[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


      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov




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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

                              ----------                              
                                                                   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:]
    [GRAPHIC] [TIFF OMITTED] 76582A.003
    
    [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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