[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
EFFECTS OF DEVELOPMENTS IN SYNTHETIC GENOMICS
=======================================================================
HEARING
BEFORE THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
SECOND SESSION
__________
MAY 27, 2010
__________
Serial No. 111-127
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COMMITTEE ON ENERGY AND COMMERCE
HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan JOE BARTON, Texas
Chairman Emeritus Ranking Member
EDWARD J. MARKEY, Massachusetts RALPH M. HALL, Texas
RICK BOUCHER, Virginia FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California JOHN SHIMKUS, Illinois
BART STUPAK, Michigan JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York ROY BLUNT, Missouri
GENE GREEN, Texas STEVE BUYER, Indiana
DIANA DeGETTE, Colorado GEORGE RADANOVICH, California
Vice Chairman JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California MARY BONO MACK, California
MIKE DOYLE, Pennsylvania GREG WALDEN, Oregon
JANE HARMAN, California LEE TERRY, Nebraska
TOM ALLEN, Maine MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois SUE WILKINS MYRICK, North Carolina
HILDA L. SOLIS, California JOHN SULLIVAN, Oklahoma
CHARLES A. GONZALEZ, Texas TIM MURPHY, Pennsylvania
JAY INSLEE, Washington MICHAEL C. BURGESS, Texas
TAMMY BALDWIN, Wisconsin MARSHA BLACKBURN, Tennessee
MIKE ROSS, Arkansas PHIL GINGREY, Georgia
ANTHONY D. WEINER, New York STEVE SCALISE, Louisiana
JIM MATHESON, Utah PARKER GRIFFITH, Alabama
G.K. BUTTERFIELD, North Carolina ROBERT E. LATTA, Ohio
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin
Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE BRALEY, Iowa
PETER WELCH, Vermont
C O N T E N T S
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Page
Hon. Robert E. Latta, a Representative in Congress from the State
of Ohio, prepared statement.................................... 3
Hon. Phil Gingrey, a Representative in Congress from the State of
Georgia, opening statement..................................... 5
Hon. Joseph R. Pitts, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 5
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 6
Prepared statement........................................... 8
Hon. Joe Barton, a Representative in Congress from the State of
Texas, opening statement....................................... 12
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 13
Hon. John Shimkus, a Representative in Congress from the State of
Illinois, opening statement.................................... 14
Hon. Kathy Castor, a Representative in Congress from the State of
Florida, prepared statement.................................... 117
Hon. Edward J. Markey, a Representative in Congress from the
Commonwealth of Massachusetts, prepared statement.............. 119
Witnesses
J. Craig Venter, Ph.D., Founder, Chairman and President, J. Craig
Venter Institute............................................... 16
Prepared statement........................................... 19
Jay D. Keasling, Ph.D., Acting Deputy Director, Lawrence Berkley
National Laboratory............................................ 55
Prepared statement........................................... 57
Drew Endy, Ph.D., Assistant Professor, Stanford University,
President, Biobricks Foundation................................ 62
Prepared statement........................................... 64
Gregory E. Kaebnick, Ph.D., Editor, Hastings Center Report,
Associate for Philosophical Studies, The Hastings Center....... 69
Prepared statement........................................... 71
Anthony S. Fauci, M.D., National Institute of Allergy and
Infectious Diseases, National Institutes of Health............. 77
Prepared statement........................................... 80
Submitted Material
Letter of May 26, 2010, from international civil society
organizations to the committee, submitted by Mr. Waxman........ 120
EFFECTS OF DEVELOPMENTS IN SYNTHETIC GENOMICS
----------
THURSDAY, MAY 27, 2010
House of Representatives,
Committee on Energy and Commerce,
Washington, DC.
The Committee met, pursuant to call, at 9:08 a.m., in Room
2123 of the Rayburn House Office Building, Hon. Henry A. Waxman
[Chairman of the Committee] presiding.
Members present: Representatives Waxman, Markey, Pallone,
Gordon, Eshoo, Barrow, Castor, McNerney, Barton, Shimkus,
Pitts, Bono Mack, Burgess, Gingrey, Scalise, Griffith, and
Latta.
Staff present: Phil Barnett, Staff Director; Bruce Wolpe,
Senior Advisor; Karen Nelson, Deputy Committee Staff Director
for Health; Ruth Katz, Chief Public Health Counsel; Naomi
Seiler, Counsel; Robert Clark, Policy Advisor; Stephen Cha,
Professional Staff Member; Allison Corr, Special Assistant;
Eric Flamm, FDA Detailee; Greg Dotson, Chief Counsel, Energy
and Environment; Lorie Schmidt, Senior Counsel; Alex Barron,
Professional Staff Member; Melissa Cheatham, Professional Staff
Member; Karen Lightfoot, Communications Director, Senior Policy
Advisor; Elizabeth Letter, Special Assistant; Lindsay Vidal,
Special Assistant; Earley Green, Chief Clerk; Jen Berenholz,
Deputy Clerk; Mitchell Smiley, Special Assistant; Clay Alspach,
Counsel, Health; Ryan Long, Chief Counsel, Health; and Andrea
Spring, Professional Staff Member, E&E.
Mr. Waxman. The meeting of the committee will please come
to order. While we expect to call on our witnesses and have
them give us their testimony at ten o'clock, I did want to have
this hour available for members to be able to make opening
statements. I will make my opening statement and Mr. Barton
will make his opening statement just before we begin the
testimony. But I want to call on members who wish to make
opening statements and to recognize them at this time for that
opportunity. So let me--Mr. Burgess?
Mr. Burgess. Well, Mr. Chairman, actually I didn't realize
this was the arrangement. I will waive an opening statement in
deference time for questions because of the firepower we have
on our panel this morning. So I will waive the opening
statement.
Mr. Waxman. OK. Very good. We are not going to give you
extra time. We will just have--those are the rules of
subcommittee. Any other members seek recognition for an opening
statement? Yes, Mr. Latta?
Mr. Latta. Well, thanks, Mr. Chairman. If I may, I would
like to waive opening statement, just submit my opening
statement for the record please, my written statement.
[The prepared statement of Mr. Latta follows:]
[GRAPHIC] [TIFF OMITTED] 76582A.001
[GRAPHIC] [TIFF OMITTED] 76582A.002
Mr. Waxman. Certainly. We--without objection, we are going
to allow all members to submit written opening statements and
this is an opportunity for those who want to give their opening
statements at this--in an oral presentation at the committee
meeting. Gentleman from Georgia, Mr. Gingrey.
OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF GEORGIA
Mr. Gingrey. Mr. Chairman, thank you. Certainly, I look
forward to hearing from these high powered witnesses as my
colleague from Texas, my physician colleague just said, in
exploring these issues further. However, it seems a bit ironic
that we are holding a hearing on the future of medicine and
synthetic biology when the future of our health system, I
submit, indeed is in doubt.
A new study by Towers Watson found that one in six
employers are likely to reduce employment and retirement plan
contribution, such as 401(k)s, to pay for health reform. Forty-
three percent of employers are likely to eliminate or reduce
retiree medical programs because of this bill that we just
passed. Ninety percent of employers believe healthcare reform
will increase their organization's healthcare costs. Employers
like AT&T are already filing billion dollar losses with the
SEC.
Today, we should be meeting to explore why the Democrats
health reform bill is hurting so many employers and
subsequently, their employees. Such a hearing might also
explore how spending trillions of dollars to turn our
healthcare over to government bureaucrats may indeed very--may
ruin the very market we need to produce groundbreaking new
treatments like these witnesses are going to describe to us in
this hearing today.
With that, Mr. Chairman, I will yield back my remaining
time.
Mr. Waxman. Thank you. The gentleman yields back his time.
Mr. Pitts.
OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Pitts. Thank you, Mr. Chairman and thank you for
scheduling this hearing. Synthetic biology or synthetic
genomics has been in the headlines recently with the news last
week that Dr. Venter, who is testifying this morning, has
developed the first self-replicating cell to be made from
synthesized DNA. Advances in synthetic biology or synthetic
genomics have potential applications across a wide variety of
fields, healthcare and energy and the environment, to name a
few, and synthetic genomics can already be used to produce
medications and may possibly aid in tissue reconstruction.
In the future, these techniques could be used to create
biofuels or lessen pollution and while these are exciting
prospects, I think we all need to learn more about this science
of synthetic biology and synthetic genomics. I also think we
should carefully investigate the moral, the ethical issues, as
well as public health and safety issues, that advances in the
field are raising and I look forward to hearing from our
distinguished witnesses, learning from them today. Thank you,
Mr. Chairman and I yield back.
Mr. Waxman. Thank you very much, Mr. Pitts. Mr. McNerney,
do you wish to make an opening statement?
Mr. McNerney. Thank you, Mr. Chairman and I want to thank
the panel for coming--what a distinguished list of speakers and
they have made tremendous advances in the field and a lot more
to come. Of course, there is always the risk that is associated
with these sort of advances and we want to make sure that we
are on good standing with those risks but the potential for
good, in my opinion, outweighs the risk at this point, as long
as we keep mindful of that, and I just want to say I am a
little disappointed that our colleague from Georgia decided to
make this into a political spectacle, but that is what happens
in this committee.
But welcome aboard. I look forward to your testimony and
thank you.
Mr. Waxman. Thank you, Mr. McNerney.
Any other member wish to be recognized for the purpose of
giving an oral opening statement? We are going to recess until
ten o'clock. We will then begin the hearing, with opening
statements from the chairman and the ranking member, the
chairman of the two subcommittees that have a specific interest
in this, the energy and environment subcommittee and the health
subcommittee and the chairman and the ranking members of those
subcommittees as well and then we were going to call on this
very distinguished panel.
So we are going to recess now and all other members will
have an opportunity to put an opening statement, in writing, in
the record. We are in recess until ten o'clock.
[Recess.]
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. The meeting of the committee will come to
order.
The scope and depth of scientific research in America is
unrivaled. As a result, we and others around the world live
healthier lives and enjoy of the many advantages of modern
technology. As policymakers, we want to foster promising
discoveries, while ensuring that research is conducted and
applied responsibly. To this end, it is our job to understand
what the science does and does not entail. We need to separate
splashy headlines and science fiction scenarios from the
reality of what scientists are doing and where their research
might lead.
Last Thursday, we learned that researchers had taken a
major step forward by synthesizing the entire set of genetic
instructions for a bacteria and using it to reprogram another
bacterial cell. Observers as diverse as the American Society
for Microbiology and a Vatican City newspaper have noted the
potential benefits of this research. Today, we will learn more
about this and other advances in synthetic biology, the science
of constructing or adapting DNA cells and tissues. We will
explore potential applications to improve health, protect the
environment, and meet our energy needs.
We have also discussed the ethical implications and the
need to responsibly manage risks. Of course, this field did not
just spring up. Scientists have been harnessing the power of
DNA for decades. While most research involves one celled
organisms, like bacteria or yeast, the results are far
reaching. For example, in 1982, the FDA approved human insulin
from a gene inserted into yeast cells. Genetic engineering has
been used to make human growth hormone, hepatitis vaccine, and
other products and as we will hear, newer methods are already
leading to important medical applications. Synthetic biology
also has a potential to reduce our dependence on oil and to
address climate change. Research is underway to develop
microbes that would produce oil, giving us a renewable fuel
that could be used interchangeably with gasoline, without
creating more global warming pollution. Research can also lead
to oil eating microbes, an application that, as the Gulf spill
unfortunately demonstrates, would be extremely useful. The
promise of synthetic biology does not diminish the importance
of it being conducted and applied responsibly, as is true
whenever science advances.
We must weigh and manage the safety, health, and
environmental risks posed by this evolving science.
Fortunately, this assessment can build on existing regulatory
frameworks and I am pleased to see that President Obama has
just asked his bioethics commission to conduct a thorough
analysis of these issues. I look forward to hearing more today
from three leaders in the field of synthetic biology, Dr. Craig
Venter, Dr. Jay Keasling, and Dr. Drew Endy. They will explain
their work and its current and potential applications.
Dr. Kaebnick of The Hastings Center will offer a framework
for discussing the ethical questions related to synthetic
biology, questions about risk, and also about fundamental
beliefs about life and we also look forward, as always, to
learning from Dr. Fauci on NIH's role in synthetic biology and
how the agency's current approach can adapt to advances in the
science. Before we call on our witnesses, I want to recognize
the ranking member of the committee, Mr. Barton, for opening
statement.
[The prepared statement of Mr. Waxman follows:]
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[GRAPHIC] [TIFF OMITTED] 76582A.004
[GRAPHIC] [TIFF OMITTED] 76582A.005
[GRAPHIC] [TIFF OMITTED] 76582A.006
OPENING STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Barton. Good. Thank you, Chairman Waxman. I sincerely
do appreciate you scheduling this hearing today. It is good to
have a hearing about positive--at least what I consider to be
potentially very positive developments in the field of
bioresearch. We are going to hear today from scientists at the
Craig Venter Institute and others. They announced, not too long
ago, that they had created the first living organism with a
completely synthetic genome. Just amazing. They have used more
than 1,000 sections of preassembled units of DNA to create an
altered version of a bacteria that causes arthritis in goats.
It is an odd thing to recreate, but they have done it. Their
version is a little jazzier than the original, apparently. It
is blue and includes the scientists' names in code. I want the
next one to be red. OK? You have done one for the blue side,
now do one for the red side.
I hear that there are many potential applications of this
new technology for both energy and health innovations. In fact,
the first biotech patent is for a microorganism that could
clean up oil spills and that is really good news. Companies are
also looking into enhancing algae to make it a better producer
of ethanol or perhaps even to produce oil. One of our witnesses
today has reengineered a yeast to help produce an antimalarial
drug. I am also told that this technology could be especially
valuable in producing vaccines for fast mutating viruses, such
as influenza.
We must not only review the potential benefits of this new
technology though, Mr. Chairman. We must also look at the
possible ethical and safety implications. It is very important
that safeguards prevent new viruses from being created and
accidently, or maybe even intentionally, released to infect
humans or animals. It also creates additional bioterrorism risk
if terrorists erode nations, using the technology for bad
purposes. Although we are a long way from using synthetic
genomes to create large life forms, this is also a long-term
concern.
I hope to hear from the witnesses what sort of voluntary
and mandatory safeguards and procedures should be put into
place to ensure that we see only the benefits from these
exciting new developments. Mr. Chairman, the rest of my
statement, which is three pages, is about the healthcare bill.
I am not going to spoil this hearing by reading all that
because this is an important hearing and I wanted to be
positive and focus on the positive implications. I do hope
though in the near future though, Mr. Chairman, that we could
be in to schedule some hearings about the implications of the
new healthcare law. We are having a Republican meeting this
afternoon, briefing at one o'clock in the Visitor's Center. So
I am not going to put that into the record. I will simply say
that hopefully in the future, we can hold some hearings on that
new bill, new law.
But for this hearing today, I am sincerely appreciative of
our witnesses. I think this is a good thing for the committee
to be doing and look forward to positive interaction in the
question and answer period.
Mr. Waxman. Thank you very much, Mr. Barton. I want to
recognize the chairman of our health subcommittee, Mr. Pallone,
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, Mr. Chairman and thank you for
calling what I consider a very important hearing. It is
certainly going to be beneficial to hear directly from our
witnesses on the effects of the developments in synthetics
genomics. Advancements in science over the past several decades
have led to exciting developments in medical treatments and
today, we will learn about the current state of research to
effectively synthesize or modify DNA, explore the applications
of this research related to health and energy and discuss the
frameworks for ensuring compliance with ethical and regulatory
guidelines.
Research in the '70s and '80s related to recombinant DNA
technology led to one of the most notable early successes for
advances in drug development. In 1982, human insulin became the
first of many FDA approved medicines which utilizes technology
and later, the first recombinant vaccine was produced for the
hepatitis B virus. New strategies related to combining
engineering and biological techniques have strengthened
advancements and science related to genetic cellular and tissue
level biology and one of our witnesses today, Dr. Jay
Keasling--hope I am pronouncing it properly--will testify about
the innovative work he has done related to production of the
anti-malarial drug, artemisinin. The disease malaria kills over
a million people each year and it second only to tuberculosis
in its impact on world health. This disease spread by
mosquitoes is endemic in 90 countries and infects one in ten of
the world's population and malaria is a major cause of death
globally and a significant threat to the health of children.
The drug Artemisinin is currently far too expensive for the
people in developing countries who need it the most and
advances in drug production has the potential to dramatically
lower the price of this treatment, which will be notable
advance for global health.
Our good friend and frequent witness from the NIH, Dr.
Fauci--I hope I am pronouncing it--is also here with us today.
Dr. Fauci, the director of the National Institute of Allergy
and Infectious Diseases, will discuss the role of the NIH and
research using recombinant DNA and synthetic biology. NIAID
supported research have sequenced the complete genomes of
hundreds of disease-causing organisms, such as malaria,
tuberculosis, and seasonal and pandemic influenza. NIAID has
been a leader in providing support to research applying
recombinant DNA technologies, genomics, and other related
disciplines to the study of these infectious diseases and we
will also hear from Dr. J. Craig Venter of the J. Craig Venter
Institute about the exciting work he and his colleagues have
recently published this week and how this team believes their
work will lead to greater application in vaccine and energy
production.
Advancements in science must always be balanced by strict
and appropriate ethical guidelines. Clearly, there are many who
remain concerned that someone with nefarious intentions could
take advantage of new technologies and create a biological
weapon and we are fortunate to have with us today Gregory
Kaebnick, a research scholar at The Hastings Center. The Center
is an independent, nonpartisan, nonprofit research institute
that has been studying ethical issues in medicine, health
policy, medical research, and biotechnology since 1969. Mr.
Kaebnick will address concerns related to biosafety, deliberate
misuse and governance of bioethical issues, including the role
of NIH recombinant DHA advisory committee and the institutional
biosafety committees at research universities that receive
federal funding.
These boards, along with President Obama's presidential
commission for the study of bioethical issues, provide
important oversight and safety measures that accompany our
advancements in scientific discovery.
Again, thank you, Mr. Chairman. I know that this is,
frankly, I think, very interesting material but not easily
understood and I know that, you know, we need to do more
hearings like this and of course, it is--since it goes beyond
health into energy and other issues, it is important that we
have it at the full committee level. So thank you, Mr.
Chairman.
Mr. Waxman. Thank you very much. Now I would like to
recognize the ranking member of the subcommittee, the gentleman
from Illinois.
OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ILLINOIS
Mr. Shimkus. Thank you, Mr. Chairman, and welcome to the
panel. Synthetic genomes have a great potential to make
advancements in health in humans, as well as reducing Americans
dependent upon foreign energy and so I welcome you all here to
help educate us. From perfecting drugs, detecting and
preventing infections, strengthening human tissue and
developing enzymes that break down plant waste and convert into
biofuels, synthetic genomes hold a great potential in the
health area.
There are some ethical and safety concerns we must remain
mindful of as this technology advances but the opportunity for
growth is certainly encouraging.
Having said that, I wish I was as magnanimous as my ranking
member, but I have asked this question for about four weeks
straight now for hearings on a healthcare law and I will use my
time to address some concerns in that vein. You know, another
week and another opportunity lost to address issues that are
pressing in this healthcare law. The committee has seemingly
dropped everything for this hearing, including cancelling a
previously scheduled hearing, yet there has never, ever been a
hearing on the actual health reform law that we passed.
Every day we are hearing from constituents with questions
and concerns on how the new law will affect them and
businesses, small and large, are trying to understand how they
can keep their doors open and provide insurance to their
employees. The state of Virginia recently estimated the impact
of the unfunded mandate on states will be 40 percent more than
their initial estimate. Will all states have similar
unsustainable increases? The Medicare flier sent this week by
the administrator highlights improvements of Medicare
Advantage. But the CMS actuary report says 50 percent of
seniors will lose their Medicare Advantage plans and for the
other 50 percent, CBO said their benefits will be gutted an
average of $816 per senior. How can we look at these seniors
and tell them these are improvements? Last week, the
administration taunted the tax incentives for small businesses
and how it would provide relief to small firms. CBO says only
12 percent of businesses would see any relief at all, even with
fewer eligible for the small tax credit and to get that full
tax credit, you have 10 or less employees making an average of
$25,000 or less. This leaves 88 percent of the entire small
business workforce employed at a small firm that won't get any
tax credit at all.
I sent a letter to Chairman Pallone last week requesting a
hearing on the impact on small business. We look forward to a
response on that request in the near future. There was recently
also a letter from Republicans on the committee, requesting a
hearing with the CMS Actuary on the report. To my knowledge, we
have not had a response. Could that have been on the schedule
today? Can we, as members of this committee, honestly say these
concerns in the public do not rise to the level of greater
immediate importance? I am hopeful the committee will hold
formal hearings. But we have asked on several occasions and our
requests have been ignored.
Starting this afternoon at 1 p.m. in the Capitol Visitor's
Center, the Republican Healthcare Solution Group will hold its
first of a series of forums on the new health reform law.
Today, we will have expert witnesses testifying on the true
cost of the health reform law, as cost estimates continue to
rise for families, businesses, and taxpayers as a whole. Press
has been invited. We will be webcasting and Tweeting live, as
well as posting the video on the hearing online. I would
encourage anyone interested in the impact of this government
takeover of healthcare to contact any office on the Republican
side for more details. With that, Mr. Chairman, thank you and I
yield back my time.
Mr. Waxman. Thank you very much, Mr. Shimkus. I would like
to talk about the necessary war in Iraq, the deficits that we
are experienced because of unpaid for tax credits for the upper
income, and other very bad decisions made by the Republican
administration, but that is not what this is all about. We have
another hearing scheduled. This is May, 2010. We are a number
of months off from an election. Had this been made 2009, you
might have heard the same story. Seems like campaigns go on
forever----
Mr. Shimkus. Would the chairman yield for one second?
Mr. Waxman. Sure.
Mr. Shimkus. Yes, I remember in the Medicare debate, when
you continued to push for the Actuary to have a hearing here,
after the fact. We are just asking--I am just doing the same
thing that you did when you were in the minority and I think
that when the CMS Actuary has an opportunity to give us the
real numbers and we have asked numerous times that, you know,
we--and there is issues out there that we could fix. We should
do that.
Mr. Waxman. The gentleman and I--I would be pleased to
discuss it with you further but I want to proceed with this----
Mr. Shimkus. Thank you, Mr. Chairman.
Mr. Waxman [continuing]. Hearing. Thank you for the points.
Our witnesses today, Dr. J. Craig Venter is the president and
founder of the J. Craig Venter Institute, the not-for-profit
genomics research institute. He is also the founder and chief
executive officer of Synthetic Genomics Incorporated.
Dr. Jay Keasling is a professor in the Department of
Chemical Engineering and Bioengineering at the University of
California Berkley. He is also acting deputy director of the
Lawrence Berkley National Lab and chief executive officer of
the DOE funded Joint BioEnergy Institute.
Dr. Drew Endy is an assistant professor in the Department
of Bioengineering at Stanford University, president of the
BioBricks Foundation and director of BioFab, the international
open facility advancing biotechnology.
Dr. Gregory Kaebnick is a research scholar at The Hastings
Center, a nonpartisan bioethics research institution. He is
also editor of the Bioethics Journal, The Hastings Center
report and Dr. Anthony Fauci is the director of the National
Institute of Allergy and Infectious Diseases and the National
Institutes of Health.
We are pleased to welcome all of you today at our hearing.
It is the custom of all oversight hearings to ask that the
witnesses testify under oath so I would like to ask if you
would please rise and hold up your right hand.
[Witnesses sworn.]
Mr. Waxman. The record will indicate each of the witnesses
answered in the affirmative. We are anxious to hear what you
have to say. If you do want to comment on the health insurance
plan adopted by the Congress, save that for another hearing.
But we have got a lot of information that we want to learn
about from you. Dr. Venter, why don't we start with you?
TESTIMONY OF J. CRAIG VENTER, PH.D., FOUNDER, CHAIRMAN AND
PRESIDENT, J. CRAIG VENTER INSTITUTE; JAY D. KEASLING, PH.D.,
ACTING DEPUTY DIRECTOR, LAWRENCE BERKLEY NATIONAL LABORATORY;
DREW ENDY, PH.D., ASSISTANT PROFESSOR, STANFORD UNIVERSITY,
PRESIDENT, BIOBRICKS FOUNDATION; GREGORY E. KAEBNICK, PH.D.,
EDITOR, HASTINGS CENTER REPORT, ASSOCIATE FOR PHILOSOPHICAL
STUDIES, THE HASTINGS CENTER; AND ANTHONY S. FAUCI, M.D.,
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL
INSTITUTES OF HEALTH
TESTIMONY OF J. CRAIG VENTER
Mr. Venter. Chairman Waxman, Mr. Barton, committee members,
thank you for the opportunity to be here today. I will just
make a few introductory comments to explain what it is we
announced last week with our publication in science. We
announced the first synthetic species. Its genome was read,
encoded in the computer, as we have been doing since 1995. Now
we have been able to reverse that process. We have been able to
start with a digital code in the computer, four bottles of
chemicals, and write the over one million letters of genetic
code for this small microbe. We then were able to transplant
that into a recipient cell. The synthetic genome took over that
cell and converted that cell into a new species. The only
genome in that species is the synthetic genome. All the
proteins there are made from that synthetic code and that is
why we call it a synthetic cell. What it is not, it is not life
from scratch. We used a living cell and converted it into a new
cell, based on this synthetic genome. But it is the first cell
to have its parent being a computer and this is the first, even
though there has been a long trend, a real merging of the
digital world and the biological world, we can now start in the
digital computer and go out and write new software of life, the
software's DNA.
This is a baby step, in our view. This is a proof of
concept. This organism was not made for any other purpose,
other than for the proof of concept. We have been working on
this for 15 years, since we sequenced the first two genomes in
history in 1995, trying to have the tools to understand a
minimal cellular life. But over the course of that time, we
have clearly become aware of other possibilities and uses for
this powerful technology and we have been exploring that. I
started, along with Hamilton Smith and two others, a new
biotech company a few years back called Synthetic Genomics in
La Joya, California, aimed to build on these new tools, these
new technologies. One of our partners is Exxon Mobil. We are
trying to look at algae to make new sources of hydrocarbons
that can go into the refineries, starting with carbon dioxide.
We have seen, for this last month, a very visible reminder
about oil coming out of the ground. We don't see CO2 in the
atmosphere but we can certainly see the oil on the water and
the beaches in the Gulf.
I feel very strongly we need to wean ourselves off of oil.
If we can start with carbon dioxide as the feed stock, it could
be a tremendous advance. Looking at tens of thousands of
species of algae, there is nothing out there that we found yet
that has the power to get up to the billions of gallons of fuel
that are needed. So the tools of molecular biology, the modern
tools, including the ones we have just developed are going to
be key to that success. We also see potentially next year's flu
vaccine could come from these tools that we developed, not from
the synthetic cell but the ability to write the genetic code
and we have funding from NIH, actually from Dr. Fauci's
institute, to start building the segments of all the flu
viruses that we have been sequencing with funding from the NIH,
we will have these on the shelf and we could very rapidly, we
think in less than one day, build new vaccine candidates in
contrast to the months that it currently takes. These could
feed in. One of our partners is Novartis. They are building an
NVCK cell facility that these new candidates could go into
rapidly producing vaccines. These are powerful tools that give
us a new way to look at the world.
The last thing I will mention is we, I think almost
unprecedented in science, asked for ethical review of this
research before we did the first experiments. This was back in
1997. This was done at the University of Pennsylvania. They
published our results in Science in 1999. We have had ongoing
discussion, trying to drive the discussion. We have had funding
from the Sloan Foundation, along with MIT. The reports have
been published looking at the security. In fact, many of my
colleagues here have been looking at these issues and driving
them. So the scientists, I think, not only are being
responsible, we are asking the questions before anybody else
has.
We have worked with different administrations. In 2003, our
early work was funded by the Department of Energy. The
Secretary of Energy held a press conference with our
announcement then of a synthetic virus. This work has been
vetted in the past administration through the White House and
came down on a side of open scientific publication, which I
think is a real victory for science.
I have briefed the Administration and many members of
Congress before our announcement. We think this is an important
initial step in science, gives us some tools to go a long way.
So Mr. Chairman, Mr. Barton, committee members, if you will
incorporate--I ask my statement get incorporated into the
record and thank you for the opportunity.
[The prepared statement of Mr. Venter follows:]
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Mr. Waxman. Thank you very much, Dr. Venter. By the way,
all of your statements, all your prepared statements will be in
the record in their entirety and I am going to run a clock and
it will turn red when the time is up. But if you are in the
middle of discussing something, you can go ahead and complete
your thoughts. We are not going to run strictly by the clock
but it is a way of giving us guidance.
Dr. Keasling, we want to hear from you.
TESTIMONY OF JAY D. KEASLING
Mr. Keasling. Chairman Waxman, Ranking Member Barton, and
distinguished members of the committee, thank you very much for
holding this hearing and for inviting me to testify.
Synthetic biology is the engineering of biology with
standardized, well characterized biological components, much
like we might build a computer from various components, like a
hard drive, a sound card, a video card, and a power supply.
Using these standardized, well characterized components,
synthetic biologists are making biological engineering more
reliable, easier, and less expensive than with traditional
genetic engineering techniques and the resulting engineered
organisms will be safer. Not only will synthetic biology enable
a host of important applications to solve societal problems, it
will decrease the cost of doing biological research.
Federal funding has played an important role in the
development of synthetic biology. The National Science
Foundation has funded the Synthetic Biology Engineering
Research Center, SynBERC, which brings together many of the
pioneers of synthetic biology to create new biological
components, set standards for connections between these
components, and demonstrate the use of these components in
important applications.
SynBERC investigators are also steadying safety, security,
preparedness, and ethics around this new field of synthetic
biology to ensure that these powerful technologies are used
safely and wisely.
One of the most important and well-known applications of
synthetic biology has been our work on engineering yeast to
produce the antimalarial drug, artemisinin. There are 300 to
500 million cases of malaria at any one time, with one to three
million people dying every year of the disease. Ninety percent
are children under the age of five. While traditional quinine-
based drugs are no longer effective, plant derived artemisinin
combination therapies are highly effective but cost prohibitive
for much of the world. Soon artemisinin will be in short
supply, which will mean that millions of children will die
needlessly. To decrease the cost and increase the supply of
artemisinin, we engineered brewer's yeast to produce a
precursor to the drug, by transferring into the yeast, the
genes responsible for making the drug and the plant that makes
it naturally. The resulting process for producing artemisinin
is akin to brewing beer. The engineered yeast consumes sugar
and secretes a precursor to artemisinin that can be readily
converted into the drug. Through funding from the Bill and
Melinda Gates Foundation, we completed the science in three
years, largely due to access to well characterized biological
components. The microbial production process has been licensed
to Sanofi Aventis and--which will scale the process and produce
the drug in the next 2 years, selling it at cost in the
developing world. We predict that this process, when fully
implemented, will save a large fraction of the two million or
so children who dies every year from malaria. Fortuitously,
artemisinin is also a hydrocarbon, which is the fundamental
building block of transportation fuels.
Through advances in synthetic biology, we can reengineer
this artemisinin producing yeast to produce biofuels that will
work within our existing transportation infrastructure. The
Joint BioEnergy Institute in Emeryville, California, one of
three DOE funded research--bioenergy research centers, is using
the advances in synthetic biology to engineer microbes to
transform sugars into--from cellulose and starch into
hydrocarbon based biofuels that have the same quality of the
fuels currently produced from petroleum. These new advanced
biofuels will not require a change in our transportation
infrastructure that would be necessary if ethanol were used as
a pure fuel. In addition, these advanced biofuels will reduce
the production of greenhouse gases, reduce our dependence on
foreign oil, and could reinvigorate the U.S. agriculture
economy. I am from a farm, by the way.
My research is the foundation for two California-based
advanced biofuel companies that are currently employing
hundreds of people and in the next 2 years, they will have
fuels out on the market. Very similar technologies are being
used by JBEI to engineer plants to become efficient producers
of cellulose, with minimal input of water and fertilizer.
Indeed, the advances in synthetic biology will allow us to have
plentiful food to feed the population and biomass for fuels.
Many other applications could benefit from advances in
synthetic biology, including nitrogen fixing crops that do not
need ammonia-based fertilizers, microbes engineered to produce
all the chemicals currently produced from petroleum, and
entirely new classes as drugs to fight cancer, infections of
bacteria, and a host of other diseases.
I hope that my testimony has illustrated for you the
remarkable potential of synthetic biology and important role
that it has to play in our Nation's research and innovative--
innovation enterprise. Your actions in the support of Congress
will determine whether the efforts described today are
ultimately successful. This is a marathon, not a sprint, and
requires consistent and continuous nurturing and case. Finally,
thank you for holding this important hearing and for inviting
me to participate. Please let me know if I may be of any
assistance. I am happy to answer any questions at the
conclusion.
[The prepared statement of Mr. Keasling follows:]
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Mr. Waxman. Thank you very much for your testimony. Dr.
Endy.
TESTIMONY OF DREW ENDY
Mr. Endy. Thank you and good morning, Chairman Waxman,
Ranking Member Barton, and members of the committee. In
addition to my professional appointments, let me note that I
serve on the Committee of Science, Technology, and Law at the
National Academies, have recently been nominated to the
National Science Advisory Board for Biosecurity, and was an ad
hoc member of the Recombinant DNA Advisory Committee as the
biosafety guidelines were recently updated to account for
advances in synthetic biology and other matters.
I thought I would start by introducing some of our own
work. In 2005, my lab, then at MIT, published a redesign for
the genome of a virus. We did not have access to the advanced
DNA and genome synthesis tools that are bringing us here today
and so the students in my lab spent the entirety of a research
budget, about $200,000, struggling to build 12,000 base pairs
of designer DNA, 12,000 letters. We made 600 changes to the
virus genome, all at once, and we are very curious just to see
if it would work.
To our great relief, the virus was capable of reproducing.
Before you are alarmed, I will quickly note that the virus grew
half as well as the natural isolate. That was our first
experience with synthetic biology and synthetic genomics.
Also at MIT, I was involved in the development of six new
courses, comprising part of what is now the new undergraduate
major in biological engineering. Imagine being a teenager,
matriculating at MIT, and having the possibility of becoming a
biological engineer, much like you might become an electrical
engineer or chemical engineer. What would you expect to learn?
Well, one of the things that came out of those six courses,
under Randy Rettberg's leadership, is now known as iGEM. It is
the International Genetically Engineered Machines competition.
This is a worldwide event. It is akin to a genetic engineering
Olympics for undergraduates and so now each summer, thousands
of students at hundreds of universities around the world
compete and work together to build engineered genetic systems
that solve problems they define. For example, we have students
engineering bacteria to detect pollutants in the environment
and change colors so that people might more cheaply be able to
find out where problems are.
As a third example, now at Stanford, my lab is struggling
to implement data storage systems inside living cells. We
basically want to be able to control a small amount of
information, one, two, three, or four bits, inside a yeast cell
or inside a liver cell. We are not trying to replace computers.
We are trying to bring computers into life so that we can act
on information in places where we haven't been able to
previously. For example, imagine being able to count how many
times a cell has divided. That would let you study aging. It
would let you begin to consider reprogramming aging. It would
help to instrument cancer research and reprogram cancer or
perhaps development in regenerative medicine applications.
In all of our work, we find ourselves speaking as an
engineer to be very poor as engineers of biology. The genetic
programs we write tend to be 10 or 20,000 base pairs or letters
of DNA law. I would have no idea how to take advantage of a
million base pair fragment of synthetic DNA today and quickly
program up a thousand different genes and get it to do
something useful.
As it has been mentioned previously, the needs of the
engineering community and the scientific community to get
better at putting together the pieces of DNA and the pieces of
biology to solve useful problems, will be a formidable basic
research challenge for decades.
Let me turn briefly to issues of bioenergy and the national
policy around bioenergy. I want to make one point quite quickly
that I think is an old story and in the excitement around
bioenergy, it might have been short stepped. Here is my
favorite bioenergy application. In 1980, researchers figured
out that you could improve laundry detergents for treating
stains on clothing by using enzymes, adapted to function at
cold water wash temperatures. This was an early genetic
engineering project. The impact of widespread deployment of
this enzyme throughout the Nation is to reduce the need for
domestic hot water heating. The estimate in 1980 was the
reduction in oil equivalent was about 100,000 barrels a day.
One enzyme integrated upstream into our daily lives can have a
net energy impact of 100,000 barrels of oil a day. I hope that
is greater than the current spill in the Gulf of Mexico and if
you look at biofuels as a complement to this, which are
individually and independently important, 100,000 barrels of
oil a day might be 100 to 200,000 acres of cropland or about 1/
2000th of our cropland. So the point I would simply like to
note here is as we have forward to bioenergy investments, in
addition to biofuels, I would urge us to consider how future
applications of biotechnology could be more directly integrated
into our daily lives and upstream existence in ways that are
responsible.
In the brief time I have left, let me note that I think the
tools that bring us here today around genome construction raise
a number of specific issues having to do with safety, security,
and property rights. I will not go into those in detail here
but would welcome questions on the matter. Thank you.
[The prepared statement of Mr. Endy follows:]
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Mr. Waxman. Thank you very much. Dr. Kaebnick.
TESTIMONY OF GREGORY E. KAEBNICK
Mr. Kaebnick. Mr. Chairman, Ranking Member Barton, and----
Mr. Waxman. There is a button on the base of the mic, yes.
Mr. Kaebnick. There we go.
Mr. Waxman. Good.
Mr. Kaebnick. Mr. Chairman, Ranking Member Barton, and
distinguished members of the committee, thank you for inviting
me here and for bringing attention to the ethical issues of
this field. My name is Greg Kaebnick, I am a research scholar
at The Hastings Center, nonpartisan, nonprofit, non-independent
research institute that studies ethical issues in medicine and
the biological sciences, editor of one of our journal, The
Hastings Center Report. We are now in a 2-year project funded
by the Alfred P. Sloan Foundation to investigate the ethical
issues of synthetic biology.
What I want to do this morning is just to set synthetic
biology within a widely used framework for we are thinking
about ethics of biotechnologies and then comment very briefly
on its governance.
The ethical issues fall into two broad categories. First
are intrinsic concerns, as they are called, which are about
whether the science is good or bad in and of itself, aside from
consequences. Many people have an intrinsic objection to
cloning human beings, for example. They just feel it is wrong
to do full stop.
The second category involves concerns about potential
consequences, risk and benefits for example. The classic
intrinsic concerns about synthetic biology are that scientists
are playing God, as people often say, or that life is something
more than just a soup of interacting chemicals that we can see
in a microscope, maybe something sacred, and scientists are
overstepping their bounds in creating it.
You might worry also that synthetic biology will undermine
the moral value of life, even if you don't believe that life is
something more than interacting chemicals. I think beliefs
about the specialness of life or the sacredness of life, for
those who put it that way, are not undercut by this science. We
are just talking about microbes at this point. More
importantly, whatever value we do attach to microbial life, we
can also find in the life of a synthesized microbe as well.
Yet another possible intrinsic objection to synthetic
biology is environmentalists. We might think that it is an
intrinsically undesirable intrusion into nature. Of course,
even environmentalists accept that forests may sometimes be
logged, so there is a question of balance here, a question of
where to draw the line. If synthetic biology turned out to be
beneficial to the environment, many environmentalists, myself
included, would find it attractive.
Intrinsic moral concerns are important and can be important
for policy, but in the case of synthetic biology as it now
stands, I do not think they point the way toward regulation. I
think the field should be judged and governed on the basis of
the second category of moral concerns, the consequences. The
field holds significant promise of benefit. There are also,
however, morally serious risks. First, there are concerns about
justice. Some worry that synthetic biology could be such a
powerful way of making and distributing goods, that if we
aren't careful about how it is used, the benefits from it, who
owns it, there could be long-term social and environmental
harms.
Two other kinds of concern are about possible physical
dangers. There are concerns about accidents, organisms escaping
and running amuck, and about deliberate misuse. I once heard a
microbiologist say that he was very enthusiastic about
synthetic biology and the only thing that worries him is the
possibility of catastrophe.
Synthetic biology aims at simplicity and control. One of
the themes of traditional biology though is that living things
usually turn out to be more complex than we thought. I believe
we should guard against an overconfidence that we understand
the risks of this field. We should not assume that synthetic
organisms will shed the unpredictability. Inherent life tends
to find a way, so might artificial life.
I would not at all call for a general moratorium on the
work. I would offer some broad recommendations for how to
proceed. We need, I think, first, more study of the emergence
plausibility and impact of potential risks. Second, a strategy
for studying the risks that brings together different
disciplines and perspectives. Third, a strategy that is
grounded in good science, not sheer speculation, but is
flexible enough to look for the unexpected. And fourth, an
analysis of whether our current regulatory framework is
adequate and we should also continue the conversation about
ethics.
Thank you for this opportunity to share my thoughts.
[The prepared statement of Mr. Kaebnick follows:]
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Mr. Waxman. Thank you very much, Dr. Gaebnick. Dr. Fauci.
TESTIMONY OF ANTHONY S. FAUCI
Dr. Fauci. Thank you, Mr. Chairman, Ranking Member Barton,
members of the committee.
Mr. Waxman. Is your mic on?
Dr. Fauci. Yes, it is.
Mr. Waxman. OK.
Dr. Fauci. Thank you for the opportunity to discuss with
you for a couple of minutes and certainly answer any questions
that you would like on the role of the NIH in genome research
and related research activities.
[Slide shown.]
I have here on the first visual that you could see on the
screen that this is an enervative process that has been going
on with NIH support in the arena of recombinant DNA technology
and genomics for decades. It has everything and even things
that I have recently testified before a subcommittee of this
committee on, everything from the sequencing of the human
genome to the sequencing of thousands of viruses and over a
thousand bacteria and other microbes. Just a couple of weeks
ago, we had a hearing here, shared by Mr. Pallone, Chairman
Pallone, on antibiotic resistance and we spoke of the power of
the tools of sequencing and recombinant DNA technology. Also,
we are studying the mind microbiome, which is the flora that is
contained in the human body and how it relates to both health
and disease. Also, the whole arena of recombinant DNA
technology, the fundamental basic and applied researched that
emanated from that, largely with support from the NIH, has
actually resulted in a transformation of the field of the
biotech industry and all of the very good things that have
occurred regarding drugs and vaccines that you have already
heard of, as well as a variety of other issues related to this.
[Slide shown.]
On the second visual, it is very interesting. I did a
search just a couple of days ago and I just plugged into Pubmed
three components, recombinant DNA, technology, genome or
genomics and it turns out that almost 800,000 papers have been
published on this so we are not talking about a field that was
born yesterday. As you have heard from Dr. Venter, he has been
working on this for decades.
[Slide shown.]
So if you go over to the next visual, I think this is
important and might explain it. It is really a continuum.
Synthetic biology is a continuum of a process of understanding
genes and genomics that has been going on for a very long time.
First, the sequencing or finding out the natural blueprint of a
genome from nature. Then there was synthesis of fragments of
that, genome segments or genes themselves, again, from
naturally occurring blueprints, and there came the insertion of
genes, either splicing out from one and putting it into another
or synthesizing little fragments and putting it into a vector
that can have that particular microbe or whatever do what you
would like it to do, like produce insulin or human growth
hormone or what have you. What you have heard today, and will
hear during the question period, is the synthesis of whole
genome from a naturally occurring blueprint. The next step
being, and this is going to be very, very difficult, how you
can synthesize genes and genome and circuits that are really
novel, that can make them de novo do what you want them to do.
So it really is a continuum over many years.
I won't dwell on what was already said by several of the
panelists. The extraordinary potential good applications of
synthetic biology, related from everything from the environment
to energy to agriculture and to the area that I and my
institution are most interested in, is medicine and health. Dr.
Kaebnick gave you a very nice summary of some of the ethical
concerns and how he feels confident that we are on the right
track here. Let me give you some specifics about that.
[Slide shown.]
If you go to this next visual here, there are a number of
areas of review and oversight that really have followed along
very nicely the history of the emerging field of recombinant
DNA technology. When scientists first realized the power of the
tools of recombinant DNA technology, they themselves did what
we call self-scrutiny and self-policing. They got together and
what was born of that is what we know now of the Recombinant
DNA Advisory Committee or the RAC, which is housed at NIH,
which sets forth the guidelines for the use of these
technologies. In 2003, Dr. Venter, in a very transparent way,
brought before us, we had DOE funding at the time and he came
to me and others to talk about what the best approach would be,
at the time that he had synthesized a virus, a much smaller
microbe than what he has just done now, and out of that came
the birth of what is now known as the National Science Advisory
Board for BioSecurity, or NSABB, which is also housed at the
NIH, which is involved in the same sort of philosophical
approach as the RAC. A lot of overlap and inter-digitation
there, but also concerned not only about biosafety, but about
biosecurity. We can talk a bit in the question period about
what is also going on about how we are going to bring into the
arena of synthetic biology, the reviews and the oversights that
we have had for the pre-synthetic era, namely just the
sequencing and recombinant DNA technology era.
You have also heard and you mentioned in your own
statement, Mr. Chairman, that President Obama, on the 20th of
May, has asked his commission for the study of bioethical
issues, to examine this, and within 6 months to come back to
him with a report of anything that might need to be done.
[Slide shown.]
And on this last visual, I just want to tell you how I
think everyone at this table thinks. What these guidelines have
really established, not only for the people with government
funding, in which you have some sort of a stick that you can
make sure these guidelines are followed, but also it has
created in the field what we call a culture of responsibility,
namely to get the people involved in doing this work to realize
and to understand that even when you are trying to do something
good, you have got to be very careful, careful about the safety
of the people that are working with you and careful about the
security of what others might use in a nefarious way. So I have
shown here on this, it really is a balance, the balance of
fostering and enabling scientific research and innovation with
some extraordinary potential, as you have heard from the other
witnesses, with making sure, according to the guidelines that I
just mentioned, that we do prevent the dangerous uses of this
technology.
I would be happy to answer any questions. Thank you.
[The prepared statement of Dr. Fauci follows:]
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Mr. Waxman. Thank you very much for your testimony. I am
going to now recognize members for 5 minute intervals to ask
questions. I will start with myself.
Dr. Venter, this is a remarkable advance for science. You
have described it as the software of life. I know at one point
you said it was a computer created life and some of the writers
about your announcement almost acted as if this is the creation
of Frankenstein. Now to put it in perspective, without in any
way diminishing what you achieved, the--you had to have a life
to build on. You didn't develop a life from scratch. Isn't that
right?
Mr. Venter. That is absolutely correct. We, as Dr. Fauci
said, we copied basically a genome of known organism. As Mr.
Barton said, a goat pathogen, but we removed 14 genes that
according to the scientific letter chart result of that--
control its pathogenicities, so we have changed it so it is no
longer a goat pathogen. But if you think about doing the very
first experiment, we had to start with a control--something
that would work. If we went to the bottom phase of Dr. Fauci's
slide of trying to design something new, the odds are pretty
low that it would have worked. Ninety-nine out of 100 of our
experiments failed. Even with one error out of a million in the
genetic code, we did not get life. So we copied life and we
used a living cell to boot up that life. So it is, as all life
on this planet, it has been life out of life. It is not new
life from scratch.
Mr. Waxman. And as I understand it, the genome for this
bacteria is about a million base pairs they use to make up
strands of DNA. If we compare that with a human being, we are
talking about one million to around three billion. Is that
correct?
Mr. Venter. Well, sir we have--if we count the genome
components from both our parents, we have six billion letters
in our genetic code. If you were looking under a microscope and
you could see the human chromosomes, the piece we just made
would be so small as to be invisible. So it is a gargantuan
leap from what we did to anything in human beings.
Mr. Waxman. So people who are worried about human beings
being created should relax. But meanwhile, this is a very
dramatic and important step and I want to ask you more about
the potential for this--for these technologies to improve
health and healthcare. We are always concerned about vaccines,
whether it is a vaccine for influenza or HIV. Let me just ask
you about the flu vaccine first. There have been problems with
using chicken eggs to make flu vaccine. It is a long, labor
intensive process and the flu virus is changing and it is hard
to keep up with it. Does your innovation add to the cell-based
technology for influenza vaccine production and what can you
project for us in the future there?
Mr. Venter. Yes, in fact, it provides a new front end for
the cell-based technology. So with these fragments that we are
going to be building with NIH funding, if as we saw with H1N1,
we are sequencing and tracking all these viruses, we can in 24
hours or less, with the hands of Dan Gibson sitting behind me,
reconstruct new vaccine candidates that could go immediately
into these cell systems for testing. So it would eliminate at
least three months, possibly more. But there are other
potential advantages because now we can synthesize so many
different pieces. Diseases that we have not been able to get
good vaccines against, such as HIV, such as the common cold,
because the virus mutates so quickly, at least the hypothetical
possibility exists to make sufficient antigen components to
cover a wide range in a single injection, perhaps just getting
a flu shot once a decade instead of once a year.
Mr. Waxman. Well, HIV is a major concern and Dr. Fauci and
I have been dealing with each other on that for decades now.
What--tell me more about your thinking of a possible vaccine
potential using this technology. How does it get us closer to
accomplishing that goal?
Mr. Venter. Well, I might defer to Dr. Fauci on that----
Mr. Waxman. OK.
Mr. Venter [continuing]. He is the world's expert on HIV
but I think the rapid mutation of the virus is what, from my
understanding, has made it--once you make a vaccine, the virus
just moves on beyond it.
Mr. Waxman. Dr. Fauci, you want to add anything here?
Dr. Fauci. Yes, it is a bit more complicated with HIV, Mr.
Chairman, because what Dr. Venter was describing for influenza
was being able to synthesize essentially all the possible prime
mutations of--you know, when we make an influenza vaccine, we
make it against mostly the hemagglutinin and that is how, you
know, H3N2, H2N1, H1N1, H stands for the hemagglutinin and if
you are able to synthesize fragments and get, just by
computational biology, you get all the possible prime
mutations, you can get a head start of having those things all
ready to go in a vector that you might use recombinant DNA
technology to get that off the shelf more rapidly because you
know what the antigen is in influenza. You don't need to
synthesize a whole genome. You could just synthesize all of the
possible components that you want the body to make an immune
response. So it could save time when you make the initial
assessment of what kind of vaccine you want and then you could
just jump right into it because you already have it in the
computer on the shelf. HIV is a different story because we
don't even know yet what the particular protein antigen or on
the envelope of that virus is that is going to induce
protection. But when we do, and as you mentioned, we have
testified a lot about the difficulties and that when we do, I
think some of the technologies might help in being able to get
an entire array of confirmations already predetermined by
synthesizing them. But it is not ready for that now because we
still don't know what the particular component of that virus
induces the immune response that we want.
Mr. Waxman. OK. Thank you very much. Mr. Barton.
Mr. Barton. Thank you, Mr. Chairman. I am not sure I am
competent to ask questions in this field. It is obviously a
huge intellectual challenge and a real accomplishment but the
non-biologic mind of mine, I am a little bit overwhelmed by it.
I will say though before I start asking questions and I kind of
like the traditional way of making human beings. It is fun and
it is recreational, therapeutic, and there are a lot of
positives and you have these little babies that you get to let
your wife raise. I mean, it is a fun thing. I am trying to
understand the significance of what has transpired. Dr. Venter,
what your group did, is there--you did something by create--
putting things together that in and of themselves had no life
but you were able to put them together so that there was life?
I mean, what is it that you have accomplished that was not
accomplished before you accomplished it? What is the, in
layman's terms, what has transpired that is a real leap
forward?
Mr. Venter. Well, let me first assure you we do not want to
replace any of those human processes. I am a fan of them
myself.
Mr. Barton. I am--we are of like mind on that.
Mr. Venter. So probably the best way to describe what we
did, it provides a new understanding of life. When we look at
these tiny microbial cells, any photographs of them, like
anything we see in life, look like a fixed entity. But what is
happening second to second is that genetic code is being read,
making new proteins. There is turnover of these proteins. So it
is a dynamic system constantly working. DNA is the software of
life. If you take out the genetic code, the cell dies very
quickly. That would happen to us as well. That is why radiation
damage is so damaging to us. If we put in new genetic code,
that cell starts reading the new genetic code, starts making
new proteins and converts that cell into another species. I
mean, it is the basis of life at the most dramatic level.
Mr. Barton. Well, what did you do differently or uniquely
that all these other gentlemen are patting you on the back for
and saying way to go? You did----
Mr. Venter. We started with the computer and wrote new
genetic codes, starting with four bottles of chemicals. So----
Mr. Barton. So you created that? I mean, you put together a
genetic code that didn't exist in life, in the real world?
Mr. Venter. It was largely copied off the living goat
pathogen but we modified it substantially. There are 46 names
written in the genetic code. It is the first species with its
own Web site built into its genetic code. There are some
quotations from literature and we eliminated the 14 genes
associated with pathogens----
Mr. Barton. And that had not been done before?
Mr. Venter. That has never been done before.
Mr. Barton. OK. And now that you have done it----
Mr. Venter. I actually did that in the cell, converting it
into a new cell. Now the only genetic code in that cell is this
synthetic molecule that we made and all the proteins, all the
characteristics of that cell are driven from this synthetic DNA
molecule. It is self-replicating. It is a real cell. It is not
an artificial cell----
Mr. Barton. But it is a cell that did not exist before----
Mr. Venter. That is correct.
Mr. Barton [continuing]. The new variety.
Mr. Venter The new variety is a great description.
Mr. Barton. OK. All right. Now what you did, is it
proprietary? Is it patentable or is it universal knowledge that
anybody can take advantage of?
Mr. Venter. It is all of those.
Mr. Barton. It is all of those.
Mr. Venter. We published our paper in the Journal of
Science. It is open in the scientific literature. Synthetics
genomics that funded this work has also filed for patent
applications on it. As you know, there has been a recent debate
about whether naturally occurring DNA is patentable. All that
goes back several decades to the Chakrabarty decision of the
Supreme Court, saying that life forms are patentable. This is
clearly the first life form totally developed out of a computer
and by humans, so it is much closer to a human invention.
Mr. Barton. OK. Now best case, what is the best thing in a
practical layman's understandable sense that could come out of
what you did? If you would--a cure for cancer--could a cure for
Alzheimer's, a cure for congressional ineptitude of solving the
budget deficit? I mean----
Mr. Venter. Now we are looking for miracles.
Mr. Barton. Well, why not? Why not?
Mr. Venter. So let me say in with the work of my
colleagues, as well, I liken this to the early days of the
electronics industry, where we have a number of design
components and I viewed now the 40 million genes, most of which
have been discovered by my institute, as design components for
the future and I do not think we can imagine all the
discoveries. Some of the students in Drew's classes come up
with amazing little circuits out of biology. I hope in terms of
our own work the immediate applications.
We are trying to do it synthetic genomics, is for example,
with Exxon, see if we can capture back substantial amounts of
carbon dioxide and convert it into new hydrocarbons that could
go into refinery to replace taking oil out of the ground. I
would be totally satisfied if that is our only accomplishment.
Mr. Barton. I know my time has expired but I want to ask
Dr. Fauci a question, if I could. What is the biggest ethical
challenge from a regulatory or a moral standpoint to what Dr.
Venter has discovered or accomplished?
Dr. Fauci. Well, at this point, when you are dealing with
microbes, I think the ethical challenge is probably in the
field mostly of safety and security that someone does not use
this technology in a nefarious manner. When you leapfrog ahead
and I think that the chairman asked a question and Dr. Venter
answered it appropriately, you are talking about a microbe. You
are not talking about creating the human being. But for the
present time, it is to make sure that the balance of benefit
for humanity in the areas that I mentioned in my testimony,
agriculture, medicine, energy, et cetera, clearly weigh very,
very heavily down and we do all the things appropriately and in
an iterative process, Mr. Barton, to look at implications and
that was the reason why the President himself, in his letter of
May 20, to the Commission on Bioethics said I want you to look
into this and in an open, transparent discussion figure out
what the implications of this might be.
Mr. Barton. OK. Well, thank you, panel and thank you, Mr.
Chairman. I do hope they discover a way to create a synthetic
genome that would predispose folks to vote Republican. If they
can work on that, I will support you funding that research to
try that on a practical application basis. Thank you.
Mr. Waxman. Thank you, Mr. Barton.
Mr. Pallone.
Mr. Pallone. Mr. Barton's comment there kind of intrigued
me because I think that you cannot really program somebody to
be political or not.
Mr. Barton. You can try.
Mr. Pallone. You can? All right. Well, whatever.
I wanted to follow up on Dr. Fauci. When you talk about the
nefarious aspect of this and obviously there is some concern
about that and you mentioned it in your testimony too, and of
course, we think about, you know, weapons of mass destruction
and you know, that type of thing. This committee oversees the
select agent program at the Centers for Disease Control, which
oversees the handling of many biological agents and the concern
is that the genetic instructions for these agents are not
themselves under the purview of this program. Nightmare
scenario, for example, is if someone orders parts of DNA for a
biological agent, such as smallpox from five--four to five
different DNA segment manufacturers, reassembles them, and
creates a weapon of mass destruction, how do we safeguard to
insure that that scenario doesn't develop?
Dr. Fauci. Thank you for that question. That is an
excellent question and in anticipation of the era of synthetic
biology, you know that the CDC, when someone wants to get a
select agent to work with, they have to go through some very,
very strict scrutiny, and as you appropriately pointed out, if
people can order from a company a genome segment, not the whole
organism, if they have the technological capability, they may
be able to theoretically put it together, though that is really
a stretch because we have Dr. Venter, who took years and years
and years to do that. But in any event, if they wanted to do
that, what has happened now is that the NSABB, that I mentioned
to you in one of the safeguards and the areas of review and
oversight, recommended to the Department of Health and Human
Services to have what is called a voluntary approach on the
part of the companies that make these segments. So you would
get on the phone and order I would like an X-length segment of
a particular sequence, that if it has to do with something that
could be related to a select agent, that the person would be
queried as to who you are, what your qualifications are, where
you work, what you intend to do with that. To develop a
consciousness of that, you don't want to be giving these
segments out to anybody. That has been put in the Federal
Register on November the 27th of 2009 for public comment and it
is in the process now of reviewing for what particular action
will be taken in that. So in anticipation of this, that has
been going on.
Mr. Pallone. Is there anything else that could be used to
safeguard against, you know, that scenario other than the
guidance that you mentioned? Are there any other precautions
that could be taken?
Dr. Fauci. You know, I--yes, but let me answer that
question, Mr. Pallone, in a way that I think some people get a
little bit confused about the balance between what can be done
good and what can be done bad. Right now, microbes themselves,
in their own evolutionary capacity to mutate, to change when
you try and treat, to have someone manipulate, without even
going near synthetic biology, the possibility of doing really
bad things exists. The bad guys are not going to listen to any
rules. They are going to do what they want. They do not even
need this technology. So this technology has a much greater
applicability to doing something really good because this type
of technology doesn't exist to do--for example, you have heard
of some of the things that could be done. There is not a
microbe out there saying you know what I am really waiting to
do, mutate myself so I could make billions of gallons of fuel.
But there are a lot of microbes that are already out there
mutating, that anybody can manipulate.
Mr. Pallone. So you are--if you know, again, I am trying to
understand you as best I can, you are saying that this new
technology really doesn't add much to the ability to do bad
stuff. It is----
Dr. Fauci. I----
Mr. Pallone. That is pretty much already out there.
Dr. Fauci. Overall, Mr. Pallone, the answer is I agree with
that statement. It adds much more to what can be done in a
positive sense than it pushes the envelope of what you can do
in the bad sense. Because there are already enough things
existing out there that if people with nefarious motives wanted
to do it, they could do it. They do not need synthetic biology
to do it.
Mr. Pallone. OK. Well, that is very valuable. Thank you.
Thank you, Mr. Chairman.
Mr. Waxman. Thank you, Mr. Pallone.
Mr. Pitts.
Mr. Pitts. Did he say me? Thank you, Mr. Chairman. Dr.
Fauci, did you say there are NIH guidelines that apply to
research on synthetic biology?
Dr. Fauci. Thank you for that question. Right now, the
current guidelines that emanate out of the RAC or the
Recombinant DNA Advisory Committee and the NSABB do not
currently involve synthetic biology. However, because of the
anticipation of what we are talking about here today, the
Recombinant DNA Advisory Committee put out for public comment
guidelines that they are proposing would apply to synthetic
biology.
Mr. Pitts. All right.
Dr. Fauci. That has been out for public comment. The
comments are in. They are being analyzed and we anticipate in
June of this year that the guidelines will be revised.
Mr. Pitts. And would these guidelines apply only to
institutions that accept federal funding?
Dr. Fauci. As with the Recombinant DNA Advisory Committee,
with regard to what you can do about it, mainly withdraw
federal funding, the stick part of that applies to
organizations that receive federal funding. But I want to
reiterate what I said in my opening statement, that the
guidelines of the Recombinant DNA Advisory Committee have
created in institutions not only in the United States, but
throughout the world, private industry or what have you, a
culture of responsibility so that even though the government
cannot withdraw funds, when people out there work with these
technologies, it is almost unheard of to not adhere to the
guidelines of the recombinant DNA technology. So over decades,
it has created what we call a culture of responsibility.
Mr. Pitts. But there are no other federal biosafety
guidelines that would apply to other people that use the
technology?
Dr. Fauci. There are guidelines that they use, but there is
no enforcement in the sense of a private industry deciding they
may want to do that. But we have now over three decades of
experience of the private industry adhering very, very closely
to the recombinant DNA guidelines.
Mr. Pitts. OK. Dr. Venter, now can synthetic genomes
replicate, did you say?
Mr. Venter. So the cell that I made or that our team made
is self-replicated and is replicated over a billion times----
Mr. Pitts. And----
Mr. Venter [continuing]. That is part of the definition of
life.
Mr. Pitts [continuing]. Is there the potential to replicate
a synthetic genome in a transplantable organ?
Mr. Venter. I am not sure I understand the question.
Mr. Pitts. You can--you can implant this into a
transplantable organ?
Mr. Venter. The cell that we made only grows in the
laboratory and in extremely rich media. This species was
initially confined to goats and occasionally to sheep as sort
of a commensal organism. It doesn't grow in human tissue and
with the modifications we made, we don't think it will grow
outside of the laboratory in any form. But we have not tested
it in animals yet.
Mr. Pitts. How far away do you think we are from that
scenario?
Mr. Venter. From the scenario of microbes growing in a
transplantable organ?
Mr. Pitts. Yes.
Mr. Venter. Well, one of the studies that was published in
the same issue of Science and Dr. Fauci referred to it of what
we doing with the microbiome project, you have 200 trillion
microbes on your body and in your body right now and you only
have a 100 trillion human cells. So it is pretty hard to get
any human tissue anything that is not contaminated with a wide
range of microbes. We live in a microbial environment.
Synthetic genomics offers nothing new there at all.
Mr. Pitts. OK. Now as far as the possible misuse of the
technology was raised using to create a disease or weapon of
mass destruction. What type of restraint is there in the
regulatory field or out there that would prevent that? Anyone
can respond.
Mr. Venter. I will defer to Dr. Fauci or somebody else.
Dr. Fauci. Yes, thank you for that question. I actually
went over it but I would happy to briefly review it.
There are guidelines for anyone who receives federal
funding that need to be adhered to from both a biosafety and
most recently, with the new boards that we have for biosecurity
and bio-assurity. The guidelines themselves are enforceable by
the withdrawal of federal funding. However, it has been our
uniform experience, that even those organizations that do not
take any federal funding, when they do work in the area of
recombinant DNA technology, and remember this synthetic biology
that we are talking about today is not a technique that is out
there for everyone to use. It took Dr. Venter many, many years
to get to the point where we are today is that even if you
stick just with recombinant DNA technology, that even those who
don't have the federal funding have over the decades uniformly
adhered to those guidelines.
If you talk about bad people wanting to do bad things,
guidelines don't stop them. So if someone wants to use the
technology that is available widely to try and engineer a
microbe to be resistant to a particular drug, they are going to
do that in a nefarious, secretive way that a guideline would
not at all have anything--any deterrence on that. So the issue
that we try to do is to make sure that since these technologies
can do so much good, to make sure that people don't
inadvertently, mistakenly, accidentally do something bad and
that is what the guidelines are for, for the people with the
expertise with the people who are trying to do very good things
with them don't inadvertently hurt themselves, others, or
create something that they wish they did not create. But when
you are talking about what kinds of--beyond guidelines, what
kind of enforcement do we have, the people who are going to
break that are not going to be out there publicly looking to be
enforced. It is going to be in a manner that is nefarious and
secretive.
Mr. Waxman. Thank you, Mr. Pitts.
Mr. Pitts. Thank you.
Mr. Waxman. Ms. Eshoo.
Ms. Eshoo. Mr. Chairman, thank you for holding this
hearing. We go to many hearings and some have a feeling of
drudgery to them and there are other adjectives that one--that
come to mind. This is really stunning and I am very, very
grateful to each one of you for being here today and what you
are doing is extraordinary. Thank you, Dr. Endy, for coming.
Dr. Endy is, as he said, is from Stanford University, which I
am so proud to represent. Lawrence Livermore is here. You
really represent, I think, the genius of the country in this
area and Dr. Fauci, you always honor us with your presence and
your knowledge. I can't help but think that in the 20th century
that it was marked by the advances that we made in the physical
sciences and that what you are presenting here today is that
the 21st century that America will be known or can be known for
the mark that we will make in the life sciences. So I thank you
for the work that you are doing. I think it is stunning. I
think it is hopeful and as I try to bring together, you know,
the whole issue of synthetics biology, in many ways, it is a
description of what goes on in my district because it is a
combination of the engineering of the high technology and the
biology and again, I think it is not only stunning, I think it
is exciting. What I would like to learn from you are what--how
far off some of the practical applications of this--of
synthetic biology is. The committee has spent some time, of
course, we were--spent a lot of time on H1N1 and how it would
be handled and the whole issue of--you know, the problems of
using chicken eggs and the time that, you know, that the
process is long and labor intensive. So we worked hard to
ensure the development of the cell-based alternatives that
would then be used to reduce production time by weeks. So Dr.
Venter, I would like to know from you or maybe you can help us
by answering the following question. How does your innovation
add to these cell-based technologies for influenza vaccine
production?
Mr. Venter. Well, thank you very much for your question and
your kind comments.
Ms. Eshoo. Thank you.
Mr. Venter. It is an exciting time in this field. So the
ability to now write the genetic code, to actually build DNA
fragments and put them together to make larger pieces gives us
the ability to reconstitute small things, like the influenza
virus, very quickly. So as Dr. Fauci said, with H1N1, there was
a variation and the H and the N genes that created a new
biological response, we think with these new techniques in less
than 24 hours if, as soon as a new virus was detected, we could
have new candidates out there that could go into, for example,
the new facility that Novartis has built, based on cell lines
to much more rapidly and reproducibly produce vaccines that we
are in the process of testing that this year and if it is
successful, the flu vaccine you get next year could be a result
of these new technologies.
Ms. Eshoo. That is exciting. I wish I had an hour to ask
you questions but let me ask this of the entire panel, and that
is, what recommendations do you have to the Congress on what we
should be doing to facilitate the use of synthetic biology in
the development of innovative and affordable drugs?
Mr. Venter. Well, if I can start, I think it is an
excellent question. As I said, we probably can't even imagine
all the ideas. When I talk to students, I tell them we are
primarily limited now by our imaginations. We need to make sure
that is a primary limitation as our imaginations develop in
these new areas going forward. I think it is a very exciting
time that could influence almost every aspect of human life and
we want to drive that forward. We want to prevent frivolous
uses. It would be tragic if somebody could call in to one of
these companies and order Ebola virus via the--just to
inadvertently make something to cause trouble and I think the
guidelines coming out of NIH are a great step in the direction
to prohibit these frivolous uses. So----
Mr. Keasling. I would like to put a plug in for basic
science and foundation of research so a lot of the technologies
that we have developed in the applications are based on basic
science and funding for basic science. So it continued funding
for basic science, I think is an important step in supporting
synthetic biology. I would also like to compare and contrast
the ease of funding research that is application based versus
foundational based. A lot of my work is application based so it
was relatively easy to get funding for production of biofuels
or for production even of an antimalarial drug for Bill and
Melinda Gates Foundation. Much more difficult is to get funding
for foundational work, such as the funding we are getting from
the National Science Foundation for the Synthetic Biology and
Engineering Research Center. This allows us to develop the
tools and the technologies so that they are available to any
number of problems that might come up. So funding for
foundational research, I think, is incredibly important.
Ms. Eshoo. Thank you.
Mr. Kaebnick. I wonder if you could imagine a hearing
around 1952 with John von Neumann and his team of early
computer engineers and asking the same sorts of questions. What
should we be doing now to fund the applications in computing
that will lead to Silicon Valley? So let us move to today.
Well, what should we be doing now to fund the future of Silicon
Valley, which might also become known as Carbon, Nitrous, and
Phosphorus Valley, the elements that comprise life? And it is
not, as Dr. Keasling and Venter are saying, only driven by the
applications. It is the investment in the basic tools.
Let me give you one very specific example. Consider the
manufacturing of silicon wafers, upon which microprocessors are
built. Think of the public and private investments over
decades, just in getting better at building silicon wafers and
how the entire computing and information technology industries
are based upon those foundational investments.
Now let us consider synthetic biology. All of synthetic
biology genomics depends on being able to synthesize and
construct genetic material, the information and coding molecule
that defines life. What is our national strategic initiative at
getting better at building DNA? We don't have one. Arguably,
you could make the case that genetic material is at least as
important as doped silicon going into a computer. So one
specific recommendation I add to just basic funding is to look
at core strategic priorities that could define the tool kit,
powering the next generation of biotechnology, such as a
national strategic DNA synthesis and construction initiative.
Ms. Eshoo. Thank you very much.
Dr. Fauci. Well, thank you for that question, Ms. Eshoo. I
would think the committee, at least from a historical
standpoint, has been extraordinarily supportive of what we do
at NIH. I have testified before this committee many times and
its subcommittees and the only thing I ask of you is to
continue to do what you do. We will be transparent with you. Do
not overregulate something that needs care and responsibility
and integrity and work with us in making sure we lay the
foundation that that transparency, integrity and responsibility
are there. We will try our best but we really rely very much on
your support that you have given us over so many years. So
thank you for that.
Ms. Eshoo. Thank you.
Mr. Waxman. Thank you, Ms. Eshoo.
Ms. Eshoo. Thank you for each of you--thank you, Mr.
Chairman.
Mr. Waxman. Dr. Burgess.
Mr. Burgess. Thank you, Mr. Chairman. While there is so
many places to go, Dr. Venter, let me just ask you. I think the
question that Mr. Pitts was trying to pose to you is would it
be possible utilizing your techniques to grow a new pancreas or
a pancreatic cell that then could be given to a person with
diabetes?
Mr. Venter. Well, thank you for the question. I am sorry I
did not understand that.
Mr. Burgess. Well, perhaps not that specifically but, as an
end--as a goal, with your basic science applied to say the
treatment of diabetes, would it be possible to bioengineer, for
you to build the software, the lab, that would create a cell
that could produce insulin when it was given to a person and
have it perhaps reside at their liver and take over the
function of a failed pancreas?
Mr. Venter. Well, it is an excellent question. In fact, the
production of insulin was one of the very first biotech
products, once these early techniques were developed at
Stanford and University of California, San Francisco, to start
producing human insulin genetically. People are working on a
variety of genetic circuits to see if small units could be
built, where you would have the appropriate regulation. People
have been doing this electronically. I think this opens the
avenue to do genetically.
Mr. Burgess. Well, correct, because then you have all of
the cellular mediators of insulin response and you wouldn't
have to rely upon some of sort outside electronic mediated
response if you could actually grow a pancreatic with the
antigenicity that would duplicate the person who was receiving
it.
Mr. Venter. But make--let me make it clear. It is not
growing a pancreatic cell. It would be making a small circuit
that could work maybe within one of those cells----
Mr. Burgess. Well, let me ask you this----
Mr. Venter [continuing]. They are so many decades, maybe
centuries away from reproducing a human cell----
Mr. Burgess. Now wait a minute. Fifteen years ago, in 1995,
if someone said how long will it take you to get your computer
to make a goat virus with your name and address imprinted into
it and all the pathogens removed, what would you have estimated
as the timeline there?
Mr. Venter. I actually thought it was going to be a whole
lot faster. We feel bad it has taken us so long.
Mr. Burgess. Well, I do too then. We will rescind the
funding then. On the----
Mr. Venter. It was privately funded then.
Mr. Burgess. Let me--and that is an excellent point and I--
--
Mr. Venter. We got your goat.
Mr. Burgess. I wish Ms. Eshoo was still here. The--what you
guys are capable of doing with private funding, without
government interference, I mean, I shudder to think what
computers would look like if we had been in charge of
developing those silicon wafers but that is a separate story.
On the issue and I don't know whether to ask this of Dr. Venter
of Dr. Fauci, but on the issue of the nefarious activities that
might occur, but so much of what I have seen in Congress, we
don't actually choose to be nefarious but our uneducated
consequences are sometimes extremely pernicious. What if we
created the artificial life form, the viral equivalent of the
zebra mussel, for example, not particularly pernicious in and
of itself, but because it replicates so fast and it is so
invasive and tenacious that it clogs up waterways and this sort
of thing, what do we have to protect us from say the unintended
consequence of one of these experiments gone wild?
Mr. Venter. It is an excellent question and it is one of
the top two questions I get when I am speaking about this topic
around the world. People are worried about the unintended
environmental consequences and we have now close to a 40 year
history with molecular biology, with scientists such as
ourselves putting genes from almost every species in the
bacteria E. coli in the laboratory, with no unintended
consequences and the reason for that is that bacteria is
designed where it can't survive outside of the laboratory. We
have argued this as a key tenet for this new field. We need to
design into future genomes the ability to have suicide genes--
--
Mr. Burgess. Well, I was going to ask you do you have a
killswitch that you designed into it or a blowup protector if I
could sure that term.
Mr. Venter [continuing]. The variety of these to do that
exactly. In fact, the exciting part of this is we can now use
artificial amino acids so that these organisms could grow only
in a very well chemically defined environment and never survive
in the environment and I think these are very important aspects
of this whole field, that we and others have been pushing for
from the beginning. If we are going to make a synthetic algae,
about 40 percent of the oxygen that you and I are breathing
right now comes from these algae in the ocean. We don't want to
mess up that process.
Mr. Burgess. Right, we don't want to compete with them. You
are correct. Dr. Fauci, last August, you were good enough to
talk to me about the following months might hold with the H1N1
virus and not having a vaccine at that point and how to advise
people were taking care of patients who might be pregnant and
teach schoolchildren. The ability to deliver that vaccine eight
weeks earlier because of this type of technique, that would
have been significant last August. Would it not?
Dr. Fauci. Absolutely. As you know from our painful
experience that we, at the peak of the time that the virus was
at its worst, we were still essentially waiting for the full
component of the vaccine. So if we had had an eight week more
lead time that the availability of the vaccine would have
coincided with the demand, we had a dichotomy between demand
and supply that would have actually eliminated that gap.
Mr. Burgess. Right, as we bore down on the beginning of a
school year, which obviously was going to throw another wrinkle
into that. Now you brought up and you really didn't expound
upon it but----
Mr. Waxman. Dr. Burgess, we are going to have votes in
around 15 minutes. I wanted to----
Mr. Burgess. OK. I would point out to the chairman that
other members of Congress have been allowed considerable----
Mr. Waxman. No, you are absolutely right that we won't have
time for everybody.
Mr. Burgess. But this is an important question. It deals
with oversight----
Mr. Waxman. Please ask it.
Mr. Burgess [continuing]. And we did swear the witnesses
in.
Dr. Fauci, you brought up the issue of reviews and
oversight of the synthetic--as we enter the synthetic era and
perhaps you can respond to this in writing offline if it would
be helpful, but would you give us the benefit of your wisdom on
the direction that oversight of this committee should take in
the synthetic era?
Dr. Fauci. I would be happy to do that in writing but as I
mentioned, I think the kind of support that you have given for
the oversight mechanisms that we have already been put in place
and you are now updating and upgrading the guidelines that are
out for public comment, that have come back now to incorporate
the synthetic biology aspect of it.
Mr. Burgess. Would you----
Mr. Waxman. Mr.--Dr. Burgess----
Mr. Burgess [continuing]. Perhaps come before us and talk
about that at length?
Mr. Waxman [continuing]. It really is not fair to the
others because we will have to refuse any time to the junior
members and it would not really be fair. Probably will end up
on your side. Ms. Castor.
Ms. Castor. Thank you, Mr. Chairman Waxman, for calling
this very interesting hearing. I would like to thank all of you
for your testimony. The work you are doing is fascinating and
it is important and it is obviously that synthetic biology
holds such great promise for Americans, whether it is medicine
and health or energy, or the environment.
Dr. Keasling, I would like to ask you some questions. This
committee has been working very hard on clean energy
technologies and it is our challenge is to make energy clean
and affordable and this--and BP's deep water horizon oil
disaster has been forced on us really highlights the need for
our country to focus on clean energy technologies. I understand
that Amyris, a company you founded, used synthetic biology to
develop a promising method for reaching these goals using--by
producing diesel from sugar cane.
Mr. Keasling. That is correct.
Ms. Castor. Could you tell me how this process works? What
advantage did synthetic biology provide in producing this
biodiesel that conventional technologies could not?
Mr. Keasling. Right, thanks for that question. So it is a
very simple process. The yeast that we have engineered consumes
sugar and turns it into a diesel fuel that the yeast pumps out
of the cell and it floats to the top and you skim it off. The
way this technology or what enables this is that we took the
genes that encode enzymes that would transform the sugar into
the fuels. So we take these genes from various different
organisms and we put them into brewer's yeast. In fact, we put
them into industrial strains of yeast that have been widely
used for many decades, so these are safe organisms and the
process is very much akin to brewing beer. Now what is so great
about this fuel that you get out is that it is extremely clean.
It reduces greenhouse gas emission by about 80 percent because
it is derived from sugar, which comes from sugar cane and that
uses carbon dioxide and sunlight to fix that carbon dioxide and
it is very environmentally friendly. It has been certified by
the U.S. EPA and it is a very clean fuel. What is more is it
actually gives extremely good fuel mileage on a gallon of this
renewable energy when it is used even pure in the diesel tanks.
Ms. Castor. Are you going to be able to take the next step
to jet fuel or----
Mr. Keasling. That is right.
Ms. Castor [continuing]. Smart gasoline?
Mr. Keasling. In fact, we are working quite extensively on
that now, Amyris and at the Joint BioEnergy Institute, using
the same synthetic biology techniques to now engineer yeast and
E. coli to produce jet fuels.
Ms. Castor. And how does it compare to the current diesel
fuel that is already available and how well does it work in
trucks or other equipment?
Mr. Keasling. And so we have done extensive testing of this
fuel with manufacturers of engines. So Cummins, for instance,
has done extensive testing of this fuel and many other
manufacturers. We now have alliances with airplane
manufacturers and engine manufacturers for airplanes so that we
can test these new generation of jet fuels in those engines.
Ms. Castor. Is it affordable yet?
Mr. Keasling. We project that when we are up to the yields
we need to be, we can produce this for under $4 a gallon and of
course, affordability also depends on the competition and so
right now that would be nearly affordable.
Ms. Castor. Now your production process right now, it is
not really--you are doing a lot currently. It is not just a
long term goal but you are doing this in Brazil.
Mr. Keasling. That is correct.
Ms. Castor. Why not--why Brazil and why not the U.S.?
Mr. Keasling. Brazil has some of the cheapest sources of
sugar. They also have an infrastructure that is built for
producing fuels. Currently, they are producing ethanol. Ethanol
is obviously not the best fuel and it can't be used in diesel
engines. We can use very similar processes and we are, in fact,
refitting those microbes that would normally produce that
ethanol to now produce diesel fuel. So we are down
manufacture--building facilities that will now manufacture this
fuel. But Amyris and the Joint BioEnergy Institute hope that we
can do this in the U.S. in the very near term. The way we are
starting with this, at least from Amyris' perspective, is by
going into Alabama and other states in the south where sugar
cane can be grown and doing tests on this and in fact, there is
an alliance now in Alabama with the U.S. Air Force to try to
study the production of jet fuels.
Eventually, through the technologies that we are developing
in the Joint BioEnergy Institute, we will be able to use our
plentiful sources of cellulosic biomass, which is primarily
sugar and turn that sugar into the same types of fuels.
Ms. Castor. Thank you very much.
Mr. Waxman. Thank you, Ms. Castor. Mr. Gingrey.
Mr. Gingrey. Mr. Chairman, thank you. I have heard some
discussion about how you can in the laboratory in this new
technique, synthetic biology, produce genes and even entire
genome and then there was some discussion of course about H1N1
and the rapid production of vaccine against that virus and it
made me think to ask this question and in fact, I will--I don't
know who to ask it of. Maybe you should go in the order of your
SAT scores but actually, I will probably ask Dr. Fauci to
begin.
Mr. Waxman. Maybe we should recognize members on that.
Mr. Gingrey. Well, I may be the last one to speak, Mr.
Chairman. But the idea of knowing what is in, let us say, a
virus from the DNA perspective, is that more difficult now than
being able to take these four thiamine, adenosine, guynime,
cytosine, whatever these amino acid payers and be able to put
together and form a gene or in fact, in some instances, form a
complete genome? But to be able to do that, you really need to
know what you are trying to produce.
Dr. Fauci. Right.
Mr. Gingrey. How difficult is it, Dr. Fauci, and I will ask
you first, to know really what is--once you have isolated a
virus, is that the tough part?
Dr. Fauci. Right.
Mr. Gingrey. Knowing exactly, you know, the multiple chains
and----
Dr. Fauci. That is really easy. If you get the naturally
occurring virus and you sequence it, you are reading the
blueprint of nature. If you want to then sequence components of
that, different genes, it is relatively easy now by common
techniques to sequence little genome fragments. You could then
take those and stick it into something that will code it to
make that protein very easily. The difficulty that was had
until now and it is still difficult but before what we are
talking about is to take an entire genome of a much bigger
length than a little snippet, and to synthesize it based on the
blueprint that you see in the computer that was a result of
your sequencing it, which was really easy. It was difficult a
long time ago but it is really easy right now.
So the microbe that Dr. Venter and I will certainly leave
it to him to explain more, that he synthesized was on the basis
of a blueprint that nature already told us what that blueprint
is. Sometimes when you sequence, there are some mistakes.
Unfortunately, for Dr. Venter, there were a couple of mistakes
in that sequence that actually lost him a few months, if not
longer, but if you get the sequence right, you can then
synthesize fragments but now you can synthesize the who thing
and take it and stick it in another bacteria, get rid of its
resident genes, and let this new synthetic one start coding.
The real challenge is going to be if you want to do
something that is entirely new, is how do you put together the
circuitry from gene to gene to do something that nature hasn't
been your teacher, hasn't told you how to do it because when
you have the sequence, nature has already told you what the
right sequence is. You just need to synthesize it. The
challenge is that the field is going to be facing is that how
do you get those new circuits, and there are a lot of people
working on these little circuitries, to figure out how you can
then make the optimal organism to do optimally with what the
panel members were talking about.
Mr. Gingrey. Dr. Fauci, thank you and the minute that I
have left, maybe one of the other panelists would also like to
comment or elaborate on that same question.
Mr. Venter. I don't think I can improve on Dr. Fauci's
answer.
Mr. Gingrey. Anybody else.
Well, that is great, Mr. Chairman. In the interest of time
and my other colleagues, I will yield back the 44 seconds.
Thank you very much, Dr. Fauci.
Mr. Waxman. Thank you, Dr. Gingrey, for being so generous.
Mr. Gordon.
Mr. Gordon. Thank you, Mr. Chairman. I want to--I will
probably be brief in just echoing Anna's earlier comments about
thanks for you bringing this hearing together and about
synthetic biology clearly is going to be a major frontier for
the 21st century and you are already pioneers in that and we
are glad that you are here. We need to continue this
conversation and I think the country that is going to lead in
innovation of synthetic biology is the one that is going to
lead the world in creating jobs, creating wealth for its
people, and there is going to have to be a federal partnership
in some ways for that early R&D. Other countries are doing it.
We are going to have to do it here and we are doing it.
As a matter of fact, Dr. Venter through the Department of
Energy, got some of his early funding that way and as a matter
of fact, in this new America Competes Act that we are in the
process of dealing with now, within the Office of Science and
the Department of Energy, we are requiring them to develop a
plan on how synthetic biology research can be focused on their
mission in terms of energy security and environmental cleanup
and those sorts of things, which also indicates that there are
different pots of money around the federal government doing
work here.
Just like we found in nano research, there are 25 different
federal agencies dealing with nano, 15 of them providing some
resources. So through the National Nanotechnology Initiative,
we put up an umbrella to coordinate that. Just last year, we
did the same thing with solar, with water, with stem education.
So my question is, should we have some type of a coordinating
counsel within the federal government to coordinate the funding
in synthetic biology and within that, should there also not
mandates, but maybe, and not picking winners or losers, but
taking some areas of emphasis? So that will be my first
question and then I will follow that on something similar.
Anyone wants--Dr. Venter.
Mr. Venter. Thank you for your comments and your question.
I agree with you. I think this technology has a chance to be
one of the most important----
Mr. Gordon. Oh yes, yes.
Mr. Venter [continuing]. Economic drivers for the future.
Mr. Gordon. Sure.
Mr. Venter. And the only thing I think would be tragic for
this country is for something, you know, quite dramatic not to
happen with federal funding. Federal funding seems to follow
innovations in my view. It seldom leads them. This is a chance
to change that as we drive the kind of tools that----
Mr. Gordon. But should we have some kind of a coordinating
agency within the federal government, coordinating where the
various areas, where NIH, where DOE or other places that are
doing research on synthetic biology?
Mr. Venter. I would defer to others. I am not sure I am
qualified to comment on that, whether that would be good or
bad.
Mr. Endy. Very good question, if I could just offer a
perspective. One of the characteristics of synthetic biology is
just bringing researchers and others together from very
different backgrounds and it would strike me as a wonderful
opportunity to create some guiding framework or a leading
umbrella that would provide the venue for which engineers and
scientists, ethicists and others could come together. So, for
example, we have a lot to learn from not just electrical
engineering and chemical engineering but every type of
engineering. We need the benefit of experts at places like
NIST, combined with the expertise at NIH and NSF and DOE and
everywhere else. And so how are we going to bring those folks
together and then bring them together with the emphasis to help
us make best decisions upstream of the work as we have done an
oK job with in getting started but now need to scale. So I am
very positively responsive to the question.
Mr. Gordon. Well, is anybody who is not and, you know, I
think we will--I want to try to follow up on that. The other
part of that, going back to the earlier discussion about the
semiconductor industry and you know, there are--we lead the
world in semiconductor production. Eighty percent of our
production goes oversees and 75 percent of the jobs and the
money stays here in this country and so I think--and a lot of
that was from this somatic, the earlier partnership between the
federal government and the industry. So one, we could say maybe
this coordinating body. Should we also look at that somatic
model and see if there should be some--a partnership is created
with public dollars, private dollars, and if so, how would you
see that being structured?
Mr. Endy. The short answer is yes. I think the question
about how to best structure it deserves some good thought.
If you look at the last 35 years of biotechnology, there
hasn't been a tremendous, although at the research level, there
has been a tremendous amount of sharing and cooperation. In
terms of translating that into commercialization, there is not
always as much of that as you might hope to see. So one of the
lessons we might take from the emergence of other technology
platforms is to create a mixture of partnerships that support,
among other things, open technology platforms. Going further
than that, I think it really would, at this point, be worth
serious consideration and follow up to figure out the best ways
to structure things and I don't know that it is going to be a
naive one to one mapping of past experiences that worked in
other fields. I think biology and the technology built upon
biology is new in many ways. So we got to sort it out.
Mr. Gordon. And can the industry--obviously, there are
proprietary advantages that folks want but are there some
breakthrough areas that everybody needs and that would we want
to focus on, you know, on some breakthroughs?
Dr. Fauci. I would----
Mr. Gordon. Dr. Venter, take it on over to any of you. To
get it into the private sector, do you need some kind of
fundamental breakthrough?
Mr. Venter. And I get some excellent questions so the
million based pair genome we made cost us a little over
$800,000, just for the chemicals to make it. DNA synthesis is
followed well behind our ability to read the genetic code.
Your--from how 10 years ago, it cost the taxpayers over three
billion dollars to get one of the two first drafts of the human
genome. The technology is now enabling that to happen for maybe
on the order of $10,000. If we get the same order of magnitude
changes and possibly this year it will go down in order of
magnitude, but will really drive it is if DNA synthesis becomes
really cheap and there has not been a lot driving that in the
recent future. That would be one avenue.
Mr. Gordon. OK.
Mr. Waxman. Thank you, Mr. Gordon. Dr. Griffith.
Dr. Griffith. Thank you, Mr. Chairman. I appreciate you
calling this. This is extremely interesting to me and I heard
Alabama mentioned and that is my state and my district is five
and I am the home of a HudsonAlpha Institute and Rick Myers and
his team and I can't tell you how nice it is to have you here.
We understand how important this is, as an oncologist and
certainly, as you are basic scientists and funding, as
Congressman Gordon is pointing out, we need to bring our public
along, as far as education is concerned. This is mysterious to
them, sometimes frightening. It sometimes goes to our culture
and we are not sure what we are doing with DNA and recombinant
DNA.
The public needs to be brought to speed on this whole area
of genomics, which they are not now and so we, in Alabama, or
the HudsonAlpha Institute has put together an educational
program where we have reached over 60,000 students and 2,500
educators. We have an application on the iPod for iCell and I
think when we go to the public to ask for funding, I think it
is important that we begin it in the grammar schools and that
someone mentioned Silicon Valley and how important it was that
this is our next Silicon Valley.
In order for us to fund it and have it accepted into our
culture, we need to start educating our young men and women who
are in grammar school about the importance of a cell and the
cellular anatomy and the things that are going on because what
we are really doing, I think, is going back to basics. We are
finally able to get to the basics of the cell, knowledge that
was not even known when I was being trained as an oncologist.
So is there, in your institutions, an educational arm for the
layperson? We have started that in Alabama and it is exciting
for the students and I was just wondering is that occurring in
other areas as well?
Mr. Venter. If I may go first, that is an excellent
question and I appreciate it very much.
There is probably in my entire career nothing that I have
seen that gets young people excited more than the notion of
combining the digital world with the biological world. I think
they are our number one fans in this area. My institute, The
Venter Institute, has a public education program. We have a bus
that was initially paid for with NIH funds. It is a research
laboratory that goes to the middle schools in the Washington
Baltimore area. My understanding of education if we don't catch
students at that age, they get lost once they are in high
school. But expanding such programs, I think, would be a huge
part of this, to capture this excitement and make sure we are
the number one nation in this field going forward.
Dr. Griffith. Thank you. Yes, sir.
Mr. Keasling. So through our funding from the National
Science Foundation for the Synthetic Biology Engineering
Research Center, we actually spent a great deal of time working
with K12 students to try to get them into education, to try to
understand science, basic science, but also the engineering of
biology. We fund part if the iGem competition that Dr. Endy
talked about. We have a new program where we bring in at risk
high school students, students that wouldn't normally go to
college and get them involved in synthetic biology in summer
periods and we have a great record, all of them going off to
college after that period.
Dr. Griffith. Fabulous. Thank you very much. Yield back,
Mr. Chairman.
Mr. Waxman. Thank you, Dr. Griffith. Mr. Markey.
Mr. Markey. Thank you, Mr. Chairman, very much. I have a
cold so I am trying to quarantine myself down here and
hopefully this will lead to the discovery of the cure for the
common cold. That would be the biggest breakthrough we could
make.
Dr. Venter, I know that you want to potentially use these
breakthroughs as a way of taking carbon and taking and making
it not this terrible thing that is warming the planet but
something that is positive. It can be used in constructive ways
in our society. Could you tell us a little bit about how you
dream, envision these breakthroughs leading to that
possibility?
Mr. Venter. Thank you very much for the question. People
have talked--in fact, Al Gore has talked about carbon based
fuels being the problem. In my view, they are not the problem.
It is the source of the carbon that is the problem. If the
carbon comes from CO2 or indirectly, as Dr. Keasling has said,
through sugar, we have a chance to capture back CO2 that is
being produced when we take new carbon out of the ground. There
is not existing biology there would be no reason to have
organisms involved to do this and pump lots of hydrocarbons. So
we need these new tools of modern molecular biology and
synthetic biology to get cells to be much more productive, to
get to the billion gallon per facility level that is required.
So we think this will help take us there.
Mr. Markey. Chairman Waxman and I, last year, out of this
committee, we moved the piece of legislation that helped to put
a price on carbon and to move to its new technological
breakthroughs in this area. Do you think that that is the right
direction for us to be heading in?
Mr. Venter. I think it is personally one of the most
important aspects that Congress can do going forward. If we are
successful and I expect that Dr. Keasling will be and we will
be as well, we will start to have replacements for oil, which
could drive the cost of oil down. If the cost of carbon doesn't
go up in a stepwise component, we will constantly drive
ourselves out of business by making oil cheaper.
Mr. Markey. But ultimately, you do believe that we can
innovate our way out of the problem as long as we give the
proper incentives for these new technological breakthroughs
flourish in a short period of time.
Mr. Venter. I am an optimist and a scientist and we have
been--I think these new tools are remarkable tools. Also as a
scientist though, I view we actually have to prove that so I
think the promise is there. We actually have to be able to
prove that potential.
Mr. Markey. How long would it take for you to do this kind
of a thing and how much would it cost, that is to make this
transformational breakthrough that turns carbon into a positive
rather than a negative?
Mr. Venter. As we announced last summer, our program with
Exxon Mobil, they are putting up 600 million dollars for this
initial stage of funding. Three hundred they are using
internally for their engineering and 300 to synthetic genomics
to try and develop the biology to make this possible. We are
talking about facilities potentially the size of San Francisco.
These have to be extremely robust things. Our optimistic
estimates, it is going to be a decade before there are
substantial replacement for gasoline and diesel fuel that is
made from CO2 in the gas pumps.
Dr. Fauci. I should mention that----
Mr. Markey. I should mention that my time is going run out.
Dr. Fauci, the notion of synthetically created DNA conjures up
images of the classic science fiction movie, Bladerunner, where
Harrison Ford hunts down synthetically created humans in a
smog-bound Los Angeles dystopia set in 2019. Now we are not
confronted with that scientific reality right now.
There is a difference between producing a synthetic microbe
or bacteria in a more complex organism. But it does raise the
question of who plays God and perhaps you could tell us what
kind of discussions or programs you have that help to discuss
the ethical ramifications of the beginning of this process that
we are now walking down in this new pathway?
Dr. Fauci. Thank you for that question, Mr. Markey. Myself,
as a scientist, my view of what I am seeing right here now is
to emphasize what you yourself said. We are talking about a
microbe, a bacteria with a one million base pair, not a three
billion base pair. That is the first thing. The second thing is
appropriately, the president himself has, in a letter of May 20
of this year, written to the Commission on Bioethics Panel and
he has asked them to review this from a variety of ethical and
other issues to lay some report back to him within six months
as to what we feel we need to do to examine this very important
question that I am sure a lot of people are going to be asking.
So we are already on that. The mandate to the Commission has
already been given by the president.
Mr. Markey. And I thank you so much for that answer,
Doctor. That bioethics panel was established after an
investigation I conducted of human experimentation, the
government using radioactive materials on human beings and that
was 1993 and I do think it is important for us to stay current
and have this ongoing discussion, while at the same time
recognizing that there are tremendous positive aspects to this.
So much so that the Vatican actually called this a very
interesting breakthrough because there are many positive
aspects to the breakthroughs that Dr. Venter and the others are
making at this time. So I thank you, Mr. Chairman.
Mr. Waxman. Thank you very much, Mr. Markey. The Chair
would like to ask unanimous consent that a letter from the ETC
Group, Friends of the Earth, and the International Center for
Technology Assessment be included in the record. Without
objection, that would be the order.
[The information appears at the conclusion of the hearing.]
Mr. Waxman. All right. I want to thank you for being here
and giving your presentation to us. We are at the dawn of a new
age of science and the breakthroughs described today have the
potential to some of the most challenging problems we face,
including global warming and global pandemics, but like any new
scientific breakthrough, it is important it be used with
appropriate guidelines and we will continue to monitor your
progress and continue our oversight and also to be available to
you to help in any way to assist you as you go forward. Thank
you very much for being here.
We will--without objection, we will leave the record open
and members may submit written questions and have a response in
writing for the record. That concludes our hearing. We stand
adjourned.
[Whereupon, at 12:04 p.m., the Committee was adjourned.]
[Material submitted for inclusion in the record follows:]
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