing committee about this information? We have
to assume there is something they don't want us to know about.
Perhaps something very, very dangerous.
I will conclude my opening remarks by noting that the
highest-ranking NIH official, Dr. Larry Tabak, appeared before
this committee in February in response to questions about NIH's
failure to enforce biosafety measures it placed on coronavirus
research it funded at the Wuhan Institute of Virology. Dr.
Tabak testified the NIH is not an enforcement agency. I am
beginning to think he is right.
It may be time for us in Congress to relieve the NIH of the
burden of conducting risky research at institutions that it
funds.
[The prepared statement of Mr. Griffith follows:]
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Mr. Griffith. I yield back. I now recognize the ranking
member of this subcommittee, Ms. Castor, for her 5 minutes for
an opening statement.
OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF FLORIDA
Ms. Castor. Well, thank you, Mr. Chairman, and thank you to
the witnesses for being here today.
There are two important complementary priorities that I
look forward to discussing with our witnesses today. The first
is to make sure that we are advancing science and research so
that we can better protect Americans from disease, achieve
scientific breakthroughs, and continue to lead the world in
innovation and discovery. The second is to ensure that the
safety standards governing our Nation's research continue to
protect the public and the scientists and researchers involved.
Extensive oversight and safety requirements already exist in
our research centers today, and I hope that our witnesses can
help us better understand that and how we can continue to
modernize.
Americans can be proud of the U.S.-led research in
laboratories in the United States and across the world,
including with infectious diseases and pathogens. When the
COVID-19 pandemic hit, we relied on this research to spur
vaccine development in record time. And each year, researchers
across the globe collaborate to study seasonal influenza so
that we can better develop vaccines to protect the public based
on real-time data in other nations. And when more infectious
flu variants like the avian flu emerge, we depend on our
researchers to go into high-containment labs to study ways to
prevent death and disease.
And as we will discuss at tomorrow's hearing, viral
research is critical to helping us prepare for and address the
emerging threat of antimicrobial resistance. Because this
research is so important, Congress should support thoughtful,
constructive steps to ensure that it is being conducted safely.
We must remain the gold standard of biosafety standards
internationally and continue to improve and modernize. I hope
to have a constructive discussion about those potential
improvements in this committee and ensure that any new policies
we consider include input from key stakeholders in the research
community.
Some of my colleagues on the other side of the aisle have
floated broad bans on international collaboration without
considering what that would mean for flu surveillance, for
vaccine development, or monitoring viruses. Many of these
proposed research restrictions and criticisms target research
in other countries, including some countries where viral
outbreaks have originated in the past.
But disease knows no borders. Since I have come to Congress
we have had to address global outbreaks of MERS, Zika, Ebola,
and, of course, COVID-19 and its changing variants. These
viruses are threats to everyone, and it is critical that our
scientists can partner with public health experts to identify
and stop potential pandemics. The administration's National
Biodefense Strategy recognizes the need for America to
galvanize support for multinational biosafety commitments so
that research in foreign countries can be done safely and up to
the high--the same high standards that we use in our labs at
home.
I also sit on the Select Committee on the Strategic
Competition between the United States and the Chinese Communist
Party, where we are focused on the threat posed by the CCP and
on a plan of action to defend the American people, our economy,
and our values. I can tell you that, if America does not lead
the world in infectious disease research, the CCP will try to
fill that role. If we don't continue to engage and collaborate
with the international research community, advise where
appropriate on development of labs, and export our best
practices and training on lab safety, the CCP will fill that
void, for sure. And if they do, we will have little
transparency into what work is being done and how.
Overbroad funding bans will not accomplish our goals and
could have detrimental impacts on future medical advancements
and scientific breakthroughs. Any discussion we have must be
done in a thoughtful manner, with the input of people who
actually conduct research on dangerous pathogens every day.
No one has a greater stake in lab safety than researchers
working in American labs. These are the people who do the hard
work to develop groundbreaking proposals, study how viruses
grow and mutate, and make sure we are protected from the next
viral outbreak. I trust that we can support these researchers
by forging a bipartisan path forward on lab safety that doesn't
stifle the research and international collaboration that all
Americans rely on to protect their health and safety.
[The prepared statement of Ms. Castor follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Ms. Castor. So I look forward to our discussion today, and
I yield back.
Mr. Griffith. The gentlelady yields back. Now I recognize
the Chair of the full committee, Mrs. McMorris Rodgers, for her
5 minutes for an opening statement.
OPENING STATEMENT OF HON. CATHY McMORRIS RODGERS, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF WASHINGTON
Mrs. Rodgers. Thank you, Mr. Chairman. With several new
books out this week about lab accidents, a recently released
Senate report with new details pointing to safety problems at
the Wuhan lab and the recent recommendations of an NIH advisory
panel on oversight of risky research, this hearing is timely,
not to mention the terrifying news that fighters in Sudan have
seized the country's National Laboratory for Public Health,
which holds samples of risky and deadly diseases, including
measles, polio, and cholera, which the World Health
Organization has said is a huge biological risk.
This is especially worrisome, considering the CDC has
supported this national lab since 2006, including its biosafety
protocols, lab quality management, and infrastructure and staff
trainings. As recently as 2018, CDC helped to establish the
first viral load monitoring facility at this lab. This is a
very dangerous situation that we must monitor closely.
We still do not know how the COVID-19 pandemic started.
However, more information has heightened our suspicions that
the origin of the pandemic was linked to a lab incident. It
raises the importance of our work to oversee biosafety of risky
research. Unfortunately, in our pursuit of solutions the
conduct of some public health officials and the loss of trust
in our public health institutions hampered our response.
Instead of openness and honest discussion, HHS and NIH have
persisted in foot dragging, stonewalling, or flat-out refusing
to engage in legitimate questions. Today the NIH still won't
provide meaningful information or straight answers to the
committee about how the PC3O framework governing risky research
was developed or who at the NIH was responsible for developing
the framework. An NIH advisory panel earlier this year found
the framework had too many loopholes and too much flexibility
to evade independent review.
We still do not have complete information about NIH experts
in 2016, how they allowed EcoHealth Alliance, through its
subgrantee, the Wuhan Institute of Virology, to proceed with a
research proposal infecting humanized mice with experimental
coronavirus strains. NIH and EcoHealth agreed to go forward
with the experiment on the condition that, if excessive virus
growth occurred, EcoHealth would immediately stop the
experiment and notify the NIH. This condition was incorporated
into the grant terms. The experiment went forward. There was
excessive virus growth, but immediate stoppage and notification
did not occur. This was the conclusion of both the NIH and the
Office of Health and Human Services' inspector general.
Under other circumstances, EcoHealth's failure to stop the
experiment and immediately notify the NIH could be described as
a near-miss safety incident. However, we have no way of knowing
whether it was a lucky break with no incident or a lab
experiment gone wrong. NIH has no way of knowing, because
EcoHealth committed another failure: It did not obtain the
laboratory notebooks and electronic files from Wuhan lab.
Yet even with these compliance failures, NIH continues to
hold EcoHealth to good standing and continues to provide them
even more funding. No changes in policy, no lessons learned, no
consequences, no accountability, no seriousness from the NIH.
No wonder the credibility of the NIH has suffered, even after
spending $1 billion in taxpayer dollars on public relations. We
are going to get to the bottom of that too.
The American people deserve answers and accountability. Dr.
Fauci admitting in The New York Times ``something clearly went
wrong'' is not going to cut it. As we learned today, we have
gaps in biosafety policy and oversight. However, even
addressing these gaps will not be sufficient if the NIH only
pays lip service to biosafety compliance with no real
commitment to implementation. The path forward to restoring
public health is having good-faith, honest discussion.
We need critical research for cures and medical
countermeasures. For years this committee, and especially this
subcommittee, have held oversight hearings about lab accidents
and other mishaps. The risk side still has not been adequately
dealt with. Today's hearing can be a constructive start, and I
thank the witnesses for being here, for your participation, and
especially participating on short notice.
I yield back.
[The prepared statement of Mrs. Rodgers follows:]
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Mr. Griffith. I thank the gentlelady. I now recognize the
ranking member of the full committee, Mr. Pallone, for his 5
minutes for an opening statement.
OPENING STATEMENT OF HON. FRANK PALLONE, Jr., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Chairman. When the coronavirus
pandemic began, many researchers with the training and
experience to examine dangerous viruses put their research on
hold to tackle the pandemic. The lab infrastructure that was in
place and the research community were essential in identifying
the virus, how it worked, and how we could slow its spread and
limit its ability to harm Americans. And the public saw the
benefits of this research in real time, with vaccinations
becoming available at an unprecedented pace.
So we will hear a lot today about the risk of certain kinds
of research, and it is important that we examine those risks.
At the same time, we need to understand the benefits of certain
research in preventing and responding to pandemics, and we also
need to discuss the training and safety measures that are
already in place in high-containment labs to reduce risk.
Thanks to the investments that have been made in research,
the scientific community was able to respond to the COVID-19
pandemic in record time. This included scientists at our public
institutions as well as those in the private sector. It was a
global effort to solve a global problem, and we should take
immense pride to the extent and quality of America's scientific
contributions towards understanding and addressing the COVID-19
pandemic.
And one of the many lessons that we should take away from
the pandemic is that a well-resourced and well-trained
scientific community is essential if we have any hope of
preventing and defeating future pandemics.
Now, studying dangerous pathogens requires carefully
considered protocols and persistent oversight to ensure that
the work is conducted safely. When it comes to risk, it is the
researchers working in high-containment labs, they are the ones
with the most to lose when labs are not adequately maintained
or corners are cut or safety protocols are insufficient. They
are the ones who are literally in the room with dangerous
pathogens so they can study how the pathogens threaten us and
how we can protect ourselves. So we must ensure that scientists
feel free to speak up about any concerns they have that could
help improve lab safety.
But I am very concerned that the tenor of the current
debate on lab safety is having a chilling effect on scientific
research and among the scientists at the forefront of disease
prevention and response. We have seen scientists, including
some of our top public health officials, maligned,
marginalized, taken out of context, and accused of covering up
the origins of COVID-19. And these actions are harmful and
counterproductive, because we must have scientists at the table
if we want to stay world leaders in science and research and if
we want researchers to feel comfortable raising safety
concerns.
So I am pleased we have a witness at the table today who
can help us understand--I should say witnesses at the table
today who can help us understand--what is working well already
and where there may be a need for additional transparency,
consistency, and safety regulation or oversight.
The Biden administration and House Democrats have taken
important steps towards increasing biosafety and biosecurity.
Last year's Consolidated Appropriations Act contained numerous
important provisions to improve biosafety, but no Republican on
this committee that is here today supported that legislation.
And just yesterday the House Republican majority jammed through
their Default on America Act that would strip funding from
important programs that could assist with pandemic preparedness
and biosafety. It also strips COVID-19 treatment and vaccine
development funds and threatens U.S.-based medical
manufacturing. With this legislation, House Republicans, I
believe, are threatening a default crisis that would devastate
everyday Americans.
So I hope today's hearing demonstrates why continuous
investment, rather than misguided funding cuts, is essential to
prevent pandemics and respond swiftly when they occur.
[The prepared statement of Mr. Pallone follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. And with that, Mr. Chairman, I would yield
back.
Mr. Griffith. I thank the gentleman for yielding back. That
concludes Member opening statements.
I would like to remind Members that, pursuant to committee
rules, all Members' opening statements will be made a part of
the record.
We want to thank all of our witnesses for being here today
and taking your time to testify before the subcommittee. Each
witness will have an opportunity to give an opening statement,
followed by a round of questions from the Members.
Our witnesses today are Dr. Rocco Casagrande, executive
chairman of Gryphon--did I say that right--Scientific; Dr.
Robert Hawley, former chief of Safety and Radiation Protection
Division of the U.S. Army Medical Research Institute, Fort
Detrick; Dr. Gregory Koblentz, associate professor and director
of biodefense graduate programs for George Mason University;
Andy Pekosz, professor of molecular microbiology and
immunology, Johns Hopkins University.
We appreciate you being here today, and I look forward to
hearing from you all on this important issue. As you are aware,
the committee is holding an oversight hearing. And when we do
so, we have the practice of taking our testimony under oath. Do
any of you have objections to testifying under oath today?
Seeing no objections, we will proceed. The Chair advises
you are also entitled to be advised by counsel pursuant to
House rules. Do you desire to be advised by counsel during your
testimony today?
Seeing that none have requested counsel, please--if each of
you would, please rise and raise your right hand.
[Witnesses sworn.]
Mr. Griffith. Seeing that all witnesses have responded in
the affirmative, you are now sworn in and under oath, subject
to the penalties set forth in title 18, section 1001 of the
United States Code.
With that, we will now recognize Dr. Rocco Casagrande for 5
minutes to give an opening statement.
But before you begin your opening statement, if you would,
introduce your two high-level staff assistants who have come
with you today. I see them sitting behind you.
Dr. Casagrande. Thank you. My senior advisors are Jack and
Kennedy. I hope that doesn't make my comments too partisan.
[Laughter.]
Mr. Griffith. No, not taken that way at all. But we welcome
your senior advisors to be with us today, and we are glad that
they are here.
If you would now proceed with your 5 minutes of opening
statement, please.
STATEMENTS OF ROCCO CASAGRANDE, Ph.D., BOARD CHAIR, GRYPHON
SCIENTIFIC; GREGORY D. KOBLENTZ, Ph.D., ASSOCIATE PROFESSOR AND
DIRECTOR, BIODEFENSE GRADUATE PROGRAMS, GEORGE MASON
UNIVERSITY; ANDY PEKOSZ, Ph.D., PROFESSOR OF MOLECULAR
MICROBIOLOGY AND IMMUNOLOGY, JOHNS HOPKINS UNIVERSITY BLOOMBERG
SCHOOL OF PUBLIC HEALTH; ROBERT J. HAWLEY, Ph.D, CONSULTANT,
BIOLOGICAL SAFETY AND SECURITY
STATEMENT OF ROCCO CASAGRANDE, Ph.D.
Dr. Casagrande. Thank you, Mr. Chairman. I am honored that
you invited me to speak about such a timely and important topic
as laboratory safety.
Today I am going to advocate for several improvements that
are critically needed to ensure that the laboratories that
study the most deadly and transmissible viruses remain safe.
This research is essential to prevent and respond to pandemics
of the future. However, it is not without risks.
The practice of mitigating such risks is called biosafety.
Historically, biosafety has been perceived as consuming time
and money that would otherwise be spent on critical research.
But I am also going to argue that needed improvements in
biosafety will not stifle or draw away resources but will help
improve the efficiency of the research enterprise if
implemented properly. The critical improvements that I will
talk about today can be grouped into six categories: oversight,
research, standards, workforce, resources, and mission.
Regarding oversight, biosafety authority in the U.S.
derives from a patchwork of regulations, laws, and guidance,
given the pathogen researched or the source of funding.
Currently, some pathogen research is conducted in the U.S.
without any Federal oversight. Theoretically, a privately
funded group could work on influenza virus in a makeshift
laboratory, and attempt to make the strain more deadly or more
transmissible. If they are not using a select agent strain of
flu and they are doing the research for peaceful purposes,
there is no Federal entity that could ensure that they are
doing their work safely or securely, or prevent them from
continuing if safety or security is lacking.
The U.S. needs a unified biosafety system that can provide
oversight for research on all dangerous pathogens, regardless
of the funding source or the affiliation of the researchers.
Unlike other high-risk endeavors like aviation and nuclear
power, biosafety does not have a robust research history
because there has been nearly no funding for research in the--
in biosafety over the past several decades. We currently lack
data on how accidents occur or the factors that can effectively
mitigate those accidents.
Historically, biosafety improvements have always added onto
existing equipment, procedures, or administration because there
were no data suggesting which specific improvements were
particularly effective versus others available. Investments in
biosafety research can determine exactly what measures
effectively reduce risk and which are simply theater, enabling
the efficient use of research dollars across the United States.
Using new evidence to eliminate wasteful measures would
also make laboratories more sustainable, as money need not be
spent maintaining equipment with little value.
Biosafety research can also directly inform laboratory
practices on the choice of equipment and procedures that are
inherently safer, improving safety in the near term.
Data generated by biosafety research can also boost
compliance with safer but inconvenient practices because
scientists are naturally skeptical and data focused.
Although there are general standards regarding safe
practices for research, more standards are needed to cement and
communicate best practices and ensure that the laboratories
doing the least don't have an advantage over those taking more
measures to be safe.
For example, standards are needed to define how many
biosafety professionals are needed to support research
facilities of various sizes and complexities and what type of
training is needed to work in containment. Developing these
standards and templates for training would save all research
facilities from developing their own.
Also, the biosafety workforce is rapidly aging and
experiencing burnout due to adopting extra duties to keep
campuses and workplaces safe during the COVID pandemic.
Fellowships, curricula, and training is needed to recruit
scientists into the safety workforce and ready them for a
career.
Biosafety has historically been underresourced for various
reasons. In most institutions, biosafety staff are paid out of
overhead costs instead of directly from research dollars,
meaning that safety workforce draws resources out of the
institution instead of paying for itself. As a colleague of
mine has aptly said, ``Biosafety has a soft money, soft jobs
problem.'' Allowing the maintenance of safe labs as a direct
cost on grants would help ensure biosafety is adequately
supported.
Moreover, in order to be properly implemented, any
additional requirement put on the biosafety workforce, such as
those recommended recently by the NSABB, should be accompanied
by an increase in funding to ensure that biosafety
professionals don't have to do more with the same resources,
which itself could hamper safety.
Regarding mission, currently there is no Federal agency
that is in charge of biosafety, funding biosafety research,
promulgating specific biosafety standards, fostering the
workforce, or providing oversight to all pathogen laboratories.
To fix this issue, either an existing or new Federal agency
must be given the comprehensive mission of improving biosafety.
Some have argued that the additional oversight of biosafety
of the type I have described would stifle research. This
position is belied by the fact that countries that have already
implemented similar systems have equally robust pathogen
research communities and bio-economies. Specifically Canada,
Switzerland, Germany, and the UK all have comprehensive
oversight of pathogen laboratories and several high-containment
laboratories.
The resources needed to sponsor research, develop
standards, foster the workforce is small compared to the
resources spent on pathogen research itself. An annual budget
of 60 million would provide sufficient funding to support this
work, and the sum is approximately 1 percent of NIAID'S 66
billion annual budget.
To close the oversight gaps I mentioned and adequately fund
biosafety professionals to take on greater responsibility would
require more funding, though the funding is clearly justified
by the risks. The pandemic, which could have plausibly been
caused by a laboratory accident, cost more American lives than
all wars in my lifetime and harmed the economy more than any
other single event. Investments on the scale of a single
defense program would transform biosafety in the U.S. and more
cost-effectively mitigate major risks facing the U.S.
Thank you, Mr. Chairman.
[The prepared statement of Dr. Casagrande follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Griffith. I thank the gentleman for yielding back and
now recognize Dr. Koblentz for his 5 minutes of opening
statement.
STATEMENT OF GREGORY KOBLENTZ, Ph.D.
Dr. Koblentz. Thank you, Mr. Chairman. Thank you for the
chance to speak with the committee today about biosafety,
biosecurity, and dual-use research oversight.
I am--welcome the opportunity to present the results of the
Global Bio Labs Initiative, which I codirect with Filippa
Lentzos at King's College, London. We've spent the last 2 years
collecting and analyzing data on high-consequence research
facilities located around the world and evaluating the national
biorisk management policies in place in these countries in
order to oversee the safe, secure, and responsible operation of
these facilities.
In cooperation with the Bulletin of the Atomic Scientists,
we have created an interactive website at globalbiolabs.org
that contains data on the locations and key characteristics of
these BSL-4 and BSL-3 enhanced laboratories, as well as details
on the biosafety, biosecurity, and dual-use research oversight
policies that these countries have in place.
Today I would like to present the key findings of our
latest report, the Global Biolabs Report 2023, which contains
our most recent research analysis on BSL-4 and BSL-3 labs, as
well as the state of biorisk management around the world. I am
going to start off talking about the BSL-4 labs, and then I
will talk about the BSL-3 enhanced labs, and then talk about
the recommendations that we have.
Since its launch in 2021, the Global Biolabs Initiative has
identified more than 100 high-consequence biological research
facilities, meaning BSL-4 and BSL-3 labs, around the world,
with more under construction and under development. Among the
BSL-4 labs, which are designed to work with the most dangerous
pathogens such as Ebola, Marburg, and smallpox, there are
currently 69 such labs in operation, under construction, or
planned in 27 countries. That is an increase of 10 labs from
our last report in 2021. Today, of those labs, approximately 75
percent are located in urban areas, which exacerbates concerns
if there was an accidental release in one of these densely
populated areas.
The COVID-19 pandemic has led to a building boom in BSL-4
labs. Nine countries have announced plans to build 12 new BSL-4
labs since the start of the pandemic. For five of these
countries, this will be their first BSL-4 lab, and most of
these new labs will be built in Asia, including in Kazakhstan,
the Philippines, India, and Singapore.
Turning now to the BSL-3 labs, we have identified 57 of
these biosafety 3 enhanced laboratories in 28 different
countries. These are BSL-3 labs that have adopted additional
biosafety and biosecurity measures in order to carry out
particularly risky research. The most common pathogen studied
in these BSL-3 enhanced laboratories is highly pathogenic avian
influenza. These labs have also been used to study the 1918
pandemic influenza virus, as well as to conduct research on
potential pandemic pathogens, which is also known as gain of
function research.
Eighty percent of the BSL-3 enhanced laboratories that we
have identified are located in urban areas. However, there is
limited national biosafety guidance and no international
guidance about what constitutes a BSL-3 enhanced laboratory. In
addition, there has been little to no research done to
determine whether the enhancements that these labs are using
are commensurate with providing a commensurate level of
biosafety benefits compared to the riskier research that they
are conducting.
The Global Biolabs Initiative is also developing a new
method for assessing the strength of biosafety, biosecurity,
and dual-use research oversight policies that are used to
conduct--oversee the operations in these labs. We have
collected this data on 27 countries that have or plan to have
BSL-4 laboratories. Let me discuss each of these in turn.
First, for biosafety, we have assessed that 21 of the 27
countries have scored high on biosafety governance. The weakest
areas we identified were lack of requirements for maintaining
an inventory of pathogens and for specifying the use of
personal protective equipment. We are doing less well on
biosecurity. Only 12 of 27 countries with BSL-4 labs have
received a high score for biosecurity.
The biggest gap was in screening of DNA orders related to
sequencing and synthesis of dangerous pathogens. Only two
countries have policies in place to screen orders to make sure
that they are not being used to develop dangerous pathogens.
Only 11 countries include cybersecurity as part of their
biosecurity requirements, and only 12 countries mandate that
labs conduct biosecurity risk assessments.
The picture is even worse when it comes to governance of
dual-use research. Only one country, Canada, scores high in
this category. Two other countries, including the United
States, score medium, and the rest of the 24 countries we study
score low. Among these low-scoring countries, many of them have
a score of zero, meaning they receive no points for having any
mandatory or voluntary measures in order to conduct oversight
of dual-use research in labs on their territory.
With that review of the virus landscape, let me offer some
recommendations for concrete steps that we can take to
strengthen biorisk management. At the national level, all
countries with high-consequence biological research facilities
should have whole-of-government biorisk management systems,
including comprehensive laws, regulations, institutions to
enforce these laws.
States should also be developing national standards for
field biosafety. This is an area that has received very little
attention so far from the biosafety research community.
And countries that don't have national biosafety
associations should develop one with the support of their local
biosafety and biosecurity professionals. Internationally, the
World Health Organization and the Biological Weapons Convention
can also be leveraged to increase global biorisk management and
improve transparency around these facilities.
With that, let me just conclude and say that there are more
countries building high-containment laboratories, conducting
riskier research with potential pandemic pathogens, and
developing dual-use biotechnologies. And our biorisk management
oversight system has not yet caught up with this changing
threat landscape. Thank you.
[The prepared statement of Dr. Koblentz follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Griffith. I thank the gentleman.
I now recognize Mr. Pekosz for his 5 minutes of opening
statement.
STATEMENT OF ANDY PEKOSZ, Ph.D.
Dr. Pekosz. Committee Chair Rodgers, Subcommittee Chair
Griffith, Vice Chair Lesko, Ranking Subcommittee Member Castor,
and all members of the subcommittee, thank you for the
opportunity to participate in today's hearing and devoting your
time and effort to a topic that is important to our Nation's
public health.
I would like to state for the record that the opinions
expressed herein are my own and do not necessarily reflect the
views of Johns Hopkins University.
My name is Andrew Pekosz, and I am a professor of molecular
microbiology and immunology at the Johns Hopkins University
Bloomberg School of Public Health. I am a virologist who has
been doing basic research into viruses, including influenza,
SARS-COV, SARS-CoV-2, bunyaviruses, and hantaviruses for over
30 years. That research has been done at biosafety levels 1, 2,
or 3, depending on the agent and the type of experiment being
used.
In addition to my research interests, I have served on
numerous review or advisory boards at the institutional, State,
and national levels, all having been focused on establishing
guidelines and biosafety recommendations that would allow
critical research to move forward under the most appropriate
biosafety conditions. I would like to start by going through
the current biosafety measures that are being used in
laboratories.
Contrary to what is often described, scientists working
with microbes across the United States pay a great deal of
attention to biosafety. Keeping their laboratory workers safe
is their top priority. Research with microbes undergoes
numerous levels of scrutiny before being performed. Pathogen
registration forms are reviewed by institutional biosafety
committees, which disclose what experiments investigators plan
to do and what agents they will be working with. Appropriate
guidelines are set based on the organism being used and the
type of experiment being proposed.
Work in animal models involves additional reviews and
worker training through animal care-and-use committees that
assess what methods are being used and what alternatives are
available to investigators. Work with human samples involves
yet more training and reviews from institutional review boards
that ensure that the privacy and safety of investigators and
participants are given the highest priority.
The availability of antivirals and vaccines is a critical
part of the process of biosafety when they are available.
Protocols for dealing with accidents are developed, and make up
a significant part of an individual's training.
The vast majority of research with BSL-2 and BSL-3
pathogens occurs at the small scale and in ways that really do
not pose an enhanced risk of infection to laboratory workers.
Methods that generate aerosols or utilize needles or other
sharp items are minimized or are often nonexistent. When there
are clear needs for some of these techniques, extra precautions
and training are put in place to maintain a safe working
environment.
There is an existing framework that targets pathogens with
pandemic potential, and research that involves potentially
enhancing their disease-causing properties. This is the PC3O
mechanism that was mentioned previously. It does lay out the
process for identifying research of concern and how that
research will be reviewed, starting at the institutional level
and progressing to the national level.
The National Science Advisory Board for Biosecurity, or
NSABB, recently released recommendations for updating guidance
regarding research of concern. The NSABB's intentions were
well-meaning, but the lack of clear definitions regarding the
type of research and the agents which would be covered by the
guidelines resulted in more, not less, confusion in the
scientific community. The risks--this risks slowing our efforts
aimed at current infectious diseases, while not gaining
additional protection from future pathogens.
Their report did hit on several important items. Loopholes
that allow certain experiments to avoid NIH review because it
was funded by private sources need to be closed. Biosafety is
independent of funding sources. Increased transparency about
the review process and individuals making decisions about
approving research of concern would also be welcomed by most
scientists in the field.
In closing, I would like to emphasize that the United
States is the world leader in infectious disease research, with
the development of antimicrobials and vaccines being the
centerpiece of those efforts. We have an opportunity to
strengthen the leadership position and expand it to include
biosafety and research into emerging and potential pathogens.
The U.S. has the engineering and manufacturing expertise to
build effective, safe laboratories. It has the scientific,
public health, and clinical expertise that can continue to
drive forward and improve our abilities to respond to current
and future outbreaks.
The U.S. can set the example of how to safely do research
with clear public health benefits. This subcommittee will play
an important role in determining that path forward, and I am
honored and grateful for the opportunity to provide my
testimony in support of this initiative. Thank you.
[The prepared statement of Dr. Pekosz follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Griffith. I thank the gentleman for his opening
statement.
I now recognize Dr. Hawley for his 5 minutes.
STATEMENT OF ROBERT HAWLEY, Ph.D.
Dr. Hawley. Thank you very much, Chairman Griffith, members
of the committee, colleagues, and friends. I am going to
address some of the issues that have been mentioned.
The origins of biological safety, or biosafety, was at the
United States Army Biological Research laboratories at Camp
Detrick, now known as Fort Detrick in Frederick, Maryland, by
Dr. Arnold G. Wedum, who was the Director of Industrial Health
and Safety from 1946 through 1969. Dr. Wedum, who is revered as
the person who is most responsible for creating our profession,
is considered the father of modern biosafety.
Through the efforts of Dr. Wedum, we saw the development of
safer work practices, the biological safety cabinet, advances
in aerobiological safety, and environmental monitoring. The
development of biosafety concepts has its roots in the work
promoted by Dr. Wedum. The type of laboratory work, principles,
and practices used and the type of facilities needed were
established on the determination of risk. This was a risk-based
approach.
What I want to emphasize is that there is no one procedure
or technique that can be used for all laboratory research and
development procedures. Putting it bluntly, no one size fits it
all. A risk assessment is conducted, followed by a risk
management procedure, whereby the risk is mitigated or
eliminated.
Also implemented was a special procedure section that
performed medical examinations on personnel assigned to work in
the biowarfare sections and the special immunizations program
that began as an immunization program to provide an additional
measure of protection of laboratory workers against the
occupational infections.
Dr. Wedum directed many applied biosafety research projects
that allowed us to better understand the interaction of
laboratory procedures and workers and subsequently be able to
mitigate the negative impacts of these interactions.
It is unfortunate that, due to today, we do not continue to
pursue applied biosafety research because of funding
constraints. The recommendation of the Trans-Federal Task Force
Report of 2009--development and maintain a robust program of
applied biosafety and biocontainment research to create
additional and update existing evidence-based practices and
technologies--has not gained momentum.
My experience at the United States Army program with the
Medical Research and Development Command at Fort Detrick during
the period 1988 through 2003. The United States Army Medical
Research Institute of Infectious Diseases, or USAMRIID, is the
Department of Defense lead laboratory for medical biological
defense research. USAMRIID was my extended family. Everyone
treated each other as family members. As an analogy, we were
like spokes in a wheel, moving smoothly to accomplish our
mission. That was research for the soldier, protecting the
warfighter from biological threats and also investigating
disease outbreaks and threats to public health. We operated
within an ideal climate of safety. Everyone embraced and
practiced a culture of safety.
During this time serving as biosafety officer at USAMRIID,
I was also a designated command biological safety officer. In
this role I was tasked to inspect national and international
contract and university laboratories to assess their
capabilities and safety program prior to the release of
fundings. This was an excellent example of command and control
and also allowed me the opportunity to champion biosafety and
learn alternative approaches to challenging situations and
policies.
Accidents, incidents, or mishaps in the laboratory or in
any workplace environment do not just happen. They are caused--
usually, because of the unsafe behaviors of people. Included in
the causes are violation of rules, procedures, inadequate
training, failure to understand process, or procedure fatigue
and mental status. Most mishaps can be mitigated or eliminated
through adequate coaching, mentoring, or training using the
best practices for facilities, equipment, and procedures.
I am a firm proponent that we have an opportunity to gain
experience from our incidents, mishaps, accidents, or near-
misses by sharing our experiences without negative
consequences. Trans-Federal Task Force, again in 2009, proposed
a centralized incident-reporting analysis and information-
sharing system. The report further states that an analysis of--
report of laboratory incidents could help improve laboratory
safety and oversight, determine why the accidents occurred, and
how they can be prevented in the future. Implementing this
recommendation will provide resources for generating and
sharing lessons learned and promoting the need for new or
revised guidelines, practices, or training.
I have a few other things to mention, but because of the
time constraints I just wanted to mention lastly that the
biosafety practitioner has to be enthusiastic about their work
and recruit and be a cheerleader for the profession. And I hope
that my comments will reveal the passion I have for biosafety
and the continuing desire to learn from my colleagues. Thank
you very much.
[The prepared statement of Dr. Hawley follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Griffith. Thank you, and I appreciate the passion of
all the witnesses.
We will now begin the question-and-answer portion of the
hearing, and I will begin by recognizing myself for 5 minutes
for questions.
Dr. Koblentz, if the NIH is not capable of enforcing or
doesn't or isn't inclined to enforce safety standards at labs
doing risky research, who would you recommend take on that
responsibility?
Dr. Koblentz. Thank you, Mr. Chairman. I think what we need
in this country is an overhaul of the biosafety, biosecurity,
and dual-use research oversight system, which would be best
placed in an independent agency that would be able to conduct
that oversight as well as conduct the kind of research that
both Dr. Casagrande and Dr. Hawley talked about being needed.
This would be an organization similar to Nuclear Regulatory
Commission or the FAA or the National Transportation Safety
Board that would be an independent technical agency that would
have responsibility for those activities.
Mr. Griffith. Several of you indicated that there were
organizations that weren't connected with the NIH or even the
U.S. Federal Government that were doing this type of research
or might be doing this type of research. Would it be possible
that we set something up that would be not necessarily
governmental or quasi-governmental that would be funded by
those private organizations that are doing this type of
research?
Back to you.
Dr. Koblentz. That is certainly a possibility. I mean, most
of the research is probably being conducted with public
funding. But again, as Dr. Casagrande mentioned, there are gaps
in the oversight system that would allow a private facility to
engage in this research without any kind of oversight
whatsoever. And so you would want to have a comprehensive
oversight that would include facilities regardless of whether
they are publicly funded or privately funded.
Mr. Griffith. I appreciate that.
We have incomplete data that suggests--and some of you all
have suggested--that there are accidents in the biosafety labs
that's not necessarily such a rarity. But how do we start to
get a more complete count of the number of accidents and
incidents at high-containment labs?
Dr. Casagrande, do you want to start?
Dr. Casagrande. Yes, thank you, Mr. Chairman. A good
accounting of not just incidents that have occurred but also
the near-misses would help us to learn from the incidents that
inevitably will occur and prevent their repetition, and also
start studying their root causes and most effective ways to
mitigate them.
Mr. Griffith. And you think we need Federal legislation
that indicates--I think both you and Dr. Koblentz indicated we
need Federal legislation that would require the labs, whether
they be government or private, to report these near-misses or
accidents.
Dr. Casagrande. A database that is missing a big portion of
the data--that would be what is drawn from the private sector--
would be less robust than one that contains all the data,
obviously. And some of the research environment in the private
sector is different from the academic sector. For instance,
their personnel is much more stable. They don't have as much
turnover as you do in academia, so they are probably going to
suffer different risks. So cutting them out would not be
adequate.
Mr. Griffith. All right, I appreciate that.
Mr. Pekosz, can you explain the necessity of progress
reports when conducting research in biosafety laboratories?
Dr. Pekosz. Absolutely. I think it demonstrates progress of
research. It demonstrates areas of research and directions of
research. Oftentimes directions of research do change from the
initial proposal that was submitted. And progress reports are a
great way for regulatory agencies, funding agencies to keep
track of how those changes are going forward and whether there
is a major change in direction of research.
Mr. Griffith. And if we are missing progress reports,
shouldn't we pause the study or the research until the progress
reports can be completed and evaluated?
Dr. Pekosz. Yes, progress reports are essential, I think,
for monitoring research.
Mr. Griffith. So when you don't have them, you should put a
stop to it. All right.
Dr. Hawley, I understand that you reviewed some of the
biosafety sections of the recently released Senate report, and
you were quoted in The Washington Post as saying that the Wuhan
Institute of Virology had imprudent laboratory practices. And
it was very, very apparent that the Wuhan Institute of
Virology's personnel's biological safety training is minimal.
Is that correct, and can you expand?
Dr. Hawley. Yes, that is my belief by reading some of the
reports. Of course, I have never visited the facility, but
based upon the reports I have read and the approaches they had
to implementation or developing biological safety equipment led
me to believe that their training was less than perfect.
Mr. Griffith. And when you say that there was some
equipment missing, are you talking about the air incinerator
that was not installed until late 2019?
Dr. Hawley. Yes, sir.
Mr. Griffith. Yes. That is of real concern, isn't it?
Dr. Hawley. It is, because the air incinerator technology
was replaced by the HEPA filter in the 1950s, early 1960s. We
had an air incinerator from our aerobiology building at Fort
Detrick, and that was eventually closed down, again, because of
the advent of the HEPA filter. Not only that, because of the
cost and maintenance involved.
Mr. Griffith. So they weren't doing anything, as I
understand it. And then they put the air incinerator in, which
was 1950s or 1960s technology, when there was better technology
available. Isn't that what you are saying?
Dr. Hawley. Yes, sir.
Mr. Griffith. And my time is----
Dr. Hawley. I believe that they implemented the air
incineration because of their lack of reliable data regarding
the killing of organisms in their primary procedures, such as
using an autoclave.
Mr. Griffith. Yes, kind of like shutting the barn door
after the horse is already out.
Dr. Hawley. It was a redundant move, yes.
Mr. Griffith. Yes, sir. I yield back, and now recognize the
ranking member of the full--excuse me, the ranking member of
the subcommittee, Ms. Castor, for her 5 minutes of questions.
Ms. Castor. Yes, thank you, Mr. Chairman.
Right off the bat I wanted to correct the record at the
outset. The Chair said that HHS had not replied to a request
for--on mpox. And here, on April 26, 2023, they did have a 3\1/
2\-page response to the committee that says, ``At the outset, I
want to respond specifically to the portion of your letter that
described a September 22 Science article that referenced a
potential subproject which you called the Clade I study. This
study has not been formally proposed, and the National
Institute of Allergy and Infectious Diseases has no plans to
move forward with this research. This type of research would
require a formal proposal to be submitted for review, and the
proposal would need to undergo the rigorous review process
described in this letter before it could be initiated.''
So I am--offer this for the record.
Mr. Griffith. And without objection, it is accepted.
[The information appears at the conclusion of the hearing.]
Mr. Griffith. For the record, let me respond--we haven't
started your 5 minutes yet, so I am not eating up your time--
that that, while we received that response almost 6 months
after our initial request, we still did not get an answer as to
what their deliberations were. Clearly, they have now told us
they weren't moving forward. The problem is that this is not
meaningful cooperation or meaningful input with the committee
of jurisdiction. And accordingly, I stand by my opening
comments.
All right, back to you, Ms. Castor.
Ms. Castor. OK, thanks so much. Well, we all share the goal
that our labs at home and abroad must adhere to stringent
safety standards.
To design any thoughtful improvements from our perspective,
as policymakers, we really need your input and advice. Dr.
Pekosz, your research involves working with infectious
pathogens to surveil and understand flu. You also oversee a
high-containment lab used to study particularly infectious
viruses. Walk us through the steps that you must take each time
you enter a high-containment lab to study an infectious
pathogen.
Dr. Pekosz. Absolutely. Thanks for the opportunity to
describe this.
I will jump past the training, which is extensive. And
oftentimes when a member joins my laboratory, for instance, it
can be anywhere from a month to 2 months before they actually
go into our high-containment laboratory, because there is about
a month or two of training that we do outside of the facility
so individuals get comfortable with their techniques and their
approaches.
Our high-containment laboratory has a security swipe, where
only limited individuals have access to the room. It is a
multiroom facility. Each of the doors have an interlock system
so that only one door can be opened at any one particular time,
and the outside door is only controlled by a security access
from the outside as well as emergency--or security access from
the inside.
We enter an area in our room, where--which we call our
gowning room or our ante room, and that is the space that is
pathogen free, and that is where we gown to enter into the
rooms of our suite where we actually will be working with
pathogens. That--the gowning part involves us putting on a
Tyvek oversuit, which is a moisture-resistant protective
barrier. We put on protective gear over our feet. We put on a
pair of gloves. We then don what is called an outerprotective
gown, which is another sort of apron that is moisture
resistant. We put on a second set of gloves, and then we
provide protection through something called PPAR, or a PPAR
unit. And what that is, is it is a unit where we put a hood
around our entire heads, we connect it via a hose to a unit on
the side of our waist which takes air from the room, purifies
it through a HEPA filter, and then sends it through the mask
out--and out the bottom of our----
Ms. Castor. This is a detailed process.
Dr. Pekosz. Yes.
Ms. Castor. And Dr. Koblentz, you said, OK, looking at it,
the U.S. and Canada ranked high when it comes to our biorisk
management score. But then you highlighted the expansion of
labs across the globe in--after the COVID-19 pandemic. So what
is our best way in America to make sure that, as labs open
across the globe, what--is it through the WHO? Is it through
our research, our collaboration? What is the way to ensure
that, as labs open, they are adhering to high standards?
Dr. Koblentz. Thank you for the question. I think we need
to take a kind of a two-pronged approach. Working through
organizations like the WHO and the Biological Weapons
Convention can enable us to set international standards for
biosafety, biosecurity, and dual-use research oversight that
all countries can aspire to.
But at the same time, we also need to have more focused
efforts that are working with the countries that are perhaps
developing their first BSL-4 laboratory, and so they need to
build up the legal and regulatory infrastructure expertise, as
well as the training for their personnel who will be working
there, and making sure they are able to work there, you know,
safely and securely, and engage that--provide the kind of
training that Dr. Pekosz is talking about.
And I think there are not only bilateral programs the U.S.
can do for that, but there are international organizations like
the International Federation of Biosafety Associations, the
National Experts Group of Biosafety and Biosecurity Regulators
that can provide those services, as well, and make sure that
labs are operating----
Ms. Castor. And here is my concern now, because I have
heard--you have made some very important recommendations to us.
Some say, ``Oh, create a new agency, do some more oversight.''
But right now, under the Republicans' Default on America
proposal, it requires a 22 percent cut to NIH and significant
cuts to the HHS Office of the Inspector General. That--it would
totally undermine the--those type of efforts and the ability to
provide oversight.
I mean, my time is running out, but for the record, Dr.
Casagrande, will you reply to us why funding NIH and its
oversight mechanisms are so important, and how are cuts of that
magnitude would completely undermine our goals on biosafety in
the U.S. and across the world?
Dr. Casagrande. Thank you for the question, Representative
Castor.
Yes, I mean----
Ms. Castor. My time is up, so I am--you will have to take
that for the record.
Dr. Casagrande. I don't understand.
Mr. Griffith. She is asking that you give a written
response later to the question----
Dr. Casagrande. Oh----
Mr. Griffith [continuing]. Because her time has----
Ms. Castor. Since my time ran out.
Mr. Griffith [continuing]. Has run out.
Dr. Casagrande. Sure.
Ms. Castor. Thank you very much.
Mr. Griffith. But thank you very much. Thank you. The
gentlelady yields back. I now recognize the gentleman from
Texas, Dr. Burgess, for 5 minutes of questioning.
Mr. Burgess. Thank you, Mr. Chairman, and I don't want to
spend my time doing this, but the exchange you just heard is
actually factually inaccurate. The appropriations that are done
that will be delivered to the NIH, the CDC, all of those are
yet TBD. There are no cuts that have been identified. There are
overall savings in the budget that will occur over the next
several years that are important because we are in a fiscal
crisis. But that type of rhetoric does nothing to advance the--
really, what we are here to discuss today.
Dr. Casagrande, you actually answered my first question
spontaneously. I was going to ask which government entity is
responsible for regulating high-containment or risky research,
and I think you have already offered that there actually isn't
one. Is that correct?
Dr. Casagrande. Right. It depends on what the entity is
researching, which pathogens, and also where its funding is
derived from. But in--for the highest level of containment,
almost all--well, all those pathogens are select agents. And so
it would fall under the select agent program either under the
CDC or the USDA. So still two separate entities. But beyond
that, it depends on if the agent is a select agent or if the
funding is derived from a Federal agency. If it is not a select
agent and it is not funded by a Federal agency, then there
might not be Federal oversight.
Mr. Burgess. Well, let me ask Mr. Pekosz--if I pronounced
your name correctly--you identified loopholes that need to be
closed. Is that along the line of what you were describing by
closing loopholes?
I think in your written testimony you say that it--you
don't differentiate between--well, let me just be sure that I
have got it correctly, because it--I thought it was an
important point that you made in reference to closing
loopholes.
Dr. Pekosz. Yes, biosafety is independent of funding
sources.
Mr. Burgess. Yes.
Dr. Pekosz. Essentially what I was saying.
Mr. Burgess. Yes.
Dr. Pekosz. And I think that is a really important point to
make. Biosafety is a standard that is dependent upon the
experiments you are doing, the pathogens you are working with,
and the facilities that you have. We shouldn't be monitoring
that--or changing that, I should say--in any way based on
simply where the money is coming from.
Mr. Burgess. Yes, I think that is such a valid point.
Dr. Hawley, I really appreciated your historical reading of
how things developed at Fort Detrick. You know, I sat in a
committee room here--it was probably 2013 or 2014.
Well, I can remember reading, as a medical student, when
smallpox was eradicated, right? In Ethiopia they had done the
ring vaccinations, they isolated the last cases. ``We are going
to beat this disease. We are going to wipe it off the face of
the Earth,'' and then to find out--many, many years later I am
elected to Congress and, oh, yes, we still actually have some
stuff. And then, after being on this committee for a while, we
had a hearing because the NIH just happened to have some in the
back of the fridge that no one knew about.
So when you went through your recitation of the historical
development, yes, we--you can make mistakes. You can have near-
misses. And one of the things that really piqued my curiosity
was you also said you have a system where it--what is almost
described as a no-fault system for reporting near-misses. Did I
understand that correctly?
Dr. Hawley. Yes, sir. Yes, sir.
Mr. Burgess. And do you--well, let's just explore that a
little bit. Do you--is that something you think we can build
upon, that type of system?
Like at NASA, if you report a near aeronautical disaster,
you actually get a get-out-of-jail-free card from the FAA
because you properly reported it. Is that what you are talking
about?
Dr. Hawley. Well, locally we had a near-miss reporting
policy and then reviewed those near-misses periodically. But
what I am calling for--and I think some of my colleagues have
mentioned--the need for a national database, so that we can all
share and learn from what happened without any negative
consequences.
There is a lot of punitive action associated with the
reporting of an incident nowadays, and that has a tendency to
drive these incidents underground so they are never reported.
And same with the near-misses, because of embarrassment or
other reasons.
Mr. Burgess. Right, and--or you don't want to end up in
front of an administrative law judge somewhere with your
credentials threatened.
So I--Mr. Chairman, I hope we can explore that concept. I
know we are not a legislative subcommittee, but I think that is
so important. And the ability to have the database and to do so
without penalty when proper reporting occurs, maybe that could
have avoided some of the difficulties that we see now with
EcoHealth Alliance.
But I really appreciate your testimony today. It has been
very instructive.
Dr. Hawley. And to emphasize that--some of my colleagues
have made, that monitoring should be done by an agency that
does not provide the funding. Because to me, that is analogous
to the fox watching the henhouse. Thank you.
Mr. Burgess. Important safety tip. Thank you, sir.
Mr. Griffith. And I suggest you lean over to your colleague
to your right, who might have jurisdiction on the legislation.
[Laughter.]
Mr. Griffith. I now recognize Ms. DeGette of Colorado for
her 5 minutes of questioning.
Ms. DeGette. Thank you so much, Mr. Chairman. And I really
have to thank you for this panel.
The chairman knows I was the Chair of this subcommittee the
last 4 years, and we have spent a lot of time talking about
what to do about our labs. And I think all of you have really
given us a lot of important food for thought.
One of the issues that we have encountered, and one of the
reasons why people are building these labs all around the
world, it is important to do the research near where these
viruses occur. Is that--Mr. Pekosz, you are nodding your head
yes.
Dr. Pekosz. Yes, there is such--especially when it comes to
emerging infectious diseases and outbreaks, having the boots on
the ground, having the local authorities not only be well
prepared but having the facilities that can deal with this is
incredible, because that is the way you can stop these
outbreaks early.
Ms. DeGette. Right.
Dr. Pekosz. Once outbreaks get too out of control, it
becomes incredibly----
Ms. DeGette. You can't stop it.
Dr. Pekosz [continuing]. Difficult to do that.
Ms. DeGette. That is right. So Dr. Koblentz, everybody is
focusing on you and what you are talking about, the biosafety
protocols and so on. And you talked about the WHO and some of
the other organizations that could oversee it. But a question
that I have is when the U.S. is entering into partnerships with
some of these countries, we could make a condition of our
funding and our joint action that they meet certain protocols
and also transparency. Wouldn't that be fair to say?
Dr. Koblentz. Yes, that would be a good approach to take
when we are working with other labs and helping them build
their capacity, to also make sure that they have in place the
right biosafety and biosecurity protocols.
Ms. DeGette. If they want to work with our scientists--
which they all want to work with our scientists and get our
money, right?
Dr. Koblentz. Yes.
Ms. DeGette. And so, let's see. What would happen, Dr.
Pekosz, if we had a ban on some of the international research
collaborations, as some of my colleagues on the other side have
talked about? Not this colleague, but other ones.
Dr. Pekosz. Yes. You know, it is incredibly important to
have epidemic and outbreak research be created and shared in
near-real time. And those resources, oftentimes, those require
multinational resources.
I run a center that actually does do surveillance both in
Taiwan and in Zambia, and the importance of being on the ground
there, training people, having a free flow of information,
establishing trust networks between individuals are all
critical in terms of being able to do these things effectively.
Ms. DeGette. Now--thank you.
Mr. Hawley, you talked about the lapses at the Wuhan Lab,
but you haven't actually seen those lapses for yourself. You
read about it in a report, isn't that correct?
Dr. Hawley. That is correct.
Ms. DeGette. OK. So the problem is--and this is the problem
the chairman is talking about, and I just read an article in
The New York Times the other day about this--China is not
transparent in what is going on at its labs. So that is what we
have to try to figure out, what to do with China, but also
other countries too, so we can be assured that the highest
levels of lab safety are met and so that we can make sure that
we don't have--that we are not sitting around here 3 years
later trying to figure out where the virus came from. And that
is really the goal.
So, Dr. Casagrande, I have got a little bit of time left,
and so I wanted--I don't want to be partisan about this, but I
do want to give you the opportunity to answer in front of
everybody and on the record why funding the NIH and its
oversight mechanisms are so important and, if we did have cuts,
what that might do to our ability to monitor these labs.
Dr. Casagrande. Yes. If you look at human progress over the
last century, a lot of it has been due to biomedical advances.
And the NIH is probably the premier institution in the world
that has fostered those advances and led to the great expansion
of life expectancy, quality of life, and reduction of childhood
mortality.
Additionally, if you look at the COVID pandemic, had this
pandemic happened 10, 15 years ago, we wouldn't have been able
to respond as quickly and get back to life as normal and to
have our economy recover as fast as it did.
So also, you know, because of the issue I mentioned, that
the biosafety jobs are often funded on soft money, cuts on
research will probably be hit somewhat hardest on safety staff.
And so you might end up accidentally creating a less safe
environment from that purpose.
Ms. DeGette. And----
Dr. Casagrande. Conversely, more funding--sorry.
Ms. DeGette. No, that is OK. I was going to say we see the
same thing with food safety, and this subcommittee has looked a
lot at food safety too, because when you have our food being
produced in China, you have to have the inspectors go over
there. But frequently, that is one of the first things that
gets cut because it is seen as fungible.
Thank you, and I yield back.
Mr. Griffith. I thank the gentlelady for yielding back and
now recognize the chairman of the Health Subcommittee, Mr.
Guthrie, for his 5 minutes of questioning.
Mr. Guthrie. Thank you, Mr. Chair.
Thanks for you all being here today. I appreciate it.
And so, Dr. Koblentz, the first question. On the topic of
high-containment labs, the December 2022 omnibus spending law
included a provision requiring the White House Office of
Science and Technology Policy to develop a strategy for
maintenance and coordination of biosafety levels 3 and 4 labs
that are federally owned and operated. You are familiar with
this provision, and support it?
Dr. Koblentz. Yes, I am.
Mr. Guthrie. All right. So the question was, what is the
current status of the implementation of this provision, and how
will this help protect our biosecurity in these facilities?
Dr. Koblentz. I'm not aware of the status of that review
process, but I will speak generally about the need for a
comprehensive review of the adequacy of our facilities at the
BSL-3 and BSL-4 level, especially in light of our experience
with COVID, in light of, you know, mpox and the other emerging
infectious diseases that we see. There needs to be now a more
rational conversation and review within the government to
understand what are our capabilities and what are our gaps and
what are areas maybe that are excessive and don't need to be in
place any longer.
And I think we have been growing this infrastructure for so
long among multiple different agencies that we haven't had that
kind of comprehensive, governmentwide review. So I do think it
is time for that to happen.
Mr. Guthrie. OK, thank you.
And Dr. Casagrande, the omnibus only specified in this
provision would apply to federally owned labs and operate--
federally owned and operated. I know you talked a little bit
about this in your opening statement. Would it be helpful to
expand this provision in any requirements developed in response
to private labs, as well? Would it be helpful? And also, would
it be appropriate to do so?
Dr. Casagrande. Yes. I mean, as was mentioned by my other
panelists, that--biosafety is independent of the funding
source. It really depends on what are the manipulations you are
doing, what is the pathogen you are working on. And so it
doesn't make any sense to have such large gaps in oversight,
support, guidance, et cetera.
Mr. Guthrie. OK, thank you.
And Dr. Koblentz, I know you are familiar with this because
you authored the report, so I will ask you a question. On the
BSL-4 laboratories, a group of international researchers you
mentioned led by King's College London research that you
participated in published the Global Biolabs Report 2023, which
noted the number of BSL-4 labs across the globe grew from 69--
to 69 across 27 countries in 2022, up from 59 and 2021. So we
mentioned that earlier.
But the report further notes the key trend is that the
number of labs handling dangerous pathogens is rapidly
increasing around the world, but the boom has not been
accompanied by sufficient oversight and raises biosafety and
biosecurity concerns.
So the question: As we look to ensure greater maintenance,
coordination, and oversight of biosecurity research, how do we
ensure we are promoting and requiring similar standards
internationally, particularly at those facilities which we are
partnering or providing funding?
Dr. Koblentz. Thank you for the question.
There is an international standard for biorisk management
called ISO 35001 that could be adopted by labs around the
world, whether they are BSL-2, BSL-3, BSL-4. These are
standards that require labs to put in place a management system
to ensure they are prioritizing biosafety and biosecurity. So
there is a very readily available standard that could be
adopted.
What we haven't really seen is the resources being put into
educating labs about this, providing the training, providing
the incentives for labs to do this. And certainly, the U.S.
Government could do that by making that a condition of working
with labs in terms of capacity building or training that we are
doing for public health purposes or for, you know, our
biosecurity engagements.
We could be making more of an effort to ensure that these
labs are adopting these standards and working through internal
organizations like the WHO to try and make that standard more
of a universally adopted protocol within these labs, and I
think that would provide a baseline that would definitely
improve the level of biosafety and biosecurity.
Mr. Guthrie. OK, thank you.
And Dr. Pekosz or Dr. Hawley, would you like to comment on
the question we just talked about? Do you have any--all right,
Dr. Pekosz, have you got a quick comment?
Dr. Pekosz. Yes.
Mr. Guthrie. Yes, OK, yes.
Dr. Pekosz. I think, you know, scientists around the world
talk to each other about these kind of things. The organization
of this becomes a political and a national discussion that
really has to involve other parties. But I think there is
willingness among scientists to talk to each other
internationally about this.
Mr. Guthrie. Dr. Hawley?
Dr. Hawley. Yes. I like to go back to the root of the
situation. I think what we need is an oversight organization to
look at the laboratories in the United States. The composition
of that organization should include some laboratory workers,
some people from the community, analogous to the membership on
an IBC. And I think, when you have this oversight, then you can
start adding ISO 35001, as other people have mentioned, or
other standards.
Well, we really don't have any standards in biosafety, to
the best of my knowledge. We have guidelines, the Biosafety and
Microbiological and Biomedical Laboratories. That textbook, so
to speak, is a risk-based approach to determine what kind of
facilities, equipment, and procedures used for the type of
work.
Mr. Guthrie. OK, thanks.
Dr. Hawley. So, to me, an oversight committee or an
oversight organization to look at research in the United States
would probably fill a lot of----
Mr. Guthrie. My time has expired, so I----
Dr. Hawley. [continuing]. Identified.
Mr. Guthrie. Thank you for that. Thank you.
I will yield back, Mr.----
Mr. Griffith. The gentleman yields back. I now recognize
the gentleman from New York, Mr. Tonko, for his 5 minutes of
questioning.
Mr. Tonko. Thank you, Chair Griffith and Ranking Member
Castor, for hosting this hearing. And I thank our witnesses for
joining us today and sharing their expertise.
The issue of lab safety is indeed an extremely important
one, and worth today's discussion. I greatly value the work of
our Nation's scientists conducting research vital to protecting
public health, and I appreciate the need for vigilance in
ensuring that our labs are operated safely, ethically, and,
certainly, responsibly.
However, I remain concerned that basic science has become
so politicized that we can't have a reasoned conversation on
how to protect the public from disease without delving into
unsupported conspiracies or unfounded allegations about what
scientists are doing in America's labs.
So, Dr. Pekosz, in your experience, have reasonable
discussions over topics like lab safety become more difficult
in recent years due to politics?
Dr. Pekosz. I think they have. I think institutions remain
vigilant. I think the laboratory workers remain vigilant. But
sharing this information to the general public has met with
some pretty harsh responses in many cases. And under the guise
of transparency, I think there is a duty for our scientists to
really communicate to the general public what we are doing and
how safe it is.
But some of the responses to those initial things have
really been quite disturbing, and I think that causes
scientists to really then go back into their shell and talk
amongst themselves more and, again, not communicate out to the
general public, which, again, is a self-fulfilling prophecy,
right, in terms of then having mistrust or a lack of trust in
those entities when there is no communication.
Mr. Tonko. Thank you. And I certainly believe that what we
do here in policy format needs to be science-based and
evidence-based. Absolutely critical that that be the given
situation.
So Dr. Koblentz and Dr. Casagrande, you both stated in a
recent New York Times op-ed that pathogens do not care about
politics, and that we need to forge an informed, bipartisan
path forward. You also wrote that, even though the weight of
the evidence on COVID-19's origins points to an animal-to-human
jump, we nonetheless should use the pandemic as an opportunity
to examine current lab safety protocols.
While I agree with that sentiment, it sometimes seems like
some of my Republican colleagues continue to conflate
legitimate issues about lab safety with allegations that some
renowned scientists are somehow covering up the origins of
COVID-19. So, Dr. Koblentz, why is it important that we move
forward with the conversation about lab safety in a politically
neutral and evidence-based way?
Dr. Koblentz. You know, even if this pandemic had no
linkage to any laboratory, we know the possibility exists that
work with either a, you know, a naturally occurring virus that
is brought back into a lab for characterization and
understanding its risks to the kinds of work with potential
pathogens that have been conducted previously, right, could
result in an accident.
And the fact that we know that is a possibility means we
need to be doing more to try and reduce that risk and prevent
the possibility from happening. And the fact that we can't rule
out the role of the ones who do virology should also provide
incentive for us to have better standards and oversight and
transparency on these kinds of labs, not just in China but in
the U.S. and around the world.
So I think, for all those reasons, this is an important
topic to be addressing, regardless of the specifics of the
controversy you are talking about.
Mr. Tonko. And Dr. Casagrande, would you want to add to
that concern?
Dr. Casagrande. Yes. I think, much like Three Mile Island
kind of transformed our thinking about nuclear power and a
series of aviation disasters transformed our thinking about
aviation safety, I think this pandemic, like Dr. Koblentz said,
just illustrates the potential consequences of an accident,
even if it had no laboratory origin.
And because the consequences can be so dire, investments in
preventing those consequences on the order of aviation or
nuclear power are definitely warranted. And that is not a
political question.
Mr. Tonko. And Dr. Hawley, in your testimony you write that
reports on lab incidents must be--and I quote--``characterized
by openness and engagement by all individuals,'' and you also
shared that one of the best ways to reduce risks of an accident
is by developing productive relationships with scientists.
How can the politicization of science and maligning of
scientists get in the way of efforts to improve biosafety?
Dr. Hawley. Well, personally, I have spent a lot of time in
the former Soviet Union countries looking at laboratories being
funded by the Department of Defense in order to redirect some
of the efforts of the former biological warfare scientists. And
I have found that the development of interpersonal
relationships, communications, and trying to earn the
individual's trust and enhance transparency--and I think it
begins with the development and sustainment and nurturing of
interpersonal relationships. And to me, that is most important.
And to the best of my knowledge, organisms do not have any
political affiliation at the present time.
Mr. Tonko. OK, we are there. I thank you.
And with that, I yield back.
Mr. Griffith. The gentleman yields back. I now recognize
the chairwoman of the full committee, Mrs. McMorris Rodgers,
for 5 minutes of questioning.
Mrs. Rodgers. Thank you, Mr. Chairman.
Dr. Koblentz, the United States scored 9 out of 10 on dual-
use research governance, while China scored 0. That is
obviously concerning, given the dual-use research on pathogens
as obvious military applications. Can you explain what factors
led to the differences in those scores?
Dr. Koblentz. Certainly. So the United States scored, I
think, 5 out of 10 because our primary mode of oversight is
through the NIH review of dual-use research and through the
DURC Policy and through the P3CO framework. And so--and the
United States also does awareness-building activities through
the National Science Advisory Board for Biosecurity, and we
have local stakeholder groups like the American Society for
Microbiology that have codes of conduct and codes of ethics
that govern the research being done by their scientists. So
those factors are what gave the U.S. the score it got for dual-
use research oversight, which is better than most countries,
but still not a perfect score by any means.
In contrast, China doesn't have in place now any meaningful
oversight of dual-use research. There is on the books a
biosecurity law from 2020 that calls for the development of
such a system within China. But those regulations have not yet
been promulgated within China, and so there is no active
oversight over the research that is being done to monitor and
oversee it, and whether or not it is--poses any dual-use risks
or not.
So I do hope that that will be forthcoming in the near
future, and we will certainly update our report when we do it
next if China and the U.S. make progress in those areas.
Mrs. Rodgers. OK. Thank you, I appreciate that
clarification.
Dr. Casagrande, for risky research involving dangerous
pathogens, why is more transparency about biosafety standards
and communicating best biosafety practices important?
Dr. Casagrande. Thank you for the question.
The communication of best practices is important because
each lab has very--has thought leaders who are carefully
considering the risks that they face and has implemented
particular mitigations to address all those risks and make them
as minimal as possible. This is often due to the creative
thought and careful effort of these individuals. And though it
is created to address risks that they have found personally in
their laboratories, those same mitigations could be beneficial
in many, many institutions. But people don't think of sharing
those innovations and best practices.
So understanding those and communicating those would enable
everyone to benefit from them, instead of reinventing them over
and over again. It would be a much more efficient use of labor.
Mrs. Rodgers. Thank you. Would you speak to how it may
benefit the public, more transparency and communication?
Dr. Casagrande. Sure. The sharing of these best practices
would benefit the public by, one, making sure our tax dollars
are best spent on doing the actual research, as opposed to
mitigating the risks of the research; and two, making labs
across the United States safer without actually having to, you
know, do trainings or anything like that. It would be just
communicating all the great work that has already been done
inside these containment labs.
Mrs. Rodgers. Would you speak--would you give us your
thoughts on what aspects of lab operations, lab safety could be
made more transparent?
Dr. Casagrande. Could be made more transparent?
Mrs. Rodgers. Yes, specific--like, what aspects of the
operations and the----
Dr. Casagrande. Sure. Well, I think the public--as was
mentioned on this panel, I don't think the public appreciates
the great effort that is going on already, how much effort is
spent on emergency response protocols, how much effort is spent
on medical surveillance, how much effort is spent on, if there
is an exposure, what those workers do, in addition to all of
the engineering controls and equipment that is spent.
People often conflate the concept of an incident in the lab
to an outbreak. And in fact, there is an incident that could
occur, and the vast majority of those are mitigated by the
equipment and procedures in place and don't result in an
infection. But if an infection were to occur, there's a lot of
procedures in place to isolate the worker and monitor them so
that they don't necessarily infect anyone else. So only a very
tiny minority of workplace infections lead to secondary
infections.
And so I think, because there is a lack of awareness on all
the different measures that exist inside U.S. laboratories, I
think people often think that you start at spilling a flask,
and then instantly you have a pandemic. And there's many, many
steps in between those two that are mitigated by all the
measures already in place.
Mrs. Rodgers. So it sounds like the increased transparency
could play a role in actually improving lab safety, also.
Dr. Casagrande. Yes, especially the public's perception of
lab safety. I don't think there is a good appreciation of all
the efforts that are currently in place.
Mrs. Rodgers. OK, thank you. Thank you all again for being
here.
I yield back.
Mr. Griffith. The gentlelady yields back. I now recognize
the chairman of the Energy Subcommittee, Mr. Duncan of South
Carolina, for his 5 minutes.
Mr. Duncan. Thank you, Mr. Chairman. And I think, when we
talk about transparency, the Chinese Government was not
transparent about what happened in Wuhan.
And I was amazed to hear Mr. Tonko talk about conspiracy
theories. During the pandemic, things that were dubbed as
conspiracy theories by the left were actually proven to be
correct in the long run. The Wuhan virus was--originated in
Wuhan, China. Whether it was natural or man-made doesn't
matter. U.S. tax dollars did go to fund grants at the Wuhan Lab
for gain-of-function research, and that was a conspiracy theory
before and now it has been proven. So over and over and over,
and I just want to push back on that.
Dr. Koblentz, a year ago today you presented at a meeting
held at NIH about oversight of research with potential pandemic
pathogens. A section of your written statement dealt with the
mishandling of the EcoHealth Alliance proposal and grant. You
noted that EcoHealth's research project concluded in vivo
experiments at the Wuhan Institute of Virology to determine the
risk of wild bat-related coronaviruses spilling over into human
populations.
Hey, we saw that.
This proposal was flagged by the NIH program officer as
potentially involving research covered by the 2014 gain-of-
function funding pause. NIH included a requirement in the
EcoHealth grant that ``if any of the chimeric viruses generated
under the grant showed evidence of enhanced virus growth
greater than 10 times that of the original virus from which
they were created, the grantee must immediately stop all
experiments with these viruses, and provide NIH and the Wuhan
Lab's Institutional Biosafety Committee with the relevant data
and information related to these unanticipated outcomes.''
So wasn't the inclusion of the excessive virus growth
policy a tacit admission that--by the NIH that such research
could be--reasonably be anticipated to produce a virus with
enhanced virulence or transmissibility, even if it was
unexpected or unintended? Yes or no.
Dr. Koblentz. Yes, I do think it could have been reasonably
anticipated.
Mr. Duncan. OK. Wasn't the proper course of action for NIH
to take was to refer this proposal to the HHS P3CO review group
to assess the risk and benefits of the research and recommend
how NIH should proceed with the grant? Yes or no.
Dr. Koblentz. I think that would have been--the appropriate
method would have been to review--forward that proposal to the
departmentwide----
Mr. Duncan. I take that as yes. But the NIH did not make
such a referral, isn't that correct?
Dr. Koblentz. Correct.
Mr. Duncan. Would you agree that NIH failed to properly
monitor the conduct and outcomes of this research?
Dr. Koblentz. Yes.
Mr. Duncan. In year 4 of the EcoHealth grant, the Wuhan Lab
conducted this experiment with humanized mice infected with
chimeric coronaviruses, and there was excessive virus growth.
EcoHealth did not stop the experiment and did not immediately
notify the NIH, as required under the grant terms. Even worse,
EcoHealth Alliance did not halt this research as required,
since it reported in its Year 5 Annual Progress Report that,
``We continued with the in vivo infection experiments of
diverse bat SARS-related coronaviruses on transgenic mice
expressing human ACE-2.''
Doesn't this raise serious questions about EcoHealth's
compliance with grant rules and show a breakdown of NIH
oversight responsibilities over such experiments of concern?
Dr. Koblentz. Yes, it calls into question implementation of
the grant.
Mr. Duncan. So there was failure for oversight of the
grant, research was done on coronavirus that--in mice that
could be transmitted to humans, there were a lot of mistakes
made, and I appreciate your forthcoming with that.
And with that I yield back, Mr. Chairman.
Mr. Griffith. I thank the gentleman for yielding back, I
appreciate his questions and now recognize the gentleman from
Alabama, Mr. Palmer, for his 5 minutes of questioning.
Mr. Palmer. Thank you, Mr. Chairman.
According to an excerpt from reporter Allison Young's new
book, ``Pandora's Gamble,'' a researcher from the University of
Wisconsin nearly contracted a lab-created bird flu virus. I
think that was in December 2019. The researcher was
accidentally exposed, and potentially--to potentially
contaminated air.
And what concerns me is that, according to Ms. Young's
reporting, the State and local health officials weren't
notified about the accident. And I really think this is part of
what we need to address in terms of oversight and more rigorous
controls, is that not only do we want to make sure we don't
have an accident like this, but if one does occur we don't sit
on it.
So I would like for your response to that from each of you,
if you don't mind.
Dr. Casagrande. I'll be happy to respond, Representative
Palmer.
So I think one of the things that we have noticed in work
with containment labs across the U.S. is that they have
different protocols for what happens after an exposure. And
once again, this is partially because of a lack of sharing of
innovations or best practices.
In some cases, every worker is given a card that they can
present to the medical system when they are exposed to an
extremely unusual virus that that practitioner might not have
ever seen in their life about treatments, about risks, et
cetera, and then they can present that card directly when they
present to the medical system. And that is an innovation that
is not copied everywhere. And the reason why it is not copied
everywhere is it hasn't been implemented into best practices or
standards yet, nor communicated.
There's also different rules about how you isolate at home,
and what flu watch looks like, how often you take your
temperature. And so these are the exact types of things that
better ``standards'' or guidance could focus on, more specific
guidance and standards.
Mr. Palmer. In the article that you and your colleague, Dr.
Koblentz, wrote, you talked about--that the U.S. has taken a
reactive and haphazard approach preventing lab accidents and
misuse of high-risk science. But--that is part of my concerns
about what happened in Wisconsin.
But you also made the point that the U.S. has more labs
than any other country. Does the U.S. have these labs that are
not located in the United States? Do you know if--when you talk
about the U.S. has more labs, are they all located in the
United States, or do we have labs elsewhere?
Dr. Casagrande. All the labs we cover in our report, which
are BSL-4 and BSL-3 enhanced labs, these are all U.S. labs that
are in the United States of America. The United States does
have labs overseas, but they are not in this category of BSL-4s
or BSL-3-enhanced that are a part of this report.
Mr. Palmer. OK. But given your concerns about research in
the U.S.--and I had to step out, so I may have missed some of
this, Mr. Chairman--but do you also have concerns about U.S.
funding through grants or subgrants and the oversight that is
applied to the labs where those grants or subgrants go?
Dr. Casagrande. Yes. I would like to see the U.S. apply the
same standards for biosafety and biosecurity that we have here
with laboratories that we are working with overseas that might
not be--you know, different countries have different biosafety
and biosecurity rules, and this is one of the issues that
becomes kind of complicated when you are trying to foster
international collaborations. So it would be advantageous to
try and harmonize those biosafety and biosecurity standards in
order for us to facilitate international cooperation.
But overall, I think it is the U.S. advantage to use our
grants and collaborations as a way to try and increase the
level of biosafety and biosecurity in the labs we are working
with overseas.
Mr. Palmer. It would help us do that if we had a really
rigorous set of oversight guidelines that we could implement.
And, I mean, you talked about the National Science Advisory
Board for Biosecurity unanimously approved some safeguards that
I assume haven't been implemented.
Dr. Casagrande. They have unanimously approved the
recommendations that have gone----
Mr. Palmer. The recommendations, all right.
Dr. Casagrande [continuing]. To the White House, and they
are being considered there. But it will be up to the, you know,
the executive branch, with the cooperation of Congress to
actually implement the recommendations----
Mr. Palmer. Well, the main point I would want to make, Mr.
Chairman, is that this board unanimously approved these
guidelines. And I think that is where we need to really focus
right now for upgrading our biosecurity and maybe having
something rigorous enough that can be applied through the
grants and subgrants.
Mr. Griffith. I appreciate that.
Mr. Palmer. And I yield back.
Mr. Griffith. The gentleman yields back. We will notify
everybody that votes have been called. We are going to try to
get our last two folks in before that happens, or before we
have to leave, so that everybody doesn't have to wait for us to
come back.
Mr. Ruiz is now recognized for his 5 minutes of
questioning.
Mr. Ruiz. Thank you very much.
As ranking member of the Select Subcommittee on the
Coronavirus Pandemic, we have been looking at this very issue--
so, like, the issue of how do we balance safety with the
necessity of robust scientific research so that we can prevent
and respond to public health emergencies like the COVID
pandemic.
Hopefully, we can all agree that lab safety is essential
and that there are ways to accomplish a safe lab environment
without stifling breakthroughs in innovation and scientific
discovery. I appreciate the testimony of our witnesses for
highlighting some ways that we might accomplish those
complementary goals.
So Dr. Casagrande, one suggestion that you proposed in your
testimony is to make sure that privately funded labs doing work
with certain pathogens are subject to similar oversight
requirements as publicly funded ones. Can you explain the
importance of uniformity and transparency in lab safety
guidance irrespective of funding sources?
Dr. Casagrande. Yes. As was mentioned by the other
panelists, the risks are independent of the funding source. It
relates to the experiments that are being done and the
pathogens studied. Also, it is--it helps level the playing
field. The unification of standards helps make sure that the
labs that are doing the most to be safe--and there's many, many
safe labs within the U.S.--aren't--don't have a competitive
disadvantage to the labs that are skating by.
And so standards and--uniform standards that apply
universally help level the playing field and ensure that the
safest labs aren't disadvantaged.
Mr. Ruiz. Thank you.
Dr. Pekosz, as someone working directly in a lab setting,
do you agree that there should be one set of biosafety rules
that everyone follows?
Dr. Pekosz. Absolutely. I think that funding sources should
not play a role in terms of setting biosafety guidelines.
I do feel that biosafety guidelines need to be very clear
and precise, because there is an area where research with
viruses such as influenza, something that is a common concern,
might be conflated with research on viruses like Ebola virus.
And it is important to note that there are very distinct
differences between what we want to do in terms of our
biosafety and how we want to monitor for those types of
experiments.
Mr. Ruiz. You know, in addition to that I am concerned that
some of the bans and moratoria on research using infectious
pathogens that have been proposed by some of my Republican
colleagues do not adequately strike the balance that we need
between mitigating risk while making sure we stay well
positioned in safe labs to achieve scientific breakthroughs.
So, Dr. Pekosz, do outright bans on research using
infectious pathogens strike the right balance between the risks
and rewards of infectious disease research?
Dr. Pekosz. Absolutely not. I mean, not only do they slow
progress of research, but they have ripple effects. Trainees
that come through the laboratory are less likely to be
interested in this type of research because they hear stories
about people's research being paused, a Ph.D. student not being
able to finish their research because of a pause that has been
implemented, and that has ripple effects on their ability to
want to go into this area and train.
And I think we know from the COVID-19 pandemic we need to
strengthen our public health infectious diseases workforce. We
can't have people leaving them or being hesitant to go into
that. We have seen the benefits that that has.
Mr. Ruiz. So can you share some examples of proposals for
lab safety improvements that, from your perspective, adequately
weigh the risks of certain research against public benefits?
And describe why they strike that balance correctly.
Dr. Pekosz. I think it is important to note that, once a
pathogen and a technique has been allocated a certain level of
biosafety, that provides a large level of security for an
individual. Experiments that were then done in those areas
already carry with it a high level of security and a high level
of safety.
I think we have to realize that oftentimes the bar is set
very high at the beginning. And when we see things later on
that are happening--sometimes this gain-of-function research is
considered that--oftentimes they still fall underneath the
safety considerations that are good to protect the individuals
that are working there.
Mr. Ruiz. Well, let me ask you another question that I am
grappling with, as ranking member of the other committee, is
that--you know, how do we build the relationships or the
influence, the incentives, or accountability structures to
ensure that there is lab safety in other countries and some
countries that may not be such allies with us, one.
And two is those countries may very well continue with
these other type of research, despite what the U.S. does, which
may put us at a vulnerable position in the future if we ever
need to investigate a virus that another country has
investigated further.
So how do we build the international structures to make
sure that labs are safe all around the world?
Dr. Pekosz. It is a challenging question, but I would say
it starts with the scientists. The scientists communicate with
each other quite well and quite effectively. If you start with
that and build the consensus as to what needs to be important,
what is important to be done, you can then work through the
political system to try to get that implemented across board.
Mr. Ruiz. Thank you.
Mr. Griffith. The gentleman yields back. I now recognize
the gentlelady, vice chair of the subcommittee from Arizona,
Mrs. Lesko.
Mrs. Lesko. Thank you, Mr. Chair. First of all, I want to
say thank you to you, Mr. Chair, because this is such an
important issue.
And I want to say thank you to all of you, because it is
absolutely vital that we pay attention to this issue. You know,
my question kind of relates to what Dr. Ruiz was talking about,
but I am going to ask it of Dr. Hawley.
In 2014, the Obama administration paused funding for gain-
of-function research due to the risk and safety incidents at
Federal laboratories that year. Then the NIH resumed funding in
2017 for gain-of-function experiments shortly after NIH, as we
have all talked about before, awarded a grant of this type to
EcoHealth Alliance. Around $600,000 of that grant went to the
Wuhan Institute of Virology.
As you know, COVID-19 happened. We have had different
hearings. It seems more likely than not, to me, that COVID-19
came from a lab leak from the Wuhan lab. Dr. Redfield, the
former CDC Director, has testified he thinks that there were
gain-of-function research that was going on there and that we
partially funded it. And Dr. Redfield actually told the other
subcommittee that I am on and the COVID Select Subcommittee
that he thinks we should put a pause on gain-of-function
enhanced potential pandemic pathogen research until we know--
until we have a broader discussion of it, until we have more
biosafety in place.
What do you think?
Dr. Hawley. It is just my opinion, ma'am, but I agree with
your comments, and I think it is most important to have an
oversight group to take a look at this.
There are gain-of-function experiments that are very
beneficial, and we have to have the appropriate panel of
individuals--scientists and lay members--to look at that and
evaluate that, and based upon--I keep repeating myself--the
risk-based approach to see whether or not it will be
beneficial. But I think we do need some sort of oversight, and
there is no question about that.
Mrs. Lesko. Yes, and since it sounds like, from what all of
you said, there is no centralized location in the Federal
Government for oversight and that some private labs don't have
any oversight, should we, do you think, pause this very
enhanced--I call it E-triple-P--research until we get the
biosafety apparatus in place?
Dr. Hawley. Yes. But again, I emphasize the fact that we do
need to start with oversight.
Mrs. Lesko. Yes, OK.
Dr. Hawley. And we are trying that. There is precedent for
not only oversight but community involvement with the Boston
Public Health Commission, the liaison with the people in the
community. They know what is going on.
The Containment Laboratory Community Advisory Committee in
Frederick, Maryland, has an interaction between the
laboratories of Fort Detrick and the community members whereby
we can openly have transparency, ask questions, publish near-
misses, and so forth. So to me, that is a form of oversight and
gaining the respect from the community.
Mrs. Lesko. Thank you. And my last question is for you,
too, Mr. Hawley. You had mentioned earlier in your testimony
that you don't think a Federal agency that provides grants for
bioresearch should be the same one that is in charge of
overlooking biosafety. I think that is what you said in so many
words. Is that accurate?
And are you talking about the NIH? That is my question.
Dr. Hawley. I am not going to name any organization, but
the bottom answer to your question is yes. I know, when I was
at Fort Detrick as a command biosafety officer, we had labs
internationally, and it was my job to go out and look and
monitor those labs. So we did have oversight, even though we
did provide funding.
Mrs. Lesko. All right. Well, thank you very much.
Thank you to all of you. Great communication--great
information, I should say.
Thank you, and I yield back.
Mr. Griffith. I thank the gentlelady for yielding back. If
there are no further Members wishing to ask questions, I would
like to thank all of our witnesses again for being here today.
In pursuant to committee rules, I remind Members they have
10 business days to submit additional questions for the record,
and I ask that witnesses submit their response within 10
business days upon receipt of the questions.
I further, in compliance with committee rules, would remind
special advisers Kennedy and Jack that they may receive test
questions, and we do expect those answers within 10 business
days, as well.
[Laughter.]
Mr. Griffith. That being said, without objection, the
subcommittee is adjourned.
[Whereupon, at 4:15 p.m., the subcommittee was adjourned.]
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