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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 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MIKE DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JANICE D. SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

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 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOHN B. SHADEGG, Arizona 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

PARKER GRIFFITH, Alabama 

ROBERT E. LATTA, Ohio 


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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 


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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? 


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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:] 


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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 selfreplicating 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. 


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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. 


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While most research involves one celled organisms, like bacteria or 

yeast, the results are far reaching. For example, in 1982, the FDA 

approved human insulin from a gene inserted into yeast cells. Genetic engineering has been used to make human growth hormone, 

hepatitis vaccine, and other products and as we will hear, newer 

methods are already leading to important medical applications. 

Synthetic biology also has a potential to reduce our dependence on 

oil and to address climate change. Research is underway to develop 

microbes that would produce oil, giving us a renewable fuel that 

could be used interchangeably with gasoline, without creating more 

global warming pollution. Research can also lead to oil eating microbes, an application that, as the Gulf spill unfortunately demonstrates, would be extremely useful. The promise of synthetic biology does not diminish the importance of it being conducted and applied responsibly, as is true whenever science advances. 

We must weigh and manage the safety, health, and environmental risks posed by this evolving science. Fortunately, this assessment can build on existing regulatory frameworks and I am 

pleased to see that President Obama has just asked his bioethics 

commission to conduct a thorough analysis of these issues. I look 

forward to hearing more today from three leaders in the field of 

synthetic biology, Dr. Craig Venter, Dr. Jay Keasling, and Dr. 

Drew Endy. They will explain their work and its current and potential applications. 

Dr. Kaebnick of The Hastings Center will offer a framework for 

discussing the ethical questions related to synthetic biology, questions about risk, and also about fundamental beliefs about life and 

we also look forward, as always, to learning from Dr. Fauci on 

NIH’s role in synthetic biology and how the agency’s current approach can adapt to advances in the science. Before we call on our 

witnesses, I want to recognize the ranking member of the committee, Mr. Barton, for opening statement. 

[The prepared statement of Mr. Waxman follows:] 


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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. 


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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 adVerDate Mar 15 2010 05:01 Feb 09, 2013 Jkt 076582 PO 00000 Frm 00017 Fmt 6633 Sfmt 6633 E:\HR\OC\A582.XXX A582

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vantage 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 


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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. 


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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 synVerDate Mar 15 2010 05:01 Feb 09, 2013 Jkt 076582 PO 00000 Frm 00020 Fmt 6633 Sfmt 6633 E:\HR\OC\A582.XXX A582

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thetic 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 


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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 


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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 ammoniabased 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 


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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 


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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 


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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 


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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 cellbased 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 


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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 


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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 selfreplicating. 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 


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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. 


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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 


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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. 


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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 deterVerDate Mar 15 2010 05:01 Feb 09, 2013 Jkt 076582 PO 00000 Frm 00106 Fmt 6633 Sfmt 6633 E:\HR\OC\A582.XXX A582

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rence 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 


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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 


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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 


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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 


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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 imporVerDate Mar 15 2010 05:01 Feb 09, 2013 Jkt 076582 PO 00000 Frm 00111 Fmt 6633 Sfmt 6633 E:\HR\OC\A582.XXX A582

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tant 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, 


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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, 


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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 

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ment 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 


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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 someVerDate Mar 15 2010 05:01 Feb 09, 2013 Jkt 076582 PO 00000 Frm 00116 Fmt 6633 Sfmt 6633 E:\HR\OC\A582.XXX A582

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times 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. 


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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—— 


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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. 


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[Whereupon, at 12:04 p.m., the Committee was adjourned.] 

[Material submitted for inclusion in the record follows:] 


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